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 firmly believe that if they restrict people the suicide rate among chronic patients will increase dramatically. As a chronic pain sufferer I myself finds days when my levels are high that I just feel like what is the point of living if I have to live life like this. I pray about it for strength. But I just couldn’t imagine what life would be like without the comfort of some relief. And pain medication does not just stop pain they buffer the amount you feel so myself and the vast amount of people on them would have incredible pain that would be certainly hard to live with. I wonder if any of these people making these decisions have ever experienced chronic pain or have loved that do. It would certainly make a difference. Thank you

    • Lucinda, I just found out yesterday, my pain meds will no longer be filled. I suffer from not only one, but several life altering diseases that make my life worthless without some form of pain control. I have been crying and sleepless since 10am yesterday. I have a 2 yr old Grandbaby that I want to see grow up! I have NO clue how this will happen for me anymore. It’s not like I was taking high doses of opioid, I was taking 5mg Oxycodone every 4 hours. I was offered 20mg, and turned it down! I could have used it, believe me, but didn’t want to chance side effects associated to the higher doses. The ones making the rules and laws have no clue what it’s like to suffer

  • I hope that one day these ppl who are trying to take away other ppls quality of life have debilitating pain and aren’t able to get any pain medication and then maybe they will understand how others feel.

  • I’m a chronic pain sufferer, on disability, also have health ins. thru my husband job. 10 yrs of paper trail, of various ways of seeking pain relief. Dr. goes on va. replacement physician has no idea of my med. history and tells me She will Not refill my pain med. Long story short, thru phone calls and I’m sure of her actually looking into my file,I was given my script. In the meantime that put undue stress, and caused my pain to increase to an unbearable level. I pray, alot of discussions and thought goes into their end game.

  • Please fight this to a reasonable process. I have a family member with terrible chronic pain from a shattered body. She’s self regulate amazingly with her doctors help. What this proposal does is destroy pain control partnership between doctor and patient. I am totally against this.

  • I am 50 yrs old and paralyzed from my neck down at the age of fourteen. My Dr. is a responsible caregiver, with the help of colleges,he gotten me through esophageal cancer, skin and bones cancer, and grandma brain anurisms. For years, my flesh eating bed sores that have eaten away my skin an muscle to the bone. My pain is so bad, my care takers are limited in the ways they can touch me in order to treat me. No one should live Like I do and I have been this way for 35yrs and I’ll only worsen until death! I live in a small 20 x 20 room permanently confined to a hospital bed and only leave to visit, transported in a ambulance with life saving equipment, my Dr.’s who are very responsible. Overseeing my treatment is a pain specialist of 15yrs, he’s no pill mill, without his ability to adjust my levels of pain meds without outside intervention is important to my quality of life! Limiting my doseage and ability to purchase my meds with medidcare part D and your putting me in an early grave! I will no live in pain because you at the CMS put out random #’s of doseage levels! Log term pain med patients must have their meds doseage increased over the years because as pain increases resistance to pain meds increases. So Dr.’s must be free and not limited by a burracratic agency that knows nothing of the patient! My meds are in a lock box that only my care taker has access to, an never get to the streets. Stay out of my Dr.’s treatment of my pain, this isn’t the answer! How will handcuffing, and scaring my Dr., keep dope imported from China from killing kids? How does your scaring my Dr. With persuction keep herion, Chinese fentnal, ICE, and imported precription meds off the streets, it won’t! The only people hurt by this policy, will be me, the long term sick I’ll and dying! I would rather die didn’t lay here and suffer from pain brought on by your policies of interference my treatment. You don’t know me you don’t know my pain it cause or my diagnosis! Arrest street drug dealers, doctors that have sold out, their easy to spot they accept only large amounts cash for visits, and they have no hospital privilidiges, and the lines outside their offices are unusually long! That’s the sign of a pill mill, buy legitimate Dr.’s should not have their patience treated from washingtom! Putting limits on my Dr. And you putting limits on my quality of life, take away my Dr.’s ability to treat me as he sees fit by taking away or limiting my doseage and your taking my life! I refuse to live what little lifeI have suffering, stay out of my relationship with my physician! Sorry people Die from street drugs but that’s the choice they made, but people die from alcohol and other vices daily. Wheres your outrage at that? Your not going to help the dead by harming the sick, dieing and suffering! I rely on my doctor for proper treatment, not on some random numbers pulled out if the air by politicians! Politics, so you can say you did something. There’s no opioid problem in America, there’s an illegal street drug Market of opioids imported that contains Fentanyl other drugs that are killing people! “Street drugs and the dealers kill people, doctors prescribing for the long term ill and dying don’t kill people! Don’t get between me, my doctor, and my pharamist! See you at the voting booth……

