Health Evidence Review Commission

March 8, 2018 1:30 PM - 4:30 PM

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

Section 1.0 Call to Order AGENDA HEALTH EVIDENCE REVIEW COMMISSION Wilsonville Training Center, Rooms 111-112 29353 SW Town Center Loop E Wilsonville, Oregon 97070 March 8, 2018 1:30-4:30 pm (All agenda items are subject to change and times listed are approximate)

Action # Time Item Presenter Item 1 1:30 PM Call to order Kevin Olson 2 1:35 PM Approval of minutes (1/18/2018) Kevin Olson X 3 1:40 PM Director’s report Darren Coffman Review New Proposed Coverage Guidance topics: . Intermittent Pneumatic Compression Devices for the Treatment of Lymphedema . Liposuction for The Treatment of Lymphedema . Interventional Treatments for Lower Extremity Chronic Venous Disease . Newer Interventions for Osteoarthritis of Cat Livingston 4 1:45 PM the Knee X . Newer Interventional Procedures for GERD Adam Obley . FoundationOne Sequencing for Advanced Solid Malignancies . Single Fraction Radiotherapy for Palliation of Bony Metastases . Spinal Cord Stimulators for Chronic Back Pain . Extracorporeal Membrane Oxygenation

Select and prioritize topics for 2018 Coverage 5 2:50 PM Cat Livingston X Guidances 6 3:30 PM Open Discussion on HERC retreat items Darren Coffman X 7 4:00 PM Conflicts of Interest Jason Gingerich Next steps 8 4:20 PM  Schedule next meeting – May 17, 2018 Kevin Olson Wilsonville Training Center, rooms 111-112 9 4:30 PM Adjournment Kevin Olson

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

MINUTES

HEALTH EVIDENCE REVIEW COMMISSION Barbara Roberts Human Services Bldg. Room 137A-D Salem, Oregon January 18, 2018

Members Present: Kevin Olson, MD, Chair; Mark Gibson; Leda Garside, RN, MBA (by phone beginning at 1:45 pm); Susan Williams, MD (by phone); Angela Senders, ND; Holly Jo Hodges, MD; Gary Allen, DMD; Devan Kansagara, MD (arrived at 1:50); Lynnea Lindsey, PhD; Leslie Sutton; Adriane Irwin, PharmD.

Members Absent: none

Staff Present: Darren Coffman; Ariel Smits, MD, MPH; Cat Livingston, MD, MPH; Denise Taray, RN; Jason Gingerich; Daphne Peck; Wally Shaffer, MD.

Also Attending: K. Renae Wentz, MD, MPH (Oregon Health Authority); Adam Obley, MD, MPH, Craig Mosbaek (OHSU Center for Evidence-based Policy); Mike Donabedian (Sarepta Therapeutics); Debby Ham, Dan Bues, Paul Blomberg (Circassia Pharmaceutics); Melissa Wood (Genome Health).

Call to Order

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

Minutes Approval

MOTION: To approve the minutes of the 11/9/2017 meeting as presented. CARRIES 7-0. (Absent: Kansagara, Garside, Williams; Abstained: Irwin)

Director’s Report

Darren Coffman introduced the new OHA Chief Medical Officer, Dana Hargunani, a pediatrician, spoke briefly about herself and her new position.

Coffman officially welcomed Adriane Irwin, the new retail pharmacy representative to the Commission, who introduced herself. Each Commissioner and staff person introduced themselves in turn.

MOTION: To Appoint Irwin to the Value-based Benefits Subcommittee. CARRIES: 9-0 (Absent: Kansagara, Garside)

HERC Minutes 1/18/2018 1

Lindsey asked when vice-chair nominations would be on the agenda. Coffman and Olson discussed the duties of a vice-chair which included running a meeting in the absence of the chair and participating in leadership calls, as appropriate. Lindsey then nominated Hodges as vice-chair. Hodges accepted the nomination.

MOTION: To appoint Hodges as HERC’s vice-chair. CARRIES: 9-0 (Abstained: Hodges; Absent: Kansagara)

Coffman shared that the OHA leadership said the legal analysis of the high cost/marginal benefit work should be completed in 60-90 days, so members can expect to hear a report at the May meeting.

Value-based Benefits Subcommittee (VbBS) Report on Prioritized List Changes Meeting materials page 7

Ariel Smits reported the VbBS met earlier in the day, 1/18/2018. She summarized the subcommittee’s recommendations.

Fractional exhaled nitric oxide (FeNo)

Smits said FeNo is a device you breathe into that measures airway inflammation. The Agency for Healthcare Research and Quality (AHRQ) did a systematic review that found it was useful for diagnosing asthma. She said there is not good evidence that FeNo is useful in management of asthma as the studies showed weak evidence in the prevention of acute exacerbations and deciding who might respond well to use of inhaled steroids. The National Institute for Health and Care Excellence (NICE) and Cochran reports agreed with the AHRQ review.

VbBS recommended adding FeNo to the diagnostic file with a guideline note that states it is used for diagnosing asthma but not for management of the disease.

Public comment for FeNo:

Debby Ham, MD, of Circassia Pharmaceutics, testified about exacerbation findings in the AHRQ review saying they are hard to tease out, being composite outcomes, including unscheduled visits to the doctor, emergency room visits, hospitalizations and adding additional therapy. She also said the AHRQ document was the most recent review and included data through April of 2017, encompassing the largest body of evidence for FeNo.

Dan Bues of Circassia Pharmaceutics testified that 39 other states do not distinguish between coverage for diagnostics and disease management and he urged the Commission to follow their example. He said Medicare reimbursement is $20.52 and stated that Medicaid is always less, probably around $13-15. He said some payers cap usage at 4 times per year.

Paul Blomberg of Circassia Pharmaceutics testified about the number of devices in the state, totaling 14. The biggest users are allergists and pulmonologists.

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Gibson said at the VbBS meeting, members could not reconcile use of FeNo for disease management because the studies did not show a decrease in rescue medication or increase in quality of life measurements.

Olson asked the members if they wished to amend the VbBS recommendations. Members discussed feeling torn because the cost is very minimal but the evidence is low; perhaps setting a limit would be a good compromise.

Olson said it is important to be consistent with how evidence is used, no matter how low the cost. Kansagara said the AHRQ report did show a reduction in exacerbations but he cautioned that composite outcomes evidence are not considered strong evidence.

Wentz said there is value in avoiding exacerbations, especially for children avoiding school absences. Gibson said, based on the composite outcomes, he didn’t think he had the information he needed to expand coverage beyond what VbBS was recommending. Members agreed they needed more information to approve anything beyond diagnostics.

MOTION: To approve staff recommendation to add FeNo as presented for diagnostic purposes with a guideline note and bring back for further consideration of exacerbations at a future meeting. CARRIES: 11-0.

RECOMMENDED CODE MOVEMENT (effective 10/1/2018) • Add the procedure codes for implantable cardiac defibrillators to the congestive heart failure line with a new guideline • Add the procedure codes for deep brain stimulation to the Parkinson’s Disease line with a new guideline and removed from the epilepsy line • Delete the procedure codes for catheter directed dissolving of a blood clot in a leg or arm from several lines with no appropriate diagnoses and remove from the deep vein thrombosis line • Add iliotibial band syndrome to an uncovered line and keep on a covered line with a modified guideline to clarify when it appears on which line • Recommend the Health Systems Division add the procedure code for fractional exhaled nitric oxide to the Diagnostic File and add a new guideline note to the Prioritized List specifying it is only covered for the diagnoses of asthma, not management of asthma • Delete the procedure code for laser discectomy from several back condition lines and add to line 660 • Various straightforward coding changes were made

RECOMMENDED GUIDELINE CHANGES (effective 10/1/2018) • Amend the cataract guideline to remove visual acuity as a criteria and replace it with effects of vision on ADLs. • Add a new guideline regarding implantable cardiac defibrillators • Amend the injuries of joints line to specify that the guideline criteria applies to both medical and surgical therapy • Add several procedures to the list of non-covered services in the back guideline • Amend the biomarker for cancer tissue guideline to indicate several prostate cancer tests are now included on line 660

HERC Minutes 1/18/2018 3

• Add several new entries to the procedures of marginal and no benefit guideline notes

MOTION: To accept the VbBS recommendations on Prioritized List changes not related to coverage guidances, as stated. See the VbBS minutes of 1/18/2018 for a full description. Carries: 11-0.

Coverage Guidance Topic: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions for Low Back Pain Meeting materials, pages 103-196

Obley and Livingston presented an overview of the evidence, including the GRADE-Informed Framework (page 106) as well as the proposed coverage guidance from EbGS and Prioritized List change recommendations from VbBS.

There was no discussion.

MOTION: To approve the proposed coverage guidance for Minimally Invasive and Non-Corticosteroid Percutaneous Interventions for Low Back Pain as presented. Carries 11-0.

MOTION: To approve the proposed changes to the Prioritized List, including the guideline note modification, as proposed. Carries 11-0.

Approved Coverage Guidance:

HERC COVERAGE GUIDANCE Minimally invasive discectomy is recommended for coverage as an alternative to microdiscectomy or open discectomy, when discectomy is indicated (weak recommendation). The following are not recommended for coverage for low back pain: • Percutaneous laser disc decompression (strong recommendation) • Ozone therapy injections (strong recommendation) • Radiofrequency denervation (weak recommendation)

Changes for the Prioritized List of Health Services: 1) ADD S2348 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar to Line 660 (currently on Services Not Recommended for Coverage Table -- SNRC) 2) REMOVE 62287 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method, single or multiple levels, lumbar (e.g., manual or automated percutaneous discectomy, percutaneous laser discectomy) from lines 346, 361, and 527. Place on Line 660. 3) Add an entry to Guideline Note 173 as follows:

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

HERC Minutes 1/18/2018 4

The following interventions are prioritized on Line 660 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS: Procedure Code Intervention Description Rationale Last Review 62287, S2348 Percutaneous laser disc Insufficient evidence January, 2018 decompression of effectiveness Ozone therapy injections Coverage Guidance Blog Radiofrequency denervation

4) Modify Guideline Note 37 to read as follows:

GUIDELINE NOTE 37, SURGICAL INTERVENTIONS FOR CONDITIONS OF THE BACK AND SPINE OTHER THAN SCOLIOSIS Lines 346,527 Spine surgery is included on Line 346 only in the following circumstances: A) Decompressive surgery is included on Line 346 to treat debilitating symptoms due to central or foraminal spinal stenosis, and only when the patient meets the following criteria: 1) Has MRI evidence of moderate or severe central or foraminal spinal stenosis AND 2) Has neurogenic claudication OR 3) Has objective neurologic impairment consistent with the MRI findings. Neurologic impairment is defined as objective evidence of one or more of the following: a) Markedly abnormal reflexes b) Segmental muscle weakness c) Segmental sensory loss d) EMG or NCV evidence of nerve root impingement e) Cauda equina syndrome f) Neurogenic bowel or bladder g) Long tract abnormalities Foraminal or central spinal stenosis causing only radiating pain (e.g. radiculopathic pain) is included only on Line 527. B) Spinal fusion procedures are included on Line 346 for patients with MRI evidence of moderate or severe central spinal stenosis only when one of the following conditions are met: 1) spinal stenosis in the cervical spine (with or without spondylolisthesis) which results in objective neurologic impairment as defined above OR 2) spinal stenosis in the thoracic or lumbar spine caused by spondylolisthesis resulting in signs and symptoms of neurogenic claudication and which correlate with xray flexion/extension films showing at least a 5 mm translation OR 3) pre-existing or expected post-surgical spinal instability (e.g. degenerative scoliosis >10 deg, >50% of facet joints per level expected to be resected)

For all other indications, spine surgery is included on Line 527.

The following interventions are not included on these lines due to lack of evidence of effectiveness for the treatment of conditions on these lines, including cervical, thoracic, lumbar, and sacral conditions: prolotherapy local injections (including ozone therapy injections) botulinum toxin injection intradiscal electrothermal therapy therapeutic medial branch block coblation nucleoplasty percutaneous intradiscal radiofrequency thermocoagulation percutaneous laser disc decompression radiofrequency denervation corticosteroid injections for cervical pain

Corticosteroid injections for low back pain with or without radiculopathy are only included on Line 527.

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The development of this guideline note was informed by HERC coverage guidances on Percutaneous Interventions for Low Back Pain, Percutaneous Interventions for Cervical Spine Pain, Low Back Pain: Corticosteroid Injections, and Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions. See http://www.oregon.gov/oha/HPA/CSI-HERC/Pages/Evidence-based-Reports.aspx.

Coverage Guidance Topic: Gene Expression Profiling for Prostate Cancer Meeting materials, pages 197-274

Obley and Shaffer presented an overview of the evidence including the GRADE-Informed Framework (page 202). They also presented the proposed coverage guidance from HTAS and the Prioritized List changes proposed from VbBS.

Olson said if you test a lot of older men you find a lot of prostate cancer and much of that will not affect their lives. How do you figure out who needs to be treated? There are current tools to manage the condition. Do these newer tools allow us to achieve better outcomes? The community in Oregon is not endorsing this yet.

Gingerich said the appointed expert gave input that agreed with our conclusions but another urologist advocated for their use. Obley said that Medicare is collecting data from clinical outcomes of patients who undergo these tests.

Prior to 2018, CPT 81479 (unlisted molecular pathology procedure) was used for these three prostate gene expression tests (Oncotype DX, Prolaris, Decipher). This nonspecific procedure code does not appear on the Prioritized List. A new 2018 CPT code (81541) is now available to use for Prolaris. HERC placed this code on Line 660 for the January 1, 2018 Prioritized List, based on a previous coverage guidance.

MOTION: To approve the proposed coverage guidance for Gene Expression Profiling for Prostate Cancer as presented. Carries 11-0.

MOTION: To approve the proposed changes and guideline note changes for the Prioritized List as presented. Carries 11-0.

Approved Coverage Guidance: HERC Coverage Guidance Gene expression profiling tests for prostate cancer (including Prolaris, Oncotype DX, and Decipher) are not recommended for coverage (strong recommendation).

Changes to the Prioritized List of Health Services:

Affirm placement of Prolaris (CPT 81541) on Line 660, and add Oncotype DX and Decipher (utilizing CPT 81479) to Line 660. Modify one entry and add two entries to GN 173 as shown below:

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

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The following interventions are prioritized on Line 660 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 81479 Oncotype DX Genomic Prostate Unproven interventions January, 2018 Score Assay, Decipher Prostate RP Coverage Guidance Blog

81504 Biomarker tests for tumor tissue: Insufficient evidence of August, 2015 • Mammaprint, Mammostrat and effectiveness. More costly than ImmunoHistoCHemistry 4 (IHC4) equally effective therapies for Coverage Guidance for breast cancer this condition Blog • Microsatellite instability (MSI) for colorectal cancer • Urovysion for bladder cancer • Prolaris for prostate cancer • Multiple molecular testing to select targeted cancer therapy 81541 Prolaris. Oncology (prostate), mRNA Unproven interventions January, 2018 gene expression profiling by real-time RT-PCR of 46 genes (31 content and Coverage Guidance 15 housekeeping) Blog

Revise Guideline Note 148 to read as follows:

GUIDELINE NOTE 148, BIOMARKER TESTS OF CANCER TISSUE Lines 157,184,191,230,263,271,329 The use of multiple molecular testing to select targeted cancer therapy (CPT 81504) is included on the Services recommended for non-coverage table.

For breast cancer, Oncotype Dx testing (CPT 81519, HCPCS S3854) is included on Line 191 only for early stage breast cancer when used to guide adjuvant chemotherapy treatment decisions for women who are lymph node negative. Oncotype Dx is not included on this line for lymph node-positive breast cancer. Mammaprint, ImmunoHistoChemistry 4 (IHC4), and Mammostrat for breast cancer are included on the Services recommended for noncoverage table.

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

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

For colorectal cancer, KRAS gene mutation testing (CPT 81275) is included on Line 157. BRAF (CPT 81210) and Oncotype DX are not included on this line. Microsatellite instability (MSI) is included on the Services recommended for noncoverage table.

For bladder cancer, Urovysion testing is included on Services recommended for noncoverage table.

For prostate cancer, Oncotype DX Genomic Prostate Score, Prolaris Score Assay, and Decipher Prostate RP are included on Line 660.

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

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Conflict of Interest Forms Meeting materials, pages 275-282

HERC’s existing Conflict of Interest (COI) Form has some ambiguities. The information received from some potential ad hoc experts was discordant with Dollars for Docs or CMS Open Payments. Gingerich said we realized it was because of the way our COI questions were worded.

Gingerich introduced two new forms, one for Commissioners and subcommittee members, and the other for ad hoc appointed experts, which are based on his research. These forms clarify the purpose is transparency, as most members and experts have some conflicts inherent in their roles which also give them relevant expertise. Each would be made available electronically. Members discussed the merits of each.

Members discussed sections of the proposed form including financial and non-financial interests and when it is appropriate to recuse oneself from a topic. They wanted to add a statement to not disclose personal health information and to ensure requests are framed positively and are respectful of the professional.

Staff will make edits and bring this topic back at a future meeting.

Wentz asked if COI forms are available by public records request. Coffman answered yes. COI forms are completed by Commissioners, subcommittees and appointed ad hoc experts.

Public Comment

No additional public comment was made at this time.

Adjournment

Meeting adjourned at 4:00 pm. Next meeting will be from 1:30-4:30 pm on Thursday, March 8, 2018 at Clackamas Community College Wilsonville Training Center, Rooms 111-112, Wilsonville, Oregon.

HERC Minutes 1/18/2018 8

Value-based Benefits Subcommittee Recommendations Summary For Presentation to: Health Evidence Review Commission on January 18, 2018

For specific coding recommendations and guideline wording, please see the text of the 1/18/2018 VbBS minutes.

RECOMMENDED CODE MOVEMENT • Add the procedure codes for implantable cardiac defibrillators to the congestive heart failure line with a new guideline • Add the procedure codes for deep brain stimulation to the Parkinson’s disease line with a new guideline and removed from the epilepsy line • Delete the procedure codes for catheter directed dissolving of a blood clot in a leg or arm from several lines with no appropriate diagnoses and removed from the deep vein thrombosis line • Add iliotibial band syndrome to an uncovered line and keep on a covered line with a modified guideline to clarify when it appears on which line • Add the procedure code for fractional exhaled nitric oxide to the diagnostic file with a new guideline specifying it is only covered for the diagnoses of asthma, not management of asthma • Delete the procedure code for laser discectomy from several back condition lines and add to line 660 • Various straightforward coding changes were made

ITEMS CONSIDERED BUT NO RECOMMENDATIONS FOR CHANGES MADE • Yttrium-90 therapy was considered for addition to the liver cancer line, but was not added due to lack of evidence of cost-effectiveness compared to standard chemotherapy

RECOMMENDED GUIDELINE CHANGES • Amend the cataract guideline to remove visual acuity as a criteria and replace it with effects of vision on ADLs. • Add a new guideline regarding implantable cardiac defibrillators • Amend the injuries of joints line to specify that the guideline criteria applies to both medical and surgical therapy • Add several procedures to the list of non-covered services in the back guideline • Amend the biomarker for cancer tissue guideline to indicate several prostate cancer tests are now included on line 660 • Add several new entries to the procedures of marginal and no benefit guideline notes

Value-based Benefits Subcommittee Summary Recommendations, 1/18/2018

VALUE-BASED BENEFITS SUBCOMMITTEE Barbara Roberts Human Services Building 500 Summer Street NE Salem, Oregon January 18, 2018 8:00 AM – 1:00 PM

Members Present: Kevin Olson, MD, Chair; Susan Williams, MD (via phone); Mark Gibson; Holly Jo Hodges, MD (via phone until 11:30, then present); Vern Saboe, DC; Gary Allen, DMD.

Members Absent: None

Staff Present: Darren Coffman; Ariel Smits, MD, MPH; Cat Livingston, MD, MPH; Jason Gingerich; Denise Taray, RN; Daphne Peck, Wally Shaffer, MD.

Also Attending: K. Renae Wentz, MD (via phone) (Oregon Health Authority); Adam Obley, MD & Craig Mosbaek (Center for Evidence-based Medicine); David Barhoum (Genentech); Jonathan Earnes (Egins Consulting on behalf of Genentech); Debby Ham, MD, Dan Bues and Paul Blomberg (Circassia); Michael Donbedian (Sarepta); Joanie Cosgrove (Medtronic); Suzy Sultan (Abbott).

 Roll Call/Minutes Approval/Staff Report

The meeting was called to order at 9:10 am and roll was called. Minutes from the November 9, 2017 VbBS meeting were reviewed and approved.

Smits referred members to the errata documents in the packet. There were no questions or concerns.

Coffman updated the group on planning for the HERC retreat in early February. He also updated the group on OHA’s plan to review the legal aspects of adding pharmaceuticals to lines 500 and 660 of the Prioritized List, which is expected to be completed within the next 60-90 days.

Topic: Straightforward/Consent Agenda

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

Recommended Actions: 1) Add 65435 (Removal of corneal epithelium; with or without chemocauterization (abrasion, curettage)) to line 310 CORNEAL OPACITY AND OTHER DISORDERS OF CORNEA 2) Add 66682 (Suture of iris, ciliary body (separate procedure) with retrieval of suture through small incision (eg, McCannel suture)) to line 404 APHAKIA AND OTHER DISORDERS OF LENS 3) Add 50590 (Lithotripsy, extracorporeal shock wave) to line 180 URETERAL STRICTURE OR OBSTRUCTION; HYDRONEPHROSIS; HYDROURETER 4) Add 50432 (Placement of nephrostomy catheter, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (eg, ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation) and 52332 (Placement of nephrostomy catheter, percutaneous, including diagnostic nephrostogram and/or

Value-based Benefits Subcommittee Minutes, 1/18/2018 Page 2

ureterogram when performed, imaging guidance (eg, ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation) to line 275 UROLOGIC INFECTIONS 5) Add 11012 (Debridement including removal of foreign material at the site of an open fracture and/or an open dislocation (eg, excisional debridement); skin, subcutaneous tissue, muscle fascia, muscle, and bone) and 27122 (Acetabuloplasty; resection, femoral head (eg, Girdlestone procedure)) to line 81 FRACTURE OF HIP 6) Add 11740 (Evacuation of subungual hematoma) to line 208 DEEP OPEN WOUND, WITH OR WITHOUT TENDON OR NERVE INVOLVEMENT 7) Add 61020 (Ventricular puncture through previous burr hole, fontanelle, suture, or implanted ventricular catheter/reservoir; without injection) to line 285 COMPLICATIONS OF A PROCEDURE ALWAYS REQUIRING TREATMENT 8) Add 90869 (Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-determination with delivery and management) to line 7 MAJOR DEPRESSION, RECURRENT; MAJOR DEPRESSION, SINGLE EPISODE, SEVERE 9) Add 11005 (Debridement of skin, subcutaneous tissue, muscle and fascia for necrotizing soft tissue infection; abdominal wall, with or without fascial closure), 44180 (Laparoscopy, surgical, enterolysis (freeing of intestinal adhesion)), 62142 (Removal of bone flap or prosthetic plate of skull), and 69602 (Revision mastoidectomy; resulting in modified radical mastoidectomy) to line 285 COMPLICATIONS OF A PROCEDURE ALWAYS REQUIRING TREATMENT 10) Add inpatient CPT codes to line 118 NUTRITIONAL DEFICIENCIES 11) Add H0038 (Self-help/peer services, per 15 minutes) to lines 62 SUBSTANCE-INDUCED MOOD, ANXIETY, DELUSIONAL AND OBSESSIVE-COMPULSIVE DISORDERS and 312 GENDER DYSPHORIA/TRANSEXUALISM 12) Add 10140 (Incision and drainage of hematoma, seroma or fluid collection) to line 1 PREGNANCY 13) Add 33750 (Shunt; subclavian to pulmonary artery (Blalock-Taussig type operation) to line 77 PATENT DUCTUS ARTERIOSUS; AORTIC PULMONARY FISTULA/WINDOW 14) Add 33606 (Anastomosis of pulmonary artery to aorta (Damus-Kaye-Stansel procedure) to line 134 INTERRUPTED AORTIC ARCH 15) Add 75573 (Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morphology in the setting of congenital heart disease (including 3D image postprocessing, assessment of LV cardiac function, RV structure and function and evaluation of venous structures, if performed) to line 134 INTERRUPTED AORTIC ARCH 16) Add Q25.49 (Other congenital malformations of aorta) to line 77 PATENT DUCTUS ARTERIOSUS; AORTIC PULMONARY FISTULA/WINDOW 17) Add 52332 (Cystourethroscopy, with insertion of indwelling ureteral stent (eg, Gibbons or double-J type)) to line 49 CONGENITAL HYDRONEPHROSIS 18) Add 64788 (Excision of neurofibroma or neurolemmoma; cutaneous nerve), 64790 (Excision of neurofibroma or neurolemmoma; major peripheral nerve) and 64792 (Excision of neurofibroma or neurolemmoma; extensive (including malignant type)) to line 126 BENIGN NEOPLASM OF THE BRAIN AND SPINAL CORD 19) Remove 27590 (Amputation, thigh, through femur, any level) from line 605 SPRAINS AND STRAINS OF ADJACENT MUSCLES AND JOINTS, MINOR 20) Add 92133 (Scanning computerized ophthalmic diagnostic imaging, posterior segment, with interpretation and report, unilateral or bilateral; optic nerve), 92134 (Retina) and 92250 (Fundus photography with interpretation and report) to line 126 BENIGN NEOPLASM OF THE BRAIN AND SPINAL CORD 21) Add 97802 (Medical nutrition therapy; initial assessment and intervention, individual, face-to- face with the patient, each 15 minutes) and 97803 (Medical nutrition therapy; re-assessment

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and intervention, individual, face-to-face with the patient, each 15 minu) to line 71 NEUROLOGICAL DYSFUNCTION IN BREATHING, EATING, SWALLOWING, BOWEL, OR BLADDER CONTROL CAUSED BY CHRONIC CONDITIONS; ATTENTION TO OSTOMIES 22) Add 11640-11646 (Excision, malignant lesion including margins, face, ears, eyelids, nose, lips) to line 287 CANCER OF ORAL CAVITY, PHARYNX, NOSE AND LARYNX 23) Add 90675-90676 (Rabies vaccine) to line 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS 24) Add 96150-5 (Health and behavior assessment/intervention) to lines 71 NEUROLOGICAL DYSFUNCTION IN BREATHING, EATING, SWALLOWING, BOWEL, OR BLADDER CONTROL CAUSED BY CHRONIC CONDITIONS; ATTENTION TO OSTOMIES, 103 POISONING BY INGESTION, INJECTION, AND NON-MEDICINAL AGENTS, 121 ABUSE AND NEGLECT, and 467 GONADAL DYSFUNCTION, MENOPAUSAL MANAGEMENT 25) Add 44202-44203 (Laparoscopy, surgical; enterectomy, resection of small intestine), 44950 (Appendectomy) and 44955 (Appendectomy; when done for indicated purpose at time of other major procedure) to line 157 CANCER OF COLON, RECTUM, SMALL INTESTINE AND ANUS 26) Add ICD-10 Z20.828 (Contact with and (suspected) exposure to other viral communicable diseases) to line 1 PREGNANCY 27) Add CPT 66020 (Injection, anterior chamber of eye (separate procedure); air or liquid), 66250 (Revision or repair of operative wound of anterior segment, any type, early or late, major or minor procedure), 68200 (Subconjunctival injection), and 92025 (Computerized mapping of corneal curvature) to line 285 COMPLICATIONS OF A PROCEDURE ALWAYS REQUIRING TREATMENT 28) Remove ICD-10 A34 (Obstetrical tetanus) from line 35 TERMINATION OF PREGNANCY and add to line 237 TETANUS 29) Remove ICD-10 O03.87 (Sepsis following complete or unspecified spontaneous abortion) from line 35 TERMINATION OF PREGNANCY and add to line 63 SPONTANEOUS ABORTION; MISSED ABORTION 30) Remove ICD-10 O08.0 (Genital tract and pelvic infection following ectopic and molar pregnancy) from lines 35 TERMINATION OF PREGNANCY and 332 CONDITIONS REQUIRING HYPERBARIC OXYGEN THERAPY and add to line 37 ECTOPIC PREGNANCY; HYDATIDIFORM MOLE; CHORIOCARCINOMA 31) Remove ICD-10 O08.1-O08.9 (Complications following an ectopic and molar pregnancy) from line 35 TERMINATION OF PREGNANCY and add to line 37 ECTOPIC PREGNANCY; HYDATIDIFORM MOLE; CHORIOCARCINOMA 32) Remove ICD-10 O36.81 (Decreased fetal movements) from line 35 TERMINATION OF PREGNANCY 33) Remove ICD-10 Z3A (Weeks of gestation) from lines 1 PREGNANCY and 35 TERMINATION OF PREGNANCY a. Advise HSD to add Z3A to the Informational File

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

 Topic: Cataract guideline

Discussion: Smits introduced the summary document. There was minimal discussion.

