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.

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 saw the same Pain Management Dr for over 7 years. Both he and my Primary Care Physician said I had an “Excellent record” and that I would have no problems finding a new PM Dr. Every drug test he ever did was negative for illegal drugs, my lab work was perfect, the amount of medication levels were within normal limits, I never went to ER except for a steroid or Tiraspol injection when my Sciatica was at its worst (that was acceptable) I used the same pharmacy- switching only when we moved out of state, pill count was correct when I saw Dr or NP. My diagnostic test showed I had many reasons to be in legitimate pain! None of that mattered! I’m down from one pain pill every 4 hours to 2/day. It’s a joke! IThey last exactly 3 1/2 hours so I have to decide what is most important to do – sleep or do housework, etc. My quality of life has declined 80%. I could not find another PM Dr to see me for 4 months and he’s out of town. I’m lucky to get 2 pain pills a day, I know, but come on! I’m. 61 yr old Wife and Grandmother and I just want to live the rest of my life comfortable and do something productive every day. The months I was without any meds I also got Shingles. I became so depressed that I was Suicidal! I literally begged God to take my life many days. Good people are being made to suffer needlessly and the main reason is due to Fentanyl that drug dealers are cutting Heroin and other drugs with. They even make their own Oxycodone pills that look like wheat the Pharmaceutical companies make with same imprints and put Fentanyl in them! I have actually thought of trying to buy some illegally but I don’t have the guts., and I really don’t want to die of a fentanyl overdose. Government is forcing people to suffer and some commit suicide, others turn to illicit drugs because they have no alternative.
    So tests DO NOT matter- the Drs are afraid and being bullied and threatened!😥😥😥😡😡😡

  • I live in Nevada and with all the recent Opioid related fear tactics of the legislature Dr’s are refusing to even write a prescription .

    So for those of us that are legitimate users who have to use these drugs to live and have a quality of life, we have been cast aside and marginalized to suffer undue pain because of other bad actors behavior .

    And if you contact the State agency in charge they will say we never meant this to happen but there is nothing we can do, a typical government solution to a problem let’s scare the hell out of the DR’S so they will not even write the prescriptions in the first place and then there is no more problem!

    • Ernest Rhoades—You are SO right! I had the best PM Dr and he went over and beyond to document, drug test, etc. He decided to retire his PM practice because of fear of losing his license! This country is starting to look like a dictatorship lead country fueled by greed.

  • Since the governments efforts to minimize the “drug epidemic”, or their inability to control or harness this mess. Real people who are sick and deserving of these medications, are being turned away in twice the agony that brought them to the doctors in the first place. I would think one life needlessly, and unsensebly lost because of one’s inability to cope with massive pain thresholds, would be enough to send this one back to the think tank guys and gals. I know that as advanced a nation we are currently spreading throughout the world, sensible tests can be devised to weed out those who have no legitimate need for said medications. This alone will make or at least facilitate better accountability. Then perhaps the truly needful patients may be properly diagnosed, and assist in the recovery of some persons, where others need not take on greater challenges.

  • Thanks sailbum,I will and you can contact me as well at anytime you need to talk to to me about this.I am praying the best for you and anything I can help with just let me know.

  • First of all I want to thank all the people who work to help try to correct this wrong that has been placed upon all of the CP patients in this country.Next I read and digest all of the reports sent to us and also all of the comments from the CP patients as well.I am 66 years old and suffer from degenerative disc disease and degenerative osteoarthritis and spinal stenosis.Is in my cervical spine.I have been going to Pain Management and treated with Opiods for the last 20 years off and on, depending on the type of insurance I had as it kept changing due to the company wanting to save money.I am on Medicare Parts A and Bnow with supplement plan F and supplement plan D.I have been taking for the last 5 years Morphine Sulfate ER 30 mg every 12 hours and 3-10/325 Percocets for break through pain.Gets me through the day but just barely made I have asked for increases but pain doctor keeps telling me I am at the maximum amount he can prescribe to me.I do my best to make it work.Have some sleepless nights because the pain will wake me up and if I take more I will not have enough for the month.I just had a surgery on my C3 thru C-6 , was called a bilateral posterior decompression to take the pressure off of my spinal cord,the neuro surgeon had to remove the top s of the C4,C5,and C6 cervical vertibraes to be able to clean out the osteoarthritis and remove the 3 clusters of bone spurs pressing on the spinal cord and nerve roots.I was released to go home the day after the surgery.I asked about having something prescribed to me for the pain that was going to be lasting for at least the next 2 to 3 weeks and was told he was not going to prescribe anything as he said I was given by pain management more than he would prescribe to me anyway.I was a bit surprised to say the least.Has been 17 days since the surgery and the post op pain is lessoning .But I still have chronic pain from the degenerative disc disease.that will be the second surgery I will be having to have done sometime next year.So believe me when I say I understand the pain and the way we as CP patients are treated.We have real medical problems that require medications to help us to just have some kind of quality of life.But we e are treated like drug addicts just looking for a fix.Acctually we are treated worse than the real drug addicts are treated.Going to pain management the doctor and the PA’s treat you with suspetion, trying to see if they can believe you or not.

