Quality and Health Outcomes Committee AGENDA

Oregon Health Authority Quality and Health Outcomes Committee AGENDA

MEETING INFORMATION Meeting Date: February 12, 2018 Location: HSB Room 137 A-D, 500 Summer Street, NE, Salem, OR Parking : Map Phone: 503-378-5090 x0 Call in information: Toll free dial-in: 888-278-0296 Participant Code: 310477 Webinar: https://attendee.gotowebinar.com/rt/1604594670695078914 All meeting materials are posted on the QHOC website

Clinical Director Workgroup 9:00 am – 11:00 am Time Topic Owner Materials -Speaker’s Contact Sheet (1) 9:00 a.m. -Meeting Notes (2 – 7) Welcome / Announcements Maggie Bennington-Davis -Public Health Update (8 – 9) -Information Session (10) 9:10 a.m. P&T Update Roger Citron P&T Website 9:20 a.m. PDMP Drew Simpson -Presentation (11 – 14) Cat Livingston 9:40 a.m. HERC Update -HERC Materials (15 – 67) Ariel Smits Patrick Luedtke 10:20 a.m. Hep A Update -Presentation (68 – 78) Ann Thomas 10:40 a.m. 2019 Statewide PIP Lisa Bui -Presentation (79 – 80) 10:50 a.m. Break Learning Collaborative 11:00 am – 12:30 pm Oral Health Learning -Agenda (81) 11:00 Bruce Austin, DMD Collaborative -Presentation (82 – 114) 12:30 LUNCH Quality and Performance Improvement Session 1:00 pm – 3:00 pm Carla Bennett 1:00 Welcome / Announcements -ISCA update (115 – 118) Lisa Bui -Dental Dictionary (119 – 144) CCO NOA Oral Health -Writing for Medicaid Audience 1:15 Work Session (145 – 148) OHA NOA/NOAR Templates -Readability Samples (149) -Medicaid Terms (150) 2:45 Items from the Floor All

March upcoming topics: • Social Determinants of Health Framework – Medicaid Advisory Committee (MAC)

OHA contact info: [email protected] Topics may be subject to change due to availability SALEM CAPITOL MALL AREA

D STREET 810 830 850 870

Archives North Mall Building Parrish Heritage Middle 880 Park 885 School 796 N

North State Mall Lands HIGH STREET CHURCH STREET WINTER STREET COTTAGE STREET Office Building Building Railroad Pacific Southern S

Veterans Building <<<<-----SUMMER STREET CAPITOL STREET ----->>>> Employ. 605 Agri- Employment Orange Salem Cottage culture Building Lot Office Pkg Lot Building UNION STREET Dept. of ODOT Mill Energy Creek Bldg. Barbara Roberts Green Lot Human Services Public Utility Movie Land Building Comm. Building <<<<----- MARION STREET Yellow Lot Safeway (gravel) Macy's Revenue Building Red Lot STREET 12TH STREET 13TH Park & Pay Daily

Parking Real Estate CENTER STREET ----->>>> 1144 McDonalds Center Labor & Trans- Industries portation Building Building 1133

Lane >>> Chemeketa ng Structure t Lane<<< t i i CHEMEKETA STREET

Salem Transit State Public Station

Library Service Chemeketa Customer Service 1158 - 1178 Building Building

Office <<>>Bus Transi 1175 Court YMCA Capitol Mall Parki <<<<----- COURT STREET Justice Building Marion County Commerce Courthouse Willson Park State Capitol Building

Structure Building Supreme Robertson Executive Parking Executive Building Executive Court Building WAVERLY ST WAVERLY STATE STREET ----->>>>

General Services Willamette University Campus Building FERRY STREET FERRY STREET 1202 / 1240 WINTER STREET Ferry Ferry Street Str.

State of Oregon Meters - OK to use Agency issued one-day permit

Capitol Mall Structure Meters - OK to use Agency Issued one-day permit

Yellow Lot & Ferry Structure Rooftop Visitor Spaces - OK to use Agency issued one-day permit

Daily_permit.xlsx - 5/01/14

Apil 2017 QHOC Packet - Page 1 SPEAKER CONTACT SHEET QHOC – February 2018

AGENDA TOPIC SPEAKER CONTACT INFO P&T Update Roger Citron [email protected] PDMP Drew Simpson [email protected] HERC Update Cat Livingston, MD, MPH [email protected] Ariel Smits, MD, MPH [email protected] Hep A Update Ann Thomas, PhD [email protected] Patrick Luedtke, MD, MPH [email protected] Oral Health Bruce Austin, DMD [email protected] Learning Laura McKeane [email protected] Collaborative Joshua Even, DMD [email protected] Joanna Mullins, RDH [email protected] Alyssa Franzen, DMD [email protected] QHOC Chairs Medical Maggie Bennington-Davis, MD [email protected] Behavioral Health Athena Goldberg, LCSW [email protected] Oral Health Laura McKeane – effective [email protected] 10/1/17 Quality Carla Bennett – effective [email protected] 10/1/17 QHOC Leads Medical Kim Wentz, MD [email protected] Behavioral Health Royce Bowlin, MS, CPRP [email protected] Oral Health Bruce Austin, DMD [email protected] Quality Lisa Bui [email protected]

QHOC Website: http://www.oregon.gov/oha/HPA/CSI/Pages/Quality-Health-Outcomes-Committee.aspx

Questions: [email protected] or call Lisa Bui at 971-673-3397

February 2018 QHOC Packet - Page 1 February 2018 QHOC Packet - Page 2 February 2018 QHOC Packet - Page 3 February 2018 QHOC Packet - Page 4 February 2018 QHOC Packet - Page 5 February 2018 QHOC Packet - Page 6 February 2018 QHOC Packet - Page 7 PUBLIC HEALTH DIVISION Office of the State Public Health Director

Kate Brown, Governor

Quality and Health Outcomes Committee Public Health Division updates – February 2018

FluBites Getting an annual flu vaccine is the first and best way to be protected from the flu. 2017-18 flu season resources and recommendations for the public and health care providers are available at: www.flu.oregon.gov.

