An Open Letter to HHS/CMS on Proposed Rule Changes for 2021

People who follow my work in social media and other publications will be aware that I advocate for chronic pain patients and their doctors, with articles in a mix of medical journals and popular media. I also venture into direct contradictions of some of the idiocy being peddled by government bureaucrats concerning regulatory policy on prescription opioid analgesics. The following is a 5500 word commentary filed this morning with the Department of Health and Human Services Center for Medicare and Medicaid Services. It formally addresses the vast incompetence and misdirection of this Agency and its proposed rule changes for Medicare over the next two years.

In this work, I have been joined by two highly gifted medical professionals, whose qualifications are noted in the comments to CMS. My thanks for the participation of Stephen E Nadeau, MD, and Andrea Trescot MD, from whom I have learned a great deal and to whom we are all indebted for their dedication to medical facts and ethics.

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Comments to Proposed Rules: “Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes… “ etc. File code CMS-4190-P

Stephen E Nadeau MD, Andrea Trescot MD and  Richard A Lawhern PhD

March 2020

These comments respond to a public announcement of proposed rule changes for 2021 and 2022 in Medicare Advantage and the Medicare Prescription Drug Benefit programs, as announced in the Federal Register. 

About the Authors:

Stephen E Nadeau MD is an experienced pain management physician with over 100 published peer review papers in medical literature. He presently serves as Associate Chief of Staff for Research at the Malcom Randall VA Medical Center. He is a professor of Neurology and Clinical and Health Psychology at the University of Florida College of Medicine, in Gainesville. Observations communicated in this paper do not represent the policy of the Veterans Administration or the University of Florida.

Andrea Trescot MD is a past president of the American Society of Interventional Pain Physicians, and was a member of the Department of Human Services Inter Agency Task Force on Best Practices in Pain Management.

Richard A Lawhern PhD is a technically trained non-physician patient advocate and medical literature analyst, with 22+ years experience building and moderating peer-to-peer patient support groups in social media, and over 80 published papers, articles, and addresses in a mixture of medical journals and mass media. He is also principle author (with over 100 endorsers), of a November 5, 2018 petition to HHS/CMS Director Seema Verma, demanding suspension of then-proposed rules for 2020 authorizing Medicare insurance providers to conduct unilateral “safety edits” for prescriptions exceeding 100-200 morphine milligram equivalent daily dose.   

Central Issues in the Proposed Rules:

1. Implicit in these proposals is an assumption that prescription of opioids and/or benzodiazepines is the major cause of the opioid crisis. It is widely assumed that curtailing such prescriptions will have a significant positive effect on overdose morbidity and mortality. These assumptions are provably false and vastly misdirected. There is no correlation in any age group between rates of opioid prescribing by physicians and either addiction or overdose related mortality. 

The US opioid “crisis” is driven primarily by socio-economic factors and street drugs. The contribution of medically prescribed opioids is so small that it gets lost in the noise.

Reference: Jacob Sullum, “New Survey Data Confirm That Opioid Deaths Do Not Correlate with Pain Pill Abuse or Addiction Rates” Reason Magazine, August 21, 2019, https://reason.com/2019/08/21/new-survey-data-confirm-that-opioid-deaths-do-not-correlate-with-pain-pill-abuse-or-addiction-rates/

2. These rule changes assign major responsibilities and powers to Medicare Part D sponsors. Since these sponsors have a pecuniary interest in minimizing the drugs they pay for, profit rather than patient well-being will be the major driver of their procedures and protocols. Both physicians and advocates spend hours each week dealing with denial of care, including medications, by sponsors. The people denying the care are often not physicians and they make no attempt to access patient medical records to develop informed judgments. 

3. The regulations planned here will constitute a major regulatory burden on the practice of medicine and implicitly make the assumption that sponsors or pharmacists are better judges of patient benefit and risk than prescribers. This assumption is clearly wrong on fact, wrong on science, and wrong on medical ethics. 

Specific Points at Issue in the Federal Register Document. (Organized by Section)

Section: Executive Summary

A. “…Sponsors may limit access to opioids and/or benzodiazepines to a selected prescriber and/or network pharmacy and/or through a beneficiary point of sale.”

