Federal Register publishes rules on preventive health services

41726 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations

(b) The additive is used or intended DEPARTMENT OF THE TREASURY shared with the other Departments.
for use as a feed acidifying agent, to Please do not submit duplicates.
lower the pH, in complete swine feeds Internal Revenue Service All comments will be made available
at levels not to exceed 1.2 percent of the to the public. WARNING: Do not
complete feed. 26 CFR Part 54 include any personally identifiable
information (such as name, address, or
(c) To assure safe use of the additive, [TD 9493]
other contact information) or
in addition to the other information confidential business information that
RIN 1545–BJ60
required by the Federal Food, Drug, and you do not want publicly disclosed. All
Cosmetic Act (the act), the label and DEPARTMENT OF LABOR comments are posted on the Internet
labeling shall contain: exactly as received, and can be retrieved
(1) The name of the additive. Employee Benefits Security by most Internet search engines. No
(2) Adequate directions for use Administration deletions, modifications, or redactions
including a statement that ammonium will be made to the comments received,
29 CFR Part 2590 as they are public records. Comments
formate must be uniformly applied and
may be submitted anonymously.
thoroughly mixed into complete swine RIN 1210–AB44 Department of Labor. Comments to
feeds and that the complete swine feeds the Department of Labor, identified by
so treated shall be labeled as containing DEPARTMENT OF HEALTH AND
HUMAN SERVICES RIN 1210–AB44, by one of the following
ammonium formate. methods:
(d) To assure safe use of the additive, [OCIIO–9992–IFC] • Federal eRulemaking Portal: http://
in addition to the other information www.regulations.gov. Follow the
required by the act and paragraph (c) of 45 CFR Part 147 instructions for submitting comments.
this section, the label and labeling shall • E-mail: E-
RIN 0938–AQ07
contain: OHPSCA2713.EBSA@dol.gov.
Interim Final Rules for Group Health • Mail or Hand Delivery: Office of
(1) Appropriate warnings and safety Health Plan Standards and Compliance
precautions concerning ammonium Plans and Health Insurance Issuers
Relating to Coverage of Preventive Assistance, Employee Benefits Security
formate (37 percent ammonium salt of Administration, Room N–5653, U.S.
formic acid and 62 percent formic acid). Services Under the Patient Protection
and Affordable Care Act Department of Labor, 200 Constitution
(2) Statements identifying ammonium Avenue, NW., Washington, DC 20210,
formate in formic acid (37 percent AGENCIES: Internal Revenue Service, Attention: RIN 1210–AB44.
ammonium salt of formic acid and 62 Department of the Treasury; Employee Comments received by the
percent formic acid) as a corrosive and Benefits Security Administration, Department of Labor will be posted
possible severe irritant. Department of Labor; Office of without change to http://
Consumer Information and Insurance www.regulations.gov and http://
(3) Information about emergency aid Oversight, Department of Health and www.dol.gov/ebsa, and available for
in case of accidental exposure as Human Services. public inspection at the Public
follows: Disclosure Room, N–1513, Employee
ACTION: Interim final rules with request
(i) Statements reflecting requirements for comments. Benefits Security Administration, 200
of applicable sections of the Superfund Constitution Avenue, NW., Washington,
Amendments and Reauthorization Act SUMMARY: This document contains DC 20210.
(SARA), and the Occupational Safety interim final regulations implementing Department of Health and Human
and Health Administration’s (OSHA) the rules for group health plans and Services. In commenting, please refer to
human safety guidance regulations. health insurance coverage in the group file code OCIIO–9992–IFC. Because of
and individual markets under staff and resource limitations, we cannot
(ii) Contact address and telephone provisions of the Patient Protection and accept comments by facsimile (FAX)
number for reporting adverse reactions Affordable Care Act regarding transmission.
or to request a copy of the Material preventive health services. You may submit comments in one of
Safety Data Sheet (MSDS). four ways (please choose only one of the
DATES: Effective date. These interim
Dated: July 14, 2010. final regulations are effective on ways listed):
September 17, 2010. 1. Electronically. You may submit
Tracey H. Forfa,
Comment date. Comments are due on electronic comments on this regulation
Acting Director, Center for Veterinary to http://www.regulations.gov. Follow
Medicine. or before September 17, 2010.
Applicability dates. These interim the instructions under the ‘‘More Search
[FR Doc. 2010–17565 Filed 7–16–10; 8:45 am] Options’’ tab.
final regulations generally apply to
BILLING CODE 4160–01–S 2. By regular mail. You may mail
group health plans and group health
written comments to the following
insurance issuers for plan years
address ONLY: Office of Consumer
beginning on or after September 23,
Information and Insurance Oversight,
2010. These interim final regulations
Department of Health and Human
generally apply to individual health
Services, Attention: OCIIO–9992–IFC,
mstockstill on DSKH9S0YB1PROD with RULES