OHA releases a weekly influenza surveillance report. Sign up to receive weekly FluBites reports at: http://www.oregon.gov/oha/PH/DISEASESCONDITIONS/COMMUNICABLEDISEASE/DISEASESURVEILLANCE DATA/INFLUENZA/Pages/surveil.aspx. ]

Newborn Screening Care Coordinators Information Session OHA and OHSU are sponsoring an information session regarding newborn screening and birth anomalies. Topics include:

• Common birth anomalies and the Birth Anomalies Surveillance System in Oregon (BASS) • Newborn Screening: conditions and follow-up services • Pulse oximetry and early detection of Critical Congenital Heart Defects (CCHDs) • Early hearing screening and follow up • Family and community supports for new diagnoses • Family Panel: hear stories of families whose children experience birth anomalies and special healthcare needs

Date: Wednesday, February 28th Time: 1:15 – 4:15 Place: Sheraton Portland Airport Hotel 8235 NE Airport Way Portland, OR 97220

Parts of this session will be video-taped and available for later viewing. To Register: Care Coordinators Info Session

For more information contact: Tamara Bakewell at [email protected] or 503-494-0865

Colorectal cancer screening web-based learning collaborative opportunity for CCOs Oregon Health Authority’s Public Health Division and Transformation Center are partnering with Melinda Davis, PhD of Oregon Health & Science University, ORPRN and with Gloria Coronado, PhD of Kaiser

February 2018 QHOC Packet - Page 8 Permanente Center for Health Research to deliver targeted technical assistance to Coordinated Care Organizations (CCOs) for colorectal cancer (CRC) screening with a focus on reducing disparities through population outreach. Sustaining the CRC TA successes of last year, Drs. Davis and Coronado will host an interactive, web-based learning collaborative on evidence-based approaches to increase CRC screening.

This opportunity is open to CCOs and their clinic partners. Participants will have the opportunity to request additional technical assistance support from CRC screening experts. Information about this opportunity and application for participation can be found here. Applications will be accepted through February 9th.

For more information, contact Patricia Schoonmaker at [email protected] or 971-673- 1081.

New resource: Implementing Comprehensive Diabetes Prevention Programs: A Guide for CCOs The Oregon Health Authority’s (OHA) Public Health Division has developed a how-to guide to assist Oregon’s coordinated care organizations (CCOs) and other payers interested in covering the evidence- based National Diabetes Prevention Program (DPP) lifestyle change program: http://www.oregon.gov/oha/PH/DISEASESCONDITIONS/CHRONICDISEASE/DIABETES/Docume nts/Diabetes_Prevention_Program_Guide_for_CCOs.pdf. This four-part guide includes information about:

1. Partnering with lifestyle change program delivery sites 2. Partnering with clinics 3. Identifying, recruiting and retaining program participants 4. Infrastructure and sustainability

The information in this four-part guide is based on the experiences of four CCOs currently testing the DPP lifestyle change program. Representatives from each of these four CCOs participated in a survey and interview about their lessons learned in implementing the DPP, in addition to reviewing and providing improvements to this guide.

For more information, contact Nancy Goff at [email protected] or (971) 673 2283.

Oregon Quit Line business cards available The Oregon Health Authority, Public Health Division has a limited number of printed promotional materials available for the Oregon Tobacco Quit Line. Oregon Tobacco Quit Line business cards are available in English. Please contact Shira Pope ([email protected]) if you are interested.

February 2018 QHOC Packet - Page 9 Care Coordinators Information Session Wednesday, February 28, 2018 1:15-4:15 PM Sheraton Portland Airport Hotel 8235 NE Airport Way, Portland, OR 97220

Join this one-time-only information session co-hosted by Family to Family Health Information Center on topics of This program is for: interest to CCO, OHPCC Program and Qualified Health Plan • Pediatric Care Care Coordinators. You will learn about key public health Coordinators and and family programs that can help you support the families, Intensive Case children and youth you work with. Managers from CCOs Topics include: • The Oregon Health • Common birth anomalies and the Birth Anomalies Plan Coordination Surveillance System in Oregon (BASS) Program (KEPRO) • Newborn Screening: conditions and follow-up services • Qualified Health Plans • Pulse oximetry and early detection of Critical • Local Public Health Congenital Heart Defects (CCHDs) Department Staff • Early hearing screening and follow up • CaCoon Nurses • Oregon Health Plan • Family and community supports for new diagnoses Transformation • Family Panel: hear stories of families whose children Center Staff experience birth anomalies and special health • Care Managers/ care needs Coordinators from RSVP for this free event by Friday, February 23 Pediatric Practices Contact Tamara Bakewell at [email protected] or 503-494-0865 for more information. February 2018 QHOC Packet - Page 10 Prescription Drug Monitoring Program Update

