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Medicare’s upcoming Prescription Drug Coverage (Part D) will affect 50 million U.S. drug consumers. As the startup date of January 2006 nears, the program continues to evolve—yet many questions remain unanswered. The program’s Medication Therapy Management (MTM) provision—including the role special packaging will play—remains a work in progress.

The Centers for Medicare and Medicaid Services (CMS) is expected to award contracts to Prescription Drug Plans (PDPs) this month. Marketing and enrollment is scheduled to begin November 6. "We are in the beginning of a sea swell of change in terms of how product is delivered, and how individual companies will fare as a result. There will be winners and losers," said Keith Korenchuk , McGuireWoods LLP, in a recent audioconference on Part D.

Most seniors will receive coverage through PDPs, which will be sponsored by private companies contracting with CMS. The PDPs will share risk with Medicare. They will have to maintain a bottom line while showing they can provide services to beneficiaries within established program rules. The plan sponsors will compete for members, setting coverage, premiums, copays, and patient-care services. They will each establish their own formularies, or drug lists, and negotiate prices with drug manufacturers, without CMS interference. Whether or not PDPs will show an interest in "special packaging" that helps patients comply with their regimens remains to be seen.

"Power will aggregate with the purchasers. As the program is rolled out, we will see more aggregation and pricing pressure, as more of these lives are dangled in front of manufacturers, in terms of volume. This is not dissimilar to what happened to the provider side with managed care as it has become more widespread over the last 20 years," Korenchuk said.

Though CMS hasn’t released a final PDP roster, the agency fielded an "overwhelming" response from interested potential sponsors. "It appears that there will be significant choice for many seniors within their regions, and the monthly premiums will be at the lower end of the range of estimates for out-of-pocket costs," Korenchuk said.

Plans have to implement MTM programs for patients on multiple medications, with multiple chronic conditions, and who are likely to incur $4000 in drug costs a year. MTM programs should "optimize therapeutic outcomes through improved medication use and to reduce the risk of adverse events, including adverse drug interactions," the rule says.

"Right now, the MTM rules are pretty flexible. Plans can define [which patients will qualify] and the types of services they want to offer. Pharmacists are the only healthcare professionals named in the law and in the final regulation [as MTM providers], but the plans do not have to use them," says Susan Bishop, senior director of regulatory affairs, American Pharmacists Association.

"CMS has indicated they would like to wait [for the program to rollout] and then work with stakeholders and establish different MTM standards and requirements," she says.

A rule with potential impact on packaging is the "level playing field" requirement. Plans have to provide members the option of 90-day scripts—often available only through mail order—through community pharmacies.

As it stands, the Part D names "special packaging" along with compliance mechanisms such as medication refill reminders as components of MTM. CMS is requiring pharmacies serving long-term care and nursing facilities to provide specific drugs in unit-of-use packaging, a service that many pharmacies serving these communities already practice.

"We have done our best to educate CMS on the value of compliance packaging. At this point, it is up to the PDPs to outline what they propose for inclusion in their MTM programs," says Peter Mayberry, executive director of the Healthcare Compliance Packaging Council.

Historically, pharmacy benefit management has been hobbled by a narrow focus on drug prices. CMS’s inclusion of MTM services in the Part D benefit recognizes the importance of patient counseling and preventative measures like special packaging for improving healthcare and reducing cost. It remains to be seen whether CMS will put teeth into the MTM rule, and if best healthcare practices in the provision of pharmacy services are achievable in the private market place.

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