Medicare Program; Medicare Secondary Payer for Individuals Entitled to Medicare and Also Covered Under Group Health Plans

Federal RegisterAug 31, 1995

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 400 and 411

[BPD-482-FC]

RIN 0938-AD73

Medicare Program; Medicare Secondary Payer for Individuals

Entitled to Medicare and Also Covered Under Group Health Plans

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule with comment period.

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SUMMARY: These regulations establish limits on Medicare payment for

services furnished to individuals who are entitled to Medicare on the

basis of disability and who are covered under large group health plans

(LGHPs) by virtue of their own or a family member's current employment

status with an employer; and prohibit LGHPs from taking into account

that those individuals are entitled to Medicare on the basis of

disability.

They also implement certain other provisions of section 1862(b) of

the Social Security Act, as amended by the Omnibus Budget

Reconciliation Acts of 1986, 1989, 1990, and 1993 and the Social

Security Act Amendments of 1994. Those amendments affect the Medicare

secondary payer rules for individuals who are entitled to Medicare on

the basis of age or who are eligible or entitled on the basis of end

stage renal disease and who are also covered under group health plans

(GHPs). The provisions that apply to all three groups include--

The rules under which HCFA determines that a GHP or LGHP

is not in conformance with the requirements and prohibitions of the

statute;

The appeals procedures respecting GHPs and LGHPs that HCFA

finds to be nonconforming.

The referral of nonconforming plans to the Internal

Revenue Service; and

The rules for recovery of conditional or mistaken Medicare

payments made by HCFA.

The intent of the MSP provisions is to ensure that Medicare does

not pay primary benefits for services for which a GHP or LGHP is the

proper primary payer and that beneficiaries covered under these plans

are not disadvantaged vis-a-vis other individuals who are covered under

the plan but are not entitled to Medicare.

DATES: Effective Dates: These regulations are effective on October 2,

1995.

Comment Date: We will consider comments that we receive no later

than 5 p.m. on October 30, 1995.

ADDRESSES: Mail an original and 3 copies of written comments to the

following address:

Health Care Financing Administration, Department of Health and Human

Services, Attention: BPD-482-FC, P.O. Box 26676, Baltimore, MD 21207.

If you prefer, you may deliver original and 3 copies of your

written comments to one of the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201, or

Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Because of staffing and resource limitations, we cannot accept

comments by facsimile (FAX) transmission. In commenting, please refer

to file code BPD-482-FC. Comments received timely will be available for

public inspection as they are received, generally beginning

approximately 3 weeks after publication of a document, in Room 309-G of

the Department's offices at 200 Independence Avenue, SW., Washington,

DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m.

(phone: (202) 690-7890).

For comments that relate to information collection requirements,

mail a copy of comments to:

Office of Information and Regulatory Affairs, Office of Management and

Budget, Room 10235, New Executive Office Bldg., Washington, D.C. 30503,

Attention: Allison Herron Eydt, Desk Officer for HCFA

Copies: To order copies of the Federal Register containing this

document, send your request to: New Orders, Superintendent of

Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date

of the issue requested and enclose a check or money order payable to

the Superintendent of Documents, or enclose your Visa or Master Card

number and expiration date. Credit card orders can also be placed by

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2250. The cost for each copy is $8. As an alternative, you can view and

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libraries throughout the country that receive the Federal Register.

FOR FURTHER INFORMATION CONTACT: Herbert Pollock, (410) 786-4474.

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SUPPLEMENTARY INFORMATION:

I. Background

During the first 15 years of the Medicare program, Medicare was the

primary payer for all Medicare-covered services with the sole exception

of services covered under workers' compensation as provided in section

1862 of the Act. Beginning in 1980, the Congress passed a series of

amendments to section 1862 of the Act to make Medicare the secondary

payer for services covered by other types of insurance. In general,

Medicare is now secondary to all of the following:

1. All forms of liability insurance.

2. Automobile and non-automobile no-fault insurance.

3. Group health plans (GHPs) that cover end-stage renal disease

(ESRD) patients (during the first 18 months of Medicare eligibility or

entitlement).

4. GHPs that cover aged individuals who have current employment

status with an employer and aged spouses of individuals of any age who

have current employment status with an employer.

5. Large group health plans (LGHPs) that cover disabled individuals

if the individual or a member of the individual's family has current

employment status with an employer.

(Current employment status is sometimes referred to as ``current

employment.'')

II. Statutory Amendments

A. Overview

1. Section 9319 of the OBRA '86 (Pub. L. 99-509) added a new

section 1862(b)(4), which made Medicare secondary to benefits payable

by ``large group health plans'' for services furnished to ``active

individuals,'' who are entitled to Medicare based on disability.

2. Section 6202(b) of OBRA '89 (Pub. L. 101-239) reorganized and

clarified the Medicare secondary payer (MSP) provisions and transferred

the provisions applicable to the disabled to section 1862(b)(1)(B) of

the Act.

3. Section 4204(g) of OBRA '90 (Pub. L. 101-508) added a new

section 1862(b)(3)(C), which prohibits employers and other entities

from offering Medicare beneficiaries incentives not to enroll or to

terminate enrollment in a GHP that would otherwise be primary to

Medicare. Section 1862(b)(3)(C) of the Act provides for a civil money

penalty of up to $5,000 for each violation.

Section 4203(c)(1) of OBRA '90 redefined the 12-month ESRD MSP

coordination period, during which GHPs are required to pay primary to

Medicare, and extended that redefined period from 12 to 18 months. A

final rule with comment period addressing the section 4203(c)(1)

changes was published in the Federal Register on August 12, 1992 (57 FR

36006-36016).

4. Section 13561(e) of OBRA '93 (Pub. L. 103-66), effective August

10, 1993, changed the MSP provisions for the disabled to make Medicare

the secondary payer for individuals who have LGHP coverage by virtue of

the individual's own or a family member's ``current employment status

with an employer''. An individual has current employment status with an

employer if the individual is an employee, is the employer (including a

self-employed person), or is associated with the employer in a business

relationship. In general, this means that the individual is on the

employment rolls of the employer. Before this change in the law,

Medicare was also secondary payer for certain nonworking disabled

individuals who were considered to have employee status based on their

relationship with the employer, even though they may not have been on

the employment rolls.

5. Sections 151(c) and 157(b) of the Social Security Act Amendments

of 1994 (SSAA '94) (Pub. L. 103-432) made miscellaneous and technical

corrections to OBRA '89, OBRA '90, and OBRA '93. Section 151(b)(3)

added express authority to assess interest if a conditional Medicare

payment is not refunded within 60 days.

B. OBRA '86 Amendments--Active Individuals Entitled to Medicare on the

Basis of Disability

These amendments--

1. Defined the term ``active individual'' as ``an employee (as may

be defined in regulations), the employer, an individual associated with

the employer in a business relationship, or a member of the family of

any of such persons.''

2. Defined ``large group health plan'' by reference to section

5000(b) of the Internal Revenue Code (IRC) of 1986, which defined the

term as ``a plan of, or contributed to by, an employer or employee

organization (including a self-insured plan), to provide health care

(directly or otherwise) to the employees, former employees, the

employer, others associated or formerly associated with the employer in

a business relationship, or their families, that covers employees of at

least one employer that normally employed at least 100 employees on a

typical business day during the previous calendar year.'' (We have

interpreted the phrase ``normally employed at least 100 employees on a

typical business day'' to mean that the employer employed at least 100

full-time or part-time employees during 50 percent or more of the

employer's business days during the previous calendar year.)

3. Provided that Medicare may not pay for services furnished to an

active individual on or after January 1, 1987, and before January 1,

1992, to the extent that payment has been made or can reasonably be

expected to be made by an LGHP. (Section 4203(b) of OBRA '90 changed

the sunset provision from January 1, 1992, to October 1, 1995, and

section 13561(b) of OBRA '93 changed that date to October 1, 1998.)

4. Expanded HCFA's recovery rights under previous amendments to the

Medicare statute by providing that HCFA may bring an action against any

entity that fails to pay primary benefits for services furnished to

active individuals entitled on the basis of disability, as required

under section 1862(b) of the Act, and may collect double damages.

5. Created a private cause of action under which any claimant may

seek double damages from any entity responsible for payment that fails

to pay primary benefits as required by the statute.

6. Provided that an LGHP ``may not take into account that an active

individual is eligible for or receives'' Medicare benefits on the basis

of disability. The effect of this prohibition was to--

Make Medicare secondary payer for active individuals who

were entitled to Medicare on the basis of disability and whose LGHP

coverage was linked to their status as active individuals; for example,

individuals who had LGHP coverage because they were employees or

spouses of employees; and

Require the LGHP to treat such active individuals the same

way it treated similarly situated individuals.

C. OBRA '89 Amendments

The OBRA '89 amendments--

1. Revised the definition of ``active individual'' to include the

phrase ``self-employed individual (such as the employer)'';

2. Extended to individuals with ESRD and to the aged the

prohibition against taking into account Medicare entitlement.

3. Required that GHPs--

Furnish to aged employees and spouses the same benefits,

under the same conditions, that they furnish to employees and spouses

under 65; and

Not differentiate in the benefits they provide between

individuals with ESRD and other plan enrollees, on the basis of

[[Page 45346]]

the existence of ESRD, the need for dialysis, or in any other manner.

4. Extended to the MSP provisions for the aged and for those with

ESRD, the Federal Government's right to recover double damages; and

5. Exempted from the MSP provisions services performed for a

religious order by members of the order who take a vow of poverty; and

6. Provided a single formula for determining Medicare secondary

payment amounts under all MSP provisions.

D. OBRA '90 Amendments

These amendments made the following changes:

1. Added a new section 1862(b)(3)(C) to the Act, which prohibited

employers or other entities from offering to an individual entitled to

Medicare any financial or other incentive not to enroll, or to

terminate enrollment, in a GHP that would be primary to Medicare,

unless the incentive was also offered to all individuals who are

eligible for coverage under the plan. That section also provided for a

penalty of up to $5,000 for each violation, which was to be applied in

accordance with provisions of section 1128A of the Act.

2. Redefined and extended the ESRD MSP coordination period. The 12-

month ESRD coordination period was redefined to begin with the first

month of ESRD-based eligibility or entitlement, and that redefined

period was extended to 18 months. (Previously, the ESRD coordination

period was a 12-month period that began with the first month of

dialysis rather than with the first month of ESRD-based eligibility or

entitlement, which generally occurs as of the fourth month of

dialysis.) On August 12, 1992, we published a final rule with comment

period (57 FR 36006-36016) that incorporated this change. We received

one comment on this particular aspect, but made no change in the

confirming final rule published on November 2, 1993 (58 FR 58502-

58504).

E. OBRA '93--Amendments Treatment of Individuals Entitled to Medicare

on the Basis of Disability Who Have LGHP Coverage by Virtue of Their

Own or a Family Member's Current Employment Status

The OBRA '93 amendments made the following changes, effective

August 10, 1993:

1. Eliminated the concept ``active individual'' and provided

instead that the MSP disability provision applies only if the

individual, or a family member, is covered under an LGHP ``by virtue of

the individual's current employment status with an employer''.

2. Provided that an individual has ``current employment status'' if

the individual is an employee, the employer (including a self-employed

person), or is associated with the employer in a business relationship.

3. Required use of the IRS aggregation rules for determining

employer size under the working aged and disability provisions.

4. Modified the MSP provisions for individuals who are eligible for

or entitled to Medicare on the basis of ESRD and also entitled on the

basis of age or disability.

5. Clarified that GHPs and LGHPs of governmental entities are

subject to the MSP provisions (although governmental entities are

exempt from the excise tax applicable to employers that participate in

nonconforming plans.)

F. The Social Security Act Amendments of 1994 (SSAA '94)

The SSAA '94 made the following miscellaneous and technical

corrections:

1. Effective as if included in the enactment of OBRA '93--

A. Clarified that plans must offer the same benefits under the same

conditions to the age 65 or older spouse of any employee; that is,

without regard to the employee's age. (With regard to spouses, the

wording of OBRA '93 could have been misconstrued as applying the

working aged provision only to age 65 or older spouses of employees age

65 or older.) (Section 151(c)(1).)

B. Clarified that GHPs and LGHPs of governmental entities have

always been subject to the MSP provisions. (OBRA '93 could have been

misconstrued as providing that plans of governmental entities are

subject to the MSP provisions only as of August 10, 1993, the date of

enactment of OBRA '93, whereas governmental entities have always been

subject to the MSP provisions, with the exception of the excise tax

applicable to employers that participate in the nonconforming plans.)

(Sections 151(c) (9) and (10).)

2. Effective as if included in the enactment of OBRA '90--

A. Clarified that employers and other entities are prohibited from

offering to an individual entitled to Medicare any financial or other

incentive not to enroll in, or to terminate enrollment in, a GHP that

would be primary to Medicare, irrespective of whether the incentive is

also offered to all other individuals who are eligible for coverage

under the plan. (Section 157(b)(7). Refer to section VIII-K of this

preamble.)

B. Clarified the extent to which section 1128A of the Act applies

to the civil money penalty of section 1862(b)(3)(C) of the Act.

(Section 157(b)(7). Refer to section VIII-K of this preamble.)

3. Effective as if included in the enactment of OBRA '89--Clarified

that under section 1862(b)(1)(C) plans may pay benefits secondary to

Medicare after the 18-month period during which the plan is prohibited

from taking into account ESRD-based eligibility or entitlement but may

not otherwise differentiate in benefits provided vis-a-vis other plan

enrollees. The OBRA '89 language could have been misconstrued as

permitting plans to discriminate against enrollees who had ESRD after

the 18-month coordination period. That is, OBRA '89 broadly stated that

plans were not prohibited from ``taking into account'' ESRD-based

eligibility or entitlement after the 18-month coordination period; the

SSAA '94 corrected that language to narrowly state that plans are not

prohibited from paying benefits secondary to Medicare after the 18-

month coordination period. (Section 151(c)(5). Refer to section VIII-D

of this preamble.)

The SSAA '94 also added express authority to assess interest if a

conditional Medicare primary payment is not refunded within 60 days. As

authorized under common law, and in accordance with HHS regulations,

consistent with the Federal Claims Collection Act (31 U.S.C. 3711),

HCFA may charge interest on amounts that any responsible party does not

refund timely. Section 151(b)(3) amended section 1862(b)(2)(B)(i) of

the Act to make explicit that the Secretary may charge interest when

timely reimbursement is not made. This self-implementing statutory

clarification is effective for items and services furnished on or after

the date of enactment, October 31, 1994. The rate of interest provided

in section 1862(b)(2)(B)(i) of the Act is the same as in sections

1815(d) and 1833(j), which is reflected in regulations at 42 CFR

405.376(d). We will include detailed policies regarding the statutory

provision in a future regulation. (Refer to section VIII-L of this

preamble.)

III. Study by the Comptroller General

OBRA '86 required the Comptroller General to conduct a study to

determine the impact of the MSP provisions for the disabled on the

access that disabled individuals and members of their families have to

employment and health insurance. In the April 10, 1991, report entitled

Medicare: Millions in Disabled Beneficiary Expenditures Shifted to

[[Page 45347]]

Employers, the Comptroller General concluded that ``The OBRA '86

secondary payer provision has met its objective of shifting

considerable Medicare expenditures to LGHPs apparently without

significant adverse effect'' on the access of disabled beneficiaries

and their families to employment and health services. The report

further stated: ``In addition to suffering little adverse effect from

the provision, the disabled are safeguarded by regulations proposed by

HCFA. These rules discourage employers from taking many of the actions

they were considering that would discriminate against disabled

beneficiaries and their families in regard to health insurance.'' The

report also recommended that HCFA change its policy to remove the

``indicators'' that, prior to the changes made by OBRA '93, were used

to determine whether an individual who is not actively working for an

employer is considered an employee. That recommendation echoes those

made by many of the commenters in their responses to the proposed rules

published on March 8, 1990 at 55 FR 8491.

