[Federal Register Volume 60, Number 32 (Thursday, February 16, 1995)]
[Rules and Regulations]
[Pages 8951-8955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3835]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 410
[BPD-424-F]
RIN 0938-AE94
Medicare Program; Medicare Coverage of Prescription Drugs Used in
Immunosuppressive Therapy
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule.
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SUMMARY: This final rule amends the regulations to provide Medicare
coverage for prescription drugs used in immunosuppressive therapy
furnished to an individual who receives an organ transplant for which
Medicare payment is made. This rule reflects the enactment of section
1861(s)(2)(J) of the Social Security Act that provides Medicare
coverage for prescription drugs used in immunosuppressive therapy for a
period of up to 1 year from the date of discharge from an inpatient
hospital stay during which the Medicare-covered organ or tissue
transplant was performed.
This final rule also implements section 13565 of the Omnibus Budget
Reconciliation Act of 1993 (Public Law 103-66) and section 160 of the
Social Security Act Amendments of 1994 (Public Law 103-432) that,
beginning January 1, 1995, expand Medicare coverage for prescription
drugs used in immunosuppressive therapy from 1 year to a phased-in
period of 3 years from the date of discharge from a hospital stay
during which the Medicare-covered organ or tissue transplant was
performed.
DATES: These regulations are effective January 1, 1995, the effective
date of the statute.
FOR FURTHER INFORMATION CONTACT: Debra McKeldin, (410) 966-9671.
SUPPLEMENTARY INFORMATION:
I. Background
Before enactment of section 9335(c) of the Omnibus Budget
Reconciliation Act of 1986 (OBRA '86), Public Law 99-509, there was no
specific Medicare benefit that provided for Medicare Part B coverage of
prescription drugs used in immunosuppressive therapy.
OBRA '86 added subparagraph (J) to section 1861(s)(2) of the Social
Security Act (the Act) to provide Medicare coverage for
immunosuppressive drugs, furnished to an individual who receives an
organ transplant for which Medicare payment is made, for a period not
to exceed 1 year after the transplant procedure. Coverage of these
drugs under Medicare Part B began January 1, 1987.
We published a proposed rule with a 60-day public comment period
(53 FR 1383) on January 19, 1988, which we discuss below. Before its
publication, however, the Omnibus Budget Reconciliation Act of 1987
(OBRA '87), Public Law 100-203, was enacted and effective December 22,
1987, revised section 1861(s)(2)(J) of the Act so that the scope of
coverage was expanded from coverage of ``immunosuppressive drugs'' to
coverage of ``prescription drugs used in immunosuppressive therapy.''
We issued the proposed rule before changes could be made to reflect
this new terminology. We did propose, however, coverage that would
include, in addition to immunosuppressive drugs, other drugs used in
conjunction with immunosuppressive therapy. In addition, in April 1988,
we issued manual instructions to Medicare contractors that reflected
the new terminology.
Also, section 202 of the Medicare Catastrophic Coverage Act of
1988, Public Law 100-360, enacted on July 1, 1988, extended coverage of
drugs used in immunosuppressive therapy to include drugs furnished in
subsequent years after the first year following a covered transplant.
It also extended coverage to include drugs used following a noncovered
transplant irrespective of any prescribed time limitations. This
extended coverage, which was to be effective on January 1, 1990, was
part of the outpatient drug coverage set forth in section 202(a) of
Public Law 100-360. On December 19, 1989, however, these provisions of
the law were repealed as part of the Medicare Catastrophic Coverage
Repeal Act of 1989, Public Law 101-234. As a result, the extended
Medicare coverage of drugs used in immunosuppressive therapy set forth
in Public Law 100-360 never became effective.
Since publication of the proposed rule, section 13565 of the
Omnibus Reconciliation Act of 1993 (OBRA '93), Public Law 103-66,
amended section 1861(s)(2)(J) of the Act. In accordance with OBRA '93,
the coverage period for prescription drugs used in immunosuppressive
therapy will be extended to 18 months from the hospital discharge date
following a covered transplant procedure for drugs furnished in 1995;
24 months for drugs furnished in 1996; 30 months for drugs furnished in
1997; and 36 months for drugs furnished after 1997. Subsequently,
section 160 of the Social Security Act Amendments of 1994, Public Law
103-432, enacted on October 31, 1994, allows us to administer the OBRA
'93 provision in such a way that coverage would be continued
consecutively.