insurance issuers for policy years
P.O. Box 8016, Baltimore, MD 21244–
beginning on or after September 23,
1850.
2010.
Please allow sufficient time for mailed
ADDRESSES: Written comments may be comments to be received before the
submitted to any of the addresses close of the comment period.
specified below. Any comment that is 3. By express or overnight mail. You
submitted to any Department will be may send written comments to the

VerDate Mar<15>2010 15:50 Jul 16, 2010 Jkt 220001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:FRFM19JYR1.SGM 19JYR1

Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 41727

following address ONLY: Office of headquarters of the Centers for Medicare and add to the provisions of part A of
Consumer Information and Insurance & Medicaid Services, 7500 Security title XXVII of the Public Health Service
Oversight, Department of Health and Boulevard, Baltimore, Maryland 21244, Act (PHS Act) relating to group health
Human Services, Attention: OCIIO– Monday through Friday of each week plans and health insurance issuers in
9992–IFC, Mail Stop C4–26–05, 7500 from 8:30 a.m. to 4 p.m. EST. To the group and individual markets. The
Security Boulevard, Baltimore, MD schedule an appointment to view public term ‘‘group health plan’’ includes both
21244–1850. comments, phone 1–800–743–3951. insured and self-insured group health
4. By hand or courier. If you prefer, Internal Revenue Service. Comments plans.1 The Affordable Care Act adds
you may deliver (by hand or courier) to the IRS, identified by REG–120391– section 715(a)(1) to the Employee
your written comments before the close 10, by one of the following methods: Retirement Income Security Act (ERISA)
of the comment period to either of the • Federal eRulemaking Portal: http://
and section 9815(a)(1) to the Internal
following addresses: www.regulations.gov. Follow the
Revenue Code (the Code) to incorporate
a. For delivery in Washington, DC— instructions for submitting comments.
• Mail: CC:PA:LPD:PR (REG–120391– the provisions of part A of title XXVII
Office of Consumer Information and
Insurance Oversight, Department of 10), room 5205, Internal Revenue of the PHS Act into ERISA and the
Health and Human Services, Room 445– Service, P.O. Box 7604, Ben Franklin Code, and make them applicable to
G, Hubert H. Humphrey Building, 200 Station, Washington, DC 20044. group health plans, and health
Independence Avenue, SW., • Hand or courier delivery: Monday insurance issuers providing health
Washington, DC 20201. through Friday between the hours of 8 insurance coverage in connection with
(Because access to the interior of the Hubert a.m. and 4 p.m. to: CC:PA:LPD:PR group health plans. The PHS Act
H. Humphrey Building is not readily (REG–120391–10), Courier’s Desk, sections incorporated by this reference
available to persons without Federal Internal Revenue Service, 1111 are sections 2701 through 2728. PHS
government identification, commenters are Constitution Avenue, NW., Washington Act sections 2701 through 2719A are
encouraged to leave their comments in the DC 20224. substantially new, though they
OCIIO drop slots located in the main lobby All submissions to the IRS will be incorporate some provisions of prior
of the building. A stamp-in clock is available open to public inspection and copying
for persons wishing to retain a proof of filing law. PHS Act sections 2722 through
by stamping in and retaining an extra copy