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Recommended Actions: 1) Revise GN 32 as shown in Appendix A

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

 Topic: Implantable cardiac defibrillators for congestive heart failure

Discussion: Smits reviewed the summary document. Gibson raised concerns about the counseling process for patients receiving this type of technology. He felt that a conversation should be held with the patient prior to implantation to specify when the patient wants the ICDs shut off. Smits noted that counseling requirement could be added to the proposed new guideline. Taray noted that such a discussion could be part of a goals of care discussion and/or palliative care consult. The group consensus was that it should be noted in the minutes that counseling should be standard of care prior to implantation of devices such as ICDs.

Recommended Actions: 1) Add implantable cardiac defibrillator (ICD) insertion, replacement and removal CPT codes to line 98 HEART FAILURE a. CPT 33215, 33216, 33218-33273, 93282-93296, 93644, 93745 2) Adopt a new guideline regarding ICD placement as shown in Appendix B

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

 Topic: Deep brain stimulation for Parkinson’s disease

Discussion: Smits introduced the summary document. Gibson stated that this type of procedure requires a risk/benefit discussion with the treating physician prior to implantation. Olson requested that staff spell out the acronyms in the proposed new guideline note, and the subcommittee gave staff the leeway to add the wording to define the acronyms without needing to bring the guideline back for approval.

Recommended Actions: 1) Add deep brain stimulation to line 250 PARKINSON'S DISEASE a. CPT 61863 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), without use of intraoperative microelectrode recording; first array b. CPT 61864 each additional array c. CPT 61867 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), with use of intraoperative microelectrode recording; first array d. CPT 61868 each additional array e. CPT 61880 Revision or removal of intracranial neurostimulator electrodes f. CPT 61885 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array

Value-based Benefits Subcommittee Minutes, 1/18/2018 Page 5

g. CPT 61886 with connection to 2 or more electrode arrays 2) Adopt a new guideline note as shown in Appendix B

MOTION: To recommend the code and guideline note changes as presented with the note that staff will spell out the acronyms in the proposed new guideline. CARRIES 5-0. (Absent: Hodges)

 Topic: Deep brain stimulation (DBS) for epilepsy

Discussion: Smits reviewed the summary document. Olson raised concerns for possible harms with vagal nerve stimulation based on a recent NPR story. Smits offered to add review of vagal nerve stimulation to a future agenda, but the group felt that was not needed at this time.

There was discussion about the proposed entry to GN173. There was some evidence that DBS may have some benefit in reduction of seizure numbers, but it is not clinically significant. The decision was to change the wording to “evidence of no clinically significant effectiveness” rather than “no effectiveness.”

Recommended Actions: 1) Add CPT 64553 (Percutaneous implantation of neurostimulator electrode array; cranial nerve) to line 174 GENERALIZED CONVULSIVE OR PARTIAL EPILEPSY WITHOUT MENTION OF IMPAIRMENT OF CONSCIOUSNESS a. Advise HSD to remove CPT 64553 from the Ancillary File 2) Remove the following CPT codes from line 174 GENERALIZED CONVULSIVE OR PARTIAL EPILEPSY WITHOUT MENTION OF IMPAIRMENT OF CONSCIOUSNESS a. CPT 61863 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), without use of intraoperative microelectrode recording; first array b. CPT 61864 each additional array c. CPT 61867 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), with use of intraoperative microelectrode recording; first array d. CPT 61868 each additional array e. CPT 61880 Revision or removal of intracranial neurostimulator electrodes f. CPT 61886 with connection to 2 or more electrode arrays 3) Add the following coding specification to line 174 GENERALIZED CONVULSIVE OR PARTIAL EPILEPSY WITHOUT MENTION OF IMPAIRMENT OF CONSCIOUSNESS a. “CPT 61885 is included on this line only for vagal nerve stimulation. It is not included on this line for deep brain stimulation.” 4) Add an entry to GN173 for deep brain stimulation as shown in Appendix A

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

Value-based Benefits Subcommittee Minutes, 1/18/2018 Page 6

 Topic: Diagnosis of sleep apnea guideline updates

Discussion: Livingston reviewed the summary document. Holly Jo Hodges raised an issue about home testing given that a follow-up test is necessary for those that qualify for CPAP to titrate the CPAP. Because of this need for two tests, it seems less cost-effective than having a split-night attended lab polysomnography.

Gibson raised a question about the current mandibular advanced devices being second line therapy to CPAP. Allen shared that while many dentists would prefer mandibular advancementdevices to be considered first line therapy, requiring CPAP prior to mandibular advancement devices is standard among commercial plans.

Members agreed to table the discussion on diagnosis of sleep apnea so staff can work with experts to understand the need for repeat testing for CPAP titration.

Recommended Actions: 1) Table the discussion and bring back to a future meeting

 Topic: Statement of intent for public health emergencies

Discussion: Smits introduced the summary document and discussed issues identified by HERC staff regarding the proposed new guideline. Staff felt that wording should be added to the first sentence in the guideline to clarify that it applies only during declared public health emergencies. Staff is also concerned about wording that seems to require coverage of all FDA approved treatments/ prophylaxis regardless of the evidence of effectiveness.

Olson asked who could determine what rises to the level of an emergency? The law says it is the state public health officer. Hodges noted that a county public health officer may declare something a public health emergency for a local area. Smits noted that the CDC may declare a national emergency. The group agreed that the SOI should reference the person who is responsible for declaring an emergency. Smits proposed adding wording such as “as declared by a county, state or national public health officer.” There was general agreement on adding this wording.

Gibson wanted to add a definition of what is meant by “prophylaxis.” He raised concerns that medications like Tamiflu are used for prophylaxis but have poor evidence of effectiveness.

Williams suggested adding wording to the second sentence replacing the FDA reference with wording like “as recommended by public health officials.”

Hodges noted that she was on the workgroup required by the bill. The issue identified by the workgroup was lack of payment by private payers, not by CCOs. The CCOs have been supportive of covering medications and vaccinations that support public health measures.

Gibson was concerned with the wording “public health recommendations.” Some public health recommendations are dubious when you look at the evidence. He wanted the wording to allow evidence to be considered and not give up decision making entirely to another authority. However, Olson was concerning that such a clause might get in the way of public health officials when there is

Value-based Benefits Subcommittee Minutes, 1/18/2018 Page 7

a true emergency. Olson also noted that it is hard to get evidence for use of something during an emergency as by definition these types of situations are difficult to study.

HERC staff was directed to go back to the bill and look at the intent and wording in the bill. Staff will revise the SOI and consult Public Health and OHA leadership and bring back to a future VbBS meeting.

Recommended Actions: 1) Table this topic until staff can revised the SOI and obtain additional input from Public Health and OHA leadership

 Topic: Catheter directed thrombolysis for DVT

Discussion: Smits reviewed the summary document. There was minimal discussion.

Recommended Actions: 1) Remove catheter directed thrombolysis for non-intracranial and non-coronary thrombosis (CPT 37211-37214) from lines: A. 47 DEEP ABSCESSES, INCLUDING APPENDICITIS AND PERIORBITAL ABSCESS B. 317 STROKE C. 349 NON-LIMB THREATENING PERIPHERAL VASCULAR DISEASE D. 446 ATHEROSCLEROSIS, AORTIC AND RENAL 2) Remove catheter directed thrombolysis from lines 79 PHLEBITIS AND THROMBOPHLEBITIS, DEEP A. CPT 37212 Transcatheter therapy, venous infusion for thrombolysis, any method…initial treatment day B. CPT 37213 Transcatheter therapy, arterial or venous infusion for thrombolysis other than coronary, any method…continued treatment on subsequent day C. CPT 37214 Transcatheter therapy, arterial or venous infusion for thrombolysis other than coronary, any method…continued treatment on subsequent day during course of thrombolytic therapy, including follow-up catheter contrast injection, position change, or exchange, when performed; cessation of thrombolysis including removal of catheter and vessel closure by any method 3) Add the following coding specification to line 280 BUDD-CHIARI SYNDROME, AND OTHER VENOUS EMBOLISM AND THROMBOSIS A. “Catheter directed thrombolysis (CPT 37212-37214) is not paired on this line with peripheral DVT (CPT I82.6, I82.7, I82.A, I82.B, I82.8, I82.9).” 4) Add an entry to GN173 as shown in Appendix A

MOTION: To approve the code and guideline note changes as presented. CARRIES 5-0. (Absent: Hodges)

 Topic: Yttrium-90 for treatment of liver cancer

Discussion: Smits reviewed the summary document. Olson noted that Y-90 is a low volume procedure. Gibson asked whether Y-90 should be placed on line 500 or on line 660. Olson noted that Y-90 has harms and that 660 might be appropriate. Smits stated that she had concerns with line 660

Value-based Benefits Subcommittee Minutes, 1/18/2018 Page 8

as NCCN has recommendations for Y-90 as a treatment option and normally HERC follows NCCN guidelines. The group agree with the line 500 placement.

Recommended Actions: 1) Add a new entry to GN172 as shown in Appendix A

MOTION: To recommend the guideline note change as presented. CARRIES 5-0. (Absent: Hodges)

 Topic: IT band syndrome

Discussion: Smits reviewed the summary document. Saboe raised a concern that chiropractors can effectively treat IT band syndrome and chiropractic services are not included. However, Saboe noted that chiropractors can provide PT services and suggested changing the staff recommendation of “2 PT visits” to “2 visits with a provider certified to provide PT services in the scope of their licensure.” Saboe felt that this change allows chiropractic physicians to provide these services. The group decided on the modified wording: “2 PT visits with a provider licensed to provide physical therapy services.”

Williams raised a concern that the HERC does not want to cover IT band lengthening surgery. HERC staff will identify the CPT code used for IT band lengthening and place on line 605 and remove from line 376, if there, as a consent item for March.

Recommended Actions: 1) Add Iliotibial (IT) band syndrome (ICD10 M76.3) to line 605 SPRAINS AND STRAINS OF ADJACENT MUSCLES AND JOINTS, MINOR 2) Modify GN98 as shown in Appendix A 3) Change the treatment description on line 376: REPAIR, MEDICAL THERAPY

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

 Topic: Fractional exhaled nitric oxide (FeNO) for the diagnosis and management of asthma

Discussion: Smits introduced the summary document. Gibson asked how the data could show that FeNO reduced exacerbations but did not affect quality of life. Debby Ham, MD from Circassia replied that FeNO studies were very heterogeneous regarding the definition of exacerbation. Also, quality of life measures are harder to do.

Testimony was heard from Circassia representatives Dan Bues, Dr. Debbie Hamm and Paul Blomberg: Ham reviewed the evidence. She noted that the Cochrane review found a statistically significant reduction exacerbations in adults and children by 40%. She noted the FeNO was not to be used as a sole diagnostic method. She also noted that FeNO could be useful to determine if patients will respond to inhaled corticosteroids (ICS). FeNo should be used as an adjunct to clinical evaluation. She noted that subgroup analysis for exacerbations requiring oral steroids when pooling data for kids and adults found statistically significant improvement.

Bues noted that FeNO is covered by 41 state Medicaid programs. Many payers have dropped coverage policies as the low cost of the test outweighs the cost of administering the policy. He

Value-based Benefits Subcommittee Minutes, 1/18/2018 Page 9

noted that FeNO is generally used by pulmonologists, allergists and pediatric practices with large asthma populations. FENO is inexpensive: in the $13-15 range for Medicaid. Economic value of FeNO testing outweighs cost of managing the test. Wentz raised a concern that most asthma is managed by primary care in Oregon due to the rural nature of the state. She was concerned that this test would end up in primary care offices and be overused. Ham responded by saying that Cicassia does training when a FeNO device is placed in an office; additionally, the HERC could put in a guideline to address concerns with misuse or overuse.

Gibson raised questions about whether reducing exacerbation was an important outcome if other things like QOL are not affected. He was unclear what the usefulness of FeNO is on the management of asthma.

Allen raised a concern that FeNO is FDA approved for kids 7 and over and the staff proposed guideline was for children over the age of 5. Smits noted that the studies were all in kids over the age of 5. Ham noted that the studies presented to the FDA for approval only included children aged 7 and older. There was concern about OAR restricting the CCOs from covering non-FDA approved treatments. The proposed guideline was amended to include patients aged 7 and older.

[Note: see HERC minutes for further testimony and discussion]

Recommended Actions: 1) Remove fractional exhaled nitric oxide (FeNO; CPT 95012) from line 660 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS and GN173 a. Advise HSD to add fractional exhaled nitric oxide (FeNO; CPT 95012) to the Diagnostic Procedures File 2) Add a new diagnostic guideline as shown in Appendix B

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

 Topic: Coverage Guidance—Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions

Discussion: Obley presented the draft coverage guidance. Livingston addressed the domains of resource allocation, values and preferences, and other considerations and the coverage recommendations for each of the four interventions reviewed.

Gibson raised questions about relative harms associated with microdiscectomy. Obley provided the absolute numbers which are a reduction of 32/1000 infections reduced to 2.3/1000 infections. For rehospitalization, this was increased from 43/1000 to 75/1000. Gibson expressed some discomfort around the need for rehospitalization but in recognition of the work EbGS did on this, was comfortable supporting their recommendation.

Olson complimented the quality of the draft coverage guidance.

Gibson asked about the move in patient outcomes from pain to function. Livingston discussed the process of scoping outcomes to prioritize function.. Gibson talked to Chair Olson about the need to

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readdress and guide this process about pain versus function. Hodges suggested that the Chronic Pain Task Force could address this issue.

Recommended Actions: 1) Add S2348 (Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar) to Line 660 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS and add an entry to GN 173 as shown in Appendix A 2) Remove 62287 (Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method, single or multiple levels, lumbar (e.g., manual or automated percutaneous discectomy, percutaneous laser discectomy)) from lines 346 CONDITIONS OF BACK AND SPINE WITH URGENT SURGICAL INDICATIONS, 361 SCOLIOSIS, and 527 CONDITIONS OF THE BACK AND SPINE WITHOUT URGENT SURGICAL INDICATIONS. Place on line 660 and add an entry to GN 173 as shown in Appendix A 3) Modify Guideline Note 37 as shown in Appendix A

MOTION: To approve the recommended changes to the Prioritized List based on the draft 1/18/18 coverage guidance scheduled for review by HERC at their 1/18/18 meeting. CARRIES 5-0. (Absent: Allen)

 Topic: Coverage Guidance—Gene Expression Profiling for Prostate Cancer

Discussion: Obley and Shaffer reviewed the evidence report. Olson reflected on how difficult it is to study these types of tests in urology offices. He reflected on the parallels with genetic testing in breast cancer and the difficulty to validate the effectiveness of testing in breast cancer. Cost of these tests is approximately $3400. Cost-effectiveness data is hard to find.

Discussion was brief. Staff noted that GN 148 included several references to the “services recommended for non-coverage table” which need to be changed to “Line 660.” Staff will work on these changes and bring back to a future meeting. There was no other discussion of Prioritized List changes.

Recommended Actions: 1) Affirm placement of Prolaris (CPT 81541) on Line 660, and add Oncotype DX and Decipher (utilizing CPT 81479) to Line 660. Add an entry to GN 173 as shown in Appendix A 2) Revise Guideline Note 148 as shown in Appendix A

MOTION: To approve the recommended changes to the Prioritized List based on the draft 1/18/18 coverage guidance scheduled for review by HERC at their 1/18/18 meeting. CARRIES 6-0.

 Public Comment:

Jonathan Eames, on behalf on Genetech: addressed GN95 regarding the treatment of primary progressive multiple sclerosis. GN95 was appropriate until March 28, 2017 when the FDA approved Ocrevus for PPMS. PPMS accounts for approximately 15% of MS cases. All other Medicaid programs

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are covering Ocrevus for PPMS, as well as commercial payers, to his knowledge. He is aware of providers who have requested that HERC review this in the past year. He wants to ensure that this issue is placed on the HERC agenda and GN95 is updated.

Coffman reported that the P&T Committee recently reviewed Ocrevus. He noted that a related process on the placement of certain pharmaceuticals on the Prioritized List is currently under review.

 Issues for next meeting: • Diagnosis of sleep apnea guideline • Statement of intent for public health emergencies

 Next meeting:

March 8, 2018 at Clackamas Community College, Wilsonville Training Center, Wilsonville Oregon, Rooms 111-112.

 Adjournment:

The meeting adjourned at 1:15 PM.

Value-based Benefits Subcommittee Minutes, 1/18/2018 Page 12 Appendix A

Revised Guideline Notes

GUIDELINE NOTE 32, CATARACT Line 296 Cataract extraction is covered for binocular visual acuity of 20/50 or worse OR monocular visual acuity of 20/50 or worse with the recent development of symptoms related to poor vision that affect activities of daily living (ADLs). Cataract causing symptomatic (i.e. causing the patient to seek medical attention) impairment of visual function not correctable with a tolerable change in glasses or contact lenses resulting in the patient's inability to function satisfactorily while performing activities of daily living (ADLs). Cataract removal must be likely to restore vision and allow the patient to resume activities of daily living. There are rare instances where cataract removal is medically necessary even if visual improvement is not the primary goal: A) Hypermature cataract causing inflammation and glaucoma OR B) To see the back of the eye to treat posterior segment conditions that could not be monitored due to the poor view and very dense lens opacity (i.e. diabetic retinopathy, glaucoma) OR C) Significant anisometropia causing aniseikonia.

B) Spinal fusion procedures are included on Line 346 for patients with MRI evidence of moderate or severe central spinal stenosis only when one of the following conditions are met: 1) spinal stenosis in the cervical spine (with or without spondylolisthesis) which results in objective neurologic impairment as defined above OR 2) spinal stenosis in the thoracic or lumbar spine caused by spondylolisthesis resulting in signs and symptoms of neurogenic claudication and which correlate with xray flexion/extension films showing at least a 5 mm translation OR

Value-based Benefits Subcommittee Minutes, 1/18/2018 Appendix A A-1 Appendix A

3) pre-existing or expected post-surgical spinal instability (e.g. degenerative scoliosis >10 deg, >50% of facet joints per level expected to be resected)

For all other indications, spine surgery is included on Line 527.

The following interventions are not included on these lines due to lack of evidence of effectiveness for the treatment of conditions on these lines, including cervical, thoracic, lumbar, and sacral conditions: • prolotherapy • local injections (including ozone therapy injections) • botulinum toxin injection • intradiscal electrothermal therapy • therapeutic medial branch block • coblation nucleoplasty • percutaneous intradiscal radiofrequency thermocoagulation • percutaneous laser disc decompression • radiofrequency denervation • corticosteroid injections for cervical pain

Corticosteroid injections for low back pain with or without radiculopathy are only included on Line 527.

GUIDELINE NOTE 98, SIGNIFICANT INJURIES TO LIGAMENTS AND TENDONS Lines 376,430,605 Significant injuries to ligaments and/or tendons are those that result in clinically demonstrable joint instability or mechanical interference with motion. Significant injuries are covered on Line 376 or Line 430 for both medical and surgical interventions; non-significant injuries are included on Line 605.

Iliotibial (IT) band syndrome (ICD10 M76.3) is included on line 376 only for pairing with 2 physical therapy visits with a provider licensed to provide physical therapy services, anti-inflammatory medications, and primary care office visits. Otherwise, it is included on line 605.

Value-based Benefits Subcommittee Minutes, 1/18/2018 Appendix A A-2 Appendix A

cancer. Mammaprint, ImmunoHistoChemistry 4 (IHC4), and Mammostrat for breast cancer are included on the Services recommended for noncoverage table.

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

For bladder cancer, Urovysion testing is included on Services recommended for noncoverage table.

For prostate cancer, Oncotype DX Genomic Prostate Score, Prolaris Score Assay, and Decipher Prostate RP are included on Line 660. For prostate cancer, Oncotype DX is not included on line 329 and Prolaris is included on the services recommended for non-coverage table.

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

Add the following entry to GN172: GUIDELINE NOTE 172, INTERVENTIONS WITH MARGINAL CLINICAL BENEFIT OR LOW COST- EFFECTIVENESS FOR CERTAIN CONDITIONS Line 500 The following interventions are prioritized on Line 500 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS RESULT IN MARGINAL CLINICAL BENEFIT OR LOW COST-EFFECTIVENESS:

Procedure Code Intervention Description Rationale Last Review 79445 Radiopharmaceutical therapy, by Low cost-effectiveness January, 2018 intra-arterial particulate compared to equally administration for use in treating effective but less primary hepatocellular carcinoma or expensive standard colorectal cancer metastatic to the chemotherapies; liver concern for possible harms compared to C2616 Brachytherapy source, non- standard chemotherapy stranded, yttrium-90, per source, for use in treating primary liver cancer or metastatic cancer to the liver

Add the following entries to GN173 (and modify in the case of CPT 81504): GUIDELINE NOTE 173, TREATMENTS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS

Value-based Benefits Subcommittee Minutes, 1/18/2018 Appendix A A-3 Appendix A

The following treatments are prioritized on Line 660, CONDITIONS FOR WHICH CERTAIN TREATMENTS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS, for the conditions listed here: Procedure Code Intervention Description Rationale Last Review 37212-37214 Transcatheter therapy, Increased risk of January, 2018 venous infusion for harm compared to thrombolysis for treatment equally effective of peripheral deep vein alternative therapy; thrombosis significantly less cost effective 61863, 61864, 61867, Deep brain stimulation for Evidence of no January, 2018 61868, 61880, any type of epilepsy clinically significant 61886 effectiveness, evidence of harm 62287, S2348 Percutaneous laser disc Insufficient evidence January, 2018 decompression of effectiveness Ozone therapy injections Coverage Guidance Blog Radiofrequency denervation 81504 Biomarker tests for tumor Insufficient evidence August, 2015 tissue: of effectiveness. • Mammaprint, More costly than Coverage Guidance Blog Mammostrat and equally effective ImmunoHistoCHemistry 4 therapies for this (IHC4) for breast cancer condition • Microsatellite instability (MSI) for colorectal cancer • Urovysion for bladder cancer • Prolaris for prostate cancer • Multiple molecular testing to select targeted cancer therapy 81479 Oncotype DX Genomic Unproven January, 2018 Prostate Score Assay, interventions Decipher Prostate RP Coverage Guidance Blog

81541 Prolaris. Oncology (prostate), mRNA gene expression profiling by real- time RT-PCR of 46 genes (31 content and 15 housekeeping)

Value-based Benefits Subcommittee Minutes, 1/18/2018 Appendix A A-4 Appendix B New Guideline Notes

DIAGNOSTIC GUIDELINE DX Fractional exhaled nitric oxide (FeNO) is covered only for the initial diagnosis of asthma in patients 7 years of age and older. It is not included for the monitoring of asthma, selection of medications, or diagnosis of acute asthma exacerbations.

GUIDELINE NOTE XXX, IMPLANTABLE CARDIAC DEFIBRILLATORS Lines 98, 99,111,281,285 Implantable cardiac defibrillators are included on these lines for patients with 1) Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause 2) Life threatening arrhythmias not due to transient or reversible cause 3) Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause 4) Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy 5) Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction (LVEF) ≤ 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.) 6) Documented prior MI and a measured LVEF ≤ 0.30. Patients must not have: a) New York Heart Association (NYHC) classification IV; b) Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; c) Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months; d) Had an acute MI in the past 40 days; e) Clinical symptoms or findings that would make them a candidate for coronary revascularization; or f) Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year. 7) Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart failure, and measured LVEF ≤ 35%; 8) Non-ischemic dilated cardiomyopathy (NIDCM) >9 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%; 9) All current Centers for Medicare & Medicaid Services (CMS) coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure;

All indications must meet the following criteria: i. Patients must not have irreversible brain damage from preexisting cerebral disease; ii. MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction

Value-based Benefits Subcommittee Minutes, 1/18/2018 Appendix B B-1 Appendix B New Guideline Notes

Indications 3 - 8 (primary prevention of sudden cardiac death) must also meet the following criteria: a. Patients must be able to give informed consent; b. Patients must not have: • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; • Had a CABG or PTCA within the past 3 months; • Had an acute MI within the past 40 days; • Clinical symptoms or findings that would make them a candidate for coronary revascularization; • Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year; c. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography;

10) Patients with NIDCM >3 months, NYHA Class II or III heart failure, and measured LVEF ≤ 35%, only if the following additional criteria are also met: a) Patients must be able to give informed consent; b) Patients must not have: a) Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; b) Had a CABG or PTCA within the past 3 months; c) Had an acute MI within the past 40 days; d) Clinical symptoms or findings that would make them a candidate for coronary revascularization; e) Irreversible brain damage from preexisting cerebral disease; f) Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year; c) Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; d) MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction

GUIDELINE NOTE XXX, DEEP BRAIN STIMULATION FOR PARKINSON’S DISEASE Line 250 Unilateral or bilateral deep brain stimulation (DBS) is included on this line only for treatment of intractable tremors due to Parkinson’s disease (PD) when all of the following conditions are met: 1) For thalamic ventrointermediate nucleus (VIM) DBS, patients must meet all of the following criteria: a. A diagnosis of idiopathic PD (presence of at least 2 cardinal PD features (tremor, rigidity or bradykinesia)) which is of a tremor- dominant form

Value-based Benefits Subcommittee Minutes, 1/18/2018 Appendix B B-2 Appendix B New Guideline Notes

b. Marked disabling tremor of at least level 3 or 4 on the Fahn-Tolosa-Marin Clinical Tremor Rating Scale (or equivalent scale) in the extremity intended for treatment, causing significant limitation in daily activities despite optimal medical therapy. c. Willingness and ability to cooperate during conscious operative procedure, as well as during postsurgical evaluations, adjustments of medications and stimulator settings. 2) For subthalamic nucleus (STN) or globus pallidus interna (GPi) DBS, patients must meet all of the following criteria: a. Diagnosis of PD based on the presence of at least 2 cardinal PD features (tremor, rigidity or bradykinesia). b. Advanced idiopathic PD as determined by the use of Hoehn and Yahr stage or Unified Parkinson’s Disease Rating Scale (UPDRS) part III motor subscale. c. L-dopa responsive with clearly defined “on” periods. d. Persistent disabling Parkinson’s symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling “off” periods) despite optimal medical therapy. e. Willingness and ability to cooperate during conscious operative procedure, as well as during postsurgical evaluations, adjustments of medications and stimulator settings. 3) DBS is not included on this line for PD patients with any of the following: a. Non-idiopathic Parkinson’s disease or “Parkinson’s Plus” syndromes. b. Cognitive impairment, dementia or depression which would be worsened by or would interfere with the patient’s ability to benefit from DBS c. Current psychosis, alcohol abuse or other drug abuse. d. Structural lesions such as basal ganglionic stroke, tumor or vascular malformation as etiology of the movement disorder. e. Previous movement disorder surgery within the affected basal ganglion. f. Significant medical, surgical, neurologic or orthopedic co-morbidities contraindicating DBS surgery or stimulation.