  • These rules have not helped 1 drug addict only hurt people that need the drugs .. Doctors need to make The decision not the government .. Bad people will always find away .. people that need them should be able to get them

  • I think it’s time for politicians to be politicians,and let doctors be drs. Americans are now going to be told by elected officials how there body feels. How many senators and congressman have the medical degrees in health care. So my feet are so swollen mr. Congressman … what’s wrong with them… I’m to the point I can’t walk,wear shoes, my right foot is blue and swelled so big I can’t put on a shoe…ive been like this for quite some time I can’t even sleep for the pain… any suggestions? Well after hearing a line of crap for almost 2 years…. after laying in pain and even to the point of crying…. and spending tons of money… to have a doctor it go throgh one ear and out the other… finally found a real dr.instead of a nurse practioner…i have tendons torn all throgh my ankle… thank you so much for me having to lay in severe pain and not being treated accruately… I hope you break your leg and are made walk on it for 2 years and get harassed at your work place when you are expected to perform certain duties…

  • PEOPLE. WILL. FIND. A
    WAY. TO. GET. MORE. PAIN. KILLER. FROM. CHINA. POSTAL. INSPECTION. MORE. CONCERNED. ABOUT. BOMBS. IN. THE. MAIL. !!!

  • It’s about time that doctors and patients voices are heard! This heavy-handed double fisted attempt to Snuff out Lives who depend on their medications in order to have any quality of life and who have no other choice in the matter thanks to disease and disability is an overreach by so many government agencies to legislate morality! Leave legitimate pain patients and their doctors alone! We are not out of compliance it is illegal drugs you need to focus on you stupid SOB’s!!!

    • I totally agree with you, I have been with pain management for over 10 years.. my meds give me quality of life.. I have back issues have done everything that can be done I still have pain , I go for back shots every 3 months and with my pain meds I live pain free.. I used to be on 80 OxyContin for 4 years 3 times a day.. but with my pain management dr who really cares and myself the shot I was getting every 3 months and being on flexeral 10mg and OxyContin 80 mg I ask my dr if I could try being lowered down and he agreed to try me, I got down to OxyContin 30 mg every 12 hours.. which I’m on right now and I’m doing well…. I don’t like being on them but my dr explains to me if it helps you, that reason enough.. I don’t like telling people what meds im on but they look at you funny and judge you. Until they walk a day in my shoes, keep your comments and judgement to yourselves… not everyone on pain meds is a addicted or trying to get high on there meds.. there just trying to live a life pain free, and enjoy everyday that’s all. It’s people who abuse pain meds and dr shop that ruin it for the people who really need pain meds… so sad…. hope my story shines some insight on people who take pain meds cause they need them to have quality of life.. thank you Dawn from NJ

  • Who remembers President John F. Kennedy?? Anyone? He was the most powerful man in the United States as president. He was a chronic pain patient. He took opioids and other medications to help manage his pain. The levels of medication he took would, by these standards that are more than likely going to go into affect, be considered a drug addict.
    I bet most people, probably some of those making these incomprehensible limits, don’t know that. Would it even make a difference?
    Overdoses are happening because of true addicts that use these medications to get high. Or because chronic pain patients are taking to their last resort, the streets, to get medication to try and have some type of life. These street drugs are made with who knows what. The dealers will continue to get rich and the true addicts will continue to get high and overdose. This limitation is not going to stop that. Look for an increase in street sales and an increase in suicides.
    I just hope when this happens the poor souls that resort to buying from the streets or taking their own lives are accounted for properly in these almighty statistics. Accounted for correctly; as suicide due to pain. Not “accidental overdose”. I think there will be a substantantial increase in suicides due to intolerable pain.
    I don’t want to be one of those statistics. I have a disease and it’s called chronic pain. Arachnoiditis to be exact.
    Please talk to the real people that this is going to affect.
    John F. Kennedy was our president and he did it while taking this oh so evil medication called opioids.

