Health Evidence Review Commission

January 16, 2020 1:30 PM - 4:30 PM

Clackamas Community College Wilsonville Training Center, Room 111-112 29373 SW Town Center Loop E, Wilsonville, Oregon, 97070

Section 1.0 Call to Order AGENDA HEALTH EVIDENCE REVIEW COMMISSION Clackamas Community College Wilsonville Training Center, Rooms 111-112 29353 SW Town Center Loop E Wilsonville, Oregon 97070 January 16, 2020 1:30-4:30 pm (All agenda items are subject to change and times listed are approximate)

Action # Time Item Presenter Item 1 1:30 PM Call to order Kevin Olson 2 1:35 PM Approval of minutes (November 14, 2019) Kevin Olson X 3 1:40 PM Director’s report Jason Gingerich 4 1:45 PM Subcommittee appointments Jason Gingerich X Ariel Smits 5 1:50 PM Value-based Benefits Subcommittee report X Cat Livingston Coverage Guidance Topic: Temporary Percutaneous Mechanical Circulatory Support Cat Livingston 6 2:45 PM with Impella Devices Adam Obley X • Coverage guidance • Prioritized List changes Next steps 7 4:20 PM • Schedule next meeting – March 12, 2019 Kevin Olson Wilsonville Training Center, rooms 111-112 8 4:30 PM Adjournment Kevin Olson

Note: Public comment will be taken on each topic per HERC policy at the time at which that topic is discussed.

MINUTES

HEALTH EVIDENCE REVIEW COMMISSION Clackamas Community College Wilsonville Training Center, Rooms 111-112 Wilsonville, Oregon November 14, 2019

Members Present: Kevin Olson, MD, Chair; Holly Jo Hodges, MD, Vice-Chair; Mark Gibson; Leda Garside, RN, MBA (arrived at 1:35 p.m.); Angela Senders, ND; Gary Allen, DMD; Lynnea Lindsey, PhD; Leslie Sutton; Adriane Irwin, PharmD, Michael Adler, MD (by phone); Kevin Cuccaro, DO; Kathryn Schabel, MD.

Members Absent: Devan Kansagara, MD.

Staff Present: Darren Coffman; Ariel Smits, MD, MPH; Cat Livingston, MD, MPH; Jason Gingerich; Daphne Peck, Jaime Taylor.

Also Attending: Dana Hargunani, MD (Oregon Health Authority); Adam Obley, MD, MPH (OHSU Center for Evidence-based Policy); Chris Hennessy (Abiomed); Katy McDowell (Tonkon Torp).

Call to Order

Kevin Olson, Chair of the Health Evidence Review Commission (HERC), called the meeting to order; roll was called. A quorum of members was present at the meeting.

Minutes Approval

MOTION: To approve the minutes of the August 8, 2019 meeting as presented. CARRIES 10-0. (Absent: Garside, Adler)

Director’s Report

Darren Coffman announced his retirement at the end of November.

Membership Coffman thanked Mark Gibson and Dr. Kevin Cuccaro as this is their last meeting. He announced the Governor has appointed two new members who are awaiting Senate confirmation: Maximilian Kaiser, DO, of Corvallis and Michael Collins, who is with the Warm Springs Tribe.

Dana Hargunani, MD then thanked Coffman for his years of service as it is also his last meeting and presented him with some gifts. She also thanked Gibson and Cuccaro. Hargunani also spoke about Jason Gingerich’s new role as Director.

Gibson spoke about the early days of the Prioritized List and praised Coffman for his years of service.

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Coffman reintroduced Kathryn Schabel, MD who joined the Commission in August. With the Health Technology Assessment Subcommittee (HTAS) being sunset, Coffman discussed subcommittee roles. Drs. Schabel (an orthopedic surgeon) and Brian Duty (a urologist and surgeon), had served on HTAS and would now like to serve on the Value-based Benefits Subcommittee (VbBS). Leda Garside had originally been on the Evidence-based Guidelines Subcommittee (EbGS) but was moved at some point to HTAS and would like to move back to EbGS.

MOTION: To appoint Schabel and Duty to the Value-based Benefits Subcommittee (VbBS) and Garside to the Evidence-based Guidelines Subcommittee (EbGS). CARRIES 11-0. (Absent: Adler)

Conflicts of Interest (COI) Coffman reminded the members of the importance of asking those testifying or presenting to declare their potential conflicts of interest. He mentioned that Hargunani is currently reviewing all the COI processes and procedures with the Department of Justice.

Value-based Benefits Subcommittee (VbBS) Report on Prioritized List Changes Meeting materials, pages 66-250

Ariel Smits reported the VbBS met earlier in the day, 11/14/2019. She summarized the subcommittee’s recommendations.

RECOMMENDED CODE MOVEMENT (changes to 1/1/2020 Prioritized List) • Add the 2020 CDT, CPT, and HCPCS codes on various lines and lists o HCPCS H0004 (Behavioral health counseling and therapy, per 15 minutes) was not added to Line 1 PREGNANCY • Add wraparound services to the covered autism line o Leslie Sutton asked if OHA and DHS were involved in this discussion and connected; she will connect with Gingerich after the meeting • Add neuropsychological status exams and neuropsychological testing services to the Diagnostic Procedures File with a new guideline • Add coverage for intestinal transplants for patients with short gut syndrome failing total parenteral nutrition (TPN) to include all ages • Add two codes for umbilical hernias to the uncovered hernia line • Add a vestibular rehabilitation procedure to a dysfunction line • Add a code for fall risk to the dysfunction line to enable coverage according to U.S. Preventive Services Task Force (USPSTF) recommendations • Add new codes for patient-provider online interaction codes to E&M lines. Interprofessional consultation codes are recommended for addition to the Fee Schedule. • Make other various straightforward coding and guideline note changes as described in meeting materials

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o The second paragraph of the new guideline “Supervision of pregnancy codes (ICD-10 O09.X, Z34.X), encounter for screening for maternal depression (ICD-10 Z13.32), and encounter for routine postpartum follow-up (ICD-10 Z39.2) are appropriate to pair with health behavior assessment and interventions for these purposes” was struck as it was determined to not be needed • Edit the non-prenatal, non-hereditary cancer guideline to include indications for pharmacogenetic (P450) testing, modify the microarray analysis entries and include additional cystic fibrosis testing codes • Edit the prenatal genetic testing guideline to remove restrictions on one non-prenatal test • Edit the hereditary cancer genetic testing guideline to update NCCN references and clarify when breast cancer panel testing is covered • Add a new Ancillary guideline on non-face-to-face visits and telephonic and electronic consultation • Delete the prior Guideline Note on telephone consultations • Modify the preventive services guideline to clarify intended coverage of falls prevention • Add a new guideline to the intestinal transplant line outlining when a patient was eligible for consideration for transplant • Edit the breast reconstruction guideline and create a new guideline outlining coverage for revisions to breast surgeries • Edit the hernia guideline to further define ventral hernia to include umbilical hernia and distinguish between incarcerated and obstructed hernias • Edit the guidelines regarding cervical cancer screening and other preventive services to reflect U.S. Preventive Services Task Force (USPSTF) recommendation updates

MOTION: To accept the VbBS recommendations on Prioritized List changes not related to coverage guidances, as amended. See the VbBS minutes of 11/14/2019 for a full description. Carries: 12-0

Multisector Intervention Report: Community Health Workers for Patients with Chronic Disease Meeting materials, pages 251-305

Adam Obley, MD and Cat Livingston, MD MPH presented an overview of the evidence. Livingston read the proposed multisector intervention box language.

Garside added she has worked with community health workers for many years and has seen a lot of improvement in care. There are many layers to the services they provide.

Lynnea Lindsey asked if it were possible to parse the providers so that, for example, doulas were not in the same category as peer wellness specialists. It seems there are many diverse categories of providers in the same “bucket.” She said these factors may affect preference, efficacy and outcome. Obley said parsing out different types of providers would be difficult since sensitivity analysis was not performed in the meta-review. Livingston said Oregon has their own definitions for community health workers that may differ from the definitions in the studies.

Schabel asked why the report calls out the three conditions listed that have limited or insufficient evidence (HIV, serious mental illness and congestive heart failure). Staff explained it is because they looked for evidence for those topics and felt it right to include their findings. There was discussion about how that information might be misleading to Coordinated Care Organizations (CCOs); it may be

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incorrectly interpreted to mean that services are not effective when in fact it simply means less research has been conducted in these populations.

Lindsey said this is evolving topic and suggested retaining that information in the in-depth multisector interventions report research but to not include the MSI statement attached to the Prioritized List.

After discussion, text was added to the Prioritized List MSI statement to clarify: Community health works may be effective for patients with other conditions however, limited or insufficient evidence was found for any other chronic condition.

MOTION: To approve the proposed multisector intervention report for Community Health Workers for Patients with Chronic Disease as presented. Carries 12-0.

MOTION: To approve the proposed multisector intervention statement for the Prioritized List as amended. Carries 12-0.

Approved Multisector Intervention statement: Multisector Interventions To improve beneficial outcomes in patients with chronic conditions, the preponderance of evidence supports that community health workers (CHWs) serving as a part of an integrated care team appear to improve outcomes in: • Children with asthma with preventable emergency department visits • Adults with uncontrolled diabetes or uncontrolled hypertension This evidence includes an emphasis on minority and low-income populations.

Characteristics of effective interventions include: o Higher intensity interventions including longer duration o Targeting populations with more severe chronic disease at baseline Limited or insufficient evidence is available on the use of CHWs to improve outcomes for the following: • HIV • Serious mental illness • Congestive heart failure

Changes for the Prioritized List of Health Services:

1) Add a Multisector Intervention Statement

MULTISECTOR INTERVENTION STATEMENT 4: COMMUNITY HEALTH WORKERS To improve beneficial outcomes in patients with chronic conditions, the preponderance of evidence supports that community health workers (CHWs) serving as a part of an integrated care team appear to improve outcomes in:

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• Children with asthma with preventable emergency department visits • Adults with uncontrolled diabetes or uncontrolled hypertension This evidence includes an emphasis on minority and low-income populations.

Characteristics of effective interventions include: o Higher intensity interventions including longer duration o Targeting populations with more severe chronic disease at baseline Community health workers may be effective for patients with other conditions, however, limited or insufficient evidence was found for any other chronic condition.

This Multisector Interventions statement is based on a HERC evidence review, Community Health Workers for Patients with Chronic Disease https://www.oregon.gov/oha/HPA/DSI- HERC/Pages/Evidence-based-Reports.aspx

2) Add numbers to the other Multisector Interventions statements a. MULTISECTOR INTERVENTIONS STATEMENT 1: TOBACCO PREVENTION AND CESSATION, INCLUDING DURING PREGNANCY b. MULTISECTOR INTERVENTIONS STATEMENT 2: PREVENTION OF EARLY CHILDHOOD CARIES c. MULTISECTOR INTERVENTIONS STATEMENT 3: PREVENTION AND TREATMENT OF OBESITY

Coverage Guidance Topic: Temporary Percutaneous Mechanical Circulatory Support with Impella Devices Meeting materials, pages 306-346

Livingston read through the summary document (pages 343-346).

Mark Gibson said that he was not satisfied with the decisions at the last meeting. He said the Commission had a very good report from a subcommittee that did a good job finding middle ground between evidence and anecdotal stories. Yet in the meeting, the commission kept pushing the envelope toward anecdotes. He said he is conflicted about including poor evidence in the coverage guidance and how it is applied to the Prioritized List. There are other interventions that have better outcomes with considerably less cost, yet we kept broadening the availability of this intervention. Some of our rationale for making those edits focused on how it was unlikely to find more good quality studies when in fact there is a trial being currently assembled. He said we can watch that study to determine if more coverage of this intervention is warranted. Gibson said when we base decisions on anecdotal accounts of positive outcomes there is no accounting of the negative outcomes.

Olson said he had similar misgivings. He asked what would happen if the Commission remained silent on the topic? Gingerich said the intervention was covered on the Prioritized List but on the incorrect lines prior to the August meeting; in August (and with the subsequent errata) coverage was moved to the appropriate lines and coverage went into effect October 1, 2019. If the Commission takes no action, the changes made in August (with errata) would remain in effect.

The Commission discussed payment issues, especially the Commission’s role given the cost of the device is most often part of an inpatient diagnosis-related group (DRG) payment where no additional payment

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would be made. In general, a DRG payment covers all facility charges associated with an inpatient stay from the time of admission to discharge.

Obley said the public testimony heard in August included anecdotes about scenarios which had not been envisioned for non-coverage such as people with acute viral myocarditis who needed Impella on a temporary basis until they had myocardial recovery. He went on to say there are two issues. One is the extraordinarily broad clinical scenarios in which Impella can be placed; the second issue is that the present use and the enthusiasm for the device is greater than the evidence.

Gibson said it might be helpful to have our expert present at the meeting when starting to deliberate this topic. Coffman said the appointed expert was not able to make additional meetings after the evidence was presented to the subcommittee.

Livingston laid out some options for moving forward: 1. Edit the language currently have 2. Revert to EbGS’s recommendation 3. Return the topic to EbGS

Obley said that one way to simplify the topic is to narrow the scope by focusing expert input on elective high-risk percutaneous coronary intervention (PCI).

Olson suggested the topic might go to VbBS. Lindsey said giving this work to another group might create extra rework; perhaps the work should be done by the Commission members and not a subcommittee.

Holly Jo Hodges said she was not in attendance in August but reported she felt shocked about the expanded coverage that came from the meeting.

The group reviewed the edits that were approved at the August meeting. After some discussion, Lindsey said she feels it would be easier to go back to the work that EbGS completed to edit. Sutton said she would like to maintain certain practical aspects of the edit, such as only requiring one cardiothoracic surgeon to concur rather than two.

Adriane Irwin said she felt, if we were going to rework the language, the stakeholders should be invited to be present. She suggested the Commission vote either to accept the recommendation from the last meeting or work from the document staff prepared for this meeting. She expressed discomfort about reverting to the version of the recommendations proposed in August.

The Commission discussed whether the next review should return to the Commission or a subcommittee. Obley said that there have not been new randomized clinical trials since EbGS last reviewed the topic.

Sutton requested a chart outlining the different options with an additional column showing the coverage implications. She emphasized the importance of stakeholder stories in informing decisions where there is limited evidence. Hodges said that it’s also important to consider the patients who don’t come to testify, particularly those who died during the procedure.

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Livingston said the STEMI to STEACS population was one of the biggest changes. After additional discussion Olson asked staff to work with leadership on how to present the changes from the older version of the document to the newer version, so that the decision is presented more clearly.

In addition, Irwin asked for clarity about whether Impella is covered within the DRG.

MOTION: To table consideration of the policy. Carries: 9-3 (Opposed: Cuccaro, Lindsey, Hodges)

Olson said this topic will be brought back, with clarity about key decision points, to a future meeting.

Additional Public Comment

There was no public comment at this time.

Items for next meeting

• Temporary Percutaneous Mechanical Circulatory Support with Impella Devices

Adjournment

Meeting adjourned at 4:30 pm. Next meeting will be from 1:30-4:30 pm on Thursday, January 16, 2020 at Clackamas Community College Wilsonville Training Center, Rooms 111-112, Wilsonville, Oregon.

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Value-based Benefits Subcommittee Recommendations Summary For Presentation to: Health Evidence Review Commission on November 14, 2019

For specific coding recommendations and guideline wording, please see the text of the 11/14/2019 VbBS minutes.

RECOMMENDED CODE MOVEMENT (changes to 1/1/2020 Prioritized List) • Add the 2020 CDT, CPT, and HCPCS codes on various lines and lists • Add wraparound services to the covered autism line • Add neuropsychological status exams and neuropsychological testing services to the Diagnostic Procedures File with a new guideline • Add coverage for intestinal transplants for patients with short gut syndrome failing total parenteral nutrition (TPN) to include all ages • Add two codes for umbilical hernias to the uncovered hernia line • Add a vestibular rehabilitation procedure to a dysfunction line • Add a code for fall risk to the dysfunction line to enable coverage according to USPSTF recommendations • Add new codes for patient-provider online interaction codes to lines with evaluation and management codes. Interprofessional consultation codes are recommended for addition to the OHP fee schedule. • Make other various straightforward coding and guideline note changes as described in the meeting materials

RECOMMENDED GUIDELINE CHANGES (changes to 1/1/2020 Prioritized List) • Add a new guideline regarding neuropsychological status exams and neuropsychological testing services • Add a new guideline regarding counseling for prevention of peripartum mood disorders • Edit the non-prenatal, non-hereditary cancer guideline to include indications for pharmacogenetic (P450) testing, modify the microarray analysis entries and include additional cystic fibrosis testing codes • Edit the prenatal genetic testing guideline to remove restrictions on one non-prenatal test • Edit the hereditary cancer genetic testing guideline to update NCCN references and clarify when breast cancer panel testing is covered • Add new Ancillary guideline on non-face-to-face visits and telephonic and electronic consultation • Delete the prior Guideline Note on telephone consultations • Modify the preventive services guideline to clarify intended coverage of falls prevention • Add a new guideline to the intestinal transplant line outlining when a patient was eligible for consideration for transplant • Edit the breast reconstruction guideline and create a new guideline outlining coverage for revisions to breast surgeries • Edit the hernia guideline to further define ventral hernia to include umbilical hernia and distinguish between incarcerated and obstructed hernias • Edit the guidelines regarding cervical cancer screening and other preventive services to reflect US Preventive Services Task Force recommendation updates

Value-based Benefits Subcommittee Summary Recommendations, 11/14/2019

VALUE-BASED BENEFITS SUBCOMMITTEE Clackamas Community College Wilsonville Training Center, Rooms 111-112 Wilsonville, Oregon November 14, 2019 8:00 AM – 1:00 PM

Members Present: Kevin Olson, MD, Chair; Holly Jo Hodges, MD, Vice Chair; Mark Gibson; Vern Saboe, DC; Adriane Irwin, PharmD; Gary Allen, DMD (via phone).

Members Absent: None.

Staff Present: Darren Coffman; Jason Gingerich; Ariel Smits, MD, MPH; Cat Livingston, MD, MPH; Daphne Peck; Jaime Taylor.

Also Attending: Nat Jacobs, Diane Quiring, and Kellie Skenandore (Oregon Health Authority); Mark Rivas, Mary Hlady, and Jamie Caulkey (Providence Rehab); Edward Boyle, MD (via phone).

 Roll Call/Minutes Approval/Staff Report

The meeting was called to order at 8:05 am and roll was called. A quorum of members was present at the meeting. Minutes from the 8/8/19 VbBS meeting were reviewed and approved.

Smits reviewed the errata; there were no questions or comments. Coffman announced his retirement at the end of November and Jason Gingerich’s new role as the director of the HERC. This is also Mark Gibson’s last meeting. Both Darren and Mark were thanked for their many years of outstanding service to the state.

 Topic: Straightforward/Consent Agenda

Discussion: There was no discussion about the consent agenda items.

Recommended Actions: 1) Add F17.210 (Nicotine dependence, cigarettes, uncomplicated) to line 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS 2) Remove 81507 (Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy) and 81420 (Fetal chromosomal aneuploidy (eg, trisomy 21, monosomy X) genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18, and 21) from line 1 PREGNANCY and add to Diagnostic Procedures File. 3) Change the line title of line 25 to ABNORMAL PAP SMEARS; DYSPLASIA OF CERVIX AND CERVICAL CARCINOMA IN SITU, CERVICAL CONDYLOMA a. Remove the following codes from line 25 and advise HSD to add to the Diagnostic Workup File i. ICD10 R87.615 Unsatisfactory cytologic smear of cervix ii. ICD10 R87.616 Satisfactory cervical smear but lacking transformation zone

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b. Add the following codes to line 25 and advise HSD to remove them from the Diagnostic Workup File i. ICD10 R87.618 Other abnormal cytological findings on specimens from cervix uteri ii. ICD10 R87.619 Unspecified abnormal cytological findings in specimens from cervix uteri 4) Remove ICD10 R87.625 (Unsatisfactory cytologic smear of vagina) from line 286 CANCER OF VAGINA, VULVA, AND OTHER FEMALE GENITAL ORGANS and advise HSD to add to the Diagnostic Workup File 5) Add ICD10 R87.811 (Vaginal high risk human papillomavirus (HPV) DNA test positive) to line 286 CANCER OF VAGINA, VULVA, AND OTHER FEMALE GENITAL ORGANS and advise HSD to remove from the Diagnostic Workup File 6) Remove ICD10 R87.820 (Cervical low risk human papillomavirus (HPV) DNA test positive) from line 25 ABNORMAL PAP SMEARS; DYSPLASIA OF CERVIX AND CERVICAL CARCINOMA IN SITU, CERVICAL and advise HSD to add to the Informational File 7) Advise HSD to remove ICD10 R87.821 (Vaginal low risk human papillomavirus (HPV) DNA test positive) from the Diagnostic Workup File and add to the Informational File 8) Modify GN173 as shown in Appendix A regarding 3D image rendering

MOTION: To approve the recommendations stated in the consent agenda. CARRIES 6-0.

 Topic: Oral Health Advisory Panel (OHAP)

Discussion: There was no discussion about the staff recommendations regarding the 2020 CDT codes, which reflected input from the All Dental Plans Workgroup and OHAP members.

Recommended Action: 1) Place the 2020 CDT codes as shown in Appendix B

MOTION: To recommend the code placements as presented. CARRIES 6-0.

 Topic: Behavioral Health Advisory Panel (BHAP)

Discussion: Smits introduced the wraparound services for autism topic. There was discussion about the possible increase in cost to OHA and the CCOs. Nat Jacobs from OHA testified that these services are reserved for the top 5% of children with high needs to youth state programs. These services can reduce ER and other downstream costs. Adding wraparound service codes to the autism line creates consistency among mental health diagnoses. Hodges requested that HERC staff consult with actuarial services regarding the possible costs of this addition. Coffman noted that if VbBS approves this change today, OHA can still put a hold on implementation if the cost is found to be too high.

Recommended Action: 1) Add wraparound services to line 193 AUTISM SPECTRUM DISORDERS a. HCPCS H2021 (Community-based wrap-around services, per 15 minutes) b. HCPCS H2022 (Community-based wrap-around services, per diem)

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MOTION: To recommend the code changes as presented. CARRIES 6-0.

Smits then introduced the neuropsychological status and testing topic. Hodges expressed concern that the suggested changes would greatly increase testing coverage volume, noting that there are many non-appropriate requests. Irwin expressed concern that these tests would be used for monitoring a condition rather than diagnosis, but Hodges felt that the CCOs could refuse coverage if the test had been done previously. The decision was to approve as suggested by staff and readdress the topic if CCOs find issues once they operationalize the change.

Recommended Actions: 1) Remove the following codes from all current lines on the Prioritized List and advise HSD to add these codes to the Diagnostic Procedures File a. CPT 96116 Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment, [eg, acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities]), by physician or other qualified health care professional, both face-to-face time with the patient and time interpreting test results and preparing the report; first hour b. CPT 96121 each additional hour c. CPT 96132 Neuropsychological testing evaluation services by physician or other qualified health care professional, including integration of patient data, interpretation of standardized test results and clinical data, clinical decision making, treatment planning and report, and interactive feedback to the patient, family member(s) or caregiver(s), when performed; first hour d. CPT 96133 each additional hour 2) Modify GN173 as shown in Appendix A, removing the entry for neurobehavioral status exams (CPT Codes 96116 and 96121) 3) Add a new diagnostic guideline NEUROBEHAVIORAL STATUS EXAMS AND NEUROPSYCHOLOGICAL TESTING as shown in Appendix C

MOTION: To recommend the code and guideline changes as presented. CARRIES 5-0. (Absent: Saboe)

Livingston introduced the summary on counseling for peripartum mood disorders. Irwin requested the addition of coverage for women with spontaneous or therapeutic pregnancy loss. The proposed guideline was modified to reflect this. The health and behavior assessment codes were already on the lines for spontaneous and therapeutic abortions. Staff was charged with determining if any ICD- 10 codes should be added to the proposed new guideline to account for these populations. [Note: at the 11/14/19 HERC meeting, the second paragraph of the new guideline, containing these codes, was removed from the guideline as the Commission decided it was unnecessary.]

Recommended Actions: 1) Add a new guideline COUNSELING FOR PREGNANT AND POSTPARTUM WOMEN to various lines regarding counseling for prevention of peripartum mood disorders as shown in Appendix C 2) Add HCPCS H0004 (Behavioral health counseling and therapy, per 15 minutes) to Line 1 PREGNANCY [Note: this addition was not approved by HERC at the 11/14/19 HERC meeting]

MOTION: To recommend the code and guideline note changes as modified. CARRIES 6-0.

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 Topic: Genetics Advisory Panel

Discussion: Non-prenatal, non-hereditary cancer genetic guideline Smits first reviewed issues with the Guideline Note D1 NON-PRENATAL GENETIC TESTING GUIDELINE. First, coverage of P450 testing was reviewed. The subcommittee modified the guideline wording to include additional classes of medications that do not have covered P450 testing in addition to psychiatric medications.

Smits then reviewed CALR testing. There was discussion about what panel test CPT code should be used; Smits indicated that it would be a generic molecular testing code. Hodges expressed concern about possible confusion with results that are part of the panel, but not requested by the provider. Olson felt that it is still cheaper to do the panel testing. The staff recommendation was approved.

There was no discussion about the changes to the entry for CPT 81229 or the CPT changes for cystic fibrosis carrier screening.

Guideline note D17 PRENATAL GENETIC TESTING The one minor change recommended had no discussion.

GUIDELINE NOTE D25 HEREDITARY CANCER GENETIC TESTING NCCN references were updated and the breast cancer panel testing section was clarified as in the summary document; there was no discussion.

Recommended Actions: 1) Remove the following codes from line 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS and advise HSD to add to the Diagnostic Procedure File: a. CPT 81226 (CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN)) b. CPT 81230 (CYP3A4 (cytochrome P450 family 3 subfamily A member 4) (eg, drug metabolism), gene analysis, common variant(s) (eg, *2, *22)) c. CPT 81231 (CYP3A5 (cytochrome P450 family 3 subfamily A member 5) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *7)) 2) Remove CPT 81227 (CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *5, *6)) from line 251 MULTIPLE SCLEROSIS AND OTHER DEMYELINATING DISEASES OF CENTRAL NERVOUS SYSTEM 3) Remove P450 codes CPT 81225, 81226, 81230 and 81231 (CYP3A5 (cytochrome P450 family 3 subfamily A member 5) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *7)) from GN173 as shown in appendix A. 4) Guideline Note D1 NON-PRENATAL GENETIC TESTING GUIDELINE as shown in Appendix A 5) Add CPT 81219 (CALR (calreticulin) (eg, myeloproliferative disorders), gene analysis, common variants in exon 9) to line 502/GN172 6) Modify Guideline note D17 PRENATAL GENETIC TESTING as shown in Appendix A 7) Modify GUIDELINE NOTE D25 HEREDITARY CANCER GENETIC TESTING as shown in Appendix A

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MOTION: To recommend the code and guideline note changes as modified. CARRIES 5-0. (Absent: Saboe)

 Topic: 2020 CPT Code Review

Discussion: There was no discussion regarding the recommended placement of new codes with the following exceptions:

1) Orthopedic drug delivery devices: the option to place on various orthopedic lines was selected 2) Preperitoneal packing: Hodges suggested adding codes to the pregnancy line as well, for use in cases where a pre-eclamptic patient with severe bleeding needs preperitoneal packing after cesarean section. This was accepted. 3) Computerized dynamic posturography: the subcommittee removed the original code from current lines and place on line 662/GN173 4) Remote physiologic monitoring: HSD should also be advised to remove CPT codes 99453 and 99457 in addition to 99458 from the Ancillary File. Staff was charged to review that remote home INR monitoring is covered.

Recommended Actions: 1) 2020 CPT code placement as shown in Appendix B 2) Add entries for certain 2020 CPT codes to GN173 as shown in Appendix A 3) Modify GN161 SACROILIAC ANESTHETIC INJECTIONS AND SACROILIAC JOINT FUSION as shown in Appendix A 4) Advise HSD to add CPT 64640 (Destruction by neurolytic agent; other peripheral nerve or branch) to the Ancillary File and remove it from Line 662/GN173. 5) Modify GN148 BIOMARKER TESTS OF CANCER TISSUE as shown in Appendix A 6) Remove CPT 92548 (computerized dynamic posturography) from current lines and add to line 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS/GN173 7) Place the following codes on cardiac and pulmonary lines and advise HSD to remove CPT 99453 and 99457 from the Ancillary File: a. 99453 Remote monitoring of physiologic parameter(s) (eg, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment b. 99457 Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month c. 99458 Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; each additional 20 minutes (List separately in addition to code for primary procedure) d. CARDIAC AND PULMONARY LINES 9 ASTHMA 20 CYSTIC FIBROSIS 48 CHRONIC RESPIRATORY DISEASE ARISING IN THE NEONATAL PERIOD

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58 BRONCHIECTASIS 69 ACUTE AND SUBACUTE ISCHEMIC HEART DISEASE, MYOCARDIAL INFARCTION 75 HYPERTENSION AND HYPERTENSIVE DISEASE 81 MYOCARDITIS, PERICARDITIS, AND ENDOCARDITIS 97 HEART FAILURE 98 CARDIOMYOPATHY 110 CONGENITAL HEART BLOCK, OTHER OBSTRUCTIVE ANOMALIES OF HEART 172 HYPERTENSIVE HEART AND RENAL DISEASE 189 CHRONIC ISCHEMIC HEART DISEASE 202 SLEEP APNEA, NARCOLEPSY AND REM BEHAVIORAL DISORDER 213 ACUTE PULMONARY HEART DISEASE AND PULMONARY EMBOLI 219 PULMONARY FIBROSIS 222 OCCUPATIONAL LUNG DISEASES 223 DISEASES AND DISORDERS OF AORTIC VALVE 225 ACUTE INFLAMMATION OF THE HEART DUE TO RHEUMATIC FEVER 233 ADULT RESPIRATORY DISTRESS SYNDROME; ACUTE RESPIRATORY FAILURE; RESPIRATORY CONDITIONS DUE TO PHYSICAL AND CHEMICAL AGENTS 257 DISEASES OF MITRAL, TRICUSPID, AND PULMONARY VALVES 264 CONGESTIVE HEART FAILURE, CARDIOMYOPATHY, MALIGNANT ARRHYTHMIAS, AND COMPLEX CONGENITAL HEART DISEASE 281 LIFE-THREATENING CARDIAC ARRHYTHMIAS 283 CHRONIC OBSTRUCTIVE PULMONARY DISEASE; CHRONIC RESPIRATORY FAILURE 304 VIRAL PNEUMONIA 341 RHEUMATIC FEVER 347 CARDIAC ARRHYTHMIAS 366 ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS 464 ATELECTASIS (COLLAPSE OF LUNG) 566 PLEURISY 635 CHRONIC BRONCHITIS 647 AGENESIS OF LUNG 653 CARDIOVASCULAR CONDITIONS WITH NO OR MINIMALLY EFFECTIVE TREATMENTS OR NO TREATMENT NECESSARY 657 RESPIRATORY CONDITIONS WITH NO OR MINIMALLY EFFECTIVE TREATMENTS OR NO TREATMENT NECESSARY 8) Add 99091 (Collection and interpretation of physiologic data (eg, ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time, each 30 days) to the cardiac and pulmonary lines above, and additionally the following lines: 1 PREGNANCY 8 TYPE 1 DIABETES MELLITUS 27 TYPE 2 DIABETES MELLITUS 9) Place 99454 (Remote monitoring of physiologic parameter(s) (eg, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30) on Line 502 CONDITIONS FOR WHICH INTERVENTIONS RESULT IN MARGINAL CLINICAL BENEFIT OR LOW COST-EFFECTIVENESS and modify GN172 as shown in Appendix A

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MOTION: To recommend the code and guideline note changes as modified. CARRIES 6-0.

 Topic: Telephone and email consult guideline

Discussion: Livingston reviewed the issue summary. Hodges raised the question as to whether it should actually be an ancillary guideline. Coffman explained the proposal to make it a diagnostic guideline due to the issue of having an ancillary guideline with some appropriate codes not being on Prioritized List. Hodges said there are ongoing issues with regular access to HSD’s Ancillary File. Subcommittee members clarified that having a guideline as ancillary would mean that electronic consultations for unfunded conditions such as fibromyalgia would not be covered. If the procedures are diagnostic, diagnostic workup of signs and symptoms as well as unfunded condition will continue to be covered, just like face-to-face consultations.

Gingerich raised the question about use of signs and symptoms codes and Hodges shared in her experience these get paid. The difficulty with making this a diagnostic guideline is that many of these consults would not be for diagnostic purposes, they would be to help with ongoing management of a chronic diagnosed condition. After this discussion, the decision was made to make this an ancillary guideline but clarify that it includes services related to the diagnostic workup. This would enable 1-2 consults to establish a diagnosis as is typically allowed.

The discussion turned to a series of examples to see how the new proposed guideline would impact coverage. Members discussed getting rid of the requirement that the consulting provider needs to be a specialist. Examples given included: • PCP in a remote location consults another PCP in a more urban location for a second opinion (therefore the consulting provider does not need to be a specialist) • Provider consults another provider for advice regarding medication assisted treatment

Recommended Actions: 1. Add the following codes to all lines with E&M codes 1) 98970-98972 2) 99421-99423 2. Recommend HSD add the following codes to the fee schedule a. 99446-99449 b. 98970-98972 c. 99421-99423 d. G2012 3. Delete 99444 and 98969 from all lines on the Prioritized List. The codes are now obsolete. 4. Delete Guideline Note 65 TELEPHONE AND EMAIL CONSULTATIONS from 638 lines of the Prioritized List. 5. Add a new ancillary guideline note named TELECONSULTATIONS AND NON-FACE-TO -FACE TELEHEALTH SERVICES as shown in Appendix C. 6. Recommend HSD update OARs (still refers to Health Services Commission and new language is indicated)

MOTION: To recommend the code and guideline note changes as amended. CARRIES 6-0.

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 Topic: 2020 HCPCS Code Review

Discussion: Smits reviewed the documents related to the 2020 HCPCS code placements. There was no discussion except for C1839 (Iris prosthesis). There was discussion that the iris prosthesis might be beneficial for children for reading, but the general thought was that the rare cases with aniridia in children could be dealt with through the exceptions process. The decision was to add C1839 to line 662/GN173.

Recommended Actions: 1) 2020 HCPCS code placement as shown in Appendix B 2) Add entries for certain 2020 HCPCS codes to line 662 and GN173 as shown in Appendix A

MOTION: To recommend the code and guideline note changes as presented. CARRIES 6-0.

 Topic: Chronic lower extremity venous disease (CLEVD)

Discussion: Smits reviewed the summary document. Dr. Ed Boyle testified regarding the benefits of treatment on patients’ quality of life. He noted that NICE coverage is much more expansive than the coverage contemplated by the HERC. He noted that treatment of CLEVD affects pain and quality of life. He felt that severe swelling should be included as an indication and would like to see severe pain as an indication as well. Olson commented that the HERC generally leans toward having objective findings around coverage, and that pain is subjective. Subjective indications are much more difficult for CCOs to manage. Boyle noted that private insurers manage benefits with pain as an indication, and that physicians are familiar with the documentation necessary to indicate the patient’s pain. Boyle also was interested in expanding coverage to include stasis dermatitis. Olson asked whether there was a grading system for stasis dermatitis and Boyle indicated that there was not. Hodges agreed with the need to have objective findings to determine coverage. Boyle stated that the diagnosis of severe venous reflux is made by ultrasound findings. CMS and private insurers require the ultrasound findings when determining coverage. Hodges noted that it was hard to define stasis dermatitis—what level of skin change would be considered stasis dermatitis? Boyle argued that the proposed guideline as written only covers severe end stage CLEVD. He again reiterated that CMS covers severe refractory edema and stasis dermatitis and advocated for inclusion of these indications, which would match the major private insurers. There was discussion that treating less severe disease may not result in any improvements. There was general consensus that the proposed guideline should include objective measures only.

Based on the discussion above, the VbBS members suggested modifying the proposed guideline to include ultrasound findings of severe reflux, defined as “severe axial venous reflux (>1 second in the greater or small saphenous vein or accessory saphenous vein).”

There was further discussion about the proposed guideline requirement for 3 months of conservative therapy. Livingston raised the issue that this would include compression stockings, which are currently not covered by OHP. There was discussion about when compression stockings should be covered. There was suggested wording that the guideline include compression stockings only if the patient meets all the other guideline criteria. Mary Hlady from Providence Rehab noted that the physical therapy community could assist the HERC in determining which patients should qualify for compression stockings.

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The decision was to table this topic and have HERC staff look at the evidence for the effectiveness of compression stockings, as well as which patients should have compression stockings covered by OHP.

Recommended Action: 1) HERC staff will look at the literature and work with community experts to determine the effectiveness of compression stockings for CLEVD, and what coverage for these stockings, if any, should be included in the proposed new guideline. This topic will be brought back to a future meeting for further discussion.

 Topic: Vestibular rehabilitation

Discussion: Livingston presented the issue summary. Saboe asked about the differential effectiveness of canalith repositioning versus other types of vestibular testing and interventions. Livingston pointed to the evidence in the issue summary which addressed a variety of types of vestibular rehabilitation, but that there is specific evidence for canalith repositioning. Members discussed the prioritization of vertiginous conditions below the funding line.

Public commenters, Mary Hlady and Jamie Caulkey , both physical therapists from Providence, expressed happiness that canalith repositioning would be moved to the funded region of the Prioritized List. They raised concern about the proposed limitation to those 65 years and older. Livingston clarified that while others may be at risk of falls, older adults were at higher risk based on the USPSTF review. Public comment discussed the importance of a variety of comorbidities, particularly neuromuscular conditions, that may increase morbidity of fall risk. Subcommittee members addressed that pairing on the neurologic dysfunction line would allow canalith repositioning to pair with a variety of neuromuscular conditions. There was a proposal to remove the proposed coding specification and allow pairing without age limitations. Subcommittee members adopted this proposal, as there is a high risk of bad outcomes for a variety of comorbid neuromuscular conditions which may affect younger patients.

Recommended Actions: 1) Add the following codes to Line 512 VERTIGINOUS SYNDROMES AND OTHER DISORDERS OF VESTIBULAR SYSTEM 97112 Therapeutic procedure, 1 or more areas, each 15 minutes; neuromuscular reeducation of movement, balance, coordination, kinesthetic sense, posture, and/or proprioception for sitting and/or standing activities S9476 Vestibular rehabilitation program, non-physician provider, per diem 2) Add Z91.81 History of falling (and including those at risk of falling) to Line 292 NEUROLOGICAL DYSFUNCTION IN POSTURE AND MOVEMENT CAUSED BY CHRONIC CONDITIONS o Delete Z91.81 from Line 3 o Add CPT code 95992 (Canalith repositioning) to Line 292 NEUROLOGICAL DYSFUNCTION IN POSTURE AND MOVEMENT 3) Modify Guideline Note 106 as shown in Appendix A.

MOTION: To recommend the code and guideline note changes as amended. CARRIES 6-0.

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 Topic: Indications for intestinal transplantation

Discussion: Smits reviewed the summary document. There was minimal discussion. There was general agreement that coverage should be expanded to all ages. The guideline was slightly modified to include “OR” at the end of each indication to clarify that only one indication was required.

Recommended Actions: 1) Change the line title for line 239 to Line 239 SHORT BOWEL SYNDROME - AGE 5 OR UNDER Treatment: INTESTINE AND INTESTINE/LIVER TRANSPLANT 2) Adopt the new guideline for line 239 as shown in Appendix C 3) Add 44133 (Donor enterectomy from living donor) and 44136 (Intestinal allotransplantation, from living donor) to line 662/GN173 as shown in Appendix A

MOTION: To recommend the code and guideline note changes as presented. CARRIES 6-0.

 Topic: Breast reconstruction revisions for previous cosmetic procedures

Discussion: Smits reviewed the summary document; there was minimal discussion.

Recommended Actions: 1) Revise GN79 BREAST RECONSTRUCTION as shown in Appendix A 2) Add a new guideline BREAST SURGERY REVISION to multiple lines addressing revision of breast surgeries

MOTION: To recommend the guideline note changes as presented. CARRIES 6-0.

 Topic: Umbilical hernias with non-intestinal obstruction

Discussion: Smits reviewed the summary document. The proposed guideline revisions were amended slightly to clarify the wording. There was some discussion about adding ICD10 codes K42.0 and K45.0 to line 524, as the descriptions include the word “obstruction.” Staff clarified that these codes are used for incarceration, and the guideline defines their use as for this indication. True intestinal obstruction would remain on the covered upper hernia line.

Recommended Actions: 1) Add ICD-10 codes K42.0 (Umbilical hernia with obstruction, without gangrene) and K45.0 (Other specified abdominal hernia with obstruction, without gangrene) to line 524 UNCOMPLICATED HERNIA AND VENTRAL HERNIA (OTHER THAN INGUINAL HERNIA IN CHILDREN AGE 18 AND UNDER OR DIAPHRAGMATIC HERNIA) and keep on line 168 2) Modify GN24 COMPLICATED HERNIAS as shown in Appendix A

MOTION: To recommend the code and guideline note changes as presented. CARRIES 6-0.

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 Topic: USPSTF Recommendation Update for GN106

Discussion: Livingston reviewed the summary document; there was minimal discussion.

Recommended Actions: 1) Modify Guideline Note 1 ROUTINE CERVICAL CANCER SCREENING as shown in Appendix A 2) Modify Guideline Note 106 PREVENTIVE SERVICES as shown in Appendix A

MOTION: To recommend the guideline note changes as presented. CARRIES 6-0.

 Public comment on topics not on the agenda

No additional public comment was received.

 Issues for next meeting: o Chronic lower extremity venous disease and compression stockings o Intracardiac echocardiogram o Yttrium 90 embolization mapping o Vitamin D screening o Frequency specific microcurrent therapy and similar TENS-like therapies o Low level laser therapy o Fetal myelomeningocele repair

 Next meeting:

January 16, 2020 at Clackamas Community College, Wilsonville Training Center, Wilsonville Oregon, Rooms 111-112.

 Adjournment:

The meeting adjourned at 1:17 PM.

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DIAGNOSTIC GUIDELINE D1, NON-PRENATAL GENETIC TESTING GUIDELINE A) Genetic tests are covered as diagnostic, unless they are listed below in section E1 as excluded or have other restrictions listed in this guideline. To be covered, initial screening (e.g. physical exam, medical history, family history, laboratory studies, imaging studies) must indicate that the chance of genetic abnormality is > 10% and results would do at least one of the following: 1) Change treatment, 2) Change health monitoring, 3) Provide prognosis, or 4) Provide information needed for genetic counseling for patient; or patient’s parents, siblings, or children B) Pretest and posttest genetic counseling is required for presymptomatic and predisposition genetic testing. Pretest and posttest genetic evaluation (which includes genetic counseling) is covered when provided by a suitable trained health professional with expertise and experience in genetics. 1) “Suitably trained” is defined as board certified or active candidate status from the American Board of Medical Genetics, American Board of Genetic Counseling, or Genetic Nursing Credentialing Commission. C) A more expensive genetic test (generally one with a wider scope or more detailed testing) is not covered if a cheaper (smaller scope) test is available and has, in this clinical context, a substantially similar sensitivity. For example, do not cover CFTR gene sequencing as the first test in a person of Northern European Caucasian ancestry because the gene panels are less expensive and provide substantially similar sensitivity in that context D) Related to diagnostic evaluation of individuals with intellectual disability (defined as a full scale or verbal IQ < 70 in an individual > age 5), developmental delay (defined as a cognitive index <70 on a standardized test appropriate for children < 5 years of age), Autism Spectrum Disorder, or multiple congenital anomalies: 1) CPT 81228 and 81229, Cytogenomic constitutional microarray analysis for copy number variants for chromosomal abnormalities: Cover for diagnostic evaluation of individuals with intellectual disability/developmental delay; multiple congenital anomalies; or, Autism Spectrum Disorder accompanied by at least one of the following: dysmorphic features including macro or microcephaly, congenital anomalies, or intellectual disability/developmental delay in addition to those required to diagnose Autism Spectrum Disorder. 2) CPT 81229, Cytogenomic constitutional microarray analysis for copy number variants for chromosomal abnormalities; plus cytogenetic constitutional microarray analysis for single nucleotide polymorphism (SNP) variants for chromosomal abnormalities: Cover for diagnostic evaluation of individuals with intellectual disability/developmental delay; multiple congenital anomalies; or, Autism Spectrum Disorder accompanied by at least one of the following: dysmorphic features including macro or microcephaly, congenital anomalies, or intellectual disability/developmental delay in addition to those required to diagnose Autism Spectrum Disorder; only if (a) consanguinity and recessive disease is suspected, or (b) uniparental disomy is suspected, or (c) another mechanism is suspected that is not detected by the copy number variant test alone. (combine with 81228 entry)

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3) CPT 81243, 81244, 81171,81172 Fragile X genetic testing is covered for individuals with intellectual disability/developmental delay. Although the yield of Fragile X is 3.5-10%, this is included because of additional reproductive implications. 4) A visit with the appropriate specialist (often genetics, developmental pediatrics, or child neurology), including physical exam, medical history, and family history is covered. Physical exam, medical history, and family history by the appropriate specialist, prior to any genetic testing is often the most cost-effective strategy and is encouraged. E) Related to other tests with specific CPT codes: 1) Certain genetic tests have not been found to have proven clinical benefit. These tests are listed in Guideline Note 173, INTERVENTIONS THAT HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS; UNPROVEN INTERVENTIONS 2) The following tests are covered only if they meet the criteria in section A above AND the specified situations: a) CPT 81205, BCKDHB (branched-chain keto acid dehydrogenase E1, beta polypeptide) (eg, Maple syrup urine disease) gene analysis, common variants (eg, R183P, G278S, E422X): Cover only when the newborn screening test is abnormal and serum amino acids are normal b) Diagnostic testing for cystic fibrosis (CF) i) CFTR, cystic fibrosis transmembrane conductance regulator tests. CPT 81220, 81221, 81222, 81223: For infants with a positive newborn screen for cystic fibrosis or who are symptomatic for cystic fibrosis, or for clients that have previously been diagnosed with cystic fibrosis but have not had genetic testing, CFTR gene analysis of a panel containing at least the mutations recommended by the American College of Medical Genetics* (CPT 81220) is covered. If two mutations are not identified, CFTR full gene sequencing (CPT 81223) is covered. If two mutations are still not identified, duplication/deletion testing (CPT 81222) is covered. These tests may be ordered as reflex testing on the same specimen. c) Carrier testing for cystic fibrosis i) CFTR gene analysis of a panel containing at least the mutations recommended by the American College of Medical Genetics* (CPT 81220-81224) is covered once in a lifetime. d) CPT 81224, CFTR (cystic fibrosis transmembrane conductance regulator) (eg. cystic fibrosis) gene analysis; introm 8 poly-T analysis (eg. male infertility): Covered only after genetic counseling. e) CPT 81226-81231 (cytochrome P450). Covered only for determining eligibility for medication therapy if required or recommended in the FDA labelling for that medication. These tests have unproven clinical utility for decisions regarding medications when not required in the FDA labeling (e.g. psychiatric, anticoagulant, opioids). f) CPT 81240. F2 (prothrombin, coagulation factor II) (eg, hereditary hypercoagulability) gene analysis, 20210G>A variant: Factor 2 20210G>A testing should not be covered for adults with idiopathic venous thromoboembolism; for asymptomatic family members of patients with venous thromboembolism and a Factor V Leiden or Prothrombin

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20210G>A mutation; or for determining the etiology of recurrent fetal loss or placental abruption. g) CPT 81241. F5 (coagulation Factor V) (eg, hereditary hypercoagulability) gene analysis, Leiden variant: Factor V Leiden testing should not be covered for: adults with idiopathic venous thromoboembolism; for asymptomatic family members of patients with venous thromboembolism and a Factor V Leiden or Prothrombin 20210G>A mutation; or for determining the etiology of recurrent fetal loss or placental abruption. h) CPT 81247. G6PD (glucose-6-phosphate dehydrogenase) (eg, hemolytic anemia, jaundice), gene analysis; common variant(s) (eg, A, A-) should only be covered i) After G6PD enzyme activity testing is done and found to be normal; AND either (a) There is an urgent clinical reason to know if a deficiency is present, e.g. in a case of acute hemolysis; OR (b) In situations where the enzyme activity could be unreliable, e.g. female carrier with extreme Lyonization. i) CPT 81248. G6PD (glucose-6-phosphate dehydrogenase) (eg, hemolytic anemia, jaundice), gene analysis; known familial variant(s) is only covered when the information is required for genetic counseling. j) CPT 81249. G6PD (glucose-6-phosphate dehydrogenase) (eg, hemolytic anemia, jaundice), gene analysis; full gene sequence is only covered i) after G6PD enzyme activity has been tested, and ii) the requirements under CPT 81247 above have been met, and iii) common variants (CPT 81247) have been tested for and not found. k) CPT 81256, HFE (hemochromatosis) (eg, hereditary hemochromatosis) gene analysis, common variants (eg, C282Y, H63D): Covered for diagnostic testing of patients with elevated transferrin saturation or ferritin levels. Covered for predictive testing ONLY when a first degree family member has treatable iron overload from HFE. l) CPT 81332, SERPINA1 (serpin peptidase inhibitor, clade A, alpha-1 antiproteinase, antitrypsin, member 1) (eg, alpha-1-antitrypsin deficiency), gene analysis, common variants (eg, *S and *Z): The alpha-1-antitrypsin protein level should be the first line test for a suspected diagnosis of AAT deficiency in symptomatic individuals with unexplained liver disease or obstructive lung disease that is not asthma or in a middle age individual with unexplained dyspnea. Genetic testing of the anpha-1 phenotype test is appropriate if the protein test is abnormal or borderline. The genetic test is appropriate for siblings of people with AAT deficiency regardless of the AAT protein test results. m) CPT 81329, Screening for spinal muscular atrophy: is covered once in a lifetime for preconception testing or testing of the male partner of a pregnant female carrier n) CPT 81415-81416, exome testing: A genetic counseling/geneticist consultation is required prior to ordering test o) CPT 81430-81431, Hearing loss (eg, nonsyndromic hearing loss, Usher syndrome, Pendred syndrome); genomic sequence analysis panel: Testing for mutations in GJB2 and GJB6 need to be done first and be negative in non-syndromic patients prior to panel testing. p) CPT 81440, 81460, 81465, mitochondrial genome testing: A genetic counseling/geneticist or metabolic consultation is required prior to ordering test.

