[Federal Register Volume 60, Number 88 (Monday, May 8, 1995)]
[Rules and Regulations]
[Pages 22533-22535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11173]
[[Page 22533]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 406
[BPD-738-F]
RIN 0938-AG19
Medicare Program; Clarification of Resumption of Entitlement
Rules for Medicare Patients With End-Stage Renal Disease (ESRD)
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule.
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SUMMARY: In this final rule, we clarify the terms of Medicare
entitlement when an individual resumes a regular course of renal
dialysis treatment or receives a kidney transplant after a previous
course of treatment has been terminated (with or without a transplant)
and add the same considerations for those who have a second transplant
or begin dialysis after a previous transplant. We also respond to
comments on a proposal to revise the definition of ESRD for the purpose
of qualifying for Medicare.
These revisions are necessary so that beneficiaries, providers,
suppliers, and other insurers can determine with certainty when
Medicare coverage begins and ends. Beneficiaries rely on this
information to make informed decisions whether or not to enroll or re-
enroll in the Medicare Supplementary Medical Insurance Program (part
B).
EFFECTIVE DATE: These regulations are effective on June 7, 1995.
FOR FURTHER INFORMATION CONTACT: Denis Garrison, (410) 966-5643.
SUPPLEMENTARY INFORMATION:
I. Background
End-stage renal disease (ESRD) is a disease that results from the
destruction of normal kidney tissues over a long period of time. The
individual often does not experience any symptoms until the kidney has
lost more than half of its function. The loss of kidney function in
ESRD is usually irreversible and permanent.
Definition of ESRD
Section 226A of the Social Security Act (the Act) provides for
Medicare coverage for certain individuals who are medically determined
to have ESRD. Once an individual is medically determined to have ESRD,
the Act specifies that one of two conditions must be met before
entitlement begins. That is, the individual must begin a regular course
of dialysis or receive a kidney transplant. The Act provides that
entitlement begins with the third month after the month in which a
regular course of renal dialysis is initiated or, if earlier, with the
month the transplant occurs.
The Act does not define ESRD. Our regulations, in Sec. 406.13(b),
define it as that stage of kidney impairment that appears irreversible
and permanent and requires a regular course of dialysis or kidney
transplantation to maintain life. (A parallel definition of ESRD also
appears in Sec. 405.2102 which defines ESRD as it relates to the
conditions for coverage that must be met by suppliers furnishing ESRD
care to Medicare beneficiaries.)
Resumption of Entitlement to ESRD Benefits
Paragraphs (c)(2) and (c)(3) of section 226A of the Act specify the
conditions for beginning a new period of entitlement when a kidney
transplant fails or a regular course of dialysis begins again. However,
this section refers to those instances when entitlement has not yet
ended and specifies that Part A (Hospital Insurance) entitlement
``begins'' (although it may not yet have ended) with the month when
regular dialysis treatments begin again. The importance of
``beginning'' Part A entitlement again is that it offers the
opportunity for those who previously refused Part B (Supplementary
Medical Insurance) entitlement or allowed their Part B entitlement to
lapse to enroll in Part B without waiting for the annual general
enrollment period (January through March). Most kidney dialysis
treatments are covered under Part B.
Proposed Rule
On January 6, 1994, we published a proposed rule, at 59 FR 714,
which proposed a change in the definition of end-stage renal disease
(ESRD) and a clarification regarding Medicare entitlement when an
individual's regular course of renal dialysis treatment resumes after a
previous course of treatment has been terminated (with or without a
transplant). The proposal resulted from our concern that there may be a
misunderstanding of the extent of kidney failure that constitutes ESRD
for which the law grants Medicare entitlement. We were also concerned
that our regulations on resumption of entitlement based on ESRD might
be misinterpreted resulting in loss of benefits for some individuals.
Further, for those individuals whose Part A entitlement had not yet
ended, we believe that the intention is to re-enroll the individual in
Part A with that month, without a new application.
Proposed definition--We were concerned that data revealed nearly 1
percent of newly entitled individuals terminated their course of
dialysis with a return of kidney function. We believed that physicians'
certifications leading to eligibility for the patients who terminated
dialysis may have arisen from a misunderstanding of the extent of the
kidney failure that is a predicate to Medicare entitlement.
Consequently, we proposed to amend the definition of ESRD that appeared
in Sec. 406.13 to require that the condition be ``evidenced by
generally accepted diagnostic criteria and laboratory findings.'' We
believed that this addition would make clear that an individual who
receives dialysis does not necessarily have end-stage renal disease.
End of and Resumption of Entitlement--We proposed to treat the
situation in which dialysis ends, then begins again within 12 months,
or in which a second transplant is received within 36 months, as a
resumption of entitlement. Accordingly, we proposed to delete from
paragraph (f) of Sec. 406.13 the reference to continuation of
entitlement. We would revise paragraph (g), which specifies the
conditions for resumption of entitlement, to include the situation
where coverage resumes despite a previous course of treatment.
