[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR410.30]

[Page 267]
 
                         TITLE 42--PUBLIC HEALTH
 
                    CHAPTER IV--CENTERS FOR MEDICARE
                          & MEDICAID SERVICES,
                        DEPARTMENT OF HEALTH AND
                             HUMAN SERVICES
 
PART 410_SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS--Table of Contents
 
               Subpart B_Medical and Other Health Services
 
Sec. 410.30  Prescription drugs used in immunosuppressive therapy.

    (a) Scope. Payment may be made for prescription drugs used in 
immunosuppressive therapy that have been approved for marketing by the 
FDA and that meet one of the following conditions:
    (1) The approved labeling includes the indication for preventing or 
treating the rejection of a transplanted organ or tissue.
    (2) The approved labeling includes the indication for use in 
conjunction with immunosuppressive drugs to prevent or treat rejection 
of a transplanted organ or tissue.
    (3) Have been determined by a carrier (in accordance with part 421, 
subpart C of this chapter), in processing a Medicare claim, to be 
reasonable and necessary for the specific purpose of preventing or 
treating the rejection of a patient's transplanted organ or tissue, or 
for use in conjunction with immunosuppressive drugs for the purpose of 
preventing or treating the rejection of a patient's transplanted organ 
or tissue. (In making these determinations, the carriers may consider 
factors such as authoritative drug compendia, current medical 
literature, recognized standards of medical practice, and professional 
medical publications.)
    (b) Period of eligibility. Coverage is available only for 
prescription drugs used in immunosuppressive therapy, furnished to an 
individual who receives an organ or tissue transplant for which Medicare 
payment is made, for the following periods:
    (1) For drugs furnished before 1995, for a period of up to 1 year 
beginning with the date of discharge from the hospital during which the 
covered transplant was performed.
    (2) For drugs furnished during 1995, within 18 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (3) For drugs furnished during 1996, within 24 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (4) For drugs furnished during 1997, within 30 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (5) For drugs furnished after 1997, within 36 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (c) Coverage. Drugs are covered under this provision irrespective of 
whether they can be self-administered.

[60 FR 8955, Feb. 16, 1995. Redesignated at 63 FR 34327, June 24, 1998]