TO CMS ADMINISTRATOR SCULLY
Thomas A. Scully
We are writing to bring to your attention potential noncompliance of some Medicare contractors with a provision of the Benefits Improvement and Protection Act of 2000 (BIPA) that requires payment for drugs that are "not usually self-administered." As you may know, this provision was the culmination of a multi-year debate among patient advocates, Congress and Medicare officials regarding the circumstances under which Medicare would cover drugs that could conceivably be self-administered but were in fact usually administered by a provider. Efforts by some Medicare officials to deny reimbursement for these drugs were initially blocked on a one-year basis through an Appropriations limitation, and then last year the policy of covering the drugs was made permanent through BIPA. If there was ever any doubt about the coverage status of these drugs, it has clearly been resolved by the 2000 legislation.
Now, however, it appears that individual carriers and intermediaries may not be apprised of the impact of the legislation. We understand that some contractors have asserted that coverage should be determined by reference to instructions for self-administration in labeling approved by the Food and Drug Administration (FDA). These contractors have sought to deny coverage for drugs that could possibly be, but are not usually, self-administered. It is absolutely clear that the content of FDA-approved labeling does not establish or deny Medicare coverage; rather, under BIPA, coverage depends on how the drug is usually administered to patients. We strongly encourage you to inform the carriers and intermediaries that they lack discretion to second-guess coverage of these drugs on the basis of FDA-approved labeling.
Another issue that
has been raised is whether Medicare coverage could be determined beneficiary-by-beneficiary
based on the individual patient's inability to self-administer a drug.
Such coverage on an individual basis of otherwise non-covered drugs is
currently recognized in the Medicare Carriers Manual in the case of certain
emergencies, such as a diabetic coma, and an expansion of this policy
may well be warranted. However, such an expansion would be additive to
the coverage guaranteed by BIPA for all drugs that are not usually self-administered.
In light of apparent lack of appreciation of the BIPA provision by some Medicare contractors, we urge you to communicate its terms promptly to the carriers and fiscal intermediaries. Thank you for your attention to this issue of great importance to people with cancer, and we look forward to working with you on this and other matters in the future.
Cancer Leadership Council
Alliance for Lung
Cancer Advocacy, Support, and Education
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