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 am a chronic pain patient i have ra oa rsd and have had to undergo several operations and radiation for cancer it is already dificult and stressful to try and get my meds i get my meds once a month i have had the same dr for over 30 years he is the only one i get pain meds from what no one seems to understand is people like myself that have been on pain meds long term do not get high or have a buzz from their meds but the reason they have to raise the dose is because your body gets use to the drug so to get pain relief the dr ups the dose my dr and i go as long as i can but at some point my pain becomes more then i can bare so my dr ups my dose but now they want to restrict my dr even more yet i have allways followed the rules all the meds do is help are pain and help us to function it is starting to feel as if these politicians want to kill off people that are ill i pray that someone grows a brain sick people are not the enemy drug dealers on the corners selling meth and heroin and the like they are the enemy please leave decisions about what we need to our drs that spent years in med school and see their patients every month the dea and such agency need to do the job they were hired for not trying to stop sick people that only want to be able to function with as little pain as possible from getting thier meds for me if my meds were to stop i would become bedridden this would be a death sentence for me and many others a holocaust of sick people please please stop the insanity

  • I have Porphyria Cutaneous Tarda, Sjogren’s, Lupus, and Cervical, Lumbar, and Thoracic spine isses that have totally altered my Quality of Life to the extent I can not do a lot for myself, the only relief I get is from my pain meds, If they take them away my Quality of life will be diminished even further. So people in pain just are told to suffer? It is bad enough it take Drs long enough to figure it out to help people but now they cant take each individuals case and cant prescribe to help them patients? How can the government rule on what a medical doctor decides one way or another…are we turning into Russia where our government gets to control every aspect of your life? Pretty sad when people cant get any help from those they turn to for it! We the people need to act and stop our government from even having any say in our doctors treating we the people for our medical issues, that should be up to the doctor, if a DR is over-precribing..go after the doctor not the patients!!!!

    • Dear Andrea,
      I don’t have FB, because of ID problems that their stupid algorithms can’t solve– almost as stupid as the DEA! I am a pain- patient affected in this current no-win situation; would like to get more involved. Perhaps Twitter? Some other way? Have already posted petitions and signed statement to CMS, a few days ago. (I see your reply, below; I would be willing to talk w/ a journalist. I don’t have cancer, but have other multiple pain issues; have tried all those other non-narc. pain meds; severe adverse reactions, or they just don’t work.) Refuse to be labeled psych pt. or addict because of chronic pain issues! Thx.

    • The Facebook page is an open page, not a group, so you do not need Facebook account to access it. You can also find us online at ATIPUSA.org.

  • I am a cancer patient and I need opioids to control the pain of cancer that runs throughout my body
    Now I find I have a new battle trying to get my prescriptions filled I am not alone we need help who do we turn to add such a dire time in our lives

    • Would be willing to discuss this with a reporter or journalist? Or contact us at ATIPUSA on FB for a way to get your story told.

    • Oh Good… got the one to Marguerite to post, so I’ll try yours again, Andrea. I can’t get FB; some problem with my ID and the idiot algorithms on there (as idiotic as certain gov’t policies and agencies?) So is there another way? Twitter? Also, I’d be willing to talk to a journalist. Chronic pain for about 40 years; have been stable on low- dose opiods for about as long. Multiple conditions. My doc finally caved in to the DEA, though, as of about 2 weeks ago. Desperately seeking legal solutions that I can afford (herbs? acupuncture clinic? I don’t know…). I refuse to be labeled a psych pt. and given toxic drugs that I cannot tolerate– or, to be labeled an addict, when I’m not. Thx.

  • The people making these suggestions are not in the front line of patient care, they do not care about patients, only getting their names published. The many patients that have sustained traumatic injuries or have worn out their bodies doing heavy physical labor need treatment to carry on daily activities. The opioid death totals cited in the news do not mention that eighty percent of these individuals have illicit drugs in their blood stream. If all the talking heads would pressure the federal government and law enforcement agencies to keep these illicit compounds from entering this country perhaps these deaths would decrease greatly. The addiction issue must also be addressed. Addicted individuals with insurance coverage have a hard time paying for treatment due to high out of pocket copays for both physician treatment and medications in the pharmacy or outright denial of treatment by insurance carriers. Their is much to be done in this area and Washington just continues to only run its mouth.

