WASHINGTON — 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.

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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.

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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.

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  • 25 years as a severe chronic pain sufferer, I became disgusted on how my own doctor used the 90 mg law on me. Knowing full well being a chronic pain patient and a palliative care person was or is willing to do so. I take injectable morphine and ms contain . I used to take double that, but now any less I began having excruciating pain. My doctor has lowered morphine on the premises of the 90mg law. I’ve been to the emergency room 4 times already and suffered. A slow torture. Knowing that it does not apply to me gives me relief. My Doctor was so worried that she be sued that she would rather torture me. Reading this article has given me hope. I am seeing my doctor at the end of the month and would like to show her the true guidelines and laws pertaining to the 90 mg law. Where can I find the guidelines and can she legally reduce my prescriptions on these facts? I also thought about suing the government but don’t think that will do anything. I do need help.

    • Kathleen,
      Firstly, I am so sorry that you are also experiencing this “torture,” too.

      The countless emails from others like yourself, have addressed this question about suing the government. I encourage you to read the ones that explain the reason why we are not probably going to be able to find an attorney, or any law firm that would take on a case to try to sue the government ( although the vast majority of us would do so without hesitation )!

      Some commentators, on this particular thread have been excellent responses about this topic. I wish I could recommend the individuals who have been researching this topic. I do know of one who has a more knowledge based responses to the community of people on this specific thread; his screenID, is Sailbum. He resides in CA, and has been a great resource for many of the individuals who are experiencing this torture, because of the government restrictions. I don’t think you will find anyone who disagree about the government’s actions of intimidation, and a one for all approach to our personal lives; we are extremely opposed by the federal government’s intrusion into our personal healthcare issues. Our physicians are also being harassed by the federal government’s decisions about the healthcare issues that are personal and our physicians are under attack by the current administration’s deliberate negative consequences for us all.

      There is absolutely no reason for this intrusion, yet the current administration doesn’t want any of us, to survive, as has been noted by individuals everywhere in other venues who are enraged with the obvious reasons for this administration’s actions that are contraindicated, with their cruel actions against those of us who have to live with the torturous consequences from the federal government’s actions that they know well, what they are doing, or better yet, insuring that we all give up, and out of this life. A life of no quality whatsoever. The current administration only exists for the other wealthiest individuals in our nation; they want us to give up, and save the costs of healthcare for the rest of the citizens who have the resources to pay for their own healthcare issues.

      Personally, I have been thinking about sending a letter with this sites name and address, and the title of this article, for the benefit of the entire community here and across our nation. No one else is going to do it for us, so we must do everything possible for us, and the rest of the citizens of our once great nation, that is no longer in existence!

      Please take as good care as possible for yourself, and try looking through the emails from the others on this thread; don’t forget about Sailbum, he has some knowledge about this topic and shares it with us all. Peace and good health always.

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