Drew Simpson Program Coordinator Injury and Violence Prevention Section Public Health Division Oregon Health Authority Feb 12, 2018

Overview

• Research update / Metrics

• Recent Changes to the system / Implementation of 2017 mandates

• Upcoming Changes to system / Possible 2018 mandates

• Statewide Subscription for PDMP EHR Integration

• Questions

February 2018 QHOC Packet - Page 11 Program Metrics

• Number of PDMP queries continues to rise. 15% increase in 2017. • Number of active users continues to rise. Approx. 20% last year • Overall number of registered users stagnate at approx. 50%

Research • Summary of research published using OR PDMP data handout

Recent Changes

• Medical director and pharmacy director are now able to register for PDMP accounts for the purpose of overseeing operations.

• Established a clinical review subcommittee of the PDMP Advisory Commission to review PDMP data and recommend training or education for providers.

• Include dispensed Naloxone and patient phone number in the PDMP.

• Interstate data sharing

February 2018 QHOC Packet - Page 12 Up-coming Changes

• HB 4143 mandatory registration possible – System enhancement / staff development – Outreach and collaboration efforts

• Prescriber dashboard (Threshold matrix) – Similar to previous version, delivery end of February

• New System Procurement – Request input from stakeholders

• Statewide subscriptions for EHR integration

PDMP Gateway Roll Out & Next Steps

• PDMP Gateway to integrate PDMP with health IT systems (EHRs, HIEs, etc.) soft launch as of late summer 2017 • Early Adopters - Health IT Systems Connecting: o EDIE Utility – PDMP data pushed through EDIE alerts to ED providers (Asante Rogue Regional, Grand Ronde Hospital & 8 Providence hospitals live, Salem & Adventist onboarding). Only hospitals who have integrated EDIE into their EHR may receive PDMP data in notification o Reliance eHealth Collaborative & Intercommunity Health Network (IHN) CCO have signed paperwork and are working with their technology vendors for implementation • Subscription Cost for Appriss PMP Gateway: o Currently $50/prescriber/year for approved entities • Establishment of Statewide Subscription Under HIT Commons: o HIT Commons to support statewide subscription (PDMP Gateway) – jointly funded: ‹ OHA submitted request for 90/10 federal/state matching funds for Medicaid share (82%) ‹ HIT Commons dues-paying members supporting non-Medicaid share (18%) o PDMP Gateway Steering Committee defined by the end of 1Q2018 o Roll out of statewide subscription mid-spring 2018

February 2018 QHOC Packet - Page 13 PDMP Web Portal to Gateway Process Example

Current State - PDMP Future State – STATEWIDE PDMP

Prescribers must use separate login to access Providers access PDMP database through their PDMP database through a web portal normal workflow in their health IT system (EHR/HIE) via Gateway (no separate login). Results come back to patient record Prescriber

PDMP Database Prescriber EHR PDMP Gateway PDMP Database EHR

Manual Query Separate Login

Fees Fees • $25 annual access fee per authorized • $25 annual access fee per authorized prescriber prescriber • Statewide PDMP assessment fee (82% covered by federal/state funding)

Benefits Benefits

• Authorized prescribers can access Oregon’s • Direct access to PDMP information as part of prescription drug information normal workflow: saves time, increases adoption, reduces redundancy, better informs clinical decisions in real time • Access to other state database information through Gateway

February 2018 QHOC Packet - Page 14 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 February 2018 QHOC Packet - Page 15 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 February 2018 QHOC Packet - Page 16

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

Value-based Benefits Subcommittee Minutes, 1/18/2018 Page 3 February 2018 QHOC Packet - Page 17 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.

Value-based Benefits Subcommittee Minutes, 1/18/2018 Page 4 February 2018 QHOC Packet - Page 18 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 February 2018 QHOC Packet - Page 19 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 February 2018 QHOC Packet - Page 20  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 February 2018 QHOC Packet - Page 21 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

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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 February 2018 QHOC Packet - Page 23 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.

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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

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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.

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.

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.

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.

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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. 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

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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 61886 significant effective ness, 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 • Mammaprint, effectiveness. More Coverage Guidance Blog Mammostrat and costly than equally ImmunoHistoCHemistry 4 effective therapies (IHC4) for breast cancer for this 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)

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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

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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

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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.

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HEALTH EVIDENCE REVIEW COMMISSION Lincoln Building Transformation Center Conference Room Teleconference Portland, Oregon January 5, 2018

Members Present (all by phone): Kevin Olson, MD, Chair; Mark Gibson; Leda Garside, RN, MBA; Angela Senders, ND; Holly Jo Hodges, MD; Devan Kansagara, MD; Lynnea Lindsey, PhD; Leslie Sutton; Adriane Irwin, PharmD.

Members Absent: Susan Williams, MD; Gary Allen, DMD.

Staff Present: Darren Coffman; Ariel Smits, MD, MPH (by phone); Denise Taray, RN (by phone); Jason Gingerich.

Also Attending: Jeremy Vandehey (Oregon Health Authority); Ted Falk (DOJ); Meganne Leach (OHSU); Rocky Dallum, (Tonken Torp/Sarepta); Alison Little, MD, MPH (Pacific Source); Courtney Iverson (Pac/West).