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q) CPT 81412 Ashkenazi Jewish carrier testing panel: panel testing is only covered when the panel would replace and would be similar or lower cost than individual gene testing including CF carrier testing.

* American College of Medical Genetics Standards and Guidelines for Clinical Genetics Laboratories. 2008 Edition, Revised 7/2018 and found at http://www.acmg.net/PDFLibrary/Cystic-Fibrosis-Population- Based-Carrier-Screening-Standards.pdf.

DIAGNOSTIC GUIDELINE D17, PRENATAL GENETIC TESTING The following types of prenatal genetic testing and genetic counseling are covered for pregnant women:

A) Genetic counseling (CPT 96040, HPCPS S0265) for high-risk women who have family history of inheritable disorder or carrier state, ultrasound abnormality, previous pregnancy with aneuploidy, or elevated risk of neural tube defect. B) Genetic counseling (CPT 96040, HPCPS S0265) prior to consideration of chorionic villus sampling (CVS), amniocentesis, microarray testing, Fragile X, and spinal muscular atrophy screening C) Validated questionnaire to assess genetic risk in all pregnant women D) Screening high-risk ethnic groups for hemoglobinopathies (CPT 83020, 83021) E) Screening for aneuploidy with any of five screening strategies [first trimester (nuchal translucency, beta-HCG and PAPP-A), integrated, serum integrated, stepwise sequential, and contingency] (CPT 76813, 76814, 81508-81511,81512,82105,82677) F) Cell free fetal DNA testing (CPT 81420, 81507) for evaluation of aneuploidy in women who have an elevated risk of a fetus with aneuploidy (maternal age >34, family history or elevated risk based on screening). G) Ultrasound for structural anomalies between 18 and 20 weeks gestation (CPT 76811, 76812) H) CVS or amniocentesis (CPT 59000, 59015, 76945,76946, 82106, 88235, 88261-88264, 88267, 88269, 88280, 88283, 88285, 88289,88291) for a positive aneuploidy screen, maternal age >34, fetal structural anomalies, family history of inheritable chromosomal disorder or elevated risk of neural tube defect. I) Array CGH (CPT 81228, 81229) when major fetal congenital anomalies are apparent on imaging, or with normal imaging when array CGH would replace karyotyping performed with CVS or amniocentesis in (H) above. J) FISH testing (CPT 88271, 88272, 88274, 88275, 81171, 81172) only if karyotyping is not possible due a need for rapid turnaround for reasons of reproductive decision-making (i.e. at 22w4d gestation or beyond) K) Screening for Tay-Sachs carrier status (CPT 81255) in high-risk populations. First step is hex A, and then additional DNA analysis in individuals with ambiguous Hex A test results, suspected variant form of TSD or suspected pseudodeficiency of Hex A L) Screening for cystic fibrosis carrier status once in a lifetime (CPT 81220-81224) M) Screening for fragile X status (CPT 81243, 81244, 81171. 81172) in patients with a personal or family history of a. fragile X tremor/ataxia syndrome b. premature ovarian failure

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c. unexplained early onset intellectual disability d. fragile X intellectual disability e. unexplained autism through the pregnant woman’s maternal line N) Screening for spinal muscular atrophy (CPT 81329) once in a lifetime O) Screening those with Ashkenazi Jewish heritage for Canavan disease (CPT 81200), familial dysautonomia (CPT 81260), and Tay-Sachs carrier status (CPT 81255). Ashkenazi Jewish carrier panel testing (CPT 81412) is covered if the panel would replace and would be of similar or lower cost than individual gene testing including CF carrier testing. P) Expanded carrier screening only for those genetic conditions identified above

The following genetic screening tests are not covered: A) Serum triple screen B) Screening for thrombophilia in the general population or for recurrent pregnancy loss C) Expanded carrier screening which includes results for conditions not explicitly recommended for coverage

The development of this guideline note was informed by a HERC coverage guidance. See https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports.aspx.

GUIDELINE NOTE 1, ROUTINE CERVICAL CANCER SCREENING Line 3 Cervical cancer screening is covered on Line 3 for women:

Age group in years Type of screening covered Frequency <21 None Never 21-29 Cytology alone Every 3 years Mandatory HPV testing (87620-87621) is not covered for women age 21-29 30-65 Co-testing* or cytology alone Co-testing every 5 High-risk human papillomavirus (hrHPV) testing years alone, co-testing (hrHPV and cytology) or hrHPV testing alone cytology alone every 5 years Cytology alone every 3 years >65 None Never Unless adequate screening* has not been achieved or it is <20 years after regression or appropriate management of a high-grade precancerous lesion Women who have None Never had a hysterectomy with removal of cervix for non cervical cancer

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Age group in years Type of screening covered Frequency related reasons (i.e. other than high grade precancerous lesion, CIN 2 or 3, or cervical cancer) Women who have Per ASCCP** Guideline, until indicated to resume Per ASCCP Guideline, abnormal testing routine screening until indicated to resume routine screening *Co-testing is defined as simultaneous cytology and mandatory HPV testing. * Adequate screening is defined as 3 consecutive negative cytology results or 2 consecutive negative HPV results within 10 years of the cessation of screening, with the most recent test occurring within 5 years. ** American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology guideline (Saslow 2012)

Women who have received a diagnosis of a high-grade precancerous cervical lesion or cervical cancer, women with in utero exposure to diethylstilbestrol, or women who are immunocompromised (such as those who are HIV positive) are intended to have screening more frequently than delineated in this guideline.

The development of this guideline note was informed by a HERC coverage guidance. See https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports.aspx.

GUIDELINE NOTE 24, COMPLICATED HERNIAS Lines 168,524 Complicated hernias are included on Line 168 if they cause symptoms of intestinal obstruction and/or strangulation. Incarcerated hernias (defined as non-reducible by physical manipulation) are also included on Line 168, excluding incarcerated ventral hernias. Incarcerated ventral hernias (including incarcerated abdominal incisional and umbilical hernias and umbilical hernias) are included on Line 524, because the chronic incarceration of large ventral hernias does not place the patient at risk for impending strangulation. Ventral hernias are defined as anterior abdominal wall hernias and include primary ventral hernias (epigastric, umbilical, Spigelian), parastomal hernias, and most incisional hernias (ventral incisional hernias). ICD-10-CM K42.0, K43.0, K43.3, K43.6, K45.0 and K46.0 are included on Line 524 when used to designate incarcerated abdominal incisional and umbilical hernias without intestinal obstruction or gangrene.

GUIDELINE NOTE 79, BREAST RECONSTRUCTION Line 191 Breast reconstruction is only covered after mastectomy as a treatment for breast cancer or as prophylactic treatment for the prevention of breast cancer in a woman who qualifies under Guideline Note 3, and must be completed within 5 years of initial mastectomy. Revision of previous reconstruction

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix A A-6 Appendix A Revised Guideline Notes

is only covered in cases where the revision is required to address complications of the surgery (wound dehiscence, fistula, chronic pain directly related to the surgery, etc.). Revisions are not covered solely for cosmetic issues.

Breast reconstruction may include contralateral reduction mammoplasty (CPT 19318) or contralateral mastopexy (CPT 19316). Mastopexy is only to be covered when contralateral reduction mammaplasty is inappropriate for breast reconstruction and mastopexy will accomplish the desired reconstruction result

GUIDELINE NOTE 106, PREVENTIVE SERVICES Lines 3,622 Included on Line 3 are the following preventive services: A) US Preventive Services Task Force (USPSTF) “A” and “B” Recommendations in effect and issued prior to January 1, 2019 January 1, 2018. 1) http://www.uspreventiveservicestaskforce.org/Page/Name/uspstf-a-and-b- recommendations/ a) Treatment of falls prevention with exercise interventions is included on Line 292. 2) USPSTF “D” recommendations are not included on this line or any other line of the Prioritized List. B) American Academy of Pediatrics (AAP) Bright Futures Guidelines: 1) http://brightfutures.aap.org. Periodicity schedule available at http://www.aap.org/en- us/professional-resources/practice-support/Periodicity/Periodicity Schedule_FINAL.pdf. 2) Screening for lead levels is defined as blood lead level testing and is indicated for Medicaid populations at 12 and 24 months. In addition, blood lead level screening of any child between ages 24 and 72 months with no record of a previous blood lead screening test is indicated. C) Health Resources and Services Administration (HRSA) Women’s Preventive Services-Required Health Plan Coverage Guidelines as as updated by HRSA on December 20, 2016. Available at https://www.hrsa.gov/womens-guidelines-2016/index.html as of 311/195/2019. D) Immunizations as recommended by the Advisory Committee on Immunization Practices (ACIP): http://www.cdc.gov/vaccines/schedules/hcp/index.html or approved for the Oregon Immunization Program: https://public.health.oregon.gov/PreventionWellness/VaccinesImmunization/ImmunizationProv iderResources/Documents/DMAPvactable.pdf

Colorectal cancer screening is included on Line 3 for average-risk adults aged 50 to 75, using one of the following screening programs: A) Colonoscopy every 10 years B) Flexible sigmoidoscopy every 5 years C) Fecal immunochemical test (FIT) every year D) Guaiac-based fecal occult blood test (gFOBT) every year

Colorectal cancer screening for average-risk adults aged 76 to 85 is covered only for those who A) Are healthy enough to undergo treatment if colorectal cancer is detected, and B) Do not have comorbid conditions that would significantly limit their life expectancy.

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix A A-7 Appendix A Revised Guideline Notes

The development of this guideline note was informed by a HERC coverage guidance. See https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports.aspx.

GUIDELINE NOTE 148, BIOMARKER TESTS OF CANCER TISSUE Lines 157,184,191,230,263,271,329 The use of tissue of origin testing (e.g. CPT 81504) is included on Line 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS.

For early stage breast cancer, the following breast cancer genome profile tests are included on Line 191 when the listed criteria are met. One test per primary breast cancer is covered when the patient is willing to use the test results in a shared decision-making process regarding adjuvant chemotherapy. Lymph nodes with micrometastases less than 2 mm in size are considered node negative. • Oncotype DX Breast Recurrence Score (CPT 81519) for breast tumors that are estrogen receptor positive, HER2 negative, and either lymph node negative, or lymph node positive with 1-3 involved nodes. • EndoPredict (using CPT 81599 81522) and Prosigna (CPT 81520 or PLA 0008M) for breast tumors that are estrogen receptor positive, HER2 negative, and lymph node negative. • MammaPrint (using CPT 81521 or HCPCS S3854) for breast tumors that are estrogen receptor or progesterone receptor positive, HER2 negative, lymph node negative, and only in those cases categorized as high clinical risk.

EndoPredict, Prosigna, and MammaPrint are not included on Line 191 for early stage breast cancer with involved axillary lymph nodes. Oncotype DX Breast Recurrence Score is not included on Line 191 for breast cancer involving four or more axillary lymph nodes or more extensive metastatic disease.

Oncotype DX Breast DCIS Score (CPT 81479) and Breast Cancer Index (CPT 81518) are included on Line 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS.

For melanoma, BRAF gene mutation testing (CPT 81210) is included on Line 230.

For lung cancer, epidermal growth factor receptor (EGFR) gene mutation testing (CPT 81235) is included on Line 263 only for non-small cell lung cancer. KRAS gene mutation testing (CPT 81275) is not included on this line.

For colorectal cancer, KRAS gene mutation testing (CPT 81275) is included on Line 157. BRAF (CPT 81210) and Oncotype DX are not included on this line. Microsatellite instability (MSI) is included on the Line 662. For bladder cancer, Urovysion testing is included on Line 662.

For prostate cancer, Oncotype DX Genomic Prostate Score, Prolaris Score Assay, and Decipher Prostate RP (CPT 81542) are included on Line 662.

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix A A-8 Appendix A Revised Guideline Notes

The development of this guideline note was informed by a HERC coverage guidance on Biomarkers Tests of Cancer Tissue for Prognosis and Potential Response to Treatment; the prostate-related portion of that coverage guidance was superseded by a Coverage Guidance on Gene Expression Profiling for Prostate Cancer. See https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports.aspx.

GUIDELINE NOTE 161, SACROILIAC ANESTHETIC JOINT INJECTIONS AND SACROILIAC JOINT FUSION Line 527 Sacroiliac joint (SIJ) injection (CPT 20610 and 27096, and HCPCS G0260) is included on this line for diagnostic sacroiliac injections with anesthetic only, but not for therapeutic injections or corticosteroid injections. Injections are only covered for patients for whom SIJ fusion surgery is being considered.

SIJ fusion (CPT 27279) is included on this line for patients who have all of the following: A) Baseline score of at least 30% on the Oswestry Disability Index (ODI) B) Undergone and failed a minimum six months of intensive non-operative treatment that must include non-opioid medication optimization and active therapy. Active therapy is defined as activity modification, chiropractic/osteopathic manipulative therapy, bracing, and/or active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ and hip including a home exercise program. Failure of conservative therapy is defined as less than a 50% improvement on the ODI. C) Typically unilateral pain that is caudal to the lumbar spine (L5 vertebrae), localized over the posterior SIJ, and consistent with SIJ pain. D) Thorough physical examination demonstrating localized tenderness with palpation over the sacral sulcus (Fortin’s point, i.e. at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (e.g. greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist. E) Positive response to at least three of six provocative tests (e.g. thigh thrust test, compression test, Gaenslen’s test, distraction test, Patrick’s sign, posterior provocation test). F) Absence of generalized pain behavior (e.g. somatoform disorder) and generalized pain disorders (e.g. fibromyalgia). G) Diagnostic imaging studies that include ALL of the following: 1) Imaging (plain radiographs and a CT or MRI) of the SIJ that excludes the presence of destructive lesions (e.g. tumor, infection), fracture, traumatic sacroiliac joint instability, or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion 2) Imaging of the pelvis (AP plain radiograph) to rule out concomitant hip pathology 3) Imaging of the lumbar spine (CT or MRI) to rule out neural compression or other degenerative condition that can be causing low back or buttock pain 4) Imaging of the SIJ that indicates evidence of injury and/or degeneration H) At least 75 percent reduction of pain for the expected duration of two anesthetics (on separate visits each with a different duration of action), and the ability to perform previously painful maneuvers, following an image-guided, contrast-enhanced intra-articular SIJ injection.

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix A A-9 Appendix A Revised Guideline Notes

GUIDELINE NOTE 172, INTERVENTIONS WITH MARGINAL CLINICAL BENEFIT OR LOW COST- EFFECTIVENESS FOR CERTAIN CONDITIONS Line 502 The following interventions are prioritized on Line 502 CONDITIONS FOR WHICH INTERVENTIONS RESULT IN MARGINAL CLINICAL BENEFIT OR LOW COST-EFFECTIVENESS:

Procedure Intervention Description Rationale Last Review Code 81219 CALR (calreticulin) (eg, Individual test not cost- November myeloproliferative disorders), effective; should only be done 2019 gene analysis, common variants in as part of a gene panel exon 9 99454 Remote monitoring of physiologic This code does not require November, parameters, 30 days medical decision making nor 2019 communication with a patient

Procedure Intervention Description Rationale Last Review Code C1824 Cardiac contractility modulation Insufficient evidence of November, 2019 effectiveness C1839 Iris prosthesis Insufficient evidence of November, 2019 effectiveness C9756 Intraoperative near-infrared Insufficient evidence of November, 2019 fluorescence lymphatic mapping effectiveness of lymph node(s) C9757 Laminotomy with repair of Insufficient evidence of November, 2019 annular defect with implantation effectiveness of bone anchored annular closure device 15773, 15774 Grafting of autologous fat Insufficient evidence of November 2019 harvested by liposuction effectiveness; utilization technique to face, eyelids, mouth, mainly for cosmetic purposes neck, ears, orbits, genitalia, hands, and/or feet 20560, 20561 Dry needling Insufficient evidence of November 2019 effectiveness

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix A A-10 Appendix A Revised Guideline Notes

Procedure Intervention Description Rationale Last Review Code 44133, 44136 Donor enterectomy and intestinal Insufficient evidence of November 2019 allotransplantation from living effectiveness donor 64451, 64625 Anesthetic or steroid injection Insufficient evidence of November 2019 and/or radiofrequency ablation, effectiveness nerves innervating the sacroiliac joint, with image guidance 64640 Destruction by neurolytic agent; Insufficient evidence of May, 2019 (knee other peripheral nerve or branch effectiveness osteoarthritis) 64454, 64624 Nerve blocks and/or destruction Insufficient evidence of May, 2019 by neurolytic agent, genicular effectiveness nerve branches including imaging guidance, when performed 76376-76377 3D rendering of imaging studies No additional proven benefit November 2019 beyond the standard study, therefore not reimbursed separately 78429-78434, Myocardial imaging, positron Insufficient evidence of January, 2015 78459, 78491- emission tomography (PET), benefit, unclear harms of 78492 metabolic evaluation and/or radiation exposure Updated perfusion November 2019

Coverage Guidance Blog 78491-78492 Myocardial imaging, positron Insufficient evidence of January, 2015 emission tomography (PET), benefit, unclear harms of perfusion radiation exposure Coverage Guidance Blog 81225,81226, Cytochrome P450 gene analysis Insufficient evidence of December, 2011 81230-81231 effectiveness November, 2017 81277 Cytogenomic neoplasia (genome- Insufficient evidence of November 2019 wide) microarray analysis, effectiveness interrogation of genomic regions for copy number and loss-of- heterozygosity variants for chromosomal abnormalities 81542 Oncology (prostate), mRNA, Insufficient evidence of January 2018 microarray gene expression effectiveness profiling of 22 content genes, utilizing formalin-fixed paraffin- embedded tissue, algorithm reported as metastasis risk score

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix A A-11 Appendix A Revised Guideline Notes

Procedure Intervention Description Rationale Last Review Code 81552 Oncology (uveal melanoma), Insufficient evidence of November 2019 mRNA, gene expression profiling effectiveness by real-time RT-PCR of 15 genes (12 content and 3 housekeeping), utilizing fine needle aspirate or formalin-fixed paraffin-embedded tissue, algorithm reported as risk of metastasis 92548, 92549 Computerized dynamic Insufficient evidence of November 2019 posturography effectiveness 93356 Myocardial strain imaging using Insufficient evidence of November 2019 speckle tracking-derived effectiveness assessment of myocardial mechanics 96116 Neurobehavioral status exam November, 2018 96121 (clinical assessment of thinking, reasoning and judgment, eg, acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities)

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix A A-12 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 15769 Grafting of autologous soft tissue, other, harvested by direct excision (eg, fat, Ancillary Procedure File dermis, fascia) 15771 Grafting of autologous fat harvested by liposuction technique to trunk, breasts, 191 CANCER OF BREAST; AT HIGH RISK OF BREAST CANCER scalp, arms, and/or legs; 50 cc or less injectate 15772 Grafting of autologous fat harvested by liposuction technique to trunk, breasts, 191 CANCER OF BREAST; AT HIGH RISK OF BREAST CANCER scalp, arms, and/or legs; each additional 50 cc injectate, or part thereof (List separately in addition to code for primary procedure)

15773 Grafting of autologous fat harvested by liposuction technique to face, eyelids, 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE mouth, neck, ears, orbits, genitalia, hands, and/or feet; 25 cc or less injectate UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 15774 Grafting of autologous fat harvested by liposuction technique to face, eyelids, 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE mouth, neck, ears, orbits, genitalia, hands, and/or feet; each additional 25 cc UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE injectate, or part thereof (List separately in addition to code for primary HARMS THAT OUTWEIGH BENEFITS procedure) 20560 Needle insertion(s) without injection(s); 1 or 2 muscle(s) 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 20561 Needle insertion(s) without injection(s); 3 or more muscles 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 20700 Manual preparation and insertion of drug-delivery device(s), deep (eg, 47, 80,82,98,107,131,132,150,153,160,183, subfascial) (List separately in addition to code for primary procedure) 184,199,200,205,207,235,254,272,285,292, 309,346,355,356,359,372,376,379,401,418, 424,431,442,505,527,529,558,578,598,643 20701 Removal of drug-delivery device(s), deep (eg, subfascial) (List separately in 47, 80,82,98,107,131,132,150,153,160,183, addition to code for primary procedure) 184,199,200,205,207,235,254,272,285,292, 309,346,355,356,359,372,376,379,401,418, 424,431,442,505,527,529,558,578,598,643 20702 Manual preparation and insertion of drug-delivery device(s), intramedullary (List 47, 80,82,98,107,131,132,150,153,160,183, separately in addition to code for primary procedure) 184,199,200,205,207,235,254,272,285,292, 309,346,355,356,359,372,376,379,401,418, 424,431,442,505,527,529,558,578,598,643

1 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 20703 Removal of drug-delivery device(s), intramedullary (List separately in addition to 47, 80,82,98,107,131,132,150,153,160,183, code for primary procedure) 184,199,200,205,207,235,254,272,285,292, 309,346,355,356,359,372,376,379,401,418, 424,431,442,505,527,529,558,578,598,643 20704 Manual preparation and insertion of drug-delivery device(s), intra-articular (List 47, 80,82,98,107,131,132,150,153,160,183, separately in addition to code for primary procedure) 184,199,200,205,207,235,254,272,285,292, 309,346,355,356,359,372,376,379,401,418, 424,431,442,505,527,529,558,578,598,643 20705 Removal of drug-delivery device(s), intra-articular (List separately in addition to 47, 80,82,98,107,131,132,150,153,160,183, code for primary procedure) 184,199,200,205,207,235,254,272,285,292, 309,346,355,356,359,372,376,379,401,418, 424,431,442,505,527,529,558,578,598,643 21601 Excision of chest wall tumor including rib(s) 200 CANCER OF BONES 262 CANCER OF LUNG, BRONCHUS, PLEURA, TRACHEA, MEDIASTINUM AND OTHER RESPIRATORY ORGANS 372 BENIGN NEOPLASM OF RESPIRATORY AND INTRATHORACIC ORGANS 21602 Excision of chest wall tumor involving rib(s), with plastic reconstruction; without 200, 262, 372 mediastinal lymphadenectomy 21603 Excision of chest wall tumor involving rib(s), with plastic reconstruction; with 200, 262, 372 mediastinal lymphadenectomy 33016 Pericardiocentesis, including imaging guidance, when performed 81 MYOCARDITIS, PERICARDITIS, AND ENDOCARDITIS 33017 Pericardial drainage with insertion of indwelling catheter, percutaneous, 81 MYOCARDITIS, PERICARDITIS, AND ENDOCARDITIS including fluoroscopy and/or ultrasound guidance, when performed; 6 years and older without congenital cardiac anomaly

33018 Pericardial drainage with insertion of indwelling catheter, percutaneous, 81 MYOCARDITIS, PERICARDITIS, AND ENDOCARDITIS including fluoroscopy and/or ultrasound guidance, when performed; birth through 5 years of age or any age with congenital cardiac anomaly

33019 Pericardial drainage with insertion of indwelling catheter, percutaneous, 81 MYOCARDITIS, PERICARDITIS, AND ENDOCARDITIS including CT guidance

2 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 33858 Ascending aorta graft, with cardiopulmonary bypass, includes valve suspension, 284 DISSECTING OR RUPTURED AORTIC ANEURYSM when performed; for aortic dissection 33859 Ascending aorta graft, with cardiopulmonary bypass, includes valve suspension, 325 NON-DISSECTING ANEURYSM WITHOUT RUPTURE when performed; for aortic disease other than dissection (eg, aneurysm)

33871 Transverse aortic arch graft, with cardiopulmonary bypass, with profound 134 INTERRUPTED AORTIC ARCH hypothermia, total circulatory arrest and isolated cerebral perfusion with 284 DISSECTING OR RUPTURED AORTIC ANEURYSM reimplantation of arch vessel(s) (eg, island pedicle or individual arch vessel 325 NON-DISSECTING ANEURYSM WITHOUT RUPTURE reimplantation) 34717 Endovascular repair of iliac artery at the time of aorto-iliac artery endograft 284 DISSECTING OR RUPTURED AORTIC ANEURYSM placement by deployment of an iliac branched endograft including pre- 325 NON-DISSECTING ANEURYSM WITHOUT RUPTURE procedure sizing and device selection, all ipsilateral selective iliac artery catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally in the internal iliac, external iliac, and common femoral artery(ies), and treatment zone angioplasty/stenting, when performed, for rupture or other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation, penetrating ulcer, traumatic disruption), unilateral (List separately in addition to code for primary procedure)

34718 Endovascular repair of iliac artery, not associated with placement of an aorto- 284 DISSECTING OR RUPTURED AORTIC ANEURYSM iliac artery endograft at the same session, by deployment of an iliac branched 325 NON-DISSECTING ANEURYSM WITHOUT RUPTURE endograft, including pre-procedure sizing and device selection, all ipsilateral selective iliac artery catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally in the internal iliac, external iliac, and common femoral artery(ies), and treatment zone angioplasty/stenting, when performed, for other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation, penetrating ulcer), unilateral

3 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 35702 Exploration not followed by surgical repair, artery; upper extremity (eg, axillary, 236 LIMB THREATENING VASCULAR DISEASE, INFECTIONS, AND brachial, radial, ulnar) VASCULAR COMPLICATIONS 349 NON-LIMB THREATENING PERIPHERAL VASCULAR DISEASE

35703 Exploration not followed by surgical repair, artery; lower extremity (eg, common 236 LIMB THREATENING VASCULAR DISEASE, INFECTIONS, AND femoral, deep femoral, superficial femoral, popliteal, tibial, peroneal) VASCULAR COMPLICATIONS 349 NON-LIMB THREATENING PERIPHERAL VASCULAR DISEASE

46948 Hemorrhoidectomy, internal, by transanal hemorrhoidal dearterialization, 2 or 472 THROMBOSED AND COMPLICATED HEMORRHOIDS 618 more hemorrhoid columns/groups, including ultrasound guidance, with UNCOMPLICATED HEMORRHOIDS mucopexy, when performed 49013 Preperitoneal pelvic packing for hemorrhage associated with pelvic trauma, 1 PREGNANCY including local exploration 183 FRACTURE OF PELVIS, OPEN AND CLOSED 49014 Re-exploration of pelvic wound with removal of preperitoneal pelvic packing, 1 PREGNANCY including repacking, when performed 183 FRACTURE OF PELVIS, OPEN AND CLOSED 62328 Spinal puncture, lumbar, diagnostic; with fluoroscopic or CT guidance Diagnostic Procedures File 62329 Spinal puncture, therapeutic, for drainage of cerebrospinal fluid (by needle or 19 HYDROCEPHALUS AND BENIGN INTRACRANIAL HYPERTENSION catheter); with fluoroscopic or CT guidance 125 BENIGN NEOPLASM OF THE BRAIN AND SPINAL CORD 196 SUBARACHNOID AND INTRACEREBRAL HEMORRHAGE/HEMATOMA; CEREBRAL ANEURYSM; COMPRESSION OF BRAIN 285COMPLICATIONS OF A PROCEDURE ALWAYS REQUIRING TREATMENT 294 CANCER OF BRAIN AND NERVOUS SYSTEM 371 ENCEPHALOCELE

64451 Injection(s), anesthetic agent(s) and/or steroid; nerves innervating the sacroiliac 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE joint, with image guidance (ie, fluoroscopy or computed tomography) UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 64454 Injection(s), anesthetic agent(s) and/or steroid; genicular nerve branches, 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE including imaging guidance, when performed UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS

4 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 64624 Destruction by neurolytic agent, genicular nerve branches including imaging 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE guidance, when performed UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 64625 Radiofrequency ablation, nerves innervating the sacroiliac joint, with image 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE guidance (ie, fluoroscopy or computed tomography) UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 66987 Extracapsular cataract removal with insertion of intraocular lens prosthesis (1- 139 GLAUCOMA, OTHER THAN PRIMARY ANGLE-CLOSURE stage procedure), manual or mechanical technique (eg, irrigation and aspiration 296 CATARACT or phacoemulsification), complex, requiring devices or techniques not generally 370 AMBLYOPIA used in routine cataract surgery (eg, iris expansion device, suture support for 393 STRABISMUS WITHOUT AMBLYOPIA AND OTHER DISORDERS intraocular lens, or primary posterior capsulorrhexis) or performed on patients OF BINOCULAR EYE MOVEMENTS; CONGENITAL ANOMALIES OF in the amblyogenic developmental stage; with endoscopic EYE; LACRIMAL DUCT OBSTRUCTION IN CHILDREN cyclophotocoagulation

66988 Extracapsular cataract removal with insertion of intraocular lens prosthesis (1 139 GLAUCOMA, OTHER THAN PRIMARY ANGLE-CLOSURE stage procedure), manual or mechanical technique (eg, irrigation and aspiration 296 CATARACT or phacoemulsification); with endoscopic cyclophotocoagulation 370 AMBLYOPIA 393 STRABISMUS WITHOUT AMBLYOPIA AND OTHER DISORDERS OF BINOCULAR EYE MOVEMENTS; CONGENITAL ANOMALIES OF EYE; LACRIMAL DUCT OBSTRUCTION IN CHILDREN

74221 Radiologic examination, esophagus, including scout chest radiograph(s) and Diagnostic Procedures File delayed image(s), when performed; double-contrast (eg, high-density barium and effervescent agent) study 74248 Radiologic small intestine follow-through study, including multiple serial images Diagnostic Procedures File (List separately in addition to code for primary procedure for upper GI radiologic examination) 78429 Myocardial imaging, positron emission tomography (PET), metabolic evaluation 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE study (including ventricular wall motion[s] and/or ejection fraction[s], when UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE performed), single study; with concurrently acquired computed tomography HARMS THAT OUTWEIGH BENEFITS transmission scan

5 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 78430 Myocardial imaging, positron emission tomography (PET), perfusion study 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE (including ventricular wall motion[s] and/or ejection fraction[s], when UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE performed); single study, at rest or stress (exercise or pharmacologic), with HARMS THAT OUTWEIGH BENEFITS concurrently acquired computed tomography transmission scan

78431 Myocardial imaging, positron emission tomography (PET), perfusion study 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE (including ventricular wall motion[s] and/or ejection fraction[s], when UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE performed); multiple studies at rest and stress (exercise or pharmacologic), with HARMS THAT OUTWEIGH BENEFITS concurrently acquired computed tomography transmission scan

78432 Myocardial imaging, positron emission tomography (PET), combined perfusion 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE with metabolic evaluation study (including ventricular wall motion[s] and/or UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE ejection fraction[s], when performed), dual radiotracer (eg, myocardial viability); HARMS THAT OUTWEIGH BENEFITS

78433 Myocardial imaging, positron emission tomography (PET), combined perfusion 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE with metabolic evaluation study (including ventricular wall motion[s] and/or UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE ejection fraction[s], when performed), dual radiotracer (eg, myocardial viability); HARMS THAT OUTWEIGH BENEFITS with concurrently acquired computed tomography transmission scan

78434 Absolute quantitation of myocardial blood flow (AQMBF), positron emission 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE tomography (PET), rest and pharmacologic stress (List separately in addition to UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE code for primary procedure) HARMS THAT OUTWEIGH BENEFITS 78830 Radiopharmaceutical localization of tumor, inflammatory process or distribution Diagnostic Procedures File of radiopharmaceutical agent(s) (includes vascular flow and blood pool imaging, when performed); tomographic (SPECT) with concurrently acquired computed tomography (CT) transmission scan for anatomical review, localization and determination/detection of pathology, single area (eg, head, neck, chest, pelvis), single day imaging

6 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 78831 Radiopharmaceutical localization of tumor, inflammatory process or distribution Diagnostic Procedures File of radiopharmaceutical agent(s) (includes vascular flow and blood pool imaging, when performed); tomographic (SPECT), minimum 2 areas (eg, pelvis and knees, abdomen and pelvis), single day imaging, or single area imaging over 2 or more days 78832 Radiopharmaceutical localization of tumor, inflammatory process or distribution Diagnostic Procedures File of radiopharmaceutical agent(s) (includes vascular flow and blood pool imaging, when performed); tomographic (SPECT) with concurrently acquired computed tomography (CT) transmission scan for anatomical review, localization and determination/detection of pathology, minimum 2 areas (eg, pelvis and knees, abdomen and pelvis), single day imaging, or single area imaging over 2 or more days 78835 Radiopharmaceutical quantification measurement(s) single area (List separately Diagnostic Procedures File in addition to code for primary procedure) 80145 Adalimumab Diagnostic Procedures File 80187 Posaconazole Diagnostic Procedures File 80230 Infliximab Diagnostic Procedures File 80235 Lacosamide Diagnostic Procedures File 80280 Vedolizumab Diagnostic Procedures File 80285 Voriconazole Diagnostic Procedures File 81277 Cytogenomic neoplasia (genome-wide) microarray analysis, interrogation of 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE genomic regions for copy number and loss-of-heterozygosity variants for UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE chromosomal abnormalities HARMS THAT OUTWEIGH BENEFITS 81307 PALB2 (partner and localizer of BRCA2) (eg, breast and pancreatic cancer) gene Diagnostic Procedures File analysis; full gene sequence 81308 PALB2 (partner and localizer of BRCA2) (eg, breast and pancreatic cancer) gene Diagnostic Procedures File analysis; known familial variant 81309 PIK3CA (phosphatidylinositol-4, 5-biphosphate 3-kinase, catalytic subunit alpha) 191 CANCER OF BREAST; AT HIGH RISK OF BREAST CANCER (eg, colorectal and breast cancer) gene analysis, targeted sequence analysis (eg, exons 7, 9, 20) 81522 Oncology (breast), mRNA, gene expression profiling by RT-PCR of 12 genes (8 191 CANCER OF BREAST; AT HIGH RISK OF BREAST CANCER content and 4 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence risk score

7 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 81542 Oncology (prostate), mRNA, microarray gene expression profiling of 22 content 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE metastasis risk score HARMS THAT OUTWEIGH BENEFITS 81552 Oncology (uveal melanoma), mRNA, gene expression profiling by real-time RT- 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE PCR of 15 genes (12 content and 3 housekeeping), utilizing fine needle aspirate UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE or formalin-fixed paraffin-embedded tissue, algorithm reported as risk of HARMS THAT OUTWEIGH BENEFITS metastasis 87563 Infectious agent detection by nucleic acid (DNA or RNA); Mycoplasma Diagnostic Procedures File genitalium, amplified probe technique 90619 Meningococcal conjugate vaccine, serogroups A, C, W, Y, quadrivalent, tetanus 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS toxoid carrier (MenACWY-TT), for intramuscular use 90694 Influenza virus vaccine, quadrivalent (aIIV4), inactivated, adjuvanted, 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS preservative free, 0.5 mL dosage, for intramuscular use 90912 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including 455 URINARY INCONTINENCE EMG and/or manometry, when performed; initial 15 minutes of one-on-one physician or other qualified health care professional contact with the patient

90913 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including 455 URINARY INCONTINENCE EMG and/or manometry, when performed; each additional 15 minutes of one- on-one physician or other qualified health care professional contact with the patient (List separately in addition to code for primary procedure)

92201 Ophthalmoscopy, extended; with retinal drawing and scleral depression of Any line with 92226 peripheral retinal disease (eg, for retinal tear, retinal detachment, retinal tumor) with interpretation and report, unilateral or bilateral

92202 Ophthalmoscopy, extended; with drawing of optic nerve or macula (eg, for Any line with 92226 glaucoma, macular pathology, tumor) with interpretation and report, unilateral or bilateral

8 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 92549 Computerized dynamic posturography sensory organization test (CDP-SOT), 6 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE conditions (ie, eyes open, eyes closed, visual sway, platform sway, eyes closed UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE platform sway, platform and visual sway), including interpretation and report; HARMS THAT OUTWEIGH BENEFITS with motor control test (MCT) and adaptation test (ADT)

93356 Myocardial strain imaging using speckle tracking-derived assessment of 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE myocardial mechanics (List separately in addition to codes for echocardiography UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE imaging) HARMS THAT OUTWEIGH BENEFITS 93985 Duplex scan of arterial inflow and venous outflow for preoperative vessel Diagnostic Procedures File assessment prior to creation of hemodialysis access; complete bilateral study

93986 Duplex scan of arterial inflow and venous outflow for preoperative vessel Diagnostic Procedures File assessment prior to creation of hemodialysis access; complete unilateral study

95700 Electroencephalogram (EEG) continuous recording, with video when performed, Diagnostic Procedures File setup, patient education, and takedown when performed, administered in person by EEG technologist, minimum of 8 channels 95705 Electroencephalogram (EEG), without video, review of data, technical Diagnostic Procedures File description by EEG technologist, 2-12 hours; unmonitored 95706 Electroencephalogram (EEG), without video, review of data, technical Diagnostic Procedures File description by EEG technologist, 2-12 hours; with intermittent monitoring and maintenance 95707 Electroencephalogram (EEG), without video, review of data, technical Diagnostic Procedures File description by EEG technologist, 2-12 hours; with continuous, real-time monitoring and maintenance 95708 Electroencephalogram (EEG), without video, review of data, technical Diagnostic Procedures File description by EEG technologist, each increment of 12-26 hours; unmonitored

95709 Electroencephalogram (EEG), without video, review of data, technical Diagnostic Procedures File description by EEG technologist, each increment of 12-26 hours; with intermittent monitoring and maintenance

9 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 95710 Electroencephalogram (EEG), without video, review of data, technical Diagnostic Procedures File description by EEG technologist, each increment of 12-26 hours; with continuous, real-time monitoring and maintenance 95711 Electroencephalogram with video (VEEG), review of data, technical description Diagnostic Procedures File by EEG technologist, 2-12 hours; unmonitored 95712 Electroencephalogram with video (VEEG), review of data, technical description Diagnostic Procedures File by EEG technologist, 2-12 hours; with intermittent monitoring and maintenance

95713 Electroencephalogram with video (VEEG), review of data, technical description Diagnostic Procedures File by EEG technologist, 2-12 hours; with continuous, real-time monitoring and maintenance 95714 Electroencephalogram with video (VEEG), review of data, technical description Diagnostic Procedures File by EEG technologist, each increment of 12-26 hours; unmonitored

95715 Electroencephalogram with video (VEEG), review of data, technical description Diagnostic Procedures File by EEG technologist, each increment of 12-26 hours; with intermittent monitoring and maintenance 95716 Electroencephalogram with video (VEEG), review of data, technical description Diagnostic Procedures File by EEG technologist, each increment of 12-26 hours; with continuous, real-time monitoring and maintenance 95717 Electroencephalogram (EEG), continuous recording, physician or other qualified Diagnostic Procedures File health care professional review of recorded events, analysis of spike and seizure detection, interpretation and report, 2-12 hours of EEG recording; without video

95718 Electroencephalogram (EEG), continuous recording, physician or other qualified Diagnostic Procedures File health care professional review of recorded events, analysis of spike and seizure detection, interpretation and report, 2-12 hours of EEG recording; with video (VEEG) 95719 Electroencephalogram (EEG), continuous recording, physician or other qualified Diagnostic Procedures File health care professional review of recorded events, analysis of spike and seizure detection, each increment of greater than 12 hours, up to 26 hours of EEG recording, interpretation and report after each 24-hour period; without video

10 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 95720 Electroencephalogram (EEG), continuous recording, physician or other qualified Diagnostic Procedures File health care professional review of recorded events, analysis of spike and seizure detection, each increment of greater than 12 hours, up to 26 hours of EEG recording, interpretation and report after each 24-hour period; with video (VEEG) 95721 Electroencephalogram (EEG), continuous recording, physician or other qualified Diagnostic Procedures File health care professional review of recorded events, analysis of spike and seizure detection, interpretation, and summary report, complete study; greater than 36 hours, up to 60 hours of EEG recording, without video

95722 Electroencephalogram (EEG), continuous recording, physician or other qualified Diagnostic Procedures File health care professional review of recorded events, analysis of spike and seizure detection, interpretation, and summary report, complete study; greater than 36 hours, up to 60 hours of EEG recording, with video (VEEG)

95723 Electroencephalogram (EEG), continuous recording, physician or other qualified Diagnostic Procedures File health care professional review of recorded events, analysis of spike and seizure detection, interpretation, and summary report, complete study; greater than 60 hours, up to 84 hours of EEG recording, without video

95724 Electroencephalogram (EEG), continuous recording, physician or other qualified Diagnostic Procedures File health care professional review of recorded events, analysis of spike and seizure detection, interpretation, and summary report, complete study; greater than 60 hours, up to 84 hours of EEG recording, with video (VEEG)

95725 Electroencephalogram (EEG), continuous recording, physician or other qualified Diagnostic Procedures File health care professional review of recorded events, analysis of spike and seizure detection, interpretation, and summary report, complete study; greater than 84 hours of EEG recording, without video

11 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 95726 Electroencephalogram (EEG), continuous recording, physician or other qualified Diagnostic Procedures File health care professional review of recorded events, analysis of spike and seizure detection, interpretation, and summary report, complete study; greater than 84 hours of EEG recording, with video (VEEG)

96156 Health behavior assessment, or re-assessment (ie, health-focused clinical All lines with 96150 interview, behavioral observations, clinical decision making) 96158 Health behavior intervention, individual, face-to-face; initial 30 minutes All lines with 96152

96159 Health behavior intervention, individual, face-to-face; each additional 15 All lines with 96152 minutes (List separately in addition to code for primary service) 96164 Health behavior intervention, group (2 or more patients), face-to-face; initial 30 All lines with 96153 minutes 96165 Health behavior intervention, group (2 or more patients), face-to-face; each All lines with 96153 additional 15 minutes (List separately in addition to code for primary service)

96167 Health behavior intervention, family (with the patient present), face-to-face; All lines with 96154 initial 30 minutes 96168 Health behavior intervention, family (with the patient present), face-to-face; All lines with 96154 each additional 15 minutes (List separately in addition to code for primary service) 96170 Health behavior intervention, family (without the patient present), face-to-face; All lines with 96155 initial 30 minutes 96171 Health behavior intervention, family (without the patient present), face-to-face; All lines with 96155 each additional 15 minutes (List separately in addition to code for primary service)

12 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 97129 Therapeutic interventions that focus on cognitive function (eg, attention, 91 SEVERE/MODERATE HEAD INJURY: HEMATOMA/EDEMA WITH memory, reasoning, executive function, problem solving, and/or pragmatic PERSISTENT SYMPTOMS functioning) and compensatory strategies to manage the performance of an 178 INTRACEREBRAL HEMORRHAGE activity (eg, managing time or schedules, initiating, organizing, and sequencing 196 SUBARACHNOID AND INTRACEREBRAL tasks), direct (one-on-one) patient contact; initial 15 minutes HEMORRHAGE/HEMATOMA; CEREBRAL ANEURYSM; COMPRESSION OF BRAIN 201 CHRONIC ORGANIC MENTAL DISORDERS INCLUDING DEMENTIAS 285 COMPLICATIONS OF A PROCEDURE ALWAYS REQUIRING TREATMENT 317 STROKE 345 NEUROLOGICAL DYSFUNCTION IN COMMUNICATION CAUSED BY CHRONIC CONDITIONS 377 DYSFUNCTION RESULTING IN LOSS OF ABILITY TO MAXIMIZE LEVEL OF INDEPENDENCE IN SELF-DIRECTED CARE CAUSED BY CHRONIC CONDITIONS THAT CAUSE NEUROLOGICAL DYSFUNCTION 97130 Therapeutic interventions that focus on cognitive function (eg, attention, 91, 178, 196, 201, 285, 317, 345, 377 memory, reasoning, executive function, problem solving, and/or pragmatic functioning) and compensatory strategies to manage the performance of an activity (eg, managing time or schedules, initiating, organizing, and sequencing tasks), direct (one-on-one) patient contact; each additional 15 minutes (List separately in addition to code for primary procedure)

98970 Qualified nonphysician health care professional online digital evaluation and Add to all lines with E&M codes management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5-10 minutes 98971 Qualified nonphysician health care professional online digital evaluation and Add to all lines with E&M codes management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 11-20 minutes 98972 Qualified nonphysician health care professional online digital evaluation and Add to all lines with E&M codes management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 21 or more minutes

13 Appendix B 2020 CPT Codes Code Code Description Placement Recommendation 99421 Online digital evaluation and management service, for an established patient, Add to all lines with E&M codes for up to 7 days, cumulative time during the 7 days; 5-10 minutes

99422 Online digital evaluation and management service, for an established patient, Add to all lines with E&M codes for up to 7 days, cumulative time during the 7 days; 11-20 minutes

99423 Online digital evaluation and management service, for an established patient, Add to all lines with E&M codes for up to 7 days, cumulative time during the 7 days; 21 or more minutes

99458 Remote physiologic monitoring treatment management services, clinical 9, 20, 48, 58, 69, 75 81, 97, 98, 110, 172, 189, 202, 213, 219, 222, staff/physician/other qualified health care professional time in a calendar 223, 225, 233, 257, 281, 283, 304, 341, 347, 366, 464, 566, 635, month requiring interactive communication with the patient/caregiver during 647, 653, 657 the month; each additional 20 minutes (List separately in addition to code for primary procedure) 99473 Self-measured blood pressure using a device validated for clinical accuracy; 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS patient education/training and device calibration 75 HYPERTENSION AND HYPERTENSIVE DISEASE 97 HEART FAILURE 172 HYPERTENSIVE HEART AND RENAL DISEASE 264 CONGESTIVE HEART FAILURE, CARDIOMYOPATHY, MALIGNANT ARRHYTHMIAS, AND COMPLEX CONGENITAL HEART DISEASE 534 HYPOTENSION

99474 Self-measured blood pressure using a device validated for clinical accuracy; 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS separate self-measurements of two readings one minute apart, twice daily over 75 HYPERTENSION AND HYPERTENSIVE DISEASE a 30-day period (minimum of 12 readings), collection of data reported by the 97 HEART FAILURE patient and/or caregiver to the physician or other qualified health care 172 HYPERTENSIVE HEART AND RENAL DISEASE professional, with report of average systolic and diastolic pressures and 264 CONGESTIVE HEART FAILURE, CARDIOMYOPATHY, subsequent communication of a treatment plan to the patient MALIGNANT ARRHYTHMIAS, AND COMPLEX CONGENITAL HEART DISEASE 534 HYPOTENSION

14 Appendix B 2020 HCPCS HCPCS LONG DESCRIPTION Recommended Placement C1824 Generator, cardiac contractility modulation (implantable) 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS C1839 Iris prosthesis 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS C9756 Intraoperative near-infrared fluorescence lymphatic mapping 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS of lymph node(s) (sentinel or tumor draining) with ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT administration of indocyanine green (icg) (list separately in BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS addition to code for primary procedure)

C9757 Laminotomy (hemilaminectomy), with decompression of 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS nerve root(s), including partial facetectomy, foraminotomy ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT and excision of herniated intervertebral disc, and repair of BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS annular defect with implantation of bone anchored annular closure device, including annular defect measurement, alignment and sizing assessment, and image guidance; 1 interspace, lumbar E0787 External ambulatory infusion pump, insulin, dosage rate 8 TYPE 1 DIABETES MELLITUS adjustment using therapeutic continuous glucose sensing

G2058 Chronic care management services, each additional 20 Any line with CPT 99490 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (list separately in addition to code for primary procedure). (do not report g2058 for care management services of less than 20 minutes additional to the first 20 minutes of chronic care management services during a calendar month). (use g2058 in conjunction with 99490). (do not report 99490, g2058 in the same calendar month as 99487, 99489, 99491)).