in room 1621, 1111 Constitution 2728 are sections of prior law
of the comments being filed.) Avenue, NW., Washington, DC from 9 renumbered, with some, mostly minor,
a.m. to 4 p.m. changes.
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid FOR FURTHER INFORMATION CONTACT:
Subtitles A and C of title I of the
Services, Department of Health and Amy Turner or Beth Baum, Employee
Affordable Care Act amend the
Human Services, 7500 Security Benefits Security Administration,
requirements of title XXVII of the PHS
Boulevard, Baltimore, MD 21244–1850. Department of Labor, at (202) 693–8335;
Act (changes to which are incorporated
If you intend to deliver your Karen Levin, Internal Revenue Service,
Department of the Treasury, at (202) into ERISA section 715). The
comments to the Baltimore address, preemption provisions of ERISA section
please call (410) 786–7195 in advance to 622–6080; Jim Mayhew, Office of
Consumer Information and Insurance 731 and PHS Act section 2724 2
schedule your arrival with one of our (implemented in 29 CFR 2590.731(a)
staff members. Oversight, Department of Health and
Human Services, at (410) 786–1565. and 45 CFR 146.143(a)) apply so that the
Comments mailed to the addresses
Customer Service Information: requirements of part 7 of ERISA and
indicated as appropriate for hand or
Individuals interested in obtaining title XXVII of the PHS Act, as amended
courier delivery may be delayed and
received after the comment period. information from the Department of by the Affordable Care Act, are not to be
Submission of comments on Labor concerning employment-based ‘‘construed to supersede any provision
paperwork requirements. You may health coverage laws may call the EBSA of State law which establishes,
submit comments on this document’s Toll-Free Hotline at 1–866–444–EBSA implements, or continues in effect any
paperwork requirements by following (3272) or visit the Department of Labor’s standard or requirement solely relating
the instructions at the end of the Web site (http://www.dol.gov/ebsa). In to health insurance issuers in
‘‘Collection of Information addition, information from HHS on connection with group or individual
Requirements’’ section in this document. private health insurance for consumers health insurance coverage except to the
Inspection of Public Comments. All can be found on the Centers for extent that such standard or
comments received before the close of Medicare & Medicaid Services (CMS) requirement prevents the application of
the comment period are available for Web site (http://www.cms.hhs.gov/ a requirement’’ of the Affordable Care
viewing by the public, including any HealthInsReformforConsume/01_ Act. Accordingly, State laws that
personally identifiable or confidential Overview.as) and information on health impose on health insurance issuers
business information that is included in reform can be found at http:// requirements that are stricter than those
a comment. We post all comments www.healthreform.gov. imposed by the Affordable Care Act will
received before the close of the SUPPLEMENTARY INFORMATION: not be superseded by the Affordable
comment period on the following Web Care Act.
site as soon as possible after they have I. Background
been received: http:// The Patient Protection and Affordable 1 The term ‘‘group health plan’’ is used in title
www.regulations.gov. Follow the search Care Act (the Affordable Care Act), XXVII of the PHS Act, part 7 of ERISA, and chapter

