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

(b) The additive is used or intended 

for use as a feed acidifying agent, to 

lower the pH, in complete swine feeds 

at levels not to exceed 1.2 percent of the 

complete feed. 

(c) To assure safe use of the additive, 

in addition to the other information 

required by the Federal Food, Drug, and 

Cosmetic Act (the act), the label and 

labeling shall contain: 

(1) The name of the additive. 

(2) Adequate directions for use 

including a statement that ammonium 

formate must be uniformly applied and 

thoroughly mixed into complete swine 

feeds and that the complete swine feeds 

so treated shall be labeled as containing 

ammonium formate. 

(d) To assure safe use of the additive, 

in addition to the other information 

required by the act and paragraph (c) of 

this section, the label and labeling shall 

contain: 

(1) Appropriate warnings and safety 

precautions concerning ammonium 

formate (37 percent ammonium salt of 

formic acid and 62 percent formic acid). 

(2) Statements identifying ammonium 

formate in formic acid (37 percent 

ammonium salt of formic acid and 62 

percent formic acid) as a corrosive and 

possible severe irritant. 

(3) Information about emergency aid 

in case of accidental exposure as 

follows: 

(i) Statements reflecting requirements 

of applicable sections of the Superfund 

Amendments and Reauthorization Act 

(SARA), and the Occupational Safety 

and Health Administration’s (OSHA) 

human safety guidance regulations. 

(ii) Contact address and telephone 

number for reporting adverse reactions 

or to request a copy of the Material 

Safety Data Sheet (MSDS). 

Dated: July 14, 2010. 

Tracey H. Forfa, 

Acting Director, Center for Veterinary 

Medicine. 

[FR Doc. 2010–17565 Filed 7–16–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

[TD 9493] 

RIN 1545–BJ60 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

RIN 1210–AB44 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[OCIIO–9992–IFC] 

45 CFR Part 147 

RIN 0938–AQ07 

Interim Final Rules for Group Health 

Plans and Health Insurance Issuers 

Relating to Coverage of Preventive 

Services Under the Patient Protection 

and Affordable Care Act 

AGENCIES: Internal Revenue Service, 

Department of the Treasury; Employee 

Benefits Security Administration, 

Department of Labor; Office of 

Consumer Information and Insurance 

Oversight, Department of Health and 

Human Services. 

ACTION: Interim final rules with request 

for comments. 

SUMMARY: This document contains 

interim final regulations implementing 

the rules for group health plans and 

health insurance coverage in the group 

and individual markets under 

provisions of the Patient Protection and 

Affordable Care Act regarding 

preventive health services. 

DATES: Effective date. These interim 

final regulations are effective on 

September 17, 2010. 

Comment date. Comments are due on 

or before September 17, 2010. 

Applicability dates. These interim 

final regulations generally apply to 

group health plans and group health 

insurance issuers for plan years 

beginning on or after September 23, 

2010. These interim final regulations 

generally apply to individual health 

insurance issuers for policy years 

beginning on or after September 23, 

2010. 

ADDRESSES: Written comments may be 

submitted to any of the addresses 

specified below. Any comment that is 

submitted to any Department will be 

shared with the other Departments. 

Please do not submit duplicates. 

All comments will be made available 

to the public. WARNING: Do not 

include any personally identifiable 

information (such as name, address, or 

other contact information) or 

confidential business information that 

you do not want publicly disclosed. All 

comments are posted on the Internet 

exactly as received, and can be retrieved 

by most Internet search engines. No 

deletions, modifications, or redactions 

will be made to the comments received, 

as they are public records. Comments 

may be submitted anonymously. 

Department of Labor. Comments to 

the Department of Labor, identified by 

RIN 1210–AB44, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: EOHPSCA2713.EBSA@dol.gov. 

• Mail or Hand Delivery: Office of 

Health Plan Standards and Compliance 

Assistance, Employee Benefits Security 

Administration, Room N–5653, U.S. 

Department of Labor, 200 Constitution 

Avenue, NW., Washington, DC 20210, 

Attention: RIN 1210–AB44. 

Comments received by the 

Department of Labor will be posted 

without change to http:// 

www.regulations.gov and http:// 

www.dol.gov/ebsa, and available for 

public inspection at the Public 

Disclosure Room, N–1513, Employee 

Benefits Security Administration, 200 

Constitution Avenue, NW., Washington, 

DC 20210. 

Department of Health and Human 

Services. In commenting, please refer to 

file code OCIIO–9992–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Office of Consumer 

Information and Insurance Oversight, 

Department of Health and Human 

Services, Attention: OCIIO–9992–IFC, 

P.O. Box 8016, Baltimore, MD 21244– 

1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

mstockstill on DSKH9S0YB1PROD with RULES

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

1The term ‘‘group health plan’’ is used in title 

XXVII of the PHS Act, part 7 of ERISA, and chapter 

100 of the Code, and is distinct from the term 

‘‘health plan,’’ as used in other provisions of title I 

of the Affordable Care Act. The term ‘‘health plan’’ 

does not include self-insured group health plans. 

2Code section 9815 incorporates the preemption 

provisions of PHS Act section 2724. Prior to the 

Affordable Care Act, there were no express 

preemption provisions in chapter 100 of the Code. 

following address ONLY: Office of 

Consumer Information and Insurance 

Oversight, Department of Health and 

Human Services, Attention: OCIIO– 

9992–IFC, Mail Stop C4–26–05, 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Office of Consumer Information and 

Insurance Oversight, Department of 

Health and Human Services, Room 445– 

G, Hubert H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the Hubert 

H. Humphrey Building is not readily 

available to persons without Federal 

government identification, commenters are 

encouraged to leave their comments in the 

OCIIO drop slots located in the main lobby 

of the building. A stamp-in clock is available 

for persons wishing to retain a proof of filing 

by stamping in and retaining an extra copy 

of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call (410) 786–7195 in advance to 

schedule your arrival with one of our 

staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by following 

the instructions at the end of the 

‘‘Collection of Information 

Requirements’’ section in this document. 

Inspection of Public Comments. All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately three weeks after 

publication of a document, at the 

headquarters of the Centers for Medicare 

& Medicaid Services, 7500 Security 

Boulevard, Baltimore, Maryland 21244, 

Monday through Friday of each week 

from 8:30 a.m. to 4 p.m. EST. To 

schedule an appointment to view public 

comments, phone 1–800–743–3951. 

Internal Revenue Service. Comments 

to the IRS, identified by REG–120391– 

10, by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: CC:PA:LPD:PR (REG–120391– 

10), room 5205, Internal Revenue 

Service, P.O. Box 7604, Ben Franklin 

Station, Washington, DC 20044. 

• Hand or courier delivery: Monday 

through Friday between the hours of 8 

a.m. and 4 p.m. to: CC:PA:LPD:PR 

(REG–120391–10), Courier’s Desk, 

Internal Revenue Service, 1111 

Constitution Avenue, NW., Washington 

DC 20224. 

All submissions to the IRS will be 

open to public inspection and copying 

in room 1621, 1111 Constitution 

Avenue, NW., Washington, DC from 9 

a.m. to 4 p.m. 

FOR FURTHER INFORMATION CONTACT: 

Amy Turner or Beth Baum, Employee 

Benefits Security Administration, 

Department of Labor, at (202) 693–8335; 

Karen Levin, Internal Revenue Service, 

Department of the Treasury, at (202) 

622–6080; Jim Mayhew, Office of 

Consumer Information and Insurance 

Oversight, Department of Health and 

Human Services, at (410) 786–1565. 

Customer Service Information: 

Individuals interested in obtaining 

information from the Department of 

Labor concerning employment-based 

health coverage laws may call the EBSA 

Toll-Free Hotline at 1–866–444–EBSA 

(3272) or visit the Department of Labor’s 

Web site (http://www.dol.gov/ebsa). In 

addition, information from HHS on 

private health insurance for consumers 

can be found on the Centers for 

Medicare & Medicaid Services (CMS) 

Web site (http://www.cms.hhs.gov/

HealthInsReformforConsume/01_

Overview.as) and information on health 

reform can be found at http:// 

www.healthreform.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Patient Protection and Affordable 

Care Act (the Affordable Care Act), 

Public Law 111–148, was enacted on 

March 23, 2010; the Health Care and 

Education Reconciliation Act (the 

Reconciliation Act), Public Law 111– 

152, was enacted on March 30, 2010. 

The Affordable Care Act and the 

Reconciliation Act reorganize, amend, 

and add to the provisions of part A of 

title XXVII of the Public Health Service 

Act (PHS Act) relating to group health 

plans and health insurance issuers in 

the group and individual markets. The 

term ‘‘group health plan’’ includes both 

insured and self-insured group health 

plans.1 The Affordable Care Act adds 

section 715(a)(1) to the Employee 

Retirement Income Security Act (ERISA) 

and section 9815(a)(1) to the Internal 

Revenue Code (the Code) to incorporate 

the provisions of part A of title XXVII 

of the PHS Act into ERISA and the 

Code, and make them applicable to 

group health plans, and health 

insurance issuers providing health 

insurance coverage in connection with 

group health plans. The PHS Act 

sections incorporated by this reference 

are sections 2701 through 2728. PHS 

Act sections 2701 through 2719A are 

substantially new, though they 

incorporate some provisions of prior 

law. PHS Act sections 2722 through 

2728 are sections of prior law 

renumbered, with some, mostly minor, 

changes. 

Subtitles A and C of title I of the 

Affordable Care Act amend the 

requirements of title XXVII of the PHS 

Act (changes to which are incorporated 

into ERISA section 715). The 

preemption provisions of ERISA section 

731 and PHS Act section 2724 2

(implemented in 29 CFR 2590.731(a) 

and 45 CFR 146.143(a)) apply so that the 

requirements of part 7 of ERISA and 

title XXVII of the PHS Act, as amended 

by the Affordable Care Act, are not to be 

‘‘construed to supersede any provision 

of State law which establishes, 

implements, or continues in effect any 

standard or requirement solely relating 

to health insurance issuers in 

connection with group or individual 

health insurance coverage except to the 

extent that such standard or 

requirement prevents the application of 

a requirement’’ of the Affordable Care 

Act. Accordingly, State laws that 

impose on health insurance issuers 

requirements that are stricter than those 

imposed by the Affordable Care Act will 

not be superseded by the Affordable 

Care Act. 

mstockstill on DSKH9S0YB1PROD with RULES

41728 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 

3Under PHS Act section 2713(a)(5), the Task 

Force recommendations regarding breast cancer 

screening, mammography, and prevention issued in 

or around November of 2009 are not to be 

considered current recommendations on this 

subject for purposes of any law. 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 (i.e., 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 the 

Health Resources and Services Administration 

concerning preventive care and screenings for 

women. 

The Departments of Health and 

Human Services, Labor, and the 

Treasury (the Departments) are issuing 

regulations in several phases 

implementing the revised PHS Act 

sections 2701 through 2719A and 

related provisions of the Affordable Care 

Act. The first phase in this series was 

the publication of a Request for 

Information relating to the medical loss 

ratio provisions of PHS Act section 

2718, published in the Federal Register 

on April 14, 2010 (75 FR 19297). The 

second phase was interim final 

regulations implementing PHS Act 

section 2714 (requiring dependent 

coverage of children to age 26), 

published in the Federal Register on 

May 13, 2010 (75 FR 27122). The third 

phase was interim final regulations 

implementing section 1251 of the 

Affordable Care Act (relating to status as 

a grandfathered health plan), published 

in the Federal Register on June 17, 2010 

(75 FR 34538). The fourth phase was 

interim final regulations implementing 

PHS Act sections 2704 (prohibiting 

preexisting condition exclusions), 2711 

(regarding lifetime and annual dollar 

limits on benefits), 2712 (regarding 

restrictions on rescissions), and 2719A 

(regarding patient protections), 

published in the Federal Register on 

June 28, 2010 (75 FR 37188). These 

interim final regulations are being 

published to implement PHS Act 

section 2713 (relating to coverage for 

preventive services). PHS Act section 

2713 is generally effective for plan years 

(in the individual market, policy years) 

beginning on or after September 23, 

2010, which is six months after the 

March 23, 2010 date of enactment of the 

Affordable Care Act. The 

implementation of other provisions of 

PHS Act sections 2701 through 2719A 

will be addressed in future regulations. 

II. Overview of the Regulations: PHS 

Act Section 2713, Coverage of 

Preventive Health Services (26 CFR 

54.9815–2713T, 29 CFR 2590.715–2713, 

45 CFR 147.130) 

Section 2713 of the PHS Act, as added 

by the Affordable Care Act, and these 

interim final regulations require that a 

group health plan and a health 

insurance issuer offering group or 

individual health insurance coverage 

provide benefits for and prohibit the 

imposition of cost-sharing requirements 

with respect to: 

• Evidence-based items or services 

that have in effect a rating of A or B in 

the current recommendations of the 

United States Preventive Services Task 

Force (Task Force) with respect to the 

individual involved.3

• 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, evidenceinformed preventive care and screening 

provided for in comprehensive 

guidelines supported by HRSA (not 

otherwise addressed by the 

recommendations of the Task Force). 

The Department of HHS is developing 

these guidelines and expects to issue 

them no later than August 1, 2011. 

The complete list of recommendations 

and guidelines that are required to be 

covered under these interim final 

regulations can be found at http:// 

www.HealthCare.gov/center/ 

regulations/prevention.html. Together, 

the items and services described in 

these recommendations and guidelines 

are referred to in this preamble as 

‘‘recommended preventive services.’’ 

These interim final regulations clarify 

the cost-sharing requirements when a 

recommended preventive service is 

provided during an office visit. First, if 

a recommended preventive service is 

billed separately (or is tracked as 

individual encounter data separately) 

from an office visit, then a plan or issuer 

may impose cost-sharing requirements 

with respect to the office visit. Second, 

if a recommended preventive service is 

not billed separately (or is not tracked 

as individual encounter data separately) 

from an office visit and the primary 

purpose of the office visit is the delivery 

of such an item or service, then a plan 

or issuer may not impose cost-sharing 

requirements with respect to the office 

visit. Finally, if a recommended 

preventive service is not billed 

separately (or is not tracked as 

individual encounter data separately) 

from an office visit and the primary 

purpose of the office visit is not the 

delivery of such an item or service, then 

a plan or issuer may impose costsharing requirements with respect to the 

office visit. The reference to tracking 

individual encounter data was included 

to provide guidance with respect to 

plans and issuers that use capitation or 

similar payment arrangements that do 

not bill individually for items and 

services. 

Examples in these interim final 

regulations illustrate these provisions. 

In one example, an individual receives 

a cholesterol screening test, a 

recommended preventive service, 

during a routine office visit. The plan or 

issuer may impose cost-sharing 

requirements for the office visit because 

the recommended preventive service is 

billed as a separate charge. A second 

example illustrates that treatment 

resulting from a preventive screening 

can be subject to cost-sharing 

requirements if the treatment is not 

itself a recommended preventive 

service. In another example, an 

individual receives a recommended 

preventive service that is not billed as 

a separate charge. In this example, the 

primary purpose for the office visit is 

recurring abdominal pain and not the 

delivery of a recommended preventive 

service; therefore the plan or issuer may 

impose cost-sharing requirements for 

the office visit. In the final example, an 

individual receives a recommended 

preventive service that is not billed as 

a separate charge, and the delivery of 

that service is the primary purpose of 

the office visit. Therefore, the plan or 

issuer may not impose cost-sharing 

requirements for the office visit. 