    • For about 2 years I’ve been begging people with Clarity of mind and words to write government officials and explain that the pain many of us are now left to supper with is tantamount to torture and it’s not fair or kind or doing no harm nor is it reasonable care and you’re absolutely right on the results people have two choices well three that I have found and they are as you mentioned turn to street drugs because even though I take a UA every month to verify that I’m not only taking the proper medications but that I’m taking them in the proper dose there for not hoarding them or diverting them to the street… I have not been able to get the dose of medication that was effective enough to allow me to do things like buy food and cook it in the same day, or take a shower and do some laundry in the same day… My days at 90 morphine milliequivalents reduced to picking the one task that needs done most and sometimes it’s wash my hiney and sometimes it’s cook and eat food… The majority of the time I get to stay at home in my house and they say pain patients want the pill to fix it but I have saved up to purchase a TENS unit and EMS unit the combo unit I have heating pads every where I sit to include one that plugs into the car power port I have a walker and a cane and a portable potty and I do the rehab exercises every other day minimum and when Groupon has a sale and I can get a good massage that’s an amazing time but none of it is covered by insurance Medicaid or Medicare or anything else so they say people don’t do anything other than take the pills but I do a lot of things other than take the pills and I’m still stuck at 90 and MME although for multiple years I was significantly higher than that – but being housebound with the exception of going to take the UA and seeing the doctor every month for an amount of pain medication she knows barely lets me not cry all day everyday in pain with doing every single thing I’m comfortable doing and and try to afford other than pain medications but now I am home bound… and I would love to find a doctor that would look at the chronic pain that I’m in since I was never supposed to walk and my hips aren’t right and my knees don’t have cartilage and I’ve got many ruptured disc and multiple other problems that happened before I was born and I’ve dealt with my whole life and all I would like is for the people making these decisions to Shadow or actually be in this kind of pain all day everyday 24/7 365 the question isn’t are you in pain it’s how bad is it and can you still make it to get food and stuff on your own? Because when we take pain meds away from chronic pain patients we limit their choices of activities and when it becomes so limited that it is the choice between self care and no care or it’s between trying to find something else that works which the only thing I have not personally tried is having acupuncture for two reasons the first is financial it’s scary and at my medical practice they’ve had a sign that says that were receiving Care at a low dose Clinic to who I was referred to from my primary care provider but that if I would like to see a pain doctor they would be happy to put in a referral to do that and I’m like well that’s how I got here in the first place so what would that even do for me and then it also says that we are receiving palliative care and we have to sign a waiver that were aware that that puts us at risk or not breathing accidental overdose heart attacks the sudden the 3rd but that we’re doing it in order to have a life worth living and be able to deal with the pain yet they still don’t go over the 90 morphine equivalent regardless of your bowling while you’re there or not or if you’re doing all of the rehab exercises and stretches and wearing the TENS unit and EMS and Heat and everything else that you’ve ever tried your whole life just to try to be in a little less pain and get one more choice of the list of things that people generally do in one day but that there has been no way I’ve been able to do and one day since my mid to early twenties… So instead my life has been reduced to trying to prevent pain at all costs and that cost is self care and house care and maintaining friendships outside of the home and other similar things but I know that the next to I have left are the ones that you mentioned of trying to find illicit drugs that are measured the same and spoke about in the same way when I’m sorry but I feel like heroin that is laced with fentanyl is drastically different and then in person taking perscription medication as prescribed and it should not count as 2 deaths which it does since it gets counted as one illicit opiate that and one pharmaceutical grade opiate death…

