A large group of health, pharma and payer organizations are hoping to stop what some think are the most pernicious changes to Medicare Part D in the program's history.
The public comment period closes March 7 for proposed changes that include reductions in the number of protected classes of drugs and their negotiated prices, limits to the number of plans available in a region, a new "fair market value" broker compensation system and, significantly for payers, an overhaul of price negotiations.
Among the new ideas that has garnered some of the most vocal criticism is a proposal to eliminate three of the six original protected classes of pharmaceuticals -- antidepressants, antipsychotics and immunosuppressants -- leaving only anticonvulsants, anticancers and antiretrovirals.
"CMS has really misinterpreted the intent of Congress," argued Andrew Sperling, director of federal legislative advocacy at National Alliance on Mental Illness in reference to an Affordable Care Act provision allowing the Centers for Medicare & Medicaid Services to add criteria for protected dug classes.
In its justification for removing the three classes in all Part D formularies, CMS regulators wrote that "Instead of mandating coverage of all drug products in a particular class on all Part D formularies, we can save costs by identifying more efficient formulary requirements or other beneficiary protections in most cases."
Other changes also have wide-ranging implications for plan sponsors. CMS is proposing to limit sponsors to selling no more than two plans per region, as well as a new system of drug pricing discounts.
CMS regulators said they want to "revise the regulatory definition of negotiated prices to require all price concessions from pharmacies to be reflected in negotiated prices."
The goal, they wrote, is to have "greater cost savings for beneficiaries in return for offering preferred cost sharing, so that sponsors cannot incentivize use of selected pharmacies, including the sponsors' own related-party pharmacies that charge higher rates than their competitors."
Mary Grealy, president of the Healthcare Leadership Council, called that proposal "a flawed-solution to a nonexistent problem."
"There is no compelling rationale to make such changes," said Grealy, who organized a letter signed by 279 health organizations, including Aetna and Humana, urging CMS to "go back to the drawing board" with the proposed Part D changes.
Grealy and other critics argue that limiting the number of plans available would erode competition and lead to fewer choices and potentially higher drug prices.
"We've heard from PBMs that the low end, Humana-WalMart partnership plans might not be able to continue if this goes into effect," said Sperling, of the National Alliance on Mental Illness.
Grealy, Sperling and Tennessee Republican Congresswoman Marsha Blackburn, who outlined their opposition during a recent conference call, argue that CMS is too narrowly focused on reducing Part D costs, and not fully considering the impact to the rest of the Medicare program.
"Sometimes when I hear that we have few hospital beds being used right now," Blackburn said, "I think... there is a benefit coming from Medicare Part D. Seniors have had access to pharmaceuticals and at lower costs."