With respect to a plan or health 

insurance coverage that has a network of 

providers, these interim final 

regulations make clear that a plan or 

issuer is not required to provide 

coverage for recommended preventive 

services delivered by an out-of-network 

provider. Such a plan or issuer may also 

impose cost-sharing requirements for 

recommended preventive services 

delivered by an out-of-network 

provider. 

These interim final regulations 

provide that if a recommendation or 

mstockstill on DSKH9S0YB1PROD with RULES

Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 41729 

4Section 2713(b)(1) refers to an interval between 

‘‘the date on which a recommendation described in 

subsection (a)(1) or (a)(2) or a guideline under 

subsection (a)(3) is issued and the plan year with 

respect to which the requirement described in 

subsection (a) is effective with respect to the service 

described in such recommendation or guideline.’’ 

While the first part of this statement does not 

mention guidelines under subsection (a)(4), it 

would make no sense to treat the services covered 

under (a)(4) any differently than those in (a)(1), 

(a)(2), and (a)(3). First, the same sentence refers to 

‘‘the requirement described in subsection (a),’’ 

which would include a requirement under (a)(4). 

Secondly, the guidelines under (a)(4) are from the 

same source as those under (a)(3), except with 

respect to women rather than infants, children and 

adolescents; and other preventive services 

involving women are addressed in (a)(1), so there 

is no plausible policy rationale for treating them 

differently. Third, without this clarification, it 

would be unclear when such services would have 

to be covered. These interim final regulations 

accordingly apply the intervals established therein 

to services under section 2713(a)(4). 

5For example, if a recommendation of the United 

States Preventive Services Task Force is 

downgraded from a rating of A or B to a rating of 

C or D, or if a recommendation or guideline no 

longer includes a particular item or service. 

guideline for a recommended preventive 

service does not specify the frequency, 

method, treatment, or setting for the 

provision of that service, the plan or 

issuer can use reasonable medical 

management techniques to determine 

any coverage limitations. The use of 

reasonable medical management 

techniques allows plans and issuers to 

adapt these recommendations and 

guidelines to coverage of specific items 

and services where cost sharing must be 

waived. Thus, under these interim final 

regulations, a plan or issuer may rely on 

established techniques and the relevant 

evidence base to determine the 

frequency, method, treatment, or setting 

for which a recommended preventive 

service will be available without costsharing requirements to the extent not 

specified in a recommendation or 

guideline. 

The statute and these interim final 

regulations clarify that a plan or issuer 

continues to have the option to cover 

preventive services in addition to those 

required to be covered by PHS Act 

section 2713. For such additional 

preventive services, a plan or issuer may 

impose cost-sharing requirements at its 

discretion. Moreover, a plan or issuer 

may impose cost-sharing requirements 

for a treatment that is not a 

recommended preventive service, even 

if the treatment results from a 

recommended preventive service. 

The statute requires the Departments 

to establish an interval of not less than 

one year between when 

recommendations or guidelines under 

PHS Act section 2713(a) 4 are issued, 

and the plan year (in the individual 

market, policy year) for which coverage 

of the services addressed in such 

recommendations or guidelines must be 

in effect. These interim final regulations 

provide that such coverage must be 

provided for plan years (in the 

individual market, policy years) 

beginning on or after the later of 

September 23, 2010, or one year after 

the date the recommendation or 

guideline is issued. Thus, 

recommendations and guidelines issued 

prior to September 23, 2009 must be 

provided for plan years (in the 

individual market, policy years) 

beginning on or after September 23, 

2010. For the purpose of these interim 

final regulations, a recommendation or 

guideline of the Task Force is 

considered to be issued on the last day 

of the month on which the Task Force 

publishes or otherwise releases the 

recommendation; a recommendation or 

guideline of the Advisory Committee is 

considered to be issued on the date on 

which it is adopted by the Director of 

the Centers for Disease Control and 

Prevention; and a recommendation or 

guideline in the comprehensive 

guidelines supported by HRSA is 

considered to be issued on the date on 

which it is accepted by the 

Administrator of HRSA or, if applicable, 

adopted by the Secretary of HHS. For 

recommendations and guidelines 

adopted after September 23, 2009, 

information at http:// 

www.HealthCare.gov/center/ 

regulations/prevention.html will be 

updated on an ongoing basis and will 

include the date on which the 

recommendation or guideline was 

accepted or adopted. 

Finally, these interim final regulations 

make clear that a plan or issuer is not 

required to provide coverage or waive 

cost-sharing requirements for any item 

or service that has ceased to be a 

recommended preventive service.5

Other requirements of Federal or State 

law may apply in connection with 

ceasing to provide coverage or changing 

cost-sharing requirements for any such 

item or service. For example, PHS Act 

section 2715(d)(4) requires a plan or 

issuer to give 60 days advance notice to 

an enrollee before any material 

modification will become effective. 

Recommendations or guidelines in 

effect as of July 13, 2010 are described 

in section V later in this preamble. Any 

change to a recommendation or 

guideline that has—at any point since 

September 23, 2009—been included in 

the recommended preventive services 

will be noted at http:// 

www.HealthCare.gov/center/ 

regulations/prevention.html. As 

described above, new recommendations 

and guidelines will also be noted at this 

site and plans and issuers need not 

make changes to coverage and costsharing requirements based on a new 

recommendation or guideline until the 

first plan year (in the individual market, 

policy year) beginning on or after the 

date that is one year after the new 

recommendation or guideline went into 

effect. Therefore, by visiting this site 

once per year, plans or issuers will have 

straightforward access to all the 

information necessary to determine any 

additional items or services that must be 

covered without cost-sharing 

requirements, or to determine any items 

or services that are no longer required 

to be covered. 

The Affordable Care Act gives 

authority to the Departments to develop 

guidelines for group health plans and 

health insurance issuers offering group 

or individual health insurance coverage 

to utilize value-based insurance designs 

as part of their offering of preventive 

health services. Value-based insurance 

designs include the provision of 

information and incentives for 

consumers that promote access to and 

use of higher value providers, 

treatments, and services. The 

Departments recognize the important 

role that value-based insurance design 

can play in promoting the use of 

appropriate preventive services. These 

interim final regulations, for example, 

permit plans and issuers to implement 

designs that seek to foster better quality 

and efficiency by allowing cost-sharing 

for recommended preventive services 

delivered on an out-of-network basis 

while eliminating cost-sharing for 

recommended preventive health 

services delivered on an in-network 

basis. The Departments are developing 

additional guidelines regarding the 

utilization of value-based insurance 

designs by group health plans and 

health insurance issuers with respect to 

preventive benefits. The Departments 

are seeking comments related to the 

development of such guidelines for 

value-based insurance designs that 

promote consumer choice of providers 

or services that offer the best value and 

quality, while ensuring access to 

critical, evidence-based preventive 

services. 

The requirements to cover 

recommended preventive services 

without any cost-sharing requirements 

do not apply to grandfathered health 

plans. See 26 CFR 54.9815–1251T, 29 

CFR 2590.715–1251, and 45 CFR 

147.140 (75 FR 34538, June 17, 2010). 

III. Interim Final Regulations and 

Request for Comments 

Section 9833 of the Code, section 734 

of ERISA, and section 2792 of the PHS 

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41730 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 

Act authorize the Secretaries of the 

Treasury, Labor, and HHS (collectively, 

the Secretaries) to promulgate any 

interim final rules that they determine 

are appropriate to carry out the 

provisions of chapter 100 of the Code, 

part 7 of subtitle B of title I of ERISA, 

and part A of title XXVII of the PHS Act, 

which include PHS Act sections 2701 

through 2728 and the incorporation of 

those sections into ERISA section 715 

and Code section 9815. 

In addition, under Section 553(b) of 

the Administrative Procedure Act (APA) 

(5 U.S.C. 551 et seq.) a general notice of 

proposed rulemaking is not required 

when an agency, for good cause, finds 

that notice and public comment thereon 

are impracticable, unnecessary, or 

contrary to the public interest. The 

provisions of the APA that ordinarily 

require a notice of proposed rulemaking 

do not apply here because of the 

specific authority granted by section 

9833 of the Code, section 734 of ERISA, 

and section 2792 of the PHS Act. 

However, even if the APA were 

applicable, the Secretaries have 

determined that it would be 

impracticable and contrary to the public 

interest to delay putting the provisions 

in these interim final regulations in 

place until a full public notice and 

comment process was completed. As 

noted above, the preventive health 

service provisions of the Affordable 

Care Act are applicable for plan years 

(in the individual market, policy years) 

beginning on or after September 23, 

2010, six months after date of 

enactment. Had the Departments 

published a notice of proposed 

rulemaking, provided for a 60-day 

comment period, and only then 

prepared final regulations, which would 

be subject to a 60-day delay in effective 

date, it is unlikely that it would have 

been possible to have final regulations 

in effect before late September, when 

these requirements could be in effect for 

some plans or policies. Moreover, the 

requirements in these interim final 

regulations require significant lead time 

in order to implement. These interim 

final regulations require plans and 

issuers to provide coverage for 

preventive services listed in certain 

recommendations and guidelines 

without imposing any cost-sharing 

requirements. Preparations presumably 

would have to be made to identify these 

preventive services. With respect to the 

changes that would be required to be 

made under these interim final 

regulations, group health plans and 

health insurance issuers subject to these 

provisions have to be able to take these 

changes into account in establishing 

their premiums, and in making other 

changes to the designs of plan or policy 

benefits, and these premiums and plan 

or policy changes would have to receive 

necessary approvals in advance of the 

plan or policy year in question. 

Accordingly, in order to allow plans 

and health insurance coverage to be 

designed and implemented on a timely 

basis, regulations must be published 

and available to the public well in 

advance of the effective date of the 

requirements of the Affordable Care Act. 

It is not possible to have a full notice 

and comment process and to publish 

final regulations in the brief time 

between enactment of the Affordable 

Care Act and the date regulations are 

needed. 

The Secretaries further find that 

issuance of proposed regulations would 

not be sufficient because the provisions 

of the Affordable Care Act protect 

significant rights of plan participants 

and beneficiaries and individuals 

covered by individual health insurance 

policies and it is essential that 

participants, beneficiaries, insureds, 

plan sponsors, and issuers have 

certainty about their rights and 

responsibilities. Proposed regulations 

are not binding and cannot provide the 

necessary certainty. By contrast, the 

interim final regulations provide the 

public with an opportunity for 

comment, but without delaying the 

effective date of the regulations. 

For the foregoing reasons, the 

Departments have determined that it is 

impracticable and contrary to the public 

interest to engage in full notice and 

comment rulemaking before putting 

these interim final regulations into 

effect, and that it is in the public interest 

to promulgate interim final regulations. 

IV. Economic Impact 

Under Executive Order 12866 (58 FR 

51735), a ‘‘significant’’ regulatory action 

is subject to review by the Office of 

Management and Budget (OMB). 

Section 3(f) of the Executive Order 

defines a ‘‘significant regulatory action’’ 

as an action that is likely to result in a 

rule (1) having an annual effect on the 

economy of $100 million or more in any 

one year, or adversely and materially 

affecting a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local or tribal governments or 

communities (also referred to as 

‘‘economically significant’’); (2) creating 

a serious inconsistency or otherwise 

interfering with an action taken or 

planned by another agency; (3) 

materially altering the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or (4) 

raising novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. OMB 

has determined that this regulation is 

economically significant within the 

meaning of section 3(f)(1) of the 

Executive Order, because it is likely to 

have an annual effect on the economy 

of $100 million in any one year. 

Accordingly, OMB has reviewed these 

rules pursuant to the Executive Order. 

The Departments provide an assessment 

of the potential costs, benefits, and 

transfers associated with these interim 

final regulations, summarized in the 

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) delayed 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 distribute 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: 

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Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 41731 

6All participant counts and the estimates of 

individual policies are from the U.S. Department of 

Labor, EBSA calculations using the March 2008 

Current Population Survey Annual Social and 

Economic Supplement and the 2008 Medical 

Expenditure Panel Survey. 

7Estimate is from the 2007 Census of 

Government. 

8US Census Bureau, Current Population Survey, 

March 2009. 

9 75 FR 34538 (June 17, 2010). 

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 covered 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 premiums 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 

Action 

As discussed later in this preamble, 

there is current underutilization of 

preventive services, which stems from 

three main factors. First, due to turnover 

in the health insurance market, health 

insurance issuers do not currently have 

incentives to cover preventive services, 

whose benefits may only be realized in 

the future when an individual may no 

longer be enrolled. Second, many 

preventive services generate benefits 

that do not accrue immediately to the 

individual that receives the services, 

making the individual less likely to 

take-up, especially in the face of direct, 

immediate costs. Third, some of the 

benefits of preventive services accrue to 

society as a whole, and thus do not get 

factored into an individual’s decisionmaking over whether to obtain such 

services. 

These interim final regulations 

address these market failures through 

two avenues. First, they require 

coverage of recommended preventive 

services by non-grandfathered group 

health plans and health insurance 

issuers in the group and individual 

markets, thereby overcoming plans’ lack 

of incentive to invest in these services. 

Second, they eliminate cost-sharing 

requirements, thereby removing a 

barrier that could otherwise lead an 

individual to not obtain such services, 

given the long-term and partially 

external nature of benefits. 

These interim final regulations are 

necessary in order to provide rules that 

plan sponsors and issuers can use to 

determine how to provide coverage for 

certain preventive health care services 

without the imposition of cost sharing 

in connection with these services. 

B. PHS Act Section 2713, Coverage of 

Preventive Health Services (26 CFR 

54.9815–2713T, 29 CFR 2590.715–2713, 

45 CFR 147.130) 

1. Summary 

As discussed earlier in this preamble, 

PHS Act section 2713, as added by the 

Affordable Care Act, and these interim 

final regulations require a group health 

plan and a health insurance issuer 

offering group or individual health 

insurance coverage to provide benefits 

for and prohibit the imposition of costsharing requirements with respect to the 

following preventive health services: 

• Evidence-based items or services 

that have in effect a rating of A or B in 

the current recommendations of the 

United States Preventive Services Task 

Force (Task Force). While these 

guidelines will change over time, for the 

purposes of this impact analysis, the 

Departments utilized currently available 

guidelines, which include blood 

pressure and cholesterol screening, 

diabetes screening for hypertensive 

patients, various cancer and sexually 

transmitted infection screenings, and 

counseling related to aspirin use, 

tobacco cessation, obesity, and other 

topics. 

• 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. 

• 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, evidenceinformed preventive care and screening 

provided for in comprehensive 

guidelines supported by HRSA (not 

otherwise addressed by the 

recommendations of the Task Force). 

The Department of HHS is developing 

these guidelines and expects to issue 

them no later than August 1, 2011. 

2. Preventive Services 

For the purposes of this analysis, the 

Departments used the relevant 

recommendations of the Task Force and 

Advisory Committee and current HRSA 

guidelines as described in section V 

later in this preamble. In addition to 

covering immunizations, these lists 

include such services as blood pressure 

and cholesterol screening, diabetes 

screening for hypertensive patients, 

various cancer and sexually transmitted 

infection screenings, genetic testing for 

the BRCA gene, adolescent depression 

screening, lead testing, autism testing, 

and oral health screening and 

counseling related to aspirin use, 

tobacco cessation, and obesity. 