Our Comment: Such restrictions on prescription access create major burdens on patients as well as their providers, particularly in rural US States and under-served communities.

B. The definition of “at risk beneficiaries” (ARBs) will be expanded to include patients who have a history of opioid overdose as defined by the appearance of a primary diagnosis of opioid overdose in the clinical record.

Our comment: There is anecdotal evidence that emergency department evaluations and hospital admissions for patients with altered mental status often culminate in a diagnosis of opioid overdose simply on the basis of patients taking opioids chronically. This seems particularly likely to be the case if they are also taking benzodiazepines. Such mis-assignments of cause of death may be the case even when the results of a Naloxone test are negative and a urine drug screen is negative for benzodiazepines. Thus, the diagnosis of opioid overdose is likely to often be incorrect, even as it stigmatizes the patient.

A second and general concern on Benzodiazepine Prescriptions:  Special attention seems devoted at various points in the proposed regulations to a perceived need to impose regulatory oversight and access restrictions on the co-prescription of opioids and benzodiazepine medications. We believe this emphasis is highly over-done and contrary to patient health and quality of life. We also believe it is a matter that should be left to the judgment of the medical practitioner.

While it is true that overdose mortality tends to be increased among patients managed on high doses of both opioids and benzodiazepine drugs, it is by no means established that co-prescription is the “culprit” or that a cause and effect relationship leads to significant numbers of deaths by accidental respiratory depression. 

Patients for whom these medications are co-prescribed tend to be among the sickest and most complex cases that any physician will see, often dealing with multiple interactive and progressive medical disorders and sources of pain. Situational depression, social isolation, and high anxiety are frequently co-morbid with painful disorders. Failure to treat depression and anxiety is also clearly associated with bad outcomes, including suicidal ideation, actual suicide, and death directly related to pain and the stress of the psychiatric conditions.

On the issue of co-prescription, the landmark work of Nabarun Dasgupta et al. is highly instructive. Dasgupta and his colleagues traced all opioid prescriptions for the State of North Carolina for a year, to analyze incidence of prescribing and of opioid-overdose related mortality. 

Their abstract seems directly pertinent to this affidavit:

Objective. Previous studies examining opioid dose and overdose risk provide limited granularity by milligram strength and instead rely on thresholds. We quantify dose-dependent overdose mortality over a large spectrum of clinically common doses. We also examine the contributions of benzodiazepines and extended release opioid formulations to mortality.

Design. Prospective observational cohort with one year follow-up. 

Setting. One year in one state (NC) using a controlled substances prescription monitoring program, with name-linked mortality data.

Subjects. Residential population of North Carolina (n 59,560,234), with 2,182,374 opioid analgesic patients.

Methods. Exposure was dispensed prescriptions of solid oral and transdermal opioid analgesics; person-years calculated using intent-to-treat principles. Outcome was overdose deaths involving opioid analgesics in a primary or additive role. Poisson models were created, implemented using generalized estimating equations.

Results. Opioid analgesics were dispensed to 22.8% of residents. Among licensed clinicians, 89.6% prescribed opioid analgesics, and 40.0% prescribed ER formulations. There were 629 overdose deaths, half of which had an opioid analgesic prescription active on the day of death. Of 2,182,374 patients prescribed opioids, 478 overdose deaths were reported (0.022% per year). Mortality rates increased gradually across the range of average daily milligrams of morphine equivalents. 80.0% of opioid analgesic patients also received benzodiazepines. Rates of overdose death among those co-dispensed benzodiazepines and opioid analgesics were ten times higher (7.0 per 10,000 person-years, 95 percent CI: 6.3, 7.8) than opioid analgesics alone (0.7 per 10,000 person years, 95 percent CI: 0.6, 0.9).

Conclusions. Dose-dependent opioid overdose risk among patients increased gradually and did not show evidence of a distinct risk threshold. There is urgent need for guidance about combined classes of medicines to facilitate a better balance between pain relief and overdose risk.

