By Pat Anson, Editor

Over 1,200 people have left public comments in the Federal Register about changes to Medicare's Part D prescription drug plan, most of them sharply critical of rules that would make it harder for Medicare patients to obtain high doses of opioid pain medication.

Under the proposed regulations for 2019, a ceiling for opioid doses would be set at 90mg morphine equivalent units (MME) for all Medicare beneficiaries.  Any prescription at or above that level would trigger a “hard edit” rule requiring pharmacists to talk with the insurer and doctor about the appropriateness of the dose – with the insurer being the final arbiter in deciding who gets the higher dose.  

If adopted, critics say the rule would force many high-dose opioid patients to be abruptly tapered to lower doses, causing severe pain and withdrawal symptoms -- and possibly leading to illegal drug use and suicide.

“Suddenly dropping opioid doses will cause acute opioid withdrawal, exacerbation of pain, and increased disability with decreased productivity. It also increases the risk that patients will migrate to riskier alternatives such as heroin or fentanyl,” wrote David Kan, MD, an addiction psychiatrist.

“The proposed rule change is in the right spirit but very, very risky in reality. I urge CMS to reconsider the arbitrary dose limit on opioids. The unintended consequences are potentially devastating to our patients and community.”

“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... You are complicit in the pain, suffering, and documented damage that will result.”

“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. Each person who needs medication deserves the best care possible, and that will depend on both condition and need.”

“I think it is absolutely ludicrous to imagine that a third party could presume to place a maximum daily or monthly limit on my, or any other chronic pain patient's, medication. Each person's tolerance for and requirement of medication varies tremendously. How could you possibly imagine that you could come up with a generic formula which could fit every chronic pain patient across the board?” wrote Cyrynda Walker.

A joint letter opposing the rule change was submitted by 180 doctors and academics, including some who assisted in drafting the CDC’s controversial 2016 opioid prescribing guidelines. The letter points out that a 48 percent reduction in high dose prescribing since 2010 has not reduced the number of opioid overdoses. And it faults CMS for being focused on reducing high dose prescriptions – not the quality of patient care.

“The proposal does not consider adverse impacts on pharmacies, physicians or patients in the context of multiple regulatory initiatives, 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.”

The public comment period on the CMS proposal ended March 5. To see the comments that were posted, click here.

CMS Seeking ‘Dialogue’ About Opioids

According to CMS, 1.6 million Medicare beneficiaries met or exceeded opioid doses of 90mg MME for at least one day in 2016. Medicare officials said the goal of the “hard edit” rule is to get pharmacists, doctors and insurers to “engage in a dialogue” about the risks associated with high dose opioid prescriptions.

"We are proposing important new actions to reduce seniors' risk of being addicted to or overdoing it on opioids while still having access to important treatment options," said CMS deputy administrator Demetrios Kouzoukas in announcing the rule changes last month. “We believe these actions will reduce the oversupply of opioids in our communities."

To reduce the risk of “unintended consequences” from the hard edit rule, CMS would allow high dose patients to receive a temporary 7-day supply of opioids while they seek an exception to the 90mg MME rule. If approved, patients would then need to get a new prescription from their doctor. The 7-day supply would only be granted once.

Under the proposed rules, CMS would also create a new 7-day limit for initial prescriptions of opioids for acute, short-term pain. CMS would also start monitoring “high risk beneficiaries” who are prescribed opioids and “potentiator” drugs such as gabapentin (Neurontin) and pregabalin (Lyrica). Recent research has shown that combining the medications increases the risk of overdose.

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.

Unless changes are made, the proposed Medicare Part D rules for 2019 will be finalized April 2.