Page 74 - Medicare Benefit Policy Manual

(ROs) become aware that other companies are possibly operating in violation of the
FFDCA, the A/B MAC (B) or RO notifies:

Centers for Medicare & Medicaid Services
Center for Medicare Management
7500 Security Blvd.
Baltimore, MD 21244-1850

50.4.8 - Process for Amending the List of Compendia for Determination
of Medically-Accepted Indications for Off-Label Uses of Drugs and
Biologicals in an Anti-Cancer Chemotherapeutic Regimen

50.5 - Self-Administered Drugs and Biologicals
(Rev. 1, 10-01-03)
B3-2049.5

Medicare Part B does not cover drugs that are usually self-administered by the patient
unless the statute provides for such coverage. The statute explicitly provides coverage,
for blood clotting factors, drugs used in immunosuppressive therapy, erythropoietin for
dialysis patients, certain oral anti-cancer drugs and anti-emetics used in certain situations.

50.5.1 - Immunosuppressive Drugs
(Rev.11764, Issued: 12-22-2022; Effective: 01-01-2023; Implementation: 01-01-2023)

Until January 1, 1995, immunosuppressive drugs were covered under Part B for a period
of one year following discharge from a hospital for a Medicare covered organ transplant.
The CMS interpreted the 1-year period after the date of the transplant procedure to mean
365 days from the day on which an inpatient is discharged from the hospital.
Beneficiaries are eligible to receive additional Part B coverage within 18 months after
the discharge date for drugs furnished in 1995; within 24 months for drugs furnished in
1996; within 30 months for drugs furnished in 1997; and within 36 months for drugs
furnished after 1997.

For immunosuppressive drugs furnished on or after December 21, 2000, this time limit
for coverage is eliminated.

The Consolidated Appropriations Act of 2021 amended section 1836(b) of the Social
Security Act to add a new form of coverage that provides solely for coverage of
immunosuppressive drugs beginning January 1, 2023, for eligible individuals whose
entitlement to Medicare based on End-Stage Renal Disease (ESRD) ends the 36 month
th
after the month in which the individuals receive a successful kidney transplant. This new
benefit is referred to as the Part B immunosuppressive drug benefit or “Part B-ID.” Refer
to Pub. 100-01, Chapter 2, Section 40.9 for more information on Part B-ID.