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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  • Responding to Mike B.,
    Your comment resonates with myself and many others. Government prejudice and mis-guided regulations are frustrating and hard to overcome.
    Others can tell you better than I what actions to take.
    The alternatives are narrowing down to alcoholism and suffering. (I don’t accept suicide as a solution. And I’m not going to smoke marijuana.)
    My doctor gives me (inadequate) pain meds, 57 equivalents, of which some are T-4.
    I agree that our rights are being violated. We (and our doctors and pharmacists) are being intimidated and treated like drug addicts (or dealers) because we have medical conditions that include chronic pain.
    We are not getting high, using illegal drugs, or shunning our responsibilities.
    Unless the government uses proper guidelines, a portion of patients will always be maltreated and suffer.
    Mike, good luck, Tom

    • Marijuana salve does not work. Smoking marijuana is illegal and I dont like alcohol and the rehab from alcohol would be detrimental to future employment. 20 Advil per day will destroy the liver and kidneys over a period of time. That was why I was sent to pain management to start with – to minimize the ingestion of nsaid’s. There must be something political about the hydrocodone synthetic version f codeine? I just dont know. I will give it a shot. I do not wish for my pain physician, of 9 years, to be on some sort of juvenile resembling naughty list. All of this is ONLY absurd to those of us with real pain. Most of the fake pain people have already left the clinics. I have seen the numbers dwindle, significantly, over the last nine years. It is time for them to leave us alone. Thank you for your response and listening to my input.

  • Just a FYI. T-3 is Tylenol and Codeine. Did your Doc give you the same strength?? Be well. This sucks for all of us.

    • She gave me T3 which is 30mg codeine. Hydrocodone 5/325 is suppose to be the synthetic equivalent to Tylenol #3(codeine). Well, if so, why is it OK for a prescriber to not be on a list for prescribing Tylenol 3 but to be on a list for prescribing it’s synthetic equivalent? This is not logical. Is this political involving payoffs for certain manufacturers? I am just not sure. I have no choice but to try the Tylenol #3 for now. Wish me luck. Insurance companies have badgered me, the national media has badgered the entire pain management industry and now the government. Meanwhile prohibition is over and the lawmakers doing the badgering are having cocktails and wine every evening. Craziness! Lunacy!

  • I feel as though I may need to hire an attorney or sue the authorities. I was just informed my Hydrocodone 5mg is being switched to Tylenol 3 mainly because my doctor did not want to get on a government list of excessive hydrocodone subscribers? This is crazinesss!! Communism! They are pain management clinincs – this is what they are here for!! I have been in a successful program,utilizing hydrocodone, for 9 years and now they are changing the rules. I have to work at least another 7 years, maybe 10. I figured by now that any pain patients, not really in need, would have rehabbed by now with all the struggle they have made for pain med procurement. Now, it seems like they are going after people that were supposed to be in pain management in the first place and have never succumbed to their efforts of intended guilt and remorse they were trying to project on folks! Meanwhile, in my little Texas town here I just drove by seven brand new liquor stores opening up in the community.

    • Mike – As I have talked about in earlier posts, suing is not an option. This is why the government made these “guidelines” not regulations. Regulations can be legally challenged, guidelines that doctors are theoretically able to go against can not be challenged in court. The fact that the doctors are being threatened with action against their licenses if they do not follow the guidelines makes no difference because none of these threats are ever put in writing.

      I would tell your doctor about the letter that just came out from the CDC the end of last month regarding the misapplication of the previously issued guidelines and that they should not be used to justify forced reduction in medication for existing patients. Here is a link to the letter: https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html

  • Empathy please for the people that suffer and have never abused their meds and need them to function or for at least a few hours a day to take care of what has to be done. People will give up, what else can they do???

  • The CDC is now saying their strongly worded suggestion for prescribing opioid pain medications were misunderstood and doctors are to be empathetic towards chronic pain patients. The doctors are only to cut patients back if they agree to be tapered, but otherwise they are to educate pain patients to the dangers and affects of opioid pain medications.

