April 1, 2019
Vanila M. Singh, MD
Chief Medical Officer
U.S. Department of Health and Human Services
Office of the Assistant Secretary of Health
200 Independence Avenue, SW
Washington DC 20201
RE: HHS–OS–2018–0027; Request for Public Comments on the Pain Management Best Practices Inter-Agency Task Force Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations
Dear Dr. Singh:
The American College of Occupational and Environmental Medicine (ACOEM) appreciates the opportunity to review the US Department of Health and Human Services’ Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations. This is a comprehensive document that clearly lays out many of the problems facing patients with pain, as well as the clinicians who care for them and as the insurance systems that need to establish appropriate policies for authorization and payment for care.
ACOEM is a national medical society representing over 4,000 occupational medicine physicians and other health care professionals devoted to preventing and managing occupational injuries.
We note that the emphasis on relief of pain as a goal, rather than the pursuit of optimal function and participation in life, is part of the reason for this current opioid crisis. As long as the primary goal of treatment of pain is relief of pain, there will be patients who do not find this relief and are at risk for receiving excessive and harmful treatment that is unlikely to work.
The primary focus throughout the recommendations should be a central focus on function
It is functional improvement, functional restoration and functional preservation that should drive recommendations. This is particularly true as, after exhausting the search for (infrequent) curative interventions, chronic pain is simply not curable. Further, the opioid epidemic has been heavily driven by the past focus on pain improvement, thus accepting the 0 to 10 pain scale for rating improvements despite the worsening of function that is frequently associated with opioids. This focus on pain improvements is also currently driving interventional pain procedures that also do not materially change function but medicalize the patient, who, when enough procedures are performed, frequently ends up on opioids prescriptions.
Complex, multi-modal treatments may be needed for certain patients, but not for all patients with chronic pain. On the contrary, for the typical chronic pain patient, less is often more. Chronic pain is most effectively treated with cognitive behavioral therapy (CBT), aerobic exercise, strengthening exercise and NSAIDs/acetaminophen. We strongly agree with the recommendations to remove authorization and reimbursement barriers to proven forms of treatment such as CBT.
It is important for primary care providers to understand that the vast majority of chronic pain patients can and should be successfully managed by primary care. Multi-disciplinary pain teams are necessary and may be needed for those with chronic pain and poor function and/or other complications.
What is most needed to advance knowledge about successful treatments is randomized, sham- controlled clinical trials performed at centers without conflict of interests to assess interventional pain procedures. It would be advisable to have sufficiently sized protocols thoroughly double-blinding (patient, assessor), using objective functional measures with controls for co-interventions and careful procedures to control for participation/dropout problems. Statistical analyses should include intention to treat. These protocols should be approved in advance and closely monitored with Data and Safety Monitoring Boards.
For those interventions with evidence of efficacy compared with sham, there should be quality comparative trials to assess relative value of the interventions, including sufficient follow-up over time.
We note that many of the interventions and procedures recommended in the DHHS Draft Report have not been shown to be effective or safe using such research criteria. ACOEM agrees with most of the gaps and recommendations in the report, but we offer the following comments on specific recommendations that we think would benefit from revision.
Section 2.1.1 Acute Pain
Procedures and interventions should only be recommended if there is research evidence of effectiveness and safety. Many of the procedures listed in this section do not have such evidence to support them. All patients with pain should be screened for risk of addiction (with consideration of risks such as pain catastrophization, disability beliefs, and history of substance use disorders), and for those with increased risk, there should be a thoughtful and detailed pain management plan with start and stop dates. Patients at the highest risk, e.g., those with history of substance use disorder, would benefit from a multimodal consultation with an addiction specialist.
Section 2.2 Medication
We disagree with the inclusion of muscle relaxants or benzodiazepines for pain relief in chronic pain. Their use may cause more harm than good. If used in acute pain, the indications should be clear, and the course very short. We have some concern about the recommendation to increase referral to pain management experts; there is a wide range of actual expertise among those who are so labeled, and some studies have shown worse outcomes for patients under their care.1 A better approach would be to increase the competency and confidence of primary care clinicians in managing their patients’ pain.
Patients with pain that meets clinical indication for consideration of opioids should receive screening for risk, and there should be an informed decision-making discussion with the patient. DHHS should consider developing tools for such screening and to support informed decision-making discussions in acute, subacute and chronic pain situations.
Regarding buprenorphine, there should be re-evaluation of the approach of needing waivers to prescribe this for patients with opioid use disorder (OUD) but not when used for patients with chronic pain. There is much overlap in these patients and much stigma attached to the OUD diagnosis. All clinicians prescribing buprenorphine for any indication should be required to have education about this topic. Much research is needed on the long-term risks vs. benefits of buprenorphine, impact of its long- term use on alertness and employment, and indications for and approaches to weaning.
Section 2.2.1 Risk Assessment
Risk assessment is very important. There are many possible validated scales that can help identify patients at risk for adverse outcomes, including work disability. Note that there are some risks, such as pain catastrophization, that increase risk of many important outcomes, such as work disability, opioid addiction and excessive medical care. Treating providers need more education about these risks and screening for them. We agree that there needs to be a mechanism for reimbursing clinicians for the time it takes to do such screening, and counseling to mitigate these risks.
Section 126.96.36.199 Prescription Drug Monitoring Programs
We disagree with relaxing requirements to check state PDMPs but agree with the need for streamlining access.
Thank you for your consideration of this request. Please do not hesitate to contact Patrick O’Connor, ACOEM’s Director of Government Affairs, at 703-351-6222 with any questions.
William G. Buchta, MD, MPH, FACOEM
1Bernacki J. The impact of cost intensive physicians on workers' compensation. J Occup Environ Med. 2010;52(1):22-8.