instructions on that Web site to view Public Law 111–148, was enacted on 100 of the Code, and is distinct from the term
public comments. March 23, 2010; the Health Care and ‘‘health plan,’’ as used in other provisions of title I
Comments received timely will also Education Reconciliation Act (the of the Affordable Care Act. The term ‘‘health plan’’
does not include self-insured group health plans.
be available for public inspection as Reconciliation Act), Public Law 111– 2 Code section 9815 incorporates the preemption
they are received, generally beginning 152, was enacted on March 30, 2010. provisions of PHS Act section 2724. Prior to the
approximately three weeks after The Affordable Care Act and the Affordable Care Act, there were no express
publication of a document, at the Reconciliation Act reorganize, amend, preemption provisions in chapter 100 of the Code.



The Departments of Health and Force (Task Force) with respect to the not billed separately (or is not tracked
Human Services, Labor, and the individual involved.3 as individual encounter data separately)
Treasury (the Departments) are issuing • Immunizations for routine use in from an office visit and the primary
regulations in several phases children, adolescents, and adults that purpose of the office visit is the delivery
implementing the revised PHS Act have in effect a recommendation from of such an item or service, then a plan
sections 2701 through 2719A and the Advisory Committee on or issuer may not impose cost-sharing
related provisions of the Affordable Care Immunization Practices of the Centers requirements with respect to the office
Act. The first phase in this series was for Disease Control and Prevention visit. Finally, if a recommended
the publication of a Request for (Advisory Committee) with respect to preventive service is not billed
Information relating to the medical loss the individual involved. A separately (or is not tracked as
recommendation of the Advisory individual encounter data separately)
ratio provisions of PHS Act section
Committee is considered to be ‘‘in from an office visit and the primary
2718, published in the Federal Register
effect’’ after it has been adopted by the purpose of the office visit is not the
on April 14, 2010 (75 FR 19297). The Director of the Centers for Disease delivery of such an item or service, then
second phase was interim final Control and Prevention. A a plan or issuer may impose cost-
regulations implementing PHS Act recommendation is considered to be for sharing requirements with respect to the
section 2714 (requiring dependent routine use if it appears on the office visit. The reference to tracking
coverage of children to age 26), Immunization Schedules of the Centers individual encounter data was included
published in the Federal Register on for Disease Control and Prevention. to provide guidance with respect to
May 13, 2010 (75 FR 27122). The third • With respect to infants, children, plans and issuers that use capitation or
phase was interim final regulations and adolescents, evidence-informed similar payment arrangements that do
implementing section 1251 of the preventive care and screenings provided not bill individually for items and
Affordable Care Act (relating to status as for in the comprehensive guidelines services.
a grandfathered health plan), published supported by the Health Resources and Examples in these interim final
in the Federal Register on June 17, 2010 Services Administration (HRSA). regulations illustrate these provisions.
(75 FR 34538). The fourth phase was • With respect to women, evidence- In one example, an individual receives
interim final regulations implementing informed preventive care and screening a cholesterol screening test, a
PHS Act sections 2704 (prohibiting provided for in comprehensive recommended preventive service,
preexisting condition exclusions), 2711 guidelines supported by HRSA (not during a routine office visit. The plan or
(regarding lifetime and annual dollar otherwise addressed by the issuer may impose cost-sharing
limits on benefits), 2712 (regarding recommendations of the Task Force). requirements for the office visit because
restrictions on rescissions), and 2719A The Department of HHS is developing the recommended preventive service is
(regarding patient protections), these guidelines and expects to issue billed as a separate charge. A second
published in the Federal Register on them no later than August 1, 2011. example illustrates that treatment
June 28, 2010 (75 FR 37188). These The complete list of recommendations resulting from a preventive screening
and guidelines that are required to be can be subject to cost-sharing
interim final regulations are being
covered under these interim final requirements if the treatment is not
published to implement PHS Act
regulations can be found at http:// itself a recommended preventive
section 2713 (relating to coverage for
www.HealthCare.gov/center/ service. In another example, an
preventive services). PHS Act section regulations/prevention.html. Together,
2713 is generally effective for plan years individual receives a recommended
the items and services described in preventive service that is not billed as
(in the individual market, policy years) these recommendations and guidelines
beginning on or after September 23, a separate charge. In this example, the
are referred to in this preamble as primary purpose for the office visit is
2010, which is six months after the ‘‘recommended preventive services.’’ recurring abdominal pain and not the
March 23, 2010 date of enactment of the These interim final regulations clarify delivery of a recommended preventive
Affordable Care Act. The the cost-sharing requirements when a service; therefore the plan or issuer may
implementation of other provisions of recommended preventive service is impose cost-sharing requirements for
PHS Act sections 2701 through 2719A provided during an office visit. First, if the office visit. In the final example, an
will be addressed in future regulations. a recommended preventive service is individual receives a recommended
II. Overview of the Regulations: PHS billed separately (or is tracked as preventive service that is not billed as
Act Section 2713, Coverage of individual encounter data separately) a separate charge, and the delivery of
Preventive Health Services (26 CFR from an office visit, then a plan or issuer that service is the primary purpose of
may impose cost-sharing requirements the office visit. Therefore, the plan or
54.9815–2713T, 29 CFR 2590.715–2713,
with respect to the office visit. Second, issuer may not impose cost-sharing
45 CFR 147.130)
if a recommended preventive service is requirements for the office visit.
Section 2713 of the PHS Act, as added With respect to a plan or health
by the Affordable Care Act, and these
3 Under PHS Act section 2713(a)(5), the Task
insurance coverage that has a network of
Force recommendations regarding breast cancer providers, these interim final
interim final regulations require that a screening, mammography, and prevention issued in
group health plan and a health or around November of 2009 are not to be regulations make clear that a plan or
insurance issuer offering group or considered current recommendations on this issuer is not required to provide
individual health insurance coverage subject for purposes of any law. Thus, the coverage for recommended preventive
recommendations regarding breast cancer services delivered by an out-of-network
provide benefits for and prohibit the