G2061 Qualified nonphysician healthcare professional online Add to all lines with E&M codes assessment, for an established patient, for up to seven days, cumulative time during the 7 days; 5-10 minutes

1 Appendix B 2020 HCPCS HCPCS LONG DESCRIPTION Recommended Placement G2062 Qualified nonphysician healthcare professional online Add to all lines with E&M codes assessment service, for an established patient, for up to seven days, cumulative time during the 7 days; 11-20 minutes G2063 Qualified nonphysician qualified healthcare professional Add to all lines with E&M codes assessment service, for an established patient, for up to seven days, cumulative time during the 7 days; 21 or more minutes G2064 Comprehensive care management services for a single high-Any line with CPT 99487 risk disease, e.g., principal care management, at least 30 minutes of physician or other qualified health care professional time per calendar month with the following elements: one complex chronic condition lasting at least 3 months, which is the focus of the care plan, the condition is of sufficient severity to place patient at risk of hospitalization or have been the cause of a recent hospitalization, the condition requires development or revision of disease- specific care plan, the condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities

G2065 Comprehensive care management for a single high-risk Any line with CPT 99487 disease services, e.g. principal care management, at least 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month with the following elements: one complex chronic condition lasting at least 3 months, which is the focus of the care plan, the condition is of sufficient severity to place patient at risk of hospitalization or have been cause of a recent hospitalization, the condition requires development or revision of disease-specific care plan, the condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities

2 Appendix B 2020 HCPCS HCPCS LONG DESCRIPTION Recommended Placement G2066 Interrogation device evaluation(s), (remote) up to 30 days; Diagnostic Procedures File implantable cardiovascular physiologic monitor system, implantable loop recorder system, or subcutaneous cardiac rhythm monitor system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results

G2067 Medication assisted treatment, methadone; weekly bundle 4 SUBSTANCE USE DISORDER including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a medicare-enrolled opioid treatment program)

G2068 Medication assisted treatment, buprenorphine (oral); weekly 4 SUBSTANCE USE DISORDER bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)

G2069 Medication assisted treatment, buprenorphine (injectable); 4 SUBSTANCE USE DISORDER weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)

G2070 Medication assisted treatment, buprenorphine (implant 4 SUBSTANCE USE DISORDER insertion); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program) G2071 Medication assisted treatment, buprenorphine (implant 4 SUBSTANCE USE DISORDER removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)

3 Appendix B 2020 HCPCS HCPCS LONG DESCRIPTION Recommended Placement G2072 Medication assisted treatment, buprenorphine (implant 4 SUBSTANCE USE DISORDER insertion and removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program) G2073 Medication assisted treatment, naltrexone; weekly bundle 4 SUBSTANCE USE DISORDER including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare- enrolled opioid treatment program)

G2074 Medication assisted treatment, weekly bundle not including 4 SUBSTANCE USE DISORDER the drug, including substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program) G2075 Medication assisted treatment, medication not otherwise 4 SUBSTANCE USE DISORDER specified; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a medicare-enrolled opioid treatment program)

4 Appendix B 2020 HCPCS HCPCS LONG DESCRIPTION Recommended Placement G2076 Intake activities, including initial medical examination that is 4 SUBSTANCE USE DISORDER a complete, fully documented physical evaluation and initial assessment by a program physician or a primary care physician, or an authorized healthcare professional under the supervision of a program physician qualified personnel that includes preparation of a treatment plan that includes the patient's short-term goals and the tasks the patient must perform to complete the short-term goals; the patient's requirements for education, vocational rehabilitation, and employment; and the medical, psycho- social, economic, legal, or other supportive services that a patient needs, conducted by qualified personnel (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure

G2077 Periodic assessment; assessing periodically by qualified 4 SUBSTANCE USE DISORDER personnel to determine the most appropriate combination of services and treatment (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure

G2080 Each additional 30 minutes of counseling in a week of 4 SUBSTANCE USE DISORDER medication assisted treatment, (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure

G2082 Office or other outpatient visit for the evaluation and 7 MAJOR DEPRESSION, RECURRENT; MAJOR DEPRESSION, management of an established patient that requires the SINGLE EPISODE, SEVERE supervision of a physician or other qualified health care professional and provision of up to 56 mg of esketamine nasal self-administration, includes 2 hours post- administration observation G2083 Office or other outpatient visit for the evaluation and 7 MAJOR DEPRESSION, RECURRENT; MAJOR DEPRESSION, management of an established patient that requires the SINGLE EPISODE, SEVERE supervision of a physician or other qualified health care professional and provision of greater than 56 mg esketamine nasal self-administration, includes 2 hours post- administration observation

5 Appendix B 2020 HCPCS HCPCS LONG DESCRIPTION Recommended Placement G2086 Office-based treatment for opioid use disorder, including 4 SUBSTANCE USE DISORDER development of the treatment plan, care coordination, individual therapy and group therapy and counseling; at least 70 minutes in the first calendar month

G2087 Office-based treatment for opioid use disorder, including 4 SUBSTANCE USE DISORDER care coordination, individual therapy and group therapy and counseling; at least 60 minutes in a subsequent calendar month G2088 Office-based treatment for opioid use disorder, including 4 SUBSTANCE USE DISORDER care coordination, individual therapy and group therapy and counseling; each additional 30 minutes beyond the first 120 minutes (list separately in addition to code for primary procedure)

6 Appendix B New CDT 2020 Codes

Procedure Nomenclature Recommended placement

D0419 Assessment of salivary flow by EXCLUDED FILE measurement D1551 Re-cement or re-bond bilateral 53 PREVENTIVE DENTAL SERVICES space maintainer – maxillary D1552 Re-cement or re-bond bilateral space 53 PREVENTIVE DENTAL SERVICES maintainer – mandibular D1553 Re-cement or re-bond unilateral 53 PREVENTIVE DENTAL SERVICES space maintainer – per quadrant

D1556 Removal of fixed unilateral space 53 PREVENTIVE DENTAL SERVICES maintainer – per quadrant

D1557 Removal of fixed bilateral space 53 PREVENTIVE DENTAL SERVICES maintainer – maxillary D1558 Removal of fixed bilateral space 53 PREVENTIVE DENTAL SERVICES maintainer – mandibular D2753 Crown - porcelain fused to 591 ADVANCED RESTORATIVE-ELECTIVE titanium or titanium alloy

D5284 Removable unilateral partial 591 ADVANCED RESTORATIVE-ELECTIVE denture – one piece flexible base (including clasps and teeth)- per quadrant D5286 Removable unilateral partial 591 ADVANCED RESTORATIVE-ELECTIVE denture – one piece resin (including clasps and teeth) - per quadrant D6082 Implant supported crown - 619 IMPLANTS porcelain fused to predominantly base alloys D6083 Implant supported crown - 619 IMPLANTS porcelain fused to noble alloys D6084 Implant supported crown - 619 IMPLANTS porcelain fused to titanium or titanium alloy D6086 Implant supported crown - 619 IMPLANTS predominantly base alloys D6087 Implant supported crown - noble 619 IMPLANTS alloys

1 Appendix B New CDT 2020 Codes

Procedure Nomenclature Recommended placement

D6088 Implant supported crown - 619 IMPLANTS titanium/titanium alloys D6097 Abutment supported crown - 619 IMPLANTS porcelain fused to titanium or titanium alloys D6098 Implant supported retainer for 619 IMPLANTS metal FPD - porcelain fused to predominantly base alloys D6099 Implant supported retainer for 619 IMPLANTS metal FPD - porcelain fused to noble alloys D6120 Implant supported retainer - 619 IMPLANTS porcelain fused to titanium or titanium alloy D6121 Implant supported retainer for 619 IMPLANTS metal FPD - predominantly base alloys D6122 Implant supported retainer for 616 IMPLANTS metal FPD - noble alloys D6123 Implant supported retainer for 619 IMPLANTS metal FPD- titanium or titanium alloy D6195 Abutment supported retainer - 619 IMPLANTS porcelain fused to titanium or titanium alloy D6243 Pontic - porcelain fused to 619 IMPLANTS titanium or titanium alloys D6753 Retainer crown - porcelain fused 619 IMPLANTS to titanium or titanium alloys

D6784 Retainer crown ¾ - titanium and 591 ADVANCED RESORATIVE-ELECTIVE titanium alloys D7922 Placement of intra-socket EXCLUDED FILE biological dressing to aid in hemostasis or clot stabilization, per site D8696 Repair of orthodontic appliance – 42 CLEFT PALATE WITH AIRWAY OBSTRUCTION maxillary 257 DEFORMATIES OF HEAD 300 CLEFT PALATE AND/OR CLEFT LIP 615 ORTHODONTIA

2 Appendix B New CDT 2020 Codes

Procedure Nomenclature Recommended placement

D8697 Repair of orthodontic appliance – 42 CLEFT PALATE WITH AIRWAY OBSTRUCTION mandibular 256 DEFORMATIES OF HEAD 300 CLEFT PALATE AND/OR CLEFT LIP 618 ORTHODONTIA

D8698 Re-cement or re-bond fixed 42 CLEFT PALATE WITH AIRWAY OBSTRUCTION retainer – maxillary 256 DEFORMATIES OF HEAD 300 CLEFT PALATE AND/OR CLEFT LIP 618 ORTHODONTIA

D8699 Re-cement or re-bond fixed 42 CLEFT PALATE WITH AIRWAY OBSTRUCTION retainer – mandibular 256 DEFORMATIES OF HEAD 300 CLEFT PALATE AND/OR CLEFT LIP 618 ORTHODONTIA

D8701 Repair of fixed retainer, includes 42 CLEFT PALATE WITH AIRWAY OBSTRUCTION reattachment – maxillary 257 DEFORMATIES OF HEAD 300 CLEFT PALATE AND/OR CLEFT LIP 615 ORTHODONTIA

D8702 Repair of fixed retainer, includes 42 CLEFT PALATE WITH AIRWAY OBSTRUCTION reattachment – mandibular 256 DEFORMATIES OF HEAD 300 CLEFT PALATE AND/OR CLEFT LIP 618 ORTHODONTIA

D8703 Replacement of lost or broken 42 CLEFT PALATE WITH AIRWAY OBSTRUCTION retainer – maxillary 256 DEFORMATIES OF HEAD 300 CLEFT PALATE AND/OR CLEFT LIP 618 ORTHODONTIA

D8704 Replacement of lost or broken 42 CLEFT PALATE WITH AIRWAY OBSTRUCTION retainer – mandibular 256 DEFORMATIES OF HEAD 300 CLEFT PALATE AND/OR CLEFT LIP 618 ORTHODONTIA

D9997 Dental case management – ANCILLARY patients with special health care needs

3 Appendix C New Guideline Notes

DIAGNOSTIC GUIDELINE D26, NEUROBEHAVIORAL STATUS EXAMS AND NEUROPSYCHOLOGICAL TESTING

Neurobehavioral status exams (CPT 96116 and 96121) and neuropsychological testing services (CPT 96132 and 96133) are only covered when all of the following are met: 1) Symptoms are not explained by an existing diagnosis; AND 2) When the results of such testing will be used to develop a care plan.

GUIDELINE NOTE 197, COUNSELING FOR PREGNANT AND POSTPARTUM WOMEN Lines 1, 3, 35, 63 Counseling for the prevention of peripartum mood disorders for pregnant and postpartum women (including up to 1 year after birth or pregnancy loss) are included on these lines according to USPSTF recommendations https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/peri natal-depression-preventive-interventions and should be coded with health behavior assessment and intervention procedure codes.

Supervision of pregnancy codes (ICD-10 O09.X, Z34.X), encounter for screening for maternal depression (ICD-10 Z13.32), and encounter for routine postpartum follow-up (ICD-10 Z39.2) are appropriate to pair with health behavior assessment and interventions for these purposes.

[Note: purple wording above was removed from the guideline by the HERC at the 11/14/19 HERC meeting]

ANCILLARY GUIDELINE NOTE A5, TELECONSULTATIONS AND NON-FACE-TO -FACE TELEHEALTH SERVICES

Patient to Clinician Services (via telephone or electronic)

Telephonic and electronic services, including services related to diagnostic workup (CPT 98966- 98968, 99441-99443, 99421-99423, 98970-98972, G2012, G2061-G2063) between a patient and clinician must meet the following criteria: 1) Ensure pre-existing relationship as demonstrated by at least one prior office visit within the past 36 months. 2) Documentation must: a. model SOAP charting, or be as described in program’s OAR; b. include patient history, provider assessment, treatment plan and follow-up instructions; c. support the assessment and plan; d. be retained in the patient’s medical record and be retrievable. 3) Medical decision making (or behavioral health intervention/ psychotherapy) is necessary. 4) Ensure permanent storage (electronic or hard copy) of the encounter. 5) Meet HIPAA standards for privacy.

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix C C-1 Appendix C New Guideline Notes

6) Include a patient-clinician agreement of informed consent, which is discussed with and signed by the patient and documented in the medical record. 7) Not be billed when the same services are billed as care plan oversight or anticoagulation management (CPT codes 99339-99340, 99374-99380 or 99363-99364). 8) When a telephone or electronic service refers to an E/M service performed and billed by the physician within the previous seven days, it is not separately billable, regardless of whether it is the result of patient-initiated or physician-requested follow-up. 9) This service is not billed if the service results in the patient being seen within 24 hours or the next available appointment. 10) If the service relates to and takes place within the postoperative period of a procedure provided by the physician, the service is considered part of the procedure and is not be billed separately.

Examples of reimbursable telephone or electronic services include but are not limited to: 1) Extended counseling when person-to-person contact would involve an unwise delay. 2) Treatment of relapses that require significant investment of provider time and judgment. 3) Counseling and education for patients with complex chronic conditions.

Examples of non-reimbursable telephone consultations include but are not limited to: 1) Prescription renewal. 2) Scheduling a test. 3) Reporting normal test results. 4) Requesting a referral. 5) Follow up of medical procedure to confirm stable condition, without indication of complication or new condition. 6) Brief discussion to confirm stability of chronic problem and continuity of present management.

Clinician-to-Clinician Telehealth Consultations (telephonic and electronic)

Telehealth consultations are defined as the use, including use related to diagnostic workup, of telehealth to facilitate collaboration between two or more clinicians. Requirements for coverage of electronic consultation or telephonic interprofessional consultation are as follows:

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix C C-2 Appendix C New Guideline Notes

Consulting Providers (99451, 99446-9) o Consult must be requested by another provider o Can be for a new or exacerbated condition o Cannot be reported more than 1 time per 7 days for the same patient o Cumulative time spent reported, even if time occurs over multiple days o Cannot be reported if a transfer of care or request for face-to-face visit occurs as a result of the consultation within the next 14 days o Cannot be reported if the patient was seen by the consultant within the past 14 days o Request and reason for consultation request must be documented in the patient’s medical record o Requires a minimum of 5 minutes

Requesting Providers (99452) o eConsult must be reported by requesting provider (not for the transfer of a patient or request for face-to-face consult) o Reported only when the patient is not on-site and with the provider at the time of consultation o Cannot be reported more than 1 time per 14 days per patient o Requires a minimum of 16 minutes. Includes time for referral prep and/or communicating with the consultant. o Can be reported with prolonged services, non-direct

Limited information provided by one clinician to another that does not contribute to collaboration (e.g., interpretation of an electroencephalogram, report on an x-ray or scan, or reporting the results of a diagnostic test) is not considered a consultation.

GUIDELINE NOTE 199, INTESTINE TRANSPLANT Line 239 Intestine transplant is included on this line only for patients with failure of total parenteral nutrition (TPN) as indicated by one of the following, and no contraindications to transplant: 1) Impending or overt liver failure due to TPN, indicated by elevated serum bilirubin and/or liver enzymes, splenomegaly, thrombocytopenia, gastro-esophageal varices, coagulopathy, peristomal bleeding, or hepatic fibrosis/cirrhosis; OR 2) Thrombosis of ≥ 2 central veins, including jugular, subclavian, and femoral veins; OR 3) Two or more episodes of systemic sepsis due to line infection, per year, or one episode of septic shock, acute respiratory distress syndrome, and/or line related fungemia; OR 4) Frequent episodes of dehydration despite IV fluid supplementation; OR 5) Other complications leading to loss of vascular access

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix C C-3 Appendix C New Guideline Notes

GUIDELINE NOTE 196, BREAST SURGERY REVISION Lines 191,285,312,424,560,636,642 Revision of previous breast reconstruction, augmentation, or other breast surgery is only covered in cases where the revision is required to address complications of the surgery (wound dehiscence, fistula, chronic pain directly related to the surgery, etc.). For capsular contracture, only stage 4 contractures with chronic pain are covered for revision surgery/capsulotomy. Revisions of breast reconstruction, augmentation or other breast surgery are not covered solely for cosmetic issues.

Value-based Benefits Subcommittee Minutes, 11/14/2019 Appendix C C-4

MINUTES

Evidence-based Guidelines Subcommittee Clackamas Community College Wilsonville Training Center, Rooms 111-112 29353 SW Town Center Loop E Wilsonville, Oregon 97070 December 5, 2019 2:00-5:00pm

Members Present: Devan Kansagara, MD, Chair; Eric Stecker, MD, MPH, Vice-Chair (joined by phone at 2:53pm); Alison Little, MD, MPH; Angela Senders, ND; Lynnea Lindsey, PhD; Mike Adler, MD, Leslie Sutton.

Members Absent: None

Staff Present: Cat Livingston, MD, MPH; Jason Gingerich, Jaime Taylor.

Also Attending: Val King MD, MPH, Moira Ray, Erica Shaw and Amanda Delzer Hill (OHSU Center for Evidence-based Policy); Rika Bierek (Oregon Medical Association); Melissa Cheyney, PhD (Oregon State University); Silke Akerson (Oregon Midwifery Council); Stefanie Rogers, MD (Providence); Sharron Fuchs and Karen DeWitt (Oregon Association of Birthing Centers); Diane Quiring (Oregon Health Authority- Health Systems Division); Alice Taylor, CNM, NP, MPH; Duncan Neilson, MD (Legacy Medical Group).

1. Call to Order

Devan Kansagara called the meeting of the Evidence-based Guidelines Subcommittee (EbGS) to order at 2:00 pm. A quorum of members was present at the meeting. He welcomed Gingerich in his new role as director.

2. Minutes Review

Minutes from the 9/12/2019 meeting were reviewed and approved 6-0 (Stecker absent).

3. Staff Report

Gingerich reported that his prior policy analyst position has not been filled, but that it will be posted as soon as possible.

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4. Planned Out-of-hospital Birth

Livingston and King reported on a number of changes and corrections to the draft coverage guidances since the last meeting, as described in the meeting materials. King discussed inclusion of the Strong Start study.

The subcommittee discussed the proposal for change to the behavioral risk factors, including the definition of severe and persistent mental illness (SPMI). Lindsey said the word severe is key. For instance, chronic depression or anxiety may not be severe. People with severe and persistent mental illness tend not to be employed and to have difficulties with activities of daily living. Kansagara asked about people with diagnoses like bipolar who may be stable and functional. Lindsey said you may still include these people in the definition of SPMI because of the risks that pregnancy or associated medical changes would cause instability or an unknown in what the birth will bring. Sutton asked whether this is part of the original list. Lindsey said the original definition was not as refined. Gingerich asked which definition for SPMI should be used. Lindsey said we should use the Oregon definition. Sutton said her concern is that you could have someone who is well-managed and has shifted medications ahead of time who has one of these diagnoses but could still be a candidate for out-of-hospital birth. Little and Lindsey agreed that these diagnoses create the potential for instability which may pose a danger for the mother or child. After additional discussion the subcommittee decided to list specific conditions: schizophrenia, other psychotic disorders, bipolar I disorder or schizotypal disorders as conditions for transfer rather than referring to severe and persistent mental illness, as this definition is defined in a rule which is under review. These conditions were selected because of high risk of potential complications such as delusions and self-harm, and teratogenicity of certain medications. They decided against including obsessive compulsive disorder or post traumatic stress disorder due to the variability in severity of these conditions.

Gingerich introduced ad hoc experts Duncan Neilson, Stefanie Rogers, Melissa Cheyney and Alice Taylor and reviewed their expertise and conflicts of interest.

Discussion turned to Appendices I and J, beginning with Appendix I with pulmonary conditions. The subcommittee agreed to the following changes from the 2015 guidance.

• For active respiratory distress, the subcommittee added a new transfer requirement for “respiratory distress.” The subcommittee discussed a patient who had an asthma attack at a prenatal visit, which was treated. Such a patient could still plan an out-of-hospital birth • For pulmonary disease, the subcommittee agreed to make chronic pulmonary disease a consultation criterion. Not all pulmonary diseases would require a hospital birth • Acute pyelonephritis was made a consultation requirement • For renal disease, the subcommittee created a consultation criterion for abnormal renal function and a transfer criterion for renal failure or renal disease requiring a specialist, clarifying that preeclampsia and related conditions are addressed elsewhere • Systematic lupus erythematosus and scleroderma were added as transfer requirements • Shoulder dystoria was left as a consultation requirement • Drug or alcohol misuse with high-risk for adverse effects to fetal or maternal health was made a transfer criterion; substance use disorder undermedication-assisted treatment (MAT) was added as a consultation criterion

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o Discussion indicated that the consultation requirement is necessary to ensure care coordination between the MAT provider and the birth attendant rather than for consultation about whether a planned out-of-hospital birth is appropriate. • History of substance use disorder and cigarette and/or cannabis use were not added as consultation criteria • Anatomic anomaly (e.g. bicornuate, large fibroid impacting delivery) was added as a consultation criterion • Prior hysterotomy was added as a transfer criterion (the draft was corrected to change hysterectomy to hysterotomy). This criterion was moved to the prior pregnancy table. • Prior myomectomy was added as a transfer criterion. This criterion was moved to the prior pregnancy table.

Under Appendix J the following changes were adopted: • Evidence of or suspected major congenital anomaly or abnormality, unless no resuscitation planned was added as a transfer criterion • Fewer than 3 vessels in umbilical cord was added as a consultation requirement • Persistent poor suck, poor feeding, lethargy, hypotonia or abnormal cry was added as a consultation requirement • Severe abrasions, unusual pigmentation and/or lesions was added as a consultation criterion • Any generalized rash at birth was added as a consultation criterion • Clinical evidence of prematurity (age <35 weeks) was added as a transfer criterion, with an annotation (e.g. Ballard); obstetrically determined gestational age <37 weeks was added as a transfer criterion • Infection of umbilical stump site was added as a transfer criterion • Not clinical well-appearing was not added. • Maternal chorioamnionitis was added to neonatal conditions (previously only in fetal conditions) • Direct Coombs positive was added as a consultation criterion • Evidence or suspected neonatal abstinence syndrome or withdrawal was added as a consultation criterion • Prolonged positive pressure ventilation or significant resuscitation was added as a transfer criterion • Abnormal heart rate pattern or persistent/symptomatic murmur was added as a transfer criterion • Weight criteria were clarified to require transfer at <2000 grams, and consultation from 2000 to 2500 grams.

Kansagara invited public testimony.

Sharron Fuchs offered her comments, clarifying a written comment submitted by Vern Saboe, DC, prior to the meeting, supporting the coverage guidance. She clarified that his letter means that the HERC guidance constitutes the scope of practice and some of the standards of care for the chiropractic profession around out-of-hospital birth.

Silke Akerson, a licensed direct-entry midwife, and executive director of the Oregon Midwifery Association offered her comments. She said she has been sounding an alarm that the group is far into creating practice standards for midwifery that her concerns aren’t being heard. She said it is

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inappropriate for HERC to create practice standards. She said she had reviewed other coverage guidances, such as the one for planned cesarean section and they are much less detailed and more based on evidence. They treat providers as professionals practicing within their own license and scope and practice standards.

She said that the EbGS had made practice guidelines for a broad profession, using personal opinion and professional expertise, not evidence, and said that if such guidelines are to be created there should be more midwife experts involved. She raised concern about decreased access to out-of-hospital birth and creating harm to all the professions and boards that have their own guidance.

She asked what the evidence is regarding several of the consultation/transfer requirements, including a history of postpartum psychosis. She said based on her professional expertise, for many women who have had postpartum psychosis, out-of-hospital birth is an excellent choice because they are able to have one-on-one individualized care with someone who can work with their team of mental health professionals to make a really specific plan. They don’t have the interruption or fear of going to a facility they may have a lot of tension about. In addition, postpartum psychosis happens two days to two weeks postpartum, well after labor and delivery. It’s not about what happens at the birth.

She also asked about the evidence for other factors, including that a midwife is not capable of assessing whether a 16-year-old or a woman with a prior 3rd degree tear, or cannabis use. She said that evidence- based standards should be restricted to factors we have clear evidence about such as breech, twins, gestational diabetes, pregnancy-induced hypertension and gestational diabetes. She also requested that the transfer and consult criteria be listed separately for ease of use.

Karen Dewitt spoke next. She is a naturopathic physician who attends out-of-hospital births and owns a birthing center. She believes in importance of evidence-based medicine and informed consent. While she acknowledged HERC and OHA have had good intentions, she affirmed Akerson’s comments that the criteria are not evidence-based and are too detailed. She said that from 2015 to 2017 there was a 75 percent decrease in out-of-hospital births covered by the Oregon Health Plan. She referenced the Strong Start data and said that we should be increasing access to midwifery because of lower cesarean rates, successful VBAC rates and other outcomes such as lower preterm birth rates. She said the issue isn’t the list of risk factors in itself (though there needs to be more input from out-of-hospital birth providers in order for it to work well). Rather, there are a lot of situations where a woman shouldn’t be giving birth outside a hospital but there is also a gray area where women have a right to make a choice.

She said the feedback from 95 percent of her patients is that the prior authorization process is discriminatory and traumatic and increases their overall anxiety about their prenatal care and their birth plan. This is because of how long the process takes. She does prior authorization every day for other services but this is different in terms of the amount of medical records and the distinction that no approval is given until the third trimester. (Akerson interrupted to say that the policy has recently changed and there is now a hold on payment until after the birth records are sent. The midwife can go an entire course of care and not know whether she will be paid). Dewitt confirmed that she recently became aware that they had to send labor flow notes after the birth, and for a lot of women this feels like an invasion of privacy. She also expressed concerns about PA staff denying coverage for criteria not on the list, such as Ehlers-Danlos syndrome. Her birthing center has had to hire someone just to manage the prior authorizations. She said many midwives have stopped accepting Medicaid.

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She gave an example of women who feel discriminated against, such as those with higher BMI. The majority feel the consultation doesn’t add any more safety to their care and feel humiliated to have to have the approval of a hospital-based provider who doesn’t know about out-of-hospital birth.

She recommended OHP consider process more like that used in Washington, with a one-ortwo-page summary of the woman’s overall health. It’s straightforward and not humiliating or traumatizing and it doesn’t make providers not want to accept Medicaid.

She also told of a woman whose Medicaid coverage for a home birth was denied due to mental illness. She was not comfortable in a hospital due to previous trauma experienced in a hospital, and so planned to wait to the last minute to go to the hospital. The baby came sooner than she expected and she had an unattended home birth. Fortunately, she and the baby were OK, but she could have had a hemorrhage or the baby could have needed rescussitation.

She expressed concern that many consulting providers say they don’t know enough to say that out-of- hospital birth is safe, so they don’t recommend it and coverage is denied based on the consultation.

Kansagara said he agrees with much of what Akerson and DeWitt said. He said this process is an imperfect forum for doing other things that need to be done in this field. There may need to be state level meetings between the OB community and midwives and OHA. In addition, implementation issues related to the Strong Start study should happen. EbGS, however, was tasked with coming up with a fairly decent set of guidance, despite the fact there is a lack of evidence in many areas. Therefore, this was structured as a review of guidelines. He said is unfortunate that there are a lot of barriers in the implementation process and encouraged the commenters to lobby the Oregon Health Plan about these issues. A commenter responded that HERC is driving these criteria, and Kansagara said that was not the intent.

Someone asked what the problem HERC is trying to solve. There was existing guidance from several years ago. Neilson said we were charged at reviewing it as a particular interval and we initially didn’t think we needed to review it, but there was feedback from the larger community that said we would be remiss not to review the guidelines. Gingerich clarified that EbGS did review the new evidence and recommended not updating the coverage guidance, but was overruled by the HERC, which requested the current review based on evidence and testimony regarding certain risk groups.

Akerson said the main additions to the current document are not based on that study (which she said had extremely flawed data). Kansagara said EbGS has gone into this with the intent of respecting the decisionmaking of individuals and to make this more accessible than may have been otherwise done following some of the newer studies. He said this topic is a bit different from many other topics and we certainly acknowledge that.

Stecker said he agrees to some degree with public testimony. This is an issue we confront from time to time, when there is only indirect evidence or no evidence, yet we need to make coverage guidance. In cardiology there are evidence-based guidelines, but also appropriate use criteria based on expert opinion. One time the subcommittee ran into this was with urine toxicology screening. He requested that we ask OHA and/or HERC to better structure for us how to handle these sorts of situations. Kansagara agreed.

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Gingerich reviewed the status of the report in the development process. The next step would be for the subcommittee to vote to put the coverage guidance out for a 30-day public comment period. This is the best time for members of the public to raise their concerns about the criteria, as each comment will be addressed by staff and the subcommittee will review the response at the February meeting. Upon approval the report will be forwarded to the HERC for final approval (or revision).

A motion was made to post the draft coverage guidance for public comment. Motion approved 5-0 (Not present: Adler, Sutton).

DRAFT HERC COVERAGE GUIDANCE Planned out-of-hospital birth is recommended for coverage for pregnant women who are at low risk for adverse obstetric or birth outcomes (weak recommendation). The high-risk conditions outlined below would either preclude coverage of planned out-of-hospital birth, necessitate a consultation, or require transfer of the mother or infant to a hospital setting. When a condition requiring transfer arises during labor, an attempt should be made to transfer the mother and/or her newborn; however, imminent fetal delivery may delay or preclude actual transfer prior to birth. Coverage of prenatal, intrapartum, and postpartum care is recommended with the performance of appropriate risk assessments (at initiation of care and throughout pregnancy and delivery) and the out-of-hospital birth attendant’s adherence to the consultation and transfer criteria as outlined below. Planned out-of-hospital birth is not recommended for coverage for pregnancies with identified high- risk factors necessitating a planned hospital birth, or when the listed criteria for consultation and transfer of care are not followed by the birth attendant (strong recommendation). When a high-risk condition develops that requires transfer or planned hospital birth, coverage is recommended when appropriate care is provided until the point the high-risk condition is identified. For women who have a high-risk condition requiring consultation, ongoing coverage of planned out- of-hospital birth care is recommended as long as the consulting provider’s recommendations are then appropriately managed by the out-of-hospital birth attendant in a planned out-of-hospital birth setting. HIGH-RISK CONDITIONS Conditions in the red (darker) boxes indicate high-risk conditions that require planned hospital birth (when present on intake) or transfer of the mother or infant to hospital-based care (when condition develops). Conditions in the yellow (lighter) boxes indicate potentially risky conditions that require consultation. Consultations may be with 1) a provider (MD/DO or CNM) who has active admitting privileges to manage pregnancy in a hospital and/or 2) appropriate specialty consultation (e.g., maternal-fetal medicine, hepatologist, hematologist, psychiatrist). For infectious conditions such as uncomplicated urinary tract infection or sexually transmitted infections, no consultation is necessary if the patient receives appropriate treatment. This list of high-risk conditions is not exhaustive, and other, physical health, behavioral health, obstetric, or fetal high-risk conditions may arise that require consultation and/or transfer to hospital- based care. Having multiple risk conditions requiring consultation may increase the risk sufficiently to indicate the need for transfer of care.

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MEDICAL HISTORY OR OBSTETRIC HISTORY Cancer • Cancer affecting site of delivery Cardiovascular disease • Cardiovascular disease causing functional impairment Cervical conditions • Insufficiency or cerclage Collagen-vascular diseases • Any collagen-vascular disease Delivery history • Prior cesarean section Diabetes Mellitus • Type 1 diabetes • Type 2 diabetes Endocrine Conditions • Significant endocrine conditions other than diabetes (e.g. hyperthyroidism) Fetal demise or stillbirth • History of unexplained stillbirth/neonatal death or previous death related to intrapartum difficulty • Prior unexplained stillbirth/neonatal death or death unrelated to intrapartum difficulty Fetal growth • History of intrauterine growth restriction (IUGR) • Prior small for gestational age infant • Prior baby > 4.5 kg or 9 lbs 14 oz Genetic/heritable disorders • Family history of genetic/heritable disorders that would affect labor, delivery, or care of newborn Examples include family history of thrombophilia • Prior child with congenital or hereditary disorder Hematologic disorders • History of thrombosis or thromboembolism • Maternal bleeding disorder • Anemia with hemoglobin < 8.5 g/dL during prior pregnancy • Hemoglobinopathies • History of postpartum hemorrhage requiring intervention Hypertensive disorders • Eclampsia • Pre-eclampsia requiring preterm birth • HELLP syndrome (hemolysis, elevated liver enzymes, low platelets) • Pre-existing or chronic hypertension • History of pre-eclampsia not requiring preterm birth Infectious Diseases • HIV positive Isoimmunization • Blood group incompatibility and/or Rh sensitization in a prior pregnancy Miscarriage/nonviable • 3 or more 1st trimester spontaneous miscarriages pregnancy • 1 or more 2nd trimester spontaneous miscarriages Neonatal encephalopathy in • Neonatal encephalopathy in prior pregnancy prior pregnancy

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MEDICAL HISTORY OR OBSTETRIC HISTORY Neurological disorders • Neurological disorders or active seizure disorders that would impact maternal or neonatal health (e.g. epilepsy, myasthenia gravis, previous cerebrovascular accident) • History of maternal seizure disorder (excluding eclampsia) Obesity or overweight (pre- • Class 2 or 3: BMI ≥ 35.0 pregnancy) – can be patient- reported Perineal lacerations or • 4th degree prior pregnancy without satisfactory obstetric anal sphincter injury functional recovery • 3rd degree prior pregnancy • 4th degree prior pregnancy with satisfactory functional recovery Placental conditions • History of retained placenta requiring surgical removal Preterm birth • History of >1 preterm birth • History of preterm birth (before 34 weeks) Psychiatric conditions • History of postpartum mood disorder with high risk to the infant (e.g. psychosis) • Schizophrenia, other psychotic disorders, bipolar I disorder or schizotypal disorders Pulmonary disease • Pulmonary disease (e.g. cystic fibrosis) Renal disease • Renal disease requiring supervision by a renal specialist • Renal failure (Preeclampsia and related conditions are listed separately) • Abnormal renal function Rheumatologic • Systemic lupus erythematous • Scleroderma Shoulder dystocia • History of, with or without fetal clavicular fracture Uterine conditions • Prior hysterotomy • Prior myomectomy

CONDITIONS OF CURRENT PREGNANCY • Antepartum hemorrhage, recurrent Abnormal bleeding in • Hemorrhage (hypovolemia, shock, need for pregnancy transfusion, vital sign instability) Age • < 17 years • > 40 years

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Amniotic membrane rupture • Before 37 weeks 0 days • Pre-labor rupture > 24 hours Congenital or hereditary • Evidence of congenital anomalies requiring anomaly of the fetus immediate assessment and/or management by a neonatal specialist Diabetes, gestational • Requiring medication or uncontrolled • Diet controlled Fetal demise or stillbirth • Fetal demise (after 12 weeks gestation) Fetal growth • Uteroplacental insufficiency • IUGR (defined as fetal weight less than fifth percentile using ethnically-appropriate growth tables, or concerning reduced growth velocity on ultrasound). • Inappropriate uterine growth (size-date discrepancy). (An ultrasound read by a qualified physician constitutes a consultation). • Suspected (estimated weight >4.5 kg or 9lbs 14 oz) Fetal monitoring or movement • Abnormal fetal heart rate, Doppler, or surveillance studies • Repetitive or persistent abnormal fetal heart rate pattern during labor • Inability to adequately follow an intermittent auscultation protocol • Abnormally decreased fetal movement at onset of labor • Abnormally decreased fetal movement antepartum Fetal presentation • Breech or noncephalic presentation Gastrointestinal conditions • Intrapartum excessive vomiting, dehydration, or exhaustion unresponsive to treatment Gestational age • < 37 weeks 0 days • ≥42 weeks 0 days Hematologic conditions • Anemia with hemoglobin < 8.5 g/dL (current pregnancy) • Suspected or diagnosed thrombosis or thromboembolism • Thrombocytopenia (platelets < 100,000) • Hemoglobin < 10 g/dL, unresponsive to treatment Hepatic disorders • Disorders including uncontrolled intrahepatic cholestasis of pregnancy and/or abnormal liver function tests Hyperemesis gravidarum • Refractory

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Hypertensive disorders • Elevated blood pressure on two occasions 30 minutes apart (e.g. gestational hypertension or pregnancy-induced hypertension) o Systolic ≥ 140 or diastolic ≥ 90 • Elevated blood pressure on one occasion o Systolic ≥ 160 or diastolic ≥ 110, or o Systolic ≥ 140 or diastolic ≥ 90, with severe pre-eclampsia features • Pre-eclampsia • Eclampsia • HELLP syndrome Infectious conditions • Group B strep unknown • Group B strep without prophylaxis and lack of documented informed refusal if mother is GBS positive • HIV, Hepatitis B or syphilis status unknown or positive • Chorioamnionitis • Cytomyegalovirus • Maternal temperature ≥ 38.0 C in labor/postpartum • Genital herpes at time of labor • Maternal infection postpartum (e.g., endometritis, sepsis, wound) requiring hospital treatment • Rubella • Tuberculosis (other than latent) • Toxoplasmosis • Varicella (active at labor) • Sexually transmitted infection requiring treatment unless the patient receives appropriate treatment • Untreated or complicated urinary tract infection Isoimmunization • Blood group incompatibility and/or Rh sensitization in current pregnancy Labor management • Induction • Augmentation with pharmacotherapy • Failure to progress/failure of head to engage in active labor • Lack of adequate progress in 2nd stage with cephalic presentation Meconium • Thick meconium staining of amniotic fluid Miscarriage/non-viable • Molar pregnancy Multiple gestations • Multiple gestations

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Neurological disorders • Significant maternal confusion or disorientation Oligohydramnios or • Oligohydramnios polyhydramnios • Polyhydramnios Parity • Grand multipara (5 or more previous births) Perineal laceration or obstetric • 3rd degree requiring hospital repair or beyond anal sphincter injury expertise of attendant • 4th degree • Bladder or rectal dysfunction • Enlarging hematoma • 3rd degree not requiring hospital repair Placental conditions • Low lying placenta within 2 cm or less of cervical os at 36 weeks or later • Placenta previa • Vasa previa • Evidence of or suspected placenta accreta • Abruption • Retained placenta > 60 minutes Prenatal care • Inadequate prenatal care defined as < 5 visits or care began in 3rd trimester Psychiatric conditions • Maternal mental illness requiring psychological or psychiatric intervention • Patient currently taking psychotropic medications Pulmonary • Active respiratory distress • Chronic pulmonary disease Renal • Acute pyelonephritis Substance Use • Drug or alcohol misuse with high risk for adverse effects to fetal or maternal health • Patient receiving medication-assisted treatment for opioid use disorder Surgical • Laparotomy during pregnancy Umbilical cord • Prolapse Uterine condition • Anatomic anomaly (e.g. bicornuate, large fibroid impacting delivery) • Uterine rupture, inversion or prolapse

NEONATAL CONDITIONS Anatomic • Evidence of or suspected major congenital anomaly or anomaly abnormality, unless no resuscitation planned • Fewer than 3 vessels in umbilical cord Apgar score • < 5 at 5 minutes • < 7 at 10 minutes

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Appearance • Persistent poor suck, poor feeding, lethargy, hypotonia or abnormal cry Blood sugar • Hyperglycemia/hypoglycemia unresponsive to treatment Dermatologic • Severe abrasions, unusual pigmentation and/or lesions • Any generalized rash at birth Gastrointestinal • Significant distended abdomen • Jaundice at birth • Vomiting, diarrhea Hematologic • Direct Coomb’s positive Infectious • Infection of umbilical stump site disease • Maternal chorioamnionitis Isoimmunization • Blood group incompatibility and/or Rh sensitization in a prior pregnancy Prematurity • Obstetrically-determined gestational age at delivery < 37 weeks • Clinical evidence of prematurity (age < 35 weeks; based on assessment such as Ballard) Musculoskeletal • Excessive bruising, enlarging cephalohematoma, significant birth trauma Neurological • Hypotonia, tremors, seizures, hyperirritability • Evidence or suspected neonatal abstinence syndrome or withdrawal Respiratory or • Respiratory distress, cyanosis, pallor cardiac • Prolonged positive pressure ventilation or significant resuscitation • Abnormal heart rate or persistent/symptomatic murmur Temperature • Instability, fever, suspected infection or dehydration Weight • < 5th percentile for gestational age • < 2,000 grams (4.4 lbs) • 2,000 to 2,500 grams (4.4 lbs to 5.5 lbs)

7. Adjournment

The meeting was adjourned at 5:00 pm. The next meeting is scheduled for February 6, 2020 from 2:00- 5:00 pm at Clackamas Community College, Wilsonville Training Center, Rooms 111-112, 29353 SW Town Center Loop E, Wilsonville, Oregon 97070.

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Section 2.0 Subcommittee Changes 2020 Subcommittee membership

Issue: The subcommittee make up must adjust to account for new membership. New appointments need to be made to the Value-based Benefits Subcommittee (VbBS) and the Evidence-based Guidelines Subcommittee (EbGS).

New Appointments: • Michael Collins to VbBS • Max Kaiser, DO, to EbGS

Change assignments: • Vern Saboe, DC, to EbGS (remove from VbBS) • Angela Senders, ND, remove from EbGS and appoint to VbBS. VbBS appointment will be effective upon Senate confirmation of her replacement on the Commission (otherwise there could be a quorum of commission members on VbBS, which is not allowed by law.)

Health Evidence Review Commission Proposed subcommittee membership (Proposed appointments in italics)

Value-based Benefits Subcommittee Evidence-based Guidelines Subcommittee  Gary Allen, DMD *  Michael Adler, MD*  Michael Collins*  Leda Garside, RN, BSN, MBA*  Brian Duty, MD  Max Kaiser, DO*  Holly Jo Hodges. MD, MBA, FAAFP*  Devan Kansagara, MD* (Chair) (Vice-chair)  Lynnea Lindsey, PhD*  Adrianne Irwin, MS, PharmD *  Alison Little, MD, MPH  Kevin Olson, MD* (Chair)  Vern Saboe, DC  Angela Senders, ND, MCR (after new CAM Commissioner is appointed)  Eric Stecker, MD, MPH Vice-chair  Kathryn Schabel, MD*  Leslie Sutton*

*Commissioner Section 3.0 VbBS Report January 2020 Errata

1) Changes approved by VbBS/HERC in October 2018 regarding medical indications for circumcision were left out of the minutes and not put into the Prioritized List in error. a. Add CPT 54150 (Circumcision, using clamp or other device with regional dorsal penile or ring block), 54160 (Circumcision, surgical excision other than clamp, device, or dorsal slit; neonate (28 days of age or less)) and 54161 (Circumcision, surgical excision other than clamp, device, or dorsal slit; older than 28 days of age) to lines 21 VESICOURETERAL REFLUX and 413 BALANOPOSTHITIS AND OTHER DISORDERS OF PENIS b. Add CPT 54150 (Circumcision, using clamp or other device with regional dorsal penile or ring block) and 54160 (Circumcision, surgical excision other than clamp, device, or dorsal slit; neonate (28 days of age or less)) to line 327 FUNCTIONAL AND MECHANICAL DISORDERS OF THE GENITOURINARY SYSTEM INCLUDING BLADDER OUTLET OBSTRUCTION c. Remove ICD-10 N48.0 (Leukoplakia of penis) from line 242 DERMATOLOGICAL PREMALIGNANT LESIONS AND CARCINOMA IN SITU and add to line 413 BALANOPOSTHITIS AND OTHER DISORDERS OF PENIS d. Add ICD-10 Z87.440 (Personal history of urinary (tract) infections)1-16-2020 to line 327 FUNCTIONAL AND MECHANICAL DISORDERS OF THE GENITOURINARY SYSTEM INCLUDING BLADDER OUTLET OBSTRUCTION i. HSD was advised to remove ICD-10 Z87.440 from the Informational File 2) Additional corrections: a. The title to guideline note 172 was missing from the PDF list for a few days in December but has been restored. b. Obsolete CPT code 97127 was replaced with new CPT codes 97129 and 97130 (Therapeutic interventions that focus on cognitive function) in GUIDELINE NOTE 90 COGNITIVE REHABILITATION. c. In GUIDELINE NOTE 173 INTERVENTIONS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS, the entry for HCPCS code C9746 (Transperineal implantation of permanent adjustable Summariesballoon continence device) was deleted as this code is obsolete. Obsolete CPT C9741 was also removed from the entry for CardioMEMs. d. CPT code 46948 (Hemorrhoidectomy, internal, by transanal hemorrhoidal dearterialization, 2 or more hemorrhoid columns/groups, including ultrasound guidance, with mucopexy, when performed) was moved from line 472 to line 474 THROMBOSED AND COMPLICATED HEMORRHOIDS. It remains on line 621. e. TheIssue entry for CPT code 78459 (Myocardial imaging, positron emission tomography (PET), metabolic evaluation) was deleted from Guideline Note 173. This code is now listed in a separate entry along with other related codes 78429-78434 and 78491-78492. f. Codes 97110 (Therapeutic procedure, 1 or more areas, each 15 minutes; therapeutic exercises to develop strength and endurance, range of motion and flexibility) and 97530 (Therapeutic activities, direct (one-on-one) patient contact (use of dynamic activities to improve functional performance), each 15 minutes) were removed from line 512 VbBS VERTIGINOUS SYNDROMES AND OTHER DISORDERS OF VESTIBULAR SYSTEM. g. HCPCS code G2012 Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related

January 2020 Errata

e/m service provided within the previous 7 days nor leading to an e/m service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion was added back to all lines with evaluation and management codes. h. CPT code 81227 (CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *5, *6) ) was removed from line 252 (it is now recommended for the Diagnostic Procedure File). i. Guideline note D26 had incorrect codes when approved at the November 2019 meeting. The codes were corrected.