IV. Related Statutes

A. Internal Revenue Code (IRC)

1. OBRA '86 also amended the IRC to--

Define ``nonconforming group health plan'' as a large

group health plan that at any time during a calendar year takes into

account that an active individual is eligible for or is receiving

Medicare benefits based on entitlement to Social Security disability

benefits; and

Impose, on any employer or employee organization (other

than a governmental entity) that contributes to a nonconforming LGHP, a

tax equal to 25 percent of the expenses the employer or employee

organization incurred during the calendar year for each LGHP to which

the employer or employee organization contributes.

2. OBRA '89 further amended the IRC to--

Substitute the following definition of ``nonconforming

group health plan'' to replace the OBRA '86 definition.

``For purposes of this section, the term nonconforming group

health plan means a group health plan or large group health plan

that at any time during a calendar year does not comply with the

requirements of subparagraphs (A) and (C) or subparagraph (B),

respectively, of section 1862(b)(1) of the Social Security Act.''

Provide that the tax imposed by OBRA '86 on employers and

employee organizations that contribute to or sponsor LGHPs that do not

comply with the MSP provisions for the disabled also applies with

respect to such sponsors or contributors that do not comply with the

MSP provisions for the working aged or the MSP provisions for ESRD

beneficiaries.

OBRA '93 expanded the definition of ``nonconforming group

health plan'' to include a group health plan or LGHP that fails to

refund to HCFA conditional primary Medicare payments.

Under these IRC amendments, HCFA reports to the IRS GHPs and LGHPs

that do not comply with any of the following:

The prohibition against taking into account Medicare

entitlement when Medicare is the secondary payer for aged, ESRD, or

disabled beneficiaries.

The requirement that employees and spouses age 65 or older

be given equal benefits under the same conditions as those under 65.

The prohibition against differentiating, in the services

covered and payments made, between persons having ESRD and other

individuals covered by the plan.

The requirement that GHPs and LGHPs refund conditional

primary Medicare payments.

B. Americans With Disabilities Act

The Americans with Disabilities Act of 1990, Pub. L. 101-336 (42

U.S.C. 12101 et seq.) is related to the aims of this rule with respect

to the MSP provision for the disabled. Section 102 of that statute

prohibits discrimination against the physically or mentally disabled in

private places of employment. This Act is administered by the Equal

Employment Opportunity Commission.

C. COBRA Continuation Coverage Amendments

Title X of the Consolidated Omnibus Budget Reconciliation Act of

1985 (Pub. L. 99-272, commonly referred to as COBRA) amended the

following statutes:

Section 4980B of the IRC (26 U.S.C. 4980B).

Part 6 of title I, subtitle B of the Employee Retirement

Income Security Act (ERISA) (29 U.S.C. 1161-1168).

Title XXII of the Public Health Service Act (42 U.S.C.

300bb-1 et seq.)

Under the COBRA amendments, certain GHPs must offer employees (and

their dependents), who would otherwise lose coverage under the plan as

a result of any of five specified ``qualifying events'', an opportunity

to elect continuation of the coverage they had immediately before the

qualifying event. ``Qualifying events'' include termination of

employment (other than for gross misconduct) and reduction in hours of

work. Continuation coverage must extend at least from the date of the

qualifying event to the earliest of a list of terminating events.

Terminating events include entitlement to Medicare and expiration of

the maximum period of continued coverage specified for a particular

qualifying event. For termination of employment or reduction of hours

of work, the maximum coverage period is 18 months. This is extended to

29 months in the case of a qualified beneficiary who is determined to

have been disabled at the time of the qualifying event. For other

qualifying events the maximum is generally 36 months.

GHP COBRA continuation coverage is generally exempt from the

Medicare secondary payer provisions. Part VII-E of this preamble

contains a detailed discussion of the MSP provisions vis-a-vis the

COBRA provisions.

V. Provisions of the Proposed Rule

The March 8, 1990, notice of proposed rulemaking proposed to add a

new subpart G to part 411--Exclusions from Medicare and Limitations on

Medicare Payment.

At that time, subpart B of part 411 set forth general rules and

definitions applicable to all of the Medicare secondary payer

provisions. Included were rules on recovery and waiver of recovery,

Medicare secondary payments, and the effect of third-party payments on

benefit utilization and deductibles. Accordingly, proposed subpart G

included only those rules that apply exclusively to LGHPs or that

differed to some extent from similar rules applicable to other third

party payers.

A. In Section 411.82, Definitions, we proposed to--

1. Interpret ``typical business day'' as 50 percent or more of the

employer's regular business days during the previous calendar year; and

2. Define ``employee'' as an individual who is actively working or

whose relationship to an employer shows that he or she has employee

status within the ordinary understanding of the term ``employee.'' In

Sec. 411.83, Determination of Employee Status, we proposed that

employee status be established if the individual met any of the

following conditions:

Received from an employer payments that are subject to

taxes under the Federal Insurance Contributions Act (FICA) or would be

subject to such taxes except for the fact that the payment is exempt

from those taxes under the IRC.

[[Page 45348]]

Was termed an employee under a Federal or State law or in

accordance with a court decision.

Was designated as an employee in the employer's records;

that is, had not had his or her employee status terminated. We proposed

that termination from payroll, in and of itself, not be considered

termination from employee status.

We also gave examples of other commonly accepted indicators of

employment status, examples that we developed in consultation with

other government agencies, including the Department of Labor and the

IRS.

We considered adding the following indicators to the list that

appeared in proposed Sec. 411.83(b):

Accrues years of service credits for pension purposes

(that is, the individual's age-based pension rights continue to

increase); and

May become vested under the employer's retirement plan,

even though he or she was not vested at the time the disability was

established.

We specifically requested comments on whether to include these two

indicators in the final rule.

B. In Section 411.88, Basis for Medicare primary payments, we

proposed that failure to furnish information necessary for HCFA to

determine whether an LGHP was primary to Medicare could lead to denial

of payment of Medicare primary benefits.

The proposed rule also--

1. Defined three key terms as follows:

``Disabled active individual'', as an active individual

who has been determined to be ``under a disability'' under section 223

of the Act, as evidenced by issuance of an SSA notification to that

effect, and who is not, and could not upon filing an application

become, entitled to Medicare on the basis of ESRD.

``Nonconforming LGHP'', as an LGHP that, at any time

during a calendar year, discriminates against a disabled active

individual who is eligible for, or receives, Medicare benefits on the

basis of disability.

``Family member'', as any person whose relationship to the

active individual is the basis for coverage under an LGHP; for example,

the relationship of a divorced or common law spouse or that of an

adopted, foster, natural or step-child, parent, or sibling.

2. Specified that a disabled active individual could accept or

reject the LGHP coverage offered by the employer, and that, if the

individual refuses the LGHP, the employer may not offer a plan that

pays benefits secondary to Medicare.

3. Provided examples of LGHP actions that would be considered

discriminatory.

4. Indicated the kinds of information that HCFA might require to

document an LGHP's compliance with the nondiscrimination rule.

5. Specified that HCFA would refer to the IRS any LGHP that it

finds to be a nonconforming LGHP.

6. Specified that the IRS imposes, on employers or employee

organizations that contribute to a nonconforming LGHP, the tax provided

for under section 5000 of the IRC of 1986.

VI. Reorganization of the Rules and Conforming Changes

Because of the statutory changes discussed above, we needed a new

subpart for the provisions that now apply generally to all GHP MSP

situations. We also needed to make room for incorporating in logical

order any additional regulations that may be required by future

amendments to the Act. Accordingly, this final rule--

Redesignates subparts E and F as F and G, respectively;

Establishes a new subpart E for the general provisions,

including appeals provisions that were not in the NPRM; and

Designates the special provisions for the disabled under a

new subpart H.

New subpart E includes--

Most of the definitions that were previously scattered

among several subparts (Sec. 411.101).

A statement of the basic prohibitions under the ESRD,

working aged, and disability MSP provisions (Sec. 411.102).

A statement of the prohibition against employers offering

incentives to encourage Medicare beneficiaries not to enroll in or to

terminate enrollment in a GHP that would be primary to Medicare

(Sec. 411.103).

An explanation of the terms ``current employment status''

and ``coverage by virtue of current employment status'' (Sec. 411.104).

The method for determining employer size (Sec. 411.106).

Examples of actions that constitute ``taking into

account'' Medicare entitlement and of permissible actions

(Sec. 411.108).

Basis for determination of nonconformance (Sec. 411.110).

Documentation of conformance (Sec. 411.112).

Determination of nonconformance and notice of that

determination (Secs. 411.114 and 411.115).

Appeals procedures (Secs. 411.120 through 411.126).

Referral to IRS (Sec. 411.130).

The following table shows how the section numbers in the final rule

differ from the numbers in the NPRM. The revised designations reflect

the reorganization of the text required by the addition of rules that

now apply to all three groups of beneficiaries (aged, disabled, and

ESRD) and the new rules on appeals procedures.

----------------------------------------------------------------------------------------------------------------

Proposed rule designation Final rule designation

Heading as shown in final rule section section

----------------------------------------------------------------------------------------------------------------

Basis and scope........................................ 411.80........................ 411.100

Definitions............................................ 411.82........................ 411.101; 411.201

Current employment status.............................. 411.83........................ 411.104

Medicare benefits secondary to LGHP benefits........... 411.85........................ 411.204

Basis for Medicare primary payments and limits on 411.88........................ 411.206

secondary payments.

Recovery of conditional Medicare payments.............. 411.92........................ 411.24

Basic prohibitions and requirements.................... 411.94(b)..................... 411.102

Taking into account entitlement to Medicare............ 411.94(d)..................... 411.108

Basis for determination of nonconformance.............. 411.94(c)..................... 411.110

Documentation of conformance........................... 411.94(e)&(f)................. 411.112

Determination of nonconformance........................ 411.94(d)..................... 411.114

Referral to the Internal Revenue Service (IRS)......... 411.94(g)..................... 411.130

----------------------------------------------------------------------------------------------------------------

Note: The headings are those used in the final rule. In

referring to the proposed rule in the preamble discussion, we use

the column 1 designations. In referring to the final rule, we use

the column 2 designations.

[[Page 45349]]

The statutory changes, the reorganization of the regulations text,

and other changes that have occurred since these rules were published

required the following conforming changes in subpart B:

1. Revise Sec. 411.20 (Basis and scope) to--

Transfer to the new subpart E the statutory basis for the

rules that apply to GHP coverage.

Reflect this change in the ``Scope'' paragraph of the

section.

Expand references (in this section and in Sec. 411.21) to

include the new subpart H.

2. Revise Sec. 411.24 (Amount of recovery) as follows:

a. In paragraph (c), to--

Reflect the fact that OBRA '89 extended to all MSP

situations the right (previously limited to MSP for the disabled) to

recover double the amount of damages if it is necessary for HCFA to

take legal action in order to recover;

Remove the parenthetical reference to the double damages

provision and expressly state the circumstances under which HCFA can

recover double damages; and

Specify that responsible parties include both third party

payers and individuals or entities that have received third party

payments that must be refunded.

b. In paragraph (e), to make clear that third parties against which

HCFA may take action are those that are ``required to make'', as well

as those who are ``responsible for making'', primary payments. This

change is necessary to conform to a language change made by OBRA '89.

c. To add a new paragraph (m) (Interest charges) to specify the

explicit authority provided by the Social Security Act Amendments of

1994, which is in addition to the long-standing authority provided by

common law and by HHS regulations (45 CFR 30.13) that are consistent

with the Federal Claims Collection Act (31 U.S.C. 3711), for HCFA to

charge interest on amounts that any responsible party does not refund

timely.

3. Amend Sec. 411.33 (Amount of Medicare secondary payment) to make

clear that Medicare payment may now be based on fee schedules (as well

as reasonable charge) and to remove paragraphs (c) and (d), which set

forth a special formula for computing Medicare secondary payments under

the MSP provisions for ESRD. (OBRA '89 provided a single formula for

all MSP situations.)

VII. Comments on the NPRM of March 8, 1990 and Responses to Those

Comments

We received 36 timely letters of comment from employers, insurance

companies, law firms, actuarial firms, individuals, associations (two

business and one medical), and beneficiary rights organizations.

Following is a discussion of those comments and our responses to them.

Thirty-three of the comments dealt with the term ``active

individual,'' including the statutory definition of that term. Since

the term ``active individual'' was deleted from the law by OBRA '93,

effective August 10, 1993, we are not responding to those comments,

except for the comment in A. below.

A. Definitions--(Section 411.82)

The law prior to OBRA '93 defined the term ``active individual'' as

``an employee (as may be defined in regulations), the employer, self-

employed individual (such as the employer), an individual associated

with the employer in a business relationship, or a member of the family

of any of such persons.'' We received a comment about one of the

categories under this definition; that is, ``individual associated with

the employer in a business relationship.''

Comment: The commenter suggested that the rules define the term

``individual associated with the employer in a business relationship.''

The commenter went on to propose that individuals who are receiving

health care coverage through an employer are associated with the

employer in a business relationship regardless of whether they are

employees. The commenter suggested that such a definition would be

appropriate because employers provide such benefits as part of a quid

pro quo for services.

Response: We do not agree that a definition of the term

``individual associated with the employer in a business relationship''

is necessary in the regulations. Any individual who qualifies for LGHP

coverage because of a business relationship with the employer (for

example, suppliers and contractors who do business with the employer)

is included within the term. We also do not agree with the commenter's

proposed definition of the term. Defining the term in the manner

proposed would bring many former employees, including retirees, who

receive benefits from an employer within the scope of the MSP provision

for the disabled. The Congress clearly did not intend the MSP provision

for the disabled to extend to retirees and other former employees,

since the term ``former employee under age 65'' was specifically

deleted from an early draft of legislation on MSP for the disabled

legislation (Senate Report 99-348 July 31, 1986).

Comment: One commenter objected to the inclusion of ``divorced

spouse'' in the definition of ``family member''. The commenter

contended that the inclusion of that term exceeded HCFA's authority,

since a ``former family member'' is not a ``family member''.

Response: We disagree. As used in new subpart H, ``family member''

means anyone who has LGHP coverage on the basis of another person's

enrollment. Spouses, children, parents, and siblings are merely

examples. Any individual to whom a LGHP grants coverage because of such

an enrollment is a family member for purposes of subpart H.

Comment: One commenter asked why the term ``spouse who was married

to an active individual'' was not included in the definition of

``family member.'' The commenter also requested clarification of the

status of an ex-spouse who is eligible to receive or is receiving

health care benefits under the continuation of coverage provisions of

COBRA and what is the LGHP's obligation to such an individual.

Response: We have revised the definition of ``family member'' to

include the term ``spouse''. The matter of an ex-spouse is discussed in

response to the previous comment. The rules that apply to disabled

individuals who have LGHP benefits as a result of the COBRA

continuation provisions are discussed under Part VII-E of this

preamble.

Comment: One commenter objected to inclusion of an ``employee-pay-

all'' plan in the definition of LGHP in the proposed rule

(Sec. 411.82(4)(ii)) on the basis that these plans are generally

``franchise arrangements'' in which the contracts are individually

underwritten and the employer merely performs the ministerial role of

collecting the premiums but not enrolling the participants.

Response: We have considered the status of ``employee-pay-all

plans'' in the past and addressed the issue in the preamble to the

Medicare regulations published on October 11, 1985 (50 FR 41503), and

in Sec. 411.70(d) of the Medicare regulations published on October 11,

1989 (54 FR 41745). Those regulations apply to the working aged and

make clear that ``employee-pay-all'' plans may satisfy the statutory

definition of GHP. We apply the same principles in the MSP rules for

the disabled. (See 52 FR 35966, September 24, 1987.)

[[Page 45350]]

Medicare is secondary to ``employee-pay-all'' plans if they meet

the statutory definition of LGHP; that is, plans that are under the

auspices of, or contributed to, by an employer or employee organization

and that cover at least one employer of 100 or more employees.

