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eAlerts are the latest industry information regarding regulatory changes, helpful compliance reminders, or any number of relevant topics in the fast-paced, ever-evolving specialty of anesthesia.

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April 2, 2018

Summary

Changes to the rules regarding opioid prescriptions through Medicare Part D for 2019 include a “hard edit” for opioid prescriptions at or above a cumulative daily equivalent of 90 milligrams of morphine; no more than a seven-day supply of opioid medication for opioid naïve patients; and restrictions on concurrent prescribing of opioids and opioid potentiators, such as gabapentin and pregabalin.  We summarize the anesthesia community’s response.

The opioid crisis has impelled a wave of legislative and regulatory proposals to tackle the largest drug problem in United States history on several fronts, including prevention, treatment, research, fraud and abuse detection, prescribing practices and more.  This eAlert provides an overview of proposed regulatory changes from the Centers for Medicare and Medicaid Services (CMS), scheduled to go into effect in 2019, with special significance for anesthesiologists and chronic pain specialists.

As anesthesiologists and pain specialists know, while opioid medications carry significant risks, they also have an appropriate, indeed essential, place in treatment for many patients with acute and chronic pain.  Safe and effective pain management is an intricate balancing act in which the benefits and complications of medications alone or in combination must be carefully weighed and monitored.

The CMS policies would add a different level of complexity to the delivery of that care.  Changes to the Medicare Part D overutilization monitoring system (OMS) would empower Medicare sponsors (private insurance companies that contract with CMS to provide prescription drug coverage for beneficiaries) to implement a “hard edit”—a denial of authorization—for opioid prescriptions at or above a cumulative daily equivalent of 90 milligrams of morphine (MME).

The “soft edit” currently in place, which allows insurers to deny coverage for the medications, also allows pharmacists to approve prescriptions based on their own judgment and the patient’s medical history.  Under the new policy, pharmacists would be required to discuss the dose’s appropriateness with the patient’s physician and the insurer.  The policy would allow high-dose patients to receive a one-time seven-day supply of opioids while they appeal the 90 MME rule.  If approved, patients would then need to obtain a new prescription from their physicians.

The hard edit could only be overridden by the sponsor after efforts to consult with the prescribing physician, according to Demetrios Kouzoukas, CMS deputy administrator.  “We believe these actions will reduce the oversupply of opioids in our communities,” he said.

But opponents of the policy, including many across the anesthesia community, fear serious unintended consequences—including severe pain, withdrawal symptoms, illegal drug use and suicide—for many chronic pain patients whose medication dosages would be abruptly reduced.  “The decision to taper opioids should be based on whether the benefits for pain and function outweigh the harm for that patient,” said Joanna L. Starrels, MD, of Albert Einstein College of Medicine, in a New York Times article.  “That takes a lot of clinical judgment.  It’s individualized and nuanced.  We can’t codify it with an arbitrary threshold.”

In a March 5th letter to CMS, the American Society of Anesthesiologists called for a specific exception in the policy for patients under the care of a pain specialist, noting that the 90 MME limit established by the Centers for Disease Control and Prevention Guideline in 2016—the guideline on which the new policy is based—was meant as a recommendation for primary care physicians, not for pain specialists caring for patients with severe, chronic conditions.

A second change, which also cites the 2016 CDC guideline as justification, would enable Part D sponsors to cover only a seven-day supply of opioid medication for opioid-naïve patients.  In the letter, ASA urged CMS to take into consideration patients who have just undergone surgery, “where the appropriate opioid dose should be at the discretion of the physician, weighing the patient-specific factors in the relevant circumstance.  Depending upon the type of surgery, severity of trauma, and differences between patients, a seven-day supply is often not sufficient enough for both opioid naïve and non-naïve patients.”

Stefan Kertesz, MD, MSc, an opioid researcher at the University of Alabama at Birmingham, spearheaded a letter to CMS opposing the policies that was signed by 200 pain medicine and addiction experts.  “There is a universal presumption that if any patient is at a higher dose, they are always and in nearly every instance going to be more safe if they are taken to a lower dose,” he said in comments.  “For physicians wishing to get out of the firing line, the implicitly encouraged step is involuntary dose reduction to bring doses down, even if the patient is functionally ‘stable’ on their current dose, and without their consent.  But that course of action has absolutely no trial data to support it.”  Although expert teams, working with voluntary patients, can taper high doses safely, “the impact of the CMS plan will not involve voluntary dose tapering by expert physicians, but involuntary tapering by non-expert physicians,” he said.

The changes would also include the flagging in the OMS of concurrent prescribing of opioid medications and opioid potentiators such as gabapentin and pregabalin.  In its letter, ASA said the rule “ignores the real-life setting of pain management and is contrary to the emerging research literature supporting the use of multiple classes of medications to ultimately reduce a patient’s opiate consumption—a care standard that the country needs to adopt.”

While no one can dispute that opioid addiction and over-prescribing are major public health problems, is it advisable to swing in the other direction with policies that many believe would unintentionally exacerbate these problems?  As Dr. Kertsz stated in Health Affairs, “the irony is that these developments are hurting people who are reasonably unlikely to misuse opioids, although opioids do present important safety concerns, including risk of overdose.  As federal and private survey data indicate, pain patients are not at highest risk for misuse of prescription opioids. Instead, most misuse reflects diversion.”

With best wishes,

Tony Mira
President and CEO