Since this provision is self-executing, we have issued it as part
of this final rule, rather than in proposed form.
II. Provisions of the Proposed Rule
In the January 1988 proposed rule, we proposed to amend 42 CFR part
410 (``Supplementary Medical Insurance (SMI) Benefits'') to incorporate
the following:
Cover immunosuppressive drugs under Medicare Part B by
revising Sec. 410.10 to include immunosuppressive drugs in the term
``medical and other health services'';
Add a new Sec. 410.31 to provide specifically for coverage
of immunosuppressive drugs generally; and
Add a new Sec. 410.65 to provide Medicare coverage of
drugs used in immunosuppressive therapy, that are furnished to an
individual who receives an organ transplant for which Medicare payment
is made, for a period of up to 1 year beginning with the date of
discharge from the inpatient hospital stay during which the transplant
was performed (the proposed rule did not, of course, include the OBRA
'93 phased-in extension to the coverage period that follows a Medicare
approved transplant). We proposed that coverage include: (1) Those
immunosuppressive drugs specifically labeled as immunosuppressive drugs
and approved for marketing by the Food and Drug Administration (FDA)
and (2) other drugs that FDA-approved labeling indicates are used in
conjunction with immunosuppressive drug therapy.
III. Discussion of Comments
We received 11 timely comments in response to the January 1988
proposed rule. The comments were from representatives of hospitals,
medical centers, national associations representing health care
professionals, and a university. The specific comments and our
responses follow:
Comment: Several commenters suggested that coverage of
immunosuppressive drugs be extended beyond 1 year.
Response: As stated earlier, since the publication of the proposed
rule, OBRA [[Page 8952]] '93 has authorized phased-in extensions to the
Medicare coverage period for prescription drugs used in
immunosuppressive therapy. In accordance with this new legislation, the
period after the hospital discharge date in which a Medicare
beneficiary is eligible to receive Part B coverage of prescription
drugs used in immunosuppressive therapy has been extended as follows:
For drugs furnished during 1995, a Medicare beneficiary is
eligible for coverage within 18 months after the date of discharge from
an inpatient stay during which the covered transplant was performed.
For drugs furnished during 1996, a Medicare beneficiary is
eligible for coverage within 24 months after the date of discharge from
an inpatient stay during which the covered transplant was performed.
For drugs furnished during 1997, a Medicare beneficiary is
eligible for coverage within 30 months after the date of discharge from
an inpatient stay during which the covered transplant was performed.
For drugs furnished after 1997, a Medicare beneficiary is
eligible for coverage within 36 months after the date of discharge from
an inpatient stay during which the covered transplant was performed.
Thus, the extension provides a range of coverage extending from 12
to 36 months depending on the date of discharge from an inpatient stay
during which the covered transplant was performed.
For example, if prescription drugs used in immunosuppressive
therapy are furnished to a beneficiary who received a covered
transplant and was discharged on February 1, 1994, the initial coverage
period is for 12 months (February 1, 1994 to January 31, 1995). In
accordance with OBRA '93, on January 1, 1995, the coverage period for
prescription drugs used in immunosuppressive therapy will be extended
to 18 months from the hospital discharge date following a covered
transplant procedure. Therefore, the initial 12-month coverage period
is extended to July 31, 1995 because section 13565 of OBRA '93 extends
coverage for drugs furnished in 1995 to 18 months. Subsequently, the
eligibility for coverage for drugs furnished in 1996 is extended to 24
months after the discharge date. Because January 31, 1996 is 24 months
after the discharge date of the covered transplant procedure in this
example, the beneficiary is eligible for an additional month of
coverage beginning January 1, 1996 and ending on January 31, 1996.
Thus, the beneficiary will receive a total of 19 months of coverage for
prescription drugs used in immunosuppressive therapy.
The following chart illustrates how the extension periods
prescribed by OBRA '93 will be phased in using a discharge date of the
first day of each month.
