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.


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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    • There is a nationwide Don’t Punish Pain Rally happening on April 7th. You can find info on Google or FB. There are also many Chronic Pain Patient Groups on FB, some supporting our cause. You can also call or write your state reps and senators.

  • Once again,,the facts/truth were WILLFULLY attempted to be ignored by our government.This time however,STAT, is recognizing the MAJORITY of Doctors,who recognize there oath,that FORCED physical pain,perpatrated by themselves,is NOT ACCEPTABLE ,,as these proposed new restriction on a MEDICINE would force them to do,,its not what they sign up for,when choosing to become a doctor,,FORCING medically ill human beings to endure great physical pain,because a minuet few choose to be irresponsible,,is not humane or good medicine,,and FINNALY the doctors have recognized,,that is exactly what our government is asking them to do,,FORCE PHYSICAL PAIN ONTO our medically ill in physical pain from their medical illness..No good humane doctor would want forced physical pain onto their medically ill patients,,,when physical pain is treatable w/the MEDICINE opiates..Another fact,thatmost media outlets will not report,,because 44 million $$$ was used to buy them off,,to promote opiatephobia,,our tax dollars btw,,,but it is a fact,,,that NO-ONE ,,NOT 1 PERSON,,HAS ENDED UP IN A E.R.,,,OR O.D.,,,EVER,,, FROM TAKING THEIR OPIATE MEDICINE AS PRESCRIBED BY THEIR DOCTOR,,,,,NEVER EVER HAS ANYONE O.D. BY TAKING THEIR MEDICINE AS THEIR DOCTORS TELL THEM TOO,,,AS PRESCRIBED!!…A fact/truth that no-one is telling..it is only when a lawful medicine is taken against the doctor written words,,or mixed w/something illegal,,or alcohols,,,is there a o.d.,,or a e.r.visit,,,,,,but
    listen up Doc’s,,,,what u were taught on ,”how to,” prescribe a medicine designed to lessen physical pain,,what u were taught,is exactly right,,for again,,not 1 case,ever,,of anyone ending up o.d’n,or a e.r. visit when we,your patients take our medicine as prescribe, as our doctors tell us to…So THANK YOU to all the people,the Doctors,who still care about truth,who are smart enough to see thru the prop-agenda campaign,and put their patients HUMANE care 1st,,and not the liars prop-agenda,,,and stood up and fought for the truth to be heard this time,,,,maryw

    • Mary
      Just to put thing straight and to not get into the details of your need there are as many doctors who haven’t “taken an oath” as there are those who do
      The Hypocratic Oath has been optional since long before I graduated and that was the early 80’s
      So don’t assume we all agree that the details of the oath are binding. In my case, I didn’t take it so that I can help terminally ill patients easier than having to be restrained by the “do no harm clause”
      Dr. Dave

    • Mary
      You lose ALL credibility when you make assumptions and rant about torture and the like
      I happen to be a stage 4 terminal cancer patient on Fentanyl Patches for several years now so I DO know what it is like. I no longer can walk and I still manage patient care but only from a keyboard and video monitor.
      I am unique in that I know the legislative side (one of three docs who advise the US Senate on all things health related), the medical side (surgeon), the law enforcement side (former director federal drug task force), and the patient side
      So before you continue your non-credible yelling and the like you need to realize that we MUST enact change in order to control the 65 THOUSAND deaths last year from drug overdoses and that didn’t include the suicides
      Without some alteration, we will spiral into a nation of addicts. We are the ONLY nation to have this issue and yet we are the only nation to have a volunteer healthcare system meaning that anyone can direct their OWN care as opposed to other nations who have Universal care models who dictate care regimen to their civilians.
      Everyone in the US is asking for a UK type system but in the UK if the system or the doctor says NO it is NO and that is IT not only do you not get it paid for but you don’t even GET it period
      So stop with the no one cares and no one understands. We DO understand it is you who don’t understand the bigger picture that people are dying and we are doing next to nothing about it
      Dr. Dave

  • I would add a footnote to Lev Facher’s article, if I may. I am one of the 200+ who signed Dr Kertesz’ group comment letter to the Centers for Medicare and Medicaid. I counsel and advocate for pain patients every day in social media, as a non-doctor subject matter expert in pain management and in opioid policy.

    I assert from prolonged and deep study of medical literature that there is no science whatever beneath the 90 MMED threshold of risk proposed by the CDC Opioid Guidelines of 2016, and more recently picked up by CMS. We have no reason to believe that dose levels above 90 MMED actually comprise an increased risk of opioid abuse for legitimate and well-screened pain patients, or that these patients will benefit from being forced to taper down from high doses. There is no real medical evidence for that idea.

