ASHINGTON — In the final hours of public input on a controversial new rule limiting opioid prescriptions, a last-minute coalition emerged on Monday to oppose it.
The Centers for Medicare and Medicaid Services rule would restrict opioid doses to Medicare patients to the equivalent of 90 milligrams of morphine per day.
But a vocal group of doctors, pain patients, and public health experts — including three who contributed to the Centers for Disease Control and Prevention’s own prescribing guidelines — emerged near the Monday deadline to voice their opposition via comment, letter, and social media.
Hundreds of comments had been submitted to the CMS website on the rule as of Monday afternoon — the vast majority in opposition.
Dozens of other academics, doctors, and editors of pain journals have signed on to a letter claiming the proposed rule constitutes overreach by CMS into medical treatment and would carry serious consequences for the 1.6 million Medicare beneficiaries who reached that threshold for at least one day in 2016.
The critics say the regulation is heavy-handed and measures health outcomes only in prescription levels. The 90-milligram morphine daily equivalent is roughly equal to four mid-range doses in a typical prescription of immediate-release oxycodone.
“There are a lot of Medicare providers that already do very aggressive dose control now,” said Dr. Stefan Kertesz, a professor at the University of Alabama, Birmingham, who focuses on addiction and works with a variety of chronic pain patients. “We know what real opioid safety looks like. This is not that.”
Instead, their letter says, the approach is a one-size-fits-all response to external pressure on CMS, and one that takes decision-making power away from doctors.
Government pressure to act
This proposal echoes a similar one last year in which CMS proposed to restrict opioid doses to 120 morphine milligram equivalents per day. This year’s proposal, however, goes even further, by reducing the threshold and allowing pharmacists to deny prescriptions that exceed it. The rule would create a potentially time-consuming exemption process that would require the consent of pharmacies, payers, and doctors.
The rule, set to be finalized April 2, is the first daily opioid dose limit proposal issued under the leadership of new CMS Administrator Seema Verma.
Verma, who served as Indiana’s top health official when Vice President Mike Pence was governor there, has cited the opioid crisis as a priority, and she has been a mainstay at administration events on the topic — including the White House’s “opioids summit” held last week.
But Verma’s agency is under pressure to act from multiple government oversight bodies, which have placed much of the responsibility for high opioid prescription levels on the agency.
The Office of Inspector General in July highlighted that 1 in 3 Medicare Part D beneficiaries received opioids, for which Medicare paid $4.1 billion — a statistic Attorney General Jeff Sessions cited last week in announcing the Justice Department’s involvement in a slate of lawsuits against opioid manufacturers.
The Government Accountability Office doubled down on the the inspector general’s conclusion in January, issuing a report titled “Medicare Should Expand Oversight Efforts to Reduce the Risk of Harm.”
CMS’ new plan does neither, its opponents argue. Among the problems they see with opioid prescribing thresholds are the potential for decreased quality of life, pursuit of illicit drugs to replace opioids, and the potential for increased suicidal ideation among patients whose opioid doses are reduced or discontinued.
“The plan avows no metric for success other than reducing certain measures of prescribing,” the letter reads. “Neither patient access to care nor patient health outcomes are mentioned.”
Instead, Kertesz said in an interview with STAT, CMS should pursue a system that considers risk factors, and develops plans of care for patients being prescribed opioids.
“This is just an elaborate, bureaucratic show of force which CMS is under pressure to produce,” he said.
While the letter’s authors acknowledged the role of opioid overprescription in creating the current crisis, their resistance to the CMS proposal comes at a time of broader concerns that the federal government’s desire to forcefully address the epidemic could come at the expense of patients. A sweeping addiction bill introduced in the Senate last week goes further than any state legislature and even the CDC guidelines in limiting first-time opioid prescriptions to three days.