====end extract====

Reference: Dasgupta, MPH, PhD, Michele Jonsson, Funk, PhD, Scott Proescholdbell, MPH, Annie Hirsch, MPH, Kurt M. Ribisl, PhD, and Steve Marshall, PhD, “Cohort Study of the Impact of High-Dose Opioid Analgesics on Overdose Mortality,” Pain Medicine 2016; 17: 85–98 doi: 10.1111/pme.12907 

Following on the published work discussed above, Dr Lawhern located and followed up by email to Dr Dasgupta, to further explore the relationship between prescription opioids and benzodiazepine drugs. As often found in medical literature, it turns out that one needs to understand not only relative risks, but also absolute numbers to assess potential or actual harms that attend co-prescription of opioid analgesics and benzodiazepine drugs. 

The following is a faithful copy of Dr Dasgupta’s response to Dr Lawhern’s inquiry, by email. Dr Dasgupta has granted permission to share this communication with by-name attribution.

“The percent of all opioid analgesic recipients who were also prescribed a benzodiazepine in the past year was 80.0% (n=1,747,166). Benzodiazepines were determined to be involved by medical examiners in 61.4% (n=386) of overdose deaths involving opioid analgesics.”

“So, nearly 2 million people got both a benzo and an opioid, but only 386 died of an overdose where both were implicated in the span of 1 year. Every overdose death is a heartbreak; but the numbers here clearly speak to a general safe use of the meds together.

“However my study also found that “Rates of overdose death were about ten times higher among those receiving benzodiazepines and opioids concurrently (7.0 per 10,000 person-years, 95 percent CI: 6.3, 7.8)” on a relative scale. But this was mostly at the higher end of the opioid MME spectrum (300-5000 MME daily): 

“When compared to patients receiving the same MME of opioid analgesics, difference in mortality rates among those receiving benzodiazepines was greater at higher opioid analgesic doses. At the lowest stratum, >0 to 74.9 mg/day average daily MME, the rate difference was 2.8 per 10,000 person-years, increasing to 45.8 per 10,000 person-years at the highest stratum of 300 to 5,000 mg/day average daily MME.”

“On a patient and physician level, the last sentence is most important. Allow me to reinterpret using the concept of “number needed to harm” by taking the inverse of the rate differences (table attached). You would need to treat 3,623 opioid patients (<75 MME) for a whole year with a benzodiazepine before you would see one excess overdose death from the combination. At 75-125 daily MME you would have to treat 905 opioid patients with benzos for a year before there was one additional overdose death. Whether this is a worthwhile tradeoff is up to you and your physician. To me, it seems like an awful lot of suffering that would be unnecessarily visited on patients by taking away a medication if it’s working for them.

=== End Extract from Dasgupta Correspondence ===

Subsection C. Escalation to external reviewer (“independent outside entity”) for review and resolution.

      Our comment: Most obviously, this process sets up the patient’s care for review involving third parties who may be possessed of an unreasonably biased anti-opioid mindset and incentivized by institutional conflicts of interest (e.g. reduction of costs to insurance companies).

        In the considerable experience of Dr Nadeau, outside reviews fail to reflect adequate perspective on the patient, their problems, and their care. Outside reviews can typically be appealed via phone call. However, this process inevitably involves the patient or their doctor negotiating a complex and time consuming phone triage system which routes them down several blind allies, and a dropped call or two. Ultimately, contesting such a review may require an hour or more of a physician’s time.

The outside reviewer, in Dr Nadeau’s experience, typically backs down when confronted with the documented facts of the case. But the net result is still an hour of precious medical provider time wasted. Dr Lawhern confirms that such outcomes are also reported by patients themselves in social media support groups.

Section III.A.1. The overuse management system (OMS) criteria for potential at risk beneficiaries (PARBS) are to include beneficiaries with a history of filling opioids from multiple doctors and/or multiple pharmacies.

Our Comment: Filling from multiple doctors is generally unacceptable (there are exceptions, e.g., when a surgeon prescribes extra opioids for a short period of time to get the patient through an operation). However, patients often are forced to fill from multiple pharmacies because pharmacists refuse to fill their prescriptions or pharmacy chain policies restrict the amounts of opioid analgesics maintained in inventory. The regulation as proposed makes no acknowledgement of these widely reported realities of patient lived experience. 

