April 5, 2005 Mark B. McClellan, M.D.
Administrator
Center for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244 Mark.mcclellan@cms.hhs.gov Re: "Information for Part D Sponsors on Requirements for a Transition Plan"
and "Long Term Care Guidance" Dear Dr. McClellan, Families USA would like to take this opportunity to express our concern and disappointment with CMS's Guidance for Transition Process and Long Term Care, both published on March 16, 2005. Although we have some similar concerns with both, we have addressed each separately below. Transition Process Guidance In the overview of the Transition Process Guidance, CMS states "our goal is to ensure beneficiaries receive clinically appropriate medication at the lowest possible cost" and further states, "Part D plans are required to establish an appropriate transition process.....to ensure a safe accommodation of an individual's medical needs with the plan formulary." These are important goals and meeting them is essential for the health and well-being of individuals in Medicare, particularly those who will have to transition from Medicaid to Medicare, and for the success of Medicare Part D. However, the Guidance falls far short of ensuring that these goals will be met. Particularly, far too little is done in the Guidance to see that plans do all that is necessary to ensure that, after Part D begins, dual eligibles will have ongoing access to essential medications on which they are already stabilized. The Transition Guidance is so vague that it barely constitutes any "guidance" at all. Phrases such as "we expect plan sponsors would consider" or "we recommend that plan sponsors consider" are used throughout. The plan sponsor's independent operating procedures seem to carry much greater weight than individuals' medical needs. This is particularly disturbing since a large number of beneficiaries will likely be randomly assigned to plans with no knowledge of the plan formulary and probably little or no opportunity to review the formulary prior to their first attempt to fill a prescription. The process outlined for the 30-day temporary supply that CMS "expects plans to consider" gives plans too much discretion and places far too great a burden on patients. Filling a temporary supply should be mandatory for all plans. In addition, patients should not have to make an exception request; rather, the dispensing of a temporary prescription should automatically initiate an exception review unless the patient affirmatively declines. Furthermore, there are far too few protections to ensure that individuals will be able, without financial penalty, to continue on essential medications that cannot safely be switched. Although the Guidance states that "(w)e would expect that a plan's pharmacy and therapeutics (P&T) committee will review and provide recommendations regarding the procedures for medical review of non-formulary drug requests....", the preamble to the final regulation states that P&T committee determinations regarding formulary exceptions are advisory, not binding. The final determination is up to the plan. P&T committees should have the authority to provide binding recommendations on appropriate treatments, so that non-clinical issues, such as medication cost, do not trump individuals' medical needs. With regard to transition processes for individuals moving from an inpatient to outpatient setting, again the Guidance does little to ensure that individuals' medical needs will be met. The Guidance states that "we recommend that plan sponsors consider" a one-time emergency supply. This is hardly compelling guidance for ensuring continuity of care in the critical time period immediately after discharge. It is particularly disconcerting that CMS is not more direct in its recommendations given that is acknowledges that "there may exist some period of time in which beneficiaries have a temporary gap in coverage" during transitions from one treatment setting to another. CMS should require that plans provide an emergency supply in such circumstances. Long-Term Care Guidance As with the Transition Process Guidance, the Long Term Care Guidance is vague. It does not set out requirements to ensure that long term care residents will receive the drugs prescribed to them. The Guidance does not make appropriate accommodations for the special needs of residents of long term care facilities. The Guidance correctly notes that for many residents of long term care facilities enrolled in Part D, "cognitive, mental or physical impairments" may necessitate that appointed representatives act on their behalf in the appeals process. But the reality is that in many cases, these residents will not have authorized representatives meeting the requirements of the MMA. These patients will still be unable to participate in treatment coverage determinations. There should be provisions for such situations, such as automatically initiating an appeal when a plan sponsor denies coverage for a prescribed drug. The procedures suggested in the Guidance indicate a lack understanding of the urgent and complex needs of residents in long-term care facilities. Finally, the Guidance ignores the Nursing Home Reform Law's requirement that facilities meet residents' needs for pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) regardless of source of payment, as well as CMS' long-standing guidance to surveyors that recognizes that changing medications for some short-stay residents and for residents who have successfully taken medications for many years may not be medically appropriate. We understand that CMS will be reviewing plan formularies and pharmacy networks as part of the approval process. However, the Guidance discussed above is inadequate to ensure that plans will develop procedures that protect beneficiaries. We hope that CMS will conduct its review with more attention to beneficiary rights than evidenced in either Guidance discussed above. Both lack important details that would help ensure that beneficiaries have access to the medicines they need. Given the deficiencies in both, we are particularly disappointed that CMS published these in what appears to be final form with no opportunity for formal comment on issues that are critically important to people in Medicare. Sincerely,
Ron Pollack
Executive Director cc: Lkocot@cms.hhs.gov (Larry Kocot)
Ablock@cms.hhs.gov (Abbey Block)
Jkelman@cms.hhs.gov (Jeff Kelman)
Jgoon@cms.hhs.gov (Julie Goon)
Families USA
April 5, 2005 | 
