Materials Pages 56-120

Health Evidence Review Commission

January 21, 2021 1:30 PM - 3:30 PM

Online Meeting

Join online meeting here +1 971-277-2343,,517191744# Section 1.0 Call to Order AGENDA HEALTH EVIDENCE REVIEW COMMISSION Online Meeting January 21, 2021 1:30-3:30 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 (11/12/2020) Kevin Olson X 3 1:40 PM Director’s report Jason Gingerich Ariel Smits 4 1:45 PM Value-based Benefits Subcommittee report X

Review Scope Statements • Deep brain neurostimulators for refractory Ariel Smits/CeBP 5 2:15 PM epilepsy Staff X • High-frequency chest wall oscillation devices Next steps 6 3:25 PM • Schedule next meeting – 3/11/2021, virtual Kevin Olson meeting 7 3:30 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 Virtual meeting November 12, 2020

Members Present: Kevin Olson, MD, Chair; Holly Jo Hodges, MD, MBA, Vice-Chair; Leda Garside, RN, MBA; Gary Allen, DMD; Devan Kansagara, MD; Lynnea Lindsey, PhD; Leslie Sutton (arrived at 1:50 pm); Adriane Irwin, PharmD; Kathryn Schabel, MD; Max Kaiser, DO; Mike Collins; Deborah Espesete, LAc, MAcOM, MPH, DiplOM.

Members Absent: Michael Adler, MD.

Staff present: Ariel Smits, MD, MPH; Jason Gingerich; Liz Walker, PhD, MPH; Daphne Peck.

Also Attending: Dawn Mautner, MD, MS & Dianne Quiring (Oregon Health Authority); Koa Kai; Renee Doan; Amara M, Ashely Svenson; Devki Nagar; Hannah Baer; Jeanne McLaws; Katy McDowell; Kellie Skenandore; Lisa Sumerlin; Rika (no last name); Wendy Sinclair; Karen Heller; Rodica; Steven Hix; Charice & Q; Mareinna (Shawn) Kangiser.

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 10/1/2020 meeting as presented. CARRIES 11-0. (Absent: Sutton)

Director’s Report

COVID-19 updates Jason Gingerich reported that COVID-19 coding and telehealth related changes are ongoing.

Coverage Guidance updates Gingerich said the December Evidence-based Guidelines Subcommittee (EbGS) meeting was cancelled. Staff are soliciting topics. One potential new topic, Expanded Carrier Screening, was identified today at the Value-based Benefits Subcommittee (VbBS) meeting.

Membership updates Gingerich said, with Leda Garside’s departure, there is a potential replacement for the public health nurse role on the Commission. A new person will hopefully be appointed soon. He thanked Garside for

HERC Minutes 11/12/2020 1

all her work on the Commission for the past eight years. She expressed gratitude for the experience. Garside will remain on EbGS for the time being.

Value-based Benefits Subcommittee (VbBS) Report on Prioritized List Changes Meeting materials pages 56-120

Ariel Smits reported the VbBS met earlier in the day, 11/12/2020. She summarized the subcommittee’s recommendations.

She asked Commissioners to contact her with any 2022 biennial review topics they may have. Biennial review topics generally involve either moving a line up or down the List or might impact costs. The two topics she has identified currently are 1) expansion of coverage for inguinal hernias and 2) creating a separate line for uterine polyps.

Smits also reviewed the items that were reviewed by Leadership or advisory panels but not recommended for change: • No change to Cologuard noncoverage • No change to sphenopalatine ganglion blocks for treatment of migraine • No recommendation for cone beam CT coverage expansion • No change to current coverage/guideline regarding whole exome sequencing • No change recommended to the lack of coverage for ICD10 F43.9 (Reaction to severe stress, unspecified) as many more specific diagnoses exist • No change recommended for including HCPCS H0031 on the Diagnostic Procedures file

There was no discussion.

Smits said between the VbBS and HERC meetings today, new COVID-19 codes were discovered.

Recommendation to add the following codes to line 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS: • 91300 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use • 91301 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use • 0001A Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted; first dose • 0002A Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted; second dose • 0011A Immunization administration by intramuscular injection of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage; first dose

HERC Minutes 11/12/2020 2

• 0012A Immunization administration by intramuscular injection of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage; second dose

RECOMMENDED CODE MOVEMENT (changes to the 1/1/2021 Prioritized List unless otherwise noted) • Add new COVID testing codes to the Diagnostic Procedure File • Place the 2021 CDT codes on various lines and files • Finalize the placement of the 2021 CPT codes • Add an unspecified developmental code to three covered lines to allow therapy for young children at risk of developmental delays • Make several straightforward coding changes

RECOMMENDED GUIDELINE CHANGES (changes to the 1/1/2021 Prioritized List unless otherwise noted) • Add a new guideline regarding nerve allografts to a funded line • Update the COVID testing guideline to allow antibody testing for patients undergoing evaluation for multi-system inflammatory syndrome in adults (MIS-A) • Add a new guideline regarding dental implant removal • Delete the guideline regarding dental amalgam use • Edit the prenatal genetic testing guideline to allow non-invasive prenatal screening (NIPS) testing for all pregnancies and correct CPT code errors • Edit the hereditary cancer genetic testing guideline to update the NCCN guideline references • Make minor changes to the neuropsychological testing guideline and the cognitive testing guideline • Revise the guideline for repetitive transcranial magnetic stimulation • Add a new guideline regarding coding related to developmental delays, including children at risk of developmental delays • Substantially edit the guideline for opioids for conditions of the back and spine

Expanded Carrier Screening is being considered as a possible coverage guidance topic through the EbGS. Olson asked the Commission if anyone had thoughts about the plan to explore this topic as a coverage guidance. There was no discussion.

Smits said there were changes to Guideline Note 60 from the meeting materials, in particular language changed from “must” to “should” to account for patients who are unable to take part in the types of therapies described.

Public testimony Devki Nagar testified about Expanded Carrier Screening (ECS). Ms. Nagar is a Myriad Genetic’s genetic counselor and was otherwise silent on conflicts of interest. She applauded the Commission for continuing to review this topic. She feels that ECS provides equity across ethnicities. Ms. Nagar said there are a wide range of panels, including panels with 15 genes or more. Some labs are publishing data stating that their tests align with American College of Obstetricians and Gynecologists (ACOG) recommendations. ACOG supports this approach so that patients have a choice which would align with their values and preferences. Based on the information, patients are making appropriate changes for their current or future pregnancies.

HERC Minutes 11/12/2020 3

Guideline Note 60 Koa Kai from the Chronic Disease Coalition stated no conflicts of interest. Ms. Kai lauded the changes to Guideline Note 60 (GN 60). She said it is imperative to provide options for pain relief and patient safeguards from harm. She said one of the misperceptions HERC seems to have is that GN 60 is merely a guideline but in the past, this policy has been aggressively implemented without regard to patient safety. It is imperative to recognize the patient harms caused by the unintended consequences from the history of GN 60 and to recognize the organization’s responsibility to remedy the resulting harms from forced tapers and denials of pain medication. It is also important to recognize the damage this policy has done to the doctor-patient relationship. She urged HERC to make small changes and evaluate the outcomes and adjusting policies based on those assessments in a timely manner. There are other issues from the creation of GN 60 which must be acknowledged including one multi-committee member’s excessive participation in the policy’s conception authorship, voting, promotion and subsequent review participation. The additional destruction of the taskforces public records and the various taskforce member’s undisclosed conflicts of interest has allowed for a lack of public transparency and consideration of public input in the creation of public health policy.

Wendy Sinclair, founder of the Oregon Pain Action Group, declared no conflicts of interest. Ms. Sinclair said she appreciated the proposed changes to Guideline Note 60. She has been involved with this issue for some time. She said people have reached out to her to share that they have been taken off their medication and are contemplating suicide as they try to cope with pain as they are unable to manage. Guideline Note 60 has caused a lot of harm to people. She said she was able to read letters given to doctors stating that opioids are not safe or effective for back pain, so you need to taper your patient. This has caused entire clinics to eliminate opioids for back pain for all Medicaid patients, sending patients into turmoil. She said she appreciates the language has changed but she is concerned that this new language will not get the same level of promotion as the taper- language notice did. She would like to see providers notified of these changes.

Steven Hix testified; he declared no conflicts of interest. Mr. Hix said he is a pain patient and an advocate for pain patients. He thanked the Commission for hearing the concerns brought forward about GN 60. He asked if he would now get his medication paid for a whole month rather than seven days. He said he agreed with the first two speakers about the damage that has been done with the implementation of the original GN 60 and there is a lot of repair work that needs to be done.

Smits said there is nothing in the proposed revised guideline note that precludes writing a longer prescription for opioid medication. However, the Commission is not involved in the mechanics of how the CCOs administer medication plans. There may be prior authorization criteria in place that would limit prescriptions to 7 days. Mr. Hicks was advised to contact the OHA Ombuds office or his CCO care coordinator for assistance, as the Commission is not equipped to address individual cases.

Amara M, a mother, advocate for human rights and co-founder of the Oregon Pain Action Group testified. Ms. M. declared no conflicts of interest. She commended HERC for making significant positive changes to GN 60. She said she hopes the gravity of the effect the policy has had on patients is looked into further. She said she was a patient at a clinic when GN 60 was first enforced. All Medicaid patients with back conditions, regardless of severity, were handed a letter to inform them

HERC Minutes 11/12/2020 4

that patients would be force-tapered off their opioid medication in six weeks. Amara said her regular doctor at the clinic decided to retire rather than be instructed to go against her Hippocratic Oath. She said she had many meetings with the new clinic director and that led her to the underlying guideline note that caused the forced tapers. She then started attending meetings. She said she would like to see promotion and clarity of the new language given to the CCOs. EOCCO has force-taper language live on their website right now. She said an analysis of the Health Authority’s ombuds program said that the volume and acuity of client calls from pain conditions significantly increased in the last two years, more than doubled. The number one concern is continuity of care for pain management.

MOTION: To accept the VbBS recommendations on Prioritized List changes as stated. See the VbBS minutes of 11-12-2020 for a full description. Carries: 12-0.

MOTION: To accept the new COVID-19 vaccine codes recommendations as stated. Carries: 12-0.

Public Comment

Mareinna (Shawn) Kangiser offered comments about facial feminization surgery (FFS). Ms. Kangiser said she wanted to talk about changing facial feminization surgery from a cosmetic procedure to a medical necessity. Ms. Kangiser said that gender reassignment surgery (GRS) changes a person’s relationship to their body and affects interactions with one’s partner but argued that one’s face is how a person is identified in society. She said that make up is cosmetic, meant to improve one’s appearance, but FFS is meant to feminize one’s appearance, not to make one more attractive. Part of the diagnostic criteria for gender dysphoria is the desire to live and be accepted as a member of the gender they identify as; the inability to achieve this can cause significant distress. That distress is why it's being treated, because of this need to be accepted as one's true gender. Part of treating gender dysphoria means helping one be accepted as their true gender. FFS is protective against violence and discrimination. Violence is often the result of being “visibly gender non-conforming,” which has been found to elicit anti-transgender bias. She said when a trans woman has an appearance that conforms to the typical conceptions of gender, it serves as protection from violence and discrimination, and by extension reduces their risk of depression and suicide. The high rates of suicide in transgender people is largely due to their treatment by society. She said this treatment is even cost effective. California did an economic-impact analysis and found that removing transgender exclusions had an immaterial effect on premium costs, which were far exceeded by the benefits. Those benefits include improved health outcomes among transgender people such as reduced suicide risk, lower rates of substance use and increased adherence to HIV treatment. She said a recent study estimated that without the transition surgeries (a one-time cost) healthcare for a transgender person is, on average, $10,712 a year. Therefore, FFS is a cost-effective intervention, and it needs to be covered by insurance policies. She said the fact that GRS is covered and FFS is not shows that gender dysphoria and its implications are not being well understood by insurance companies. Until one is accepted in society as their true gender, something necessary to function in our current American society, gender dysphoria will persist, and procedures such as FFS will still be medically necessary as a potential treatment of gender dysphoria.

HERC Minutes 11/12/2020 5

Smits said HERC will look at this issue when the World Professional Association for Transgender Health (WPATH) releases its updated guidelines. Ms. Kangiser asked to be contacted when the issue is up for review. Gingerich said we can make that happen.

Ms. Kangiser said OHSU has a billing issue and she cannot be seen. She was advised to contact the OHA Ombuds office or her CCO care coordinator for assistance.

Adjournment

Meeting adjourned at 3:00 pm. Next meeting will be from 1:30-4:30 pm on Thursday, 1/21/2021 virtually.

HERC Minutes 11/12/2020 6

Value-based Benefits Subcommittee Recommendations Summary For Presentation to: Health Evidence Review Commission on November 12, 2020

For specific coding recommendations and guideline wording, please see the text of the 11/12/2020 VbBS minutes.

ITEMS CONSIDERED BUT NO RECOMMENDATIONS FOR CHANGES MADE • Home intraocular pressure monitoring was not added to the glaucoma line

Value-based Benefits Subcommittee Summary Recommendations, 11/12/2020

VALUE-BASED BENEFITS SUBCOMMITTEE Virtual Meeting November 12, 2020 9:00 AM – 1:00 PM

Members Present: Kevin Olson, MD, Chair; Holly Jo Hodges, MD, MBA, Vice-chair; Gary Allen, DMD; Kathryn Schabel, MD; Brian Duty, MD; Adriane Irwin, PharmD; Regina Dehen, ND, Lac.

Members Absent: Mike Collins.

Staff Present: Ariel Smits, MD, MPH; Jason Gingerich; Liz Walker, PhD, MPH; Daphne Peck.

Also Attending: Dawn Mautner MD MPH, Diane Quiring and Kellie Skenandore (OHA); Amara M; An Do; DeAnn (no last name); Devki Saraiya and Ashley Svenson (Myriad Genetics); Eric Owens; Karen Heller; Kim Martin; Koa Kai; Manu Chaudhry; Rashelle Kukuk; Robin (no last name); Stacey (no last name); Taryn Couture; Tracy Futch; Vanessa Nitibhon (Integrated Genetics); Hannah Proffitt-Allee; Jenn O’Neill; Rika (no last name); Anne Fuqua; Hannah Baer (Coalition for Access to Prenatal Screening); Nidhi Maheshwari; Dana Peterson; Robert Slotnick MD; Jeanne McLaws; Katy McDowell; Peggy Tighe; Tedra Stuart; Kareem Shafi; Wendy Sinclair; Mareinna/Shawn Kangiser.

 Roll Call/Minutes Approval/Staff Report

The meeting was called to order at 9:00 am and roll was called. A quorum of members was present at the meeting. Minutes from the 10/1/2020 VbBS meeting were reviewed and approved.

Smits noted the errata document; there was no discussion. She also reviewed the items not recommended for change in consultation with leadership or advisory panels. There was also no discussion on these items.

Smits then brought up the upcoming 2022 biennial review. The two topics to date that staff are working on are 1) expansion of coverage for inguinal hernias, and 2) creating a separate line for uterine polyps. She invited members to send staff suggestions for other topics.

Value-based Benefits Subcommittee Minutes, 11/12/2020 Page 2

 Topic: Straightforward/Consent Agenda

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

Recommended Actions: 1) Add 11981-11983 (Insertion/removal/removal with reinsertion, non-biodegradable drug delivery implant) to line 312 GENDER DYSPHORIA/TRANSEXUALISM 2) Add 26480 and 26483 (Transfer or transplant of tendon, carpometacarpal area or dorsum of hand; without/with free graft, each tendon) to line 356 RHEUMATOID ARTHRITIS, OSTEOARTHRITIS, OSTEOCHONDRITIS DISSECANS, AND ASEPTIC NECROSIS OF BONE 3) Add CPT 64912-64913 (Nerve repair; with nerve allograft) to line 536 PERIPHERAL NERVE DISORDERS 4) Modify GN173 INTERVENTIONS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS as shown in Appendix A 5) Add a new guideline regarding nerve allographs as shown in Appendix B

MOTION: To approve the recommendations stated in the consent agenda. CARRIES 7-0.

 Topic: COVID-19 Updates

Discussion: There was no discussion about the new COVID-19 CPT codes or the testing guideline modification.

Note: Additional new CPT codes were identified after the VbBS meeting and placements were approved at the afternoon HERC meeting.

Recommended Actions: 1) Modify Diagnostic Guideline D27 SARS-COV-2 (COVID-19) TESTING as shown in Appendix A 2) Advise HSD to place CPT 87636 (Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique), 87637 (Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) (Coronavirus disease [COVID-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique) and 87811 (Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])) to the DIAGNOSTIC PROCEDURES file

Note: In the afternoon, the Health Evidence Review Commission (HERC) added the following codes to line 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS: 1) 91300 (Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use) 2) 91301 (Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use)

Value-based Benefits Subcommittee Minutes, 11/12/2020 Page 3

3) 0001A (Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted; first dose) 4) 0002A (Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted; second dose) 5) 0011A (Immunization administration by intramuscular injection of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage; first dose) 6) 0012A (Immunization administration by intramuscular injection of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage; second dose)

MOTION: To recommend the code and guideline note changes as presented. CARRIES 7-0.

 Topic: Oral Health Advisory Panel Report

Discussion: A. 2021 CDT code placement: There was no discussion on code placement B. Straightforward CDT code changes: There was no discussion on this topic C. Dental implant removal guideline: Allen noted that this guideline will be helpful for the Dental Care Organizations (DCOs.) D. Mercury containing amalgam: There was no discussion on this topic

Recommended Actions: 1) 2021 CDT code placement as shown in Appendix D 2) GN139 FRENOTOMY FOR TONGUE TIE IN NEWBORNS was modified as shown in Appendix A 3) Add D0320 (Temporomandibular joint arthrogram, including injection) to line 643 TMJ DISORDERS a. Advise HSD to remove D0320 from the DIAGNOSTIC PROCEDURES file 4) Add D0321 (Other temporomandibular joint radiographic images, by report) to line 643 TMJ DISORDERS a. Advise HSD to remove D0321 from the DIAGNOSTIC PROCEDURES file 5) A new guideline regarding implant removal was adopted as shown in appendix B 6) GN123 DENTAL FILLINGS FOR POSTERIOR TEETH was deleted as shown in Appendix A

MOTION: To recommend the code and guideline note changes as presented. CARRIES 7-0.

 Topic: Genetic Advisory Panel Report

Discussion: A. Genetic 2021 CPT code placement: There was no discussion

B. Prenatal genetic testing guideline a. Update to aneuploidy testing CPT codes: There was no discussion.

Value-based Benefits Subcommittee Minutes, 11/12/2020 Page 4

b. Non-invasive prenatal screening for aneuploidies (NIPS): Smits introduced the topic. Schabel stressed the importance of reduced amniocentesis rates with this technology. She asked about comparative costs of different screening strategies and staff provided estimates.

Testimony: 1. Hannah Baer: Coalition for Access to Prenatal Screening (CAPS) representative. CAPS is a group sponsored by seven genetic testing companies. Ms. Baer testified that NIPS is a sensitive and specific screening tool that should be offered to all pregnant women. In 2020, Washington and Idaho Medicaid programs added NIPS for average-risk pregnancies. Other states’ Medicaid program, such as Alaska and Delaware, changed their policy to cover NIPS for all pregnant women (CPTs 81420 and 81507). Additionally, Connecticut and Wisconsin made changes in their Medicaid policy based on Practice Bulletin 226 by the American College of Obstetricians and Gynecologists (ACOG, August 2020). Many private insurers cover NIPS testing for average-risk pregnancies. Six other state Medicaid programs (Iowa, Massachusetts, Louisiana, Maryland, Nevada and Texas) are considering coverage for NIPS. Ms. Baer said these tests should be covered for all women regardless of age or risk. 2. Vanessa Nitibhon: Ms. Nitibhon is a certified genetic counselor employed by and speaking on behalf of Integrated Genetics. She was formerly a genetic counselor at OHSU. She testified that NIPS coverage ensured the most equitable care for all pregnant women. ACOG and SMFM support NIPS testing for all women per ACOG’s Practice Bulletin 226. NIPS screening has the lowest chance for error and has the best detection rate for the common aneuploidies. Fewer false positive results means fewer invasive procedures. Ms. Nitibhon cited a paper by Norton (2015) which stated that the false positive rate is 100 times lower than standard serum screening. A reduction in false positive rates also reduces anxiety as well as complications from invasive testing. Ms. Nitibhon shared scenarios she encountered when counseling average-risk women in her practice, stating that those commercially-insured patients who had access to NIPS had more timely results than her Medicaid patients, leading to a division of care based on insurance coverage. Covering NIPS can also allow patients and families prepare for the arrival of a special needs baby. This test is more equitable, and, in rural areas, easier to access than fetal nuchal lucency ultrasound. 3. Ashley Svenson: Ms. Svenson is a policy specialist employed by Myriad Genetics. She was formerly a genetic counselor practicing at a large academic perinatology clinic. Ms. Svenson cited cost-effectiveness modeling studies that demonstrated NIPS as net cost effective when additional costs are taken into account such as increased number of ultrasounds, consults, amniocenteses, etc. Svenson stated that NIPS is also easier for women with low medical literacy or resource constraints, underscoring the anxiety and emotional burden of a positive screening test. Svenson read a patient quote from “Stand Up for Accurate Prenatal Answers,” a patient group. The patient quote recounted a women’s second trimester of pregnancy while waiting for a diagnostic test result from a positive 20-week ultrasound. Ms. Svenson cited her own clinical experience stating that false positive results after traditional serum screening were common. Svenson concluded by citing an article from the “Healthy African American Families” patient group, who stated that disparities in coverage lead to racial disparities in aneuploidy screening, with women of color disproportionately not being screened. Svenson stated that non-white women are significantly less likely to pursue NIPS when coverage is unclear. 4. Kim Martin: Dr. Martin is an obstetrician-gynecologist and board-certified clinical geneticist. She is also a consultant to a genetics testing company but states she is not being reimbursed for her testimony today. Dr. Martin stated that the introduction of cell-free DNA in 2012 should have

Value-based Benefits Subcommittee Minutes, 11/12/2020 Page 5

revolutionized aneuploidy screening for all women regardless of age or risk given the dramatically improved performance of the screen as well as the ability to perform it early in pregnancy. This test can be performed in the office during a routine OB visit. This is in contrast to the second most sensitive test, which is the nuchal translucency ultrasound, which requires a certified nuchal translucency provider. Oregon has 22 of these certified providers in Oregon, but the vast majority are not in rural areas. Martin states this disadvantages woman living in rural areas. Martin also states that over 80% of Asian and Caucasian women enter prenatal care in first trimester of pregnancy compared to <70% of women of color, leaving women of color with less access to tests like fetal nuchal lucency screening that need to be performed early in pregnancy. Another test, the quad screen, has poor accuracy if the dating is poor for the pregnancy. Martin stated that about 10% of women get poorly dated. NIPS is better for uncertain dates, as its results are independent of gestational age. 5. Nathan Slotnick: He is a medical geneticist and high-risk obstetrician, practicing in Nevada. Dr. Slotnick spoke about his clinical experience. He cited Norton’s 2015 study that NIPS has a higher positive predictive value and a high negative predictive value. If the test is negative, the chance that the result is wrong is near zero, which makes this a powerful screening tool. Slotnick says that the question of screening then becomes a question of justice and equity. He noted the equity issue with limited access in rural areas.

There was little additional discussion. The VBBS members present voted unanimously to expand NIPS coverage to all pregnant women.

c. Expanded carrier testing: Smits introduced the topic. Duty expressed concern about the high rate of positive results, and the consequences of trying to interpret these. Irwin noted that the proposed guideline might be hard to operationalize for the CCOs. She felt that the VBBS needed to know cost comparisons. Hodges agreed that it might be hard for CCOs to operationalize. She requested adding the CPT code (81443) to the guideline for clarity. Hodges was also concerned with the proposed guideline wording. How were reviewers supposed to verify genetic counseling is ordered or obtained? Should the CPT 81443 only be submitted with genetic counseling codes?

Testimony: 1. Devki Nagar: Nagar is a genetic counselor, employed by and representing Myriad Genetic Laboratories. She supports the staff and GAP recommendation to add coverage. She feels that expanded carrier screening (ECS) provides equity across ethnicities. A Blue Cross Blue Shield TEC review recently found that ECS improved net health outcomes. The test might also reduce barriers to care. She agrees with adding the CPT code 81443 to the guideline to allow for consistency of adoption. She said that only clinically meaningful variants and those that are pathogenic are reported by labs (variants of uncertain significance are not reported), given that these test results can potentially be used to make pregnancy-related decisions. Ms. Nagar stated that different companies offer different panels which vary in the number of included genes. She feels that pretest education is important, but limiting access to testing to patients seeing genetic counselors is problematic given the time sensitivity of carrier screening during pregnancy and limited availability of genetic counselors. Currently, the other screenings allowed in the prenatal genetic testing guideline do not require genetic counseling (CF, SMA, etc.) Thus, this could reintroduce inequity in care by requiring genetic counseling for this one particular type of test. ACOG endorses ECS in Committee Opinion 690 as an appropriate option given the diversity of

Value-based Benefits Subcommittee Minutes, 11/12/2020 Page 6

Americans. She requested that the proposed guideline be changed to allow prenatal care providers to be able to order test or include components of informed consent in the guideline.

2. Kim Martin: Dr. Martin is an OB-Gyn who consults for a genetic testing company. Martin said that professional societies have recommendations regarding ECS coverage. She noted that the increasing diversity of the US population makes ethnicity-based testing more problematic given two societal changes: 1) individuals partnering with those of different ethnicities, and 2) individuals cannot or do not accurately report their ancestry, as defined by the ethnicity of the individual’s four biological grandparents. Pan-ethnic expanded carrier screening results in identifying more at-risk couples, who are commonly missed. Martin concludes that professional societies have not acknowledged X-linked disorders (such as Fragile X), which should be included in pan-ethnic panels, as carriers of these disorders are at increased risk of premature ovarian failure, cardiomyopathies, and arrythmias, among other conditions.

Olson questioned requiring pretest genetic counseling before this test. Genetic counseling is a rare resource; specialty societies expect counseling to take place in the maternity care provider office. Duty was concerned that there were a lot of genes tested, which may result in unintended results, unlike simpler testing like CF screening. Dehen also had concerns about the types of genes included and about the possible lack of coverage for partner testing. Irwin noted that the VBBS had a similar conversation in 2018, with similar concerns brought up.

Olson felt that practicing OBs and family doctors should be brought into the conversation to find out what they feel about ECS testing. Schabel echoed this thought, asking if this is actually a test that providers what to offer or that patients are requesting. Duty felt that there should be a content specialist to assist the VBBS in determining coverage for ECS. Schabel and Dehen both expressed concern about the tension between the harm to the couple with lack of knowledge of a gene defect vs the harm of knowledge of a defect of unknown significance.

The VBBS decision was to table this topic. HERC staff were directed to get additional input from maternity care providers and content experts. HERC staff will look into putting this topic through the coverage guidance process with EGBS.

C. Hereditary cancer genetic testing guideline updates: There was no discussion

Recommended Actions: 1) Add CPT 81351-81353 (TP53 (tumor protein 53) (eg, Li-Fraumeni syndrome) gene analysis) to the Diagnostic Procedures File 2) Add CPT 81419 (Epilepsy genomic sequence analysis panel, must include analyses for ALDH7A1, CACNA1A, CDKL5, CHD2, GABRG2, GRIN2A, KCNQ2, MECP2, PCDH19, POLG, PRRT2, SCN1A, SCN1B, SCN2A, SCN8A, SLC2A1, SLC9A6, STXBP1, SYNGAP1, TCF4, TPP1, TSC1, TSC2, and ZEB2) to line 30 EPILEPSY AND FEBRILE CONVULSIONS 3) The prenatal genetic testing guideline was modified as shown in Appendix A 4) Expanded carrier screening was recommended for referral to EGBS as a possible coverage guidance 5) Diagnostic Guideline D25 HEREDITARY CANCER GENETIC TESTING was modified as shown in Appendix A

Value-based Benefits Subcommittee Minutes, 11/12/2020 Page 7

MOTION: To recommend the code and guideline note changes as modified. CARRIES 7-0.

 Topic: Behavioral Health Advisory Panel report

Discussion: A. Straightforward code change recommendations: There was no discussion B. Neurobehavioral status exam and neuropsychological testing guideline: There was no discussion C. Cognitive rehabilitation guideline: There was no discussion D. Repetitive transcranial magnetic stimulation: Hodges requested clarification about how often Repetitive Transcranial Magnetic Stimulation (rTMS) should be administered. Staff suggested adding language limiting rTMS therapy to one session per day, which is consistent with the studies supporting effectiveness. Hodges said she had seen requests for multiple sessions per day with different magnet settings; one session would target depression and the other would target obsessive compulsive disorder. Smits said that rTMS is covered only for depression.