3. Estimated Number of Affected 

Entities 

For purposes of the new requirements 

in the Affordable Care Act that apply to 

group health plans and health insurance 

issuers in the group and individual 

markets, the Departments have defined 

a large group health plan as an employer 

plan with 100 or more workers and a 

small group plan as an employer plan 

with less than 100 workers. The 

Departments estimated that there are 

approximately 72,000 large and 2.8 

million small ERISA-covered group 

health plans with an estimated 97.0 

million participants in large group plans 

and 40.9 million participants in small 

group plans.6 The Departments estimate 

that there are 126,000 governmental 

plans with 36.1 million participants in 

large plans and 2.3 million participants 

in small plans.7 The Departments 

estimate there are 16.7 million 

individuals under age 65 covered by 

individual health insurance policies.8

As described in the Departments’ 

interim final regulations relating to 

status as a grandfathered health plan,9

the Affordable Care Act preserves the 

ability of individuals to retain coverage 

under a group health plan or health 

insurance coverage in which the 

individual was enrolled on March 23, 

2010 (a grandfathered health plan). 

Group health plans, and group and 

individual health insurance coverage, 

that are grandfathered health plans do 

not have to meet the requirements of 

these interim final regulations. 

Therefore, only plans and issuers 

offering group and individual health 

insurance coverage that are not 

grandfathered health plans will be 

affected by these interim final 

regulations. 

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41732 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 

10See 75 FR 34538 (June 17, 2010). 

11See 75 FR 34538 (June 17, 2010) for a detailed 

description of the derivation of the estimates for the 

percentages of grandfathered health plans. In brief, 

the Departments used data from the 2008 and 2009 

Kaiser Family Foundations/Health Research and 

Educational Trust survey of employers to estimate 

the proportion of plans that made changes in costsharing requirements that would have caused them 

to relinquish grandfather status if those same 

changes were made in 2011, and then applied a set 

of assumptions about how employer behavior might 

change in response to the incentives created by the 

grandfather regulations to estimate the proportion 

of plans likely to relinquish grandfather status. The 

estimates of changes in 2012 and 2013 were 

calculated by using the 2011 calculations and 

assuming that an identical percentage of plan 

sponsors will relinquish grandfather status in each 

year. 

12To estimate the number of individuals covered 

in grandfathered health plans, the Departments 

extended the analysis described in 75 FR 34538, 

and estimated a weighted average of the number of 

employees in grandfathered health plans in the 

large employer and small employer markets 

separately, weighting by the number of employees 

in each employer’s plan. Estimates for the large 

employer and small employer markets were then 

combined, using the estimates supplied above that 

there are 133.1 million covered lives in the large 

group market, and 43.2 million in the small group 

market. 

13Adele M. Kirk. The Individual Insurance 

Market: A Building Block for Health Care Reform? 

Health Care Financing Organization Research 

Synthesis. May 2008. 

14Of note, State insurance requirements do not 

apply to self-insured group health plans, whose 

participants and beneficiaries make up 57 percent 

of covered employees (in firms with 3 or more 

employees) in 2009 according to a major annual 

survey of employers due to ERISA preemption of 

State insurance laws. See e.g., Kaiser Family 

Foundation and Health Research and Education 

Trust, Employer Health Benefits 2009 Annual 

Survey (2009). 

15See e.g., American Academy of Pediatrics, 

State Legislative Report (2009). 

16See Kaiser Family Foundation, 

www.statehealthfacts.org. 

17See e.g., Mary Ann Bondi et. al., ‘‘Employer 

Coverage of Clinical Preventive Services in the 

United States,’’ American Journal of Health 

Promotion, 20(3), pp. 214–222 (2006). 

18The specific immunizations include: DTaP 

(diphtheria and tetanus toxoids and acellular 

Pertussis), Hib (Haemophilus influenza type b), 

Hepatitis B, inactivated polio, influenza, MMR 

(measles, mumps, and rubella), pneumococcal, and 

varicella vaccine. 

19McPhillips-Tangum C., Rehm B., Hilton O. 

‘‘Immunization practices and policies: A survey of 

health insurance plans.’’ AHIP Coverage. 47(1), 32– 

7 (2006). 

20See e.g., Matthew M. Davis et. al., ‘‘Benefits 

Coverage for Adult Vaccines in EmployerSponsored Health Plans,’’ University of Michigan 

for the CDC National Immunizations Program 

(2003). 

21See e.g., Kaiser Family Foundation and Health 

Research and Education Trust, Employer Health 

Benefits 2009 Annual Survey (2009) available at 

http://ehbs.kff.org/pdf/2009/7936.pdf. 

22See e.g., Mary Ann Bondi et. al., ‘‘Employer 

Coverage of Clinical Preventive Services in the 

United States,’’ American Journal of Health 

Promotion, 20(3), pp. 214–222 (2006). 

23See e.g., Matthew M. Davis et. al., ‘‘Benefits 

Coverage for Adult Vaccines in EmployerSponsored Health Plans,’’ University of Michigan 

Plans can choose to relinquish their 

grandfather status in order to make 

certain otherwise permissible changes to 

their plans.10 The Affordable Care Act 

provides plans with the ability to 

maintain grandfathered status in order 

to promote stability for consumers while 

allowing plans and sponsors to make 

reasonable adjustments to lower costs 

and encourage the efficient use of 

services. Based on an analysis of the 

changes plans have made over the past 

few years, the Departments expect that 

more plans will choose to make these 

changes over time and therefore the 

number of grandfathered health plans is 

expected to decrease. Correspondingly, 

the number of plans and policies 

affected by these interim final 

regulations is likely to increase over 

time. In addition, the number of 

individuals receiving the benefits of the 

Affordable Care Act is likely to increase 

over time. The Departments’ mid-range 

estimate is that 18 percent of large 

employer plans and 30 percent of small 

employer plans would relinquish 

grandfather status in 2011, increasing 

over time to 45 percent and 66 percent 

respectively by 2013, although there is 

substantial uncertainty surrounding 

these estimates.11

Using the mid-range assumptions, the 

Departments estimate that in 2011, 

roughly 31 million people will be 

enrolled in group health plans subject to 

the prevention provisions in these 

interim final regulations, growing to 

approximately 78 million in 2013.12 The 

mid-range estimates suggest that 

approximately 98 million individuals 

will be enrolled in grandfathered group 

health plans in 2013, many of which 

already cover preventive services (see 

discussion of the extent of preventive 

services coverage in employersponsored plans later in this preamble). 

In the individual market, one study 

estimated that 40 percent to 67 percent 

of individual policies terminate each 

year. Because all newly purchased 

individual policies are not 

grandfathered, the Departments expect 

that a large proportion of individual 

policies will not be grandfathered, 

covering up to and perhaps exceeding 

10 million individuals.13

However, not all of the individuals 

potentially affected by these interim 

final regulations will directly benefit 

given the prevalence and variation in 

insurance coverage today. State laws 

will affect the number of entities 

affected by all or some provision of 

these interim final regulations, since 

plans, policies, and enrollees in States 

that already have certain requirements 

will be affected to different degrees.14

For instance, 29 States require that 

health insurance issuers cover most or 

all recommended immunizations for 

children.15 Of these 29 States, 18 States 

require first-dollar coverage of 

immunizations so that the insurers pay 

for immunizations without a deductible 

and 12 States exempt immunizations 

from copayments (e.g., $5, $10, or $20 

per vaccine) or coinsurance (e.g., 10 

percent or 20 percent of charges). State 

laws also require coverage of certain 

other preventive health services. Every 

State except Utah mandates coverage for 

some type of breast cancer screening for 

women. Twenty-eight States mandate 

coverage for some cervical cancer 

screening and 13 States mandate 

coverage for osteoporosis screening.16

Estimation of the number of entities 

immediately affected by some or all 

provisions of these interim final 

regulations is further complicated by the 

fact that, although not all States require 

insurance coverage for certain 

preventive services, many health plans 

have already chosen to cover these 

services. For example, most health plans 

cover most childhood and some adult 

immunizations contained in the 

recommendations from the Advisory 

Committee. A survey of small, medium 

and large employers showed that 78 

percent to 80 percent of their point of 

service, preferred provider organization 

(PPO), and health maintenance 

organization (HMO) health plans 

covered childhood immunizations and 

57 percent to 66 percent covered 

influenza vaccines in 2001.17 All 61 

health plans (HMOs and PPOs) 

responding to a 2005 America’s Health 

Insurance Plans (AHIP) survey covered 

childhood immunizations 18 in their 

best-selling products and almost all 

health plans (60 out of 61) covered 

diphtheria-tetanus-pertussis vaccines 

and influenza vaccines for adults.19 A 

survey of private and public employer 

health plans found that 84 percent 

covered influenza vaccines in 2002– 

2003.20

Similarly, many health plans already 

cover preventive services today, but 

there are differences in the coverage of 

these services in the group and 

individual markets. According to a 2009 

survey of employer health benefits, over 

85 percent of employer-sponsored 

health insurance plans covered 

preventive services without having to 

meet a deductible.21 Coverage of 

preventive services does vary slightly by 

employer size, with large employers 

being more likely to cover such services 

than small employers.22 In contrast, 

coverage of preventive services is less 

prevalent and varies more significantly 

in the individual market.23 For PPOs, 

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Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 41733 

for the CDC National Immunizations Program 

(2003). 

24See Individual Health Insurance 2006–2007: A 

Comprehensive Survey of Premiums, Availability, 

and Benefits. Available at http:// 

www.ahipresearch.org/pdfs/ 

Individual_Market_Survey_December_2007.pdf. 

25This differs from the Task Force 

recommendation that individuals aged 50–75 

receive fecal occult blood testing, sigmoidoscopy, or 

colonoscopy screening for colorectal cancer. 

26For Behavioral Risk Factor Surveillance System 

Numbers see e.g. Centers for Disease Control and 

Prevention (CDC). Behavioral Risk Factor 

Surveillance System Survey Data. Atlanta, Georgia: 

U.S. Department of Health and Human Services, 

Centers for Disease Control and Prevention, (2008) 

at http://apps.nccd.cdc.gov/BRFSS/ 

page.asp?cat=CC&yr=2008&state=UB#CC. 

27See http://www.cdc.gov/vaccines/stats-surv/ 

imz-coverage.htm#nis for vaccination rates. 

28See e.g., Jonathan Gruber, The Role of 

Consumer Copayments for Health Care: Lessons 

from the RAND Health Insurance Experiment and 

Beyond, Kaiser Family Foundation (Oct. 2006). This 

paper examines an experiment in which copays 

randomly vary across several thousand individuals. 

The author finds that individuals are sensitive to 

prices for health services—i.e. as copays decline, 

more services are demanded. See e.g., Sharon Long, 

‘‘On the Road to Universal Coverage: Impacts of 

Reform in Massachusetts At One Year,’’ Health 

Affairs, Volume 27, Number 4 (June 2008). The 

author investigated the case of Massachusetts, 

where coverage of preventive services became a 

requirement in 2007, and found that for individuals 

under 300 percent of the poverty line, doctor visits 

for preventive care increased by 6.1 percentage 

points in the year after adoption, even after 

controlling for observable characteristics. 

Additionally, the incidence of individuals citing 

cost as the reason for not receiving preventive 

screenings declined by 2.8 percentage points from 

2006 to 2007. In the Massachusetts case, these 

preventive care services were not necessarily free; 

therefore, economists would expect a higher 

differential under these interim final rules because 

of the price sensitivity of health care usage. 

29The Task Force defines good and fair evidence 

as follows. Good: Evidence includes consistent 

results from well-designed, well-conducted studies 

in representative populations that directly assess 

effects on health outcomes. 

Fair: Evidence is sufficient to determine effects 

on health outcomes, but the strength of the 

evidence is limited by the number, quality or 

consistency of the individual studies, 

generalizability to routine practice or indirect 

nature of the evidence on health outcomes. See 

http://www.ahrq.gov/clinic/uspstf/ 

gradespre.htm#drec. 

30See http://www.ahrq.gov/clinic/uspstf/ 

gradespre.htm#drec for details of the Task Force 

grading. 

31Woolf, Steven. A Closer Look at the Economic 

Argument for Disease Prevention. JAMA 

2009;301(5):536–538. 

32See National Commission on Prevention 

Priorities. Preventive Care: A National Profile on 

Use, Disparities, and Health Benefits. Partnership 

for Prevention, August 2007 at http:// 

www.prevent.org/content/view/129/72/#citations 

accessed on 6/22/2010. Lives saved were estimated 

using models previously developed to rank clinical 

preventive services. See Maciosek MV, Edwards 

NM, Coffield AB, Flottemesch TJ, Nelson WW, 

Goodman MJ, Rickey DA, Butani AB, Solberg LI. 

Priorities among effective clinical preventive 

services: methods. Am J Prev Med 2006; 31(1):90– 

96. 

only 66.2 percent of single policies 

purchased covered adult physicals, 

while 94.1 percent covered cancer 

screenings.24

In summary, the number of affected 

entities depends on several factors, such 

as whether a health plan retains its 

grandfather status, the number of new 

health plans, whether State benefit 

requirements for preventive services 

apply, and whether plans or issuers 

voluntarily offer coverage and/or no cost 

sharing for recommended preventive 

services. In addition, participants, 

beneficiaries, and enrollees in such 

plans or health insurance coverage will 

be affected in different ways: Some will 

newly gain coverage for recommended 

preventive services, while others will 

have the cost sharing that they now pay 

for such services eliminated. As such, 

there is considerable uncertainty 

surrounding estimation of the number of 

entities affected by these interim final 

regulations. 

4. Benefits 

The Departments anticipate that four 

types of benefits will result from these 

interim final regulations. First, 

individuals will experience improved 

health as a result of reduced 

transmission, prevention or delayed 

onset, and earlier treatment of disease. 

Second, healthier workers and children 

will be more productive with fewer 

missed days of work or school. Third, 

some of the recommended preventive 

services will result in savings due to 

lower health care costs. Fourth, the cost 

of preventive services will be 

distributed more equitably. 

By expanding coverage and 

eliminating cost sharing for 

recommended preventive services, these 

interim final regulations could be 

expected to increase access to and 

utilization of these services, which are 

not used at optimal levels today. 

Nationwide, almost 38 percent of adult 

residents over 50 have never had a 

colorectal cancer screening (such as a 

sigmoidoscopy or a colonoscopy) 25 and 

almost 18 percent of women over age 18 

have not been screened for cervical 

cancer in the past three years.26

Vaccination rates for childhood 

vaccines are generally high due to State 

laws requiring certain vaccinations for 

children to enter school, but 

recommended childhood vaccines that 

are not subject to State laws and adult 

vaccines have lower vaccination rates 

(e.g., the meningococcal vaccination rate 

among teenagers is 42 percent).27

Studies have shown that improved 

coverage of preventive services leads to 

expanded utilization of these services,28

which would lead to substantial benefits 

as discussed further below. 

In addition, these interim final 

regulations limit preventive service 

coverage under this provision to 

services recommended by the Task 

Force, Advisory Committee, and HRSA. 

The preventive services given a grade of 

A or B by the Task Force have been 

determined by the Task Force to have at 

least fair or good 29 evidence that the 

preventive service improves important 

health outcomes and that benefits 

outweigh harms in the judgment of an 

independent panel of private sector 

experts in primary care and 

prevention.30 Similarly, the mission of 

the Advisory Committee is to provide 

advice that will lead to a reduction in 

the incidence of vaccine preventable 

diseases in the United States, and an 

increase in the safe use of vaccines and 

related biological products. The 

comprehensive guidelines for infants, 

children, and adolescents supported by 

HRSA are developed by 

multidisciplinary professionals in the 

relevant fields to provide a framework 

for improving children’s health and 

reducing morbidity and mortality based 

on a review of the relevant evidence. 