    However, there is a great deal of evidence that there can never be a one-size-fits-all safe dose limit for all patients. This is true because individual patients break down (metabolize) opioids very differently due to their genetics. In some patients, the therapeutic dose for a given medical condition may be 20 times higher than in other patients with very similar symptoms.

    We also know beyond any reasonable contradiction, that prescription of opioid pain relievers to millions of post-surgical patients does not contribute significantly to addiction or overdose in America. Two independent studies of post-surgical patients prescribed opioids for pain management have fixed the rate of opioid abuse diagnoses, and of long term renewal of medical prescriptions at less than 0.6%. Emphasis here must be on “less than”. It is highly plausible that many diagnoses of opioid abuse were actually incorrect diagnoses of emerging chronic pain caused by failed surgery, rendered by general practitioners who have little training in assessing or treating addiction.

    In each study , the medical insurance records of over 600,000 patients were followed over several years, to identify patients whose initial prescriptions were renewed or in whom multiple additional prescriptions were made.

    In one study, fewer than 1% of post surgical patients renewed their prescriptions longer than 13 weeks. Incidence of diagnosed opioid abuse rose with the length of renewed prescriptions, but increased only weakly for dose levels varying from less than 20 to over 150 Morphine Milligram Equivalent per day. These results directly contradict the weak science and biased research quoted in the CDC Guidelines.

    There is a general feeling among medical professionals that risk of opioid abuse may be higher among patients seen for pain who have a past history of alcohol or drug abuse, or of previous exposure to medically managed opioids. But that’s exactly what it is: a generalized and untested “feeling”. When patients are properly screened for previous or recent opioid use, much of this risk can be managed even in those who need opioids for serious pain. And what are doctors to do when they identify such a patient? Refuse to treat them? This way lies MADNESS.

    It is time to lay aside the mythology that “over-prescription” caused America’s opioid crisis. Diversion and theft of unused pain pills in home medicine closets do play a role in beginning addiction (particularly in young people). But opioid abuse among people in severe chronic pain is unusual or even rare. Over 90% of drug-related deaths are the result of untreated depression, poly-pharmacy (use of multiple drugs and alcohol), and street drugs (notably illegally imported fentanyl). Prescriptions to pain patients play a minor role. Economic hardship, hopelessness and mental-health issues are far more important.

    MEssage to CDC: retract your dangerous and unsupported opioid guidelines for a major rewrite. You got the story desperately wrong!

    • Richard
      AMAZINGLY well said and exactly on point
      Like the recent influx of gun control bills, the Gov is simply responding rather than properly applying proper influence to solve a problem
      There is absolutely NO scientific reason for the limits as indicated
      YES I admit in the 80’s 90’s and into the 2000’s most of us surgeons used to write for pretty much “more than enough” to make sure our patients were not in any pain after we lost control of them during discharge
      Today, however, EVERY surgeon provider ED doc etc is aware that we need to provide smaller does but to suggest a set figure means that no one was actually IN my OR to see how much pain to expect
      Thank you for the great incite
      Dr. Dave

  • April 7, 2018 12 Noon Don’t Punish Pain Rally Nationwide! Enough is enough! I have been caught up in a medication nightmare, since, Jan. when new insurance company and PBM: OptumRX through husband’s Employer took effect. The ER med that I have successfully been taking and allowing me to participate in non pharma interventions, now being denied, along with 3 other prescriptions written to try to find something the insurance company will approve, while I appeal the original denial. Every single, medication requires a preauthorization, which are denied by a Pharmacist (OptumRx employee), who one, does not have a license to practice medicine, 2. has no understanding of my multiple medical issues. I have contacted the company twice, they try to lay the blame at my doctor’s office and when I inquired if they had record of my last call in mid Feb. I was informed there was not any documentation of the call. Well, I am 100% sure I contacted the Preauth Dept. and if one looks at the complaints regarding this PBM, there are several, just like mine. Total of over 1300 complaints on one site regarding their incompetence as a PBM. I was shocked to learn, PBMs are not regulated or overseen by anyone! There are already enough laws, regs and policies in place regarding medications and yes, it is the responsible patients, who are suffering the consequences, of all these laws, regs and policies!