Recommended Actions: 1) Add H2014 (Skills training and development) to line 4 SUBSTANCE USE DISORDER 2) Remove 96156-96159 (Health and behavior assessment codes) from line 4 SUBSTANCE USE DISORDER 3) Modify Diagnostic Guideline D26 NEUROBEHAVIORAL STATUS EXAMS AND NEUROPSYCHOLOGICAL TESTING as shown in Appendix A 4) Remove CPT 97129 and 97130 (Therapeutic interventions that focus on cognitive function) from lines 201 CHRONIC ORGANIC MENTAL DISORDERS INCLUDING DEMENTIAS, 345 NEUROLOGICAL DYSFUNCTION IN COMMUNICATION CAUSED BY CHRONIC CONDITIONS, and 377 DYSFUNCTION RESULTING IN LOSS OF ABILITY TO MAXIMIZE LEVEL OF INDEPENDENCE IN SELF-DIRECTED CARE CAUSED BY CHRONIC CONDITIONS THAT CAUSE NEUROLOGICAL DYSFUNCTION 5) Add CPT 97129 and 97130 (Therapeutic interventions that focus on cognitive function) to line 294 CANCER OF BRAIN AND NERVOUS SYSTEM 6) Modify GN90 COGNITIVE REHABILITATION as shown in Appendix A 7) Modify GN102 REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION as shown in Appendix A

MOTION: To recommend the code and guideline note changes as presented. CARRIES 7-0.

 Topic: 2021 CPT code placement

Discussion: There was no discussion about placement of the new CPT code 76145 3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality with image postprocessing under concurrent supervision; not requiring image postprocessing on an independent workstation. Smits reported that the 2021 HCPCS codes have not yet been released. These codes will be reviewed at the January 2021 VBBS meeting. In the meantime, staff will publish recommendations and the Health Systems may make changes to its systems in order to ensure appropriate claims processing.

Value-based Benefits Subcommittee Minutes, 11/12/2020 Page 8

Recommended Actions: 1) Advise HSD to place CPT 76145 (Medical physics dose evaluation for radiation exposure that exceeds institutional review threshold, including report) on the EXCLUDED FILE 2) See all 2021 CPT code placements in Appendix C

MOTION: To recommend the code placement as presented. CARRIES 7-0.

 Topic: Home intraocular pressure monitoring

Discussion: Smits reviewed the summary document. There was no discussion.

Recommended Actions: 1) Do not add CPT 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] to Line 139 GLAUCOMA, OTHER THAN PRIMARY ANGLE-CLOSURE

 Topic: Developmental motor delay update

Discussion: Smits reviewed the summary document. There was no discussion.

Recommended Actions: 1) Add ICD-10-CM code R62.50 Unspecified lack of expected normal physiological development in childhood to the three dysfunction lines to enable pairing with physical, occupational, and speech therapy. • 292 NEUROLOGICAL DYSFUNCTION IN POSTURE AND MOVEMENT CAUSED BY CHRONIC CONDITIONS • 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 2) Delete the coding specification from line 292, 345 and 377 o ICD-10-CM R62.0 is included on Lines 292, 345 and 377 for children 8 and under. 3) Delete the following coding specification from lines 292, 345, 377 and 661. o ICD-10-CM F88 is included on these lines for developmental delay. When it is used to indicate sensory integration disorder or sensory processing disorder, it is included on Line 661. 4) Adopt a new guideline for lines 292, 345, 377 and 661 as shown in Appendix B

Note: The meeting materials incorrectly omitted the deletion of the coding specification from line 661 and the attachment of the new guideline note to line 661. MOTION: To recommend the code and guideline note changes as presented. CARRIES 7-0.

 Topic: Opioid guideline for conditions of the back and spine

Value-based Benefits Subcommittee Minutes, 11/12/2020 Page 9

Discussion: Smits introduced the topic. Olson asked who created the Oregon opioid guidelines referenced in the revised guideline. Smits explained that they were created by a multi-stakeholder group convened by the state.

Testimony: 1. Koa Kai: Ms. Kai is a patient advocate with the Chronic Disease Coalition and declared no conflicts of interest. She testified that the proposed guideline changes will decrease patient harms. She noted that while integrated care is the gold standard, disabilities can affect a patient’s ability to participate in complementary therapies. The option of alternative and complementary therapies can be beneficial, but making it a requirement may be harmful for the over 170 diagnoses this guideline affects. She recommended changing the section where the guideline had a “must” for having patients participate in alternative care be changed to “providers can consider when clinically appropriate”. She also said that the requirement to take into account “biological, behavioral, psychosocial factors” is confusing. She stated that the requirement for assessment of risk can be discriminatory. Patients with a history of opioid misuse can safely use opioids with close clinical monitoring.

2. Amara M: Ms. M is an advocate and cofounder of the Oregon Pain Action Group and declared no conflicts of interest. She said that many of the proposed guideline changes are positive. She requested research into impact of the policy. She noted that mandates are not good care and undermine patient-doctor relationships. She also asked for more patient input in HERC decisions on future policy decisions. She also requested that the guideline not require additional therapies as a mandatory requirement and instead be reworded as “when medically advisable.”

3. Wendy Sinclair: Ms. Sinclair is an advocate from the Oregon Pain Action Group. She thanked the committee for listening to stakeholders and advocates. Doctors should be able to practice individualized care. Chronic pain is a broad category, and it is wrong to assume everyone will respond to the same treatments. When GN60 was enacted, providers received a letter requesting they taper patients. She expressed concern with the current changes not being promoted as strongly to providers. She also requested that the VBBS consider adding “when medically advisable” to phrases about alternative treatments.

The subcommittee made several changes to the proposed guideline edits, including changing “must” be prescribed when referring to alternative treatments to “should” be prescribed “unless contraindicated.”

Recommended Actions: 1) GN60 OPIOIDS FOR CONDITIONS OF THE BACK AND SPINE was modified as shown in Appendix A

MOTION: To recommend the guideline note changes as modified. CARRIES 7-0.

 Public Comment:

Mareinna Kansiger testified; she is a transgender person and declared no affiliations or conflicts of interest. She testified on facial feminization surgery (FFS) procedures. Facial feminization is not covered by the Oregon Health Plan as cosmetic, where there is comorbidity. Because of this policy,

Value-based Benefits Subcommittee Minutes, 11/12/2020 Page 10

OHSU (the only provider of FFS procedures in the area) won’t schedule a consultation with her, and there is no way to start an appeal process as no treatment has been denied, creating a Catch-22. Part of the diagnostic criterial for gender dysphoria is the desire to live and be accepted as the gender one identifies with. Treating gender dysphoria means helping one be accepted as their true gender. Kansiger said that gender reassignment surgery (GRS) is only a partial treatment for gender dysphoria. The primary way people gender you is the face. The face is one’s identity. Thus, FFS is as important or more important than GRS for treatment of gender dysphoria. Prioritizing which body part gets treatment is in direct opposition to scientific understanding of gender dysphoria and professional guidelines; FFS is not cosmetic, as it is designed to make a patient’s appearance feminine, not to make it more attractive. It is recommended for coverage by the World Professional Association for Transgender Health (WPATH). She said that facial gender confirming surgery is a newer term for this surgery because the purpose is to treat gender dysphoria. FFS helps protect people against violence and helps the mental health of patient. FFS is also cost effective—its benefits include lower rates of suicide and depression along with higher rates of HIV treatment. Until insurance companies better understand gender dysphoria and cover FFS, gender dysphoria will persist.

Olson said we would look at this offline before the next meeting.

 Issues for next meeting: • 2021 HCPCS codes

 Next meeting:

January 21, 2021, virtual meeting

 Adjournment:

The meeting adjourned at 12:35 PM.

Value-based Benefits Subcommittee Minutes, 11/12/2020 Page 11 Appendix A

Revised Guideline Notes

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 six screening strategies [first trimester (nuchal translucency, beta-HCG and PAPP-A), integrated, serum integrated, stepwise sequential, and contingency, and cell free fetal DNA testing] (CPT 76813, 76814, 81508, -81510, 81511, 81420, 81507, 81512, 82105, 82677,84163) 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 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

Value-based Benefits Subcommittee Minutes, 11/12/2020 Appendix A Appendix A

The following genetic screening tests are not covered: A) Serum triple screen B) 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.

DIAGNOSTIC GUIDELINE D25, HEREDITARY CANCER GENETIC TESTING Related to genetic testing for patients with breast/ovarian and colon/endometrial cancer or other related cancers suspected to be hereditary, or patients at increased risk to due to family history, services are provided according to the Comprehensive Cancer Network Guidelines. A) Lynch syndrome (hereditary colorectal, endometrial and other cancers associated with Lynch syndrome) services (CPT 81288, 81292-81300, 81317-81319, 81435, 81436) and familial adenomatous polyposis (FAP) services (CPT 81201-81203) should be provided as defined by the NCCN Clinical Practice Guidelines in Oncology. Genetic/Familial High-Risk Assessment: Colorectal V1.2018 (7/12/18). V1.2020 (7/21/20) www.nccn.org. B) Breast and ovarian cancer syndrome genetic testing services (CPT 81162-81167, 81212, 81215- 81217) for patients without a personal history of breast, ovarian and other associated cancers should be provided to high-risk patients as defined by the US Preventive Services Task Force or according to the NCCN Clinical Practice Guidelines in Oncology: Genetic/Familial High-Risk Assessment: Breast, Ovarian and Pancreatic and ovarian. V2.2019 (7/30/18). V1.2021 (9/8/20) www.nccn.org. C) Breast and ovarian cancer syndrome genetic testing services (CPT 81162-81167, 81212, 81215- 81217)) for women with a personal history of breast, ovarian, or other associated cancers and for men with breast or other associated cancers should be provided according to the NCCN Clinical Practice Guidelines in Oncology. Genetic/Familial High-Risk Assessment: Breast, Ovarian and Pancreatic and ovarian. V2.2019 (7/30/18). V1.2021 (9/8/20) www.nccn.org. D) PTEN (Cowden syndrome) services (CPT 81321-81323) should be provided as defined by the NCCN Clinical Practice Guidelines in Oncology. Genetic/Familial High-Risk Assessment: Breast and Ovarian. V2.2019 (7/30/18) or Genetic/Familial High-Risk Assessment: Colorectal V1.2018 (7/12/18). V1.2020 (7/21/20) www.nccn.org.

Genetic counseling should precede genetic testing for hereditary cancer whenever possible. A) Pre and post-test genetic counseling should be covered when provided by a suitable trained health professional with expertise and experience in cancer genetics. Genetic counseling is recommended for cancer survivors when test results would affect cancer screening. 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. B) If timely pre-test genetic counseling is not possible for time-sensitive cases, appropriate genetic testing accompanied by pre- and post- test informed consent and post-test disclosure performed by a board-certified physician with experience in cancer genetics should be covered. 1) Post-test genetic counseling should be performed as soon as is practical.

If the mutation in the family is known, only the test for that mutation is covered. For example, if a mutation for BRCA 1 has been identified in a family, a single site mutation analysis for that mutation is covered (CPT 81215), while a full sequence BRCA 1 and 2 (CPT 81163) analyses is not. There is one

Value-based Benefits Subcommittee Minutes, 11/12/2020 Appendix A Appendix A

exception, for individuals of Ashkenazi Jewish ancestry with a known mutation in the family, the panel for Ashkenazi Jewish BRCA mutations is covered (CPT 81212).

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: A) Symptoms are not explained by an existing diagnosis; AND B) When the results of such testing will be used to develop a care plan. OR when neuropsychological testing is done as part of the pre-operative evaluation prior to epilepsy surgery or post-operative follow up after epilepsy surgery.

DIAGNOSTIC GUIDELINE D27, SARS-COV-2 (COVID-19) TESTING Testing for SARS-CoV-2 (COVID-19) virus RNA or viral antigen is a covered diagnostic service.

Antibody testing for SARS-CoV-2 (COVID-19; CPT 86413, 86328 or 86769) is covered as diagnostic only when such testing meets the following criteria: A) Testing is done using tests that have FDA Emergency Use Authorization (EUA) or FDA approval; AND B) Testing is used as part of the diagnostic work up of multisystem inflammatory syndrome in children (MIS-C) or multisystem inflammatory syndrome in adults (MIS-A) for hospitalized persons under the age of 21.

GUIDELINE NOTE 60, OPIOIDS FOR CONDITIONS OF THE BACK AND SPINE Lines 346,361,402,529 Opioid medications are only included on these lines under the following criteria. Time periods described below are relative to the patient’s initial injury or condition for which opioids were originally prescribed, regardless of whether the individual or any plan paid for the medication. Providers are encouraged to consider the recommendations of the Oregon Opioid Prescribing Guidelines Task Force when prescribing opioid medications: Oregon Acute Opioid Prescribing Guideline (October 2018) and the Oregon Chronic Opioid Prescribing Guidelines (2017-2018).

For acute injury, acute flare of chronic pain, or after surgery:

For acute conditions and flares

During the first 6 weeks after an acute injury, acute flare of chronic pain, or surgery opioid treatment is included on these lines ONLY: 1) When each prescription is limited to 7 days of treatment, AND 2) For short acting opioids only, AND 3) When one or more alternative first line pharmacologic therapies such as NSAIDs, acetaminophen, and muscle relaxers have been tried and found not effective or are contraindicated, AND

Value-based Benefits Subcommittee Minutes, 11/12/2020 Appendix A Appendix A

4) When prescribed with a plan to keep active (home or prescribed exercise regime) and with consideration of additional therapies such as spinal manipulation, physical therapy, yoga, or acupuncture, AND 5) There is documented verification that evaluation of the patient’s risk factors is not high risk for opioid misuse or abuse (e.g. history of opioid misuse, verification of prescription history in the PDMP, etc.).

During subacute period

Treatment with opioids after 6 weeks of continuous therapy and up to 90 days after the initial injury/flare/surgery is included on these lines ONLY: 1) With documented evidence of improvement of function of at least thirty percent as compared to baseline based on a validated tools (e.g. Oswestry, Neck Disability Index, SF-MPQ, and MSPQ). 2) When prescribed with a plan to keep active (home or prescribed exercise regime) and with consideration of additional therapies such as spinal manipulation, physical therapy, yoga, or acupuncture, AND 3) With verification that the patient is not high risk for opioid misuse or abuse. Such verification may involve a) Documented verification from the state's prescription monitoring program database that the controlled substance history is consistent with the prescribing record b) Use of a validated screening instrument to verify the absence of a current substance use disorder (excluding nicotine) or a history of prior opioid misuse or abuse c) Administration of a baseline urine drug test to verify the absence of illicit drugs and non- prescribed opioids. 4) Each prescription must be limited to 7 days of treatment and for short-acting opioids only

Long-term opioid therapy

Long-term opioid treatment (>90 days) after the initial injury/flare/surgery is not included on these lines except for the taper process as described below.

Transitional coverage for patients on long-term opioid therapy:

For patients receiving long-term opioid therapy (>90 days) for conditions of the back and spine, continued coverage of opioid medications requires a comprehensive individual treatment plan for chronic pain, taking into account the biological, behavioral, psychological and social factors which may influence each individual’s experience of chronic pain as well as any current and past treatments. Treatment plans should be prescribed (unless contraindicated) with a plan to keep active (home or prescribed exercise regime) and should include additional therapies such as spinal manipulation, physical therapy, yoga or acupuncture unless contraindicated if available in a patient’s community and reasonably accessible to the patient. The treatment plan should conform with the Oregon Chronic Opioid Prescribing Guidelines (2017-2018). A taper plan may be included if and when clinically appropriate.

Opioid tapers

Opioid taper plans are not required in order for continued inclusion of long-term opioid therapy on these lines. Providers initiating taper plans are encouraged to follow Oregon Opioid Tapering Guidelines

Value-based Benefits Subcommittee Minutes, 11/12/2020 Appendix A Appendix A

(January 2020). For patients receiving long-term opioid therapy (>90 days) for conditions of the back and spine, continued coverage of opioid medications requires an individual treatment plan which includes a taper plan when clinically indicated. Opioid tapering should be done on an individualized basis with a shared goal set by the patient and provider based on the patient’s overall status. Taper plans should include nonpharmacological treatment strategies for managing the patient’s pain. During the taper, behavioral health conditions need to be regularly assessed and appropriately managed.

In some situations (e.g., in the setting of active substance use disorder, history of opioid overdose, aberrant behavior), more rapid tapering or transition to medication assisted treatment may be appropriate and should be directed by the prescribing provider. If a patient has developed an opioid use disorder, treatment is included on Line 4 SUBSTANCE USE DISORDER.

GUIDELINE NOTE 90, COGNITIVE REHABILITATION Lines 91,178,196,201,285,294,317,345,377 Once physical stabilization from acute brain injury has occurred, as determined by an attending physician, cognitive rehabilitation (CPT 97129 and 97130) is included on this line for a three month period. This three month period does not have to be initiated immediately following stabilization from the injury. For up to 3 years following the acute event, an additional 6 visits of cognitive rehabilitation are included on this line each time the patient has a major change in status resulting in a significantly improved prognosis. Cognitive rehabilitation is not included on this line for those in a vegetative state or for those who are unable or unwilling to participate in therapy

GUIDELINE NOTE 102, REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION Line 7 Repetitive transcranial magnetic stimulation (CPT 90867-90869 90868) is covered included on this line only after failure of at least two antidepressants. when ALL of the following criteria are met 1) The patient has a confirmed diagnosis of severe major depressive disorder based on standardized rating scales, AND 2) The patient has treatment resistant depression as evidenced by BOTH of the following a. ongoing symptoms despite treatment with at least 2 psychopharmacologic regimens each used for 8 weeks unless not tolerated or contraindicated, AND b. failure of a trial of psychotherapy conducted for a minimum duration of 6 weeks at least 1 time a week with no improvement in depressive symptoms as documented by standardized rating scales; AND 3) The patient does not have psychosis, acute suicidal risk, catatonia, significantly impaired essential function, or other condition for which electroconvulsive therapy (ECT) would be clinically superior to TMS; AND 4) The patient has no contraindications to rTMS such as implanted devices in or around the head, increased risk of seizure, etc.; AND 5) The therapy is administered by an FDA approved device in accordance to labeled indications; AND 6) The patient is 18 years of age or older.

Value-based Benefits Subcommittee Minutes, 11/12/2020 Appendix A Appendix A

Repetitive transcranial magnetic stimulation is covered for a maximum of 30 sessions (once a day up to 5 times a week for 6 weeks) for initial treatment. Repeat treatment may be covered if the patient responded to the initial treatment (defined as at least of 50 percent reduction in depression score on standardized rating scale) and at least 3 months have elapsed since the initial treatment.

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 123, DENTAL FILLINGS FOR POSTERIOR TEETH Line 343 For dental fillings in posterior teeth, amalgam is preferred for extensive restorations. If amalgam is unavailable or contraindicated, composite is acceptable.

GUIDELINE NOTE 139, FRENOTOMY FOR TONGUE TIE IN NEWBORNS Lines 18,596 Ankyloglossia (ICD-10-CM Q38.1 is included on Line 18 for pairing with frenotomy (CPT 41010, CDT D7962 D7960) only when it interferes with breastfeeding. Otherwise, Q38.1 and CPT 41010 are included on Line 596

GUIDELINE NOTE 173, TREATMENTS THAT HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS; UNPROVEN TREATMENTS

The following treatments are prioritized on Line 662, CONDITIONS FOR WHICH CERTAIN TREATMENTS HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS; UNPROVEN TREATMENTS for the conditions listed here:

CPT/HCPCS INTERVENTION Rationale Date of last Review code 64912-64913 Nerve repair; with nerve allograft Unproven treatment November, 2017

Value-based Benefits Subcommittee Minutes, 11/12/2020 Appendix A Appendix B

New Guideline Notes

GUIDELINE NOTE XXX NERVE ALLOGRAFTS Line 536 Nerve allografts (CPT 64912-64913) are only on this line for repair of digital nerve injury (ICD-10-CM S64.4 code category).

GUIDELINE NOTE XXX DENTAL IMPLANT REMOVAL Lines 344, 619 Removal of dental implants (D6100) is included on line 344 only when there is advanced peri-implantitis with bone loss and mobility, abscess or implant fracture. Otherwise, this procedure is included on line 619.

GUIDELINE NOTE XXX DEVELOPMENTAL DELAY CODING Lines 292,345,377,661 ICD-10-CM R62.0 and R62.50 are included on these lines for children 5 and under used to identify dysfunction substantially below chronological age, when significantly and persistently interfering with activities of daily living appropriate for chronological age, and there is an opportunity for skill learning. ICD-10-CM F88 is included on these lines for developmental delay. When it is used to indicate sensory integration disorder or sensory processing disorder, it is included on Line 661.

Value-based Benefits Subcommittee Minutes, 11/12/2020 Appendix B Appendix C 2021 CPT Codes Unless otherwise noted, the entries below reflect the October 1, 2020 VBBS/HERC placement decisions Code Code description Placement Recommendation 30468 Repair of nasal valve collapse with subcutaneous/submucosal lateral 465 CHRONIC SINUSITIS wall implant(s) 506 NASAL POLYPS, OTHER DISORDERS OF NASAL CAVITY AND SINUSES 576 DEVIATED NASAL SEPTUM, ACQUIRED DEFORMITY OF NOSE, OTHER DISEASES OF UPPER RESPIRATORY TRACT

32408 Core needle biopsy, lung or mediastinum, percutaneous, including DIAGNOSTIC PROCEDURES imaging guidance, when performed 33741 Transcatheter atrial septostomy (TAS) for congenital cardiac anomalies Any line which currently has 92992-92998 to create effective atrial flow, including all imaging guidance by the proceduralist, when performed, any method (eg, Rashkind, Sang-Park, balloon, cutting balloon, blade) 33745 Transcatheter intracardiac shunt (TIS) creation by stent placement for All congential heart disease lines congenital cardiac anomalies to establish effective intracardiac flow, including all imaging guidance by the proceduralist, when performed, left and right heart diagnostic cardiac catherization for congenital cardiac anomalies, and target zone angioplasty, when performed (eg, atrial septum, Fontan fenestration, right ventricular outflow tract, Mustard/Senning/Warden baffles); initial intracardiac shunt

33746 Transcatheter intracardiac shunt (TIS) creation by stent placement for All congential heart disease lines congenital cardiac anomalies to establish effective intracardiac flow, including all imaging guidance by the proceduralist, when performed, left and right heart diagnostic cardiac catherization for congenital cardiac anomalies, and target zone angioplasty, when performed (eg, atrial septum, Fontan fenestration, right ventricular outflow tract, Mustard/Senning/Warden baffles); each additional intracardiac shunt location (List separately in addition to code for primary procedure)

1 Appendix C 2021 CPT Codes Unless otherwise noted, the entries below reflect the October 1, 2020 VBBS/HERC placement decisions Code Code description Placement Recommendation 33995 Insertion of ventricular assist device, percutaneous, including 69 ACUTE AND SUBACUTE ISCHEMIC HEART DISEASE, MYOCARDIAL radiological supervision and interpretation; right heart, venous access INFARCTION only 33997 Removal of percutaneous right heart ventricular assist device, venous 69 CUTE AND SUBACUTE ISCHEMIC HEART DISEASE, MYOCARDIAL cannula, at separate and distinct session from insertion INFARCTION 81 MYOCARDITIS, PERICARDITIS, AND ENDOCARDITIS 97 HEART FAILURE 264 CONGESTIVE HEART FAILURE, CARDIOMYOPATHY, MALIGNANT ARRHYTHMIAS, AND COMPLEX CONGENITAL HEART DISEASE 55880 Ablation of malignant prostate tissue, transrectal, with high intensity- 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, focused ultrasound (HIFU), including ultrasound guidance HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 57465 Computer-aided mapping of cervix uteri during colposcopy, including 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, optical dynamic spectral imaging and algorithmic quantification of the HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT acetowhitening effect (List separately in addition to code for primary OUTWEIGH BENEFITS procedure) 69705 Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, 654 SENSORY ORGAN CONDITIONS WITH NO OR MINIMALLY EFFECTIVE balloon dilation); unilateral TREATMENTS OR NO TREATMENT NECESSARY 69706 Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, 654 SENSORY ORGAN CONDITIONS WITH NO OR MINIMALLY EFFECTIVE balloon dilation); bilateral TREATMENTS OR NO TREATMENT NECESSARY 71271 Computed tomography, thorax, low dose for lung cancer screening, 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS without contrast material(s) 76145 Medical physics dose evaluation for radiation exposure that exceeds EXCLUDED ***new recommendation*** institutional review threshold, including report 80143 Acetaminophen DIAGNOSTIC PROCEDURES 80151 Amiodarone DIAGNOSTIC PROCEDURES 80161 Carbamazepine; -10,11-epoxide DIAGNOSTIC PROCEDURES 80167 Felbamate DIAGNOSTIC PROCEDURES 80179 Salicylate DIAGNOSTIC PROCEDURES 80181 Flecainide DIAGNOSTIC PROCEDURES 80189 Itraconazole DIAGNOSTIC PROCEDURES 80193 Leflunomide DIAGNOSTIC PROCEDURES

2 Appendix C 2021 CPT Codes Unless otherwise noted, the entries below reflect the October 1, 2020 VBBS/HERC placement decisions Code Code description Placement Recommendation 80204 Methotrexate DIAGNOSTIC PROCEDURES 80210 Rufinamide DIAGNOSTIC PROCEDURES 81168 CCND1/IGH (t(11;14)) (eg, mantle cell lymphoma) translocation DIAGNOSTIC PROCEDURES analysis, major breakpoint, qualitative and quantitative, if performed

81191 NTRK1 (neurotrophic receptor tyrosine kinase 1) (eg, solid tumors) DIAGNOSTIC PROCEDURES translocation analysis 81192 NTRK2 (neurotrophic receptor tyrosine kinase 2) (eg, solid tumors) DIAGNOSTIC PROCEDURES translocation analysis 81193 NTRK3 (neurotrophic receptor tyrosine kinase 3) (eg, solid tumors) DIAGNOSTIC PROCEDURES translocation analysis 81194 NTRK (neurotrophic-tropomyosin receptor tyrosine kinase 1, 2, and 3) DIAGNOSTIC PROCEDURES (eg, solid tumors) translocation analysis 81278 IGH@/BCL2 (t(14;18)) (eg, follicular lymphoma) translocation analysis, DIAGNOSTIC PROCEDURES major breakpoint region (MBR) and minor cluster region (mcr) breakpoints, qualitative or quantitative 81279 JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) targeted DIAGNOSTIC PROCEDURES sequence analysis (eg, exons 12 and 13) 81338 MPL (MPL proto-oncogene, thrombopoietin receptor) (eg, DIAGNOSTIC PROCEDURES myeloproliferative disorder) gene analysis; common variants (eg, W515A, W515K, W515L, W515R) 81339 MPL (MPL proto-oncogene, thrombopoietin receptor) (eg, DIAGNOSTIC PROCEDURES myeloproliferative disorder) gene analysis; sequence analysis, exon 10

81347 SF3B1 (splicing factor [3b] subunit B1) (eg, myelodysplastic DIAGNOSTIC PROCEDURES syndrome/acute myeloid leukemia) gene analysis, common variants (eg, A672T, E622D, L833F, R625C, R625L) 81348 SRSF2 (serine and arginine-rich splicing factor 2) (eg, myelodysplastic DIAGNOSTIC PROCEDURES syndrome, acute myeloid leukemia) gene analysis, common variants (eg, P95H, P95L) 81351 TP53 (tumor protein 53) (eg, Li-Fraumeni syndrome) gene analysis; full DIAGNOSTIC PROCEDURES gene sequence ***new recommendation***

3 Appendix C 2021 CPT Codes Unless otherwise noted, the entries below reflect the October 1, 2020 VBBS/HERC placement decisions Code Code description Placement Recommendation 81352 TP53 (tumor protein 53) (eg, Li-Fraumeni syndrome) gene analysis; DIAGNOSTIC PROCEDURES targeted sequence analysis (eg, 4 oncology) ***new recommendation*** 81353 TP53 (tumor protein 53) (eg, Li-Fraumeni syndrome) gene analysis; DIAGNOSTIC PROCEDURES known familial variant ***new recommendation*** 81357 U2AF1 (U2 small nuclear RNA auxiliary factor 1) (eg, myelodysplastic DIAGNOSTIC PROCEDURES syndrome, acute myeloid leukemia) gene analysis, common variants (eg, S34F, S34Y, Q157R, Q157P) 81360 ZRSR2 (zinc finger CCCH-type, RNA binding motif and serine/arginine- DIAGNOSTIC PROCEDURES rich 2) (eg, myelodysplastic syndrome, acute myeloid leukemia) gene analysis, common variant(s) (eg, E65fs, E122fs, R448fs)