Comment: One commenter requested that the term ``Medicare payment''

in Sec. 411.92, Recovery, should be defined to eliminate confusion with

another term, ``gross amount payable'', used in Medicare contractor

manuals.

Response: The term, ``gross amount payable'', is defined at 42 CFR

411.33(e)(1) as ``* * * the amount payable without considering the

effect of the Medicare deductible and coinsurance or the payment by the

third party payer * * *.''

We have revised proposed Sec. 411.92 (now Sec. 411.24) to specify

that HCFA recovers the Medicare primary payment amount.

Comment: A commenter objected to the definition of LGHP, because it

casts too broad a net and captures many employers who have fewer than

100 employees, but who are required to provide primary coverage to

disabled active individuals because these ``small employers''

participate in a plan that has at least one employer of 100 or more

employees.

Response: The term ``large group health plan'' is defined in the

IRC of 1986 as ``a plan of, or contributed to by, an employer or

employee organization (including a self-insured plan) to provide health

care (directly or otherwise) to the employees, former employees, the

employer, others associated or formerly associated with the employer in

a business relationship, or their families, that covers employees of at

least one employer that normally employed at least 100 employees on a

typical business day during the previous calendar year.'' HCFA has no

discretion to exempt from the Medicare secondary payer provision for

the disabled employees of employers of fewer than 100 employees if they

belong to a multi-employer plan that meets the above definition. In the

MSP statute, as revised by OBRA '89, the Congress could have provided

an exception for small employers that participate in multi-employer or

multiple employer plans, similar to the exception that is specifically

provided in the statute with respect to the working aged. Since the

Congress chose to provide the exception only under the working aged

provision, we conclude that it was not the Congress' intent to allow a

similar exception under the MSP provision for the disabled.

B. Indicators of Employee Status

We received 30 comments on Sec. 411.83, which proposed to

incorporate into the regulations the policy that some disabled

individuals who are not working are considered to be employees for MSP

purposes if certain indicators of ``employee status'' are present. Only

one commenter supported the policy without reservation. The other

commenters expressed either opposition to the policy as a whole or to

one or more of the indicators used to establish whether a non-working

disabled person has employee status. We are not addressing these

comments because we have deleted the policy on indicators of employee

status, to reflect changes made by OBRA '93, effective August 10, 1993.

In the legislative history that preceded enactment of OBRA '93

(Conference Report of the House Committee on the Budget to accompany

H.R. 2264, H.R. Rep. No. 213, 103rd Cong. 1st Sess. (1993)), the

Congress provided explicit direction on how it expected us to construe

the new law. It made clear on page 805 that the term ``current

employment status with an employer'' should be implemented ``consistent

with the provision that applies to aged beneficiaries (working aged)''

and, on page 806, that ``the definition of active employee for disabled

beneficiaries (should) conform with the definition for working aged

beneficiaries.''

C. Prohibition of Discrimination

Several commenters addressed the provisions of proposed

Sec. 411.94, which dealt with the prohibition of discrimination by

LGHPs against disabled active individuals on the basis of Medicare

entitlement.

Comment: One commenter requested that HCFA discard all of the rules

on nondiscrimination on the grounds that ``they represent an

unjustified and unsupported foray into the role of the Congress.'' In

the event that HCFA decides to promulgate the proposed

nondiscrimination rules, the commenter requested that HCFA conduct

public hearings to gauge the effect of the rules.

Response: Under the law in effect before August 10, 1993, section

1862(b)(1)(B)(i) of the Act prohibited LGHPs from ``taking into

account'' that an active individual is entitled to Medicare on the

basis of disability. As amended by OBRA '93, the law prohibits LGHPs

from taking into account the entitlement to Medicare on the basis of

disability of an individual who has LGHP coverage by virtue of the

individual's own or a family member's current employment status. This

provision simultaneously makes Medicare benefits secondary to LGHP

coverage for these individuals and prohibits LGHPs from taking into

account that these individuals are entitled to Medicare on the basis of

disability. For example, without this prohibition LGHPs could deny,

reduce, or restrict coverage or access to coverage for these

individuals and thereby shift to the Medicare program the primary

responsibility for payment of their medical expenses. This would defeat

the purpose of the MSP provision for the disabled.

The public has had ample opportunity to comment on the proposed

nondiscrimination rules during the public comment period that followed

the publication of the notice of proposed rulemaking. We received a

number of substantive comments regarding the proposed nondiscrimination

rules, and we discuss these comments below. We therefore do not believe

that there is need for public hearings on the final rules.

Comment: Several commenters objected that the criteria for

prohibited discrimination in proposed Sec. 411.94(d) exceed the

statutory requirement. These commenters contended that while the

statute prohibits LGHPs only from denying coverage to disabled active

individuals on account of their Medicare entitlement, the criteria in

proposed Sec. 411.94(d) appear to prohibit LGHPs from terminating

disabled individuals on grounds other than Medicare entitlement. One

commenter expressed concern that an employer would be unable to

terminate a disabled active individual's coverage for any reason after

the individual becomes entitled to Medicare. Another commenter

recommended that the final rule specify that prohibited discrimination

occurs only when a plan treats disabled active individuals differently

from ``similarly situated'' individuals not entitled to Medicare.

Response: The statute, as amended by OBRA '86, prohibited an LGHP

from taking into account that an active individual is entitled to

Medicare on the basis of disability. As amended by OBRA '93, the

statute prohibits LGHPs from taking into account entitlement to

Medicare on the basis of disability of an individual who has LGHP

coverage by virtue of the individual's own or a family member's current

employment status. The basic rule is that, with regard to individuals

entitled to Medicare on the basis of disability who (1) have current

employment status or (2) are family members of individuals with current

employment status, LGHPs must offer the same enrollment opportunities

[[Page 45351]]

and the same coverage under the same conditions as they offer to

similarly situated individuals. In the case of employees, all other

employees enrolled or seeking to enroll in the plan are considered to

be similarly situated. In the case of each of the other categories of

individuals who have current employment status (such as business

associates or family members), all other persons in those categories

are considered to be similarly situated.

An LGHP may refuse to provide coverage, terminate enrollment, or

limit coverage (for individuals who are entitled to Medicare on the

basis of disability) only on grounds that apply to all similarly

situated individuals enrolled, or seeking to enroll, in the plan,

including individuals not entitled to Medicare. Plan provisions that

have the effect of denying, restricting, or terminating benefits for

disabled beneficiaries who have LGHP coverage by virtue of current

employment status, but not for similarly situated individuals, are

prohibited. An LGHP may make benefit distinctions among various

categories of similarly situated individuals, distinctions based, for

example, on length of time employed, employment status, or marital

status but not on disability. If the LGHP makes such distinctions, it

may also make them among disabled beneficiaries who have LGHP coverage

by virtue of current employment status.

Comment: Several commenters objected that proposed Sec. 411.94(d)

appeared to force employers to decide, before an employee who has

become disabled is determined to be ``under a disability'' within the

meaning of section 223 of the Social Security Act, whether to cease

covering the individual under the LGHP or to continue providing

benefits for as long as benefits are provided to active employees. One

commenter contended that the Congress clearly did not intend to impose

such a choice upon employers. Another commenter noted that the proposed

policy would only encourage employers to cut off health benefits to

injured workers before the individual receives a determination of

disability from the Social Security Administration.

Response: In the NPRM, we proposed to compare what an LGHP offers

or provides at or after the point of disability determination with what

it offered or provided at or after the point of Medicare entitlement.

The idea was to prevent employers from avoiding the obligation of

providing primary benefits by terminating coverage during the 29 month

waiting period between the onset of disability and Medicare

entitlement.

We agree that the proposed policy could be interpreted as

encouraging employers to terminate coverage of injured or sick workers

prior to the determination of disability. In addition, the proposed

policy could lead to an anomalous situation in which an LGHP's changing

or termination of a disabled individual's coverage would be permissible

or impermissible, depending on the variable timing of disability

determinations.

We are, therefore, not including the proposed policy in the final

regulation. The prohibition against taking Medicare entitlement into

account does not compel LGHPs to make an irrevocable choice, before the

determination of disability, between discontinuing coverage of disabled

individuals and providing coverage indefinitely. Rather, as discussed

earlier in this preamble, LGHPs are prohibited from treating

individuals entitled to Medicare on the basis of disability and covered

by virtue of their own or a family member's current employment status

differently from similarly situated individuals (that is, individuals

of the same category such as spouse, child, or employee) who are

enrolled or seeking to enroll in the plan. No change, restriction, or

termination of coverage may be imposed because individuals are entitled

to Medicare on the basis of disability. Also prohibited are changes,

restrictions, or terminations of coverage that have the effect of

treating those individuals differently from similarly situated

individuals.

Comment: Several commenters raised questions about the application

of the nondiscrimination rules to various employer health plan

provisions.

Proposed Sec. 411.94(d) appears to prohibit employers from

terminating or amending their health benefits plans, if doing so would

have the effect of reducing or terminating benefits provided under an

LGHP to a disabled active individual.

Proposed Sec. 411.94(d)(6) (denial or termination of

coverage of a disabled active individual on the basis of disability)

would prevent employers from offering employees who become disabled,

coverage under an LGHP for a limited period of time and then

terminating the coverage once the designated period has expired. This

could be interpreted to prohibit employers who voluntarily provide

extended coverage to disabled individuals from terminating the extended

coverage once the individual becomes entitled to Medicare benefits.

The rules prohibiting discrimination should not prevent an

employer from changing the status of a disabled individual in a way

that disqualifies the individual for coverage under the employer's

LGHP. For example, an employer should not be considered to be

discriminating if he removes a disabled individual from the roster of

employees, thus disqualifying the individual from coverage under the

employer's plan.

Proposed Sec. 411.94(d)(3) appears to provide that an LGHP

is discriminatory if it has a policy of offering ``disabling condition-

only'' coverage to employees who become disabled, since such coverage

is less comprehensive than coverage provided to other individuals under

the plan.

Response: An employer is not prohibited from adopting any of the

provisions described above, provided that those provisions (1) apply to

all enrollees and potential enrollees, without regard to whether they

are entitled to Medicare on the basis of disability; and (2) do not

have the effect of treating disabled Medicare beneficiaries who have

LGHP coverage by virtue of current employment status differently from

similarly situated individuals.

Thus, a ``disabling condition-only'' provision is prohibited if it

has the effect of restricting coverage for individuals entitled to

Medicare on the basis of disability but not for similarly situated

individuals who are not so entitled. The regulation does not allow an

employer to terminate the LGHP coverage of those disabled individuals

unless the employer also terminates coverage for similarly situated

individuals not entitled to Medicare on the basis of disability.

If an employer voluntarily provides LGHP coverage to an individual

who is entitled to Medicare on the basis of disability and who has LGHP

coverage by virtue of current employment status, that coverage is

primary to Medicare.

We do not believe that the statute prohibits employers from

terminating a benefit that they voluntarily provide to those disabled

individuals above the coverage given to similarly situated individuals

who are not entitled to Medicare on the basis of disability (see item

b. of comment).

Section 411.108 of this final rule makes clear that an LGHP may

not, for example, deny or terminate coverage, offer less comprehensive

coverage, or charge increased premiums for individuals entitled to

Medicare on the basis of disability and covered by virtue of current

employment status unless it takes the same actions for similarly

situated individuals who are not so entitled. However, as stated above,

employers are not required to continue indefinitely LGHP coverage that

they

[[Page 45352]]

have voluntarily provided to those disabled individuals.

Comment: One commenter objected that the nondiscrimination criteria

of proposed Sec. 411.94(d) failed to prohibit cost avoidance techniques

used by LGHPs and employers to reduce their exposure. One such tactic

is to ``churn'' insurance contracts in order to reimpose waiting

periods and pre-existing condition exclusions on ``high-exposure''

employees and their dependents. Another tactic is to pay ``high

exposure'' individuals an amount equivalent to the per capita premium

of the plan so that they can purchase health insurance on an individual

basis. The commenter recommended that the criteria in proposed

Sec. 411.94(d) specifically prohibit ``the payment of wages which are

to be dedicated toward the purchase of an individual contract for the

disabled active individual.''

Response: The Medicare law does not prohibit LGHPs from engaging in

cost-avoidance practices and from imposing cost-avoidance provisions

such as waiting periods and pre-existing condition exclusions, provided

that such practices and provisions apply equally to all enrollees and

potential enrollees and do not have the effect of treating individuals

entitled to Medicare on the basis of disability who have LGHP coverage

by virtue of current employment status differently from similarly

situated individuals. (However, other State or Federal laws should be

consulted for any effect they may have on this situation.)

Comment: One commenter asked for guidance about what constitutes

adequate notification to active individuals of the consequences of

rejecting LGHP coverage, as required under proposed Sec. 411.94(d)(8).

The commenter specifically suggested that the rules include a provision

that a statement in a Summary Plan Description satisfies this

requirement.

Response: Beneficiaries need to understand the consequences of

rejecting LGHP coverage; that is, that Medicare will be the primary

payer and the employer will not be permitted to pay secondary benefits

for Medicare-covered services. In recognition of this, we have

provided, in Sec. 411.108, that a plan would be taking into account

Medicare entitlement if it gave individuals information on their right

to accept or reject the employer plan but failed to inform them of the

consequences of rejection.

Comment: One commenter recommended that proposed Sec. 411.94

provide examples of ``taking into account.'' The commenter offered

several examples of ``taking into account'' for inclusion in the final

regulation.

Response: The criteria of proposed Sec. 411.94(d), clarified and

expanded on the basis of the commenter's suggestions, appear in the

final rule as examples of ``taking into account'' (Sec. 411.108).

Comment: One commenter recommended that the Sec. 411.94 criteria

for determining that an LGHP is discriminating explicitly apply to

employees' spouses and dependents, if the LGHP covers them. The

commenter also recommended that an LGHP be considered nonconforming if

it requires that an active individual receive health care benefits from

a prescribed provider, while other covered individuals are not mandated

to receive services from that provider.

Response: The criteria in proposed Sec. 411.94 and the final rules'

examples of ``taking into account'' clearly apply to employees' spouses

and dependents covered by an LGHP, since those persons are included

within the meaning of the term ``family member.'' Therefore, it is not

necessary to state explicitly in Sec. 411.110 that the criteria that

define a nonconforming GHP apply to LGHP coverage of employees' spouses

and dependents. An LGHP that required disabled beneficiaries covered by

virtue of current employment status, but not similarly situated

individuals, to receive services from a preferred provider would

clearly be considered nonconforming under the criteria in Sec. 411.110

of the final rule.

D. Referral to the Internal Revenue Service (Section 411.94(g))

Comment: One commenter expressed concern that proposed

Sec. 411.94(g), dealing with the reporting of nonconforming LGHPs to

the IRS, would not achieve the goal of ensuring nondiscriminatory

treatment of active individuals by LGHPs. The commenter recommended

that sanctions be incorporated into the rules to provide incentives for

LGHPs to meet the nondiscrimination requirements.

Response: HCFA reports nonconforming GHPs and LGHPs to the IRS

because the IRS administers section 5000 of the IRC, which imposes a

tax on employers and employee organizations that contribute to a

nonconforming GHP. This provision indicates the Congress' intent that

employers and employee organizations be ultimately held responsible for

the actions of their health plans. We believe that this tax provides an

incentive for employers and employee organizations to ensure that the

plans they create, participate in, or contribute to, comply with the

prohibition against taking into account Medicare entitlement. We expect

that employers and employee organizations will pursue available

remedies under contract or insurance law, if necessary, to assure that

their plans comply with the requirements of the statute and thus avoid

imposition of the tax. The tax and the requirement to report

nonconforming LGHPs were imposed for the disabled by OBRA '86 and

extended to all GHP situations by OBRA '89.

Comment: One commenter recommended that insurers of LGHPs be

reported to the IRS to provide an incentive for them to conform to the

requirements of a nondiscriminatory LGHP.