Phased-in Benefit Periods for Immunosuppressive Drug Therapy
------------------------------------------------------------------------
Coverage
Discharge date Coverage period Coverage Total months
period ends resumes period ends of coverage
------------------------------------------------------------------------
08/1/93....... 07/31/94 01/1/95 01/31/95 13
09/1/93....... 08/31/94 01/1/95 02/28/95 14
10/1/93....... 09/30/94 01/1/95 03/31/95 15
11/1/93....... 10/31/94 01/1/95 04/30/95 16
12/1/93....... 11/30/94 01/1/95 05/31/95 17
01/1/94....... 06/30/95 ............. ............ 18
02/1/94....... 07/31/95 01/1/96 01/31/96 19
03/1/94....... 08/31/95 01/1/96 02/29/96 20
04/1/94....... 09/30/95 01/1/96 03/31/96 21
05/1/94....... 10/31/95 01/1/96 04/30/96 22
06/1/94....... 11/30/95 01/1/96 05/31/96 23
07/1/94....... 06/30/96 ............. ............ 24
08/1/94....... 07/31/96 01/1/97 01/31/97 25
09/1/94....... 08/31/96 01/1/97 02/28/97 26
10/1/94....... 09/30/96 01/1/97 03/31/97 27
11/1/94....... 10/31/96 01/1/97 04/30/97 28
12/1/94....... 11/30/96 01/1/97 05/31/97 29
01/1/95....... 06/30/97 ............. ............ 30
02/1/95....... 07/31/97 01/1/98 01/31/98 31
03/1/95....... 08/31/97 01/1/98 02/28/98 32
04/1/95....... 09/30/97 01/1/98 03/31/98 33
05/1/95....... 10/31/97 01/1/98 04/30/98 34
06/1/95....... 11/30/97 01/1/98 05/31/98 35
07/1/95....... 06/30/98 ............. ............ 36
------------------------------------------------------------------------
As illustrated in the chart, the statutory construction of the
provision in OBRA '93 that prescribed the phased-in extension of
coverage for drugs used in immunosuppressive therapy resulted in gaps
in the coverage period. However, as stated earlier, section 160 of the
Social Security Act Amendments of 1994 allows us to administer this
provision in such a way that consecutive months of coverage are
furnished provided the total number of months of coverage allowed by
OBRA '93 are the same. Thus, in the above example, the beneficiary who
was discharged on February 1, 1994 will receive 19 consecutive months
of coverage (through August 31, 1995) for prescription drugs used in
immunosuppressive therapy.
The periods of consecutive coverage for prescription drugs used in
immunosuppressive therapy are illustrated in the following chart. The
chart demonstrates how the OBRA '93 provisions would be phased in using
a discharge date of the first day of each month.
Phased-in Consecutive Benefit Periods for Immunosuppresive Drug Therapy
------------------------------------------------------------------------
Total months of
Discharge date Coverage period ends coverage
------------------------------------------------------------------------
08/1/93................ 08/31/94 13
09/1/93................ 10/31/94 14
10/1/93................ 12/31/94 15
11/1/93................ 02/28/95 16
12/1/93................ 04/30/95 17
01/1/94................ 06/30/95 18
02/1/94................ 08/31/95 19
03/1/94................ 10/31/95 20
[[Page 8953]]
04/1/94................ 12/31/95 21
05/1/94................ 02/29/96 22
06/1/94................ 04/30/96 23
07/1/94................ 06/30/96 24
08/1/94................ 08/31/96 25
09/1/94................ 10/31/96 26
10/1/94................ 12/31/96 27
11/1/94................ 02/28/97 28
12/1/94................ 04/30/97 29
01/1/95................ 06/30/97 30
02/1/95................ 08/31/97 31
03/1/95................ 10/31/97 32
04/1/95................ 12/31/97 33
05/1/95................ 02/28/98 34
06/1/95................ 04/30/98 35
07/1/95................ 06/30/98 36
------------------------------------------------------------------------
Comment: One commenter recommended that each patient be given a
card showing eligibility dates for immunosuppressive drug therapy.
Response: We have not adopted this suggestion because it would add
an unnecessary paperwork burden without a commensurate benefit to the
program. This information is contained in the Medicare Handbook.
The Medicare contractors processing claims for prescription drugs
used in immunosuppressive therapy are prepared to implement the
extended periods of coverage. The claims processing systems are capable
of determining the periods for which Part B coverage is available
beginning with the date of discharge from a hospital stay during which
a covered transplant was performed.
Comment: One commenter requested that we define several classes of
drugs, such as treatment related drugs (for example, prednisone,
antihypertensives, and cardiac medicines) that, in his opinion, would
be eligible for payment. This classification would provide guidelines
for coverage of each type of drug. Another commenter urged that there
be flexible criteria to permit providers to use a full range of drug
therapy, including drugs prescribed for unapproved indications, rather
than limiting coverage to ``other drugs that are used in conjunction
with immunosuppressive drugs as part of a therapeutic regimen.''
