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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  • WHAT OPIOID CRISES? Take a look at the numbers, not the manufactured hysteria. In 2016, the last year for which the CDC has issued firm numbers, the total opioid deaths from PRESCRIPTION drug overdoses was 17,087. Of this amount a total of 916 NINE HUNDRED SIXTEEN came from the over 65 population. Note: Both numbers include deaths caused by ill health and suicide. For a moment, lets say those were zero. Are we at the state of affairs where we need Medicare to start denying needed prescriptions just to prevent LESS THAN ONE THOUSAND DEATHS nationwide??? That is pure, unfiltered feldercarb.

    Finally, consider the fact that we have laws preventing keeping a dog in pain. Don’t I deserve the same consideration that we give a dog?

  • What a joke. It’s a huge overreaction to the epidemic. The majority of over dose deaths were by illicit drugs like heroin laced with fentynal. I have had 2 back surgeries with titanium rods put in. My doctors are so afraid of prescribing anymore pain meds. In fact one doctor told me no. I have tried several other forms of pain management like injections and physical therapy. I believe they have some benefit but not by themselves. I now am taking Buprenorphine to help control the withdrawal of coming off opiates and it does help a little with some of the pain but with major flare-ups it’s useless. I’m very fearful of what lies ahead as far as pain control and so-called restrictions our gov is trying to put into place on opiates. If there were something better we would be using it but there isn’t. The prescription writing needs to be left up to the doctor, end of story.

  • Over 20 years ago I had a bad shoulder surgery preformed by a licence orthopedic surgeon . It left me with pain from a tick. I can’t stop twitching my shoulder which is giving me the pain . My primary doctor prescribed a medium dose of hydrocodone and the tick and pain subsided. The real problem is that I earn my living as an artist and the tick interferes with my art. The Hydrocodone is the only thing that calms it down . My doctor informs me that he can no longer subscribe this medication to me. I have been taking it for the last 20 years exactly as subscribed. I have never abused it it. He sent me to a pain management office and they wanted to shoot steroid or cortisone into my shoulder. What is worse “steroids or a drug I have been using for 20 years with no bad results or side effects” A copy of this letter is being sent to my doctor in Maryland. His name is Stanley Kman.

  • I’ve been a chronic pain sufferer for 28 years suffering from RSD. I now also suffer with many severe back issues. In all the years I have taken opiods I have never once abuse the use in any way. Of course as time went on the pain progressed and I am on now on morphine for the last 18 years. That still doesnt control my pain, now you want to lower my dose. How do you expect persons like myself to have any quality of life. I feel all this is going to accomplish is make the drug lords rich. people go to the street to control their pain, others will commit suicide, RSD is one of the highest pain conditions according to pain index chart. so many will become so depressed, then they’ll be popping out anxiety pills like there candy, is that safer, I don’t think so. your statistics are inacurate because they include herion addicts because it’s laced with fenytenal. And who gives the right to take our doctors treatment and tell them its wrong. I feel like I’m living in a country of dictators.where are our rights….!

  • Yet another fine example of “We have to do something, quick light your hair on fire”. Opioid prescribing is down almost 20% since 2010. Clearly, the medical profession is responding to the problem. Heroin overdose deaths are up 400% in that same time frame. Clearly, prescription opioids are not the “gateway drug” we thought they were. The NIH tells us that 99% of people who do use prescription opioids NEVER go on to use heroin. So the heroin issue is NOT related to this class of medications. Letting the government take over medical decision making from the doctors is akin to letting passengers take the controls of airplanes from experienced pilots. It spells doom!!!

    • I agree. I believe more suicides will take place and more people will turn to the street which will result in more overdose. Government deciding what is medically necessary for us, is bullshit. This is all for them they don’t give a fuck what happens to us.