81419 Epilepsy genomic sequence analysis panel, must include analyses for 30 EPILEPSY AND FEBRILE CONVULSIONS ALDH7A1, CACNA1A, CDKL5, CHD2, GABRG2, GRIN2A, KCNQ2, MECP2, ***new recommendation*** PCDH19, POLG, PRRT2, SCN1A, SCN1B, SCN2A, SCN8A, SLC2A1, SLC9A6, STXBP1, SYNGAP1, TCF4, TPP1, TSC1, TSC2, and ZEB2

81513 Infectious disease, bacterial vaginosis, quantitative real-time DIAGNOSTIC PROCEDURES amplification of RNA markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species, utilizing vaginal-fluid specimens, algorithm reported as a positive or negative result for bacterial vaginosis 81514 Infectious disease, bacterial vaginosis and vaginitis, quantitative real- DIAGNOSTIC PROCEDURES time amplification of DNA markers for Gardnerella vaginalis, Atopobium vaginae, Megasphaera type 1, Bacterial Vaginosis Associated Bacteria-2 (BVAB-2), and Lactobacillus species (L. crispatus and L. jensenii), utilizing vaginal-fluid specimens, algorithm reported as a positive or negative for high likelihood of bacterial vaginosis, includes separate detection of Trichomonas vaginalis and/or Candida species (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, Candida krusei, when reported

4 Appendix C 2021 CPT Codes Unless otherwise noted, the entries below reflect the October 1, 2020 VBBS/HERC placement decisions Code Code description Placement Recommendation 81529 Oncology (cutaneous melanoma), mRNA, gene expression profiling by 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, real-time RT-PCR of 31 genes (28 content and 3 housekeeping), HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT utilizing formalin-fixed paraffin-embedded tissue, algorithm reported OUTWEIGH BENEFITS as recurrence risk, including likelihood of sentinel lymph node metastasis 81546 Oncology (thyroid), mRNA, gene expression analysis of 10,196 genes, 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, utilizing fine needle aspirate, algorithm reported as a categorical result HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT (eg, benign or suspicious) OUTWEIGH BENEFITS 81554 Pulmonary disease (idiopathic pulmonary fibrosis [IPF]), mRNA, gene 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, expression analysis of 190 genes, utilizing transbronchial biopsies, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT diagnostic algorithm reported as categorical result (eg, positive or OUTWEIGH BENEFITS negative for high probability of usual interstitial pneumonia [UIP])

82077 Alcohol (ethanol); any specimen except urine and breath, DIAGNOSTIC PROCEDURES immunoassay (eg, IA, EIA, ELISA, RIA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase) 82681 Estradiol; free, direct measurement (eg, equilibrium dialysis) DIAGNOSTIC PROCEDURES 86408 Neutralizing antibody, severe acute respiratory syndrome coronavirus EXCLUDED 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); screen

86409 Neutralizing antibody, severe acute respiratory syndrome coronavirus EXCLUDED 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); titer

90377 Rabies immune globulin, heat- and solvent/detergent-treated (RIg-HT 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS S/D), human, for intramuscular and/or subcutaneous use

92229 Imaging of retina for detection or monitoring of disease; point-of-care 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, automated analysis and report, unilateral or bilateral HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 92517 Vestibular evoked myogenic potential (VEMP) testing, with 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, interpretation and report; cervical (cVEMP) HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS

5 Appendix C 2021 CPT Codes Unless otherwise noted, the entries below reflect the October 1, 2020 VBBS/HERC placement decisions Code Code description Placement Recommendation 92518 Vestibular evoked myogenic potential (VEMP) testing, with 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, interpretation and report; ocular (oVEMP) HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 92519 Vestibular evoked myogenic potential (VEMP) testing, with 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, interpretation and report; cervical (cVEMP) and ocular (oVEMP) HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS 92650 Auditory evoked potentials; screening of auditory potential with DIAGNOSTIC PROCEDURES broadband stimuli, automated analysis 92651 Auditory evoked potentials; for hearing status determination, DIAGNOSTIC PROCEDURES broadband stimuli, with interpretation and report 92652 Auditory evoked potentials; for threshold estimation at multiple DIAGNOSTIC PROCEDURES frequencies, with interpretation and report 92653 Auditory evoked potentials; neurodiagnostic, with interpretation and DIAGNOSTIC PROCEDURES report 93241 External electrocardiographic recording for more than 48 hours up to 7 DIAGNOSTIC PROCEDURES days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation

93242 External electrocardiographic recording for more than 48 hours up to 7 DIAGNOSTIC PROCEDURES days by continuous rhythm recording and storage; recording (includes connection and initial recording) 93243 External electrocardiographic recording for more than 48 hours up to 7 DIAGNOSTIC PROCEDURES days by continuous rhythm recording and storage; scanning analysis with report 93244 External electrocardiographic recording for more than 48 hours up to 7 DIAGNOSTIC PROCEDURES days by continuous rhythm recording and storage; review and interpretation 93245 External electrocardiographic recording for more than 7 days up to 15 DIAGNOSTIC PROCEDURES days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation

6 Appendix C 2021 CPT Codes Unless otherwise noted, the entries below reflect the October 1, 2020 VBBS/HERC placement decisions Code Code description Placement Recommendation 93246 External electrocardiographic recording for more than 7 days up to 15 DIAGNOSTIC PROCEDURES days by continuous rhythm recording and storage; recording (includes connection and initial recording) 93247 External electrocardiographic recording for more than 7 days up to 15 DIAGNOSTIC PROCEDURES days by continuous rhythm recording and storage; scanning analysis with report 93248 External electrocardiographic recording for more than 7 days up to 15 DIAGNOSTIC PROCEDURES days by continuous rhythm recording and storage; review and interpretation 94619 Exercise test for bronchospasm, including pre- and post-spirometry DIAGNOSTIC PROCEDURES and pulse oximetry; without electrocardiographic recording(s)

99417 Prolonged office or other outpatient evaluation and management All lines with E&M codes service(s) beyond the minimum required time of the primary procedure which has been selected using total time, requiring total time with or without direct patient contact beyond the usual service, on the date of the primary service, each 15 minutes of total time (List separately in addition to codes 99205, 99215 for office or other outpatient Evaluation and Management services)

99439 Chronic care management services with the following required All lines with E&M codes elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, comprehensive care plan established, implemented, revised, or monitored; each additional 20 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)

7 Appendix D 2021 CDT Codes Code Descriptor Suggested Placement D0604 Antigen testing for a public health related pathogen, Diagnostic Procedure File including coronavirus D0605 Antibody testing for a public health related Excluded File pathogen, including coronavirus D0701 Panoramic radiographic image – image capture Diagnostic Procedure File only D0702 2-D cephalometric radiographic image – image Diagnostic Procedure File capture only D0703 2-D oral/facial photographic image obtained intra- Diagnostic Procedure File orally or extra-orally – image capture only D0704 3-D photographic image – image capture only Diagnostic Procedure File D0705 Extra-oral posterior dental radiographic image – Diagnostic Procedure File image capture only D0706 Intraoral – occlusal radiographic image – image Diagnostic Procedure File capture only D0707 Intraoral – periapical radiographic image – image Diagnostic Procedure File capture only D0708 Intraoral – bitewing radiographic image – image Diagnostic Procedure File capture only D0709 Intraoral – complete series of radiographic images Diagnostic Procedure File – image capture only D1321 Counseling for the control and prevention of 53 PREVENTIVE DENTAL SERVICES adverse oral, behavioral, and systemic health effects associated with high-risk substance use D1355 Caries preventive medicament application – per 53 PREVENTIVE DENTAL SERVICES tooth D2928 Prefabricated porcelain/ceramic crown – permanent Excluded File tooth D3471 Surgical repair of root resorption - anterior 646 DENTAL CONDITIONS WHERE TREATMENT RESULTS IN MARGINAL IMPROVEMENT D3472 Surgical repair of root resorption – premolar 646 D3473 Surgical repair of root resorption – molar 646 D3501 Surgical exposure of root surface without 646 apicoectomy or repair of root resorption – anterior

D3502 Surgical exposure of root surface without 646 apicoectomy or repair of root resorption – premolar

D3503 Surgical exposure of root surface without 646 apicoectomy or repair of root resorption – molar D5995 Periodontal medicament carrier with peripheral seal 646 DENTAL CONDITIONS WHERE – laboratory processed – maxillary TREATMENT RESULTS IN MARGINAL IMPROVEMENT D5996 Periodontal medicament carrier with peripheral seal 646 – laboratory processed – mandibular D6191 Semi-precision abutment – placement 619 DENTAL CONDITIONS (E.G., MISSING TEETH) D6192 Semi-precision attachment – placement 619 D7961 Buccal / labial frenectomy (frenulectomy) 344 DENTAL CONDITIONS (E.G., SEVERE CARIES, INFECTION)

1 Appendix D 2021 CDT Codes Code Descriptor Suggested Placement D7962 Lingual frenectomy (frenulectomy) 18 FEEDING PROBLEMS IN NEWBORNS 344 DENTAL CONDITIONS (E.G., SEVERE CARIES, INFECTION) D7993 Surgical placement of craniofacial implant – extra Excluded File oral D7994 Surgical placement: zygomatic implant Excluded File

2 Section 2.0 VbBS Report Consent Agenda Issues—January 2021

Code Code Description Line(s) Involved Issue Recommendation(s) 99366- Medical team conference with All lines with E&M codes Several lines are missing one or Add 99366-99368 to any line with 99368 interdisciplinary team of health more of the codes in the 99366- E&M codes that currently does care professionals 99368 series. not have one or more of these codes

S2115 Osteotomy, periacetabular, 309 CONGENITAL DISLOCATION HCPCS S2115 is on one hip surgical Add HCPCS S2115 to line 309 with internal fixation OF HIP; COXA VARA AND VALGA line (359) but not on line 309. There are appropriate diagnoses on line 309 to pair.

17110 Destruction (eg, laser surgery, 387 ANOGENITAL VIRAL WARTS A CCO requested that CPT 17110 Add 17110 to line 387 electrosurgery, cryosurgery, be added to line 387 to pair with chemosurgery, surgical ICD10 A63.0 (Anogenital curettement), of benign lesions (venereal) warts). 17110 is other than skin tags or currently on 2 covered and one cutaneous vascular uncovered line. A63.0 is the only proliferative lesions; up to 14 diagnosis code on line 387. Many lesions similar treatment codes are on line 387

25107 Arthrotomy, distal radioulnar 376 DISRUPTIONS OF THE A CCO requested that 25107 and Add 25107 and 29846 to line 376 joint including repair of LIGAMENTS AND TENDONS OF 29846 be added to line 376 to pair triangular cartilage, complex THE ARMS AND LEGS, EXCLUDING with ICD10 S63.591A (Other 29846 Arthroscopy, wrist, surgical; THE KNEE, RESULTING IN specified sprain of right wrist, excision and/or repair of SIGNIFICANT initial encounter), which includes triangular fibrocartilage and/or INJURY/IMPAIRMENT cartilage tears. Both CPT codes joint debridement are on other covered lines.

1 VbBS Issue Summaries for 1-21-2021 Consent Agenda Issues—January 2021

Code Code Description Line(s) Involved Issue Recommendation(s) 29846 Arthroscopy, wrist, surgical; 376 DISRUPTIONS OF THE A CCO requested that these CPT Add 29846, 29847, 25320, and excision and/or repair of LIGAMENTS AND TENDONS OF codes be paired with wrist 25332 to line 376 triangular fibrocartilage and/or THE ARMS AND LEGS, EXCLUDING ligament tear ICD10 codes, which joint debridement THE KNEE, RESULTING IN appear on line 376. All of the 29847 Arthroscopy, wrist, surgical; SIGNIFICANT listed CPT codes appear on at least internal fixation for fracture or INJURY/IMPAIRMENT one other covered line. Line 376 instability has a guideline that would only 25320 Capsulorrhaphy or allow significant injuries to be reconstruction, wrist, open (eg, surgically repaired. capsulodesis, ligament repair, tendon transfer or graft) (includes synovectomy, capsulotomy and open reduction) for carpal instability Arthroplasty, wrist, with or 25332 without interposition, with or without external or internal fixation

2 VbBS Issue Summaries for 1-21-2021 Cystatin C

Issue: Cystatin C (CPT 82610) is a measure of kidney function. It was reviewed as a new code in 2007 and Excluded. This code was re-reviewed in October 2020 as part of the completion of partially missing entries to GN173. At that time, HERC staff concluded “Cystatin C is a test with little evidence to support its use in clinical decision making. It is not covered by most payers.” It currently appears on line 662/GN173.

The FDA has recently issued prescribing requirements for a new medication for Duchenne’s muscular dystrophy, Viltepso (viltolarsen). These FDA requirements state that cystatin C must be measured prior to drug initiation. The FDA notes that the standard renal evaluation using creatinine is not reliable in a muscle wasting disease such as Duchenne’s. Furthermore, animal studies found renal toxicity; therefore, renal function needs to be determined prior to drug initiation. P&T requested that CPT 82610 be opened for use for patients being considered for treatment with viltolarsen as OHP must provide a path to coverage for all FDA approved medications and viltolarsen cannot be prescribed without this test.

Cystatin C is used to measure renal function. It is also proposed as a test to risk stratify cardiac patients in certain clinical situations.

Other guidelines NICE 2015, Assessment and Management of Chronic Kidney Disease https://www.nice.org.uk/guidance/cg182/resources/chronic-kidney-disease-in-adults-assessment-and- management-pdf-35109809343205 1) When to use a cystatin C-based estimate of GFR for diagnosis of CKD a. Consider using eGFRcystatinC at initial diagnosis to confirm or rule out CKD in people with: i. an eGFRcreatinine of 45–59 ml/min/1.73 m2, sustained for at least 90 days and ii. no proteinuria (albumin:creatinine ratio [ACR] less than 3 mg/mmol) or other marker of kidney disease. [new 2014] 2) Potential impact of implementation a. Estimates of GFR (eGFR) based on serum cystatin C have a higher specificity for significant disease outcomes than those based on serum creatinine. For people with a borderline diagnosis, eGFRcystatinC is an additional diagnostic tool that may reduce over diagnosis. Using this tool may result in a significant proportion of people classified as having stage 3 CKD being reclassified as not having CKD (G1A1 or G2A1). This could benefit patients and clinicians by reducing unnecessary appointments, reducing patients' concerns and reducing the overall burden of CKD in the population. This additional test may have a cost impact, but there will be financial benefits, with fewer diagnoses leading to reduced management costs.

The cost of CPT 82610 is $18.52 (Medicare fee schedule).

VbBS Issue Summaries for 1-21-2021

Cystatin C

HERC staff summary The evidence supporting the use of cystatin C for evaluation of renal function or cardiac risk stratification (previously reviewed in October 2020) is poor. However, OHP must provide a pathway to coverage for FDA approved drugs, and the FDA requires cystatin C testing prior to use of viltolarsen. HERC staff do not feel a guideline is necessary due to the low cost of the test and the NICE clinical guideline which endorses use in certain situations.

HERC staff recommendation: 1) Remove CPT 82610 (Cystatin C) from line 662/GN173 2) Advise HSD to add CPT 82610 to the Diagnostic Procedures File

VbBS Issue Summaries for 1-21-2021

2021 HCPCS

HCPC LONG DESCRIPTION Suggested Placement notes C1062 Intravertebral body fracture augmentation with 478 CLOSED DISLOCATIONS/FRACTURES Similar codes 22510-22514 (Percutaneous vertebral implant (e.g., metal, polymer) OF NON-CERVICAL VERTEBRAL COLUMN augmentation) are on line 478 CLOSED WITHOUT NEUROLOGIC INJURY OR DISLOCATIONS/FRACTURES OF NON-CERVICAL STRUCTURAL INSTABILITY VERTEBRAL COLUMN WITHOUT NEUROLOGIC INJURY OR STRUCTURAL INSTABILITY C1825 Generator, neurostimulator (implantable), non- 662 CONDITIONS FOR WHICH CERTAIN See Carotid sinus barorecptor stimulation review rechargeable with carotid sinus baroreceptor INTERVENTIONS ARE UNPROVEN, HAVE NO stimulation lead(s) CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS

C9770 Vitrectomy, mechanical, pars plana approach, 95 DIABETIC AND OTHER RETINOPATHY CPT 67036 (Vitrectomy, mechanical, pars plana with subretinal injection of pharmacologic/biologic 139 GLAUCOMA, OTHER THAN PRIMARY approach) is on lines agent ANGLE-CLOSURE 95,139,247,279,285,299,318,348,360,383 424 247 RETAINED INTRAOCULAR FOREIGN BODY, MAGNETIC AND NONMAGNETIC 279 RETINAL DETACHMENT AND OTHER RETINAL DISORDERS 285 COMPLICATIONS OF A PROCEDURE ALWAYS REQUIRING TREATMENT 299 VITREOUS DISORDERS 318 PURULENT ENDOPHTHALMITIS 348 MILD/MODERATE BIRTH TRAUMA FOR BABY 360 CHORIORETINAL INFLAMMATION 383 CENTRAL SEROUS CHORIORETINOPATHY 424 COMPLICATIONS OF A PROCEDURE USUALLY REQUIRING TREATMENT C9771 Nasal/sinus endoscopy, cryoablation nasal 662 CONDITIONS FOR WHICH CERTAIN See Nasal cryoablation for chronic rhinitis review tissue(s) and/or nerve(s), unilateral or bilateral INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS

C9772 Revascularization, endovascular, open or 662 CONDITIONS FOR WHICH CERTAIN See intravascular lithotripsy for peripheral vascular percutaneous, tibial/peroneal artery(ies), with INTERVENTIONS ARE UNPROVEN, HAVE NO disease review intravascular lithotripsy, includes angioplasty CLINICALLY IMPORTANT BENEFIT OR HAVE within the same vessel (s), when performed HARMS THAT OUTWEIGH BENEFITS

VbBS Issue Summaries for 1-21-2021 1 2021 HCPCS

HCPC LONG DESCRIPTION Suggested Placement notes C9773 Revascularization, endovascular, open or 662 CONDITIONS FOR WHICH CERTAIN See intravascular lithotripsy for peripheral vascular percutaneous, tibial/peroneal artery(ies); with INTERVENTIONS ARE UNPROVEN, HAVE NO disease review intravascular lithotripsy, and transluminal stent CLINICALLY IMPORTANT BENEFIT OR HAVE placement(s), includes angioplasty within the HARMS THAT OUTWEIGH BENEFITS same vessel(s), when performed C9774 Revascularization, endovascular, open or 662 CONDITIONS FOR WHICH CERTAIN See intravascular lithotripsy for peripheral vascular percutaneous, tibial/peroneal artery(ies); with INTERVENTIONS ARE UNPROVEN, HAVE NO disease review intravascular lithotripsy and atherectomy, includes CLINICALLY IMPORTANT BENEFIT OR HAVE angioplasty within the same vessel (s), when HARMS THAT OUTWEIGH BENEFITS performed C9775 Revascularization, endovascular, open or 662 CONDITIONS FOR WHICH CERTAIN See intravascular lithotripsy for peripheral vascular percutaneous, tibial/peroneal artery(ies); with INTERVENTIONS ARE UNPROVEN, HAVE NO disease review intravascular lithotripsy and transluminal stent CLINICALLY IMPORTANT BENEFIT OR HAVE placement(s), and atherectomy, includes HARMS THAT OUTWEIGH BENEFITS angioplasty within the same vessel (s), when performed G0088 Professional services, initial visit, for the All lines with E&M codes administration of anti-infective, pain management, chelation, pulmonary hypertension, inotropic, or other intravenous infusion drug or biological (excluding chemotherapy or other highly complex drug or biological) for each infusion drug administration calendar day in the individual's home, each 15 minutes

G0089 Professional services, initial visit, for the All lines with E&M codes administration of subcutaneous immunotherapy or other subcutaneous infusion drug or biological for each infusion drug administration calendar day in the individual's home, each 15 minutes

G0090 Professional services, initial visit, for the All lines with E&M codes administration of intravenous chemotherapy or other highly complex infusion drug or biological for each infusion drug administration calendar day in the individual's home, each 15 minutes

VbBS Issue Summaries for 1-21-2021 2 2021 HCPCS

HCPC LONG DESCRIPTION Suggested Placement notes G2211 Visit complexity inherent to evaluation and All lines with E&M codes management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious condition or a complex condition. (add-on code, list separately in addition to office/outpatient evaluation and management visit, new or established) G2212 Prolonged office or other outpatient evaluation All lines with E&M codes and management service(s) beyond the maximum required time of the primary procedure which has been selected using total time on the date of the primary service; each additional 15 minutes by the physician or qualified healthcare professional, with or without direct patient contact (list separately in addition to cpt codes 99205, 99215 for office or other outpatient evaluation and management services) (do not report g2212 on the same date of service as 99354, 99355, 99358, 99359, 99415, 99416). (do not report g2212 for any time unit less than 15 minutes)

G2213 Initiation of medication for the treatment of opioid 4 SUBSTANCE USE DISORDER use disorder in the emergency department setting, including assessment, referral to ongoing care, and arranging access to supportive services (list separately in addition to code for primary procedure) G2214 Initial or subsequent psychiatric collaborative care All lines with E&M codes management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional

VbBS Issue Summaries for 1-21-2021 3 2021 HCPCS

HCPC LONG DESCRIPTION Suggested Placement notes G2250 Remote assessment of recorded video and/or 662 CONDITIONS FOR WHICH CERTAIN See telehealth related codes review images submitted by an established patient (e.g., INTERVENTIONS ARE UNPROVEN, HAVE NO store and forward), including interpretation with CLINICALLY IMPORTANT BENEFIT OR HAVE follow-up with the patient within 24 business HARMS THAT OUTWEIGH BENEFITS hours, not originating from a related service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment

G2251 Brief communication technology-based service, All lines with E&M codes See telehealth related codes review e.g. virtual check-in, by a qualified health care professional who cannot report evaluation and management services, provided to an established patient, not originating from a related service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment; 5?10 minutes of clinical discussion

G2252 Brief communication technology-based service, All lines with E&M codes See telehealth related codes review 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 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; 11-20 minutes of medical discussion

M0239 Intravenous infusion, bamlanivimab-xxxx, 399 INFLUENZA, NOVEL RESPIRATORY See COVID related code review includes infusion and post administration VIRUSES monitoring M0243 Intravenous infusion, casirivimab and imdevimab 399 INFLUENZA, NOVEL RESPIRATORY See COVID related code review includes infusion and post administration VIRUSES monitoring

VbBS Issue Summaries for 1-21-2021 4 2021 HCPCS

HCPC LONG DESCRIPTION Suggested Placement notes U0005 Infectious agent detection by nucleic acid (dna or Diagnostic Procedures File See COVID related code review rna); severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19]), amplified probe technique, cdc or non- cdc, making use of high throughput technologies, completed within 2 calendar days from date of specimen collection (list separately in addition to either hcpcs code u0003 or u0004) as described by cms-2020-01-r2

VbBS Issue Summaries for 1-21-2021 5 Carotid Sinus Baroreceptor Stimulation 2021 HCPCS Code Review

Code: C1825 Generator, neurostimulator (implantable), non-rechargeable with carotid sinus baroreceptor stimulation lead(s)

Definition: Implanting a baroreceptor stimulation device for resistant hypertension aims to lower blood pressure by electrically stimulating the carotid baroreflex, which controls blood pressure by regulating autonomic nervous activity

Similar codes: none

Evidence: 1) NICE 2015, Implanting a baroreceptor stimulation device for resistant hypertension i. Current evidence on the safety and efficacy of implanting a baroreceptor stimulation device for resistant hypertension is inadequate. Therefore, this procedure should only be used in the context of research. ii. Efficacy 1. RCT of 265 patients a. Non-statistically significant difference in blood pressure between group with initial turn on of device vs group with delayed turn on b. Response rates at 6 months (defined as a 10 mmHg or more drop in systolic blood pressure at month 6 compared with systolic blood pressure obtained 1 month after implantation) were 54% and 46% respectively (p=0.97). c. The mean decreases in systolic blood pressure at 6 months were 16±29 mmHg for immediate stimulation and 9±29 mmHg for deferred simulation (p=0.08). 2. Cohort study of 322 patients a. reported a mean decrease in blood pressure of 35/16 mmHg compared with pre-implantation, after a mean follow-up of 28 months 3. A case series of 45 patients treated by implantation of a bilateral baroreceptor stimulation device reported that mean blood pressure decreased by 21/12 mmHg in 37 evaluable patients after 3 months of baroreceptor stimulation (p=0.001). 4. A case series of 30 patients treated by implantation of a unilateral stimulation device reported a mean reduction in systolic blood pressure from the preimplant baseline of 26±3 mmHg at 3-month follow-up (p<0.001). The mean reduction was 26±4 mmHg at 6-month follow-up (p<0.001). iii. Safety 1. Nerve injury with residual deficit was reported in 5% (13/265) of patients and transient nerve injury was reported in 5% (12/265) of patients in a randomized controlled trial of 265 patients 2) Chunbin 2018, Systematic review and meta-analysis of baroreflex activation therapy VbBS Issue(BAT) for treatment Summaries of resistant hypertension for 1-21-2021 i. N=12 studies (1 RCT and 11 prospective studies)

Carotid Sinus Baroreceptor Stimulation 2021 HCPCS Code Review

ii. The data of analysis showed office systolic blood pressure (SBP)(WMD = −24.01, 95% CI = −28.65 to −19.36, P= 0.753I2 = 0.0%) and diastolic blood pressure (DBP)(WMD = −12.53, 95% CI = −15.82 to −9.24,P = 0.893,I2 = 0.893) decreased by BAT treatment. The effect on SBP was both significant in the Barostim neo TM device (WMD = −22.49, 95% CI = −29.13 to 15.84, P= 0.443; I2 = 0.0%) and Rheos System (WMD = 25.46, 95% CI = −31.96 to −18.96, P= 0.703; I2 = 0.0%). iii. Our study found office BP were significantly decreased by BAT treatment, but available evidence is limited by risk of bias, small sample size, and few RCTs. Thus, there is presently insufficient evidence to fully evaluate the efficacy and safety of BAT for Patients with Resistant Hypertension. Additional high-quality RCT research with long-term follow-up is required

Expert Guidelines 1) 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults https://www.jacc.org/doi/pdf/10.1016/j.jacc.2017.11.006 i. Several studies have investigated devices that interrupt sympathetic nerve activity (carotid baroreceptor pacing and catheter ablation of renal sympathetic nerves); however, these studies have not provided sufficient evidence to recommend the use of these device in managing resistant hypertension

Other payer policies 1) No private payer surveyed covered carotid sinus baroreceptor stimulators

VbBS Issue Summaries for 1-21-2021

Carotid Sinus Baroreceptor Stimulation 2021 HCPCS Code Review

HERC staff summary Systematic reviews and expert guidelines find insufficient evidence of effectiveness of carotid sinus baroreceptor stimulation for the treatment of resistant hypertension. This procedure appears to be experimental.

HERC staff recommendation: 1) Place HCPCS C1825 Generator, neurostimulator (implantable), non-rechargeable with carotid sinus baroreceptor stimulation lead(s) on line 662/GN173 as experimental

VbBS Issue Summaries for 1-21-2021

Nasal Cryoablation for Chronic Rhinitis 2021 HCPCS Code Review

Code: C9771 Nasal/sinus endoscopy, cryoablation nasal tissue(s) and/or nerve(s), unilateral or bilateral

Description: Chronic rhinitis is frequent inflammation of the nose with symptoms such as a runny nose, nasal congestion and post-nasal drip. Chronic rhinitis is typically treated with medications such as nasal steroids or allergy medications. Cryoablation of the posterior nasal nerve at the middle meatus is a new procedure for treatment nasal obstruction and symptoms of chronic rhinitis. This procedure is done in the office with topical anesthetic. Currently, the only device on the market for cryoablation of the nasal nerve is ClariFix.