Response: Section 1861(s)(2)(J) of the Act provides for coverage of
only prescription drugs used in immunosuppressive therapy. We interpret
this to mean that coverage is limited to those drugs that are medically
necessary and appropriate for the specific purpose of preventing or
treating the rejection of a transplanted organ or tissue by suppressing
a patient's natural immune responses. To meet this definition, a drug
must be approved by the FDA, be available only through a prescription,
and belong to one of the following three categories:
It is a drug approved for marketing by the FDA and is
labeled as an immunosuppressive drug.
It is a drug, such as a corticosteroid, that is approved
by the FDA and is labeled for use in conjunction with immunosuppressive
drugs to treat or prevent the rejection of a patient's transplanted
organ or tissue.
It is a drug that a Part B carrier, in processing a
Medicare claim, determined 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 those
immunosuppressive drugs for the purpose of preventing or treating the
rejection of a patient's transplanted organ or tissue.
Accordingly, drugs that are used for the treatment of conditions
that may result from an immunosuppressive drug regimen (for example,
antibiotics, antihypertensives, analgesics, vitamins, and other drugs
that are not directly related to organ rejection) are not covered under
this benefit.
Comment: One commenter suggested that we clarify the statement in
the proposed rule (53 FR 1383) that implied that corticosteroids may be
covered by Medicare only if used in association with Sandimmune (that
is, cyclosporine).
Response: The statement in the proposed rule was meant as an
example of a drug treatment regimen that included corticosteroids. It
was not our intention to imply that corticosteroids would not be
covered if prescribed in conjunction with another immunosuppressive, or
alone, to prevent rejection of an organ or tissue transplant.
Comment: One commenter concluded that our statement that commonly
prescribed immunosuppressive drugs are available at substantial
discounts from prices listed in the Red Book (an annual publication
that lists drugs and their wholesale prices) is wrong because the drugs
we listed (with the exception of prednisone) are sole source drugs and
there is no competition to reduce the prices.
Response: Since publication of the proposed rule in January 1988,
payment for Medicare Part B drugs was modified by the November 25, 1991
final rule for the fee schedule for physicians' services (56 FR 59502).
Section 405.517 states that payment for drugs (other than those paid on
a cost or prospective basis) is based on the lower of the estimated
acquisition cost or the national average wholesale price of the drug.
The estimated acquisition cost is determined by individual carrier
surveys of actual invoice prices paid for the drug. If physicians or
pharmacies receive price discounts, the reductions are reflected in
their invoice costs.
Comment: One commenter objected to our statement in the preamble to
the proposed rule (53 FR 1385) that mail service pharmacies ``offer
reduced prices that minimize beneficiaries' coinsurance liability,'' on
the grounds that it amounted to a ``commercial'' on behalf of mail
service pharmacies.
Response: Our intent was not to endorse one source of drugs over
another, but to make the public aware of the alternative of mail
service pharmacies.
Comment: One commenter expressed concern that ordering drugs
through the mail eliminates patient-pharmacist contact.
Response: The absence of face-to-face contact is one of the many
things a beneficiary would want to consider in deciding from whom he or
she will obtain prescribed drugs.
Comment: One commenter suggested that we buy drugs from
manufacturers and have them shipped directly to participating
transplant centers.
Response: We lack the legal authority to do this. We administer the
Medicare program at the national level as authorized by the law. We are
not empowered to participate in the delivery of health care services.
Comment: One commenter asked that we update prices for
immunosuppressive drugs.
Response: Medicare carriers use the Red Book or a similar
publication that is updated periodically during the year for current
prices.
Comment: One organization suggested that our payment policy cover
not only the costs of drugs, but also pharmaceutical care services. The
organization explained that in addition to traditional drug
distribution services, contemporary pharmaceutical services include
clinical functions that ensure the safe and effective use of drug
therapy. Examples of these functions, which were characterized by the
commenter as ``pharmacy'' services, are providing patient education,
assessing patient compliance, and monitoring for therapeutic
effectiveness and adverse effects.