    • Like you, I have degenerative disc disease which has caused spinal stenosis. On top of that I also deal with peripheral neuropathy that affects both arms. The spinal stenosis also gives me problems walking as one leg has some numbness and weakness. I have been on pain management for more than 15 years and have also felt the effects of the changes. A little over a year ago my doctor took me off my pain medication which was working reasonably well and switched me to a different medication all because the guidelines indicated that meperidine was no longer a preferred medication to use for long term pan management. The other medication that I used to alternate the meperidine with to address the build up of tolerance is also not on the preferred list, so that is not an option either. Never mind the fact that over the years I had been tried on every medication out there and these two were what worked best for me, because some idiot behind a desk decided they were no longer a preferred treatment I was forced to give them up for something that does not work as well. In addition, because of the guidelines, the doctor will not give me a dose higher than the equivalent dose to the meperidine I was on, despite the fact that the other medications are not as effective for me. My quality of life has gone down hill significantly since this forced change and it is extremely frustrating. Not that I would ever wish anyone to have to go through what I deal with, sometimes I wish that these bureaucrats making these rules would get seriously injured and have to deal with the nonsense they have created – then they might realize what they are inflicting on us and change their attitude along with the guidelines.

    • I hear ya sailbum.This is just absolutely crazy what the CDC has done to us CP patients.I too have numbness and ting-a-ling in both of my forearms and both of my hands .Even after the surgery for the spinal stenosis it is still there.always is the ting-a-ling and then at times is just plain numbness.It worries me that if I have the next surgery next year to remove the 4 degenerative deseased discs and put in 4 new ones in their place / put the 8 small metal plates and the 32 metal screws to hold the Cervical Spine on place what do I expect on the post op for Pain level.I was told by my Pain Management Dr and the Neurologist / Surgeon that will be a 1/3 chance the Chronic pain will decrease and a 1/3 chance the Chronic Pain will stay about the same ,and a 1/3 chance that the Chronic Pain may increase.I am going to have to think hard and long before I have the second surgery done unless I can get better odds on the Chronic pain levels.I had the first surgery done because the spinal cord was getting flattened a bit and the stenosis was getting worse and the clusters of bone spurs were if left alone was a very good chance that I would and up either paralized in someway or dead.Therewas no other option but the bilateral posterior decompression surgery to keep this from happening.But geez,no prescription for additional pain medications to help with the post op pain I will be facing for 2 to 3 weeks after the surgery.The doctors are pretty scared to prescribe them.the second surgery to replace the degerative discs and to be all secured in place with the 8 metal plates and the 32 metal screws will be a much more extensive type surgery.I have 5 friends who had surgeries similar to that and 4 of them the pain got much worse.They said they wished that had not have that surgery done.The 1 friend said the Chronic pain level stayed about the same as before the surgery was done.But the good news was that it will keep the new discs from moving to and causing damage to the spinal cord.Good luck to you Brother and I pray the best for you !!!

    • @Walter – I have had four surgeries on my cervical spine so far so I understand your apprehension about the additional surgery. I had two discs removed and a fusion done due to discs pressing on my spinal cord. This was done before the artificial discs you are talking about had been approved for use in the US by the FDA, so the disc replacement was not an option for me. I have also had both a laminaplasty at one level an a laminectomy at two levels done to relieve additional pressure on the cord. Like you I was in a position of either having the surgery or ending up in a wheelchair, so there really was no option. I hope everything goes well for you and if you ever need to talk, drop me a note and we can take this offline to email.

  • I believe in the old adage that if the government say’s it is here to help ,you had better lock the door ! because you are about to get something you can neither use or want!
    As usual they have made a mess out of a well intended solution to help and wound up hurting the elderly and in firmed !

  • the paragraph that states..decreased quality of life, the pursuit of illicit drugs , potential for increased suicidal ideation, is right on the problem with long term chronic pain patients….thank you for standing up for all of us..

    • Amen to that and God Bless every individual, Senator, Representative, Physician, that will stand up and fight for the right for the rights of all individuals in chronic pain. With chronic pain and little or no pain medication makes the quality of life null. When you find a dosage that is right for your situation you begin to live a more productive life and begin enjoy outings with your families and friends, exercising and laughing. Decrease your pain meds by just one a day can through your life back into a deep hole of pain, depression and solitude, I’m that person and I have furry for those in the Government agency’s that has no empathy for the innocent chronic pain patients in treatment that has broken no laws but are being treated like the abusers and addicts that started this epidemic now our lives being crushed even though we are not the guilty. Our doctors are puppets and are guided by the Government and have to do what they say because it written in law and to break it they lose their licenses. I know in my heart if President Trump realized the life threatening hardship that we the chronic pain patients are being put through he would correct this immediately. All I ask is for all Americans to stand together as one people and start fixing these horrible problems and stop waiting time in Congress and start working together , get your heads together and start using common sense. Leave the President alone . The House of Representatives is the biggest threat of all to our Country I blame you for letting the opioid crisis and the crisis upon the senior citizens and yes there is one but how would you know?

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