Advocacy Issues

Nursing Home Residents and Advocates Will Confront Many Issues in Transition to Medicare Drug Act Coverage  

On January 21, the Centers for Medicare and Medicaid Services (CMS) published over 1,000 pages of final regulations to implement the new prescription drug benefit for Medicare beneficiaries, which will become effective January 1, 2006 . This will be a critical issue for nursing home residents and their advocates in the coming year because, as of January 1, 2006, residents who are dually eligible for Medicare and Medicaid will have prescription drugs they use in the nursing home paid for by Medicare Part D – not Medicaid.  

The new Medicare Part D will provide a drug discount for most Medicare beneficiaries, who will be able to elect whether or not it is worth it to them to enroll. But for those who are financially dependent on Medicaid for drugs provided inside the nursing home, it will be the only source of prescription drug coverage they have. Dually eligible beneficiaries must enroll in one of the yet-to-be-created Prescription Drug Plans (PDPs) to get their medications. (While residents are hospitalized or in a Medicare-covered stay in a skilled nursing facility, Medicare Part A will still pay for their prescriptions.)  

The good news for nursing home residents with dual coverage is that the Medicare Part D benefit is free coverage for them – no premiums, no co-pays, and no deductibles. Moreover, they won’t – at least initially – have to wade through multiple drug plans to decide which one is best for them; the government plans to begin automatically enrolling people with dual eligibility in September or October. The bad news is that the final regulations have left substantial concerns about whether they will be able to obtain the drugs they need in a form they can use.  

CMS has not finished explaining how it will implement the new Medicare Part D – it is in the process of drafting an operational guidance that will clarify and perhaps modify some provisions in the regulations. In the meantime, following are issues that advocates are struggling with:  

·        PDPs will decide which drugs will be included in their formularies (the list of drugs for which they provide coverage). PDPs are not required to offer more than two medications per pharmacologic class (for 146 classes), and they are also not required to cover the dosage form of the drug that the individual may require.  So, for example, while a PDP may include a particular drug in its formulary in tablet form, it is not required to cover the drug in liquid or injectable form – even if that is the only method the individual can tolerate.  Also, whole classes of medications will not be covered at all, including benzodiazepines (which include drugs used to prevent seizures), barbiturates, vitamins, and over-the-counter drugs.  

·        Residents of nursing homes are generally sicker and more vulnerable than the average Medicare beneficiary, but the regulations do not take their vulnerability into account.  For example, PDPs can determine whether medications prescribed by a resident’s personal physician are medically necessary and therefore covered by Medicare.  The final rule gives the PDP 72 hours to approve or deny requests for non-formulary medications – a timeframe that can be shortened to 24 hours if the physician requests an expedited review for medical reasons.  Advocates had requested CMS to provide exemptions from formulary restrictions for special populations, including nursing home residents, so that they would have adequate, timely, and appropriate access to medically necessary medications.  However, formulary flexibility for special populations was not included in the final regulations.  

·        PDPs cannot pay for infusion solutions or other supplies associated with medication administration, such as for IV medications; they can only pay for the actual vial of medication.  CMS’s expectation is that the infusion solutions and other supplies will be paid separately and by a different payor than the medication. 

·        The rule specifies that requests for coverage determinations must be submitted by the “prescribing physician,” the Medicare beneficiary, or the beneficiary’s appointed representative.  Long-term care pharmacies are specifically excluded from assisting with coverage determinations. Advocates are concerned that this will affect the willingness of physicians and specialists to see nursing home residents.  

·        Further, while a five-step process for appealing coverage determinations exists, no provisions are made for ensuring that necessary medications are provided during the appeals process, or for ensuring that residents without a personal representative to act on their behalf will have access to the appeals process.  

·        Dually eligible residents will be permitted to change PDPs at any time. Providers favor this rule because they believe it will allow them to enroll all their residents in the same PDP – thus ensuring that all residents have access to the same formulary. The Center for Medicare Advocacy says this could result in all residents having to use the same pharmacy, which would violate state law in at least 28 states that allow residents to choose their pharmacy.  

Advocates should be thinking about such issues as:

ü      How to inform consumers about these changes so that the transition will go as smoothly as possible for residents;

ü      Joining statewide discussions or forums with other stakeholders to address  problems that may arise with necessary medications not being covered by PDPs, as well as work to educate consumers.  

The American Society of Consultant Pharmacists presented an audioconference last week on the final regulations for Medicare Part D, with special emphasis on long-term care considerations. The slides and audio are archived on the Internet.  The program is free and available at: http://www.scoup.net  

CMS is currently drafting an “operational guidance” that will include additional clarification of the regulations.   

Some of these concerns are expected to be addressed in the Operational Guidance that CMS is developing. NCCNHR is coordinating discussions on these topics at a national level through our Campaign for Quality Care coalition (which includes providers, health care professionals, unions and other consumer groups) and will be advocating with CMS to make important clarifications on implementation of this rule.   Look for future QCAs addressing this topic.