The statute and interim final regulations 

limit the preventive services covered to 

those recommended by the Task Force, 

Advisory Committee, and HRSA 

because the benefits of these preventive 

services will be higher than others that 

may be popular but unproven. 

Research suggests significant health 

benefits from a number of the 

preventive services that would be newly 

covered with no cost sharing by plans 

and issuers under the statute and these 

interim final regulations. A recent 

article in JAMA stated, ‘‘By one account, 

increasing delivery of just five clinical 

preventive services would avert 100,000 

deaths per year.’’ 31 These five services 

are all items and services recommended 

by the Task Force, Advisory Committee, 

and/or the comprehensive guidelines 

supported by HRSA. The National 

Council on Prevention Priorities (NCPP) 

estimated that almost 150,000 lives 

could potentially be saved by increasing 

the 2005 rate of utilization to 90 percent 

for eight of the preventive services 

recommended by the Task Force or 

Advisory Committee.32 Table 2 shows 

eight of the services and the number of 

lives potentially saved if utilization of 

preventive services were to increase to 

90 percent. 

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41734 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 

33The Commonwealth Fund. ‘‘Insurance Coverage 

and the Receipt of Preventive Care.’’ 2005. http:// 

www.commonwealthfund.org/Content/ 

Performance-Snapshots/Financial-and-StructuralAccess-to-Care/Insurance-Coverage-and-Receipt-ofPreventive-Care.aspx. 

34Curry, Susan J., Byers, Tim, and Hewitt, Maria, 

eds. 2003. Fulfilling the Potential of Cancer 

Prevention and Early Detection. Washington, DC: 

National Academies Press. 

35Centers for Disease Control and Prevention. 

2010. Diabetes at a Glance. See http://www.cdc.gov/ 

chronicdisease/resources/publications/aag/pdf/ 

2010/diabetes_aag.pdf. 

36See Modern Infectious Disease Epidemiology 

by Johan Giesecke 1994, Chapter 18, The 

Epidemiology of Vaccination. 

37Health and Productivity Among U.S. Workers, 

Karen Davis, Ph.D., Sara R. Collins, Ph.D., Michelle 

M. Doty, Ph.D., Alice Ho, and Alyssa L. Holmgren, 

The Commonwealth Fund, August 2005 http:// 

www.commonwealthfund.org/Content/ 

Publications/Issue-Briefs/2005/Aug/Health-andProductivity-Among-U-S-Workers.aspx. 

38 Ibid. 39See e.g., RAND, The Health Insurance 

Experiment: A Classic RAND Study Speaks to the 

Current Health Care Reform Debate, Rand Research 

Brief, Number 9174 (2006), at 

http://www.rand.org/pubs/research_briefs/2006/ 

RAND_RB9174.pdf and Janet Currie et al., ‘‘Has 

Public Health Insurance for Older Children 

Reduced Disparities in Access to Care and Health 

Outcomes?’’, Journal of Health Economics, Volume 

27, Issue 6, pages 1567–1581 (Dec. 2008). With 

early childhood interventions, there appear to be 

improved health outcomes in later childhood. 

Analogously, health interventions in early 

adulthood could have benefits for future 

productivity. 

40 In a RAND policy brief, the authors cite results 

from the RAND Health Insurance Experiment in 

which cost-sharing is found to correspond with 

workers having fewer restricted-activity days— 

evidence that free care for certain services may be 

productivity enhancing. See e.g., RAND, The Health 

Insurance Experiment: A Classic RAND Study 

Speaks to the Current Health Care Reform Debate, 

Rand Research Brief, Number 9174 (2006), at 

http://www.rand.org/pubs/research_briefs/2006/ 

RAND_RB9174.pdf. See e.g. Janet Currie et. al., ‘‘Has 

Public Health Insurance for Older Children 

Reduced Disparities in Access to Care and Health 

Outcomes?’’ Journal of Health Economics, Volume 

27, Issue 6, pages 1567–1581 (Dec. 2008). With 

early childhood interventions, there appears to be 

improved health outcomes in later childhood. 

Analogously, health interventions in early 

adulthood could have benefits for future 

productivity. Council of Economic Advisers. ‘‘The 

Economic Case for Health Reform.’’ (2009). 

TABLE 2.—LIVES SAVED FROM INCREASING UTILIZATION OF SELECTED PREVENTIVE SERVICES TO 90 PERCENT

Preventive service Population group 

Percent utilizing 

preventive 

service in 

2005 

Lives saved annually if percent 

utilizing preventive service 

increased to 

90 percent 

Regular aspirin use ................................................................... Men 40+ and women 50+ ....................... 40 45,000 

Smoking cessation advice and help to quit .............................. All adult smokers ..................................... 28 42,000 

Colorectal cancer screening ..................................................... Adults 50+ ................................................ 48 14,000 

Influenza vaccination ................................................................. Adults 50+ ................................................ 37 12,000 

Cervical cancer screening in the past 3 years ......................... Women 18–64 ......................................... 83 620 

Cholesterol screening ............................................................... Men 35+ and women 45+ ....................... 79 2,450 

Breast cancer screening in the past 2 years ............................ Women 40+ ............................................. 67 3,700 

Chlamydia screening ................................................................. Women 16–25 ......................................... 40 30,000 

Source: National Commission on Prevention Priorities, 2007. 

Since financial barriers are not the 

only reason for sub-optimal utilization 

rates, population-wide utilization of 

preventive services is unlikely to 

increase to the 90 percent level assumed 

in Table 2 as a result of these interim 

final regulations. Current utilization of 

preventive services among insured 

populations varies widely, but the 

Departments expect that utilization will 

increase among those individuals in 

plans affected by the regulation because 

the provisions eliminate cost sharing 

and require coverage for these services. 

These interim final regulations are 

expected to increase the take-up rate of 

preventive services and are likely, over 

time, to lead physicians to increase their 

use of these services knowing that they 

will be covered, and covered with zero 

copayment. In the absence of data on 

the elasticity of demand for these 

specific services, it is difficult to know 

precisely how many more patients will 

use these services. Evidence from 

studies comparing the utilization of 

preventive services such as blood 

pressure and cholesterol screening 

between insured and uninsured 

individuals with relatively high 

incomes suggests that coverage 

increases usage rates in a wide range 

between three and 30 percentage points, 

even among those likely to be able to 

afford basic preventive services out-ofpocket.33 A reasonable assumption is 

that the average increase in utilization 

of these services will be modest, 

perhaps on the order of 5 to 10 

percentage points for some of them. For 

services that are generally covered 

without cost sharing in the current 

market, the Departments would expect 

minimal change in utilization. 

Preventive services’ benefits have also 

been evaluated individually. Effective 

cancer screening, early treatment, and 

sustained risk reduction could reduce 

the death rate due to cancer by 29 

percent.34 Improved blood sugar control 

could reduce the risk for eye disease, 

kidney disease and nerve disease by 40 

percent in people with Type 1 or Type 

2 diabetes.35

Some recommended preventive 

services have both individual and 

public health value. Vaccines have 

reduced or eliminated serious diseases 

that, prior to vaccination, routinely 

caused serious illnesses or deaths. 

Maintaining high levels of 

immunization in the general population 

protects the un-immunized from 

exposure to the vaccine-preventable 

disease, so that individuals who cannot 

receive the vaccine or who do not have 

a sufficient immune response to the 

vaccine to protect against the disease are 

indirectly protected.36

A second type of benefit from these 

interim final regulations is improved 

workplace productivity and decreased 

absenteeism for school children. 

Numerous studies confirm that ill 

health compromises worker output and 

that health prevention efforts can 

improve worker productivity. For 

example, one study found that 69 

million workers reported missing days 

due to illness and 55 million workers 

reported a time when they were unable 

to concentrate at work because of their 

own illness or a family member’s 

illness.37 Together, labor time lost due 

to health reasons represents lost 

economic output totaling $260 billion 

per year.38 Prevention efforts can help 

prevent these types of losses. Studies 

have also shown that reduced costsharing for medical services results in 

fewer restricted-activity days at work,39

and increased access to health insurance 

coverage improves labor market 

outcomes by improving worker health.40

Thus, the expansion of benefits and the 

elimination of cost sharing for 

preventive services as provided in these 

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41Bloom B, Cohen RA. Summary health statistics 

for U.S. children: National Health Interview Survey, 

2006. Vital Health Stat 2007;10(234). Available at 

http://www.cdc.gov/nchs/nhis.htm. 

42University of Pennsylvania 2007: http:// 

www.upenn.edu/pennnews/news/childhoodobesity-indicates-greater-risk-school-absenteeismuniversity-pennsylvania-study-revea. 

43 Davis, Mollie M., James C. King, Ginny 

Cummings, and Laurence S. Madger. ‘‘Countywide 

School-Based Influenza Immunization: Direct and 

Indirect Impact on Student Absenteeism.’’ 

Pediatrics 122.1 (2008). 

44Moonie, Sheniz, David A. Sterling, Larry Figgs, 

and Mario Castro. ‘‘Asthma Status and Severity 

Affects Missed School Days.’’ Journal of School 

Health 76.1 (2006): 18–24. 

45Bye, ‘‘Effectiveness of Compliance with 

Pediatric Preventative Care Guidelines Among 

Medicaid Beneficiaries.’’ 

46Fangjun Zhou, Jeanne Santoli, Mark L. 

Messonnier, Hussain R. Yusuf, Abigail Shefer, 

Susan Y. Chu, Lance Rodewald, Rafael Harpaz. 

Economic Evaluation of the 7-Vaccine Routine 

Childhood Immunization Schedule in the United 

States. Archives of Pediatric and Adolescent 

Medicine 2005; 159(12): 1136–1144. The estimates 

of the cost savings are based on current 

immunization levels. The incremental impact of 

increasing immunization rates is likely to be 

smaller, but still significant and positive. 

47Maciosek MV, Coffield AB, Edwards NM, 

Coffield AB, Flottemesch TJ, Goodman MJ, Solberg 

LI. Priorities among effective clinical preventive 

services: Results of a Systematic Review and 

Analysis. Am J Prev Med 2006; 31(1):52–61. 

48Solberg LI, Maciosek, MV, Edwards NM, 

Khanchandani HS, and Goodman MJ. Repeated 

tobacco-use screening and intevention in clinical 

practice: Health impact and cost effectiveness. 

American Journal of Preventive Medicine. 

2006;31(1). 

49Congressional Budget Office. ‘‘Technological 

Change and the Growth of Health Care Spending.’’ 

January 2008. Box 1, pdf p. 18. http://www.cbo.gov/ 

ftpdocs/89xx/doc8947/01-31-TechHealth.pdf. 

50 ‘‘Working Group Report on Future Research 

Directions in Childhood Obesity Prevention and 

Treatment.’’ National Heart, Lung and Blood 

Institute, National Institutes of Health, U.S. 

Department of Health and Human Services (2007), 

available at http://www.nhlbi.nih.gov/meetings/ 

workshops/child-obesity/index.htm. 

51 Ibid. 

52Centers for Disease Control and Prevention. 

‘‘Obesity and Overweight.’’ 2010. http:// 

www.cdc.gov/nchs/fastats/overwt.htm. 

53Agency for Healthcare Research and Quality 

(AHRQ). ‘‘Screening for Obesity in Adults.’’ 

December 2003. http://www.ahrq.gov/clinic/ 

3rduspstf/obesity/obesrr.pdf. 

54Thorpe, Kenneth E. ‘‘The Future Costs of 

Obesity: National and State Estimates of the Impact 

of Obesity on Direct Health Care Expenses.’’ 

November 2009; McKinsey Global Institute. 

‘‘Sample data suggest that obese adults can incur 

nearly twice the annual health care costs of normalweight adults.’’ 2007. 

55Congressional Budget Office. ‘‘Technological 

Change and the Growth of Health Care Spending.’’ 

January 2008. Box 1, pdf p. 18. http://www.cbo.gov/ 

ftpdocs/89xx/doc8947/01-31-TechHealth.pdf. 

interim final regulations can be 

expected to have substantial 

productivity benefits in the labor 

market. 

Illnesses also contribute to increased 

absenteeism among school children, 

which could be avoided with 

recommended preventive services. In 

2006, 56 percent of students missed 

between one and five days of school due 

to illness, 10 percent missed between 

six and ten days and five percent missed 

11 or more days.41 Obesity in particular 

contributes to missed school days: One 

study from the University of 

Pennsylvania found that overweight 

children were absent on average 20 

percent more than their normal-weight 

peers.42 Studies also show that 

influenza contributes to school 

absenteeism, and vaccination can 

reduce missed school days and 

indirectly improve community health.43

These interim final regulations will 

ensure that children have access to 

preventive services, thus decreasing the 

number of days missed due to illness.44

Similarly, regular pediatric care, 

including care by physicians 

specializing in pediatrics, can improve 

child health outcomes and avert 

preventable health care costs. For 

example, one study of Medicaid 

enrolled children found that when 

children were up to date for their age on 

their schedule of well-child visits, they 

were less likely to have an avoidable 

hospitalization at a later time.45

A third type of benefit from some 

preventive services is cost savings. 

Increasing the provision of preventive 

services is expected to reduce the 

incidence or severity of illness, and, as 

a result, reduce expenditures on 

treatment of illness. For example, 

childhood vaccinations have generally 

been found to reduce such expenditures 

by more than the cost of the 

vaccinations themselves and generate 

considerable benefits to society. 

Researchers at the Centers for Disease 

Control and Prevention (CDC) studying 

the economic impact of DTaP 

(diphtheria and tetanus toxoids and 

acellular Pertussis), Td (tetanus and 

diphtheria toxoids), Hib (Haemophilus 

influenza type b), IPV (inactivated 

poliovirus), MMR (measles, mumps and 

rubella), Hepatitis B and varicella 

routine childhood vaccines found that 

every dollar spent on immunizations in 

2001 was estimated to save $5.30 on 

direct health care costs and $16.50 on 

total societal costs of the diseases as 

they are prevented or reduced (direct 

health care associated with the diseases 

averted were $12.1 billion and total 

societal costs averted were $33.9 

billion).46

A review of preventive services by the 

National Committee on Prevention 

Priorities found that, in addition to 

childhood immunizations, two of the 

recommended preventive services— 

discussing aspirin use with high-risk 

adults and tobacco use screening and 

brief intervention—are cost-saving on 

net.47 By itself, tobacco use screening 

with a brief intervention was found to 

save more than $500 per smoker.48

Another area where prevention could 

achieve savings is obesity prevention 

and reduction. Obesity is widely 

recognized as an important driver of 

higher health care expenditures.49 The 

Task Force recommends children over 

age six and adults be screened for 

obesity and be offered or referred to 

counseling to improve weight status or 

promote weight loss. Increasing obesity 

screening and referrals to counseling 

should decrease obesity and its related 

costs. If providers are able to proactively 

identify and monitor obesity in child 

patients, they may reduce the incidence 

of adult health conditions that can be 

expensive to treat, such as diabetes, 

hypertension, and adult obesity.50 One 

recent study estimated that a onepercentage-point reduction in obesity 

among twelve-year-olds would save 

$260.4 million in total medical 

expenditures.51

A full quantification of the cost 

savings from the extension of coverage 

of preventive services in these interim 

final regulations is not possible, but to 

illustrate the potential savings, an 

assessment of savings from obesity 

reduction was conducted. According to 

the CDC, in 2008, 34.2 percent of U.S. 

adults and 16.9 percent of children were 

obese (defined as having a body mass 

index (BMI) of 30.0 or greater).52

Obesity is associated with increased risk 

for coronary heart disease, 

hypertension, stroke, type 2 diabetes, 

several types of cancer, diminished 

mobility, and social stigmatization.53 As 

a result, obesity is widely recognized as 

an important driver of higher health 

care expenditures on an individual 54

and national level.55

As described below, the Departments’ 

analysis assumes that the utilization of 

preventive services will increase when 

they are covered with zero copayment, 

and these interim final regulations are 

expected to increase utilization of 

dietary counseling services both among 

people who currently have the service 

covered with a copayment and among 

people for whom the service is not 

currently covered at all. 