DIAGNOSTIC GUIDELINE D26, NEUROBEHAVIORAL STATUS EXAMS AND NEUROPSYCHOLOGICAL TESTING

Neurobehavioral status exams (CPT 96116 and 96121) and neuropsychological testing services (CPT 96132 and 96133 96116 and 96121) are only covered when all of the following are met: 1) Symptoms are not explained by an existing1-16-2020 diagnosis; AND 2) When the results of such testing will be used to develop a care plan.

Summaries

Issue

VbBS

Consent Agenda Issues—January 2020

Code Code Description Line(s) Involved Issue Recommendation(s) 99490 Chronic care management 346 CONDITIONS OF THE BACK 99490 is on all other lines with Add 99490 to lines 346, 361, 529, services, at least 20 minutes of AND SPINE WITH URGENT E&M codes and 661 clinical staff time directed by a SURGICAL INDICATIONS physician or other qualified health care professional, per 361 SCOLIOSIS calendar month, with the following required elements: 529 CONDITIONS OF THE BACK multiple (two or more) chronic AND SPINE WITHOUT URGENT conditions expected to last at SURGICAL INDICATIONS 1-16-2020 least 12 months, or until the death of the patient; chronic 661 MISCELLANEOUS conditions place the patient at CONDITIONS WITH NO OR significant risk of death, acute MINIMALLY EFFECTIVE exacerbation/decompensation, TREATMENTS OR NO TREATMENT or functional decline; NECESSARY comprehensive care plan established, implemented, revised, or monitored.

G2058 Chronic care management 346, 361, 529, and 661 G2058 was added to all lines with Add G2058 to lines 346, 361, 529, services, each additional 20 Summaries99490 with the 2020 HCPCS and 661 minutes of clinical staff time review in November, 2019 directed by a physician or other qualified health care professional, per calendar month (list separately in addition to code for primary procedure) Issue

VbBS 1 Consent Agenda Issues—January 2020

Code Code Description Line(s) Involved Issue Recommendation(s) M40.0 Postural kyphosis 402 CONDITIONS OF THE BACK Postural kyphosis and lordosis Remove M40.0, M40.4 and M40.5 M40.4 Postural lordosis AND SPINE need no treatment but education from lines 402 and 529 M40.5 Lordosis, unspecified 529 CONDITIONS OF THE BACK on better posture. Lordosis is the AND SPINE WITHOUT URGENT normal curvature of the spine and Add M40.0, M40.4 and M40.5 to SURGICAL INDICATIONS also does not require treatment. line 659 659 MUSCULOSKELETAL These codes are being overused CONDITIONS WITH NO OR by PT according to one CCO who MINIMALLY EFFECTIVE requested movement to an TREATMENTS OR NO TREATMENT uncovered line.1-16-2020 They were added NECESSARY to the covered back line as part of a code series.

Summaries

Issue

VbBS 2 Cytochrome P450 Correction

Issue: CPT 81225 (CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *8, *17)) was missed at the November, 2019 discussion regarding P450 testing. The other P450 codes were removed from line 662 and added to the Diagnostic Procedures File. CPT 81225 was struck from GN173 INTERVENTIONS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS, but no other action was approved for it.

On review, HERC staff identified that the code series added to Diagnostic Guideline D1, in addition to not including CPT 81225, including two non-P450 codes in error.

HERC staff recommendations: 1) Remove CPT 81225 (CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *8, *17)) from line 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS and1-16-2020 recommend that HSD add the code to the Diagnostic Procedure File. 2) Modify the entry regarding P450 testing in section D of DIAGNOSTIC GUIDELINE D1, NON- PRENATAL GENETIC TESTING GUIDELINE as shown below. a. CPT 812256-81227, 81230-81231 (cytochrome P450). Covered only for determining eligibility for medication therapy if required or recommended in the FDA labelling for that medication. These tests have unproven clinical utility for decisions regarding psychiatric medications and are not covered for testing prior to psychiatric medication therapy, except when required in the FDA labelling for the medication.

Summaries

Issue

VbBS

INR Monitoring

Issue: the CPT codes for INR monitoring are on nearly all lines, including many that stakeholders feel are not appropriate. HERC staff feels that it would be less confusing to have these codes be on the Diagnostic Procedures File. One related ICD-10 code would also need to be moved from lines on the Prioritized List to The Diagnostic Workup File.

CPT Code Description Current Code Placement 93792 Patient/caregiver training for initiation of home international normalized 640 lines ratio (INR) monitoring under the direction of a physician or other qualified health care professional, face-to-face, including use and care of the INR monitor, obtaining blood sample, instructions for reporting home INR test results, and documentation of patient's/caregiver's ability to perform testing and report results 93793 Anticoagulant management for a patient taking warfarin, must include 640 lines review and interpretation of a new home, office, or lab international1-16-2020 normalized ratio (INR) test result, patient instructions, dosage adjustment (as needed), and scheduling of additional test(s), when performed ICD-10 Codes Z51.81 Encounter for therapeutic drug level monitoring Diagnostic Workup File Z79.01 Long term (current) use of anticoagulants 14 cardiac lines

HERC staff recommendations: 1) Remove CPT 93792-93793 from all current lines on the Prioritized List and advise HSD to add to the Diagnostic Procedures File 2) Remove ICD-10 Z79.01 from allSummaries current lines on the Prioritized List and advise HSD to add to the Diagnostic Workup File

Issue

VbBS

Bone Marrow Transplant for Severe Sickle Cell Disease

Question: Should bone marrow transplant (BMT) be covered for qualifying patients with severe sickle cell disease (SSD)?

Question source: OHSU BMT transplant program, CCO, OHSU sickle cell program

Issue: Sickle cell disease is an inherited disorder of the red blood cells, with higher incidence among persons of African ancestry. Symptoms include severe anemia, jaundice, infection, delayed growth, pain crises, chronic pain, strokes, and damage to various organs. Treatments are generally supportive and include blood transfusions and pain medication. Bone marrow transplant has been used to treat severe sickle cell disease in certain patients, generally those with repeated episodes of acute chest syndrome, stroke, or other severe disease symptoms, and who have an unaffected HLA matched sibling to serve as the donor.

OHSU recently contacted the HERC to request a review of BMT for SSD. In 2016, Medicare approved coverage for the procedure, as long as it is conducted as part of an approved, prospective clinical trial to allow for evidence development. BMT is currently the only curative therapy for1-16-2020 SSD, though genetic therapies are being tested in humans.

HSC/HERC history: 1) Sickle cell disease ICD-9 diagnosis was deleted from the bone transplant line in June 2000, with the note that “sickle cell disease is not an indication for transplant.” 2) In December 2003, HSC discussed bone marrow transplant for sickle cell disease, and noted that “between 5-20% of patients with sickle cell have severe morbidity from vaso-occlusive crisis resulting in pulmonary, renal, and central nervous system damage. Indications for bone marrow transplant include a history of strokes, recurrent chest syndrome or recurrent vaso-occlusive crises; however, it is not clear whether or not it [BMT] significantly prolongs survival.” 3) In March 2004, a cost-effectiveness analysis of bone marrow transplant for sickle cell disease was reviewed, and there was “no difference in QALY based on intention to treat analysis.” Based on this, “It was elected toSummaries remove sickle cell disease from the current bone marrow transplant line.”

Current Prioritized List status: 1) ICD-10 D57 series (sickle cell disease) is on the medical line 194 HEREDITARY ANEMIAS, HEMOGLOBINOPATHIES, AND DISORDERS OF THE SPLEEN 2) Bone marrow transplant is found on lines: a. 95Issue HEREDITARY IMMUNE DEFICIENCIES b. 114 APLASTIC ANEMIAS; AGRANULOCYTOSIS c. 116 HODGKIN'S DISEASE d. 163 NON-HODGKIN'S LYMPHOMAS e. 179 ACUTE LEUKEMIA, MYELODYSPLASTIC SYNDROME f. 261 MULTIPLE MYELOMA g. 331 ACUTE PROMYELOCYTIC LEUKEMIA VbBSh. 396 ACUTE MYELOID LEUKEMIA i. 399 CHRONIC MYELOID LEUKEMIA

Bone Marrow Transplant for Severe Sickle Cell Disease

Evidence 1) Oringanje 2017, Cochrane review of BMT for SSD a. Ten trials were identified by the initial search and none for the update. None of these trials were suitable for inclusion in this review (not RCTs or quasi-RCTs) b. Reports on the use of hematopoietic stem cell transplantation improving survival and preventing symptoms and complications associated with sickle cell disease are currently limited to observational and other less robust studies. No randomized controlled trial assessing the benefit or risk of hematopoietic stem cell transplantations was found. c. Conclusion: Over 30 years after the discovery of the use of hematopoietic stem cells to cure sickle cell disease (SCD), it is surprising that there are no randomized controlled trials to provide concrete evidence for its use in people with SCD…this leaves observational studies to assess these interventions. These studies report that hematopoietic stem cell transplantations (HSCT) does improve survival and/or prevent symptoms and complications associated with SCD but there is the issue of risk which is still being investigated. In the absence of any relevant randomized controlled trial comparing HSCT to standard care or comparing the different methods of HSCT in SCD, this systematic review found no evidence for or against these interventions.1-16-2020 2) Gluckman 2017, registry study of outcomes of HLA identical sibling BMT for SCC a. N=1000 patients (846 children, 154 adults) i. The median age at transplantation was 9 years (range 4 months to 54 years), and the median follow-up was longer than 5 years. ii. Data from the Center for International Blood and Marrow Transplant Research (CIBMTR), European Society for Blood and Marrow Transplantation (EBMT), and Eurocord databases b. The 5-year event-free survival and overall survival were 91.4% (95% confidence interval, 89.6%-93.3%) and 92.9% (95% confidence interval, 91.1%-94.6%), respectively [note: reported survival in SCD overall is 93.4% from birth to adulthood]. Event free survival was lower with increasing age at transplantation (hazard ratio [HR], 1.09; P<.001) and higher for transplantation performed after 2006 (HR, 0.95; P 5 .013). Twenty-three patients experienced graft failure c. 70 patients (7%) died, Summarieswith the most common cause of death being infection. followed by GVHD (n = 9), toxicity (n = 9), hemorrhage (n=3), secondary malignancy (n=2; 1 CNS lymphoma and 1 cerebral tumor), and other or not specified causes (n = 33). a. Conclusion: The excellent outcome of a cohort transplanted over the course of 3 decades confirms the role of HLA-identical sibling transplantation for children and adults with SCD. 3) Shenoy 2017, trial of unrelated BMT for SSD a. N=29Issue children b. Blood and Marrow Transplant Clinical Trials Network (BMT CTN) phase 2 trial conducted from 2008 to 2014 c. Transplant indications included stroke (n 5 12), transcranial Doppler velocity >200 cm/s (n = 2), ≥3 vaso-occlusive pain crises per year (n = 12), or ≥2 acute chest syndrome episodes (n = 4) in the 2 years preceding enrollment. Median follow-up was 26 months (range, 12-62 months) VbBSd. graft rejection rate was 10%. e. The 1- and 2-year event free survival rates were 76% and 69%, respectively. The corresponding rates for overall survival were 86% and 79%. The day 100 incidence rate of grade II-IV acute GVHD was 28%, and the 1-year incidence rate of chronic GVHD was

Bone Marrow Transplant for Severe Sickle Cell Disease

62%; 38% classified as extensive. There were 7 GVHD-related deaths. A 34% incidence of posterior reversible encephalopathy syndrome was noted in the first 6 months. f. Although the 1-year EFS met the prespecified target of ≥75%, this regimen cannot be considered sufficiently safe for widespread adoption without modifications to achieve more effective GVHD prophylaxis. 4) Arnold 2017, retrospective cohort study of health care utilization after BMT for SSD a. Databases study, children transplanted for SSD in the US 2000-2013 i. Center for International Blood and Marrow Transplant Research (CIBMTR) database ii. Healthcare utilization data from the Pediatric Health Information System, a confidential database of 43 member hospitals in the USA iii. The most commonly documented transplant indication was stroke (29%) followed by recurrent vaso-occlusive crises (22%). However, 39% had stroke as a documented SCD complication, 55% vaso-occlusive crises, and 53% acute chest syndrome. iv. The most common source of a graft for transplantation was a matched sibling donor (MSD) (42%) 1-16-2020 b. The 2-year overall survival was 90% [95% confidence interval (CI): 85-95%]: 96% (95% CI: 89-100%) for cord blood transplant (CBT), 94% (95% CI: 86-98%) for MSD transplants, and 74% (95% CI: 54-90%) for transplants from well-matched unrelated donors (MUD) (P=0.002) c. The cumulative incidence of acute GvHD at day 100 was 14% (95% CI: 9-20%), and chronic GvHD developed in 31% (95% CI: 23-38%) at 2 years. d. Among 161 patients with a 2-year overall survival rate of 90% (95% confidence interval [CI] 85-95%) mortality was significantly higher in those who underwent late transplantation versus early (hazard ratio (HR) 21, 95% CI 2.8-160.8, P=0.003) and unrelated compared to matched sibling donor transplantation (HR 5.9, 95% CI 1.7-20.2, P=0.005). Chronic graft versus host disease was significantly more frequent among those translanted late (HR 1.9, 95% CI 1.0-3.5, P=0.034) and those who received an unrelated graft (HR 2.5, 95% CI 1.2-5.4; P=0.017). e. Merged data for 176 patientsSummaries showed that the median total adjusted transplant cost per patient was $467,747 (range: $344,029-$799,219). Healthcare utilization was lower among recipients of matched sibling donor grafts and those with low severity disease compared to those with other types of donor and disease severity types (P<0.001 and P=0.022, respectively); no association was demonstrated with late transplantation (P=0.775). f. Among patients with 2-year pre- and post-transplant data (n=41), early transplantation wasIssue associated with significant reductions in admissions (P<0.001), length of stay (P<0.001), and cost (P=0.008). g. Conclusion: Reduced post-transplant healthcare utilization inpatient care indicates that transplantation may provide a sustained decrease in healthcare costs over time

Expert society guidelines VbBS1) Majhail 2015, The American Society for Blood and Marrow Transplantation (ASBMT) Indications for Autologous and Allogeneic Hematopoietic Cell Transplantation a. Sickle cell disease is listed as an indication for allogenic HCT, noted to be standard of care with clinical evidence available

Bone Marrow Transplant for Severe Sickle Cell Disease

2) Angelucci 2014, European guidelines for BMT for SSD a. Young patients with symptomatic SCD who have an HLA matched sibling donor should be transplanted as early as possible, preferably at pre-school age. b. Unmanipulated BM or UCB (whenever available) from matched sibling donors are the recommended stem cell source. c. SCT from unrelated BM or CB donors should only be considered in the presence of at least one of the indications suggested by Walters et al (stroke, recurrent vaso-occlusive pain, etc.) and should be performed only in the context of controlled trials in experienced centers

Other payer policies: 1) Aetna 2019 a. Aetna considers allogeneic hematopoietic cell transplantation medically necessary for the treatment of sickle cell anemia in children or young adults when the member meets transplanting institution's written eligibility criteria. In the absence of such criteria, Aetna considers allogeneic hematopoietic cell transplantation medically1-16-2020 necessary for the treatment of sickle cell anemia in children or young adults when both of the following criteria are met: i. Members have a haploidentical to HLA-matched donor; and ii. Members with either a history of stroke or at increased risk of stroke or end- organ damage (recurrent chest syndrome, recurrent vaso-occlusive crises, and red blood cell alloimmunization on chronic transfusion therapy). b. Aetna considers autologous hematopoietic cell transplantation for thalassemia major or sickle cell anemia in children or young adults experimental and investigational due to insufficient evidence in the peer-reviewed literature. 2) Cigna 2019 a. Myeloablative allogeneic HSCT is considered medically necessary for the treatment of a child or young adult at increased risk of complications of sickle cell disease (SCD) or thalassemia major. b. Non-myeloablative allogeneicSummaries HSCT for a child or young adult with SCD or thalassemia major is considered experimental, investigational or unproven. c. HSCT for an adult with SCD or thalassemia major is considered experimental, investigational or unproven.

Issue

VbBS

Bone Marrow Transplant for Severe Sickle Cell Disease

HERC staff summary: Bone marrow transplant for sickle cell disease from an HLA matched sibling is recommended by expert groups, and has retrospective cohort data to support its effectiveness. There are no RCT level data to support this intervention; however, transplants in the US are being performed as part of clinical trials to collect such data. Unrelated matched donor transplant has higher risks of graft-vs-host disease and lower survival rates compared to sibling transplants. Sickle cell disease affects a vulnerable population, which should be considered in decisions regarding therapy.

Insurance coverage is currently limited to patients 40 and younger, per experts.

HERC staff recommendations: 1) Add ICD-10 D57 series (sickle cell disease) to line 114 APLASTIC ANEMIAS; AGRANULOCYTOSIS Treatment: BONE MARROW TRANSPLANT a. Modify the line title of line 114 to APLASTIC ANEMIAS; AGRANULOCYTOSIS; SICKLE CELL DISEASE b. Keep D57 series on line 194 HEREDITARY ANEMIAS,1-16-2020 HEMOGLOBINOPATHIES, AND DISORDERS OF THE SPLEEN for medical therapy 2) Add a guideline to line 114 as shown below a. Discuss whether to require sibling donor or any matched donor b. Discuss if any age limits should apply

GUIDELINE XXX BONE MARROW TRANSPLANT FOR SICKLE CELL DISEASE Line 114 Allogeneic hematopoietic cell transplantation for sickle cell disease is included on this line only when all of the following are met: 1) Patient is age 40 or younger; and 2) Patient has a haploidentical to HLA-matched sibling donor; and 3) Patient has either a history of stroke or is at increased risk of stroke or end-organ damage (recurrent chest syndrome, recurrentSummaries vaso-occlusive crises, and red blood cell alloimmunization on chronic transfusion therapy).

Issue

VbBS

Neuropsychological Status Exams and Neuropsychological Testing

Question: How should the newly adopted guideline regarding neuropsychological testing be modified for pre-epilepsy surgery indications?

Question source: OHSU epilepsy surgery department

Issue: At the November 2019 VbBS/HERC meetings, the neuropsychological testing CPT code (CPT 96132-96133) were made Diagnostic with a new guideline as suggested by the BHAP. However, the OHSU epilepsy surgery department requires this testing prior to epilepsy surgery. The guideline as adopted would not allow such testing as it requires “symptoms not explained by current diagnosis.” The epilepsy surgery patients have an established diagnosis; rather, this testing is used to see if the epilepsy surgery will affect various areas of functioning. These codes had previously been added to the epilepsy surgery guideline to allow this specialized use.

HERC staff recommendations:

1) Modify the newly adopted Diagnostic Guideline as shown below 1-16-2020 DIAGNOSTIC GUIDELINE DXX, NEUROBEHAVIORAL STATUS EXAMS AND NEUROPSYCHOLOGICAL TESTING

Summaries

Issue

VbBS

Lower Extremity Chronic Venous Disease January 2020

Question: Should coverage of lower extremity chronic venous disease (e.g. varicose veins) on the Prioritized List be moved to a higher priority line?

Question source: HERC Staff, Dr. Ed Boyle

Issue: Coverage of lower extremity chronic venous disease (LECVD) was discussed at the August and November VbBS meetings. Currently, varicose veins that cause swelling or pain are including on line 639 VARICOSE VEINS OF LOWER EXTREMITIES WITHOUT ULCER OR OTHER MAJOR COMPLICATION, with various treatments pairing on that line. A similar condition to varicose veins, post-thrombotic syndrome, is included on line 519 POSTTHROMBOTIC SYNDROME. If a varicose vein is associated with an ulcer, treatment is paired on line 379 CHRONIC ULCER OF SKIN. If the varicose vein is causing inflammation (phlebitis), then the diagnosis is included on line 516 PHLEBITIS AND THROMBOPHLEBITIS, SUPERFICIAL. Based on discussion in August and November it would appear VBBS intent would be to move superficial thrombophlebitis to the funded region, along with significant bleeding. At the November meeting there was an outstanding question about whether compression stockings should be included for these conditions, or just surgery. If compression stockings are covered,1-16-2020 then there would need to be a determination of whether a trial of conservative therapy (including compression stockings) would be required prior to surgery.

HERC staff reviewed the evidence of effectiveness of various treatments for varicose veins, including conservative care, minimally invasive surgery, and vein stripping. The majority of the literature on treatment of lower extremity chronic venous disease focuses on comparing various endovascular or surgical treatments against other such interventions. For the purposes of HERC coverage determination, the question of interest is comparing no or standard therapy (compression therapy) against invasive interventions. For this question, the literature is sparse, and studies are generally of low quality. NICE concluded that compression therapy vs no therapy reduced patient symptoms, but reductions were small and possibly not clinically significant. NICE concluded that, based on 5 studies, surgery resulted in better quality of life compared to compression therapy, but the effect was small and possibly not clinically significant (low quality evidence); surgery also resulted in significant clinical benefit at reducing patients’ symptoms (aching, itching, andSummaries swelling). NICE concluded that surgery was cost effect compared to conservative care. There was no evidence review found comparing compression or other conservative therapy vs endovenous interventions. Based on systematic reviews and meta-analyses, there is no difference in outcomes between the various surgical and endovenous interventions.

Expert submitted literature included an RCT of conservative vs surgical therapy for varicose veins (Michaels 2006). InIssue this study of 246 patients with severe reflex (significant skin changes, reflux >1 s in the groin, LVS or popliteal fossa, above-knee varicose veins >5 mm in diameter of any varicose veins in upper third of thigh, below-knee varicose veins >5 mm in more than one quadrant) and a BMI <32, there was a clinically significant improvement in quality of life, and a subsequent economic evaluation found a cost per QALY of £3500-£7175 depending on the type of surgery. Of note, no significant differences in any measured outcome were found in patients with mild or moderate vein reflux between conservative and surgical therapy groups.

VbBSExpert groups and NICE recommend treatment of lower extremity chronic venous disease for a much wider range of indications that is currently included on the Prioritized List.

Lower Extremity Chronic Venous Disease January 2020

Testimony was heard from Dr. Ed Boyle a vein surgeon, and from representatives of Medtronix, which manufactures devices used in minimally invasive vein surgery. Dr. Boyle testified that the HERC coverage only treats the end stage of CLEVD, and he recommended expanding coverage to include refractory lower extremity edema, pain, bleeding from a varicosity, and stasis dermatitis. Dr. Boyle testified that conservative therapy is significantly less effective than invasive therapy for non-ulcerated varicose veins. There is high quality evidence that interventions targeted to reduce venous reflux by eliminating the saphenous veins and its varicose branches are superior to conservative therapy. From a payer policy perspective, however, there is ample predicate to support a policy that defines the indication that a procedure should be for patients with moderate to severe venous symptoms who have tried and failed conservative measures. In a system with constrained financial resources, this is an approach where utilization can be best directed to those who need it most.

Dr. Boyle testified at the November meeting that severe swelling and/or severe pain affecting quality of life as well as stasis dermatitis should be covered indications for vein surgery. There was hesitation on the part of VbBS members to include subjective criteria such as pain or swelling for coverage. VbBS members agreed with the proposed guideline criteria to cover varicose veins in the presence of ulcers (current coverage), recurrent superficial thrombophlebitis (historic intention of1-16-2020 coverage, but not current covered), and serious bleeding.

Dr. Boyle felt that ultrasound findings of severe venous reflux with the above symptoms would be adequate criteria for coverage. Based on this discussion, the VbBS members suggested modifying the HERC staff proposed guideline to include ultrasound findings of severe reflux, defined as “severe axial venous reflux (>1 second in the greater or small saphenous vein or accessory saphenous vein).”

There was further discussion about the proposed guideline requirement for 3 months of conservative therapy. Livingston raised the issue that this would include compression stockings, which are currently not covered by OHP. There was discussion about when compression stockings should be covered. There was suggested wording that the guideline include compression stockings only if the patient meets all the other guideline criteria. The decision was to table this topic and have HERC staff look at the evidence for the effectiveness of compression stockings, as well as which patients should have compression stockings covered by OHP. Summaries

Issue

VbBS

Lower Extremity Chronic Venous Disease January 2020

Evidence for compression stockings 1) Shingler 2013, Cochrane review of compression stockings for chronic lower extremity venous disease a. N=7 studies (356 patients) i. Patients varicose veins without healed or active venous ulceration were included. ii. Different levels of pressure were exerted by the stockings in the studies, ranging from 10 to 50 mmHg. iii. One study assessed compression hosiery versus no compression hosiery, but no data was reported for the group randomized to no stockings. The other six compared different types or pressures of stockings. iv. The methodological quality of all included trials was unclear, mainly because of inadequate reporting. b. No studies assessed symptom change when wearing stockings compared to not wearing stockings c. The symptoms subjectively improved with the wearing of stockings across trials that assessed this outcome, but these assessments were not made by1-16-2020 comparing one randomised arm of a trial with a control arm and are therefore subject to bias. d. Authors’ conclusions There is insufficient, high quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in people without healed or active venous ulceration, or whether any type of stocking is superior to any other type. Future research should consist of a large RCT of participants with trunk varices either wearing or not wearing compression stockings to assess the efficacy of this intervention. 2) Azirar 2019, Cochrane review of compression stockings for treatment of post-thrombotic syndrome a. N=4 trials (116 patients) b. Two trials studied the effect of graduated elastic compression stockings (GECS) on improvement of PTS symptoms. One study reported beneficial haemodynamic effects, while the other found no benefits on PTS severity compared to placebo (very low- certainty evidence). ThereSummaries was very limited evidence available for adverse effects and quality of life (QoL). The two studies did not report on compliance rates during the study period. c. Authors' conclusions There is very low-certainty evidence regarding the use of GECS for treatment of PTS as assessed by two small studies of short duration. One study reported beneficial haemodynamic effects, while one found no benefits on PTS severity comparedIssue to control/placebo stockings. There is very limited evidence for adverse effects, patient satisfaction, QoL, and compliance rates. High certainty evidence to support the use of compression therapy in prevention of PTS is lacking and any conclusions drawn from current evidence should be interpreted with care. Further research is needed to assess whether compression can result in long-term reduction and relief of the symptoms caused by PTS, or prevent deterioration and leg ulceration

Evidence based expert guidelines VbBS1) Rabe 2017 , evidence based consensus statement on compression stockings a. N=51 articles

Lower Extremity Chronic Venous Disease January 2020

i. Symptoms: Reviewed studies finding that venous symptoms, quality of life (QoL) and edema formation in patients with lower clinical classes of chronic venous diseases (CVD) (C1s–C3) can be significantly improved by low-pressure compression stockings, compared with placebo stockings 1. Recommendation 1: We recommend the use of MCS (medical compression stockings) to alleviate venous symptoms in patients with CVD (GRADE 1B) 2. Recommendation 2: We recommend the use of MCS to improve QoL and venous severity scores in patients with CVD (GRADE 1B) 3. Recommendation 3: We recommend the use of MCS to prevent leg swelling in patients with CVD (GRADE 1B) ii. Venous stasis: The improvement of skin changes – including eczema, induration and lipodermatosclerosis, caused by chronic venous insufficiency (CVI) – by compression therapy is regularly observed in routine clinical practice. However, there is a paucity of evidence from RCTs. The recommendation to use MCS for the improvement of skin changes in general is therefore based on low-level evidence. 1-16-2020 1. Recommendation 5: We suggest MCS for the improvement of skin changes in patients with CVD (GRADE 1C) iii. Recurrence of lower extremity ulceration: all evidence was comparing low vs high pressure stockings (no studies of compression stockings vs no stockings). 1. Recommendation 7: We recommend the use of MCS to reduce recurrence of VLU (GRADE 1A) iv. Prevention of clinical progression in chronic venous disease. There is insufficient information from RCTs on the prevention of CVD progression by MCS that would allow for an evidence-based recommendation. 1. Recommendation 10: Insufficient data are available on the use of MCS for the prevention of CVD progression, so we recommend further studies are needed to be able to make evidence-based recommendations Summaries

Issue

VbBS

Lower Extremity Chronic Venous Disease January 2020

HERC staff summary There is minimal published data supporting the use of compression stockings for the treatment of chronic lower extremity venous disease or post-thrombotic syndrome, based on trusted sources. This technology is standard of care, and generally low risk. One possible reason for the lack of evidence to support use is that compliance with use is typically low.

Previous discussion of this topic at several meetings led to a consensus among VbBS members for coverage of varicose veins in the presence of ulceration, recurrent superficial thrombophlebitis or serious bleeding. The consensus was that swelling, pain, or stasis dermatitis were not sufficient criteria for coverage.

1-16-2020

Summaries

Issue

VbBS

Lower Extremity Chronic Venous Disease January 2020

HERC staff recommendations: 1) Add coverage of chronic lower extremity venous disease for patients with recurrent thrombophlebitis, consistent with prior HSC/HERC intent to cover with “cellulitis;” add coverage for bleeding varicose veins a. Add varicose veins with other complications to line 379 CHRONIC ULCER OF SKIN and keep on line 519 POSTTHROMBOTIC SYNDROME/639 VARICOSE VEINS OF LOWER EXTREMITIES WITHOUT ULCER OR OTHER MAJOR COMPLICATION i. ICD10 I83.89 (Varicose veins of lower extremities with other complications) ii. ICD10 I87.09 (Postthrombotic syndrome with other complications of lower extremity) b. Adopt a new guideline note to line 379 as shown below i. Discuss whether to include wording in purple given limited evidence of effectiveness of compression stockings 2) Clarify when ulceration is an indication for varicose vein treatment in the new guideline 3) Modify the line title of line 379 to CHRONIC ULCER OF SKIN; VARICOSE VEINS WITH MAJOR COMPLICATIONS 1-16-2020

GUIDELINE NOTE XXX, TREATMENT OF CHRONIC LOWER EXTREMITY VENOUS DISEASE Lines 379,519,639 Surgical treatment of chronic lower extremity venous disease is only included on line 379 when 1) The patient has had an adequate 3-month trial of conservative therapy and failed; AND 2) Ultrasound findings of severe axial venous reflux (>1 second in the greater or small saphenous vein or accessory saphenous vein; AND 3) The patient has one of the following: a. Non-healing skin ulceration in the area of the varicose vein(s), OR b. Recurrent episodes of superficial thrombophlebitis, OR c. Serious bleeding from varicose vein(s) Compression stockings are included on line 379 as part of conservative therapy if the patient meets criteria #2 and #3 above. Summaries Otherwise, these diagnoses are included on lines 519 or 639.

Issue

VbBS

Deletion of Pharmacist Prescribing Guideline

Question: Should the pharmacist prescribing guideline be deleted?

Question source: HERC staff, P&T staff

Issue: The pharmacist prescribing guideline has not been updated in many years. When this guideline was created, pharmacists could review medications and provide recommendations to providers regarding medication adjustments or changes. Pharmacists now have a much broader scope of practice and can by statute prescribe a variety of medication and immunizations independently. P&T staff have indicated to HERC staff that there are adequate OAR and pharmacy board rules governing pharmacist prescribing and that the guideline is no longer needed and is outdated. The CCO medical directors concur that they never refer to this guideline.

Current Oregon Board of Pharmacy rules regarding pharmacist prescribing: https://www.oregon.gov/pharmacy/Imports/Laws_RulesPDF/OBOPCurrent_Laws_Rules.pdf

HERC staff recommendation: 1-16-2020 1) Delete GN64

GUIDELINE NOTE 64, PHARMACIST MEDICATION MANAGEMENT Included on all lines with evaluation & management (E&M) codes Pharmacy medication management services must be provided by a pharmacist who has: 1) A current and unrestricted license to practice as a pharmacist in Oregon. 2) Documentation must be provided for each consultation and must reflect communication with the patient’s primary care provider. Documentation should model SOAP charting; must include patient history, provider assessment and treatment plan; follow up instructions; be adequate so that the information provided supports the assessment and plan; and must be retained in the patient’s medical record and beSummaries retrievable.

Issue

VbBS

Intracardiac Echocardiogram

Question: Should intracardiac echocardiogram be moved to covered line(s) on the Prioritized List or to the Ancillary List?

Question source: Holly Jo Hodges, CCO medical director

Issue: Intracardiac echocardiogram (CPT 93662 Intracardiac echocardiography during therapeutic/diagnostic intervention, including imaging supervision and interpretation (List separately in addition to code for primary procedure)) is currently on line 662/Guideline Note 173. However, this procedure is considered standard of care during certain percutaneous cardiac interventions.

Intracardiac echocardiography involves the use of a catheter-based ECHO device that replaces transesophageal echocardiography (TEE) for certain transcutaneous cardiac procedures, such as valve replacement or ablation procedures [see Enriquez 2018].

Intracardiac echocardiography was reviewed in 2001 and recommended for the Ancillary File. It was again reviewed in January 2008. At that time, based on cardiologist consultation,1-16-2020 intracardiac echocardiography was recommended for the Diagnostic Procedures List; however, the HOSC/HSC determined that it should be Never Covered. The HOSC/HSC minutes do not contain documentation as to the rationale for this decision.

CMS lists CPT 93662 as only billable as a secondary code to one of the following primary CPT codes:

CPT CPT description Current Placement code 92987 Percutaneous balloon valvuloplasty; mitral valve 39 lines 93453 Combined right and left heart catheterization including Diagnostic Procedures File intraprocedural injection(s) for left ventriculography, imaging supervision and interpretation, when performed 93460- Catheter placement in coronary artery(s) for coronary Diagnostic Procedures File 93462 angiography, including intraproceduralSummaries injection(s) for coronary angiography, imaging supervision and interpretation; with right and left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed 93532 Combined right heart catheterization and transseptal left Diagnostic Procedures File heart catheterization through intact septum with or withoutIssue retrograde left heart catheterization, for congenital cardiac anomalies 93580 Percutaneous transcatheter closure of congenital 118 ATRIAL SEPTAL DEFECT, interatrial communication (ie, Fontan fenestration, atrial SECUNDUM septal defect) with implant 93581 Percutaneous transcatheter closure of a congenital 67 VENTRICULAR SEPTAL ventricular septal defect with implant DEFECT VbBS93621 Comprehensive electrophysiologic evaluation including 281 LIFE-THREATENING insertion and repositioning of multiple electrode CARDIAC ARRHYTHMIAS catheters with induction or attempted induction of 347 CARDIAC ARRHYTHMIAS

Intracardiac Echocardiogram

CPT CPT description Current Placement code arrhythmia; with left atrial pacing and recording from coronary sinus or left atrium (List separately in addition to code for primary procedure) 93622 with left ventricular pacing and recording 281,347 93653 Comprehensive electrophysiologic evaluation including 281,347 insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with right atrial pacing and recording, right ventricular pacing and recording (when necessary), and His bundle recording (when necessary) with intracardiac catheter ablation of arrhythmogenic focus; with treatment of supraventricular tachycardia by ablation of fast or slow atrioventricular pathway, accessory atrioventricular connection, cavo-tricuspid isthmus or other single atrial focus or source of atrial re-entry 1-16-2020 93654 Comprehensive electrophysiologic evaluation including 281,347 insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with right atrial pacing and recording, right ventricular pacing and recording (when necessary), and His bundle recording (when necessary) with intracardiac catheter ablation of arrhythmogenic focus; with treatment of ventricular tachycardia or focus of ventricular ectopy including intracardiac electrophysiologic 3D mapping, when performed, and left ventricular pacing and recording, when performed 93656 Comprehensive electrophysiologic evaluation including 281,347 transseptal catheterizations, insertion and repositioning of multiple electrode cathetersSummaries with induction or attempted induction of an arrhythmia including left or right atrial pacing/recording when necessary, right ventricular pacing/recording when necessary, and His bundle recording when necessary with intracardiac catheter ablation of atrial fibrillation by pulmonary vein isolationIssue

Similar codes 1) Standard transthoracic echocardiogram (CPT 93303-93314, 93320-93352) are on the Diagnostic Procedures File 2) Transesophageal ECHO for congenital diseases (CPT 93315, 93316) are on the Diagnostic Procedures File 3) CPT 93355 (Echocardiography, transesophageal (TEE) for guidance of a transcatheter VbBSintracardiac or great vessel(s) structural intervention(s) (eg, TAVR, transcatheter pulmonary valve replacement, mitral valve repair, paravalvular regurgitation repair, left atrial appendage occlusion/closure, ventricular septal defect closure) (peri-and intra-procedural), real-time image

Intracardiac Echocardiogram

acquisition and documentation, guidance with quantitative measurements, probe manipulation, interpretation, and report, including diagnostic transesophageal echocardiography and, when performed, administration of ultrasound contrast, Doppler, color flow, and 3D) is on 26 lines

HERC staff recommendations: 1) Remove CPT 93662 (Intracardiac echocardiography during therapeutic/diagnostic intervention, including imaging supervision and interpretation (List separately in addition to code for primary procedure) from line 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 2) Strike the entry below from Guideline Note 173 3) Advise HSD to add CPT 93662 to the Diagnostic Procedure File a. Will be a secondary billing code to appropriate procedure codes

GUIDELINE NOTE 173, INTERVENTIONS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS1-16-2020 Line 662 The following Interventions are prioritized on Line 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS:

Procedure Intervention Description Rationale Last Review Code 93662 Intracardiac echocardiography during therapeutic/diagnostic intervention

Summaries

Issue

VbBS

Frequency Specific Microcurrent Therapy and Other TENS-like Therapies

Question: Should frequency specific microcurrent therapy, or similar types of therapy such as electro therapeutic point stimulation, microcurrent therapy, or microcurrent electrical nerve stimulation, be covered on the Prioritized List?

Question source: Primary Health CCO

Issue: Electrical stimulation therapy, such as TENS units, are included on line 662/GN173 which an entry that specifically mentions TENS therapy. Similar types of therapy, specifically frequency specific microcurrent therapy, have been requested for coverage. It appears that all of these types of therapy use the same CPT code, 97014 (Application of a modality to 1 or more areas; electrical stimulation (unattended)). Primary Health CCO is requesting clarification of the HERC coverage intent for these non- TENS electrical stimulation therapy.

Evidence review: Medline was searched for microcurrent therapy, microcurrent, and frequency specific microcurrent therapy. The literature mostly consisted of case studies and small pilot studies 1-16-2020of various types of microcurrent therapy on various soft tissue pain or dysfunction conditions.

1) Page 2016, Cochrane review of electrotherapy modalities for rotator cuff disease a. In single, small trials, no clinically important benefits of pulsed electromagnetic field therapy (PEMF), microcurrent electrical stimulation (MENS), acetic acid iontophoresis and microwave diathermy were observed (low or very low quality evidence). b. Authors’ conclusions: We are uncertain whether TENS is superior to placebo, and whether any electrotherapy modality provides benefits over other active interventions (e.g. glucocorticoid injection) because of the very low quality of the evidence. 2) Kwon 2014, RCT of microcurrent therapy for infants with congenital muscular torticollis a. N=20 (10 ultrasound, 10 microcurrent therapy) i. All received standard PT b. The mean passive cervical rotational range of motion measured at three months posttreatment was significantlySummaries greater in the microtherapy group (101.1°) than that in the ultrasound group (86.4°) The mean duration of treatment was significantly shorter in the microcurrent group (2.6 months) than in the ultrasound group (6.3 months). c. Conclusions: Microcurrent therapy may increase the efficacy of therapeutic exercise with ultrasound for the treatment of congenital muscular torticollis involving the entire sternocleidomastoid muscle.

Issue

VbBS

Frequency Specific Microcurrent Therapy and Other TENS-like Therapies

HERC staff recommendation: 1) Modify the GN173 entry for CPT 97014 (Application of a modality to 1 or more areas; electrical stimulation (unattended)) to reflect additional electrical stimulation types of therapies other than TENS a. No proven efficacy of any of these modalities

GUIDELINE NOTE 173, INTERVENTIONS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS Line 662 The following Interventions are prioritized on Line 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS: Procedure Intervention Description Rationale Last Review Code 97014, 97032, Transcutaneous electrical nerve No clinically important benefit November 0278T, stimulation (TENS), frequency (CES) or insufficient evidence 2019 E0720, E0730, specific microcurrent therapy, of effectiveness (all other)1-16-2020 for G0283 microcurrent electrical chronic pain; insufficient stimulation, and all similar evidence of effectiveness for therapies; Scrambler therapy; all other indications Cranial electrical stimulation; all similar transcutaneous electrical neurostimulation therapies

Summaries

Issue

VbBS

Y90 Embolization and Mapping

Question: Should the coverage of mapping and embolization for Yttrium 90 therapy for hepatocellular carcinoma be modified?

Question source: Salem Radiology Clinic, Dr. Nicholas Hanson and Dr. Yama Kharoti; Dr. Hodges MVIPA

Issue: Drs. Hanson and Kharoti contacted Dr. Hodges regarding a denial for 37242 which is used in the mapping stages prior to treatment of Y90. This does not pair on the Prioritized List, rather the 37243 which is specific for tumors, pairs. Dr. Kharoti says both are necessary. The first mapping appointment is to determine if there are other nontumor areas that require embolization prior to administration of Y90. If they are identified then 37242 is used prophylactically to protect bowel and gallbladder. For example, they may embolize the right gastric branch so no Y90 beads would go there. There are sufficient collaterals that this does not cause bowel ischemia. The following appointment is when the Y90 is used for the liver cancer. Currently, only the code for liver cancer embolization (37243) pairs with liver cancer, but not this1-16-2020 preventive embolization that is used to protect bowel and/or gallbladder (37242).

“The y90 treatment (37243) can NOT be done without the Y90 mapping (37242). It would be medical malpractice to do treatment without mapping.”

From Ken Kolbeck, MD, Director of Y90 program at OHSU When both of these products were developed, the biggest fear/complication risk was non-target embolization of the radioactive beads (either in right gastric, gastroduodenal, or cystic arterial distributions). A radiation induced GI ulcer can be very painful and require several additional hospitalizations. So the “instructions for use” and all the initial teaching included embolization of vessels “at risk”. When we first startedSummaries our Y90 program, we did embolize a few of these vessels, but with experience were able to find ways to avoid embolizing them (by using a different catheter position/split dose/modifying delivery techniques). I would say in the last few years, we coil embolize less than 5% of cases. When we did embolize—we purposefully chose to embolize on the day of the Y90 treatment – knowing full well that we would not be reimbursed for the coil (protective) embolization on the SAME DAY as the treatment embolization with the Y90.Issue So our practice essentially “ate the cost” for the extra embolization— but it was a small percentage of the patients.

From the insurance perspective-the key question will be balancing the risk/benefit. If I’m reading them correctly, the IFUs from both companies instruct to embolize/protect vessels at risk. If the IR sites reimbursement as the reason VbBSs/he didn’t embolize it—the legal ramifications of a radiation induced gastric ulcer may be propagated beyond the IR / MD up to OHP.

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Y90 Embolization and Mapping

So, at OHSU, we would rarely be impacted by the denials described below- because of our practice patterns. However, if other institutions routinely rely on the extra protection, there may be an increase in the amount of re- admissions/complications following the Y90 treatment.

Background for expectations around pre-treatment planning from manufacturer

Manufacturer coding guide https://www.sirtex.com/media/168654/2019-sirtex-coding- guide-final-approved-085-u-0119-0101019docx.pdf

Pre-treatment mapping includes

1-16-2020

Summaries

Background from Borggreve 2016 Nontarget embolizationIssue might subsequently result in complications, including gastrointestinal ulceration (0.7–28.6 %) and cholecystitis (0.6–6.0 %). Non-target embolization can be prevented through prophylactic embolization of hepaticoenteric arteries during a pretreatment angiography after which technetium-99m-labeled macroaggregated albumin (99mTc-MAA) can be injected as an additional screening procedure. VbBS Experienced centers increasingly omit the occlusion of the vessels originating proximal to the microsphere injection site. Several studies have shown that collateralization and

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Y90 Embolization and Mapping

recanalization of arteries can occur after occlusion of hepaticoenteric arteries, opposing the initial purpose of this procedure and bringing its benefit into question.

Current Prioritized List Status

Line: 315 Condition: CANCER OF LIVER (See Guideline Notes 7,11,12,64,65,78,185) Treatment: MEDICAL AND SURGICAL TREATMENT, WHICH INCLUDES CHEMOTHERAPY AND RADIATION THERAPY ICD-10: C22.0-C22.9,C49.A9,C78.7,D37.6,D61.810,G89.3,Z51.0,Z51.11-Z51.12, Z85.05 CPT: 32553,36260-36262,37243,37617,43260-43265,43274-43277,47120-47130, 47370,47371,47380-47382,47533-47540,47542,47562,47600-47620,47711, 47712,48150,49411,77014,77261-77295,77300-77370,77385-77387,77402- 77417,77424-77432,77469,77470,79005-79403,79445,93792,93793,96150- 96155,96377,96405,96406,96420-96450,96542,96549,989661-16-2020-98969,99051, 99060,99070,99078,99184,99201-99239,99281-99285,99291-99404,99408- 99449,99451,99452,99468-99480,99487-99491,99495-99498,99605-99607 HCPCS: C2616,C9725,G0068,G0070,G0071,G0248-G0250,G0396,G0397,G0406- G0408,G0425-G0427,G0463-G0467,G0490,G0508-G0511,G0513,G0514, G2010-G6017,S2095,S9537

Code Code Description Current Prioritized List Status 36246 Selective catheter placement, arterial system; ANCILLARY PROCEDURES initial second order abdominal, pelvic, or lower extremity artery branch, within a vascular family 36247 Selective catheter placement,Summaries arterial system; ANCILLARY PROCEDURES initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family 36248 Selective catheter placement, arterial system; ANCILLARY PROCEDURES additional second order, third order, and beyond, abdominal,Issue pelvic, or lower extremity artery branch, within a vascular family (List in addition to code for initial second or third order vessel as appropriate) 37242 Vascular embolization or occlusion, inclusive of 305 DISORDERS OF all radiological supervision and interpretation, ARTERIES, OTHER THAN intraprocedural roadmapping, and imaging CAROTID OR CORONARY VbBSguidance necessary to complete the intervention; 327 FUNCTIONAL AND arterial, other than hemorrhage or tumor (eg, MECHANICAL DISORDERS congenital or acquired arterial malformations, OF THE GENITOURINARY

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Y90 Embolization and Mapping

Code Code Description Current Prioritized List Status arteriovenous malformations, arteriovenous SYSTEM INCLUDING fistulas, aneurysms, pseudoaneurysms) BLADDER OUTLET OBSTRUCTION 547 SUBLINGUAL, SCROTAL, AND PELVIC VARICES 627 BENIGN NEOPLASMS OF SKIN AND OTHER SOFT TISSUES 37243 Vascular embolization or occlusion, inclusive of 315 CANCER OF LIVER all radiological supervision and interpretation, 403 UTERINE LEIOMYOMA intraprocedural roadmapping, and imaging AND POLYPS guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction 75726 Angiography, visceral, selective or supraselective Diagnostic1-16-2020 Procedures File (with or without flush aortogram), radiological supervision and interpretation 75774 Angiography, selective, each additional vessel Diagnostic Procedures File studied after basic examination, radiological supervision and interpretation (List separately in addition to code for primary procedure) 78205 Liver imaging (SPECT) Diagnostic Procedures File

GUIDELINE NOTE 185, YTTRIUM 90 THERAPY Line 315 Yttrium 90 therapy is only includedSummaries on this line for treatment of hepatocellular carcinoma (HCC) and only when recommended by a multidisciplinary tumor board or team in the following circumstances: A) Downsizing tumors in patients who could become eligible for curative treatment (transplant, ablation, or resection), OR B) Palliative treatment of incurable patients with unresectable or inoperable tumorsIssue that are not amenable to ablation therapy and 1) who have good liver function (Child-Pugh class A or B) and 2) good performance status (ECOG performance status 0-2), and 3) who have intermediate stage disease with tumors > 5 cm OR advanced stage HCC with unilateral (not main) portal vein tumor thrombus.

