In response to the opioid epidemic that is killing tens of thousands of Americans a year, the U.S. government is poised to further restrict the amount of opioids Medicare patients can have access to at any one time, via a policy that would tell insurers to deny coverage for certain prescriptions on the spot. But a group of doctors and researchers is pleading with officials to reconsider, saying the move would harm cancer patients and others who desperately need pain relief.
In a proposal paper released last month, the Centers for Medicare and Medicaid Services (CMS) laid out two policies affecting opioid prescriptions obtained through Medicare Part D that would come into effect starting in 2019.
One would call for a “hard edit” of opioid prescriptions made to patients on Medicare Part D that exceed a specific cumulative daily dose—the equivalent of 90 milligrams of morphine (MME). When pharmacists go to fill these prescriptions by submitting the request electronically, they would encounter a denial of payment from the insurer or pharmacy benefit manager followed by a brief explanation of why. Patients could still be allowed to have their prescription paid by Medicare, but only after an appeal and acknowledgment from their doctor that they qualify for certain exceptions, such as having cancer, being terminally ill, or otherwise having pre-existing approval for a higher dose.
The second proposed policy would tell Part D plan providers to deny coverage for prescriptions made to first-time opioid users, flagged via a database that tracks prescriptions obtained through Part-D, that provide more than a 7-day-long supply, regardless of their diagnosis.
The new limits would be a step up from the current ones encouraged by the agency, which implement a “soft edit” for Part D prescriptions at 90 MME, and a hard edit for those at 200 MME. Soft edits still dictate that these prescriptions can be denied for coverage by the insurer, but the pharmacist can then approve it at the register based on their own judgement of the patient and their medical history. The CMS estimates that the change could affect up to 1.6 million Medicare patients, based on data showing the percentage of patients without an approved exception who received more than 90 MME worth of opioids for at least a day in 2016.
CMS argues that the new rules would encourage prescription plan providers to “do more to address chronic, high prescription opioid overuse.” However, more than 150 doctors across the addiction, pain, and rehabilitation field have signed an open letter addressed to the CMS that claims otherwise. Though they acknowledged that doctors’ prescribing standards for opioids have needed to change, they say the wide-sweeping policy would only harm chronic pain patients while doing little to address the actual problem of addiction.
“While a strong case can be made for consensual, supported opioid dose reductions for voluntary patients, no data support nonconsensual/forcible dose reductions or curtailment in otherwise stable patients that have become common as prescribers react to regulations, mandates, insurers and fear for professional security,” says the letter, which was signed by clinicians from medical schools at Harvard, Yale, and Stanford, among others, as well as former presidents from various medical organizations, including the Society of General Internal Medicine and the Association for Medical Education and Research on Substance Abuse.
“These policies represent a knee-jerk response that is unmoored from evidence,” Leo Beletsky, an opioid policy researcher at Northeastern University, told Gizmodo via email. “For example, the best available evidence is that legitimate patient need for opioid analgesia ranges from about 4 to 17 days, so it makes no sense to limit initial prescriptions across the board. This should be done on an informed case-to-case basis.”
Beletsky was not one of the signatories of the letter, meant to be exclusively issued by health care providers in the field, but he said he has seen the letter and agrees with the points it makes.
For one, the writers argue that while the changes would certainly steer more people away from opioids, they’d do so in a destructive way. In the wake of less strict prescribing guidelines already issued by agencies like the Centers for Disease Control and Prevention, the letter notes, there have been anecdotes of stable patients spiraling out of control after losing or having their prescriptions lowered, including those who seemingly fulfilled the exception criteria. In response, and without proper follow-up care, some patients have even turned to illicit drugs.
“There is little reason to believe these policies will drive down overdose risk—they have never been tested with that metric in mind,” Beletsky said. “There are, however, highly foreseeable collateral risks from these policies, including continuing the process of forcing patients to the black market.”
“We need to find ways of engaging and supporting patients without resorting to easy fixes that end up backfiring in very predictable ways,” he added.
Even with the appeal process laid out by the CMS, the letter argues that it’s likely many patients will be left suffering needlessly, thanks to delays in getting through to doctors for their approval, which could require coordination between doctors’ offices, pharmacies, insurers, and prior authorization managers. The CMS’s proposal would allow for a 7-day supply to be prescribed through Part D to certain patients going through the exception process, but only once. Longer or recurrent prescriptions would need to be paid out of pocket.
“The CMS plan risks accelerating a chaotic pattern of churn, abandonment and medical harm to patients who receive opioids as physicians flee an increasingly risk-laden and cumbersome decision matrix that may not advance patient safety,” says the letter.
More than that, the doctors say the CMS plan mischaracterizes previous guidelines. In recommending a hard drop to 90 MME, the agency cites as support the CDC’s recommendation that patients be voluntarily steered away from that high a dosage if possible. But the CDC guidelines actively recommend against forcing patients already on a higher dose onto a specific lower dose without their consent—a fact that some of the signatories know well, given they helped draft the guidelines.
Stefan Kertesz, a clinical researcher in addiction at the University of Alabama at Birmingham*, spearheaded the creation of the letter, which was submitted to the CMS on Monday night, March 5. That was the deadline for public comment on the CMS proposals. Both prescription rules are expected to be finalized by April 3.
“There really is a continuing story here of an effort by our political leaders to boil a rather complex and devastating problem down to something that will be settled at the pharmacy counter with forced dose reductions for patients who are very disabled and have complex forms of pain and suffering,” Kertesz told Gizmodo via email, who noted elsewhere that doctors have continued to sign onto the letter even after the deadline. “This scenario, where we would traumatize patients to create the impression of a response to an addiction crisis, is what has so many experts alarmed.”
*This article previously misstated Stefan Kertesz was affiliated with the University of Alabama . He is actually affiliated with the University of Alabama at Birmingham. It has also been updated to include comments from Kertesz.
A previous version of this article incorrectly said that pharmacists would be able to deny opioid prescriptions under the new proposal; in fact, insurers would be the party responsible for denying a prescription. We regret the errors.