    • Kathy
      You like SO many people misunderstand the difference between “medically necessary” and “contract provision” clauses
      In your case, you are screaming at a system that your employer has bought into don’t blame the system blame the employer. They have FAR more clout then you do. The InsCo doesn’t work for YOU they do indeed assist you BUT they work for your boss. With that in mind, your boss wanted to save money so they agreed to a contract clause that states that various medications can be substituted at will.
      That is MUCH different then medically necessary/
      If you had cancer for example and had tried ABC treatment and it no longer worked and your Oncologist wanted to try XYZ the InsCo could implement the “not medically necessary” clause if the drug was not specifically approved by the FDA for that specific diagnosis
      In your case that is NOT the issue you are up against the issue of several drugs are medically similar or possibly medically identical (in the eyes of the FDA) and the InsCo is ALLOWED to substitute one over another for COST
      Your MD can jump and scream and you can yell and carry on but the clause exists NOT for your wellbeing but your employer’s pocketbook
      This is EXACTLY Senator Hatch from UT and former Senator Price and POTUS candidate Carson all proposed a replacement to the employer-based insurance system one that would give every person the ability to buy their OWN insurance plan from anyone they wanted to and to get quotes based on their specific needs. EVERY year I ask my insurance company to verify that my drug regimen is going to be accepted as written before I renew
      People need to STOP asking someone else to take responsibility for their personal needs
      If the Hatch/Carson plan was approved (it was also the same plan that DJT supported during the campaign) then employers would give each worker the funds they currently pay into a special account that could ONLY be used for medical care and insurance premiums
      Those funds could be transferred down from generation to generation and accumulate for ANY medical need
      Instead of asking for LESS Governmental interference we keep on voting for people who want to give us MORE interference
      I wonder how many of you with chronic pain have also voted for a Democratic official in the last several elections?
      You get exactly what you voted for if you did and it is going to get MUCH worse
      There was a chance that this all could have gone away but McCain refused to support POTUS due to the non-hero comment and yet AZ still hasn’t forced his resignation even though he no longer attends most session or votes in critical agendas
      Dr. Dave

    • For both Kathy and Dr Dave: a complication in all medical treatment of pain is “off-label” prescribing. I’ve seen this for over 20 years in patients diagnosed with typical or atypical Trigeminal Neuralgia.

      The first-line treatment for facial neuropathy disorders like TN is anti-seizure medications like Tegretol, Trileptal or Gabapentin. However, these medications aren’t approved specifically for treatment of chronic neuropathy. And some insurance companies seem to have concluded that Gabapentin in particular constitutes an addiction hazard when combined with opioids. I’ve never seen a scrap of evidence to prove that association. But insurance companies are now discouraging the use of these meds — when there are no other effective medications that can be used ON label. The tricyclic antidepressant drugs like Amitriptyline and Nortriptyline are also used off-label for atypical TN. In some people, ANY of these drugs can be associated with severe side effects. But I see absolutely no reason why insurance formularies should be allowed to determine medical practice in this class of disorders.

  • Yes, what happened to, “First, do no harm”. These ridiculous laws are only hurting the law abiding citizen who go to the doctor constantly to be monitored by the doctor, because they are in chronic pain.

    • More of us docs have NOT taken the oath then have
      The oath is too much interference to current day healthcare provision
      MOST schools have made it optional going back to the 80’s
      Dr Dave

  • Do the people who are making these EXTRA HARSH LAWS really think they are hurting the people who are BREAKING the laws? The only thing happening here is a lot of law abiding, registered to vote, United States of America citizens life’s are getting harder because NOBODY knows how to win this!!!

  • What about the people who are in pain, follow all the rules, pay Dr monthly fees to monitor them and never abuse them? How are we suppose to manage our pain? Why is always the people who need it suffer? Since when do govt and pharmacists become in charge of my health care? Than why do we need Dr? Keep penalizing the good people and those who abuse it, will still get it to abuse because rust never pay consequences

  • This was inevitable. This is what comes from the media and politicians conflating heroin and a prescriptions for Percocet by calling them all “opioids” and making people afraid of medication that is helpful and harmless if taken sensibly. Now, we face the indignity having to sit in judgment by pharmacists, and maybe having pain medication withheld.

    And it’s all to help the government get drugs that addicts also abuse out of circulation. Stay tuned. Drug addiction will continue and so will overdose deaths. Bet on it. The main effect of the “opioid” panic will be to deprive patients in pain of the relief they need.

    One tragic possibility is that as the “opioid” panic induces self-righteous pharmacists to withhold drugs, it may drive patients in pain into the streets seeking relief.

    • Most of the pharmacies here in the city that used to be detroit fill any and all prescriptions for controlled substances. They turn a blind eye, knowing grandma is selling most of her monthly script.

    • Mike
      I think the issue is EXACTLY unfortunately as you stated
      The 1980’s mentality was these drugs are harmless and serve a great purpose and need to be used as the patient determines for pain
      The REALITY is that these drugs are NOT harmless they DO cause severe addiction and also drug dependence and they DO lead to street level addiction like heroin and to a point cocaine
      I started my career decades ago as the director of a federal drug interdiction task force and I can tell you that MANY (surely not all) current street addicts started out with a “harmless prescription” for some back injury or a toothache or fall off a roof or surgical procedure
      THAT is the issue
      We need to have DIFFERENT drugs to use to reduce pain that actually works BUT don’t rely on the current opioid type of drugs.
      There is NO doubt that Congress fueled this when in the early 2000’s it REQUIRED every Medicare patient to be queried about their current pain level and recording the answer in the medical record in order to get paid
      That, of course, started the issue of once we ask and get a response other then “I am fine thanks” we are obligated to medicate for the pain rather than explaining that NO ONE going to be pain-free forever and deal with it
      So we took MILLIONS of people who were NOT complaining about pain and started them on narcotics and the road to dependence and in many cases addiction (there is a difference)
      NOW the US is looking to rein in the horse but way too late and we lack the tools to do so
      We STILL have NO narcotic substitute and so we still have to use them which is the whole issue. HOW much do we allow to float in the system without absolutely knowing that the patient is in actual pain and not just discomfort
      Dr. Dave