Data from the 2009 Kaiser Family 

Foundation Employer Health Benefits 

Survey shows that 73 percent of 

employees with employer-sponsored 

insurance from a small (< 200 

employees) employer do not currently 

have coverage for weight loss programs, 

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41736 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 

56 Kaiser Family Foundation. 2009 Employer 

Health Benefits Annual Survey. Public Use File 

provided to CEA; documentation of statistical 

analysis available upon request. See http:// 

ehbs.kff.org. 57 Davis NJ, Emerenini A, Wylie-Rosett J. ‘‘Obesity 

management: physician practice patterns and 

patient preference,’’ Diabetes Education. 2006 Jul– 

Aug; 32(4):557–61. 

58Molly E. Waring, PhD, Mary B. Roberts, MS, 

Donna R. Parker, ScD and Charles B. Eaton, MD, 

MS. ‘‘Documentation and Management of 

Overweight and Obesity in Primary Care,’’ The 

Journal of the American Board of Family Medicine 

22 (5): 544–552 (2009). 

59This estimate is constructed using a weighted 

average obesity rate taking into account the share 

of the population aged 0 to 19 and 20 to 74 and 

their respective obesity rates, derived from Census 

Bureau and Centers for Disease Control and 

Prevention data. U.S. Census Bureau. ‘‘Current 

Population Survey (CPS) Table Creator.’’ 2010. 

http://www.census.gov/hhes/www/cpstc/ 

cps_table_creator.html. Centers for Disease Control 

and Prevention. ‘‘Obesity and Overweight.’’ 2010. 

http://www.cdc.gov/nchs/fastats/overwt.htm. 

60McKinsey Global Institute Analysis provided to 

CEA. 

61Agency for Healthcare Research and Quality 

(AHRQ). ‘‘Screening for Obesity in Adults.’’ 

December 2003. p. 4. http://www.ahrq.gov/clinic/ 

3rduspstf/obesity/obesrr.pdf. 

62See e.g., Jonathan Gruber, The Role of 

Consumer Copayments for Health Care: Lessons 

from the RAND Health Insurance Experiment and 

Beyond, Kaiser Family Foundation (Oct. 2006). This 

paper examines an experiment in which copays 

randomly vary across several thousand individuals. 

The author finds that individuals are sensitive to 

prices for health services—i.e., as copays decline, 

more services are demanded. 

compared to 38 percent at large firms.56

In the illustrative analysis below, the 

share of individuals without weight loss 

coverage in the individual market is 

assumed to be equal to the share in the 

small group market. 

The size of the increase in the number 

of individuals receiving dietary 

counseling or other weight loss services 

will be limited by current physician 

practice patterns, in which relatively 

few individuals who are obese receive 

physician recommendations for dietary 

counseling. In one study of patients at 

an internal medicine clinic in the 

Bronx, NY, approximately 15 percent of 

obese patients received a 

recommendation for dietary 

counseling.57 Similarly, among 

overweight and obese patients enrolled 

in the Cholesterol Education and 

Research Trial, approximately 15 to 20 

percent were referred to nutrition 

counseling.58

These interim final regulations are 

expected to increase the take-up rate of 

counseling among patients who are 

referred to it, and may, over time, lead 

physicians to increase their referral to 

such counseling, knowing that it will be 

covered, and covered without cost 

sharing. The effect of these interim final 

regulations is expected to be magnified 

because of the many other public and 

private sector initiatives dedicated to 

combating the obesity epidemic. 

In the absence of data on take-up of 

counseling among patients who are 

referred by their physicians, it is 

difficult to know what fraction of the 

estimated 15 percent to 20 percent of 

patients who are currently referred to 

counseling follow through on that 

referral, or how that fraction will change 

after coverage of these services is 

expanded. A reasonable assumption is 

that utilization of dietary counseling 

among patients who are obese might 

increase by five to 10 percentage points 

as a result of these interim final 

regulations. If physicians change their 

behavior and increase the rate at which 

they refer to counseling, the effect might 

be substantially larger. 

The share of obese individuals 

without weight loss coverage is 

estimated to be 29 percent.59 It is 

assumed that obese individuals have 

health care costs 39 percent above 

average, based on a McKinsey Global 

Institute analysis.60 The Task Force 

noted that counseling interventions led 

to sustained weight loss ranging from 

four percent to eight percent of body 

weight, although there is substantial 

heterogeneity in results across 

interventions, with many interventions 

having little long-term effect.61

Assuming midpoint reduction of six 

percent of body weight, the BMI for an 

individual taking up such an 

intervention would fall by six percent as 

well, as height would remain constant. 

Based on the aforementioned McKinsey 

Global Institute analysis, a six percent 

reduction in BMI for an obese 

individual (from 32 to around 30, for 

example) would result in a reduction in 

health care costs of approximately five 

percent. This parameter for cost 

reduction is subject to considerable 

uncertainty, given the wide range of 

potential weight loss strategies with 

varying degrees of impact on BMI, and 

their interconnectedness with changes 

in individual health care costs. 

Multiplying the percentage reduction 

in health care costs by the total 

premiums of obese individuals newly 

gaining obesity prevention coverage 

allows for an illustrative calculation of 

the total dollar reduction in premiums, 

and dividing by total premiums for the 

affected population allows for an 

estimate of the reduction in average 

premiums across the entire affected 

population. Doing so results in a 

potential private premium reduction of 

0.05 percent to 0.1 percent from lower 

health care costs due to a reduction in 

obesity for enrollees in nongrandfathered plans. This does not 

account for potential savings in 

Medicaid, Medicare, or other health 

programs. 

A fourth benefit of these interim final 

regulations will be to distribute the cost 

of preventive services more equitably 

across the broad insured population. 

Some Americans in plans affected by 

these regulations currently have no 

coverage of certain recommended 

preventive services, and pay for them 

entirely out-of-pocket. For some 

individuals who currently have no 

coverage of certain recommended 

preventive services, these interim final 

regulations will result in a large savings 

in out-of-pocket payments, and only a 

small increase in premiums. Many other 

Americans have limited coverage of 

certain recommended preventive 

services, with large coinsurance or 

deductibles, and also make substantial 

out-of-pocket payments to obtain 

preventive services. Some with limited 

coverage of preventive services will also 

experience large savings as a result of 

these interim final regulations. 

Reductions in out-of-pocket costs are 

expected to be largest among people in 

age groups in which relatively 

expensive preventive services are most 

likely to be recommended. 

5. Costs and Transfers 

The changes in how plans and issuers 

cover the recommended preventive 

services resulting from these interim 

final regulations will result in changes 

in covered benefits and premiums for 

individuals in plans and health 

insurance coverage subject to these 

interim final regulations. New costs to 

the health system result when 

beneficiaries increase their use of 

preventive services in response to the 

changes in coverage of preventive 

services. Cost sharing, including 

coinsurance, deductibles, and 

copayments, divides the costs of health 

services between the insurer and the 

beneficiaries. The removal of cost 

sharing increases the quantity of 

services demanded by lowering the 

direct cost of the service to consumers. 

Therefore, the Departments expect that 

the statute and these interim final 

regulations will increase utilization of 

the covered preventive services. The 

magnitude of this effect on utilization 

depends on the price elasticity of 

demand. 

Several studies have found that 

individuals are sensitive to prices for 

health services.62 Evidence that 

consumers change their utilization of 

preventive services is available from 

CDC researchers who studied out-ofpocket costs of immunizations for 

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Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 41737 

63See e.g., Noelle-Angelique Molinari et al., ‘‘Outof-Pocket Costs of Childhood Immunizations: A 

Comparison by Type of Insurance Plan,’’ Pediatrics, 

120(5) pp. 148–156 (2006). 

64The National Health Expenditure Accounts 

(NHEA) are the official estimates of total health care 

spending in the United States. See http:// 

www.cms.gov/NationalHealthExpendData/ 

02_NationalHealthAccountsHistorical.asp. 

65The model does not distinguish between 

recommended and non-recommended preventive 

services, and so this likely represents an 

overestimate of the insurance benefits for 

preventive services. 

66The Blue Cross Blue Shield standard option 

plan documentation is available online at http:// 

fepblue.org/benefitplans/standard-option/ 

index.html. 

67Frey A, Mika S, Nuzum R, and Schoen C. 

‘‘Setting a National Minimum Standard for Health 

Benefits: How do State Benefit Mandates Compare 

with Benefits in Large-Group Plans?’’ Issue Brief. 

Commonwealth Fund June 2009 available at 

http://www.commonwealthfund.org/Content/ 

Publications/Issue-Briefs/2009/Jun/Setting-aNational-Minimum-Standard-for-HealthBenefits.aspx. 

68The Task Force recommends that women 

whose family history is associated with an 

increased risk for deleterious mutations in BRCA1 

or BRCA2 genes be referred for genetic counseling 

and evaluation for BRCA testing and screening of 

adolescents (12–18 years of age) for major 

depressive disorder (MDD) when systems are in 

place to ensure accurate diagnosis, psychotherapy 

(cognitive-behavioral or interpersonal), and followup. 

69Lead, autism, and oral health screening are 

from the HRSA comprehensive guidelines. 

privately insured children up to age 5 in 

families in Georgia in 2003, to find that 

a one percent increase in out-of-pocket 

costs for routine immunizations (DTaP, 

IPV, MMR, Hib, and Hep B) was 

associated with a 0.07 percent decrease 

in utilization.63

Along with new costs of induced 

utilization, there are transfers associated 

with these interim final regulations. A 

transfer is a change in who pays for the 

services, where there is not an actual 

change in the level of resources used. 

For example, costs that were previously 

paid out-of-pocket for certain preventive 

services will now be covered by plans 

and issuers under these interim final 

regulations. Such a transfer of costs 

could be expected to lead to an increase 

in premiums. 

a. Estimate of Average Changes in 

Health Insurance Premiums 

The Departments assessed the impact 

of eliminating cost sharing, increases in 

services covered, and induced 

utilization on the average insurance 

premium using a model to evaluate 

private health insurance plans against a 

nationally representative population. 

The model is based on the Medical 

Expenditure Panel Survey data from 

2004, 2005, and 2006 on household 

spending on health care, which are 

scaled to levels consistent with the CMS 

projections of the National Health 

Expenditure Accounts.64 This data is 

combined with data from the Employer 

Health Benefits Surveys conducted by 

the Kaiser Family Foundation and 

Health Research and Education Trust to 

model a ‘‘typical PPO coverage’’ plan. 

The model then allows the user to 

assess changes in covered expenses, 

benefits, premiums, and induced 

utilization of services resulting from 

changes in the characteristics of the 

plan. The analysis of changes in 

coverage is based on the average perperson covered expenses and insurance 

benefits. The average covered expense is 

the total charge for covered services; 

insurance benefits are the part of the 

covered expenses covered by the 

insurer. The effect on the average 

premium is then estimated based on the 

percentage changes in the insurance 

benefits and the distribution of the 

individuals across individual and group 

markets in non-grandfathered plans. 

The Departments assume that the 

percent increase for insurance benefits 

and premiums will be the same. This is 

based on two assumptions: (1) That 

administrative costs included in the 

premium will increase proportionally 

with the increase in insurance benefits; 

and (2) that the increases in insurance 

benefits will be directly passed on to the 

consumer in the form of higher 

premiums. These assumptions bias the 

estimates of premium changes upward. 

Using this model, the Departments 

assessed: (1) Changes in cost-sharing for 

currently covered and utilized services, 

(2) changes in services covered, and (3) 

induced utilization of preventive 

services. There are several additional 

sources of uncertainty concerning these 

estimates. First, there is no accurate, 

granular data on exactly what baseline 

coverage is for the particular preventive 

services addressed in these interim final 

regulations. Second, there is uncertainty 

over behavioral assumptions related to 

additional utilization that results from 

reduced cost-sharing. Therefore, after 

providing initial estimates, the 

Departments provide a sensitivity 

analysis to capture the potential range of 

impacts of these interim final 

regulations. 

From the Departments’ analysis of the 

Medical Expenditure Panel Survey 

(MEPS) data, controlled to be consistent 

with projections of the National Health 

Expenditure Accounts, the average 

person with employer-sponsored 

insurance (ESI) has $264 in covered 

expenses for preventive services, of 

which $240 is paid by insurance, and 

$24 is paid out-of-pocket.65 When 

preventive services are covered with 

zero copayment, the Departments expect 

the average preventive benefit (holding 

utilization constant) will increase by 

$24. This is a 0.6 percent increase in 

insurance benefits and premiums for 

plans that have relinquished their 

grandfather status. A similar, but larger 

effect is expected in the individual 

market because existing evidence 

suggests that individual health 

insurance policies generally have less 

generous benefits for preventive services 

than group health plans. However, the 

evidence base for current coverage and 

cost sharing for preventive services in 

individual health insurance policies is 

weaker than for group health plans, 

making estimation of the increase in 

average benefits and premiums in the 

individual market highly uncertain. 

For analyses of changes in covered 

services, the Departments used the Blue 

Cross/Blue Shield Standard (BC/BS) 

plan offered through the Federal 

Employees Health Benefits Program as 

an average plan.66 Other analyses have 

used the BC/BS standard option as an 

average plan as it was designed to 

reflect standard practice within 

employer-sponsored health insurance 

plans.67 BC/BS covers most of the 

preventive services listed in the Task 

Force and Advisory Committee 

recommendations, and most of the 

preventive services listed in the 

comprehensive guidelines for infants, 

children, and adolescents supported by 

HRSA. Not covered by the BC/BS 

Standard plan are the recommendations 

for genetic testing for the BRCA gene, 

adolescent depression screening,68 lead 

testing, autism testing, and oral health 

screening.69

The Departments estimated the 

increase in benefits from newly covered 

services by estimating the number of 

new services that would be provided 

times the cost of providing the services, 

and then spread these new costs across 

the total insured population. The 

Departments estimated that adding 

coverage for genetic screening and 

depression screening would increase 

insurance benefits an estimated 0.10 

percent. Adding lead testing, autism 

testing, and oral health screening would 

increase insurance benefits by an 

estimated 0.02 percent. This results in a 

total average increase in insurance 

benefits on these services of 0.12 

percent, or just over $4 per insured 

person. This increase represents a 

mixture of new costs and transfers, 

dependent on whether beneficiaries 

previously would have purchased these 

services on their own. It is also 

important to remember that actual plan 

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41738 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 

70Standard formula best described in ‘‘QuantityPrice Relationships in Health Insurance’’, Charles L 

Trowbridge, Chief Actuary, Social Security 

Administration (DHEW Publication No. (SSA)73– 

11507, November 1972). 

impacts will vary depending on baseline 

benefit levels, and that grandfathered 

health plans will not experience any 

impact from these interim final 

regulations. The Departments expect the 

increase to be larger in the individual 

market because coverage of preventive 

services in the individual market is less 

complete than coverage in the group 

market, but as noted previously, the 

evidence base for the individual market 

is weaker than that of the group market, 

making detailed estimates of the size of 

this effect difficult and highly uncertain. 

Actuaries use an ‘‘induction formula’’ 

to estimate the behavioral change in 

response to changes in the relative 

levels of coverage for health services. 