Call to order

Darren Coffman, Director of the Health Evidence Review Commission (HERC), called the meeting to order at 9:05 a.m.; roll was called. Coffman welcomed Adrian Irwin as it was her first meeting.

Chair election

Garside nominated Olson as Chair, who accepted the nomination. There were no other nominations.

MOTION: Elect Kevin Olson as Chair of the Health Evidence Review Commission. CARRIES 9-0.

A vice-chair will be elected at a later meeting.

Minutes approval

MOTION: To approve the minutes of the 11/9/20107 meeting as presented. CARRIES 8-0. (Irwin abstained)

HERC Minutes 1/5/2018 1 February 2018 QHOC Packet - Page 34 Prioritization of eteplirsen and deflazacort for treatment of Duchenne muscular dystrophy Meeting materials, pages 78-79

Coffman said the reason for the meeting is to revisit the Commission’s decision in September and November, 2017 to place deflazacor and eteplirsen on lines 500 and 660, respectively. The consideration for placing certain drugs on these lines of the Prioritized List is a new area of work for HERC. Drug manufacturers have raised questions about federal rebate law which requires states to cover certain FDA-approved drugs. From the time the decision was made by HERC regarding eteplirsen, those objecting to the November 9th decision have 60 days to file a lawsuit. As we are bumping against 60 days, OHA recommended that HERC remove the two drugs from their placement below the funding line on the Prioritized List for the time being. This will allow OHA and HERC more time to review the legal questions that were raised and determine the best path forward for addressing drugs with marginal or no established clinical benefit, harms that outweighs benefits, or have low cost-effectiveness. OHA is not questioning the evaluation of the evidence of these drugs. Rather, OHA will be reviewing the process and authority to place these drugs on the list.

Vandehey thanked the Commission for its service and expressed appreciation for the Commission’s work and its commitment to use the best evidence to prioritize benefit. The issue is about taking the time to hit pause and remove the drugs from the list while legal analysis related to this work proceeds. Leadership is watching other states processes as well.

Members asked if there is a time estimate for how long it will take to do the further review. Vandehey said there is not a time-frame but they will have a better sense by the March HERC meeting.

Members asked if this potential decision will allow patients to receive the medication temporarily. Coffman said by taking these drugs off lines 500 and 660, the drugs become an ancillary service and just like other drugs that are not called out; they would be covered if medically appropriate and meeting other criteria including prior authorization (PA) criteria already adopted by the P&T Committee. The PA criteria for eteplirsen mirrors the FDA criteria while the deflazacort PA states it as being second-line therapy, after a failure of prednisone. Roger Citron, staff to the P&T Committee, confirmed this information.

Vandehey confirmed that HERC would not take up any new drug topics during this process review period.

Public Comment

Written comment received from CCO medical director from Samaritan Health was forwarded to all members. The testimony was in support of the Commission’s original decision to place the drugs in question on lines 500 and 660.

Meganne Leach, nurse practitioner at OHSU and Doernbecher Children’s Hospital, who is in support of covering eteplirsen. She thanked Commission for potentially removing the low-prioritization of these drugs and allowing treatment. This is an exciting time as more information about the efficacy of the drug is forthcoming.

HERC Minutes 1/5/2018 2 February 2018 QHOC Packet - Page 35 HERC Staff Recommendations: 1. To remove deflazacort (Emflaza) from Guideline Note 172, and thereby line 500, due to procedural issues, while still affirming our finding that this drug has marginal benefit/low cost-effectiveness compared to equally effective but much less expensive alternative corticosteroids. 2. To remove eteplirsen (Exondys 51) from Guideline Note 173, and thereby line 660, due to procedural issues, while still affirming that we have not found this drug to have a clinically important benefit.

MOTION: To approve the staff recommendation to remove the drugs deflazacor and eteplirsen from lines 500 and 660 respectively. Carries 8-1. (Opposed: Gibson)

Next steps

Staff will publish a revised Prioritized List and Health Services Division will adopt a rule to incorporate the approved changes.

Olson asked about a communication plan. Vandehey said a letter was sent to the CCO CEOs and medical directors. There are questions about impact on rates and the Actuarial Services Unit is looking at some other actuarial issues.

Hodges expressed her discomfort about going forward without a timeline and wanted to set one by the next HERC meeting. Vendehey commented he would provide one by the January 18th HERC meeting.

Gibson explained his vote, expressing disappointment that members of the Commission are put in a situation where they cannot fully use evidence and clinical research to govern the Oregon Health Plan. He hoped that Oregon will be aggressive and work with other states so we can use evidence to make sound decisions in our health care programs. Others echoed this sentiment.

Hodges shared, for the record, there were 44 interested listeners on the call.

Adjournment

Meeting adjourned at 9:37 a.m. Next meeting will be from 1:30-4:30 pm on Thursday, 1/18/2018 at Barbara Robert’s Human Services Building, Rooms 137A-D, Salem, Oregon 97301.

HERC Minutes 1/5/2018 3 February 2018 QHOC Packet - Page 36 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 February 2018 QHOC Packet - Page 37

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.

HERC Minutes 1/18/2018 2 February 2018 QHOC Packet - Page 38 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 February 2018 QHOC Packet - Page 39 • 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 February 2018 QHOC Packet - Page 40 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.

HERC Minutes 1/18/2018 5 February 2018 QHOC Packet - Page 41 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

HERC Minutes 1/18/2018 6 February 2018 QHOC Packet - Page 42 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:

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 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.