    • To Dr.Dave,,u sir I disagree with,,but the heart of the matter,,the shear truth/fact,,is that people like u whom have not experience 1 ounce of the forced physical pain we have,,u know nothing about anyones medical conditions,nothing,,yet,,,u still think u have the right to decide who gets tortured today by denial of access to effective pain MEDICINE,,
      Opiates are a medicine,and your ,”addiction,” theories are based /solely on the flawed ideation that addiction means simple taking a opiate..a medicine.If there is a medical reason to take a medicine,that effectively lessens the symptoms associated w/that medical condition, then I guess insulin dependent diabetics are ,”addicted,” to insulin?
      At anytime as responsible adults we can and will say NO DOCTOR,, I no-longer need that medicine,,its called ,”informed consent,”We are adults not children,,and that is called being responsible.
      Many Chronic Pain Patients are humanbeings w/medical diseases that are NOT curable,ie,lymes,pancreatis,screw-up surgeries, medical imaging ,’misses,”etc,,,,yet Someone who knows nothing about our medical conditions think they have the right to decide how much we are to forcible suffer in forced physical pain,,what gives then the right to literally, lawfully defined as torture someone??Your statement that these MEDICINES are dangerous is wrong,.Many of us have had the same dosage,same medicine,opiate medicine for years,w/no side effects what so-ever,,10,000,,,if not 1,000,000.00 have taken these medicine for long peroids of times w/no side effects ,,except occasional constipation w/any otc medicine will cure./..Again u have your propaganda mess -up..
      The truth/heart/reality of this issue is,,that some think they have the right to decide for all medically ill human beings in physical pain how much forced physical pain they are to endure!!That is factually what ,”they,” are doing..Again,the last person in recent history who thought he had the right to torture a group of people was Adolf Hitler,,and like Hitler,,many Cpp have been forced to far,,literally tortured to death,,I wish once,those who think they have that right to torture another human being,some to death,,See the reality of what they have done,,that reality is,they have tortured another human being.They have forced others,,faced w/the option of a life time of FORCED physical pain,,have choosen death to stop their physical pain..Its not that they wanted to die,,they just wanted a life time w/the medicines that lessen their physical pain enough to live life..That is the truth,the fact of what has been happen to all the medically ill in physical pain,,now being FORCED to endure that physical pain from a medical condition because someone who knew NOTHING about their medical illness thinks they have the right to decide thru abuse of power,the right to decide which medically ill persons their gonna torture today,,thats the truth,Washington refuses to accept,,,,because the truth proves the willful harm place upon the weakest in our society,the medically ill in physical pain from that medical condition,,That is the true harm these forced ill-will unlawful,guideline, and regulations have done..And don’t even get me started on the monies aspect of all of this,,for that is thee other 1/2 of this, is money driving this.,maryw

  • I work as a pharmacy technician and am a chronic pain patient. Saw this coming last summer and switched to Subutex. I feel great, my pain is so much less. Now I just wish I could have the last 10 years of my life back.

    • Suboxone is nit intended to be used for the treatment of intractable pain. So you’ve done exactly what the manufacturers of suboxone hoped you and every other Incurable pain patient would do. That is their detailed marketing plan.

      So, were you paid to write this, because it’s right out of their playbook.
      Most patients do not find do not obtain relief from suboxone, but the few who do, do so from from straight bupreneorphine (the only FDA approved member of this class drugs approved to treat long-term pain). And if the abuse helps, any benefit usually fades by 12 weeks.

      And if you’re a real person, good luck having Suboxone in your medical records. You’ll be suspected of being an addict for the rest of your life at this rate.

      This is not wise advice, generally speaking, so please, do your own research on this issue.

  • My father is 81 and has prostrate cancer, cancer lesions on his liver, malignant nodes on his lungs and bouts of pancreatitis and has been on chemo for over 2 years. He is prescribed 5 mg of percocet mixed with acedominiphin every 4-6 hours. He is by no means abusing the drug and it helps manage his pain in a daily basis. This regulation will cause him to suffer even more than he is now. What happened to “Do no harm”?

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