VbBSEvidence Borggreve, 2016 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4821864/pdf/270_2016_Article_1310. pdf

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Y90 Embolization and Mapping

• Systematic review of prophylactic embolization • Authors with conflicts of interest • 8 studies, 1237 patients, 456 received embolization of one or more arteries. • No difference was seen in the incidence of gastrointestinal complications in patients with prophylactic embolization of the gastroduodenal artery (GDA), right gastric artery (RGA), cystic artery (CA) or hepatic falciform artery (HFA) compared to patients without embolization. The risk differences between patients in the embolized group and patients in the non-embolized group varied from 0 to 12%. None of the included studies showed evidence in favor of routine performance of prophylactic embolization. • Few complications were reported when microspheres were injected distal to the origin of these arteries or when reversed flow of the GDA was present. • A high risk of confounding by indication was present because of the nonrandomized nature of the included studies. • Conclusion: It is advisable to restrict embolization to those hepaticoenteric arteries that originate distally or close to the injection site of microspheres.1-16-2020 There is no conclusive evidence that embolization of hepaticoenteric arteries influences the risk of complications. • Recommendation: According to the best available evidence, refraining from embolization of the GDA, RGA and CA is justified when the catheter tip can be placed distal to the origin of these arteries or when reversed flow is present in the GDA. The hepatic falciform artery can be embolized if a large uptake in the abdominal wall is seen.

Ward, 2017 https://www.jvir.org/article/S1051-0443(16)30519-X/fulltext • Consecutive case series of 62 patients undergoing 69 treatments • Planning angiography wasSummaries performed and embolization most commonly performed of the right gastric and supradudoenal arteries. Only 2 patients received gastroduodenal artery prophylactic embolization. Issue

VbBS

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Y90 Embolization and Mapping

• Conclusions: Radioembolization without prophylactic embolization of the gastroduodenal artery can be performed safely

Other payers Aetna, 2018 http://www.aetna.com/cpb/medical/data/200_299/0268.html

1. Intra-Hepatic Microspheres

Aetna considers intra-hepatic microspheres (e.g., TheraSphere, MDS Nordion Inc.; SIR-Spheres, Sirtex Medical Inc.) medically necessary for any of the following:

1. For treatment of neuroendocrine cancers (i.e., carcinoid tumors and pancreatic endocrine tumors) involving the liver. For carcinoid tumors, intra-hepatic microspheres are considered medically necessary1-16-2020 only in persons who have failed systemic therapy with octreotide to control carcinoid syndrome (e.g., debilitating flushing, wheezing and diarrhea); or 2. For unresectable, primary HCC; or 3. For unresectable liver tumors from primary colorectal cancer; or 4. For unresectable and chemo-refractory intra-hepatic cholangiocarcinoma if member exhibits liver metastases only and has an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better with adequate liver function (serum total bilirubin of less than 2 mg/dL); or 5. Pre-operative use as a bridge to orthotopic liver transplantation for HCC.

Aetna considers intra-hepatic microspheres experimental and investigational for metastases from esophageal cancer and gallbladder cancer and other indications because of insufficient evidenceSummaries in the peer-reviewed literature.

Selective Internal Radiation Therapy (SIRT), also known as radioembolization, is a procedure in which tiny radiation filled beads, called microspheres, are delivered directly to the tumor. The microspheres are delivered through a catheter placed in the femoral artery and threaded through the hepatic artery to the tumor site. The microspheresIssue contain yttrium -90. Examples of this type of treatment include: SIR- Spheres, which are resin spheres that are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer; and Theraspheres, which are spheres made of glass, and are indicated for primary unresectable hepatocellular carcinoma (HCC). VbBSDancey et al (2000) indicated that the following criteria be used to select appropriate patients for administration of intra-hepatic microspheres as an adjuvant to chemotherapy, surgery or transplantation for persons with unresectable HCC. These criteria are based on the selection criteria for clinical studies of the TheraSphere

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Y90 Embolization and Mapping

submitted for FDA approval, and contraindications to use of TheraSphere in the FDA- approved product labeling. These criteria may also be applied to persons with metastatic liver tumors from primary CRC (see discussion of SIR-Spheres below):

1. Histologically confirmed non-resectable lesion confined to the liver and at least 1 measurable lesion; and

o Absolute granulocyte count greater than or equal to 2.0 x 10 9/L o Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) less than 5 x upper normal limit [AST = 5 to 40 IU/L, ALT = 5 to 35 IU/L, ALP = 42 to 128 U/L] o Bilirubin less than 1.5 x upper normal limit [total bilirubin = 0.1 to 1.0 mg/dL or 5.1 to 17.0 mmol/L] o Estimated life expectancy greater than or equal to 12 weeks o Normal pulmonary function defined as within 30 % of the expected values for each parameter (e.g., forced vital capacity, forced1-16-2020 expiratory volume in 1 second, maximal mid-expiratory flow, maximal voluntary ventilation, and arterial blood gases); o Platelet count greater than or equal to 100 x 109/L o Prothrombin time (PT) and activated partial prothrombin time (APTT) within normal limits [PT = 11.0 to 12.5 seconds; APTT = 30 to 40 seconds]; and o Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to 3

2. Adequate bone marrow and hepatic function; and 3. No contraindications to hepatic artery catheterization (e.g., vascular abnormalities, bleeding Summariesdiathesis, allergy to contrast dye, or portal vein thrombosis); and 4. No other concurrently planned oncotherapy; and 5. At least 1 month post other chemotherapy or surgery.

The following exclusion criteria apply:

1. PreviousIssue chemotherapy or radiation therapy for hepatoma; or 2. Potential absorbed dose to lungs greater than 30 Gy; or 3. Any uncorrectable angiographic flow to the gastrointestinal tract; or 4. Co-morbid disease that would preclude safe delivery of intra-hepatic microspheres treatment and place the member at undue risk. VbBSDiagnostic work-up prior to the use of intra-hepatic microspheres includes: 1. Hepatic angiogram which entails placement of intra-hepatic catheter to assess vasculature and TheraSphere delivery route, and

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Y90 Embolization and Mapping

2. Technetium-99 macroaggregated albumin (Tc-99 MAA) study to evaluate hepatic flow to gastrointestinal tract and/or pulmonary shunting.

These studies are medically necessary and thus are eligible for coverage.

In the United States, SIR-Spheres are indicated for the treatment of unresectable metastatic liver tumors from primary CRC with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (floxuridine). The Food and Drug Administration (FDA) approval of SIR-Spheres was based on the results of a RCT involving 70 persons with CRC metastatic to the liver, 34 of whom received FUDR chemotherapy (control group), and 36 of whom received FUDR plus SIR-Spheres. Two of the patients receiving FUDR plus SIR-Spheres had a CR, and 16 had a partial response (PR). By comparison, 1 patient receiving FUDR alone achieved a CR and 7 had a PR. There is a statistically significant delay of time to progression of the disease in the group treated with FUDR plus SIR- Spheres, when compared with the group treated with FUDR only. 1-16-2020 The FDA-approved product labeling for SIR-Spheres states that treatment with SIR- Spheres may be indicated when the metastatic CRC in the liver is considered unresectable. According to the FDA-approved labeling, metastatic CRC may be considered non-resectable in any of the following circumstances:

1. Multiple liver metastases together with involvement of both lobes; or 2. Tumor invasion of the hepatic confluence where the 3 hepatic veins enter the inferior vena cava (IVC) such that none of the hepatic veins could be preserved if the metastases were resected; or 3. Tumor invasion of the porta hepatis such that neither origin of the right or left portal veins could be preserved if resection were undertaken; or 4. Widespread metastases Summariessuch that resection would require removal of more liver than is necessary to maintain life.

The FDA-approved product labeling for SIR-Sphere’s states that resectability may be evaluated via imaging with a triple phase contrast angio-portal CT scan or magnetic resonance imaging (MRI).

The FDA-approvedIssue labeling for SIR-Sphere states that the following tests are recommended before treatment.

1. A hepatic angiogram should be performed to establish arterial anatomy of the liver. 2. A nuclear medicine break-through scan (intra-hepatic technetium MAA Scan) to VbBSdetermine the percent lung shunting. If a port has been inserted, this test can be performed through the port. 3. Serologic tests of liver function should be performed to determine the extent of liver function/damage.

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The FDA-approved product labeling for SIR-Spheres states that appropriate imaging studies are recommended to determine the extent of disease. These may include chest x-ray, CT scan of chest and abdomen, abdominal ultrasound and a bone scan.

The product labeling states that SIR-Spheres are contraindicated in patients who have:

• Ascites or are in clinical liver failure, or • Been treated with capecitabine within the 2 previous months, or who will be treated with capecitabine at any time following treatment with SIR-Spheres, or • Disseminated extra-hepatic malignant disease, or • Greater than 20 % lung shunting of the hepatic artery blood flow determined by technetium MAA scan, or • Had previous external beam radiation therapy to the liver, or • Markedly abnormal synthetic and excretory liver function tests (LTFs), or • Portal vein thrombosis; or • Pre-assessment angiogram that demonstrates abnormal vascular1-16-2020 anatomy that would result in significant reflux of hepatic arterial blood to the stomach, pancreas or bowel.

The manufacturer of SIR-Spheres recommends a SPECT scan of the upper abdomen be performed immediately after implantation of SIR-Spheres to confirm placement of the microspheres in the liver.

Both 37242 and 37243 are covered.

National Institute for Clinical Excellence, 2013. Excerpt from https://www.nice.org.uk/guidance/ipg460/chapter/2-The-procedure

2.2 Outline of the procedure Summaries 2.2.1 Selective internal radiation therapy (SIRT) for primary hepatocellular carcinoma involves infusion of microspheres loaded with yttrium-90, which aims to deliver radiation directly into the tumour, minimising the risk of radiation damage to healthy surrounding tissues.Issue 2.2.2 Before undertaking the treatment, a nuclear medicine liver-to-lung shunt study is carried out to assess the risk of radioactive microspheres causing lung damage. Radiographic imaging and selective coil embolisation of arteries to the stomach and duodenum are also commonly carried out.

VbBS

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United Health Care, 2019 https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm- medical-drug/implantable-beta-emitting-microspheres-treatment-malignant-tumors.pdf

Transarterial radioembolization (TARE) using yttrium-90 (90Y) microspheres is proven and medically necessary for the following indications: • Unresectable metastatic liver tumors from primary colorectal cancer (CRC) • Unresectable metastatic liver tumors from neuroendocrine tumors • Unresectable primary hepatocellular carcinoma (HCC) • Unresectable intrahepatic cholangiocarcinoma

Transarterial radioembolization (TARE) using yttrium-90 (90Y) microspheres is unproven and not medically necessary for all other indications due to insufficient evidence of efficacy. 1-16-2020

There is no menton of CPT code 37242.

Summaries Professional Society Guidelines https://www.acr.org/-/media/ACR/Files/Practice-Parameters/RMBD.pdf Consensus Practice Parameter, 2019 - American College of Radiology (ACR), the American Brachytherapy Society (ABS), the American College of Nuclear Medicine (ACNM), the American Society for Radiation Oncology (ASTRO), the Society of InterventionalIssue Radiology (SIR), and the Society of Nuclear Medicine and Molecular Imaging (SNMMI)

II. INDICATIONS AND CONTRAINDICATIONS A. Indications for both agents include, but are not limited to, the following: 1. The presence of unresectable or inoperable primary or secondary liver VbBSmalignancies (particularly CRC and NET metastases). The tumor burden should be liver dominant, not necessarily exclusive to the liver. Patients should also have a performance status that will allow them to benefit from such therapy. 2. A life expectancy of at least 3 months

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Y90 Embolization and Mapping

B. Absolute contraindications include the following: 1. Inability to catheterize the hepatic artery 2. Fulminant liver failure 3. Initial mapping angiography and/or technetium-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy demonstrating nontarget deposition to the gastrointestinal organs that cannot be corrected by angiographic techniques. 4. Pretreatment hepatic arterial administration with technetium-99m MAA demonstrative of unfavorable (or unacceptable) shunt fraction between the liver and the pulmonary parenchyma. This shunt fraction must not be greater than acceptable limits specific to each brachytherapy device. 5. Active hepatic infection 6. Therapy during pregnancy may possibly be an option in extraordinary circumstances and with multidisciplinary consult and considerations. 1-16-2020 Article on costs Steele, 2016 https://ascopubs.org/doi/pdfdirect/10.1200/JOP.2014.001523 Article on costs discussing different methods of intervention (balloon versus coil). Argues that pretreatment diagnostic visit is still necessary but balloon occlusion technique would be less expensive than coil embolization.

Gabr, 2019 https://www.techvir.com/article/S1089-2516(19)30016-2/fulltext • Institutional description of same day preplanning and Y90 administration • Possible model for decreased costs

Summaries

Issue

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Y90 Embolization and Mapping

HERC Staff Summary Pre-treatment mapping appears to be commonly performed and may involve prophylactic embolization of vasculature to the bowel to avoid Y90 going to bowel, gallbladder, and abdominal wall. While the manufacturer recommends it, evidence supporting embolization is limited, however, with no evidence showing benefit. Expert opinion suggests pre-treatment embolization is necessary in less than 5% of cases. For surgeons accustomed to using older techniques including pre-embolization, it may be less safe to perform Y90 surgery without embolization. This may limit access to Y90 or differentially impact safety, since not all physicians are trained on the technique that allows Y90 to be delivered without embolization, and some providers or plans may be concerned about liability if embolization is not performed.

Pre-treatment mapping codes are in the Diagnostic File and would be covered, the relevant pre-treatment code that includes non-tumor embolization does not pair with liver cancer. 1-16-2020 HERC Staff Recommendations: 1. Do not add CPT 37242 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; arterial, other than hemorrhage or tumor (eg, congenital or acquired arterial malformations, arteriovenous malformations, arteriovenous fistulas, aneurysms, pseudoaneurysms) to Line 315 1) Alternatively, 37242 could be added to Line 315 without a guideline, due to the variation in practice standards across the state and some interventionists lack of comfort with proceeding without pre-treatment embolization and possible potential increased risks.

2. Modify Guideline Note 185Summaries as follows: GUIDELINE NOTE 185, YTTRIUM 90 THERAPY Line 315 Yttrium 90 therapy is only included on this line for treatment of hepatocellular carcinoma (HCC) and only when recommended by a multidisciplinary tumor boardIssue or team in the following circumstances: A) Downsizing tumors in patients who could become eligible for curative treatment (transplant, ablation, or resection), OR B) Palliative treatment of incurable patients with unresectable or inoperable tumors that are not amenable to ablation therapy and 1) who have good liver function (Child-Pugh class A or B) and 2) good performance status (ECOG performance status 0-2), and VbBS 3) who have intermediate stage disease with tumors > 5 cm OR advanced stage HCC with unilateral (not main) portal vein tumor thrombus.

Y90 Embolization and Mapping, Issue #1602 Page 12

Y90 Embolization and Mapping

Pretreatment mapping is included on this line, however, pre-treatment embolization is not included on this line due to insufficient evidence of effectiveness.

1-16-2020

Summaries

Issue

VbBS

Y90 Embolization and Mapping, Issue #1602 Page 13

Vitamin D

Question: How should coverage of vitamin D testing be clarified on the Prioritized List?

Question source: Oregon Health Leadership Council, OHA Staff

Issue: The Oregon Health Leadership Council http://www.orhealthleadershipcouncil.org/about/ is looking at opportunities to reduce health care waste. One of the identified areas by the Evidence-Based Best Practice Committee is on vitamin D screening. Vitamin D screening is considered broadly overused.

This is the agreed upon OHLC guideline: 25 OH Vitamin D: Screening is medically necessary and covered for patients with the following risk factors for Vitamin D Deficiency: A. Chronic kidney disease stage III or greater B. Cirrhosis C. Hypocalcemia 1-16-2020 D. Hypercalcemia E. Hypercalciuria F. Hypervitaminosis D G. Parathyroid disorders H. Malabsorption states I. Obstructive jaundice J. Osteomalacia K. Osteoporosis if: 1. T score on DEXA scan <-2/5; or 2. History of fragility fractures; or 3. FRAX >3% (any fracture) with T-score <-1.5; or 4. Initiating bisphosphonateSummaries therapy (vitamin D level should be determined and managed as necessary before bisphosphonate is initiated) L. Osteosclerosis/petrosis M. Rickets N. Vitamin D deficiency on replacement therapy related to a condition listed above; to monitor the efficacy of treatment. Issue 1,25-OH Vitamin D: This is a more expensive test, and is only considered medically necessary and covered for patients in the setting of the following conditions: A. Unexplained hypercalcemia (suspected granulomatous disease or lymphoma) B. Unexplained hypercalciuria (suspected granulomatous or lymphoma) C. Suspected genetic childhood rickets VbBSD. Suspected tumor induced osteomalacia E. Nephrolithiasis or hypercalciuria F. End stage renal disease

Vitamin D - OHLC, Issue #1640 Page 1

Vitamin D

Current Prioritized List Status: Prioritized List Fee Code Code Description Placement Schedule 82306 Vitamin D; 25 hydroxy, includes fraction(s), if Diagnostic 23.02 performed Procedures File 82652 Vitamin D; 1, 25 dihydroxy, includes Diagnostic 29.95 fraction(s), if performed Procedures File

OHP utilization. Paid CPT only Procedure Code Procedure Description Claim Indicator Cnt 82306 Vitamin D 25 Hydroxy CCO 85,253 82306 Vitamin D 25 Hydroxy FFS 12,212 82652 Vit D 1 25-Dihydroxy CCO 2,219 82652 Vit D 1 25-Dihydroxy FFS 199 1-16-2020

At OHP fee-for-service rates: Vitamin D 25 hydroxy expenditures = (85253 +12212)*23.02 = $2,243,644 Vitamin D 1,25 dihydroxy expenditures = (2219+199)*29.95 = $72,419

Many of the primary diagnoses with which the blood tests are paired appearing to be for screening purposes, for example: • Encntr for general adult medical exam w/o abnormal findings • Encntr screen for dis of the bld/bld-form org/immun mechnsm • Encntr for routine child health exam w/o abnormal findings • Encounter for general adult medical exam w abnormal findings • Encounter for screening for lipoid disorders • Essential (primary) hypertensionSummaries

Evidence review USPSTF, 2014 https://www.ncbi.nlm.nih.gov/books/NBK263419/

The USPSTF concludesIssue that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults. “I” recommendation

USPSTF, 2018 VbBSVitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Fractures in Community-Dwelling Adults: Preventive Medication

Vitamin D - OHLC, Issue #1640 Page 2

Vitamin D

https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/ vitamin-d-calcium-or-combined-supplementation-for-the-primary-prevention-of- fractures-in-adults-preventive-medication Population Recommendation Grade The USPSTF concludes that the current evidence is Men and insufficient to assess the balance of the benefits and

premenopausal harms of vitamin D and calcium supplementation, alone I women or combined, for the primary prevention of fractures in men and premenopausal women. The USPSTF concludes that the current evidence is insufficient to assess the balance of the benefits and Postmenopausal harms of daily supplementation with doses greater than

I women 400 IU of vitamin D and greater than 1000 mg of calcium for the primary prevention of fractures in community- dwelling, postmenopausal women. 1-16-2020 The USPSTF recommends against daily supplementation Postmenopausal with 400 IU or less of vitamin D and 1000 mg or less of

D women calcium for the primary prevention of fractures in community-dwelling, postmenopausal women.

USPSTF, 2018 https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/ falls-prevention-in-older-adults-interventions1 Population Recommendation Grade The USPSTF recommends against vitamin D Adults 65 years or

supplementation to prevent falls in community- D older dwelling adultsSummaries 65 years or older.

Recommendations from professional societies

American SocietyIssue of Clinical Pathology (ASCP), 2013 http://www.choosingwisely.org/clinician-lists/american-society-clinical-pathology- population-based-screening-for-vitamin-d-deficiency/

Don’t perform population based screening for 25-OH-Vitamin D deficiency.

Vitamin D deficiency is common in many populations, particularly in patients at higher VbBSlatitudes, during winter months and in those with limited sun exposure. Over the counter Vitamin D supplements and increased summer sun exposure are sufficient for most otherwise healthy patients. Laboratory testing is appropriate in higher risk patients

Vitamin D - OHLC, Issue #1640 Page 3

Vitamin D

when results will be used to institute more aggressive therapy (e.g., osteoporosis, chronic kidney disease, malabsorption, some infections, obese individuals).

Endocrine Society, 2013 https://www.choosingwisely.org/clinician-lists/endocrine-society-vitamin-d-testing/

Don’t routinely measure 1,25-dihydroxyvitamin D unless the patient has hypercalcemia or decreased kidney function.

Holick, 2011, Endocrine Society clinical practice guideline. https://academic.oup.com/jcem/article/96/7/1911/2833671

1.1 We recommend screening for vitamin D deficiency in individuals at risk for deficiency. We do not recommend population screening for vitamin D deficiency in individuals who are not at risk (1|⊕⊕⊕⊕). 1-16-2020 1.2 We recommend using the serum circulating 25-hydroxyvitamin D [25(OH)D] level, measured by a reliable assay, to evaluate vitamin D status in patients who are at risk for vitamin D deficiency. Vitamin D deficiency is defined as a 25(OH)D below 20 ng/ml (50 nmol/liter), and vitamin D insufficiency as a 25(OH)D of 21–29 ng/ml (525–725 nmol/liter). We recommend against using the serum 1,25-dihydroxyvitamin D [1,25(OH)2D] assay for this purpose and are in favor of using it only in monitoring certain conditions, such as acquired and inherited disorders of vitamin D and phosphate metabolism (1|⊕⊕⊕⊕).

4.1 We recommend prescribing vitamin D supplementation for fall prevention. We do not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventingSummaries cardiovascular disease or death or improving quality of life (2|⊕⊕⊕⊕).

Other Payer Policies CMS LCD, 2018 Revision https://www.cms.gov/medicare-coverage-database/details/lcd- details.aspx?LCDId=34051&ver=27&Date=&DocID=L34051&bc=iAIssue AAABAAAAAA& Indications:

Measurement of 25-OH Vitamin D, CPT 82306, level is indicated for patients with: • chronic kidney disease stage III or greater • cirrhosis VbBS• hypocalcemia • hypercalcemia • hypercalciuria • hypervitaminosis D

Vitamin D - OHLC, Issue #1640 Page 4

Vitamin D

• parathyroid disorders • malabsorption states • obstructive jaundice • osteomalacia • osteoporosis if

i. T score on DEXA scan <-2.5 or ii. History of fragility fractures or iii. FRAX > 3% 10-year probability of hip fracture or 20% 10-year probability of other major osteoporotic fracture or iv. FRAX > 3% (any fracture) with T-score <-1.5 or v. Initiating bisphosphanate therapy (Vit D level should be determined and managed as necessary before bisphosphonate is initiated)

• osteosclerosis/petrosis • rickets 1-16-2020 • vitamin D deficiency on replacement therapy related to a condition listed above; to monitor the efficacy of treatment.

Measurement of 1, 25-OH Vitamin D, CPT 82652, level is indicated for patients with: • unexplained hypercalcemia (suspected granulomatous disease or lymphoma) • unexplained hypercalciuria (suspected granulomatous disease or lymphoma) • suspected genetic childhood rickets • suspected tumor-induced osteomalacia • nephrolithiasis or hypercalciuria

Limitations:

Testing may not be used for routineSummaries or other screening.

Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1,25-dihydroxy vitamin D deficiency exists; mostly, in those with renal disease. Although it is not the activeIssue form of the hormone, 25-OH vitamin D is much more commonly measured because it better reflects the sum total of vitamin D produced endogenously and absorbed from the diet than does the level of the active hormone 1, 25 -dihydroxy vitamin D. Deficiency of 1,25-dihydroxy vitamin D, which is present at much lower concentrations, does not necessarily reflect deficiency of 25-OH vitamin D and its measurement should be limited to the indications listed. Documentation must justify the test(s) chosen for a particular disease entity. Various component sources of 25-OH VbBSvitamin D, such as stored D or diet-derived D, should not be billed separately.

Once a beneficiary has been shown to be vitamin D deficient, further testing may be

Vitamin D - OHLC, Issue #1640 Page 5

Vitamin D

medically necessary only to ensure adequate replacement has been accomplished. If Vitamin D level is between 20 and 50 ng/dl and patient is clinically stable, repeat testing is often unnecessary; if performed, documentation most clearly indicate the necessity of the test. If level <20 ng/dl or > 60 ng/dl, a subsequent level(s) may be reimbursed until the level is within the normal range.

HERC Staff Summary USPSTF has found insufficient evidence for vitamin D screening and has recommended against vitamin D supplementation for fall prevention and for fracture prevention. The Oregon Health Leadership Council is working on a coordinated effort to improve appropriate utilization of vitamin D testing in Oregon across payers. There appears to be significant use of vitamin D testing in the OHP population, with a proportion of it for screening purposes which is not supported by the evidence. 1-16-2020 HERC Staff Recommendations: 1) Advise HSD to remove 82306 Vitamin D; 25 hydroxy and 82652 Vitamin D; 1, 25 dihydroxy, from the Diagnostic File 2) Add 82306 to the following lines:

• 24 ENDOCRINE AND METABOLIC DISTURBANCES SPECIFIC TO THE FETUS AND NEWBORN • 55 COMPLICATED STONES OF THE GALLBLADDER AND BILE DUCTS; CHOLECYSTITIS • 102 POISONING BY INGESTION, INJECTION, AND NON-MEDICINAL AGENTS • 117 NUTRITIONAL DEFICIENCIES • 151 DISORDERS OF MINERALSummaries METABOLISM, OTHER THAN CALCIUM • 195 ACUTE PANCREATITIS • 224 DISORDERS OF PARATHYROID GLAND; BENIGN NEOPLASM OF PARATHYROID GLAND; DISORDERS OF CALCIUM METABOLISM • 227 INTESTINAL MALABSORPTION • 239 SHORT BOWEL SYNDROME - AGE 5 OR UNDER • 248 METABOLICIssue BONE DISEASE • 250 CHRONIC PANCREATITIS • 259 CANCER OF ENDOCRINE SYSTEM, EXCLUDING THYROID; CARCINOID SYNDROME • 288 OSTEOPETROSIS • 293 ANOMALIES OF GALLBLADDER, BILE DUCTS, AND LIVER • 307 CIRRHOSIS OF LIVER OR BILIARY TRACT; BUDD-CHIARI SYNDROME; HEPATIC VbBSVEIN THROMBOSIS; INTRAHEPATIC VASCULAR MALFORMATIONS; CAROLI'S DISEASE • 334 ALCOHOLIC FATTY LIVER OR ALCOHOLIC HEPATITIS, CIRRHOSIS OF LIVER • 339 CHRONIC KIDNEY DISEASE

Vitamin D - OHLC, Issue #1640 Page 6

Vitamin D

• 352 URINARY SYSTEM CALCULUS

3) Add 82652 Vitamin D; 1, 25 dihydroxy to the following lines • 224 DISORDERS OF PARATHYROID GLAND; BENIGN NEOPLASM OF PARATHYROID GLAND; DISORDERS OF CALCIUM METABOLISM • 151 DISORDERS OF MINERAL METABOLISM, OTHER THAN CALCIUM • 248 METABOLIC BONE DISEASE • 352 URINARY SYSTEM CALCULUS

3) Add R82.994 Hypercalciuria (currently in the Diagnostic Workup File) to Lines 224 and 352 1-16-2020

Summaries

Issue

VbBS

Vitamin D - OHLC, Issue #1640 Page 7

Fetal Repair of Myelomeningocele

Question: Should fetal repair of myelomeningocele be added to the Prioritized List?

Question source: HSD Hearings Division

Issue: HSD Hearings recently had a case in which a patient with a fetus with myelomeningocele requested fetal repair. The HCPCS code S2404 (Repair, myelomeningocele in the fetus, procedure performed in utero) is not listed on the Prioritized List, and the surgery is not included in Guideline Note 2, Fetoscopic Surgery. Several other HCPCS codes for fetal repair of congenital conditions are included on line 1 PREGNANCY and in GN2.

Myelomeningocele is the most severe form of spina bifida, in which the lower portion of the spine is open and the spinal cord and spinal nerves protrude out of the opening. It is frequently accompanied by hydrocephalus and other intracranial abnormalities. It frequently results in bowel and bladder control loss, and partial or complete lower extremity paralysis. The standard treatment for myelomeningocele is to repair the defect shortly after birth. 1-16-2020 The Management Of Myelomeningocele Study (MOMS) study, published in 2011, established fetal repair of myelomeningocele as a viable alternative option for treatment of myelomeningocele. However, this surgery is only offered at a few centers in the US and carries considerable risk for both mom and baby.

GUIDELINE NOTE 2, FETOSCOPIC SURGERY Line 1 Fetal surgery is only covered for the following conditions: repair of urinary tract obstructions via placement of a urethral shunt, repair of congenital cystic adenomatoid malformation, repair of extralobal pulmonary sequestration, repair of sacrococcygeal teratoma, and therapy for twin-twin transfusion syndrome.

Fetoscopic repair of urinary tract obstructionSummaries (S2401) is only covered for placement of a urethral shunt. Fetal surgery for cystic adenomatoid malformation of the lung, extralobal pulmonary sequestration and sacrococcygeal teratoma must show evidence of developing hydrops fetalis.

Certification of laboratory required (76813-76814).

Issue

VbBS

Fetal Repair of Myelomeningocele

Evidence 1) Grivell 2014, Cochrane review of fetal surgery for spina bifida a. N=1 trial of 158 women (MOMS trial—see below) i. Low risk of bias b. For the primary infant outcome of neonatal mortality, there was no clear evidence of a difference identified for prenatal versus postnatal repair (one study, 158 infants, risk ratio (RR) 0.51, 95%confidence interval (CI) 0.05 to 5.54), however event rates were uncommon and so the analysis is likely to be underpowered to detect differences. c. Prenatal repair was associated with an earlier gestational age at birth (one study, 158 infants, mean difference (MD) -3.20 weeks, 95% CI -3.93 to -2.47) and a corresponding increase in both the risk of preterm birth before 37 weeks (one study, 158 infants, RR 5.30, 95% CI 3.11 to 9.04) and preterm birth before 34 weeks (one study, 158 infants, RR 9.23, 95% CI 3.45 to 24.71). Prenatal repair was associated with a reduction in shunt dependent hydrocephalus and moderate to severe hindbrain herniation. For women, prenatal repair was associated with increased preterm ruptured membranes (one study, 158 women, RR 6.15, 95% CI 2.75 to 13.78), although there was no clear evidence of difference in the risk of chorioamnionitis or blood transfusion, although1-16-2020 again, event rates were uncommon. d. A number of this review’s secondary infant and maternal outcomes were not reported. For the infant: days of hospital admission; survival to discharge; stillbirth; need for further surgery (e.g. skin grafting); neurogenic bladder dysfunction; childhood/infant quality of life. For the mother: admission to intensive care; women’s emotional wellbeing and satisfaction with care. e. Authors’ conclusions: This review is based on one small well-conducted study. There is insufficient evidence to recommend drawing firm conclusions on the benefits or harms of prenatal repair as an intervention for fetuses with spina bifida. Current evidence is limited by the small number of pregnancies that have been included in the single conducted randomized trial to date. 1) Adzick 2011, MOMS trial a. N=158 patients i. trial was stoppedSummaries for efficacy of prenatal surgery after the recruitment of 183 of a planned 200 patients. ii. This paper reports on the 158 patients with a child evaluation of 12 months iii. Inclusion criteria: singleton gestation, myelomeningocele with an upper boundary between T1 and S1, evidence of hindbrain herniation of fetal MRI, gestation age between 19 0/7 weeks and 25 6/7 weeks at randomization, normal karyotype Issueiv. Exclusion criteria: fetal anomalies unrelated to the myelomeningocele, risk of preterm birth, placental abruption, contraindication to surgery, and a maternal body mass index of 35 or more b. There were 2 perinatal deaths in each group c. Need for cerebrospinal fluid shunt by 12 months occurred in 68% of the infants in the prenatal-surgery group and in 98% of those in the postnatal surgery group (relative risk, 0.70; 97.7% confidence interval [CI], 0.58 to 0.84; P<0.001). Actual rates of shunt VbBS placement were 40% in the prenatal-surgery group and 82% in the postnatal-surgery group (relative risk, 0.48; 97.7% CI, 0.36 to 0.64; P<0.001). d. At 12 months of age, the proportion of infants who had no evidence of hindbrain herniation was higher in the prenatal-surgery group (36%) than in the postnatal-surgery

Fetal Repair of Myelomeningocele

group (4%). Similarly, at 12 months, the prenatal-surgery group had a lower rate of moderate or severe hindbrain herniation (25%) than the postnatal-surgery group (67%), as well as lower rates of brain-stem kinking, abnormal fourth-ventricle location, and syringomyelia e. Infants in the prenatal-surgery group underwent more procedures for delayed spinal cord tethering f. Prenatal surgery resulted in improvement in the composite score for mental development and motor function at 30 months (P = 0.007) and in improvement in several secondary outcomes, including hindbrain herniation by 12 months and ambulation by 30 months. g. However, prenatal surgery was associated with an increased risk of preterm delivery and uterine dehiscence at delivery. h. Conclusions Prenatal surgery for myelomeningocele reduced the need for shunting and improved motor outcomes at 30 months but was associated with maternal and fetal risks. 2) Johnson 2016, MOMS study complications a. N=183 women (91 prenatal, 92 postnatal surgery) 1-16-2020 b. prenatal surgery was associated with an increased risk for membrane separation, oligohydramnios, spontaneous membrane rupture, spontaneous onset of labor, and earlier gestational age at birth. c. Gestational age at birth was significantly lower in the fetal surgery group (34.0 vs 37.3 weeks, P<0.001). Overall, 74 (81.3%) in the fetal surgery group were preterm vs 11 (11.9%) in the post natal surgery group. i. Risk of deliver at <30 weeks was significantly greater in the fetal surgery group (10 vs 0, P<0.001) a. CONCLUSION: Despite the confirmed benefits of prenatal surgery, considerable maternal and fetal risk exists compared with postnatal repair. Early gestational age at surgery and development of chorioamniotic membrane separation are risk factors for ruptured membranes. Oligohydramnios is a risk factor for preterm delivery and nulliparity is a risk factor for nonintact hysterotomy at delivery. 3) Farmer 2018, maternal and fetal/infantSummaries outcomes at 30 months for entire MOMS cohort a. N=183 maternal/fetal pairs b. prenatal repair improves the primary outcome composite score of mental development and motor function (199.4 ± 80.5 vs 166.7 ± 76.7,P=.004). Prenatal surgery also resulted in improvement in the secondary outcomes of independent ambulation (44.8% vs 23.9%, P = .004), WeeFIM self-care score (20.8 vs 19.0, P = .006), functional level at least 2 better than anatomic level (26.4% vs 11.4%, P=.02), and mean Bayley Scales of Infant Development,Issue Second Edition, psychomotor development index (17.3% vs 15.1%, P = .03), but does not affect cognitive development at 30 months. c. CONCLUSION: The full cohort data of 30-month cognitive development and motor function outcomes validate in utero surgical repair as an effective treatment for fetuses with myelomeningocele. Current data suggest that outcomes related to the need for shunting should be counseled separately from the outcomes related to distal neurologic functioning. VbBS

Fetal Repair of Myelomeningocele

Expert guidelines 1) ACOG 2017, committee opinion on fetal surgery for myelomeningocele a. ACOG and the Society for Maternal-Fetal Medicine make the following recommendations: i. Open maternal-fetal surgery for myelomeningocele repair has been demonstrated to improve a number of important pediatric outcomes at the expense of procedure-associated maternal and fetal risks ii. Women with pregnancies complicated by fetal myelomeningocele who meet established criteria for in utero repair should be counseled in nondirective fashion regarding all management options, including the possibility of open maternal-fetal surgery iii. Interested candidates for fetal myelomeningocele repair should be referred for further assessment and consultation to a fetal therapy center that offers this intervention and possesses the expertise, multi-disciplinary team, services, and facilities to provide detailed information regarding maternal-fetal surgery and the intensive care required for patients who choose to undergo open maternal- fetal surgery 1-16-2020

Other payer policies 1) Aetna 2019 and United Health Care 2019 cover fetal repair of myelomeningocele

Expert input Mark Tomlinson, Maternal Fetal Medicine and Director of Obstetrics for Providence There are fetal benefits to in utero myelomeningocele repair and I would recommend coverage. These [patients] require a lot of counseling though because of the maternal morbidity associated with the uterine scar. This is particularly important for young mothers who plan future children. The rate of rupture in subsequent pregnancies is significant, 10-30% depending on definitions used. There is an article presented at the annual meeting in [February] and recently published in the AJOGSummaries in the last couple of months looking at a registry of maternal outcomes suggesting a risk of rupture at the lower end of the range. There are some groups doing the surgery fetoscopically, but currently that is controversial. It decreases adverse maternal outcomes, however the fetal outcomes are uncertain at this time.

Issue

VbBS

Fetal Repair of Myelomeningocele

HERC staff summary Fetal repair of myelomeningocele improves infant outcomes, based on one good quality RCT. However, there are significant risks to both mother and baby. ACOG recommends that fetal repair be offered as one option to women with a fetus affected by myelomeningocele who meet the inclusion criteria to the MOMS trial. Cochrane cautions that the evidence base for this procedure includes only 1 trial conducted at highly specialized centers. Our expert consultant also recommends coverage for patients who have been appropriately counseled.

HERC staff recommendations 1) Add HCPCS S2404 (Repair, myelomeningocele in the fetus, procedure performed in utero) to line 1 PREGNANCY 2) Modify GN2 as shown below

GUIDELINE NOTE 2, FETOSCOPIC FETAL SURGERY Line 1 Fetal surgery is only covered for the following conditions: repair of urinary tract1-16-2020 obstructions via placement of a urethral shunt, repair of congenital cystic adenomatoid malformation, repair of extralobal pulmonary sequestration, repair of sacrococcygeal teratoma, and therapy for twin-twin transfusion syndrome, and repair of myelomeningocele.

Fetoscopic repair of urinary tract obstruction (S2401) is only covered for placement of a urethral shunt. Fetal surgery for cystic adenomatoid malformation of the lung, extralobal pulmonary sequestration and sacrococcygeal teratoma must show evidence of developing hydrops fetalis.

Certification of laboratory required (76813-76814).

Summaries

Issue

VbBS

iStent Inject for Glaucoma with Cataract Removal

Question: Should iStent Inject (CPT 0376T) be added to the Prioritized List for treatment of glaucoma?

Question source: Glaukos

Issue: In October and November, 2018, iStent (CPT 0191T) was added to the open angle glaucoma line with a new guideline restricting use to concurrent cataract removal. Glaukos, the manufacturer of iStent has requested that the HERC consider their newly FDA approved product, iStent Inject. Per the manufacturer materials, iStent inject has two channels, rather than the one channel in iStent and is designed to work in either eye (iStent is eye specific). It is also smaller than the iStent.

Per the FDA memo from June, 2018, “This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma.”

IStent uses CPT 0191T (Insertion of anterior segment aqueous drainage device, without extraocular reservoir, internal approach, into the trabecular meshwork; initial insertion) while1-16-2020 iStent Inject uses CPT 0376T (Insertion of anterior segment aqueous drainage device, without extraocular reservoir, internal approach, into the trabecular meshwork; each additional device insertion).

From Glaukos: On behalf of Glaukos, your contracted Ophthalmic Surgeons, and patients in Oregon with Mild to Moderate Open Angle Glaucoma our hope is to provide an update regarding your recent decision to add 0191T to line 139 Glaucoma, Other Than Primary Angle-Closure of the Prioritized Health List, which is effective on 10/1/19. Thank you for the addition of 0191T and our current request is based on the 2018 FDA approval of a second generation stent commercially named iStent Inject. Though relatively new to the market, iStent Inject has received strong commercial acceptance in many Oregon Ophthalmic Surgeon’s treatment algorithm and is supported by strong data that is in line with your standards for supporting evidence. We respectfully ask the Commission to consider addingSummaries 0376T to support coverage for iStent Inject to line 139 Glaucoma, Other Than Primary Angle-Closure of the Prioritized Health List due to the rapid acceptance of iStent Inject into the marketplace and providing Oregon Medicaid patients access to this advancement in technology.

Other relevant codes: HCPCS C1783 (OcularIssue implant, aqueous drainage assist device): never reviewed HCPCS L8612 (Aqueous shunt): never reviewed

VbBS

iStent Inject for Glaucoma with Cataract Removal

Evidence 1) Samuelson 2019, RCT of iStent Inject vs no stent for glaucoma patients undergoing cataract surgery a. Eyes were randomized 3:1 intraoperatively to implantation of iStent inject (Model G2- M-IS; treatment group, n = 387) or no stent implantation (control group, n = 118). Subjects were followed through 2 years postoperatively b. At 24 months, 75.8% of treatment eyes versus 61.9% of control eyes experienced ≥20% reduction from baseline in unmedicated DIOP (P < 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0 ± 4.0 mmHg) than in control eyes (5.4 ± 3.7 mmHg; P < 0.001). Of the responders, 84% of treatment eyes and 67% of control eyes were not receiving ocular hypotensive medication at 23 months. c. The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up. d. Conclusions: Clinically and statistically greater reductions in IOP without medication were achieved after iStent inject implantation with cataract surgery versus cataract surgery alone, with excellent safety through 2 years. 1-16-2020 e. No notation of study funding in paper 1) Paletta Guedes 2019, retrospective cohort study of iStent and iStent inject a. Funded by Glaukos Corp. b. N=73 eyes with open angle glaucoma and cataract (38 iStent, 35 iStent Inject) c. At 6 months after surgery, mean IOP had fallen from 16.5 ± 3.9 to 13.9 ± 2.3 mmHg in eyes with the iStent implant (p<0.001), and from 17.3 ± 3.0 to 12.7 ± 1.8 mmHg in those with the iStent inject implant (p<0.001). This reduction was significantly greater in the iStent inject eyes than in the iStent eyes (26.6 vs. 15.8%) (p = 0.005). Significantly more eyes receiving the iStent inject device compared to the iStent device achieved an IOP of <18 mmHg at 6 months post surgery (100 vs. 86.8%) (p = 0.033). Average medication usage was reduced from 1.8 to 0.4 medications in iStent eyes (p<0.001) and from 2.3 to 0.4 medications in iStent inject eyes (p<0.001). Over 70% of eyes in both groups became medication- free by 6 months post implantation. d. Adverse events in iStentSummaries eyes were mild and resulted in no sequelae; two iStent eyes underwent non-penetrating deep sclerectomy during follow-up. No complications or secondary surgeries were noted in iStent inject eyes. e. Conclusion: Significant and safe IOP and medication reductions were observed after iStent or iStent inject implantation with concomitant cataract surgery. Trends toward greater effectiveness and fewer adverse events were observed with the iStent inject device compared with the iStent device Issue

Other payer policies: 1) Aetna 2019 covers both CPT 0191T and 0376T for glaucoma in conjunction with cataract surgery a. Unclear of 0376T refers to a second iStent or to iStent Inject in their policy b. Also cover Hydrus Microstent (same CPT codes)

VbBS Cost: 1) CPT 0191T: $2680-3640 2) CPT0376T: bundled into other service (presumably 0191T or cataract surgery codes)

iStent Inject for Glaucoma with Cataract Removal

HERC staff summary: There is limited literature regarding iStent Inject, but based on the one published RCT comparing iStent Inject to no stent and a cohort study comparing to iStent Inject to iStent, the iStent Inject appears to be equally effective to iStent at reducing intraocular pressure with a similar safety profile.

HERC staff also found that there is more than one product on the market that provides anterior segment aqueous drainage. The CPT code requested for addition (CPT 0376T) can also be used for insertion of a second iStent. There appears to be no additional cost for CPT 0376T at this time.

HERC staff recommendations: 1) Add CPT 0376T (Insertion of anterior segment aqueous drainage device, without extraocular reservoir, internal approach, into the trabecular meshwork; each additional device insertion) to line 139 GLAUCOMA, OTHER THAN PRIMARY ANGLE-CLOSURE 2) Add HCPCS C1783 (Ocular implant, aqueous drainage assist device) and L8612 (Aqueous shunt) to line 139 1-16-2020 3) Modify Guideline Note 184 as shown below a. Remove brand name as other devices are FDA approved. IStent Inject would be allowable with current guideline wording

GUIDELINE NOTE 184, ANTERIOR SEGMENT AQUEOUS DRAINAGE DEVICE INSERTION Line 139 Anterior segment aqueous drainage device (e.g. iStent©) insertion is only included on this line when done at the same time as cataract removal and when the two procedures are billed together as a bundled service.

Summaries

Issue

VbBS

Spinal Cord Stimulators

Question: Should spinal cord stimulators continue to be included on a covered back surgery line? If so, are there any guidelines or limitations which should apply?

Question source: Multiple CCOs

Issue: Spinal cord stimulation is a technology that can help manage chronic back pain, most commonly used to treat failed back surgery syndrome. The device consists of an electrode connected to a generator. By placing a stimulating electrode over the spinal cord, the pain signal cannot be sent up from the spine to the brain. The stimulation is a very mild electrical pulse that the patient usually does not feel. These electrical pulses mask the pain signal and can be adjusted over the course of the trial to get the greatest improvement in pain. Patients generally have a two week trial before permanent insertion of the spinal cord stimulation system. Trials are considered successful if they can remove half of a patient’s pain.

Currently, the CPT codes for placement of spinal cord stimulators are on all three surgical back lines.

This topic was nominated for a coverage guidance; however, the Center for Evidence1-16-2020 Based Policy found insufficient evidence for all outcomes (long term pain, function and quality of life) and concluded that the evidence base for this intervention is very poor. HERC staff recommended that this be brought directly to VbBS for discussion.