Similar codes Previously, nasal cryoablation was coded with CPT 30117 (Excision or destruction (eg, laser), intranasal lesion; internal approach) and 31231 (Nasal endoscopy, diagnostic, unilateral or bilateral (separate procedure)). 30117 is on lines 202,287,465,506,525,576. 31231 is Diagnostic

Evidence 1) Yen 2020 Multiple Site Cryoablation Treatment of the Posterior Nasal Nerve for Treatment of Chronic Rhinitis: An Observational Feasibility Study a. N=30 patients b. prospective, nonrandomized, interventional, postmarket feasibility study c. The research for this study was funded by Arrinex, now part of Stryker ENT. a. There was a significant improvement from baseline in the median reflective Total Nasal Symptom Score (–4.0, P<.001) at 3months. Statistically significant improvements from baseline (P<.001) were also observed with the Nasal Obstruction Symptom Score (NOSE), nasal symptom visual analog scale (VAS), Sino-Nasal Outcomes Score (SNOT-22), and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ). Clinical Global Impression – Improvement (CGI-I) indicated that 89.7% (26/29) of participants experienced improvement at 3months. No serious adverse events were reported. b. Conclusion: Cryoablation at both the middle meatus and inferior meatus appears to be a safe and feasible option for treatment of chronic rhinitis. In this feasibility study, there is significant improvement in symptoms post treatment. Adverse events are minor and transient 2) Chang 2019, Cryosurgical Ablation for Treatment of Rhinitis: A Prospective Multicenter Study a. N=98 patients b. Prospective single arm trial c. Patients had to fail 4 weeks of intranasal steroid therapy, but not failure with ipratropium or other nonsteroidal medications a. many patients had tried other forms of medication b. Reflective Total Nasal Symptom Score significantly improved over pretreatment baseline (6.1 _ 1.9) at 1 month (2.9 ±1.9, P < 0.001), 3 months (3.0 ± 2.3, P < 0.001), 6 months (3.0 ± 2.1, P < 0.001), and 9 months (3.0 ± 2.4, P < 0.001) postprocedure. Nasal congestion and rhinorrhea subscores improved significantly at all time points (P < 0.001). Both allergic and nonallergic rhinitis subcohorts showed improvement (P < VbBS Issue0.001), with a comparable Summaries degree of improvement between for groups. 1-21-2021RQLQ significantly improved over pretreatment baseline (3.0 ± 1.0) at 3 months (1.5 ± 1.0, P < 0.001), and

Nasal Cryoablation for Chronic Rhinitis 2021 HCPCS Code Review

all RQLQ subdomains demonstrated improvement. Of 54 patients using intranasal medication at baseline, 19 (35.2%) were able to discontinue use. Twenty-nine adverse effects were reported, including headache, epistaxis, and sinusitis. c. Conclusion: Cryoablation of the PNN for chronic rhinitis is safe and can result in relief of nasal symptoms and improvements in quality of life. d. Limitations: Future randomized controlled studies, perhaps incorporating a sham treatment arm, would be helpful to further validate the efficacy of PNN cryoablation 3) Hwang 2017 Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis a. N=27 patients b. Prospective single arm study c. This study was sponsored by Arrinex, Inc. d. Reflective Total Nasal Symptom Score was reduced significantly at 30 days (mean ± standard deviation: 6.2 ± 0.5 at baseline, 2.6 ± 0.3 at 30 days, n = 27, p < 0.001), with continued reduction at 90 (2.7 ± 0.4, n = 24, p < 0.001), 180 (2.3 ± 0.5, n = 21, p < 0.001), and 365 days (1.9 ± 0.3, n = 15, p < 0.001). e. Conclusion: Office-based cryotherapy of the PNN region is safe and well tolerated. Symptom scores were significantly decreased by 7 days postprocedure and remained lower at 30, 90, 180, and 365 days

Other payer policies: None found

HERC staff summary Nasal cryoablation for chronic rhinitis has only been studied in small, non-randomized trials. This technology appears to be experimental.

HERC staff recommendation 1) Add nasal cryoablation for chronic rhinitis to line 662/GN173

Intravascular Lithotripsy for Peripheral Vascular Disease 2021 HCPCS Code Review

Codes C9772 Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies), with intravascular lithotripsy, includes angioplasty within the same vessel (s), when performed C9773 Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies); with intravascular lithotripsy, and transluminal stent placement(s), includes angioplasty within the same vessel(s), when performed C9774 Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies); with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel (s), when performed C9775 Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies); with intravascular lithotripsy and transluminal stent placement(s), and atherectomy, includes angioplasty within the same vessel (s), when performed

Description: Peripheral arterial disease (PAD) involves the partial or total occlusion of blood vessels in the legs. Severe PAD can result in ulcers, claudication, and limb amputation. There are multiple treatment options for peripheral vascular disease, including revascularization, balloon angioplasty, and stenting. A newly FDA approved treatment is intravascular lithotripsy, which uses pulsatile sonic waves to fracture intimal and medial vascular calcium. The only device currently on the market is the Shockwave Medical Peripheral IVL System (Shockwave Medical, Santa Clara, CA).

Evidence 1) Madahavan 2020, individual patient-level data (IPD) pooled meta-analysis of available trial data on intravascular lithotripsy for the treatment of peripheral arterial disease a. N=5 trials (N=336 patients) i. Trials: DISRUPT PAD I, PAD II, PAD III, Disrupt BTK, and CFA. ii. All trials were “single arm studies with no comparators” iii. Add data provided by Shockwave Medical iv. Procedure performed on the iliac artery (9.0%), common femoral artery (13.4%), superficial femoral artery (54.1%), popliteal (16.5%), and infrapopliteal (7.0%) lesions b. There was a significant reduction between pre-procedural and final percent diameter stenosis of 55.1% (95% confidence interval 53.3–57.0%, p < .0001). c. Assessed lesion-level complications, including flow-limiting dissections (Types D–F), vessel perforation, distal embolization, thrombus, abrupt closure, and no reflow, occurred in 4/328 (1.22%) of treated lesions d. Unable to effectively compare the efficacy and safety of IVL with other endovascular PAD treatment devices e. Conclusions: This IPD of five prospective studies, marking the largest analysis to date evaluating the use of IVL in significantly calcified PAD lesions, demonstrates this treatment strategy to be both effective and safe. f. Limitations: Larger cohorts will need to be studied to verify these observations. To fully understand the comparative effectiveness of these therapies, head-to-head strategy VbBS Issuetrials would need Summaries to be conducted for 1-21-2021

Intravascular Lithotripsy for Peripheral Vascular Disease 2021 HCPCS Code Review

Private payers: 1) Aetna 2020 a. Aetna considers intravascular shockwave lithotripsy of the anterior tibial, common iliac, external iliac, internal iliac, popliteal, posterior tibial, peroneal arteries, and superficial femoral artery for the treatment of atherosclerosis / calcified peripheral arterial lesions / intermittent claudication experimental and investigational because the effectiveness of this approach has not been established 2) No other published policies found

HERC staff summary intravascular shockwave lithotripsy of the lower extremity arteries has only been studied in small, nonrandomized trials. This technology appears to be experimental.

HERC staff recommendation 1) Add peripheral artery shockwave lithotripsy to line 662/GN173

VbBS Issue Summaries for 1-21-2021

Telehealth Related Codes 2021 HCPCS Code Review

Codes Store and forward 1) G2250 Remote assessment of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment a. CMS comment: We…proposed to allow billing of other Communications Technology- based Services (CTBS) by certain NPPs, consistent with the scope of these practitioners’ benefit categories, through the creation of two additional HCPCS G codes that can be billed by practitioners who cannot independently bill for E/M services b. Explanation: Expands the group of providers who can bill G2010 type services (store and forward) to include PT, OT, speech language pathologists, and similar providers c. Similar code: G2010 Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related 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 i. HCPCS G2010 was previously on all lines with E&M codes. It was removed from all lines and placed on Line 662 in March 2020. The March 2020 meeting materials state: “Store-and-forward is currently on 600+ lines but not open for payment. Medical decision making based on review of patient-submitted images could be captured by other approved codes and through the new guideline, as appropriate. The code for store-and-forward can be removed from funded lines.” ii. However, G2010 was never removed from Ancillary Guideline A5 TELEHEALTH, TELECONSULTATIONS AND ONLINE/TELEPHONIC SERVICES and no entry was made for it in Guideline note 173.

Brief virtual check in (by audio (including telephone) or audio/video) 1) G2251 Brief communication technology-based service, e.g. virtual check-in, by a qualified health care professional who cannot report evaluation and management services, provided to an established patient, not originating from a related service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of clinical discussion 2) G2252 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 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; 11-20 minutes of medical discussion a. CMS comment: Given the widespread concerns expressed by commenters about the continuing need for audio-only conversations with patients, we believe it would be expedient to establish additional coding and payment for an extended audio-only assessment service on an interim basis for CY 2021. We believe that establishing payment for this service on an interim basis will support access to care for beneficiaries VbBS Issuewho may be reluctant Summaries to return to in-person visits unless forabsolutely necessary,1-21-2021 and

Telehealth Related Codes 2021 HCPCS Code Review

allow us to consider whether this policy should be adopted on a permanent basis. Therefore, for CY 2021, on an interim basis, we are establishing HCPCS code G2252…. We are finalizing a direct crosswalk to CPT code 99442… In the case of HCPCS code G2252 and CPT code 99442, both codes describe 11-20 minutes of medical discussion when the practitioner may not necessarily be able to visualize the patient, and is used when the acuity of the patient’s problem is not necessarily likely to warrant a visit, but when the needs of the particular patient require more assessment time from the practitioner. In the case of HCPCS code G2252, the additional time would be used to determine the necessity of an in person visit result in a work time/intensity that is similar to the crosswalk code. We are finalizing a work RVU of 0.50 b. Explanation: G2251 expands the billing for G2012-type service to providers who are not able to bill E/M codes (PT/OT/Speech). G2252 expands the time involved in G2012 past 10 minutes c. Similar 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 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 i. All lines with E&M codes, in Ancillary Guideline A5 ii. Added to the HSD fee schedule in 2020; new code as of 2019

VbBS Issue Summaries for 1-21-2021

Telehealth Related Codes 2021 HCPCS Code Review

HERC staff recommendations: 1) Add HCPCS G2250 to line 662 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS a. Matches intended placement of HCPCS G2010 2) Create an entry for HCPCS G2010 and G2250 in GN173 as shown below a. HCPCS 2010 was never added to GN173 when previously removed from all lines 3) Add HCPCS G2251- G2252 to all lines with E&M codes a. Matches placement of similar codes HCPCS G2012 4) Modify Ancillary Guideline A5 as shown below a. Adds G2251 and G2252 b. Removes G2010 (as previously removed from all lines and placed on line 662)

ANCILLARY GUIDELINE A5, TELEHEALTH, TELECONSULTATIONS AND ONLINE/TELEPHONIC SERVICES Telehealth services include a variety of health services provided by synchronous or asynchronous electronic communications, including secure electronic health portal, audio, or audio and video as well as remote monitoring devices.

Criteria for coverage

The clinical value of the telehealth service delivered must reasonably approximate the clinical value of the equivalent services delivered in-person.

Coverage of telehealth services requires the same level of documentation, medical necessity, and coverage determinations as in-person visits. Specifically, covered telehealth services must meet all of the following criteria. A) Documentation must include all of the following: 1) use model SOAP charting, or as described in program’s OAR; 2) include patient history, provider assessment, treatment plan and follow-up instructions; 3) support the assessment and plan; 4) retain encounter in the patient’s medical record and be retrievable. B) Include medical decision making or service delivery (e.g. behavioral health intervention/psychotherapy, other forms of therapy). VbBSC) Include Issue permanent storage Summaries (online or hard copy) of the encounter. for 1-21-2021

Telehealth Related Codes 2021 HCPCS Code Review

D) Meet applicable HIPAA standards for privacy and security, except for regulations for which federal authorities are exercising enforcement discretion. (Certain requirements for encryption will not be enforced by federal authorities (or required by OHP) during the COVID-19 emergency.) This means services such as Facetime, Skype or Google Hangouts can be used for service delivery. See https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency- preparedness/notification-enforcement-discretion-telehealth/index.html for details.) HIPAA compliant platforms should be used whenever possible. E) Include patient-clinician agreement of informed consent, discussed with and agreed to by the patient and documented in the medical record.

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

Examples of non-reimbursable telehealth services include but are not limited to: A) Prescription renewal. B) Scheduling a test. C) Reporting normal test results. D) Requesting a referral. E) Services which are part of care plan oversight or anticoagulation management (CPT codes 99339-99340, 99374-99380 or 99363-99364). F) Services which relate to or take place within the postoperative period of a procedure provided by the physician are not separately covered. (Such a service is considered part of the procedure and is not be billed separately.)

Telehealth services billed using in-person codes

Telehealth services described in this section are synchronous services, generally provided with both audio and video capability and billed with the same procedure codes that would be billed for in-person services, with mode of delivery indicated by the use of specific modifiers and/or place of service codes specified by the plan. Telephone visits are an acceptable replacement for the equivalent service provided by synchronous audio and video, if synchronous audio and video capabilities are not available or feasible.

The patient may be in the community or in a health care setting. The provider may be in any location in which appropriate privacy can be ensured. If language services are provided, the interpreter may be in any location in which appropriate privacy can be ensured.

Codes eligible for telehealth delivery billed in this manner include 90785, 90791, 90792, 90832-90834, 90836, 90837-90840, 90846, 90847, 90951, 90952, 90954, 90955, 90957, 90958, 90960, 90961, 90963, 90964-90970, 96116, 96156-96171, 96160, 96161, 97802-97804, 99201-99205, 99211-99215, 99231- 99233, 99307-99310, 99354-99357, 99406-99407, 99495-99498, G0108-G0109, G0270, G0296, G0396, G0397, G0406-G0408, G0420, G0421, G0425-G0427, G0438-G0439, G0442-G0447, G0459, G0506, G0508, G0509, G0513, G0514, G2086-G2088. Additional codes are covered when otherwise appropriate VbBSaccording to Issuethis guideline note andSummaries other applicable coverage criteria. for 1-21-2021

Telehealth Related Codes 2021 HCPCS Code Review

The originating site code Q3014 is covered only when the patient is present in an appropriate health care setting and receiving services from a provider in another location.

Telehealth services are covered for inpatient, outpatient and emergency services for new or established patients.

Clinician to Patient Services billed using specified codes indicating telephone or online service delivery

Telephonic and online services, including services related to diagnostic workup (CPT 98966-98968, 99441-99443, 99421-99423, 98970-98972, G2010, G2012, G2061-G2063, G2251-G2253) are covered for services for new and established patients.

Covered telephone and online services billed using these codes do not include either of the following: A) Services related to a service performed and billed by the physician or qualified health professional within the previous seven days, regardless of whether it is the result of patient- initiated or physician-requested follow-up. B) Services which result in the patient being seen within 24 hours or the next available appointment.

Clinician-to-Clinician Consultations (telephonic, online or using electronic health record)

Coverage of interprofessional consultations delivered online, through electronic health records or by telephone is included as follows:

Consulting Providers (CPT 99451, 99446-99449) A) For new or established patients. B) Consult must be requested by another provider. C) Can be for a new or an exacerbated condition. D) Cannot be reported more than 1 time per 7 days for the same patient. E) Must report cumulative time spent, even if time occurs over multiple days. F) Cannot be reported if a transfer of care or request for face-to-face visit occurs as a result of the consultation within the following 14 days. G) Cannot be reported if the patient was seen by the consultant within the past 14 days. H) The request and reason for consultation is documented in the patient’s medical record. I) Requires a minimum of 5 minutes of medical consultation, discussion and/or review.

Requesting Providers (CPT 99452) A) Consult must be reported by requesting provider. (not for the transfer of a patient or request for face-to-face consult) B) Reported only when the patient is not on-site with the requesting provider at the time of consultation. C) Cannot be reported more than 1 time per 14 days per patient. D) Requires a minimum of 16 minutes. Includes time for referral prep and/or communicating with the consultant. E) Can be reported with prolonged services, non-direct. VbBS Issue Summaries for 1-21-2021

Telehealth Related Codes 2021 HCPCS Code Review

Limited information provided by one clinician to another that does not constitute 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.

VbBS Issue Summaries for 1-21-2021

COVID Related 2021 HCPCS Codes

HCPCS Code description Notes Proposed placement Additional information Code M0239 Intravenous infusion, bamlanivimab-xxxx, Used for monoclonal 399 INFLUENZA, NOVEL Effective 11/10/2020 includes infusion and post administration antibody therapy for RESPIRATORY VIRUSES monitoring COVID-19 HSD has placed on the Ancillary List until the next published Prioritized List M0243 Intravenous infusion, casirivimab and Used for monoclonal 399 INFLUENZA, NOVEL Effective 11/10/2020 imdevimab includes infusion and post antibody therapy for RESPIRATORY VIRUSES administration monitoring COVID-19 See M0239 above U0005 Infectious agent detection by nucleic acid U0005 is an add on code Diagnostic Procedures File Effective January 1, (dna or rna); severe acute respiratory that allows CMS to pay a 2021 syndrome coronavirus 2 (sars-cov-2) bonus to labs that have a (coronavirus disease [covid-19]), amplified 48 hour or less turn around Unclear if this code is probe technique, cdc or non-cdc, making use time on COVID testing allowable for use by of high throughput technologies, completed any non-Medicare within 2 calendar days from date of payers specimen collection (list separately in addition to either hcpcs code u0003 or u0004) as described by cms-2020-01-r2

VbBS Issue Summaries for 1-21-2021 2022 Biennial Review Uterine Polyps

Questions: 1) Should a new line for uterine polyps be created on the Prioritized List? 2) Should the Prioritized List coverage of hysteroscopy with or without polypectomy be clarified?

Question sources: 1) CareOregon 2) Samaritan Health CCO

Issue: Hysterectomy and other treatments pair with uterine polyps (ICD 10 N84.0 Polyp of corpus uteri) on line 404 UTERINE LEIOMYOMA AND POLYPS. There is a guideline attached to line 404 regarding when hysterectomy is covered for leiomyoma (fibroids) but nothing in the guideline regarding treatment of uterine polyps.

Uterine polyps are growths attached to the inner wall of the uterus that extend into the uterine cavity. Overgrowth of cells in the endometrium leads to the formation of uterine polyps, also known as endometrial polyps. These polyps are usually benign, although some can be cancerous or can eventually turn into cancer (precancerous polyps). Uterine polyps can be asymptomatic or cause abnormal uterine bleeding.

Polyps are diagnosed by transvaginal ultrasound or hysteroscopy. Treatment includes observation, (generally reserved for small, asymptomatic polyps), hormonal medications, or surgical removal via hysteroscopy with polypectomy or dilation and curettage (D&C). Hysterectomy is only required if the polyp is found to be cancerous. In that case, the hysterectomy would be a radical hysterectomy for endometrial cancer.

CareOregon has gotten requests for hysterectomy for uterine polyps without any biopsy or other information indicating that the polyp is cancerous.

Samaritan Health requested clarification regarding coverage for hysteroscopy for uterine polyp treatment. Hysteroscopy is on the Diagnostic Procedure File, which generally requires that the CPT code be paired with a ICD-10 code from the Diagnostic Workup File (DWF) or a line on the Prioritized List. For example, hysteroscopy might be paired with menorrhagia. Of note, all ICD10 codes for abnormal uterine bleeding other than post-coital bleeding (ICD10 N93.0) appear on line 422 MENSTRUAL BLEEDING DISORDERS.

VbBS Issue Summaries for 1-21-2021

2022 Biennial Review Uterine Polyps

Current Prioritized List status ICD10 Code Description Current Placement Comments Code C54 Malignant neoplasm of 208 CANCER OF UTERUS Per coding convention, to be uterus used for malignant uterine polyp, although N84.0 is also commonly used N84.0 Polyp of corpus uteri 404 UTERINE LEIOMYOMA AND POLYPS N84.1 Polyp of cervix uteri 629 BENIGN GYNECOLOGICAL CONDITIONS N84.2 Polyp of vagina 25 ABNORMAL PAP SMEARS; DYSPLASIA OF CERVIX AND CERVICAL CARCINOMA IN SITU, CERVICAL CONDYLOMA N84.3 Polyp of vulva 629 N84.8 Polyp of other parts of 404 Subdiagnoses are polyps of female genital tract the fallopian tube N84.9 Polyp of female genital 404 No subdiagnoses tract, unspecified

CPT code Code Description Current Placement 58120 Dilation and curettage, diagnostic 25 ABNORMAL PAP SMEARS; DYSPLASIA OF and/or therapeutic (nonobstetrical) CERVIX AND CERVICAL CARCINOMA IN SITU, CERVICAL CONDYLOMA 37 ECTOPIC PREGNANCY; HYDATIDIFORM MOLE; CHORIOCARCINOMA 208 CANCER OF UTERUS 353 STRUCTURAL CAUSES OF AMENORRHEA 404 UTERINE LEIOMYOMA AND POLYPS 422 MENSTRUAL BLEEDING DISORDERS 438 FOREIGN BODY IN UTERUS, VULVA AND VAGINA 58558 Hysteroscopy, surgical; with sampling DIAGNOSTIC PROCEDURES (biopsy) of endometrium and/or polypectomy, with or without D & C

GUIDELINE NOTE 40, UTERINE LEIOMYOMA Line 404 Hysterectomy, myomectomy, or uterine artery embolization for leiomyomata may be indicated when all of the following are documented (A-D): A) One of the following (1 or 2): 1) Patient history of 2 out of 3 of the following (a, b and c): VbBS a.Issue Leiomyomata enlarging Summaries the uterus to a size of 12 weeks orfor greater gestation1-21-2021 b. Pelvic discomfort cause by myomata (i or ii or iii):

2022 Biennial Review Uterine Polyps

i) Chronic lower abdominal, pelvic or low backpressure ii) Bladder dysfunction not due to urinary tract disorder or disease iii) Rectal pressure and bowel dysfunction not related to bowel disorder or disease c. Rapid enlargement causing concern for sarcomatous changes of malignancy 2) Leiomyomata as probable cause of excessive uterine bleeding evidenced by (a, b, c and d): a. Profuse bleeding lasting more than 7 days or repetitive periods at less than 21-day intervals b. Anemia due to acute or chronic blood loss (hemoglobin less than 10 or hemoglobin less than 11 g/dL if use of iron is documented) c. Documentation of mass by sonography d. Bleeding causes major impairment or interferes with quality of life B) Nonmalignant cervical cytology, if cervix is present C) Assessment for absence of endometrial malignancy in the presence of abnormal bleeding D) Negative preoperative pregnancy test result unless patient is postmenopausal or has been previously sterilized

Expert input: Dr. Michael Adler: uterine polyps should not be treated with hysterectomy. If the polyp is malignant, then the diagnosis is endometrial cancer and the surgery is much more extensive.

VbBS Issue Summaries for 1-21-2021

2022 Biennial Review Uterine Polyps

HERC staff summary Uterine polyps are inappropriately paired with hysterectomy, which is causing confusion. Hysteroscopy is Diagnostic, which is also causing confusion with providers and CCOs.

HERC staff recommendations: 1) Create a new line for uterine polyps as shown below 2) Rename line 404 UTERINE LEIOMYOMA AND POLYPS a. Remove ICD=10 N84.1 (Polyp of corpus uteri), N84.8 (Polyp of other parts of female genital tract) and N84.9 (Polyp of female genital tract, unspecified) from line 404 3) Add CPT 58558 (Hysteroscopy, surgical; with sampling (biopsy) of endometrium and/or polypectomy, with or without D & C) to all lines with D&C and advise HSD to remove CPT 58558 from the Diagnostic Procedure File a. 25 ABNORMAL PAP SMEARS; DYSPLASIA OF CERVIX AND CERVICAL CARCINOMA IN SITU, CERVICAL CONDYLOMA b. 37 ECTOPIC PREGNANCY; HYDATIDIFORM MOLE; CHORIOCARCINOMA c. 208 CANCER OF UTERUS d. 353 STRUCTURAL CAUSES OF AMENORRHEA e. 404 UTERINE LEIOMYOMA AND POLYPS f. 422 MENSTRUAL BLEEDING DISORDERS g. 438 FOREIGN BODY IN UTERUS, VULVA AND VAGINA

Line: XXX Condition: UTERINE POLYPS Treatment: MEDICAL AND SURGICAL TREATMENT ICD-10: N84.1 (Polyp of corpus uteri), N84.8 (Polyp of other parts of female genital tract) and N84.9 (Polyp of female genital tract, unspecified) CPT: 58120 (Dilation and curettage, diagnostic and/or therapeutic (nonobstetrical)), 58558 (Hysteroscopy, surgical; with sampling (biopsy) of endometrium and/or polypectomy, with or without D & C); ,98966-98972,99051,99060,99070,99078,99184,99201-99239,99281- 99285,99291-99404,99408-99449,99451,99452,99468-99472,99475-99480,99487-99491, 99495-99498,99605-99607 (office visits, etc.) HCPCS: G0068,G0071,G0248-G0250,G0396,G0397,G0406-G0408,G0425-G0427,G0463-G0467, G0490,G0508-G0511,G2011,G2012,G2058-G2065 (FQHC visits, etc.)

Prioritization of UTERINE POLYPS Treatment: MEDICAL AND SURGICAL TREATMENT (Current scores for line 404 shown in parentheses) Category: 7 (7) Healthy life years: 3 (3) Suffering: 2 (2) Population effects: 0 (0) Vulnerable population: 0 (1) Tertiary prevention: 2 (2) Effectiveness: 5 (5) Need for treatment: 0.5 (0.5) Net cost: 3 (3) Score: 350 (400) VbBSLine placement: Issue 422 (404) Summaries for 1-21-2021

2022 Biennial Review Symptomatic Inguinal Hernias in Adults

Question: Should symptomatic inguinal hernias in adults be moved to a covered line?

Question source: Multiple CCOs, OHA ombudsperson office, legislators

Issue: Currently, inguinal hernias are only on a covered line for children 18 and under, and for adults if strangulated or obstructed. Uncomplicated inguinal hernias that are painful or impede the patient’s ability to work are included on uncovered line. The OHA ombudsperson reports multiple calls and complaints about OHP patients who cannot return to work due to symptomatic hernias. Several CCOs also are requesting consideration of repair of symptomatic hernias in adults.

Hernia repair surgery is the most common elective surgery in the US. Coverage for repair of uncomplicated ventral and/or inguinal hernia has been discussed extensively at the Health Services Commission and the HERC (see below).

History: 1) 1998 biennial review considered moving uncomplicated hernias for patients over age 18 from the low uncovered line to a covered line. Noted that complicated/obstructed hernias had a death rate of 10% if untreated, and 0.5% if treated. No change was made with that review other than adding some surgical CPT codes missing from the covered line. 2) 2002 biennial review looked at coverage for uncomplicated hernia. In that review, ventral hernias were added to the lower, uncovered hernia line. 3) In 2005, ventral hernias were considered for addition to the upper hernia line, but not moved. Reducible umbilical hernias in children were moved to the lower, uncovered line. 4) In 2006, the current guideline was added to clarify when hernias were on the covered upper line. 5) In 2007, coverage for hernias in children was reviewed, and coverage maintained due to evidence of higher rates of complications for children. 6) In 2008, the guideline was clarified that all incarcerated hernias are on the upper line. Laparoscopic repair codes were added to the upper hernia line 7) In 2008, repair of large ventral hernias was reviewed. The outcomes of repair of large ventral hernias, with our without mesh, was found to be poor. 8) In 2010, Dr. Gubler, a surgeon on the HOSC, recommended coverage of inguinal hernias, as femoral hernias were covered. He also felt that fat incarceration rather than intestinal incarceration, should be a covered indication for repair. No changes were made based on his recommendations. 9) In 2012, the ICD-10 general surgery review group proposed diving the two hernia lines into 3 lines. The evidence supporting the safety of expectant management was discussed. Members decided to continue the current line structure for hernias. All ventral hernias were moved to the lower, uncovered line. 10) In 2014, ventral hernias were again discussed and the hernia guideline modified to clarify coverage. 11) In 2015, ventral hernias were again discussed and lack of any coverage, even when incarcerated, was clarified again. 12) In November 2016, VBBS and HERC elected to not change current coverage of inguinal hernias VbBSas partIssue of the 2018 biennial Summaries review. for 1-21-2021

1 2022 Biennial Review Symptomatic Inguinal Hernias in Adults

The 2015-2016 review of hernias included several RCTs and meta-analyses. The staff summary was: “Based on two large RCTs as well as several meta-analyses, there appears to be a low rate of progression of inguinal hernia to incarceration or obstruction. When obstruction or incarceration does occur, the complication rate for emergency surgery compared to elective repair appears to be similar. It is important to note that these studies were all done in asymptomatic or minimally symptomatic patients, and patients who developed pain were no longer followed by watchful waiting. In several large studies, the rate of eventual surgical repair, mainly due to the development of pain, was very high. The AHRQ report found that quality of life was significantly improved with surgical repair. Repair of inguinal hernia was not generally associated with improved function, but the functional measures were likely skewed by the repair of painful hernias. It appears to be standard of care to allow repair for painful inguinal hernia.”

Current Prioritized List lack of coverage of uncomplicated painful hernias cannot be evaluated using the current literature, as it is standard of care to repair such hernias. No modern medical system is studying non-coverage of painful hernias. The literature that is found focuses on which patients can be safely watched, due to their being poor surgical risks of refusing surgery. However, the baseline assumption of those studies is that the patients should have their hernias repaired unless there is a high surgical risk or patient refusal.