    • What ,”addiction issue,”Mr Hackney??The ,”addiction rate has not changed,,it is still 1-2 % of anyone who were prescribed a lawful medicine my a lawful doctor and choose to NOT TAKE THAT MEDICINE AS PRESCRIBED,, anotherwards,1-2 % broke the laws.Again someone is having a problem distinguishing propaganda from truth.
      Let me ask you a hypothetical ???,,,If u sold cool-aid for a living….and someone spent 44 million dollars of tax payers money to badwrapp cool-aid w/lies…lies like,,Cool-aid will cause addiction…Cool-aid will cause you to o.d.,,,Cool-aid is BAD BAD BAD DEMON DRINK FROM HELL,,,,AND then dea puts out a article stating anyone selling cool-aid is under survellieance and if u sold 5 koolaids a day we will arrest you,take your home,your lifes work,,before,,,u are ever yet in a court room to prove your innocence,,,and for good measure,,we will flood the news papers w/propaganda about u selling cool-aid excessively at 5 kool-aids a day beforecv trail to contaiminate the jury pool.A knock on your door,its the dea,,,taking all your life position because u sold Kool-Aid??This is the how,,they created the #’s for their addiction false epidemic..The used fear on our doctors,,,those doctors then dropped a whole lot of medically ill patient in physical pain,or offer’d them 1 other thing,,,rehab,,,another methodogy they used to trump up addiction numbers..For any former CPP WHO STEP FOOT IN A REHAB is now documented as a addict,,,Furthermore they have literally changed the definition of a addict to trump up these addictions number,,Now,,since the pdmp,,,ANYONE WHO HAS TAKEN THE OPIATE MEDICOINE AS PRESCRIBED BY A LAWFUL DOCTOR,AND WHO HAS TAKEN THAT MEDICINE AS PRESCRIBED BY THEIR LAWFUL DOCTOR,,PASSED 30 DAYS,,,,IS DEEMED A ADDICT,,,IN ALL DATA,,,ALL CHRONIC PAIN PEOPLE/INTRACTABLE PAIN WE ARE ALL DOCUMENT BY LAW AS ADDDICTS NOW,,again to trump up those addictions numbers,,, COMPLETE LIE,,,,..So I ask you again,,,,what addiction epidemic?maryw

    • Like all who are chronic pain/intractable pain patients,,via the reply to Mr.Hackney,,,give us our day in court,,and WE would eat the dea,doj,klowndy,cdc,nida,,etc,,we would eat your false data for breakfast,,and they know it@!!!!!Some day soon,,a lawyer will step up to the plate,,,and we will have our breakfast!!!,,maryw

  • I suffered through five spine surgeries over a period of ten years. Any Fentnyl patches and bottles of oxytocin I had left over I turned in to a local police department when I finished. Then there was some determination that I was hooked on drugs because I started shaking most of the day. The right neurologist diagnosed restless legs. Some of you laugh at such. After trying several of the standard drugs I fell asleep at the wheel of my car while driving. There were not many options left but discovered through a pain management that an opioid (Dilaudid) made me stop shaking. I have reserved my use, keep a written journal about when I use it and why. I have a daily limit and abide by the rules. YetI go to an ER for a torn up knee and I had to listen to a PA lecture me. Didn’T matter what I said. Yet they gave me eight(OxyContin) pills to cover me until I went to the orthopedic doctor. He yelled and carried on about “What kind of a quack “ I went to and stormed out the door. That was seven months ago and I haven’t been back. Wrote a review on the hospital and doctors practice I received in mail and online. Wrote a letter directly but never received an answer. My neurologist is the head of a regional center in New Jersey. I travel one and a half hours to see him at a clinic. My story is no different than thousands of others who experience the same problems I do. But I have been fortunate to find the right doctor and have the insurance I need to find help. Within a group that I belong many do not have these plusses. Reading the stories of many they are panicky that the opiates will become even more difficult to obtain.. They are talking suicide rather than live like they do. This is wrong. They need to work and raise their families. Some have major pain and others like myself shake in parts or all of their bodies all day. Best thing invent a drug to handle it. Reality ……Not in my life time. I am 74 years old. Have had this miserable disease for thirty years. Others are children trying to make their way in addition to adults. We are not addicts. Walk “two weeks” in my shoes. And AG Sessions hasn’t’ a clue as to what goes on in medicine so he has no right to offer an opinion. He can take two aspirin and call me in the morning! Call me we can talk!

    • Wow, Marguerite, I am impressed! I am 68– wish I could express myself as well as you! Tried to reply to Andrea– it didn’t go thru. I would like to get more involved. Am also a chronic pain patient with multiple conditions, but have been able to maintain on low dose of Percocet for about 40 years (along with some other non-Opioids that they’ll probaby take away from me, next– older, inexpensive drugs, don’t ‘ya know?) Please tell me what I can do– you or Andrea; I hope I can get this to post… Thx, and hang in there!