Value-based Benefits Subcommittee Minutes, 1/18/2018 Appendix B B-3

MINUTES

Evidence-based Guidelines Subcommittee Clackamas Community College Wilsonville Training Center, Rooms 111-112 29353 SW Town Center Loop E Wilsonville, Oregon 97070 February 1, 2018 2:00-5:00pm

Members Present: Devan Kansagara, MD, Chair; Eric Stecker, MD, MPH, Vice-Chair; Alison Little, MD, MPH; Angela Senders, ND; Lynnea Lindsey, PhD; George Waldmann, MD.

Members Absent: ; Leslie Sutton

Staff Present: Darren Coffman; Cat Livingston, MD, MPH; Jason Gingerich.

Also Attending: Mark Telles (Abbott); Tony Howell (Linn Country Alcohol and Drug Program); David Zarba (Millennium Health); Sue Jacoby (Cordant Health); Tanya Pruitt (Milestone Family Recovery); Heather Jefferis (Oregon Prevention Education and Recovery Association); Lalori Lager (ReConnections); Chris Wig (Emergence); Jessica Gregg, MD (OHSU); Adam Obley, MD and Craig Mosbaek (OHSU Center for Evidence-based Policy).

1. CALL TO ORDER

Devan Kansagara called the meeting of the Evidence-based Guidelines Subcommittee (EbGS) to order at 2:00 pm.

2. MINUTES REVIEW

Minutes from the 11/7/2017 meeting were reviewed and approved 6-0.

3. STAFF REPORT

Livingston asked members who were to attend the retreat February 9 to think about things that the staff are doing well and things that staff could do better for discussion at the retreat.

She also discussed the multisector interventions reports. Staff have been looking at a topic on supportive housing. It is a hot topic and there is evidence emerging. The plan is to take a different technique and connect with stakeholders in order to focus the report. How to best proceed with multisector interventions will also be a topic at the retreat.

EbGS 2-1-2018 Minutes Page 1

Waldmann said that affordable housing is known to be a huge problem around the state. He asked what HERC can do to help with this problem? Livingston said that there is a role for health plans to provide housing for people whose housing issues are affecting their health. It is short-term help and has been shown to result in health improvements. Waldmann said that CareOregon is doing this already. What would be added? Obley said that a report might focus on which populations are most essential to serve, how to prioritize people and what are the elements that produce good outcomes. Little said she is interested but she is still getting messages that her CCO can’t use flexible services funds. Gingerich said he is working with a team to provide guidance on flexible funds. Little said the report would be helpful, as the requirements will require evidence that the service would be expected to improve health. Kansagara asked that staff get guidance from stakeholders on how to focus the topic. Staff will work on that before bringing the topic.

4. SCOPE STATEMENTS

Obley reviewed the draft scope statements from the meeting packet. Each report has been posted for a brief 7-day comment period. Kansagara and Livingston described the scope process and how it impacts the report development.

Changes and key points of discussion are summarized below:

 Extracorporeal membrane oxygenation (ECMO) Stecker said that it would be as important to define groups with high mortality as well as low mortality since the baseline mortality for the population eligible for ECMO is so high. Obley said this would be captured by the scope and likely available from observational studies. The subcommittee added a contextual question on patient characteristics that are associated with survival and functional recovery. Stecker said that contemporary observational trials showing which patients will not benefit will be more valuable than older randomized trials. This technology is expensive and offered to families and patients facing a poor prognosis, so it would be helpful to know when it is futile.  Interventional treatments for lower extremity chronic venous disease The subcommittee added a subpoint to key question #2 about whether effectiveness affects prior or concurrent complications. There were public comments advocating coverage. The subcommittee discussed whether venous symptom scores should be a critical outcome because of the rarity of the outcomes of infections and ulcers but decided to leave it as important after Livingston’s explanation that these treatments are currently only covered when there are complications. She said that pain and swelling might be less likely to lead the Value-based Benefits Subcommittee and HERC to change coverage than prevention of the more severe complications. The subcommittee can weigh the detailed evidence and make its decision regardless of whether the symptom scores are important or critical.  Intermittent pneumatic compression devices for the treatment of lymphedema There was little discussion. Recurrent lymphedema and limb volume are commonly reported, but this report will focus instead on lymphedema symptom scores.  Liposuction for lymphedema Kansagara asked about recurrent lymphedema as an outcome for this topic but not the previous one. Obley said it would be fair to make them match, but he included it for this one as there is some evidence that liposuction can produce a lasting effect. Based on discussion, EbGS removed recurrent lymphedema as a critical outcome and added lymphedema symptom scores.

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 Newer interventions for knee osteoarthritis The subcommittee discussed appropriate comparators and excluded interventions that are not proven effective (viscosupplementation, corticosteroid injections and other listed interventions). Obley said he will specify the comparators that are reported and the subcommittee can judge the results. Knee replacement was not selected as a comparator, and intermediate pain was added as an outcome, replacing delay of surgery. Little said HERC can’t avoid the pain outcomes as they are important in many conditions. Waldmann said we should be consistent about how we address pain. Avoidance of knee surgery was dropped as an outcome since data is unlikely to be reported. Little added that she was not excited about this topic since these procedures are outside the standard of care. Kansagara agreed this is a lower-priority topic. There was discussion about allopathic bias; the subcommittee wanted to include interventions and comparators without regard to that bias. In addition, the subcommittee requested that HERC reconsider the issue of when to use pain vs. function as an outcome based on recent experience where these outcomes were considered even if not originally included in scope.

A motion was made to refer the draft scope statements to HERC as amended for consideration and scoring. Motion approved 6-0.

5. URINE DRUG TESTING

Livingston reviewed the status on this topic. Livingston also reviewed the changes to the recommendations and values & preferences statement that were requested at the previous meeting.

Gingerich reported on a new utilization analysis he did for July 2016 through June 2017. The presentation was later posted as a handout on the Commission’s website. Livingston introduced Gregg, who is serving as ad hoc expert for this topic.

Obley reviewed the information in the coverage guidance regarding testing for substance use disorder, including professional guidelines and other payer policies. Livingston said because of the limited evidence, the limits in the recommendations were modelled on Washington’s and North Carolina’s policies.

Waldmann asked about false positives. Obley said there is limited data on this, and that accuracy rates vary depending on the substance used and the cutoff used by the laboratory. He recommended caution in interpreting this, as techniques may have changed and accuracy may vary by the lab.

Little suggested creating a coverage range like 8 to 24 tests per year. Several people expressed concern that this might be interpreted as a minimum number of tests per year, and this idea was not adopted.

Lindsey said the frequency of testing varies by the acuity of the patient and the frequency of need. This is in tension with the cost and the types of testing offered. She said she has gotten feedback that providers are more open to limits on the types of testing rather than the frequency. She said you might use a broader panel for an initial test than for follow-up. Providers want some discretion. Lindsey suggested any limits around the cost or complexity of the tests would be appropriate for discussion.

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Kansagara asked in what scenario you might require a 22 substance test. Dr. Gregg and others had said it was hard to imagine a scenario where this amount of substances would need to be tested. Gregg confirmed this. Kansagara said given the huge range of variation in practice, it suggests that there may not be a clinical rationale for some ends of the utilization.

The subcommittee discussed whether making the recommendation box a different color might help explain why the subcommittee is making a recommendation based on such limited evidence, to avoid the perception that evidence around this issue does exist. Livingston said we often make recommendations when there is insufficient evidence. She asked whether this situation is different because we are recommending coverage? Lindsey said it is different because of the lack of evidence as well as the standard of care. Obley said a study on the optimal frequency of testing is unlikely to be performed.

The group discussed the recommendation against definitive testing except to confirm results of presumptive tests. To clarify this, the subcommittee added language to clarify that there is no need to routinely use definitive test except as confirmatory. Gregg said she agrees that screening tests should be done first. However she expressed concern about the lower limits for the number of definitive tests than qualitative tests since the consequences of a false positive test can be so severe.

Gregg was asked whether the limit of 24 tests is too restrictive. She said others will disagree, but in general, active substance use disorders will declare themselves. Testing weekly is sufficient. Lindsey said she is hearing a request for no limits; the subcommittee needs to find a place that allows enough testing without being overly restrictive. Gregg said when someone is in early recovery, she will often get more than two drug screens a month. Generally, however, over the course of a year, 24 tests per year is reasonable. Providers will like 32 better, but she can’t say that reflects better clinical care. Lindsey asked whether it is reasonable for a person who relapses. Little suggested that this is the reason for the requirement for individual review. Lindsey said providers would want to know when exceptions would be appropriate.

Little asked whether language suggesting that less frequent testing may be appropriate would be important. Kansagara said we don’t have data to say that any amount of testing is appropriate. He suggested adding a paragraph at the top saying that there is significant variation in utilization, with clear patterns of overuse, and for that reason we are going to recommend limits.

Lindsey suggested that there is no prohibition against plans reviewing appropriateness for testing over a certain frequency; couldn’t plans do that without having a coverage limit? Little was thinking that some payers may be putting too strict of a limit in place. Lindsey said that may be true.

Kansagara polled the subcommittee, and no one supported allowing definitive tests as first-line (not confirmatory). There was debate about whether the limit of 24 presumptive tests is appropriate. Some members advocated a limit of 32. Waldmann suggested following Washington and North Carolina, since it works in those states. Gingerich pointed out that in Washington, drug testing provided in residential settings is not included in the 24 test limit as it is bundled into the payment for the residential care.

Lindsey said you don’t want to see a treatment center become a de facto arm of the court which may order frequent testing; at the same time you don’t want to restrict appropriate testing. That may be why New York said you can do all the presumptive testing you want, but placed limits on definitive tests.

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Kansagara asked for feedback on the idea of changing the ratio of the limits for presumptive to definitive tests. There was no feedback. Kansagara invited public comment.

Tony Howell commented. He is a licensed clinical social worker for Linn County. He said setting arbitrary limits on urine drug screens is going to hurt people in certain circumstances. For example, people who are homeless may have severe addiction, and there is no residential treatment available. The county treats them in an outpatient setting. He said having frequent testing encourages them to stay abstinent by speaking to their “better angels.” He said that this screening needs to be random and frequent. For some, having urine testing may be critical for getting their children back. He cited the ASAM policy which recommends that the frequency and test type be determined by the provider, not the plan. For cost savings he recommended looking at definitive tests that come in without presumptive tests. His plan gets $10-$15 per test. If there is a need for more expensive testing, the county pays the cost.

Heather Jefferis spoke next. She distributed written testimony from Tanya Pruitt from the Milestone Family Recovery Center. Jefferis is the Executive Director of the Oregon Prevention Education and Recovery Association (OPERA). She expressed concerns about removing clinician freedom in applying a very important test to a fragile treatment system that struggles with having appropriate resources to meet patient needs. These restrictions would limit the tools available. She said it would be important to have evidence. She knows that housing is important and in many cases housing programs require drug testing. Patients undergoing treatment and needing housing cannot pay for their own testing. She said the tests can be done in conjuction with motivational interviewing and cognitive behavioral therapy to help people talk about their substance use disorder in a healthy way and to reduce stigma and create an opportunity to get them into recovery.

Chris Wig testified next. He works for Emergence Behavioral Therapies in Eugene. The clients he treats are participants in the Lane County Drug Court and Veteran’s Court. He expressed concern about the limits on frequency. He said that the testing is medically appropriate and compared it to blood glucose testing for patients with diabetes. He said that treatment can often be changed based on the results of a urine test. Some treatments may not be appropriate for a patient still using substances since they lack the insight to make changes. He acknowledged the cost concerns but said he doesn’t believe that the proposed changes would result in as much cost savings as hoped for. He said a colleague showed him a bill for $800-$1200 for a urinalysis from a pain specialist. He said OHP reimbursed that claim and this should be totally illegal and that no one here is asking for that. The tests his agency uses are reimbursed at a rate of about $20. In certain cases they do more extensive testing, with the cost going to the agency. He said the standards and practices manual for drug court requires at least 2 urinalysis screens per week. Limiting the number reimbursable through OHP wouldn’t reduce the amount of drug testing but would cause his agency to need to pay for those tests. Currently the money that would be used for this is being used to address social determinants of health. He provided additional materials from the director of Emergence.

Jay Worscher testified. He is the Alcohol and Drug Services coordinator for the Office of Child Welfare Programs in the Oregon Department of Human Services. He said 65 percent of the approximately 7,500 children in foster care on a given day are there because of parental substance use disorders. As child welfare works to reunite families, it is necessary to have accurate information for the court to use in making decisions. To have timely and accurate information they require gas chromatography/mass spectrometry (GCMS) confirmation tests rather than presumptive tests. He said the treatment centers his program works with tests in a way to give as much clarity and depth as possible, as this is to the benefit of children and parents. Otherwise there is a ripple effect far beyond the child and the family.

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Waldmann said the testimony was excellent. He suggested that perhaps if more money is spent on drug screening there may be less money spent on counseling and other treatments. Senders suggested waiting until the coverage guidance is approved and do another data analysis before revisiting the topic. Livingston said staff could redo the data analysis after a period of time, but for the topic to be updated, it would need to be nominated and approved again.

Kansagara said that the frequency of testing might vary depending on where someone is in treatment. A member of the audience said that high risk clients may be tested multiple times a week for several months, with less frequent testing after that. If they relapse there may be another period of more frequent testing per year. She also said that fentanyl detection may require a definitive test.

Lindsey said she is still listening and isn’t comfortable voting the draft out for public comment. Waldmann said the clock needs to start again with a relapse. Hard numbers per year aren’t going to work. Livingston asked whether plans would be able to monitor relapse and adjust coverage. Little said it would require an appeal.

Livingston reviewed the remaining recommendations. The subcommittee decided to retain the exception for patients with altered medical status.

After discussion the subcommittee requested staff to delete the prohibition against billing separately for urine drug screening when provided in a residential facility. The group also discussed retrospective review and reference-based pricing as cost control tools. Little said that much of the problem is with non-participating providers where contractual tools are not effective.

No vote was made on this topic and further review will occur at the next EbGS meeting.

6. ADJOURNMENT

The meeting was adjourned at 5:00 pm. The next meeting is scheduled for April 12, 2018 from 2:00- 5:00 pm at Clackamas Community College, Wilsonville Training Center, Rooms 111-112, 29353 SW Town Center Loop E, Wilsonville, Oregon 97070.

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Section 2.0 VbBS Issue Summary Documents Consent Agenda Issues—March, 2018

Code Code Description Line(s) Involved Issue Recommendation(s) 27006 Tenotomy, abductors and/or 605 SPRAINS AND STRAINS OF VBBS requested that HERC staff Add 27006 and 27305 to line 605 extensor(s) of hip, open ADJACENT MUSCLES AND JOINTS, identify CPT codes for IT band (separate procedure) MINOR lengthening and add to line 605 to 27305 Fasciotomy, iliotibial further clarify the intent to not (tenotomy), open cover surgery for this condition. 3-8-18 27006 is currently on lines 292,309. 27305 is currently on lines 131,236 for 38760 Inguinofemoral 259 CANCER OF PENIS AND HSD requested that 38760 and Add 38760 and 38765 to line 259 lymphadenectomy, superficial, OTHER MALE GENITAL ORGANS 38765 pair with ICD-10 C60.9 including Cloquet's node (Malignant neoplasm of penis, 38765 Inguinofemoral unspecified). lymphadenectomy, superficial, in continuity with pelvic 38760 is on lines 230, 238, 276, lymphadenectomy, including 286,396,397,421,569 external iliac, hypogastric, and 38765 is on lines 230,276 obturator nodes N93.8 Other specified abnormal 353 STRUCTURAL CAUSES OF ICD-10 N93.8 is currently only on Add N93.8 to line 420 uterine and vaginal bleeding AMENORRHEA line 353. The main subdiagnosis 420 MENSTRUAL BLEEDING for this code is “Dysfunctional Remove N93.8 from line 353 DISORDERS uterine bleeding.” The ICD-9 Summariesequivalent, 626.8 “Disorders of menstruation and other abnormal bleeding from female genital tract,” was on both the equivalent of lines 353 and 420. The subdiagnosis of 626.8 that placed that code on line 353 was Issue “retained menstruation” which is now coded with N92.5.

VbBS 1 Consent Agenda Issues—March, 2018

Code Code Description Line(s) Involved Issue Recommendation(s) 401 CONDITIONS OF THE BACK Line 401 is not directly linked to Add line 401 to GN6 AND SPINE GN 6 REHABILITATIVE AND HABILITATIVE THERAPIES. GN56, which is attached to line 401, requires PT to be done according to GN6, but there is no direct3-8-18 link and this is causing confusion with CCOs. for

Summaries

Issue

VbBS 2 Guideline Note Correction

Issue: 1) An extensive revision to the cataract guideline was approved in January, 2018 by VBBS and HERC. On review, HERC staff noted that there is a grammar problem with the new guideline. The proposed correction has no substantial difference in intent or coverage.

HERC staff recommendation: 1) Modify GN32 as shown below

GUIDELINE NOTE 32, CATARACT Line 296 Cataract extraction is included on this line for cCataracts causing symptomatic (i.e. causing the patient to seek medical attention) impairment of visual function not correctable with a tolerable change3-8-18 in glasses or contact lenses resulting in the patient's inability to function satisfactorily while performing activities of daily living (ADLs). Cataract removal must be likely to restore vision and allow the patient to resume activities of daily living. There are rare instances where cataract removal is medicallyfor necessary even if visual improvement is not the primary goal: A) Hypermature cataract causing inflammation and glaucoma OR B) To see the back of the eye to treat posterior segment conditions that could not be monitored due to the poor view and very dense lens opacity (i.e. diabetic retinopathy, glaucoma) OR C) Significant anisometropia causing aniseikonia.

Summaries

Issue

VbBS

Acne Conglobata Line Error

Issue: The acne conglobata line contains a series of ICD-10 codes that appear to be in error. When the ICD-10 Dermatology review group created the line, they specified that only the diagnosis code for acne conglobata (ICD-10 L70.1) should appear on the new line. However, the entire L70 family was added, by apparent mistake. L73.0 (Acne keloid) was also added, with no record of an intention to add this code to the new line. There are a large number of paid claims for professional visits for various acne diagnoses despite the intention to have this diagnosis below the funding line. All of the L70 diagnoses also appear on line 520 ROSACEA; ACNE.

From the 2012 minutes: Create new line ACNE CONGLOBATA (SEVERE CYSTIC ACNE) (derived from line 545 Cystic Acne). ICD 10 codes: Includes acne conglobate only 3-8-18

A guideline is attached to line 373 GUIDELINE NOTE 132, ACNE CONGLOBATA for Line 373 Acne conglobata is only included on Line 373 if it involves recurrent abscesses or communicating sinuses.

ICD-10 Code Description code L70.0 Acne vulgaris L70.1 Acne conglobata L70.2 Acne varioliformis L70.3 Acne tropica L70.4 Infantile acne L70.5 Acne excoriee Summaries L70.8 Other acne L70.9 Acne, unspecified L70.3 Acne keloid

HERC staff recommendation:Issue 1) Remove all ICD-10 codes from line 373 ACNE CONGLOBATA (SEVERE CYSTIC ACNE) other than L70.1 (Acne conglobata)

VbBS

Ear Cartilage Grafts for Tympanic Membrane Repair

Question: Should ear cartilage grafts be added to the line with tympanic membrane perforations to be used for perforation repair?

Question source: Primary Health CCO

Issue: Tympanic membrane (TM) perforations can be repaired in a variety of ways. The most common is using a paper like substance to close the hole, which is done in the office. More complicated or larger perforations are repaired with fascia from muscles near the ear. The cartilage of the tragus can also be used. Currently, the CPT code for using an ear cartilage graft to repair the TM is not included on the hearing loss lines that contain TM perforation ICD-10 codes.

Current Prioritized list status CPT 21235 Graft; ear cartilage, autogenous, to nose or ear (includes obtaining graft) on lines3-8-18 203 SLEEP APNEA, NARCOLEPSY AND REM BEHAVIORAL DISORDER, 276 CANCER OF SKIN, EXCLUDING MALIGNANT MELANOMA, 375 CHOLESTEATOMA; INFECTIONS OF THE PINNA, 641 TMJ DISORDERS. for ICD-10 H72 (perforation of tympanic membrane) family is on lines 311 HEARING LOSS - AGE 5 OR UNDER, 444 HEARING LOSS - OVER AGE OF FIVE, 473 CHRONIC OTITIS MEDIA; OPEN WOUND OF EAR DRUM. All of these lines contain the CPT codes for Tympanoplasty (CPT 69610, 69631-69646).

HERC staff recommendation 1) Add CPT 21235 (Graft; ear cartilage, autogenous, to nose or ear (includes obtaining graft)) to lines 311 HEARING LOSS - AGE 5 OR UNDER, 444 HEARING LOSS - OVER AGE OF FIVE, 473 CHRONIC OTITIS MEDIA; OPEN WOUND OF EAR DRUM.

Summaries

Issue

VbBS

ICD Guideline Note

Issue: A new implantable cardiac defibrillator (ICD) guideline was approved at the January, 2018 VBBS/HERC meetings based on the CMS National Coverage Determination (NCD). CMS published an updated NCD regarding ICDs on February 18, 2018. Staff has edited the ICD guideline to reflect the updated NCD. There was also a few grammatical changes proposed by staff to further clarify the guideline.

On review, the new CMS NCD (https://www.cms.gov/medicare-coverage-database/details/nca-decision- memo.aspx?NCAId=288) has extensive revisions, but the majority of these merely clarifies language and makes a more readable document. The only substantial coverage changes are: 1) Patient criteria: Require patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy for at least 3 months; Require a patient shared decision making interaction prior to ICD implantation for certain patients; Remove3-8-18 the Class IV heart failure requirement for cardiac resynchronization therapy (CRT). 2) Waiting periods: To allow ICD insertion during the required waiting period after events like a myocardial infarction if the patient otherwise qualifies for an ICD and is forgetting an indicated pacemaker. This change makes sense and reduces duplicate procedures. There is also a new exception to the waiting period for a patient with an existing ICD who requires a replacement device.

HERC staff recommendation: 1) Modify the newly adopted guideline on implantable cardiac defibrillators as shown below a. The guideline is first shown without edits for ease of review; edits are shown further below

ICD Guideline Note

3) Patients who have severe ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have New York Heart Association (NYHA) Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%. Additionally, patients must not have: a) Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or b) Had a myocardial infarction within the past 40 days; or c) Clinical symptoms and findings that would make them a candidate for coronary revascularization. 4) Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have New York Heart Association (NYHA) Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%, been on optimal medical therapy (OMT) for at least 3 months. Additionally, patients must not have: 3-8-18 a) Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or b) Had a myocardial infarction within the past 40 days; or for c) Clinical symptoms and findings that would make them a candidate for coronary revascularization. 5) Patients with documented familial, or genetic disorders with a high risk of life-threatening tachyarrhytmias (sustained ventricular tachycardia or ventricular fibrillation), to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy.

For these patients identified in #2-5, a formal shared decision making encounter must occur between the patient and a physician or qualified non-physician practitioner using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision making encounter may occur at a separate visit.

6) Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, elective replacement indicator (ERI) or device/lead malfunction. Summaries All indications above in #1-6 must meet the following criteria: 1. Patients must be clinically stable (e.g., not in shock, from any etiology); 2. Left ventricular ejection fraction (LVEF) must be measured by echocardiography, radionuclide (nuclear medicine) imaging, or catheter angiography; 3. Patients must not have: a. Significant, irreversible brain damage; or b. AnyIssue disease, other than cardiac disease (e.g., cancer, renal failure, liver failure) associated with a likelihood of survival less than 1 year; or c. Supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate.

ICD Guideline Note

2) Replacement of ICDs: Patients with an existing ICD may receive a ICD replacement if it is required due to the end of battery life, elective replacement indicator (ERI) or device/lead malfunction.

Other Indications: For patients who are candidates for heart transplantation on the United Network for Organ Sharing (UNOS) transplant list awaiting a donor heart, coverage of ICDs, as with cardiac resynchronization therapy, as a bridge to transplant to prolong survival until a donor becomes available.

GUIDELINE NOTE XXX, IMPLANTABLE CARDIAC DEFIBRILLATORS Lines 98, 99,111,281,285 Implantable cardiac defibrillators are included on these lines for patients with one or more3-8-18 of the following: 2) Patients with a personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation. Patients must have demonstrated one of the following:for a) Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause b) Life threatening arrhythmias not due to transient or reversible cause c) Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause d) Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy 3) Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction (LVEF) ≤ 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.) 3) Documented prior MI and a measured LVEF ≤ 0.30. Patients must not have: Patients with a prior myocardial infarction and a measuredSummaries left ventricular ejection fraction (LVEF) ≤ 0.30. Patients must not have: a) New York Heart Association (NYHC) classification IV heart failure; or b) Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; or c) Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) intervention (PCI) with angioplasty and/or stenting, within past 3 months; or d) HadIssue an acute MI a myocardial infarction in the past 40 days; or e) Clinical symptoms or findings that would make them a candidate for coronary revascularization; or f) Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year. 4) Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart failure, and measured LVEF ≤ 35%; Patients who have severe ischemic dilated cardiomyopathy VbBSbut no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have New York Heart Association (NYHA) Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%. Additionally, patients must not have:

ICD Guideline Note

a) Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or b) Had a myocardial infarction within the past 40 days; or c) Clinical symptoms and findings that would make them a candidate for coronar revascularization. 5) Non-ischemic dilated cardiomyopathy (NIDCM) >9 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%; Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have New York Heart Association (NYHA) Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%, been on optimal medical therapy (OMT) for at least 3 months. Additionally, patients must not have: a) Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or b) Had a myocardial infarction within the past 40 days; or 3-8-18 c) Clinical symptoms and findings that would make them a candidate for coronary revascularization. 7) Patients with documented familial, or genetic disorders with a high risk forof life-threatenin g tachyarrhytmias (sustained ventricular tachycardia or ventricular fibrillation), to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy.