From the ombudsperson office: I suspect about 5 or 6 cases since the beginning of the year, including the one I sent you. This is not a lot in relation to the call volume we receive but as a concern about a singular service and benefit, it stands out.

I am aware of the reason HERC has hernia repairs below the line. Surgeries may be successful in the short run but not the long. I have no idea how HERC might consider parsing this issue out more finely. But here is what I would share as common themes for the cases the Ombuds program receives: • The hernia is causing mobility issues, employment issues or/and pain. Sometimes those mobility issues impact things those of us without these kinds of hernias take for granted, ability to lean over and pick up kids for example. • I suspect that in all the cases we receive, had the patients had private insurance or Medicare or public employee insurance, hernia repair surgery would have been done without question.

VbBS Issue Summaries for 1-21-2021

2022 Biennial Review Symptomatic Inguinal Hernias in Adults

Current Prioritized List status Line: 168 Condition: COMPLICATED HERNIAS; UNCOMPLICATED INGUINAL HERNIA IN CHILDREN AGE 18 AND UNDER; PERSISTENT HYDROCELE (See Guideline Notes 24,63,149) Treatment: REPAIR ICD-10: K40.00-K40.91,K41.00-K41.11,K41.30-K41.41,K42.0-K42.1,K43.0-K43.1,K43.3-K43.4,K43.6- K43.7,K44.0-K44.1,K45.0-K45.1,K46.0-K46.1,N43.0,N43.2-N43.3,P83.5 CPT: 39503-39541,39560,39561,43281-43283,44050,44120,44346,49491-49572,49582,49587, 49590,49650-49659,55040-55060,98966-98972,99051,99060,99070,99078,99184,99201- 99239,99281-99285,99291-99404,99408-99449,99451,99452,99468-99472,99475-99480, 99487-99491,99495-99498,99605-99607 HCPCS: G0068,G0071,G0248-G0250,G0396,G0397,G0406-G0408,G0425-G0427,G0463-G0467, G0490,G0508-G0511,G2011,G2012,G2058-G2065

Line: 524 Condition: UNCOMPLICATED HERNIA AND VENTRAL HERNIA (OTHER THAN INGUINAL HERNIA IN CHILDREN AGE 18 AND UNDER OR DIAPHRAGMATIC HERNIA) (See Guideline Note 24) Treatment: REPAIR ICD-10: K40.20-K40.21,K40.90-K40.91,K41.20-K41.21,K41.90-K41.91,K42.0,K42.9,K43.0,K43.2- K43.3,K43.5-K43.6,K43.9,K45.0,K45.8,K46.0,K46.9 CPT: 44050,49250,49505,49520,49525-49550,49555,49560,49565,49568,49570,49580,49585, 49590,49650-49659,55540,98966-98972,99051,99060,99070,99078,99184,99201-99239, 99281-99285,99291-99404,99408-99449,99451,99452,99468-99472,99475-99480,99487- 99491,99495-99498,99605-99607 HCPCS: G0068,G0071,G0248-G0250,G0396,G0397,G0406-G0408,G0425-G0427,G0463-G0467, G0490,G0508-G0511,G2011,G2012,G2058-G2065

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) 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 and K46.0 are included on Line 524 when used to designate incarcerated abdominal incisional and umbilical hernias without intestinal obstruction or gangrene.

VbBS Issue Summaries for 1-21-2021

2022 Biennial Review Symptomatic Inguinal Hernias in Adults

Evidence Inguinal hernia, watchful waiting (WW) vs surgical repair 1) Gong 2018, meta-analysis of watchful watching vs surgical repair for asymptomatic or minimally symptomatic inguinal hernias a. N=8 RCTs (1303 patients) b. The meta-analysis showed statistically less pain on movement in the Operation group than the WW group [OR=0.43, 95%CI (0.30,0.61), p < 0.01] i. Pain was a important factor for patients to cross over to surgery in WW group c. There was no significant difference in physical component score (quality of life) between Operation group and WW group (p=0.29) d. There was no significant difference in mortality [OR=1.11, 95%CI (0.67, 1.83), p=0.70] e. estimated crossover rate was 68% at 10 years from randomization. f. Based on the present meta-analysis, we suggest that watchful waiting is a relative safe and acceptable method for asymptomatic or minimally symptomatic inguinal hernias in short-term, and WW would merely delay rather than avoid operation in the majority of patients. 2) Schroeder 2019, review of watchful waiting for inguinal hernia a. 3 RCTs of watchful waiting vs elective hernia repair b. Recent evidence from 3 randomized controlled trials suggests that routine repair of all inguinal hernias at diagnosis is not necessary in asymptomatic or minimally symptomatic men. c. Patients with symptoms caused by their hernias benefit from operative therapy to eliminate pain. d. A strategy of watchful waiting for patients with minimally symptomatic hernias has been shown to be safe; however, patients should be counseled that the crossover rate to surgery approaches 75% by 10 years. i. Crossover most commonly is due to the development of pain (47-91% of patients) e. These data should not be extrapolated to women, as the natural history is different from men, and watchful waiting should not be routinely recommended. f. The European Hernia Society (EHS) guidelines were updated in 2014 and include the following statement and recommendation: i. Watchful waiting is safe and an acceptable option for men with minimally symptomatic or asymptomatic inguinal hernias. It is very likely (70% chance) that, in time, the symptoms will increase leading to surgical intervention. (Level 1B)

Surgical technique 1) Lockhart 2018, Cochrane review of mesh vs non-mesh for inguinal hernia repair a. N=25 studies (6293 patients) with inguinal hernias b. Mesh repair probably reduces the risk of hernia recurrence compared to non-mesh repair (21 studies, 5575 participants; RR 0.46, 95% CI 0.26 to 0.80, I2 = 44%, moderate- quality evidence). In absolute numbers, one hernia recurrence was prevented for every 46 mesh repairs compared with non-mesh repairs. c. Twenty-four studies (6293 participants) assessed a wide range of complications with varying follow-up times. Neurovascular and visceral injuries were more common in non- VbBS Issuemesh repair groups Summaries (RR 0.61, 95% CI 0.49 to 0.76, I2 = 0%, for NNTB = 22,1-21-2021 high-quality

2022 Biennial Review Symptomatic Inguinal Hernias in Adults

evidence). Wound infection was found slightly more commonly in the mesh group (20 studies, 4540 participants; RR 1.29, 95% CI 0.89 to 1.86, I2 = 0%, NNTB = 200, low- quality evidence). Mesh repair reduced the risk of hematoma compared to non-mesh repair (15 studies, 3773 participants; RR 0.88, 95% CI 0.68 to 1.13, I2 = 0%, NNTB = 143, low-quality evidence). Seromas probably occur more frequently with mesh repair than with non-mesh repair (14 studies, 2640 participants; RR 1.63, 95% CI 1.03 to 2.59, I2 = 0%, NNTB = 72, NNTB = 72, moderate-quality evidence). The comparative effect on wound dehiscence is uncertain due to wide confidence intervals (two studies, 329 participants; RR 0.55, 95% CI 0.12 to 2.48, I2 = 37% NNTB = 77, low-quality evidence). Testicular complications showed nearly equivocal results; they probably occurred slightly more often in the mesh group however the confidence interval around the effect was wide (14 studies, 3741 participants; RR 1.06, 95% CI 0.63 to 1.76, I2 = 0%, NNTB = 2000, low-quality evidence). Mesh reduced the risk of postoperative urinary retention compared to non-mesh (eight studies, 1539 participants; RR 0.53, 95% CI 0.38 to 0.73, I2 = 56%, NNTB = 16, moderate quality evidence). d. Postoperative and chronic pain could not be compared due to variations in measurement methods and follow-up time (low-quality evidence). e. No deaths occurred during the follow-up periods reported in the seven studies (2546 participants) reporting this outcome (high-quality evidence). f. The average operating time was longer for non-mesh repairs by a mean of 4 minutes 22 seconds, despite wide variation across the studies regarding size and direction of effect, thus this result is uncertain (20 studies, 4148 participants; 95% CI -6.85 to -1.60, I2= 97%, very low quality evidence). Hospital stay may be shorter with mesh repair, by 0.6 days (12 studies, 2966 participants; 95% CI -0.86 to -0.34, I2 = 98%, low-quality evidence), and participants undergoing mesh repairs may return to normal activities of daily living a mean of 2.87 days sooner than those with non-mesh repair (10 studies, 3183 participants; 95% CI -4.42 to -1.32, I2 = 96%, low-quality evidence), although the results of both these outcomes are also limited by wide variation in the size and direction of effect across the studies. g. Authors' conclusions Mesh and non-mesh repairs are effective surgical approaches in treating hernias, each demonstrating benefits in different areas. Compared to non-mesh repairs, mesh repairs probably reduce the rate of hernia recurrence, and reduce visceral or neurovascular injuries, making mesh repair a common repair approach.

VbBS Issue Summaries for 1-21-2021

2022 Biennial Review Symptomatic Inguinal Hernias in Adults

HERC staff summary Inguinal hernias are common. Watchful waiting can be a reasonable option for asymptomatic or minimally symptomatic patients. However, studies of watchful waiting showed that the majority (approximately 75%) of patients cross over to having surgery, generally due to pain. There are no studies on outcomes in patients who developed pain or dysfunction due to inguinal hernias and do not have repair. It is standard of care in high-income countries to allow repair for painful inguinal hernia. One systematic review pointed out that the natural history of inguinal hernias is different in women, and all women should have such hernias repaired.

Meta-analysis of type of repair finds that mesh vs non-mesh repair are equivalent in outcomes, including pain, need for repeat surgery, and complications.

HERC staff recommendations: 1) Modify GN24 as shown below to allow inguinal hernia repair in an expanded set of circumstances a. Continue to not cover inguinal hernia repair for asymptomatic or minimally symptomatic patients b. Discuss whether women should be treated as a separate group

GUIDELINE NOTE 24, COMPLICATED HERNIAS Lines 168,524 Complicated inguinal and femoral hernias in men are included on Line 168 if 1) They cause symptoms of intestinal obstruction and/or strangulation; OR 2) They are incarcerated (defined as non-reducible by physical manipulation); OR 3) They cause significant pain or functional limitations; OR 4) Affect the patient’s ability to obtain or maintain gainful employment.

Repair of inguinal and femoral hernias in women are included on Line 168 due to the different natural history of disease in this population.

Ventral hernias are included on line 524. Incarcerated ventral hernias (including incarcerated abdominal incisional 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). K42.0, K43.0, K43.3, K43.6 and K46.0 are included on Line 524 when used to designate incarcerated abdominal incisional and umbilical hernias without intestinal obstruction or gangrene.

VbBS Issue Summaries for 1-21-2021

6 Panniculectomy

Question: Should panniculectomy be moved to a covered line; if so, with what restrictions?

Question source: OHA Ombuds office, HERC staff

Issue: Panniculectomy [15830 (Excision, excessive skin and subcutaneous tissue (includes lipectomy); abdomen, infraumbilical panniculectomy) is currently on Line 625 SEBORRHEIC KERATOSIS, DYSCHROMIA, AND VASCULAR DISORDERS, SCAR CONDITIONS, AND FIBROSIS OF SKIN. CPT 15847 (Removal of Excess Abdominal Tissue Add-on Excision, excessive skin and subcutaneous tissue (includes lipectomy), abdomen (e.g. abdominoplasty) includes umbilical transposition and fascial placation)] is currently on the Excluded File.

With bariatric surgery, panniculectomy to remove excess skin and adipose tissue can be performed to reduce excess weight burden, decrease risk of infection, and improve quality of life/physical appearance. Bariatric surgery is currently covered for some patients on the Prioritized List. However, panniculectomy is not. The Ombuds office has received multiple complaints from patients who are unable to obtain a panniculectomy despite multiple episodes of cellulitis, inability to work in chosen field due to restrictions from hanging skin, etc.

From the Ombuds office: I would like to ask HERC to consider review of and look at including in HERC Guideline Note 8 language for HERC line 320 that indicates that this also covers all needed follow-up surgeries as a result of successful bariatric surgery including subsequent skin reduction surgeries and physical therapy.

HERC history Panniculectomy was last reviewed in 2011 at the request of the CCO medical directors. The staff summary of that review was “Most of the evidence on panniculectomy relates to complications relating to panniculectomy and abdominoplasty procedures. No reviews were found identifying long-term outcomes among those who had undergone these procedures. No studies were identified looking at long-term outcomes of panniculectomy were found.” Complication rates were found to range from 30- 50% for this procedure. The result of this review was to add CPT 15830 to an uncovered line and make CPT 15847 Excluded as a cosmetic procedure.

From the May, 2011 HOSC minutes: Gubler felt that this procedure should not be linked with bariatric surgery, as this type of procedure can be used for patients with any type of significant weight loss. He thinks that this procedure is useful for patients with chronic wounds and skin breakdown. It was brought up that 15830 would be covered via the co-morbidity rule for chronic wounds and skin issues if this code was left on a lower, uncovered line rather than the Never Covered File (Excluded File). Livingston pointed out that there is no evidence that panniculectomy helps chronic infection and therefore thought it best to put this code on the Excluded File. Saha stated that the HSC should be consistent in not covering cosmetic procedures, and only allow this type of procedure for chronic infection. McKelvey was concerned about the high rates of complications of this VbBSprocedure Issue in the literature. Summaries The group decided that due to the high for complication 1-21-2021 rate, this

1 Panniculectomy

procedure should continue to be located on a low priority line. However, patients with skin breakdown would have coverage through the co-morbidity rule.

Evidence Systematic review 1) Staalesen 2012, systematic review of outcomes of abdominoplasty a. One small controlled study on abdominoplasty was found indicating a positive effect on quality-of-life. b. No controlled studies evaluating the other outcomes respiratory function and back pain were found. c. One prospective study reported minor complications averaging to 25%. Fourteen retrospective studies reported the same pattern. The major complication, venous thromboembolism, was found in 2%–8% in three series. d. It is concluded that the quality of evidence of positive health effects for patients having abdominoplasty is very low concerning all studied outcomes.

Cohort studies 1) Suijker 2018, quality of life after body contouring surgery (BCS) a. Cohort study of 112 patients (57 participated in the short-term assessment and 84 in the long-term assessment) i. The BCS procedures were abdominal liposuction, abdominoplasty, lower body lift, or a combination of 2 of these procedures ii. QOL scores were for body satisfaction, sex life, self-esteem, social performance, and physical symptoms a. Total Body-QoL scores increased significantly (P < 0.0001), from 44.0 ± 14.1 preoperatively to 85.5 ± 17.5 short-term postoperatively and to 84.4 ± 12.7 long-term postoperatively. Scores for the 2 postoperative assessments did not differ significantly. Although preoperative scores were lower for the significant weight loss cohort than the cosmetic cohort (33.9 ± 15.6 vs 46.1 ± 12.8; P = 0.0002), they improved substantially after BCS, approaching scores for the cosmetic cohort. b. Conclusions: QoL increases significantly after BCS. This favorable outcome remained stable throughout long-term follow-up and was true for both cohorts. 2) Staalesen 2015, quality of life after abdominoplasty a. Prospective cohort study b. N=73 patients undergoing isolated abdominoplasty who previously had underwent bariatric surgery c. Significant improvements were reported at the follow-up concerning physical, functional, and psychosocial dimensions of health-related quality of life. d. The mean preoperative abdominal discomfort value was 7.5 ± 1.7. At follow-up, the mean abdominal discomfort decreased significantly (p < 0.001) to 1.4 ± 2.6 e. The most common preoperative impairment in terms of physical symptoms was itching and rash (94 percent). Postoperatively, 10% of patients reported itching and rash f. The most frequent preoperative impairment of physical function was hindrance in daily life (88 percent). g. A significant increase in the physical function subscale was observed at the follow-up VbBS Issueassessment (p = 0.031)Summaries for 1-21-2021

Panniculectomy

h. No significant changes in the EuroQol-5D dimensions or scores were observed when comparing the preoperative assessment and the follow-up after abdominoplasty. i. A significant low correlation was identified between the change in the Short-Form physical function subscale after abdominoplasty and measured amount of excess abdominal skin (rs = 0.26, p = 0.033) or resection weight (rs = 0.20, p = 0.10). j. Conclusions: Isolated abdominoplasty in post–bariatric surgery patients seems to improve both physical and psychosocial dimensions of health-related quality of life. In addition, the correlation between the objectively measured amount of abdominal excess skin and improvements in health-related quality of life after abdominoplasty in post–bariatric surgery patients appears to be low 3) Evans 2014, functional outcomes after major panniculectomy a. Retrospective cohort study, N=27 patients b. The overall complication rate was 74%. The most common complications were related to wound healing and included seroma, hematoma, cellulitis, skin necrosis, and wound infection. Major complications occurred in 37% of the patients (10 of 27 patients) and included 3 deaths. Two deaths were attributed to postoperative sepsis and 1 death was attributed to a stroke. Nine patients (33%) had to be returned to the operating room a. A statistically significant improvement in functional capacity (preop mean 3.7 vs postop mean 2.0; P < .0001) was identified. Note: the 3 postoperative deaths were not included in this measure. b. CONCLUSIONS: Panniculus morbidus is a functionally debilitating condition and major panniculectomy is often the only treatment available. The data suggest that major panniculectomy is a viable option for patients functionally incapacitated by panniculus morbidus.

Note: there was a large body of literature found on the complications of panniculectomy and methods to reduce the complication rate. This evidence was not reviewed as the complication rate was previously discussed in 2011 and found to be very high.

Other payer policies 1) Aetna 2020, Abdominoplasty, Suction Lipectomy, and Ventral Hernia Repair a. Aetna considers panniculectomy/apronectomy medically necessary according to the following criteria: i. Panniculus hangs below level of pubis, documented by photographs; and ii. The medical records document that the panniculus causes chronic intertrigo (dermatitis occurring on opposed surfaces of the skin, skin irritation, infection or chafing) that consistently recurs over 3 months while receiving appropriate medical therapy (e.g., oral or topical prescription medication), or remains refractory to appropriate medical therapy over a period of 3 months; and iii. Photographs with pannus lifted to document presence of intertrigo. b. Aetna considers panniculectomy/apronectomy cosmetic when these criteria are not met. c. Aetna considers panniculectomy/apronectomy experimental and investigational for minimizing the risk of hernia formation or recurrence. There is inadequate evidence that pannus contributes to hernia formation. The primary cause of hernia formation is VbBS Issuean abdominal wall Summaries defect or weakness, not a pulling effect for from a large 1-21-2021 or redundant pannus

Panniculectomy

d. Aetna considers panniculectomy for the treatment of back pain experimental and investigational because of insufficient evidence of its effectiveness. 2) Cigna 2020, panniculectomy and abdominoplasty a. Panniculectomy is considered medically necessary when ALL of the following conditions are met as demonstrated on preoperative photographs: i. The pannus hangs at or below the level of the symphysis pubis. ii. The pannus is causing persistent intertriginous dermatitis, cellulitis, or skin ulceration, which is refractory to at least three (3) months of medical management, including all applicable treatments. In addition to good hygiene practices, treatment should include topical antifungals, topical and/or systemic corticosteroids, and/or local or systemic antibiotics. iii. There is presence of a functional deficit due to a severe physical deformity or disfigurement resulting from the pannus. iv. The surgery is expected to restore or improve the functional deficit. v. The pannus is interfering with activities of daily living. b. Note: If the procedure is being performed following significant weight loss, in addition to meeting the criteria noted above, there should be evidence that the individual has maintained a stable weight for at least six months. If the weight loss is the result of bariatric surgery, panniculectomy should not be performed until at least 18 months after bariatric surgery and only when weight has been stable for at least the most recent six months. c. Panniculectomy is considered not medically necessary for any other indication, including but not limited to when performed primarily for ANY of the following: i. treatment of neck or back pain ii. improving appearance (i.e., cosmesis) iii. treating psychological symptomatology or psychosocial complaints iv. when performed in conjunction with abdominal or gynecological procedures (e.g., abdominal hernia repair, hysterectomy, obesity surgery) unless criteria for panniculectomy are met separately d. Surgical procedures to correct diastasis recti are considered cosmetic in nature and not medically necessary for any indication. e. Suction-assisted lipectomy is considered cosmetic in nature and not medically necessary when performed alone and not as part of a medically necessary panniculectomy procedure. 3) Anthem BCBS 2020, panniculectomy and abdominoplasty a. Panniculectomy is considered medically necessary for the individual who meets the following criteria: i. The panniculus hangs below the level of the pubis (which is documented in photographs); and ii. One of the following: 1. There are documented recurrent or chronic rashes, infections, cellulitis, or non-healing ulcers, that do not respond to conventional treatment (for example, dressing changes; topical, oral or systemic antibiotics, corticosteroids or antifungals) for a period of 3 months; or 2. There is documented difficulty with ambulation and interference with the activities of daily living; VbBS Issue andSummaries for 1-21-2021

Panniculectomy

iii. Symptoms or functional impairment persists despite significant weight loss which has been stable for at least 3 months or well-documented attempts at weight loss (medically supervised diet or bariatric surgery) have been unsuccessful; and iv. If the individual has had bariatric surgery, is at least 18 months post-operative or has documented stable weight for at least 3 months b. Not Medically Necessary: i. Panniculectomy is considered not medically necessary when the criteria above are not met. ii. Panniculectomy is considered not medically necessary as an adjunct to other medically necessary procedures, including, but not limited to, hysterectomy, or incisional or ventral hernia repair unless the criteria above are met. iii. Panniculectomy or abdominoplasty, with or without diastasis recti repair, for the treatment of back pain is considered not medically necessary.

VbBS Issue Summaries for 1-21-2021

Panniculectomy

HERC staff summary There is very limited evidence based on small cohort studies that abdominoplasty or panniculectomy after significant weight loss improves quality of life and functional scores. This surgery carries with it an extremely high rate of complications, including death. All major private insurers cover panniculectomy after major weight loss with restrictions. Staff judgement is that the evidence of benefit does not outweigh the risk of the surgery enough to move this surgery into the covered region of the Prioritized List; however, adding a guideline to the current uncovered line could be considered to assist CCOs in standardizing reviews for medical exceptions.

When queried, the CCOs medical directors who responded said that they were only allowing exceptions under extremely serious circumstances. Most did not believe a guideline was necessary.

HERC staff recommendation 1) Option 1: Make no change to the Prioritized List 2) Option 2: Add a new guideline to line 625 SEBORRHEIC KERATOSIS, DYSCHROMIA, AND VASCULAR DISORDERS, SCAR CONDITIONS, AND FIBROSIS OF SKIN as shown below

GUIDELINE NOTE XXX, PANNICULECTOMY Line 625 Panniculectomy (CPT 15830) is included on this line when ALL of the following conditions are met: 1) The pannus hangs at or below the level of the symphysis pubis as evidence by photographs; AND 2) The pannus is causing persistent intertriginous dermatitis, cellulitis, or skin ulceration, which is refractory to at least three months of medical management, including topical antifungals, topical and/or systemic corticosteroids, and/or local or systemic antibiotics; AND 3) There is documented difficulty with ambulation and/or interference with the activities of daily living due to the pannus.

If the procedure is being performed following significant weight loss, in addition to meeting the criteria noted above, there should be evidence that the individual has maintained a stable weight for at least six months. If the weight loss is the result of bariatric surgery, panniculectomy should not be performed until at least 18 months after bariatric surgery and only when weight has been stable for at least the most recent six months.

Panniculectomy is not included on this line for any other indication, including but not limited to when performed primarily for ANY of the following: 1) treatment of neck or back pain; OR 2) improving appearance (i.e., cosmesis); OR 3) treating psychological symptomatology or psychosocial concerns; OR 4) when performed in conjunction with abdominal or gynecological procedures (e.g., abdominal hernia repair, hysterectomy, obesity surgery) unless criteria for panniculectomy are met separately. .

VbBS Issue Summaries for 1-21-2021

COVID CPT codes for January 2021

Issues: 1) Two COVID-related codes have previously been published, but were not reviewed by the HERC in error. 2) Additional CPT codes were recently released relating to the AstraZeneca vaccine. 3) The CDC has also recently published ICD-10 codes related to COVID.

HCPCS code effective March 1,2020 C9803 Hospital outpatient clinic visit specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19])

CPT code effective November 10, 2020: 87428 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B

Released December 17, 2020, CPT codes effective upon FDA emergency use authorization of the AstraZeneca vaccine 91302 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative free, 5x1010 viral particles/0.5mL dosage, for intramuscular use 0021A Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative free, 5x1010 viral particles/0.5mL dosage; first dose 0022A second dose

ICD-10 codes effective January 1, 2021 Z11.52 Encounter for screening for COVID-19 Z20.822 Contact with and (suspected) exposure to COVID-19 Z86.16 Personal history of COVID-19 M35.81 Multisystem inflammatory syndrome (MIS) M35.89 Other specified systemic involvement of connective tissue J12.82 Pneumonia due to coronavirus disease 2019

VbBS Issue Summaries for 1-21-2021

COVID CPT codes for January 2021

HERC staff recommendations: Alternate presentation of recommendations on next page 1) Advise HSD to place CPT 87428 and HCPCS C9803 to the DIAGNOSTIC PROCEDURES file 2) Advice HSD to place ICD10 Z11.52 on the DIAGNOSTIC WORKUP FILE 3) Add CPT 91301, 0021A and 0022A and ICD-10 Z20.822 to line 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS a. Advise HSD to place these codes on the Ancillary List until the next published Prioritized List 4) Advise HSD to place ICD-10 Z86.16 on the INFORMATIONAL DIAGNOSES file 5) Add ICD-10 J12.82 to line 304 VIRAL PNEUMONIA a. Advise HSD to place on the Ancillary List until the next published Prioritized List 6) Add M35.89 to line 73 DERMATOMYOSITIS, POLYMYOSITIS a. Matches M35.8 (Other specified systemic involvement of connective tissue) b. Advise HSD to place on the Ancillary List until the next published Prioritized List 7) Add ICD-10 M35.81 to line 399 INFLUENZA, NOVEL RESPIRATORY VIRUSES a. Advise HSD to place on the Ancillary List until the next published Prioritized List

VbBS Issue Summaries for 1-21-2021

COVID-19 Related Codes January 2021

Code Code descriptions Recommended Placement Notes (Italicized lines are unfunded) J12.82 Pneumonia due to coronavirus disease 304 VIRAL PNEUMONIA HSD covering 2019 on an interim basis until new list published M35.81 Multisystem inflammatory syndrome 399 INFLUENZA, NOVEL HSD covering (MIS) RESPIRATORY VIRUSES on an interim basis until new list published M35.89 Other specified systemic involvement of 73 DERMATOMYOSITIS, HSD covering connective tissue POLYMYOSITIS on an interim basis until new list published Z11.52 Encounter for screening for COVID-19 DIAGNOSTIC WORKUP FILE HSD placed on DWF in the interim Z20.822 Contact with and (suspected) exposure 3 PREVENTION SERVICES WITH HSD covering to COVID-19 EVIDENCE OF EFFECTIVENESS on an interim basis until new list published Z86.16 Personal history of COVID-19 INFORMATIONAL DIAGNOSES HSD has placed on informational file

Code Code descriptions Recommended Placement Notes (Italicized lines are unfunded) 87428 Infectious agent antigen detection by Diagnostic Procedures File immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B VbBS91302 SevereIssue acute respiratory Summaries syndrome 3 PREVENTION SERVICES for WITH 1-21-2021 HSD treated coronavirus 2 (SARS-CoV-2) (coronavirus EVIDENCE OF EFFECTIVENESS as ancillary

COVID-19 Related Codes January 2021

Code Code descriptions Recommended Placement Notes (Italicized lines are unfunded) disease [COVID-19]) vaccine, DNA, spike procedure on protein, chimpanzee adenovirus Oxford an interim 1 (ChAdOx1) vector, preservative free, basis 5x1010 viral particles/0.5mL dosage, for intramuscular use C9803 Hospital outpatient clinic visit specimen Diagnostic Procedures File collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19])

Vaccine Code descriptions Recommended Placement Notes therapy (Italicized lines are administration/ unfunded) lab codes 0021A Immunization administration by 3 PREVENTION SERVICES Effective on FDA intramuscular injection of severe WITH EVIDENCE OF approval acute respiratory syndrome EFFECTIVENESS coronavirus 2 (SARS-CoV-2) HSD to place on (coronavirus disease [COVID-19]) Ancillary File until vaccine, DNA, spike protein, next published List chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative free, 5x1010 viral particles/0.5mL dosage; first dose

0022A second dose 3 PREVENTION SERVICES See 0021A WITH EVIDENCE OF EFFECTIVENESS

VbBS Issue Summaries for 1-21-2021

Expanded Carrier Screening VBBS 2020

Question: Should coverage of expanded carrier screening be added to the Prioritized List?

