W

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.

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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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  • As a health care workers and chronic intractable pain patient, I see nothing positive in this proposed legislation. My problem is congenital, and has been aggravated by, “therapeutic surgical proceedures”. When my pain is controlled, I am able to hold a job, and have a positive quality of life. I am one of many people who has been on long term opoid therapy, determined after very rigorous evaluations by pain management, over my lifetime, having done the pain ladder protocol 3 times, over the years. I am 70, and have been on aggressive pain management since I was 16, after suffering multiple, misdiagnosis. Most chronic pain patients, myself included, do not experience a high, or euphoria of any kind, following taking opoid medication. When given in the appropriate dosage, which may often be much higher than the equivalent of 90 mg.of morphine, daily, we experience considerable pain relief, though we are NEVER pain free. We are able to live relatively normal lives, to which every human has a God given right ! I had a prolonged periods, after a move to another state, where I was unable to find a physician that would prescribe my needed medications, even though they had my medical records. I did, seriously considering ending my life, and very well may have, had I not found a compassionate physician, who understood chronic intractable pain. The proposed restrictions on opoid medication access, to those patients who have legitimate need, is akin to the US experiment on caller, Prohibition, which made alcohol illegal. Don’t any of our legislators remember the Nationwide fiasco that created? Reducing access of necessary pain relief to those who need it will do nothing to keep drug addicts from obtaining drugs and overdosing, it will only help to increase the access of illegal and contaminated drugs and cause an increase in overdoses and deaths!

    • SO VERY WELL SAID, RENEE!! Ya know, It just absolutely kills me how so many of us normal every day citizens are able to “SO VERY CLEARLY” see EXACTLY, what this new law that our supposedly, very caring, extremely trustworthy, and highly educated government has come up with in order to get a handle on (what THEY are calling) this country’s, “Opioid Crisis”!!! A “Crisis” (if there is one) in which THEY (if anyone) played a huge roll in starting, by telling all the, already wasted, Heroin junkies in our country….. Hey all you junkies, come in to our Methadone Clinics you If you want to kick heroine. We’ll get ya all strung out on a drug that isn’t illegal “in our eyes”!! Yeah, that really worked out well, didn’t it!! Our governments moto is, “LET’S SAVE THE JUNKIES, AND KILL OUR LEGITIMATE CITIZENS”!!!

  • I think that pain management paitents that receive more than the new Medicare limit should consider large group suicide pact. This would have to be done as one massive group of people who cannot continue to live a normal life without proper pain control. I truly believe that of thousands of people all decided to end their suffering the same day and time it would bring attention to this issue. If anyone attempts to organize such an effort please make it very public. For many patients it is simply not worth living to suffer continuously without treatments that work. The government should force the medical industry to develop real non- medication approaches to pain management that are effective with all patients. I can predict a major increase in heroin and fentynal addicts who were on pain management. These persons will then take whatever amount they want without any controls since they can buy however much they need. The patients that cannot afford to buy there street drugs will either steal them or end life. THIS WILL ONLY MAKE A PROBLEM MUCH WORSE.

  • I am a 70 year old patient that has chronic pain from fibromyalgia pelvic floor spasms and back pain. Been on Vicodin for 7 years and now what I get from doctors is “too bad so sad.”

  • There is, obviously, a problem with people obtaining and selling opioid pain medications in this country, and almost every other country in the world. But isn’t it shame, how such a pathetic goverment in…(supposedly) the greatest and freest country in the world, makes their most vulnerable citizens pay dearly, for every single problem that arises, that they are to stupid and to ignorant to come up with a logical solution for, other than making its own people suffer? And to think, every time you turn your TV or radio on, their wanting to go to war with some country that’s making their people suffer, I mean Seriously, REALLY?!! It’s no wonder that all these other countries laughing at us and wanting to wipe us off the face of the earth!!! Our own pathetic goverment makes laughing stocks of the United States who also makes their own people suffer!!
    And, Just like the pathetic, (MULTI BILLION DOLLAR) fence that our “Wanna Be” President wants to build, and seriously thinks, that it’s going to stop Mexico’s drugs and it’s citizens from entering the United States… If they seriously think that by passing this new law…. (limiting the amount pain medication, Dr’s can prescribe their own patients… (something a good Dr, spent years in college, and countless hrs studying medicine , on top of their years of experience being a Dr and learning …. something the government HASN’T GOT A CLUE ABOUT, AND ABSOLUTELY NO KNOWLEDGE OF, other than they “THINK” that everyone… (who has to live with chronic pain every single day of their lives, and depends on Opiate pain medications to give them somewhat of a better quality of life)… Is selling them to the hood on the street corner)… they’re going to somehow put a stop their so called “OPIATE CRISES”, they need to be ALL pack up and find new jobs!! They say they’re trying to cut the number of overdoses and suicides… Lmao, yeah right!! Watch and see how many people start swallowing bullits, because they just can’t live with the pain our goverment seems to think we should!! I guarantee I’ll be one of them too!

    • I really think the government should put more $$$$$$$ into mental health programs. I think a lot of people who kill themselves could probably have been helped. Instead! “They” decided to go after the people in pain and take away our quality of life. I 100% agree with you Reed that the M.D. who went to school for years and years should be the one making ALL the decisions about how much pain medication people in pain can have. I am so sick of being in pain and I do think about ending my life because my pain is so severe. Then I remember my kids and even though I am in pain 24/7 I am still their mom and I still have to try some how to be here for them.
      My husband has recently had to quit his job because of my health. I receive disability. We receive NO other public assistance. I would love to go to work. But here I sit or lie with senators, congressmen and Trump telling me that my pain isn’t so bad. That I don’t need those opiates, because I am probably going to sell them on the corner. DAMN! If only I could walk that far!

  • I have had adhesive arachnoiditis (AA) since 2003. If you never heard of AA here is a brief definition. It is a poorly known disease because it is listed as “rare” by the National Organization for Rare Disorders. To those of us who deal with severe, intractable pain, however, arachnoiditis (/pain/spine/suspecting-diagnosing-arachnoiditis) is well-known. It ranks at the top of the list of “worst pain conditions,” along with metastatic bone cancer, renal colic, chronic regional pain syndrome, and migraines.
    The gov’t. wants to reduce my ms contin, my life expectancy has dropped tremendously if this does occur. Apparently the gov’t does not care for those who suffer each and every day and now, I can guarantee life expectancy for us will now drop substantially. I am already seeing a physiatrist/phycologist to help me stay alive. Appears the gov’t cares more for those that abuse opioids than those that need the medication to live. The gov’t should let these people kill themselves instead of us committing suicide. Goes to show how ignorant our govt is.

    • “Appears the gov’t cares more for those that abuse opioids than those that need the medication to live. ” Robert you could not have made a better statement!

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