Formulary References

Reference Information for Answers

Question 3. See the CMS document Medicare Part B vs. Part D Coverage Issues. At the bottom of page 20 it reads:

There is no change in Part B coverage of immunosuppressants on January 1, 2006. The only change is that coverage would become available under Part D for uses not covered under Part B. Pharmacists would bill Part B or the individual’s Part D plan based on information received from the individual or from the drug plan. Part B would be billed if the individual had a Medicare-covered transplant; otherwise, the Part D plan would be billed.

Question 4. See also the CMS Formulary Guidance.

Question 5. CMS’s answer to this question on its FAQ page reads:

Infusion drugs not covered by Medicare Part B or that are provided for conditions other than those covered under Part B will be covered under the new Medicare Part D drug benefit. However, supplies, equipment and services involved in delivering home infusion are not covered under Part D, as such coverage would be beyond what we believe to have been Congressional intent regarding the scope of an outpatient drug benefit.

More information about Medicare Part B coverage of drugs and biologicals is available in Section 50 of Chapter 15 of the Medicare Benefit Policy Manual. To access Section 50, open the Bookmarks tab on the left-hand side of the web page and click on 50- Drugs and Biologicals. Information about supplies necessary for the effective use of durable medical equipment (DME) is available in Section 110.3 of Chapter 15 of the Medicare Benefit Policy Manual. Access Section 110.3 from the Bookmarks tab on the left-hand side of the web page.

Question 6. The definition of a covered outpatient drug is cited in Section 1927(k)(2)(A)(i) through (iii) of the Social Security Act.

(2) COVERED OUTPATIENT DRUG.—Subject to the exceptions in paragraph (3), the term "covered outpatient drug" means—

(A) of those drugs which are treated as prescribed drugs for purposes of section 1905(a)(12), a drug which may be dispensed only upon prescription (except as provided in paragraph (5)), and—

(i) which is approved for safety and effectiveness as a prescription drug under section 505 or 507 of the Federal Food, Drug, and Cosmetic Act[126] or which is approved under section 505(j) of such Act;
(ii)(I) which was commercially used or sold in the United States before the date of the enactment of the Drug Amendments of 1962 or which is identical, similar, or related (within the meaning of section 310.6(b)(1) of title 21 of the Code of Federal Regulations[127] ) to such a drug, and (II) which has not been the subject of a final determination by the Secretary that it is a "new drug" (within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act[128] ) or an action brought by the Secretary under section 301, 302(a), or 304(a) of such Act to enforce section 502(f) or 505(a) of such Act; or
(iii)(I) which is described in section 107(c)(3) of the Drug Amendments of 1962 and for which the Secretary has determined there is a compelling justification for its medical need, or is identical, similar, or related (within the meaning of section 310.6(b)(1) of title 21 of the Code of Federal Regulations) to such a drug, and (II) for which the Secretary has not issued a notice of an opportunity for a hearing under section 505(e) of the Federal Food, Drug, and Cosmetic Act on a proposed order of the Secretary to withdraw approval of an application for such drug under such section because the Secretary has determined that the drug is less than effective for some or all conditions of use prescribed, recommended, or suggested in its labeling

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