W

ASHINGTON — 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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  • Hi I’m a chronic pain patient I’ve had so many kidney stone surgery s and perseagers done on me in the last 30 years I’ve had so many lipotripsys and foren object put up in metoprolol last a life time I’ve had my kidney cut into four times as far as the lipotrpsy for a while about rufly three a year. Worked construction – concrete with tubes hanging out of my back to leg bags and worked through it all .now sence I’m disabled and everything hurts like hell
    The doctors aren’t aloud to give me enough painkiller to help with even a quarter of the pain I find that ins

  • With America quitting the UNHRC,,,,i wonder how much they care if there breaking International laws on torture and torture in a healthcare setting?Also obviously genocide..I find it very curious the U.S. chooses to stand behind Isreal,,,when 80% of the generica medicine come out of Isreal,,,,and I hope u all know,,,Generic medicines can have as much as 25-30%% less real medicine in them,,,and still call it oxycodone,or what-ever generic form of a medicine u r getting..Soo all of u whpo are claiming,,your medicines seems less effective w/the generics,,,,your right,,,thats because there is 25 % less medicine in all generics!!!just fyi,,,
    Completely off topic here,,,w/the
    U.S. quitting UNHRC,,, they claim for Israel,,,,I was privy to meet a man who was born in Bethleham,a palestinian,,,,,he told me,,the Israelis’ treat the Palestinians,,,,like America treated its blacks,,,sooo????just fyi’s,,,maryw

  • Wow Mia I know a lot of people feel this way but u put it the best (not like drs.)
    Anyway just curious there r Drs out there that take opiods. BET THEY FIND A WAY AROUND THE NEW LAWS

    • To Christina,’:,,,America has found a way around it,,,have since being formally charge w/torture in 2009,,by the aclu,,for Gitmo,,,,they claim a word,,a made up word,,called ,”lawful sanctions,” Now Europe denounce the U.S.A. for it use of torture,stating,”the west has lost its way,” unquote,,,But u r correct,,America Government way around treating us worse then animals is a made up word by them called ,”lawful sanctions,” which they claim,,,if they put any regulation,ie,90 me,,or new law,ie,,moving our meds to a class ll,,,verses class lll,,,they can torture anyone they want.Also they claim,,,if other countries agree w/America,,,they can torture us.Which is why B.C. Canada has reversed its policy,,now threating arrest of any doctor who does not give chronic pain peoples there medicine at the dosages that works for them,Deeming denial of access a human rights issue,,as it truly is,,Why Europe,,does not agree w/U.S.A. opiate policies either,,or Germany,Switzerland,,,hell now,,,the USA,,,is theee only country out of 167,,,that are denying access to effective dosages of our medicines ,,,other countries have now reversed their policies for the better or never agree’d w/America in the 1st place.I know for a fact,,the U.N knows all about what America has done to us,,I know for a fact,,a complete ,”redress,” has been asked of our government by a CPP,,FOR THEIR NON-HUMAN policy on our medicines,,and the USA,, just puts their nose in the air,,,and continues to torture us,,some of us,,,too death,,,maryw

  • The government has no place in dictating what our physicians prescribe for chronic pain or anything else for that matter. The days of “pill mills” and doctor shopping are a thing of the past. Our “opiod epidemic” now consists of 80% heroin and 20 % Fentanyl. By the way, this is not prescription Fentanyl from the U.S. It is a strain India or China never approved or used in any prescription in this country. The public has been lied to. They still believe that doctors hand out pain pills like candy. Politicians want votes. THE END. Statistics were compiled using the terminally ill who had opiod in their system at the time of death, all heroin overdoses, all illicit foreign strains of Fentanyl, Adderall was tossed in there for a time. The remainder were those who illegally obtained prescription opiods who combined them with alcohol and or other illegal drugs, those who commited suicide due to being weaned off opiods that left the pain intolerable. The instance of chronic pain patients, including those on very high doses for years upon years was virtually zero. True statistics are 0.2% – (this is a high figure and likely not true) 6%. The United Nations and The World Health Organization have stated the the U.S. is breaking international treaties signed by inflicting torture on it’s citizens in the same way as citizens given refugee status because they are afraid of their government inflicting pain up to and including death. Our C.D.C. cites 200 suicides per year since 2016 due to lowered doses of opiods. The figures are far higher. Many families of suicides do not disclose this reason because they believe their loved one will be deemed a junkie. This is eugenics at it’s finest. This is how Hitler started before the Jews and Slavs. Our Government need not even pay to exterminate chronic pain patients. They do it by their own hand or assisted by a loved one. Those who assist in some suicides immediately turn themselves into the police, hoping for an arrest and publicity so the suicide will raise public awareness of what is really occurring in this country and in hopes of the suicide helping others. The media buries these stories. Unless you are affected, you do not even know what this country has done. Doctors are raided by the D.E.A. repeatedly and threatened with charges of drug trafficking. A serious Federal offense. In my state, there is not one single solitary pain management clinic or doctor. They may advertise as such, but they only give injections, useless to most, may cause permanent damage and insurers refuse reimbursement. Many insurers now refuse to cover drug testing, even if it is law in a state. Pharmacies are burdened with additional paperwork due with 24 hours for every opiod prescription filled. They do not have to fill them and some don’t, leaving a patient in pain, who has been forced to sign a contract with their doctor, which includes using one pharmacy at one location. Pharmacies cannot order what they deem they will need. The Government rations them. A partial refill is illegal. The patient cannot return for what they were shorted. This is life and death, decided by politicians with no medical training or knowledge. Targeted are those least able to fight for themselves, while the rest of the country protests en mass for any perceived injustice with media coverage, community organizers and often bussed in protesters. We sign petitions that end up in the nearest trash can and have for years, now. We have people like Christie taking meetings with our President who said that he did not understand the “opiod crisis” he inherited. He now understands that Christie’s friend died from prescription opiods. True enough. An entire bottle chased with a bottle of vodka. That little detail was omitted and I don’t see vodka being pulled from the shelves. The remainder were families of overdoses. Mind you, not chronic pain patients that overdosed. Trump has alcoholism in his family and was led to believe that if a patient with acute pain takes prescription opiods for over 7 days, they will turn into a desperate junkie, just as those in his family became alcoholics. He was lied to and mislead. Now we have a further division muddying this waters turning this into an ant-Trump issue. Sorry, but I am going on my 7th year and Trump was not in office. It is a bi-partisan issue. No one should have to live like this. Third world countries are getting more assistance in making Morphine more accessible than is available to us. Manufacturing mandated cuts by the Government are affecting us as well. This has been politics and money. Follow the money. It will lead you to where we currently are. Opiod pain medications are for the most generic. There is no money to be made in generics. Big pharma lobbyists are very powerful. Get the Government out of our doctors offices and medicine cabinets. This suffering and legal genocide MUST STOP! We are chronic pain patients that need opiods. They work. They give us quality of life. We are not junkies. We do not get high on our medications. No one that takes them for any period of time does. That is why when there were pill mills and doctor shopping junkies would overdose. They had to mix them with alcohol and or other illegal substances to get high. There are no prescription pain pills on the streets. Stop lumping us into the same category as junkies. The Government is violating the most basic human rights. If an animal were treated as we are, their owners would be arrested.

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