There are also significant weaknesses of present methodology in the identification of “potential at risk beneficiaries”. We believe that false identifications and unjustified restrictions on pain therapy may outweigh any likely benefits for people so identified. Likewise, there is a profound ethical issue in the casual at-arms-length identification of patients presumed to be at risk due to past diagnoses – or erroneous diagnosis -- of opioid overdose, if such identification results in refusal of effective pain therapy under rules imposed by insurance providers.  

For many patients, there are simply no reliable or effective substitutes for opioid analgesics in the treatment of severe pain. This is no less true of people with addiction than for patients who have never misused prescribed opioids. If patients with a history of overdose diagnoses are to be denied medical treatment with opioids, then a central question is how are these patients to be treated? The authors have seen no published proven-reliable therapies that are safer for such patients than opioids themselves.

Reference:  Richard A Lawhern and Steven E Nadeau, “Behind the AHRQ Report - Understanding the limitations of “non-pharmacological, non-invasive” therapies for chronic pain.” Practical Pain Management Volume 18, Issue 7, October 2018, https://www.practicalpainmanagement.com/resources/practice-management/behind-ahrq-report

Patient addiction from medical exposure is in fact rare. We are informed by no less an authority than Nora Volkow MD, Director of the National Institute on Drug Abuse, that:

“Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with pre-existing vulnerabilities...Older medical texts and several versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) either overemphasized the role of tolerance and physical dependence in the definition of addiction or equated these processes (DSM-III and DSM-IV). However, more recent studies have shown that the molecular mechanisms underlying addiction are distinct from those responsible for tolerance and physical dependence, in that they evolve much more slowly, last much longer, and disrupt multiple brain processes.”

Reference: Nora D Volkow, MD, and Thomas A McLellan, Ph.D., “Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies” . NEMJ 2016; 374:1253-1263 March 31, 2016]. https://www.nejm.org/doi/full/10.1056/NEJMra1507771

Section III.A.2. No later than 1/1/22, Part D sponsors must have drug management programs (DMPs)

Our Comment: This mandates that sponsors intrude upon the day to day management of chronic pain in a manner that unnecessarily duplicates existing State Prescription Drug Programs, and which unnecessarily adds to regulatory over-burden on doctors and their patients.

Section III.E.1. Each Part D sponsor has the latitude to develop specific eligibility criteria….All part D sponsors would be required to enroll ARBs in their Medication Therapy Management (MTM) Program….Sponsors must offer ARBs an annual comprehensive medication review (CMR)….The minimum level of MTM services includes a requirement for this plan to include targeted medication reviews no less often than quarterly.

Our Comment: Clearly such bureaucratic over-reach comprises a mandate for major bureaucratic intrusion into patient care. It is predictable that the pecuniary interest of the sponsor will be the primary driver for any such reviews. This is practically an invitation to “say no” to appropriate and safe opioid therapies for hundreds of thousands of pain patients. Furthermore, there is no scientific evidence that such oversight results in improved patient care.

Also pertinent in this discussion is the reality that existing HHS programs for detection and flagging of medication “over-utilizers” have demonstrated very limited predictive accuracy in identifying individual patients whose “high” prescribing levels may indicate a risk of opioid abuse disorder or mortality. Over half of all high-dose Medicare patients identified as having elevated risk of substance abuse are not diagnosed with any medication use disorder within 18 months.  

[Reference:] https://www.healio.com/family-medicine/pain-management/news/online/%7b279c0f20-e628-412b-b1a1-42864319b3c3%7d/cms-criteria-do-not-accurately-identify-patients-at-risk-for-opioid-use-disorder-overdose?M_BT=4081560204617

Section III.F. Automatic escalation for external review. Sponsor may establish DMPs for ARBs to address overutilization of frequently abused drugs.

Our Comment: This measure feeds directly into a widely prevalent “one size fits all” mythology, in effect weaponizing scientifically unsupported judgments of unqualified regulators in a bureaucratic casing, as applied to the term “over-prescribing.” Over-prescription should be defined as it is for all other drugs: prescription of doses that cause serious side effects, side effects disproportionate to the benefit achieved, or side effects that are deemed unacceptable by the patient.