    Here is the CDC website describing their intended approach towards chronic pain patient care:

    https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html

    I hope this gives us some protections from forced taper. Next time I see my doctor, her and I will discuss this and I will be asking to be brought back up to the doses of my pain medications that worked for me in the past.

    Best wishes to all of you chronic pain sufferers. Eventually this extreme swing of the pendulum will balance closer to the center.

  • I understand the major problems with the opioids. However, I am unable to take ANY nsaids of any kind. I wish I could because some over the counter pain relievers worked just fine, however, I am unable to use these as I am stage 4 renal disease and was recommended I check into pain management. Without my medicine I am unable to function. There are those of us that don’t abuse the medicine. Is there not some way to fix this?

    • Susan, I am one of so many individuals who have written their own experiences on this particular topic, here in response to this article. It is one of the most significant chronicles of the individuals’ who have shared their experiences within this specific article. I highly recommend that you try to read the stories about each individual who has provided the rest of the readers and commenters, with not only their own experiences, struggling with the most egregious suffering that I have ever read. I am always coming back to the article each time I receive a notification from STAT, that there is a new comment on this “community section,” of some of the bravest people I have ever read before.

      The story that you have generously shared with us all, is a well documented case for why we are all having to needlessly endure this tragedy; because for so many reasons that are considered to be a genuine concern that the current administration is responsible for the consequences of people who are truly going through a situation that is nothing short of a never ending nightmare.

      I strongly encourage you to read the countless responses from the entire nation. There will be some strongly suggested reasons from the entire community of individuals who have endured experiences that will be something that none of us could ever forget. There are some individuals who actually have some recommendations about what might make you think about how you might be able to overcome your own experiences enough to read about these recommendations that several individuals have shared with those who us who are also going through the same experiences that you are too.

      I want you to know that you are now one of us, who are here for everyone who has shared their experiences with all of the individuals who read and try to be of some type of help, and to remember you in the ways that we all try to keep you in whatever way that is generally a prayer, a hope, a reminder that we are all here to try to help everyone who writes, in what many individuals think of as our community that might be a conduit for us to remain in hope and peace, and who want to do something to end this tragedy of our being abused by those who could stop this dreadful situation because of the federal government. One individual who asks “what can we do?” We have the same agenda, and we must vote for this tragic situation to be over. Until we have that opportunity ( which we hopefully might not have to wait until we vote for a compassionate group of individuals who are amongst many who also want this to end, for us all.
      Thank you for your sharing with us, and we are all trying to stay strong enough so that we may prevail against the current administration whose tyranny over our physicians who are put on notice that the DEA is going to make sure that our physicians do not have to do what this administration has done to our physicians and us- their patients.
      Catherine Dunn

  • My doctor in Arizona is weaning me back. I’m a cancer survivor left in pain from treatments. Theres no mercy I feel I’m ready to die. I want cancer to come back so I can

    • Please send me your email address and contact information? I might have some ideas on how to assist you.

      Thank you,

      Andrea

    • Sojmds like your best bet is to go to a methadone pay clinic..they accept patients for pain. Not just addiction.

  • Dear sailbum, I find myself in a very similar circumstance, slowly approaching less and less driving, housework, socializing, etc. Ironically, only some meds, including opioids, give me moments of more normal thoughts and functioning. That the government is threatening this frightens me deeply.

  • i receive a prescription for Norco 5/325. I have United Health Care and with their effort to help fight the Opioid epidemic, they only cover 1 week of my prescription at a time. the problem is that i go to my specialist monthly, so i have to pay out of pocket for 3/4 of my monthly prescription (unless i go to my Dr. weekly, then they would cover it 100%).
    This is so wrong, United Health Care would rather pay for me to see my doctor 4 times a month so i can have them pay 100% of my medication, o i have to pat for my medication myself if i go see him monthly..
    this policy is not going to stop me from taking my medication, it just makes it more expensive.. for either medicare or myself depending on what road i take.. lot of times i go bi-weekly and pay for half mt Rx each time (just to make United Health Care have to pay for more visits to a specialist because of my inconvenience)

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