For these patients identified in #2-5, a formal shared decision making encounter must occur between the patient and a physician or qualified non-physician practitioner using an evidence- based decision tool on ICDs prior to initial ICD implantation. The shared decision making encounter may occur at a separate visit.

8) Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, elective replacement indicator (ERI) or device/lead malfunction.

All indications above in #1-6 must meet the following criteria: i. Patients must not have irreversible brain damage from preexisting cerebral disease; ii. MIs must be documented and definedSummaries according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction 1. Patients must be clinically stable (e.g., not in shock, from any etiology); 2. Left ventricular ejection fraction (LVEF) must be measured by echocardiography, radionuclide (nuclear medicine) imaging, or catheter angiography; 3. Patients must not have: a. Significant,Issue irreversible brain damage; or b. Any disease, other than cardiac disease (e.g., cancer, renal failure, liver failure) associated with a likelihood of survival less than 1 year; or c. Supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate.

Indications 3 - 8 (primary prevention of sudden cardiac death) must also meet the following criteria: VbBSa. Patients must be able to give informed consent; b. Patients must not have:  Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;

ICD Guideline Note

 Had a CABG or PTCA within the past 3 months;  Had an acute MI within the past 40 days;  Clinical symptoms or findings that would make them a candidate for coronary revascularization;  Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year; c. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography;

1) Patients with NIDCM >3 months, NYHA Class II or III heart failure, and measured LVEF ≤ 35%, only if the following additional criteria are also met: a) Patients must be able to give informed consent; b) Patients must not have: a) Cardiogenic shock or symptomatic hypotension while in a stable baseline3-8-18 rhythm; b) Had a CABG or PTCA within the past 3 months; c) Had an acute MI within the past 40 days; for d) Clinical symptoms or findings that would make them a candidate for coronary revascularization; e) Irreversible brain damage from preexisting cerebral disease; f) Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year; c) Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; d) MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction

Exceptions to waiting periods for patients that have had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months, or had a myocardial infarction within the pastSummaries 40 days: 3) Cardiac Pacemakers: Patients who meet all CMS coverage requirements for cardiac pacemakers and who meet the criteria in this national coverage determination for an ICD may receive the combined device in one procedure at the time the pacemaker is clinically indicated; 4) Replacement of ICDs: Patients with an existing ICD may receive a ICD replacement if it is required due to the end of battery life, elective replacement indicator (ERI) or device/lead malfunction. Issue Other Indications: For patients who are candidates for heart transplantation on the United Network for Organ Sharing (UNOS) transplant list awaiting a donor heart, coverage of ICDs, as with cardiac resynchronization therapy, as a bridge to transplant to prolong survival until a donor becomes available.

VbBS

Yttrium Internal Radiation Therapy March, 2018

Question: Should yttrium internal radiation therapy (CPT 79445) be removed from all current lines on the Prioritized List?

Question source: HERC staff

Issue: Yttrium-90 as a treatment for hepatocellular carcinoma (HCC) and for colorectal cancer (CRC) metastatic to the liver was discussed at the January, 2018 VBBS/HERC meeting. At that time, the evidence of several large, new RCTs were reviewed and yttrium-90 was found to be no better than standard chemotherapy for treating either of these conditions but much more expensive [SARAH for HCC; FOXFIRE, SIRFLOX and FOXFIRE-Global for CRC metastatic to liver]. HERC voted to place the CPT code used for yttrium-90 (CPT 79445 Radiopharmaceutical therapy, by intra-arterial particulate administration) as well as the HCPCS code for the actual yttrium-90 (HCPCS C2616 (Brachytherapy3-8-18 source, non-stranded, yttrium-90, per source) on GUIDELINE NOTE 172, INTERVENTIONS WITH MARGINAL CLINICAL BENEFIT OR LOW COST-EFFECTIVENESS FOR CERTAIN CONDITIONS which accompanies line 500 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS RESULT IN MARGINAL CLINICAL BENEFIT OR LOW COST-EFFECTIVENESS. for

On review, HERC staff have identified an additional HCPCS code which is specific for yttrium-90 infusion in the liver, which also need to be added to GN172/line 500: S2095 (Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres). This code is currently on the Services Recommended for Non-Coverage List.

Additionally, HERC staff identified that the CPT code 79445 is on nearly all the cancer lines, but does not appear to be used for any procedure other than yttrium-90 infusion. During the January review, it was assumed that other radiopharmaceuticals administration would be coded with CPT 97445; however, it does not appear to be the case. A data query for CPT 79445 was run, and nearly all diagnoses that were paired with HCC or CRC metastatic to the liver, or similar types of liver or GI cancer metastases. There was one claim for lung cancer and one for treatment of hyperparathyroidism. Summaries Currently, Yttrium-90 microsphere products are approved by the US FDA as radiation treatment or neoadjuvant to surgery for unresectable hepatocellular carcinoma (TheraSphere) or unresectable metastatic colorectal cancer (SIR-Spheres).

To current HERC staff knowledge, there has never been a review of the effectiveness of yttrium-90 radiotherapy for any indication other than HCC and CRC metastatic to the liver. There are several other CPT codes for non-particulateIssue radiopharmaceutical administration. For example, I131, a common treatment for thyroid cancer, has its own CPT code.

Current Prioritized List status: 79445 (Radiopharmaceutical therapy, by intra-arterial particulate administration) is on lines 129,130,160,161,162,165,195,204,214,238,242,262,265,274,279,291,292,299,319,321,333,346,376,439, VbBS465,533,600,611

Yttrium Internal Radiation Therapy March, 2018

Evidence 1) Kuei 2015, systematic review of yttrium-90 for non HCC/CRC indications (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4507097/pdf/WJG-21-8271.pdf) a. Breast cancer: i. 4 retrospective case series (N=75, 21, 40, 77), 3 prospective case series (N=30,44,27) and an additional 37 patients in other studies with discrete response data on the patients with breast primaries ii. Collective analysis of current literature ranges in response rates between 18%- 61% and median overall survival between 6.6 to 13.6 months 1. baseline historical estimated cumulative survival with metastatic breast cancer at time of diagnosis is 18.5 months. Median survival in patients with unresectable, chemoresistant breast cancer liver metastases (BRCLM) ranges between 3-10 months with standard therapy3-8-18 iii. The tendency of BRCLM to present with extrahepatic involvement limits SIRT from a prognostic perspective. iv. Although the number of studies on the effects of SIRT on breast cancer metastasis is gradually increasing, they have so far involvedfor only relatively small, heterogeneous patient cohorts. In order to validate SIRT as a potential first-line adjuvant to chemotherapy, larger multicenter randomized control studies are needed b. Cholangiocarcinoma i. N=6 prospective case series (N=24, 25, 26, 19, 46, 21) and 1 retrospective case series (N=35) ii. meta-analysis of 5 of these studies found the highest median overall survival was with hepatic arterial infusion (22.8 months) compared to transarterial radioembolization (13.9 months), transarterial chemoembolization (12.4 months), and drug-eluting transarterial chemoembolization (12.3 months). iii. In the other 3 studies, overall survival varied between 5.7 months and 16.3 months. iv. Historical medianSummaries overall survival for patients with ICC is currently 22 months with standard therapy. c. Melanoma i. N=4 retrospective case series (N=28, 16, 32, 11) and 3 additional cases extracted from larger studies ii. Median survival 7.6-10.1 months iii. Reported median overall survival is 2.4 months with liver involvement with Issuestandard therapy iv. Based on the few small cohort studies so far, SIRT has been demonstrated to be safe and effective at prolonging survival, however without further comparative studies the ideal selection criteria and benefit over other regional therapies remains uncertain. d. Pancreatic cancer i. N=2 retrospective case series (N=19, 7) VbBS ii. Though the limited available data makes survivability benefits unclear, initial reports as a salvage treatment are encouraging. Median survival with the small cohort is attributed to a roughly 2-4 month improvement over conventional therapy

Yttrium Internal Radiation Therapy March, 2018

e. Renal cell carcinoma: i. N=1 retrospective case series (N=6) and 1 case study (N=1) ii. preliminary data on a handful of patients…are promising for the use of SIRT of hepatic metastases by renal cell carcinoma with a palliative rather than curative intent f. Lung cancer i. N=1 retrospective case series (N=6) and 1 case study (N=2) ii. The few cases of yttrium-90 SIRT of lung cancer liver metastases so far demonstrate SIRT’s potential as an effective salvage therapy

3-8-18 for

Summaries

Issue

VbBS

Yttrium Internal Radiation Therapy March, 2018

HERC staff summary: The literature on the effectiveness of yttrium 90 radiotherapy for treatment of liver metastases for non-hepatocellular carcinoma/colorectal cancer metastatic to the liver consists solely of small case series. These case series do not show significant improvement in survival compared to conventional chemotherapy for most of the cancers studied. Additionally, yttrium 90 products are not FDA approved for treatment of cancers other than HCC and CRC metastatic to the liver. Yttrium 90 is a much higher cost therapy than traditional chemotherapy.

HERC staff recommendations: 1) Add the additional HCPCS code for yttrium-90 radioembolization (CPT 79445) to line 500/GN172 a. S2095 Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres 2) Modify the entry to GN172/line 500 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS3-8-18 RESULT IN MARGINAL CLINICAL BENEFIT OR LOW COST-EFFECTIVENESS as shown below for yttrium-90 for treatment of primary hepatocellular carcinoma, or colorectal cancer metastatic to the liver

GUIDELINE NOTE 172, INTERVENTIONS WITH MARGINAL CLINICAL BENEFIT OR LOWfor COST- EFFECTIVENESS FOR CERTAIN CONDITIONS Line 500 The following interventions are prioritized on Line 500 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS RESULT IN MARGINAL CLINICAL BENEFIT OR LOW COST-EFFECTIVENESS:

Procedure Intervention Description Rationale Last Review Code 79445 Radiopharmaceutical therapy, by Low cost- January, 2018 intra-arterial particulate effectiveness administration for use in treating compared to equally primary hepatocellular effective but less carcinoma or colorectal cancer expensive standard metastatic to the liverSummaries chemotherapies; concern for possible C2616 Brachytherapy source, non- harms compared to stranded, yttrium-90, per source, standard for use in treating primary liver chemotherapy cancer or metastatic cancer to the liver Issue S2095 Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres

VbBS 3) Remove CPT 79445 (Radiopharmaceutical therapy, by intra-arterial particulate administration) from all current lines on the Prioritized List

Yttrium Internal Radiation Therapy March, 2018

a. Lines 129,130,160,161,162,165,195,204,214,238,242,262,265,274,279,291,292,299,319, 321, 333,346,376,439,465,533,600,611 b. Evidence for efficacy is extremely limited; appears experimental; not FDA approved for these indications 4) Add an entry to GN173/line 660 for all non-HCC/CRC metastatic to the liver indications as experimental

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 660, 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 Code TREATMENT Rational Date of Last Review/Link3-8-18 to Meeting Minutes 79445 Radiopharmaceutical therapy, No evidence of March, 2018 by intra-arterial particulate effectiveness administration for use in for treating cancers other than primary hepatocellular carcinoma or colorectal cancer metastatic to the liver

C2616 Brachytherapy source, non- stranded, yttrium-90, per source, for use in treating primary liver cancer or metastatic cancer to the liver

S2095 Transcatheter occlusion or embolization for Summariestumor destruction, percutaneous, any method, using yttrium-90 microspheres

Issue

VbBS

Diagnosis of sleep apnea - guideline update

Question: Should the guideline on the diagnosis of sleep apnea be modified?

Question source: Douglas Carr, MD, Umqua Health Alliance CCO

Issue: From Dr. Carr

I would propose that OHP adopt a two tier coverage guideline that requires that home testing be performed first for suspected Obstructive Sleep Apnea in uncomplicated adult members. Facility based PSG could be performed subsequently if home testing was not adequate.

Facility PSG is appropriately used first in children, adults with complicating3-8-18 comorbidities (eg COPD, CHF), inability to utilize a home study, suspected central sleep apnea, or sleep related conditions such as periodic leg movements, parasomnias, etc. Split session PSG should always be done withfor trial of PAP once Dx obtained.

With the new Auto-PAP machines, titration need not be part of the diagnostic session.

I’d base this tiered recommendation to reduce unnecessary costs to OHP.

For follow up of the 1/18/18 VbBS questions, Dr. Carr clarified that after a diagnostic home sleep study, autotitrating CPAP is provided by his CCO for a 3 month trial rather than a single-night trial.

All CPAP devices now are auto-titrating (So technically they are all APAPs, not CPAPs). The titration occurs during Summariesuse and further adjustments (rarely needed) are apparent with the download data from the device’s memory chip. That development has allowed home studies to be used effectively in the real world.

Background Issue The guideline note on diagnosis of sleep apnea was derived from a Health Technology Assessment Subcommittee (HTAS) Coverage Guidance adopted in 2013. The box language for this guidance is as follows:

The following diagnostic tests for Obstructive Sleep Apnea (OSA) should be VbBScovered for adults: 1. Type I PSG is covered when used to aid the diagnosis of OSA in patients who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 1

Diagnosis of sleep apnea - guideline update

2. Type II or Type III sleep testing devices are covered when used to aid the diagnosis of OSA in patients who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. 3. Type IV sleep testing devices measuring three or more channels, one of which is airflow, are covered when used to aid the diagnosis of OSA in patients who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. 4. Sleep testing devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone, are covered when used to aid the diagnosis of OSA in patients who have signs and symptoms indicative of OSA if performed unattended in or out of3-8-18 a sleep lab facility or attended in a sleep lab facility.

HTAS completed an updated literature search in 2015 to see if the Coveragefor Guidance needed to be reopened.

Bottom Line: Most of the newly available evidence pertains to the comparability of portable level III testing with the gold standard level I testing that is done in a sleep lab. Portable level III testing appears to have favorable diagnostic performance in adults with a high pre-test probability of uncomplicated OSA and may be less expensive. While the additional evidence identified in this search would be unlikely to substantially alter the existing coverage guidance, HERC may wish to consider addressing clinical pathways to encourage the most efficient use of less costly diagnostic tests or empiric therapeutic trials in selected patients with a high pre-test probability of uncomplicated sleep apnea. Summaries Definition of sleep apnea (from AASM, 2017 Clinical Practice Guideline) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5337595/pdf/jcsm.13.3.479.pdf) International Classification of Sleep Disorders (ICSD-3) defines OSA as a PSG-determined obstructive respiratory disturbance index (RDI) ≥ 5 events/h associated with the typical symptoms of OSA (e.g., unrefreshing sleep, daytime sleepiness, fatigue or insomnia, awakening with a gasping or choking sensation, loud snoring, or witnessed apneas), or an obstructiveIssue RDI ≥ 15 events/h (even in the absence of symptoms).

Increased risk of moderate to severe OSA is indicated by the presence of excessive daytime sleepiness and at least two of the following three criteria: habitual loud snoring; witnessed apnea or gasping or choking; or diagnosed hypertension.

VbBSA technically adequate HSAT includes a minimum of 4 hours of technically adequate oximetry and flow data, obtained during a recording attempt that encompasses the habitual sleep period.

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 2

Diagnosis of sleep apnea - guideline update

Current Prioritized List Status

Line: 207 Condition: SLEEP APNEA, NARCOLEPSY AND REM BEHAVIORAL DISORDER (See Guideline Notes 27,64,65,118) Treatment: MEDICAL AND SURGICAL TREATMENT ICD-10: G47.30-G47.31,G47.33-G47.39,G47.411-G47.429,G47.52 CPT: 21193-21235,30117,30140,30520,31600,31601,31610,31820,31825, 42140-42160,42820-42836,94660,96150-96155,98966-98969,99051, 99060,99070,99078,99184,99201-99239,99281-99285,99291-99404, 99408-99449,99468-99480,99487-99498,99605-99607 HCPCS: G0396,G0397,G0406-G0408,G0425-G0427,G0463-G0467,G0490,G0508, G0509 3-8-18

Prioritized Fee Code Code Description Listfor Schedule Placement 95800 Sleep study, unattended, simultaneous recording; Diagnostic Not on fee heart rate, oxygen saturation, respiratory analysis (eg, Procedures schedule by airflow or peripheral arterial tone), and sleep time File 95801 Sleep study, unattended, simultaneous recording; Diagnostic Not on fee minimum of heart rate, oxygen saturation, and Procedures schedule respiratory analysis (eg, by airflow or peripheral File arterial tone) 95806 Sleep study, unattended, simultaneous recording of, Diagnostic $119.36 heart rate, oxygen saturation, respiratory airflow, and Procedures respiratory effort (eg, thoracoabdominalSummaries movement) File 95807 Sleep study, simultaneous recording of ventilation, Diagnostic $326.19 respiratory effort, ECG or heart rate, and oxygen Procedures saturation, attended by a technologist File 95808 Polysomnography; any age, sleep staging with 1-3 Diagnostic $448.92 additional parameters of sleep, attended by a Procedures technologistIssue File 95810 Polysomnography; age 6 years or older, sleep staging Diagnostic $437.03 with 4 or more additional parameters of sleep, Procedures attended by a technologist File 95811 Polysomnography; age 6 years or older, sleep staging Diagnostic $459.07 with 4 or more additional parameters of sleep, with Procedures initiation of continuous positive airway pressure File VbBStherapy or bilevel ventilation, attended by a technologist

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 3

Diagnosis of sleep apnea - guideline update

Prioritized Fee Schedule HCPCS Code Description List Code Placement G0398 Home sleep study test (hst) with type ii portable Diagnostic $167.43 monitor, unattended; minimum of 7 channels: eeg, Procedures eog, emg, ecg/heart rate, airflow, respiratory effort File and oxygen saturation G0399 Home sleep test (hst) with type iii portable monitor, Diagnostic $167.43 unattended; minimum of 4 channels: 2 respiratory Procedures movement/airflow, 1 ecg/heart rate and 1 oxygen File saturation G0400 Home sleep test (hst) with type iv portable monitor, Diagnostic $105.113-8-18 unattended; minimum of 3 channels Procedures File for

DIAGNOSTIC GUIDELINE D8, DIAGNOSTIC TESTING FOR OBSTRUCTIVE SLEEP APNEA (OSA) IN ADULTS Type I PSG is covered when used to aid the diagnosis of OSA in patients who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.

OHP clients should have access to least one of the alternatives listed below: 1) Type II or Type III sleep testing devices when used to aid the diagnosis of OSA in patients who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. 2) Type IV sleep testing devicesSummaries measuring three or more channels, one of which is airflow, when used to aid the diagnosis of OSA in patients who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. 3) Sleep testing devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone, when used to aid the diagnosis of OSA in patientsIssue who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. CPAP titration should be performed as part of the diagnostic study, if possible.

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

VbBSGUIDELINE NOTE 27, SLEEP APNEA Line 203 CPAP is covered initially when all of the following conditions are met:

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 4

Diagnosis of sleep apnea - guideline update

 12 week ‘trial’ period to determine benefit. This period is covered if apnea- hypopnea index (AHI) or respiratory disturbance index (RDI) is greater than or equal to 15 events per hour; or if between 5 and 14 events with additional symptoms including one or more of the following: o excessive daytime sleepiness defined as either an Epworth Sleepiness Scale score>10 or daytime sleepiness interfering with ADLs that is not attributable to another modifiable sedating condition (e.g. narcotic dependence), or o documented hypertension, or o ischemic heart disease, or o history of stroke;  Providers must provide education to patients and caregivers prior to use of CPAP machine to ensure proper use; and 3-8-18  Positive diagnosis through polysomnogram (PSG) or Home Sleep Test (HST).

CPAP coverage subsequent to the initial 12 weeks is based on documentedfor patient tolerance, compliance, and clinical benefit. Compliance (adherence to therapy) is defined as use of CPAP for at least four hours per night on 70% of the nights during a consecutive 30-day period.

Mandibular advancement devices (oral appliances) are covered for those for whom CPAP fails or is contraindicated.

Surgery for sleep apnea in adults is not included on this line (due to lack of evidence of efficacy). Surgical codes are included on this line only for children who meet criteria according to GUIDELINE NOTE 118 OBSTRUCTIVE SLEEP APNEA DIAGNOSIS AND TREATMENT FOR CHILDREN. Summaries The development of this guideline note was informed by a HERC coverage guidance. See http://www.oregon.gov/oha/HPA/CSI-HERC/Pages/Evidence-based-Reports.aspx.

GUIDELINE NOTE 118, OBSTRUCTIVE SLEEP APNEA DIAGNOSIS AND TREATMENT FOR CHILDREN Line 203 Issue Obstructive sleep apnea (OSA) in children (18 or younger) must be diagnosed by

A) nocturnal polysomnography with an AHI >5 episodes/h or AHI>1 episodes/h with history and exam consistent with OSA, OR B) nocturnal pulse oximetry with 3 or more SpO2 drops <90% and 3 or more VbBSclusters of desaturation events, or alternatives desaturation (>3%) index >3.5 episodes/h, OR C) use of a validated questionnaire (such as the Pediatric Sleep Questionnaire or OSA 18), OR

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 5

Diagnosis of sleep apnea - guideline update

D) consultation with a sleep medicine specialist.

Polysomnography and/or consultation with a sleep medicine specialist to support the diagnosis of OSA and/or to identify perioperative risk is recommended for

A) high risk children (i.e. children with cranio-facial abnormalities, neuromuscular disorders, Down syndrome, etc.) B) children with equivocal indications for adenotonsillectomy (such as discordance between tonsillar size on physical examination and the reported severity of sleep-disordered breathing), C) children younger than three years of age

Adenotonsillectomy is an appropriate first line treatment for children with OSA.3-8-18 Weight loss is recommended in addition to other therapy in patients who are overweight or obese. Adenoidectomy without tonsillectomy is only covered when a child with OSA has previously had a tonsillectomy, when tonsillectomy is contraindicated,for or when tonsillar hypertrophy is not present. More complex surgical treatments are only included on this line for children with craniofacial anomalies.

Intranasal corticosteroids are an option for children with mild OSA in whom adenotonsillectomy is contraindicated or for mild postoperative OSA.

CPAP is covered for a 3 month trial for children through age 18 who have

1. undergone surgery or are not candidates for surgery, AND 2. have documented residual sleep apnea symptoms (sleep disruption and/or significant desaturations) with residual daytime symptoms (daytime sleepiness or behavior problems) Summaries

CPAP will be covered for children through age 18 on an ongoing basis if:

 There is documentation of improvement in sleep disruption and daytime sleepiness and behavior problems with CPAP use  Annual re-evaluation for CPAP demonstrates ongoing clinical benefit and complianceIssue with use, defined as use of CPAP for at least four hours per night on 70% of the nights in a consecutive 30 day period

VbBS

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 6

Diagnosis of sleep apnea - guideline update

Evidence summary HTAS Coverage Guidance, 2013

Overall Summary of evidence

Although PSG (type I monitor) is considered the gold standard for diagnosing sleep apnea, the strength of evidence that AHI is a strong and independent predictor of all‐cause mortality is limited to AHI > 30. The association between baseline AHI and the other long‐term clinical outcomes is less robust, no current established threshold level for AHI exists that indicates the need for treatment. Type II, III and IV monitors can all accurately diagnosis OSA, although there is wide variation in estimating the actual AHI for type II monitors, and type3-8-18 III monitors perform better than type IV monitors. Some clinical prediction models and the Berlin questionnaire have evidence of efficacy as screening tools for OSA. for Box language

Summaries

Issue

Jonas, 2017 https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0091057/pdf/PubMedHealth_PMH0 091057.pdf VbBS AHRQ systematic review of screening for obstructive sleep apnea for the USPSTF.  110 studies  Studies reporting accuracy of portable monitors (PMs) for diagnostic testing of persons with suspected OSA found wide ranges for sensitivity and specificity

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 7

Diagnosis of sleep apnea - guideline update

(Type II monitors: 85% to 94% and 77% to 95%; Type III monitors: 49% to 92% and 79% to 95%; Type IV monitors: 7% to 100% and 15% to 100%, respectively, for polysomnography AHI ≥15). Data were limited by imprecision and inconsistency for Type IV monitors. We found sparse data on reliability of PMs.  Authors Conclusions: There is uncertainty about the clinical utility of all potential screening tools. Although screening with Multivariable Apnea Prediction Score followed by home PM testing may have promise for distinguishing persons in the general population who are more or less likely to have OSA, current evidence is limited. Multiple treatments for OSA reduce AHI, ESS, and blood pressure. Although good evidence has established that persons with severe OSA die at twice the rate of controls, trials of CPAP and other treatments have not established whether treatment reduces mortality or improves most other health outcomes, barring evidence of some possible benefit for sleep-related quality3-8-18 of life.

El Shayeb, 2014 for (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3883848/pdf/18600e25.pdf)

1. Systematic review and meta-analysis of the diagnostic accuracy of level 1 versus level 3 portable sleep tests for the diagnosis of sleep-disordered breathing 2. 59 studies involving 5026 patients (mostly patients suspected of having OSA). 19 studies included in meta-analysis 3. Results: a. The estimated area under the receiver operating characteristics curve (AUROC) was high, ranging between 0.85 and 0.99 across different levels of disease severity. b. Summary sensitivity ranged between 0.79 and 0.97 c. Summary specificitySummaries ranged between 0.60 and 0.93 across different apnea–hypopnea cut-offs. d. No significant difference in the clinical management parameters between patients who underwent either test to receive their diagnosis. 4. Authors Interpretation: Level 3 portable devices showed good diagnostic performance compared with level 1 sleep tests in adult patients with a high pretest probability of moderate to severe obstructive sleep apnea and no unstableIssue comorbidities.