We assert that there are presently no proven profiling instruments with predictive accuracy to assess risks of opioid prescribing in individual patients. This assessment is fully supported by a recently reported medical trials literature review conducted by the Agency for Healthcare Research and Quality and circulated in an October 2019 draft report titled “Opioid Treatments for Chronic Pain”

Reference: US Agency for Healthcare Research and Quality, “Opioid Treatments for Chronic Pain” - Draft Comparative Effectiveness Review, circulated October 2019 for public comment, pp 202-204.

Key Messages from the report: “No instrument has been shown to be associated with high accuracy for predicting opioid overdose, addiction, abuse, or misuse “

           Note: The AHRQ draft was withdrawn from public circulation after a 30 day review to an agency-specific mailing list; the draft has never been opened to wider public comment via Federal Register announcement, and the authors of the draft have not been revealed publicly.

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Omissions and Distortions in Proposed Rules

Section 3 Proposed Provisions, Subsection A (2) “Inappropriate Prescribing of Opioids” includes the following:

“…We propose that inappropriate prescribing means that, after consideration of all the facts and circumstances of a particular situation identified through investigation or other information or actions taken by MA organizations and Part D Plan Sponsors, there is an established pattern of potential fraud, waste and abuse related to prescribing of opioids, as reported by the Plan Sponsors. Plan Sponsors may consider any number of factors including, but not limited to the following: Documentation of a patient's medical condition; identified instances of patient harm or death; medical records, including claims (if available); concurrent prescribing of opioids with an opioid potentiator in a manner that increases risk of serious patient harm; levels of Morphine Milligram Equivalent (MME) dosages prescribed; absent clinical indication or documentation in the care management plan, or in a manner that may indicate diversion; State level prescription drug monitoring program (PDMP) data; geography, time and distance between a prescriber and the patient; refill frequency and factors associated with increased risk of opioid overdose.”

“…We believe the many steps that CMS, the CDC, and HHS have taken in response to the nation's opioid crisis have had an overall positive impact on clinician prescribing patterns, resulting in safer and more conscientious opioid prescribing across clinician types and across the settings where beneficiaries receive treatment for pain, and have also resulted in heightened public awareness of the risks associated with opioid medications. Recent HHS guidance [40] for example, highlights the importance of judicious opioid prescribing that minimizes risk and; urges collaborative, measured approaches to opioid dose escalation, dose reduction, and discontinuation; furthermore, a 2019 HHS Task Force report [41] outlines best practices for multimodal approaches to pain care. In this definition, we recognize that there are legitimate clinical scenarios that may necessitate a higher level of opioid prescribing based on the clinician's professional judgement, including, the beneficiary's clinical indications and characteristics, whether the prescription is for an initial versus a subsequent dose, clinical setting in which the beneficiary is being treated, and various other factors. We welcome public comments on specific populations or diagnoses that could be excluded for purposes of this definition, such as cancer, hospice, and/or sickle cell patients. Based upon widely accepted principles of statistical analysis and taking into account clinical considerations mentioned previously, CMS may consider certain statistical deviations to be instances of inappropriate prescribing of opioids. We also welcome evidence from clinical experts regarding evidence based guidelines for opioid prescribing across clinical specialties and care settings that could be considered to develop meaningful and appropriate outlier methodologies. Therefore, we propose that inappropriate prescribing of opioids should be based on an established pattern as previously described in this section utilizing many parameters.”

Our Comments:

The authors find this section of the CMS rule change proposals remarkable not only for what is said without references or medical evidence, but for what is not said. To characterize these changes candidly and with no intention of professional discourtesy, HHS/CMS seems to be cherry picking from medical evidence to advocate a hugely unsupported, restrictive and inappropriate view of the “risks” of opioid prescribing for people in pain. The “established pattern” to which this section refers seems to offer a blank check for denial of pain treatment to millions of Medicare beneficiaries. This rule change will almost certainly be employed in this manner by Medicare insurers.

The provisions proposed here make several scientifically unwarranted assumptions.

First, no one has ever provided convincing scientific evidence that physician prescribing, other than through pill mills, has caused harm or in any way contributed to the opioid crisis. Thus, these provisions seek to address a problem that does not exist to an extent that warrants changes in public policy.