Question source: Access to Expanded Carrier Screening Coalition

Issue: Expanded carrier screening is genetic testing of pregnant woman or women who plan to become pregnant, and her reproductive partner if needed, that tests for a much wider array of genetic conditions that targeted carrier screening. Targeted screening tests for conditions for which there is good evidence that finding these conditions can affect reproductive decisions and/or outcomes. Targeted screening usually included testing for carrier status for cystic fibrosis, spinal muscular atrophy, fragile X, and conditions generally seen in Ashkenazi Jewish populations (eg Canavan’s syndrome). Expanded carrier screening tests for carrier status for a much larger variety of genetic conditions. Some screens include 500+ possible mutations.

Expanded carrier screening was first reviewed in 2014 as part of a coverage guidance on prenatal testing. It received a weak recommendation for non-coverage

Coverage of expanded carrier screening was discussed by Genetics Advisory Panel (GAP) at their 2018 meeting. The GAP felt that this was reasonable to cover, and noted that often the cost of expanded carrier screening is the same to test for a single gene as a panel. All pregnant patients should be offered expanded carrier screening per ACOG guidelines.

However, subsequent review of this topic by VBBS in November 2018 resulted in VBBS recommending non-coverage. The major concerns of VBBS were: 1) Coverage for partners. Partners should only be tested for the few genes that mom tested positive for 2) There was general concern about how to interpret the results. The VBBS members felt that the interpretation would be difficult for most maternity care providers, and that patients should have genetic counseling with this test, which is a limited resource. There was discussion about unintended harm of too much genetic information being given to patients with an unclear idea of how to deal with this information. 3) There was concern over interventions that might be done that might not be needed, or additional testing done that might not be needed. Medicaid is a vulnerable population. 4) There was also concern about how to control the quality of what genes are in the panel, to ensure that all include genes are recommended by ACOG guidelines.

The Access to Expanded Carrier Screening Coalition has requested a re-review of the VBBS/HERC decision from 2018. The major concern of this group is the difficulty in determining a patient’s ancestry for ordering specific ethnic-based testing.

The GAP re-reviewed expanded carrier screening at their fall 2020 meeting. GAP members were unanimously in favor of adding expanded carrier screening for pre-pregnancy and prenatal genetic screening. GAP members felt unanimously that such screening removed reliance on a patient to define their race or ethnicity. Gap members had concerns about the fact that the commercially available tests vary dramatically in the number and types of genes tested. This larger the number of genes in the panel, the higher the likelihood for finding a positive result. The number of women with positive results VbBScould overwhelm Issue the capacity of Summariesgenetic counselors in the state, although for it was noted 1-21-2021 that virtual visits

Expanded Carrier Screening VBBS 2020

could help with this. Families could receive information of unknown significance without access to expertise to aid them in interpretation. There was discussion about adding restrictions on the type of testing offered, such as limiting the included number of genes or only clinically meaningful variants.

Public testimony was heard, which was unanimously in favor of coverage of expanded carrier screening. It was brought up that screening should be offered pre-conception as well as prenatally. There is an equity issue in that the current coverage is mainly for conditions seen in people of European ancestry, while expanded carrier screening includes tests more likely to be seen in people of other ancestry, such as African. Testifiers felt that there should be pretest education, but not genetic counseling per se. It was noted that the correct CPT code for expanded carrier screening is CPT 81443.

VBBS reviewed the GAP recommendation at their November, 2020 meeting. There was concern from members about the high rate of positive results, and the consequences of trying to interpret these. There were concerns about access to genetic counseling. Additionally, there were concerns for possible lack of coverage for partner testing. It was noted that concerns over lack of coverage have not been brought up by practicing maternity care providers in Oregon; instead, the current concerns appeared to be coming from the testing companies. The VBBS requested that HERC staff get additional input from experts on this topic, and possibly consider this topic for the coverage guidance process.

Since the November VBBS meeting, HERC staff requested a policy review by the Center for Evidence Based Policy. The CEBP did not identify evidence reviews on this topic, but did identify two evidence- based expert position statements. A genetic testing expert who consults with the CEBP was asked for further input as well.

Current Prioritized List status: Line 662/GN173: CPT 81443 (Genetic testing for severe inherited conditions (eg, cystic fibrosis, Ashkenazi Jewish- associated disorders [eg, Bloom syndrome, Canavan disease, Fanconi anemia type C, mucolipidosis type VI, Gaucher disease, Tay-Sachs disease], beta hemoglobinopathies, phenylketonuria, galactosemia), genomic sequence analysis panel, must include sequencing of at least 15 genes)

Diagnostic Procedures File: CPT 81412 is for Ashkenazi Jewish carrier testing CPT 81220 for CF panel testing CPT 81329 for spinal muscular atrophy

VbBS Issue Summaries for 1-21-2021

Expanded Carrier Screening VBBS 2020

Expert evidence-based guidelines 1) American College of Medical Genetics and Genomics (ACMG) 2013, position statement on prenatal/preconception expanded carrier screening a. The American College of Medical Genetics and Genomics believes that advances in genetic technology need to be considered carefully before their incorporation into routine clinical care. The organization has defined the standard of care for prenatal/preconception population carrier screening for common single-gene autosomal recessive disorders (such as cystic fibrosis and spinal muscular atrophy) and a panel of single-gene autosomal recessive conditions specifically for the Ashkenazi Jewish population b. The proper selection of appropriate disease-causing targets for general population- based carrier screening (i.e., absence of a family history of the disorder) should be developed using clear criteria, rather than simply including as many disorders as possible i. Disorders should be of a nature that most at-risk patients and their partners identified in the screening program would consider having a prenatal diagnosis to facilitate making decisions surrounding reproduction ii. Ideally, testing should be limited to disorders that present in childhood iii. For each disorder, the causative gene(s), mutations, and mutation frequencies should be known in the population being tested, so that meaningful residual risk in individuals who test negative can be assessed. iv. There must be validated clinical association between the mutation(s) detected and the severity of the disorder c. It appears from their website that the only genes meeting the above criteria are i. Ashkenazi Jewish related disorders ii. Cystic fibrosis iii. Fragile X iv. Spinal muscular atrophy 2) Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) 2019, Genetic carrier screening a. All pregnant women should be offered basic screening for thalassaemia carrier status by a full blood examination at initial presentation. Screening with specific assays for haemoglobinopathies (such as HPLC or EPG and haemoglobinopathy DNA testing) should be considered in high probability ethnic or population groups b. Information on carrier screening for other genetic conditions should be offered to all women planning a pregnancy or in the first trimester of pregnancy. Options for carrier screening include screening with a panel for a limited selection of the most frequent conditions (e.g. cystic fibrosis, spinal muscular atrophy and fragile X syndrome) or screening with an expanded panel that contains many disorders (up to hundreds). c. For individuals of Eastern European (Ashkenazi) Jewish descent, additional screening for Tay Sachs disease, Niemann Pick disease type A, Fanconi anaemia group C, familial dysautonomia, Bloom syndrome, Canavan disease and mucolipidosis type IV should be offered. d. Women wanting more information about carrier screening should be given the opportunity to have a more detailed discussion about carrier screening with an informed clinician. Informed consent for screening should be obtained and this should VbBS Issueinclude any out ofSummaries pocket expenses that are required for thisfor testing 1-21-2021

Expanded Carrier Screening VBBS 2020

e. Laboratories should only report carrier status for class 4 and 5 mutations. Variants of unknown significance should not be reported. f. All couples with a high chance of having a child with one of the conditions screened for should be referred for genetic counselling to be informed of available reproductive options and to assist with prenatal testing if the woman in the couple found to have a high chance is pregnant when the result becomes known.

CEBP genetics consultant Alison Adams Martinez, PhD in Genetics and previously the Geneticist and Clinical Data Specialist for the Oklahoma Health Care Authority. She has worked as a consultant to the MED Genetic Testing Workgroup for 2 years, and the Center has contracted with her to help with other work, including as an expert advisor and reviewer for the WA HTA portfolio.

How to match available panels with ACOG Committee Opinion recommendations? -Would not cover the code for “at least 15 genes”, because there is not recommendations for that many genes (81443), but could use the unlisted code and specify the selection of genes (81479) -Self-identification tends to work for knowing whom to test for genetic disorders related to Ashkenazi Jewish heritage, so no need to offer those tests universally (except for CF) If the full panel is reported, how to address inconclusive results or variants of unknown significance? -Unclear. Some labs will provide some kind of genetic counseling as part of their service, which might help address this issue. Not sure how often variants of unknown significance come up, and there is more information about the link between variants and pathogenic pathways for CF, SMA, compared to some of the other conditions. Coverage of testing of the reproductive partner? -Screening the mother does not do a whole lot of good without also screening reproductive partner, but did not offer solutions for covering partner. The consultant noted that many payers do not cover services for someone who is not enrolled with that payer. Who provides pre- and post-test counseling? Can the ordering clinician do the pretest and a genetic counselor do the post-test, if needed? Are there alternatives for genetic counselors (workforce shortage)? -The results for Fragile X, SMA, and CF are relatively easy to interpret from most labs, and the ordering clinician can likely provide counseling for at least those results -Importance of talking to the patient about the compounding risk of false positives with adding more tests, and challenge of providing clear counseling and informed consent

Input from Oregon maternity care providers: From Maria Rodriquez, MD I was tapped to respond to you on behalf of OHSU Obgyn generalists…At this time, OHP coverage is aligned with professional society guidelines (ACOG and others) and women who are “high risk” for a condition not on the panel are already eligible for covered genetic counseling services (CPT 96040). This is adequate. OB providers should be able to provide adequate pre- VbBStest counIssueseling and order Summaries expanded carrier screening when indicated. for The only1-21-2021 indication we can think of to expand beyond current coverage or to change policy might be cost…expanded

Expanded Carrier Screening VBBS 2020

carrier screening is likely more cost effective in the long run than some of the other individual tests or smaller panels.

From Laura Jensen, CNM, OHSU --not much interest from our pts beyond these basic screenings / don’t see our genetic counselors recommending strongly the expanded carrier screenings (like Counsyl) --ACOG’s guidance only addresses CF, SMA, the Ashkenazi Jewish panel, fragile X it https://www.acog.org/womens-health/faqs/carrier-screening --as far as equity, doesn’t seem to be 100% coverage for any of the expanded carrier screening tests although this could be wrong

Would recommend that the committee revisit in two years as things change all the time…

From Duncan Nielson, MD OB/Gyn from Legacy Our lead MFM physician for prenatal diagnosis, Dr. John Buckmaster who is also boarded in Medical Genetics, agrees that expanded carrier screening should be supported if at all possible.

From Jaellah Thalberg, geneticist at Legacy and member of GAP

I provided testimony at the last HERC genetics meeting about this.

I advocate for coverage for expanded carrier screening. To me this is an issue of justice and all patients having equal access to testing options and it becoming standard of care. With the cost of testing decreasing and our ability to identify risk, it seems to make sense that all families should have equal access to these tests. Additionally, it is rare a person is only one ethnicity/ancestry.

VbBS Issue Summaries for 1-21-2021

Expanded Carrier Screening VBBS 2020

HERC staff summary Expanded carrier screening is a controversial area of pre-conception and prenatal genetic screening. ECS will identify more at-risk couples; however, the high rate of finding genetic mutations (75% of women) will require pre- and posttest genetic counseling to address the implications of the results. ACOG recommends ECS as one screening option and, if chosen, recommends inclusion only of genes with significant childhood disease potential. The ACMG and other authorities recommend a more limited set of tests. Other than gene variants associated with Ashkenazi Jewish ancestry, carrier screening for all autosomal recessive traits recommended by ACMG and other sources is already available to OHP members regardless of reported ancestry.

GAP members and public testimony at the GAP meeting was unanimously in favor of covering expanded carrier screening for both prenatal and pre-conception testing. However, multiple Oregon providers we consulted appear to be mixed in their thoughts on expanded carrier screening, with low risk OB/Gyn and certified nurse midwife not advocating for it, but at least one maternal-fetal medicine physician recommending expansion of such testing.

HERC staff recommendations: 1) Do not add expanded carrier screening coverage i) Update GN173 date 2) Add option to screen for Ashkenazi Jewish-related conditions regardless of ancestry to Diagnostic Guideline D17 a) See wording below

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

Expanded Carrier Screening VBBS 2020

E) Screening for aneuploidy with any of six screening strategies [first trimester (nuchal translucency, beta-HCG and PAPP-A), integrated, serum integrated, stepwise sequential, contingency, and cell free fetal DNA testing] (CPT 76813, 76814, 81508, -81510, 81511, 81420, 81507, 81512, 82105, 82677,84163) F) Ultrasound for structural anomalies between 18 and 20 weeks gestation (CPT 76811, 76812) G) 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. H) 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. I) 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) J) 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 K) Screening for cystic fibrosis carrier status once in a lifetime (CPT 81220-81224) L) Screening for fragile X status (CPT 81243, 81244, 81171. 81172) in patients with a personal or family history of b. fragile X tremor/ataxia syndrome c. premature ovarian failure d. unexplained early onset intellectual disability e. fragile X intellectual disability f. unexplained autism through the pregnant woman’s maternal line M) Screening for spinal muscular atrophy (CPT 81329) once in a lifetime N) 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. O) Expanded carrier screening only for those genetic conditions identified above

The following genetic screening tests are not covered: A) Serum triple screen B) 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.

VbBS Issue Summaries for 1-21-2021

Biofeedback

Question: Should biofeedback be added to any line on the Prioritized List?

Question source: Holly Jo Hodges, CCO medical director

Issue: The CPT codes for biofeedback (90875, 90876 and 90901) are not on the Prioritized List but are treated as ancillary by the Health Systems Division and appear on the fee-for-service fee schedule. Dr. Hodges has received requests for biofeedback for treatment of various behavioral health conditions including anxiety, OCD, autism, PTSD and oppositional defiant disorder. She requested clarification of whether biofeedback is a covered treatment for any condition on the Prioritized list, particularly mental health conditions.

Biofeedback is a non-invasive psychophysiological treatment technique with a bio-monitoring system and sensors to measure, amplify, and feedback information that enables an individual to learn how to change physiological activity (such as respiration, heart rate variability, blood flow and blood pressure) and thus improve health and performance. Neurofeedback is a specific type of biofeedback. Biofeedback has been used for the treatment of migraine headaches, urinary incontinence, pelvic floor dysfunction, and cancer pain.

Neurofeedback focusses on the central nervous system and the brain to improve neuro regulation and stabilization.

HERC/HSC history Review of old minutes finds that 90901 was on all the cancer lines at one point. In May 2004, the HSC removed 90901 from all lines and placed on the Never Covered File.

Current Prioritized List status CPT Code Description Current Placement code 90875 Individual psychophysiological therapy incorporating NEVER REVIEWED biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 30 minutes 90876 45 minutes NEVER REVIEWED 90901 Biofeedback training by any modality NEVER REVIEWED 90912 Biofeedback training, perineal muscles, anorectal or urethral 455 URINARY sphincter, including EMG and/or manometry, when INCONTINENCE performed; initial 15 minutes of one-on-one physician or other qualified health care professional contact with the patient 90913 each additional 15 minutes 455 URINARY INCONTINENCE E0746 Electromyography (emg), biofeedback device NEVER REVIEWED VbBS Issue Summaries for 1-21-2021

Biofeedback

GUIDELINE NOTE 47, URINARY INCONTINENCE Line 455 Surgery for genuine stress urinary incontinence may be indicated when all of the following are documented (A-G): A) Patient history of (1, 2, and 3): 1) Involuntary loss of urine with exertion 2) Identification and treatment of transient causes of urinary incontinence, if present (e.g., delirium, infection, pharmaceutical causes, psychological causes, excessive urine production, restricted mobility, and stool impaction) 3) Involuntary loss of urine on examination during stress (provocative test with direct visualization of urine loss) and low or absent post void residual B) Patient’s voiding habits C) Physical or laboratory examination evidence of either (1 or 2): 1) Urethral hypermobility 2) Intrinsic sphincter deficiency D) Diagnostic workup to rule out urgency incontinence E) Negative preoperative pregnancy test result unless patient is postmenopausal or has been previously sterilized F) Nonmalignant cervical cytology, if cervix is present G) Patient required to have 3 months of alternative therapy (e.g., pessaries or physical therapy, including bladder training, pelvic floor exercises and/or biofeedback, as available). If limited coverage of physical therapy is available, patients should be taught pelvic floor exercises by their treating provider, physical therapist or trained staff, and have documented consistent practice of these techniques over the 3 month period.

GUIDELINE NOTE 50, PELVIC ORGAN PROLAPSE SURGERY Line 466 Hysterectomy, cystocele repair, and/or other surgery for pelvic organ prolapse may be indicated when all of the following are documented (A-E): A) Patient history of symptoms of pelvic prolapse such as: 1) Complaints of the pelvic organs prolapsing at least to the introitus, and one or more of the following: a) Low back discomfort or pelvic pressure, or b) Difficulty in defecating, or c) Difficulty in voiding B) For hysterectomy 1) Nonmalignant cervical cytology, if cervix is present, and 2) Assessment for absence of endometrial malignancy in the presence of abnormal bleeding C) Physical examination is consistent with patient’s symptoms of pelvic support defects indicating either symptomatic prolapse of the cervix, enterocele, cystocele, rectocele or prolapse of the vaginal vault D) Negative preoperative pregnancy test unless patient is postmenopausal or has been previously sterilized E) Patient required to have 3 months of alternative therapy (e.g., pessaries or physical therapy, including bladder training, pelvic floor exercises and/or biofeedback, as available). If limited VbBScoverage Issue of physical therapy Summaries is available, patients should be taught for pelvic floor 1-21-2021 exercises by their

Biofeedback

treating provider, physical therapist or trained staff, and have documented consistent practice of these techniques over the 3 month period.

GUIDELINE NOTE 192, SACRAL NERVE STIMULATION FOR URINARY CONDITIONS Lines 327,455 Sacral nerve stimulation is included on these lines only for urinary incontinence, non-obstructive urinary retention, and overactive bladder AND only when all of the following criteria are met: A) The patient has had symptoms for at least 12 months and the condition has resulted in significant disability (the frequency and/or severity of symptoms are limiting the member's ability to participate in daily activities); AND B) Documented failure or intolerance to pharmacotherapies and behavioral treatments (e.g., pelvic floor exercise, biofeedback, timed voids, and fluid management) and, for non-obstructive urinary retention, intermittent catheterization; AND C) The patient must be an appropriate surgical candidate such that implantation with anesthesia can occur; AND D) The patient does not have stress incontinence, urinary obstruction, or specific neurologic diseases (e.g., diabetes with peripheral nerve involvement, spinal cord injury, or multiple sclerosis); AND E) Patient must have had a successful test stimulation, defined as a 50% or greater improvement in symptoms.

VbBS Issue Summaries for 1-21-2021

Biofeedback

Evidence 1) CADTH 2017, Systematic review of neurofeedback and biofeedback for mood and anxiety disorders a) N=5 RCTs (n=220 patients) b) Evidence from single randomized controlled trials suggests that compared with no treatment there is a statistically significant improvement in symptoms with neurofeedback treatment in patients with post-traumatic stress disorder (PTSD) or generalized anxiety disorder (GAD). c) A single randomized controlled trial (RCT) showed that for patients with PTSD there was improvement in symptoms with biofeedback (BF) plus treatment as usual (TAU) and also with TAU alone but the improvement occurred faster in the BF plus TAU group. A single RCT showed that for patients with PTSD there were no between group differences for BF and various mindfulness related treatment modalities. d) A single RCT showed that for patients with major depressive disorder, there was a statistically significant improvement in depression with BF plus TAU. e) Results need to be interpreted in the light of limitations (such as small sample size, lack of randomization details, lack of reporting of adverse events, lack of long-term data). f) No relevant studies on the clinical effectiveness of biofeedback using home equipment for treatment of PTSD, GAD, or depression without continued support from health professionals were identified. g) No relevant evidence based guidelines regarding the use of neurofeedback or biofeedback for the treatment of PTSD, GAD, or depression were identified 2) Kondo 2019, evidence review of biofeedback for medical conditions from the VA Evidence Synthesis Program a) N=16 good quality systematic reviews b) We found clear, consistent evidence across a large number of trials that biofeedback can reduce headache pain and can provide benefit as adjunctive therapy to men experiencing urinary incontinence after a prostatectomy. c) Consistent evidence across fewer trials suggests biofeedback may improve fecal incontinence and stroke recovery. d) There is insufficient evidence to draw conclusions about effects for most conditions including bruxism, labor pain, and Raynaud’s. e) Biofeedback was not beneficial for urinary incontinence in women, nor for hypertension management, but these conclusions are limited by small sample sizes and methodologic limitations of these studies. f) DISCUSSION: Available evidence suggests that biofeedback is effective for improving urinary incontinence after prostatectomy and headache, and may provide benefit for fecal incontinence and balance and stroke recovery. Further controlled trials across a wide range of conditions are indicated

Expert based guidelines 1) NCCN 2020 Adult Cancer pain a. Biofeedback listed as an evidence based treatment modality 2) NICE 2019 Urinary incontinence and pelvic organ prolapse in women: management https://www.nice.org.uk/guidance/ng123/resources/urinary-incontinence-and-pelvic- VbBSorgan Issue-prolapse-in-women Summaries-management-pdf-66141657205189 for 1-21-2021

Biofeedback

a. Do not use perineometry or pelvic floor electromyography as biofeedback as a routine part of pelvic floor muscle training 3) American Headache Society 2018, guideline on integrating newer migraine treatments in to clinical practice https://headachejournal.onlinelibrary.wiley.com/doi/epdf/10.1111/head.13456 a. There is a large and growing body of published evidence examining the use of behavioral therapies for migraine (and other forms of headache) including meta-analytic studies and evidence-based reviews. Biobehavioral therapy, including cognitive behavioral therapy (CBT) and biofeedback, and relaxation therapies have been shown to be effective in the acute and preventive treatment of migraine and have Grade A evidence for their use preventively

Other payer policies 1) Wellmark BCBS 2020 a. Biofeedback may be considered medically necessary as part of the overall treatment plans for i. cancer pain ii. migraine headaches and iii. tension-type headaches 2) Aetna 2020 a. Aetna considers biofeedback medically necessary for the following conditions: i. Cancer pain ii. Chronic constipation iii. Fecal incontinence iv. Irritable bowel syndrome v. Levator ani syndrome (also known as anorectal pain syndrome) vi. Migraine and tension headaches (muscle (EMG), skin or thermal biofeedback; EEG biofeedback is considered experimental and investigational for this indication because its effectiveness for this indication has not been established) vii. Neuromuscular rehabilitation of stroke and traumatic brain injury (TBI) viii. Refractory severe subjective tinnitus ix. Temporomandibular joint (TMJ) syndrome x. Urinary incontinence 3) Cigna 2020 a. Medically Necessary Biofeedback performed by a licensed healthcare professional is considered medically necessary for ANY of the following conditions*: i. Chronic constipation with dyssynergic defecation (adults only) ii. Fecal incontinence for patients with: 1. some degree of rectal sensation, and 2. ability to contract the sphincter voluntarily, and 3. failure/intolerance/contraindication of treatment with dietary changes, devices or drugs iii. Stress, urgency, mixed, or overflow urinary incontinence when there is failure/intolerance/contraindication of other nonpharmacologic treatment (e.g., bladder training and/or pelvic floor muscle training [PFMT]) (children and VbBS Issueadults) Summaries for 1-21-2021

Biofeedback

iv. Migraine and tension headaches (children and adults) as part of a comprehensive treatment plan v. Muscle re-education of specific extremity muscle groups or for treating pathological muscle abnormalities of spasticity, incapacitating muscle spasm, or weakness when: 1. Patient is diagnosed with stroke, and 2. Failure/intolerance/contraindication of conventional treatments (e.g. modalities, massage, soft tissue mobilization, exercise) vi. Refractory levator ani syndrome (e.g. proctalgia fugax, chronic anal pain syndrome, anal spasm) with dyssynergic defecation when: 1. Condition is not neurological or disease-based 2. Failure/intolerance/contraindication of conservative treatment including: a. high-fiber diet b. withdrawal of drugs that cause constipation (e.g., calcium channel blockers, narcotics) or diarrhea (e.g., antibiotics, quinidine, theophylline) c. perineal strengthening exercises d. rectal massage e. warm baths, and f. drug therapy (e.g., muscle relaxants, non-narcotic analgesics, and sedatives)

BHAP input The panel felt that biofeedback should not be added to any behavioral health or SUD lines.

Claims data: CPT 90875, 90876 and 90901 had significant numbers of paid claims, despite no intent for coverage. These codes currently do not appear on any line or list. There were no claims for perineal biofeedback.

VbBS Issue Summaries for 1-21-2021

Biofeedback

HERC staff summary: Biofeedback has evidence to support its use in the treatment of headache (migraine and tension) and is recommended by expert guidelines for prophylactic treatment of migraine. Private payers are all covering biofeedback for the treatment of migraine and tension headache. However, no cognitive behavioral therapy or psychotherapy CPT codes are currently on the migraine or tension headache lines.

Biofeedback has expert guideline recommendation for use in treatment of cancer pain; it is covered for this indication by private payers.

The use of biofeedback for the treatment of urinary incontinence was not found to be effective on systematic evidence review or included in trusted source guideline for urinary incontinence (NICE). However, biofeedback is currently listed as a treatment modality required before surgery or sacral nerve stimulation for urinary stress incontinence, as well as surgery for pelvic organ prolapse. Of note, the CPT codes for pelvic biofeedback are not included on the line for pelvic organ prolapse.

There is no evidence supporting the use of biofeedback for the treatment of mental health conditions, and no private payer is covering biofeedback for this indication. BHAP does not recommend its use for behavioral health conditions. However, the CPT codes used for these indications are being paid and do not appear on any current line or list.

HERC staff recommendations: 1) Do not add biofeedback to any behavioral health line due to lack of evidence of effectiveness and following the recommendation of BHAP 2) Add CPT 90875 and 90876 (Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy) and 90901 (Biofeedback training by any modality) to line 662/GN173 as shown below a. Alternatively, refer these codes back to BHAP for input on appropriate placement 3) Add biofeedback to lines 410 MIGRAINE HEADACHES and 540 TENSION HEADACHES a. CPT 90875 Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 30 minutes b. CPT 90876 Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 45 minutes c. CPT 90901 Biofeedback training by any modality 4) Modify SOI 1 as shown below a. Adds biofeedback as an example of a covered treatment modality for cancer pain 5) Remove biofeedback from line 455 URINARY INCONTINENCE a. 90912 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry, when performed; initial 15 minutes of one-on- one physician or other qualified health care professional contact with the patient b. 90913 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry, when performed; each additional 15 minutes 6) Modify GN 47 and GN 192 as shown below a. Remove reference to biofeedback VbBS7) ModifyIssue GN 50 as shown Summaries below for 1-21-2021 a. CPT codes for biofeedback are not currently on line 466

Biofeedback

b. This is not a studied indication for biofeedback 8) Place CPT 90912 and 90913 on line 662/GN173 as shown below

STATEMENT OF INTENT 1: PALLIATIVE CARE It is the intent of the Commission that palliative care services are covered for patients with a life- threatening or serious progressive illness to alleviate symptoms and improve quality of life.

Palliative care services should include culturally appropriate discussions and medical decision making aligned with patient’s personal goals of therapy, assessment of symptom burden, assistance with advance care planning, care coordination, emotional, psychosocial and spiritual support for patients and their families. Palliative care services may be provided concurrently with life prolonging/curative treatments.

Some examples of services associated with an encounter for palliative care (ICD-10 Z51.5) that should be available to patients without regard to Prioritized List line placement: A) Inpatient palliative care consultations 1) Hospital Care E&M (CPT 99218-99233) B) Outpatient palliative care consultations provided in either the office or home setting 1) E&M Services (CPT 99201-99215) 2) Transitional Care Management Services (CPT 99495-6) 3) Advance Care Planning (CPT 99497-8) 4) Chronic Care Management (CPT 99487-99490) C) Psychological support and grief counseling (CPT 99201-99215) D) Medical equipment and supplies for the management of symptomatic complications or support activities of daily living E) Medications or acupuncture to reduce pain and symptom burden F) Surgical procedures or therapeutic interventions (for example, palliative radiation therapy) to relieve pain or symptom burden G) Biofeedback (CPT 90875, 90876, 90901) for treatment of cancer pain

Other services associated with palliative care includes: A) Social Work B) Clinical Chaplain/ Spiritual Care C) Care Coordination

It is NOT the intent of the Commission that coverage for palliative care encompasses those treatments that seek to prolong life despite substantial burdens of treatment and limited chance of benefit. See Guideline Note 12 PATIENT-CENTERED CARE OF ADVANCED CANCER.