Summaries

Issue

VbBS

Spinal Cord Stimulators

CODES DESCRIPTION CPT Codes 292 NEUROLOGICAL DYSFUNCTION IN POSTURE AND MOVEMENT CAUSED BY CHRONIC CONDITIONS NEUROLOGICAL DYSFUNCTION IN POSTURE AND MOVEMENT CAUSED BY CHRONIC CONDITIONS Percutaneous implantation of neurostimulator 63650 346 CONDITIONS OF THE BACK AND electrode array, epidural SPINE WITH URGENT SURGICAL INDICATIONS 361 SCOLIOSIS 529 CONDITIONS OF THE BACK AND SPINE WITHOUT URGENT SURGICAL INDICATIONS Laminectomy for implantation of neurostimulator 292,346,361,529 63655 1-16-2020 electrodes, plate/paddle, epidural 285 COMPLICATIONS OF A PROCEDURE ALWAYS REQUIRING Removal of spinal neurostimulator electrode TREATMENT 63661 percutaneous array(s), including fluoroscopy, when 424 COMPLICATIONS OF A performed PROCEDURE USUALLY REQUIRING TREATMENT Removal of spinal neurostimulator electrode 285,424 plate/paddle(s) placed via laminotomy or 63662 laminectomy, including fluoroscopy, when performed Revision including replacement, when performed, 285,424 63663 of spinal neurostimulator electrodeSummaries percutaneous array(s), including fluoroscopy, when performed Revision including replacement, when performed, 285,424 of spinal neurostimulator electrode plate/paddle(s) 63664 placed via laminotomy or laminectomy, including fluoroscopy, when performed Insertion or replacement of spinal neurostimulator 292,346,361,529 63685 pulse generatorIssue or receiver, direct or inductive coupling Revision or removal of implanted spinal 285,424 63688 neurostimulator pulse generator or receiver Electronic analysis of implanted neurostimulator DIAGNOSTIC PROCEDURES pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency VbBS95970 [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by

Spinal Cord Stimulators

physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming Electronic analysis of implanted neurostimulator DIAGNOSTIC PROCEDURES pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed 95971 loop parameters, and passive parameters) by physician or other qualified health care professional; with simple spinal cord or peripheral nerve (e.g., sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional HCPCS Level II Codes 1-16-2020 Generator, neurostimulator (implantable), non- 174,249,292,327,346,361,441,455, C1767 rechargeable 538, 529 C1778 Lead, neurostimulator (implantable) Multiple lines C1787 Patient programmer, neurostimulator 327,455,528 Receiver and/or transmitter, neurostimulator 174,249,292,346,361,441,529 C1816 (implantable) Generator, neurostimulator (implantable), with 174,249,292,346,361,441,529 C1820 rechargeable battery and charging system Generator, neurostimulator (implantable), high 174,249,292,346,361,441,529 C1822 frequency, with rechargeable battery and charging system Generator, neurostimulator (implantable), non- 174,249,292,346,361,441,529 C1823 rechargeable, with transvenous sensing and stimulation leads Summaries Adapter/extension, pacing lead or neurostimulator Ancillary C1883 lead (implantable) C1897 Lead, neurostimulator test kit (implantable) Multiple Lines L8679 Implantable neurostimulator, pulse generator, any 327,455,528 type L8681 PatientIssue programmer (external) for use with 327,455,528 implantable programmable neurostimulator pulse generator, replacement only L8682 Implantable neurostimulator radiofrequency 327,455,528 receiver L8683 Radiofrequency transmitter (external) for use with 327,455,528 implantable neurostimulator radiofrequency VbBSreceiver L8684 Radiofrequency transmitter (external) for use with 327,455,528 implantable sacral root neurostimulator receiver for bowel and bladder management, replacement

Spinal Cord Stimulators

L8685 Implantable neurostimulator pulse generator, 327,455,528 single array, rechargeable, includes extension L8686 Implantable neurostimulator pulse generator, 327,455,528 single array, non-rechargeable, includes extension L8687 Implantable neurostimulator pulse generator, dual 327,455,528 array, rechargeable, includes extension L8688 Implantable neurostimulator pulse generator, dual 327,455,528 array, non-rechargeable, includes extension L8689 External recharging system for battery (internal) 327,455,528 for use with implantable neurostimulator, replacement only L8695 External recharging system for battery (external) Ancillary for use with implantable neurostimulator, replacement only

Coding specification for line 292 1-16-2020 Spinal cord stimulation (63650-63688) is not included on this line when paired with ICD-10-CM category G90.5 Complex regional pain syndrome/reflex sympathetic dystrophy.

Rationale for the above coding specification: an evidence review by the Health Services Commission from August, 2009 found spinal cord stimulation to be harmful when used for complex regional pain syndrome. This review included 4 Cochrane reviews and 3 systematic reviews that found minimal pain relief and a high (>35%) rate of complications.

Summaries

Issue

VbBS

Spinal Cord Stimulators

Evidence 1) Mekhail 2018, systematic review and meta-analysis of spinal cord stimulator RCTs a. CEBP rated this review poor quality b. N=7 RCTs examining trunk and limb pain (includes failed back surgery syndrome) c. there was significant heterogeneity in the specific devices used for SCS, as well as the comparators. Two of the included trials had sham control arms and two had active control arms (one with repeat surgery as the comparator and one with conventional medical management as the comparator). The remaining 3 trials compared one mode of SCS to another mode of SCS. d. For pain outcomes, a variety of measures were used across the studies including the visual analog scale (VAS), numeric rating scale (NRS), and the percentage of patients reporting >50% reduction in pain. Because of the heterogeneity of interventions, comparators, and outcomes in this population, the authors report results narratively. e. For pain outcomes, all but one of the studies found improvements in a pain measure for patients treated with SCS compared to controls. Two of the studies (one comparing SCS to repeat surgery for FBSS and one comparing SCS to conventional medical management) found that the proportion of patients reporting improvement1-16-2020 in pain of >50% increased by approximately 35% to 40% in the SCS groups at 6 months to two years of mean follow-up. The latter study also found that SCS improved VAS scores for back pain (mean improvement of 11 mm) and leg pain (mean improvement of 26.7 mm). One trial with three arms compared Medtronic SCS at 5 kHz to Medtronic SCS at 40 to 50 Hz and to a sham control; this study found no significant differences between the groups in VAS pain scores. A second sham controlled trial of the St Jude burst SCS compared to tonic 500 Hz SCS and to sham control found that burst stimulation resulted in statistically significant decreases in VAS pain scores (2.4 mm for burst SCS vs. tonic SCS and 3.6 for burst SCS vs. sham control). i. Mean clinically significant difference for VAS scores is 10-15 mm f. Functional and quality of life (QoL) outcomes were more sparsely reported in the included studies. One ofSummaries the sham controlled studies found no statistically significant differences in the Oswestry disability index (ODI) when comparing St Jude burst stimulation to tonic 500 Hz SCS to sham control. The other sham controlled study did not report functional outcomes. One trial comparing Medtronic SCS to conventional medical management found a mean reduction in ODI of 11.2 favoring SCS. The trial comparing high-frequency 10 kHz stimulation to conventional stimulation found a small improvementIssue in ODI with high-frequency stimulation (mean difference of -3.5), but no statistically significant difference in the Global Assessment of Functioning (GAF) score. Only two of the included studies reported quality of life outcomes. The trial comparing SCS to conventional medical management found significant improvements for SCS treated patients in QoL scores in 7 of 8 SF-36 domains with improvements ranging from 9.5 to 21.8 points. The trial comparing 5 kHz SCS to 40 to 50 Hz SCS to sham control found no differences between the groups in QoL as assessed by the EuroQoL-5D VbBS instrument. g. The authors note that while none of the included trials had pre-specified outcomes related to analgesic use, four studies reported on this outcome. While the studies comparing SCS to repeat operation and laminectomy electrodes to percutaneous

Spinal Cord Stimulators

electrodes found reductions in analgesic use with SCS and laminectomy electrodes, the remaining two trials (SCS vs. conventional medical management and 5 kHz SCS vs. 40 to 50 Hz SCS vs. sham control) found no statistically significant differences in opioid use. h. Overall, the authors conclude that there is “moderately strong” evidence of that SCS improves pain, function, and patient satisfaction when compared to conventional medical management. When compared with repeat surgery, pain and patient satisfaction improved, but the functional gains were not significant. 2) Rigoard 2019, PROMISE study RCT of spinal cord stimulator plus optimal medical therapy vs optimal medical therapy alone for failed back surgery syndrome a. CEBP rated this study as poor quality b. N=218 patients i. OMM included both non-invasive and invasive treatments including acupuncture, behavioral therapies, physical therapy, spinal epidural injections, adhesiolysis, and neurotomies. Patients randomized to OMM alone were allowed to crossover to SCS after six months. c. The primary outcome of greater than 50% reduction in low back1-16-2020 pain in the ITT analysis was achieved in 15 patients in the SCS plus OMM group (13.6%) and 5 patients in the OMM alone group (4.6%) (absolute risk difference 9%, 95% CI 0.6% to 17.5%, p = 0.036). Notably, the SCS group responder rate ranged from 0% to 50% across the study sites. In the ITT analysis the between group difference in ODI at 6 months was 6.3 (95% CI 2.5 to 10.2, p < 0.001) favoring the SCS plus OMM arm. In the ITT analysis the between group difference in SF-36 physical component score at 6 months was 3.9 (95% CI 2.0 to 5.9, p < 0.001) favoring the SCS plus OMM arm. d. The between group difference in morphine milligram equivalents (MME) was 8.3 MME (95% CI -3.1 to 19.6, p = 0.031) with lower MME observed in in the SCS group. e. There were 13 serious and 21 total adverse events in the SCS arm (17.6% of patients experienced any adverse event). The most common adverse event reported in the SCS arm was implant site infection occurring in 7 patients (6.9%); five of these patients required surgical intervention.Summaries Other adverse events included device stimulation issues, paresthesias, implant site pain, pulmonary edema, and urinary tract infection. f. The study was limited by the inability to blind patients or investigators as well as the heterogeneous treatments that were available as OMM in both arms of the trial. The study was funded by Medtronic. g. Author’s conclusions: Adding multicolumn SCS to OMM improved pain relief, HRQoL, andIssue function in a traditionally difficult-to-treat population of failed back surgery syndrome patients with predominant LBP. Improvements were sustained at 12 and 24 months.

VbBSEvidence of harms 1) Labaran 2019 a. Medicare database retrospective cohort study b. N=12,297 patients

Spinal Cord Stimulators

c. The most common indications for SCS placement were postlaminectomy syndrome (25.2%) and chronic pain syndrome (20.2%). d. There was a 4.2 and 17.2% incidence of postoperative back or spine emergency department (ED) visits, and a 0.3 and 3.4% incidence of SCS electrode removal or reimplantation within 90 days and 1 year, respectively. Other reported surgical complications were wound infection (4.3%), hematoma (0.5%), and seroma (0.4%) at one year postoperatively. Within 90 days after SCS implantation, the rate of subsequent spine surgery or revision was 0.9%. This incidence was 7.1, 11.7, and 15.5% at one, two, and three years, respectively. e. Conclusions: In our retrospective analysis of Medicare patients, the most common indication for SCS implantation was postlaminectomy syndrome. Common postoperative complications included wound infection, and removal of SCS electrodes at one year postoperatively. About 17% patients had an ED visit for spine-related symptoms within one year of device implantation, and 15.5% underwent subsequent spinal decompression and/or fusion within 3 years after primary SCS placement. 2) Falowski 2019 a. Retrospective cohort study of MarketScan® Databases 1-16-2020 b. N=6615 patients c. 12 month device-related infection rate was 3.11%. d. Conclusions: The 3.11% SCS-related infection rate within 12 m of implant emphasizes the need for improved infection control practices. Research is needed to limit SCS infections in younger patients and those with infection history.

Other payer policies Medicare National Coverage Determination (NCD)

Covers spinal cord stimulators for chronic back pain under certain conditions. This procedure is covered only as a late resort for patients with chronic intractable pain. Patients must undergo screening and evaluation by a multidisciplinary team, including psychological and physical evaluation. Successful trial associatedSummaries with at least a 50% reduction of target pain, or 50% reduction of analgesic medications, and show some element of functional improvement. There should be no active substance abuse issues

Aetna A trial of percutaneousIssue dorsal column stimulation is medically necessary to predict whether a dorsal column stimulator will induce significant pain relief for: • Low back pain and significant radicular pain due to failed back surgery syndrome • Last resort treatment of moderate to severe (5 or more on a 10-point VAS scale) chronic neuropathic pain of certain origins (i.e., lumbosacral arachnoiditis, phantom limb/stump pain, peripheral neuropathy, post-herpetic neuralgia, intercostal neuralgia, cauda equina injury, VbBSincomplete spinal cord injury, or plexopathy) that is refractory to 12 or more months of standard therapy (including non-steroidal anti-inflammatory drugs, tricyclic antidepressants, and anticonvulsants). Coverage is provided when all these criteria are met:

Spinal Cord Stimulators

• Member has undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation (Note: screening must include psychological as well as physical evaluations) • Member does not have any untreated existing drug addiction problems (per American Society of Addiction Medicine guidelines) • Member has obtained clearance from a psychiatrist, psychologist, or other qualified mental health professional • Other more conservative methods of pain management have been tried and failed • There is documented pathology, i.e., an objective basis for the pain complaint Implantation of a dorsal column stimulator is medically necessary when the trial criteria are met and the patient experienced significant pain reduction (50% or more) with a 3 to 7 day trial of percutaneous spinal stimulation.

High-frequency dorsal column stimulators (also known as BurstDR spinal cord stimulators) are an equal effective alternative to standard dorsal column stimulators. Replacement of a functioning standard dorsal column stimulator with a high-frequency dorsal column stimulator is considered1-16-2020 not medically necessary.

Replacement of a cervical, lumbar or thoracic dorsal column stimulator or battery/generator is medically necessary for individuals who meet medical necessity criteria for dorsal column stimulation and the existing stimulator or battery/generator are no longer under warranty and cannot be repaired.

Up to 16 electrodes/contacts, 2 percutaneous leads, or 1 paddle lead is medically necessary for a trial of a dorsal column stimulator. An additional 16 electrodes/contacts, 2 percutaneous leads, or 1 paddle lead are considered medically necessary for implantation of a dorsal column stimulator.

The use of intra-operative motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP) experimental and investigational for implantation of spinal cord stimulators. The use of cervical dorsal column stimulationSummaries is experimental and investigational for the treatment of cervical trauma, disc herniation, failed cervical spine surgery syndrome presenting with arm pain, neck pain, cervicogenic headache, because its effectiveness for these indications has not been established.

Dorsal root ganglion stimulators (e.g., Axium Neurostimulator System) are medically necessary for moderate to severe chronic intractable pain of the lower limbs in persons with complex regional pain syndrome, and Aetna’sIssue policy does not mention dorsal root ganglion stimulators for back pain.

Cigna A short-term trial (i.e., greater than 48 hours) of spinal cord stimulation (i.e., non-high-frequency, high- frequency) is considered medically necessary for the treatment of chronic intractable pain secondary to failed back surgery syndrome with intractable neuropathic leg pain when all the following criteria are VbBSmet: • Failure of at least six consecutive months of physician-supervised conservative medical management (e.g., pharmacotherapy, physical therapy, cognitive therapy, and activity lifestyle modification)

Spinal Cord Stimulators

• Surgical intervention is not indicated or the individual does not wish to proceed with spinal surgery • An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would impact perception of pain and/or negatively impact the success of a SCS or contraindicate placement of the device. Permanent implantation of a spinal cord stimulator is considered medically necessary for the treatment of chronic intractable pain secondary to failed back surgery syndrome with intractable neuropathic leg pain when at least 50% reduction in pain has been demonstrated during a short-term trial of SCS.

The replacement of an existing high frequency or non-high-frequency dorsal column spinal cord stimulator, battery, or generator is considered medically necessary for an individual when the existing stimulator, battery, or generator is malfunctioning, cannot be repaired, and is no longer under warranty.

Replacement of a functioning non high-frequency dorsal column spinal cord stimulator with a high frequency spinal cord stimulator is considered not medically necessary. 1-16-2020

Dorsal root ganglion stimulation is considered experimental, investigational or unproven for all indications

Moda A trial of spinal cord stimulation for intractable pain is covered when all of the following criteria are met: • Pain is neuropathic with documented pathology related to pain complaint (i.e., abnormal MRI) for 1 or more of the following: o Failed back surgery syndrome o Complex regional pain syndrome (also known as reflex sympathetic dystrophy) o Inoperable chronic ischemicSummaries limb pain secondary to peripheral vascular disease o Moderate to severe chronic neuropathic pain, including but not limited to, one of the following: ▪ Arachnoiditis ▪ Radiculopathies ▪ Phantom limb/stump pain Issue▪ Peripheral neuropathy ▪ Post-herpetic neuralgia ▪ Incomplete spinal cord injury ▪ Cauda equina injury • Other more conservative methods of pain management have been tried and failed including one or more of the following: o For limb ischemia, failed surgical or endovascular revascularization, or inoperable VbBS vascular disease o For neuropathic pain, stellate ganglion or lumbar sympathetic block o Conservative treatment tried and failed for 3 or more months for ALL of the following:

Spinal Cord Stimulators

▪ Pharmacological (including NSAIDs, tricyclic antidepressants, and anticonvulsants unless contraindicated or unable to tolerate) ▪ Physical therapy ▪ Psychological or cognitive behavioral therapies • Patient is not a candidate for further surgical intervention • Psychiatric and substance abuse disorders have been ruled out • Patient is capable of operating stimulating device and willing to comply with the treatment plan • No coagulopathy, severe thrombocytopenia, or anticoagulant or antiplatelet therapy • No current or chronic infection • Patient has had a face to face evaluation by a psychologist or psychiatrist and cleared for a trial of spinal cord stimulation Permanent placement of a spinal cord stimulator is covered when all of the following criteria are met: • Patient has experienced significant pain reduction of 50% or more with a temporary trial of 3 to 7 days. • Patient has met criteria for trial placement of a spinal cord stimulator 1-16-2020 • Patient is capable of operating stimulating device and willing to comply with treatment plan

Regence Spinal cord stimulation should be initiated with a trial period of spinal cord stimulation with a temporarily implanted lead and may be followed by permanent implantation.

Spinal cord stimulation (standard or high frequency) may be considered medically necessary when all of the following criteria are met: • Presence of severe and chronic refractory pain of the trunk or limbs, other than critical limb ischemia • The treatment is used only as a last resort; other treatment modalities (pharmacological, surgical, psychological, or physical,Summaries if applicable) have been tried and failed or are judged to be unsuitable or contraindicated • Trunk and limb pain is neuropathic in nature (i.e. resulting from actual damage to the peripheral nerves). Common indications include, but are not limited to the following: failed back surgery syndrome, complex regional pain syndrome (i.e., reflex sympathetic dystrophy), arachnoiditis, radiculopathies, phantom limb/stump pain, and peripheral neuropathy • No seriousIssue untreated drug habituation exists • Patient has been carefully screened, evaluated, and diagnosed by appropriate consultants of different specialties, who document agreement with application of these therapies or, at a minimum, do not object to application of these therapies This policy only applies to the initial (temporary and permanent) placement of the device and does not apply to revision(s) or replacement(s) after the device has been placed.

VbBSDorsal root ganglion stimulation is considered investigational for all indications.

Spinal Cord Stimulators

HERC staff summary The evidence supporting the efficacy of spinal cord stimulation for back conditions is poor, making it difficult to draw firm conclusions. The rate of complications of SCS is high. Private insurers cover the procedure, but with restrictions. There are currently no explicit restrictions on SCS placement on the Prioritized List.

Generally, the HERC does not remove services from the Prioritized List unless there is evidence of ineffectiveness or of harms that outweigh benefits. HERC staff reading of the literature is that the evidence is insufficient to determine the ratio of benefits to harms. However, a new guideline restricting the procedure to the most symptomatic group of patients would be appropriate given the high cost and risks of the procedure, and the lack of good evidence of effectiveness, as well as the availability of alternative therapies.

The CCO medical director guideline test group have reviewed the proposed new guideline and agree with its wording and feel that it would be valuable to add to the Prioritized List.

1-16-2020

Summaries

Issue

VbBS

Spinal Cord Stimulators

HERC staff recommendations: 1) Remove all spinal cord stimulator CPT and HCPCS codes from line 361 SCOLIOSIS as this is not an appropriate diagnosis for this therapy a. CPT 63650, 63655, 63685 b. HCPCS C1767, C1778, C1816, C1820, C1822, C1823, C1897 2) Add the new guideline below to lines a. 292 NEUROLOGICAL DYSFUNCTION IN POSTURE AND MOVEMENT CAUSED BY CHRONIC CONDITIONS NEUROLOGICAL DYSFUNCTION IN POSTURE AND MOVEMENT CAUSED BY CHRONIC CONDITIONS b. 346 CONDITIONS OF THE BACK AND SPINE WITH URGENT SURGICAL INDICATIONS c. 529 CONDITIONS OF THE BACK AND SPINE WITHOUT URGENT SURGICAL INDICATIONS 3) Delete the coding specification regarding spinal cord stimulators from line 292 as the wording is now incorporated into the new guideline

GUIDELINE NOTE XXX SPINAL CORD STIMULATOR THERAPY Lines 292, 346, 529 1-16-2020 A spinal cord stimulator trial is included on lines 292 and 346 only when a patient meets all of the following criteria: 1) The patient has moderate to severe (>5 on the VAS pain scale) neuropathic pain and objective neurologic impairment with documented pathology related to pain complaint (i.e. abnormal MRI). Neurologic impairment is defined as objective evidence of one or more of the following: a. Markedly abnormal reflexes b. Segmental muscle weakness c. Segmental sensory loss d. EMG or NCV evidence of nerve root impingement e. Cauda equina syndrome f. Neurogenic bowel or bladder g. Long tract abnormalities; AND 2) The patient has failed 12 or moreSummaries months of other treatment modalities (e.g. pharmacological, surgical, physical therapy, cognitive therapy, and activity lifestyle modification); AND 3) The patient has had an evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) which revealed no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) and the patient receives written clearance from the mental health provider for device placement; AND 4) The patientIssue has no contraindications (e.g. no coagulopathy, severe thrombocytopenia, or anticoagulant or antiplatelet therapy, or current or chronic infection).

Implantation of a spinal cord stimulator is included on lines 292 and 346 when the trial criteria above are met and the patient experienced significant pain reduction (50% or more) with a 3 to 7 day trial of percutaneous spinal stimulation.

VbBSSpinal cord stimulation (63650-63688) is not included on line 292 when paired with ICD-10-CM category G90.5 Complex regional pain syndrome/reflex sympathetic dystrophy.

Otherwise, spinal cord stimulation therapy is included on line 529.

Yoga and Acupuncture for Treatment of PTSD and Anxiety Disorders

Question: Should yoga and acupuncture CPT codes be paired with post traumatic stress disorder (PTSD) and/or anxiety?

Question source: OHA leadership

Issue: Due to issues with access to psychiatric services in Oregon, OHA leadership has developed several recommendations to try to expand access and treatment types for conditions including PTSD and anxiety. Specifically, the HERC has been asked to look at the effectiveness of yoga and acupuncture for treatment of PTSD and anxiety disorders.

From Pat Allen, Director of OHA Consider pairing alternative treatments (such as acupuncture and yoga) with PTSD and other anxiety- related diagnoses that are a result of trauma to decrease demand for psychiatric medication management. OHA believes it would be appropriate for Oregon’s Health Evidence Review Commission (HERC) to consider this recommendation. HERC staff will review the literature on alternative therapies, including acupuncture and yoga, for the treatment of PTSD and anxiety. If the literature shows that these treatments are effective, then we will ask the HERC to consider1-16-2020 pairing these treatments with anxiety-related conditions on the Prioritized List of Health Services.

Current Prioritized List status 1) Acupuncture (CPT 97810-97814) appears on multiple lines, including the lines for substance abuse and substance-induced anxiety and delirium 2) HCPCS S9451 (Exercise classes, non-physician provider, per session) appears on line 401 CONDITIONS OF THE BACK AND SPINE, with a guideline specifying that it be used for the provision of yoga classes.

This topic was discussed with the Behavioral Health Advisory Panel at their October 2019 meeting. Laura Ocker, LAc testified that she has treated many patients with these conditions and finds acupuncture to be beneficial for Summariesa variety of anxiety conditions. Ocker noted that acupuncture is hard to study, as acupuncture services involve a variety of treatments, such as lifestyle advice and motivational interviewing, as well as acupuncture needle placement.

Lindsey noted that Medicare does not cover acupuncture or yoga for mental health issues. She expressed concern with coverage of yoga for these conditions, given the lack of licensure and oversight for yoga providers. Savicki commented that yoga and/or acupuncture might help divert patients fromIssue psychiatric services and need for psychiatric medication. She noted that the evidence that medication helps PTSD is poor. Savicki also felt that adding these services would add tools for OHP patients dealing with these conditions.

The BHAP felt that they did not have the expertise to fully analyze the evidence for acupuncture and yoga for PTSD/anxiety and deferred further discussion to the VbBS

VbBS

Yoga and Acupuncture for Treatment of PTSD and Anxiety Disorders

Evidence review Acupuncture for treatment of PTSD 1) Grant 2017, systematic review and meta-analysis of acupuncture for PTSD a. N=7 RCTs (709 patients) i. Acupuncture sessions ranged from 30 to 60 minutes per session, 2 to 4 sessions per week, and 3 to 12 weeks total in duration ii. Included Hollifield 2007, Zhang 2010 and Zhang 2011 as in Young-Dae below a. We identified very low quality body of evidence indicating significant differences favoring acupuncture (versus any comparator) at post-intervention on PTSD symptoms (standardized mean difference [SMD] = −0.80, 95% confidence interval [CI] [−1.59, −0.01], 6 RCTs), and low quality body of evidence at longer follow-up on PTSD (SMD = −0.46, 95% CI [−0.85, −0.06], 4 RCTs) b. Safety data (7 RCTs) suggest little risk of serious adverse events, though some participants experienced minor/moderate pain, superficial bleeding, and hematoma at needle insertion sites. c. Conclusions: Results from meta-analyses of published RCTs indicate positive effects of acupuncture but warrant caution regarding claims that acupuncture1-16-2020 is an evidence- based treatment for patients with PTSD based on the best available evidence for key clinical outcomes. To increase confidence in findings, sufficiently powered replication trials are needed that measure all relevant clinical outcomes and dedicate study resources to minimizing participant attrition. 2) Young-Dae 2013, systematic review of acupuncture for PTSD a. N= 4 RCTs (N=543 patients) and 2 uncontrolled clinical trials i. Compared acupuncture to waitlist, sham acupuncture, conventional therapy or no controls b. One high-quality RCT (Hollifield 2007) reported that acupuncture was superior to waitlist control. No statistical difference was found between acupuncture and CBT. a. One RCT (Zhang 2010) showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). b. One RCT (Zhang 2011) reported a favorable effect of acupoint stimulation plus CBT against CBT alone. Summaries c. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. d. No serious adverse events were reported. e. Conclusion: Our main finding of this review is that acupuncture is effective for PTSD based on one high-quality RCT and a meta-analysis. This systematic review and meta- analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouragingIssue but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

Acupuncture for treatment of anxiety 1) Grant 2017, systematic review and meta-analysis of acupuncture for PTSD a. N=7 RCTs (709 patients) b. No significant differences were observed between acupuncture and comparators at VbBS post-intervention for anxiety symptoms (SMD = −0.82, 95% CI [−2.16, 0.53], 4 RCTs, very low quality of evidence) 2) Goyata 2016, review of acupuncture of treatment of anxiety a. N=19 studies

Yoga and Acupuncture for Treatment of PTSD and Anxiety Disorders

i. 6 RCTs (5 of reasonable quality) ii. 11 (57.9%) had a strong level of evidence; four of them (21.0%) had a moderate level; and four (21.0%) had a weak level of evidence b. Conclusion: acupuncture seems to be a promising treatment for anxiety; however, there is a need for improving the methodological quality of the research on this field. 3) Li 2019, Systematic review of acupuncture for treatment of anxiety a. N=10 reviews (included Amorim 2018 below) i. The assessment results of AMSTAR-2 showed that the methodological quality of all included studies was critically low. ii. A total of four MAs reported pooled results of acupuncture therapy (AT) versus sham acupuncture. Their results showed that the effect of acupuncture on anxiety is controversial. A meta-analysis (6 RCTs) compared acupuncture to placebo/sham acupuncture using the (80-point) State-Trait Anxiety Inventory (STAI) score, they found a clinically irrelevant and non-significant reduction (mean differences (MD)=−1.54, 95% CI−4.73 to 1.64). However, Doreen et al combined results of the five trials showed a greater overall reduction in anxiety in the acupuncture group than in the sham controls (standardized1-16-2020 mean differences (SMD)=−1.11; 95% CI−1.61 to −0.61). The other two reviews concluded that acupuncture seems to be an effective approach in relieving anxiety, and placebo effects may partially contribute to the benefits. All of them mentioned that there is currently insufficient research evidence for firm conclusions to be drawn. iii. One review focused on AT versus non treatment. Results showed that acupuncture interventions led to greater reductions in preoperative anxiety relative non treatment (STAI score, MD=5.63, p < 0.00001, 95%CI 4.14-–7.11, 14 RCTs). iv. Three reviews compared electroacupuncture (EA) with conventional treatment or drug treatment on the effectiveness on anxiety. All showed higher overall efficacy in the EA group, Luo et al pooled OR=1. 98, 95%CI (1. 10, 3. 55), p=0.02, I2=0, 5 RCTs). v. Conclusion: AlthoughSummaries most of the included reviews indicated that acupuncture group was more effective than control group in the treatment of anxiety, more importantly, the methodological quality of the included reviews and the quality of evidence were low. More high-quality evidence is needed to determine whether acupuncture is more effective than other treatments. 4) Amorim 2018, systematic review of acupuncture for treatment of anxiety a. N=13 trials Issuei. Interventions ranged from 1 session to 36 sessions ii. Outcomes measured varied widely between studies b. All 13 studies reported an anxiety decrease for their treatment group relative to the control groups c. Conclusions: Acupuncture seems to be an adequate, safe and effective alternative for the treatment of anxiety. More research studies in this area are however required with more robust methodologies to ensure acupuncture efficacy on the treatment of anxiety VbBS disorders. 5) Bae 2014, systematic review and meta-analysis of acupuncture for treatment of pre-operative anxiety a. N=14 studies (1034 patients)

Yoga and Acupuncture for Treatment of PTSD and Anxiety Disorders

b. Six publications, using the State-Trait Anxiety Inventory-State (STAI-S), reported that acupuncture interventions led to greater reductions in preoperative anxiety relative to sham acupuncture (mean difference = 5.63, P < .00001, 95% CI [4.14, 7.11]). c. Further eight publications, employing visual analogue scales (VAS), also indicated significant differences in preoperative anxiety amelioration between acupuncture and sham acupuncture (mean difference = 19.23, P < .00001, 95%CI [16.34, 22.12]). d. Conclusions. Acupuncture therapy aiming at reducing preoperative anxiety has a statistically significant effect relative to placebo or nontreatment conditions. Well- designed and rigorous studies that employ large sample sizes are necessary to corroborate this finding

Yoga for treatment of PTSD 1) Cramer 2018, systematic review and meta-analysis for yoga in the treatment of PTSD a. N=7 RCTs (N = 284 patients) b. Meta-analysis revealed evidence for statistically significant effects of yoga on PTSD symptoms compared to no treatment (SMD = − 1.10, 95% CI [− 1.72, − 0.47], p < .001), with significant heterogeneity (I2 = 72%, p = .007). The mean difference1-16-2020 (MD = − 13.11, 95% CI [− 17.95, − 827]) was above the defined threshold of 10 points indicating clinical relevance, while the confidence interval also included values below the threshold for clinical relevance. The quality of evidence was downgraded to low due to high likelihood of bias, imprecision of results and the unclear risk of publication bias. c. Only three RCTs reported any safety-related data; no adverse events were reported d. Conclusions: There is low quality evidence that yoga interventions including physical postures could be an effective, acceptable and safe intervention for PTSD. According to the GRADE guidelines, only a weak recommendation for the use of yoga as an adjunctive intervention for PTSD can be made because the true effect may be substantially different from the effect estimated in this analysis. Therefore, more high-quality studies are needed to confirm or disconfirm these findings. 2) Gallegos 2017, meta-analysis of RCTs for meditation and yoga for treatment of PTSD a. N=4 RCTs for yoga (3 included in the Cramer review above) b. Effect size (ES = −.71, pSummaries < .055, 95% CI = [−1.44, .02]) which was only marginally significant c. These findings suggest that meditation and yoga are promising complementary approaches in the treatment of PTSD among adults and warrant further study. 3) Sciarrino 2017, systematic review of yoga for PTSD a. N=7 RCTs (5 included in Carter 2018 above) b. Results: Cohen’s d for each study ranged (in absolute value) from a low of -0.06 to a high ofIssue 1.42 (average weighted d across studies was 0.48; 95% CI: 0.26, 0.69). c. Conclusions: the weighted average effect of studies is in the moderate range, which indicates that these results are promising and warrant additional empirical inquiry. 4) Institute of Medicine 2014, report of Committee on the Assessment of Ongoing Efforts in the Treatment of Posttraumatic Stress Disorder https://www.ncbi.nlm.nih.gov/books/NBK224878/pdf/Bookshelf_NBK224878.pdf a. Acupuncture used in several VA programs. Report notes lack of evidence to support VbBS use.

Yoga for treatment of anxiety 1) Cramer 2017, systematic review and meta-analysis of yoga for anxiety

Yoga and Acupuncture for Treatment of PTSD and Anxiety Disorders

a. N=8 RCTs with 319 participants b. Meta-analyses revealed evidence for small short-term effects of yoga on anxiety compared to no treatment (standardized mean difference [SMD]=−0.43; 95% confidence interval [CI]=−0.74, −0.11; P = .008), and large effects compared to active comparators (SMD=−0.86; 95% CI=−1.56, −0.15; P = .02). c. Effects were robust against potential methodological bias. d. No effects were found for patients with anxiety disorders diagnosed by Diagnostic and Statistical Manual criteria, only for patients diagnosed by other methods, and for individuals with elevated levels of anxiety without a formal diagnosis. e. Only three RCTs reported safety-related data but these indicated that yoga was not associated with increased injuries. f. In conclusion, yoga might be an effective and safe intervention for individuals with elevated levels of anxiety. There was inconclusive evidence for effects of yoga in anxiety disorders. More high-quality studies are needed and are warranted given these preliminary findings and plausible mechanisms of action. 2) Weaver 2016, systematic review of yoga for treatment of anxiety in children and adolescents a. N=16 studies (6 RCTs,9 pre-post studies, 1 case study) 1-16-2020 b. CONCLUSION. Nearly all studies indicated reduced anxiety after a yoga intervention. However, because of the wide variety of study populations, limitations in some study designs, and variable outcome measures, further research is needed to enhance the ability to generalize and apply yoga to reduce anxiety

Disposition of other submitted articles: 1) Hollifield 2007: study included in included systematic reviews 2) Errington-Evans 2011: article appeared to be a study protocol 3) Herman 2012: 2 articles listed as examining acupuncture treatment for mental health disorders, but no details of these articles given 4) Spackman 2014: study examined acupuncture for treatment of depression

Summaries Other payer coverage: 1) No private payers surveyed covered acupuncture for either PTSD or anxiety treatment. No policies on yoga coverage were found.

Comparisons to evidence for back conditions: AHRQ 2018 https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/nonpharmaIssue -chronic-pain-cer- 209.pdf

Short term reduction of pain from chronic back conditions Yoga (SOE moderate). Acupuncture (SOE low) VbBSIntermediate/long term reduction of pain from chronic back conditions Yoga (SOE low). Acupuncture (no effectiveness for intermediate, SOE low for long term)

Yoga and Acupuncture for Treatment of PTSD and Anxiety Disorders

HERC staff summary: Yoga and acupuncture appear to be promising treatments for PTSD and anxiety. However, acupuncture has not been adequately studied for either condition to allow determination of effectiveness. Yoga has a low level of evidence that it is effective for treatment of PTSD with considerable uncertainty to the level of evidence; yoga has inconclusive evidence for the treatment of anxiety disorders.

BHAP members and experts who testified at BHAP felt that both yoga and acupuncture might be valuable additions to the treatment options for PTSD and anxiety and reduce the need for psychiatric medications and other psychiatric services for these conditions. Experts noted that medications for PTSD also have low level of evidence to support their use. Yoga and acupuncture both have a good safety profile, and may be preferred by some patients. Compared to evidence for back conditions, yoga and acupuncture have a lower level of evidence for PTSD and anxiety disorders (yoga: low for anxiety/PTSD vs moderate for back pain; acupuncture: inconclusive for anxiety/PSTD vs low for back pain).

The CCO medical directors had concerns regarding inclusion of yoga for PTSD due to difficulty in managing such a benefit. 1-16-2020

Summaries

Issue

VbBS

Yoga and Acupuncture for Treatment of PTSD and Anxiety Disorders

HERC staff recommendations: 1) Discuss adding HCPCS S9451 (Exercise classes, non-physician provider, per session) to line 173 POSTTRAUMATIC STRESS DISORDER with the following coding specification: a. “HCPCS S9451 appears on this line for provision of yoga classes.” 2) Discuss adding acupuncture to lines 173 POSTTRAUMATIC STRESS DISORDER and 414 OVERANXIOUS DISORDER; GENERALIZED ANXIETY DISORDER; ANXIETY DISORDER, UNSPECIFIED a. CPT 97810-97814 b. Modify GN92 ACUPUNCTURE as shown below i. 12 visit limit is consistent with other conditions

GUIDELINE NOTE 92, ACUPUNCTURE Lines 1,5,173,202,361,401,409,414,461,538 Inclusion of acupuncture (CPT 97810-97814) on the Prioritized List has the following limitations:

Line 1 PREGNANCY Acupuncture pairs on Line 1 for the following conditions and codes. 1-16-2020 Hyperemesis gravidarum ICD-10-CM: O21.0, O21.1 Acupuncture pairs with hyperemesis gravidarum when a diagnosis is made by the maternity care provider and referred for acupuncture treatment for up to 12 sessions of acupressure/acupuncture per pregnancy. Breech presentation ICD-10-CM: O32.1 Acupuncture (and moxibustion) is paired with breech presentation when a referral with a diagnosis of breech presentation is made by the maternity care provider, the patient is between 33 and 38 weeks gestation, for up to 6 session per pregnancy. Back and pelvic pain of pregnancy ICD-10-CM: O99.89 Acupuncture is paired with back and pelvic pain of pregnancy when referred by maternity care provider/primarySummaries care provider for up to 12 sessions per pregnancy. Line 5 TOBACCO DEPENDENCE Acupuncture is included on this line for a maximum of 12 sessions per quit attempt up to two quit attempts per year; additional sessions may be authorized if medically appropriate. Line 173 POSTTRAUMATIC STRESS DISORDER Acupuncture is included on this line for up to 12 sessions per year. Line 202 CHRONIC ORGANIC MENTAL DISORDERS INCLUDING DEMENTIAS AcupunctureIssue is paired with the treatment of post-stroke depression only. Treatments may be billed to a maximum of 30 minutes face-to-face time and limited to 12 total sessions per year, with documentation of meaningful improvement; patients may have additional visits authorized beyond these limits if medically appropriate. Line 361 SCOLIOSIS Acupuncture is included on this line with visit limitations as in Guideline Note 56 NON- INTERVENTIONAL TREATMENTS FOR CONDITIONS OF THE BACK AND SPINE. VbBSLine 401 CONDITIONS OF THE BACK AND SPINE Acupuncture is included on this line with visit limitations as in Guideline Note 56 NON- INTERVENTIONAL TREATMENTS FOR CONDITIONS OF THE BACK AND SPINE. Line 409 MIGRAINE HEADACHES

Yoga and Acupuncture for Treatment of PTSD and Anxiety Disorders

Acupuncture pairs on Line 409 for migraine (ICD-10-CM G43.0, G43.1, G43.5, G43.7, G43.8, G43.9), for up to 12 sessions per year. Line 414 OVERANXIOUS DISORDER; GENERALIZED ANXIETY DISORDER; ANXIETY DISORDER, UNSPECIFIED Acupuncture is included on this line for up to 12 sessions per year. Line 461 OSTEOARTHRITIS AND ALLIED DISORDERS Acupuncture pairs on Line 461 for osteoarthritis of the knee only (ICD-10-CM M17), for up to 12 sessions per year. *Line 538 TENSION HEADACHES Acupuncture is included on Line 538 for treatment of tension headaches (ICD-10-CM G44.2), for up to 12 sessions per year.

The development of this guideline note was informed by a HERC coverage guidance. See https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports.aspx.

*Below the current funding line 1-16-2020

Summaries

Issue

VbBS

Section 4.0 Temporary Percutaenous Circulatory Support Impella Revision Temporary Percutaneous Mechanical Circulatory Support with Impella Devices

Decision points around indications Population/ EbGS HERC Evidence of Evidence of Other Coverage Decision Treatment Goal version 8/8 benefit harm considerations implications point version Elective high-risk PCI Not Not No difference No difference Evidence of Significant: This Confirm covered covered in mortality in vascular improvement in is scheduled as noncoverage (Goal of PCI is to (1 RCT) complications morbidity and an outpatient reduce symptoms of or major mortality of procedure and chest pain) No difference bleeding elective PCI in may be subject in major (1 those with to prior adverse observational chronic stable authorization. cardiovascular study) angina is Therefore, non- events inconsistent. coverage may (1 RCT) There is no result in either evidence among elective PCI those in the high- without risk category. Impella, or ongoing medical management. Without Impella some cardiologists might be reluctant to perform PCI. STE-ACS without Not Covered No evidence No evidence This is treated as Retrospective Decide cardiogenic shock covered for STE-ACS an emergency review; between without with a 90-minute coverage coverage and (Goal of improving cardiogenic door-to- decision noncoverage. outcomes—survival, shock. unlikely to Temporary Percutaneous Mechanical Circulatory Support with Impella Devices

Population/ EbGS HERC Evidence of Evidence of Other Coverage Decision Treatment Goal version 8/8 benefit harm considerations implications point version disability—by intervention impact supporting timeline. utilization and revascularization (PCI) would impact during a serious life- surgeon fees threatening heart but uncertain attack) as to the impact on facility fees. NSTE-ACS without Covered Covered No evidence No evidence This is less of an Retrospective Confirm cardiogenic shock for NSTE-ACS emergency than review (same coverage without the STE-ACS as STE-ACS) (Goal of improving cardiogenic population, outcomes—survival, shock. enabling the disability—by potential for supporting more time to revascularization (PCI) determine need during a somewhat for Impella and less serious heart the need for attack) revascularization.

Cardiogenic shock, not Not Not No difference Similar or Critically ill Retrospective Confirm a candidate for LVAD covered covered between higher population. It review. noncoverage or transplant Impella and vascular may be IABP in AMI complications challenging to IABP could be Severe heart and (STE-ACS) with (based on 4 ascertain used or medical circulatory cardiogenic studies) whether or not management malfunction resulting shock someone is a with pressors. in need for circulation (3 RCTs) candidate for Temporary Percutaneous Mechanical Circulatory Support with Impella Devices

Population/ EbGS HERC Evidence of Evidence of Other Coverage Decision Treatment Goal version 8/8 benefit harm considerations implications point version support (with or Similar or LVAD or without PCI). Includes No evidence in higher major transplant and/or ischemic and nonischemic bleeding quickly consult. nonischemic cardiogenic complications cardiogenic shock. shock. (based on 5 Goal would be to studies) assist with pumping blood and maintaining circulation until heart possibly recovers or support PCI. Cardiogenic shock, a Covered Covered No difference Similar or Critically ill Retrospective Confirm candidate for LVAD or between higher population. review. coverage transplant Impella and vascular Expert states that IABP in AMI complications no studies could IABP could be Severe heart and (STE-ACS) with (based on 4 be done due to used or medical circulatory cardiogenic studies) the acuity of the management malfunction resulting shock population. with pressors. in need for circulation (3 RCTs) Similar or support (with or higher major without PCI) and No evidence in bleeding patient may be a nonischemic complications candidate for LVAD or cardiogenic (based on 5 transplant. Includes shock. studies) ischemic and nonischemic cardiogenic shock. Goal to keep the Temporary Percutaneous Mechanical Circulatory Support with Impella Devices

Population/ EbGS HERC Evidence of Evidence of Other Coverage Decision Treatment Goal version 8/8 benefit harm considerations implications point version patient alive long enough to stabilize and receive LVAD or transplant or support PCI.

Decision points around specific details of indications:

Specific requirements EbGS HERC Considerations Decision point Cardiogenic shock who may be candidates for LVAD or transplant Advanced heart failure and transplant Required Required Limited access to advanced Confirm required cardiologist agrees that Impella should heart failure and transplant consultation be used as a bridge to a decision for cardiologists has been raised LVAD or a transplant. as a concern. Hence the allowance for exceptions was added as below. Appropriate effort should be made to Required Required Emergency decision making Confirm allowance of consult with a heart failure and may be necessary when the exceptional transplant cardiologist, but coverage is advanced heart failure and circumstances recommended in circumstances where transplant cardiologist is not consultation cannot reasonably be immediately available for obtained without endangering the consultation patient’s life and the treating physician believes the patient meets the criteria above. NSTE-ACS without cardiogenic shock Temporary Percutaneous Mechanical Circulatory Support with Impella Devices

A heart team discussion determines Required Required Confirm requirement that the patient needs of heart team revascularization with coronary artery discussion bypass graft (CABG) or PCI Cardiothoracic surgeons are consulted Require 2 Require 1 Testimony received that in Choose 1 or 2 and agree that the patient is cardiothoracic cardiothoracic some areas 2 cardiothoracic cardiothoracic inoperable (i.e., surgeons are not surgeons surgeon surgeons may not be surgeons willing to perform CABG, but agree available for consultation. that revascularization is indicated) Patient has complex left main or last Required Required Confirm requirement remaining conduit disease Ejection fraction less than 30% Required Required Confirm requirement …or at high risk for hemodynamic N/A Allowed Testimony suggests that Decide whether to collapse during intervention other physiologic allow “at high risk for circumstances besides hemodynamic collapse ejection fraction are during intervention” in important predictors of addition to EF < 30%) hemodynamic collapse. The EF requirement was chosen based on the relevant studies. STE-ACSwithout cardiogenic shock (only address if in discussion above, decision for coverage was made A heart team discussion determines N/A Required Not clinically appropriate Staff recommends that the patient needs against requirement revascularization with coronary artery due to emergent bypass graft (CABG) or PCI nature of the condition Two cardiothoracic surgeons are N/A Required Not clinically appropriate Staff recommends consulted and agree that the patient is against requirement inoperable (i.e., surgeons are not due to emergent Temporary Percutaneous Mechanical Circulatory Support with Impella Devices willing to perform CABG, but agree nature of the that revascularization is indicated) condition Patient has complex left main or last N/A Required Confirm requirement remaining conduit disease Ejection fraction less than 30% N/A Required Confirm requirement …or at high risk for hemodynamic N/A Required Decide whether to collapse during intervention allow “at high risk for intraprocedural hemodynamic collapse” in addition to EF < 30%)

Health Evidence Review Commission (HERC) Coverage Guidance: Temporary Percutaneous Mechanical Circulatory Support with Impella Devices DRAFT for 1/16/2020 HERC meeting materials

HERC Coverage Guidance Elective high-risk PCI Temporary percutaneous mechanical circulatory support with Impella devices is not recommended for coverage for patients receiving elective high-risk PCI (weak recommendation).

Acute Coronary Syndrome (ACS) without cardiogenic shock (Select either red or green text) Temporary percutaneous mechanical circulatory support with Impella devices is not recommended for coverage (weak recommendation) in ST Elevation Acute Coronary Syndrome (STE-ACS) without cardiogenic shock when Impella support during PCI is necessary due to ejection fraction (EF) <30% or other factors which create a high risk of intraprocedural hemodynamic collapse.

Temporary percutaneous mechanical circulatory support with Impella devices is recommended for coverage (weak recommendation) in non-ST elevation ACS (NSTE-ACS) without cardiogenic shock when all of the following conditions are met: • A heart team discussion determines the patient needs revascularization with coronary artery bypass graft (CABG) or PCI • A cardiothoracic surgeon is consulted and agrees the patient is inoperable (i.e., is not willing to perform CABG but agrees revascularization is indicated) • Patient has complex left main or last remaining conduit disease • Ejection fraction (EF) < 30% or at high risk for intraprocedural hemodynamic collapse

Cardiogenic shock Temporary percutaneous mechanical circulatory support with Impella devices is recommended for coverage (weak recommendation) only for patients with cardiogenic shock who might be candidates for left ventricular assist device (LVAD) (destination therapy) or transplant (bridge to transplant), AND an advanced heart failure and transplant cardiologist agrees that Impella should be used as a bridge to a decision for LVAD or a transplant. Appropriate effort should be made to consult with an advanced heart failure and transplant cardiologist, but coverage is recommended in circumstances where consultation cannot reasonably be obtained without endangering the patient’s life and the treating physician believes the patient meets the criteria above.

