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Regulations for New Medicare Drug Benefit Open for Comment

Kate Traynor

Health and Human Services Secretary Tommy G. Thompson yesterday announced the release of the long-awaited proposed regulations (PDF) to govern the new Medicare Part D drug benefit, including provisions that allow pharmacists to manage medication therapy for some Medicare beneficiaries.

"For seniors without drug coverage, this is real and significant savings. It will help them cut their bills in half, not their pills," Thompson said by teleconference at a media briefing in Washington, D.C.

"There is a lot of discussion in the regulations about medication therapy management," Centers for Medicare and Medicaid Services (CMS) Administrator Mark B. McClellan told reporters. "We expect to get a lot of comments in this regulatory process so that we can implement medication therapy management as effectively as possible."

McClellan said CMS would like to receive comments on how "to give beneficiaries and fee-for-service Medicare access to disease management and care management services and how we can best integrate that with services that could be provided by pharmacists to educate beneficiaries and help them manage their medications effectively."

According to the rule, medication therapy management services will be made available to so-called targeted beneficiaries—those who have "multiple chronic diseases, are taking multiple Part D covered drugs, and are likely to incur annual costs that exceed a certain level" to be determined by CMS. Drug plan sponsors can extend the services beyond the targeted beneficiaries but are not required to do so.

The rule states that CMS expects the bulk of medication therapy management services to be provided by pharmacists but will allow drug plan sponsors to use "other qualified health care professionals" to offer the services.

CMS stated in its proposed rule that fees associated with medication therapy management services are "separate and distinct" from dispensing fees. The agency wants potential drug plan sponsors to include medication therapy management fees in the plans' general administrative and overhead cost estimates. CMS expects bids from would-be drug plan sponsors to include an explanation of fees paid to pharmacists and other medication therapy management providers and to disclose the dollar amount of the fees.

Although CMS expects pharmacists to receive payment for medication therapy management services, the rule states that CMS does not believe it has the authority to set specific fees for the services.

The proposed rule features a prominent place for pharmacists on the pharmacy and therapeutics (P&T) committees that drug plan sponsors are required to put in place. In the rule, CMS proposes a requirement that the majority of the P&T committee consist of "practicing physicians and/or practicing pharmacists."

CMS also proposed that at least one practicing pharmacist and physician on each P&T committee be "independent experts" with "no stake, financial or otherwise, in formulary determinations."

McClellan said CMS will hold a public meeting next month to discuss a model formulary for Medicare Part D that is being developed by the United States Pharmacopoeia. (More information on the model formulary is available at the USP Web site.)

The formulary for Medicare Part D, McClellan said, will not be based on formularies used by Medicare-Approved Discount Card Program sponsors. Formularies for the discount card programs, which began this year but will expire when the new drug benefit takes effect in 2006, include more than 200 drug classes that represent the most common prescription medications used by Medicare beneficiaries.

The proposed rule went on display yesterday afternoon, and CMS is accepting comments on the proposal through Oct. 4. The rule is scheduled for publication in the Aug. 3 Federal Register.