HERC Minutes 1/18/2018 7 February 2018 QHOC Packet - Page 43 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 February 2018 QHOC Packet - Page 44 http://www.oregon.gov/oha/HPA/CSI-HERC/Pages/Evidence-based-Current-Topics.aspx

February 2018 QHOC Packet - Page 45

Health Evidence Review Commission (HERC) Coverage Guidance: Gene Expression Profiling for Prostate Cancer Approved January 18, 2018

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

Note: Definitions for strength of recommendation are in Appendix A. GRADE Informed Framework Element Description.

February 2018 QHOC Packet - Page 46 Appendix A. GRADE-Informed Framework Element Descriptions

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

Strong recommendation In Favor: The subcommittee concludes that the desirable effects of adherence to a recommendation outweigh the undesirable effects, considering the balance of benefits and harms, resource allocation, values and preferences and other factors. Against: The subcommittee concludes that the undesirable effects of adherence to a recommendation outweigh the desirable effects, considering the balance of benefits and harms, resource allocation, values and preferences and other factors. Weak recommendation In Favor: The subcommittee concludes that the desirable effects of adherence to a recommendation probably outweigh the undesirable effects, considering the balance of benefits and harms, resource allocation, values and preferences and other factors., but further research or additional information could lead to a different conclusion. Against: The subcommittee concludes that the undesirable effects of adherence to a recommendation probably outweigh the desirable effects, considering the balance of benefits and harms, cost and resource allocation, and values and preferences, but further research or additional information could lead to a different conclusion. Confidence in estimate rating across studies for the intervention/outcome Assessment of confidence in estimate includes factors such as risk of bias, precision, directness, consistency and publication bias. High: The subcommittee is very confident that the true effect lies close to that of the estimate of the effect. Typical sets of studies are RCTs with few or no limitations and the estimate of effect is likely stable.

22 │ Gene Expression Profiling for Prostate Cancer Approved January 18, 2018 February 2018 QHOC Packet - Page 47 Moderate: The subcommittee is moderately confident in the estimate of effect: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Typical sets of studies are RCTs with some limitations or well-performed nonrandomized studies with additional strengths that guard against potential bias and have large estimates of effects. Low: The subcommittee’s confidence in the estimate of effect is limited: The true effect may be substantially different from the estimate of the effect. Typical sets of studies are RCTs with serious limitations or nonrandomized studies without special strengths. Very low: The subcommittee has very little confidence in the estimate of effect: The true effect is likely to be substantially different from the estimate of effect. Typical sets of studies are nonrandomized studies with serious limitations or inconsistent results across studies.

23 │ Gene Expression Profiling for Prostate Cancer Approved January 18, 2018 February 2018 QHOC Packet - Page 48

Appendix B. GRADE Evidence Profile

Quality Assessment (Confidence in Estimate of Effect) No. of Risk of Studies Study Design(s) Bias Inconsistency Indirectness Imprecision Other Factors Quality Prostate cancer mortality 0 Insufficient data Prostate cancer morbidity 0 Insufficient data Quality of life 0 Insufficient data Change in management 11 Observational High None Serious Not estimable Industry Very low sponsorship and ●◌◌◌ conflict of interest Harms 0 Insufficient data

24 │ Gene Expression Profiling for Prostate Cancer Approved January 18, 2018 February 2018 QHOC Packet - Page 49

Appendix C. Methods Scope Statement Populations Men with prostate cancer Population scoping notes: None Interventions Gene expression profiling on cancer tissue Intervention exclusions: None Comparators Usual care, other methods of risk stratification (e.g., Gleason score, tumor stage, PSA values), gene expression profiling tests compared to each other Outcomes Critical: Prostate cancer morbidity, prostate cancer mortality Important: Quality of life, harms, change in management of prostate cancer Considered but not selected for the GRADE table: Analytic validity, clinical validity Key Questions KQ1: What is the comparative effectiveness of gene expression profiling for prostate cancer? KQ2: How does the comparative effectiveness of gene expression profiling for prostate cancer vary by:  Age  Race or ethnicity  Patient and family history  Previous treatments and response  Life expectancy  Clinical-pathologic characteristics (e.g., PSA level, tumor size, type of tumor, Gleason score, proliferation rate, cancer stage) KQ3: What are the harms of gene expression profiling for prostate cancer? Search Strategy A full search of the core sources was conducted to identify systematic reviews, meta-analyses, and technology assessments that met the criteria for the scope described above. Searches of core sources were limited to citations published after 2012. The core sources searched included: Agency for Healthcare Research and Quality (AHRQ) Blue Cross/Blue Shield Center for Clinical Effectiveness Canadian Agency for Drugs and Technologies in Health (CADTH) Cochrane Library (Wiley Online Library)

25 │ Gene Expression Profiling for Prostate Cancer Approved January 18, 2018 February 2018 QHOC Packet - Page 50

Institute for Clinical and Economic Review (ICER) Medicaid Evidence-based Decisions Project (MED) National Institute for Health and Care Excellence (NICE) Tufts Cost-effectiveness Analysis Registry Veterans Administration Evidence-based Synthesis Program (ESP) Washington State Health Technology Assessment Program

