In December 2000, Congress amended the Medicare statute to provide for coverage of self-injectable drugs when they are administered under a doctor’s care and "are not usually self-administered by the patient." Benefits Improvement and Protect Act (BIPA) P.L. No. 106-113, 42 U.S.C. § 1395x(s)(2). This provision is a limited exception to Medicare’s failure to cover outpatient prescription drugs. It was designed to clarify and expand upon Medicare’s previous coverage of "self-injectables."

Despite the legislation, the government did not take any action to implement the new coverage provision. Early in 2002, members of both the House of Representatives and of the Senate sent letters to the Centers for Medicare and Medicaid Services (CMS), the agency that administers Medicare, urging the agency to issue guidance on implementation.

In May, CMS released policy guidance regarding payment for injectable drugs administered in outpatient settings. CMS PM, "Medicare Payment for Drugs and Biologicals Furnished Incident to a Physician’s Service" AB-02-072, http://www.hcfa.gov/pubforms/transmit/AB02072.pdf The CMS guidance, which becomes effective on August 1, 2002, interprets how contractors should implement the December 2000 provision.

THE ISSUES

Advocates contend that CMS’ interpretation of the BIPA provision penalizes and discriminates against persons with Alzheimer’s and other debilitating conditions. For example, the term "by the patient" indicates that each claim should be evaluated on a case-by-case basis, depending upon the patient’s individual characteristics and overall health status. In the Program Memorandum, however, CMS defines "by the patient" as "beneficiaries as a collective whole" and instructs contractors to make coverage determinations on a "drug-by-drug" rather than "beneficiary-by-beneficiary" basis. This interpretation clearly disadvantages persons with Alzheimer’s and other debilitating illnesses who often experience difficulty self-injecting drugs.

CMS compounds the problem by indicating that persons who can never self-inject should be excluded in assessing whether beneficiaries as a collective whole generally self-administer the medicine. It says, "an individual afflicted with dementia would not have the capacity to self-administer any injectable drug, so such individuals would not be included in the population upon which the determination for self-administration by the patient was based." Alzheimer’s and other progressive diseases are found in higher incidences in the Medicare population and to exclude them from the assessment of the collective whole is not only discriminatory but does not accurately reflect the Medicare population. Finally, despite being excluded from the assessment of the collective Medicare population, the CMS policy seems to indicate that patients who cannot self-inject cannot receive Medicare coverage if their healthier counterparts can generally self-administer the drug.

© Center for Medicare Advocacy, Inc. 01/08/2010