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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  • If they think there is a problem with abusing pain medications, just wait to see what happens when suffering people can not get their legal medications any more. I see people in Maine who have already been cut back on opioid pain medications by their doctors who are now seeking out heroin to help alleviate their suffering. For some, these pain medications are a real necessity that help us live as close to a good quality of life as we can.

  • My view is that the gov’t is attempting to remove the control, ability, and professional opinion of the patient’s doctors to prescribe what they know and feel is correct and necessary for each individual doctor/patient case. Laws like these will do absolutely nothing to curb the illegal use, abuse, and illicit addictions for those acting in these conditions. It will severely decrease the quality of life for those of us legitimate patient’s who rely on these types of medications to get by with their day to day living routines. There have been 3 suicides of elderly (70’s-80’s+) people in my facility in just 2 years after having the majority of their pain medications reduced to the degree they felt living onward with the pain, and poor quality of life was no longer something they would or could endure. It’s unfair, unconstitutional, and an act medical of malpractice. This is not the answer. The drugs will always be available legally or not and uncontrollable by laws restricting them from the people who need and take them as prescribed. The issues lie within the illegal trade coming from over our unrestrained borders, those who choose to use their privileges wrongfully, and the greedy. Please don’t cause the lives of us legitimate patients to be cut short by these types of federal and state powers. We deserve better.

    • Changing Marijuana laws are an example of how wrong not only is the government in their control, but also how wrong most physicians are about what medications are safe and effective. The relationship between the drug companies and physicians is to chummy and just another example of how they are not providing anywhere near the type of care we should be receiving. The care provided is sub par.

    • Dear Gary Aziz,
      You have hit the nail square on head, (too bad you can’t drive it into these thick headed beaurocrats heads). I was just cut back myself today. From 50 mg. percocet daily to 37.5 mg daily. Pretty soon they are going to remove aspirin from the shelves.(LOL)

  • People can only tolerate so much pain. When you reach your tolerance level you become desperate and will do anything to ease your pain, including suicide. Can’t these politicians get it through their thick heads and work on what is needed and not on their own agendas.

    Tom Bradley CHRONIC PAIN SUFFER FOR OVER 50 YEARS!!!!!!!!!!!!!!!!!!!!!!!!!!!!

  • I think that the issue for pain medication is wrong. They need to be realistic when it comes to pain. I have watched family members in so much pain. My own daughter broke her arm between her shoulder and elbow. She’s 34. The doctors told her that was the worst place to break a bone as far as pain is concerned. My mother has had a few toes amputated due to diabetes. In the hospital they told her to enjoy her pain meds now because she’s not going home with any., I’m 61 and drugs have been a problem for as far as I can remember. I also lost my 23 year old nephew to an O.D. I’ve also had two cousins O.D. on alchohol and died. I understand where the parents are coming from. But it has swung too far for people with genuine pain. I’d like to know how to change the new rules.

  • Please have a heart. I have been taking oxycodone for 15 years. Life is hard enough without having to deal with constant pain problems. It is difficult to leave the house to obtain required household necessities and go to appointments. Please try to understand this is the only hope I have to have quality of life. (quality of life: the ability to maintain oneself). Being disabled is a very hard life, please do not reduce or diminish the only thing that helps.

  • Government needs to leave the prescribing up to the doctor and take care of their own business. 90mg morphine daily isn’t enough for a lot of people experiencing chronic pain, my wife being one. As a pharmacist just let the physician and pharmacist handle it.

    • Gerald, Perhaps the most significant comment on this entire thread. I always called my pharmacist first, then I would call my physician. Too many physicians don’t have the same knowledge that the pharmacist has, regarding medications that are probably best suited for their patients. A good number of them are too quick to write a prescription based on the last pharma representative that was last in the physician’s office. This is something that I miss since moving back to New England; the pharmacists where I have lived before, were much more inclined to have an interest in their patient’s medical issues; and yes, they at first reminded me that they could not have the same insight as to the patient’s needs as the physicians.

      Nevertheless, I always received a call from my pharmacist, who was invested in our healthcare issues, especially the more serious condition. I miss that relationship with the pharmacists that I have always been treated like our lives mattered to them, especially one who is retiring soon.
      Thank you for your comment, and I hope that the future is going to include the recommendations of the pharmacists; if anyone else is in the physician’s office with the patient, it’s the pharmacist, not the federal government.

  • This overreach will be responsible for the deaths of thousands of people who legitimately need large doses of opioids or synthetic opioids to manage chronic pain. One of those people may be my brother.

  • I do not think they should be put on Oxycontin or oxycodone the 5 325 mg of Percocet is not going to kill somebody if they’re on it for a week at the most. Have you ever had your. Nominal region cut open 3 or 4 times it hurts in 3 days will not take the pain away it helps but not to the point after a week that you can’t live without it

    • MS.Hawkins,,i hope u r smart enough to understand,,,,your statement to exempt oxy for medical conditions in your ,”nominal region,” is the same mentality as our government..Restriction on all thee other regions but the nominal,,,It about the FREEDOM,, for each ad every body,,that is different from yours,,,to give everyone in physical pain from a medical issue,,,EFFECTIVE AMOUNTS of a medicine,,to EFFECTIVELLY lessen physical pain,,,Its about the bigotry and prejudice of a medicine ad the people who take it by doctors orders as prescribed at effective dosage to effectively to lesson the physical pain from medical conditions to function everyday..Do u call a diabetic a insulin addict?Then why,,when their is a medical condition that is painful,,do u call anyone who lawfully takes the medicine opiates,,opiate addicts?Its a age old archaic bigotry,the same ,”group think,” that led the witch hunts of 1660,,,why some people still have that stupidiy in their genes,,I don’t know,,but obviously they do,,,and again,,like the witch hunt,,people are dead because of it,,For human nature was never in thee equation of this,,Its NORMAL human nature,,to want physical pain ended or at least lessen’d to acceptable levels.JMO,,i BELIEVE HUMAN NATURE WASN’T NOT EVEN THOUGHT OF BECAUSE THEY,,THEE SO-CALLED ,”SCHOOLED ONES,” USE DATA,,,MACHINE DATA,,,AND THAT WAS IT!Was it not Einstein who said,,,,when mankind soley rely on machines,,,WE HAVE RAISED A BUNCH OF IDIOTS!!!!!!!!!!!!!,,I bellive Einstein over some machine and idiots,,ie addiction specialist,,warehousing medically ill cripples is Pennhurst,waverly all over again,,,,Addiction professions is about $$$$$$ and that’s it!!!We have raised a bunch on idiots,,,,,prejudice ones at that,,,maryw

    • The problem with your idea is that you ignore the toxic effects of acetaminophen on the liver when used in high doses. Acetaminophen is used in many over the counter medications so it is very easy to exceed the daily limit of 4000 mg without even realizing it. Taking 6 Percocet in a day (one every 4 hours) which is a typical prescription gets you almost half way to that limit. Also, even amounts less than 4000 mg a day can cause permanent damage if the dosage is continued for any length of time as the effect can be cumulative if there is not enough time for the body to flush the drug out. Oxycodone is the the same thing as Percocet except without the acetaminophen, so taking a 5 mg oxycodone tablet has the same amount of opiate as a 5/325 Percocet without the risk to the liver from the acetaminophen.

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