A MEDLINE® search was also conducted to identify systematic reviews, meta-analyses, and technology assessments, using the search terms (Prolaris or Oncotype or Decipher or Cell-Cycle Progression Gene Panel) and (prostate cancer or prostatectomy). The search was limited to publications in English published since 2012. In addition, a MEDLINE® search was conducted for randomized controlled trials published after the search dates of the most recent systematic review selected for each intervention. Searches for clinical practice guidelines were limited to those published since 2012. A search for relevant clinical practice guidelines was also conducted using MEDLINE® and the following sources: Australian Government National Health and Medical Research Council (NHMRC) Canadian Agency for Drugs and Technologies in Health (CADTH) Centers for Disease Control and Prevention (CDC) – Community Preventive Services National Guidelines Clearinghouse National Institute for Health and Care Excellence (NICE) Scottish Intercollegiate Guidelines Network (SIGN) United States Preventive Services Task Force (USPSTF) Veterans Administration/Department of Defense (VA/DOD) Clinical Practice Guidelines Inclusion/Exclusion Criteria Studies were excluded if they were not published in English, did not address the scope statement, or were study designs other than systematic reviews, meta-analyses, technology assessments, randomized controlled trials, or clinical practice guidelines.

26 │ Gene Expression Profiling for Prostate Cancer Approved January 18, 2018 February 2018 QHOC Packet - Page 51 Appendix D. Applicable Codes

CODES DESCRIPTION CPT Codes 81479 Unlisted Molecular Pathology Procedure (Decipher, Oncotype DX, Prolaris) Note: Inclusion on this list does not guarantee coverage.

27 │ Gene Expression Profiling for Prostate Cancer Approved January 18, 2018 February 2018 QHOC Packet - Page 52 HEALTH EVIDENCE REVIEW COMMISSION (HERC) COVERAGE GUIDANCE: LOW BACK PAIN: MINIMALLY INVASIVE AND NON-CORTICOSTEROID PERCUTANEOUS INTERVENTIONS Approved January 18, 2018

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)

Note: Definitions for strength of recommendation are provided in Appendix A GRADE Informed Framework Element Description.

February 2018 QHOC Packet - Page 53

APPENDIX A. GRADE INFORMED FRAMEWORK – ELEMENT DESCRIPTIONS

Strong recommendation In Favor: The subcommittee concludes that the desirable effects of adherence to a recommendation outweigh the undesirable effects, considering the balance of benefits and harms, resource allocation, values and preferences and other factors. Against: The subcommittee concludes that the undesirable effects of adherence to a recommendation outweigh the desirable effects, considering the balance of benefits and harms, resource allocation, values and preferences and other factors. Weak recommendation In Favor: The subcommittee concludes that the desirable effects of adherence to a recommendation probably outweigh the undesirable effects, considering the balance of benefits and harms, resource allocation, values and preferences and other factors., but further research or additional information could lead to a different conclusion. Against: The subcommittee concludes that the undesirable effects of adherence to a recommendation probably outweigh the desirable effects, considering the balance of benefits and harms, cost and resource allocation, and values and preferences, but further research or additional information could lead to a different conclusion. Confidence in estimate rating across studies for the intervention/outcome1 High: The subcommittee is very confident that the true effect lies close to that of the estimate of the effect. Typical sets of studies are RCTs with few or no limitations and the estimate of effect is likely stable. Moderate: The subcommittee is moderately confident in the estimate of effect: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Typical sets of

1 Includes risk of bias, precision, directness, consistency and publication bias 28 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions Approved January 18, 2018

February 2018 QHOC Packet - Page 54

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

29 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions Approved January 18, 2018

February 2018 QHOC Packet - Page 55 APPENDIX B. GRADE EVIDENCE PROFILE

Quality Assessment (Confidence in Estimate of Effect) Minimally Invasive Discectomy No. of Study Risk of Other Studies Design(s) Bias Inconsistency Indirectness Imprecision Factors Quality Short-term function 2 to 3 RCTs Moderate Serious None Serious Low confidence in estimate of the effect ●●◌◌ Long-term function Insufficient data Long-term risk of undergoing surgery Insufficient data Change in utilization of comparators Insufficient data Adverse events 6 to 9 RCTs Moderate Serious None Serious Low to moderate confidence in estimate of the effect ●●◌◌ to ●●●◌

30 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions

Approved January 18, 2018 February 2018 QHOC Packet - Page 56 Quality Assessment (Confidence in Estimate of Effect) Ozone Therapy No. of Study Risk of Other Studies Design(s) Bias Inconsistency Indirectness Imprecision Factors Quality Short-term function 1 RCT Moderate N/A None N/A Sparse Very low data confidence in estimate of the effect ●◌◌◌ Long-term function Insufficient data Long-term risk of undergoing surgery Insufficient data Change in utilization of comparators 1 RCT Moderate N/A None N/A Sparse Very low data confidence in estimate of the effect ●◌◌◌ Adverse events Insufficient data

31 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions

Approved January 18, 2018 February 2018 QHOC Packet - Page 57

Quality Assessment (Confidence in Estimate of Effect) Radiofrequency denervation low back pain due to facet joint arthropathy? No. of Study Risk of Other Studies Design(s) Bias Inconsistency Indirectness Imprecision Factors Quality Short-term function 1 RCT Moderate N/A None None Inconsistent Very low findings in confidence subsequent in estimate RCT of the effect ●◌◌◌ Long-term function 1 RCT Moderate N/A None None Very low Inconsistent confidence findings in in estimate subsequent of the RCT effect ●◌◌◌ Long-term risk of undergoing surgery Insufficient data Change in utilization of comparators Insufficient data Adverse events Insufficient data

