Radar on Drug Benefits

Carrying out another directive from President Trump’s Medicare-focused executive order issued last fall, CMS on Aug. 31 released a proposed rule that aims to fast-track Medicare coverage of certain innovative FDA therapies once they are approved. Although the rule applies to Medicare fee for service, it has implications for Medicare Advantage organizations that are required to cover Medicare Parts A and B approved services.

According to a CMS fact sheet on the rule, CMS is proposing a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (MCIT), for medical devices that are granted breakthrough designation by the FDA. The MCIT proposal would allow for national Medicare coverage on the same day as a breakthrough device receives FDA approval. CMS proposes a coverage duration of four years, which it suggests will “encourage manufacturers to voluntarily develop evidence to show these treatments improve the health of Medicare patients.”

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system.

Avalere Health founder Dan Mendelson tells AIS Health that the disjointed rollout of the executive orders doesn’t alter their impact.

With the deadline approaching for Medicare Part D plans to implement a Real Time Benefit Tool (RTBT) — which informs prescribers when lower-cost alternative therapies are available under a beneficiary’s drug benefit — one PBM is offering up a new tool to fulfill the requirement.

Prime Therapeutics, LLC, a PBM collectively owned by 18 Blue Cross and Blue Shield plans, said on Sept. 2 that it is rolling out a tool called Real Time Benefit Check, which works through the ePrescribe function of a health care provider’s electronic health record (EHR) system. The idea is to offer providers “comprehensive information so they can easily prescribe the most appropriate and cost-effective medications at the point of care,” per a news release from the PBM.

With the economic fallout from COVID-19 driving billions of dollars in projected state budget shortfalls over the next few years, officials around the country are taking a hard look at how to cut costs. Against that backdrop, more states may consider replicating a concept pioneered by New Jersey: a reverse-auction PBM procurement model.

Trish Riley, executive director of the National Academy for State Health Policy (NASHP), tells AIS Health that states “definitely are” looking at the idea more closely, “particularly as the budgets get tighter in state governments.”

Cigna Corp.-owned PBM Express Scripts says it will exclude nearly 150 brand medications in its 2021 National Preferred Formulary. But one consultant says only a handful of the exclusions — notably, Novartis Pharmaceuticals Corp.’s biologic Cosentyx (secukinumab) and Amgen, Inc.’s bone marrow stimulant Neulasta (pegfilgrastim) — are likely to cause much member disruption.

“They [Express Scripts] essentially said 98.7% [of customers] don’t really experience any disruption with their formulary changes,” says Stephen Wolff, Pharm.D., R.Ph., pharmacy management consultant for Milliman Inc. He notes that many of the exclusions were multi-source brands, which aren’t likely to be particularly disruptive for members. “So we’re really thinking about those 45 or so single source brands that they excluded,” Wolff tells AIS Health.