Second, if physician over-prescribing is contributing to any degree, by far the best approach would be to incentivize better training of physicians in the management of chronic pain. Although such management is extraordinarily challenging, physicians often receive little more than a lecture or two on the subject in the entire course of their training.

Third, it is stated above that “the many steps that CMS, the CDC, and HHS have taken in response to the nation's opioid crisis have had an overall positive impact on clinician prescribing patterns.” This statement is true only if “positive impact” is defined exclusively in terms of the reduction in total amounts of opioid’s prescribed. It is blatantly false if the impact takes into account the tremendous increase in suffering that has been incurred by the 15-20 million Americans in moderate to severe chronic pain and the number that have been driven to the illicit drug market or to suicide. Furthermore, the correlation between state by state prescription rates and state mortality is less than 1%.

Finally, fully 2/3 of opioid deaths (~30,000 people/year) are due to use of illicit drugs, most particularly heroin combined with fentanyl. The measures taken by CMS, the CDC, and HHS have focused on what is likely to be a minor problem (physician overprescribing) even as they cannot possibly impact that true opioid crisis that is occurring in the streets (see also below).

Missing from the CMS document is the issue of appropriate reimbursement for physician time expended in evaluating and monitoring chronic pain patients. CMS could significantly increase the quality and precision of care for patients in chronic pain by increasing reimbursement for patient visits. It takes 30 minutes to do a good job with a patient who is stable and has reasonably well controlled pain. It may take 45-60 minutes to work up a patient whose pain or co-morbidities have significantly worsened.

In light of the problems we see in the rule change proposals, it seems appropriate to remind HHS/CMS of a number of outright repudiations of key elements of the narratives in these rules.  The 2016 CDC guidelines on prescription of opioids to adults with chronic non-cancer pain are mentioned multiple times. It is important to understand not only that these guidelines have been largely repudiated by the American Medical Association, but also in what language they have been repudiated. The following is a direct quote:

          “RESOLVED, that our AMA affirms that some patients with acute or chronic pain can benefit from taking opioid pain medications at doses greater than generally recommended in the CDC Guideline for Prescribing Opioids for Chronic Pain and that suchcare may be medically necessary and appropriate, and be it further

"RESOLVED, that our AMA advocate against misapplication of the CDC Guideline for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit patients’ medical access to opioid analgesia,

and be it further

"RESOLVED, that our AMA advocate that no entity should use MME (morphine milligram equivalents) thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guideline for Prescribing Opioids.”

Reference: American Medical Association House of Delegates Report of Reference Committee B. Resolution 235 – Inappropriate Use of CDC Guidelines for Prescribing Opioids. November 2018. Available at: www.ama-assn.org/system/files/2018-11/i18-refcomm-b-annotated.pdf. (Last accessed June 6, 2019).

From this background, it is clear that absent other demonstrable harm to patients, “high prescribing” is not by itself an appropriate criterion for sanctions against any physician who prescribes opioids to their patients in pain. This principle needs to be made explicit and prominent in any rule changes proposed for Medicare and Medicare Advantage.

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Also directly applicable and possibly deliberately omitted from consideration by HHS/CMS, is an AMA Board of Trustees Report of June 2019, further addressing “Inappropriate Use of CDC Guidelines for Prescribing Opioids.” This report includes the following text in part:

“…Health insurance companies, national pharmacy chains and pharmacy benefit management companies (PBMs) all have—to varying degrees—implemented their own policies governing physician prescribing of controlled substances as well as patients’ abilities to have a controlled substance prescription dispensed to them. The result of this type of quasi-regulation is incredibly difficult to quantify on a large scale basis due to the lack of transparency in the public sphere, but the AMA and many medical societies continue to receive concerns from physicians and patients as to the disruptive nature of health plan, pharmacy chain or PBM interference in the patient-physician relationship. The concern and/or perceived interference has included pharmacists calling to ask about a patient’s diagnosis or request patient records, a pharmacist asking for clarification about a prescription or alerting the physician to red flags, a pharmacist recommending a different medication strategy, and in some cases, a pharmacist informing the physician that the prescription will not be filled.”