32 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions

Approved January 18, 2018 February 2018 QHOC Packet - Page 58

Quality Assessment (Confidence in Estimate of Effect) Radiofrequency Denervation for Discogenic Low Back Pain No. of Study Risk of Other Studies Design(s) Bias Inconsistency Indirectness Imprecision Factors Quality Short-term function 1 RCT Moderate N/A None None Sparse Low data confidence in estimate of the effect ●●◌◌ Long-term function 2 RCTs Moderate None None Serious Moderate confidence in estimate of the effect ●●●◌ Long-term risk of undergoing surgery Insufficient data Change in utilization of comparators Insufficient data Adverse events Insufficient data

33 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions

Approved January 18, 2018 February 2018 QHOC Packet - Page 59

Quality Assessment (Confidence in Estimate of Effect) Radiofrequency Denervation for Sacroiliac Joint Pain No. of Study Risk of Other Studies Design(s) Bias Inconsistency Indirectness Imprecision Factors Quality Short-term function 1 to 2 RCTs Moderate Serious None Serious Very low confidence in estimate of the effect ●◌◌◌ Long-term function 1 RCT Moderate N/A None None Low confidence in estimate of the effect ●●◌◌ Long-term risk of undergoing surgery Insufficient data Change in utilization of comparators Insufficient data Adverse events Insufficient data

34 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions

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APPENDIX C. METHODS

Scope Statement Populations Adults with acute, subacute, or chronic low back pain with or without radiculopathy Population scoping notes: None Interventions* Local injections (including trigger point injections), botulinum toxin injection, coblation nucleoplasty, radiofrequency denervation, prolotherapy, intradiscal electrothermal therapy (IDET), medial branch block, percutaneous intradiscal radiofrequency thermocoagulation, lumbar radiofrequency neurotomy, spinal cord (dorsal column) stimulators, sacroiliac joint injections Intervention exclusions: Corticosteroid injections are considered separately; these interventions, when used for diagnostic purposes, are beyond the scope of this review. Anesthetic injections are excluded. Comparators Other interventions for low back pain (including others listed above, alone or in combination), no treatment Outcomes Critical: Short-term function, long-term function, long-term risk of undergoing surgery Important: Adverse events, change in utilization of comparators Considered but not selected for the GRADE table: Short-term pain, long-term pain Key Questions KQ1: What is the comparative effectiveness of non-corticosteroid percutaneous or minimally invasive interventions for low back pain? KQ2: Does the comparative effectiveness of the interventions vary by: a. Duration of back pain b. Etiology of back or radicular pain (e.g., stenosis, disc herniation) c. Frequency of the intervention d. Presence or absence of neurological deficit e. Anatomic approach f. Use of imaging guidance g. Previous back interventions h. Response to previous percutaneous interventions (diagnostic or therapeutic) i. Risk level for poor functional prognosis j. Comorbidities (physical or behavioral)

35 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions

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KQ3: What are the harms of non-corticosteroid percutaneous or minimally invasive interventions for low back pain? Contextual Questions 1: Does the use of these therapies affect subsequent use of health care resources? 2: How would availability of these therapies affect the need for imaging to determine appropriate candidates for these interventions? Search Strategy A full search of the core sources was conducted to identify systematic reviews, meta-analyses, technology assessments, and clinical practice guidelines using terms for the interventions. Searches of core sources were limited to citations published after 2012. The core sources searched included: Agency for Healthcare Research and Quality (AHRQ) Blue Cross/Blue Shield Health Technology Assessment (HTA) program BMJ Clinical Evidence Canadian Agency for Drugs and Technologies in Health (CADTH) Cochrane Library (Wiley Interscience) Hayes, Inc. Institute for Clinical and Economic Review (ICER) Medicaid Evidence-based Decisions Project (MED) National Institute for Health and Care Excellence (NICE) Tufts Cost-effectiveness Analysis Registry Veterans Administration Evidence-based Synthesis Program (ESP) Washington State Health Technology Assessment Program

A MEDLINE® search was also conducted to identify systematic reviews, meta-analyses, and technology assessments. The search was limited to publications in English published since 2012. In addition, a MEDLINE® search was conducted for randomized controlled trials published after the search dates of the most recent systematic review selected for each intervention. Searches for clinical practice guidelines were limited to those published since 2012. A search for relevant clinical practice guidelines was also conducted, using the following sources: Australian Government National Health and Medical Research Council (NHMRC) Centers for Disease Control and Prevention (CDC) – Community Preventive Services Choosing Wisely Institute for Clinical Systems Improvement (ICSI) National Guidelines Clearinghouse New Zealand Guidelines Group NICE Scottish Intercollegiate Guidelines Network (SIGN) United States Preventive Services Task Force (USPSTF) Veterans Administration/Department of Defense (VA/DOD)

36 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions

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

Interventions Not Reviewed Several interventions were originally included in the scope, but later excluded to best utilize resources because most other payers do not cover the procedures for reasons of experimental status or insufficient evidence. These procedures are botulinum toxin injection, coblation nucleoplasty, prolotherapy, intradiscal electrothermal therapy, and percutaneous intradiscal radiofrequency thermocoagulation. In addition, other interventions were included in the search, but no systematic reviews were found. These procedures are trigger point injections, spinal cord stimulators, medial branch blocks, and sacroiliac joint injections.