Cooksey, 2016

1. Non-systematic review of portable sleep apnea testing 2. Summarized a number of studies VbBSa. Kuna, 2011 i. Randomized trial of 296 VA patients ii. PSG followed by in-laboratory CPAP titration or a home portable study followed by in-home autotitrating positive airway pressure

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 8

Diagnosis of sleep apnea - guideline update

(APAP). After 4 to 5 days of APAP, a fixed CPAP pressure was selected based on the 90th percentile APAP pressure (ie, the pressure below which a study participant spent 90% of the time and which led to AHI # 10 events per hour). iii. home testing pathway was noninferior to the traditional in- laboratory pathway in terms of CPAP adherence at 3 months and functional outcomes of sleepiness (ESS, FOSQ), and depression. iv. 25% of patients required PSG due to either technical failure of the portable study (5.6%) or due to a negative portable study result based on a diagnostic threshold of an AHI > 15 events per hour (18.9%). This false-negative rate, albeit at a different diagnostic threshold, supports the AASM recommendation that a negative portable study result should be followed up with in-laboratory3-8-18 PSG if the pretest probability of moderate to severe OSA is high. b. Berry, 2014 i. 156 symptomatic VA patients diagnosed with Levelfor 3 study ii. Randomized to undergo in-laboratory CPAP titration or outpatient APAP titration iii. Results: no difference in PAP adherence, residual AHI, or functional outcomes. But higher satisfaction in APAP group. c. Rosen 2012 HomePAP study i. Multicenter trial of 373 patients ii. Compared traditional in-laboratory PSG vs home testing followed by APAP titration followed by CPAP at the 90th percentile pressure. iii. Results: ESS scores were similar between the two groups but that CPAP adherence was higher at 3 months in the home testing and titration group.Summaries 3. Concluded portable monitoring is a reasonable substitute for in-laboratory PSG in appropriately selected patients. 4. Close follow up to improve CPAP adherence is important 5. Importantly, there is a continuing role for in-laboratory PSG within home testing algorithms. In-laboratory testing is still indicated in the event of technical failure of the portable monitoring study, in the event of a negative portable study result with a Issuehigh suspicion of OSA, or to rule out other concomitant sleep disorders in patients who remain symptomatic despite effective PAP therapy.

Corral, 2017 (http://dx.doi.org/10.1164/rccm.201612-2497OC)

1. Noninferiority, randomized controlled trial with two open parallel arms and a VbBScost-effectiveness analysis 2. 12 tertiary hospitals in Spain 3. 430 Patients with intermediate to high suspicion of sleep apnea, treated with or without CPAP

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 9

Diagnosis of sleep apnea - guideline update

4. Randomized to respiratory polygraphy or polysomnography protocols a. Our HRP (Embla-Embletta; Natus, Pleasanton, CA) measurements included oxygen saturation, airflow through nasal pressure, and thoracic and abdominal movements measured by piezoelectric bands. 5. Respiratory polygraphy protocol was noninferior to the polysomnography protocol based on the Epworth scale. Quality of life, blood pressure, and polysomnography were similar between protocols. 6. Respiratory polygraphy was the most cost-effective protocol, with a lower per- patient cost of 416.7€. 7. Considerations: The home testing resulted in CPAP in 15% fewer patients than the polysomnography group. However, this was not associated with important consequences because improvements in the primary and secondary outcomes were similar between the arms in the subgroup of patients not treated with3-8-18 CPAP (with the exception of a smaller deep-sleep percentage with the HRP protocol). 8. Author conclusions: Home respiratory polygraphy managementfor is similarly effective to polysomnography, with a substantially lower cost. Therefore, polysomnography is not necessary for most patients with suspected sleep apnea. This finding could change established clinical practice, with a clear economic benefit. 9. HERC Staff Conclusions: This study supports that home testing has similar outcomes to polysomnography, even though there is 15% less CPAP prescribed.

Chai-Coetzer 2017 http://dx.doi.org/10.7326/M16-1301

1. Multicenter randomized non-inferiority trial 2. 7 academic sleep centersSummaries in Australia 3. Patients (n = 406) aged 25 to 80 years with suspected OSA. 4. 3 way comparison between Level 1 polysomnography data, Level 3 which included airflow, thoracoabdominal bands, body position, electrocardiography, and oxygen saturation; or level 4 which included oxygen saturation and heart rate (n = 135). 5. Results:Issue Change in Functional Outcomes of Sleep Questionnaire (FOSQ) score at 4 months was not inferior for L3 (mean difference [MD], 0.01 [95% CI, -0.47 to 0.49; P = 0.96]) or L4 (MD, -0.46 [CI, -0.94 to 0.02; P = 0.058]) versus L1 (noninferiority margin [NIM], -1.0). Compared with L1, change in Epworth Sleepiness Scale (ESS) score was not inferior for L3 (MD, 0.08 [CI, -0.98 to 1.13; P = 0.89]) but was inconclusive for L4 (MD, 1.30 [CI, 0.26 to 2.35; P = 0.015]) (NIM, VbBS2.0). For L4 versus L1, there was less improvement in Sleep Apnea Symptoms Questionnaire (SASQ) score (-17.8 vs. -24.7; P = 0.018), less CPAP use (4.5 vs. 5.3 hours per night; P = 0.04), and lower physician diagnostic confidence (P = 0.003).

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 10

Diagnosis of sleep apnea - guideline update

6. Major limitation – the limited channel studies were not actually done at home. They were simulated by laboratory PSG data. 7. Authors Conclusion: The results support manually scored L3 testing in routine practice. Poorer outcomes with L4 testing may relate, in part, to reduced physician confidence. 8. HERC Staff Conclusions: This study reaffirms the utility of level 3 testing with patient oriented RCT outcomes, but doesn’t take into account additional factors related to home-based testing. Level 4 studies may be inferior.

Goldstein, 2017

1. Retrospective cohort study 196 patients 3-8-18 2. First home sleep apnea testing performed. Those with negative tests had in lab polysomnography. Patients were also characterizied by a modified STOP Score (2 symptoms of STOP plus either BMI > 35 or male gender. Negativefor sleep apnea tests were followed up by polysomnography (except for 27% which did not have a f/u polysomnography) 3. Results: Among 196 individuals, pre-test probability was low in 74 (38%) and high in 122 (62%). A lower percentage of individuals with a low versus high pre-test probability for moderate to severe OSA had HSAT results that confirmed OSA (61versus 84%, p = 0.0002) resulting in an odds ratio (OR) of 0.29 for confirmatory HSAT in the low pre-test probability group (95% CI [0.146, 0.563]). Multivariate logistic regression demonstrated that age ≤ 50 (OR 3.10 [1.24– 7.73]), female gender (OR 3.58[1.50–8.66]), non-enlarged neck circumference (OR 11.50 [2.50–52.93]), and the absence of loud snoring (OR 3.47 [1.30–9.25]) best predicted non-diagnostic HSAT. OSA was diagnosed by PSG in 54%of individuals with negativeSummaries HSAT which was similar in both pre-test probability groups. 4. Authors conclusions: HSATs should be reserved for individuals with high pre-test probability for moderate to severe disease as opposed to any individual with suspected OSA. 5. HERC Staff Consideration – Authors have strong opinions on insurer mandates to require home apnea testing first Issue Guidelines Kapur, 2017 - American Academy of Sleep Medicine (AASM) guidelines http://jcsm.aasm.org/ViewAbstract.aspx?pid=30972

AASM Good Practice Statements: VbBS Diagnostic testing for OSA should be performed in conjunction with a comprehensive sleep evaluation and adequate follow-up.

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Diagnosis of sleep apnea - guideline update

 Polysomnography is the standard diagnostic test for the diagnosis of OSA in adult patients in whom there is a concern for OSA based on a comprehensive sleep evaluation.

AASM Recommendations: 1. We recommend that clinical tools, questionnaires and prediction algorithms not be used to diagnose OSA in adults, in the absence of polysomnography or home sleep apnea testing. (STRONG) 2. We recommend that polysomnography, or home sleep apnea testing with a technically adequate device, be used for the diagnosis of OSA in uncomplicated adult patients presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA. (STRONG) 3. We recommend that if a single home sleep apnea test is negative, 3-8-18 inconclusive, or technically inadequate, polysomnography be performed for the diagnosis of OSA. (STRONG) 4. We recommend that polysomnography, rather than home sleepfor apnea testing, be used for the diagnosis of OSA in patients with significant cardiorespiratory disease, potential respiratory muscle weakness due to neuromuscular condition, awake hypoventilation or suspicion of sleep related hypoventilation, chronic opioid medication use, history of stroke or severe insomnia. (STRONG) 5. We suggest that, if clinically appropriate, a split-night diagnostic protocol, rather than a full-night diagnostic protocol for polysomnography be used for the diagnosis of OSA. (WEAK) 6. We suggest that when the initial polysomnogram is negative and clinical suspicion for OSA remains, a second polysomnogram be considered for the diagnosis of OSA. (WEAK) Summaries

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Diagnosis of sleep apnea - guideline update

Other payers: Cigna, 2016 http://help.carecentrix.com/ProviderResources/Cigna%20Medical%20Coverage%20Polic y.pdf

Home/Portable Study: Cigna covers a home/portable sleep study* as medically necessary for the diagnosis of obstructive sleep apnea (OSA) in an adult (age 18 or older) when ALL of the following criteria are met:  Study/test equipment meets the minimum definition described in at least one of the following Current Procedural Terminology (CPT) or Health Care Procedure Coding System (HCPCS) codes: o 95800: Sleep study, unattended, simultaneous recording: heart rate,3-8-18 oxygen saturation, respiratory analysis (eg, by airflow or peripheral arterial tone) and sleep time o 95801: Sleep study, unattended, simultaneous recording: minimumfor of heart rate, oxygen saturation, and respiratory analysis (eg, by airflow or peripheral arterial tone) o 95806: Sleep study, unattended, simultaneous recording of heart rate, oxygen saturation, respiratory airflow, and respiratory effort (eg, thoracoabdominal movement) o G0398: Home sleep study test (HST) with type II portable monitor, unattended; minimum of 7 channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort and oxygen saturation o G0399: Home sleep test (HST) with type III portable monitor, unattended; minimum of 4 channels: 2 respiratory movement/airflow, 1 ECG/heart rate and 1 oxygen saturation  medical necessity criteriaSummaries for a sleep study for suspected OSA as outlined above have been met  absence of significant comorbid condition that would be expected to degrade the accuracy of a home/portable study, such as any of the following: o moderate to severe pulmonary disease, such as chronic obstructive pulmonary disease (COPD), documented on pulmonary function studies (PFTs)Issue o moderate to severe neuromuscular/neurodegenerative disorder causing restrictive lung diseases (e.g., kyphoscoliosis, myasthenia gravis, amyotropic lateral sclerosis (ALS), post-polio, syndrome, polymyositis, Guillian Barre syndrome) o congestive heart failure New York Heart Association (NYHA) Class III or IV (LVEF ≤ 45%) VbBSo obesity hypoventilation syndrome, previously documented (defined as pCO2 > 45 mmHg and pO2 < 60 mmHg on arterial blood gas) o pulmonary hypertension (defined as mean pulmonary artery pressure (mPAP) ≥ 25 mmHg)

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Diagnosis of sleep apnea - guideline update

 no sleep disorder other than OSA is suspected (e.g., central sleep apnea, periodic limb movement disorder, complex; potentially injurious or violent parasomnias, narcolepsy, REM behavior sleep disorder, nocturnal seizures)

*Note: A home/portable study is considered to be one study, whether performed during a single night or during two or more consecutive nights.

Cigna covers a follow-up home/portable sleep study when the diagnosis of OSA has been established in an adult (age 18 or older) when ALL of the following criteria are met:  testing is to be performed for ANY of the following: o confirmation of therapeutic benefit following final adjustment of a mandibular repositioning appliance (MRA) 3-8-18 o assessment of results following surgical treatment for OSA o clinical response is insufficient or symptoms return despite a good initial response to oral appliance therapy for o no significant oxygen desaturation (O2 saturation < 80% for > 1% of sleep time or < 90% for > 30% of sleep time during prior diagnostic facility-based study) during diagnostic sleep study  absence of comorbid sleep disorder or significant comorbid medical condition, as described above, that would be expected to degrade the accuracy of a home/portable study

Cigna covers full night in-facility polysomnography (PSG) (CPT codes 95808, 95810) as medically necessary in an adult (age 18 or older) when BOTH of the following criteria are met:  medical necessity criteria for a sleep study for suspected obstructive sleep apnea (OSA) as outlined above haveSummaries been met  ANY of the following: o significant comorbid condition that would be expected to degrade the accuracy of a home/portable study such as any of the following:  moderate to severe pulmonary disease, such as chronic obstructive pulmonary disease (COPD)  Issuemoderate to severe neuromuscular/neurodegenerative disorder causing restrictive lung diseases (e.g., kyphoscoliosis, myasthenia gravis, amyotropic lateral sclerosis (ALS), post-polio syndrome, polymyositis, Guillian Barre syndrome)  congestive heart failure (moderate to severe) NYHA Class III or IV (LVEF ≤ 45%)  obesity hypoventilation syndrome, previously documented (defined as VbBS pCO2 > 45 mmHg and pO2 < 60 mmHg on arterial blood gas)  pulmonary hypertension (defined as mPAP ≥ 25 mmHg) o sleep disorder other than OSA is suspected (e.g., central sleep apnea, periodic limb movement disorder, complex; potentially injurious of violent

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Diagnosis of sleep apnea - guideline update

parasomnias, narcolepsy, REM behavior sleep disorder, nocturnal seizures) that is corroborated by the clinical documentation o recent home/portable testing proved to be technically inadequate or failed to establish the diagnosis of OSA in an individual with high pretest likelihood of OSA o individual and caregiver/companion incapable of operating home testing equipment

Cigna covers full night in-facility polysomnography (PSG) (CPT codes 95808, 95810) as medically necessary prior to a planned multiple sleep latency test (MSLT) in an adult (age 18 or older) with suspected narcolepsy.

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Aetna, 2017 http://www.aetna.com/cpb/medical/data/1_99/0004.html for

Aetna considers the diagnosis and treatment of obstructive sleep apnea (OSA) in adults aged 18 and older medically necessary according to the criteria outlined below.

I. Diagnosis

Aetna considers attended full-channel nocturnal polysomnography (NPSG) (Type I device) performed in a healthcare facility medically necessary for diagnosis in members with symptoms suggestive of obstructive sleep apnea (see appendix), when attended NPSG is used as part of a comprehensive sleep evaluation, and member has one or more of the following indicationsSummaries for attended NPSG:

A. Member has at least one of the following comorbid medical conditions that degrade the accuracy of portable monitoring:

1. moderate to severe pulmonary disease (for example, COPD or ashma) (with nocturnalIssue oxygen use or daytime hypercapnea with documented arterial blood gasses showing pO2 less than 60 or pCO2 greater than 45), 2. neuromuscular disease (e.g., Parkinson’s disease, spina bifida, myotonic dystrophy, amyotrophic lateral sclerosis), 3. stroke with residual respiratory effects, 4. epilepsy, 5. congestive heart failure (NYHA class III or IV or LVEF less than 45%), VbBS6. super obesity (BMI greater than 45, or pulmonary function studies show obesity hypoventilation syndrome (BMI greater than 35 plus arterial blood gas with PCO2 greater than 45, or BMI greater than 35 plus inability to lie flat

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Diagnosis of sleep apnea - guideline update

in bed)); or

B. Member has one or more of the following comorbid sleep disorders:

1. periodic limb movement disorder (involuntary, jerking movements of the legs during sleep causing excessive daytime sleepiness (EDS) due to sleep fragmentation), 2. parasomnias that are unusual or atypical because of the individual’s age at onset, the time, duration or frequency of occurrence of the behavior including, but not limited to: nocturnal seizures, psychogenic dissociative states, REM sleep behavior disorder, sleep talking and/or confusional arousals, 3-8-18 3. narcolepsy, 4. central sleep apnea or complex sleep apnea; or

C. Member has negative or technically inadequate portable monitoringfor results; or D. Member has low pretest probability of obstructive sleep apnea (normal BMI (less than 30), normal airway (Mallampati score 1 or 2), no snoring, and normal neck circumference (less than 17 inches in men, and less than 16 inches in women)); or E. Member lacks the mobility or dexterity to use portable monitoring equipment safely at home.

Note: Where attended NPSG is indicated, a split-night study NPSG is considered medically necessary, in which the final portion of the NPSG is used to titrate continuous positive airway pressure (CPAP), if the Apnea Hypopnea Index (AHI) is greater than 15 in first 2 hours of a diagnostic sleep study. An additional full-night CPAP titration NPSG is considered medically necessary only if the AHI is less than or equal to 15 during the first 2 hoursSummaries of a diagnostic sleep study, or if the split-night study did not allow for the abolishment of the vast majority of obstructive respiratory events (see section III below).

II. UnattendedIssue (Home) Sleep Studies Aetna considers unattended (home) sleep studies using any of the following diagnostic techniques (see appendix for definition of device types) medically necessary for members with symptoms suggestive of OSA (see appendix) when the home sleep study is used as part of a comprehensive sleep evaluation:

VbBSA. Sleep monitoring using a Type II device; or B. Sleep monitoring using a Type III device, or C. Sleep monitoring using a Type IV(A) device, measuring airflow and at least 2 other channels and providing measurement of apnea-hypopnea index (AHI); or

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Diagnosis of sleep apnea - guideline update

D. Sleep monitoring using a device that measures 3 or more channels that include pulse oximetry, actigraphy, and peripheral arterial tone (e.g., Watch-PAT device).

Note: Sleep studies using devices that do not provide a measurement of apnea- hypopnea index (AHI) and oxygen saturation are considered not medically necessary because they do not provide sufficient information to prescribe treatment. Examples include the Biancamed SleepMinder, SNAP testing with fewer than three channels, and the SleepImage Sleep Quality Screener. Note that the ApneaLink does not meet criteria as a covered type IV device because it does not measure airflow; however, the ApneaLink Plus records 5 channels, including airflow, and meets criteria for a covered sleep study device.

Repeat home sleep testing on multiple consecutive nights has no proven value.3-8-18

III. Attended Nocturnal Polysomnography (NPSG) for

Attended full-channel nocturnal polysomnography (NPSG) (Type I device) performed in a healthcare facility is considered medically necessary for persons diagnosed with obstructive sleep apnea who have any of the following indications for attended NPSG:

A. To titrate CPAP in persons diagnosed with clinically significant OSA for whom in- laboratory NPSG was medically necessary, but who were unable to undergo a split-night study because they had an insufficient AHI (less than 15) during the first two hours of an attended NPSG; or B. To titrate CPAP in persons with clinically significant OSA for whom in- laboratory NPSG was medicallySummaries necessary, and who underwent a split-night study that did not abolish the vast majority of obstructive respiratory events; or C. To monitor results from CPAP in persons with OSA who have persistent significant symptoms (disturbed sleep with significant arousals) despite documented AHI less than 5 on CPAP and documented compliance with CPAP (CPAP used for 70 percent of nights for four or more hours per night, for two or more months); or D. To confirmIssue diagnosis of obstructive sleep apnea prior to surgical modifications of the upper airway.

MODA, 2017 https://www.modahealth.com/pdfs/med_criteria/ObstructiveSleepApnea_NonSurgical VbBSMgmt.pdf

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 17

Diagnosis of sleep apnea - guideline update

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HERC Staff Summary Insufficient evidence supports screening for obstructive sleep apnea with clinical tools. Home sleep studies appear to be of reasonable efficacy compared to laboratory polysomnography. There will be a number of patients (approximately 15-25%) with a negative home sleep study who would test positive with laboratory polysomnography, but the clinical value of identifyingSummaries this “false negative” group is unclear. Home sleep studies are much less costly than laboratory polysomnography. Other insurers generally require home sleep studies over attended polysomnography unless there are specific clinical indications which would decrease the potential accuracy of home testing.

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Diagnosis of sleep apnea - guideline update, Issue #1350 Page 18

Diagnosis of sleep apnea - guideline update

HERC Staff Recommendations: 1. Modify Diagnostic Guideline D8 as follows: DIAGNOSTIC GUIDELINE D8, DIAGNOSTIC TESTING FOR OBSTRUCTIVE SLEEP APNEA (OSA) IN ADULTS Type I PSG is covered when used to aid the diagnosis of OSA in patients who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.

OHP clients should have access to least one of the alternatives listed below: 1) Type II or Type III sleep testing devices when used to aid the diagnosis of OSA in patients who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.3-8-18 2) Type IV sleep testing devices measuring three or more channels, one of which is airflow, when used to aid the diagnosis of OSA in patients who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. for 3) Sleep testing devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone, when used to aid the diagnosis of OSA in patients who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. CPAP titration should be performed as part of the diagnostic study, if possible.

In adults with clinical signs and symptoms consistent with obstructive sleep apnea (OSA), a home sleep study is the first-line diagnostic test for most patients, when available.

Polysomnography in a sleep lab is indicated as a first-line test for patients with significant cardiorespiratory disease,Summaries potential respiratory muscle weakness due to a neuromuscular condition, awake hypoventilation or suspicion of sleep related hypoventilation, chronic opioid medication use, history of stroke or severe insomnia. If a patient has had an inconclusive (or negative) home sleep apnea test and a clinical suspicion for OSA remains, then attended polysomnography is included on this line. Split night diagnostic protocols are required when a diagnosis of OSA is confirmed in the first portion of theIssue night.

For portable devices, Type II-III are included on this line. Type IV sleep testing devices must measure three or more channels, one of which is airflow, to be included on this line. Sleep testing devices that are not Type1-IV and measure three or more channels that include actigraphy, oximetry, and peripheral arterial tone, are included on this line.

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

Diagnosis of sleep apnea - guideline update, Issue #1350 Page 19

Tobacco smoking cessation and elective surgery

Question: How should the smoking cessation and elective surgery guideline be modified for clarity?

Question source: CCO Medical Directors

Issue: There is ongoing clarification needed about the tobacco cessation and elective surgery guideline. A number of queries have come back to HERC staff about HERC intent, particularly with intent around the language “cancer-related” and “reproductive.” The prior HERC intent had been to not delay a surgery if a cancer would be progressive, but not to address anything related to a cancer if there is not a specific urgency related to cancer progression. For reproductive procedures, there have been questions as to whether this applies to any surgery related to reproductive organs.3-8-18 This is not the intent. The intent is to allow for desired sterilization or pregnancy termination which are time-sensitive procedures, but not for routine procedures such as hysterectomy for menorrhagia. There was also a question about definingfor what constituted a diagnostic procedure that would be exempt from the 1 month delay.

HERC Staff Recommendations: 1) Modify the Ancillary Guideline A4 as follows:

ANCILLARY GUIDELINE A4, SMOKING CESSATION AND ELECTIVE SURGICAL PROCEDURES Smoking cessation is required prior to elective surgical procedures for active tobacco users. Cessation is required for at least 4 weeks prior to the procedure and requires objective evidence of abstinence from smoking prior to the procedure. Summaries Elective surgical procedures in this guideline are defined as surgical procedures which are flexible in their scheduling because they do not pose an imminent threat nor require immediate attention within 1 month. Procedures excluded from this guideline include select reproductive procedures (i.e. for contraceptive purposes), cancer-related targeted procedures (i.e. when a delay in the procedureIssue could lead to cancer progression) and diagnostic procedures.

The well-studied tests for confirmation of smoking cessation include cotinine levels and exhaled carbon monoxide testing. However, cotinine levels may be positive in nicotine replacement therapy (NRT) users, smokeless tobacco and e- cigarette users (which are not contraindications to elective surgery coverage). In patients using nicotine products aside from combustible cigarettes the following VbBSalternatives to urine cotinine to demonstrate smoking cessation may be considered:  Exhaled carbon monoxide testing

Tobacco smoking cessation and elective surgery, Issue #1366 Page 1

Tobacco smoking cessation and elective surgery

 Anabasine or anatabine testing (NRT or vaping)

Certain procedures, such as lung volume reduction surgery, bariatric surgery, erectile dysfunction surgery, and spinal fusion have 6 month tobacco abstinence requirements. See Guideline Notes 8, 100, 112 and 159.

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Summaries

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Tobacco smoking cessation and elective surgery, Issue #1366 Page 2

Fractional Exhaled Nitric Oxide Testing for Asthma Management March 2018

Question: Should fractional exhaled nitric oxide (FeNO) determination be covered for management of asthma in addition to the diagnosis of asthma?

Question source: HERC

Issue: Nitric oxide expired gas determination (CPT 95012) was discussed at the January, 2018 VBBS and HERC meetings. VBBS approved FeNO for the diagnosis of asthma, but requested additional information regarding its use in the management of asthma. The HERC reviewed the VBBS report on FeNO, and heard additional testimony from the manufacturer’s representatives. The HERC requested that VBBS re- review the evidence regarding the use of FeNO for the management of asthma.

