Medicare Part D: clear as a physician's signature? An interview with Thomas R. Clark, RPh, MHS.

For America's Medicare-eligible seniors, December 31, 2005, will signify more than the rollover of another year. Just after the stroke of midnight, fireworks of a less celebratory nature may be ignited when the Medicare Part D prescription drug benefit becomes effective. As it is currently written, the proposed legislation has neglected to include provisions and medications specifically aimed at serving the nation's nursing home residents.

The final rule of the Medicare Prescription Drug Improvement and Modernization Act, commonly referred to as the Medicare Modernization Act (MMA), was issued in late January of this year. Upon stakeholder review, it was found that many problems remain unaddressed, especially as they affect nursing home residents. Nursing Homes/Long Term Care Management asked Thomas R. Clark, RPh, MHS, director of Policy and Advocacy for the American Society of Consultant Pharmacists (ASCP), to address the questions needing answering to make Medicare Part D a viable program for the institutionalized elderly.

As the MMA Part D currently stands, what problems does it present to LTC facilities for medication administration safety and procedures?

Clark: ASCP, in a February letter to Centers for Medicare & Medicaid Services [CMS] Administrator Mark B. McClellan, expressed its concern that the final regulations provide little detail or insight into how Part D will relate to long-term care facilities. We want to ensure that the needs of these residents will be met during and following the transition without adverse consequences.

Another, and perhaps the most important issue, is that of the approved formulary for Part D. As it now stands, the formulary in place is structured for ambulatory beneficiaries, that is, community-dwelling Medicare recipients whose medication needs are well below those of more medically complex nursing home residents. For LTC residents this formulary is like putting a square peg in a round hole. It is inappropriate for this special population, and access to medication might be so restricted that hospitalizations could occur in order for residents to access the necessary medications and drug therapies.

In particular, what formulary restrictions will most seriously impact nursing home residents?

Clark: Our primary concern about this legislation is that it does not provide coverage for four types of medicines: benzodiazepines, barbiturates, over-the-counter medications, and medications to treat weight loss. These medications are critical to at-risk LTC residents. Not only would lack of access create a health risk, it could also drive up health costs for such things as ambulance service, hospitalizations, and the like. State Medicaid programs could pay for these medications for dual eligibles, but are not required to do so. Our main goal, therefore, is to see these medications added to the formulary. In addition, we suggest that CMS accept a three- to six-month delay after Part D is implemented before imposing its formulary on LTC settings.

What recommendations has ASCP offered to CMS to carry to lawmakers and regulators to make Part D responsive to institutionalized elderly?

Clark: ASCP has offered a number of recommendations. First of all, we ask that CMS specify that LTC residents must receive all the medications prescribed as necessary by their physicians and that the prescription drug plans [PDPs] do not deny access to them. Because the current formulary may delay access to necessary medications, we recommend that PDPs expedite coverage determinations, even if the medication has already been dispensed by a long-term care pharmacy.

[ILLUSTRATION OMITTED]

It is also beneficial if an LTC facility nurse or pharmacist can act on behalf of a resident's physician to seek prior authorization for nonformulary drug requests. This would help to ensure the timeliness of medication delivery. If, as it may turn out, PDPs impose specific formularies on facilities, there must be a simple, straightforward process to access medications outside the formulary.

What effect does the law have on dual eligibles?

Clark: In January, individuals covered by both Medicare and Medicaid [dual eligibles] will surrender their Medicaid benefit for the new Medicare Part D coverage. This affects nearly two-thirds of nursing home residents. Before the end of the year, all dual eligibles will be randomly and automatically assigned to a PDP from which they will receive their drug benefit. This is where the limited access to formularies becomes especially risky. LTC facilities are required to follow physician orders in providing medications and treatments deemed necessary. If the physician considers the drug necessary and the PDP refuses to pay for it, what will the facility do? In a situation such as that will the resident be discharged? We're working with CMS to prevent this kind of scenario. Furthermore, if state Medicaid agencies choose not to cover the excluded medications for dual eligibles, that will be another gap in coverage for needed medicines.

How will LTC residents select an MMA Part D plan?

Clark: The Part D program was basically designed for noninstitutionalized seniors who are expected to "shop around" and compare prices of the different plans available and make their choice. As daunting as this is for community-dwelling seniors, consider the challenge this presents to nursing home residents in general, not to mention residents with dementia. Moreover, although facilities may hand out educational brochures on the subject and have discussions, it is not for them to sign up their residents for a PDP. Some states have laws that prevent facility staff from representing the resident in medical matters.

In any case, what can facilities do to prepare for the January 1, 2006, implementation date of Medicare Part D?

Clark: Right now, it's really still too early to make detailed plans for transition. In the near future, CMS will be issuing advisories that will give us a better idea of how things will work. ASCP will post information and recommendations on its Web site [www.ascp.com] as it becomes available. In addition, an audioconference/slide show explaining Medicare Part D, "Medicare Drug Benefit: Threat or Opportunity," can be accessed at www.scoup.net.

ASCP is continuing discussions with CMS on implementation of Medicare Part D in long-term care settings. We have talked to the folks on Capitol Hill about the excluded medications, but prospects for legislative changes to the MMA do not look good.

Thomas R. Clark, RPh, MHS, is Director of Policy and Advocacy for the American Society of Consultant Pharmacists. For further information, call [phone] or e-mail [e-mail]. To send your comments to the editors, e-mail [e-mail]. To order reprints in quantities of 100 or more, call [phone].