[Code of Federal Regulations]

[Title 42, Volume 2]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR410.30]



[Page 326-327]

 

                         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.



[[Page 327]]



    (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]