Response: See our response to the previous comment. Under section

5000 of the IRC, the tax is imposed only on employers and employee

organizations that contribute to nonconforming GHPs. This should

discourage employers and employee organizations from doing business

with an underwriting insurer that does not conform to the prohibition

against taking into account the Medicare entitlement of individuals who

are entitled on the basis of age, ESRD, or disability. It should

encourage employers and employee organizations to enforce their

insurance contracts to ensure that both the promise and the performance

under the contract conform to the MSP requirements. Insurers thus

should have an incentive to conform with MSP requirements.

Additional incentives for compliance are provided by the following

statutory provisions:

The law provides for a private right of legal action to

collect double damages from any entity (including insurers, and

employers) that fails to provide primary coverage when required by law.

The Federal Government has the right to take legal action

to collect double damages from those entities if they fail to provide

primary benefits.

E. Relation to COBRA Continuation Coverage Provisions

Under the COBRA continuation coverage provisions, an individual (or

the individual's dependents) who would otherwise lose coverage under an

employer's GHP because of specified circumstances that include

termination and reduction in hours of employment must be offered

continued coverage at his or her own expense for a designated period of

time. Under a 1989 amendment to the COBRA continuation of coverage

provisions, the period of continued coverage is up to 29 months for

individuals who were disabled (as determined under the Social Security

[[Page 45353]]

Act) at the time of their termination of employment or reduction of

hours of work. The COBRA provisions permit termination of continuation

coverage at the point of Medicare entitlement, which, for a disabled

person, begins 29 months after the onset of disability if the

individual has been entitled to monthly social security disability

benefits for 24 months. Several commenters raised the following issues:

The effect of the proposed regulations on coverage

provided to active individuals under the COBRA continuation coverage

provisions was not clear.

Section 411.94(d)(6) of the proposed regulations--

+ Appears to have the effect of extending COBRA's limited period of

continuation coverage to an unlimited period while an active individual

receives Social Security benefits. (That result would be directly

contrary to the intent of the Congress).

+ Appears to prohibit LGHPs from terminating continuation coverage

of active individuals who become entitled to Medicare benefits, even

though COBRA specifically permits this.

+ Could be interpreted to forbid employers who voluntarily provide

extended coverage beyond the maximum period mandated by COBRA from

terminating that coverage once the individual becomes entitled to

Medicare.

HCFA should include in the final regulation a specific

rule to the effect that the operation of an LGHP in any manner

permitted under the COBRA continuation coverage provision will not be

considered discriminatory.

The proposed regulations create a ``very basic conflict''

with COBRA. COBRA mandates coverage for individuals who were disabled

at the time of a COBRA ``qualifying event'' for 29 months (which is

generally the length of the waiting period for Medicare entitlement

based on receipt of Social Security disability benefits) but permits a

plan to terminate coverage at the end of the 29 months, or at the point

of Medicare entitlement. The proposed regulations, however, do not

require coverage during the Medicare waiting period but appear to

mandate coverage thereafter.

Proposed Sec. 411.94(d)(7) appears to prohibit charging

active individuals who are also COBRA beneficiaries the higher premiums

(up to 150 percent of the applicable premium) permitted under COBRA.

Response: When the proposed regulation was published, it was HCFA's

position that there was no real conflict between the MSP for the

disabled provision and the COBRA continuation of coverage provision,

since COBRA permits but does not mandate termination of coverage at the

time of Medicare entitlement. The statutes amended by COBRA state that

continuation coverage may be terminated upon entitlement to Medicare.

The Medicare statute stated that the LGHP may not take into account

entitlement to Medicare based on disability. It was HCFA's policy that

the MSP for the disabled provision prohibited termination of COBRA

continuation coverage of an active individual entitled to Medicare on

the basis of disability if the termination was based on that

entitlement. Since some people who have COBRA continuation coverage

because they have stopped working would be considered to be employees

under the indicators of employee status, the result would be that the

proposed regulation would have prohibited what the COBRA law permitted.

Blue Cross and Blue Shield of Texas filed a lawsuit challenging

HCFA's same policy with respect to COBRA continuation coverage in ESRD

MSP cases (Blue Cross and Blue Shield of Texas v. Sullivan, case No. 3-

91 2760-H (N.D. Tex.)). On April 7, 1992, the District Court for the

Northern District of Texas ruled against the government. The government

appealed that ruling to the Fifth Circuit Court of Appeals. On July 13,

1993, the appeals court held that the MSP statute ``does not require

health plans to provide continuation coverage to individuals who become

entitled to Medicare benefits because they have ESRD.'' Blue Cross and

Blue Shield of Texas v. Shalala, 995 F.2d 70, 74 (5th Cir. 1993). The

court held that the ESRD MSP provision did not modify, nor did it

preclude, acts specifically authorized under COBRA.

The issue raised in the Texas case with respect to ESRD was never

raised with respect to the MSP provisions for the aged and the

disabled. Under previous law the issue might have been raised with

respect to the disabled because the MSP provision for them did not

require (as it did for the aged) that GHP coverage be based on

``current employment''.

Under the OBRA '93 amendments, which were effective one month after

the appeals court decision, there is no issue for either group

because--

The MSP provisions for both the aged and the disabled

apply only when GHP coverage is ``by virtue of current employment

status''; and

COBRA continuation coverage is based on termination of

employment or on reduction of work hours to the point where the

individual no longer qualifies for coverage based on employment.

This final rule provides (in Sec. 411.161(a)(3)) that a GHP may

terminate COBRA continuation coverage if the individual becomes

entitled to Medicare on the basis of ESRD, notwithstanding the general

prohibition against taking into account eligibility for, or entitlement

to, Medicare benefits. Section 411.162(a)(3) makes clear that Medicare

is secondary when the plan is required by COBRA to keep the

continuation coverage in effect after Medicare entitlement or does so

voluntarily. (Changes to the regulation are discussed under part VIII-I

of this preamble.)

F. Miscellaneous Comments

Comment: One commenter asked that the final rules address the

situation in which the LGHP paid primary benefits for services provided

to an active individual and later learned that the LGHP was not primary

payer for the individual because, for example, the individual entitled

to Medicare on the basis of disability also has end-stage-renal

disease. In that case, the law provides that Medicare is primary payer.

The commenter believed that the final rule should provide for HCFA to

reimburse the LGHP directly in the same manner that an LGHP must pay

HCFA when it failed to make correct primary payments.

Response: Under current law, HCFA has an explicit right to recover

conditional primary payments from an LGHP. There is no equivalent

statutory provision for an LGHP seeking to recover its mistaken

payments. HCFA and its intermediaries and carriers do not have

authority to pay insurers and other third party payers. Sections

1815(c) and 1842(b)(6) of the Act, respectively, generally preclude

payment for provider services to anyone but the provider and preclude

payment for services of physicians and other suppliers to anyone other

than the supplier or the beneficiary. The limited exceptions allowed do

not include payment to LGHPs. Section 3491.15 of the Medicare

Intermediary Manual and section 3336.16 of the Medicare Carrier Manual

contain instructions for dealing with situations in which third party

payers have made mistaken primary payments. The person or entity that

receives HCFA's primary Medicare payment would make the refund to the

LGHP. If no Medicare claim was originally filed, the provider, supplier

or beneficiary may file one, within the time limits specified in

Secs. 424.44 and 424.45 of the regulations. We note that the situation

cited by the commenter

[[Page 45354]]

(Medicare is primary payer because the individual is entitled on the

basis of disability and also has ESRD) has a different outcome under

OBRA '93. For such a dually entitled beneficiary, Medicare is now

ordinarily secondary for the first 18 months of ESRD-based eligibility

or entitlement.

Comment: Two commenters expressed concern that the proposed rules

give HCFA the right to recover twice the amount payable by the LGHP as

primary payer if HCFA has made conditional primary payments and the

LGHP is later determined to have been the primary payer. One of the

commenters stated that the proposed rule did not take into account the

possibility that the disabled employee may have never filed a claim

with the LGHP and only with Medicare. The commenter suggested that

LGHP's be exempt from the double damages provision, since the LGHP

would be unaware of the existence of a claim for primary benefits.

Medicare should instruct beneficiaries to file claims first with the

LGHP.

Response: The MSP statute provides no authority for us to exempt

LGHPs from the double damages provision. However, we have the right to

recover double damages only if the LGHP refuses to make appropriate

reimbursement. Before instituting legal action to recover our

conditional payments, we make every attempt to inform the LGHP of its

obligations under the law and of the consequences of failure to comply.

We also provide ample time for the LGHP to reimburse the Medicare

payments.

We routinely remind beneficiaries and providers and suppliers to

file claims first with other insurance and then with Medicare. Medicare

intermediaries and carriers deny payment on claims when they have

reason to believe that there is another payer responsible for primary

payment and instruct the claimant to seek payment from that other

source before filing claims under Medicare. Since claims are often

filed by the provider or physician or other supplier, we also remind

them of their responsibility to determine whether their claims should

be filed with entities other than HCFA. In addition, we encourage GHPs

and other insurers who are obligated to pay primary to Medicare to

inform their Medicare-eligible participants that claims should first be

submitted to the responsible primary plan.

Comment: One commenter suggested that the employer or other entity

not be subject to double damages or to referral to the IRS as a

nonconforming GHP if--

The facts and circumstances show that any noncompliance

with the law or regulations was unintentional; or

The employer relied in good faith on third party

administrators, insurers, or other entities to administer or provide

health benefits.

Another commenter recommended that, until the final regulations

become effective, an employer or plan administrator be protected if he

or she acted on the basis of a reasonable good faith interpretation of

the statute.

Response: There is no provision in the law to extend protection to

employers or plan administrators, who act on the basis of a reasonable

good faith (albeit erroneous) interpretation of the law, if the GHP or

LGHP is found to be a nonconforming GHP. The individuals involved could

have sought advice directly from the Medicare contractors or from HCFA.

We have in place a comprehensive program to inform the public of its

obligations under the MSP provisions. Since the passage of the MSP

statute, we have made available to interested parties a variety of

informational materials to assist them in complying with this

provision. The Medicare intermediaries and carriers and the HCFA

regional offices are available to answer questions about the

responsibility of employers, insurers, and other entities subject to

the MSP provisions.

Comment: One commenter noted that Medicare currently makes

conditional payments when parties fail to respond to information

requests on disabled beneficiaries. The commenter supports continuation

of this policy.

Response: The basic rule, as set forth in Secs. 411.165, 411.175,

and 411.206, is that if a provider, supplier, beneficiary, or other

party fails to provide information necessary to process a claim, HCFA

may deny the claim. However, in order not to disadvantage a beneficiary

who may not be responsible for providing the needed information, HCFA

considers the specific circumstances of each failure to provide

information. Depending on those circumstances, HCFA has in the past

made, and may continue to make, conditional payments in some cases for

which information is not submitted in response to HCFA's request.

Comment: One commenter recommended that provision for an expedited

compliance procedure be added to proposed Secs. 411.92(a) and 411.94(g)

in order to reduce the administrative burden and expense of

enforcement. The commenter specifically mentioned the expedited

compliance procedure established in HCFA Program Memorandum AB-88-9

(August 1988). That procedure was designed for LGHPs that wish to

expedite payments to reimburse HCFA for Medicare conditional primary

payments.

Response: The expedited compliance procedure established by Program

Memorandum AB-88-9 was based specifically on the concept of ``active

individual''. Since OBRA '93 abolished this concept, the procedure is

obsolete. LGHPs that identify mistaken Medicare primary payments should

send their repayments to the Medicare contractor that made the mistaken

payment.

Comment: One commenter expressed concern that if an active

individual is covered as a dependent by his spouse's LGHP, and his

employer is not large enough for the employer's GHP to be considered an

LGHP and the employer does not participate in a multi-employer LGHP,

then the order of payment based on the MSP regulations would be the

spouse's LGHP as primary payer, Medicare second, and the health plan of

the disabled person's employer last. The commenter pointed out that the

proposed rule is not in accordance with the normal ``coordination of

benefits'' rules. Under those rules, if the disabled person is still

actively employed, his own health plan would be primary and the

spouse's health plan would be secondary. The commenter recommended that

the MSP rules determine only whether Medicare, or the plan covering the

disabled person as an employee, should be primary. In any event, the

plan covering the individual as a dependent should be secondary to

Medicare. Employers should not be penalized for extending health

coverage to dependents.

Response: Section 1862(b) of the Act, and the regulations, alter

State and private coordination of benefit rules so that GHPs and LGHPs

are made primary to Medicare under certain circumstances, regardless of

whether the individual is employed or is a dependent. When the health

plan of a family member is primary payer under the MSP law, that payer

must pay before Medicare even if the coordination of benefits rules

established under State law or private contract call for a different

order of payment. The Group Coordination of Benefits Model Regulation

adopted by the National Association of Insurance Commissioners (NAIC)

specifically recognizes that the usual order of payment for dependent

and nondependent coverage is reversed under the circumstances described

by the commenter. This means that, in the situation described above,

the spouse's LGHP pays first if the spouse has coverage by virtue of

current

[[Page 45355]]

employment status, Medicare second, and the disabled person's employer

plan last. However, when the disabled person's health plan coordinates

payment with the spouse's LGHP in the way described in the comment,

that is, where the disabled person's plan pays primary to the spouse's

LGHP, the combined payments of both plans constitute the primary

payment to which Medicare payment is secondary. (Further information

regarding the model regulation may be obtained by writing to the NAIC,

120 W. 12th St., Kansas City, MO 64105; phone (816) 842-3600.)

Comment: One commenter suggested that HCFA should apply the

nondiscrimination rules on a prospective basis after the date they are

adopted in final form and that HCFA should refrain from initiating any

nondiscrimination provision compliance requests until after adoption of

the final rules. Another commenter recommended that the final

regulations be made effective with plan years that begin at least six

months after the date of publication.

Response: HCFA does not have the authority to delay enforcement of

the nondiscrimination provisions. Section 9319 of OBRA '86, which

included the nondiscrimination provision, was effective for items and

services furnished on or after January 1, 1987. As indicated in the

general notice we published on September 24, 1987 (52 FR 35966), this

provision was self-implementing. It did not provide any waiver under

which we could delay the effective date.

We will enforce these provisions in accordance with our statutory

responsibility. If it is alleged that an LGHP took into account

Medicare entitlement on the basis of disability before the effective

date of this final rule, we will base our decision on the statute. This

final rule will be effective 30 days after publication in accordance

with the usual rulemaking procedures.

Comment: One commenter suggested that provisions be added to the

final regulation to ensure a formal review and appeals procedure before

HCFA takes any action adverse to an employer.

Response: Sections 411.120 through 411.126 of the new subpart E set

forth appeals procedures with respect to any GHP that HCFA has

determined to be nonconforming. These sections specify the parties and

explain the various steps in the appeals process and the rights of the

plans and of the employers and employee organizations that contribute

to the plans, including the following:

How to request a hearing (Sec. 411.120).

Provision for on-the-record review or oral hearing (at the

request of a party or on the hearing officer's own motion) and the

procedures that the hearing officer follows at an oral hearing with

respect to notice, prehearing discovery, evidence, subpoenas, etc., and

record of the hearing (Sec. 411.121).

Timing, content, distribution, and effect of the hearing

officer's decision (Sec. 411.122).

Administrator's review of the hearing decision, including

basis for decision to review, basis for remand, and finality of the

review or remand decision (Sec. 411.124).

Reopening of determinations or decisions (Sec. 411.126).

These procedures are very similar to those in effect for other

determinations that adversely affect providers or suppliers of Medicare

services. We believe that, by making them available before referral to

the IRS, we ensure due process.

Comment: One commenter encouraged HCFA to adopt a policy of

applying ``Alternative Dispute Resolution (ADR)'' techniques in MSP

cases before proceeding with litigation or referrals to the IRS. The

commenter contended that such techniques could lead to fairer and more

effective implementation of the MSP law than protracted and expensive

litigation.

