Doctors Are Protesting Medicare Change That Would Let Pharmacists Deny Opioid Prescriptions

https://gizmodo.com/doctors-are-protesting-medicare-change-that-would-let-p-1823544391

In response to the opioid epidemic that is killing tens of thousands of Americans a year, the U.S. government is poised to further restrict the amount of opioids Medicare patients can have access to at any one time, via a policy that would tell pharmacies to reject certain prescriptions on the spot. But a group of doctors and researchers is pleading with officials to reconsider, saying the move would harm cancer patients and others who desperately need pain relief.

In a proposal paper released last month, the Centers for Medicare and Medicaid Services (CMS) laid out two policies affecting opioid prescriptions obtained through Medicare Part D that would come into effect starting in 2019.

 One would call for a “hard edit” of opioid prescriptions made to patients on Medicare Part D that exceed a specific cumulative daily dose—the equivalent of 90 milligrams of morphine (MME). Pharmacists would be allowed to deny payment at the register for these prescriptions, while notifying the doctor(s) who prescribed the drugs. Patients would still be allowed to obtain their prescription, but only after an appeal and acknowledgment from their doctor that they qualify for certain exceptions, such as having cancer, being terminally ill, or otherwise having pre-existing approval for a higher dose.

The second proposed policy would tell pharmacists to deny prescriptions made to first-time opioid users, flagged via a database that tracks prescriptions obtained through Part-D, that provide more than a 7-day-long supply, regardless of their diagnosis.

The new limits would be a step up from the current ones encouraged by the agency, which implement a “soft edit” for Part D prescriptions at 90 MME, and a hard edit for those at 200 MME. Soft edits still dictate that a pharmacist deny the prescription, but they can then approve it based on their own judgement of the patient and their medical history. The CMS estimates that the change could affect up to 1.6 million Medicare patients, based on data showing the percentage of patients without an approved exception who received more than 90 MME worth of opioids for at least a day in 2016.

 CMS argues that the new rules would encourage prescription plan providers to “do more to address chronic, high prescription opioid overuse.” However, more than 150 doctors across the addiction, pain, and rehabilitation field have signed an open letter addressed to the CMS that claims otherwise. Though they acknowledged that doctors’ prescribing standards for opioids have needed to change, they say the wide-sweeping policy would only harm chronic pain patients while doing little to address the actual problem of addiction.

“While a strong case can be made for consensual, supported opioid dose reductions for voluntary patients, no data support nonconsensual/forcible dose reductions or curtailment in otherwise stable patients that have become common as prescribers react to regulations, mandates, insurers and fear for professional security,” says the letter, which was signed by clinicians from medical schools at Harvard, Yale, and Stanford, among others, as well as former presidents from various medical organizations, including the Society of General Internal Medicine and the Association for Medical Education and Research on Substance Abuse.

“These policies represent a knee-jerk response that is unmoored from evidence,” Leo Beletsky, an opioid policy researcher at Northeastern University, told Gizmodo via email. “For example, the best available evidence is that legitimate patient need for opioid analgesia ranges from about 4 to 17 days, so it makes no sense to limit initial prescriptions across the board. This should be done on an informed case-to-case basis.”

 Beletsky was not one of the signatories of the letter, meant to be exclusively issued by health care providers in the field, but he said he has seen the letter and agrees with the points it makes.

For one, the writers argue that while the changes would certainly steer more people away from opioids, they would do so in a destructive way. In the wake of less strict prescribing guidelines already issued by agencies like the Centers for Disease Control and Prevention, the letter notes, there have been anecdotes of stable patients spiraling out of control after losing or having their prescriptions lowered, including those who seemingly fulfilled the exception criteria. In response, and without proper follow-up care, some patients have even turned to illicit drugs.

“There is little reason to believe these policies will drive down overdose risk—they have never been tested with that metric in mind,” Beletsky said. “There are, however, highly foreseeable collateral risks from these policies, including continuing the process of forcing patients to the black market.”

 Even with the appeal process laid out by the CMS, the letter argues that it’s likely many patients will be left suffering needlessly, thanks to delays in getting through to doctors for their approval, which could require coordination between doctors’ offices, pharmacies, insurers, and prior authorization managers. The CMS’s proposal would allow for a 7-day supply to be prescribed to certain patients going through the exception process, but only once.

