Coverage for Breast Reconstruction and Related Services After a Mastectomy

DEPARTMENT OF LABOR

Pension and Welfare Benefits Administration

29 CFR Chapter XXV

RIN 1210-AA75

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

45 CFR Subtitle A

RIN 0938-AJ44

Coverage for Breast Reconstruction and Related Services After a

Mastectomy

AGENCIES: Pension and Welfare Benefits Administration, Department of

Labor; and Health Care Financing Administration, Department of Health

and Human Services.

ACTION: Solicitation of comments.

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SUMMARY: This document is a request for information regarding issues

under the Women's Health and Cancer Rights Act of 1998 (WHCRA). The

Department of Labor and the Department of Health and Human Services

(collectively, the Departments) have received numerous inquiries from

the public on a number of issues arising under WHCRA. Further comments

from the public are welcome.

DATES: Comments should be submitted on or before June 28, 1999.

ADDRESSES: Written comments should be submitted with a signed original

and 2 copies to the Pension and Welfare Benefits Administration (PWBA)

at the address specified below. PWBA will provide copies to the

Department of Health and Human Services for its consideration. All

comments will be available for public inspection and copying in their

entirety. Comments should be sent to: Health Care Task Force, Pension

and Welfare Benefits Administration, Room N-5677, U.S. Department of

Labor, 200 Constitution Avenue, NW, Washington, DC 20210, Attn: WHCRA

Solicitation of Comments. Written comments may also be sent by Internet

to the following address: [email protected].

All comments received will be available for public inspection and

copying at the Public Disclosure Room, Pension and Welfare Benefits

Administration, U.S. Department of Labor, Room N-5638, 200 Constitution

Avenue, NW, Washington, DC 20210, on Monday through Friday of each week

from 8:30 a.m. to 4:30 p.m. Comments received timely will also be

available for public inspection approximately 3 weeks after the end of

the comment period, in Room 443-G of the Department of Health and Human

Services 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 FURTHER INFORMATION CONTACT: Mila Kofman, Department of Labor,

Pension and Welfare Benefits Administration, at 202-219-8671 (not a

toll-free number); or Suzanne Long, Health Care Financing

Administration, at 410-786-1565 (not a toll-free number) for inquiries

regarding WHCRA.

Customer service information. To assist consumers and the regulated

community, the Departments have issued questions and answers concerning

the Women's Health and Cancer Rights Act. Individuals interested in

obtaining a copy of the Department of Labor's publication may call a

toll free number, 800-998-7542, or access the publication on-line at

www.dol.gov/dol/pwba, the Department of Labor's website. Questions and

answers pertaining to WHCRA are also available on-line at www.hcfa.gov/

hipaa, HCFA's website.

SUPPLEMENTARY INFORMATION:

Background

The Women's Health and Cancer Rights Act of 1998 (WHCRA) was

enacted on October 21, 1998 (Pub. L. 105-277). WHCRA amended the

Employee Retirement Income Security Act of 1974, as amended, (ERISA)

and the Public Health Service Act (PHS Act) to provide protection for

patients who elect breast reconstruction in connection with a

mastectomy. WHCRA applies to both employment-based health coverage

(group coverage) and individual (non-employment based) health

insurance. WHCRA amended ERISA and the PHS Act by adding new

requirements to Part 7 of Subtitle B of Title I of ERISA and to Title

XXVII of the PHS Act. Part 7 and Title XXVII (health insurance reform

provisions) were previously added to ERISA and the PHS Act by the

Health Insurance Portability and Accountability Act of 1996 (HIPAA).

While those HIPAA provisions amended the Internal Revenue Code (Code)

as well, WHCRA did not amend the Code.

WHCRA is intended to provide new protections for mastectomy

patients. Group health plans and health insurance issuers, e.g.,

insurance companies or health maintenance organizations

(HMOs),1 offering medical and surgical benefits for a

mastectomy are subject to WHCRA.

