Coverage for Breast Reconstruction and Related Services After a
Mastectomy; Proposed Rule [05/28/1999]
Volume 64, Number 103, Page 29185-29188[[Page 29185]]
_______________________________________________________________________
Part VI
Department of Labor
Pension and Welfare Benefits Administration
Department of Health and Human Services
Health Care Financing Administration
_______________________________________________________________________
29 CFR Chapter XXV
45 CFR Subtitle A
Coverage for Breast Reconstruction and Related Services After a
Mastectomy; Proposed Rule
[[Page 29186]]
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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: whcra-comments@pwba.dol.gov.
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),<SUP>1</SUP> 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--
<bullet> Reconstruction of the breast on which the mastectomy has
been performed;
<bullet> Surgery and reconstruction of the other breast to produce
a symmetrical appearance; and
<bullet> 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
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