screening, mammography, and prevention issued by
imposition of cost-sharing requirements the Task Force prior to those issued in or around provider. Such a plan or issuer may also
with respect to: November of 2009 (i.e., those issued in 2002) will impose cost-sharing requirements for
be considered current until new recommendations recommended preventive services
• Evidence-based items or services in this area are issued by the Task Force or appear delivered by an out-of-network
that have in effect a rating of A or B in in comprehensive guidelines supported by the
Health Resources and Services Administration provider.
the current recommendations of the concerning preventive care and screenings for These interim final regulations
United States Preventive Services Task women. provide that if a recommendation or



guideline for a recommended preventive individual market, policy years) site and plans and issuers need not
service does not specify the frequency, beginning on or after the later of make changes to coverage and cost-
method, treatment, or setting for the September 23, 2010, or one year after sharing requirements based on a new
provision of that service, the plan or the date the recommendation or recommendation or guideline until the
issuer can use reasonable medical guideline is issued. Thus, first plan year (in the individual market,
management techniques to determine recommendations and guidelines issued policy year) beginning on or after the
any coverage limitations. The use of prior to September 23, 2009 must be date that is one year after the new
reasonable medical management provided for plan years (in the recommendation or guideline went into
techniques allows plans and issuers to individual market, policy years) effect. Therefore, by visiting this site
adapt these recommendations and beginning on or after September 23, once per year, plans or issuers will have
guidelines to coverage of specific items 2010. For the purpose of these interim straightforward access to all the
and services where cost sharing must be final regulations, a recommendation or information necessary to determine any
waived. Thus, under these interim final guideline of the Task Force is additional items or services that must be
regulations, a plan or issuer may rely on considered to be issued on the last day covered without cost-sharing
established techniques and the relevant of the month on which the Task Force requirements, or to determine any items
evidence base to determine the publishes or otherwise releases the or services that are no longer required
frequency, method, treatment, or setting recommendation; a recommendation or to be covered.
for which a recommended preventive guideline of the Advisory Committee is The Affordable Care Act gives
service will be available without cost- considered to be issued on the date on authority to the Departments to develop
sharing requirements to the extent not which it is adopted by the Director of guidelines for group health plans and
specified in a recommendation or the Centers for Disease Control and health insurance issuers offering group
guideline. Prevention; and a recommendation or or individual health insurance coverage
The statute and these interim final guideline in the comprehensive to utilize value-based insurance designs
regulations clarify that a plan or issuer guidelines supported by HRSA is as part of their offering of preventive
continues to have the option to cover considered to be issued on the date on health services. Value-based insurance
preventive services in addition to those which it is accepted by the designs include the provision of
required to be covered by PHS Act Administrator of HRSA or, if applicable, information and incentives for
section 2713. For such additional adopted by the Secretary of HHS. For consumers that promote access to and
preventive services, a plan or issuer may recommendations and guidelines use of higher value providers,
impose cost-sharing requirements at its adopted after September 23, 2009, treatments, and services. The
discretion. Moreover, a plan or issuer information at http:// Departments recognize the important
may impose cost-sharing requirements www.HealthCare.gov/center/ role that value-based insurance design
for a treatment that is not a regulations/prevention.html will be can play in promoting the use of
recommended preventive service, even updated on an ongoing basis and will appropriate preventive services. These
if the treatment results from a include the date on which the interim final regulations, for example,
recommended preventive service. recommendation or guideline was permit plans and issuers to implement
The statute requires the Departments accepted or adopted. designs that seek to foster better quality
to establish an interval of not less than Finally, these interim final regulations and efficiency by allowing cost-sharing
one year between when make clear that a plan or issuer is not for recommended preventive services
recommendations or guidelines under required to provide coverage or waive delivered on an out-of-network basis
PHS Act section 2713(a) 4 are issued, cost-sharing requirements for any item while eliminating cost-sharing for
and the plan year (in the individual or service that has ceased to be a recommended preventive health
market, policy year) for which coverage recommended preventive service.5 services delivered on an in-network
of the services addressed in such Other requirements of Federal or State basis. The Departments are developing
recommendations or guidelines must be law may apply in connection with additional guidelines regarding the
in effect. These interim final regulations ceasing to provide coverage or changing utilization of value-based insurance
provide that such coverage must be cost-sharing requirements for any such designs by group health plans and
provided for plan years (in the item or service. For example, PHS Act health insurance issuers with respect to
section 2715(d)(4) requires a plan or preventive benefits. The Departments
4 Section 2713(b)(1) refers to an interval between
issuer to give 60 days advance notice to are seeking comments related to the
‘‘the date on which a recommendation described in an enrollee before any material
subsection (a)(1) or (a)(2) or a guideline under
development of such guidelines for
subsection (a)(3) is issued and the plan year with modification will become effective. value-based insurance designs that
respect to which the requirement described in Recommendations or guidelines in promote consumer choice of providers
subsection (a) is effective with respect to the service effect as of July 13, 2010 are described or services that offer the best value and
described in such recommendation or guideline.’’ in section V later in this preamble. Any
While the first part of this statement does not quality, while ensuring access to
mention guidelines under subsection (a)(4), it change to a recommendation or critical, evidence-based preventive
would make no sense to treat the services covered guideline that has—at any point since services.
under (a)(4) any differently than those in (a)(1), September 23, 2009—been included in The requirements to cover
(a)(2), and (a)(3). First, the same sentence refers to
‘‘the requirement described in subsection (a),’’
the recommended preventive services recommended preventive services
which would include a requirement under (a)(4). will be noted at http:// without any cost-sharing requirements
Secondly, the guidelines under (a)(4) are from the www.HealthCare.gov/center/ do not apply to grandfathered health
same source as those under (a)(3), except with regulations/prevention.html. As plans. See 26 CFR 54.9815–1251T, 29

