Federal Register, Volume 76, Number 149, August 3, 2011, Pages 46595-47054

Federal Register/Vol. 76, No. 149 /Wednesday, August 3, 2011 /Rules and Regulations

* Immunizations for routine use in
children, adolescents, and adults that
have in effect a recommendation from
the Advisory Committee on
Immunization Practices of the Centers
for Disease Control and Prevention
(Advisory Committee) with respect to
the individual involved. A
recommendation of the Advisory
Committee is considered to be "in
effect" after it has been adopted by the
Director of the Centers for Disease
Control and Prevention. A
recommendation is considered to be for
routine use if it appears on the
Immunization Schedules of the Centers
for Disease Control and Prevention.
* With respect to infants, children,
and adolescents, evidence-informed
preventive care and screenings provided
for in the comprehensive guidelines
supported by the Health Resources and
Services Administration (HRSA).
* With respect to women, preventive
care and screening provided for in
comprehensive guidelines supported by
HRSA (not otherwise addressed by the
recommendations of the Task Force),
which will be commonly known as
HRSA's Women's Preventive Services:
Required Health Plan Coverage
Guidelines.
The requirements to cover
recommended preventive services
without any cost-sharing do not apply to
grandfathered health plans.4 The
Departments previously issued interim
final regulations implementing PHS Act
section 2713; these interim final rules
were published in the Federal Register
on July 19, 2010 (75 FR 41726). For the
reasons explained below, the
Departments are now issuing an
amendment to these interim final rules.
II. Overview of the Amendment to the
Interim Final Regulations
The interim final regulations provided
that a group health plan or health
insurance issuer must cover certain
items and services, without cost-
sharing, as recommended by the U.S.
Preventive Services Task Force, the
Advisory Committee on Immunization
Practices of the Centers for Disease
Control and Prevention, and the Health
Thus, the recommendations regarding breast cancer
screening, mammography, and prevention issued by
the Task Force prior to those issued in or around
November of 2009 (that is, those issued in 2002)
will be considered current until new
recommendations in this area are issued by the
Task Force or appear in comprehensive guidelines
supported by HRSA concerning preventive care and
screenings for women, which will be commonly
known as HRSA's Women's Preventive Services:
Required Health Plan Coverage Guidelines.
4 See 26 GFR 54.9815-1251T, 29 GFR 2590.715-

1251 and 45 CFR 147.140 (75 FR 34538, June 17,
2010).

Resources and Services Administration.
Notably, to the extent not described in
the U.S. Preventive Services Task Force
recommendations, HRSA was charged
with developing comprehensive
guidelines for preventive care and
screenings with respect to women (i.e.,
the Women's Preventive Services:
Required Health Plan Coverage
Guidelines or "HRSA Guidelines"). The
interim final regulations also require
that changes in the required items and
services be implemented no later than
plan years (in the individual market,
policy years) beginning on or after the
date that is one year from when the new
recommendation or guideline is issued.
In response to the request for
comments on the interim final
regulations, the Departments received
considerable feedback regarding which
preventive services for women should
be considered for coverage under PHS
Act section 2713(a)(4). Most
commenters, including some religious
organizations, recommended that HRSA
Guidelines include contraceptive
services for all women and that this
requirement be binding on all group
health plans and health insurance
issuers with no religious exemption.
However, several commenters asserted
that requiring group health plans
sponsored by religious employers to
cover contraceptive services that their
faith deems contrary to its religious
tenets would impinge upon their
religious freedom. One commenter
noted that some religious employers do
not currently cover such benefits under
their group health plan due to their
religious beliefs.
The Departments note that PHS Act
section 2713(a)(4) gives HRSA the
authority to develop comprehensive
guidelines for additional preventive care
and screenings for women "for purposes
of this paragraph." In other words, the
statute contemplated HRSA Guidelines
that would be developed with the
knowledge that certain group health
plans and health insurance issuers
would be required to cover the services
recommended without cost-sharing,
unlike the other guidelines referenced
in section 2713(a), which pre-dated the
Affordable Care Act and were originally
issued for purposes of identifying the
non-binding recommended care that
providers should provide to patients.
These HRSA Guidelines exist solely to
bind non-grandfathered group health
plans and health insurance issuers with
respect to the extent of their coverage of
certain preventive services for women.
In the Departments' view, it is
appropriate that HRSA, in issuing these
Guidelines, takes into account the effect

on the religious beliefs of certain

religious employers if coverage of
contraceptive services were required in
the group health plans in which
employees in certain religious positions
participate. Specifically, the
Departments seek to provide for a
religious accommodation that respects
the unique relationship between a house
of worship and its employees in
ministerial positions. Such an
accommodation would be consistent
with the policies of States that require
contraceptive services coverage, the
majority of which simultaneously
provide for a religious accommodation.
In light of the above, the Departments
are amending the interim final rules to
provide HRSA additional discretion to
exempt certain religious employers from
the Guidelines where contraceptive
services are concerned. The amendment
to the interim final rules provides HRSA
with the discretion to establish this
exemption. Consistent with most States
that have such exemptions, as described
below, the amended regulations specify
that, for purposes of this policy, a
religious employer is one that: (1) Has
the inculcation of religious values as its
purpose; (2) primarily employs persons
who share its religious tenets; (3)
primarily serves persons who share its
religious tenets; and (4) is a non-profit
organization under section 6033(a)(1)
and section 6033(a)(3)(A)(i) or (iii) of the
Code. Section 6033(a)(3)(A)(i) and (iii)
refer to churches, their integrated
auxiliaries, and conventions or
associations of churches, as well as to
the exclusively religious activities of
any religious order. The definition of
religious employer, as set forth in the
amended regulations, is based on
existing definitions used by most States
that exempt certain religious employers
from having to comply with State law
requirements to cover contraceptive
services. We will be accepting
comments on this definition as well as
alternative definitions, such as those
that have been developed under Title 26
of the United States Code. The
definition set forth here is intended to
reasonably balance the extension of any
coverage of contraceptive services under
the HRSA Guidelines to as many
women as possible, while respecting the
unique relationship between certain
religious employers and their employees
in certain religious positions. The
change in policy effected by this
amendment to these interim final rules
is intended solely for purposes of PHS
Act section 2713 and the companion
provisions of ERISA and the Internal
Revenue Code.
Because HRSA's discretion to
establish an exemption applies only to

group health plans sponsored by certain

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United States. Office of the Federal Register. Federal Register, Volume 76, Number 149, August 3, 2011, Pages 46595-47054. Washington D.C.. UNT Digital Library. http://digital.library.unt.edu/ark:/67531/metadc52326/. Accessed January 28, 2015.