  • Its a about to get worse folks,,,did u all know,,20 different senators,,I do not need to mention which party,,but,,,have a lawsuit or something pending in Texas,,,to GET RID OF PAYMENT OR COVERAGE FOR ALLLL PRE-EXISTING CONDITION?!!!!Now,,seeing as though the word chronic pretty much means pre-existing,,,,This in my book proves it,,THIS WAS WHAT IT S ALL ABOUT FROM THE GET GOO..$$$$$$.,,,, they exploited these poor mothers weeping over their dead adult sons body from illicit drugs,,NOT legal medicine opiates,,they defrauded the American people w/this false flag epidemic,,,thus why allll the data has proven to be corrupted,,lie after lie etc,,changing definition /regulation to make innocent people guilty of now some new made up word Opiate use disorders or long term opiate user,,,Alll to defame,slander and discredit the pre-existing medically ill people,,to censore us,,,See corrupted regimes have no use for truth,,soo they censor and kill the messengers,ie,,,us!!!They bought our doctors off w/the cheaper malpractice insurance and outright threats of arrest,the dea,,to take everything,to exstinguish all their life work,,THIS IS NOT THE AMERICA I WAS RAISED IN,,,THIS IS A CORRIUPTED REGIME,,TORTUREING AND GENOCIDAL ONTO ALL W/PRE-EXISTING MEDICAL CONDITION,, This USA put a price tag on human life,,,so some corrupt ceo sob can make 15 million at BcBs,,or medicare ceo,,,,on the death of a pre-existing medically ill person,,,THEY TRULY WANT US DEAD PEOPLE,,,,,,THIS IS GENOCIDE AND MURDER,,,a false flag if u will,,ie,,”epidemic opiate bullshit,” to get rid of all the pre-exiting sick people!!!maryw

  • I have found a site on facebook called don’t punish pain. It has helped me alot in trying to cope with being taken off the opiates that did help me to being put on all these other meds that do not.

  • This is a bunch of shit. The gov. can regulate my dose of pills but they cant regulate the the price of medication from the pharmaceutical companies. It sounds a lot like socialism or communism to me. Why does my quality of life have to suffer because parents dont lock their shit up and dumbasses eat the whole bottle in 3 days. Well, that’s not me. People with real pain don’t get high from it. They get relief

    • It is all about $$$$$$$. Now States are sueing the Purdue etc. Who make oxycodone and oxycotin. They are bling the people that they have loss to heroin on these drugs! It is media blowing everything out of perspective. And people that are not in our situation do not no anything about it. People need to be educated. I also heard that now they are putting gabapentin in the same category! Frankly I hated being on it myself. It really sedated me and really did not help much. But everyone is different.

    • Although it’s true that there is an increase of death from opioid abuse I highly doubt it to be directly related to legally prescribe medication in the year 2018. I believe that the drug cartels are flooding our nation which has a very high percentage of people who just want or need to get high.
      I am willing to bet most of the deaths you claim to be opioid related if were to be traced back will found to have heroin and other illegal drug use.
      I am a chronic pain sufferer and as a result of incorrect or outdated statics and new laws the doctors are now in complete fear to treat their patients. At a time in my treatment where I probably would benefit greatly with a small increase in my dose because of tolerance issues, I was cut back instead. My doctors keep leaving the pain clinics because they can’t treat their patients as they see fit. My last doctor were forced to cut me back because according to their boss the DEA came to the facility and told them to do so. This sounds grossly exaggerated as there is no law in place forcing doctors to cut ALL of their patients back from medicine that has been giving chronic pain sufferers some level of quality of life.
      My life has been dramatically changed because of one dose being removed from my regime.
      The media also plays a huge role is placing blame in the wrong place. It’s heroin and other street /black market opioid killing people.
      If this false reporting continue to cut medical care to chronic pain sufferers, more people who are just trying to get through a day and do their daily duties will be forced to seek the crap on the street that’s actually killing people.
      There is so much more to be said…but I am limited in what I can do and typing is not a priority for me. But I must try to disagree and put my input because my quality of life has been drastically reduced because of insufficient data. Go deeper in your investigations. I bet you’ll find the real probably is illegal drug use.

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