Federal Register / Vol. 60, No. 88 / Monday, May 8, 1995 / Rules and Regulations 22533

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.

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 reenroll 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 § 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 § 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 § 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 § 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 § 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

§ 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 § 406.13(g) to state that

entitlement would begin when an

individual initiates a new, regular
22534 Federal Register / Vol. 60, No. 88 / Monday, May 8, 1995 / Rules and Regulations

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 § 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 § 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

§ 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

§ 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

§ 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 § 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
Federal Register / Vol. 60, No. 88 / Monday, May 8, 1995 / Rules and Regulations 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 § 406.13, paragraphs (f) and (g)

are revised to read as follows:

§ 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

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

43 CFR Public Land Order 7139

[AZ–930–1430–01; AZA 26964]

Withdrawal of National Forest System

Land for Houston Mesa Campground;

Arizona

AGENCY: Bureau of Land Management,

Interior.

ACTION: Public land order.

SUMMARY: This order withdraws 320

acres of National Forest System land

from mining for 20 years to protect the

Houston Mesa Campground site. The

land has been and will remain open to

mineral leasing and other uses

authorized by the Forest Service.

EFFECTIVE DATE: May 8, 1995.

FOR FURTHER INFORMATION CONTACT: John

Mezes, BLM Arizona State Office, P.O.

Box 16563, Phoenix, Arizona 85011,

602–650–0509.

By virtue of the authority vested in

the Secretary of the Interior by Section

204 of the Federal Land Policy and

Management Act of 1976, 43 U.S.C.

1714 (1988), it is ordered as follows:

1. Subject to valid existing rights, the

following described National Forest

System land is hereby withdrawn from

location and entry under the United

States mining laws (30 U.S.C. Ch. 2

(1988)), but not from leasing under the

mineral leasing laws, to protect the

Houston Mesa Campground site.

Gila and Salt River Meridian

T. 11 N., R. 10 E.,

Sec. 27, N1⁄2.

The area described contains 320 acres in

Gila County.

2. The withdrawal made by this order

does not alter the applicability of those

land laws governing the use of the

National Forest System lands under

lease, license or permit, or governing the

disposal of their mineral or vegetative

resources other than under the mining

laws.

3. This withdrawal will expire 20

years from the effective date of this

order unless, as a result of a review

conducted before the expiration date

pursuant to section 204(f) of the Federal

Land Policy and Management Act of

1976, 43 U.S.C. 1714(f) (1988), the

Secretary determines that the

withdrawal be extended.

Dated: April 21, 1995.

Bob Armstrong,

Assistant Secretary of the Interior.

[FR Doc. 95–11191 Filed 5–5–95; 8:45 am]

BILLING CODE 4310–32–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[MM Docket No. 90–90; RM–7128, RM–7332,

RM–7410, RM–7411, RM–7412]

FM Radio Broadcasting Services;

Sulphur and South Fort Polk, LA; Bay

City, Edna, Galveston, Jasper,

LaGrange, New Ulm, Palacios,

Redland, Rosenberg, and Winnie, TX

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: This document grants the rule

making petition filed by KSIG

Broadcasting Company, Inc.,