Response: Payment for functions furnished by pharmacists is
included in the amount that Medicare pays for the drugs. [[Page 8954]]
Comment: One commenter recommended that all payments, including
those to hospital outpatient departments, should be made under Part B
on a reasonable charge basis. The commenter maintained that payments
based on costs do not allow the hospital to be paid a reasonable rate
for pharmaceutical services and overhead and that many hospitals
maintain separate inventory and purchasing practices for drugs used in
the outpatient setting.
Response: The statute mandates that the outpatient department of a
hospital be paid based on the lower of reasonable cost or customary
charges as established in the following sections of the Act:
Sections 1832(a)(2)(B) and 1861(s)(2)(J), which establish
that drugs used in immunosuppressive therapy furnished in a provider
are a covered medical service.
Section 1833(a)(2)(B), which states that payment is based
on the lesser of the reasonable cost of hospital outpatient department
services as determined under section 1861(v), or the customary charges
with respect to these services.
Section 1861(u), which defines a provider of services to
include a hospital.
Section 1862(a)(14), which states, in part, that no
payment may be made under Part A or Part B for any expenses incurred
for items or services, other than for statutorily specified exceptions,
that are furnished to an individual who is a patient of a hospital by
an entity other than the hospital or under arrangements with the
hospital. (``Patient'' means inpatients and outpatients of a hospital.)
Therefore, if a patient is an outpatient of a hospital and receives
prescription drugs from the hospital pharmacy, payment would have to be
made to the hospital pharmacy according to the mandate of section
1833(a)(2)(B) of the Act. That section establishes that payment to any
provider of services (in this case, the outpatient pharmacy department
of a hospital) must be the lesser of the reasonable cost of these
services, as determined under section 1861(v) (which includes
recognition of both direct and indirect costs), or the customary
charges with respect to these services.
Comment: One commenter suggested that we improve our communication
with fiscal intermediaries, because some intermediaries are unaware
that they should be paying for prescription drugs used in
immunosuppressive therapy.
Response: We have taken steps to ensure that all contractors
processing claims for prescription drugs used in immunosuppressive
therapy are aware of current Medicare coverage and payment policies. We
have not been informed of any specific problems in this area of program
administration.
IV. Provisions of This Final Rule
The provisions of this final rule restate the provisions of the
January 1988 proposed rule. The final rule differs from the proposed
rule in that we have changed the term ``immunosuppressive drugs,''
wherever it appears, to ``prescription drugs used in immunosuppressive
therapy'' to conform with section 4075 of OBRA `87. Also, we have
redesignated the proposed Sec. 410.65 as Sec. 410.31. The final rule
also differs from the proposed rule in that we have specified that
drugs also will be covered if they have been determined, by a Part B
carrier in processing a Medicare claim, to be reasonable and necessary
(that is, safe and effective) for the purpose of treating or preventing
the rejection of a patient's transplanted organ or tissue, or for use
in conjunction with these immunosuppressive drugs for the purpose of
preventing or treating the rejection of a patient's transplanted organ
or tissue. The carriers make these determinations by considering
factors such as authoritative drug compendia, current medical
literature, recognized standards of medical practice, and professional
medical publications. This change makes the policy governing drugs used
in immunosuppressive therapy consistent with Medicare's general drug
coverage policy.
An additional point of clarification is that the coverage of
prescription drugs for transplants under this rule includes
prescription drugs used in immunosuppressive therapy furnished to an
individual who receives a bone marrow tissue transplant for which
Medicare payment is made. For purposes of this rule, we consider bone
marrow tissue transplants to be subsumed within the term ``organ
transplant'' under section 1861(s)(2)(J) of the Act. Medicare currently
covers heart, kidney, bone marrow, and certain liver transplants.
The final rule also differs from the proposed rule in that OBRA '93
requires phased-in extensions (up to 3 years) to the coverage period
for prescription drugs used in immunosuppressive therapy.
V. Collection of Information Requirements
This notice does not impose information collection or recordkeeping
requirements. Consequently, it need not be reviewed by the Office of
Management and Budget under the authority of the Paperwork Reduction
Act of 1980 (44 U.S.C 3501 et seq.).
VI. Regulatory Impact Statement
A. Introduction
This final rule amends the regulations to provide Medicare coverage
for prescription drugs used in immunosuppressive therapy following an
inpatient hospital stay during which a Medicare-covered organ
transplant was performed. OBRA '86 amended section 1861(s)(2) of the
Act to provide Part B coverage for a period not to exceed 1 year
beginning July 1, 1987. As a result of OBRA '93, the period of coverage
of prescription drugs used in immunosuppressive therapy after the
discharge from a hospital has been increased to 18 months for drugs
furnished in 1995, 24 months for drugs furnished in 1996, 30 months for
drugs furnished in 1997, and 36 months for drugs furnished after 1997.