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\1\ WHCRA was added to the existing health insurance reform

provisions in Part 7 of Title I of ERISA and Title XXVII of the PHS

Act and is subject to the definitions in Part 7 and Title XXVII. The

term group health plan is defined in 29 CFR 2590.701-2 (1997) and 45

CFR 144.103 (1997) (``* * * an employee welfare benefit plan * * *

to the extent that the plan provides medical care * * * to employees

or their dependents * * * directly or through insurance,

reimbursement, or otherwise.''). The term health insurance issuer is

defined in 29 CFR 2590.701-2 (1997) and 45 CFR 144.103 (1997) (``* *

* an insurance company, insurance service, or insurance organization

(including an HMO) that is required to be licensed to engage in the

business of insurance in a State and that is subject to State law

that regulates insurance * * *''). These terms also apply to the

Newborns' and Mothers' Health Protection Act and the Mental Health

Parity Act and the regulations implementing these laws.

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Under WHCRA, group health plans and health insurance issuers must

provide coverage for reconstructive surgery if an individual who is

receiving benefits in connection with a mastectomy elects breast

reconstruction. WHCRA requires group health plans and health insurance

issuers to provide coverage for--

Reconstruction of the breast on which the mastectomy has

been performed;

Surgery and reconstruction of the other breast to produce

a symmetrical appearance; and

Prostheses and physical complications at all stages of a

mastectomy, including lymphedemas.

WHCRA requires coverage to be provided in a manner determined in

consultation with the attending physician and the patient.

WHCRA's requirements apply only to group health plans and health

insurance issuers that provide coverage for a mastectomy. However,

WHCRA does not require such entities to provide coverage for a

mastectomy. WHCRA also does not prohibit group health plans and health

insurance issuers from imposing deductibles or coinsurance requirements

for health benefits relating to reconstructive surgery in connection

with a mastectomy as long as such requirements are consistent with

those established for other benefits under the plan or coverage.

Additionally, WHCRA does not require mastectomy patients to undergo

reconstructive surgery.

WHCRA also prohibits certain compensation arrangements.

Specifically, WHCRA prohibits group health plans and health insurance

issuers from providing incentives (monetary or otherwise) to an

attending provider to induce such provider to provide care to an

individual in a manner inconsistent with the law.

[[Page 29187]]

WHCRA also prohibits group health plans and health insurance issuers

from penalizing or otherwise reducing or limiting the reimbursement of

an attending provider because such provider provided care to an

individual in accordance with the law. Additionally, WHCRA prohibits

group health plans and health insurance issuers from denying a patient

eligibility or continued eligibility to enroll or renew coverage under

the terms of the plan or policy solely to avoid the requirements of

WHCRA. WHCRA further requires group health plans and health insurance

issuers to notify participants, and in the individual market,

policyholders, of their rights under the law upon enrollment and

annually thereafter.

The requirements under WHCRA apply to group health plans and health

insurance issuers offering coverage in connection with such plans, for

plan years beginning on or after October 21, 1998 (the date of

enactment of WHCRA). For health insurance issuers in the individual

market, the requirements apply with respect to health insurance

coverage offered, sold, issued, renewed, in effect, or operated in the

individual market on or after October 21, 1998. Accordingly, the

Departments are working actively to develop and promulgate regulations

implementing WHCRA.

Economic Analysis/Paperwork Reduction Act Information/Regulatory

Flexibility Act Information

Executive Order 12866 requires that the Departments assess the

costs and benefits of a significant rule making action and the

alternatives considered, using the guidance provided by the Office of

Management and Budget. These costs and benefits are not limited to the

Federal government, but pertain to the affected public as a whole.

Under Executive Order 12866, the Departments must also determine

whether implementation of WHCRA will be economically significant. A

rule that has an annual effect on the economy of $100 million or more

is considered economically significant.

In addition, the Regulatory Flexibility Act may require the

Departments to prepare an analysis of the economic impact on small

entities of proposed rules and regulatory alternatives. An analysis

under the Regulatory Flexibility Act must generally include, among

other things, an estimate of the number of small entities subject to

the regulations (for this purpose, plans, employers, and issuers and,

in some contexts small governmental entities), the expense of the

reporting and other compliance requirements (including the expense of

using professional expertise), and a description of any significant

regulatory alternatives considered that would accomplish the stated

objectives of the statute and minimize the impact on small entities.

The Departments seek additional information from small entities

regarding any special problems they might encounter in implementing the

requirements of WHCRA and any regulatory guidance that might minimize

those problems.

The Paperwork Reduction Act requires that the Departments estimate

how many ``respondents'' will be required to comply with any

``collection of information'' aspects of the regulations and how much

time and cost will be incurred as a result. A collection of information

includes record-keeping, reporting to governmental agencies, and third-

party disclosures.