GUIDELINE NOTE 47, URINARY INCONTINENCE Line 455 Surgery for genuine stress urinary incontinence may be indicated when all of the following are documented (A-G): H) Patient history of (1, 2, and 3): VbBS4) InvoluntaryIssue loss of urineSummaries with exertion for 1-21-2021

Biofeedback

5) Identification and treatment of transient causes of urinary incontinence, if present (e.g., delirium, infection, pharmaceutical causes, psychological causes, excessive urine production, restricted mobility, and stool impaction) 6) Involuntary loss of urine on examination during stress (provocative test with direct visualization of urine loss) and low or absent post void residual I) Patient’s voiding habits J) Physical or laboratory examination evidence of either (1 or 2): 3) Urethral hypermobility 4) Intrinsic sphincter deficiency K) Diagnostic workup to rule out urgency incontinence L) Negative preoperative pregnancy test result unless patient is postmenopausal or has been previously sterilized M) Nonmalignant cervical cytology, if cervix is present N) Patient required to have 3 months of alternative therapy (e.g., pessaries or physical therapy, including bladder training, and/or pelvic floor exercises and/or biofeedback, as available). If limited coverage of physical therapy is available, patients should be taught pelvic floor exercises by their treating provider, physical therapist or trained staff, and have documented consistent practice of these techniques over the 3 month period.

GUIDELINE NOTE 50, PELVIC ORGAN PROLAPSE SURGERY Line 466 Hysterectomy, cystocele repair, and/or other surgery for pelvic organ prolapse may be indicated when all of the following are documented (A-E): F) Patient history of symptoms of pelvic prolapse such as: 2) Complaints of the pelvic organs prolapsing at least to the introitus, and one or more of the following: d) Low back discomfort or pelvic pressure, or e) Difficulty in defecating, or f) Difficulty in voiding G) For hysterectomy 3) Nonmalignant cervical cytology, if cervix is present, and 4) Assessment for absence of endometrial malignancy in the presence of abnormal bleeding H) Physical examination is consistent with patient’s symptoms of pelvic support defects indicating either symptomatic prolapse of the cervix, enterocele, cystocele, rectocele or prolapse of the vaginal vault I) Negative preoperative pregnancy test unless patient is postmenopausal or has been previously sterilized J) Patient required to have 3 months of alternative therapy (e.g., pessaries or physical therapy, including bladder training, and/or pelvic floor exercises and/or biofeedback, as available). If limited coverage of physical therapy is available, patients should be taught pelvic floor exercises by their treating provider, physical therapist or trained staff, and have documented consistent practice of these techniques over the 3 month period.

Biofeedback

F) The patient has had symptoms for at least 12 months and the condition has resulted in significant disability (the frequency and/or severity of symptoms are limiting the member's ability to participate in daily activities); AND G) Documented failure or intolerance to pharmacotherapies and behavioral treatments (e.g., pelvic floor exercise, biofeedback, timed voids, and fluid management) and, for non-obstructive urinary retention, intermittent catheterization; AND H) The patient must be an appropriate surgical candidate such that implantation with anesthesia can occur; AND I) The patient does not have stress incontinence, urinary obstruction, or specific neurologic diseases (e.g., diabetes with peripheral nerve involvement, spinal cord injury, or multiple sclerosis); AND J) Patient must have had a successful test stimulation, defined as a 50% or greater improvement in symptoms.

90901 Biofeedback training by any modality 90912-90913 Biofeedback training, perineal Insufficient evidence of January 2021 muscles, anorectal or urethral effectiveness sphincter, including EMG and/or manometry, when performed

VbBS Issue Summaries for 1-21-2021

Acupuncture for SUD Therapy

Question: Should any limits be placed on acupuncture for substance use disorder (SUD) treatment?

Question source: Barbara Scaturro BSN, RN Clinical Manager, National Outpatient Utilization Management, Centene

Issue: Currently, the CPT codes for acupuncture are on line 4 SUBSTANCE USE DISORDER, but this line is not included in the acupuncture guideline. Therefore, there are no limits on the use of acupuncture for SUD therapy. Additionally, the lack of mention of line 4 in the acupuncture guideline has led to many questions for HERC staff from providers and others who read this as implying lack of coverage for line 4 diagnoses.

From Ms. Scaturro I am searching the HERC and OHP site in hopes that I can find some evidence based guidelines or standards regarding the use of acupuncture in a SUD/MAT setting. I have not been able to locate any specific evidence based reports or guidance other than the associated OAR and guideline note below. Do you have any additional supporting evidence regarding the use of acupuncture in a SUD/MAT setting? Any help you could provide would be greatly appreciated!

This topic has been considered in the past, with no desire on the part of BHAP or HERC to put in limits for number of acupuncture sessions for SUD therapy.

There is a guideline note regarding the need for opioid use treatment to include multiple components. GN175 requires a “variety of evidence-based interventions including behavioral interventions, social support, and Medication Assisted Treatment (MAT) and are individualized to the patient’s needs.”

GUIDELINE NOTE 92, ACUPUNCTURE Lines 1,5,92,111,112,114,125,129,133,135,157,158,191,199-202,208,210,214,215,229,234,237,238, 258,259,261,262,271,276,286,287,294,314-316,329,342,361,372,396,397,401,402,409,410,420,434, 461,463,538,540,558 Inclusion of acupuncture (CPT 97810-97814) on the Prioritized List has the following limitations:

Acupuncture for SUD Therapy

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/primary 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. Lines 92, 111, 112, 114, 125, 129, 133, 135, 157, 158, 191, 199, 200, 208, 210, 214, 215, 229, 234, 237, 238, 258, 259, 261, 262, 271, 276, 286, 287, 294, 314, 315, 316, 329, 342, 372, 396, 397, 420, 434 and 558 Acupuncture is paired only with the ICD-10 code G89.3 (Neoplasm related pain (acute) (chronic)) when there is active cancer and limited to 12 total sessions per year; patients may have additional visits authorized beyond these limits if medically appropriate. Line 201 CHRONIC ORGANIC MENTAL DISORDERS INCLUDING DEMENTIAS Acupuncture 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. Line 402 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 410 MIGRAINE HEADACHES Acupuncture pairs on Line 410 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 463 OSTEOARTHRITIS AND ALLIED DISORDERS Acupuncture pairs on Line 463 for osteoarthritis of the knee only (ICD-10-CM M17), for up to 12 sessions per year. *Line 540 TENSION HEADACHES Acupuncture is included on Line 540 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.

GUIDELINE NOTE 175, MEDICATION-ASSISTED TREATMENT OF OPIOID DEPENDENCE Lines 1,4 In patients who meet criteria for opioid use disorder, programs that offer treatment of opioid use disorder must offer patients a variety of evidence-based interventions including behavioral interventions, social support, and Medication Assisted Treatment (MAT) and are individualized to the VbBSpatient’s needs. Issue Intensive programs, Summaries such as inpatient residential treatment for programs, 1-21-2021 are required to

Acupuncture for SUD Therapy

inform patients about MAT and to offer access to and support for MAT (including at least one form of opioid substitution therapy) if patients elect to receive it, to be included on this line.

MAT includes pharmacotherapy with opioid substitution therapy (methadone and buprenorphine) and opioid antagonists (naltrexone).

Detoxification alone is likely ineffective for producing long-term benefit and should be followed by a formal substance use disorder individualized treatment plan.

In pregnant women with opioid dependence, comprehensive treatment (including opioid substitution therapy) is included on this line

Evidence 1) RAND 2015, Needle Acupuncture for Substance Use Disorders, A Systematic Review a. N=41 studies (reported in 48 publications) with 5,227 participants b. Acupuncture sessions ranged from 15 to 45 minutes per session, from one to 21 sessions, and for one to 32 weeks in total duration c. When the data were pooled across studies, no significant effects of acupuncture (as adjunctive or monotherapy versus any comparator) versus any comparator were observed at postintervention for relapse (SMD −0.12; 95% CI −0.46 to 0.22; 10 RCTs), frequency of substance use (SMD −0.27; CI −2.67 to 2.13; 2 RCTs), quantity of substance use (SMD 0.01; CI −0.40 to 0.43; 3 RCTs), or treatment dropout (OR 0.82; CI 0.63 to 1.09; 22 RCTs). We did identify statistically significant, clinically medium effects in favor of acupuncture (as an adjunctive or monotherapy) versus any comparator at postintervention for withdrawal/craving (SMD −0.57, CI −0.93 to −0.20; 20 RCTs) and anxiety (SMD −0.74, CI −1.15 to −0.33; 6 RCTs), though pooled effects were not statistically significant at longer follow-up points. d. acupuncture is not typically associated with serious adverse events, though some participants may experience slight bleeding/pain at the needle insertion site e. low or very low quality of evidence and the limited power to detect statistically significant differences due to the number of studies and amount of participants within studies f. Conclusions: The available evidence suggests no consistent effect of acupuncture versus comparator interventions on substance use outcomes. There were positive effects for withdrawal symptoms and anxiety, yet these results were based on low or very low quality of evidence.

BHAP input: Lindsey felt acupuncture should be part of a larger package. Cobb noted that acupuncture is also used for anxiety and post-treatment support. Lindsey felt that even post treatment, most patients are still in therapy or in other supportive programs. HERC staff will draft up guideline wording for the acupuncture guideline indicating that acupuncture is included for treatment of SUD only as part of a larger treatment VbBSprogram. Lindsey Issue and Gary Cobb Summarieswant to look at guideline changes for HERC for staff. 1-21-2021

Acupuncture for SUD Therapy

HERC staff summary

The current lack of reference to line 4 in the acupuncture guideline is confusing to stakeholders. The evidence does not support use of acupuncture as the sole therapy for SUD; rather, it supports its use for treatment of craving and withdrawal. Other guidelines on the Prioritized List refer to the need for a variety of evidence-based therapies for SUD treatment.

HERC staff recommendation: 1) Modify GN92 as shown below

Line 1 PREGNANCY Acupuncture pairs on Line 1 for the following conditions and codes. 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/primary care provider for up to 12 sessions per pregnancy. Line 4 SUBSTANCE USE DISORDER Acupuncture is included on this line only when used as part of a program that offer patients a variety of evidence-based interventions including behavioral interventions, social support, and Medication Assisted Treatment (MAT), as appropriate. 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. Lines 92, 111, 112, 114, 125, 129, 133, 135, 157, 158, 191, 199, 200, 208, 210, 214, 215, 229, 234, 237, 238, 258, 259, 261, 262, 271, 276, 286, 287, 294, 314, 315, 316, 329, 342, 372, 396, 397, 420, 434 and 558 Acupuncture is paired only with the ICD-10 code G89.3 (Neoplasm related pain (acute) (chronic)) when there is active cancer and limited to 12 total sessions per year; patients may have additional visits authorized beyond these limits if medically appropriate. VbBSLine 201 CHRONIC Issue ORGANIC MENTAL Summaries DISORDERS INCLUDING DEMENTIAS for 1-21-2021

Acupuncture for SUD Therapy

Acupuncture 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. Line 402 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 410 MIGRAINE HEADACHES Acupuncture pairs on Line 410 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 463 OSTEOARTHRITIS AND ALLIED DISORDERS Acupuncture pairs on Line 463 for osteoarthritis of the knee only (ICD-10-CM M17), for up to 12 sessions per year. *Line 540 TENSION HEADACHES Acupuncture is included on Line 540 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.

VbBS Issue Summaries for 1-21-2021

Localized Prostate Cancer Therapies

Question: Should treatments for prostate cancer be updated on the Prioritized List based on a new AHRQ evidence review?

Question source: HERC staff

Issue: Multiple treatments exist for localized prostate cancer. Several of these procedures are included on the Prioritized List, mainly on line 662/GN173. AHRQ recently published an evidence based review of various therapies. Certain therapies, such as radical prostatectomy, watchful waiting, external beam radiation, and androgen deprivation therapy are standard of care and are included on the prostate cancer line. Two of these therapies were reviewed at the October, 2020 VBBS/HERC meeting, including high intensity focused ultrasound (HIFU) and cryotherapy. Additional therapies reviewed in the AHRQ report include brachytherapy, laser ablation, and photodynamic therapy. The coverage and GN173 entries for these modalities should be updated based on the AHRQ report.

Evidence 1) AHRQ 2020, Therapies for Clinically Localized Prostate Cancer a. N=17 RCTs b. For these modalities…including cryotherapy, laser ablation, and high-intensity focused ultrasound, evidence was insufficient. c. We found no evidence for effects of photodynamic therapy on mortality or metastases. d. Brachytherapy: i. adding brachytherapy to radiation therapy and androgen deprivation therapy may provide a small reduction in all-cause mortality (low certainty of evidence [COE]) but may make little to no difference on metastatic disease (low COE). ii. The evidence was very uncertain about the effect of brachytherapy with external beam radiation therapy on overall survival versus brachytherapy alone (insufficient COE).

VbBS Issue Summaries for 1-21-2021

Localized Prostate Cancer Therapies

Current Prioritized List status CPT Code Description Current Placement Code Brachytherapy 55875 Transperineal placement of needles or Never reviewed catheters into prostate for interstitial radioelement application, with or without Note: the prior HCPCS code for cystoscopy brachytherapy (G0256) was reviewed in 2001 and placed on the Ancillary List Laser ablation 52647 Laser coagulation of prostate, including 662 CONDITIONS FOR WHICH CERTAIN control of postoperative bleeding, complete INTERVENTIONS ARE UNPROVEN, HAVE NO (vasectomy, meatotomy, cystourethroscopy, CLINICALLY IMPORTANT BENEFIT OR HAVE urethral calibration and/or dilation, and HARMS THAT OUTWEIGH BENEFITS internal urethrotomy are included if performed) 52648 Laser vaporization of prostate, including 327 FUNCTIONAL AND MECHANICAL control of postoperative bleeding, complete DISORDERS OF THE GENITOURINARY SYSTEM (vasectomy, meatotomy, cystourethroscopy, INCLUDING BLADDER OUTLET OBSTRUCTION urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed) 52649 Laser enucleation of the prostate with 327 morcellation, including control of 329 CANCER OF PROSTATE GLAND postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed) Photodynamic therapy 96570 Photodynamic therapy by endoscopic 40+ lines including 329 CANCER OF PROSTATE application of light to ablate abnormal tissue GLAND via activation of photosensitive drug(s); first 30 minutes (List separately in addition to code for endoscopy or bronchoscopy procedures of lung and gastrointestinal tract) 96571 Photodynamic therapy by endoscopic 40+ lines including 329 CANCER OF PROSTATE application of light to ablate abnormal tissue GLAND via activation of photosensitive drug(s); each additional 15 minutes (List separately in addition to code for endoscopy or bronchoscopy procedures of lung and gastrointestinal tract)

VbBS Issue Summaries for 1-21-2021

Localized Prostate Cancer Therapies

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 C9747, 55880 Ablation of prostate/ablation of Insufficient evidence of October, 2020 malignant prostate tissue, effectiveness transrectal, high-intensity focused ultrasound (hifu), including imaging guidance 52647 Laser coagulation of prostate No evidence of effectiveness March, 2015 Coverage guidance 53854 Transurethral destruction of Insufficient evidence of November, prostate tissue; by radiofrequency effectiveness 2018 generated water vapor 55873 Cryosurgical ablation of the Insufficient evidence of October, 2020 prostate effectiveness Prostate • Oncotype DX Genomic Prostate Unproven Intervention January, 2018 Cancer Gene Score Expression • Decipher RP for prostate cancer Coverage tests billed guidance with nonspecific codes (e.g. 81479, 81599, 84999)

VbBS Issue Summaries for 1-21-2021

Localized Prostate Cancer Therapies

HERC staff recommendations: 1) Remove CPT 52649 (Laser enucleation of the prostate with morcellation, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed)) from line 329 CANCER OF PROSTATE GLAND a. Remains on line 327 FUNCTIONAL AND MECHANICAL DISORDERS OF THE GENITOURINARY SYSTEM INCLUDING BLADDER OUTLET OBSTRUCTION 2) Remove CPT 96570 and 96571 (Photodynamic therapy by endoscopic application of light to ablate abnormal tissue via activation of photosensitive drug(s)) from line 329 CANCER OF PROSTATE GLAND a. Remains on multiple other lines 3) Add CPT 55875 (Transperineal placement of needles or catheters into prostate for interstitial radioelement application, with or without cystoscopy) to line 662/GN173 as shown below a. Currently listed as “never reviewed”

VbBS Issue Summaries for 1-21-2021

Biomarkers for Prostate Cancer

Question: Should Oncotype Dx and other biomarkers for prostate cancer be added for coverage on the Prioritized List?

Question source: Exact Sciences

Issue: Oncotype Dx and other biomarkers for prostate cancer were last reviewed in January, 2018, and placed on line 662/GN173 due to lack of evidence for effectiveness. The manufacturer of this proprietary test is requesting re-review. Since the last review of this topic, the Washington HTA and AHRQ have both conducted evidence reviews which included evaluation of Oncotype Dx for prostate cancer.

Oncotype Dx for prostate cancer is a proprietary test done on prostate cancer tissue which is designed to help with risk stratification (low vs intermediate vs high risk). Men with newly diagnosed low and favorable intermediate risk prostate cancer can use this information to inform their treatment decision between Active Surveillance (AS) and immediate intervention.

Oncotype Dx for prostate cancer was reviewed as part of a coverage guidance in 2017-2018, and had a strong recommendation for non-coverage. “Gene expression profiling tests for prostate cancer (including Prolaris, Oncotype DX, and Decipher) are not recommended for coverage (strong recommendation).” This Coverage Guidance included 4 studies: 1 database study, 2 cohort studies, and 1 practitioner survey.

Other biomarkers for prostate cancer include Decipher and Prolaris. These tests were also included in the coverage guidance review in 2017-2018.

Evidence 1) AHRQ 2020, Therapies for Clinically Localized Prostate Cancer a. N=17 RCTs b. Key question: How do tumor characteristics modify comparative effectiveness and harms of CLPC therapies? i. Biomarker Status 1. Decipher (Genomic Classifier) 2. Oncotype Dx (Genomic Prostate Score) 3. Prolaris (Cell Cycle Progression) c. We found no evidence that met our predefined inclusion criteria for the newer prognostic (proprietary) biomarkers such as Decipher, Oncotype Dx and Prolaris as it relates to comparative effectiveness modification 2) Washington HTA 2018, Gene expression profile testing of cancer tissue a. N=8 studies regarding prostate cancer, all rated high risk of bias b. For Oncotype DX and Prolaris, however, there were consistent findings associating the use of the tests with decreased treatment intensity. Two studies on the Prolaris test found that for between 40% and 70% of patients, the recommended or actual treatments were less invasive or intensive with the use of the test than before test VbBS Issueresults were available. Summaries Similar results were reported for allfor four of the1-21-2021 Oncotype DX

Biomarkers for Prostate Cancer

studies, which found that more men had recommendations for watchful waiting or active surveillance rather than more intensive forms of treatment in three of the studies c. The magnitude of these changes to noninvasive forms of treatment varied by study, but ranged from 21% to 51% of subjects compared to the group without the test. The fourth study reported that treatment intensity decreased for 15.8%, increased for 8.9% and was unchanged for 38.7%. d. No studies found on impact of any of these tests on mortality or morbidity e. Very low evidence found regarding patient management decisions f. Very low evidence found on impact on quality of life g. No evidence found on harms h. Low evidence found on cost-effectiveness i. The overall quality of evidence for these findings is very low because of substantial limitations, including use of before-after designs and recommended rather than actual treatments, in addition to the lack of important patient outcomes such as survival or treatment-related morbidity. j. Conclusion: There is a mix of low-quality, very low-quality, and no evidence to support the other included tests for prostate cancer, colon cancer, and multiple myeloma. Multiple ongoing clinical trials on most of the tests will be reporting results in the next few years and will hopefully improve the evidence base for decision making regarding the clinical usefulness and economic effects of these tests.

Expert guidelines 1) NCCN 2020, Prostate Cancer a. Initial risk stratification and staging workup for clinically localized disease i. Men with low or favorable intermediate-risk disease and life expectancy ≥ 10 yrs may consider the use of the following tumor-based molecular assays: Decipher, Oncotype DX Prostate, Prolaris, and Promark

VbBS Issue Summaries for 1-21-2021

Biomarkers for Prostate Cancer

HERC staff summary Since the 2017-2018 review, new systematic reviews have not found evidence to support the use of biomarkers for prostate cancer.

HERC staff recommendation: 1) Update GN173 entry for prostate cancer gene expression tests as shown below a. Updates review date b. Standardizes rationale statement

2) Make no change to GN148

GUIDELINE NOTE 148, BIOMARKER TESTS OF CANCER TISSUE Lines 157,184,191,229,262,271,329 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 (CPT 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 VbBSprogesterone Issue receptor positive,Summaries HER2 negative, lymph node negative, for and only1-21-2021 in those cases categorized as high clinical risk.

Biomarkers for Prostate Cancer

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 229.

For lung cancer, epidermal growth factor receptor (EGFR) gene mutation testing (CPT 81235) is included on Line 262 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.

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.

VbBS Issue Summaries for 1-21-2021

Hybrid Surgery of Cervical Fusion with Cervical Artificial Intervertebral Disc Implantation

Question: Should the Prioritized List be clarified as to whether hybrid surgery consisting of cervical fusion with cervical artificial intervertebral disc implantation is covered?

Question source: Kristin Garrett, CCO medical director

Issue: Both cervical fusion and cervical artificial intervertebral disc implantation are covered procedures on the Prioritized List. However, most private insurers find that the hybrid surgery of both procedures done concurrently is experimental. Cervical artificial discs were recently reviewed by HERC regarding expanding coverage to two disc; this change was not approved. The data reviewed by the HERC focused on artificial discs being a replacement for fusion procedures. No data was reviewed on the hybrid procedure.

From Dr. Garrett I was wondering if you’ll be discussing hybrid procedures as well (cervical fusion with cervical artificial intervertebral disc implantation). For our commercial policy we consider hybrid procedures investigational and don’t cover them. Our medical policy team recently delved into the evidence again, and based on their findings, cervical hybrid procedures remain investigational for our commercial lines of business.

Evidence 1) Lu 2017 Treating multi-level cervical disc disease with hybrid surgery compared to anterior cervical discectomy and fusion: a systematic review and meta-analysis a. N=8 studies (169 patients for hybrid surgery (HS) and 193 patients with anterior cervical discectomy and fusion (ACDF procedures) b. Operative time was greater after HS by 42 min (p < 0.00001), with less intraoperative blood loss by 26 mL (p < 0.00001) and shorter return to work by 32 days (p < 0.00001). c. HS was associated with greater C2–C7 range of motion (ROM) preservation (p < 0.00001) and less functional impairment (p = 0.008) after surgery compared to ACDF. There was no significant difference between HS and ACDF with respect to postoperative pain (p = 0.12). d. The postoperative course following HS was not significantly different to ACDF in terms of length of stay (p = 0.24) and postoperative complication rates (p = 0.18). e. Conclusions: HS is a novel surgical approach to treat multi-level cervical disc disease, associated with a greater operative time, less intraoperative blood loss and comparable if not superior clinical outcomes compared to ACDF. While it remains a viable consideration, there is a lack of robust clinical evidence in the literature. Future large prospective registries and randomised trials are warranted to validate the findings of this study. 2) Zhang 2016, meta analysis of Hybrid Surgery and Anterior Cervical Discectomy and Fusion in Cervical Diseases a. N=7 controlled trials (2 prospective, 5 retrospective) b. The results of the meta-analysis indicated that hybrid surgery (HS) achieved better recovery of NDI score (P=0.038) and similar recovery of VAS score (P=0.058) compared with anterior cervical discectomy and fusion (ACDF) at 2 years follow-up. VbBS c.Issue Moreover, the totalSummaries cervical ROM (C2–C7) after HS was preservedfor significantly1-21-2021 more than the cervical ROM after ACDF (P=0.000) at 2 years follow-up. Notably, the

Hybrid Surgery of Cervical Fusion with Cervical Artificial Intervertebral Disc Implantation

compensatory increase of the ROM of superior and inferior adjacent segments was significant in ACDF groups at 2-year follow-up (P<0.01), compared with HS. d. The results demonstrate that HS provides equivalent outcomes and functional recovery for cervical disc diseases, and significantly better preservation of cervical ROM compared with ACDF in 2-year follow-up. This suggests the HS is an effective alternative invention for the treatment of multilevel cervical spondylosis to preserve cervical ROM and reduce the risk of adjacent disc degeneration. Nonetheless, more well-designed studies with large groups of patients are required to provide further evidence for the benefit and reliability of HS for the treatment of cervical disk diseases.

Private insurance coverage 1) Wellmark 2020 a. Hybrid constructs in a single procedure, involving cervical fusion with cervical artificial intervertebral disc implantation is considered investigational for all indications. Concurrent or planned sequential artificial cervical disc replacement with cervical spinal fusion are investigational for the management of neck pain, spinal disorders, and all other indications at all times. 2) Cigna 2020 a. Surgical implantation of a cervical intervertebral disc (IVD) prosthesis is considered experimental, investigational or unproven for ANY other indication, including the following: i. The planned procedure includes the combined use of a prosthesis and spinal fusion (i.e., hybrid surgery)

VbBS Issue Summaries for 1-21-2021

Hybrid Surgery of Cervical Fusion with Cervical Artificial Intervertebral Disc Implantation

HERC staff summary Little evidence exists regarding the clinical outcomes of artificial disc with fusion hybrid procedure for treatment of cervical disc disease. The evidence that exists is limited by retrospective design, lack of controls, small sample populations and short-to mid-term outcomes. Artificial disc replacement was added to the Prioritized List as an alternative to fusion, as explicitly stated in GN101. Private payers consider the hybrid procedure to be experimental.

HERC staff recommendation 1) Modify GN 101 as shown below

GUIDELINE NOTE 101, ARTIFICIAL DISC REPLACEMENT Lines 346,529 Artificial disc replacement (CPT 22856-22865) is included on these lines line 346 as an alternative to fusion only when all of the following criteria are met:

Lumbar artificial disc replacement A) Patients must first complete a structured, intensive, multi-disciplinary program for management of pain, if covered by the agency; B) Patients must be 60 years or under; C) Patients must meet FDA approved indications for use and not have any contraindications. FDA approval is device specific but includes: • Failure of at least six months of conservative treatment • Skeletally mature patient • Replacement of a single disc for degenerative disc disease at one level confirmed by patient history and imaging Cervical artificial disc replacement A) Patients must meet FDA approved indications for use and not have any contraindications. FDA approval is device specific but includes: • Skeletally mature patient • Reconstruction of a single disc following single level discectomy for intractable symptomatic cervical disc disease (radiculopathy or myelopathy) confirmed by patient findings and imaging.

Otherwise, artificial disc replacement is included on line 529.

Artificial disc replacement combined with fusion in a single procedure (hybrid procedure) is not covered.

The development of this guideline note was informed by a HERC coverage guidance. See http://www.oregon.gov/oha/herc/Pages/blog-artificial-disc-replace.aspx

VbBS Issue Summaries for 1-21-2021

Clarification of Coverage of Replacement of Spinal Cord Stimulators

Question: Should spinal cord stimulator replacement be covered if the stimulator does not meet initial insertion criteria in GN178?

Question source: Tracy Muday, CCO medical director

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.

In January, 2020, the evidence regarding the efficacy of spinal cord stimulation was reviewed in detail and a new guideline adopted to clarify which patients qualify for initial stimulator insertion. The HERC staff summary of that review was that

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.

Since that time, questions have arisen about the intent for replacement of spinal cord stimulators which have malfunctioned and for which the patient does not meet the initial placement set out in the new spinal cord stimulator guideline. Part of the confusion arises from the CPT code description for CPT 63685 (Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling) which is not on the complications lines, although replacement of the other parts of the stimulator, such as the electrode array, is on the complications lines.

VbBS Issue Summaries for 1-21-2021

Clarification of Coverage of Replacement of 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 Percutaneous implantation of neurostimulator BY CHRONIC CONDITIONS 63650 electrode array, epidural 346 CONDITIONS OF THE BACK AND

SPINE WITH URGENT SURGICAL INDICATIONS 529 CONDITIONS OF THE BACK AND SPINE WITHOUT URGENT SURGICAL INDICATIONS Laminectomy for implantation of neurostimulator 292,346 529 63655 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 electrode 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, 529 63685 pulse generator or receiver, direct or inductive coupling Revision or removal of implanted spinal 285,424 63688 neurostimulator pulse generator or receiver

VbBS Issue Summaries for 1-21-2021

Clarification of Coverage of Replacement of Spinal Cord Stimulators

Other payer coverage: Both Aetna and Cigna have very explicit criteria for initial insertion. Both policies also state “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.“

VbBS Issue Summaries for 1-21-2021

Clarification of Coverage of Replacement of Spinal Cord Stimulators

HERC staff recommendations: 1) Revise GN 178 as shown below

GUIDELINE NOTE 178, SPINAL CORD STIMULATOR THERAPY Lines 292,346,529 A spinal cord stimulator trial is included on Lines 292 and 346 only when a patient meets all of the following criteria: A) 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: 1) Markedly abnormal reflexes 2) Segmental muscle weakness 3) Segmental sensory loss 4) EMG or NCV evidence of nerve root impingement 5) Cauda equina syndrome 6) Neurogenic bowel or bladder 7) Long tract abnormalities; AND B) The patient has failed 12 or more months of other treatment modalities (e.g. pharmacological, surgical, physical therapy, cognitive therapy, and activity lifestyle modification); AND C) 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.

