February 25, 2004
The Honorable Tommy Thompson
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20515
Dear Secretary Thompson:
Re: People with disabilities, regulations for and implementation of Medicare prescription drug legislation
We are writing as co-chairs of the Consortium for Citizens with Disabilities Health Task Force. CCD is a Washington-based coalition of national disability organizations that advocates on behalf of the 54 million people with disabilities and chronic conditions in the United States. Medicare is a critical issue for millions of these individuals with disabilities, as is the nexus between Medicare and Medicaid. CCD requests the opportunity to meet with essential HHS/CMS policymakers prior to the development of regulations to implement P.L. 108-173. The decisions that will be made during this process will have a major impact on the health and independence of many people with disabilities. Therefore, it is imperative that full consideration is given to the unique and extensive needs of this population as regulations and policy guidance are drafted.
Over 13 million Medicare beneficiaries have a disability or chronic health condition. The most vulnerable of these are those individuals who are dually-eligible for Medicare and Medicaid and currently rely extensively on Medicaid prescription drug coverage to meet critical health care needs. The CCD strongly believes that the implementation of this legislation should also include discussion and consideration of ways to ameliorate any negative consequences for this population resulting from the shift from receiving a Medicaid drug benefit to purchasing private prescription drug coverage through Medicare.
The CCD has numerous major concerns about the legislation as enacted. We have included some especially problematic issues below. In each of these cases, we believe that any regulations developed to guide future implementation of this bill must be sensitive to the needs of individuals with disabilities and designed to avoid any negative impact on people with disabilities.
· Many people with disabilities and chronic health conditions must have access to certain drugs to maintain their health and independence. These individuals, along with their physicians, have discovered over time what works best for them and what is not adequate or even safe. At the same time, in a world where new scientific achievements happen at breakneck speed, often there is the need for the use of new and/or experimental drugs. There is also the issue of off-label use of certain drugs. Another issue is the need for a particular combination of drugs in order to ensure not only compliance to a drug regimen but also the most efficacious treatment outcomes. Taken together, these factors call for regulations that include strong consumer protections in implementing the Part D Formulary requirements.
· Our concerns specific to Part D Formulary requirements include the make-up of the P&T Committee; the definitions of “therapeutic categories” and “classes” of covered drugs; the determination of preferred and non-preferred drugs; the loss of access to critical drugs which may be excluded from a formulary; and the costs associated with tiered formularies. Regulations implementing these provisions must recognize the special needs of individuals with disabilities and make accommodations for this population of beneficiaries.
· Basic education on the new law must be tailored specifically to the needs of people with disabilities and chronic conditions. There must be sufficient information in appropriate and accessible formats that allows people to make informed decisions on drug plans. The regulations must require that sufficient information be provided about the specific drugs which a plan will cover prior to a consumer selecting a drug plan. This is particularly important for people with disabilities who may find themselves stuck for a full year in a drug plan that does not cover the drugs they need to stay healthy and independent. Even if a plan’s coverage is adequate to begin with, mid-year formulary changes may also leave individuals without access to the specific drugs they need. The regulations must allow beneficiaries to switch drug plans if a mid-year formulary change would otherwise deny them coverage for the drugs they need.
· Other critical formulary issues for people with disabilities relate to the exceptions and appeals process. Currently, Medicaid law is much more consumer friendly not only with its open formulary process (vs. the closed process in this new law) but also with the more accessible Medicaid appeals process. It is important that physicians be able to assist individuals with disabilities, particularly consumers with cognitive and other mental disabilities, with the appeals process. Current Medicaid law allows for expedited appeals on coverage determinations regarding medications. It also allows for the continuation of a drug until that appeal is decided. The regulations for the new Medicare drug benefit must include these critical consumer protections.
o We specifically request that HHS immediately clarify that drugs excluded from a prescription drug plan’s formulary will be considered non-preferred drugs for purposes of the exceptions process for tiered cost-sharing. We also request immediate clarification that disputes regarding coverage of non-formulary drugs are eligible for expedited organization determinations and expedited reconsiderations as provided for in §1852(g) paragraphs 1 through 3 of the Social Security Act (as referenced by §1860D-4(g)(1) of the Social Security Act as amended by P.L. 108-173).
· Under the new Medicare prescription drug benefit people who are dually-eligible for Medicare and Medicaid could lose access to potentially live saving drugs. Individuals who are dually-eligible currently are covered by a number of important Medicaid protections. We hope that these protections will not be lost for this could place both an individual’s health and independence in jeopardy. One issue of major concern relates to cost. If a person who is dually-eligible is forced to choose a higher cost plan in order to get access to critical drugs, that individual still will be unable to get those drugs if co-payments are too high. The regulations for the Medicare drug benefit must ensure that dually-eligible individuals have access to the medications they need.
The CCD Health Task Force urges you to address these critical issues in developing the regulations implementing the Medicare prescription drug bill. The health and safety of individuals with disabilities and chronic health conditions depend on strong consumer protections to ensure that people have access to essential medications. A lack of access poses a definite threat to the independence that people with disabilities want and deserve – and certainly will not be a positive reflection on President Bush’s New Freedom Initiative.
Please contact Kathleen McGinley (202) 408-9514 or Julie Ward (301) 459-3700 for answers to any questions you may have and to set up a face-to-face meeting to discuss our concerns and recommendations.
Sincerely,
Kristen Beronio
National Mental Health Association
Kathleen McGinley
National Association of Protection and Advocacy Systems
Elizabeth Savage
The Arc/UCP Public Policy Collaboration
Julie Ward
Epilepsy Foundation of America
Peter Thomas
American Academy of Physical Medicine and Rehabilitation
cc:
Michael O’Grady, HHS Assistant Secretary for Planning and Evaluation
Margaret Giannini, Director, HHS Office on Disability
Dennis Smith, Acting Administrator, Centers for Medicare and Medicaid Services
Leslie Norwalk, Deputy Administration, Centers of Medicare and Medicaid Services