respect to women rather than infants, children and
adolescents; and other preventive services
described above, new recommendations CFR 2590.715–1251, and 45 CFR
involving women are addressed in (a)(1), so there and guidelines will also be noted at this 147.140 (75 FR 34538, June 17, 2010).
is no plausible policy rationale for treating them
differently. Third, without this clarification, it 5 For example, if a recommendation of the United III. Interim Final Regulations and
would be unclear when such services would have States Preventive Services Task Force is Request for Comments
to be covered. These interim final regulations downgraded from a rating of A or B to a rating of
accordingly apply the intervals established therein C or D, or if a recommendation or guideline no Section 9833 of the Code, section 734
to services under section 2713(a)(4). longer includes a particular item or service. of ERISA, and section 2792 of the PHS



Act authorize the Secretaries of the regulations require significant lead time comment, but without delaying the
Treasury, Labor, and HHS (collectively, in order to implement. These interim effective date of the regulations.
the Secretaries) to promulgate any final regulations require plans and For the foregoing reasons, the
interim final rules that they determine issuers to provide coverage for Departments have determined that it is
are appropriate to carry out the preventive services listed in certain impracticable and contrary to the public
provisions of chapter 100 of the Code, recommendations and guidelines interest to engage in full notice and
part 7 of subtitle B of title I of ERISA, without imposing any cost-sharing comment rulemaking before putting
and part A of title XXVII of the PHS Act, requirements. Preparations presumably these interim final regulations into
which include PHS Act sections 2701 would have to be made to identify these effect, and that it is in the public interest
through 2728 and the incorporation of preventive services. With respect to the to promulgate interim final regulations.
those sections into ERISA section 715 changes that would be required to be IV. Economic Impact
and Code section 9815. made under these interim final
In addition, under Section 553(b) of regulations, group health plans and Under Executive Order 12866 (58 FR
the Administrative Procedure Act (APA) health insurance issuers subject to these 51735), a ‘‘significant’’ regulatory action
(5 U.S.C. 551 et seq.) a general notice of provisions have to be able to take these is subject to review by the Office of
proposed rulemaking is not required changes into account in establishing Management and Budget (OMB).
when an agency, for good cause, finds their premiums, and in making other Section 3(f) of the Executive Order
that notice and public comment thereon changes to the designs of plan or policy defines a ‘‘significant regulatory action’’
are impracticable, unnecessary, or benefits, and these premiums and plan as an action that is likely to result in a
contrary to the public interest. The or policy changes would have to receive rule (1) having an annual effect on the
provisions of the APA that ordinarily necessary approvals in advance of the economy of $100 million or more in any
require a notice of proposed rulemaking plan or policy year in question. one year, or adversely and materially
do not apply here because of the affecting a sector of the economy,
specific authority granted by section Accordingly, in order to allow plans productivity, competition, jobs, the
9833 of the Code, section 734 of ERISA, and health insurance coverage to be environment, public health or safety, or
and section 2792 of the PHS Act. designed and implemented on a timely State, local or tribal governments or
However, even if the APA were basis, regulations must be published communities (also referred to as
applicable, the Secretaries have and available to the public well in ‘‘economically significant’’); (2) creating
determined that it would be advance of the effective date of the a serious inconsistency or otherwise
impracticable and contrary to the public requirements of the Affordable Care Act. interfering with an action taken or
interest to delay putting the provisions It is not possible to have a full notice planned by another agency; (3)
in these interim final regulations in and comment process and to publish materially altering the budgetary
place until a full public notice and final regulations in the brief time impacts of entitlement grants, user fees,
comment process was completed. As between enactment of the Affordable or loan programs or the rights and
noted above, the preventive health Care Act and the date regulations are obligations of recipients thereof; or (4)
service provisions of the Affordable needed. raising novel legal or policy issues
Care Act are applicable for plan years The Secretaries further find that arising out of legal mandates, the
(in the individual market, policy years) issuance of proposed regulations would President’s priorities, or the principles
beginning on or after September 23, not be sufficient because the provisions set forth in the Executive Order. OMB
2010, six months after date of of the Affordable Care Act protect has determined that this regulation is
enactment. Had the Departments significant rights of plan participants economically significant within the
published a notice of proposed and beneficiaries and individuals meaning of section 3(f)(1) of the
rulemaking, provided for a 60-day covered by individual health insurance Executive Order, because it is likely to
comment period, and only then policies and it is essential that have an annual effect on the economy
prepared final regulations, which would participants, beneficiaries, insureds, of $100 million in any one year.
be subject to a 60-day delay in effective plan sponsors, and issuers have Accordingly, OMB has reviewed these
date, it is unlikely that it would have certainty about their rights and rules pursuant to the Executive Order.
been possible to have final regulations responsibilities. Proposed regulations The Departments provide an assessment
in effect before late September, when are not binding and cannot provide the of the potential costs, benefits, and
these requirements could be in effect for necessary certainty. By contrast, the transfers associated with these interim
some plans or policies. Moreover, the interim final regulations provide the final regulations, summarized in the
requirements in these interim final public with an opportunity for following table.