FeNO has been proposed for use in selecting medications for treatment of asthma, determining3-8-18 when a patient may not be compliant with medications, and helping to reduce exacerbations when used as a part of a management algorithm. for Evidence 1) AHRQ 2017, Systematic review of the Clinical Utility of Fractional Exhaled Nitric Oxide in Asthma Management (https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/cer-197-fractional- exhaled-nitric-oxide_0.pdf) a. Total included studies: N=175 studies in adults and children over the age of 5 b. Clinical utility in monitoring disease activity and predicting exacerbations i. N= 58 studies with a total of 8,999 patients 1. N=30 adults only, N=28 children and/or adolescents 2. 34 studies were nonrandomized longitudinal studies, 7 RCTs, and 17 cross sectional studies; most were low risk of bias 3. Heterogeneity in study populations, designs, and outcome types precluded meta-analysis 4. “Exacerbation” was defined variably among studies, with definitions includingSummaries systemic corticosteroids use, hospitalizations, ED visits, ICU admission/intubations, death ii. Adults >18 1. Outcome: reducing urgent care visits. No evidence found in 1 study 2. Outcome: improved asthma control as measured by asthma control questionnaire (ACQ) scores. Weak correlation, and FeNO did not Issuereliably differentiate patients who were well-controlled versus borderline controlled versus not well-controlled. 3. Outcome: improved asthma control as measured by asthma control test (ACT) scores: An inverse correlation between ACT and FeNO was noted across numerous studies with various ACT and FeNO cutoffs a. The association between asthma control (measured by ACT or ACQ) and FeNO was weakened in patients on ICS as VbBS observed in four studies 4. Outcome: predicting asthma exacerbations: conflicting results among studies. 1

Fractional Exhaled Nitric Oxide Testing for Asthma Management March 2018

5. Summary: In adults with asthma, numerous observational studies showed that FeNO levels have weak associations both with asthma control (as measured by ACQ and ACT) and that FeNO can modestly predict exacerbations. The magnitude of association between FeNO and control tests is likely reduced in patients on ICS, smoke, or who are pregnant. The overall strength of this evidence is low because of the observational nature of the majority of evidence. iii. Children (ages 5 - 12) and adolescents (ages 13 - 18), 1. Outcome: adherence to asthma medications (mainly inhaled corticosteroids (ICS)). FeNO levels were inversely associated with adherence to asthma medications (SOE: Low). a. Based on 3 observational studies of 1,035 patients3-8-18 2. Outcome: acute visits, emergency department visits, unscheduled doctor visits, or hospitalization. FeNO measurement every 3 months did not reduce use in a high risk population in 1 study 3. Outcome: predicting exacerbations: mixed resultsfor in studies 4. Outcome: Asthma control as measured by ACT or ACQ: no differences found with FeNO included on control strategy 5. Outcome: asthma free days. No change in 1 study 6. Outcome: Lower ICS use. Found in 1 study 7. Outcome: Quality-adjusted life years (QALYs) and costs were not statistically significantly different in 1 study. 8. Evidence supporting a FeNO-based adherence monitoring program are unavailable (in terms of cost effectiveness, acceptability, feasibility and outcomes, of such program). c. Adults and children i. Use of FeNO to monitor asthma status during acute exacerbations 1. FeNO levels do not correlate with exacerbation severity and were poorly Summariesreproducible 2. 4 observational studies (N= 1,012 patients) 3. SOE: low d. Using FeNO to monitor adherence to medications i. In children and adolescents, elevated FeNO level was associated with lower adherence to inhaled corticosteroids Issueii. N=3 observational studies (N=1,035 patients) iii. SOE: low (due to observational nature of studies) e. FeNO used to monitor patients and change medications/management if indicated i. N= 24 studies with a total of 2,820 patients 1. 14 randomized controlled trials 2. adults (ages of >18 years) and children (ages of 5-18 years) 3. using asthma management algorithms that incorporate FeNO testing VbBS ii. Outcome: reduced exacerbations: yes, with high SOE. The number of patients needed to treat using FeNO-based algorithms to prevent one person with exacerbation is 9 (for both adults and children). 2

Fractional Exhaled Nitric Oxide Testing for Asthma Management March 2018

iii. Outcome: use of oral steroids. In adults, reduced with FeNO monitoring (OR 0.71, 95% CI 0.44 to 1.15) based on 3 RCTs (N=1,041 patients); moderate SOE. For children, reduced with FeNO monitoring (OR 0.58; 95% CI 0.31 to 1.07) based on 6 RCTs (N=733 patients); moderate SOE 1. For the outcome of exacerbations requiring oral steroids, exploratory analysis that combines data from adults and children, demonstrated that the reduction was statistically significant (I2=0%), suggesting that this analysis in each subgroup analysis (adults or children) was underpowered because of small sample sizes. i. Outcomes with no effect: hospitalization, quality of life, asthma control, or FEV1% predicted. f. Management algorithms that incorporate FeNO testing may be associated 3-8-18with a modest reduction in medical expenses, compared to management approaches that do not include FeNO testing. i. 5 studies; 3 found cost savings to strategies incorporating FeNO into an asthma control algorithm, 1 study found no savings, 1 found higherfor costs with mild asthma and cost savings with more severe asthma g. Using FeNO testing to identify patients who are more likely to respond to inhaled corticosteroids (SOE: Low). Yes, FeNO reliably predicted responders to inhaled corticosteroids for adults and children h. Clinical utility for assessing response to treatment ii. N= 41 studies with a total of 1,728 patients iii. FeNO levels are reduced when patients with asthma take inhaled corticosteroids, leukotriene receptor antagonists or omalizumab. FeNO levels are not reduced when patients with asthma take long acting beta agonists. iv. FeNO predicts exacerbations in patients undergoing ICS reduction or withdrawal, but FeNO alone is likely insufficient and its ability to predict exacerbations can be substantially enhanced by clinical measures (e.g. ACT). i. Conclusions. This systematic review provides the diagnostic accuracy measures of FeNO in people ages 5 years andSummaries older. Test performance is modestly better in steroid-naïve asthmatics, children, and nonsmokers than the general population with suspected asthma. Algorithms that include FeNO measurements can help in monitoring response to anti-inflammatory, or long-term control medications, including dose titration, weaning, and treatment adherence. At this time, evidence is insufficient to support the measurement of FeNO in children under the age of 5 as a means for predicting a future diagnosisIssue of asthma. 2) Gomersal 2016, systematic review of FeNO in the management of asthma in children a. N=7 RCTs b. There was some evidence that FeNO-guided monitoring results in improved asthma control during the first year of management, although few results attained statistical significance. The impact on severe exacerbations was unclear. Similarly, the impact on use of anti-asthmatic drugs was unclear, and appears to depend on the step up/down VbBSprotocols, and the clinical characteristics of patients. c. Conclusions: The potential benefit of FeNO monitoring is equivocal. Trends toward reduced exacerbation and increased medication use were seen, but typically failed to

Fractional Exhaled Nitric Oxide Testing for Asthma Management March 2018

reach statistical significance. There are a number of issues that complicate data interpretation, including differences in the likely severity of included cohorts and variations in treatment algorithms. Further work is needed to systematically explore the impact of these parameters. 3) Essat 2016, systematic review of FeNO on the management of asthma in adults (https://pdfs.semanticscholar.org/64b4/2c3e405f111ceee372e36e782e34fbbc0d71.pdf) a. N=6 studies b. Four studies reported a wider definition of exacerbation rates (major or severe exacerbation) with a pooled rate ratio of 0.80 (95% CI 0.63–1.02). Two studies reported rates of severe exacerbations (requiring oral corticosteroid use) with a pooled rate ratio of 0.89 (95% CI 0.43–1.72). Inhaled corticosteroid use was reported by four studies, with a pooled standardised mean difference of −0.24 (95% CI −0.56–0.07). No statistically significant differences for health-related quality of life or asthma control were3-8-18 found. c. FeNO guided management showed no statistically significant benefit in terms of severe exacerbations or inhaled corticosteroid use, but showed a statistically significant reduction in exacerbations of any severity. However, further researchfor is warranted to clearly define which management protocols (including cut-off points) offer best efficacy and which patient groups would benefit the most. 4) Petsky 2016, Cochrane review of FeNO to guide treatment of asthma in adults (http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011440.pub2/pdf) a. N=7 trials (1546 patients), b. Results: i. In the meta-analysis, there was a significant difference in the primary outcome of asthma exacerbations between the groups, favouring the FeNO group. The number of people having one or more asthma exacerbations was significantly lower in the FeNO group compared to the control group (odds ratio (OR) 0.60, 95% confidence interval (CI) 0.43 to 0.84). The number needed to treat to benefit (NNTB) over 52 weeks was 12 (95% CI 8 to 32). Those in the FeNO group were also significantly more likely to have a lower exacerbation rate than the controls (rate ratioSummaries 0.59, 95% CI 0.45 to 0.77). However, we did not find a difference between the groups for exacerbations requiring hospitalisation (OR 0.14, 95% CI 0.01 to 2.67) or rescue oral corticosteroids (OR 0.86, 95% CI 0.50 to 1.48). There was also no significant difference between groups for any of the secondary outcomes (FEV1, FeNO levels, symptoms scores, or inhaled corticosteroid doses at final visit). ii. The GRADE quality of the evidence ranged from moderate (for the outcome Issue’exacerbations’) to very low (for the outcome ‘inhaled corticosteroid dose at final visit’) based on the lack of blinding and statistical heterogeneity. iii. Authors’ conclusions With new studies included since the last version of this review, which included adults and children, this updated meta-analysis in adults with asthma showed that tailoring asthma medications based on FeNO levels (compared with primarily on clinical symptoms) decreased the frequency of asthma exacerbations but did not impact day-to-day clinical symptoms, end-of- VbBS study FeNO levels, or inhaled corticosteroid dose. Thus, the universal use of FeNO to help guide therapy in adults with asthma cannot be advocated.

Fractional Exhaled Nitric Oxide Testing for Asthma Management March 2018

c. Petsky 2016, Cochrane review of FeNO to guide treatment of asthma in children (http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011439.pub2/epdf) i. N=9 studies ii. There was a significant difference in the number of children having one or more asthma exacerbations over the study period, they were significantly lower in the FeNO group in comparison to the control group (odds ratio (OR) 0.58, 95% confidence interval (CI) 0.45 to 0.75; 1279 participants; 8 studies). The number needed to treat for an additional beneficial outcome (NNTB) over 52 weeks was 9 (95% CI 6 to 15). There was no difference between the groups when comparing exacerbation rates (mean difference (MD) -0.37, 95% CI -0.8 to 0.06; 736 participants; 4 studies; I2 = 67%). The number of children in the FeNO group requiring oral corticosteroid courses was lower in comparison to the children in the control group (OR 0.63, 95% CI 0.48 to 0.83; 1169 participants;3-8-18 7 studies; I2 = 0%). There was no statistically significant difference between the groups for exacerbations requiring hospitalisation (OR 0.75, 95% CI 0.41 to 1.36; 1110 participants; 6 studies; I2 = 0%). There were no significantfor differences between the groups for any of the secondary outcomes (forced expiratory volume in one second (FEV1), FeNO levels, symptom scores or inhaled corticosteroid doses at final visit). The included studies recorded no adverse events. iii. The GRADE quality of the evidence ranged from moderate (for the outcome ’Number of participants who had one or more exacerbations over the study period’) to very low (for the outcome ’Exacerbation rates’), based on lack of blinding, statistical heterogeneity and imprecision. d. Authors’ conclusions In this updated review with five new included studies, tailoring asthma medications based on FeNO levels (in comparison with primarily guideline management) significantly decreased the number of children who had one or more exacerbations over the study period but did not impact the day-to-day clinical symptoms or inhaled corticosteroid doses. Therefore, the use of FeNO to guide asthma therapy in children may be beneficial in a subset of children, it cannot be universally recommended for all childrenSummaries with asthma.

Practice guideline 1) NICE 2017, diagnosis, monitoring and management of chronic asthma (https://www.nice.org.uk/guidance/ng80/resources/asthma-diagnosis-monitoring-and-chronic- asthma-management-pdf-1837687975621) a. 1.14Issue Monitoring asthma control i. 1.14.4 Do not routinely use FeNO to monitor asthma control. ii. 1.14.5 Consider FeNO measurement as an option to support asthma management in people who are symptomatic despite using inhaled corticosteroids.

VbBS

Fractional Exhaled Nitric Oxide Testing for Asthma Management March 2018

Expert guidelines 1) Dinakar 2017, AAP asthma control tools a. Peak flow, spirometry, PFTs, standardized questionnaires listed as the main tools for asthma diagnosis and monitoring b. FeNO listed as an option, with concerns about false positive tests in patients with atopy c. “The value of additional FENO monitoring in children whose asthma is appropriately managed using guideline-based strategies is unproven” d. “some asthma specialists have adopted the use of FENO as an adjunct ambulatory clinical tool for measuring airway inflammation and serial monitoring asthma control in individual patients with difficult-to-control asthma” 2) Chung 2013, ATS guideline for diagnosis and management of severe asthma a. We suggest that clinicians do not use FeNO to guide therapy in adults or children with severe asthma. 3-8-18

Cost: The national average Medicare reimbursement for 2015 is $19.69 with 0.55for relative value unit assigned (no physician work relative value units). The average commercial reimbursement for FENO testing is between $25 and $35. (Mummadi et al 2016)

HERC staff summary: The AHRQ meta-analysis found evidence that asthma control algorithms with included FeNO measurements reduced exacerbations (defined variably, usually meaning a reduction in FVC or other test) and use of oral steroids. Such algorithms did not reduce urgent office visits, ER visits, or asthma quality of life. FeNO has evidence that it can predict when patients will respond to inhaled corticosteroids and may be useful for monitoring compliance to inhaled corticosteroids. FeNO is not helpful during acute exacerbations. FeNO may be useful for monitoring adherence to therapy, based on observational data. Cochrane concludes that the evidence for use of FeNO for the management of asthma does not support its use for adults or children. NICE guidelines do not recommend routine use for the management of asthma. The AAPSummaries currently does not recommend use for routine management of asthma.

HERC staff recommendation: 1) Consider addition of fractional exhaled nitric oxide (FeNO; CPT 95012) to line 9 ASTHMA a. Evidence of decreased oral steroid use and utility in determining patients who will respondIssue to inhaled corticosteroids/adherence to inhaled corticosteroids b. If added to line 9, remove diagnostic guideline approved at January meeting shown below

DIAGNOSTIC GUIDELINE DX Fractional exhaled nitric oxide (FeNO) is covered only for the initial diagnosis of asthma in patients 7 VbBSyears of age and older. It is not included for the monitoring of asthma, selection of medications, or diagnosis of acute asthma exacerbations.

Guideline on Immune Modifying Therapies for Multiple Sclerosis

Question: Should the guideline on immune modifying therapies for multiple sclerosis (MS) be deleted?

Question source: Genentech, OHA leadership, HERC staff

HERC staff summary: GN95 IMMUNE MODIFYING THERAPIES FOR MULTIPLE SCLEROSIS was added to the Prioritized List at a time when there were no effective therapies for primary progressive MS. Recently, the FDA approved Ocrevus (ocrelizumab), the first medication approved to treat primary progressive MS.

In light of this, OHA is recommending that HERC remove the guideline note that excludes coverage of immune modifying therapies for the treatment of the progressive forms of MS. This change would allow plans to manage medical treatment for multiple sclerosis based on medical appropriateness and FDA indications as occurs for other conditions on the prioritized list. This change would be implemented on 4/1/2018 as a special interim modification. 3-8-18

As previously shared, the Oregon Health Authority is currently undergoing analysis on the ability of the HERC to review findings of the Pharmacy and Therapeutics Committee in order tofor prioritize drugs on the Prioritized List.

Current guideline GUIDELINE NOTE 95, IMMUNE MODIFYING THERAPIES FOR MULTIPLE SCLEROSIS Line 252 Once a diagnosis of primary progressive or secondary progressive multiple sclerosis is reached, immune modifying therapies are no longer covered.

HERC staff recommendation: 1) Delete GN 95

GUIDELINE NOTE 95, IMMUNE MODIFYINGSummaries THERAPIES FOR MULTIPLE SCLEROSIS Line 252 Once a diagnosis of primary progressive or secondary progressive multiple sclerosis is reached, immune modifying therapies are no longer covered.

Issue

VbBS

Auricular Electro-Acupuncture

Question: how should the intended coverage of auricular acupuncture be clarified on the Prioritized List?

Question source: HSD staff, HERC staff

Issue: Auricular electrostimulation with devises such as P-Stim and E-pulse were reviewed in 2013 and determined to be experimental. The HCPCS code for this service (S8930 Electrical stimulation of auricular acupuncture points; each 15 minutes of personal one-on-one contact with the patient) was placed on the Services Recommended for Non-Coverage Table. This code was not moved to line 660 during the review of SRNC codes/movement of SRNC codes to line 660. P-Stim and E-Pulse are meant to be devices that a patient can use in a non-clinical setting. There are 2 CPT codes (97813 and 97814 Acupuncture, 1 or more needles; with electrical stimulation) that acupuncturists can use for auricular electrostimulation if done in the clinical setting. 3-8-18

During the 2013 review of S8930, staff had discussed adding some type of coding specification that stated that ear electrostimulation was covered if done in a clinical setting by a licensed profession using CPT 97813/4; however, the SNRC table was not amenable to such clarifications. for The new GN183 on line 660 however is amenable to clarifications.

There have been several recent questions raised to HERC staff about coverage of auricular electrostimulation and staff feel that clarification of coverage on the List could be helpful.

HERC staff recommendation: 1) Place S8930 (Electrical stimulation of auricular acupuncture points; each 15 minutes of personal one-on-one contact with the patient) on line 660 and add the following entry to Guideline Note 173:

GUIDELINE NOTE 173, TREATMENTS THAT HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS; UNPROVEN TREATMENTS Summaries The following treatments are prioritized on Line 660, 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 Code TREATMENT Rational Date of Last Review/Link to Meeting Minutes S8930 Electrical stimulation of No evidence of January, 2013 Issueauricular acupuncture points by effectiveness proprietary electrical stimulation devices, such as P- Stim and E-pulse [note: auricular electroacupuncture provided by a licensed provider in a clinical setting is covered VbBS under CPT 97813-97814]

Special “Consult Only” Lines

Question: Should lines designated as “consultation only” include inpatient and skilled nursing facility (SNF) CPT codes?

Question source: HERC staff

Issue: There are currently 3 lines designated as “consultation” lines. These lines were created to allow limited treatment for conditions which generally have no definitive long term therapies. These lines in actuality contain a variety of inpatient, SNF and ER CPT codes. Should the services on these lines be changed, or should their treatment descriptions be changed to reflect the actual services available for pairing?

Line 202 contains all inpatient and SNF CPT codes (no ER) Line 436 contains all inpatient, ER and SNF CPT codes 3-8-18 Line 549 has a single inpatient CPT code and domiciliary/rest home CPT codes

Staff ran a data query regarding the CPT codes being used for stereotyped movementfor disorder with self- injurious behavior and found several ER visits, likely for injuries resulting from this self-harm. There were one or two hospitalizations, with other diagnoses present as well.

Line: 202 Condition: CHRONIC ORGANIC MENTAL DISORDERS INCLUDING DEMENTIAS (See Guideline Notes 6,64,65,86,90,121) Treatment: CONSULTATION/MEDICATION MANAGEMENT/BEHAVIORAL SUPPORT ICD-10: E51.2,F01.50-F01.51,F02.80-F02.81,F03.90-F03.91,F04,F06.0-F06.2,F06.30-F06.8,F07.0, F07.81,F10.26-F10.27,F10.96-F10.97,F13.26-F13.27,F13.96-F13.97,F18.17,F18.27,F18.97, F19.16-F19.17,F19.26-F19.27,F19.96-F19.97,G30.0-G30.9,G31.01-G31.2,G31.83 CPT: 90785,90832-90840,90846-90853,90882,90887,96101,96118,97161-97168,97532,98966- 98969,99051,99060,99201-99239,99304-99357,99366,99415,99416,99441-99449,99487- 99498,99605-99607 HCPCS: G0176,G0177,G0406-G0408,G0410,G0411,SummariesG0425-G0427,G0459,G0463-G0467,G0469, G0470,G0508,G0509,H0004,H0017-H0019,H0023,H0032-H0039,H0045,H2010,H2012- H2014,H2021,H2022,H2027,H2032,S5151,S9125,S9484,T1005,T1016

Line: 436 Condition: STEREOTYPED MOVEMENT DISORDER WITH SELF-INJURIOUS BEHAVIOR DUE TO NEURODEVELOPMENTAL DISORDER (See Guideline Notes 64,65,126) Treatment: CONSULTATION/MEDICATIONIssue MANAGEMENT/LIMITED BEHAVIORAL MODIFICATION ICD-10: F98.4 CPT: 0359T-0374T,90785,90832-90840,90846-90853,90882,90887,96101,98966-98969,99051, 99060,99201-99239,99281-99285,99304-99357,99366,99415,99416,99441-99449,99487- 99498,99605-99607 HCPCS: G0176,G0177,G0406-G0408,G0410,G0411,G0425-G0427,G0459,G0463-G0467,G0469, G0470,G0508,G0509,H0004,H0017,H0019,H0023,H0032-H0039,H0045,H2010,H2012- VbBSH2014,H2021,H2022,H2027,H2032,S5151,S9125,S9480,S9484,T1005,T1016

Special “Consult Only” Lines

Line: 549 Condition: SOMATIC SYMPTOMS AND RELATED DISORDERS (See Guideline Notes 64,65) Treatment: CONSULTATION ICD-10: F44.0-F44.7,F44.81-F44.9,F45.0-F45.1,F45.20-F45.9,F52.5,F68.10-F68.13 CPT: 90785,90832-90840,90846-90853,90882,90887,96101,96150-96155,98966-98969,99051, 99060,99201-99215,99224,99324-99355,99366,99415,99416,99441-99449,99487-99498, 99605-99607 HCPCS: G0176,G0177,G0410,G0411,G0425-G0427,G0459,G0463-G0467,G0469,G0470,H0004, H0017,H0019,H0023,H0032-H0039,H2010,H2012-H2014,H2021,H2022,H2027,H2032, H2033,S9484,T1016

HERC staff recommendations: 3-8-18 1) Remove all inpatient and SNF CPT codes from line 436 STEREOTYPED MOVEMENT DISORDER WITH SELF-INJURIOUS BEHAVIOR DUE TO NEURODEVELOPMENTAL DISORDER, but leave ER visit codes for a. Remove 99217-99239 (hospital observation or inpatient care), 99304-99318 (SNF), 99324-99337 (domiciliary or rest home care), 99356-99357 (prolonged inpatient services) from line 436 2) Remove any inpatient, SNF and ER codes from line 549 SOMATIC SYMPTOMS AND RELATED DISORDERS a. Remove 99224 (Subsequent observation care, per day, for the evaluation and management of a patient…Typically, 15 minutes are spent at the bedside and on the patient's hospital floor or unit.) and 99324-99337 (domiciliary or rest home care) from line 549 3) Make no changes to line 202 CHRONIC ORGANIC MENTAL DISORDERS INCLUDING DEMENTIAS a. Many diagnoses on this line require hospitalization and/or SNF care b. Consider changing treatment description to “CONSULTATION/MEDICATION MANAGEMENT/BEHAVIORAL SUPPORT MEDICAL THERAPY” Summaries

Issue

VbBS

Surgical Treatment of Deforming Foot Lesions in High Risk Patients for Prevention and Treatment of Ulcers

Question: Should surgical treatment of deforming foot lesions such as bunions or hammer toe be added to the high risk foot care line for prevention of diabetic foot ulcer or to the chronic skin ulcer line for treatment of a current ulcer?

Question source: Dr. Chris Seuferling, the ICD-10 Podiatry Workgroup

Issue: In 2012, the podiatry lines were reviewed as part of the ICD-10 List review. At that time, there was discussion of adding treatment for certain deforming foot lesions such as hallux valgus (bunion; ICD-10 M20.1), hallux varus (ICD-10 M20.3), corns and calluses (ICD-10 L84), juvenile ostochondrosis (ICD-10 M92.6 and M92.7), and hammer toe (ICD-10 M20.4) to the preventive foot care line to allow treatment for the prevention of foot ulcers.

HERC staff performed an evidence review of the effectiveness of surgical interventions 3-8-18for these conditions on the prevention of ulcers and other foot complications. NICE and SIGN did not mention surgical interventions in their guidelines for prevention of diabetic foot ulcers. Several reviews were found, which staff concluded showed “There is moderate to good evidence for foot exams, referral to podiatry, use of padding or other shoe wear interventionsfor for the prevention of ulcers in diabetic patients. There is minimal evidence for elective surgery for the prevention of foot ulcers in diabetic patients.” Staff recommended adding the diagnosis codes for deforming foot lesions to the high risk foot line, along with CPT codes for podiatry visits and paring/cutting of corns and calluses to the high risk foot line, but not surgical procedures due to lack of evidence of effectiveness. A new guideline was proposed which would have limited preventive foot care visits for deforming foot lesions to high risk patients, defined as “patients with 1) diabetes, 2) peripheral vascular disease, 3) peripheral neuropathy or 4) history of foot ulcer.”

The discussion at VBBS centered around how the increase in cost of these procedures would have balanced with the limited evidence of prevention of complications. No decision was made and the issues of this ICD-10 review were tabled. Summaries Since 2012, several podiatrists have contacted the HERC regarding coverage of surgery for conditions like hammer toe and bunions in high risk diabetic patients. Most recently, Dr. Seuferling requested a review of repair of bunions in high risk diabetic patients. HERC staff have conducted an updated evidence review looking at the effectiveness of surgical interventions in the prevention of recurrent foot ulceration in high risk patients.

At the time of theIssue 2012 podiatry review, only a limited number of CPT codes were present on the high risk foot line; mainly codes for nail cutting and care. No CPT changes were adopted as part of the 2012 review, as no conclusions were ever reached about the line. However, multiple CPT codes now appear on line 165 PREVENTIVE FOOT CARE IN HIGH RISK PATIENTS, including CPT 28011 (Tenotomy, percutaneous, toe; multiple tendons), although 28010 (Tenotomy for single tendon) is not there. These codes are treatment for hammer toes. The open hammer toe CPT codes are not on this line. Review of minutes and materials does not find a VbBSrecommendation for placement of 28011 on this line. A large series of office visit codes were added to this line at some point after 2012, again with no clear intent for addition. These codes were likely added when HERC staff was attempting to standardize office visit codes on

Surgical Treatment of Deforming Foot Lesions in High Risk Patients for Prevention and Treatment of Ulcers

outpatient lines. Repair of flexor and extensor tendons CPT 28200-28210 also appear on this line with no record of an intent for this placement.

Current Prioritized List: 165 PREVENTIVE FOOT CARE IN HIGH RISK PATIENTS 379 CHRONIC ULCER OF SKIN

Evidence review Major guidelines 1) NICE 2017 https://www.nice.org.uk/guidance/ng19/resources/diabetic-foot- problems-prevention-and-management-pdf-1837279828933 a. Recommendations for care of diabetic patients with high risk feet 3-8-18 i. Foot inspections at least yearly by a clinician, more frequently in higher risk patients ii. Vascular assessment and consideration for revascularization iii. Foot care education for iv. Specialist footwear and insoles v. Skin and nail care vi. Surgical correction of deformities not mentioned b. Diabetic foot problem (ulcer, etc.) care i. Offloading ii. Wound care and/or debridement iii. Treatment of infection iv. Do not offer hyperbaric oxygen therapy (currently paired on the PL) 2) ADA 2017, standards of medication care of diabetic patients http://care.diabetesjournals.org/content/diacare/suppl/2016/12/15/40.Supplement_1. DC1/DC_40_S1_final.pdf a. High risk foot care: i. Perform a comprehensiveSummaries foot evaluation at least annually to identify risk factors for ulcers and amputations (Level B recommendation) ii. Refer patients who smoke or who have histories of prior lower extremity complications, loss of protective sensation, structural abnormalities, or peripheral arterial disease to foot care specialists for ongoing preventive care and lifelong surveillance (Level C recommendation) Issueiii. Provide general preventive foot self-care education to all patients with diabetes. (Level B recommendation) iv. The use specialized therapeutic footwear is recommended for high-risk patients with diabetes including those with severe neuropathy, foot deformities, or history of amputation. (Level B recommendation) 3) International Working Group on the Diabetic Foot 2015 (See Bus 2016 below for summary of the evidence review) VbBShttp://www.iwgdf.org/files/2015/website_prevention.pdf a. Examine the feet annually to seek evidence for signs or symptoms of peripheral neuropathy and peripheral artery disease. (GRADE recommendation: strong; Quality of evidence: low)

Surgical Treatment of Deforming Foot Lesions in High Risk Patients for Prevention and Treatment of Ulcers

b. Treat any pre-ulcerative sign on the foot of a patient with diabetes. This includes: removing callus; protecting blisters and draining when necessary; treating ingrown or thickened toe nails; treating haemorrhage when necessary; and prescribing antifungal treatment for fungal infections. (Strong; Low) c. When a foot deformity or a pre-ulcerative sign is present, consider prescribing therapeutic shoes, custom-made insoles, or toe orthosis. (Strong; Low) d. To prevent a recurrent plantar foot ulcer in an at-risk patient with diabetes, prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking (i.e. 30% relief compared to plantar pressure in standard of care therapeutic footwear), and encourage the patient to wear this footwear. (Strong; Moderate) e. To prevent a recurrent foot ulcer in an at-risk patient with diabetes, provide integrated foot care, which includes professional foot treatment, adequate3-8-18 footwear and education. This should be repeated or re-evaluated once every one to three months as necessary. (Strong; Low) f. Consider digital flexor tenotomy to prevent a toe ulcer when conservative treatment fails in a high-risk patient with diabetes, hammertoesfor and either a pre-ulcerative sign or an ulcer on the toe. (Weak; Low) g. Consider Achilles tendon lengthening, joint arthroplasty, single or pan metatarsal head resection, or osteotomy to prevent a recurrent foot ulcer when conservative treatment fails in a high-risk patient with diabetes and a plantar foot ulcer. (Weak; Low) h. Do not use a nerve decompression procedure in an effort to prevent a foot ulcer in an at-risk patient with diabetes, in preference to accepted standards of good quality care. (Weak; Low)

Review articles 1) Bus 2015, systematic review on surgical interventions to prevent foot ulcers in patients with diabetes http://onlinelibrary.wiley.com/doi/10.1002/dmrr.2702/epdfSummaries Prevention of ulcer a. Achilles tendon lengthening (ATL) i. An RCT with low risk of bias randomized 63 patients with limited ankle dorsiflexion to ATL in addition to total contact cast (TCC) or to TCC alone and found after 7 months follow-up significantly fewer recurrent ulcers in the ATL group than in the TCC-alone Issuegroup (15% vs 59% s, p=0.001), an effect that persisted at 2 years: 38% versus 81%, p=0.002. ii. One non-controlled retrospective study found 2% recurrence at a mean 3 years follow-up in 138 patients treated with ATL compared with 25% in a historic cohort of 149 patients treated with wound closure surgery (p<0.001) but found significantly more transfer lesions (12% vs 4%, p=0.001). Several other non- VbBS controlled studies show recurrence rates between 0 and 20% over 17 to 48 months follow-up after ATL treatment.

