Introduction: As the US comes to grips with a crisis of opioid overdose and addiction, many professionals have assessed that excessive opioid prescribing, based on weak data, helped us reach this point. Efforts to reduce prescribing while optimizing care for patients with pain, and expanding access to addiction treatment, are of cardinal importance. How we advance these objectives depends partly on changing our shared understandings of what it means to deliver good care. It also depends on policies, resources and formal methods to assess if we are doing a good job. The 2016 Guideline on Prescribing Opioids for Chronic Pain from the Centers for Disease Control and Prevention (CDC) represents one such effort.

In early 2017, a new and consequential proposal was made by the National Committee for Quality Assurance (NCQA), which seeks to advance health care quality through measurement and accreditation. NCQA’s highly influential performance measures help purchasers and consumers to assess whether health care quality is good or bad. When NCQA issued a draft set of standards related to opioids in 2017, they requested public comment. One of the measures counts the percentage of health plan members receiving opioid doses greater than the equivalent of 120 milligrams of morphine (MME), with a lower percentage counting as evidence of better care.

The premise, focused on dose, is similar to recent proposal from the Centers for Medicare and Medicaid Services. The concern about dose as an important risk factor for adverse opioid outcomes is well-justified. But well-justified concerns do not always translate into fault-free performance targets, particularly when doing so entails clinical practices not yet tested in scientific trials, and not endorsed by the CDC Guideline. Eighty doctoral level clinicians from across the country, mostly academic physicians, have endorsed the letter submitted to NCQA on March 22, 2017. They include four who had roles assisting the Centers for Disease Control and Prevention in development of the 2016 CDC Guideline, and five who edit scholarly journals in addiction medicine or pain. This document represents the opinion of signers, and not that of any agency for which they work. We welcome your feedback here or on Twitter, including two of the authors (@StefanKertesz @SubstanceAbuseJ) as well as NCQA itself (@NCQA).

Mary Barton, MD, MPP Vice President, Performance Measurement

National Commission for Quality Assurance

1100 13th Street, NW Suite 1000 Washington, DC, 20005

March 22, 2017

Dear Dr. Barton:

We write to register strong objection to the proposed “Opioid High Dosage” HEDIS measure, focused on minimizing the number patients receiving greater than 120 morphine milligram equivalents. As doctoral-level professionals in pain, in medicine and allied fields, we believe this measure will incentivize care that violates principles in the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. As a result, it will pose a serious risk to some patients currently receiving opioids. Many signatories to this letter have expertise in addiction medicine (signified “A” next to signature), or pain medicine (“P”). Persons among us who assisted the Centers for Disease Control and Prevention (CDC) in the 2016 Guideline are designated “C”. Many of us play professional roles in helping patients at high doses to taper, in mitigating opioid risk, in minimizing new opioid starts and in restraining dose escalation. Given these commitments, we understand that our strong objection to the proposed NCQA measure may come as a surprise.

To explain this objection, we must distinguish between the language of the CDC Guideline itself, and the perverse care decisions that the NCQA “Opioid High Dosage” binary measure will incentivize.

The CDC Guideline cites observational evidence associating higher opioid doses with increased adverse outcomes, including overdose. Such data justify restraint in opioid initiation (Recommendation 1) and dose escalation, with particularly careful reassessment of “evidence of individual benefits and risks” when considering increasing dosage to ≥50 mg/day and avoiding or carefully justifying decisions to titrate to ≥90 mg/day (Recommendation 5). However, the CDC Guideline did not prohibit dose escalation. Nor did it propose that any dose above a numeric threshold was “bad care”. Rather it insisted on “individual assessment of risk and benefit” as the primary basis for decision making related to both opioid dose titration and opioid dose reduction. For patients already receiving high opioid daily dosages, the CDC guideline states that “clinicians should discuss their safety concerns with the patient, consider tapering to a safer dosage (see Recommendations 5 and 7), and consider offering naloxone (see Recommendation 8).” High dose alone is not an indication for tapering or discontinuation.

On this basis, most of us wish to see an evolution toward fewer opioid starts and fewer patients at high doses. The proposed NCQA measure indulges no such subtleties. It will incentivize rapid efforts to minimize the number of patients whose current opioid dose exceeds 120 MME. The most efficient action to optimize measure performance would involve dose reduction for patients at >120 MME, regardless of patient acceptance, the mix of benefits and harms specific to the individual patient, or the potential harms of rapidly tapering patients prescribed high doses for many years. This is happening in many health systems today, despite the lack of any evidence to assess its impact on risk to patients, and the reality that the CDC Guideline did not endorse this approach.

Of particular concern, widespread unilateral dose reductions that would be incentivized by this HEDIS measure contradict Recommendations 5 and 7 of the CDC Guideline, both of which emphasize individualized assessment and decision making. Recommendation 5 applies only to new opioid starts. Recommendation 7 suggests working with patients on an individual basis to taper opioids when benefits are not sustained or when risks outweigh benefits. High dose is cited as simply one indicator of risk in the discussion of tapering. The proposed “Opioid High Dosage” measure eviscerates the CDC Guideline of these patient-centered considerations.

