HHS Docket – Pain Management Task Force Draft Report (Comments Due April 1, 2019)

by adatompson on March 15, 2019

Hello ARPO Members and Friends,

It has been a long time since we have communicated with the ARPO community!  We have kept watch on developments with the opioid epidemic, so that we can advocate when needed.  One such moment is upon us.  Read on – and then please post a comment if you or a loved one have had an adverse experience with a prescription opioid.

In March of 2016, the Centers for Disease Control (CDC) published a long-needed guideline for prescribing opioids for “chronic pain outside of active cancer treatment, palliative care, and end-of-life care”.  The CDC guideline is directed at primary care clinicians (which include physicians as well as nurse practitioners and physician assistants), who prescribe a significant (roughly half) and growing percentage of opioid prescriptions, yet who all too frequently lack the proper expertise to prescribe opioids in an evidence-based manner.  The CDC guideline is based on a systematic review of the best available evidence and is designed to promote “safer and more effective treatment including improved patient outcomes such as reduced pain and improved function, while reducing the number of persons who develop opioid use disorder, overdose, or experience other adverse events”.  The CDC guideline provides a critically important tool to help primary care clinicians prescribe opioids for chronic pain in an appropriate manner (CDC 2016).  We believe the CDC Guideline is already reducing opioid prescribing in opioid-naive patients with chronic non-cancer pain and is reducing both opioid-related deaths and addiction which originates with prescription opioids.

Recently, pursuant to the Comprehensive Addiction and Recovery Act of 2016, the U.S. Department of Health and Human Services (HHS) established the Pain Management Best Practices Inter-Agency Task Force, whose mission is to “determine whether gaps in or inconsistencies between best practices for acute and chronic pain management exist and to propose updates and recommendations to those best practices” (Task Force Draft Report 2018).  This Task Force, which is comprised of pain experts from the federal government as well as industry and academia, appears tilted in favor of the opioid industry.  It has produced a draft report which offers recommendations concerning pain management best practices.  Of particular concern to ARPO and other advocate organizations are the generally critical comments in the report concerning the CDC guideline, despite an acknowledgement in the report that the aggressive marketing of opioids by pharmaceutical companies has resulted in the liberalization of opioid prescribing that is fueling the epidemic.  This report, if it is allowed to go forward without further revision, could set us back and gravely exacerbate confusion and inconsistency with prescribing, and ultimately lead to more overdoses, addictions, and deaths.

HHS has opened a public docket on this draft report.  As often happens with these public dockets, a groundswell of pain organizations and pain patients have been organized to provide comments.  Of hundreds of comments filed to date, almost all of them are from pain patients who are afraid of losing their opioid medications.  However, this fear is improperly directed toward the CDC guideline, which is voluntary and does not recommend cutting legacy patients off their opioids.  Almost no one is speaking up in support of more cautious opioid prescribing in general, and the CDC guideline in particular.  That’s where you come in.  ARPO needs your help to submit a comment in support of the CDC guideline.

The draft report is actually quite lengthy.  To make things easier we will offer some suggestions for those who simply want to log in with a comment.  In addition, the section on the CDC guideline begins on page 51; you might want to read this part of the report to gain an understanding of what the task force is recommending.  Here is the link to the draft report: https://www.hhs.gov/ash/advisory-committees/pain/index.html  For additional background, the CDC guideline can be found at the following link: https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

Previous surveys of our members have shown that a majority of ARPO members’ experiences involved a doctor’s prescription.    When posting your comment, you should include how prescription opioids have affected you and your loved one(s) as a basis for why you strongly support the CDC guideline.  Following are some points to emphasize in your comments – feel free to borrow from these.

The report’s criticism of the CDC guideline should be removed from the report or significantly revised for the following reasons:

1) Primary care clinicians often lack adequate training in the use of opioids for chronic pain management.  The CDC guideline provides a critically important tool to help primary care clinicians prescribe opioids for chronic pain in an evidence-based manner.

2) The CDC guideline appropriately reflects the high risk inherent in the use of opioids for chronic pain management and emphasizes non-opioid treatment strategies in opioid-naive chronic non-cancer pain patients.

3) The CDC guideline is voluntary and does not recommend involuntarily cutting legacy patients off their opioids.  While the guideline does encourage clinicians to evaluate benefits and harms of continued opioid therapy and to work with patients to optimize other therapies and taper opioids to lower dosages or to discontinue opioid therapy if feasible, the guideline does not recommend forced opioid tapering of patients with chronic noncancer pain.  Each case needs to be evaluated individually, especially to diagnose opioid use disorder/addiction and to get patients into proper treatment.  We support clarification on this point.

4) The CDC guideline does not address use of opioids for patients less than 18 years of age, nor does it address treatment of pain for cancer, end-of- life, or palliative care.  Additional guidelines may be warranted for use of opioids with these patients, and also for legacy opioid patients.

5) The CDC guideline is intended to promote non-opioid multidisciplinary strategies as a first-line therapy for chronic non-cancer pain, with more cautious, evidenced-based opioid prescribing.  The implication in the Draft Report that a lack of clinical trials with a duration of one year or longer is a “limitation” of the CDC guideline is in fact just the opposite – it is an important justification for more cautious opioid prescribing.

6)  Much of the criticism of the CDC guideline in the Draft Report concerns what the report refers to as “misinterpretation” and “misapplication” of the guideline. However, the guideline as written is abundantly clear that it is intended for primary care clinicians.

When you are ready to submit your comment, go to this link to the docket:  https://www.regulations.gov/docket?D=HHS-OS-2018-0027

Comments are due by April 1st at 5 p.m. Eastern Time.  If you are affiliated with another advocate organization which supports the CDC guideline, please share this with your distribution list.  Thank you for helping out with a comment!

Pete Jackson, President

Advocates for the Reform of Prescription Opioids

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