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Proposed Rule Discusses Medicare Medication Management Services

Kate Traynor

Health and Human Services Secretary Tommy G. Thompson announced in late July the release of the long-awaited proposed regulations to govern the new Medicare Part D drug benefit, including provisions that allow pharmacists to manage medication therapies for some Medicare beneficiaries.1

Kathleen Cantwell, director of federal legislative affairs and government affairs attorney for ASHP, said her group is "pretty enthused" about the proposed medication therapy management regulations. "I think there's nothing negative in this for our members," she said.

The Part D drug benefit begins in January 2006. By law, organizations that deliver the new benefit must develop programs for managing therapies for targeted Medicare beneficiaries and pay pharmacists or other health care providers for performing that service.

Pharmacy Groups Discuss Medication Management

The new Medicare Part D drug benefit mandates the provision of medication therapy management services by drug-benefit sponsors, but little detail is available from the Centers for Medicare and Medicaid Services (CMS) about what the services will be.

In regulations proposed August 3, CMS asked for comments about implementing medication management services—an issue that ASHP and 10 other national pharmacy organizations discussed during a meeting in May.

The stakeholders' resulting agreement, dubbed the Pharmacy Profession Stakeholders Consensus Document, describes critical issues in medication management, including

  • The need to formulate a patient-specific treatment plan,
  • The importance of monitoring therapy and identifying and resolving medication-related problems,
  • The importance of educating patients about their therapy,
  • The preference for face-to-face interactions between the pharmacist and the patient, and
  • The need for adequate reimbursement consistent with contemporary health care provider rates.

The entire consensus document is available at legislative/August_2004.cfm#MMA.

Targeted beneficiaries are patients with multiple chronic conditions, such as asthma, diabetes mellitus, hypertension, high cholesterol, and congestive heart failure. To be eligible for the service, these beneficiaries must take multiple medications for their chronic conditions and be likely to incur high drug costs.

The proposed regulations ask for input on the development of requirements and guidelines for providers of medication management services, including current best practices for the programs.

During a July 26 media briefing in Washington, D.C., Centers for Medicare and Medicaid Services (CMS) Administrator Mark B. McClellan said CMS wants 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."

Cantwell said ASHP will send comments to CMS about implementing medication management services. Public comments on the proposed regulations are due October 4.

"What we need to do is encourage CMS to provide a little bit more guidance for the prescription drug plans about what types of services they're going to offer," Cantwell said. "In the rule itself at this point, there's not much guidance for the plans. It's completely up to them to determine who are the targeted beneficiaries and how they are selected and what services will be provided."

Cantwell encouraged pharmacists to send their own comments about the proposal to CMS.

"It will be important for our members to provide CMS a better understanding of what's actually happening in practice today," Cantwell said. "Medication therapy management services really are individualized patient care services. That's probably one of the things we were most excited about. The proposed rule specifically cites that they aren't talking about population-based therapies but individualized services."

Although the proposed rule states that CMS expects the bulk of medication therapy management services to be provided by pharmacists, it will allow "other qualified health care professionals" to deliver the services. Cantwell said that, despite that caveat, pharmacists are the best-qualified health professionals to provide higher-level medication management services.

CMS estimates that premiums for the new drug benefit will be about $35 per month in 2006 for a basic plan. Drug plan sponsors can offer so-called enhanced alternative coverage, including expanded medication management services, to Medicare beneficiaries for an additional premium.

Targeted Medicare beneficiaries will not be charged separate fees for basic medication management services, but premium prices can be set to reflect the availability of the services. Drug-plan sponsors can extend the services beyond the targeted beneficiaries but are not required to do so.

CMS expects that competition for enrollees will force drug-plan sponsors to create reasonably priced customized medication management programs that are attractive to targeted Medicare beneficiaries, a line of reasoning that mirrors the agency's strategy for implementing the Medicare-approved drug discount card program earlier this year.

The discount card program will be abandoned when the new benefit begins. CMS estimated that each year it will receive bids from 100 potential drug-plan sponsors and 350 Medicare Advantage programs to participate in Part D.

Medicare Advantage programs, formerly known as Medicare + Choice plans, are private health plans that receive a flat monthly fee from CMS to provide Medicare benefits to enrollees.

CMS expects bids from would-be drug-plan sponsors explain the 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 proposed rule states that CMS does not believe it has the authority to set specific fees for the services.

The proposed rule creates a prominent place for pharmacists on the pharmacy and therapeutics (P&T) committees that drug-plan sponsors must put in place. CMS proposed 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 is working with the United States Pharmacopeia (USP) and other stakeholders to develop formulary guidelines for the drug benefit.

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 include more than 200 drug classes that represent the most common prescription medications used by Medicare beneficiaries.

USP said it will submit a final version of the model formulary guidelines to CMS in December. Information about USP's model formulary for Medicare is available on the organization's Web site,

1. Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare program; Medicare prescription drug benefit. 2004. Fed Regist. 2004; 69:46632-863.