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On October 4, 2004, the Alzheimer’s Association commented on the proposed regulations published on August 3, 2004 by the Centers for Medicare and Medicaid Services (CMS) to implement the Medicare prescription drug benefit established in the Medicare Prescription, Drug, Improvement and Modernization Act of 2003 (MMA). Our comments reflected our objective to ensure access to medications that treat beneficiaries with Alzheimer’s disease . We encouraged CMS to consider the impact of these regulations on the most vulnerable Medicare beneficiaries, including the chronically ill, the dual eligibles and the residents in nursing facilities. The following is a brief summary of our key recommendations to CMS. A copy of our comments can be obtained on www.alz.org or by contacting the Association’s Public Policy office at (202) 393-7737. Enrollment Process: CMS must take steps to prevent a coverage gap for the beneficiaries that get both Medicare and Medicaid (dual eligibles). On January 1, 2006, more than 6.4 million dual eligible individuals will lose their Medicaid drug benefit and transfer their drug coverage to Medicare Part D. The proposed regulations provide that dual eligibles who do not enroll in a plan will be automatically enrolled in a low income plan on May 15, 2006, more than five months after the termination of their Medicaid drug coverage. These individuals must be enrolled in a Medicare Part D plan prior to the end of 2005. Disenrollment by the Prescription Drug Plans: CMS should eliminate the provisions allowing for involuntary disenrollment of beneficiaries for “disruptive or threatening” behavior. The proposed rule would permit plans to involuntarily disenroll beneficiaries due to disruptive, unruly, abusive, uncooperative or threatening behavior. The Alzheimer’s Association strongly believes that this provision could result in the inappropriate disenrollment of beneficiaries with Alzheimer’s disease or other dementias. Access to Covered Part D Drugs: We urged CMS to explore administrative or legislative remedies to ensure coverage of benzodiazepines in 2006. We are extremely concerned that benzodiazepines are specifically excluded from coverage by statute as passed by Congress. This exclusion will result in a loss of coverage for dual eligibles since benzodiazepines are currently covered by nearly every state. Benzodiazepines are a group of medications commonly prescribed to Alzheimer’s beneficiaries for the treatment of insomnia and anxiety. Formulary Requirements: CMS should ensure that the full range of prescription drugs commonly used in clinical practice for treating chronically ill and disabled populations is available to all Medicare beneficiaries. In addition, the Alzheimer’s Association urged CMS to revise its proposal to allow for coverage of more than two drugs for each formulary category or class. “Off-label” Use: CMS should create standards for off-label use of prescription drugs as well as combination therapies. We strongly recommended that CMS preserve the flexibility for drugs to be prescribed for “off-label” uses. Vulnerable Populations: CMS should recognize beneficiaries with Alzheimer’s disease as a vulnerable population for purposes of the Part D benefit. Additional protections and restrictions on plan sponsors should be incorporated to protect this vulnerable patient population. In the proposed rule, CMS expressed concern regarding the potential impact of plans’ cost-saving strategies on vulnerable populations. The Alzheimer’s Association shares CMS’ concern for vulnerable patient populations and urged CMS to recognize patients with Alzheimer’s disease as a vulnerable population for purposes of the Part D benefit. Prohibit “fail first” requirements: CMS should not allow plans to require an enrollee to try the preferred drug and suffer adverse consequences when there has been a change in the sponsor’s formulary. For many Alzheimer’s enrollees, a fail first requirement per se would cause adverse effects and would be dangerous for the medically vulnerable populations of frail elderly, dual eligible, and long-term care individuals. Mid-year formulary changes: We recommended that the final rule place strict limitations on mid-year formulary changes, requiring plans to justify a decision to remove drugs from a formulary. Permitted reasons for discontinuing coverage would include the availability of new clinical evidence indicating that a particular covered Part D drug is unsafe or contraindicated for a specific use or when all manufacturers discontinue supplying a particular covered Part D drug in the United States. Medication Therapy Management Programs: The Alzheimer’s Association believes that the medication therapy management programs (MTMP) could provide a special opportunity to enhance health outcomes and reduce adverse effects for chronically ill beneficiaries, such as those with Alzheimer’s disease. We believe that individuals with Alzheimer’s disease should be identified as “targeted beneficiaries” who should be eligible to receive these services. Nondiscrimination provision: CMS must ensure that the design of all plans and their respective benefits (including any formulary and tiered-formulary structure) do not discourage enrollment of people with chronic diseases and/or disabilities. Grievances, Exceptions and Appeals: CMS proposed regulations in this area are highly complicated and fail to provide needed protections for Medicare beneficiaries. This entire subpart needs to be made much simpler. The timeframes, the paperwork, and the processes should be simplified and consistent so that beneficiaries will use them. In addition, beneficiaries should have access to drugs while their dispute is pending. 
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