The Problem: Berlex came to Dutko Worldwide to seek help in making BETASERON® eligible for Medicare coverage when administered by a patient. The Medicare, Medicaid and SCHIP Benefits and Improvement and Protection Act of 2000 sought to clarify Medicare’s coverage of “drugs and biologicals which are not usually self-administered by the patient” and are administered “incident to a physician’s service.” As a result, only one of four FDA-Approved treatments for MS qualified for Medicare coverage when administered by the patient. This decision meant that many patients who self-inject would not have access to important treatments like BETASERON®.
Strategic Recommendation: Dutko Worldwide’s approach centered around forming a coalition of support that included MS patient and advocate groups, physicians and nurses, advocates for people with disabilities and the manufacturers of all four injected MS therapies. The coalition’s goal would be to ensure that Medicare beneficiaries with MS have coverage for all FDA-approved injected therapies and that coverage allows for self-administration in all settings.
Program Elements:
- Formed an agreement with the National Multiple Sclerosis Society (NMSS) to work together.
- Secured support from drug manufacturers of other MS self-injectable therapies and groups representing physicians and MS patients.
- Developed core messages for the effort – making the argument that there was an inequity in drug coverage that both limited patient access and prohibited free market business practices.
- Developed target list of key legislators and government decision makers who could influence the debate, including members of Congress on appropriate committees and those believed to have a personal connection with MS.
- Worked to gain support by educating top-level staff in the Centers for Medicare and Medicaid Services (CMS) along with targeted Members of Congress and congressional staff. This education was completed through a combination of meetings, formal briefings and preparation/distribution of educational materials.
- Within a year, successfully had a bill introduced in the House – with 52 cosponsors – to grant equitable Medicare coverage for all four MS therapies. Worked to get legislation included in the Medicare Modernization Act.
- Worked to gain support among the Senate Finance and Senate Health, Education, Labor and Pensions Committees. Success was demonstrated when several Senators asked Health and Human Services Secretary Tommy Thompson about the policy on self-injectables during a Medicare committee hearing.
- Worked to ensure language addressing the inequity in coverage for MS patients was included in the final Medicare Modernization Act.
Results: Dutko Worldwide’s effort on behalf of Brelex and MS patients was a success. In addition to raising awareness of this important issue among key government decision makers, a demonstration project was included in the Medicare Modernization Act that provides $500 million for 2004 and 2005. The money will allow Medicare coverage for MS patients and patients from other disease groups who use self-injectable therapies in any setting. We are now working with the Centers for Medicare and Medicaid Services to make certain the demonstration project is implemented in a way that ensures success for Brelex, drug manufacturers and MS patients.
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