The Departments are requesting comments that may contribute to the

analyses that will be performed under these requirements.

Comments

Comments have been received from the public on a number of issues

arising under WHCRA. These comments include questions about the notice

requirements under WHCRA. More specifically, the Departments have been

asked what information must be included in the annual notice and the

enrollment notice required by WHCRA. To assist the regulated community

and individuals, the Departments are considering whether to include in

the regulation a model notice which will describe the information that

must be included in these notices. The model notice would include

information on the benefits required by WHCRA and permitted deductibles

and coinsurance limitations. Comments are invited on whether a model

notice would be helpful.

In addition to the questions relating to the notice requirements,

the Departments have received questions regarding the timing of the

requirements under WHCRA. For example, the Departments have received

questions on whether, to what extent, and how WHCRA applies if an

individual had a mastectomy, but not breast reconstruction, before

changing health plans or coverage. Similarly, questions have been

raised about whether there is a specific time period following a

mastectomy after which WHCRA requirements no longer apply. Additional

comments are welcome.

The Departments have also received questions concerning how WHCRA

would interact with State law. Under WHCRA, State law protections

continue to apply to certain health coverage if the State law in effect

on October 21, 1998 (date of enactment of WHCRA) ``requires coverage of

at least the coverage of reconstructive breast surgery otherwise

required'' by the federal requirements under WHCRA. The Departments

have been asked which State laws would continue to apply. Additional

questions are invited, and in particular, the Departments are

interested in comments from State regulators on the scope of specific

State laws.

The Departments welcome any and all comments related to WHCRA.

However, the Departments are particularly interested in receiving

comments on the aforementioned questions and those related to the

following specific topics. While the information supplied by the public

related to these specific topics will be used to formulate overall

policy, it will also be used for analyses under Executive Order 12866,

Paperwork Reduction Act, and Regulatory Flexibility Act.

Specific areas with respect to the Departments' responsibilities

and analysis under Executive Order 12866, Paperwork Reduction Act, and

Regulatory Flexibility Act in which the Departments are interested

include:

1(a). Prior to WHCRA's enactment, what proportion of group health

plans and/or health insurance issuers had excluded, restricted, or

limited coverage of reconstructive surgery following mastectomies?

1(b). What specific exclusions, restrictions, or limits applied?

1(c). Did patient cost sharing for such surgery differ from that

for other covered benefits?

1(d). Did coverage for such surgeries vary depending on whether

they were performed immediately following mastectomies or later as a

separate procedure?

2. How did group health plans and health insurance issuers

covering such surgery compensate providers for their related services?

3. Were small group health plans more or less likely than large

group health plans to exclude, restrict, or limit coverage for such

surgery?

4(a). Among group health plans and health insurance issuers

covering such surgery at a level consistent with WHCRA, what was the

incidence and cost of such surgery?

4(b). Do group health plans and health insurance issuers currently

notify participants and beneficiaries of their coverage consistent with

WHCRA's notification requirements?

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5(a). Among group health plans and health insurance issuers that

must increase coverage of such surgery to comply with WHCRA, what are

the anticipated claims or premium cost associated with that increase?

5(b). What is the anticipated administrative cost to amend plan

documents and/or insurance contracts?

5(c). Will some group health plans and health insurance issuers

make other amendments to offset WHCRA's cost?

5(d). Will plans' costs and responses vary with plans' size?

6. Does the extent and nature of coverage for such surgery affect

the likelihood that patients will elect it and/or the timing of such

surgery?

7. What are the benefits of coverage for reconstructive surgery

following mastectomy?

The purpose of this announcement is to advise the public that

further comments and suggestions concerning any area or issue pertinent

to the assessment and development of regulatory guidance regarding

WHCRA are welcome.

All submitted comments will be made part of the official record and

will be available for public inspection.

Signed at Washington, DC this 17th day of March 1999.

Richard M. McGahey,

Assistant Secretary, Pension and Welfare Benefits Administration,

Department of Labor.

Signed at Washington, DC this 22nd day of March 1999.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing Administration, Department of

Health and Human Services.

[FR Doc. 99-13625 Filed 5-27-99; 8:45 am]

BILLING CODE 4510-29-P; 4120-01-P