      I would also like to know why they count from the 90s and why they don’t consider other things that were happening in the around that time… We have much improved battle medicine so people come home from wounds they would have never survived in World War 1 or World War II or even subsequent battles and people from the world wars that were wounded or in the time of their lives as well as all of the Baby Boomers that has them in more pain with more types of arthritis and more types of pain cause by basically living and pushing through what you needed to do in order to get what you needed to get done finished so that you could move on to whatever was next… So we’re going to use the time frame but we’re not going to consider the fact that there’s a gigantic number of Baby Boomers in that or a gigantic number of people that have been hurt in the various conflicts and wars in the Middle East in that time frame… We’re also not going to consider any of the extenuating circumstances that have caused actual pain patients without access to actual pain doctors and frequently don’t have access to actual pain medication so they have to guess based on what’s available on the street or like the pharmacy I’ve been using for 20 years has been robbed a number of times since these rules are changed and there’s now an armed guard at each one that lets you in and out between every customer and the opiates also safe – that to me shows that when people are suffering, people in pain are now not only being punished and suffering to the point of torture but also being labeled as addict and lazy and not willing to try anything but a simple pill which in my experience is never or at least the greater majority is not the case it’s because everybody I’ve been through the pain cycle with or talk to at the pain doctor first tried stuff like rest ice compression elevation and alternating between heat and ice ice and over the counter medications, and then after turning blue twice and being carried to Student Health in college twice because I wanted to take naproxen sodium twice a day instead of ibuprofen every 4 hours and now I turn blue when I take any NSAID, so I am automatically looked at as a drug seeking addict just because I like to breathe and with anti-inflammatories I cannot. I have yet to meet a pain patient that waited to see their primary care doctor without doing home treatment first and I have not found anybody who went to the pill first or expected the pill to completely fix anything which it never does and some of us would just like to be able to live at a point where we can take care of ourselves physically and opiates are not a magic medicine then allows people in extreme pain to be able to take a pill and then go back to work after it had been years and it’s all just so frustrating because now people have missed the deadline and even though I had been supporting websites like don’t punish pain and other websites that explain how not treating pain and physically torturing somebody is the same. Apparently only people that fall under the Geneva Convention don’t have to worry about being tortured with pain but those of us who have sought Medical Care and failed multiple other treatments and we’re on a semi effective dose 2 years ago before they started changing stuff with Medicaid also and having medical clinics that just said everybody’s going to be at 90 whether it works or not hyphen it kind of makes me feel like why don’t we just have a computer Doctor or pharmacist what you need and how much I’m just cut the doctor out of the program since they are not part of real medical care anymore… And maybe I’m the only one but I would prefer if the people that went to med school not the people that went to Capitol Hill or the ones making my medical decisions and I would also prefer not to be compared with my stepfather who’s been caught nine times as DUI but I got in trouble for refusing to change the foam coolie cup around his can that said Pepsi and put in a new opened beer after I had the Dare program from the police department at school which is drug abuse resistance education at which point I was thinking out of the car I’m told that I am to do as I am told and if I am told to get the man in new drink I get the man a new drink and that was a fun lesson at 5th grade… I’m like chronic pain and issues with bones and joints that cause a significant portion of my pain does not have anything at all to do with addiction and I can’t go to meetings at AA or Al-Anon in order to have help with my pain… The drug czar who was on either 2020 or 60 minutes approximately 2 or two and a half years ago who equated being alcohol addict to having breast cancer since they’re both diseases in my opinion is just nuts since his analogy was that he went to court after a bad wreck when he was drunk and he was given the option of treatment or prison and he picked and he picked prison and he chose AA and has been doing great ever since- I still have yet to meet anybody with breast cancer or any other kind of cancer that you can go to a meeting every week or every day or any amount of time at all and have their cancer subsequently get better because they stood up and shared and got there six-months sobriety chip or they’re year sobriety chip and there is no reward of you of cancer and maybe was Eastern medicine you get your tumors to shrink let that make them operable and have insurance save half of the normal bill, even if they did – it would not be like the addict who had a bad wreck and was offered something good and positive or something punitive and he pitched good and positive and never had to do anything punitive and this somehow puts him in a place to be able to be the drugs are under President Obama and make these decisions outside of the supervision of medical care providers but I would agree with the statistics that the number of people using pain meds has gone up and that there are cities were it’s a gigantic problem when there are 300 people that live there and 30000 prescriptions a month go there that should be an obvious red flag to the mail order pharmacy the town itself and an enormous amount of other levels of control but when you live in a military town after Decades of conflict in the Middle East with car bombs and IEDs and other things along those lines and also has a ton of baby boomers and still has the same rate of people with Moore ordinary problems like getting in a car wreck when they’re young and being raised by two parents whose backs always hurt so never complaining feeling like that made them a good kid or kids that are born different and have chronic pain everyday… We don’t need one size fits some medical care… We need one-on-one personalized care which was one understanding was the entire point of going to a primary care provider and being sent to a pain specialist was to get not only pain meds but also the other things that can help pain and then maintaining them weather physically going to rehab at the moment or not because the balls to do the exercises and the straps and the other things are all available outside of rehab but doesn’t mean you’re not doing rehab or using a TENS EMS machine or lots of heat to try to relax muscles to help… At this point there will not be another day in my life where I am able to wash my hiney and do a load of laundry and get some groceries and have enough energy and or pain control left to be able to make food and then be able to eat it… These are not the choices people should be left to make everyday eat or buy the food, shower or wash clothes, do dishes or eat the food that was actually cooked… There are just so many things that people should not have to choose between because we should be able to do basic self-care on our own or at least qualify for help because I don’t even qualify for help after you take away the pain meds that allowed me to do it for and large number of years. It is so frustrating in addition to making myself and other people at least at My Pain Clinic feel and like we are cared for less than prisoners of War because being in intense pain every minute of every day is torture and there’s laws against that if you happen to be a prisoner of war but if you happen to be a chronic pain patient then you’re on your own!

    • Well said my friend, I’ll say a prayer for you and know I’m thinking of you … sending you gentle HUGS

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