Response: The commenter did not identify specifically the

techniques of dispute resolution to which he was referring. As

indicated above, this final rule provides appeal rights if HCFA

determines that a GHP is a nonconforming GHP.

VIII. Final Rule Provisions that Implement or Reflect Statutory

Amendments

A. Medicare Secondary to GHPs

Redesignated Secs. 411.162 and 411.172 and new Sec. 411.204 specify

that Medicare benefits are secondary to GHP benefits under specific

circumstances that vary depending on the basis for Medicare eligibility

or entitlement.

1. Under Sec. 411.172, aged individuals and spouses (entitled on

the basis of age), the MSP provision applies--

For plans of employers of at least 20 employees; and

For individuals covered ``by virtue of current employment

status''.

2. Under Sec. 411.204, individuals entitled on the basis of

disability, the MSP provision applies--

For plans of employers of at least 100 employees; and

For individuals covered ``by virtue of current employment

status''.

3. Under Sec. 411.162, individuals eligible or entitled on the

basis of ESRD, the MSP provision applies to employer plans, including

retirement plans, regardless of employer size and the individual's

employment status.

We note that OBRA '93 changed the coordination of benefits rules

for ESRD beneficiaries who are also entitled to Medicare on the basis

of age or disability. This change is discussed under section VIII-G of

this preamble.

B. Current Employment Status

New Sec. 411.104 explains the term and sets forth general and

special rules.

Under the general rule, an individual is considered to have current

employment status if he or she (1) is actively working or (2) is not

actively working but meets all of the following conditions:

Retains employment rights in the industry;

Has not had his or her employment terminated by the

employer, if the employer provides the coverage, or has not had his or

her membership in the employee organization terminated, if the employee

organization provides the coverage.

Is not receiving disability payments from an employer for

more than 6 months;

Is not receiving social security disability benefits; and

Has employment-based GHP coverage that is not COBRA

continuation coverage.

Examples of individuals who fall in the second group are teachers,

employees who are on furlough or sick leave, and active union members

between jobs. Also, self-employed persons are considered to have

current employment status only if their annual earnings related to the

employer that offers the GHP coverage equal at least the specified

statutory amount in section 211(b)(2) of the Act (currently that amount

is $400).

Members of a religious order who have taken a vow of poverty are

not considered to have current employment status if the services they

perform as members of the order are considered employment solely

because the order has elected (under section 3121(r) of the IRC) to

have those services considered as employment for social security

purposes.1

\1\ This exemption, enacted by OBRA '89 and effective October

1, 1989, was extended by OBRA '93 to cover services furnished before

October 1, 1989. Section 3121(r) of the IRC limits election to

orders that require their members to take a vow of poverty.

---------------------------------------------------------------------------

Members of religious orders who have not taken a vow of poverty are

considered to have current employment status with the religious order

if (1) the

[[Page 45356]]

religious order pays FICA taxes on behalf of that member, or (2) the

individual is receiving from the religious order cash remuneration for

services rendered.

Members of the clergy are considered to have current employment

status with a church or other religious organization if the individual

is receiving from the church or other religious organization cash

remuneration for services rendered.

Receipt of delayed compensation for work performed in

previous time periods does not confer ``current employment status'' on

an individual who is not working.

The new Sec. 411.104 is consistent with Congressional direction

regarding the manner in which coverage ``by virtue of current

employment status'' is to be construed.

The first time Congress used the term ``current employment'' with

respect to working aged individuals was in section 2338 of the Deficit

Reduction Act of 1984 (DEFRA), Pub. L. 98-369. DEFRA established in the

Act a new section 1837(i), which provided for a special Part B

enrollment period for individuals ``enrolled in a group health plan * *

* by reason of the individual's (or the individual's spouse's) current

employment * * * *'' Section 1837(i) expressly referred to individuals

who meet ``the conditions described in clauses (i) and (iii) of section

1862(b)(3)(A);'' that is, working aged individuals and their spouses.

In the legislative report that accompanied the DEFRA, the Congress

explained what it meant by the term ``by reason of current employment:

The use of the phrase ``by reason of current employment'' was

meant to distinguish those persons who are receiving health benefits

based on employment and are actually employed from those persons who

are receiving benefits based on employment, but who are now retired.

(Supplemental Report of the Committee on Ways and Means, U.S. House

of Representatives on H.R. 4170, Rept. 98-432 Part 2, March 5, 1984,

1662, emphasis added.)

This explanation encompassed individuals for whom Medicare was

secondary payer at that time under section 1862(b)(3)(A); that is,

individuals who were ``employed at the time (the) item or service is

furnished.''

By distinguishing in the DEFRA legislative report between ``persons

who are receiving health benefits based on employment'' and individuals

who are ``retired,'' the Congress demonstrated that it is not concerned

about fine distinctions regarding ``when'' employment-based coverage

was earned; that is, whether, for instance, present coverage of an

employed individual is based on a certain number of hours worked, or a

certain level of commissions earned, during the preceding months,

quarters, or years of employment. Rather, the Congress is only

interested in the broad distinction between plan coverage of

individuals who have coverage based on ``current employment'' and plan

coverage of those who are retired.

In OBRA '89, the Congress conformed the language of the secondary

payer provision to that of the special Part B enrollment provision for

working aged individuals. The phrase ``by reason of the current

employment of the individual (or the individual's spouse)'' replaced

the phrase ``employed at the time (the) item or service is furnished.''

By eliminating the provision that the individual actually be working

when the services were furnished, the Congress made clear its intent

that Medicare be secondary payer to employment based coverage in all

circumstances except retirement.

The OBRA '93 amendments that substituted ``by virtue of current

employment status'' for ``by reason of current employment,'' and

defined the term ``current employment status,'' reinforced

Congressional intent in this regard. OBRA '93 (section 13561(e)(1)(H))

added a new section 1862(b)(1)(E)(ii) to the Medicare law, which

expressly defines the term ``current employment status'':

(ii) CURRENT EMPLOYMENT STATUS DEFINED.--An individual has

``current employment status'' with an employer if the individual is an

employee, is the employer, or is associated with the employer in a

business relationship.

The inclusion of individuals ``associated with the employer in a

business relationship'' (that is, individuals whose relationship to the

employer is based on business rather than on work) demonstrates that

the Congress intended that the term ``current employment status'' be

given the broadest possible application. It encompasses not only

individuals who are actively working but also individuals under

contract with the employer whether or not they actually perform

services for the employer, such as attorneys on retainer, tradesmen and

insurance agents. Also, an independent insurance agent who is licensed

to sell insurance for a particular insurance company has ``current

employment status'' with that company by virtue of his ``business

relationship.'' If an agent age 65 or older has plan coverage through

that company based on this ``current employment status'', the coverage

is primary to Medicare (unless specific statutory exceptions apply,

such as the 20 employee rule) without regard to the extent to which the

agent is presently selling policies on behalf of the company. Only when

the agent retires (that is, no longer is authorized to sell policies on

behalf of the company) would the ``business relationship'' with the

employer be severed. However, Medicare would be the primary payer, if

the company imposes earnings thresholds or other requirements for

qualifying for health benefits that the agent does not meet based on

this ``current employment status''.

(As provided by OBRA '93, the ``current employment status''

criterion also applies to the disability MSP provision.)

C. Prohibition against Taking into Account Medicare Entitlement

This prohibition was imposed by OBRA '86 for the disabled, and

extended to ESRD and the aged by OBRA '89. On January 11, 1991, we

published a Federal Register notice explaining the import of these

self-executing provisions.

1. New Sec. 411.102 and redesignated Sec. 411.161 specify that a

GHP may not take into account an individual's ESRD-based Medicare

eligibility or entitlement during the 18-month coordination of benefits

period, which coincides with the first 18 months of eligibility or

entitlement.

2. New Sec. 411.102 and redesignated Sec. 411.170 specify that a

GHP of an employer of 20 or more employees may not take into account

age-based Medicare entitlement of an individual or spouse age 65 or

older who is covered (or seeks to be covered) under the plan by virtue

of the individual's current employment status with an employer.

3. New Secs. 411.102 and 411.200 specify that an LGHP (a plan that

includes at least one employer of 100 or more employees) may not take

into account the disability-based Medicare entitlement of an individual

who is covered (or seeks to be covered) under the plan by virtue of the

individual's or a family member's current employment status with an

employer.

D. Nondifferentiation in Providing Benefits

New Sec. 411.102 and redesignated Sec. 411.161 specify that, in

providing benefits to individuals with ESRD and those who do not have

ESRD, a GHP may not differentiate on the basis of the existence of

ESRD, or the need for dialysis, or in any other manner. These sections

further provide that plans may

[[Page 45357]]

pay benefits secondary to Medicare after the 18-month coordination of

benefits period.

E. Equal Benefits

New Sec. 411.102 and redesignated Sec. 411.170 specify that,

regardless of whether they are entitled to Medicare, individuals and

spouses age 65 or older, who are covered under the plan by virtue of

current employment status, are entitled to the same plan benefits,

under the same conditions, as individuals and spouses under 65. (These

limitations, imposed by OBRA '89, were also described in the January

1991 notice referred to above. OBRA '93 imposed the added requirement

of plan coverage based on current employment status.)

F. Definitions

In Sec. 411.101--

1. The definition of ``group health plan'' is revised to reflect

that plans of governmental employers are included within the meaning of

the term. This has always been so but was clarified by OBRA '93. The

definition also expressly clarifies that union plans and employee

health and welfare fund plans are included as employee organization

plans.

2. The definition of ``employer'' now includes self-employed

persons.

3. The definition of ``employee'' eliminates the ``indicator''

concept and references the special rules for the self-employed, for

members of religious orders, and for delayed compensation, already

noted under section VIII-B.

G. Coordination of Benefits: Dual Eligibility/Entitlement

New Sec. 411.163 implements the OBRA '93 amendments (sections

13561(c)(2) and (c)(3)) that established special rules for the 18-month

coordination of benefits period. These apply to beneficiaries who are

eligible for, or entitled to Medicare on the basis of ESRD, and are

also entitled on the basis of age or disability.

We consider the OBRA '93 changes to be self-implementing and

therefore effective August 10, 1993, the date of enactment. However, a

lawsuit was filed in United States District Court for the District of

Columbia on May 5, 1995 (National Medical Care, Inc. v. Shalala, Civil

Action No. 95-0860), challenging implementation of one aspect of these

provisions with respect to group health plan retirement coverage.

In what we describe below as the ``fourth rule,'' under OBRA '93,

Medicare remains the primary payer if a group health plan was already

secondary payer for an individual entitled on the basis of age or

disability when the individual becomes eligible on the basis of end-

stage renal disease. Section 411.163(b)(4) reflects this rule. At first

HCFA believed, in error, that OBRA '93 required a private plan to

become primary payer under these circumstances, but HCFA later

corrected its construction of the statute, and issued guidance on April

24, 1995, stating that Medicare remains the primary payer.

On June 6, 1995, the court issued a preliminary injunction order

precluding HCFA from implementing its corrected construction for items

and services furnished between August 10, 1993 and April 24, 1995,

pending the court's decision on the merits. HCFA will modify the rules,

if required, based on the final ruling by the court.

Before enactment of OBRA '93, the ESRD MSP provision applied only

when the individual was entitled solely on the basis of ESRD. For

example, if an individual, who retired at age 58 and was covered under

a retirement plan through the former employer, developed ESRD at age

60, the retirement plan was primary to Medicare during the first 18

months of ESRD-based eligibility or entitlement. However, if the

individual attained age 65 before the end of the 18-month period, the

ESRD MSP provision ceased to apply, and Medicare became the primary

payer because, upon attaining age 65, the individual became entitled

also on the basis of age and no longer met the ``solely'' requirement.

Similarly, the working aged and disability MSP provisions did not

apply to anyone who was eligible for or entitled to Medicare based on

ESRD. Therefore, those provisions ceased to apply, and Medicare became

the primary payer when an aged or disabled individual became eligible

for Medicare based on ESRD. The OBRA '93 amendments rectified these

situations. Section 13561(c)(2) provides that the ESRD MSP provision

applies in lieu of the working aged and disability MSP provisions when

an aged or disabled individual subject to those provisions becomes

eligible for Medicare based on ESRD. Thus, the plan must continue to

pay primary to Medicare throughout an 18-month ESRD MSP coordination

period. Section 13561(c)(3), which removed the word ``solely'' from the

ESRD MSP provision, provides that the ESRD MSP provision remains in

effect for the full 18-month period, even if an individual becomes

entitled to Medicare based on age or disability during that period. The

specific rules, which are set forth in Sec. 411.163 and referenced in

Sec. 411.172(g) (for the aged) and Sec. 411.204(b) (for the disabled),

are summarized below.

The first rule in Sec. 411.163, governed exclusively by previous

law, is that, if the 18-month period ended before August 1993, Medicare

is primary payer from the first month of dual eligibility/entitlement.

The second rule, for situations governed partly by previous law and

partly by the OBRA '93 amendment, is that if the first month of ESRD-

based eligibility or entitlement and the first month of dual

eligibility/entitlement both fall after February 1992 and before August

10, 1993, Medicare is--

Primary payer from the first month of dual eligibility/

entitlement through August 9, 1993;

Secondary payer from August 10, 1993 through the 18th

month of ESRD-based eligibility or entitlement; and

Primary payer again after the 18th month of ESRD-based

eligibility or entitlement.

The third rule, for situations governed exclusively by the OBRA '93

amendment, is that, if the first month of ESRD-based eligibility or

entitlement is after February 1992, and the first month of dual

eligibility or entitlement is after August 9, 1993, Medicare is--

Secondary during the first 18 months of ESRD-based

eligibility or entitlement; and

Primary after the 18th month of ESRD-based eligibility or

entitlement.

The fourth rule pertains to dual entitlement situations in which--

Age-based or disability-based entitlement precedes ESRD-

based eligibility; and

The GHP was not precluded from taking into account

Medicare entitlement based on age or disability (because the individual

was not covered under the plan ``by virtue of current employment

status'' or because the employer had fewer than 20 or 100 employees, in

the case of the aged and disabled, respectively) and was paying

benefits secondary to Medicare.

Medicare eligibility based on ESRD occurs automatically as of the

fourth calendar month of dialysis, and earlier under certain

circumstances, without regard to whether an individual is already

entitled to Medicare based on age or disability.

Under prior law, Medicare benefits were secondary to GHP benefits

for a period of 18 months for an individual eligible for or entitled to

Medicare based ``solely'' on ESRD. If that individual also became

entitled to Medicare based on age or disability during the 18-month

coordination period, Medicare became the primary payer because the ESRD

MSP provision did not apply; that is, plans were permitted to take into

account ESRD-based entitlement that

[[Page 45358]]

was not the sole basis of Medicare entitlement.

Also under prior law, Medicare benefits were secondary to plan

benefits for certain individuals entitled to Medicare based on age or

disability when their plan coverage was based on active employment

status, including the employment of a spouse in the case of aged

beneficiaries, or the employment of a family member in the case of

disabled beneficiaries. If the aged or disabled beneficiary

subsequently became eligible for Medicare based on ESRD, Medicare

became the primary payer because the working aged and disability MSP

provisions stipulated that they did not apply to anyone with ESRD-based

eligibility.

The OBRA '93 amendments rectify these situations. However, they do

not affect benefit coordination where Medicare is primary and a GHP

secondary for reasons wholly unrelated to ESRD. The ESRD MSP provision,

as amended by OBRA '93, expressly prohibits plans during the first 18

months of ESRD-based eligibility or entitlement from taking into

account Medicare eligibility or entitlement ``under section 226A'' of

the Social Security Act; that is, on the basis of ESRD. Thus, the plain

language of the statute permits a plan to pay secondary to Medicare for

reasons unrelated to ESRD.

In other words, if prior to the occurrence of ESRD-based

eligibility a plan was legitimately secondary to Medicare, the plan

clearly was not taking into account ESRD-based eligibility, because a

plan could not have taken into account eligibility that did not exist.