  • I don’t use, nor do I need opioids for pain control on a regular basis. However, I’ve had a neck fusion, fractured tailbone, bilateral foot surgeries and most recently a herniated disc at the L3-4 level posterior. This occurred while I was vacationing in Indiana and living in the great State of Florida. Thank the Lord I was in Indiana where my doctor of 40 years knew me well enough to entrust me with medication to control the excruciating pain, the likes of which you can never imagine. It’s called the electrocution disc for a reason. If you can imagine your leg, from the top of your hip, down your hip, across your thigh, wrapping around your knee and in your groin area being electrocuted 24/7 nonstop, you’d understand the absolute misery. Yes, I was prescribed opioids and thank God I was able to get some relief while awaiting surgery. And yes, my good surgeon in Indiana gave me a prescription for about 60 hydrocodone and allowed me to fly home to Opioid-phobic Florida. By the grace of God, I was able to get pain relief b/c the following day after returning home to Florida we were evacuated due to Hurricane Irma. Our neighbors and us both called every hotel we could, but the closest hotel we could find was a Holiday Inn in Mobile, AL. A 17 hour drive through what would remind you of a science fiction movie. Evacuating the State of Florida with no gas anywhere… a nightmare. 3 days in Mobile and another 17 hour drive home was so hard on me since I was still only a few days post surgery. So if I had been in FL for the surgery, Gov Scott, an opioid phobic maniac, I would have been allowed 3 days post op and I would have been screwed. So here I am, back in the great State of Florida and the herniation has returned. No doubt about it. Exact same symptoms. There’s nothing that comes close to it. It’s exactly the same. It’s back. My good Indiana doctor immediately faxes the records to my doctor here. NOTHINH for pain. He flat out refused my request. He sent me for a freaking X-ray and wants me to go to physical therapy. Are you kidding me??? I can’t even turn over in bed due to pain and you crazy man think I can do PT with nothing for pain? My husband is scheduled for hernia surgery next week, so he can’t even lift a gallon of milk post surgery. It will be up to me to take care of him and run the household. Screw you Gov. Scott and all you Opioid phobic idiots who don’t give a damn about people’s daily life. Just four weeks ago I was 100% and now it’s back. After 4 weeks of Advil, I go to the doctor thd I get a freaking X-ray and PT referral. My son, his wife, and 3 children are coming to visit first week of April and I wouldn’t miss it for the world. I get to see them maybe 3 times a year and I can’t get even a small dose of Tramadol or anything at all??? Screw Kolodny, the CDC, the FDA and all you other money hungry idiots who created this situation. I wish the electrocution disc herniation on each and every one of you. I’ll get back to Indiana as soon as my husband recuperates from his hernia surgery, likely with no pain control, and my surgeon said he’d get me in as soon as I give him a date. Doctors are like everything else; good ones who care about you and bad ones shaking in their boots afraid to give a 62 year old a pill to help with pain control. I thank God that mine is only temporary. My heart bleeds for those who have permanent pain like I have now who are being denied pain control. Just like my niece, a double amputee facing yet another amputation. She goes to pain management and gives them the urine test for illicit drugs and none are found. But because her veins, due to Factor II and Factor V Leiden blood clotting auto immune condition, can’t take his injections, she gets no oral medication. The doctor reviewed her records and correctly surmised that she can’t take injections, so because of this she gets nothing. We’re going down a very dark road here. Thank you, Dr. Kertesz, for speaking the truth. As always, folks, it’s all about the money. You may not understand or believe it, but it’s true. I was a strong advocate for a couple of years, but quite frankly, it just hurt me too bad to hear of all the suffering and being unable to help. I was a personal injury paralegal for 30 plus years and I could and did help people. My biggest concern in the war against pain patients was to try to help people. It drained me emotionally and now I do very little from the sidelines. I praise all the good doctors and advocates who continue the battle. Surely someday the truth of it all will come to light and more doctors will be willing and sable to help. Unnecessary decline in functioning and suicide due to pain is unacceptable. Everyone has their judgment day and I, for one, won’t have suffering and death on my hands.

  • I am grateful for this article and for all those who came together to help suffering chronic pain patients like me. My quality of life is about 30 % of what it was 5 years ago before my pain medications were severely cut by 80+% over a 2 1/2 year period. I no longer enjoy ANYTHING but visits from my children and grandchildren which are seldom since I am rarely able to feel up to visitors. I don’t leave my home for much more than doctors appointments squeezing my pained swollen feet into a too big pair of sneakers and wearing a rigid backbrace. God bless all pain patients and our supporters!

  • I thought the CMS was for the ageing and elderly patients in the US but when it tries to cause more pain and death as we become older I do not believe they are in their jobs to cause less suffering and illness.Their are thousands of us who will suffer needlessly if the MME equivalent is passed by the CMS to 90 MME per day there will be undue suffering and more suicides. A life as we know it will be gone and we will be left with no life at all. I believe these decision’s should be made by Pain Management Doctor’s.Why did the CMS decide that 120 mme was unsafe it is actually a midline dose per day.At 90 mme is a very low dose it only allows pain medication at low levels every 6 hours that leaves a lot of break though time in pain. Please in God’s name reconsider this action you are about to make by putting people’s entire lives in your hands to suffer needlessly and let the Medical Profession Make those kinds of decisions.

  • The real horror is around the corner for pain patients who correctly use opioids. Pain Doctors are rapidly reducing the number of pills prescribed . In a few months, no pain pills may be offered at all. What then for the one who suffers? I see the desperation building in the mind of my loved one . Live in pain and die in pain. It is insane to punish pain patients because no one has the guts to face the problem employing sensible, reasonable solutions.

    • This is where I’m at now, Judy. I have 5 mo. to figure out a solution. I hope that suicide isn’t one of them (I never thought about it until the past few days! Was trying to “cut down”… pain won’t let me; can’t function at all.) Thanks for your compassionate insight; prayers for you and for your loved one, too.

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