For this analysis, the Departments used 

the model to estimate the induced 

demand (the increased use of preventive 

services). The model uses a standard 

actuarial formula for induction 1/ 

(1+alpha*P), where alpha is the 

‘‘induction parameter’’ and P is the 

average fraction of the cost of services 

paid by the consumer. The induction 

parameter for physician services is 0.7, 

derived by the standard actuarial 

formula that is generally consistent with 

the estimates of price elasticity of 

demand from the RAND Health 

Insurance Experiment and other 

economic studies.70 Removing cost 

sharing for preventive services lowers 

the direct cost to consumers of using 

preventive services, which induces 

additional utilization, estimated with 

the model above to increase covered 

expenses and benefits by approximately 

$17, or 0.44 percent in insurance 

benefits in group health plans. The 

Departments expect a similar but larger 

effect in the individual market, although 

these estimates are highly uncertain. 

The Departments calculated an 

estimate of the average impact using the 

information from the analyses described 

above, using estimates of the number of 

individuals in non-grandfathered health 

plans in the group and individual 

markets in 2011. The Departments 

estimate that premiums will increase by 

approximately 1.5 percent on average 

for enrollees in non-grandfathered 

plans. This estimate assumes that any 

changes in insurance benefits will be 

directly passed on to the consumer in 

the form of changes in premiums. As 

mentioned earlier, this assumption 

biases the estimates of premium change 

upward. 

b. Sensitivity analysis 

As discussed previously, there is 

substantial uncertainty associated with 

the estimates presented above. To 

address the uncertainty in the group 

market, the Departments first varied the 

estimated change to underlying benefits, 

to address the particular uncertainty 

behind the estimate of baseline coverage 

of preventive services in the group 

market. The estimate for the per person 

annual increase in insurance benefits 

from adding coverage for new services 

is approximately $4. The Departments 

considered the impact of a smaller and 

larger addition in benefits of 

approximately $2 and $6 per person. To 

consider the impact of uncertainty 

around the size of the behavioral change 

(that is, the utilization of more services 

when cost sharing is eliminated), the 

Departments analyzed the impact on 

insurance benefits if the behavioral 

change were 15 percent smaller and 15 

percent larger. 

In the individual market, to 

accommodate the greater uncertainty 

relative to the group market, the 

Departments considered the impact of 

varying the increase in benefits resulting 

from cost shifting due to the elimination 

of cost sharing, in addition to varying 

the cost of newly covered services and 

behavioral change. 

Combining results in the group and 

individual markets for enrollees in nongrandfathered plans, the Departments’ 

low-end is a few tenths of a percent 

lower than the mid-range estimate of 

approximately 1.5 percent, and the 

high-end estimate is a few tenths of a 

percent higher. Grandfathered health 

plans are not subject to these interim 

final regulations and therefore would 

not experience this premium change. 

6. Alternatives Considered 

Several provisions in these interim 

final regulations involved policy 

choices. One was whether to allow a 

plan or issuer to impose cost sharing for 

an office visit when a recommended 

preventive service is provided in that 

visit. Sometimes a recommended 

preventive service is billed separately 

from the office visit; sometimes it is not. 

The Departments decided that the cost 

sharing prohibition of these interim 

final regulations applies to the specific 

preventive service as recommended by 

the guidelines. Therefore, if the 

preventive service is billed separately 

from the office visit, it is the preventive 

service that has cost sharing waived, not 

the entire office visit. 

A second policy choice was if the 

preventive service is not billed 

separately from the office visit, whether 

these interim final regulations should 

prohibit cost sharing for any office visit 

in which any recommended preventive 

service was administered, or whether 

cost sharing should be prohibited only 

when the preventive service is the 

primary purpose of the office visit. 

Prohibiting cost sharing for office visits 

when any recommended preventive 

service is provided, regardless of the 

primary purpose of the visit, could lead 

to an overly broad application of these 

interim final regulations; for example, a 

person who sees a specialist for a 

particular condition could end up with 

a zero copayment simply because his or 

her blood pressure was taken as part of 

the office visit. This could create 

financial incentives for consumers to 

request preventive services at office 

visits that are intended for other 

purposes in order to avoid copayments 

and deductibles. The increased 

prevalence of the application of zero 

cost sharing would lead to increased 

premiums compared with the chosen 

option, without a meaningful additional 

gain in access to preventive services. 

A third issue involves health plans 

that have differential cost sharing for 

services provided by providers who are 

in and out of their networks. These 

interim final regulations provide that a 

plan or issuer is not required to provide 

coverage for recommended preventive 

services delivered by an out-of-network 

provider. The plan or issuer may also 

impose cost sharing for recommended 

preventive services delivered by an outof-network provider. The Departments 

considered that requiring coverage by 

out-of-network providers at no cost 

sharing would result in higher 

premiums for these interim final 

regulations. Plans and issuers negotiate 

allowed charges with in-network 

providers as a way to promote effective, 

efficient health care, and allowing 

differences in cost sharing in- and outof-network enables plans to encourage 

use of in-network providers. Allowing 

zero cost sharing for out of network 

providers could reduce providers’ 

incentives to participate in insurer 

networks. The Departments decided that 

permitting cost sharing for 

recommended preventive services 

provided by out-of-network providers is 

the appropriate option to preserve 

choice of providers for individuals, 

while avoiding potentially larger 

increases in costs and transfers as well 

as potentially lower quality care. 

C. Regulatory Flexibility Act— 

Department of Labor and Department of 

Health and Human Services 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) (RFA) imposes 

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certain requirements with respect to 

Federal rules that are subject to the 

notice and comment requirements of 

section 553(b) of the APA (5 U.S.C. 551 

et seq.) and that are likely to have a 

significant economic impact on a 

substantial number of small entities. 

Section 9833 of the Code, section 734 of 

ERISA, and section 2792 of the PHS Act 

authorize the Secretaries to promulgate 

any interim final rules that they 

determine are appropriate to carry out 

the provisions of chapter 100 of the 

Code, part 7 of subtitle B or title I of 

ERISA, and part A of title XXVII of the 

PHS Act, which include PHS Act 

sections 2701 through 2728 and the 

incorporation of those sections into 

ERISA section 715 and Code section 

9815. 

Moreover, under Section 553(b) of the 

APA, a general notice of proposed 

rulemaking is not required when an 

agency, for good cause, finds that notice 

and public comment thereon are 

impracticable, unnecessary, or contrary 

to the public interest. These interim 

final regulations are exempt from APA, 

because the Departments made a good 

cause finding that a general notice of 

proposed rulemaking is not necessary 

earlier in this preamble. Therefore, the 

RFA does not apply and the 

Departments are not required to either 

certify that the rule would not have a 

significant economic impact on a 

substantial number of small entities or 

conduct a regulatory flexibility analysis. 

Nevertheless, the Departments 

carefully considered the likely impact of 

the rule on small entities in connection 

with their assessment under Executive 

Order 12866. Consistent with the policy 

of the RFA, the Departments encourage 

the public to submit comments that 

suggest alternative rules that accomplish 

the stated purpose of the Affordable 

Care Act and minimize the impact on 

small entities. 

D. Special Analyses—Department of the 

Treasury 

Notwithstanding the determinations 

of the Department of Labor and 

Department of Health and Human 

Services, for purposes of the Department 

of the Treasury, it has been determined 

that this Treasury decision is not a 

significant regulatory action for 

purposes of Executive Order 12866. 

Therefore, a regulatory assessment is not 

required. It has also been determined 

that section 553(b) of the APA (5 U.S.C. 

chapter 5) does not apply to these 

interim final regulations. For the 

applicability of the RFA, refer to the 

Special Analyses section in the 

preamble to the cross-referencing notice 

of proposed rulemaking published 

elsewhere in this issue of the Federal 

Register. Pursuant to section 7805(f) of 

the Code, these temporary regulations 

have been submitted to the Chief 

Counsel for Advocacy of the Small 

Business Administration for comment 

on their impact on small businesses. 

E. Paperwork Reduction Act: 

Department of Labor, Department of the 

Treasury, and Department of Health 

and Human Services 

These interim final regulations are not 

subject to the requirements of the 

Paperwork Reduction Act of 1980 (44 

U.S.C. 3501 et seq.) because it does not 

contain a ‘‘collection of information’’ as 

defined in 44 U.S.C. 3502 (11). 

F. Congressional Review Act 

These interim final regulations are 

subject to the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (5 U.S.C. 801 et seq.) and have 

been transmitted to Congress and the 

Comptroller General for review. 

G. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4) requires 

agencies to prepare several analytic 

statements before proposing any rules 

that may result in annual expenditures 

of $100 million (as adjusted for 

inflation) by State, local and tribal 

governments or the private sector. These 

interim final regulations are not subject 

to the Unfunded Mandates Reform Act 

because they are being issued as interim 

final regulations. However, consistent 

with the policy embodied in the 

Unfunded Mandates Reform Act, these 

interim final regulations have been 

designed to be the least burdensome 

alternative for State, local and tribal 

governments, and the private sector, 

while achieving the objectives of the 

Affordable Care Act. 

H. Federalism Statement—Department 

of Labor and Department of Health and 

Human Services 

Executive Order 13132 outlines 

fundamental principles of federalism, 

and requires the adherence to specific 

criteria by Federal agencies in the 

process of their formulation and 

implementation of policies that have 

‘‘substantial direct effects’’ on the States, 

the relationship between the national 

government and States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Federal agencies 

promulgating regulations that have 

these federalism implications must 

consult with State and local officials, 

and describe the extent of their 

consultation and the nature of the 

concerns of State and local officials in 

the preamble to the regulation. 

In the Departments’ view, these 

interim final regulations have 

federalism implications, because they 

have direct effects on the States, the 

relationship between the national 

government and States, or on the 

distribution of power and 

responsibilities among various levels of 

government. However, in the 

Departments’ view, the federalism 

implications of these interim final 

regulations are substantially mitigated 

because, with respect to health 

insurance issuers, the Departments 

expect that the majority of States will 

enact laws or take other appropriate 

action resulting in their meeting or 

exceeding the Federal standards. 

In general, through section 514, 

ERISA supersedes State laws to the 

extent that they relate to any covered 

employee benefit plan, and preserves 

State laws that regulate insurance, 

banking, or securities. While ERISA 

prohibits States from regulating a plan 

as an insurance or investment company 

or bank, the preemption provisions of 

section 731 of ERISA and section 2724 

of the PHS Act (implemented in 29 CFR 

2590.731(a) and 45 CFR 146.143(a)) 

apply so that the HIPAA requirements 

(including those of the Affordable Care 

Act) are not to be ‘‘construed to 

supersede any provision of State law 

which establishes, implements, or 

continues in effect any standard or 

requirement solely relating to health 

insurance issuers in connection with 

group health insurance coverage except 

to the extent that such standard or 

requirement prevents the application of 

a requirement’’ of a Federal standard. 

The conference report accompanying 

HIPAA indicates that this is intended to 

be the ‘‘narrowest’’ preemption of State 

laws. (See House Conf. Rep. No. 104– 

736, at 205, reprinted in 1996 U.S. Code 

Cong. & Admin. News 2018.) States may 

continue to apply State law 

requirements except to the extent that 

such requirements prevent the 

application of the Affordable Care Act 

requirements that are the subject of this 

rulemaking. State insurance laws that 

are more stringent than the Federal 

requirements are unlikely to ‘‘prevent 

the application of’’ the Affordable Care 

Act, and be preempted. Accordingly, 

States have significant latitude to 

impose requirements on health 

insurance issuers that are more 

restrictive than the Federal law. 

In compliance with the requirement 

of Executive Order 13132 that agencies 

examine closely any policies that may 

have federalism implications or limit 

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the policy making discretion of the 

States, the Departments have engaged in 

efforts to consult with and work 

cooperatively with affected State and 

local officials, including attending 

conferences of the National Association 

of Insurance Commissioners and 

consulting with State insurance officials 

on an individual basis. It is expected 

that the Departments will act in a 

similar fashion in enforcing the 

Affordable Care Act requirements. 

Throughout the process of developing 

these interim final regulations, to the 

extent feasible within the specific 

preemption provisions of HIPAA as it 

applies to the Affordable Care Act, the 

Departments have attempted to balance 

the States’ interests in regulating health 

insurance issuers, and Congress’ intent 

to provide uniform minimum 

protections to consumers in every State. 

By doing so, it is the Departments’ view 

that they have complied with the 

requirements of Executive Order 13132. 

Pursuant to the requirements set forth 

in section 8(a) of Executive Order 

13132, and by the signatures affixed to 

these interim final regulations, the 

Departments certify that the Employee 

Benefits Security Administration and 

the Centers for Medicare & Medicaid 

Services have complied with the 

requirements of Executive Order 13132 

for the attached regulations in a 

meaningful and timely manner. 

V. Recommended Preventive Services 

as of July 14, 2010 

The materials that follow list 

recommended preventive services, 

current as of July 14, 2010, that will 

have to be covered without cost-sharing 

when delivered by an in-network 

provider. In many cases, the 

recommendations or guidelines went 

into effect before September 23, 2009; 

therefore the recommended services 

must be covered under these interim 

final regulations in plan years (in the 

individual market, policy years) that 

begin on or after September 23, 2010. 

However, there are some services that 

appear in the figure that are based on 

recommendations or guidelines that 

went into effect at some point later than 

September 23, 2009. Those services do 

not have to be covered under these 

interim final regulations until plan years 

(in the individual market, policy years) 

that begin at some point later than 

September 23, 2010. In addition, there 

are a few recommendations and 

guidelines that went into effect after 

September 23, 2009 and are not 

included in the figure. In both cases, 

information at http:// 

www.HealthCare.gov/center/ 

regulations/prevention.html specifically 

identifies those services and the 

relevant dates. The materials at http:// 

www.HealthCare.gov/center/ 

regulations/prevention.html will be 

updated on an ongoing basis, and will 

contain the most current recommended 

preventive services. 

A. Recommendations of the United 

States Preventive Services Task Force 

(Task Force) 

Recommendations of the Task Force 

appear in a chart that follows. This chart 

includes a description of the topic, the 

text of the Task Force recommendation, 

the grade the recommendation received 

(A or B), and the date that the 

recommendation went into effect. 

B. Recommendations of the Advisory 

Committee On Immunization Practices 

(Advisory Committee) That Have Been 

Adopted by the Director of the Centers 

for Disease Control and Prevention 

Recommendations of the Advisory 

Committee appear in four immunization 

schedules that follow: A schedule for 

children age 0 to 6 years, a schedule for 

children age 7 to 18 years, a ‘‘catch-up’’ 

schedule for children, and a schedule 

for adults. Immunization schedules are 

issued every year, and the schedules 

that appear here are the 2010 schedules. 

The schedules contain graphics that 

provide information about the 

recommended age for vaccination, 

number of doses needed, interval 

between the doses, and (for adults) 

recommendations associated with 

particular health conditions. In addition 

to the graphics, the schedules contain 

detailed footnotes that provide further 

information on each immunization in 

the schedule. 

C. Comprehensive Guidelines Supported 

by the Health Resources and Services 

Administration (HRSA) for Infants, 

Children, and Adolescents 

Comprehensive guidelines for infants, 

children, and adolescents supported by 

HRSA appear in two charts that follow: 

The Periodicity Schedule of the Bright 

Futures Recommendations for Pediatric 

Preventive Health Care, and the 

Uniform Panel of the Secretary’s 

Advisory Committee on Heritable 

Disorders in Newborns and Children. 