Note: Definitions for strength of recommendation are in Appendix A. GRADE Table Element Description. Rationales for each recommendation appear below in the GRADE table.

Table of Contents

Coverage Guidance: Temporary Percutaneous Mechanical Circulatory Support with Impella Devices ...... 1 Rationale for development of coverage guidances and multisector intervention reports ...... 3 GRADE Table ...... 5 Should temporary percutaneous mechanical circulatory support (i.e., Impella) be recommended for coverage for elective high-risk percutaneous coronary intervention? ...... 5 Should temporary percutaneous mechanical circulatory support (i.e., Impella) be recommended for coverage for cardiogenic shock? ...... 8 Should temporary percutaneous mechanical circulatory support (i.e., Impella) be recommended for coverage to support PCI for acute myocardial infarction without cardiogenic shock? ...... 11 Background ...... 13 Indications ...... 13 Technology Description ...... 13 Evidence Review ...... 14 Evidence Summary ...... 15 Policy Landscape ...... 23 Payer Coverage Policies ...... 23 Recommendations from Others ...... 24 Quality Measures ...... 24 References ...... 25 Evidence Sources ...... 25 Other Citations ...... 26 Appendix A. GRADE Table Element Descriptions ...... 28 Appendix B. GRADE Evidence Profile ...... 30 Appendix C. Methods ...... 32 Scope Statement ...... 32 Search Strategy ...... 33 Appendix D. Applicable Codes ...... 34

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Rationale for development of coverage guidances and multisector intervention reports

Coverage guidances are developed to inform coverage recommendations for public and private health plans in Oregon as plan administrators seek to improve patients’ experience of care, population health, and the cost-effectiveness of health care. In the era of public and private sector health system transformation, reaching these goals requires a focus on maximizing the benefits and minimizing the harms and costs of health interventions. HERC uses the following principles in selecting topics for its reports to guide public and private payers:

• Represents a significant burden of disease or health problem • Represents important uncertainty with regard to effectiveness or harms • Represents important variation or controversy in implementation or practice • Represents high costs or significant economic impact • Topic is of high public interest HERC bases its reports on a review of the best available research applicable to the intervention(s) in question. For coverage guidances, which focus on diagnostic and clinical interventions, evidence is evaluated using an adaptation of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. For more information on coverage guidance methodology, see Appendix A. Multisector interventions can be effective ways to prevent, treat, or manage disease at a population level. In some cases, HERC has reviewed evidence and identified effective interventions, but has not made formal coverage recommendations when these policies are implemented in settings other than traditional health care delivery systems because effectiveness could depend on the environment in which the intervention is implemented. GRADE Table

HERC develops recommendations by using the concepts of the GRADE system. GRADE is a transparent and structured process for developing and presenting evidence and for performing the steps involved in developing recommendations. The table below lists the elements that determine the strength of a recommendation. HERC reviews the evidence and assesses each element, which in turn is used to develop the recommendations presented in the coverage guidance box. Estimates of effect are derived from the evidence presented in this document. Assessments of confidence are from the published systematic reviews and meta-analyses, where available and judged to be reliable. In some cases, no systematic reviews or meta-analyses encompass the most current literature. In those cases, HERC may describe the additional evidence or alter the assessments of confidence in light of all available information. Such assessments are informed by clinical epidemiologists from the Center for Evidence-based Policy. Unless otherwise noted, statements regarding resource allocation, values and preferences, and other considerations are the assessments of HERC, as informed by the evidence reviewed, public testimony, and subcommittee discussion.

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Recommendations for coverage are based on the balance of benefit and harms, resource allocation, values and preferences, and other considerations. See Appendix A for more details about the factors that constitute the GRADE table.

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GRADE Table

Should temporary percutaneous mechanical circulatory support (i.e., Impella) be recommended for coverage for elective high-risk percutaneous coronary intervention?

or Impella) is unlikely to be important to

patients. There is likely to be low

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Should temporary percutaneous mechanical circulatory support (i.e., Impella) be recommended for coverage for elective high-risk percutaneous coronary intervention?

Estimate of Effect for Outcome/ Values and Other Outcomes Resource Allocation Confidence in Estimate Preferences Considerations Major adverse No significant difference in composite outcome of variability in these cardiovascular major adverse events (including repeat values and events revascularization): preferences. (Critical outcome) 35.1% for Impella vs. 40.1% for IABP at 30 days p = 0.227

40.6% for Impella vs. 49.3% for IABP at 90 days p = 0.066

●●◌◌ (Low confidence, based on 1 RCT, n = 448) Successful bridge Not applicable to recovery (Important outcome) Successful bridge Not applicable to transplant (Important outcome)

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Should temporary percutaneous mechanical circulatory support (i.e., Impella) be recommended for coverage for elective high-risk percutaneous coronary intervention?

Estimate of Effect for Outcome/ Values and Other Outcomes Resource Allocation Confidence in Estimate Preferences Considerations Harms No significant difference in major bleeding (Important complications between Impella and IABP outcome) ●◌◌◌ (Very low confidence, based on 1 observational study, n = 75)

No significant difference in vascular complications between Impella and IABP ●◌◌◌ (Very low confidence, based on 1 observational study, n = 75)

Balance of benefits and harms: We have low confidence that there is no difference between Impella and IABP in terms of all cause-mortality and MACE and very low confidence of no difference in complications between major bleeding and vascular complications. The balance suggests no net benefit and no net harms based on limited evidence. Rationale: We make a recommendation against coverage for elective high-risk PCI in stable coronary artery disease because there appears to be no benefit for Impella over IABP and no difference in complications. There is no evidence that elective high-risk PCI improves cardiovascular outcomes; in low-risk PCI it may or may not result in an improvement in chronic stable angina. It does not impact cardiovascular morbidity or mortality. Impella is expensive, the intervention is considered elective, and patient values and preferences would not weigh in either direction. It is a weak recommendation because of the low confidence in the estimate of effect. Recommendation: Temporary percutaneous mechanical circulatory support with Impella devices is not recommended for coverage for patients receiving elective high-risk PCI (weak recommendation).

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Should temporary percutaneous mechanical circulatory support (i.e., Impella) be recommended for coverage for cardiogenic shock?

Estimate of Effect for Outcome/ Values and Other Outcomes Resource Allocation Confidence in Estimate Preferences Considerations All-cause No significant difference in all-cause mortality Impella is extremely Patients would There was mortality 40.8% for Impella vs. expensive and may be strongly prefer insufficient (Critical outcome) 41.3% for IABP at 30 days as much as 20 times interventions that evidence to include RR 0.99 (95% CI 0.62 to 1.58, p = 0.95) more than an IABP. improve their in the GRADE table outcomes (with for non-ischemic 46.9% for Impella vs. regard to death or cardiogenic shock. 41.3% for IABP at 6 months MACE) and have There were no RR 1.15 (95% CI 0.74 to 1.48, p = 0.53) fewer harms. The studies found mechanism by examining patients ●●◌◌ (Low confidence, based on 3 RCTs, n = 95) which this is bridging to LVAD or Major adverse No significant difference in major adverse achieved (i.e., IABP transplant. cardiovascular cardiovascular events or Impella) is events 26% for Impella vs. unlikely to be (Critical outcome) 33% for IABP at 4 months important to p = 0.74 patients. There is likely to be low 37% for Impella vs. variability in these 47% for IABP at 12 months values and p = 0.72 preferences.

●◌◌◌ (Very low confidence, based on 1 RCT, n = 21) Successful bridge Insufficient data to recovery (Important outcome)

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Should temporary percutaneous mechanical circulatory support (i.e., Impella) be recommended for coverage for cardiogenic shock?

Estimate of Effect for Outcome/ Values and Other Outcomes Resource Allocation Confidence in Estimate Preferences Considerations Successful bridge Insufficient data to transplant (Important outcome) Harms Range of reported vascular complications (Important Impella: 3% to 25% outcome) IABP: 0% to 6.4% ●◌◌◌ (Very low confidence, based on 4 studies, n = 222)

Range of reported bleeding complications Impella: 8% to 38.4% IABP: 0% to 32.2% ●◌◌◌ (Very low confidence, based on 5 studies, n = 272)

Balance of benefits and harms: We have low confidence that there is no difference between Impella and IABP in terms of all-cause mortality, and very low confidence that there is no difference in MACE. We have very low confidence that significant harms (such as bleeding, stroke, and vascular events) are greater with Impella compared to IABP. The evidence reviewed suggests that the balance is neutral to negative for Impella in ischemic cardiogenic shock. Insufficient evidence was found for non-ischemic cardiogenic shock to make an assessment of the balance of benefits and harms. Rationale: While the balance of benefits and harms does not appear to weigh in favor of Impella, we recommend coverage based on expert recommendations that Impella is important as a bridge to LVAD or transplant in critically-ill patients. We make this decision in light of the lack of evidence and difficulty of enrolling patients in future trials, and considering the acuity of these conditions. The recommendation is weak given the absence of supporting evidence and high costs.

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Should temporary percutaneous mechanical circulatory support (i.e., Impella) be recommended for coverage for cardiogenic shock?

Estimate of Effect for Outcome/ Values and Other Outcomes Resource Allocation Confidence in Estimate Preferences Considerations Recommendation: Temporary percutaneous mechanical circulatory support with Impella devices is recommended for coverage (weak recommendation) only for patients with cardiogenic shock who might be candidates for left ventricular assist device (LVAD) (destination therapy) or transplant (bridge to transplant), AND an advanced heart failure and transplant cardiologist agrees that Impella should be used as a bridge to a decision for LVAD or a transplant. Appropriate effort should be made to consult with a heart failure and transplant cardiologist, but coverage is recommended in circumstances where consultation cannot reasonably be obtained without endangering the patient’s life and the treating physician believes the patient meets the criteria above.

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Should temporary percutaneous mechanical circulatory support (i.e., Impella) be recommended for coverage to support PCI for acute myocardial infarctioncoronary syndrome (STE-ACS or NSTE-ACS) without cardiogenic shock?

Estimate of Effect for Outcome/ Values and Other Outcomes Resource Allocation Confidence in Estimate Preferences Considerations All-cause Insufficient data Impella is extremely Patients with acute An RCT of these mortality expensive and may be myocardial populations is (Critical outcome) as much as 20 times infarction would feasible, however, more than an IABP. likely strongly prefer given widespread Major adverse Insufficient data an intervention use of Impella in cardiovascular thought to result in current practice, events survival benefit. If might not be (Critical outcome) Impella were performed. Successful bridge Insufficient data thought to be to recovery necessary to allow (Important revascularization for outcome) high-risk patients, Successful bridge Insufficient data their preferences to transplant would likely be in (Important favor of Impella. outcome) Harms Insufficient data (Important outcome)

Balance of benefits and harms: There is insufficient evidence to evaluate the balance of benefits and harms. Expert opinion indicates that protected PCI might provide a significant survival benefit in patients with NSTEMI NSTE-ACS who are not eligible for CABG.

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Estimate of Effect for Outcome/ Values and Other Outcomes Resource Allocation Confidence in Estimate Preferences Considerations Rationale: Patients with NSTEMI and low ejection fraction are an unstudied population for whom expert opinion indicates that protected PCI might provide a significant survival benefit and PCI might not otherwise be done without Impella devices. Although resource allocation and the lack of evidence would argue against coverage, values and preferences and expert opinion suggest in this carefully selected population a true survival benefit may exist. The coverage recommendation is weak because of the lack of evidence.

There was no evidence in patients with NSTEMI without shock, but this population is very likely to be revascularized regardless of their risk. Given that the availability of Impella is unlikely to change whether or not a patient is going to be revascularized, and given the lack of evidence and the high cost, a recommendation is not made for coverage. While there is inadequate evidence supporting the utility of PCI for acute coronary syndrome without cardiogenic shock, we recognize the difficulty of enrolling patients in appropriate clinical trials. In light of this situation, we base our coverage recommendation on stakeholder testimony that Impella can provide critical hemodynamic support to enable PCI in acute coronary symdrome. Patients with NSTE-ACS and low ejection fraction who receive Impella-supported PCI might experience a significant survival benefit with Impella, and providers might not perform PCI in the absence of coverage for Impella devices. Stakeholder testimony suggested that a decreased ejection fraction alone is not a clear indicator of need for Impella support, and a cardiologist assessment of risk of hemodynamic collapse is an important consideration, therefore either of these may be present for Impella to be necessary.

Recommendation: • [replace with language from box after adoption] Note: GRADE table elements are described in Appendix A. A GRADE Evidence Profile is in Appendix B.

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Background

Temporary mechanical circulatory support may be needed in patients with cardiogenic shock or who are undergoing elective high-risk coronary interventions. The intra-aortic balloon pump (IABP) has been the most frequently used ventricular assist device since its introduction in the 1960s because of the ease of insertion and use (Ait Ichou, 2017). For some patients in severe cardiogenic shock with a systolic aortic pressure that cannot be improved to more than 60 mmHg by vasopressors, the IABP might not provide sufficient circulatory support (Ait Ichou, 2017). Temporary percutaneous mechanical circulatory support devices, such as Impella, offer greater augmentation of cardiac output and left ventricular unloading. It has been hypothesized that these hemodynamic advantages would result in improved clinical outcomes. Other circulatory support devices (not in scope for this Coverage Guidance) require open surgery or septal puncture, and could be appropriate for longer-term use. Indications

Temporary percutaneous mechanical circulatory support devices are indicated for patients in cardiogenic shock and those undergoing elective high-risk percutaneous coronary interventions (PCI). Technology Description

Impella is a device for mechanical circulatory support that has a small pump at one end of a thin, flexible tube and is implanted through an artery in the leg. The other end of the tube is connected to a control system outside the body that controls the pump rate (Health Quality Ontario, 2017). Impella works by increasing the maximal blood flow by unloading blood from the left ventricle into the ascending aorta, resulting in improved coronary perfusion pressure and end-organ perfusion. In addition to increasing cardiac output, it also decreases myocardial oxygen consumption and pulmonary capillary wedge pressure, potentially reducing the size of a myocardial infarction and accelerating its recovery (Ait Ichou, 2017). Impella has four models: 2.5, CP (or 3.5), RP, and 5.0/LD (Abiomed, 2018). The most frequently used devices, Impella 2.5 and 5.0, are capable of increasing cardiac output by up to 2.5 and 5.0 L/min, respectively (Ait Ichou, 2017). Most Impella devices can be placed percutaneously through the femoral artery (or the femoral vein for Impella RP), but the Impella 5.0 typically requires an arterial cut-down procedure, and the Impella LD is placed during open chest procedures (Ait Ichou, 2017). In 2015, the U.S. Food and Drug Administration (FDA) granted premarket approval to Impella 2.5 (FDA, 2015). This approval order stated that Impella was indicated for temporary (< 6 hours) ventricular support during high-risk PCI performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction (LVEF) (FDA, 2015). A 2016 supplemental order from the FDA approved Impella for patients experiencing ongoing cardiogenic shock immediately (< 48 hours) after acute myocardial infarction or open-heart surgery for the Impella Ventricular Support Systems (FDA, 2016). A February 2018 supplemental order expanded the indications to include patients with ongoing cardiogenic shock in the setting of cardiomyopathy, including peripartum cardiomyopathy or myocarditis (FDA, 2018).

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Evidence Review

Our search identified two systematic reviews and one briefly reported meta-analysis for inclusion. Because of the small number of comparative studies of Impella and because of the incomplete overlap of included studies (see Table 1) in the reviews, the individual comparative studies included in those reviews are summarized in Tables 2-4. The characteristics of the individual comparative studies are summarized in Table 2 and their relevant outcomes are summarized in Tables 3 and 4. The Health Quality Ontario review (2017) is a high-quality systematic review and health technology assessment of the benefits and harms of Impella for high-risk PCI or cardiogenic shock. For the high-risk PCI group, the authors identified one randomized controlled trial (RCT) (O’Neill et al., 2012), two comparative observational studies (Boudoulas et al., 2012; Schwartz et al., 2011), and eight non- comparative observational studies. The authors assessed the risk of bias in the RCT to be moderate because of insufficient statistical power, concern for selection bias, and early termination of the trial due to futility. The comparative observational studies were limited by selection bias, insufficient adjustment for confounding, and high rates of loss to follow-up. For the cardiogenic shock group, the authors identified one small RCT (Seyfarth et al., 2011), one comparative observational study (Manzo-Silberman et al., 2013), and six non-comparative observational studies. The RCT was assessed to be at high risk of bias due to small sample size and the risk of model misclassification, as well as imbalance in baseline characteristics. The comparative observational study was judged to be at moderate risk of bias because of selection bias (including an imbalance in baseline LVEF between cohorts) and potential treatment bias due to a high degree of physician discretion in managing the patients. The relevant results from the included comparative studies are summarized in Tables 3 and 4 below. Applying a GRADE methodology, the authors of the review concluded that there was: • No difference in 30-day mortality or MACE between Impella 2.5 and IABP for high-risk PCI (low strength of evidence) • No difference in bleeding or vascular complications between Impella 2.5 and IABP for high-risk PCI (very low strength evidence) • No difference in 30-day mortality or MACE between Impella 2.5 and IABP for cardiogenic shock (low strength of evidence) • Significantly higher rate of hemolysis with Impella 2.5 compared to IABP for cardiogenic shock (low strength of evidence) • No difference in vascular complications between Impella 2.5 and IABP for cardiogenic shock (low strength of evidence) The review by Ait Ichou et al. (2017) is a fair-quality systematic review of the effectiveness and safety of Impella devices in patients undergoing high-risk PCI. The review is mainly limited by incomplete reporting of risk of bias assessments. The authors identified four RCTs (Seyfarth et al., 2008; O’Neill et al., 2012; Ouweneel et al., 2017b; Ouweneel et al., 2016), two comparative observational studies (Boudoulas et al., 2012; Schwartz et al., 2011), and 14 non-comparative observational studies, for a total of 1,287 patients. The authors judged three of the RCTs to be at low risk of bias and one (Ouweneel et al., 2016) to be at high risk of bias due to early termination and changes to inclusion criteria during recruitment. The two comparative observational studies were considered to be at high risk of bias

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because of their design and the likelihood of confounding by indication. All of the non-comparative observational studies were regarded as having serious or critical risk of bias. The relevant results from the included comparative studies are summarized in Tables 3 and 4 below. Overall, the authors concluded that there were no differences in all-cause mortality between Impella and IABP, but noted a possible reduction in major adverse events at 90 days in a per-protocol analysis of the PROTECTII trial (O’Neill et al., 2012). They observed high levels of clinical heterogeneity in the studies and that most studies were inadequately powered to detect differences in clinical events. Finally, the authors asserted the need for larger RCTs to better clarify the clinical effectiveness and safety of Impella, and noted that one such trial (DANSHOCK, NCT01633502) is currently underway. The review by Ouweneel et al. (2017a) is a briefly reported meta-analysis that combines the results of the three small RCTs of Impella compared to IABP in patients with cardiogenic shock (Seyfarth et al., 2008; O’Neill et al., 2012; Ouweneel et al., 2017b; Ouweneel et al., 2016). The total population of these studies was 95 patients. In the meta-analysis (it is not stated whether a fixed or random effects model was used), there was no difference in all-cause mortality at 30 days (RR 0.99, 95% CI 0.62 to 1.58) or at six months (RR 1.15, 95% CI 0.74 to 1.48). There was also no difference in LVEF of survivors between the two groups at two to six months. Our search did not identify any additional RCTs published after the most recent systematic review (Ait Ichou et al., 2017). Additionally, the search did not identify any systematic reviews or RCTs examining the use of Impella in the setting of acute non-ischemic cardiogenic shock. Evidence Summary

On the basis of a relatively small number of comparative studies, the use of Impella devices to support elective high-risk PCI or in the setting of ischemic cardiogenic shock did not improve clinical outcomes compared to IABP. In some studies of patients with ischemic cardiogenic shock, Impella appears to increase the risk of bleeding and vascular complications compared to IABP, although a wide range of adverse effect rates are reported in the comparative studies. There were no systematic reviews or RCTs of Impella in the setting of non-ischemic cardiogenic shock.

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Table 1. Studies Included in Systematic Reviews Seyfarth 2008 O’Neill 2012 Ouweneel Ouweneel 2016 Schwartz 2011 Manzo- Boudoulas 2017b Silberman 2013 2012 (Risk of bias (Risk of bias (Risk of bias (Risk of bias assessment) assessment) (Risk of bias assessment) assessment) (Risk of bias (Risk of bias assessment) assessment) assessment) Ait Ichou 2017 X X X X X X (Low) (Low) (Low) (High) (Serious) (Serious) Ouweneel X X X 2017a (Not rated) (Not rated) (Not rated) Health Quality X X X X X Ontario 2017 (High) (Moderate) (Moderate) (Moderate) (Moderate)

Table 2. Characteristics of Individual Comparative Studies Study type Population Intervention (N) Setting Comparator (N) Seyfarth 2008 Randomized controlled trial Adults with acute myocardial infarction < 48 Impella 2.5 (13) hours and cardiogenic shock 2 centers in Germany IABP (13) Schwartz 2011 Retrospective cohort Adults undergoing high-risk PCI supported with Impella 2.5 (13) Impella, IABP, or TandemHeart between 2008 Single center TandemHeart (32) and 2010 IABP (5) Boudoulas 2012 Retrospective cohort All patients with ACS undergoing high-risk PCI Impella 2.5 (12) supported with Impella 2.5 or IABP between IABP (62) 2008 and 2010 Single center

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Study type Population Intervention (N) Setting Comparator (N) O’Neill 2012 Randomized controlled trial Adults undergoing high-risk elective PCI (defined Impella 2.5 (225) as unprotected left main or last patent vessel 112 centers in the US, Canada, and IABP (223) with LVEF < 35% or 3 vessel disease with LVEF < Germany 30%) Manzo-Silberman Retrospective cohort Adult survivors of out-of-hospital cardiac arrest Impella 2.5 (35) 2013 and post-resuscitation shock supported with Single center IABP (43) Impella or IABP after coronary angiography between 2007 and 2010 Ouweneel 2017b Randomized controlled trial Adults with STEMI and severe cardiogenic shock Impella CP (24) (SBP < 90 mmHg for more than 30 minutes or IABP (24) need for inotropes or vasopressors to maintain SBP > 90 mmHg), and requiring mechanical ventilation Ouweneel 2016 Randomized controlled trial Adults with anterior STEMI and cardiogenic pre- Impella 2.5 (11) shock (defined as HR > 100 and/or SBP < 100 5 centers IABP (9) mmHg with clinical signs of shock)

Table 3. Outcomes from RCTs All-cause mortality, 30 All-cause mortality, 90- MACE, 30 days MACE, 90-360 Adverse events days 360 days days Seyfarth 2008 46% Impella NR NR NR 1 case of acute limb ischemia following n = 26 46% IABP Impella removal RBC transfusion requirement (mean) 2.6 units Impella

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All-cause mortality, 30 All-cause mortality, 90- MACE, 30 days MACE, 90-360 Adverse events days 360 days days 1.2 units IABP O’Neill 2012 7.6% Impella 12.1% Impella 35.1% Impella 40.6% Impella NR n = 448 5.9% IABP 8.7% IABP 40.1% IABP 49.3% IABP (at 90 days) (outcome defined (outcome as major adverse defined as events) major adverse events at 90 days) Ouweneel 2017b 46% Impella 50% Impella NR NR Stroke n = 48 50% IABP 50% IABP 4.2% Impella 4.2% IABP

Major vascular event 4.2% Impella 0% IABP

Bleeding 33.3% Impella 8.3% IABP Ouweneel 2016 NR 26% Impella NR 26% Impella Severe vascular events n = 21 11% IABP 33% IABP 25% Impella (at 4 months) (at 4 months) 0% IABP

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All-cause mortality, 30 All-cause mortality, 90- MACE, 30 days MACE, 90-360 Adverse events days 360 days days 37% Impella Need for renal replacement therapy 47% IABP 18% Impella (at 12 months) 0% IABP

Ventricular arrhythmias 8% Impella 11% IABP

Stroke 8% Impella 0% IABP

Severe bleeding 8% Impella 0% IABP

Hemolysis 8% Impella 0% IABP

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Table 4. Outcomes of Comparative Observational Studies All-cause mortality, 30 All-cause mortality, 90- MACE, 30 days MACE, 90-360 Adverse events days 360 days days Schwartz 2011 15% Impella NR 15% Impella NR Limb ischemia n = 50 13% TandemHeart 19% TandemHeart 0% Impella 0% IABP 40% IABP 6% TandemHeart 0% IABP

Major bleeding 31% Impella 13% TandemHeart 20% IABP Boudoulas 2012 In-hospital mortality 15.3% Impella NR NR Vascular complications n = 75 0% Impella 25.8% IABP 15.3% Impella 20.9% IABP 6.4% IABP

Leg ischemia 15.3% Impella 3.2% IABP

Mesenteric ischemia 0% Impella 1.6% IABP

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All-cause mortality, 30 All-cause mortality, 90- MACE, 30 days MACE, 90-360 Adverse events days 360 days days

Aortic rupture 0% Impella 1.6% IABP

Bleeding 38.4% Impella 32.2% IABP

CVA 0% Impella 3.2% IABP

Bacteremia 0% Impella 4.7% IABP Manzo-Silberman Survival at day 3 NR NR NR Hemolytic anemia 2013 34% Impella 6% Impella n = 78 67% IABP 0% IABP

Survival with CPC score 1 Sustained ventricular at 28 days arrhythmias

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All-cause mortality, 30 All-cause mortality, 90- MACE, 30 days MACE, 90-360 Adverse events days 360 days days 23% Impella 17% Impella 29.5% IABP 24% IABP

Bleeding requiring transfusion 26% Impella 9% IABP

Vascular complications 3% Impella 2% IABP

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Policy Landscape Payer Coverage Policies Medicaid

The Washington State Medicaid Program billing guide (7/1/2018) provides coverage for FDA-approved percutaneous left ventricular assist devices for these indications: • Providing short-term circulatory support in cardiogenic shock • As an adjunct to PCI in the following high-risk patients: o Clients undergoing unprotected left main or last-remaining-conduit PCI with ejection fraction less than 35% o Clients with three vessel disease and diastolic ejection fraction less than 30% Medicare

No Medicare National Coverage Determination (NCD) or Local Coverage Determinations were found for percutaneous mechanical circulatory support. The NCD on ventricular assist devices provides coverage only for ventricular assist devices that are surgically attached to one or both intact ventricles. Private Payers

The Aetna policy on ventricular assist devices (last review 3/22/18) provides coverage for Impella for these indications: • Providing short-term circulatory support in cardiogenic shock • As an adjunct to PCI in the following high-risk patients: o Persons undergoing unprotected left main or last-remaining-conduit PCI with ejection fraction less than 35% o Persons with three vessel disease end diastolic ejection fraction less than 30%. The Cigna policy on ventricular assist devices and percutaneous cardiac support systems (effective 2/15/18) provides the following coverage: • Impella RP System for up to 14 days in a child or adult with a BSA ≥ 1.5m2 for the treatment of acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery • Impella Recover LP 2.5 Percutaneous Cardiac Support System, Impella 5.0 Catheters, or Impella 2.5 Plus for the treatment of cardiogenic shock for up to six hours Moda’s list of procedures and services requiring prior authorization (updated 7/1/2018) includes left ventricular assist devices. The Regence policy on ventricular assist devices and total artificial hearts (effective 2/1/2018) states that this policy does not address the use of percutaneous ventricular assist devices, which may be considered medically necessary.

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Recommendations from Others

Three guidelines were identified that include recommendations on temporary percutaneous mechanical circulatory support: • Guideline for the Management of ST-Elevation Myocardial Infarction published in 2013 by the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) Task Force on Practice Guidelines (O'Gara et al., 2013) • Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care published by the Society for Cardiovascular Angiography and Interventions, American College of Cardiology Foundation, Heart Failure Society of America, and Society for Thoracic Surgery (Rihal et al., 2015) • The 2013 International Society for Heart and Lung Transplantation Guidelines for Mechanical Circulatory Support (Feldman et al., 2013) The ACCF/AHA guideline includes a recommendation that alternative left ventricular assist devices for circulatory support may be considered in patients with refractory cardiogenic shock (O'Gara et al., 2013). The guideline from the Society for Cardiovascular Angiography and Interventions states that percutaneous mechanical circulatory support may be considered in carefully selected patients with severe hemodynamically unstable cardiovascular presentations. Suggested indications for percutaneous mechanical circulatory support include complications of acute myocardial infarction, severe heart failure in the setting of non-ischemic cardiomyopathy, acute cardiac allograft failure, post-transplant right ventricle failure, refractory arrhythmias, high-risk ablation of ventricular tachycardia, and high-risk PCI (Rihal et al., 2015). The following recommendation from the International Society for Heart and Lung Transplantation guidelines is based on level of evidence C, or consensus agreement: “The use of temporary mechanical support should be strongly considered in patients with multiorgan failure, sepsis, or on mechanical ventilation to allow successful optimization of clinical status and neurologic assessment prior to placement of a long-term [mechanical circulatory support device]” (Feldman et al., 2013, p. 165) Quality Measures

No quality measures were identified when searching the National Quality Measures Clearinghouse for percutaneous mechanical circulatory support or Impella.

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References Evidence Sources

Ait Ichou, J., Larivee, N., Eisenberg, M. J., Suissa, K., & Filion, K. B. (2018). The effectiveness and safety of the Impella ventricular assist device for high-risk percutaneous coronary interventions: A systematic review. Catheter Cardiovascular Intervention, 91(7), 1250-1260. doi: 10.1002/ccd.27316 Boudoulas, K. D., Pederzolli, A., Saini, U., Gumina, R. J., Mazzaferri, E. L., Jr., Davis, M., . . . Pompili, V. J. (2012). Comparison of Impella and intra-aortic balloon pump in high-risk percutaneous coronary intervention: Vascular complications and incidence of bleeding. Acute Cardiac Care, 14(4), 120- 124. doi: 10.3109/17482941.2012.741244 Health Quality Ontario. (2017). Percutaneous ventricular assist devices: A health technology assessment. Ontario Health Technology Assessment Series, 17(2), 1-97. Retrieved from http://www.hqontario.ca/Portals/0/Documents/evidence/reports/hta-impella-1701-en.pdf Manzo-Silberman, S., Fichet, J., Mathonnet, A., Varenne, O., Ricome, S., Chaib, A., . . . Cariou, A. (2013). Percutaneous left ventricular assistance in post cardiac arrest shock: Comparison of intra aortic blood pump and IMPELLA Recover LP2.5. Resuscitation, 84(5), 609-615. doi: 10.1016/j.resuscitation.2012.10.001 O'Neill, W. W., Kleiman, N. S., Moses, J., Henriques, J. P., Dixon, S., Massaro, J., . . . Ohman, M. (2012). A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: The PROTECT II study. Circulation, 126(14), 1717-1727. doi: 10.1161/circulationaha.112.098194 Ouweneel, D. M., Eriksen, E., Seyfarth, M., & Henriques, J. P. (2017a). Percutaneous mechanical circulatory support versus intra-aortic balloon pump for treating cardiogenic shock: Meta-analysis. Journal of the American College of Cardiology, 69(3), 358-360. doi: 10.1016/j.jacc.2016.10.026 Ouweneel, D. M., Eriksen, E., Sjauw, K. D., et al. (2017b). Impella CP versus intraaortic balloon pump in acute myocardial infarction complicated by cardiogenic shock: The IMPRESS trial. Journal of the American College of Cardiology, 69, 278-287. Ouweneel, D. M., Engstrom, A. E., Sjauw, K. D., Hirsch, A., Hill, J. M., Gockel, B., . . . Henriques, J. P. (2016). Experience from a randomized controlled trial with Impella 2.5 versus IABP in STEMI patients with cardiogenic pre-shock. Lessons learned from the IMPRESS in STEMI trial. International Journal of Cardiology, 202, 894-896. doi: 10.1016/j.ijcard.2015.10.063 Schwartz, B. G., Ludeman, D. J., Mayeda, G. S., Kloner, R. A., Economides, C., & Burstein, S. (2011). High- risk percutaneous coronary intervention with the TandemHeart and Impella devices: A single- center experience. Journal of Invasive Cardiology, 23(10), 417-424. Seyfarth, M., Sibbing, D., Bauer, I., Frohlich, G., Bott-Flugel, L., Byrne, R., . . . Schomig, A. (2008). A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. Journal of the American College of Cardiology, 52(19), 1584-1588. doi: 10.1016/j.jacc.2008.05.065

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Other Citations

Abiomed. (2018). Impella® the world's smallest heart pump. Retrieved from http://www.abiomed.com/impella Feldman, D., Pamboukian, S. V., Teuteberg, J. J., Birks, E., Lietz, K., Moore, S. A., . . . Rogers, J. (2013). The 2013 International Society for Heart and Lung Transplantation guidelines for mechanical circulatory support: Executive summary. Journal of Heart and Lung Transplantation, 32(2), 157- 187. doi: 10.1016/j.healun.2012.09.013 O'Gara, P. T., Kushner, F. G., Ascheim, D. D., Casey, D. E., Jr., Chung, M. K., de Lemos, J. A., . . . Yancy, C. W. (2013). 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation, 127(4), e362-425. doi: 10.1161/CIR.0b013e3182742cf6 Rihal, C. S., Naidu, S. S., Givertz, M. M., Szeto, W. Y., Burke, J. A., Kapur, N. K., . . . Tu, T. (2015). 2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care: Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention. Journal of the American College of Cardiology, 65(19), e7-e26. doi: 10.1016/j.jacc.2015.03.036 U.S. Food and Drug Administration. (2018). Summary of safety and effectiveness data (SSED). Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140003S018B.pdf U.S. Food and Drug Administration. (2016). Premarket approval (PMA): Impella left ventricular support system. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140003S005 U.S. Food and Drug Administration. (2015). Premarket approval (PMA): Impella 2.5 system. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140003

Coverage guidance is prepared by the Health Evidence Review Commission (HERC), HERC staff, and subcommittee members. The evidence summary is prepared by the Center for Evidence-based Policy at Oregon Health & Science University (the Center). This document is intended to guide public and private purchasers in Oregon in making informed decisions about health care services. The Center is not engaged in rendering any clinical, legal, business or other professional advice. The statements in this document do not represent official policy positions of the Center. Researchers involved in preparing this document have no affiliations or financial involvement that conflict with material presented in this document.

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Suggested citation: Obley, A., Mosbaek, C., King, V., & Livingston, C. (2018). Coverage guidance: Temporary percutaneous mechanical circulatory support with Impella devices. Portland, OR: Center for Evidence-based Policy, Oregon Health & Science University

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Appendix A. GRADE Table Element Descriptions

Element Description Balance of benefits The larger the difference between the desirable and undesirable effects, the higher the and harms likelihood that a strong recommendation is warranted. An estimate that is not statistically significant or has a confidence interval crossing a predetermined clinical decision threshold will be downgraded. Quality of evidence The higher the quality of evidence, the higher the likelihood that a strong recommendation is warranted Resource allocation The higher the costs of an intervention—that is, the greater the resources consumed in the absence of likely cost offsets—the lower the likelihood that a strong recommendation is warranted Values and The more values and preferences vary, or the greater the uncertainty in values and preferences preferences, the higher the likelihood that a weak recommendation is warranted Other considerations Other considerations include issues about the implementation and operationalization of the technology or intervention in health systems and practices within Oregon.

Strong recommendation

In Favor: The subcommittee concludes that the desirable effects of adherence to a recommendation outweigh the undesirable effects, considering the balance of benefits and harms, resource allocation, values and preferences and other factors. Against: The subcommittee concludes that the undesirable effects of adherence to a recommendation outweigh the desirable effects, considering the balance of benefits and harms, resource allocation, values and preferences and other factors. Weak recommendation

In Favor: The subcommittee concludes that the desirable effects of adherence to a recommendation probably outweigh the undesirable effects, considering the balance of benefits and harms, resource allocation, values and preferences and other factors., but further research or additional information could lead to a different conclusion. Against: The subcommittee concludes that the undesirable effects of adherence to a recommendation probably outweigh the desirable effects, considering the balance of benefits and harms, cost and resource allocation, and values and preferences, but further research or additional information could lead to a different conclusion. Confidence in estimate rating across studies for the intervention/outcome

Assessment of confidence in estimate includes factors such as risk of bias, precision, directness, consistency and publication bias. High: The subcommittee is very confident that the true effect lies close to that of the estimate of the effect. Typical sets of studies are RCTs with few or no limitations and the estimate of effect is likely stable.

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Moderate: The subcommittee is moderately confident in the estimate of effect: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Typical sets of studies are RCTs with some limitations or well-performed nonrandomized studies with additional strengths that guard against potential bias and have large estimates of effects. Low: The subcommittee’s confidence in the estimate of effect is limited: The true effect may be substantially different from the estimate of the effect. Typical sets of studies are RCTs with serious limitations or nonrandomized studies without special strengths. Very low: The subcommittee has very little confidence in the estimate of effect: The true effect is likely to be substantially different from the estimate of effect. Typical sets of studies are nonrandomized studies with serious limitations or inconsistent results across studies.

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Appendix B. GRADE Evidence Profile

Quality Assessment (Confidence in Estimate of Effect) for Elective High-Risk PCI No. of Study Risk of Other Studies Design(s) Bias Inconsistency Indirectness Imprecision Factors Quality All-cause mortality 1 RCT Moderate Not serious Not serious Serious Low ●●◌◌ Major adverse events 1 RCT Moderate Not serious Not serious Serious Low ●●◌◌ Bridge to recovery N/A N/A N/A N/A N/A N/A N/A N/A Bridge to transplant N/A N/A N/A N/A N/A N/A N/A N/A Harms 1 Observational Moderate Not serious Not serious Not serious Very low ●◌◌◌

30 │ Temporary Percutaneous Mechanical Circulatory Support with Impella Devices DRAFT for 1/16/2020 HERC meeting materials

Quality Assessment (Confidence in Estimate of Effect) for Ischemic Cardiogenic Shock No. of Study Risk of Other Studies Design(s) Bias Inconsistency Indirectness Imprecision Factors Quality All-cause mortality 3 RCTs Moderate Not serious Not serious Serious Low to high ●●◌◌ Major adverse events 1 RCT High N/A Not serious Very serious Very low ●◌◌◌ Bridge to recovery 0 N/A N/A N/A N/A N/A N/A Insufficient data Bridge to transplant 0 N/A N/A N/A N/A N/A N/A Insufficient data Harms 4 Mix of RCTs Moderate Serious Not serious Very serious Very low and to high ●◌◌◌ observational

31 │ Temporary Percutaneous Mechanical Circulatory Support with Impella Devices DRAFT for 1/16/2020 HERC meeting materials

Appendix C. Methods Scope Statement Populations Adults with cardiogenic shock or refractory heart failure (from right heart failure, left heart failure, or biventricular failure) and adults undergoing high-risk percutaneous coronary interventions (PCI) Population scoping notes: None Interventions Temporary percutaneous mechanical circulatory support devices (Impella) Intervention exclusions: Devices not marketed in the U.S., TandemHeart, extracorporeal membrane oxygenation (ECMO). Comparators Usual care, inotropes, other forms of active circulatory support (i.e., intra-aortic balloon pumps or more permanent left ventricular assist devices), extracorporeal membrane oxygenation (ECMO) Outcomes Critical: Mortality, major adverse cardiovascular events Important: Successful bridge to transplantation or bridge to recovery, length of hospitalization, harms Considered but not selected for the GRADE table: None Key Questions KQ1: What is the comparative effectiveness of temporary percutaneous mechanical circulatory support in the management of adults with heart failure or cardiogenic shock, or undergoing high-risk PCI? KQ2: Does the comparative effectiveness of temporary percutaneous mechanical circulatory support vary by: a. Indication for left ventricular support b. Patient characteristics c. Left ventricular function d. Right ventricular function e. Comorbid conditions f. Device flow rate g. Timing and duration of Impella placement KQ3: What are the harms of temporary percutaneous mechanical circulatory support?

32 │ Temporary Percutaneous Mechanical Circulatory Support with Impella Devices DRAFT for 1/16/2020 HERC meeting materials

Search Strategy

A full search of the core sources was conducted to identify systematic reviews, meta-analyses, and technology assessments that meet the criteria for the scope described above. Searches of core sources were limited to citations published after 2013. The following core sources were searched: Agency for Healthcare Research and Quality (AHRQ) Canadian Agency for Drugs and Technologies in Health (CADTH) Cochrane Library (Wiley Online Library) Institute for Clinical and Economic Review (ICER) Medicaid Evidence-based Decisions Project (MED) National Institute for Health and Care Excellence (NICE) Tufts Cost-effectiveness Analysis Registry Veterans Administration Evidence-based Synthesis Program (ESP) Washington State Health Technology Assessment Program

A MEDLINE® search was also conducted to identify systematic reviews, meta-analyses, and technology assessments, using the search terms Impella, ventricular support system, and axial flow pumps. The search was limited to publications in English published since 2013. In addition, a MEDLINE® search was conducted for randomized controlled trials published after 2013. Searches for clinical practice guidelines were limited to those published since 2013. A search for relevant clinical practice guidelines was also conducted using MEDLINE® and the following sources: Australian Government National Health and Medical Research Council (NHMRC) Canadian Agency for Drugs and Technologies in Health (CADTH) Centers for Disease Control and Prevention (CDC), Community Preventive Services National Guidelines Clearinghouse National Institute for Health and Care Excellence (NICE) Scottish Intercollegiate Guidelines Network (SIGN) United States Preventive Services Task Force (USPSTF) Veterans Administration/Department of Defense (VA/DoD) Clinical Practice Guidelines Inclusion/Exclusion Criteria

Studies were excluded if they were not published in English, did not address the scope statement, or were study designs other than systematic reviews, meta-analyses, technology assessments, randomized controlled trials, or clinical practice guidelines.

33 │ Temporary Percutaneous Mechanical Circulatory Support with Impella Devices DRAFT for 1/16/2020 HERC meeting materials

Appendix D. Applicable Codes

CODES DESCRIPTION CPT Codes Insertion of ventricular assist device, percutaneous including radiological supervision and 33990 interpretation; arterial access only Insertion of ventricular assist device, percutaneous including radiological supervision and 33991 interpretation; both arterial and venous access, with transseptal puncture 33992 Removal of percutaneous ventricular assist device at separate and distinct session from insertion Repositioning of percutaneous ventricular assist device with imaging guidance at separate and 33993 distinct session from insertion Note: Inclusion on this list does not guarantee coverage.

34 │ Temporary Percutaneous Mechanical Circulatory Support with Impella Devices DRAFT for 1/16/2020 HERC meeting materials 10.1161/CIRCULATIONAHA.119.044007

The Evolving Landscape of Impella® Use in the United States Among Patients

Undergoing Percutaneous Coronary Intervention with Mechanical

Circulatory Support

Running Title: Amin et al.; Trends, Variation and Outcomes in Impella® Use

Amit P. Amin, MD, MSc1,2; John A. Spertus, MD, MPH3; Jeptha P. Curtis, MD4;

Nihar Desai, MD, MPH4; Frederick A. Masoudi, MD, MSc5; Richard G. Bach, MD1,2;

Christian McNeely, MD1,2; Firas Al-Badarin, MD, MSc3; John A. House, MS6;

Hemant Kulkarni, MD7; Sunil V. Rao, MD8

1 2 Downloaded from http://ahajournals.org by on November 20, 2019 Cardiovascular Division, Washington University School of Medicine, St. Louis, MO; Barnes-

Jewish Hospital, St. Louis, MO; 3Saint Luke’s Mid America Heart Institute, University of

Missouri-Kansas City, Kansas City, MO; 4Yale University, New Haven, CT; 5University of

Colorado Anschutz Medical Campus Aurora, CO; 6Premier, Inc, Premier Applied Sciences,

Charlotte, NC; 7M&H Research, LLC San Antonio, TX; 8The Duke Clinical Research Institute,

Durham, NC

Address for Correspondence: Amit P. Amin, MD, MSc Washington University School of Medicine Cardiology Division, Campus Box 8086 660 S. Euclid Avenue, St. Louis, MO 63110 Tel: 314-286-2692 Fax: 314-747-1417 Email: [email protected].

1 10.1161/CIRCULATIONAHA.119.044007

Abstract

Background: Impella® was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in Impella® use, clinical outcomes and costs across US hospitals in percutaneous coronary intervention (PCI) patients treated with MCS (Impella® or intra-aortic balloon pump (IABP)). Methods: From the Premier Healthcare Database, we analyzed 48,306 patients undergoing PCI with MCS at 432 hospitals between 1/2004-12/2016. Association analyses were performed at three levels: time-period, hospitals and patients. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella® use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury (AKI), stroke, length of stay (LOS) and hospital costs). Results: Among PCI patients treated with MCS, 4,782 (9.9%) received Impella®; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella® use across hospitals (> 5-fold variation). Specifically, among Impella® patients, there was wide variation in outcomes of bleeding (> 2.5-fold variation), and death, AKI and stroke (all ~1.5-fold variation). Adverse outcomes and costs were higher in the Impella®-era (years 2008-2016) vs. the pre-Impella® era (years 2004-2007). Hospitals with higher Impella® use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella® use was associated with death: OR 1.24 (95%CI 1.13–1.36); bleeding: OR 1.10 (95%CI 1.00–1.21); and stroke: OR 1.34 (95%CI 1.18–1.53), although a similar, non-significant result was observed for AKI: OR 1.08 (95%CI 1.00–1.17).

Downloaded from http://ahajournals.org by on November 20, 2019 Conclusions: Impella® use is rapidly increasing among PCI patients treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time-periods, or at the hospital-level or the patient-level, Impella® use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.

Key Words: Impella®; Intra-aortic balloon pump; mechanical circulatory support; percutaneous coronary intervention; angioplasty procedure; cardiogenic shock.

Non-Standard Abbreviations and Acronyms MCS, mechanical circulatory support PCI, percutaneous coronary intervention IABP, intra-aortic balloon pump AKI, acute kidney injury COPD, chronic obstructive pulmonary disease CKD, chronic kidney disease STEMI, ST segment elevation myocardial infarction NSTEMI, non-ST segment elevation myocardial infarction UA, unstable angina GPIIb/IIIa inhibitors, glycoprotein IIb/IIIa inhibitors ECMO, extra corporeal membrane oxygenation PVAD, percutaneous ventricular assist device LOS, length of stay

2 10.1161/CIRCULATIONAHA.119.044007

OR, Odds ratio MOR, median odds ratio 95% CI, 95% confidence interval 95% CrI, 95% credible interval PHD, Premier healthcare database USFDA, United States Food and Drug Administration AHA, American Hospital Association ICU, intensive care unit ICD-9, international classification of diseases, 9th revision. ICD-10, international classification of diseases, 10th revision. CMS, centers for Medicare and Medicaid MCCR, Medicare Cost to Charge Ratio CPI, consumer pricing index ICC, intra-class correlation coefficient

Downloaded from http://ahajournals.org by on November 20, 2019

3 10.1161/CIRCULATIONAHA.119.044007

Clinical Perspective

What is new? • Among an unselected, real-world, clinical practice of PCI patients treated with MCS devices, Impella® use was found to be rapidly increasing, with marked variability across hospitals in not only its use, but also its associated adverse outcomes. • When analyzed by time-periods, or at the level of hospitals, or at the level of patients, Impella® use was associated with higher rates of adverse events and higher hospital costs.

What are the clinical implications? • The variability in Impella use, the variability in its associated outcomes and the association of Impella use with higher adverse events and costs, underscores the need for better defining the appropriate use of MCS devices with adequately powered randomized clinical trials and prospective real-world evidence. • Until then, perhaps a more measured approach is needed in clinical practice that balances Downloaded from http://ahajournals.org by on November 20, 2019 risks and benefits in complex patients undergoing PCI who require MCS devices.

