Richard A. “Red” Lawhern, PhD
Co-Founder and Corresponding Secretary
Alliance for the Treatment of Intractable Pain
After review and comments by medical professionals associated with ATIP, I have submitted the following commentary in the Federal Register Docket concerning Centers for Medicare and Medicaid efforts to impose hard limits on opioid prescribing. We urge all pain community members to submit their own stories and concerns by March 5th.
My response to the CMS Opioid Policies:
I am a technically trained non-physician subject matter expert on public policy for treatment of chronic pain, backed by ~200 medical professionals, healthcare writers, knowledgeable patients and caregivers in the Alliance for the Treatment of Intractable Pain.
CMS proposes “all sponsors to implement hard formulary-level cumulative opioid safety edits at point-of-sale (POS) at the pharmacy (which can only be overridden by the sponsor) at 90 morphine milligram equivalent (MME), with a 7 days supply allowance.”
Under 42 US Code ~1395, US government agencies are legally restricted from controlling the practice of medicine. Proposed regulation changes are an attempt to subvert that law by injecting financially self-interested insurance companies into control of medical practice as proxies for direct government interference. CMS proposals mandate a dangerous, unfounded and medically unethical intrusion into medical practice by third parties operating without face to face knowledge of the patient. These draconian changes will damage and deny care to large numbers of the 1.6 million patients whom CMS estimates are presently treated with opioids above 90 morphine milligram equivalent dose per day.
It is widely known that CDC Guidelines on which these changes are based are factually in error and biased in their reading of evidence on risks of opioid analgesics. Very few pain patients ever display DSM-5 markers for opioid use disorder. Managed medical exposure to opioids contributes almost nothing to the widely hyped “opioid crisis”. Drug-related overdoses have risen steadily in the past ten years despite restriction of medical supply — a death toll entirely associated with nonprescription drugs.
Over-regulation of prescribing is already harming hundreds of thousands of stable patients coerced to reduce doses below therapeutic levels. Mandated VHA restrictions on opioid prescribing are directly responsible for hundreds of deaths among Veterans.
A major study in the January 2018 British Medical Journal illustrates the foolishness of the CMS proposal. Diagnoses of opioid abuse disorder were tracked for 565,000 opioid-naïve post-surgical patients followed an average of 2.6 years. Only 0.6% were later diagnosed with OAD. Less than 1% renewed prescriptions up to 13 weeks. OAD incidence was only weakly sensitive to dose level from <20 MME to >120 MME per day. OAD diagnoses were likely made by physicians with little expertise in chronic pain and without reference to formal criteria (DSM). A second large cohort study in JAMA Internal Medicine (Sep 2016) shows incidence of extended post-surgical opioid prescriptions at 0.135%.
CMS is trying to “solve” a non-problem by means guaranteed to create far worse problems.
CDC Guidelines ignore genetic polymorphism in the expression of liver enzymes governing opioid metabolism. Imposing hard limits on MMED in “safety” audits will cause therapy failure in hundreds of thousands of patients who can benefit from opioids, but only at significantly higher doses than entertained by CDC and this regulation change.
In January 30 public hearings before the FDA Opioid Policy Steering Committee, the American Academy of Pain Management recommended against hard limits on opioid analgesics. Other speakers advocated for leaving practice standards to medical professional associations which guide doctors in each specialty.
There is no one-size-fits-all patient or treatment plan.
Forcing pain patients to go through an “exceptions” process before extending prescriptions beyond 7 days is inappropriate and dangerous nonsense. Prevailing practice allows for prescription duration sufficient to treat anticipated pain levels. The alternative is to drown doctors in useless paperwork and to prompt patients to defer needed surgery because they fear being left without pain control.
Proposals for restricting co-prescription of so-called “potentiating” drugs like Benzodiazepines, Lyrica or Gabapentin are also problematic. Conclusions regarding adverse effects of combined opioid-benzodiazepine treatment derive entirely from poorly controlled, retrospective case-control studies. Prospective studies of the combination show trivial effects on arterial oxygen saturation. However, under-treatment of anxiety and depression in pain patients are major factors in overdose deaths. Lyrica and Gabapentin are also widely used in seizures, fibromyalgia and neuropathy – conditions which produce disabling pain and mortality risk. There are presently no published data to establish a single reliable threshold criterion for safe use of combinations of these medications. But denial of this option will disable many patients and kill some by iatrogenic suicide.
CMS should stand down from attempting to force restrictions on medical practice which have such predictable and horrid consequences.