Surgical Treatment of Deforming Foot Lesions in High Risk Patients for Prevention and Treatment of Ulcers

b. Metatarsal head resection i. An RCT with low risk of bias randomized 41 patients to either surgical excision of the ulcer, eventual debridement and removal of bone segments underlying the lesion, and surgical wound closure, or to conservative treatment (i.e. relief of weight-bearing and regular dressing) and found a significant reduction in ulcer recurrence at 6 months follow-up in the surgical group: 14% vs 41%, p<0.01. ii. A retrospective cohort study with high risk of bias including 207 patients compared surgical bone removal of the toe or metatarsal head with minor amputation of the toe and found no significant difference between groups for ulcer recurrence after a mean of 40.6 months follow-up 3-8-18 iii. Another retrospective cohort study with high risk of bias including 50 patients demonstrated a lower recurrence rate at 6 months follow-up of single metatarsal head resection compared with conservative treatment (‘aggressive off-loadingfor ’): 5% versus 28%, p=0.04. iv. Another retrospective cohort study with low risk of bias including 92 patients also demonstrated lower recurrence rates at 1 year follow-up of pan-metatarsal head resection compared with conservative treatment: 15.2% versus 39.1%, p=0.02. v. One prospective and four retrospective non-controlled studies on the effect of pan-metatarsal head resection, including between 10 and 119 patients, reported between 0% and 41% recurrent ulcers after a mean of 13 to 74 months follow-up. c. Joint arthroplasty i. One retrospective cohort study with high risk of bias including 41 patients found a 5% recurrence at 6 months follow-up in patientsSummaries treated with metatarsophalangeal joint arthroplasty of the great toe compared with 35% in patients treated with removable offloading for their active ulcer (p=0.02) ii. A case–control study reported no ulcer recurrence at the site of interest after 1-year follow-up with either metatarsal- phalangeal joint arthroplasty or TCC iii. Three small non-controlled studies found 0–17% recurrent Issueulcers at 1 to 5 years follow-up in patients who underwent either interphalangeal joint arthroplasty or resection of the proximal phalanx of the great toe d. Osteotomy i. A retrospective cohort study with high risk of bias showed that subtraction osteotomy distal to metatarsal head ulcers to redress the bone alignment, plus arthrodesis, resulted in a VbBS significantly lower rate of combined recurrence and amputation when compared with conservative treatment (7.5% vs 35.5%, p=0.0013), although data on recurrent ulcers alone was not significantly different between groups (7.5% vs 18%, p=0.14)

Surgical Treatment of Deforming Foot Lesions in High Risk Patients for Prevention and Treatment of Ulcers

[64]. Conservative treatment was not clearly defined. One non- controlled study found no recurrent ulcers during 13 months of follow-up in 21 patients who underwent osteotomy e. Digital flexor tenotomy i. Seven retrospective case series showed ulcer recurrence rates between 0% and 20% in 11 to 36 months follow-up in a cumulative total of 231 patients treated with percutaneous digital flexor tendon tenotomy. Four of these studies showed no ulcer occurrence during a mean of 11–31 months follow-up in a cumulative total of 58 patients with an impending ulcer (i.e. abundant callus on tip of the toe) that were treated prophylactically with this procedure f. Other procedures 3-8-18 i. Several non-controlled studies showed relatively low ulcer recurrence rates in selected patients following any of several surgical procedures: flexor hallucis longus tendon transfer, plantar fascia release, or Achilles tenotomy.for Exostectomy appears to result in a large percentage of recurrent or transfer ulcers. Healing of ulcers a. Achilles tendon lengthening (ATL) i. 1 RCT with low risk of bias (N=63 patients) found no significant difference in healing between those patients treated with ATL in addition to TCC versus those who received TCC alone: 100% healing in 41 days versus 88% healing in 58 days, respectively. ii. Two non-controlled retrospective studies found 91–93% of plantar forefoot ulcers healed with ATL in a mean of 6 to 12 weeks. b. Metatarsal head resection i. 1 RCT with low risk of bias (N= 41 patients) showed higher healing rates andSummaries shorter time to healing of forefoot plantar ulcers for a combination of surgical excision, debridement, removal of bone segments underlying the lesion, and surgical closure when compared with conservative offloading treatment, 95% in 47 days versus 79% in 129 days (p<0.05), although conservative offloading did not involve the current standard of care ii. A retrospective cohort study with high risk of bias (N=50 patients) Issuefound that fifth metatarsal head resection was as effective as offloading treatment, both 100% healing rate, but resulted in shorter time to healing (maximum 5.8 vs 8.7 weeks) iii. A retrospective cohort study with low risk of bias N= 92 patients) found those treated with panmetatarsal head resection healed significantly faster (mean 60.1 vs 84.2 days, p=0.02) than those treated with ‘aggressive offloading’ VbBS iv. Results of six non-controlled studies of patients treated with single or pan-metatarsal head resection after failed conservative treatment showed between 88% and 100% healing

Surgical Treatment of Deforming Foot Lesions in High Risk Patients for Prevention and Treatment of Ulcers

c. Joint arthroplasty i. 2 small retrospective cohort studies with high risk of bias studied the efficacy of first metatarsal-phalangeal joint arthroplasty in comparison to knee-high (non-) removable offloading to heal plantar hallux ulcers and showed no difference between treatments in the proportion of ulcers healed but a significantly shorter time to healing with arthroplasty: mean 24.2 versus 67.1 days in one study, and maximum 23 versus 47 days in the other. ii. Three non-controlled studies showed between 91% and 100% healing of plantar, lateral, or dorsal toe ulcers using interphalangeal or metatarsal-phalangeal joint arthroplasty d. Osteotomy i. A retrospective cohort study with high risk of bias (N=22 patients)3-8-18 treated with osteotomy of the bone plus arthrodesis just distal to the metatarsal head ulcer healed in 51 days, with a 2.5% amputation rate, compared with 54 patients treated conservatively (not defined) who healed in 159 days, with 15%for amputation rate ii. Three non-controlled studies reported healing percentages between 94% and 100% for metatarsal osteotomies performed in patients with recalcitrant or frequently occurring foot ulcers e. Digital flexor tenotomy i. Seven retrospective case series found a 92–100% healing rate in a mean time to healing of 21 to 40 days, and a low rate of complications, was found in a cumulative total of 231 patients treated with percutaneous digital flexor tenotomy to heal apex toe ulcers f. Conclusions: i. Prevention of ulcers: Several surgical offloading techniques, such as ATL, joint arthroplasty, single or pan-metatarsal head resection,Summaries and other bone resections, appear to reduce the risk of ulcer recurrence in selected patients with forefoot neuropathic plantar ulcers when compared with conservative offloading treatment. Several other surgical offloading procedures, in particular digital flexor tendon tenotomy, may be promising to prevent recurrence, or even a first ulcer. However, with most of these procedures, often only one RCT or controlled Issuestudy has been performed. Additionally, the disadvantages and potential complications of surgical interventions should always be taken into consideration. Clearly, more high-quality controlled studies are needed before more definitive statements can be made about the efficacy and safety of preventative surgery. ii. Healing of ulcers: In healing plantar forefoot ulcers, ATL seems VbBS to have limited value in addition to the TCC alone. The evidence also indicates that most other surgical options do not improve the proportion of healed ulcers; they only improve time to healing. In fact, based on the available evidence, it seems that

Surgical Treatment of Deforming Foot Lesions in High Risk Patients for Prevention and Treatment of Ulcers

compared with conservative treatment, many surgical offloading procedures are more effective in preventing ulcer recurrence than they are in healing foot ulcers. Another consideration is the potentially higher risk for complications with surgery. High-quality controlled studies, preferably a multi- centred RCT, are needed to further define the role of surgical approaches compared with conservative treatment. 1) Lavery 2011—review of elective surgery to reduce deformities in reduction in diabetic ulceration a. Hammer toe reduction i. Reviewed 2 studies (case series?) which showed low recurrence rate of ulceration after hammer toe reduction b. Achilles tendon lengthening 3-8-18 i. 1 RCT of ATL vs casting found lower rates of recurrent ulceration in the ATL group, 38% in the ATL group vs 81% in the casting group at 2 yrs ii. 2 retrospective case series found reduced recurrentfor ulceration with ATL, but one series found a high level of surgical complications, including Achilles tendon rupture and development of Charcot foot c. Notes surgery on patients with diabetes and microvascular disease is risky d. “There is no high level evidence from randomized controlled trials to support the effectiveness of elective surgery, to compare adverse events, or evaluate long term risk reduction of recurrent ulcerations or amputations.” e. Conclusion: elective surgery for recalcitrant foot ulcers is effective

Expert input Summaries Dr. Chris Seuferling: Surgery to repair foot deforming conditions can be cost savings vs treating an ulcer with wound care and debridement for an extended period of time. He recommends coverage of foot deforming conditions on the chronic ulcer line to aid in ulcer healing as a more important strategy than placing on the preventive foot care line.

HERC staff summary:Issue There is minimal evidence for elective surgery including hammer toe reduction, Achilles tendon lengthening, and bunion reduction for the prevention of foot ulcers in diabetic patients. There are harms associated with surgery on patients with diabetes, neuropathy and microvascular disease including surgical complications and infections. The evidence is even more limited for elective surgery for healing of foot ulcers compared to conservative therapy.

VbBSOn review, there are multiple “code clean up” items that need to be done for line 165 PREVENTIVE FOOT CARE IN HIGH RISK PATIENTS.

Surgical Treatment of Deforming Foot Lesions in High Risk Patients for Prevention and Treatment of Ulcers

HERC staff recommendations: 1) Do not add elective surgery for deforming foot conditions to the preventive foot care line or to the chronic ulcer line due to lack of evidence of effectiveness and lack of strong recommendation by expert groups 2) Add corn/callus treatment codes to line 165 PREVENTIVE FOOT CARE IN HIGH RISK PATIENTS a. CPT codes 11055-11057 (paring or cutting of benign hyperkeratotic lesion) b. Recommended by some expert groups (IWGDF and NICE but not ADA); literature on evidence for effectiveness not found in literature search 3) Add CPT 28124 (Partial excision (craterization, saucerization, sequestrectomy, or diaphysectomy) bone (eg, osteomyelitis or bossing); phalanx of toe) to line 397 CHRONIC ULCER OF SKIN a. The rest of the CPT series 28120-28122 (Partial excision (craterization, 3-8-18 saucerization, sequestrectomy, or diaphysectomy) bone (eg, osteomyelitis or bossing, other foot bones) is present on that line 4) Remove elective foot surgeries currently appearing on line 165 PREVENTIVE FOOT CARE IN HIGH RISK PATIENTS due to lack of evidence to support use and lackfor of documentation that these surgeries were intended to be on this line a. CPT 28011 (Tenotomy, percutaneous, toe; multiple tendons) i. One of 4 similar codes, none of the other codes appear on this line. No record of intent to place on line 165 b. CPT 28100-28108 (Excision or curettage of bone cyst or benign tumor, bones of foot) i. Appear on lines 400 BENIGN CONDITIONS OF BONE AND JOINTS AT HIGH RISK FOR COMPLICATIONS and 556 BENIGN NEOPLASM OF BONE AND ARTICULAR CARTILAGE INCLUDING OSTEOID OSTEOMAS; BENIGN NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE which are more appropriate; no record of intent to place on line 165 c. CPT 28120-28124 (Partial excision (craterization, saucerization, sequestrectomy, or diaphysectomy) Summariesbone (eg, osteomyelitis or bossing, other foot bones) i. Appear on the acute and chronic osteomyelitis lines and chronic skin ulcer line 5) Remove inpatient and ER CPT codes from line 165 a. CPT 99218-99239, 99291-99292 (inpatient) b. CPT 99281-99285 (ER) c. CPT 99468-99480 (pediatric inpatient) 6) Keep outpatientIssue and SNF CPT codes on line 165 7) Make no change to the diagnosis codes on this line; all appear to be appropriate

VbBS

Shingrix

Issue: A new vaccine for shingles (Shingrix) was recently approved. Initial studies find it considerably more effective than the current vaccine (Zostavax). From the CDC website:

On October 25, 2017, the Advisory Committee on Immunization Practices (ACIP) voted that Shingrix® is:  recommended for healthy adults aged 50 years and older to prevent shingles and related complications  recommended for adults who previously received the current shingles vaccine (Zostavax®) to prevent shingles and related complications  the preferred vaccine for preventing shingles and related complications

Zostavax is approved for patients age 60 and older; Shingrix is approved and recommended for patients age 50 and older. Zostavax appears to have efficacy wanes after 5 years of administration, 3-8-18and probably has little efficacy after 10 years. Shingrix appears to maintain immune response at least 9 years after administration. Shingrix maintains >90% efficacy regardless of age at least four years after vaccination and maintains about 88% efficacy four years after vaccination in patients vaccinatedfor at 70 years of age or older.

Policy background: Because OHP+ is a benchmark plan it is required to align with requirements outlined in Section 2713 of the Affordable Care Act and associated rules (https://www.federalregister.gov/d/2015-17076/p-11), which require the following immunizations to be covered:

Immunizations for routine use in children, adolescents, and adults that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (Advisory Committee) with respect to the individual involved. A recommendation of the Advisory Committee is considered to be “in effect” after it has been adopted by the Director of the Centers for Disease Control and Prevention (CDC). A recommendation is considered to be for “routine use” if it appears on the Immunization Schedules of the CDC. Summaries

According to subregulatory guidance for for commercial health plans, the ACA does not require coverage of a vaccine without cost sharing until the plan year that begins 1 year after publication in the MMWR.

On January 26, 2018, these ACIP recommendations were published in the Morbidity and Mortality Weekly Report (https://www.cdc.gov/mmwr/volumes/67/wr/mm6703a5.htmIssue ), making them in effect; they also appear on the CDC vaccine schedule (https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) and are therefore recommended for routine use.

Therefore, there is no mandate for OHP to cover these vaccines until 1/1/2020 (the first new plan year which begins one year after the MMWR publication). HERC has discretion about whether to add the VbBScode sooner.

Shingrix

Evidence: 1) Cunningham 2016, RCT of Shingrix vs placebo for adults age 70 and older (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1603800) a. N=13,000 patients age 70 or older i. Mean follow up 3.7 years b. Herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). 3-8-18 Cost: Shingrix is estimated to cost $280 for 2 doses, compared to Zostavax which costs approximately $197 for 1 dose for HERC staff recommendations: 1) Add CPT 90750 (Zoster vaccine recombinant, adjuvanted) to line 3 PREVENTION SERVICES WITH EVIDENCE OF EFFECTIVENESS 2) Monitor ACIP recommendations for Zostavax and remove CPT 90736 (Zoster (shingles) vaccine (HZV), live, for subcutaneous injection) from line 3 if future recommendations are for removal from the vaccine schedule

Summaries

Issue

VbBS

Preventive Services Guideline

Issue: The reference to approved vaccines in GN106 was changed in January, 2015 to refer to the ACIP table at the CDC, removing the reference to the Oregon specific document maintained by public health. However, the Oregon Vaccine Program has requested that we revert back to referring to the Oregon specific table. Their table is based on the ACIP table but is Oregon specific regarding coverage. The change in January 2015 was done to comply with the requirements of the ACA.

Section 4 was modified to remove the Oregon Immunization Program reference and add in the CDC schedule link: 4. Immunizations as recommended by the Advisory Committee on Immunization Practices (ACIP) and approved for the Oregon Immunization Program: http://public.health.oregon.gov/PreventionWellness/VaccinesImmunization/ImmunizationProviderReso urces/Documents/DMAPvactable.pdf http://www.cdc.gov/vaccines/schedules/hcp/index.html 3-8-18 The Oregon specific table is generally the ACIP table, with a few small changes, such as the recommendation to finish the HPV vaccine series even if the patient is over age 26 for later shots. for The major issue between referring to the ACA/CDC document vs referring to the Oregon document is that the ACA/CDC document allows payers to not cover an immunization until a year after the recommendation is published by the CDC director in the MMWR. The Oregon specific document may not carry the same delay in coverage. This change was discussed with the CCO medical directors and did not seem to raise any concerns.

GUIDELINE NOTE 106, PREVENTIVE SERVICES Lines 3,619 Included on Line 3 are the following preventive services: A) US Preventive Services Task Force (USPSTF) “A” and “B” Recommendations in effect and issued prior to January 1, 2016. 1) http://www.uspreventiveservicestaskforce.org/Page/Name/uspstf-a-and-b- recommendations/ Summaries 2) USPSTF “D” recommendations are not included on this line or any other line of the Prioritized List. B) American Academy of Pediatrics (AAP) Bright Futures Guidelines: 1) http://brightfutures.aap.org. Periodicity schedule available at http://www.aap.org/en- us/professional-resources/practice-support/Periodicity/Periodicity%20Schedule_FINAL.pdf. 2) Screening for lead levels is defined as blood lead level testing and is indicated for Medicaid populationsIssue at 12 and 24 months. In addition, blood lead level screening of any child between ages 24 and 72 months with no record of a previous blood lead screening test is indicated. C) Health Resources and Services Administration (HRSA) Women’s Preventive Services - Required Health Plan Coverage Guidelines as retrieved from http://www.hrsa.gov/womensguidelines/ on 1/1/2017. D) Immunizations as recommended by the Advisory Committee on Immunization Practices (ACIP): VbBShttp://www.cdc.gov/vaccines/schedules/hcp/index.html

Preventive Services Guideline

HERC staff recommendation: 1) Modify GN106 as shown below a) Reverts to referencing the Oregon specific vaccine schedule

GUIDELINE NOTE 106, PREVENTIVE SERVICES Lines 3,619 Included on Line 3 are the following preventive services: A) US Preventive Services Task Force (USPSTF) “A” and “B” Recommendations in effect and issued prior to January 1, 2016. 1) http://www.uspreventiveservicestaskforce.org/Page/Name/uspstf-a-and-b- recommendations/ 2) USPSTF “D” recommendations are not included on this line or any other line of the Prioritized List. B) American Academy of Pediatrics (AAP) Bright Futures Guidelines: 3-8-18 1) http://brightfutures.aap.org. Periodicity schedule available at http://www.aap.org/en- us/professional-resources/practice-support/Periodicity/Periodicity%20Schedule_FINAL.pdf. 2) Screening for lead levels is defined as blood lead level testing and is forindicated for Medicaid populations at 12 and 24 months. In addition, blood lead level screening of any child between ages 24 and 72 months with no record of a previous blood lead screening test is indicated. C) Health Resources and Services Administration (HRSA) Women’s Preventive Services - Required Health Plan Coverage Guidelines as retrieved from http://www.hrsa.gov/womensguidelines/ on 1/1/2017. D) Immunizations as recommended by the Advisory Committee on Immunization Practices (ACIP): http://www.cdc.gov/vaccines/schedules/hcp/index.html or approved for the Oregon Immunization Program: http://public.health.oregon.gov/PreventionWellness/VaccinesImmunization/ImmunizationProvi derResources/Documents/DMAPvactable.pdf Summaries

Issue

VbBS

Section 3.0 New Coverage Guidance Topics 2018 SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

INTERMITTENT PNEUMATIC COMPRESSION DEVICES FOR THE TREATMENT OF LYMPHEDEMA

Population Adults with lymphedema description Population scoping notes: None

Intervention(s) Intermittent pneumatic compression devices

Intervention exclusions: None

Comparator(s) Usual care, manual lymphatic therapy, other decongestive lymphatic therapies, liposuction

Outcome(s) Critical: Infections, ulcers (up to five) Important: Quality of life, harms, lymphedema symptom scores

Considered but not selected for GRADE Table: None

Key questions What is the comparative effectiveness of intermittent pneumatic compression devices for the treatment of lymphedema?

Does the comparative effectiveness of intermittent pneumatic compression devices for the treatment of lymphedema vary by: a. Patient characteristics (age, gender, weight) b. Etiology of lymphedema c. Effectiveness of prior therapies d. Co-morbid conditions e. Adherence

What are the harms of intermittent pneumatic compression devices for the treatment of lymphedema?

Contextual questions

3/1/18 SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

LIPOSUCTION FOR THE TREATMENT OF LYMPHEDEMA

Population Adults with lymphedema description Population scoping notes: None

Intervention(s) Liposuction of the affected limb(s)

Intervention exclusions: None

Comparator(s) Usual care, manual lymphatic therapy, decongestive lymphatic therapy

Outcome(s) Critical: infections, ulcers (up to five) Important: Quality of life, harms, lymphedema symptom scores

Considered but not selected for GRADE Table: None

Key questions What is the comparative effectiveness of liposuction for the treatment of lymphedema?

Does the comparative effectiveness of liposuction for the treatment of lymphedema vary by: a. Patient characteristics (age, gender, weight) b. Etiology of lymphedema c. Severity of lymphedema d. Effectiveness of prior therapies e. Co-morbid conditions

What are the harms of liposuction for the treatment of lymphedema?

Contextual questions

CHANGE LOG

Date Change Rationale

2/1/2018 Removed recurrent lymphedema from the critical Resolution of lymphedema outcomes and added lymphedema scores as an would be captured in the important outcome. symptom scores, and these scores would capture other important effects.

3/1/18 SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

INTERVENTIONAL TREATMENTS FOR LOWER EXTREMITY CHRONIC VENOUS DISEASE

Population Adults with lower extremity chronic venous disease including insufficiency, description incompetence, or reflux

Population scoping notes: None

Intervention(s) Interventional venous therapies (i.e. sclerotherapy, radiofrequency ablation, ligation and stripping, and endovenous laser ablation)

Intervention exclusions: None

Comparator(s) Usual care, exercise, weight loss, medical therapy, mechanical compression, listed interventions compared to each other

Outcome(s) Critical: Venous ulcerations, infections (up to five) Important: Quality of life, harms, lower extremity venous symptom scores

Considered but not selected for GRADE Table: None

Key questions What is the comparative effectiveness of interventional treatments for lower extremity chronic venous disease?

How does the comparative effectiveness of interventional treatments for lower extremity chronic venous disease vary by a. Patient characteristics (age, gender, weight) b. Disease severity c. Etiology of lower extremity venous disease d. Co-morbid conditions e. Prior or concurrent complications f. Prior or concurrent treatments

What are the harms of interventional treatments for lower extremity chronic venous disease?

Contextual questions

CHANGE LOG

Date Change Rationale

2/1/2018 Added prior/current complications as factor by Need to determine which which effectiveness may vary. patients likely to benefit.

SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

NEWER INTERVENTIONS FOR OSTEOARTHRITIS OF THE KNEE

Population Adults with osteoarthritis of the knee(s) description Population scoping notes: None

Intervention(s) Whole body vibration, transcutaneous electrical nerve stimulation (TENS), glucosamine-chondroitin, platelet-rich plasma

Intervention exclusions: None

Comparator(s) Effective nonsurgical care (e.g., oral analgesics, exercise therapy)

Outcome(s) Critical: Long-term pain, long-term function (up to five) Important: Intermediate term function, intermediate-term pain, harms

Considered but not selected for GRADE Table: None

Key questions What is the comparative effectiveness of newer interventions for the treatment of osteoarthritis of the knees?

Does the comparative effectiveness of newer interventions for the treatment of osteoarthritis of the knees vary by: a. Patient characteristics (age, gender, socioeconomic status, baseline weight) b. Baseline severity c. Disease subtype d. Co-morbidities e. Prior treatments

What are the harms of newer interventions for the treatment of osteoarthritis of the knees?

Contextual questions

3/1/18 CHANGE LOG

Date Change Rationale

2/1/2018 Changed the comparators to reflect only effective Compare against established nonsurgical care (not knee replacement); removed effective therapies, not corticosteroid injections, viscosupplementation and marginal or ineffective other listed interventions. treatments. Added intermediate-term pain and removed avoidance and delay of surgery. Avoidance of knee surgery is seldom reported; intermediate- pain is important to patients.

3/1/18 SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

NEWER INTERVENTIONAL PROCEDURES FOR GERD

Population Adults with gastroesophageal reflux disease (GERD) description Population scoping notes: None

Intervention(s) Lapraroscopic magnetic ring procedure for augmentation of the lower esophageal sphincter, transoral incisionless fundoplication

Intervention exclusions: None

Comparator(s) Medical management, Nissen fundoplication, interventions compared to each other

Outcome(s) Critical: Incident Barrett’s esophagus, complications of GERD (e.g., stricture) (up to five) Important: GERD symptom scores, change in proton pump inhibitor (PPI) therapy, harms (e.g., repeat interventions)

Considered but not selected for GRADE Table: None

Key questions What is the comparative effectiveness of magnetic ring augmentation of the lower esophageal sphincter and transoral incisionless fundoplication in the treatment of GERD?

How does the effectiveness of magnetic ring augmentation of the lower esophageal sphincter and transoral incisionless fundoplication in the treatment vary by: a. Patient characteristics (e.g., age, gender, weight, tobacco use) b. Co-morbid conditions c. Duration of symptoms d. Response to prior treatments e. Procedural technique

What are the harms of magnetic ring augmentation of the lower esophageal sphincter and transoral incisionless fundoplication in the treatment?

Contextual questions

3/1/18 CHANGE LOG

Date Change Rationale

2/22/18 Changed outcome of “repeat interventions” to be a Public comment that this is an subset of harms; added change in Proton Pump important outcome Inhibitor therapy.

2/22/18 Added procedural technique under key question 2 Public comment that to account for technological advancements technology has improved.

3/1/18 SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

FOUNDATIONONE SEQUENCING FOR ADVANCED SOLID MALIGNANCIES

Population Adults and children with advanced solid malignancies description Population scoping notes: None

Intervention(s) FoundationOne CDx testing (next generation sequencing)

Intervention exclusions: None

Comparator(s) Usual care, targeted testing using approved companion diagnostics

Outcome(s) Critical: Overall survival, progression-free survival (up to five) Important: Cancer-realted morbidity, change in management, harms

Considered but not selected for GRADE Table: None

Key questions What is the comparative effectiveness of FoundationOne sequencing for the management of advanced solid malignancies?