Merely continuing such authorized action, when an individual becomes

eligible based on ESRD, obviously does not take into account the later

eligibility or violate the MSP provisions. In sum, the subsequent

occurrence of ESRD-based eligibility, in and of itself, does not

establish that a GHP is taking that eligibility or entitlement into

account.

In contrast, a plan that is paying primary benefits takes into

account ESRD-based eligibility if it attempts to shift that primary

payment responsibility to Medicare when an individual becomes eligible

for Medicare based on ESRD, or when an individual is always eligible

for Medicare based on ESRD but has not completed of the 18-month

coordination period. (It goes without saying that cessation of plan

benefits for reasons that would apply to any plan enrollee, such as an

individual's failure to pay plan premiums, would not be construed as

taking into account ESRD-based eligibility.)

In arriving at this synergistic construction of the whole Medicare

statute we were mindful that nothing in the legislative history of OBRA

'93 indicates that Congress intended the dual entitlement amendments to

reverse the order of payment where plans already are permissibly paying

benefits secondary to Medicare at the time ESRD-based eligibility or

entitlement occurs. In addition, the court in Blue Cross Blue Shield of

Texas v. Shalala, 995 F.2d 70 (5th Cir. 1993), construed the ESRD MSP

provision as not modifying other provisions of law that authorize plan

actions. HCFA's construction is consistent with this court decision.

Read together, the OBRA '93 changes require GHPs that are already

paying primary to Medicare under the working aged or disability MSP

provisions to continue to pay primary to Medicare for a full 18-month

coordination period when an aged or disabled individual also becomes

eligible for or entitled to Medicare based on ESRD. Similarly, when an

individual's ESRD-based eligibility or entitlement is not preceded by

age or disability-based entitlement, the plan, including a retirement

plan, is obligated to pay primary to Medicare throughout the entire 18-

month coordination period.

With respect to retirement plans, the applicability of the ESRD MSP

provision has never been limited to plan coverage based on active

employment. The OBRA '93 amendments made no change in this regard.

Accordingly, when a retirement plan is a primary payer prior to the

occurrence of ESRD-based eligibility, the plan must pay primary to

Medicare during an 18-month coordination period, even if the individual

also becomes entitled to Medicare based on age or disability during

that period.

However, as we have stated, when a plan has already permissibly

taken into account age or disability-based Medicare entitlement, and

does nothing more, the plan is not taking into account subsequently

acquired ESRD-based eligibility. Therefore, Medicare remains primary

for an aged or disabled individual who subsequently acquired ESRD-based

eligibility when Medicare is paying primary because the individual is

not covered by virtue of current employment status, or an MSP exemption

applies, such as when an employer employs fewer than 20 or 100

employees (in the case of the aged and disabled, respectively).

Note: A suit was filed in United States District Court for the

District of Columbia on May 5, 1995 (National Medical Care, Inc. v.

Shalala, Civil Action No. 95-0860), challenging the application of

Sec. 411.63 with respect to group health plan retirement coverage.

Absent further action by Congress, the court will resolve the

matter. HCFA will publish a notice in the Federal Register regarding

the court's ruling, and will make changes to Sec. 411.63 if required

by the court.

New Sec. 411.163 replaces Sec. 411.62(e), Effect of changed basis

for Medicare entitlement, which was rendered obsolete by OBRA '93.

H. Basis for Primary Payments

New Sec. 411.206 specifies that with respect to the disabled,

Medicare is primary payer for services that are not covered under the

plan for the disabled or for similarly situated individuals or,

although covered under the plan, are not available to particular

disabled individuals because they have exhausted their benefits under

the plan. (Similar rules for ESRD and aged were already in effect.)

I. Interface With COBRA Continuation Coverage Provisions

As a result of the ``current employment status'' concept

established by OBRA '93 for the aged and the disabled and the court

rulings in the ESRD case discussed under parts VII-E and VIII-G of this

preamble--

1. New Sec. 411.161(a)(3) and redesignated Sec. 411.162(a)(3)

specify, respectively, that for ESRD beneficiaries--

A plan may terminate COBRA continuation coverage of an

enrollee who becomes entitled to Medicare if expressly permitted under

the COBRA provisions; and

Medicare benefits are secondary to COBRA continuation

benefits only when the plan--

+ Is required (under COBRA) to continue COBRA coverage after

Medicare entitlement (applicable to retirees who retired before the

employer effectively terminates regular plan coverage by filing for

bankruptcy); or

+ Continues coverage voluntarily even though not required to do so

under the COBRA provisions.

2. Redesignated Sec. 411.175 and new Sec. 411.206 specify that HCFA

makes Medicare primary payments for services furnished to aged

individuals and disabled individuals whose benefits are terminated

under the COBRA provisions that permit termination upon Medicare

entitlement and when benefits are maintained under the COBRA

provisions, notwithstanding an individual's Medicare entitlement. (An

individual who is eligible for COBRA

[[Page 45359]]

continuation coverage because his working hours have been reduced below

the minimum necessary to qualify for regular plan coverage has

``current employment status''. However, Medicare is the primary payer

because the plan coverage is not ``by virtue of'' that status.)

J. Aggregation Rules

New Sec. 411.106 sets forth the rules established by OBRA '93 for

determining the number and size of employers, as required by the ``at

least 20 employees'' provision for the aged and the ``at least 100

employees'' provision for the disabled.

These rules provide for--

Treating as a single employer all employers that are so

treated under section 53 of the IRC of 1986;

Treating as employed by a single employer all employees of

an affiliated service group, as defined in section 414(m) of the IRC;

and

Treating leased employees as employees of the person for

whom they perform services, to the extent provided in section 414(n) of

the IRC.

K. Prohibitions Against Incentives

New Sec. 411.103 reflects the provisions of OBRA' 90 (section

4203(g)) and the changes made by section 157(b)(7) (C) and (D) of the

SSAA '94 with respect to prohibition of incentives and imposition of

civil money penalties for violation. Amended section 1862(b)(3)(C)

provides that it is unlawful for an employer or other entity such as an

insurer to offer Medicare beneficiaries financial or other benefits as

incentives not to enroll in, or to terminate enrollment in, a GHP that

is, or would be, primary to Medicare, even if the payments or benefits

are offered to all other individuals who are eligible for coverage

under the plan. This prohibition precludes offering to Medicare

beneficiaries an alternative to the employer's primary plan (for

example, coverage of prescription drugs) unless the beneficiary has

primary coverage other than Medicare. An example would be primary plan

coverage through his own or a spouse's employer. An entity that

violates this prohibition is subject to a civil money penalty of up to

$5000 for each violation. Certain provisions of section 1128A of the

Act would apply to the civil money penalty.

L. Assessment of Interest

New paragraph (m) of Sec. 411.24 reflects the additional authority

to assess interest provided by SSA '94 and states the rules applicable

to interest charges. HCFA has long been authorized under common law and

Departmental regulations (45 CFR 30.13), consistent with the Federal

Claims Collection Act (31 U.S.C. 3711), to charge interest on amounts

that any responsible party does not timely refund to HCFA. The SSAA '94

(section 151(b)(3) revised the Medicare law to state specifically that

HCFA may charge interest if the responsible party does not refund HCFA

within 60 days of the date HCFA receives notice or other information

that reimbursement is owed to HCFA. Amended section 1862(b)(2)(B)(i)

provides that we may charge interest beginning with the date of that

notice or other information. The rate of interest provided in section

1862(b)(2)(B)(i) is the same as in sections 1815(d) and (1833), which

is reflected in regulations at 42 CFR 405.376(d). This is also the rate

that is charged when HCFA exercises its common law authority.

M. Plan Secondary Payments After 18-Month Coordination of Benefits

Period

Section 411.102(a)(2) reflects the change made by 151(c)(5) of the

Social Security Act Amendments of 1994 to limit what a plan may do

after the end of the coordination period.

IX. Technical Amendments

A. Nomenclature Changes

The following are in addition to those described in section VI of

this preamble:

1. To conform to the statutory language, ``employer plan'' and

``employer group health plan'' are changed to ``group health plan''.

2. To conform to the new rules that apply in dual eligibility/

entitlement situations, the word ``solely'' is removed from the phrase

``entitled solely on the basis of ESRD''.

B. Date and Duration Changes

Various dates cited in paragraphs (c) and (d) of redesignated

Sec. 411.162 have been revised to conform to the OBRA '93 amendment

that changed to October 1, 1998, the date on which the 18-month ESRD

coordination of benefits period is scheduled to revert to a 12-month

period.

X. Waiver of Proposed Rulemaking

We ordinarily publish a notice of proposed rulemaking in the

Federal Register and invite prior public comment on proposed rules. The

notice of proposed rulemaking includes a reference to the legal

authority under which the rule is proposed and the terms and substance

of the proposed rule or a description of the subjects and issues

involved. This procedure can be waived, however, if an agency finds

good cause that a notice-and-public comment procedure is impractible,

unnecessary, or contrary to the public interest and incorporates a

statement of the finding and its reasons in the rule issued.

The proposed rule of March 1990 dealt only with the provisions of

OBRA '86 which pertain to the disabled and to LGHPs that cover them.

Under that rule, certain nonworking disabled persons would have been

considered employees for Medicare secondary payer purposes. Most of the

public comments we received (discussed in section VII of this preamble)

objected to that policy.

Under the OBRA '93 amendments discussed in Section IV of this

preamble, the MSP provision for the disabled applies only to persons

whose health care coverage is based on their own current employment

status or the current employment status of a family member. Since the

law and the accompanying legislative history made clear that an

individual must have ``current employment status'' for purposes of the

MSP provisions, the proposed policy is not included in the final rule.

This final rule also implements the MSP provisions of OBRA '89. The

OBRA '89 amendments (discussed under section II-C)--

Prohibited GHPs from taking into account Medicare

entitlement of aged Medicare beneficiaries and the eligibility or

entitlement of beneficiaries with ESRD. (Previously, the prohibition

against taking into account Medicare entitlement applied only to

disabled individuals.)

Required GHPs of employers of 20 or more employees to

provide to employees and spouses age 65 or over the same benefits under

the same conditions as they provide to employees and spouses under age

65;

Prohibited GHPs from differentiating, in the benefits they

provide, between individuals with ESRD and other individuals covered

under the plan;

Exempted from the MSP provisions services which members of

a religious order who have taken a vow of poverty perform as members of

the order; and

Extended to all MSP situations the Federal Government's

rights to take legal action and recover double damages from any entity

that is required or responsible to pay primary benefits.

These OBRA '89 amendments were self-implementing and as such were

reflected in a notice published on January 11, 1991 (at 56 FR 1200-

1202). The notice explained the new requirements and stated that they

could be put into effect without issuing regulations because the

statutory amendments and the Congressional

[[Page 45360]]

intent were clear. Most of the changes were applicable to services

furnished on or after December 20, 1989 and are, thus, already in

effect.

This final rule includes appeals procedures that were not in the

March 1990 proposal for appealing determinations of nonconformance.

These provisions, which have been added as a result of comments on the

proposed rule and apply to all three MSP situations, include the

following:

The rules under which HCFA determines that a plan is not

in conformance.

The appeals procedures for plans found to be

nonconforming.

Referral to the IRS.

Rules for recovery of conditional or mistaken payments.

Although notice and comment on the portions of this rule that

reflect the self-implementing statutory changes are being waived, we

will consider timely comments from anyone who believes that in issuing

these regulations we have gone beyond what the statute requires or

permits. We also welcome comments on the appeals procedures.

Since the public has already had opportunity to comment on the OBRA

'86 amendments, the OBRA '89 amendments were self-executing and went

into effect several years ago, and the OBRA '90 and the OBRA '93

amendments and the Social Security Act Amendments of 1994 addressed in

these regulations are self-implementing and clear on their face as to

Congressional intent, we find that notice and opportunity for comment

(except as provided in the preceding paragraph) are unnecessary and

that there is good cause to waive notice of proposed rulemaking.

XI. Public Comments

Although this is a final rule, we will consider comments that we

receive by the date and time specified in the DATES section of this

preamble. Because of the large number of letters of comment that we

generally receive, we cannot respond to them individually. However, if

we revise these rules as a result of comments, we will discuss all

timely comments in the preamble to the revised rules.

XII. Paperwork Reduction Act

Sections 411.112 and 411.115 of this rule contain information

collection requirements that are subject to review by the Office of

Management and Budget under the Paperwork Reduction Act of 1980. Under

Sec. 411.112, HCFA may require a GHP to demonstrate that it has

complied with the MSP provisions and to submit documentation showing

that it has not taken into account that any of its enrollees is

entitled to Medicare on the basis of age or disability or eligible or

entitled on the basis of ESRD. The estimated burden is 10 hours per

response. Under Sec. 411.115, a plan that has been determined to be

nonconforming is required to provide to HCFA the names and addresses of

all employers and employee organizations that contributed to the plan

during the year for which it was nonconforming. Since this merely

requires copies of existing data, the time required is considered

negligible.

XIII. Regulatory Impact Statement

A. Executive Order 12866

These changes are already in place, and became effective on the

statutory dates indicated in the preamble of this rule. The

discretionary portions of this regulation will not affect these changes

by more than a few million dollars at the margin. Therefore, while the

statutory changes will have economic effects in excess of $100 million,

this final rule with comment period is not an economically significant

rule under E.O. 12866. In order for the public to understand the

magnitude of the statutory changes we have prepared the following

voluntary analysis of the effects of these changes on program costs.

1. Current Employment Status

Section 13561(e) of OBRA '93 deletes the concept of ``active

individual'' and applies the MSP disability provision only to

individuals who are covered under a large group health plan by reason

of their current employment status or that of a family member.

Since disabled persons generally are not working (and therefore do

not have current employment status), fewer individuals will be subject

to the MSP provisions and Medicare will be primary payer for more

disabled beneficiaries. We estimate that the Medicare program will have

the following costs as a result of this change.

Medicare Program Costs Resulting From No Longer Treating Certain

Disabled Persons As Employees

[In million of dollars]

Fiscal year:

1995.............................................................. 3

1996.............................................................. 3

1997.............................................................. 2

1998.............................................................. 1

1999.............................................................. 0

2. Dual Eligibility/Entitlement

Before enactment of OBRA '93, if an individual was eligible for or

entitled to Medicare on the basis of ESRD and was also entitled on the

basis of age or disability, Medicare was the primary payer. This is

because the ESRD MSP provision only applied with respect to individuals

who were eligible for or entitled to Medicare solely on the basis of

ESRD. However, section 13561(c) (2) and (3) of OBRA '93 provides that

there will be an 18-month coordination period during which employer

sponsored insurance plans must pay primary benefits even if an

individual who is eligible for or entitled to Medicare based on ESRD is

also entitled to Medicare on another basis.

We estimate that the following savings will accrue to the Medicare

program as a result of this change.

Medicare Program Savings Resulting From ESRD Dual Eligibility Provisions

[In millions of dollars]

Fiscal year:

1995......................................................... 71

1996......................................................... 83

1997......................................................... 97

1998......................................................... 114

1999......................................................... 98

3. IRS Aggregation Rules

The MSP provisions for the working aged apply to employers with 20

or more employees. The MSP provisions for the disabled apply to GHPs

contributed to by at least one employer with 100 or more employees.

Large employers have been able to avoid having the MSP rules apply to

them by simply organizing themselves into small firms. Section 13561(d)

of OBRA '93 requires the use of IRS aggregation rules to determine

employer size for MSP purposes. Employers treated as single employers

under section 52 (a) or (b) of the IRC of 1986 are treated as single

employers for purposes of MSP. All employees of the members of an

affiliated service group are treated as employed by a single employer.

Leased employees (as defined in section 414(m) of the IRC) are treated

as employees of the person for whom they perform services to the same

extent as they are treated under section 414(n) of the IRC.

We estimate that the following savings will accrue to the Medicare

program as a result of this change.

