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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  • I am so sick of the government and the laws they are allowed to pass!! Is the American Medical Association doing anything about allowing non medical corrupt politicians to monitor how they practice or what they prescribe? NO the doctors are not doing a thing but follow laws that are aimed at addicts and you will be lucky to just get a competent medical assessment let alone your chronic pain. The USA is becoming a second class world failure in medical care. And do not even get me going on about patients that doctor shop,snort their pills etc.. and the addicts who do not need Narcan … let them die from the OD as that is one less burden. There are tools that doctors can use like electronic monitoring which I think is effect in all 50 states

  • I am someone who has many health issues, diseases that can not be cured and get worse every year, Spinal Stenosis, Radiculopathy, Degenerative Disc disease, to name a few of the big one’s, and some Dr.’s have said Spondylitis all very real and very painful. They take away all quality of life but when the Dr. started me on Morphine it was like a miracle to me because I was given back a large part of the quality of life I had lost. I now have lost a large part of the quality of life I had because things like brushing my teeth, washing my face, getting in and out of the bathtub, which had been another way to lessen the pain for a short amount of time, feeding the cats and watching them play, all things that require my being able to stand and walk without horrible pain has been taken away because of people who abuse pain medications, and the unfortunate few, compared to those who take the medicines illegally, who have become addicted to pain medicines because of a few Dr.’s who misused the privilege of being able to help people who are ill . All because someone, who probably has never had one of these diseases let alone 3, has decided that they know better than my Dr., who knows me and examines me, what dose of pain medicine I require to be able to do things other people take for granted. I do have sympathy for people who have become addicted to pain medicines because of a few Dr.’s but I fail to see how taking away my life helps them in anyway. Most Dr.’s monitor the medicines, all of them not just pain meds, of their patients to prevent abuse or addiction. There are conditions besides cancer that can cause patients to have unbearable pain, pain that requires long term, possibly life long, pain, pain that requires strong pain medications. People like me with diseases that only get worse with time and whose only hope for some amount of quality of life lies in the ability to take pain medicines in therapeutic doses. I am not a group of people, I am an individual with individual requirements to treat me, I, like many, don’t “fit in” to what is called the “normal” population but I am still human and wish those who are trying to put me in a bed or early grave would realize that. Taking away the hopes of people like me, and I’m sure there are a large number, who have diseases that cannot be cured and have no treatment that will make the disease cause less pain, diseases that get worse every year but with the use of pain medicines don’t end my quality of life isn’t the answer to ending the drug crisis. Causing me to have pain so bad I will become unable to do the most basic things other human beings are able to easily do isn’t going to stop someone from buying drugs on the street nor will it prevent someone who abuses the prescription of pain medicine their Dr. gave them from abusing the medicine so I don’t understand why those of us who battle these disease also have to now battle to be treated like human beings. Why isn’t all this effort being put into getting the illegal drugs off the streets along with the people who sell and or make them instead of punishing law abiding people who are already struggling against a health battle they have no control over. Why doesn’t anyone care about the people with real diseases that rob us of our quality of life and the ability to do what “normal” people can do, like play with their kids, going to school functions and be able to enjoy life for instance, instead of trying so hard to take away the legal medicines that allow us to be human?? Making us beg to be given the chance to have dignity and a life with quality and without unbearable pain cannot possibly do anything to stop the people who get these medicines illegally off the street from getting them. My and many other people being in pain will not stop anyone from selling pain medicines on the street from their house or from wherever they have been doing it, it will just cause them to find another way to get the medicines and they will continue to abuse them. While law abiding people will be left to suffer, left to wonder how much pain their body can tolerate before it kills them because severe pain can and does kill people, even people who suffer from chronic severe pain will be dying right along with the people who will continue to abuse the medicines. People who have real pain, severe pain the kind that feels like someone punched you in the stomach knocking all the wind out of you while yours legs burn and there are razor sharp pains that go from the high lumbar area of your back down to your hips and legs don’t sell their pain medicines. They use them for themselves so they can have the quality of life I keep talking about and the human dignity to not have to go into every Dr.’s appointment and beg for medication to stop the pain, not an increase in the dose just no more decreases because you have lost so much of what you had been able to do now. I pray someone will start listening to the people who do everything they are told to do when it comes to pain medications they are given because they have real diseases that cause real, severe pain. Diseases that rob them of dignity and quality of life, diseases with no cures or treatments that will stop, lessen or control, the pain accept pain medications.

  • I moved here from Northern, Mi because of the coldness affects the lower back which was fused,rods n pins put in place. My prescription of 10mg oxycodone was cut in over half. Now I’m back in the same situation. I work construction. I must take time off because of my pain now. I’ll be unemployed if this continues. Then what do I do? Become homeless and rely on state assistance which is very little for a single independent male.
    Signed,
    VERY IRRITATED!!!

  • I am one of the many here who have chronic pain from multiple injuries. I have been on my pain medication for 10 years until just recently my doctor said the state does not want anyone on these meds for more than 3 months. I can understand that if they are prescribing then to a new patient, but not someone who is dependent on them for a decade to have a decent quality of life. These lying politicians are lumping all these deaths together with street heroine and fentanl. They are also not mentioning the people over dosing on oxy are mixing it with other drugs. Now for the real reason they are cutting everyone off. The doctors that over prescribed over the years and gave these pills to people who didn’t actually need them, put them up for sale on the streets. Depending on what state we are talking about people are paying 25 to 50 for each pill. That is a ton of money the gov is not seeing in tax money. It’s the same reason why prostitution is illegal. Do you think the gov cares if a girl willing wants to have sex in exchange for money? No they don’t. They are want their piece of the pie. These girls can make a thousand a night easily and not pay tax on it. Why has Marijuana been illegal so long? Because people can grow it and sell it. No tax for the gov. It is and always has been about the money. What did they do about one of the deadliest and most addicting things in the world.? I’m talking about cigarettes. They just decided to raise the price to an astronomical price so they can fill their pockets. The gov doesn’t give a crap about anyone’s health. It is why they don’t allow the cures and only allow the treatments to come to the market.

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