The following table shows the estimated additional expenditures as a
result of the extended coverage.
Estimated Additional Cost Because of Extended Coverage of Drugs for
Immunosuppressive Therapy--Rounded to the Nearest $5 Million
------------------------------------------------------------------------
FY 1995 FY 1996 FY 1997 FY 1998 FY 1999
------------------------------------------------------------------------
$20.......... $60 $90 $110 $120
------------------------------------------------------------------------
The use of immunosuppressive drug therapy is indicated for the
prevention of organ rejection when an organ or tissue transplant is
performed. The estimated number of transplants that will be performed
in CY 1994 is 10,125, some of which will have an effect on
immunosuppressive drug therapy expenditures in CYs 1995 and 1996. The
estimated 10,850 transplants that will be performed in CY 1995 will
have an effect on drug therapy costs in CYs [[Page 8955]] 1996, 1997,
and 1998. We estimate that the annual drug cost following
transplantation for a full time user of immunosuppressive drugs will be
as follows:
Estimated Annual Cost of Immunosuppressive Drugs for Each Transplant
Patient
------------------------------------------------------------------------
CY 1995 CY 1996 CY 1997
------------------------------------------------------------------------
$5580.................. $5910 $6275
------------------------------------------------------------------------
This final rule also differs from the proposed rule in that the
term ``immunosuppressive drugs'' has been changed to ``prescription
drugs used in immunosuppressive therapy'' to conform with section 4075
of OBRA '87. This expanded coverage will allow payment for other
necessary drugs used in conjunction with immunosuppressive drugs.
B. Regulatory Flexibility Act
Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612), we prepare a regulatory flexibility analysis unless the
Secretary certifies that a rule will not have a significant economic
impact on a substantial number of small entities. For purposes of the
RFA, pharmacists, physicians who perform transplantation services, and
manufacturers of covered pharmaceuticals are considered to be small
entities. Although pharmaceutical manufacturers are frequently not
considered to be small entities, the possibility exists that certain
manufacturers affected by this final rule may meet the definition of a
small entity.
In addition, section 1102(b) of the Act requires the Secretary to
prepare a regulatory impact analysis if a rule may have a significant
impact on the operations of a substantial number of small rural
hospitals. This analysis must conform to the provisions of section 604
of the RFA. For purposes of section 1102(b) of the Act, we define a
small rural hospital as a hospital that is located outside of a
Metropolitan Statistical Area and has fewer than 50 beds.
Because of the high cost of a majority of the drugs used for
immunosuppressive therapy and the extended time that beneficiaries are
required to take the drugs to ensure that the transplanted organ is not
rejected, all Medicare transplant patients and many small entities will
benefit by this regulation. In many cases, 1 year of immunosuppressive
therapy is not sufficient. Also, it is possible that we may avoid the
additional cost of a second transplant if a patient is kept on
immunosuppressive drug therapy beyond the original 12 month coverage
period.
We are not preparing analyses for either the RFA or section 1102(b)
of the Act because we have determined, and the Secretary certifies,
that this rule will not have a significant economic impact on a
substantial number of small entities or a significant impact on the
operations of a substantial number of small rural hospitals.
In accordance with the provisions of Executive Order 12866, this
regulation was not reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 410
Medical and other health services, Medicare.
For the reasons set forth in the preamble, 42 CFR chapter IV, part
410 is amended as set forth below:
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
1. The authority citation continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
2. In Sec. 410.10, the introductory text is republished and a new
paragraph (u) is added to read as follows:
Sec. 410.10 Medical and other health services: Included services.
Subject to the conditions and limitations specified in this
subpart, ``medical and other health services'' includes the following
services:
* * * * *
(u) Prescription drugs used in immunosuppressive therapy.
3. A new Sec. 410.31 is added to read as follows:
Sec. 410.31 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.
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance)
Dated: January 9, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Approved: February 9, 1995.
Donna E. Shalala,
Secretary.
[FR Doc. 95-3835 Filed 2-15-95; 8:45 am]
BILLING CODE 4120-01-P