[[Page 45361]]

Medicare Program Savings Resulting From Use Of IRS Aggregation Rules To

Determine Firm Size

[in million of dollars]

Fiscal year:

1995......................................................... 80

1996......................................................... 100

1997......................................................... 115

1998......................................................... 125

1999......................................................... 80

In accordance with the provisions of Executive Order 12866, this

final rule with comment period was not reviewed by the Office of

Management and Budget.

B. Regulatory Flexibility Analysis

Consistent with the Regulatory Flexibility Act (RFA) and section

1102(b) of the Social Security Act, we prepare a regulatory flexibility

analysis for each rule, unless the Secretary certifies that the

particular rule will not have a significant economic impact on a

substantial number of small entities or a significant impact on the

operation of a substantial number of small rural hospitals.

The RFA defines ``small entity'' as a small business, a nonprofit

enterprise, or a governmental jurisdiction (such as a county, city, or

township) with a population of less than 50,000. We also consider all

providers and suppliers of services to be small entities. For purposes

of section 102(b) of the Act, we define small rural hospital as a

hospital that has fewer than 50 beds and is located anywhere but in a

metropolitan statistical area.

As noted earlier, this rule incorporates changes enacted by various

statutes that already are effective. Discretionary portions of the rule

are minimal and, of themselves, have no more than an incidental effect.

Therefore, we have not prepared a regulatory flexibility analysis

because we have determined, and we certify, that these rules will not

have a significant economic impact on a substantial number of small

entities or a significant impact on the operation of a substantial

number of small rural hospitals.

List of Subjects

42 CFR Part 400

Grant programs--health, Health facilities, Health maintenance

organizations (HMO), Medicaid, Medicare, Reporting and recordkeeping

requirements.

42 CFR Part 411

Exclusions from Medicare, Limitations on Medicare payments,

Medicare, Recovery against third parties. Reporting and recordkeeping

requirements.

42 CFR Chapter IV is amended as set forth below.

PART 400--INTRODUCTION; DEFINITIONS

A. The authority citation for part 400 continues to read as

follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42

U.S.C. 1302 and 1395hh) and 44 U.S.C. Chapter 35.

Sec. 400.310 [Amended]

B. In Sec. 400.310, in the table, ``411.65'' is revised to read

``411.165''.

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE

PAYMENT

A. The authority citation for part 411 is revised to read as

follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42

U.S.C. 1302 and 1395hh).

B. Subpart A is amended as set forth below.

Subpart A--General Exclusions and Exclusion of Particular Services

1. Section 411.1 is amended by adding the following sentence at the

end of paragraph (a):

Sec. 411.1 Basis and scope.

(a) Statutory basis. * * * Sections 1842(l) and 1879 of the Act

provide for refund to, or indemnification of, a beneficiary who has

paid a provider or supplier for certain services that the provider or

supplier knew were excluded from Medicare coverage.

* * * * *

C. Subpart B is amended as follows:

Subpart B--Insurance Coverage That Limits Medicare Payment: General

Provisions

1. Section 411.20 is revised to read as follows:

Sec. 411.20 Basis and scope.

(a) Statutory basis--(1) Section 1862(b)(2)(A)(i) of the Act

precludes Medicare payment for services to the extent that payment has

been made or can reasonably be expected to be made under a group health

plan with respect to--

(i) A beneficiary entitled to Medicare on the basis of ESRD during

the first 18 months of that entitlement;

(ii) A beneficiary who is age 65 or over, entitled to Medicare on

the basis of age, and covered under the plan by virtue of his or her

current employment status or the current employment status of a spouse

of any age; or

(iii) A beneficiary who is under age 65, entitled to Medicare on

the basis of disability, and covered under the plan by virtue of his or

her current employment status or the current employment status of a

family member.

(2) Section 1862(b)(2)(A)(ii) of the Act precludes Medicare payment

for services to the extent that payment has been made or can reasonably

be expected to be made promptly under any of the following:

(i) Workers' compensation.

(ii) Liability insurance.

(iii) No-fault insurance.

(b) Scope. This subpart sets forth general rules that apply to the

types of insurance specified in paragraph (a) of this section. Other

general rules that apply to group health plans are set forth in subpart

E of this part.

Sec. 411.21 [Amended]

2. In Sec. 411.21, the following changes are made:

(a) The introductory text is revised and a definition of ``monthly

capitation payment'' is added, to read as set forth below.

(b) In the definition of ``conditional payment'', ``for which

another insurer is primary payer'' is revised to read ``for which

another payer is responsible'', and ``subparts C through G'' is revised

to read ``subparts C through H''.

Sec. 411.21 Definitions.

In this subpart B and in subparts C through H of this part, unless

the context indicates otherwise--

* * * * *

Monthly capitation payment means a comprehensive monthly payment

that covers all physician services associated with the continuing

medical management of a maintenance dialysis patient who dialyses at

home or as an outpatient in an approved ESRD facility.

* * * * *

3. Section 411.24 is amended to revise paragraph (c) to read as

follows:

Sec. 411.24 Recovery of conditional payments.

* * * * *

(c) Amount of recovery--(1) If it is not necessary for HCFA to take

legal action to recover, HCFA recovers the lesser of the following:

(i) The amount of the Medicare primary payment.

(ii) The full primary payment amount that the primary payer is

obligated to pay under this part without regard to any payment, other

than a full primary payment that the primary payer has paid or will

make, or, in the case of a

[[Page 45362]]

third party payment recipient, the amount of the third party payment.

(2) If it is necessary for HCFA to take legal action to recover

from the primary payer, HCFA may recover twice the amount specified in

paragraph (c)(1)(i) of this section.

* * * * *

4. Section 411.24 is amended by adding a new paragraph (m) to read

as follows:

* * * * *

(m) Interest charges.(1) With respect to recovery of payments for

items and services furnished before October 31, 1994, HCFA charges

interest, exercising common law authority in accordance with 45 CFR

30.13, consistent with the Federal Claims Collection Act (31 U.S.C.

3711).

(2) In addition to its common law authority with respect to

recovery of payments for items and services furnished on or after

October 31, 1994, HCFA charges interest in accordance with section

1862(b)(2)(B)(i) of the Act. Under that provision--

(i) HCFA may charge interest if reimbursement is not made to the

appropriate trust fund before the expiration of the 60-day period that

begins on the date on which notice or other information is received by

HCFA that payment has been or could be made under a primary plan;

(ii) Interest may accrue from the date when that notice or other

information is received by HCFA and is charged until reimbursement is

made; and

(iii) The rate of interest is that provided at 42 CFR 405.376(d).

Sec. 411.33 [Amended]

5. In Sec. 411.33, the following changes are made:

a. The heading and introductory text of paragraph (a) are revised

to read as set forth below.

b. In paragraph (a)(1), ``(or the amount the supplier is obligated

to accept as payment in full if that is less than the charges)'' is

inserted immediately after ``the supplier''.

c. In paragraph (a)(3), ``Medicare fee schedule,'' is inserted

before ``Medicare reasonable charge'' and a comma is inserted after

``reasonable charge''.

d. In paragraph (b) introductory text and paragraph (b)(3),

``reasonable charge'' is revised to read ``fee schedule''.

e. Paragraphs (c) and (d) are removed and reserved.

f. In the heading of paragraph (e), ``fee schedule,'' is inserted

before ``reasonable charge'', and a comma is inserted after

``reasonable charge''.

Sec. Sec. 411.33 Amount of Medicare secondary payment.

(a) Services for which HCFA pays on a Medicare fee schedule or

reasonable charge basis. The Medicare secondary payment is the lowest

of the following:

* * * * *

(c) [Reserved]

(d) [Reserved]

* * * * *

D. Subparts E and F are redesignated as subparts F and G,

respectively, in accordance with the redesignation tables set forth

below, and throughout part 411, internal cross references are revised

to reflect these changes.

Old section (subpart E): New section

(subpart F)

411.60................................................. 411.160

411.62................................................. 411.162

411.65................................................. 411.165

Old section (subpart F): New section

(subpart G)

411.70................................................. 411.170

411.72................................................. 411.172

411.75................................................. 411.175

E. A new subpart E is added, to read as follows:

Subpart E--Limitations on Payment for Services Covered Under Group

Health Plans: General Provisions

Sec.

411.100 Basis and scope.

411.101 Definitions.

411.102 Basic prohibitions and requirements.

411.103 Prohibition against financial and other incentives.

411.104 Current employment status.

411.106 Aggregation rules.

411.108 Taking into account entitlement to Medicare.

411.110 Basis for determination of nonconformance.

411.112 Documentation of conformance.

411.114 Determination of nonconformance.

411.115 Notice of determination of nonconformance.

411.120 Appeals.

411.121 Hearing procedures.

411.122 Hearing officer's decision.

411.124 Administrator's review of hearing decision.

411.126 Reopening of determinations and decisions.

411.130 Referral to Internal Revenue Service (IRS).

Subpart E--Limitations on Payment for Services Covered Under Group

Health Plans: General Provisions

Sec. 411.100 Basis and scope.

(a) Statutory basis.--(1) Section 1862(b) of the Act provides in

part that Medicare is secondary payer, under specified conditions, for

services covered under any of the following:

(i) Group health plans of employers that employ at least 20

employees and that cover Medicare beneficiaries age 65 or older who are

covered under the plan by virtue of the individual's current employment

status with an employer or the current employment status of a spouse of

any age. (Section 1862(b)(1)(A))

(ii) Group health plans (without regard to the number of

individuals employed and irrespective of current employment status)

that cover individuals who have ESRD. Except as provided in

Sec. 411.163, group health plans are always primary payers throughout

the first 18 months of ESRD-based Medicare eligibility or entitlement.

(Section 1862(b)(1)(C))

(iii) Large group health plans (that is, plans of employers that

employ at least 100 employees) and that cover Medicare beneficiaries

who are under age 65, entitled to Medicare on the basis of disability,

and covered under the plan by virtue of the individual's or a family

member's current employment status with an employer. (Section

1862(b)(1)(B))

(2) Sections 1862(b)(1) (A), (B), and (C) of the Act provide that

group health plans and large group health plans may not take into

account that the individuals described in paragraph (a)(1) of this

section are entitled to Medicare on the basis of age or disability, or

eligible for, or entitled to Medicare on the basis of ESRD.

(3) Section 1862(b)(1)(A)(i)(II) of the Act provides that group

health plans of employers of 20 or more employees must provide to any

employee or spouse age 65 or older the same benefits, under the same

conditions, that it provides to employees and spouses under 65. The

requirement applies regardless of whether the individual or spouse 65

or older is entitled to Medicare.

(4) Section 1862(b)(1)(C)(ii) of the Act provides that group health

plans may not differentiate in the benefits they provide between

individuals who have ESRD and other individuals covered under the plan

on the basis of the existence of ESRD, the need for renal dialysis, or

in any other manner. Actions that constitute ``differentiating'' are

listed in Sec. 411.161(b).

(b) Scope. This subpart sets forth general rules pertinent to--

(1) Medicare payment for services that are covered under a group

health plan and are furnished to certain beneficiaries who are entitled

on the basis of ESRD, age, or disability.

(2) The prohibition against taking into account Medicare

entitlement based on age or disability, or Medicare eligibility or

entitlement based on ESRD.

(3) The prohibition against differentiation in benefits between

[[Page 45363]]

individuals who have ESRD and other individuals covered under the plan.

(4) The requirement to provide to those 65 or over the same

benefits under the same conditions as are provided to those under 65.

(5) The appeals procedures for group health plans that HCFA

determines are nonconforming plans.

Sec. 411.101 Definitions.

As used in this subpart and in subparts F through H of this part--

COBRA stands for Consolidated Omnibus Budget Reconciliation Act of

1985.

Days means calendar days.

Employee (subject to the special rules in Sec. 411.104) means an

individual who--

(1) Is working for an employer; or

(2) Is not working for an employer but is receiving payments that

are subject to FICA taxes, or would be subject to FICA taxes except

that the employer is exempt from those taxes under the Internal Revenue

Code.

Employer means, in addition to individuals (including self-employed

persons) and organizations engaged in a trade or business, other

entities exempt from income tax such as religious, charitable, and

educational institutions, the governments of the United States, the

individual States, Puerto Rico, the Virgin Islands, Guam, American

Samoa, the Northern Mariana Islands, and the District of Columbia, and

the agencies, instrumentalities, and political subdivisions of these

governments.

FICA stands for the Federal Insurance Contributions Act, the law

that imposes social security taxes on employers and employees under

section 21 of the Internal Revenue Code.

Group health plan (GHP) means any arrangement made by one or more

employers or employee organizations to provide health care directly or

through other methods such as insurance or reimbursement, to current or

former employees, the employer, others associated or formerly

associated with the employer in a business relationship, or their

families, that--

(1) Is of, or contributed to by, one or more employers or employee

organizations.

(2) If it involves more than one employer or employee organization,

provides for common administration.

(3) Provides substantially the same benefits or the same benefit

options to all those enrolled under the arrangement.

The term includes self-insured plans, plans of governmental

entities (Federal, State and local), and employee organization plans;

that is, union plans, employee health and welfare funds or other

employee organization plans. The term also includes employee-pay-all

plans, which are plans under the auspices of one or more employers or

employee organizations but which receive no financial contributions

from them. The term does not include a plan that is unavailable to

employees; for example, a plan only for self-employed persons.

IRC stands for Internal Revenue Code.

IRS stands for Internal Revenue Service.

Large group health plan (LGHP) means a GHP that covers employees of

either--

(1) A single employer or employee organization that employed at

least 100 full-time or part-time employees on 50 percent or more of its

regular business days during the previous calendar year; or

(2) Two or more employers, or employee organizations, at least one

of which employed at least 100 full-time or part-time employees on 50

percent or more of its regular business days during the previous

calendar year.

MSP stands for Medicare secondary payer.

Multi-employer plan means a plan that is sponsored jointly by two

or more employers (sometimes called a multiple-employer plan) or by

employers and unions (sometimes under the Taft-Hartley law).

Self-employed person encompasses consultants, owners of businesses,

and directors of corporations, and members of the clergy and religious

orders who are paid for their services by a religious body or other

entity.

Similarly situated individual means--

(1) In the case of employees, other employees enrolled or seeking

to enroll in the plan; and

(2) In the case of other categories of individuals, other persons

in any of those categories who are enrolled or seeking to enroll in the

plan.

Sec. 411.102 Basic prohibitions and requirements.

(a) ESRD--(1) A group health plan of any size--(i) May not take

into account the ESRD-based Medicare eligibility or entitlement of any

individual who is covered or seeks to be covered under the plan; and

(ii) May not differentiate in the benefits it provides between

individuals with ESRD and other individuals covered under the plan, on

the basis of the existence of ESRD, or the need for dialysis, or in any

other manner.

(2) The prohibitions of paragraph (a) of this section do not

prohibit a plan from paying benefits secondary to Medicare after the

first 18 months of ESRD-based eligibility or entitlement.

(b) Age. A GHP of an employer or employee organization of at least

20 employees--

(1) May not take into account the age-based Medicare entitlement of

an individual or spouse age 65 or older who is covered (or seeks to be

covered) under the plan by virtue of current employment status; and

(2) Must provide, to employees age 65 or older and to spouses age

65 or older of employees of any age, the same benefits under the same

conditions as it provides to employees and spouses under age 65.

(c) Disability. A GHP of an employer or employee organization of at

least 100 employees may not take into account the disability-based

Medicare entitlement of any individual who is covered (or seeks to be

covered) under the plan by virtue of current employment status.

Sec. 411.103 Prohibition against financial and other incentives.

(a) General rule. An employer or other entity (for example, an

insurer) is prohibited from offering Medicare beneficiaries financial

or other benefits as incentives not to enroll in, or to terminate

enrollment in, a GHP that is, or would be, primary to Medicare. This

prohibition precludes offering to Medicare beneficiaries an alternative

to the employer primary plan (for example, coverage of prescription

drugs) unless the beneficiary has primary coverage other than Medicare.

An example would be primary coverage through his own or a spouse's

employer.