Put simply, the “Opioid High Dosage” measure will accelerate a reconfiguration of care that has never been tested in prospective trials and that could actually increase risk to individual patients, as illustrated by scholarly and popular reports of acute withdrawal (with death), protracted abstinence syndrome, and suicide associated with incautious unilateral opioid discontinuation or unrelenting pain.

Finally we must underscore that institutional embrace of binary quality measures based on promising epidemiologic data has sometimes proven a mistake in retrospect. This has occurred with aggressive targets for glucose, blood pressure and lipid control. Even the widespread embrace of opioids itself (an effort to optimize pain scores) reflected extrapolation from limited data in ways that courted risk to patients.

We urge NCQA to recognize that binary metrics developed in the absence of compelling controlled trials are often treacherous. And there is little to justify a HEDIS measure that contradicts the language found in CDC Guideline Recommendations 5 and 7.

We recommend that NCQA abandon the Opioid High Dosage measure until trial data and expert review permit a more appropriate consideration of this issue. We are willing to assist you in identifying alternate measures that involve lower risk to patients.

This letter includes 80 signatories, with 4 who had formal roles assisting the Centers for Disease Control and Prevention in development of the 2016 CDC Guideline. Signers include 5 who edit scholarly journals in addiction medicine or pain, 60 with academic affiliations, 33 with special expertise in addictions, and 23 with special expertise in pain. Also, several signers have focused their careers on measuring and improving quality of care.

Disclaimer: Views expressed here are those of the signers alone, and do not represent formal positions of any employing or affiliated organization, university, or United States Federal Agency.

(A): Addiction Professional (P): Pain Professional (C ): Assisted the CDC in Opioid Guideline Development as Reviewer, Core Expert, or Author

Signatories

Stefan G. Kertesz, MD, MSc (A) University of Alabama at Birmingham School of Medicine

Adam J. Gordon, MD, MPH (A) University of Utah, Editor-in-Chief, Substance Abuse

Erin E. Krebs, MD, MPH (P, C) University of Minnesota Medical School

Joanna L. Starrels, MD, MS (A, P, C) Albert Einstein College of Medicine & Montefiore Medical Center

Chinazo Cunningham, MD, MS (A, C) Albert Einstein College of Medicine & Montefiore Medical Center

Matthew J. Bair, MD, MS Indiana University School of Medicine (P, C)

Richard Saitz MD MPH, DFASAM, FACP(A) Boston University School of Public Health, Senior Editor, Journal of Addiction Medicine

Jalie A. Tucker, PhD, MPH (A), University of Florida, Gainesville, Strategic Advisor, Addiction

Jeffrey H. Samet, MD, MPH (A) Boston University School of Medicine, Board, Addiction Medicine Foundation & Editor-in-Chief, Addiction Science & Clinical Practice

Michael E. Schatman, Ph.D (P)Tufts University School of Medicine, Editor-in-Chief, Journal of Pain Research

Peter D. Friedmann, MD, MPH, DFASAM, FACP (A) University of Massachusetts Medical School-Baystate, Deputy Editor, Journal of Substance Abuse Treatment

William M. Tierney, MD, MACP, Dell Medical School, University of Texas at Austin, Past President, Society of General Internal Medicine

Robert M Centor, MD, University of Alabama of Birmingham School of Medicine, Master, American College of Physicians, Past President, Society of General Internal Medicine

Nancy L. Keating, MD, MPH, Harvard Medical School and Brigham and Women’s Hospital

Max Michael, MD, Dean, University of Alabama at Birmingham School of Public Health

Ken Freedman, MD, MS, MBA (A) Tufts University School of Medicine, Boston, MA

Jane M. Liebschutz, MD MPH, (A,P) Boston University School of Medicine

Julia Lindenberg MD, Beth Israel Deaconess Medical Center

Terrence Shaneyfelt MD, MPh, University of Alabama at Birmingham School of Medicine

Name Redacted

Laurie Gordon, MD, New York, NY

David E. Pollio, PhD (A), Chair, Department of Social Work, University of Alabama at Birmingham

Daniel Pomerantz MD MPH FACP, Albert Einstein College of Medicine, New York

Toshiko Uchida, MD, FACP, Northwestern University Feinberg School of Medicine

John D. Goodson, MD, FACP. Harvard Medical School, Massachusetts General Hospital

Daniel P. Alford, MD, MPH, FACP, DFASAM (A, P) Boston University School of Medicine, Boston Medical Center

Carol K. Bates, MD, FACP, Harvard Medical School and Beth Israel Deaconess Medical Center