37 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions

Approved January 18, 2018 February 2018 QHOC Packet - Page 63 APPENDIX D. APPLICABLE CODES CODES DESCRIPTION CPT Codes Percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy 0275T and/or foraminotomy), any method, under indirect image guidance (e.g., fluoroscopic, CT), single or multiple levels, unilateral or bilateral; lumbar 22899 Unlisted procedure, spine Percutaneous aspiration within the nucleus pulosus, intervertebral disc, or 62267 paravertebral tissue for diagnostic purposes Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, 62287 any method, single or multiple levels, lumbar (e.g., manual or automated percutaneous discectomy, percutaneous laser discectomy) Injection procedure for chemonucleolysis, including discography, intervertebral disc, 62292 single or multiple levels, lumbar Endoscopic decompression of spinal cord, nerve root(s), including laminotomy, partial 62380 facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc, 1 interspace, lumbar Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging 64635 guidance (fluoroscopy or CT); lumbar or sacral, single facet joint … each additional facet joint (List separately in addition to code for primary 64636 procedure) Unlisted procedure, nervous system (applies to the nerve root and not the 64999 musculoskeletal system) HCPCS Level II Codes Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, S2348 using radiofrequency energy, single or multiple levels, lumbar

38 Low Back Pain: Minimally Invasive and Non-Corticosteroid Percutaneous Interventions

Approved January 18, 2018 February 2018 QHOC Packet - Page 64 Tobacco smoking cessation and elective surgery

THIS DOCUMENT AND INFORMATION CONTAINED WITHIN IT IS PRELIMINARY TO ANY FINAL AGENCY ACTION OR RECOMMENDATION. THIS DOCUMENT HAS BEEN CREATED FOR THE PURPOSE OF CONSIDERATION OF POTENTIAL REVIEW BY THE HEALTH EVIDENCE REVIEW COMMISSION (HERC) OR ONE OF ITS SUBCOMMITTEES OR ADVISORY PANELS AND DOES NOT REPRESENT THE OPINION OF THE HERC OR ANY OF ITS SUBCOMMITTEES OR ADVISORY PANELS. THIS DOCUMENT WILL NOT BE PRESENTED TO THE HERC FOR CONSIDERATION IN ITS CURRENT FORM AS THIS DOCUMENT IS EXPECTED TO UNDERGO REVISION ONCE ALL RELEVANT INFORMATION IS GATHERED FROM SUBJECT MATTER EXPERTS, MEMBERS OF THE HERC AND ITS SUBSIDIARY BODIES, AND OTHER STAKEHOLDERS. THE INFORMATION CONTAINED IN THIS DOCUMENT DOES NOT REPRESENT AN OFFICIAL POSITION OF THE OREGON HEALTH AUTHORITY OR HERC AND IS NOT TO BE USED, IN WHOLE OR IN PART, IN ANY CAPACITY IN CONDUCTING BUSINESS RELATED TO THE OREGON HEALTH PLAN EXCEPT FOR THE EXPRESS PURPOSE STATED ABOVE. THIS DOCUMENT MAY BE SUBJECT TO CERTAIN EXEMPTIONS FROM DISCLOSURE UNDER THE OREGON PUBLIC RECORDS LAW AND SHOULD NOT BE DISTRIBUTED TO ANY RECIPIENT OTHER THAN THE ORIGINAL INTENDED RECIPIENTS WITHOUT THE EXPRESS WRITTEN CONSENT OF THE HERC OR ITS DESIGNEE.

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. 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 defining 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:

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

February 2018 QHOC Packet - Page 65 Tobacco smoking cessation and elective surgery

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.

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 (i.e. when a delay in the procedure may 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 alternatives to urine cotinine to demonstrate smoking cessation may be considered: • Exhaled carbon monoxide testing • 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.

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

February 2018 QHOC Packet - Page 66 Subject line: HERC’s HTAS meeting 3-1-2018

The Health Evidence Review Commission’s Health Technology Assessment Subcommittee will meet 3/1/2018 from 1:00 to 4:00 p.m. The agenda will include discussion of the initial drafts of coverage guidances on the following topics:

• Gene Expression Profiling for Breast Cancer • Prostatic Urethral Lift for Treatment of Benign Prostatic Hypertrophy

Public listen-in only line: 1-888-204-5984, participant code 801373 Webinar Registration Link: https://attendee.gotowebinar.com/rt/7320062819860749571

Location: Clackamas Community College Wilsonville Training Center, Rooms 111-112, 29353 SW Town Center Loop E, Wilsonville, Oregon 97070

For more information about the meeting, visit the committee’s website. The meeting agenda and materials will be available one week before the meeting.

Everyone has a right to know about and use Oregon Health Authority (OHA) programs and services. OHA provides free help. Some examples of the free help OHA can provide are:

• Sign language and spoken language interpreters • Written materials in other languages • Braille • Large print • Audio and other formats

If you need help or have questions, please contact Daphne Peck at 503-373-1985, 711 TTY or [email protected] at least 48 hours before the meeting

February 2018 QHOC Packet - Page 67 Update on Hepatitis A Outbreaks

Ann Thomas, MD, MPH Acute and Communicable Disease Prevention Public Health Division