In our revision of Sec. 406.13(g) we stated that entitlement would
be resumed under any one of three conditions and we used the language
we removed from paragraph (f). Under Sec. 406.13(g)(1), a new period of
entitlement would begin if an individual initiates a regular course of
renal dialysis during the 12-month period after the previous course of
dialysis ended, and he or she would be entitled to a new period of Part
A benefits and, therefore, eligible to enroll in Part B effective with
the month the regular course of dialysis is resumed.
The Act does not mention the beginning of a new period of
entitlement when a second kidney transplant occurs during the 36-month
period following the initial transplant, since there is never a waiting
period for entitlement based on a transplant. However, we believe that,
by analogy, the provisions for beginning a new period of entitlement in
cases where a regular course of dialysis begins or recurs during the 36
months indicate that we should construe the law as requiring resumption
of Part A entitlement and a new period of Part B enrollment in cases of
re-transplantation that occur without the beneficiary's resuming (or
initiating) dialysis treatments. We, therefore, proposed to revise
Sec. 406.13(g) to state that entitlement would begin when an individual
initiates a new, regular [[Page 22534]] course of renal dialysis, or
has a kidney transplant, during the 36-month period after an earlier
kidney transplant, and that he or she would be entitled to resume Part
A and be eligible to enroll in Part B effective with the month the
regular course of dialysis begins or with the month the subsequent
kidney transplant occurs.
We also proposed to make technical revisions to Sec. 406.13(g) to
clarify the other condition for resumption of entitlement. That is,
entitlement is resumed if an individual initiates a regular course of
renal dialysis more than 12 months after the previous regular course of
dialysis ended or more than 36 months after the month of a kidney
transplant, and the individual is eligible to enroll in Part A and Part
B effective with the month in which the regular course of dialysis
treatment is resumed. If he or she is otherwise eligible to Part A
benefits under the conditions specified in Sec. 406.13(c), and files an
application, entitlement would begin with the month in which dialysis
treatments are initiated or resumed, without a waiting period, subject
to the basic limitations of entitlement in Sec. 406.13(e)(1).
II. Analysis of and Responses to Public Comments
Comment: Several commenters were concerned that the proposed
revision to the definition of ESRD would not achieve HCFA's stated
goals of clarifying the entitlement to Medicare's ESRD benefit or
eliminating the one percent alleged error rate. In fact, the change in
the definition of ESRD to refer to ``generally accepted diagnostic
criteria and laboratory findings'' could be inappropriate if HCFA
attempts to establish one easily defined set of laboratory values or
other criteria which represent a clear boundary between cases of ESRD
and non-ESRD. One commenter remarked that patients with many
comorbidities, especially cardiovascular complications, could die of
heart attacks or other events while their physicians wait to put them
on dialysis until their laboratory values reach an arbitrary and too
strict standard. The commenters asked that any system that relies on
sets of laboratory values or other criteria should provide for medical
review of questionable cases by a group of knowledgeable physicians,
with an opportunity for input by the physician of the patient in
question.
Response: In creating the Medicare ESRD program, the Congress
clearly intended that Medicare should be available only to patients who
have ESRD and require regular dialysis treatments or a kidney
transplant to survive. It was certainly not our intent in proposing a
change in the definition of ESRD to cause physicians to delay
prescribing dialysis for patients who do not yet meet a prescribed set
of laboratory values but have other comorbid conditions that the
physicians believe would benefit from dialysis treatment. In fact, we
have always been confident that physicians who believe that dialysis is
a necessary component in treating a patient's medical condition
prescribe such treatment without regard to the expectation of Medicare
coverage.
After considering the comments, we now believe that changes being
made in the way we review medical evidence of ESRD will accomplish more
to ensure that patients meet the definition of ESRD than would a change
to the definition of ESRD in the regulations. Under the screening
process that is expected to be used by the ESRD networks in reviewing
ESRD medical evidence report forms, patients who meet certain
prescribed laboratory test values will automatically be considered to
have ESRD. Cases that fail to meet the laboratory test values will then
be sent to the network's medical review board for further review. At
this stage, the treating physician will have the opportunity to furnish
additional information on the patient's condition. Only after the
medical review board has completed its review of the case and concluded
that the patient's condition is not ESRD will the patient's Medicare
claim be denied. Therefore, we have decided not to revise the
definition of ESRD, as proposed, and are retaining the existing
definition of ESRD in Sec. 406.13(b).
Comment: The proposed rule does not address the issues of
notification to HCFA to ensure continuity of benefits when a patient
returns to dialysis within 12 months after regaining kidney function or
during the 36 months following transplantation.