(b) Penalty for violation.--(1) Any entity that violates the

prohibition of paragraph (a) of this section is subject to a civil

money penalty of up to $5,000 for each violation; and

(2) The provisions of section 1128A of the Act (other than

subsections (a) and (b)) apply to the civil money penalty of up to

$5,000 in the same manner as the provisions apply to a penalty or

proceeding under section 1128A(a).

Sec. 411.104 Current employment status.

(a) General rule. An individual has current employment status if--

(1) The individual is actively working as an employee, is the

employer (including a self-employed person), or is associated with the

employer in a business relationship; or

(2) The individual is not actively working and--

(i) Is receiving disability benefits from an employer for up to 6

months (the first 6 months of employer disability benefits are subject

to FICA taxes); or

[[Page 45364]]

(ii) Retains employment rights in the industry and has not had his

employment terminated by the employer, if the employer provides the

coverage (or has not had his membership in the employee organization

terminated, if the employee organization provides the coverage), is not

receiving disability benefits from an employer for more than 6 months,

is not receiving disability benefits from Social Security, and has GHP

coverage that is not pursuant to COBRA continuation coverage (26 U.S.C.

4980B; 29 U.S.C. 1161-1168; 42 U.S.C. 300bb-1 et seq.). Whether or not

the individual is receiving pay during the period of nonwork is not a

factor.

(b) Persons who retain employment rights. For purposes of paragraph

(a)(2) of this section, persons who retain employment rights include

but are not limited to--

(1) Persons who are furloughed, temporarily laid off, or who are on

sick leave;

(2) Teachers and seasonal workers who normally do not work

throughout the year; and

(3) Persons who have health coverage that extends beyond or between

active employment periods; for example, based on an hours bank

arrangement. (Active union members often have hours bank coverage.)

(c) Coverage by virtue of current employment status. An individual

has coverage by virtue of current employment status with an employer

if--

(1) the individual has GHP or LGHP coverage based on employment,

including coverage based on a certain number of hours worked for that

employer or a certain level of commissions earned from work for that

employer at any time; and

(2) the individual has current employment status with that

employer, as defined in paragraph (a) of this section.

(d) Special rule: Self-employed person. A self-employed individual

is considered to have GHP or LGHP coverage by virtue of current

employment status during a particular tax year only if, during the

preceding tax year, the individual's net earnings, from work in that

year related to the employer that offers the group health coverage, are

at least equal to the amount specified in section 211(b)(2) of the Act,

which defines ``self-employment income'' for social security purposes.

(e) Special Rule: members of religious orders and members of

clergy--(1) Members of religious orders who have not taken a vow of

poverty. A member of a religious order who has not taken a vow of

poverty is considered to have current employment status with the

religious order if--

(a) The religious order pays FICA taxes on behalf of that member;

or

(b) The individual is receiving cash remuneration from the

religious order.

(2) Members of religious orders who have taken a vow of poverty. A

member of a religious order whose members are required to take a vow of

poverty is not considered to be employed by the order if the services

he or she performs as a member of the order are considered employment

only because the order elects social security coverage under section

3121(r) of the IRC. This exemption applies retroactively to services

performed as a member of the order, beginning with the effective dates

of the MSP provisions for the aged and the disabled, respectively. The

exemption does not apply to services performed for employers outside of

the order.

(3) Members of the clergy. A member of the clergy is considered to

have current employment status with a church or other religious

organization if the individual is receiving cash remuneration from the

church or other religious organization for services rendered.

(f) Special rule: Delayed compensation subject to FICA taxes. An

individual who is not working is not considered an employee solely on

the basis of receiving delayed compensation payments for previous

periods of work even if those payments are subject to FICA taxes (or

would be subject to FICA taxes if the employer were not exempt from

paying those taxes). For example, an individual who is not working in

1993 and receives payments subject to FICA taxes for work performed in

1992 is not considered to be an employee in 1993 solely on the basis of

receiving those payments.

Sec. 411.106 Aggregation rules.

The following rules apply in determining the number and size of

employers, as required by the MSP provisions for the aged and disabled:

(a) All employers that are treated as a single employer under

subsection (a) or (b) of section 52 of the Internal Revenue Code (IRC)

of 1986 (26 U.S.C. 52 (a) and (b)) are treated as a single employer.

(b) All employees of the members of an affiliated service group (as

defined in section 414(m) of the IRC (26 U.S.C. 414m)) are treated as

employed by a single employer.

(c) Leased employees (as defined in section 414(n)(2) of the IRC

(26 U.S.C. 414(n)(2)) are treated as employees of the person for whom

they perform services to the same extent as they are treated under

section 414(n) of the IRC.

(d) In applying the IRC provisions identified in this section, HCFA

relies upon regulations and decisions of the Secretary of the Treasury

respecting those provisions.

Sec. 411.108 Taking into account entitlement to Medicare.

(a) Examples of actions that constitute ``taking into account''.

Actions by GHPs or LGHPs that constitute taking into account that an

individual is entitled to Medicare on the basis of ESRD, age, or

disability (or eligible on the basis of ESRD) include, but are not

limited to, the following:

(1) Failure to pay primary benefits as required by subparts F, G,

and H of this part 411.

(2) Offering coverage that is secondary to Medicare to individuals

entitled to Medicare.

(3) Terminating coverage because the individual has become entitled

to Medicare, except as permitted under COBRA continuation coverage

provisions (26 U.S.C. 4980B(f)(2)(B)(iv); 29 U.S.C. 1162.(2)(D); and 42

U.S.C. 300bb-2.(2)(D)).

(4) In the case of a LGHP, denying or terminating coverage because

an individual is entitled to Medicare on the basis of disability

without denying or terminating coverage for similarly situated

individuals who are not entitled to Medicare on the basis of

disability.

(5) Imposing limitations on benefits for a Medicare entitled

individual that do not apply to others enrolled in the plan, such as

providing less comprehensive health care coverage, excluding benefits,

reducing benefits, charging higher deductibles or coinsurance,

providing for lower annual or lifetime benefit limits, or more

restrictive pre-existing illness limitations.

(6) Charging a Medicare entitled individual higher premiums.

(7) Requiring a Medicare entitled individual to wait longer for

coverage to begin.

(8) Paying providers and suppliers no more than the Medicare

payment rate for services furnished to a Medicare beneficiary but

making payments at a higher rate for the same services to an enrollee

who is not entitled to Medicare.

(9) Providing misleading or incomplete information that would have

the effect of inducing a Medicare entitled individual to reject the

employer plan, thereby making Medicare the primary payer. An example of

this would be informing the

[[Page 45365]]

beneficiary of the right to accept or reject the employer plan but

failing to inform the individual that, if he or she rejects the plan,

the plan will not be permitted to provide or pay for secondary

benefits.

(10) Including in its health insurance cards, claims forms, or

brochures distributed to beneficiaries, providers, and suppliers,

instructions to bill Medicare first for services furnished to Medicare

beneficiaries without stipulating that such action may be taken only

when Medicare is the primary payer.

(11) Refusing to enroll an individual for whom Medicare would be

secondary payer, when enrollment is available to similarly situated

individuals for whom Medicare would not be secondary payer.

(b) Permissible actions--(1) If a GHP or LGHP makes benefit

distinctions among various categories of individuals (distinctions

unrelated to the fact that the individual is disabled, based, for

instance, on length of time employed, occupation, or marital status),

the GHP or LGHP may make the same distinctions among the same

categories of individuals entitled to Medicare whose plan coverage is

based on current employment status. For example, if a GHP or LGHP does

not offer coverage to employees who have worked less than one year and

who are not entitled to Medicare on the basis of disability or age, the

GHP or LGHP is not required to offer coverage to employees who have

worked less than one year and who are entitled to Medicare on the basis

of disability or age.

(2) A GHP or LGHP may pay benefits secondary to Medicare for an

aged or disabled beneficiary who has current employment status if the

plan coverage is COBRA continuation coverage because of reduced hours

of work. Medicare is primary payer for this beneficiary because,

although he or she has current employment status, the GHP coverage is

by virtue of the COBRA law rather than by virtue of the current

employment status.

(3) A GHP may terminate COBRA continuation coverage of an

individual who becomes entitled to Medicare on the basis of ESRD, when

permitted under the COBRA provisions.

Sec. 411.110 Basis for determination of nonconformance.

(a) A ``determination of nonconformance'' is a HCFA determination

that a GHP or LGHP is a nonconforming plan as provided in this section.

(b) HCFA makes a determination of nonconformance for a GHP or LGHP

that, at any time during a calendar year, fails to comply with any of

the following statutory provisions:

(1) The prohibition against taking into account that a beneficiary

who is covered or seeks to be covered under the plan is entitled to

Medicare on the basis of ESRD, age, or disability, or eligible on the

basis of ESRD.

(2) The nondifferentiation clause for individuals with ESRD.

(3) The equal benefits clause for the working aged.

(4) The obligation to refund conditional Medicare primary payments.

(c) HCFA may make a determination of nonconformance for a GHP or

LGHP that fails to respond to a request for information, or to provide

correct information, either voluntarily or in response to a HCFA

request, on the plan's primary payment obligation with respect to a

given beneficiary, if that failure contributes to either or both of the

following:

(1) Medicare erroneously making a primary payment.

(2) A delay or foreclosure of HCFA's ability to recover an

erroneous primary payment.

Sec. 411.112 Documentation of conformance.

(a) Acceptable documentation. HCFA may require a GHP or LGHP to

demonstrate that it has complied with the Medicare secondary payer

provisions and to submit supporting documentation by an official

authorized to act on behalf of the entity, under penalty of perjury.

The following are examples of documentation that may be acceptable:

(1) A copy of the employer's plan or policy that specifies the

services covered, conditions of coverage, benefit levels and

limitations with respect to persons entitled to Medicare on the basis

of ESRD, age, or disability as compared to the provisions applicable to

other enrollees and potential enrollees.

(2) An explanation of the plan's allegation that it does not owe

HCFA any amount HCFA claims the plan owes as repayment for conditional

or mistaken Medicare primary payments.

(b) Lack of acceptable documentation. If a GHP or LGHP fails to

provide acceptable evidence or documentation that it has complied with

the MSP prohibitions and requirements set forth in Sec. 411.110, HCFA

may make a determination of nonconformance for both the year in which

the services were furnished and the year in which the request for

information was made.

Sec. 411.114 Determination of nonconformance.

(a) Starting dates for determination of nonconformance. HCFA's

authority to determine nonconformance of GHPs begins on the following

dates:

(1) On January 1, 1987 for MSP provisions that affect the disabled.

(2) On December 20, 1989 for MSP provisions that affect ESRD

beneficiaries and the working aged.

(3) On August 10, 1993 for failure to refund mistaken Medicare

primary payments.

(b) Special rule for failure to repay. A GHP that fails to comply

with Sec. 411.110 (a)(1), (a)(2), or (a)(3) in a particular year is

nonconforming for that year. If, in a subsequent year, that plan fails

to repay the resulting mistaken primary payments (in accordance with

Sec. 411.110(a)(4)), the plan is also nonconforming for the subsequent

year. For example, if a plan paid secondary for the working aged in

1991, that plan was nonconforming for 1991. If in 1994 HCFA identifies

mistaken primary payments attributable to the 1991 violation, and the

plan refuses to repay, it is also nonconforming for 1994.

Sec. 411.115 Notice of determination of nonconformance.

(a) Notice to the GHP or LGHP--(1) If HCFA determines that a GHP or

an LGHP is nonconforming with respect to a particular calendar year,

HCFA mails to the plan written notice of the following:

(i) The determination.

(ii) The basis for the determination.

(iii) The right of the parties to request a hearing.

(iv) An explanation of the procedure for requesting a hearing.

(v) The tax that may be assessed by the IRS in accordance with

section 5000 of the IRC.

(vi) The fact that if none of the parties requests a hearing within

65 days from the date of its notice, the determination is binding on

all parties unless it is reopened in accordance with Sec. 411.126.

(2) The notice also states that the plan must, within 30 days from

the date on its notice, submit to HCFA the names and addresses of all

employers and employee organizations that contributed to the plan

during the calendar year for which HCFA has determined nonconformance.

(b) Notice to contributing employers and employee organizations.

HCFA mails written notice of the determination, including all the

information specified in paragraph (a)(1) of this section, to all

contributing employers and employee organizations already known to HCFA

or identified by

[[Page 45366]]

the plan in accordance with paragraph (a)(2) of this section. Employers

and employee organizations have 65 days from the date of their notice

to request a hearing.

Sec. 411.120 Appeals.

(a) Parties to the determination. The parties to the determination

are HCFA, the GHP or LGHP for which HCFA determined nonconformance, and

any employers or employee organizations that contributed to the plan

during the calendar year for which HCFA determined nonconformance.

(b) Request for hearing.--(1) A party's request for hearing must be

in writing (not in facsimile or other electronic medium) and in the

manner stipulated in the notice of nonconformance; it must be filed

within 65 days from the date on the notice.

(2) The request may include rationale showing why the parties

believe that HCFA's determination is incorrect and supporting

documentation.

(3) A request is considered filed on the date it is received by the

appropriate office, as shown by the receipt date stamped on the

request.

Sec. 411.121 Hearing procedures.

(a) Nature of hearing.--(1) If any of the parties requests a

hearing within 65 days from the date on the notice of the determination

of nonconformance, the HCFA Administrator appoints a hearing officer.

(2) If no party files a request within the 65-day period, the

initial determination of nonconformance is binding upon all parties

unless it is reopened in accordance with Sec. 411.126.

(3) If more than one party requests a hearing the hearing officer

conducts a single hearing in which all parties may participate.

(4) On the record review. Ordinarily, the hearing officer makes a

decision based upon review of the data and documents on which HCFA

based its determination of nonconformance and any other documentation

submitted by any of the parties within 65 days from the date on the

notice.

(5) Oral hearing. The hearing officer may provide for an oral

hearing either on his or her own motion or in response to a party's

request if the party demonstrates to the hearing officer's satisfaction

that an oral hearing is necessary. Within 30 days of receipt of the

request, the hearing officer gives all known parties written notice of

the request and whether the request for oral hearing is granted.

(b) Notice of time and place of oral hearing. If the hearing

officer provides an oral hearing, he or she gives all known parties

written notice of the time and place of the hearing at least 30 days

before the scheduled date.

(c) Prehearing discovery.--(1) The hearing officer may permit

prehearing discovery if it is requested by a party at least 10 days

before the scheduled date of the hearing.

(2) If the hearing officer approves the request, he or she--

(i) Provides a reasonable time for inspection and reproduction of

documents; and

(ii) In ruling on discovery matters, is guided by the Federal Rules

of Civil Procedure. (28 U.S.C.A. Rules 26-37)

(3) The hearing officer's orders on all discovery matters are

final.

(d) Conduct of hearing. The hearing officer determines the conduct

of the hearing, including the order in which the evidence and the

allegations are presented.

(e) Evidence at hearing.--(1) The hearing officer inquires into the

matters at issue and may receive from all parties documentary and other

evidence that is pertinent and material, including the testimony of

witnesses, and evidence that would be inadmissible in a court of law.

(2) Evidence may be received at any time before the conclusion of

the hearing.

(3) The hearing officer gives the parties opportunity for

submission and consideration of evidence and arguments and, in ruling

on the admissibility of evidence, excludes irrelevant, immaterial, or

unduly repetitious evidence.

(4) The hearing officer's ruling on admissibility of evidence is

final and not subject to further review.

(f) Subpoenas.--(1) The hearing officer may, either on his or her

own motion or upon the request of any party, issue subpoenas for either

or both of the following if they are reasonably necessary for full

presentation of the case:

(i) The attendance and testimony of witnesses.

(ii) The production of books, records, correspondence, papers, or

other documents that are relevant and material to any matter at issue.

(2) A party that wishes the issuance of a subpoena must, at least

10 days before the date fixed for the hearing, file with the hearing

officer a written request that identifies the witnesses or documents to

be produced and de

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