Epilepsy Foundation Provides Comments to Centers for Medicare and Medicaid Services

EpilepsyUSA staff
Posted: November 4, 2004

When Congress passed the Medicare Modernization Act last year, a prescription drug benefit, which will become effective in January 2006, was established and will be administered by private plans.

The Centers for Medicare and Medicaid Services is responsible for interpreting and implementing the Act, including the prescription drug benefit, which is Part D of the Act. Although Congress was specific about certain aspects of Part D, many areas regarding the design and implementation of the prescription drug benefit have been left to the discretion of CMS.

Since senior citizens are the fastest-growing segment of the population to be affected by epilepsy, the Foundation believes that it is especially important to provide a broad range of pharmaceutical options to the Medicare population.

The Epilepsy Foundation, in coalition with many other voluntary health and disability organizations, has been working to ensure people with epilepsy and other chronic illnesses and disabilities have access to a full range of medications and treatment options under this new law. After reviewing proposed regulations for the implementation of the new drug benefit, the Epilepsy Foundation has submitted public comments to CMS expressing concerns about the potential impact on Medicare patients' access to needed medications.

The Epilepsy Foundation strongly encourages CMS to implement a Part D benefit that protects the needs of individuals with chronic conditions and ensures timely access to appropriate medications. Specifically, the Foundation recommends:

• Establish limits on tiered co-payments for medications.
  The regulation currently allows plans to utilize tiered cost-structures without limit. Allowing plans unlimited flexibility in establishing cost-sharing tiers facilitates their ability to discourage people who need costly or multiple medications from enrolling in their plan. Plans should not be allowed to place anticonvulsants in the highest cost tiers or price brand name versions in a higher tier, if that medication has been prescribed by the physician as medically appropriate.
• Stipulate that Pharmacy and Therapeutics committee decisions will be binding, not advisory.
  Pharmacy and Therapeutics committees are charged with objectively considering existing scientific knowledge or clinical experience and then advising plans regarding the design of its formularies. Only by requiring plans to adhere to Pharmacy and Therapeutics committee decisions will the integrity of the decision making process be preserved. Furthermore, Pharmacy and Therapeutics committee decisions should be transparent and seek consumer involvement. They should also meet regularly and develop a structure for making revisions to formularies between meetings to ensure that newer medications become available.
• Include a provision that lists conditions that should be exempt from prior authorization, fail-first therapies, dispensing limits and other restrictive procedures.
  Among these CMS should include epilepsy, mental retardation, mental illness, cancer, HIV, and other complex medical conditions.
• Protect benefits for the dual-eligibles (people who qualify both for Medicare and Medicaid).
  Individuals who are both eligible for Medicare and Medicaid will be transitioned to Medicare Part D coverage. Under federal law, states that opt to provide prescription drug coverage in their Medicaid program must cover all FDA approved drugs from every manufacturer that has entered into an agreement with the Secretary of Health and Human Services. Many dual-eligibles include people with disabilities and other chronic conditions. They must have continued access to a formulary that offers a full range of FDA approved medications.
• Safeguard the due process rights of Medicare beneficiaries.
  The proposed regulations fail to meet the requirements of the Due Process Clause of the Fifth Amendment to the United States Constitution. Due process requires adequate notice and hearings when public benefits are being terminated. Medicaid recipients, whose prescriptions have been denied, currently receive a 72-hour supply of medications pending the initial coverage request. Coverage decisions must be made within that time period. They are entitled to notice, face to face hearings and aid pending an appeal if their request is denied and they file their appeal within a specified time frame. All state Medicaid appeals processes are completed more expeditiously than Medicare appeals because of the requirements contained within the Medicaid law.
• Require plans to provide notice in writing, 90 days prior to any changes in the plan formulary.
  The notice must inform the beneficiary of their right to request an exception and appeal a plan's decision to drop a specific covered drug from their formulary.
• Eliminate the "enhanced alternative coverage" provisions.
  These provisions undermine the ability of senior citizens and people with disabilities to make informed decisions when choosing health plan options. If benefits offered by separate plans are not substantively comparable, beneficiaries will have limited success in determining what plan is most appropriate. Health plan benefit options should be standardized so that beneficiaries can make useful and informed decisions when comparing plan options.
• Require that Part D plans prescription drug plans contract with all long-term care pharmacies.
  Beneficiaries residing in long-term care facilities must have convenient access to pharmacies. Approximately 10 percent of the nursing home population uses anticonvulsant drugs. Since most nursing homes require their residents use a long-term care pharmacy, it is critical for CMS to guarantee that beneficiaries, who are institutionalized, are able to access their medications at on-site pharmacies.
• Mandate that prescription drug plans will be required to offer a standard contract to all federally qualified health centers (FQHCs) and rural health centers.
  Without such a provision, pharmacies located in small, underserved populations will not be able to compete. They will either be priced out of the marketplace or their rural constituents / customers will be unable to access need pharmaceuticals. Since FQHCs and health clinics are vital to the health and well-being of people residing in the nation's most isolated communities, a required, standardized contract for small, isolated pharmacy providers is of great importance to the Epilepsy foundation and its affiliates.

The Epilepsy Foundation wants the Centers for Medicare and Medicaid Services to ensure individuals with epilepsy have access to the care and therapies they need under the new drug benefit.

The above list is not a full representation of the concerns the Foundation has with the CMS regulations. Select the boxed link to view the full comments.