Response: The actual process used to prevent terminations from
occurring when an individual resumes dialysis or receives another
transplant is not appropriate for inclusion in regulations. However, in
cases in which an individual ceases dialysis or receives a transplant,
the individual is notified immediately that Medicare will terminate in
the future (12 months after dialysis ends or 36 months after
transplant) unless by that time dialysis is resumed or another
transplant is received. Three months before the termination is
effective, we send the individual another notice and an ESRD medical
evidence form (HCFA-2728) and advise the individual to have the form
completed by the treating source without delay if dialysis has been
resumed or another transplant received. We believe this process
provides ample time for an individual to notify us about resumption of
dialysis or receipt of a new transplant in order to prevent an
incorrect termination of Medicare entitlement.
III. Provisions of the Final Regulations
Definition of ESRD--This final rule does not incorporate the
proposed definition of ESRD. We are retaining the existing definition
of ESRD in Sec. 406.13(b).
Resumption of Entitlement to ESRD Benefits--We are incorporating
the provisions of the proposed rule. In addition, we are making a
technical revision by expanding Sec. 406.13(g)(1) to indicate that a
new period of Medicare entitlement begins if an individual receives a
kidney transplant during the 12-month period after a course of dialysis
ends; he or she is entitled to resume Part A benefits and eligible to
enroll in Part B benefits effective with the month the transplant
occurs. This was inadvertently omitted from the proposed rule and
assures that both individuals who resume dialysis and those who receive
a transplant during the 12-month period after a course of dialysis ends
will be treated the same with respect to the right to immediately
enroll in Part B benefits without having to wait for the annual general
enrollment period.
IV. Collection of Information Requirements
This rule contains no information collection requirements.
Consequently, this rule 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.).
V. Regulatory Impact Statement
We generally prepare a regulatory flexibility analysis that is
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612) unless the Secretary certifies that a final rule will not
have a significant economic impact on a substantial number of small
entities. For purposes of the RFA, we consider all physicians and
dialysis facilities to be small entities. Individuals are not included
in the definition of a small entity.
Also, section 1102(b) of the Act requires the Secretary to prepare
a regulatory impact analysis if a final rule may have a significant
impact on the operations of a substantial number of small rural
hospitals. This analysis must [[Page 22535]] 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.
This final rule incorporates the technical provisions of the
proposed rule regarding resumption of entitlement. This rule has no
budget impact because it merely conforms the regulations more closely
to the intent of the Social Security Act in order to avoid any
ambiguity concerning the conditions for resumption of Medicare
entitlement. Therefore, we are not preparing analyses for either the
RFA or section 1102(b) of the Act since we have determined, and the
Secretary certifies, that this final rule will not result in a
significant economic impact on a substantial number of small entities
and will not have 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 406
Health facilities, Kidney diseases, Medicare.
42 CFR chapter IV, part 406 is amended as follows:
PART 406--HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT
1. The authority citation for part 406 continues to read as
follows:
Authority: Secs. 202(t), 202(u), 226, 226A, 1102, 1818, and 1871
of the Social Security Act (42 U.S.C. 402(t), 402(u), 426, 426-1,
1302, 1395i-2, and 1395hh) and 103 of Pub. L. 89-97 (42 U.S.C. 426a)
unless otherwise noted.
2. In Sec. 406.13, paragraphs (f) and (g) are revised to read as
follows:
Sec. 406.13 Individual who has end-stage renal disease.
* * * * *
(f) End of entitlement. Entitlement ends with----
(1) The end of the 12th month after the month in which a regular
course of dialysis ends; or
(2) The end of the 36th month after the month in which the
individual has received a kidney transplant.
(g) Resumption of entitlement. Entitlement is resumed under the
following conditions:
(1) An individual who initiates a regular course of renal dialysis
or has a kidney transplant during the 12-month period after the
previous course of dialysis ended is entitled to Part A benefits and
eligible to enroll in Part B with the month the regular course of
dialysis is resumed or the month the kidney is transplanted.
(2) An individual who initiates a regular course of renal dialysis
or has a kidney transplant during the 36-month period after an earlier
kidney transplant is entitled to Part A benefits and eligible to enroll
in Part B with the month the regular course of dialysis begins or with
the month the subsequent kidney transplant occurs.
(3) An individual who initiates a regular course of renal dialysis
more than 12 months after the previous course of regular dialysis ended
or more than 36 months after the month of a kidney transplant is
eligible to enroll in Part A and Part B with the month in which the
regular course of dialysis is resumed. If he or she is otherwise
entitled under the conditions specified in paragraph (c) of this
section, including the filing of an application, entitlement begins
with the month in which dialysis is initiated or resumed, without a
waiting period, subject to the limitations of paragraph (e)(1) of this
section.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: November 29, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: January 5, 1995.
Donna E. Shalala,
Secretary.
[FR Doc. 95-11173 Filed 5-5-95; 8:45 am]
BILLING CODE 4120-01-P