4 10.1161/CIRCULATIONAHA.119.044007

Introduction

Device options for mechanical circulatory support (MCS) to support high risk percutaneous

coronary intervention (PCI) include intra-aortic balloon pumps (IABP) and the intravascular

microaxial blood pump (Impella®). Impella® devices are catheter-based, miniaturized

ventricular assist pumps that can provide up to 5 liters of cardiac output and rapidly reduce left

ventricular preload.1 Whether support from Impella® devices translates into better outcomes in

PCI patients treated with MCS is unknown. The PROTECT-II Study randomized 452 patients

undergoing high risk PCI to IABP or Impella® 2.5 and found no difference in 30 or 90 day

adverse CV events in the primary intent to treat analysis, but did observe lower adverse events at

90 days in the Impella® 2.5 arm among per-protocol treated patients.2 Observational studies

have suggested higher survival rates with Impella® use in cardiogenic shock3-6 but large-scale

clinical trials have not been completed.7-11 The absence of data for cardiogenic shock has Downloaded from http://ahajournals.org by on November 20, 2019 resulted in limited guideline recommendations for Impella® use both in the United States and

Europe, raising the possibility of variability in its selection and use.12-14 Furthermore, there are

few data12-14 on trends in hospitals use of Impella® devices, or variations in use, and also

limited data on costs associated with Impella® use in patients undergoing PCI with MCS15, 16.

The Impella 2.5® device received United States Food and Drug Administration’s

(USFDA) 510(k) approval in June 2008 for high risk PCI and subsequently other devices

(Impella 5.0®, Impella CP®) have also received FDA approval with an expanded indication for

cardiogenic shock in April 2016. Thus, there is an opportunity to analyze a natural experiment

among PCI patients with MCS by comparing the scenarios before and after the Impella® devices

became available. Therefore, to better clarify the potential risks and benefits of Impella® use as a

means of MCS at the time-period level, the hospital-level and the patient-level, we examined

5 10.1161/CIRCULATIONAHA.119.044007

patients undergoing PCI with MCS in a large dataset representative of contemporary PCI

practices in the United States to address the following objectives:

1) describe trends in Impella® use;

2) examine variation in Impella® use across hospitals; and separately examine, only in

the subset of patients who received Impella® devices, the hospital variation in clinical outcomes,

costs and length of stay;

3) compare clinical outcomes, hospitalization costs and length of stay a) in the pre-

Impella® vs. Impella® era and b) across low- vs. high-Impella® use hospitals (grouped by

quartiles of Impella® use);

4) examine the association between Impella® (versus IABP) use and clinical outcomes

(in-hospital mortality, bleeding, acute kidney injury (AKI) and stroke) .

Downloaded from http://ahajournals.org by on November 20, 2019 Methods

The data, analytic methods, and study materials for this analysis will not be made

available to other researchers.

Study participants

To capture the practice patterns associated with Impella® use, we used the Premier® healthcare

database (PHD), an all payer database representing ~20% of all acute care hospitalizations in the

United States.17 It has similar distributions for hospital region and hospital characteristics as the

American Hospital Association (AHA) and has less than 1% records with incomplete

information. While the number of hospitals contributing to the PHD does change from year to

year typically more hospitals are added to the database and very few are removed with a current

median duration of 7 years.17 Data from the PHD has been used in numerous publications related

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to patient care patterns, outcomes, burden of illness over time, comparative effectiveness

analyses, cost analyses and cost-effectiveness studies.17

The dataset used in this study covered a 13-year period from 1/2004 to 12/2016. The

calendar years 2004-2007 were considered the Pre-Impella® era and the calendar years 2008-

2016 were considered the Impella® era. To keep the population more uniform, and limit

unmeasured confounding, we only included patients if the device was billed on the same day of

PCI at the PCI performing hospital, essentially excluding patients who either clinically

deteriorated, or had already developed complications with MCS placement, or received MCS and

were transferred.

The inclusion and exclusion flowchart for defining the study population is shown in

supplementary figure 1. Data from a total of 1,781,900 PCIs during the study period were

available from the Premier dataset. From this set, we selected the subset of patients undergoing Downloaded from http://ahajournals.org by on November 20, 2019 PCI with MCS, defined as use of either an Impella® device (n = 5,887) or an intra-aortic balloon

pump (IABP) (n = 46,690) on the day of PCI. We excluded patients who received both Impella®

and IABP devices (n = 828), as these patients may have required escalation of MCS, and our

intent was to examine Impella® use as a primary strategy. We also excluded patients in whom

covariate information on 37 potential confounders was missing (n = 2,615). The degree of

missing covariate information was equal in the Impella® (N=277/5,059, 5.48%) patients and

IABP (N=2,338/45,862, 5.10%) patients. Thus, a total of 48,306 patients were included in the

study; with Impella® being used in 4,782 patients and IABP being used in 43,524. Institutional

Review Board approval was granted by Washington University in St Louis, MO, which

considered this study to not be human subjects research and the requirement for informed

consent was waived.

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Outcomes, predictors and costs

The Premier® database contains information on the socio-demographic characteristics,

comorbidities, interventional procedures, medications, outcomes, the total length of hospital and

intensive care unit (ICU) length of stay and hospitalization costs form a ‘hospital’ perspective,

based on a micro-costing approach.

The database contains ICD-9 and ICD-10 codes with detailed billing information. ICD-10

codes were mapped back to ICD-9 using CMS General Equivalence Mappings, however the

ICD-10 codes were used when there were no direct mappings.17 To identify Impella® ICD-9

code 37.68 and ICD-10 codes 5A0221D, 5A0211D were first used to identify potential usage

and the billing information was used to determine named devices and matched to Impella®

devices. Impella® device usage was reported if both an ICD code and a billed Impella® device

was present. A similar approach to identify IABP was used where first ICD-9 code 37.61 and Downloaded from http://ahajournals.org by on November 20, 2019 ICD-10 codes 5A02210, 5A02110 were used to identify potential usage and then verified by the

billing information. If the Impella® or IABP devices were billed on the same day as the PCI,

only then were they included in the analysis. Use of these MCS devices before or after the day of

PCI were excluded. We examined the following four clinical outcomes during index

hospitalization: death, bleeding requiring transfusion, acute kidney injury (AKI) and stroke.

Death included all-cause mortality during the index hospitalization at the PCI performing

hospital. Clinically significant bleeding was defined as a bleeding event requiring transfusion

(supplementary material). Stroke comprised of either ischemic stroke, hemorrhagic stroke

intracerebral hemorrhage or transient ischemic attack (supplementary material). All the above

outcomes were required to be present at discharge but absent in ‘present on admission’ codes.

The validity of identifying comorbidities, complications, and procedures via ICD-9 and ICD-10

8 10.1161/CIRCULATIONAHA.119.044007

codes in administrative datasets has been previously demonstrated and codes were selected based

on previously validated algorithms.18-21

Costs to the hospital and charges to the payer can be determined from the PHD from the

charge master, which is a comprehensive table of items billable to a patient or health insurance

provider.17 It includes hospital services, medical procedures, equipment fees, supplies, drugs and

diagnostic evaluations such as imaging and laboratory tests. Days of services/supplies/drugs

administered and billed are documented. Procedural costs are determined via hospitals’ cost

accounting systems using a ‘micro-costing’ approach.17 For a small proportion of patients when

micro costing was not available, Premier is provided the charges and Premier assigns Medicare

Cost to Charge Ratios (MCCR) to the data provided. Regardless of the source of the cost and

charge data, they are reviewed and validated against the data from the hospital and confirmed to

be within certain variances, before use within the database. We removed observations with Downloaded from http://ahajournals.org by on November 20, 2019 missing cost data or those below 1 percentile (N=482). All costs were inflation-adjusted to 2016

US dollars using the medical consumer pricing index (CPI) available from the Bureau of Labor

Statistics.

Statistical analyses

Our objectives were to describe the trends in Impella® use; variation in Impella® use and its

outcomes over 13 years from 1/2004 to 12/2016; and to compare the clinical outcomes (in-

hospital mortality, bleeding requiring transfusion, AKI and stroke) in patients who received

Impella® vs. IABP, among patients undergoing PCI with MCS.

Overall analytical approach

Recognizing the potential for confounding at the level of both patients and hospitals in all

association analyses, we first developed a propensity score, using a logistic regression model, to

9 10.1161/CIRCULATIONAHA.119.044007

predict the likelihood of Impella® use based on patients’ clinical characteristics (supplementary

figure 2); Next, we used mixed effects logistic or linear regression models that used hospital

identifier as random effect to account for hospital-level random effects and the propensity score.

These steps are discussed in detail below.

1. Propensity Score Adjustment: The propensity score predicting Impella® use was

generated using multivariable logistic regression with Impella® use as the dependent variable

and a total of 37 potential confounders as the independent variables listed in Supplementary

Figure 2, Panel A. Information on all the covariates was available in 48,306 patients from 432

US hospitals. The balance of covariates before and after propensity adjustment for all the 37

confounders is shown in Supplementary Figure 2, Panel A.

2. Mixed effects modeling: We then developed a hierarchical model, with ‘hospital site’ as a

random effect, adjusted for patients’ propensity to receive an Impella® device. We examined Downloaded from http://ahajournals.org by on November 20, 2019 inter-hospital variation from these models as follows: from linear regression models (with

hospital cost or length of stay as the dependent variable) we estimated the intra-class correlation

coefficient (ICC) as the contribution of the hospital-level variance to the overall variance22; from

logistic regression models we estimated the median odds ratios (MOR) and their 95% credible

interval (CrI) as described by Larsen and Merlo23. The MOR represents the median of all odds

ratios (ORs) when comparing the odds of receiving Impella® for all possible pairs of patients

with identical characteristics presenting at 2 different randomly chosen hospitals. MOR larger

than unity indicates variation in the association across hospitals.23

Statistical analyses for time trends

We examined the temporal trends in: Impella® use by plotting the proportion of Impella® use

amongst patients undergoing PCI with MCS devices, by year. When examining these trends in

10 10.1161/CIRCULATIONAHA.119.044007

Impella® use, we also plotted trends in Impella® use among critically-ill patients vs. those not

critically-ill to examine if Impella® was being used more in critically ill patients. A subset of

‘critically-ill’ patients were identified as those who received mechanical ventilation or cardiac

arrest or had a diagnosis of cardiogenic shock.

Statistical analyses to quantify variation across hospitals

We examined the variation in Impella® use across hospitals univariately and after adjusting for

patient characteristics; and expressed using the MOR. We separately examined the variation

across hospitals in outcomes, costs and length of stay in only the subset of patients who received

Impella® device (n=4,782).

Association analyses at the time-period level, hospital-level and patient-level

To examine the association of Impella® devices with clinical outcomes and costs, we compared

the pre-Impella® era (n=12,540) and Impella® era (n=35,766). We then grouped hospitals by Downloaded from http://ahajournals.org by on November 20, 2019 quartiles of Impella® use (with Quartile #1 being the lowest use, and Quartile #4 being the

highest use) to examine the associations of increasing Impella® use with outcomes. Next, we

performed patient level observational comparative effectiveness analyses comparing patients

receiving Impella® or IABP.

Sensitivity analyses

Finally, to examine the robustness of our results we also performed the following sensitivity

analyses. First, we repeated all analyses after excluding the small subset of patients escalated to

use of ECMO (n=163 [0.34%]). Second, we performed sensitivity analyses excluding hospitals

with <10 years of data . Third, to account for changing trends in MCS use, we included calendar

year as a covariate in the hierarchical regression models and repeated the analyses. Finally, we

performed a series of falsification endpoint analyses24, 25, in which endpoints not expected to be

11 10.1161/CIRCULATIONAHA.119.044007

influenced by MCS choice, but would be influenced by confounding factors, were tested to

assess residual bias. Unrelated but acute falsification endpoints indicative of unmeasured frailty

or sickness (community-acquired pneumonia, diarrhea, cellulitis, deep vein thrombosis, intestinal

obstruction and osteomyelitis) were compared between Impella® vs. IABP groups using odds

ratios (ORs) and 95% confidence intervals (CI).24, 25 For all analyses, the statistical significance

was tested at a type I error rate of 0.05 and conducted using the Stata 12.0 (Stata Corp, College

Station, TX) software package.

Results

Study participants

A total of 48,306 patients undergoing PCI with MCS from 432 hospitals over 13 years from

2004 to 2016 were included in the study. Of these patients 4,782 (9.9%) received an Impella® Downloaded from http://ahajournals.org by on November 20, 2019 device, and the remaining 43,524 (90.1%) received an intra-aortic balloon pump (IABP). Clinical

characteristics of these patients are detailed in Table 1. Briefly, patients undergoing PCI with

MCS had a high prevalence of comorbidities: heart failure (50%), chronic renal failure (20%),

diabetes (40%), COPD (20%) and atrial fibrillation (23%). Cardiogenic shock was present in

50%, 38% required mechanical ventilation, 62% of patients presented with a STEMI and 26%

underwent multivessel PCI. Patients receiving Impella® were more likely than those receiving

IABP to be male with Medicare insurance, non-white, and had a higher prevalence of diabetes,

heart failure, CKD, COPD, multivessel disease, greater use of Ticagrelor and Bivalirudin, but

lesser use of warfarin and GPIIb/IIIa use (Table 1). However, Impella® was used less in patients

who required mechanical ventilation or who had cardiac arrest or cardiogenic shock (Table 1).

12 10.1161/CIRCULATIONAHA.119.044007

Trends in Impella® use

When examined in the context of the entire Premier PCI population (N = 1,733,594), use of

MCS devices remained stable around 2.5% of all PCI procedures until 2008, thereafter

increasing to 3.5% in 2016 (Supplementary figure 3). The overall rise in MCS use after 2008

closely paralleled a concomitant rise in patients who received Impella® while the proportion of

patients who received IABP remained stable or declined slightly during the post-Impella® era.

Within the subset of the MCS-treated patients, the proportion of Impella® utilization increased

steadily, reaching 31.9% in 2016 (Figure 1). We did not observe increasing Impella® use in

more critically ill patients, defined by one or more of the following: presence of mechanical

ventilation, cardiac arrest or cardiogenic shock (Supplementary Figure 4). Also, we observed that

adjusted costs of hospitalization remained stable in the pre-Impella era from $46,989 in 2004 to

$47,282 in 2009, but increased to $51,202 in 2016, in the post-Impella® era. In contrast to the Downloaded from http://ahajournals.org by on November 20, 2019 increasing cost trend in patients undergoing PCI with MCS, when we examined the costs of PCI

when MCS devices were not used (N= 1,724,546), we observed a decline in costs

(Supplementary figure 5).

Variation in Impella® use across hospitals

We observed wide variation across hospitals in the proportional use of Impella® among patients

undergoing PCI with MCS, ranging from 0% to 100% (Figure 2). After adjustment for the

propensity score for Impella® use, and accounting for clustering of patients by hospitals in

mixed effects model, the MOR was estimated to be 5.77 (CrI 4.77 – 7.06), indicating that

statistically identical patients had an average 5.77-fold differing likelihood of receiving Impella®

at 1 randomly selected hospital as compared with another (Figure 2). Further, this variation

across hospitals was observed throughout the Impella® era (Figure 2, inset).

13 10.1161/CIRCULATIONAHA.119.044007

Variation in outcomes, costs and length of stay in patients who received Impella®

Specifically, among patients who received Impella® (n=4,782), we determined if there was

variability in Impella®-associated outcomes via additional mixed effects modeling studies. As

shown in Table 2, we found that there was significant inter-hospital variation in clinical

outcomes when Impella® was used. The median odds ratio (MOR) estimates were highest for

bleeding (MOR 2.62, indicating an average 2.6-fold greater likelihood of a clinically similar

patient experiencing a bleeding complication, followed by death (MOR 1.71), AKI (MOR 1.53)

and stroke (MOR 1.47) even after accounting for clustering of patients across hospitals (full

results in Table 2). Thus, patients with a statistically similar clinical profile who received an

Impella® device tended to have variable outcomes across hospitals. On the other hand, the ICC

estimates capturing variation in LOS and cost association across hospitals indicated that hospital

factors only explained ~5-7% of variation in LOS and ~18% of variation in hospitalization costs, Downloaded from http://ahajournals.org by on November 20, 2019 indicating less variation across hospitals in these outcomes (Table 2).

Clinical outcomes and hospitalization costs in the Pre-Impella® and Impella® era

We conducted a comparison of the adjusted clinical outcomes, LOS and costs between the pre-

Impella® (n=12,540) and Impella® eras (n=35,766) (Table 3) and observed higher rates of in-

hospital death (OR 1.17), AKI (OR 1.91) and stroke (OR 3.34) in the Impella® era. While the

LOS, and ICU stay did not change significantly in the Impella® era, average per-patient

hospitalization costs increased by US$ 1,775.

High- vs. Low-Impella® use across hospitals and its association with outcomes

When we categorized hospitals by quartiles of Impella® use, we found the adjusted odds ratios

of clinical outcomes differed such that hospitals with higher use of Impella® had a higher risk of

death, bleeding, AKI and stroke as compared to hospitals with lower use of Impella®, after

14 10.1161/CIRCULATIONAHA.119.044007

adjusting for the propensity score and accounting for clustering of patients across hospitals

(Table 4). We also observed a shorter length of stay in high-Impella® use hospitals both in and

out of the ICU. However, hospitalization costs in high-use hospitals exceeded costs in low-use

hospitals by at least $10,000 (Table 4).

Individual patient comparative effectiveness analyses

After adjustment for the propensity score for Impella® use, and accounting for clustering of

patients by hospitals in hierarchical models, Impella® use was associated with a higher risk of

the three outcomes [death: OR 1.24 (95% CI 1.13 - 1.36); bleeding: OR 1.10 (95% CI 1.00 –

1.21); and stroke: OR 1.34 (95% CI 1.18 – 1.53)] although a similar, but non-significant result

was observed for AKI: OR 1.08 (95% CI 1.00 – 1.17); (Figure 3).

Sensitivity analyses and falsification endpoint analysis

Numerous sensitivity analyses were performed to evaluate the robustness of the study results as Downloaded from http://ahajournals.org by on November 20, 2019 follows: First, hospital-level variation remained comparably high after a) excluding ECMO

patients; b) adding calendar year as covariate (adjusting for time trends); and c) excluding

hospitals contributing <10 years data. (Supplementary Table 1). Second, the outcome differences

across pre-Impella® era vs. Impella® era remained significant after a) excluding ECMO

patients; b) excluding hospitals with <10 years of data and; c) excluding hospitals with <10 years

of data and excluding ECMO patients. We observed similar variation in outcomes in each of

these sensitivity analyses as the primary analysis (Supplementary Table 2). Third, the differences

between high-Impella® use vs. low-Impella® use hospitals were demonstrable even after

excluding hospitals contributing <10 years data (Supplementary Table 3). Fourth, the strength

and direction of association of Impella® use with clinical outcomes was essentially unchanged

significant even after a) excluding ECMO patients; b) excluding hospitals with <10 years of data;

15 10.1161/CIRCULATIONAHA.119.044007

and c) excluding hospitals with <10 years of data and excluding ECMO patients (Supplementary

Table 4). Lastly, In falsification endpoint analysis, we found no association of Impella® use with

a) community-acquired pneumonia and b) a combined endpoint of acute diarrhea, cellulitis, deep

vein thrombosis, intestinal obstruction or osteomyelitis (Supplementary Figure 6), indicating that

the adverse outcomes associated with Impella® use reported in the study, were unlikely to be

driven by unmeasured comorbid conditions or its use in sicker patients.

Discussion

Several important findings were observed in this large study of contemporary US practices of

Impella® use among 48,306 patients undergoing PCI with MCS from 432 hospitals over 13

years from 2004 to 2016. First, the use of Impella® steadily increased, especially in the recent

years, reaching 31.9% of cases of PCI with MCS in 2016. In contrast to the expectation that Downloaded from http://ahajournals.org by on November 20, 2019 Impella® was being used in the sicker patients, we observed a lower use of Impella® in critically

ill patients with cardiac arrest, mechanical ventilation or cardiogenic shock (Supplementary

Figure 4). Second, with increasing Impella® use, we observed a concurrent increase in the cost

of hospitalization among patients undergoing PCI with MCS after 2009, when Impella® devices

became available. This contrasts with a decreasing trend in PCI costs in the non MCS

population, suggesting that MCS devices may be a contributor to higher costs. Our findings of

increasing hospitalization costs over time in PCI patients with MCS is consistent with a prior

study from the Canadian health system perspective observing a higher cost associated with

Impella® use.26 Third, in this population of PCI patients requiring MCS, there was more than 5-

fold variation in the use of Impella® across hospitals for statistically comparable patients.

Fourth, when comparing differential time periods of pre-Impella® and Impella® eras, we

16 10.1161/CIRCULATIONAHA.119.044007

observed that the outcomes among PCI patients receiving MCS were not any better in the

Impella® era. In the Impella® era, rates of death, AKI, stroke and costs were higher as compared

with the pre-Impella® era. Fifth, when comparing hospitals with high- vs. low-use of Impella®,

we observed that the outcomes were not better in the high use hospitals. In the highest use

quartile of hospitals, we observed a higher rate of death, bleeding, AKI, stroke and cost, but a

shorter length of stay when compared with hospitals having a lower use of Impella® devices.

Lastly, comparative effectiveness of Impella® vs IABP demonstrated that Impella® use was

associated with higher mortality, bleeding, and stroke. These results underscore the need for

higher quality evidence to inform clinical guidelines for the use of hemodynamic support

possibly contributing to variation in adverse outcomes associated with Impella® use. Trials such

as DanGerShock (ClinicalTrials.gov Identifier: NCT01633502), randomizing shock patients to

Impella® vs. no Impella® may shed light on some of these issues. Downloaded from http://ahajournals.org by on November 20, 2019 There was an association of higher risk of bleeding with Impella® use vs. IABP use in

the hospital-level and patient-level analyses of our study. While bleeding complications have

been associated with larger bore access site previously27, the association of Impella® use with

AKI is not well understood. In higher Impella® use hospitals (vs. lower Impella® use hospitals),

and Impella® era vs pre-Impella® era analyses we observed a greater risk of AKI and in patient-

level comparative effectiveness analysis, we observed a trend towards greater AKI. These

findings are at odds with a prior observation from a single center of 230 patients which found a

lower risk of AKI28, but are in agreement with a meta-analysis27 which showed a higher risk of

AKI associated with Impella® use. The PROTECT II randomized trial showed no change in

creatinine clearance between Impella® and IABP patients 24 hours after PCI in comparison with

baseline (4.65 vs 4.661, p=0.988), despite the higher volume of contrast media received by

17 10.1161/CIRCULATIONAHA.119.044007

Impella® patients.2 In reality, AKI is a multifactorial adverse event, dependent on many factors

including the comorbidities, presence of cardiogenic shock, contrast volume use and indication

for the PCI procedure. It is possible that these differences in findings are due to differences in the

risk profile of patients across studies.

In this study we noted not only a wide variation in the use of Impella® across hospitals,

but also a wide variation in the outcomes when Impella® was used. Particularly noteworthy is

the >2.5-fold variation in bleeding events implying that operator- and hospital- practices

currently lack standardization and may be deficient in adherence to best practices for preventing

bleeding complications associated with large bore sheaths. Certainly, the high-Impella® use

hospitals appeared to have a reduction in the higher risk of bleeding from 33% (Quartile 1) to

17% (quartile 4) (Table 4), confirming the well-recognized ‘volume-outcome’ relationship in

prior studies or the ‘learning curve’ seen in in the PROTECT II trial29. In contrast to bleeding, Downloaded from http://ahajournals.org by on November 20, 2019 the variation in incremental costs associated with Impella® across hospitals was smaller (ICC

17.8%) likely because of the uniformly high cost of the device. Whether mitigating bleeding

complications, associated with increased costs and worse clinical outcomes, will result in

superior outcomes amongst this sick population remains to be seen.

The occurrence of stroke associated with Impella® use was higher in our study than

PROTECT II trial2. Consistent with our study, a European study showed a high risk of stroke

with Impella®.30 Early studies are emerging that suggest a biologic plausibility with a higher rate

of stroke with greater duration of Impella® support31 or lower levels of anticoagulation with

anti-Xa levels <0.1 u/ml32. These data suggest that in real world practice where trial conditions

cannot be met, lower levels of anticoagulation or longer duration of Impella® use may be

associated with higher stroke risk. Further supporting this premise is the fact that in PROTECT

18 10.1161/CIRCULATIONAHA.119.044007

II, IABP patients had longer duration of support as compared to Impella® patients.2 However,

further studies are needed to better understand this association.

Our findings are consistent with prior studies. A study from the National Inpatient

Sample also found a substantial increase in the use of PVADs in recent years with a higher risk

of mortality, and higher associated cost33, indicating consistency across different populations.

Another study found that contrary to the belief that Impella® was being used in sicker patients,

Impella® was being used in a lower risk patients (more likely to be elective patients, less likely

to have shock and less likely to have STEMI than IABP patients)34, a finding also seen in our

study.

Limitations

The results of our study should be interpreted within the context of the following potential

limitations. First, despite adjustment with propensity scores and hierarchical models to account Downloaded from http://ahajournals.org by on November 20, 2019 for clustering of patients by hospitals, this is an observational study and cannot prove causation

and the comparative effectiveness results cannot rule out unmeasured confounding nor selection

bias. The association of Impella® use with a higher rate of adverse events or higher costs should

not be assumed to be causally linked with each other as these may be due to unmeasured

confounding amongst patients selected for PCI with Impella®. Nevertheless, these observations

are important as they describe the contemporary practice of MCS use and the costs and outcomes

trends in the United States and warrant further examination in prospective studies. Furthermore,

numerous sensitivity analyses and falsification endpoint analyses demonstrated the robustness of

these results. We found a higher risk of adverse clinical outcomes and costs at higher Impella®

use hospitals (vs. lower Impella® use hospitals) and Impella® era (vs. pre-Impella® era), a

comparison that is less likely to be influenced by confounding by indication. Second, Premier is

19 10.1161/CIRCULATIONAHA.119.044007

an administrative database and the outcomes of death, bleeding, AKI and stroke are derived from

administrative codes with potential for misclassification. Nonetheless they were derived from

discharge codes and were absent in ‘present on arrival’ codes. Third, we did not have

information on the angiographic details and were therefore unable to adjust for anatomic

complexity or other clinical factors. Replicating this work in clinical registries with granular

angiographic data, such as the National Cardiovascular Data Registry could help validate these

observations. Fourth, since the definition of cardiogenic shock is not based on accurate

hemodynamic data, we chose to use a population where a decision to use MCS support had

already been made based on clinical circumstances; this may have resulted in the inclusion of

some patients with other forms of shock in our analysis and precluded our ability to compare the

outcomes of patients with shock who did not receive MCS. Nonetheless, MCS device use

represents the real-world clinicians’ choice of Impella® use amongst less selected patients Downloaded from http://ahajournals.org by on November 20, 2019 undergoing PCI with MCS than in randomized clinical trials. It is also important to note that by

including only those patients whose day of PCI matched the day of MCS device use, we

excluded patients whose shock preceded or developed after PCI. Fifth, our analyses did not

account for the type of Impella® device used such as Impella® 2.5®, Impella CP® or Impella

5.0® which may provide different degree of hemodynamic support. Sixth, the significant

variation in outcomes observed amongst the subset of Impella® patients could result from not

only physician technique or hospital practices but also the selection of patients. Nonetheless,

Impella® was used more common in lower risk patients and this variation persisted despite

adjusting for propensity score and clustering across hospitals and therefore this variation is

important to report. Seventh, costs are from the hospital perspective and short-term costs limited

to the index hospitalization. It is possible that longer-term costs from a societal perspective may

20 10.1161/CIRCULATIONAHA.119.044007

be lower with Impella®. Finally, the clinical reasoning behind selection of Impella® use cannot

be ascertained from the data and could have resulted in known or unknown residual confounding

in the regression models, despite propensity score adjustment and accounting for clustering by

hospitals.

Conclusions

In conclusion, Impella® is increasingly being utilized instead of IABP to support PCI in the

United States, but the associated clinical outcomes did not show any substantial improvement,

while costs of hospitalization rose. Moreover, there exists a wide variation not only in the use of

Impella® across hospitals but also in its associated outcomes across hospitals. Although

unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the level of

hospitals or at the level of patients, Impella® use was associated with higher rates of adverse

events and increased costs. These data underscore the need for defining the appropriate use of Downloaded from http://ahajournals.org by on November 20, 2019 MCS in patients undergoing PCI with appropriately powered prospective randomized controlled

trials.

Disclosures

Dr. Amit P. Amin – has received a comparative effectiveness research KM1 career development

award from the Clinical and Translational Science Award (CTSA) program of the National

Center for Advancing Translational Sciences of the National Institutes of Health, Grant Numbers

UL1TR000448, KL2TR000450, TL1TR000449 and the National Cancer Institute of the National

Institutes of Health, Grant Number 1KM1CA156708-01; an AHRQ R18 grant award (Grant

Number R18HS0224181-01A1), has received an unrestricted grant from MedAxiom Synergistic

Healthcare Solutions Austin, TX and is a consultant to Terumo and GE Healthcare. Dr. John A.

21 10.1161/CIRCULATIONAHA.119.044007

Spertus discloses an equity interest in Health Outcomes Sciences and serves on the

Cardiovascular Scientific Advisory Board of United Healthcare and the board of Blue Cross

Blue Shield of Kansas City. Dr. Hemant Kulkarni provides research consultancy to MedAxiom –

Synergistic Healthcare Solutions Austin, TX. Dr. Masoudi has a contract with the American

College of Cardiology for his role as Chief Science Officer of the NCDR. Dr. Curtis reports

salary support under contracts with CMS and ACC, and equity in Medtronic. Dr. Sunil V. Rao

reports no disclosures. The other authors have nothing to disclose.

Sources of Funding

None.

Role of any Sponsor Downloaded from http://ahajournals.org by on November 20, 2019 No sponsor participated in the design and conduct of the study, collection, analysis, or

interpretation of the data, nor in the preparation, review, nor approval of the manuscript.

Data Access and Responsibility: Mr. House and Dr. Kulkarni had full access to the data in the

study and take responsibility for the integrity of the data and the accuracy of the data analysis.

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Table 1. Characteristics of the study participants.

Characteristic Impella® (n=4,782) IABP Total (n=48,306) (n=43,524) N % N % N % Hospital characteristics Total number of beds at hospital 000-099 115 2.4 423 0.97 538 1.11 100-199 255 5.33 2,499 5.74 2,754 5.70 200-299 637 13.32 6,032 13.86 6,669 13.81 300-399 744 15.56 10,247 23.54 10,991 22.75 400-499 645 13.49 7,265 16.69 7,910 16.37 500+ 2,386 49.9 17,058 39.19 19,444 40.25 Teaching Hospital 2,617 54.73 21,486 49.37 24,103 49.90 Hospital - Urban/Rural Rural 252 5.27 3,256 7.48 3,508 7.26 Urban 4,530 94.73 40,268 92.52 44,798 92.74 Patient demographics Age* 67.85 12.14 64.62 12.63 64.95 12.62 Females 1,317 27.54 13,621 31.3 14,938 30.92 Marital Status Married 2,103 43.98 21,796 50.08 23,899 49.47 Single 1,710 35.76 15,174 34.86 16,884 34.95

Downloaded from http://ahajournals.org by on November 20, 2019 Other 969 20.26 6,554 15.06 7,523 15.57 Patient Race Black 390 8.16 2,910 6.69 3,300 6.83 Hispanic 28 0.59 1,123 2.58 1,151 2.38 Other 1,129 23.61 8,748 20.1 9,877 20.45 Unknown 48 1 163 0.37 211 0.44 White 3,187 66.65 30,580 70.26 33,767 69.90 Insurance Payor Medicare 3,059 63.96 21,864 50.23 24,923 51.59 Medicaid 382 7.99 3,282 7.54 3,664 7.58 Managed Care / Commercial 985 20.6 13,487 30.99 14,472 29.96 Self-Pay 171 3.58 2,825 6.49 2,996 6.20 Other 185 3.87 2,066 4.75 2,251 4.66 Prior history Diabetes 2,564 53.62 16,659 38.28 19,223 39.79 Dyslipidemia 3,582 74.91 27,424 63.01 31,006 64.19 Hypertension 3,996 83.56 30,618 70.35 34,614 71.66 Smoking 2,267 47.41 19,339 44.43 21,606 44.73 Congestive heart failure 3,416 71.43 20,855 47.92 24,271 50.24 Atrial fibrillation 1,251 26.16 10,103 23.21 11,354 23.50 Chronic renal failure 1,673 34.99 7,860 18.06 9,533 19.73 COPD 1,266 26.47 8,793 20.2 10,059 20.82 Alcohol abuse 116 2.43 898 2.06 1,014 2.10 Drug abuse 55 1.15 362 0.83 417 0.86

26 10.1161/CIRCULATIONAHA.119.044007

Medications given during index hospitalization GPIIbIIa inhibitors 1,170 24.47 24,754 56.87 25,924 53.67 Bivalirudin 1,654 34.59 12,297 28.25 13,951 28.88 Intravenous heparin 1,063 22.23 11,858 27.24 12,921 26.75 Prasugrel 739 15.45 4,310 9.9 5,049 10.45 Ticagrelor 1,158 24.22 3,682 8.46 4,840 10.02 Novel oral anticoagulants 148 3.09 401 0.92 549 1.14 Warfarin 394 8.24 5,462 12.55 5,856 12.12 PCI and lesion characteristics Multi-vessel disease 2,554 53.41 10,044 23.08 12,598 26.08 Transradial access 529 11.06 3,358 7.72 3,887 8.05 Bifurcation lesion 382 7.99 1,230 2.83 1,612 3.34 Bare metal stents used 764 15.98 14,577 33.49 15,341 31.76 Chronic total occlusion 1,056 22.08 6,277 14.42 7,333 15.18 LASER atherectomy 666 13.93 1,498 3.44 2,164 4.48 Rotational/orbital atherectomy 340 7.11 585 1.34 925 1.91 Mechanical ventilation 1,407 29.42 16,813 38.63 18,220 37.72 Cardiac arrest 701 14.66 8,105 18.62 8,806 18.23 Cardiogenic shock 1,792 37.47 22,558 51.83 24,350 50.41 STEMI 1,267 26.5 28,509 65.5 29,776 61.64 NSTEMI/UA 2,114 44.21 10,246 23.54 12,360 25.59 Indication other than ACS 1,401 29.3 4,769 10.96 6,170 12.77 Downloaded from http://ahajournals.org by on November 20, 2019 *, numbers indicate means and SD, respectively. COPD, chronic obstructive pulmonary disease; GPIIbIIIa, glycoprotein IIbIIIa; STEMI, ST segment elevation myocardial infarction; NSTEMI, non-ST segment elevation myocardial infarction; UA, unstable angina; ACS, acute coronary syndrome.

27 10.1161/CIRCULATIONAHA.119.044007

Table 2. Hospital-level variation in the study outcomes in patients who received Impella® device*.

Outcome Variation across all hospitals (n = 4,782) Dichotomous outcomes (MOR) Death 1.71 (1.53 – 1.97) Bleeding 2.62 (2.24 – 3.17) AKI 1.53 (1.41 – 1.69) Stroke 1.47 (1.27 – 1.86) Continuous outcomes (ICC, %) Total LOS 5.18 (3.40 – 7.80) ICU LOS 6.98 (4.67 – 10.31) Total cost 17.80 (13.93 – 22.46) *Please note the sample size for this analysis is n=4,782. All results are from mixed effects models that used hospitals as random effects. Variation in dichotomous outcomes is quantified as median odds ratio (MOR) while that in continuous variables is shown as intraclass correlation coefficient (ICC). Parentheses contain 95% credible interval (for MOR) or confidence interval (for ICC). AKI, acute kidney injury; LOS, length of stay; ICU, intensive care unit. Downloaded from http://ahajournals.org by on November 20, 2019

28 10.1161/CIRCULATIONAHA.119.044007

Table 3. Comparison of the pre-Impella® and Impella® era for study outcomes*.

Pre-Impella® vs. Impella® era study outcomes across all hospitals (n = 48,306) Dichotomous outcomes Outcome OR (95% CI), p Death 1.17 (1.10 – 1.24), <0.001 Bleeding 0.99 (0.94 – 1.05), 0.843 AKI 1.91 (1.81 – 2.01), <0.001 Stroke 3.34 (2.94 – 3.79), <0.001 Continuous outcomes Outcome β coefficient (95% CI) Total LOS 0.04 (-0.08 – 0.16), 0.524 ICU LOS -0.04 (-0.12 – 0.04), 0.319 Total cost 1,774.94 (1,687.99 – 1,861.89), <0.001 *Results are from mixed effects, hierarchical models which adjusted for the propensity scores and with hospitals as random effects. Odds ratios (OR) higher than unity indicate increased risk during the Impella® era as compared to the pre-Impella® era. Similarly, positive β coefficients indicate higher values, while negative β coefficients indicate lower values associated with the Impella® era as compared to the pre-Impella® era. AKI, acute kidney injury; LOS, length of stay; ICU, intensive care unit.

Downloaded from http://ahajournals.org by on November 20, 2019

29 10.1161/CIRCULATIONAHA.119.044007

Table 4. Comparison of the higher- vs. lower-Impella® use hospitals for study outcomes*.

1st Quartile Hospitals 2nd Quartile Hospitals 3rd Quartile Hospitals 4th Quartile Hospitals (0% Impella® use) (>0% to ≤3.33% Impella® use) (>3.33% to ≤14.72% Impella® use) (>14.72% Impella® use) Dichotomous Outcomes Death - 0.71 (0.43 – 1.18), 0.1863 1.11 (0.95 – 1.30), 0.1825 1.48 (1.32 – 1.67), <0.0001 Bleeding - 1.33 (0.87 – 2.02), 0.1897 1.10 (0.95 – 1.29), 0.1897 1.17 (1.03 – 1.33), 0.015 AKI - 0.64 (0.42 – 0.96), 0.0313 1.00 (0.88 – 1.15), 0.9551 1.29 (1.17 – 1.43), <0.0001 Stroke - 1.31 (0.68 – 2.53), 0.4218 1.42 (1.15 – 1.76), 0.0012 1.26 (1.06 – 1.50), 0.0094 Continuous Outcomes Total LOS (days) - -0.99 (-1.95 – -0.02), 0.0449 -0.79 (-1.10 – -0.48), <0.0001 -0.75 (-1.00 – -0.49), <0.0001 ICU LOS (days) - -1.09 (-1.78 – -0.40), 0.0019 -0.73 (-0.95 – -0.51), <0.0001 -0.51 (-0.70 – -0.33), <0.0001 Total cost ($) - $11,002 ($6,987 – $15,018), <0.0001 $12,039 ($10,770 – $13,307), <0.0001 $12,071 ($11,067 – $13,075), <0.0001 *Results are from mixed effects, hierarchical models which adjusted for the propensity scores and accounting for clustering with hospitals as random effects. All results are shown as odds ratio or the beta coefficient estimate (95% confidence interval), p-value. Odds ratios (OR) higher than unity indicate increased risk associated at higher- Impella® use hospitals as compared to the lower-Impella® use hospitals. Similarly, positive β coefficients indicate higher values, while negative β coefficients indicate lower values associated at higher-Impella® use hospitals as compared to the lower-Impella® use hospitals. AKI, acute kidney injury; LOS, length of stay; ICU, intensive care unit. Downloaded from http://ahajournals.org by on November 20, 2019

30 10.1161/CIRCULATIONAHA.119.044007

Figure Legends

Figure 1. Trends in the use of Impella® amongst PCI patients requiring MCS. X-axis

depicts the calendar year. The black bars represent proportion of Impella® use amongst PCI

patients requiring MCS. Grey box represents the pre-Impella® era in which the Impella®

devices had not become available. MCS, hemodynamic support.

Figure 2. Variation in the use of Impella® across hospitals amongst PCI patients requiring

MCS. X-axis represents hospitals arranged in the order of increasing use of Impella®. Inset

shows the estimated median odds ratio (MOR, diamonds) and the 95% credible interval (Crl,

error bars). The MOR and its 95% Crl is obtained from a hierarchical, mixed effects logistic

regression model with hospital as a random effect. MCS, mechanical circulatory support. Downloaded from http://ahajournals.org by on November 20, 2019

Figure 3. Association of Impella® versus IABP use with clinical outcomes. The X-axis

represents the odds ratio scale, the dotted vertical line indicates the line of unity, and for each

outcome, the black diamonds represent the odds ratio estimate, while the horizontal bars indicate

the 95% confidence intervals. The OR and its 95% CI for each outcome is obtained from a

hierarchical, mixed effects logistic regression model with hospital as a random effect. AKI, acute

kidney injury; OR, odds ratio; CI, confidence interval; PCI, percutaneous coronary intervention

31 Downloaded from http://ahajournals.org by on November 20, 2019 20, November on by http://ahajournals.org from Downloaded

Proportion receiving Impella (%) 10 15 20 25 30 35 0 5 2004 200520062007200820092010201120122013201420152016 Pre-Impella Era Pre-Impella Calendar Year Impella Era Impella 100

80 14

8 60 6

4 Median Odds Ratio (MOR) 2 5.77 7.11 5.12 6.05 6.95 5.00 5.00 5.79 5.10 40 0 Overall 2009 2010 2011 2012 2013 2014 2015 2016 Calendar Year

20 Impella use (%) among patients requiring HDS Impella requiring use (%) among patients

1 108 216 324 432 Hospital Downloaded from http://ahajournals.org by on November 20, 2019 Outcome OR (95% CI) p Death 1.24 (1.13 - 1.36) <0.0001

Bleeding 1.10 (1.00 - 1.21) 0.0445

AKI 1.08 (1.00 - 1.17) 0.0521

Stroke 1.34 (1.18 - 1.53) <0.0001

0.5 1 1.5 2 Odds Ra�o Beneﬁt Harm Downloaded from http://ahajournals.org by on November 20, 2019 Temporary Percutaneous Circulatory Support Impella

Question: How should the Coverage Guidance on Temporary Percutaneous Circulatory Support with Impella be modified?

Question source: HERC, HERC staff

Issue: The Prioritized List Guideline Note may need to be modified to align with the HERC-approved Coverage guidance recommendations.

See decision point document on outstanding decisions. Based on HERC request, this document was created to summarize EbGS decisions, HERC decisions, the evidence, and contextual factors for the different populations affected and the decisions to be made.

Coverage of Impella for STEMI (or STE-ACS) was added in at the HERC meeting based on stakeholder testimony, but the guideline now requires heart team consultation and cardiothoracic surgery consultation which are not clinically appropriate.

Current Prioritized List Status Line: 69 Condition: ACUTE AND SUBACUTE ISCHEMIC HEART DISEASE, MYOCARDIAL INFARCTION (See Guideline Notes 49,64,111,195) Treatment: MEDICAL AND SURGICAL TREATMENT ICD-10: I20.0,I21.01-I21.A9,I22.0-I22.9,I23.1-I23.5,I23.7-I23.8,I24.0-I24.9,I25.110,I25.700,I25.710,I25.720, I25.730,I25.750,I25.760,I25.790,I51.81,R57.0,T81.11XA-T81.11XD,Z45.010-Z45.09 CPT: 33202,33206-33210,33212-33229,33233-33238,33310,33315,33361-33430,33465,33475,33477,33500, 33508-33545,33572,33681,33922,33946-33974,33984-33993,35001,35182,35189,35226,35256,35286, 35572,35600,92920-92944,92960-92998,93279-93284,93286-93289,93292-93296,93355,93724,93745, 93792-93798,96156-96159,96164-96171,97802-97804,98966-98972,99051,99060,99070,99078,99091, 99184,99201-99239,99281-99285,99291-99404,99408-99449,99451-99453,99457,99458,99468-99472, 99475-99480,99487-99491,99495-99498,99605-99607 HCPCS: C1721,C1722,C1777,C1779,C1785,C1786,C1895,C1896,C1898,C1899,C2619-C2621,C9600-C9608, G0068,G0071,G0157-G0161,G0248-G0250,G0396,G0397,G0406-G0408,G0422,G0423,G0425-G0427, G0463-G0467,G0490,G0508-G0511,G2010-G2012,G2058-G2065,K0606-K0609,S0340-S0342,S2205- S2209

GUIDELINE NOTE 195, TEMPORARY PERCUTANEOUS MECHANICAL CIRCULATORY SUPPORT WITH IMPELLA DEVICES Line 69 Temporary percutaneous mechanical circulatory support with Impella devices is included on Line 69 only in the two following circumstances: 1. During percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) when all of the following conditions are met: • ACS without cardiogenic shock (STEMI, NSTEMI or unstable angina) • A heart team discussion determines the patient needs revascularization with coronary artery bypass graft (CABG) or PCI • A cardiothoracic surgeon is consulted and agrees the patient is inoperable (i.e., are not willing to perform CABG but agree revascularization is indicated) • Patient has complex left main or last remaining conduit disease

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Temporary Percutaneous Circulatory Support Impella

• Ejection fraction (EF) < 30% or at high risk for hemodynamic collapse during intervention

2. In patients with cardiogenic shock who may be candidates for Left Ventricular Assist Device (LVAD) (destination therapy) or transplant (bridge to transplant), AND an advanced heart failure and transplant cardiologist agrees that Impella should be used as a bridge to decision for LVAD or transplant. Appropriate effort should be made to consult with a heart failure and transplant cardiologist, but coverage is recommended in circumstances where consultation cannot reasonably be obtained without endangering the patient’s life and the treating physician believes the patient meets the criteria above.

Temporary percutaneous mechanical circulatory support with Impella devices is not included on this or any other line for elective high-risk PCI for patients with stable coronary artery disease.

Recommendations (to be modified based on HERC deliberations): 1) Modify the current Prioritized List Guideline Note as follows:

Blue reflects fixes • If STEMI/STE-ACS is going to be covered

Italics reflects a decision point • Language about other factors creating high risk of intraprocedural hemodynamic collapse • Cardiothoracic surgeon consultation: 1 or 2

Temporary percutaneous mechanical circulatory support with Impella devices is included on Line 69 only in the two three following circumstances: 1. During percutaneous coronary intervention (PCI) in patients with ST Elevation acute coronary syndrome (STE-ACS) without cardiogenic shock when Impella support is necessary due to ejection fraction (EF) <30% or other factors which create a high risk of intraprocedural hemodynamic collapse. 2. During PCI in patients with non- ST Elevation ACS without cardiogenic shock when all of the following applyconditions are met: • ACS without cardiogenic shock (STEMI, NSTEMI or unstable angina) • A heart team discussion determines the patient needs revascularization with coronary artery bypass graft (CABG) or PCI

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• A cardiothoracic surgeon is consulted and agrees the patient is inoperable (i.e., is are not willing to perform CABG but agree revascularization is indicated) • Patient has complex left main or last remaining conduit disease • Ejection fraction (EF) < 30% or at high risk for intraprocedural hemodynamic collapse

3. In patients with cardiogenic shock who may be candidates for left ventricular assist device (LVAD) (destination therapy) or transplant (bridge to transplant) AND an advanced heart failure and transplant cardiologist agrees that Impella should be used as a bridge to decision for LVAD or transplant. Appropriate effort should be made to consult with an advanced heart failure and transplant cardiologist, but coverage is recommended in circumstances where consultation cannot reasonably be obtained without endangering the patient’s life and the treating physician believes the patient meets the criteria above.

Temporary percutaneous mechanical circulatory support with Impella devices is not included on this or any other line for elective high-risk PCI for patients with stable coronary artery disease.

Temporary Percutaenous Circulatory Support Impella Transseptal, Issue #1530 Page 3