TABLE 1—ACCOUNTING TABLE (2011–2013)

Benefits:
Qualitative: By expanding coverage and eliminating cost sharing for the recommended preventive services, the Departments expect access and
utilization of these services to increase. To the extent that individuals increase their use of these services the Departments anticipate several
benefits: (1) prevention and reduction in transmission of illnesses as a result of immunization and screening of transmissible diseases; (2) de-
layed onset, earlier treatment, and reduction in morbidity and mortality as a result of early detection, screening, and counseling; (3) increased
productivity and fewer sick days; and (4) savings from lower health care costs. Another benefit of these interim final regulations will be to dis-
tribute the cost of preventive services more equitably across the broad insured population.

Costs:
Qualitative: New costs to the health care system result when beneficiaries increase their use of preventive services in response to the changes
in coverage and cost-sharing requirements of preventive services. The magnitude of this effect on utilization depends on the price elasticity of
demand and the percentage change in prices facing those with reduced cost sharing or newly gaining coverage.
Transfers:



TABLE 1—ACCOUNTING TABLE (2011–2013)—Continued
Qualitative: Transfers will occur to the extent that costs that were previously paid out-of-pocket for certain preventive services will now be cov-
ered by group health plans and issuers under these interim final regulations. Risk pooling in the group market will result in sharing expected
cost increases across an entire plan or employee group as higher average premiums for all enrollees. However, not all of those covered will
utilize preventive services to an equivalent extent. As a result, these interim final regulations create a small transfer from those paying pre-
miums in the group market utilizing less than the average volume of preventive services in their risk pool to those whose utilization is greater
than average. To the extent there is risk pooling in the individual market, a similar transfer will occur.

