FDAnews Drug Daily Bulletin


Dec. 15, 2005

U.S. Pharmacopeia's (USP) recent decision to exclude a new Medicare Part D drug policy requiring broader coverage in its revised formulary guidelines makes it easier for the government to drop this policy and may necessitate a legislative fix, according to a key Senate staffer.

USP recently released its revised draft formulary guidelines but failed to reference recent policy from the Centers for Medicare and Medicaid Services (CMS) requiring broader Part D coverage. The move increases the likelihood that CMS will drop this policy, a Democratic Senate staffer said. But CMS denies that its decision-making would be influenced by USP's decision.

At issue is a CMS policy requiring drug plans participating in Part D to offer "all or substantially all" drugs in six specific categories: antidepressant; antipsychotic; anticonvulsant; anticancer; immunosuppressant and HIV/AIDS. As currently written, the policy is only effective during the first year of the drug benefit.

The agency issued the policy in response to lawmaker and other stakeholder concerns that Part D would limit access to certain drugs. Lawmakers such as Sen. Max Baucus (D-Mont.) and industry associations, including PhRMA, had challenged USP and CMS to provide a more comprehensive set of drug categories and classes under the plan.

These same advocates had argued that if USP adopted the CMS policy, it would make it more difficult for the agency to kill the provision after one year because the USP formulary guidelines are seen as a minimum requirement for providers. However, USP declined to include the CMS language, citing the temporary nature of the policy.

USP is meant to be an independent entity and it wanted to develop guidelines independent of CMS policy, William Zeruld, the group's vice president of corporate and international planning and development, told FDAnews during a recent briefing. The fact that the agency has not committed to making the expanded coverage permanent played a role in USP's decision, Zeruld added.

But some Democratic staffers following the issue are "concerned" with USP's decision. Without the USP providing a safety net for the program, CMS will have more "wiggle room" to drop the policy, a Senate staffer said.

As a result, the Senate Finance Committee minority staff and others on Capitol Hill will be watching closely to see what CMS does with this policy. "Now it's all on CMS' shoulders," the staffer said. If the agency does drop the policy, Democrats may seek legislation requiring this broader coverage, the source added.

Democrats are concerned that drug plan providers will pressure CMS to change the policy. However, the agency maintains that USP policy will not affect its decision-making. USP's decision not to reference CMS' policy "does not influence" the agency's decision about whether to make the policy permanent, CMS spokeswoman Barbara Cebuhar said.

Groups such as the Pharmaceutical Care Management Association (PCMA), which represents benefit managers, are concerned with the cost of expanding coverage, said Phil Blando, the group's spokesman. But he said it is "premature" to speculate whether the agency will make that policy permanent because the program has not even begun. Next year "is a learning year for everyone in this program," Blando added, making it difficult to tell if the policy needs to be made permanent.

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