“The CMS plan risks accelerating a chaotic pattern of churn, abandonment and medical harm to patients who receive opioids as physicians flee an increasingly risk-laden and cumbersome decision matrix that may not advance patient safety,” says the letter.

More than that, the doctors say the CMS plan mischaracterizes previous guidelines. In recommending a hard drop to 90 MME, the agency cites as support the CDC’s recommendation that patients be voluntarily steered away from that high a dosage if possible. But the CDC guidelines actively recommend against forcing patients already on a higher dose onto a specific lower dose without their consent—a fact that some of the signatories know well, given they helped draft the guidelines.

 Stefan Kertesz, a clinical researcher in addiction at the University of Alabama, spearheaded the creation of the letter, which was submitted to the CMS on Monday night. (Kertesz did not immediately respond to a request for comment from Gizmodo). Yesterday, March 5, was the deadline for public comment on the CMS proposals. Both prescription rules are expected to be finalized by April 3.

“We need to find ways of engaging and supporting patients without resorting to easy fixes that end up backfiring in very predictable ways,” said Beletsky.

My first thought on this is that CMS does not have the legal authority to implement dosing limits..  especially on a protect class under the Americans with Disability Act and Civil Rights Act. Especially since there is no clinical studies that supports these limits will help reduce opiate abuse and/or OD’s. If fact in the nearly two years since the CDC opiate dosing guidelines were released, statistics suggests legal opiates prescriptions are dropping and OD deaths are increasing dramatically.

It would appear that the CMS is dumping this into the lap of the Medicare Part D, who in return is dumping into the lap of the pharmacist filling the prescription.

Pharmacists are probably going to come down on this issue in two ways.. those pharmacists who don’t like to deal with the extra administrative tasks in filling C-II’s, will probably use this as justification to “JUST SAY NO “.  Generally, Pharmacist just love it when they are given the task of telling the pt that they now have a deductible, their copay has increased, their medication is no longer covered and other things that the insurance company may have sent to the pt in a pile of other paperwork when the new year come to be.  Most pts don’t understand that the pharmacy computer system sends the information to the insurance company/PBM what is being given to the pt and their computer system returns a $$$ owed by the pt as copay or deductible… or the medication is no longer covered.

So the Pharmacist – in this case the executor – is two parties removed from the “guilty party” – CMS… who will be sitting on their fat bureaucratic ass… thinking that they have done a good thing for our society as a whole.  Just like a lot of bureaucracies – like those bureaucratic moron in Ohio – that keep ignoring the fact that the majority of OD and in some counties 99% of OD’s contain illegal opiates in their toxicology.

 

5 Responses

  1. This is total bullshit, I’m glad that some doctors are fighting this, it’s about time. My daughter has Complex Regional Pain Syndrome, the most painful disease in medical history. It’s known as the Suicide Disease. I know many people who have taken their lives because they couldn’t stand the pain any longer or when they went to their pain management doctors they were told no more meds. People with chronic pain and need meds just to be able to get out of bed are not abusing their meds. Let the real drug addicts kill themselves, either way they will still find a way to buy it off the street. The CDC, the FDA , Jeff Sessions and Trump need to mind their business. Let one of them get a chronic disease or one of their family members and they will be singing a different tune. Why should the pain management doctors be afraid of losing their license.

  2. When are they gonna listen to the truth,,,???!!!!No normal human being would want to life a life in FORCED physical pain,,no-one,,and all these dumb ass regulaition,rules,that they are changing to deny us access to our medicine,,,MORE,,, will be forced to use death to stop their physical pain,,,,Again they are changing rules that stood for 150 years for a reason,,,MOST OF THEM WORKED just fine,,,,im sick this crap,,maryw

  3. Steve, they certainly don’t want to be “confused by facts” especially now that they’ve found a new cash cow in prosecuting wealthy doctors and manufacturers! As well as another form of control over law abiding citizens!!

    • Someone told me,,they are also doing this because their loosing pot as their cash cow,,sooo go after innocent Doctors..Sadly I learned long ago,,the government can MAKE any innocent person guilty,,mary

  4. Another DUMB idea by the government and the “nanny state.”

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