“This concern and/or interference has even gone so far as a pharmacist demanding patients taper their opioid prescriptions, telling them that the U. S. Drug Enforcement Administration (DEA) identified the patient’s prescription as “exceeding the maximum Morphine Milligram Equivalents (MME) as defined by the Centers for Disease Control and Prevention(CDC).”  In response to this last incident, the DEA and CDC, among others, stated to the AMA (and the Medical Association of Georgia) that the pharmacist’s actions and interpretation of CDC and DEA rules and guidelines were incorrect and inappropriate. MAG informed the AMA of this situation, and the AMA, in turn, reached out to the DEA, CDC, National Association of Boards of Pharmacy and others—all of whom quickly engaged with the AMA to register their disapproval of the pharmacy action and state that they would take all relevant actions in Georgia. Your Board appreciates the fact that DEA, CDC, NABP and others took action to support the concerns of MAG and the AMA.”

From the discussion above, and other information offered in the report, AMA Board of Trustees recommendations were drawn as follows:

“1. That our American Medical Association (AMA) support balanced opioid-sparing policies that are not based on hard thresholds, but on patient individuality, and help ensure safe prescribing practices, minimize workflow disruption, and ensure patients have access to their medications in a timely manner, without additional, cumbersome documentation requirements. (New HOD Policy) 

“2. That our AMA oppose the use of “high prescriber” lists used by national pharmacy chains, pharmacy benefit management companies or health insurance companies when those lists do not provide due process and are used to blacklist physicians from writing prescriptions for controlled substances and preventing patients from having the prescription filled at their pharmacy of choice. (New HOD Policy).”

Reference: Jack Resnick Jr, MD, Report of the Board of Trustees American Medical Association Report #22-A-19, Title “ Inappropriate Use of CDC Guidelines for Prescribing Opioids”.

Note:  As presently written, many of the CMS proposed rule changes can be read as a “high prescriber letter” of even broader and more damaging impact on patients than those issued by State Attorneys General and State Medical Boards. 

Further Insights on Section 3 Proposed Provisions, Subsection A (2)

Dr Lawhern offers further data-centric evidence of the misdirection that presently characterizes Section 3 Subsection A (2). Even the most casual consideration of data on prescribing rates and opioid overdose related mortality demonstrates beyond any reasonable contradiction that the US declared “opioid crisis” was not created by medical prescribing and is not being sustained from that source. Particularly of interest and concern is the glaring demographic inversion between prescribing to youth under age 19 versus to people over age 62, compared to overdose-related mortality rates in these age groups.

[original graphic available on request]

Figure 1: Prescribing Rates Per Hundred By Age Cohort

[original graphic available on request]

Figure 2: Overdose Related Mortality by Year and Age Cohort

Data sets in Figure 1 and Figure 2 are drawn from publications of the US CDC. From Figure 1, we observe that prescribing rates for seniors are three to six times higher than among youth under age 19. This is an expected outcome given that seniors are much more often affected by chronic pain due to the natural progression of underlying medical disorders with advancing age. However, age adjusted overdose-related mortality among Seniors is the lowest of any age cohort, and has been stable over the past 20 years, even as mortality among youth has skyrocketed.

From these two charts and other sources quoted early in these comments, we can only conclude that prescribing is not a significant cause of overdose-related mortality. The notion that “over-prescribing” constitutes a high risk to seniors under Medicare is unequivocally invalidated by medical evidence published by the CDC itself.  

Further Related Reading:  Richard A Lawhern Ph.D. “Stop persecuting doctors for legitimately prescribing opioids for chronic pain”, STAT News, June 28, 2019. https://www.statnews.com/2019/06/28/stop-persecuting-doctors-legitimately-prescribing-opioids-chronic-pain/

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In conclusion, the authors suggest that the entire proposed CMS rule set be withdrawn for rewriting and redirection, applying the AMA published positions above as a central point of departure.  It is clear that in their present form, the proposed rule changes are based on a mythology of “doctor over-prescribing”. Their misdirection will reliably be a source of medical collapse and descent into disability (and sometimes suicide) for thousands of Medicare beneficiaries. 

It may not be excessive in this context to apply a legally meaningful term: “CEASE HALT AND DESIST!”