On September 25th, 2018, Margaret Wilson, Trina Vaughn and Richard “Red” Lawhern, Ph.D., traveled to Washington DC to make presentations during the public comments period in the second meeting of the HHS Inter Agency Task Force on Best Practices in Pain Management. The Task Force is developing recommendations to Congress for resolution of gaps and inconsistencies in medical best practice standards for pain management. Several substantially revised or new directions are emerging from thousands of staff hours spent since May 2018.
The following are not exact quotes, but reflect Dr. Lawhern’s understanding or summary of the discussions and visual aids he saw and heard.
Many of the new directions of the Task Force seem to track more closely to the experience of pain patients and the advocacy positions of the Alliance and other patient groups. As reflected in presentations by some senior officials in major government healthcare organizations (notably the Veterans Administration,) not all of these insights are fully shared by senior appointed officials, but a process of education is underway and appears to be led by the medical professionals of the Task Force.
A very startling and constructive observation was echoed by two of the three legislators who spoke: we must not create a second crisis in under-treatment of pain while trying to solve the public health crisis on opioid addiction and death. This is significant progress.
For the first time in any federal forum, members of the Task Force acknowledged that the 2016 CDC Guidelines on opioid prescription have had major unintended and deadly outcomes which Task Force recommendations must seek to address. Among those outcomes:
- Patients are being deserted by doctors afraid of losing their licenses due to state and federal prosecution. Significant numbers of doctors are leaving pain practice and that unhelpful trend must be stopped.
- Some patients are almost certainly being driven into street drugs, finding no alternatives to address their pain after being denied treatment by their doctors. Part of the rising death toll in opioid overdose is a consequence of patients taking unsafe street drugs.
- The Task Force acknowledged that significant numbers of pain patients have committed suicide after being denied treatment. An estimated 8% of all suicides occur among patients currently or formerly being treated for severe chronic pain (probably more, given that these numbers are likely under-reported).
- Also central was the observation that there is no one-size-fits-all patient, and there can be no single maximum dose limit for all patients (this point was contested by the CDC representative on the Task Force.) Significant numbers of deaths occur in patients taking less than 90 MMEDD, and many patients who take much higher doses are stable and well served by their medications. This insight can be carried forward to challenge the recently dictated rule changes of HHS/Center for Medicare and Medicaid Services, which emphasize pre-authorizations and denial of high-dose opioid treatment even in patients assessed to be stable.
- There is an understanding among Task Force members that mandatory opioid tapering of legacy patients who are otherwise stable with improved function, is not medically justified and may create risks of patient physical or psychological collapse. The presentation of Dr. Beth Darnall last week to the Oregon Medicare task force appears to be known and respected by at least several of the Task Force Members.
- There is broad recognition that variable metabolism plays a significant role in the wide range of patient responses to opioids and other analgesics, and it must be accounted for in any best practice standard. This is a major evolution from the silence of the CDC Guidelines on the subject.
- Urine testing results (and pain contracts) have too often been used as a “gotcha” justification for unilateral patient discharge. This practice must stop. Discharge of patients without referral to effective treatment is medically unethical and dangerous. Urine test results should be used to identify patients who need more support or possibly changes in treatment; not to justify doctor desertion.
- Medical providers and patients must be educated to reduce and eventually eliminate stigma associated with both opioid treatment and mental health treatment for the depression which often accompanies chronic pain. Patients are not addicts, nor are they at significant risk to addiction in properly managed pain treatment. However, patients do become opioid dependent and some become highly opioid tolerant. Doctors need better training in recognizing and managing these realities of pain management, and in recognizing the strong interactions between pain and depression.
The Task Force also identified other significant points of emphasis that affect treatment of pain.
- Early diagnosis is needed of the underlying causes of pain before it transitions from acute to chronic and before a treatment plan is developed. Complex patients need access to multiple medical specialists in a team process that examines all pertinent dimensions of patient health and arrives at a joint treatment plan in which the patient participates as a responsible team member. Unmentioned initially in these proceedings was the reality that initiatives in this direction must address the current shortage of fully trained medical professionals to have a practical effect on general practice. Standards avail us nothing if there aren’t enough qualified people to practice them.
- Considerable emphasis is being placed on “integrative” care which incorporates non-opioid analgesics, anti-convulsives, anti-inflammatory meds and where appropriate, opioids. Non-medication treatments will also be trialed and observed in parallel with medications, not as “step therapy” that refuses opioids even where they are needed. The objective is to find the most effective and timely combination of therapies for each patient. It is recognized that many patients do not respond to non-invasive, non-drug therapies, though some patients do. Thus, complementary and alternative therapies are not viewed as “replacements” for opioids, but rather as adjuncts which may be tried in an effort to find the best combination of therapies for each individual.
- It is also recognized that medical evidence is presently weak for treatments such as Rational Cognitive Therapy, behavioral therapies of various types, acupuncture, mindfulness, Tai Chi, yoga, stress reduction, and other non-invasive therapies. Thus, the criterion for including such therapies will likely not be “medical evidence” (typically outcomes of large scale dual-blind randomized trials,) but rather “treatment informed by evidence” (where small scale trials indicate potential value, but no definitive standard of consistent care has yet been established.) Details and nuances of this shift of emphasis remain to be worked out, but the central premise is to explore patient-centered alternatives that are supportive rather than restrictive, and to acquire an expanding base of outcomes experience as practice is refined.
- AI-based, keyword pattern recognition tools are being applied to identify major areas of focus and input in the public responses to the Federal Docket. Some of the public remarks in the Docket from May were used in charts briefed to the Task Force by their sub-committees. Thus, I have at least a measure of confidence that public input is actually being read and characterized in the Task Force process. This seems to be a decided improvement over the performance of HHS/CMS in its public docket activity for 2019 rule changes to Medicare and Medicaid.
At the end of the meeting, the Task Force voted to proceed with near term publication of the detailed draft report, for review by both the public at large and the members of Task Force itself. Responses to the report will be adjudicated and combined in a final draft and voted upon again by the Task Force members before submission to Congress. Under the enabling legislation, this process does not require sign-off or validation by other Government departments. The House and Senate are asking for timeliness, clarity, and consistency in recommendations to guide legislation. Deadline for final publication is May 1, 2019.
Dr. Lawhern also provided a hard copy of his presentation and a forthcoming article in Practical Pain Management, coauthored with Dr. Stephen Nadeau, to the Assistant Secretary for Policy in the Department of Veterans Affairs. Dr. Lawhern observed to the Secretary that despite the VA’s self-congratulations, multiple veterans have reported that the outgrowth of the so-called “VA Opioid Safety Initiative” has been a rash of veteran suicides.
A note of encouragement:
ATIP appeared to be known in a context of being credible, evidence-based, constructive, and professional, and Dr. Lawhern’s name was recognized by many Task Force members with whom he spoke during this meeting. This is a very desirable outcome within what is often highly polarized political process. To be accepted as colleagues rather than viewed as unqualified petitioners (however sincere), gives ATIP options for greater constructive influence and collaboration. As an Alliance, we are seeing similar views expressed by intermediate level policy officials in several other state and federal lobbying efforts on behalf of people in pain.