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 have been on pain management since 2005 due to major back problems that has resulted in 4 separate surgeries. I have permanent spinal cord damage that causes severe pain. My doctor had been able to effectively control my pain so that I had some reasonable quality of life. I have not been able to work, but have been able to take care of myself and run routine errands including food shopping so long as they do not make the bags to heavy. Now with the recent changes in regulations my doctor has been forced to take me off the medication I was on that was working and prescribe something else. The new medication not only does not control my pain as well, it makes me continually tired. It seems like I have no energy to do anything anymore. After more than a dozen years on pain management, my doctor and I know what works to effectively control my pain and would periodically rotate between the medications to help prevent building up too much tolerance to the meds. The problem is that none of the medication that works is allowed to be used for long term chronic pain management under the new guidelines. Excuse me, I should not say allowed, I should say recommended even though they are effectively the same thing. The problem is that if the doctors do not follow the “recommendations’ they are threatened with investigations and possible suspension of their prescribing privileges. The government likes to hide behind the fact that these are only “recommendations” when the reality is that they have the same force as regulations because of the threats the doctors are under if they do not follow them.

    Now my doctor is telling me that not only can he not give me the medications that work best for me, but that he may also be forced to reduce my overall dosages between the long acting and breakthrough medications because of the new guidelines and pressure being placed on the doctors. Doing this will further erode my quality of life to the point where I may no longer be able to take care of myself and live on my own. It would likely make it impossible for me to take care of routine errands and shopping any more due to increased pain. This is absolutely absurd. I have tried everything to deal with my pain including physical therapy, electronic stimulation, and acupuncture – so it is not like there are any alternatives to try as the guidelines suggest. I have tried them all and they have not worked!!!

    The government needs to stop getting between doctors and the responsible pain management patients. Go after the criminals, illegal drug dealers, and pill mills but leave responsible pain management doctors and their patients alone.

  • I have been through neck surgery and hip replacement in the last 8 months.
    Percocet kept me from the neck surgery for over 3 yrs until I decided to try neck surgery in Dec last yr. The misleading “one inch incision”. DOES NOT WORK. The pain level 7 to 9 is the same. Sleeping a few hours is a miracle. Today I found out my dr will not give me a new prescription, because the Gov issued a new law.. so. Where the hell do I go. What do you do when it’s 3;00 am and no sleep at all is possible. Can you folks in the government advise me ?

  • After finally doing research on crazy problem I have come to realize Im blaming the wrong ppl it’s not healh care it’s freaking political bs! I have had back problems an chronic to severe pain for 3 or 4 years in April when I physically couldn’t work anymore an had to leave my job an found put I had 3 herniated discs in my cervical really I was jus happy to finally get an answer to why Im 32 with back problems so u did the therapy injections, gab etc nothing worked finally decided to have my fusion surgery an it was October 2… I woke up an couple hrs later I was sent home with Tylenol 3 for my post op pain?? Excuse me u jus cut my neck open an shoved instruments in there for hours an then think it’s ok to give me something I was given as a kid for a sore throat COMMON! I’ve had my foot crushed by a forklift 12 years ago an never misused the meds…..need less to say it’s 6:00 a.m. an another sleepless night with some pretty intense to extreme pain an u know what that’s fine I’ll take the karma for my ignorant generation but don’t do this to the elderly that is absolutely unethical an fuckin wrong! But hey get rid of the death penalty bc it’s “inhumane”!! Lmao what a joke

  • I am 70 and in serious pain and have been taking pain meds for many years. Agree with you 110%. I wish the government would stop trying to help me- that’s the job of my pain doctor.

  • This is such a SHAM. A huge percentage of us take the pain meds a prescribed. We do NOT abuse them, we do not get high. I’ve been on them since 1998. Recently my Dr. cut back my meds. Instead of living a normal life day to day – I am thinking of how I can get them illegally, what illicit drugs could give me relief. I’ve even thought of suicide. This needs to be looked at an the rule “FIRST DO NO HARM” must be taken into account patient by patient. I am a result of 20 years of being on these drugs. There needs to be a grandfather rule. I can understand someone new being given this set of rules. But any Dr. who understands the chemistry behind what’s happened to me would know the damage has been done. The ONLY way for me to live the rest of my life is to stay on the current level. I tried once to be off the drug – it was a miserable fail and 4 months later the only way I could live a normal life was to go back on them. So to all of you – get the body bags ready – get the jail cells ready. PEOPLE WITH MY LEVEL OF PAIN WILL COMMIT SUICIDE. THEY WILL SEEK OUT ILLICIT DRUGS LIKE HEROIN AND COCAINE. YOU ARE NOT DEALING WITH THIS CORRECTLY.

  • What a shame and political misleading , I take pain killers and never had any brush with the law. I take oxycodone because is what demise pain and I can feel normal by not thinking of pain constanly. Is a chronic pain, do to an accident 18 years ago. Only people filling this pain like me know how it’s.

    • I understand Angel. I’ve been on oxycodone and methadone many years just so I could get out of bed and go to work due to horrible chronic facial pain brought on by infected dental implants -nerve damage and
      bone loss. I will probably blow my head off if they pass this law. Can you just imagine the black market this government of ours will be creating? Fight back!

  • I have been under doctor’s care for 4 years now I have severe pain from a fractured spinal cord many years ago I also have been hospitalized three times with something that is eating my neck bone away and I have severe nerve damage in my feet my dosage has been cut to 1/3 of what I’ve been taking I have missed 5 days of work in one month I have not slept decently in the last month since my medication has been cut and they are currently trying to cut my medication even more. Send my doctor scheduled me for surgery for my neck with no x-rays not even looking at because she is a new doctor because his bureaucratic crap that’s going on I had to switch doctors. I do not understand how the government can tell a doctor’s patient or a person who has worked his entire life how much pain he or she is in or not this is a disgrace that the government gets involved in Americans medication lives next will it be who you can worship at the church and what religion you should have to choose is there any way to write about my concerns I am already losing quality of

  • I was in the hospital for 2 months and when I got out my doctor jhad to lower my prescription from oxycodone 30mg to oxycodone 20mg. Now my new medication that I have to take or I can die (Hydrocortisone 10mg) that I have to take for the rest of my life is giving me pancreaseitis. My pain medications is not enough to take care of that pain. Now I have to spend more time in the ER just to be able to live pain free. I was on oxycodone 30mg for all most 4 yrs. my body was used to that medication. That medication kept me out the hospital. Now what am I going to do? Can you tell me what to do now Mr. Government?

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