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Congress Set to Act on Bioterrorism Initiatives continued from page 3

NPAF encouraged the agency to delay adopting the proposed rule until such time as the agency makes public the data used to justify the proposed payment reductions. NPAF also provided the agency with a patient data analysis report outlining the many challenges Medicare beneficiaries are having accessing new therapies. On November 2, 2001, Senate Finance Committee Chairman Max Baucus and Ranking member Charles Grassley wrote to CMS to suggest a delay in implementation of the proposed rule due to their concern with the impact the revisions could have on both hospitals and beneficiary copayments. On November 14, 2001, NPAF was joined by the Association of Community Cancer Centers and US Oncology in a letter to Mr. Scully to express our support for a delay in implementation.

A final decision from CMS is expected in December.

Self-Administered Drugs
BACKGROUND: In general, Medicare provides coverage for prescription drugs that are not usually self-administered by the patient. However, in recent years, there has been considerable debate regarding the intent of Congress when this benefit was implemented. Last year, Congress included a provision in the Beneficiary Improvement and Protection Act (BIPA) that was intended to clarify federal policy regarding Medicare coverage for drugs that are not usually self-administered. Passage of this important provision was the culmination of many years of effort by NPAF and other patient advocacy organizations.

CURRENT STATUS: NPAF believes the intent of Congress was clearly expressed in the Report of the House Committee on Energy and Commerce, which states:

“The new language requires coverage of drugs and biologicals that are not usually self-administered by the patient. The Committee intends that in determining whether a drug or biological is usually self-administered by the patient, HCFA should only consider whether a majority of Medicare patients with the disease or condition actually administer the drug to themselves. In carrying out this intent, HCFA should assume, as it did for many years, that Medicare patients do not usually self-administer injections or infusions to themselves, while oral medications usually are self-administered. HCFA should also continue to take into account the circumstances under which the drug or biological is being administered, and continue to cover products that are administered in emergencies, for example, during which self-administered is not the usual method of administration.”

On August 28, 2001, NPAF joined our colleagues of the Cancer Leadership Council in a letter to CMS Administrator Tom Scully to request the agency to implement the provision of BIPA to meet Congressional intent.

On October 26, 2001, NPAF met with the CMS Senior Policy Advisor, Ms. Linda Fishman, to discuss the implementation of this important provision. During an in-depth meeting, NPAF provided data that showed our companion organization, Patient Advocate Foundation has been contacted by beneficiaries in 13 states who have been denied coverage for injectable therapies. Our case managers are told that denial is due, in large part, to the lack of a clear coverage policy from CMS. NPAF requested that CMS issue a Program Memorandum to instruct fiscal intermediaries and carriers to immediately begin payment based upon Congressional intent. Ms. Fishman was extremely interested in our data and views on this important issue. She indicated the agency hopes to make a final decision in the near future.

NPAF Washington Update is prepared by the NPAF Policy Department staff and our policy counsel at Shaw Pittman LLP. For additional information, contact NPAF at (757) 873-0438 or visit our website at www.npaf.org.