BILLING CODE 4830–01–P; 4510–29–P; 4210–01–P 

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BILLING CODE 4830–01–C; 4510–29–C; 4210–01–C VI. Statutory Authority 

The Department of the Treasury 

temporary regulations are adopted 

pursuant to the authority contained in 

sections 7805 and 9833 of the Code. 


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41756 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 

The Department of Labor interim final 

regulations are adopted pursuant to the 

authority contained in 29 U.S.C. 1027, 

1059, 1135, 1161–1168, 1169, 1181– 

1183, 1181 note, 1185, 1185a, 1185b, 

1191, 1191a, 1191b, and 1191c; sec. 

101(g), Pub. L. 104–191, 110 Stat. 1936; 

sec. 401(b), Pub. L. 105–200, 112 Stat. 

645 (42 U.S.C. 651 note); sec. 512(d), 

Pub. L. 110–343, 122 Stat. 3881; sec. 

1001, 1201, and 1562(e), Pub. L. 111– 

148, 124 Stat. 119, as amended by Pub. 

L. 111–152, 124 Stat. 1029; Secretary of 

Labor’s Order 6–2009, 74 FR 21524 

(May 7, 2009). 

The Department of Health and Human 

Services interim final regulations are 

adopted pursuant to the authority 

contained in sections 2701 through 

2763, 2791, and 2792 of the PHS Act (42 

USC 300gg through 300gg-63, 300gg-91, 

and 300gg-92), as amended. 

List of Subjects 

26 CFR Part 54 

Excise taxes, Health care, Health 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

29 CFR Part 2590 

Continuation coverage, Disclosure, 

Employee benefit plans, Group health 

plans, Health care, Health insurance, 

Medical child support, Reporting and 

recordkeeping requirements. 

45 CFR Part 147 

Health care, Health insurance, 

Reporting and recordkeeping 

requirements, and State regulation of 

health insurance. 

Steven T. Miller, 

Deputy Commissioner for Services and 

Enforcement, Internal Revenue Service. 

Approved: July 8, 2010 

Michael F. Mundaca, 

Assistant Secretary of the Treasury (Tax 

Policy). 

Signed this 9th day of July, 2010. 

Phyllis C. Borzi, 

Assistant Secretary, Employee Benefits 

Security Administration, Department of 

Labor. 

Dated: July 9, 2010 

Jay Angoff, 

Director, Office of Consumer Information and 

Insurance Oversight. 

Dated: July 9, 2010. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Chapter 1 

■ Accordingly, 26 CFR Part 54 is 

amended as follows: 

PART 54—PENSION EXCISE TAXES 

■ Paragraph 1. The authority citation 

for part 54 is amended by adding an 

entry for § 54.9815–2713T in numerical 

order to read in part as follows: 

Authority: 26 U.S.C. 7805. * * * 

Section 54.9815–2713T also issued 

under 26 U.S.C. 9833. * * * 

■ Par. 2. Section 54.9815–2713T is 

added to read as follows: 

§ 54.9815–2713T Coverage of preventive 

health services (temporary). 

(a) Services—(1) In general. Beginning 

at the time described in paragraph (b) of 

this section, a group health plan, or a 

health insurance issuer offering group 

health insurance coverage, must provide 

coverage for all of the following items 

and services, and may not impose any 

cost-sharing requirements (such as a 

copayment, coinsurance, or deductible) 

with respect to those items or services: 

(i) Evidence-based items or services 

that have in effect a rating of A or B in 

the current recommendations of the 

United States Preventive Services Task 

Force with respect to the individual 

involved (except as otherwise provided 

in paragraph (c) of this section); 

(ii) 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 with 

respect to the individual involved (for 

this purpose, a recommendation from 

the Advisory Committee on 

Immunization Practices of the Centers 

for Disease Control and Prevention is 

considered in effect after it has been 

adopted by the Director of the Centers 

for Disease Control and Prevention, and 

a recommendation is considered to be 

for routine use if it is listed on the 

Immunization Schedules of the Centers 

for Disease Control and Prevention); 

(iii) With respect to infants, children, 

and adolescents, evidence-informed 

preventive care and screenings provided 

for in comprehensive guidelines 

supported by the Health Resources and 

Services Administration; and 

(iv) With respect to women, to the 

extent not described in paragraph 

(a)(1)(i) of this section, evidenceinformed preventive care and screenings 

provided for in comprehensive 

guidelines supported by the Health 

Resources and Services Administration. 

(2) Office visits—(i) If an item or 

service described in paragraph (a)(1) of 

this section is billed separately (or is 

tracked as individual encounter data 

separately) from an office visit, then a 

plan or issuer may impose cost-sharing 

requirements with respect to the office 

visit. 

(ii) If an item or service described in 

paragraph (a)(1) of this section is not 

billed separately (or is not tracked as 

individual encounter data separately) 

from an office visit and the primary 

purpose of the office visit is the delivery 

of such an item or service, then a plan 

or issuer may not impose cost-sharing 

requirements with respect to the office 

visit. 

(iii) If an item or service described in 

paragraph (a)(1) of this section is not 

billed separately (or is not tracked as 

individual encounter data separately) 

from an office visit and the primary 

purpose of the office visit is not the 

delivery of such an item or service, then 

a plan or issuer may impose costsharing requirements with respect to the 

office visit. 

(iv) The rules of this paragraph (a)(2) 

are illustrated by the following 

examples: 

Example 1. (i) Facts. An individual 

covered by a group health plan visits an innetwork health care provider. While visiting 

the provider, the individual is screened for 

cholesterol abnormalities, which has in effect 

a rating of A or B in the current 

recommendations of the United States 

Preventive Services Task Force with respect 

to the individual. The provider bills the plan 

for an office visit and for the laboratory work 

of the cholesterol screening test. 

(ii) Conclusion. In this Example 1, the plan 

may not impose any cost-sharing 

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billed laboratory work of the cholesterol 

screening test. Because the office visit is 

billed separately from the cholesterol 

screening test, the plan may impose costsharing requirements for the office visit. 

Example 2. (i) Facts. Same facts as 

Example 1. As the result of the screening, the 

individual is diagnosed with hyperlipidemia 

and is prescribed a course of treatment that 

is not included in the recommendations 

under paragraph (a)(1) of this section. 

(ii) Conclusion. In this Example 2, because 

the treatment is not included in the 

recommendations under paragraph (a)(1) of 

this section, the plan is not prohibited from 

imposing cost-sharing requirements with 

respect to the treatment. 

Example 3. (i) Facts. An individual 

covered by a group health plan visits an innetwork health care provider to discuss 

recurring abdominal pain. During the visit, 

the individual has a blood pressure 

screening, which has in effect a rating of A 

or B in the current recommendations of the 

United States Preventive Services Task Force 

with respect to the individual. The provider 

bills the plan for an office visit. 

(ii) Conclusion. In this Example 3, the 

blood pressure screening is provided as part 

of an office visit for which the primary 

purpose was not to deliver items or services 

described in paragraph (a)(1) of this section. 

Therefore, the plan may impose a costsharing requirement for the office visit 

charge. 

Example 4. (i) Facts. A child covered by a 

group health plan visits an in-network 

pediatrician to receive an annual physical 

exam described as part of the comprehensive 

guidelines supported by the Health 

Resources and Services Administration. 

During the office visit, the child receives 

additional items and services that are not 

described in the comprehensive guidelines 

supported by the Health Resources and 

Services Administration, nor otherwise 

described in paragraph (a)(1) of this section. 

The provider bills the plan for an office visit. 

(ii) Conclusion. In this Example 4, the 

service was not billed as a separate charge 

and was billed as part of an office visit. 

Moreover, the primary purpose for the visit 

was to deliver items and services described 

as part of the comprehensive guidelines 

supported by the Health Resources and 

Services Administration. Therefore, the plan 

may not impose a cost-sharing requirement 

with respect to the office visit. 

(3) Out-of-network providers. Nothing 

in this section requires a plan or issuer 

that has a network of providers to 

provide benefits for items or services 

described in paragraph (a)(1) of this 

section that are delivered by an out-ofnetwork provider. Moreover, nothing in 

this section precludes a plan or issuer 

that has a network of providers from 

imposing cost-sharing requirements for 

items or services described in paragraph 

(a)(1) of this section that are delivered 

by an out-of-network provider. 

(4) Reasonable medical management. 

Nothing prevents a plan or issuer from 

using reasonable medical management 

techniques to determine the frequency, 

method, treatment, or setting for an item 

or service described in paragraph (a)(1) 

of this section to the extent not specified 

in the recommendation or guideline. 

(5) Services not described. Nothing in 

this section prohibits a plan or issuer 

from providing coverage for items and 

services in addition to those 

recommended by the United States 

Preventive Services Task Force or the 

Advisory Committee on Immunization 

Practices of the Centers for Disease 

Control and Prevention, or provided for 

by guidelines supported by the Health 

Resources and Services Administration, 

or from denying coverage for items and 

services that are not recommended by 

that task force or that advisory 

committee, or under those guidelines. A 

plan or issuer may impose cost-sharing 

requirements for a treatment not 

described in paragraph (a)(1) of this 

section, even if the treatment results 

from an item or service described in 

paragraph (a)(1) of this section. 

(b) Timing—(1) In general. A plan or 

issuer must provide coverage pursuant 

to paragraph (a)(1) of this section for 

plan years that begin on or after 

September 23, 2010, or, if later, for plan 

years that begin on or after the date that 

is one year after the date the 

recommendation or guideline is issued. 

(2) Changes in recommendations or 

guidelines. A plan or issuer is not 

required under this section to provide 

coverage for any items and services 

specified in any recommendation or 

guideline described in paragraph (a)(1) 

of this section after the recommendation 

or guideline is no longer described in 

paragraph (a)(1) of this section. Other 

requirements of Federal or State law 

may apply in connection with a plan or 

issuer ceasing to provide coverage for 

any such items or services, including 

PHS Act section 2715(d)(4), which 

requires a plan or issuer to give 60 days 

advance notice to an enrollee before any 

material modification will become 

effective. 

(c) Recommendations not current. For 

purposes of paragraph (a)(1)(i) of this 

section, and for purposes of any other 

provision of law, recommendations of 

the United States Preventive Services 

Task Force regarding breast cancer 

screening, mammography, and 

prevention issued in or around 

November 2009 are not considered to be 

current. 

(d) Effective/applicability date. The 

provisions of this section apply for plan 

years beginning on or after September 

23, 2010. See § 54.9815–1251T for 

determining the application of this 

section to grandfathered health plans 

(providing that these rules regarding 

coverage of preventive health services 

do not apply to grandfathered health 

plans). 

(e) Expiration date. This section 

expires on July 12, 2013 or on such 

earlier date as may be provided in final 

regulations or other action published in 

the Federal Register. 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Chapter XXV 

■ 29 CFR Part 2590 is amended as 

follows: 

PART 2590—RULES AND 

REGULATIONS FOR GROUP HEALTH 

PLANS 

■ 1. The authority citation for Part 2590 

continues to read as follows: 

Authority: 29 U.S.C. 1027, 1059, 1135, 

1161–1168, 1169, 1181–1183, 1181 note, 

1185, 1185a, 1185b, 1191, 1191a, 1191b, and 

1191c; sec. 101(g), Pub. L. 104–191, 110 Stat. 

1936; sec. 401(b), Pub. L. 105–200, 112 Stat. 

645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 

110–343, 122 Stat. 3881; sec. 1001, 1201, and 

1562(e), Pub. L. 111–148, 124 Stat. 119, as 

amended by Pub. L. 111–152, 124 Stat. 1029; 

Secretary of Labor’s Order 6–2009, 74 FR 

21524 (May 7, 2009). 

Subpart C—Other Requirements 

■ 2. Section 2590.715–2713 is added to 

subpart C to read as follows: 

§ 2590.715–2713 Coverage of preventive 

health services. 

(a) Services—(1) In general. Beginning 

at the time described in paragraph (b) of 

this section, a group health plan, or a 

health insurance issuer offering group 

health insurance coverage, must provide 

coverage for all of the following items 

and services, and may not impose any 

cost-sharing requirements (such as a 

copayment, coinsurance, or deductible) 

with respect to those items or services: 

(i) Evidence-based items or services 

that have in effect a rating of A or B in 

the current recommendations of the 

United States Preventive Services Task 

Force with respect to the individual 

involved (except as otherwise provided 

in paragraph (c) of this section); 

(ii) 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 with 

respect to the individual involved (for 

this purpose, a recommendation from 

the Advisory Committee on 

Immunization Practices of the Centers 

for Disease Control and Prevention is 

considered in effect after it has been 

mstockstill on DSKH9S0YB1PROD with RULES

41758 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 

adopted by the Director of the Centers 

for Disease Control and Prevention, and 

a recommendation is considered to be 

for routine use if it is listed on the 

Immunization Schedules of the Centers 

for Disease Control and Prevention); 

(iii) With respect to infants, children, 

and adolescents, evidence-informed 

preventive care and screenings provided 

for in comprehensive guidelines 

supported by the Health Resources and 

Services Administration; and 

(iv) With respect to women, to the 

extent not described in paragraph 

(a)(1)(i) of this section, evidenceinformed preventive care and screenings 

provided for in comprehensive 

guidelines supported by the Health 

Resources and Services Administration. 

(2) Office visits—(i) If an item or 

service described in paragraph (a)(1) of 

this section is billed separately (or is 

tracked as individual encounter data 

separately) from an office visit, then a 

plan or issuer may impose cost-sharing 

requirements with respect to the office 

visit. 

(ii) If an item or service described in 

paragraph (a)(1) of this section is not 

billed separately (or is not tracked as 

individual encounter data separately) 

from an office visit and the primary 

purpose of the office visit is the delivery 

of such an item or service, then a plan 

or issuer may not impose cost-sharing 

requirements with respect to the office 

visit. 

(iii) If an item or service described in 

paragraph (a)(1) of this section is not 

billed separately (or is not tracked as 

individual encounter data separately) 

from an office visit and the primary 

purpose of the office visit is not the 

delivery of such an item or service, then 

a plan or issuer may impose costsharing requirements with respect to the 

office visit. 

(iv) The rules of this paragraph (a)(2) 

are illustrated by the following 

examples: 

Example 1. (i) Facts. An individual 

covered by a group health plan visits an innetwork health care provider. While visiting 

the provider, the individual is screened for 

cholesterol abnormalities, which has in effect 

a rating of A or B in the current 

recommendations of the United States 

Preventive Services Task Force with respect 

to the individual. The provider bills the plan 

for an office visit and for the laboratory work 

of the cholesterol screening test. 

(ii) Conclusion. In this Example 1, the plan 

may not impose any cost-sharing 

requirements with respect to the separatelybilled laboratory work of the cholesterol 

screening test. Because the office visit is 

billed separately from the cholesterol 

screening test, the plan may impose costsharing requirements for the office visit. 

Example 2. (i) Facts. Same facts as 

Example 1. As the result of the screening, the 

individual is diagnosed with hyperlipidemia 

and is prescribed a course of treatment that 

is not included in the recommendations 

under paragraph (a)(1) of this section. 

(ii) Conclusion. In this Example 2, because 

the treatment is not included in the 

recommendations under paragraph (a)(1) of 

this section, the plan is not prohibited from 

imposing cost-sharing requirements with 

respect to the treatment. 

Example 3. (i) Facts. An individual 

covered by a group health plan visits an innetwork health care provider to discuss 

recurring abdominal pain. During the visit, 

the individual has a blood pressure 

screening, which has in effect a rating of A 

or B in the current recommendations of the 

United States Preventive Services Task Force 

with respect to the individual. The provider 

bills the plan for an office visit. 

