By Pat Anson, Editor

The Trump administration has finalized plans that will make it harder for many Medicare patients to obtain high doses of opioid pain medication. Medicare beneficiaries will also be limited to an initial 7-day supply of opioids for acute pain.

Under new rules released today for the 2019 Medicare Part D prescription drug program, a ceiling for opioid doses will be established at 90mg morphine equivalent units (MME).  Any prescription at or above that level would trigger a “hard safety edit” requiring pharmacists to talk with the prescribing doctor about the appropriateness of the dose. If satisfied with the explanation, the pharmacist could then override the edit and fill the prescription.

Under an earlier proposal that was widely criticized, only insurers could decide whether to override a safety edit – a requirement that would have essentially made insurers the final arbiters in deciding who gets high doses of opioid pain medication.

The new rules adopted by the Centers for Medicare and Medicaid Services (CMS) will still allow insurers to implement safety edits, but only at a much higher dose of 200 MME or more.  Insurers will also be given greater authority to identify beneficiaries at high risk of addiction and to require they use “only selected prescribers or pharmacies.”

CMS is also adopting a new policy that requires all new opioid prescriptions for short term acute pain to be limited to no more than 7 days’ supply. Several states have already adopted similar measures.

CMS says this “tailored approach” to opioid prescriptions was needed to address what it called “chronic opioid overuse” at the pharmacy level and to encourage support for the CDC’s 2016 opioid prescribing guideline.

“CMS believes it is important that (insurers) set expectations for prescribers to implement the CDC’s recommendations as a best practice through their provider contracts. PDPs (prescription drug plans) should also reinforce these messages through interactions with prescribers as an integral component of sponsors’ drug utilization management program,” CMS said.

“We also recommend that beneficiaries who are residents of a long-term care facility, in hospice care or receiving palliative or end-of-life care, or being treated for active cancer-related pain are excluded from these interventions.”

About 1.6 million Medicare beneficiaries met or exceeded opioid doses of 90mg MME for at least one day in 2016. The 90mg MME ceiling established by the CDC was only meant as a recommendation for primary care physicians, but has been widely adopted as a rule by other federal agencies, insurers, state regulators and prescribers.

'Cruel' Limits on Opioid Prescribing

"The 90 mg dose they set as a threshold for 'high' or overuse is flawed and not scientifically based.  It is totally arbitrary," says Lynn Webster, MD,  a pain management expert and past president of the American Academy of Pain Medicine.  "It is cruel to impose such a limit on people with involuntary dose reductions who have been functioning well without signs of abuse for years.

"Even the 7 day limit is misguided at best. The average length of time a person requires an opioid post-op involves several factors and include the type of operation, the genetics of the person and the type of medication. The literature states the duration of pain requiring treatment with an opioid post-operatively is 4-9 days for general surgery, 4-13 days for women's health procedures and 6- 15 days for musculoskeletal procedures.  This means half of the Medicare patients will receive less than half of what they will need."  

Over 1,200 people left public comments in the Federal Register about the Medicare proposal, most of them sharply critical of CMS.

“This is archaic medicine and does more harm than one can imagine,” wrote pain patient Henry Yennie. “The DEA, HHS, private insurers, and now CMS are pursuing policies and restrictions that will cause harm and suffering to millions of people.”

“I cannot understand how Medicare can be so uncaring about the pain people have,” wrote Mikal Casalino, a 72-year old pain patient. “Limiting the dosage to an arbitrary amount is not going to be helpful for individuals.”

A joint letter opposing the rule changes was also submitted by 180 doctors and academics, including some who helped draft the CDC guidelines. The letter points out that a steep reduction in high dose prescribing since 2010 has not reduced the number of opioid overdoses. And it faults CMS for being focused on reducing the number of high dose prescriptions – not the quality of patient care.

“The proposal does not consider adverse impacts on pharmacies, physicians or patients…and it will accelerate patient abandonment,” the letter warns. “The plan avows no metric for success other than reducing certain measures of prescribing. Neither patient access to care nor patient health outcomes are mentioned.”

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.  The new Medicare regulations will go into effect on January 1, 2019.