Will pharmacy win a seat at this table? The final rules are no help as many questions remain on medication therapy management

February 21, 2005

When the Centers for Medicare & Medicaid Services was trying to figure out how to implement the Congressional mandate for medication therapy management programs (MTMPs) in the new Medicare prescription drug benefit, the bureaucrats scratched their heads and asked for guidance. Now, the message out of Washington, D.C., is "Never mind."

The hopes of pharmacy leaders that CMS would flesh out the law requiring MTMPs were dashed last month. Instead of coming up with minimum program standards and requirements, the agency issued a final rule that leaves the details up to the prescription drug plan sponsors. Not only that, it rejected the notion that there even is a standard of practice when it comes to medication therapy management services.

"We believe that at the outset of the Medicare prescription drug benefit, plans must have maximum flexibility to develop MTM programs that can achieve the statutory goal of improving therapeutic outcomes," said CMS in the final rule.

The rationale behind MTM services is to foster appropriate medication use, improve compliance, and reduce the risk of adverse drug events among the qualified Medicare beneficiaries who agree to participate. CMS envisions that such services will range from simple to complex, such as refill reminders, brown bag sessions, evaluating patient response to drug therapy, and collaborative drug therapy management, where permitted.

The questions unanswered by the CMS final rule are the nuts and bolts of how MTM will operate. For example, it's still unclear which services will be covered and how they will be provided, which patients will be eligible and how they will be selected, which healthcare providers will be used and what qualifications will be required of them, and what reimbursement the drug plans will set.

When CMS put out the call last summer for comments on its proposed rule, national pharmacy organizations responded with information on successful MTM projects that have improved care and reduced costs. They also offered detailed suggestions about how the MTM piece of the Medicare Rx benefit should be constructed. In addition, all 11 pharmacy organizations came together last summer and crafted a definition of MTM services and criteria for creating such programs.

Despite the positive results generated by numerous pharmacy studies, such as North Carolina's Asheville Project with diabetes patients, CMS came to the conclusion that "no widely accepted MTM standards of practice were identified."

The final rule was "disappointing" because CMS didn't provide more direction on how MTM should be structured and instead fell back on leaving the details up to the drug plans, said John Coster, Ph.D., R.Ph., VP-policy and programs, National Association of Chain Drugs Stores. As part of comments submitted to CMS last October, NACDS had stumped for CMS to create a basic package of MTM services, designate community pharmacists as the primary providers, allow R.Ph.s to help identify which patients should receive the services, and mandate an initial face-to-face consultation so the R.Ph. could assess the beneficiary's MTM needs. However, those arguments and more fell on deaf ears at CMS.

With the final rule now chiseled in stone, NACDS is hopeful its members will be able to work with the drug plan sponsors in order to influence how the MTM piece of the Medicare Rx benefit plays out beginning next January. "We hope that CMS is right and that the drug plans will do the right thing and provide good community pharmacy-based MTM services," said Coster. "We're going to be watching closely. Otherwise, the beneficiaries could be the losers."

Clueless in D.C.