A. The Need for Federal Regulatory for and prohibit the imposition of cost- counseling related to aspirin use,
Action sharing requirements with respect to the tobacco cessation, and obesity.
As discussed later in this preamble, following preventive health services:
3. Estimated Number of Affected
there is current underutilization of • Evidence-based items or services
Entities
preventive services, which stems from that have in effect a rating of A or B in
three main factors. First, due to turnover the current recommendations of the For purposes of the new requirements
in the health insurance market, health United States Preventive Services Task in the Affordable Care Act that apply to
insurance issuers do not currently have Force (Task Force). While these group health plans and health insurance
incentives to cover preventive services, guidelines will change over time, for the issuers in the group and individual
whose benefits may only be realized in purposes of this impact analysis, the markets, the Departments have defined
the future when an individual may no Departments utilized currently available a large group health plan as an employer
longer be enrolled. Second, many guidelines, which include blood plan with 100 or more workers and a
preventive services generate benefits pressure and cholesterol screening, small group plan as an employer plan
that do not accrue immediately to the diabetes screening for hypertensive with less than 100 workers. The
individual that receives the services, patients, various cancer and sexually Departments estimated that there are
making the individual less likely to transmitted infection screenings, and approximately 72,000 large and 2.8
take-up, especially in the face of direct, counseling related to aspirin use, million small ERISA-covered group
immediate costs. Third, some of the tobacco cessation, obesity, and other health plans with an estimated 97.0
benefits of preventive services accrue to topics. million participants in large group plans
• Immunizations for routine use in and 40.9 million participants in small
society as a whole, and thus do not get
children, adolescents, and adults that group plans.6 The Departments estimate
factored into an individual’s decision-
have in effect a recommendation from that there are 126,000 governmental
making over whether to obtain such
the Advisory Committee on plans with 36.1 million participants in
services.
These interim final regulations Immunization Practices of the Centers large plans and 2.3 million participants
address these market failures through for Disease Control and Prevention in small plans.7 The Departments
two avenues. First, they require (Advisory Committee) with respect to estimate there are 16.7 million
coverage of recommended preventive the individual involved. individuals under age 65 covered by
• With respect to infants, children, individual health insurance policies.8
services by non-grandfathered group
and adolescents, evidence-informed As described in the Departments’
health plans and health insurance
preventive care and screenings provided interim final regulations relating to
issuers in the group and individual
for in the comprehensive guidelines status as a grandfathered health plan,9
markets, thereby overcoming plans’ lack
supported by the Health Resources and the Affordable Care Act preserves the
of incentive to invest in these services.
Services Administration (HRSA). ability of individuals to retain coverage
Second, they eliminate cost-sharing
• With respect to women, evidence-
requirements, thereby removing a under a group health plan or health
informed preventive care and screening
barrier that could otherwise lead an insurance coverage in which the
provided for in comprehensive
individual to not obtain such services, individual was enrolled on March 23,
guidelines supported by HRSA (not
given the long-term and partially 2010 (a grandfathered health plan).
otherwise addressed by the
external nature of benefits. Group health plans, and group and
recommendations of the Task Force).
These interim final regulations are individual health insurance coverage,
The Department of HHS is developing
necessary in order to provide rules that that are grandfathered health plans do
these guidelines and expects to issue
plan sponsors and issuers can use to not have to meet the requirements of
them no later than August 1, 2011.
determine how to provide coverage for these interim final regulations.
certain preventive health care services 2. Preventive Services Therefore, only plans and issuers
without the imposition of cost sharing For the purposes of this analysis, the offering group and individual health
in connection with these services. Departments used the relevant insurance coverage that are not
recommendations of the Task Force and grandfathered health plans will be
B. PHS Act Section 2713, Coverage of
Advisory Committee and current HRSA affected by these interim final
Preventive Health Services (26 CFR
guidelines as described in section V regulations.
54.9815–2713T, 29 CFR 2590.715–2713,
45 CFR 147.130) later in this preamble. In addition to
6 All participant counts and the estimates of
covering immunizations, these lists
1. Summary include such services as blood pressure
individual policies are from the U.S. Department of
Labor, EBSA calculations using the March 2008

As discussed earlier in this preamble, and cholesterol screening, diabetes Current Population Survey Annual Social and
PHS Act section 2713, as added by the screening for hypertensive patients, Economic Supplement and the 2008 Medical
Affordable Care Act, and these interim various cancer and sexually transmitted Expenditure Panel Survey.
7 Estimate is from the 2007 Census of
final regulations require a group health infection screenings, genetic testing for Government.
plan and a health insurance issuer the BRCA gene, adolescent depression 8 US Census Bureau, Current Population Survey,
offering group or individual health screening, lead testing, autism testing, March 2009.
insurance coverage to provide benefits and oral health screening and 9 75 FR 34538 (June 17, 2010).


Federal Register publishes rules on preventive health services

Federal Register publishes rules on preventive health services

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Federal Register publishes rules on preventive health services