Saying it wanted to “better align” its policies with the CDC guidelines, CMS is proposing a daily ceiling on prescribed opioids at 90 mg morphine equivalent dose (MED). Any dosage above that level would be considered excessive. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged.

Insurers would be expected to police pharmacies, doctors and patients who do not follow CMS policies, potentially dropping them from Medicare coverage and their insurance networks.

“Under the Part D opioid overutilization policy, sponsors are expected to implement appropriate plan-level claim controls at POS (point of sale) for opioids, use improved retrospective drug utilization review to identify beneficiaries at high risk for an adverse event due to opioids, and perform case management with the identified beneficiaries’ prescribers followed by beneficiary-specific POS edits to prevent Part D coverage of opioid overutilization,” CMS said.

Such a policy change would have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved. The Veterans Administration is the only other federal agency to adopt the CDC guidelines – and many veterans have complained that they are no longer able to obtain adequate pain relief at VA facilities.

Critics of the CMS strategy say it is even more draconian than the CDC guidelines, which are intended only for primary care physicians.

“CDC's ‘soft limit’ of 90 MED in treating chronic pain was a recommendation aimed at treatment of some people with chronic pain by primary care specialists. CDC stated that all of its recommendations were voluntary, and in this case, further provided prescribers with the option to use a higher dose if indicated by a careful risk/benefit analysis,” Twillman said in an email to PNN.

“In light of these limitations, it seems inappropriate for CMS to ask Part D providers to institute opioid dosing limits for people with pain who don't have cancer or are receiving hospice care, and for all prescribers, both primary care and specialists.

Strategy Developed by Insurance Industry

The agency’s proposed “Opioid Misuse Strategy” was released publicly in early January. It closely follows a 62-page “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of private insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud.

The white paper, however, goes far beyond fraud prevention by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed.

The number of Medicare patients who “overutilize” opioids is relatively small – just 15,651 beneficiaries in 2015 – which represents just 0.13% of Part D opioid users.

CMS is seeking public comment on the proposal in its 2018 Advance Notice and Draft Call Letter, which outlines a number of other changes the agency is making to its Medicare Advantage and Part D prescription drug programs. Comments will be accepted through March 3rd, with final versions published on April 3, 2017.

Comments can be emailed to: AdvanceNotice2018@cms.hhs.gov.