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.

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

Replacement of a spinal cord stimulator is included on lines 292 and 346 only for patients who 1) meet the criteria for initial insertion above; AND 2) have experienced significant pain reduction (50% or more) with the stimulator prior to its malfunction; AND 3) and the existing stimulator is no longer under warranty and cannot be repaired.

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

VbBS Issue Summaries for 1-21-2021

Stereotactic Body Radiation Therapy and Stereotactic Radiosurgery

Question: should any pairings be added or removed for stereotactic body radiation therapy (CPT 77432) or for stereotactic cranial radiation therapy (CPT 77435)?

Question source: Kristin Garrett, MD, CCO medical director

Issue: Dr. Garrett is requesting clarification on the coverage intention for stereotactic radiation therapy. The CPT code for stereotactic body radiation therapy (CPT 77432) is only present on the lung cancer line while the CPT code for stereotactic cranial radiation therapy (CPT 77435) is present on all lines with radiation therapy. GN142 specifies that both of these codes can only be used for early stage non-small cell lung cancer in medically inoperable patients.

Dr. Garrett also requested review of SBRT for other indications. Frequently covered indications by private insurance include primary tumors and tumors metastatic to the lung, liver, kidney, adrenal gland, or pancreas.

The HERC last reviewed SBRT in 2015, with the coverage decision based on a 2012 Washington HTA report and MED report. The decision was to only add the limited coverage for early stage non-small cell lung cancer in medically inoperable patients. WA HTA and MED did not find evidence for treatment of other types of cancer.

The HERC last reviewed stereotactic radiosurgery in 2013 for intracranial indications and added coverage for AVMs. Stereotactic Radiosurgery (SRS) is a distinct discipline that utilizes externally generated ionizing radiation in certain cases to inactivate or eradicate a defined target(s) in the head or spine without the need to make an incision. SRS uses very high doses of highly precise, externally generated, ionizing radiation, thereby maximizing the ablative effect on the target(s) while minimizing collateral damage to adjacent tissues. Radiation oncologists and neurosurgeons have separate CPT billing codes for SRS. The comprehensive CPT code 61796, 61797, 61798, 61799, 61800, 63620 and 63621 may be billed by the neurosurgeon. A radiation oncologist may bill the SRS management code 77432 for single fraction SRS (and only once per treatment course).

Current placement: CPT CPT Description Current Line(s) Code 32701 Thoracic target(s) delineation 262 CANCER OF LUNG, BRONCHUS, PLEURA, TRACHEA, for stereotactic body radiation MEDIASTINUM AND OTHER RESPIRATORY ORGANS therapy (SRS/SBRT), (photon or particle beam), entire course of treatment 61781 Stereotactic computer-assisted 125 BENIGN NEOPLASM OF THE BRAIN AND SPINAL CORD (navigational) procedure; 196 SUBARACHNOID AND INTRACEREBRAL cranial HEMORRHAGE/HEMATOMA; CEREBRAL ANEURYSM; COMPRESSION OF BRAIN 249 PARKINSON'S DISEASE 294 CANCER OF BRAIN AND NERVOUS SYSTEM VbBS Issue Summaries317 STROKE for 1-21-2021 333 BENIGN CEREBRAL CYSTS

Stereotactic Body Radiation Therapy and Stereotactic Radiosurgery

61782 Stereotactic computer-assisted 125,196,249,294,317,333 (navigational) procedure; 465 CHRONIC SINUSITIS extradural 506 NASAL POLYPS, OTHER DISORDERS OF NASAL CAVITY AND SINUSES 525 BENIGN NEOPLASM OF NASAL CAVITIES, MIDDLE EAR AND ACCESSORY SINUSES 576 DEVIATED NASAL SEPTUM, ACQUIRED DEFORMITY OF NOSE, OTHER DISEASES OF UPPER RESPIRATORY TRACT 61783 Stereotactic computer-assisted 196,294 (navigational) procedure; spinal 61796- Stereotactic radiosurgery 125 BENIGN NEOPLASM OF THE BRAIN AND SPINAL CORD 61800 (particle beam, gamma ray, or 294 CANCER OF BRAIN AND NERVOUS SYSTEM linear accelerator) 317 STROKE 441 TRIGEMINAL AND OTHER NERVE DISORDERS 63620 Stereotactic radiosurgery 200 CANCER OF BONES (particle beam, gamma ray, or 294 CANCER OF BRAIN AND NERVOUS SYSTEM linear accelerator); 1 spinal lesion 63621 each additional spinal lesion 200,294 77373 Stereotactic body radiation 262 CANCER OF LUNG, BRONCHUS, PLEURA, TRACHEA, therapy, treatment delivery, MEDIASTINUM AND OTHER RESPIRATORY ORGANS per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions 77432 Stereotactic radiation 71 NEUROLOGICAL DYSFUNCTION IN BREATHING, EATING, treatment management of SWALLOWING, BOWEL, OR BLADDER CONTROL CAUSED BY cranial lesion(s) (complete CHRONIC CONDITIONS; ATTENTION TO OSTOMIES course of treatment consisting 112 CANCER OF EYE AND ORBIT of 1 session) 125 BENIGN NEOPLASM OF THE BRAIN AND SPINAL CORD 157 CANCER OF COLON, RECTUM, SMALL INTESTINE AND ANUS 196 SUBARACHNOID AND INTRACEREBRAL HEMORRHAGE/HEMATOMA; CEREBRAL ANEURYSM; COMPRESSION OF BRAIN 199 CANCER OF SOFT TISSUE 214 CANCER OF KIDNEY AND OTHER URINARY ORGANS 215 CANCER OF STOMACH 229 MALIGNANT MELANOMA OF SKIN 259 CANCER OF ENDOCRINE SYSTEM, EXCLUDING THYROID; CARCINOID SYNDROME 262 CANCER OF LUNG, BRONCHUS, PLEURA, TRACHEA, MEDIASTINUM AND OTHER RESPIRATORY ORGANS 276 CANCER OF SKIN, EXCLUDING MALIGNANT MELANOMA 287 CANCER OF ORAL CAVITY, PHARYNX, NOSE AND LARYNX 294 CANCER OF BRAIN AND NERVOUS SYSTEM 315 CANCER OF LIVER VbBS Issue Summaries316 CANCER OF PANCREAS for 1-21-2021

Stereotactic Body Radiation Therapy and Stereotactic Radiosurgery

317 STROKE 372 BENIGN NEOPLASM OF RESPIRATORY AND INTRATHORACIC ORGANS 434 CANCER OF GALLBLADDER AND OTHER BILIARY 441 TRIGEMINAL AND OTHER NERVE DISORDERS 592 SECONDARY AND ILL-DEFINED MALIGNANT NEOPLASMS 77435 Stereotactic body radiation 262 CANCER OF LUNG, BRONCHUS, PLEURA, TRACHEA, therapy, treatment MEDIASTINUM AND OTHER RESPIRATORY ORGANS management, per treatment course, to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions

GUIDELINE NOTE 142, STEREOTACTIC BODY RADIATION THERAPY Line 262 Stereotactic body radiation therapy (CPT 32701, 77373, 77435) is included on Line 262 only for early stage non-small cell lung cancer in medically inoperable patients.

VbBS Issue Summaries for 1-21-2021

Stereotactic Body Radiation Therapy and Stereotactic Radiosurgery

Evidence 1) Center for Evidence Based Policy review for Washington HTA 2017, evidence update to the HTA review on stereotactic radiation surgery and stereotactic radiation therapy https://www.hca.wa.gov/assets/program/SRS-SBRT-update-lit-search-20170125.pdf a. Brain cancer: N=31 articles i. There is some additional evidence to support the conclusion that SRS is an effective treatment for brain cancer. The most recent systematic review is an update to the Cochrane systematic review that examined SRS plus whole brain radiation therapy (WBRT) versus WBRT alone for the treatment of brain metastases (Patil et al., 2016). The authors conducted meta-analyses for overall survival, median survival, and local failure using two trials with a total of 358 participants. Patil et al. (2016) found a non-significant reduction in overall survival in the SRS+WBRT group compared to the WBRT group, although the difference between groups was close to statistical significance (hazard ratio [HR], 0.82, 95% confidence interval [CI], 0.65 to 1.02; p = .08). For patients with one brain metastasis, median survival was significantly longer in SRS+WBRT compared to WBRT alone (6.5 months vs. 4.9 months; p = .04) (Patil et al., 2016). Patients in the SRS+WBRT group had decreased local failure compared to patients who received WBRT alone (HR, 0.27; 95% CI, 0.14 to 0.52; p < .0001) (Patil et al., 2016). b. Non-small cell lung cancer i. N=29 articles ii. There is some additional evidence to support the conclusion that SBRT is an effective treatment for NSCLC. The most recent systematic review concluded that use of SBRT has the possibility of improved local control and overall survival compared to historical controls (Jones et al., 2015). iii. Center researchers found insufficient evidence to conclude that SBRT is effective for treating operable NSCLC. c. Prostate cancer i. N=7 articles ii. Center researchers found insufficient evidence to indicate that SBRT is an effective treatment for prostate cancer d. Pancreatic cancer i. N=2 articles ii. Center researchers found insufficient evidence to indicate that SBRT is an effective treatment for pancreatic cancer e. Liver cancer i. N=3 articles ii. Center researchers found insufficient evidence to indicate that SBRT is an effective treatment for liver cancer. f. Spinal cancer i. N=3 articles ii. Center researchers found insufficient evidence to indicate that SRS is an effective treatment for spinal cancers. g. Adrenal cancer i. N=1 article VbBS Issueii. Center researchersSummaries found insufficient evidence tofor indicate that1-21-2021 SABR is an effective treatment for adrenal cancer

Stereotactic Body Radiation Therapy and Stereotactic Radiosurgery

Other coverage policies 1) Washington Medicaid a. SRS for central nervous system (CNS) primary and metastatic tumors is a covered benefit for adults and children when the following criteria are met: i. Patient functional status score (i.e., Karnofsky score) is greater than or equal to 50; and ii. Evaluation includes multidisciplinary team analysis (e.g., tumor board), including surgical input. b. SBRT is covered for adults and children for the following conditions when the following criteria are met: i. For cancers of spine/paraspinal structures: or ii. For inoperable non-small cell lung cancer, stage 1; and iii. Evaluation includes multidisciplinary team analysis (e.g., tumor board), including surgical input. 2) Noridian 2018; LCD, SRS coverage a. Primary central nervous system malignancies, generally under 5 cm. b. Primary and secondary tumors involving the brain or spine parenchyma, meninges/dura, or immediately adjacent boney structures. c. Benign brain tumors and spinal tumors such as meningiomas, acoustic neuromas, pituitary adenomas, and pineal cytomas. d. Cranial arteriovenous malformations and hemangiomas. e. Other cranial non-neoplastic conditions for which it has been proven effective, e.g., movement disorders such as Parkinson’s disease, essential tremor and other disabling tremor that are refractory to conventional therapy, such as severe, sustained trigeminal neuralgia not responsive to other modalities. f. As a boost treatment for larger cranial or spinal lesions that have been treated initially with external beam radiation therapy or surgery (i.e., grade III and IV gliomas, oligodendrogliomas, sarcomas, chondrosarcomas, chordomas, and nasopharyngeal or paranasal sinus malignancies). g. Metastatic brain or spine lesions, generally limited in number, with stable systemic disease, Karnofsky Performance Status 70 or greater (or expected to return to 70 or greater with treatment), and otherwise reasonable survival expectations. h. Relapse in a previously irradiated cranial or spinal field where the additional stereotactic precision is required to avoid unacceptable vital tissue radiation.

VbBS Issue Summaries for 1-21-2021

Stereotactic Body Radiation Therapy and Stereotactic Radiosurgery

HERC staff summary There has been no change in the previous Washington HTA report findings on the utility of stereotactic body radiation therapy; evidence of effectiveness if found only for non-small cell lung cancer. Stereotactic radiosurgery appears to not have been reviewed in 10+ years and is on many lines without indications.

HERC staff recommendations 1) Make no change to current coverage of stereotactic body radiation therapy a. Limits to early stage non-small cell lung cancer in medical inoperable patients 2) Remove CPT 77432 (Stereotactic radiation treatment management of cranial lesion(s)) from all lines not involving cranial lesions a. 71 NEUROLOGICAL DYSFUNCTION IN BREATHING, EATING, SWALLOWING, BOWEL, OR BLADDER CONTROL CAUSED BY CHRONIC CONDITIONS; ATTENTION TO OSTOMIES b. 157 CANCER OF COLON, RECTUM, SMALL INTESTINE AND ANUS c. 199 CANCER OF SOFT TISSUE d. 214 CANCER OF KIDNEY AND OTHER URINARY ORGANS e. 215 CANCER OF STOMACH f. 229 MALIGNANT MELANOMA OF SKIN g. 259 CANCER OF ENDOCRINE SYSTEM, EXCLUDING THYROID; CARCINOID SYNDROME h. 262 CANCER OF LUNG, BRONCHUS, PLEURA, TRACHEA, MEDIASTINUM AND OTHER RESPIRATORY ORGANS i. 276 CANCER OF SKIN, EXCLUDING MALIGNANT MELANOMA j. 287 CANCER OF ORAL CAVITY, PHARYNX, NOSE AND LARYNX k. 315 CANCER OF LIVER l. 316 CANCER OF PANCREAS m. 317 STROKE n. 372 BENIGN NEOPLASM OF RESPIRATORY AND INTRATHORACIC ORGANS o. 434 CANCER OF GALLBLADDER AND OTHER BILIARY p. 592 SECONDARY AND ILL-DEFINED MALIGNANT NEOPLASMS

VbBS Issue Summaries for 1-21-2021

Total Artificial Hearts

Question: Should coverage for total artificial hearts be added to the Prioritized List?

Question source: HERC staff

Issue: Total artificial hearts was last reviewed in 2017 as a new 2018 CPT code. At that time, they were considered experimental by CMS and were placed on line 662/GN173. CMS just removed the experimental status of total artificial hearts, allowing coverage if OHP deems appropriate.

The total artificial heart (TAH) replaces both failing heart ventricles and the four heart valves in patients with end-stage biventricular heart failure. The native heart is removed and replaced by the artificial heart. Currently, there are 2 FDA approved total artificial heart on the market. The indications for total artificial heart are bridge to transplant and treatment of biventricular heart failure in patients not eligible for heart transplant. Currently, ventricular assist devices (LVADs) are covered on the Prioritized List for severe heart failure. LVADs are the major alternative therapy to artificial hearts.

During the 2017 review of artificial hearts, HERC staff noted that NICE was conducting a review of this technology. Staff were directed to reconsider this topic once the NICE review was published. This review was published in late 2017.

CPT Codes 33927 Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy 33928 Removal and replacement of total replacement heart system (artificial heart) 33929 Removal of a total replacement heart system (artificial heart) for heart transplantation (List separately in addition to code for primary procedure)

Evidence 1) NICE 2017; Artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure a. Current evidence on the safety and efficacy of total artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure is limited in quality and quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research. b. Evidence: i. In a non-randomised prospective comparative study of patients at risk of imminent death from irreversible biventricular heart failure, total artificial heart (TAH) implantation (n=81) was compared with no TAH implantation (matched historical controls; n=35). The rates of survival to heart transplantation were 79% (95% confidence interval [CI] 68% to 87%) in the TAH group compared with 46% in the control group (p<0.001). The 1-year survival to heart transplantation rates were 70% (95% CI 63% to 77%) and 31% respectively (p<0.001). ii. In a non-randomised retrospective comparative study (United Network of Organ Sharing [UNOS] database analysis) comparing TAH support (n=212) with VbBS Issuebiventricular Summaries assisted device (BIVAD) support (n=366) for as a bridge1-21-2021 to transplantation (BTT) in adult patients, device support survival rates were

Total Artificial Hearts

similar in both groups (p=0.8): 95% compared with 93% at 30 days and 77% compared with 69% at 1 year. iii. In a non-randomised retrospective comparative study comparing TAH support (n=81) with paracorporeal BIVAD support (n=67) as a BTT in 148 adult patients, device support survival rates were similar between the groups (p=0.87): 76% compared with 72% at 30 days; 63% compared with 61% at 2 months; and 46% compared with 53% at 6 months respectively. In a case series of 101 patients at risk of imminent death from irreversible biventricular heart failure and eligible for transplant, survival to heart transplantation with TAH implantation as a BTT was 68% (69/101). iv. In a case series of 90 patients with biventricular failure treated by TAH implantation as a BTT, actuarial survival on device was 74±5%, 63±6% and 47±8% at 30, 60 and 180 days after implantation respectively. In a case series of 27 patients with TAH implantation as a BTT, 44% (12/27) of patients were discharged from hospital within a median of 88 days after implantation (range 35 to 152 days). v. In the non-randomised prospective comparative study comparing patients with TAH implantation (n=81) with matched historical controls (n=35), the survival rates at 1 and 5 years after transplantation in the TAH group were 86% and 64% compared with 69% and 34% in the control group respectively (p values not reported). c. Safety i. High rates of bleeding (14-62%), device malfunction (10-25%), and renal failure (24-73%) were reported ii. High rates of neurologic events (stroke, encephalopathy, seizure) were reported (8-27%)

Expert input Dr. Howard Song, director of the OHSU heart transplant program: I do not think outcomes from artificial hearts justify its coverage by OHP. it is a very expensive therapy associated with a lot of morbid complications. In addition, it is used exclusively as a bridge to transplant and there is lots of data showing outcomes of heart transplant in patients bridged with an artificial heart are worse. So the therapy not only is morbid in its own right, it also makes heart transplant outcomes worse.

VbBS Issue Summaries for 1-21-2021

Total Artificial Hearts

HERC staff recommendation: 1) Make no change in lack of coverage of artificial hearts

VbBS Issue Summaries for 1-21-2021

Computer Assisted Bronchoscopy

Question: Should coverage of computer assisted bronchoscopy be added?

Question source: Pacificsource CCO

Issue: Computer assisted bronchoscopy [CPT 31627 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with computer-assisted, image-guided navigation (List separately in addition to code for primary procedure[s])] was last reviewed in December, 2009 as part of the 2010 CPT code review. At that time, very little literature was found on the topic and it was determined to be experimental. CPT 31627 currently is on line 662/GN173.

Computer assisted bronchoscopy, or image-guided bronchoscopy, is a procedure in which a CT scan is done and computer modeling is used to create a 3D image of the lungs to assist in guiding the bronchoscopist to a suspicious lesion for biopsy. CPT 31627 could encompass several different modalities of image assisted bronchoscopy; however, currently it appears to be used solely to represent electromagnetic navigation (EN)-guided bronchoscopy.

Electromagnetic navigation (EN) guided bronchoscopy is used to assist in biopsy of small peripheral lung lesions to determine if they are non-small cell lung cancer. Several other modalities exist to assist in diagnosing such lesions, including endobronchial ultrasound (EBUS) bronchoscopy (CPT 31652-31654, Diagnostic) and transthoracic needle biopsy.

Pacificsource has received two recent requests for computer assisted bronchoscopy, both in patients with lung masses who are considered too high risk for transthoracic needle biopsy.

Evidence 1) NICE 2019, Medtech innovation briefing: superDimension Navigation System to help diagnostic sampling of peripheral lung lesions https://www.nice.org.uk/advice/mib194/resources/superdimension-navigation-system-to-help- diagnostic-sampling-of-peripheral-lung-lesions-pdf-2285963758495429 a. Definition: The superDimension Navigation System consists of computer software, which creates a 3D-reconstruction from CT data of the airway. Conventional bronchoscopes can only reach areas of the lung that are close to the main airways, but the superDimension Navigation System may allow access to more distant regions of the lung when needed, for example for biopsies. b. Comparative evidence shows that electromagnetic navigation bronchoscopy-guided biopsy is less effective in terms of diagnostic yield (proportion of definitive diagnoses), but with lower pneumothorax rates than CT-guided trans-thoracic needle aspiration in patients with peripheral lung and mediastinal lesions. c. Key uncertainties around the evidence are the different definitions of diagnostic yield used in the meta-analyses of primary studies d. Specific patient populations for the electromagnetic navigation bronchoscopy biopsy procedure include: i. individuals for whom CT-guided trans-thoracic needle biopsy is thought to be VbBS Issuehigh risk, Summaries including those with multiple and bilateral for lesions or1-21-2021 previous pneumonectomy

Computer Assisted Bronchoscopy

ii. individuals in whom CT-guided trans-thoracic needle biopsy is technically not possible. e. Evidence i. N=7 studies: 4 systematic reviews with meta-analyses, 1 randomized controlled trial (RCT), 1 retrospective comparative cohort study and 1 prospective single- armed global cohort study. The total number of patients in the selected studies is 8,359. However, this figure includes unquantifiable instances of multiple- counting of patients in the systematic reviews. 1. Deng et al 2018, Systematic review and meta-analysis a. N=1648 patients (31 studies) b. Electromagnetic navigation bronchoscopy (ENB) compared to CT guided transthoracic biopsy and EBUS c. ENB complication rate: pneumothorax=5.2% d. CT-guided PTNB complication rate: pneumothorax=23.0% e. Outcome measures such as detection rate and diagnostic yield are not adequately defined. 2. Zhang et al 2015, Systematic review and meta-analysis a. N=1106 patients (19 studies) b. Looked only at variations on ENB c. ENB alone; pooled values (95% CI): i. Sensitivity=0.82 (0.79 to 0.85) ii. Specificity=1.00 (0.98 to 1.00) d. Complication rate: 40 pneumothorax in 681 procedures=5.9% 3. Gex et al 2014, Systematic review and meta-analysis a. N=1033 nodules (15 studies) b. Looked only at variations on ENB c. ENB alone; pooled values (95% CI): i. Sensitivity for malignancy=71.1% (64.6 to 76.8) ii. Accuracy for malignancy=78.6% (72.8 to 83.4) iii. Diagnostic yield=64.9% (59.2 to 70.3) iv. Diagnostic accuracy=73.9% (68.0 to 79.2) v. NPV=52.1% (43.5 to 60.6) d. Complication rate: 32 pneumothorax in 1,033 procedures=3.1% (95% CI 2.1 to 4.3) 4. Wang Memoli et al 2012, Systematic review and meta-analysis a. N= 3,052 lesions (39 studies). b. Compared ENB to EBUS to virtual bronchoscopy c. Diagnostic yield (inverse variance weighted, with 95% CI values): i. ENB=67.0% (62.6 to 71.4) ii. Virtual bronchoscopy=72.0% (65.7 to 78.4) iii. Radial EBUS=71.1% (66.5 to 75.7) f. Conclusions: i. Definitive RCT evidence is lacking and the place for this technology in the NHS, alongside other guided bronchoscopy techniques, is not yet established. More evidence around the benefit and cost is needed ii. The superDimension Navigation System may be suitable for patients for whom VbBS IssueCT-guided Summaries biopsy is thought to be high risk. for 1-21-2021

Computer Assisted Bronchoscopy

Expert guidelines 1) NCCN 2021, Non small cell lung cancer a. In patients with suspected non-small cell lung cancer (NSCLC), many techniques are available for tissue diagnosis b. Diagnostic tools that should be routinely available include: i. Sputum cytology ii. Bronchoscopy with biopsy iii. Image guided transthoracic needle core biopsy iv. Thoracentesis v. Mediastinoscopy vi. Video-assisted thoracic surgery c. Diagnostic tools that provide important additional strategies for biopsy include: i. EBUS-guided biopsy 1-21-2021 ii. EUS-guided biopsy iii. Navigational bronchoscopy d. Patients with peripheral nodules may benefit from navigational bronchoscopy, radial EBUS, or transthoracic needle aspiration for

Other payer policies 1) Aetna 2020: Aetna considers electromagnetic navigation (EN)-guided bronchoscopy for the management of peripheral lung lesions experimental and investigational because of insufficient evidence of its effectiveness. 2) Anthem 2020: Electromagnetic navigational bronchoscopy is considered investigational and not medically necessary for all applications

Summaries

Issue

VbBS

Computer Assisted Bronchoscopy

HERC staff summary: Computer assisted bronchoscopy is one option for biopsy of a peripheral lung lesion. NICE found the literature to be questionable, and recommended consideration of the technology only for patients who could not undergo transthoracic biopsy. NCCN lists “navigational bronchoscopy” as just one option for evaluating peripheral lung nodules. Private payers consider this technology to be experimental and are not currently covering it. Multiple other diagnostic tests for peripheral lung lesions, such as endobronchial ultrasound (EBUS) bronchoscopy and transthoracic needle biopsy, are currently covered under OHP.

HERC staff recommendation: 1) Maintain current non-coverage of computer assisted bronchoscopy

GUIDELINE NOTE 173, INTERVENTIONS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS Line 662 1-21-2021 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: for Procedure Intervention Description Rationale Last Review Code 31627 Computer assisted bronchoscopy Insufficient evidence of December, effectiveness 2009 January 2021

Summaries

Issue

VbBS

Section 3.0 Coverage Guidances SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

DEEP BRAIN NEUROSTIMULATORS FOR REFRACTORY EPILEPSY

Population Adults with refractory epilepsy who: description 1) Have a diagnosis of epilepsy characterized by partial-onset seizures with or without secondary generalization; 2) Have not responded to adequate trials of 3 or more antiepileptic medications; and 3) Have averaged 6 or more seizures per month during the previous 3 months, with no more than 30 days between seizures; and 4) Have focal anterior thalamic nucleus targets; and 5) Are not candidates for resective epilepsy surgery or have a history of failed resective epilepsy surgery 6) Are not candidates for other treatments for refractory epilepsy (e.g., vagal nerve stimulation) or have a history of failed treatments Population scoping notes: None

Intervention(s) Deep brain stimulation of the anterior nucleus of the thalamus

Intervention exclusions: None

Comparator(s) Anti-seizure medications or other treatments

Outcome(s) Critical: Hospitalization, harms (for example, depression, suicidality, memory loss, (up to five) surgery-related adverse events)

Important: Clinically significant change in seizure frequency, clinically significant improvement in Engel Epilepsy Surgery Outcome Scale (EESOS) scoring, clinically significant change in medication use

Considered but not selected for GRADE Table: Mortality from sudden death in epilepsy

Key questions What is the comparative effectiveness of deep brain stimulation of the anterior nucleus of the thalamus to treat refractory epilepsy? Does the comparative effectiveness of deep brain stimulation of the anterior nucleus of the thalamus vary by: a. Type of epilepsy b. Patient characterisistics c. Previous treatments d. Location of seizure focus What are the harms of deep brain stimulation of the anterior nucleus of the thalamus to treat refractory epilepsy?

1/14/21 Contextual None questions

CHANGE LOG

Date Change Rationale m/d/yyyy

1/14/21 Section 4.0 Coverage Guidances SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

HIGH FREQUENCY CHEST WALL OSCILLATION DEVICES

Population Children and adults with cystic fibrosis, bronchiectasis, chronic obstructive description pulmonary disorder, or pulmonary complications from neuromuscular disease resulting in chronic lung disease

Population scoping notes: Patients without any of the above conditions are excluded.

Intervention(s) High-frequency chest wall oscillation devices approved for use in the US

Intervention exclusions: None

Comparator(s) Home physical therapy, mechanical percussors, positive expirtory pressure masks, airway clearance devices (e.g., oscillating devices, intrapulmonary percussive ventilation), or other types of high-frequncy chest wall oscillation devices not approved for use in the U.S.

Outcome(s) Critical: Hospitalizations, mortality (up to five) Important: Frequency of pulmonary exacerbations requiring antibiotics, changes in exercise capacity, symptoms of breathlessness or cough

Considered but not selected for GRADE Table: Sputum volume or weight, forced expiratory volume, forced vital capacity, total lung capacity

Key questions What is the comparative effectiveness of high-frequency chest wall oscillation devices? Does the comparative effectiveness of high-frequency chest wall oscillation devices vary by: a. Disease type b. Patient characterisistics c. Device characteristics What are the harms of high-frequency chest wall oscillation devices? What is the comparative cost effectiveness of high-frequency chest wall oscillation devices?

Contextual What resources are required to use the interventions and comparators? questions

1/14/21 CHANGE LOG

Date Change Rationale m/d/yyyy

1/14/21