(ii) Conclusion. In this Example 3, the 

blood pressure screening is provided as part 

of an office visit for which the primary 

purpose was not to deliver items or services 

described in paragraph (a)(1) of this section. 

Therefore, the plan may impose a costsharing requirement for the office visit 

charge. 

Example 4. (i) Facts. A child covered by a 

group health plan visits an in-network 

pediatrician to receive an annual physical 

exam described as part of the comprehensive 

guidelines supported by the Health 

Resources and Services Administration. 

During the office visit, the child receives 

additional items and services that are not 

described in the comprehensive guidelines 

supported by the Health Resources and 

Services Administration, nor otherwise 

described in paragraph (a)(1) of this section. 

The provider bills the plan for an office visit. 

(ii) Conclusion. In this Example 4, the 

service was not billed as a separate charge 

and was billed as part of an office visit. 

Moreover, the primary purpose for the visit 

was to deliver items and services described 

as part of the comprehensive guidelines 

supported by the Health Resources and 

Services Administration. Therefore, the plan 

may not impose a cost-sharing requirement 

with respect to the office visit. 

(3) Out-of-network providers. Nothing 

in this section requires a plan or issuer 

that has a network of providers to 

provide benefits for items or services 

described in paragraph (a)(1) of this 

section that are delivered by an out-ofnetwork provider. Moreover, nothing in 

this section precludes a plan or issuer 

that has a network of providers from 

imposing cost-sharing requirements for 

items or services described in paragraph 

(a)(1) of this section that are delivered 

by an out-of-network provider. 

(4) Reasonable medical management. 

Nothing prevents a plan or issuer from 

using reasonable medical management 

techniques to determine the frequency, 

method, treatment, or setting for an item 

or service described in paragraph (a)(1) 

of this section to the extent not specified 

in the recommendation or guideline. 

(5) Services not described. Nothing in 

this section prohibits a plan or issuer 

from providing coverage for items and 

services in addition to those 

recommended by the United States 

Preventive Services Task Force or the 

Advisory Committee on Immunization 

Practices of the Centers for Disease 

Control and Prevention, or provided for 

by guidelines supported by the Health 

Resources and Services Administration, 

or from denying coverage for items and 

services that are not recommended by 

that task force or that advisory 

committee, or under those guidelines. A 

plan or issuer may impose cost-sharing 

requirements for a treatment not 

described in paragraph (a)(1) of this 

section, even if the treatment results 

from an item or service described in 

paragraph (a)(1) of this section. 

(b) Timing—(1) In general. A plan or 

issuer must provide coverage pursuant 

to paragraph (a)(1) of this section for 

plan years that begin on or after 

September 23, 2010, or, if later, for plan 

years that begin on or after the date that 

is one year after the date the 

recommendation or guideline is issued. 

(2) Changes in recommendations or 

guidelines. A plan or issuer is not 

required under this section to provide 

coverage for any items and services 

specified in any recommendation or 

guideline described in paragraph (a)(1) 

of this section after the recommendation 

or guideline is no longer described in 

paragraph (a)(1) of this section. Other 

requirements of Federal or State law 

may apply in connection with a plan or 

issuer ceasing to provide coverage for 

any such items or services, including 

PHS Act section 2715(d)(4), which 

requires a plan or issuer to give 60 days 

advance notice to an enrollee before any 

material modification will become 

effective. 

(c) Recommendations not current. For 

purposes of paragraph (a)(1)(i) of this 

section, and for purposes of any other 

provision of law, recommendations of 

the United States Preventive Services 

Task Force regarding breast cancer 

screening, mammography, and 

prevention issued in or around 

November 2009 are not considered to be 

current. 

(d) Applicability date. The provisions 

of this section apply for plan years 

beginning on or after September 23, 

2010. See § 2590.715–1251 of this Part 

for determining the application of this 

section to grandfathered health plans 

(providing that these rules regarding 

coverage of preventive health services 

do not apply to grandfathered health 

plans). 

mstockstill on DSKH9S0YB1PROD with RULES

Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 41759 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Subtitle A 

■ For the reasons stated in the preamble, 

the Department of Health and Human 

Services amends 45 CFR part 147, 

added May 13, 2010, at 75 FR 27138, 

effective July 12, 2010, as follows: 

PART 147—HEALTH INSURANCE 

REFORM REQUIREMENTS FOR THE 

GROUP AND INDIVIDUAL HEALTH 

INSURANCE MARKETS 

■ 1. The authority citation for part 147 

continues to read as follows: 

Authority: Sections 2701 through 2763, 

2791, and 2792 of the Public Health Service 

Act (42 U.S.C. 300gg through 300gg–63, 

300gg–91, and 300gg–92), as amended. 

■ 2. Add § 147.130 to read as follows: 

§ 147.130 Coverage of preventive health 

services. 

(a) Services—(1) In general. Beginning 

at the time described in paragraph (b) of 

this section, a group health plan, or a 

health insurance issuer offering group or 

individual health insurance coverage, 

must provide coverage for all of the 

following items and services, and may 

not impose any cost-sharing 

requirements (such as a copayment, 

coinsurance, or deductible) with respect 

to those items or services: 

(i) Evidence-based items or services 

that have in effect a rating of A or B in 

the current recommendations of the 

United States Preventive Services Task 

Force with respect to the individual 

involved (except as otherwise provided 

in paragraph (c) of this section); 

(ii) 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 with 

respect to the individual involved (for 

this purpose, a recommendation from 

the Advisory Committee on 

Immunization Practices of the Centers 

for Disease Control and Prevention is 

considered in effect after it has been 

adopted by the Director of the Centers 

for Disease Control and Prevention, and 

a recommendation is considered to be 

for routine use if it is listed on the 

Immunization Schedules of the Centers 

for Disease Control and Prevention); 

(iii) With respect to infants, children, 

and adolescents, evidence-informed 

preventive care and screenings provided 

for in comprehensive guidelines 

supported by the Health Resources and 

Services Administration; and 

(iv) With respect to women, to the 

extent not described in paragraph 

(a)(1)(i) of this section, evidenceinformed preventive care and screenings 

provided for in comprehensive 

guidelines supported by the Health 

Resources and Services Administration. 

(2) Office visits—(i) If an item or 

service described in paragraph (a)(1) of 

this section is billed separately (or is 

tracked as individual encounter data 

separately) from an office visit, then a 

plan or issuer may impose cost-sharing 

requirements with respect to the office 

visit. 

(ii) If an item or service described in 

paragraph (a)(1) of this section is not 

billed separately (or is not tracked as 

individual encounter data separately) 

from an office visit and the primary 

purpose of the office visit is the delivery 

of such an item or service, then a plan 

or issuer may not impose cost-sharing 

requirements with respect to the office 

visit. 

(iii) If an item or service described in 

paragraph (a)(1) of this section is not 

billed separately (or is not tracked as 

individual encounter data separately) 

from an office visit and the primary 

purpose of the office visit is not the 

delivery of such an item or service, then 

a plan or issuer may impose costsharing requirements with respect to the 

office visit. 

(iv) The rules of this paragraph (a)(2) 

are illustrated by the following 

examples: 

Example 1. (i) Facts. An individual 

covered by a group health plan visits an innetwork health care provider. While visiting 

the provider, the individual is screened for 

cholesterol abnormalities, which has in effect 

a rating of A or B in the current 

recommendations of the United States 

Preventive Services Task Force with respect 

to the individual. The provider bills the plan 

for an office visit and for the laboratory work 

of the cholesterol screening test. 

(ii) Conclusion. In this Example 1, the plan 

may not impose any cost-sharing 

requirements with respect to the separatelybilled laboratory work of the cholesterol 

screening test. Because the office visit is 

billed separately from the cholesterol 

screening test, the plan may impose costsharing requirements for the office visit. 

Example 2. (i) Facts. Same facts as 

Example 1. As the result of the screening, the 

individual is diagnosed with hyperlipidemia 

and is prescribed a course of treatment that 

is not included in the recommendations 

under paragraph (a)(1) of this section. 

(ii) Conclusion. In this Example 2, because 

the treatment is not included in the 

recommendations under paragraph (a)(1) of 

this section, the plan is not prohibited from 

imposing cost-sharing requirements with 

respect to the treatment. 

Example 3. (i) Facts. An individual 

covered by a group health plan visits an innetwork health care provider to discuss 

recurring abdominal pain. During the visit, 

the individual has a blood pressure 

screening, which has in effect a rating of A 

or B in the current recommendations of the 

United States Preventive Services Task Force 

with respect to the individual. The provider 

bills the plan for an office visit. 

(ii) Conclusion. In this Example 3, the 

blood pressure screening is provided as part 

of an office visit for which the primary 

purpose was not to deliver items or services 

described in paragraph (a)(1) of this section. 

Therefore, the plan may impose a costsharing requirement for the office visit 

charge. 

Example 4. (i) Facts. A child covered by 

a group health plan visits an in-network 

pediatrician to receive an annual physical 

exam described as part of the comprehensive 

guidelines supported by the Health 

Resources and Services Administration. 

During the office visit, the child receives 

additional items and services that are not 

described in the comprehensive guidelines 

supported by the Health Resources and 

Services Administration, nor otherwise 

described in paragraph (a)(1) of this section. 

The provider bills the plan for an office visit. 

(ii) Conclusion. In this Example 4, the 

service was not billed as a separate charge 

and was billed as part of an office visit. 

Moreover, the primary purpose for the visit 

was to deliver items and services described 

as part of the comprehensive guidelines 

supported by the Health Resources and 

Services Administration. Therefore, the plan 

may not impose a cost-sharing requirement 

for the office visit charge. 

(3) Out-of-network providers. Nothing 

in this section requires a plan or issuer 

that has a network of providers to 

provide benefits for items or services 

described in paragraph (a)(1) of this 

section that are delivered by an out-ofnetwork provider. Moreover, nothing in 

this section precludes a plan or issuer 

that has a network of providers from 

imposing cost-sharing requirements for 

items or services described in paragraph 

(a)(1) of this section that are delivered 

by an out-of-network provider. 

(4) Reasonable medical management. 

Nothing prevents a plan or issuer from 

using reasonable medical management 

techniques to determine the frequency, 

method, treatment, or setting for an item 

or service described in paragraph (a)(1) 

of this section to the extent not specified 

in the recommendation or guideline. 

(5) Services not described. Nothing in 

this section prohibits a plan or issuer 

from providing coverage for items and 

services in addition to those 

recommended by the United States 

Preventive Services Task Force or the 

Advisory Committee on Immunization 

Practices of the Centers for Disease 

Control and Prevention, or provided for 

by guidelines supported by the Health 

Resources and Services Administration, 

or from denying coverage for items and 

services that are not recommended by 

that task force or that advisory 

committee, or under those guidelines. A 

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41760 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Rules and Regulations 

plan or issuer may impose cost-sharing 

requirements for a treatment not 

described in paragraph (a)(1) of this 

section, even if the treatment results 

from an item or service described in 

paragraph (a)(1) of this section. 

(b) Timing—(1) In general. A plan or 

issuer must provide coverage pursuant 

to paragraph (a)(1) of this section for 

plan years (in the individual market, 

policy years) that begin on or after 

September 23, 2010, or, if later, for plan 

years (in the individual market, policy 

years) that begin on or after the date that 

is one year after the date the 

recommendation or guideline is issued. 

(2) Changes in recommendations or 

guidelines. A plan or issuer is not 

required under this section to provide 

coverage for any items and services 

specified in any recommendation or 

guideline described in paragraph (a)(1) 

of this section after the recommendation 

or guideline is no longer described in 

paragraph (a)(1) of this section. Other 

requirements of Federal or State law 

may apply in connection with a plan or 

issuer ceasing to provide coverage for 

any such items or services, including 

PHS Act section 2715(d)(4), which 

requires a plan or issuer to give 60 days 

advance notice to an enrollee before any 

material modification will become 

effective. 

(c) Recommendations not current. For 

purposes of paragraph (a)(1)(i) of this 

section, and for purposes of any other 

provision of law, recommendations of 

the United States Preventive Services 

Task Force regarding breast cancer 

screening, mammography, and 

prevention issued in or around 

November 2009 are not considered to be 

current. 

(d) Applicability date. The provisions 

of this section apply for plan years (in 

the individual market, for policy years) 

beginning on or after September 23, 

2010. See § 147.140 of this Part for 

determining the application of this 

section to grandfathered health plans 

(providing that these rules regarding 

coverage of preventive health services 

do not apply to grandfathered health 

plans). 

[FR Doc. 2010–17242 Filed 7–14–10; 11:15 am] 

BILLING CODE 4830–01–P; 4510–29–P; 4210–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2010–0646] 

RIN 1625–AA00 

Safety Zone; Transformers 3 Movie 

Filming, Chicago River, Chicago, IL 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the Chicago River near Chicago, Illinois. 

This zone is intended to restrict vessels 

from a portion of the Chicago River due 

to the filming of a major motion picture. 

This temporary safety zone is necessary 

to protect the surrounding public and 

vessels from the hazards associated with 

the different types of stunts that will be 

performed during the filming of this 

movie. 

DATES: Effective Date: this rule is 

effective in the CFR from July 19, 2010 

until 9 p.m. on July 19, 2010. This rule 

is effective with actual notice for 

purposes of enforcement beginning 7 

a.m. on July 16, 2010. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2010– 

0646 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–0646 in the ‘‘Keyword’’ 

box, and then clicking ‘‘search.’’ They 

are also available for inspection or 

copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, contact or email BM1 Adam Kraft, 

U.S. Coast Guard Sector Lake Michigan, 

at 414–747–7154 or 

Adam.D.Kraft@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when an agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under U.S.C. 553 

(b)(B), the Coast Guard finds that good 

cause exists for not publishing a notice 

of proposed rulemaking (NPRM) with 

respect to the fact that the application 

for this event was not submitted to our 

office in time to allow for publishing an 

NPRM. Based on the hazards associated 

with the filming of this major motion 

picture, delaying the publication of this 

rule to provide for a comment would be 

contrary to public interest as immediate 

action is necessary to protect the public. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register because delaying the effective 

date would be contrary to the public 

interest since immediate action is 

needed to protect the public and the 

event would be over by the time the 30 

day period is completed. 

Basis and Purpose 

This temporary safety zone is 

necessary to protect vessels from the 

hazards associated with the filming of 

the major motion picture, Transformers 

3. The combination of congested 

waterways and the filming of dangerous 

stunts taking place on or near the water 

pose serious risks of injury to persons 

and property. As such, the Captain of 

the Port, Sector Lake Michigan, has 

determined that the filming of this 

motion picture does pose significant 

risks to public safety and property and 

that a temporary safety zone is 

necessary. 

Discussion of Rule 

The safety zone will encompass all 

U.S. navigable waters of the Chicago 

River between the Michigan Avenue 

Bridge, 41°53′20′′ N. 087°37′27′′ W. and 

the North Columbus Drive Bascule 

Bridge, 41°53′19′′ N. 087°37′13′′ W. 

[DATUM: NAD 83]. 

All persons and vessels shall comply 

with the instructions of the Coast Guard 

Captain of the Port, Sector Lake 

Michigan, or his or her on-scene 

representative. Entry into, transiting, or 

anchoring within the safety zone is 

prohibited unless authorized by the 

Captain of the Port, Sector Lake 

Michigan, or his or her on-scene 

representative. The Captain of the Port, 

Sector Lake Michigan, or his or her onscene representative may be contacted 

via VHF Channel 16. 

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