Lynn Webster, MD (P) Vice President, PRA Health Science and Past President, American Academy of Pain Medicine

Marcus A. Bachhuber, MD, MS, Montefiore Medical Center/Albert Einstein College of Medicine

James DeMicco, PharmD, Hackensack, New Jersey

Joseph W. Frank, MD, MPH (P) VA Eastern Colorado Health Care System and University of Colorado School of Medicine

Kimber P. Richter PhD, MPH (A) University of Kansas School of Medicine

Saul J. Weiner, MD, University of Illinois at Chicago School of Medicine

Michael Banks, MD, Orothwest

Michael Fingerhood MD FACP (A), Johns Hopkins University School of Medicine

Josiah D. “Jody” Rich, MD, MPH (A), Warren Alpert Medical School of Brown University

Signatory’s name redacted by request

Monika M. Safford, MD, Weill Cornell Medicine, New York, NY

Lauren Broyles, PhD, RN (A), Grant Writer’s Seminars and Workshops, VA Pittsburgh Healthcare System

Gerald Cochran, MSW, PhD (A), University of Pittsburgh, School of Social Work, School of Medicine

Ryan Kraemer, MD, University of Alabama at Birmingham School of Medicine

Thomas S. Huddle, MD, PhD, University of Alabama at Birmingham School of Medicine

Terri A, Lewis, PhD, NCoC, Southern Illinois University-Carbondale, Rehabilitation Institute

David Nagel, MD (P) private practice, author, “Needless Suffering; How Society Fails Those with Chronic Pain.”

Stephen J. Ziegler, PhD, JD, Indiana University-Purdue University, Dept of Public Policy

Janey C. Peterson EdD, MS, RN (P), Weill Cornell Medicine, New York, NY

Stephen A. Paget, MD (P) Hospital For Special Surgery, Weill Cornell Medicine, New York, NY

Diana Coffa, MD (P) (A), University of California, San Francisco, CA

Paula J. Lum, MD MPH FASAM (A), University of California, San Francisco, CA,

Tim Lahey, MD MMSc, Dartmouth’s Geisel School of Medicine

Diane S. Morse, MD (A), University of Rochester School of Medicine

Elvin Geng, MD MPH, University of California, San Francisco School of Medicine

Emma Stanton, MD MBA (A), Beacon Health Options

Thomas E. Reznik, MD, MPH (P), Providence VA Medical Center and Warren Alpert Medical School of Brown University

Barbara Herbert MD FASAM (A) Senior Medical Advisor, Column Health, Arlington Mass

Ingrid Binswanger, MD, MPH, MS (A) University of Colorado School of Medicine, Aurora, CO

Michael F. Bierer MD MPH (A) Harvard Medical School Boston MA

Howard Hoffberg, MD, (P) Rehabilitation and Pain Management Associates, Baltimore MD

Signatory’s name redacted by request

Thomas Sachy, MD, MSc, (P) (A) Georgia Pain and Behavioral Medicine, Gray, GA

Kevin R. Riggs, MD, MPH, University of Alabama at Birmingham School of Medicine

Calie Santana, MD, MHS, Internal Medicine, WESTMED Medical Group

Stephen Martin, MD, EdM (A) University of Massachusetts Medical School

Monica Gandhi MD, MPH, Professor of Medicine and Ward 86 Clinic Director, UCSF

Janet Grochowski, PharmD, Clinical Pharmacist, Positive Health Program (Ward 86), UCSF

Zackary Berger, MD, PhD, Johns Hopkins School of Medicine

Royce C. Lin MD, University of California, San Francisco School of Medicine

Sarah E. Wakeman, MD, FASAM (A), Massachusetts General Hospital, Harvard Medical School

Thomas Sachy, MD, MSc, (P) (A), Georgia Pain and Behavioral Medicine

Paul Arnstein, RN, PhD, FAAN (P)

David S. Craig, PharmD, Moffitt Cancer Center, Tampa FL

Michael J, Brennan, MD (P) The Pain Center of Fairfield, Fairfield CT

Sri Nalamachu, MD (P), Overland Park, KS

Jayne Pawasauskas, PharmD, BCPS (P) University of Rhode Island College of Pharmacy

Jeffrey Fudin, B.S., Pharm.D., DAAPM, FCCP, FASHP (P), President and Director, Scientific and Clinical Affairs, REMITIGATE, LLC

Debra F. Hobbins, DNP, APRN, LASUDC, CARN-AP, Anchorage, AK

Shelley Trazkovich, M.D (A) (P), Reisterstown, Maryland

James Patrick Murphy, MD, MMM, FASAM (A,P); Murphy Pain Center; Univ of Louisville Sch of Medicine; Past Pres, Greater Louisville Medical Soc

Anika Alvanzo, MD, MS, FASAM, FACP (A), Johns Hopkins University School of Medicine

Teresa Bryan, MD, University of Alabama at Birmingham School of Medicine