How does the effectiveness of FoundationOne sequencing vary by: a. Patient characteristics (e.g., age, gender) b. Solid tumor type and location c. Response to prior treatments d. Treatment setting

What are the harms of FoundationOne sequencing for the management of advanced solid malignancies?

Contextual questions

CHANGE LOG

Date Change Rationale

2/22/2018 Limited interventions to FoundationOne Narrow scope to include the only approved rather than all tests using next test. Next generation sequencing is a generation sequencing technology which may be used in other tests which do not require approval.

3/1/18 SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

SINGLE FRACTION RADIOTHERAPY FOR PALLIATION OF BONY METASTASES

Population Patients receiving palliative radiotherapy for painful bony metastases description Population scoping notes: None

Intervention(s) Single fraction radiotherapy

Intervention exclusions: None

Comparator(s) Multiple fraction radiotherapy

Outcome(s) Critical: Pain, morbidity associated with bony metastases (e.g., pathologic fractures, (up to five) spinal cord compression), quality of life

Important: Cost of treatment, harms

Considered but not selected for GRADE Table: None

Key questions What is the comparative effectiveness of single fraction radiotherapy for palliation of painful bony metastases?

Does the effectiveness of single fraction radiotherapy for painful bony metastases vary by: a. Patient characteristics b. Type of cancer c. Total planned dose of radiotherapy d. Number of treatment sites e. Location of sites

What are the harms of single fraction radiotherapy for palliation of painful bony metastases?

Contextual questions

CHANGE LOG

Date Change Rationale m/d/yyyy

3/1/18 SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

SPINAL CORD STIMULATORS FOR CHRONIC BACK PAIN

Population Adults with chronic back pain description

Intervention(s) Implanted spinal cord stimulator

Intervention exclusions: None

Comparator(s) Physical therapy, exercise therapy, home exercise programs, intensive interdisciplinary rehabilitation, massage therapy, progressive relaxation, yoga, cognitive-behavioral therapy, other behavioral health interventions, acupuncture (with or without electrical stimulation), spinal manipulation, continuous or intermittent traction, transcutaneous electrical nerve stimulation, interdisciplinary pain treatment programs, advice to remain active, oral analgesic medication, topical analgesic medications, combinations of the above, surgical procedures for back pain.

Outcome(s) Critical: Long-term function, utilization of other pain treatments (including opioids (up to five) and surgery)

Important: Long-term pain, quality of life, harms

Considered but not selected for GRADE Table: None

Key questions What is the comparative effectiveness of implanted spinal cord stimulators for the treatment of chronic back pain?

How does the effectiveness of implanted spinal cord stimulators vary by: a. Patient characteristics (e.g., age, gender) b. Etiology of chronic back pain c. Co-morbid conditions d. Response to prior or concurrent treatments (e.g., prior surgery) e. Baseline pain or functional status f. Device characteristics (e.g., waveform)

What are the harms of implanted spinal cord stimulators?

Contextual questions

3/1/18 CHANGE LOG

Date Change Rationale

2/22/2018 Added surgical procedures for back pain to Response to public comment comparators. These could be additional surgeries if that failed back surgery there had been previous surgery. syndrome is a common indication.

2/22/2018 Added example of prior surgery to question 2(d). Response to public comment Added 2(f) device characteristics to capture that devices vary and are differences among devices where possible. improving and concern that failed back surgery is a common indication.

3/1/18 SCOPE STATEMENT FOR HERC COVERAGE GUIDANCE

EXTRACORPOREAL MEMBRANE OXYGENATION

Population Adults with refractory cardiac or respiratory failure description Population scoping notes: None

Intervention(s) Extracorporeal membrane oxygenation (ECMO)

Intervention exclusions: None

Comparator(s) Usual intensive care, other forms of advanced circulatory support

Outcome(s) Critical: Mortality, survival to discharge, functional recovery (up to five) Important: Harms

Considered but not selected for GRADE Table: None

Key questions What is the comparative effectiveness of ECMO for the treatment of refractory cardiac or respiratory failure?

Does the comparative effectiveness of ECMO for the treatment of refractory cardiac or respiratory failure vary by: a. Patient characteristics b. Etiology of cardiac or respiratory failure c. Co-morbid conditions d. Prior treatments e. Location and timing of initiation

What are the harms of ECMO for the treatment of refractory cardiac or respiratory failure?

Contextual What patient characteristics are associated with survival and functional questions recovery?

What is the appropriate duration of ECMO and indications for discontinuation?

3/1/18 CHANGE LOG

Date Change Rationale

2/1/2018 EbGS added a contextual question about patient Technology is evolving and characteristics associated with survival and randomized data may not be functional recovery useful in identifying patients most and least likely to benefit.

2/22/2018 Staff added a key question about the appropriate Stakeholders provided feedback duration of ECMO and indications for that this service can sometimes discontinuation. be provided for long periods without realistic hope of benefit.

3/1/18 Topic: Extracorporeal Membrane Oxygenation Score — 0 Score — 1 Score — 2 Score — 3 Score Notes

Disease Burden (morbidity/mortality, 1 Inconsequential Minor Moderate High 3 individual perspective) 2 Prevalence of Condition Rare Low Moderate High 1 3 Uncertainty of Effectiveness/Harms None Low Moderate High 3 Variation in Care/ Controversy/ 4 Variance Between Standard of Care None Low Moderate High 2 and Evidence Magnitude of Potential Economic 5 Impact of Intervention (population None Low Moderate High 3 level, includes downstream costs) Potential of Intervention to Improve 6 None Low Moderate High 2 Health Outcomes 7 Public/Professional Interest None Low Moderate High 2 Potential of Intervention to Reduce 8 None Low Moderate High 1 Health Disparities Total Score 17

Scoping notes: Topic: Intermittent Pneumatic Compression Devices for the Treatment of Lymphedema Score — 0 Score — 1 Score — 2 Score — 3 Score Notes

Disease Burden (morbidity/mortality, 1 Inconsequential Minor Moderate High 2 individual perspective)

2 Prevalence of Condition Rare Low Moderate High 1 3 Uncertainty of Effectiveness/Harms None Low Moderate High 2 Variation in Care/ Controversy/ 4 Variance Between Standard of Care None Low Moderate High 2 and Evidence Magnitude of Potential Economic 5 Impact of Intervention (population None Low Moderate High 1 level, includes downstream costs) Potential of Intervention to Improve 6 None Low Moderate High 2 Health Outcomes 7 Public/Professional Interest None Low Moderate High 1 Potential of Intervention to Reduce 8 None Low Moderate High 0 Health Disparities Total Score 11

Scoping notes: Topic: Liposuction for the Treatment of Lymphedema Score — 0 Score — 1 Score — 2 Score — 3 Score Notes

Disease Burden (morbidity/mortality, 1 Inconsequential Minor Moderate High 2 individual perspective)

2 Prevalence of Condition Rare Low Moderate High 1 3 Uncertainty of Effectiveness/Harms None Low Moderate High 3 Variation in Care/ Controversy/ 4 Variance Between Standard of Care None Low Moderate High 2 and Evidence Magnitude of Potential Economic 5 Impact of Intervention (population None Low Moderate High 1 level, includes downstream costs) Potential of Intervention to Improve 6 None Low Moderate High 1 Health Outcomes 7 Public/Professional Interest None Low Moderate High 1 Potential of Intervention to Reduce 8 None Low Moderate High 0 Health Disparities Total Score 11

Scoping notes: Topic: Interventional Treatments for Lower Extremity Chronic Venous Disease Score — 0 Score — 1 Score — 2 Score — 3 Score Notes

Disease Burden (morbidity/mortality, 1 Inconsequential Minor Moderate High 2 individual perspective) 2 Prevalence of Condition Rare Low Moderate High 2 3 Uncertainty of Effectiveness/Harms None Low Moderate High 3 Variation in Care/ Controversy/ 4 Variance Between Standard of Care None Low Moderate High 2 and Evidence Magnitude of Potential Economic 5 Impact of Intervention (population None Low Moderate High 2 level, includes downstream costs) Potential of Intervention to Improve 6 None Low Moderate High 2 Health Outcomes 7 Public/Professional Interest None Low Moderate High 2 Potential of Intervention to Reduce 8 None Low Moderate High 1 Health Disparities Total Score 16

Scoping notes: Topic: Newer Interventional Procedures for GERD Score — 0 Score — 1 Score — 2 Score — 3 Score Notes

Disease Burden (morbidity/mortality, 1 Inconsequential Minor Moderate High 1 individual perspective) 2 Prevalence of Condition Rare Low Moderate High 3 3 Uncertainty of Effectiveness/Harms None Low Moderate High 3 Variation in Care/ Controversy/ 4 Variance Between Standard of Care None Low Moderate High 2 and Evidence Magnitude of Potential Economic 5 Impact of Intervention (population None Low Moderate High 2 level, includes downstream costs) Potential of Intervention to Improve 6 None Low Moderate High 1 Health Outcomes 7 Public/Professional Interest None Low Moderate High 1 Potential of Intervention to Reduce 8 None Low Moderate High 0 Health Disparities Total Score 13

Scoping notes: Topic: Newer Interventional Procedures for osteoarthritis of the knee Score — 0 Score — 1 Score — 2 Score — 3 Score Notes

Disease Burden (morbidity/mortality, 1 Inconsequential Minor Moderate High 2 individual perspective)

2 Prevalence of Condition Rare Low Moderate High 3 3 Uncertainty of Effectiveness/Harms None Low Moderate High 3 Variation in Care/ Controversy/ 4 Variance Between Standard of Care None Low Moderate High 2 and Evidence Magnitude of Potential Economic 5 Impact of Intervention (population None Low Moderate High 1 level, includes downstream costs) Potential of Intervention to Improve 6 None Low Moderate High 1 Health Outcomes 7 Public/Professional Interest None Low Moderate High 1 Potential of Intervention to Reduce 8 None Low Moderate High 0 Health Disparities Total Score 13

Scoping notes: Topic: FoundationOne CDx for Advanced Solid Malignancies Score — 0 Score — 1 Score — 2 Score — 3 Score Notes

Disease Burden (morbidity/mortality, 1 Inconsequential Minor Moderate High 3 individual perspective) 2 Prevalence of Condition Rare Low Moderate High 2 3 Uncertainty of Effectiveness/Harms None Low Moderate High 3 Variation in Care/ Controversy/ 4 Variance Between Standard of Care None Low Moderate High 3 and Evidence Magnitude of Potential Economic 5 Impact of Intervention (population None Low Moderate High 2 level, includes downstream costs) Potential of Intervention to Improve 6 None Low Moderate High 2 Health Outcomes 7 Public/Professional Interest None Low Moderate High 3 Potential of Intervention to Reduce 8 None Low Moderate High 2 Health Disparities Total Score 20

Scoping notes: Topic:Single fraction radiotherapy for palliation of bony metastases Score — 0 Score — 1 Score — 2 Score — 3 Score Notes

Disease Burden (morbidity/mortality, 1 Inconsequential Minor Moderate High 3 individual perspective) 2 Prevalence of Condition Rare Low Moderate High 1 3 Uncertainty of Effectiveness/Harms None Low Moderate High 2 Variation in Care/ Controversy/ 4 Variance Between Standard of Care None Low Moderate High 3 and Evidence Magnitude of Potential Economic 5 Impact of Intervention (population None Low Moderate High 1 level, includes downstream costs) Potential of Intervention to Improve 6 None Low Moderate High 2 Health Outcomes 7 Public/Professional Interest None Low Moderate High 2 Potential of Intervention to Reduce 8 None Low Moderate High 1 Health Disparities Total Score 15

Scoping notes: Topic: Spinal cord stimulators for chronic back pain Score — 0 Score — 1 Score — 2 Score — 3 Score Notes

Disease Burden (morbidity/mortality, 1 Inconsequential Minor Moderate High 2 individual perspective) 2 Prevalence of Condition Rare Low Moderate High 2 3 Uncertainty of Effectiveness/Harms None Low Moderate High 3 Variation in Care/ Controversy/ 4 Variance Between Standard of Care None Low Moderate High 3 and Evidence Magnitude of Potential Economic 5 Impact of Intervention (population None Low Moderate High 2 level, includes downstream costs) Potential of Intervention to Improve 6 None Low Moderate High 2 Health Outcomes 7 Public/Professional Interest None Low Moderate High 3 Potential of Intervention to Reduce 8 None Low Moderate High 0 Health Disparities Total Score 17

Scoping notes: Topic: Hep. Art. Inf. Pump Acell Derm mat Score — 0 Score — 1 Score — 2 Score — 3 Score Score

Disease Burden (morbidity/mortality, 1 Inconsequential Minor Moderate High 3 2 individual perspective) 2 Prevalence of Condition Rare Low Moderate High 1 1 3 Uncertainty of Effectiveness/Harms None Low Moderate High 3 2 Variation in Care/ Controversy/ 4 Variance Between Standard of Care None Low Moderate High 2 2 and Evidence Magnitude of Potential Economic 5 Impact of Intervention (population None Low Moderate High 1 1 level, includes downstream costs) Potential of Intervention to Improve 6 None Low Moderate High 1 1 Health Outcomes 7 Public/Professional Interest None Low Moderate High 1 2 Potential of Intervention to Reduce 8 None Low Moderate High 0 1 Health Disparities Total Score 12 12 Potential to Uncertainty in Variation from Economic Potential Health Public/Prof. Disease Burden Prevalence reduce Efficacy/Harm evidence Impact Benefit Interest Topic Committee disaparities Total Extracorporeal Membrane Oxygenation EbGS 3 1 3 2 3 2 2 1 17 Interventional Treatments for Lower Extremity Chronic 2 2 3 2 2 2 2 1 16 Venous Disease EbGS Newer Interventional Procedures for osteoarthritis of 2 3 3 2 1 1 1 0 13 the knee EbGS Intermittent Pneumatic Compression Devices for the 2 1 2 2 1 2 1 0 11 Treatment of Lymphedema EbGS Liposuction for the Treatment of Lymphedema EbGS 2 1 3 2 1 1 1 0 11 3 2 3 3 2 2 3 2 20 FoundationOne CDx for Advanced Solid Malignancies HTAS Spinal cord stimulators for chronic back pain HTAS 2 2 3 3 2 2 3 0 17 Single fraction radiotherapy for palliation of bony 3 1 2 3 1 2 2 1 15 metastases HTAS Newer Interventional Procedures for GERD HTAS 1 3 3 2 2 1 1 0 13 Hepatic Artery Infusion Pumps (2016) HTAS 3 1 3 2 1 1 1 0 12 Acellular Dermal Matrix (2017) HTAS 2 1 2 2 1 1 2 1 12 Sacral Nerve Stimulation (2016) HTAS 2 1 3 2 1 2 0 0 11 Topic nominations not selected

Topic: For the treatment of hepatitis C with Direct Acting Antivirals (DAAs), eliminate arbitrary fibrosis restrictions, restrictions on providers, limitations on fibrosis stratification tools.

Nominator: Andrew Seaman Current HERC status: HERC has developed a Coverage Guidance on noninvasive screening tests for the diagnosis of fibrosis in hepatitis C. HERC has not weighed in on restrictions on fibrosis scores and providers and coverage of DAAs is governed by a memorandum of understanding between the Oregon Health Authority and the Oregon Law Center. HERC Staff Recommendation and Rationale: Not recommended for review. The topic has already been addressed by HERC and OHA, and evidence is unlikely to change current prioritization.

Topic: Income testing for child eligibility for OHP, based on concern for proper use of taxpayer funds Nominator: Douglas Smith HERC Staff Recommendation and Rationale: Not recommended for review. Eligibility criteria for OHP for children not in the Commission’s purview.

Topic: Coverage of instrument-based vision screening in children less than 5 years old

Nominators: Jay Rosenbloom, Medical Director, Children's Health Alliance and Children's Health Foundation Pediatric Associates of the NW, Ken Carlson

Current HERC status: Photoscreening was considered for placement on the prioritized list for Oregon Health Plan (OHP) coverage in November 2015. Visual acuity screening is recommended by the USPSTF for children aged 3 to 5 (but not younger children), however, instrument-based screening has not been shown to be superior to clinical exam and eye chart testing but involves additional costs, therefore, it was placed on the Services Recommended for Noncoverage Table. Since then, it has moved to Line 500.

The USPSTF updated their recommendations on vision screening in September 2017. The USPSTF recommends vision screening at least once in all children aged 3 to 5 years to detect amblyopia or its risk factors. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of vision screening in children younger than 3 years. (I statement). HERC Staff Recommendation and Rationale: Not recommended for review. This would be potentially an appropriate topic for VbBS to review (rather than a Coverage Guidance topic. There is an updated USPSTF review that continues to recommend visual screening, and includes information about a variety of tests. However, the Commission considered the topic in November 2015 (with the review of CPT code 99177). At that time, the Commission recommended noncoverage of this procedure because standard clinical exam and eye charting appear sufficient to identify children who need further evaluation. .

Topic: PRiO and/or PRiO mini (customized iPADs for speech, cognitive, physical deficits), other speech augmentation devices Nominator: Cristin McQueen, FamilyCare Current HERC status: HERC has not reviewed this topic. Services are covered as durable medical equipment. There are less expensive devices (iPads) with equivalent functionality but which are not billable as clinical services due to federal and state rules. HERC staff recommendation and rationale: Not recommended for review. Evidence review is unlikely to establish indications for these devices or identify which devices are most cost- effective. Purchasing strategies for non-medical devices could be cost effective but a coverage guidance would be unlikely to facilitate these strategies.

Topic: Peer-delivered services and trauma-informed practices in physical care and mental health care Nominator: Amy Anderson, Multnomah County Detention Center, Multnomah County Mental Health and Addictions, Multnomah County Physical Health Current HERC Status: Self-help/peer services (H0038) already appear on behavioral health lines on the Prioritized List. Trauma-informed care is based in guidelines and best practices rather than coverage issues. HERC staff recommendation/rationale: Not recommended for review. Self-help related codesare already included on the Prioritized List for behavioral health conditions. Trauma- informed practices are not separately billable; rather they are about tailoring service delivery to patients and populations affected by trauma. Other OHA-sponsored initiatives support trauma- informed care based on best practices and expert recommendations.

Topic: Behavioral Health and trauma; Eye movement desensitization and reprocessing (EMDR). Mindfulness. Tapping. Neurological feedback. Cultural specific spiritual practices for women and for people of color who suffer from debilitating anxiety and pain stemming from racism assaults and violence. Nominator: Carolyn Anderson, Adult Mental Health and Substance Abuse Advisory Council, Oregon Consumer Advisory Council Current HERC status: EMDR and mindfulness-based psychotherapy would be covered under most health plans just as would other psychotherapy techniques. Neurological feedback is covered on many health plans, and is an ancillary benefit for patients on the Oregon Health Plan. Cultural specific spiritual practices are not medical services and not currently covered. Staff recommendation: Not recommended as a Coverage Guidance topic. Specified interventions are already covered, or are not appropriate for coverage consideration, though some modalities may be appropriate techniques when providing covered services.

Topic: Sleep Apnea Diagnostic Studies (requiring home tests over more expensive sleep laboratory tests in certain patients suspected of having obstructive sleep apnea) Nominator: Douglass Carr, Umpqua Health. Current HERC status: Current coverage guidance (5/9/2013) recommends coverage for several types of sleep testing, including home testing but does not specify which are appropriate first- line tests for various populations. The American Sleep Association guideline (February, 2017) recommends testing with portable (home) monitors in patients with a high pretest likelihood of moderate to severe obstructive sleep apnea. Health plans could base a requirement for home testing (rather than polysomnography in a sleep laboratory) on this guideline without any coverage change. Recommendation: While a Coverage Guidance update is not deemed necessary, this topic was reviewed at the January 2018 VbBS meeting; review is ongoing.

Topic: High-cost Innovative Treatments (Chimeric antigen receptor T (CAR-T), Kymriah, Yescarta) Nominator: Nina Lara (Primary Health) Current HERC Status: No prior recommendation. These products are regulated as drug therapies and it would be appropriate for review to begin with the Pharmacy and Therapeutics Committee, not HERC. Recommendation: Do not conduct a HERC review at this time.

Topic: Interventions for addressing high utilization Nominator: Cat Livingston (HERC) Current HERC Status: HERC has not reviewed strategies to address patients with high health care utilization and complex health care needs. This topic, often referred to as “hotspotting,” is gaining national attention and would be of great interest to health care plans. CCOs are already doing some innovative work in this area. There is a growing evidence base about interventions to effectively address avoidable health care utilization (such as housing supports). Taking on this topic would involve multisector interventions, be relevant for the new OHA designated health-related services, and address social determinants of health. Recommendation: Staff to continue working with stakeholders to refine topic to ensure that the review is focused enough to be of use to specific stakeholders and that there is a clear implementation path for the work.

Previously approved topics recommended to be dropped: In 2017, HERC approved the following topics, but they scored relatively low. HERC staff suggests dropping them and referring them for consideration by VbBS.

1. Genetic Testing of Thyroid Nodules 2. Sacral Nerve Stimulation Section 4.0 Conflict of Interest 2018 DRAFT—HERC Disclosure Form

HERC Commission/Subcommittee Conflict of Interest form

This conflict of interest form is designed for transparency regarding the perspectives of members of the Commission and its subcommittees. We recognize that most experts members are employed in a field related to the topic under consideration or have personal beliefs which will influence their testimonydecisions. This form allows the Commission and the public toprovides transparency about better understand each expert’s member’s perspective and the incentives they may be experiencing. We encourage full responses and explanations to provide the best understanding possible.

Information provided on this form will not be published routinely, but is subject to public records law and may become public.

Type of appointment Appointment (Commission, subcommittee): ______

Expert Name: ______

Employer(s)/Business(es): ______

Job Title(s): ______

Clinical/Academic Specialty (if relevant):______

Occupation/Employment

How does your principal occupation or employment relate to the work of the Commission?

Might your employment or how you do your job be affected by the Commission’s decisions? □ Yes □ No Do you work for a manufacturer or another organization whose financial interests may be affected by the Commission’s work? □ Yes □ No Do you have patients or clients who may be affected? □ Yes □ No Do you perform research related to the Commission’s work? □ Yes □ No Other conflict related to occupation or employment? □ Yes □ No): Please explain each Yes answer above: ______

DRAFT—HERC Disclosure Form

Financial Interests (other than remuneration for principal occupation)

 Only report financial relationships or interactions if they cumulatively total ≥ $200 personally or to your spouse or children, $1,000 in funds paid to your employer or institution on your behalf, or if they represent a 5 percent equity stake in an organization.  Report financial transactions with any stakeholder whose interests could be affected by topic at hand.  Include transactions within the last 36 months or planned future transactions.

You do NOT need to disclose:

 Income from mutual funds or retirement funds;  Income from service on advisory committees or review panels for public or nonprofit entities without advocacy positions related to the topic;  Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities without advocacy positions related to the topic;  Income from public funding sources, such as government agencies.

Please describe these potential conflicts in the table below:

Date Payment Company or organization Services you Additional amount or provided information ownership share

Are there any errors in publicly available sources of interest on conflicts of interest (e.g. Dollars for Docs, CMS Open Payments) that HERC staff should be aware of? If so, please explain.

______

Non-financial interestsIntellectual cConflicts of iInterest

Most appointees will have strongly-held beliefs about a topic under discussion. As an aid to transparency, we request a brief explanation of your affiliations, publications, advocacy and public positions which may prevent you from giving fair consideration to any specific issues.

Please describe any important affiliations, publications, advocacy and public positions relevant to the topics which may arise before the Commission and which may prevent you from giving fair

DRAFT—HERC Disclosure Form consideration to any specific issues. Please do not disclose any personal health information, as this form is a public record.

Most appointees will have strongly-held beliefs about a topic under discussion. As an aid to transparency, we request a brief explanation of any affiliations or positions which may be important in understanding your perspective.

Please describe any important non-financial interests you have in the topic, including research, publications, personal experiences, professional/personal affiliations or strongly-held beliefs relevant to the topic at hand which may affect your ability to work or comment on the topic in an unbiased manner:

______

Recusal/dDisclosure

We encourage verbal disclosure of any potential conflicts of interest when a related topic comes up for a discussion, including unanticipated intellectual conflicts of interest. Members may recuse themselves from related discussion or decisions at their discretion.

Signature

I certify that the information above is true and complete. I am aware that HERC routinely searches publicly available sources for conflicts of interest which would be reportable on this form; the results of these searches will be available to staff and the public. provided to the Commission and Staffstaff.

Name:

Date:

DRAFT—HERC Disclosure Form

HERC Ad Hoc Expert Conflict of Interest form

This conflict of interest form is designed for transparency in regarding the perspectives of appointed ad hoc experts who serve as volunteers for the Commission. We recognize that most experts are employed in a field related to the topic under consideration or have personal beliefs which will influence their testimony. This form allows the Commission and the public to better understand each expert’s perspective and the incentives they may be experiencing. We encourage full responses and explanations to provide the best understanding possible.

Information provided on this form will not be published routinely, but is subject to public records law and may become public. A brief verbal summary will be offered at each public meeting you attend as expert.

Topic: ______

Expert Name: ______

Employer(s)/Business(es): ______

Job Title(s): ______

Clinical/Academic Specialty (if relevant):______

Occupation/Employment

How does the topic relate to your principal occupation or employment (For instance, do you provide the service in question?) □ Yes □ No Do you work for a manufacturer or another organization whose financial interests may be affected by the decision at hand? □ Yes □ No Do you serve patients who have the condition for which this service may be considered? □ Yes □ No Do you perform research on this service or condition? □ Yes □ No Other conflict related to occupation or employment? □ Yes □ No): Please explain each Yes answer above: ______

Financial Interests (other than remuneration for principal occupation)

You do NOT need to disclose:

Please describe these potential conflicts in the table below:

Date Payment Company or organization Services you Additional amount or provided information ownership share

Are there any errors in publicly available sources of interest on conflicts of interest (e.g. Dollars for Docs, CMS Open Payments) that HERC staff should be aware of)? If so, please explain.

______

Non-financial interestsIntellectual cConflicts of iInterest

Most expert appointees will have strongly-held beliefs about the topic for which they are appointed. As an aid to transparency, we request a brief explanation of your affiliations, publications, advocacy and public positions which may introduce bias into your testimony.

Please describe any important affiliations, publications, advocacy and public positions relevant to the topic which may prevent you from giving fair consideration to any specific issues. Please do not disclose any personal health information, as this form is a public record.

______

______;______

______

Recusal/dDisclosure

We encourage verbal disclosure of any potential conflicts of interest when a related topic comes up for a discussion, including unanticipated intellectual conflicts of interest.

Non-financial interests

Signature

I certify that the information above is true and complete. I am aware that HERC routinely searches publicly available sources for conflicts of interest which would be reportable on this form; the results of these searches will be provided to the Commission and Staffstaffconsidered in the appointment process and may be read aloud during your introduction at public meetings.

Name:

Date: