us-irs-revenue-procedures-irb-2010-35-pdf•Internal Revenue Bulletin 2010-35 (PDF rendition): IRS Revenue Procedures
Internal Revenue Bulletin 2010-35 (PDF rendition): IRS Revenue Procedures
us-irs-revenue-procedures-irb-2010-35-pdfInternal Revenue Bulletin 2010-35 (PDF rendition): IRS Revenue ProceduresGuidance
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Bulletin No. 201 0-35 August 30, 2010 HIGHLIGHTS OF THIS ISSUE These synopses are intended only as aids to the reader in identifying the subject matter covered. They may not be relied upon as authoritative interpretations. INCOME TAX Rev. Proc. 2010–29, page 309. This procedure provides domestic asset/liability percentages and domestic investment yields needed by foreign life insur- ance companies and foreign property and liability insurance companies to compute their minimum effectively connected net investment income under section 842(b) of the Code for taxable years beginning after December 31, 2008. EMPLOYEE PLANS T.D. 9493, page 273. REG–120391–10, page 310. Final, temporary, and proposed regulations under section 9815 oftheCodeprovideguidanceconcerningtherequirementthat group health plans and health insurance issuers must provide coverage for preventive health services without imposing cost- sharing requirements under the Affordable Care Act. EXCISE TAX T.D. 9493, page 273. REG–120391–10, page 310. Final, temporary, and proposed regulations under section 9815 oftheCodeprovideguidanceconcerningtherequirementthat group health plans and health insurance issuers must provide coverage for preventive health services without imposing cost- sharing requirements under the Affordable Care Act. Fi nding Lists begin on page ii. Index for July through August begins on page iv. The IRS Mission Provide Americ a’s taxpayers top-quality service by helping them understa nd and meet their tax responsibilities and en- force the law wi th integrity and fairness to all. Introduction The Internal Revenue Bulletin is the authoritative instrument of the Commissioner of Internal Revenue for announcing official rulings and procedures of the Internal Revenue Service and for publishing Treasury Decisions, Executive Orders, Tax Conven- tions, legislation, court decisions, and other items of general interest. It is published weekly and may be obtained from the Superintendent of Documents on a subscription basis. Bulletin contents are compiled semiannually into Cumulative Bulletins, which are sold on a single-copy basis. It is the policy of the Service to publish in the Bulletin all sub- stantive rulings necessary to promote a uniform application of the tax laws, including all rulings that supersede, revoke, mod- ify, or amend any of those previously published in the Bulletin. All published rulings apply retroactively unless otherwise indi- cated. Procedures relating solely to matters of internal man- agement are not published; however, statements of internal practices and procedures that affect the rights and duties of taxpayers are published. Revenue rulings represent the conclusions of the Service on the application of the law to the pivotal facts stated in the revenue ruling. In those based on positions taken in rulings to taxpayers or technical advice to Service field offices, identifying details and information of a confidential nature are deleted to prevent unwarranted invasions of privacy and to comply with statutory requirements. Rulings and procedures reported in the Bulletin do not have the force and effect of Treasury Department Regulations, but they may be used as precedents. Unpublished rulings will not be relied on, used, or cited as precedents by Service personnel in the disposition of other cases. In applying published rulings and procedures, the effect of subsequent legislation, regulations, court decisions, rulings, and procedures must be considered, and Service personnel and others concerned are cautioned against reaching the same conclusions in other cases unless the facts and circumstances are substantially the same. The Bulletin is divided into four parts as follows: Part I.—19 86 Code. This part i ncludes rulings and decisions based on provisions of the Intern al Revenue Code of 1986. Part II.—Treaties and Tax Legislation. This part is divided into two subparts as follows: Subpart A, Tax Conventions and Other Related Items, and Subpart B, Leg- islation and Related Committee Reports. Part III.—Administrative, Procedural, and Miscellaneous. To the extent practicable, pertinent cross references to these subjects are contained in the other Parts and Subparts. Also included in this part are Bank Secrecy Act Administrative Rul- ings. Bank Secrecy Act Administrative Rulings are issued by the Department of the Treasury’s Office of the Assistant Secre- tary (Enforcement). Part IV .—Items of General Interest. This par t includes notices of proposed rulemakings, disbar- ment an d suspension lists, and announcements. The last Bulletin for each month includes a cumulative index for the matters published during the preceding months. These monthly indexes are cumulated on a semiannual basis, and are published in the last Bulletin of each semiannual period. The c ontents of this publication are not copyrighted and may be reprinted freely. A citation of the Internal Revenue Bulletin as the source would be appropriate. For sale by the Superintendent of Documents, U.S.Government Printing Office, Washington, DC 20402. August 30, 20102010–35 I.R.B. Part I. Rulings and Decisions Under the Internal Revenue Code of 1986 Section 9815. —Additional Market Reform s 26 CFR 54.9815–2713T: Coverage of preventive health services (temporary). T.D. 9493 DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 54 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, De- partment of Labor; Office of Consumer Information and Insurance Oversight, De- partment of Health and Human Services. ACTION:Interim final rules with request for comments. SUMMA RY:This document contains in- terim final regulations implementing the rules for group health plans and health in- suran ce coverage in the group and indi- vidu al markets under provisions of the Pa- tien t Protection and Affordable Care Act rega rding preventive health services. DATES:Effect ive Date:These interim fi- nal regulatio ns are effective on September 17, 2010. Comment date. Comments are due on or before Sept ember 17, 2010. Applicabilit y dates.Theseinterimfi- nal regulati ons generally apply to group health plans and group health insurance is- suers for pla n years beginning on or after September 23 , 2010. These interim final regulations generally apply to individual health insu rance issuers for policy years beginning o n or after September 23, 2010. ADDRESSES: Written comments may be submitted t o any of the addresses specified below. Any c omment that is submitted to any Depart ment will be shared with the other Depa rtments. Please do not submit duplicate s. All commen ts will be made available to the publ ic.WARNING: Do not in- clude any p ersonally identifiable informa- tion (such as name, address, or other con- tact info rmation) or confidential business informat ion that you do not want publicly disclose d. All comments are posted on the Internet exactly as received, and can be retriev ed by most Internet search engines. No delet ions, modifications, or redactions will be m ade to the comments received, as they are public records. Comments may be submitt ed anonymously. Departm entofLabor. Comments to the Departm ent of Labor, identified by RIN 1210–A B44, by one of the following meth- ods: •Federa leRulemakingPortal: http:/ /www.regulations.gov. Follow the ins tructions for submitting com- ments. •Email: E-OHPS CA2713.EBSA@dol.gov. •Mail or Hand Delivery:Officeof Health Plan Standards and Compliance Assis tance, Employee Benefits Secu- rity A dministration, Room N–5653, U.S. D epartment of Labor, 200 Con- stitu tion Avenue NW, Washington, DC 20210 ,Attention: RIN 1210–AB44. Comme nts received by the Depart- ment o f Labor will be posted without change tohttp ://www.regulations.govand http://www.d ol.gov/ebsa, and available for public inspec tion at the Public Disclosure Room, N–1513 , Employee Benefits Se- curity Admin istration, 200 Constitution Avenue, NW, W ashington, DC 20210. Department o f Health and Human Ser- vices.Incom menting, please refer to file code OCIIO–9 992–IFC. Because of staff and resourc e limitations, we cannot accept comments by facsimile (FAX) transmis- sion. You may subm it comments in one of four ways (p lease choose only one of the ways listed ): 1.Electron ically. You may submit electronic comments on this regulation to http://ww w.regulations.gov. Follow the instructi ons under the “More Search Op- tions” tab . 2.By regul ar mail.Youmaymail written co mments 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 a llow sufficient time for mailed comment s to be received before the close of the co mment period. 3.By exp ress or overnight mail.You may send written comments to the follow- ing addr ess 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 h and or courier . If you prefer, you ma y deliver (by hand or courier) your writt en comments before the close of the comme nt period to either of the following addre sses: a. For delivery in Washington, DC— 2010–35 I.R.B.273August 30, 2010 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 read- ily 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 retain- ing 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 ar- rival with one of our staff members. Comments mailed to the addresses in- dicated 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 require- ments by following the instructions at the end of the “Collection of Information Re- quirements” 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 re- ceived before the close of the comment period on the following website 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 ap- proximately three weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Balti- more, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. EST. To schedule an appoint- ment 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: •FederaleRulemakingPortal: http://www.regulations.gov. Follow the instructions for submitting com- ments. •Mail:CC:PA:LPD:PR (REG–120391–10), room 5205, Inter- nal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. •Hand or courier delivery: Monday through Friday between the hours of 8a.m.and4p.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 Adminis- tration, 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 Hu- man Services, at (410) 786–1565. Customer Service Information:In- dividuals interested in obtaining infor- mation from the Department of Labor concerning employment-based health cov- erage 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 ad- dition, information from HHS on pri- vate health insurance for consumers can be found on the Centers for Medicare & Medicaid Services (CMS) website (http://www.cms.hhs.gov/HealthInsRe- formforConsume/01_Overview.asp)and information on health reform can be found athttp://www.healthreform.gov. SUPPLEMENTARY INFORMATION: I. Background The Patient Protection and Affordable Care Act (the Affordable Care Act), Pub. L. 111–148, was enacted on March 23, 2010; the Health Care and Education Rec- onciliation Act (the Reconciliation Act), Pub. L. 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 Af- fordable Care Act adds section 715(a)(1) to the Employee Retirement Income Secu- rity 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 cover- age 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 Af- fordable Care Act amend the requirements of title XXVII of the PHS Act (changes to which are incorporated into ERISA section 715). The preemption provi- sions of ERISA section 731 and PHS Act 1 The 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. August 30, 20102742010–35 I.R.B. section 2724 2 (implemented in 29 CFR 2590.731(a) and 45 CFR 146.143(a)) ap- ply 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 insur- ance 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 is- suers requirements that are stricter than those imposed by the Affordable Care Act will not be superseded by the Affordable Care Act. The Departments of Health and Human Services, Labor, and the Treasury (the De- partments) are issuing regulations in sev- eral phases implementing the revised PHS Act sections 2701 through 2719A and re- lated 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 Registeron April 14, 2010 (75 FR 19297). The second phase was interim final regulations implementing PHS Act section 2714 (requiring dependent cover- age of children to age 26), published in theFederal Registeron May 13, 2010 (75 FR 27122). The third phase was in- terim final regulations implementing sec- tion 1251 of the Affordable Care Act (re- lating to status as a grandfathered health plan), published in theFederal Register on June 17, 2010 (T.D. 9489, 2010–29 I.R.B. 55 [75 FR 34538]). The fourth phase was interim final regulations im- plementing PHS Act sections 2704 (pro- hibiting preexisting condition exclusions), 2711 (regarding lifetime and annual dollar limits on benefits), 2712 (regarding restric- tions on rescissions), and 2719A (regard- ing patient protections), published in the Federal Registeron June 28, 2010 (T.D. 9491, 2010–32 I.R.B. 186 [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 gen- erally effective for plan years (in the indi- vidual 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 ahealth 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 chil- dren, 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 indi- vidual involved. A recommendation of the Advisory Committee is consid- ered 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 Im- munization Schedules of the Centers for Disease Control and Prevention. •With respect to infants, children, and adolescents, evidence-informed pre- ventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA). •With respect to women, evidence-in- formed preventive care and screening provided for in comprehensive guide- lines supported by HRSA (not other- wise addressed by the recommenda- tions of the Task Force). The De- partment 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 regula- tions can be found athttp://www.Health- Care.gov/center/regulations/preven- tion.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 clar- ify the cost-sharing requirements when a recommended preventive service is pro- vided during an office visit. First, if a recommended preventive service is billed separately (or is tracked as individual en- counter 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 isnot 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 isnot 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 ser- vice, then a plan or issuer may impose cost-sharing requirements with respect to theofficevisit. Thereferencetotracking individual encounter data was included to provide guidance with respect to plans and issuers that use capitation or similar 2 Code 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. 3 Under 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 thisarea 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. 2010–35 I.R.B.275August 30, 2010 payment arrangements that do not bill in- dividually for items and services. Examples in these interim final regula- tions illustrate these provisions. In one ex- ample, an individual receives a cholesterol screening test, a recommended preventive service, during a routine office visit. The plan or issuer may impose cost-sharing re- quirements for the office visit because the recommended preventive service is billed as a separate charge. A second exam- ple illustrates that treatment resulting from a preventive screening can be subject to cost-sharing requirements if the treatment is not itself a recommended preventive ser- vice. In another example, an individual re- ceives 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 preven- tive service; therefore the plan or issuer may impose cost-sharing requirements for the office visit. In the final example, an in- dividual receives a recommended preven- tive service that is not billed as a sepa- rate charge, and the delivery of that service is the primary purpose of the office visit. Therefore, the plan or issuer may not im- pose cost-sharing requirements for the of- fice visit. With respect to a plan or health in- surance 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 recom- mended preventive services delivered by an out-of-network provider. Such a plan orissuermayalsoimposecost-sharingre- quirements for recommended preventive services delivered by an out-of-network provider. These interim final regulations provide that if a recommendation or 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 med- ical management techniques to determine any coverage limitations. The use of rea- sonable medical management techniques allows plans and issuers to adapt these rec- ommendations 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 ser- vice will be available without cost-sharing requirements to the extent not specified in a recommendation or guideline. The statute and these interim final reg- ulations clarify that a plan or issuer con- tinues to have the option to cover preven- tive 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 re- quirements at its discretion. Moreover, a plan or issuer may impose cost-sharing re- quirements 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 in- dividual market, policy year) for which coverage of the services addressed in such recommendations or guidelines must be in effect. These interim final regulations pro- vide 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) begin- ning on or after September 23, 2010. For the purpose of these interim final regula- tions, 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 Preven- tion; 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/regu- lations/prevention.htmlwill be updated on an ongoing basis and will include the date on which the recommendation or guide- line was accepted or adopted. Finally, these interim final regulations make clear that a plan or issuer is not re- quired to provide coverage or waive cost- sharing requirements for any item or ser- vice that has ceased to be a recommended preventive service. 5 Other requirements of Federal or State law may apply in con- nection 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 modifica- tion will become effective. Recommendations or guidelines in ef- fect 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 recom- mended preventive services will be noted athttp://www.HealthCare.gov/center/reg- ulations/prevention.html. As described above, new recommendations and guide- lines will also be noted at this site and plans and issuers need not make changes to coverage and cost-sharing require- ments 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 4 Section 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 thanthose 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 guidelinesunder (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). 5 For 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. August 30, 20102762010–35 I.R.B. into effect. Therefore, by visiting this site once per year, plans or issuers will have straightforward access to all the informa- tion 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 author- ity to the Departments to develop guide- lines for group health plans and health insurance issuers offering group or indi- vidual health insurance coverage to uti- lize value-based insurance designs as part of their offering of preventive health ser- vices. Value-based insurance designs in- clude the provision of information and in- centives for consumers that promote ac- cess to and use of higher value providers, treatments, and services. The Departments recognize the important role that value- based insurance design can play in pro- moting the use of appropriate preventive services. These interim final regulations, for example, permit plans and issuers to implement designs that seek to foster bet- ter quality and efficiency by allowing cost- sharing for recommended preventive ser- vices delivered on an out-of-network basis while eliminating cost-sharing for recom- mended preventive health services deliv- ered on an in-network basis. The Depart- ments are developing additional guidelines regarding the utilization of value-based in- surance designs by group health plans and health insurance issuers with respect to preventive benefits. The Departments are seeking comments related to the develop- ment 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 preven- tive services. The requirements to cover recom- mended preventive services without any cost-sharing requirements do not apply to grandfathered health plans.See26 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 Act authorize the Secretaries of the Trea- sury, Labor, and HHS (collectively, the Secretaries) to promulgate any interim fi- nal rules that they determine are appropri- ate to carry out the provisions of chapter 100 of the Code, part 7 of subtitle B of ti- tle I of ERISA, and part A of title XXVII of the PHS Act, which include PHS Act sec- tions 2701 through 2728 and the incorpo- ration 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. 551et seq.) a general notice of proposed rulemaking is not required when an agency, for good cause, finds that notice and public comment thereon are imprac- ticable, 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 thespecificauthority granted by section 9833 of the Code, section 734 of ERISA, and section 2792 of the PHS Act. How- ever, even if the APA were applicable, the Secretaries have determined that it would be impracticable and contrary to the pub- lic 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 require- ments could be in effect for some plans or policies. Moreover, the requirements in these interim final regulations require sig- nificant 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 thesepreventive 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, regu- lations 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 is- suance of proposed regulations would not be sufficient because the provisions of the Affordable Care Act protect significant rights of plan participants and beneficia- ries 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 effec- tive date of the regulations. For the foregoing reasons, the Depart- ments have determined that it is imprac- ticable and contrary to the public interest to engage in full notice and comment rule- making before putting these interim final regulations into effect, and that it is in the public interest to promulgate interim final regulations. IV.EconomicImpact Under Executive Order 12866 (58 FR 51735), a “significant” regulatory action is subject to review by the Office of Manage- ment 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 ef- fect on the economy of $100 million or more in any one year, or adversely and ma- terially affecting a sector of the economy, productivity, competition, jobs, the envi- ronment, public health or safety, or State, 2010–35 I.R.B.277August 30, 2010 local or tribal governments or communi- ties (also referred to as “economically sig- nificant”); (2) creating a serious inconsis- tency or otherwise interfering with an ac- tion taken or planned by another agency; (3) materially altering the budgetary im- pacts 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 mean- ing of section 3(f)(1) of the Executive Or- der, because it is likely to have an annual effect on the economy of $100 million in any one year. Accordingly, OMB has re- viewed these rules pursuant to the Exec- utive Order. The Departments provide an assessment of the potential costs, benefits, and transfers associated with these interim final regulations, summarized in the fol- lowing 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 servicesto increase. To the extent that individualsincrease 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, earliertreatment, 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 ofthis 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 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 andissuers under these interimfinal 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 preven- tive 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 indi- vidual may no longer be enrolled. Second, many preventive services generate bene- fits that do not accrue immediately to the individual that receives the services, mak- ing the individual less likely to take-up, especially in the face of direct, imme- diate 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 decision-making over whether to obtain such services. These interim final regulations ad- dress 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 overcom- ing plans’ lack of incentive to invest in these services. Second, they eliminate cost-sharing requirements, thereby remov- ing 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 nec- essary in order to provide rules that plan sponsors and issuers can use to determine how to provide coverage for certain pre- ventive 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, PH S Act section 2713, as added by the Af- fo rdable Care Act, and these interim final re gulations require a group health plan and ah ealth insurance issuer offering group o r individual health insurance coverage to p rovide benefits for and prohibit the im- p osition of cost-sharing requirements with r espect to the following preventive health s ervices: •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 guide- lines will change over time, for the purposes of this impact analysis, the Departments utilized currently avail- able guidelines, which include blood pressure and cholesterol screening, diabetes screening for hypertensive August 30, 20102782010–35 I.R.B. patients, various cancer and sexually transmitted infection screenings, and counseling related to aspirin use, to- bacco cessation, obesity, and other topics. •Immunizations for routine use in chil- dren, 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 indi- vidual involved. •With respect to infants, children, and adolescents, evidence-informed pre- ventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA). •With respect to women, evidence-in- formed preventive care and screening provided for in comprehensive guide- lines supported by HRSA (not other- wise addressed by the recommenda- tions of the Task Force). The De- partment 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 recommen- dations of the Task Force and Advisory Committee and current HRSA guidelines as described in section V later in this pre- amble. In addition to covering immu- nizations, these lists include such services as blood pressure and cholesterol screen- ing, diabetes screening for hypertensive patients, various cancer and sexually trans- mitted infection screenings, genetic testing for the BRCA gene, adolescent depression screening, lead testing, autism testing, and oral health screening and counseling re- lated 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 andhealth insurance issuers in the group and individual mar- kets, 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’ in- terim final regulations relating to status as a grandfathered health plan, 9 the Af- fordable Care Act preserves the ability of individuals to retain coverage under a group health plan or health insurance cov- erage 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. Plans can choose to relinquish their grandfather status in order to make certain otherwise permissible changes to their plans. 10 The Affordable Care Act pro- vides 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 ben- efits 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 pre- vention provisions in these interim final regulations, growing to approximately 78 million in 2013. 12 The mid-range esti- mates suggest that approximately 98 mil- lion individuals will be enrolled in grand- fathered group health plans in 2013, many of which already coverpreventive services (see discussion of the extent of preventive services coverage in employer-sponsored plans later in this preamble). 6 All participant counts and the estimates of individual policies are from the U.S. Department of Labor, EBSA calculations using the March 2008 CurrentPopulation Survey Annual Social and Economic Supplement and the 2008 Medical Expenditure Panel Survey. 7 Estimate is from the 2007 Census of Government. 8 US Census Bureau, Current Population Survey, March 2009. 9 75 FR 34538 (June 17, 2010). 10 See 75 FR 34538 (June 17, 2010). 11 See 75 Fed. Reg. 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 cost-sharing 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 createdby the grandfather regulations to estimate the proportion of plans likely to relinquish grandfather status. The estimates of changes in 2012 and2013werecalculatedbyusingthe2011calculationsandassumingthatanidentical percentage of plan sponsors will relinquish grandfather statusineachyear. 12 To estimate the number of individuals covered in grandfathered health plans, the Departments extended the analysis described in 75 Fed. Reg. 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. 2010–35 I.R.B.279August 30, 2010 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 De- partments expect that a large proportion of individual policies will not be grand- fathered, covering up to and perhaps exceeding 10 million individuals. 13 However, not all of the individuals potentially affected by these interim fi- nal 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 regula- tions, since plans, policies, and enrollees in States that already have certain re- quirements 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 immu- nizations so that the insurers pay for immunizations without a deductible and 12 States exempt immunizations from copayments (e.g.,$5, $10, or $20 per vac- cine) or coinsurance (e.g.,10 percent or 20 percent of charges). State laws also require coverage of certain other preven- tive 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 pro- visions 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 Ad- visory Committee. A survey of small, medium and large employers showed that 78 percent to 80 percent of their point of service, preferred provider organi- zation (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 diph- theria-tetanus-pertussis vaccines and in- fluenza vaccines for adults. 19 Asurveyof 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 ser- vices in the group and individual markets. According to a 2009 survey of employer health benefits, over 85 percent of em- ployer-sponsored health insurance plans covered preventive services without hav- ing 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, only 66.2 percent of single policies purchased covered adult physicals, while 94.1 percent covered can- cer screenings. 24 In summary, the number of affected en- tities depends on several factors, such as whether a health plan retains its grandfa- ther status, the number of new health plans, whether State benefit requirements for pre- ventive services apply, and whether plans or issuers voluntarily offer coverage and/or no cost sharing for recommended preven- tive services. In addition, participants, beneficiaries, and enrollees in such plans or health insurance coverage will be af- fected in different ways: some will newly gain coverage for recommended preven- tive services, while others will have the cost sharing that they now pay for such ser- vices eliminated. As such, there is consid- erable 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 in- terim final regulations. First, individuals will experience improved health as a result of reduced transmission, prevention or de- layed onset, and earlier treatment of dis- ease. Second, healthier workers and chil- dren will be more productive with fewer missed days of work or school. Third, some of the recommended preventive ser- vices will result in savings due to lower health care costs. Fourth, the cost of pre- 13 Adele M. Kirk. The Individual Insurance Market: A Building Block for Health Care Reform?Health Care Financing Organization Research Synthesis.May 2008. 14 Of 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). 15 See e.g., American Academy of Pediatrics,State Legislative Report(2009). 16 See Kaiser Family Foundation, www.statehealthfacts.org. 17 See 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). 18 The specific immunizations include: DTaP (diphtheria and tetanus toxoids and acellular Pertussis), Hib (Haemophilus influenzatype b), Hepatitis B, inactivated polio, influenza, MMR (measles, mumps, and rubella), pneumococcal, and varicella vaccine. 19 McPhillips-Tangum C., Rehm B., Hilton O. “Immunization practices and policies: A survey of health insurance plans.”AHIP Coverage.47(1), 32–7 (2006). 20 See e.g., Matthew M. Davis et. al., “Benefits Coverage forAdult Vaccines in Employer-Sponsored Health Plans,” University of Michigan for the CDC National Immunizations Program (2003). 21 See 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. 22 See e.g.,MaryAnnBondiet. al., “Employer Coverage of Clinical Preventive Services in the United States,”American Journal of Health Promotion,20(3), pp. 214–222 (2006). 23 Seee.g., Matthew M. Davis et. al., “Benefits Coverage for Adult Vaccines in Employer-Sponsored Health Plans,” University of Michigan for the CDC National Immunizations Program (2003). 24 See Individual Health Insurance 2006-2007: A Comprehensive Survey of Premiums, Availability, and Benefits. Available at http://www.ahipresearch.org/pdfs/Individual_Market_Sur- vey_December_2007.pdf August 30, 20102802010–35 I.R.B. ventive 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. Nation- wide, almost 38 percent of adult residents over 50 have never had a colorectal can- cer screening (such as a sigmoidoscopy or a colonoscopy) 25 andalmost18per- cent of women over age 18 have not been screened for cervical cancer in the past three years. 26 Vaccination rates for child- hood vaccines are generally high due to State laws requiring certain vaccinations for children to enter school, but recom- mended 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 preven- tive services leads to expanded utilization of these services, 28 which would lead to substantial benefits as discussed further below. In addition, these interim final regu- lations limit preventive service coverage under this provision to services recom- mended by the Task Force, Advisory Com- mittee, and HRSA. The preventive ser- vices 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 evi- dence that the preventive service improves important health outcomes and that bene- fits outweigh harms in the judgment of an independent panel of private sector experts in primary care and prevention. 30 Simi- larly, the mission of the Advisory Com- mittee is to provide advice that will lead to a reduction in the incidence of vac- cine preventable diseases in the United States, and an increase in the safe use of vaccines and related biological prod- ucts. The comprehensive guidelines for in- fants, children, and adolescents supported by HRSA are developed by multidisci- plinary professionals in the relevant fields to provide a framework for improving chil- dren’s health and reducing morbidity and mortality based on a review of the rele- vant evidence. The statute and interim final regulations limit the preventive ser- vices covered to those recommended by the Task Force, Advisory Committee, and HRSA because the benefits of these pre- ventive 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 regu- lations. A recent article inJAMAstated, “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 rec- ommended by the Task Force, Advisory Committee, and/or the comprehensive guidelines supported by HRSA. The Na- tional Council on Prevention Priorities (NCPP) estimated that almost 150,000 lives could potentially be saved by in- creasing the 2005 rate of utilization to 90 percent for eight of the preventive services recommended by the Task Force or Advi- sory Committee. 32 Table 2 shows eight of the services and thenumber of lives po- tentially saved if utilization of preventive services were to increase to 90 percent. 25 This differs from the Task Force recommendationthat individuals aged 50–75 receive fecal occult blood testing,sigmoidoscopy, or colonoscopy screening for colorectal cancer. 26 For Behavioral Risk Factor Surveillance System Numberssee 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. 27 Seehttp://www.cdc.gov/vaccines/stats-surv/imz-coverage.htm#nisfor vaccination rates. 28 See 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). T his paper examines an experiment in which copays randomly vary across several thousand individuals. The author finds that individuals are sensitiveto prices for health services-i.e.as c opays decline, more services are demanded. Seee.g., Sharon Long, “On the Road to Universal Coverage: Impacts of Reform in Massachusetts At One Year,” Health Affairs, Volume 27, N umber 4 (June 2008). The author investigated the case of Massachusetts, where coverageof preventive services became a requirement in2007, and foundthat for individuals under 300 percent of the poverty line, doctor visits for preventive care increased by6.1 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. Inthe Massachusetts case, these preventive care services were not necessarily free; therefore, economists would expecta higher differential under these interim final rules because of the price sensitivity of health care usage. 29 The Task Force defines good and fair evidence as follows. Good: Evidence includes consistent resultsfrom well-designed, well-conducted studies inrepresentative 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. Seehttp://www.ahrq.gov/clinic/uspstf/gradespre.htm#drec. 30 Seehttp://www.ahrq.gov/clinic/uspstf/gradespre.htm#drecfor details of the Task Force grading. 31 Woolf, Steven. A Closer Look at the Economic Argument for Disease Prevention.JAMA2009;301(5):536–538. 32 See National Commission on Prevention Priorities.Preventive Care: A National Profile on Use, Disparities, and Health Benefits.Partnership for Prevention, August 2007. athttp://www.pre- vent.org/content/view/129/72/#citationsaccessed on 6/22/2010. Lives saved were estimated using models previouslydeveloped to rank clinical preventive services. See Maciosek MV, Edwards NM,Coffield AB, Flottemesch TJ, Nelson WW, Goodman MJ, Rickey DA, ButaniAB, Solberg LI. Priorities among effective clinical preventive services: methods.AmJPrevMed2006; 31(1):90–96. 2010–35 I.R.B.281August 30, 2010 TABLE 2.—Lives Saved from Increasing Utilization of Selected Preventive Services to 90 percent Preventive ServicePopulation 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 quitAll 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 yearsWomen 18-64 83%620 Cholesterol screening Men 35+ and women 45+ 79% 2,450 Breast cancer screening in the past two yearsWomen 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-optimalutilization 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 pro- visions 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 compar- ing 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-of-pocket. 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 De- partments 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 re- duce 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 ser- vices have both individual and public health value. Vaccines have reduced or eliminated serious diseases that, prior to vaccination, routinely caused serious ill- nesses 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. Numer- ous studies confirm that ill health com- promises 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 workersreportedatimewhentheywere 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 33 The Commonwealth Fund. “Insurance Coverage and the Receipt of Preventive Care.” 2005.http://www.commonwealthfund.org/Content/Performance-Snapshots/Financial-and-Structural- Access-to-Care/Insurance-Coverage-and-Receipt-of-Preventive-Care.aspx. 34 Curry,SusanJ.,Byers,Tim,andHewitt,Maria,eds.2003.Fulfilling the Potential of Cancer Prevention and Early Detection.Washington, DC: National Academies Press. 35 Centers for Disease Control and Prevention. 2010. Diabetes at a Glance . See http://www.cdc.gov/chronicdisease/resources/publications/aag/pdf/2010/diabetes_aag.pdf 36 See Modern Infectious Disease Epidemiology by Johan Giesecke 1994, Chapter 18 The Epidemiology of Vaccination. 37 Health 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, TheCommonwealth Fund, August 2005 http://www.commonwealthfund.org/Content/Publications/Issue-Briefs/2005/Aug/Health-and-Productivity-Among-U-S—Workers.aspx. 38 Ibid. August 30, 20102822010–35 I.R.B. that reduced cost-sharing for medical ser- vices 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 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 pre- ventive 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 missed11ormoredays. 41 Obesity in par- ticular contributes to missed school days: one study from the University of Pennsyl- vania 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 decreas- ing the number of days missed due to ill- ness. 44 Similarly, regular pediatric care, including care by physicians specializing in pediatrics, can improve child health out- comes and avert preventable health care costs. For example, one study of Medic- aid enrolled children found that when chil- dren were up to date for their age on their schedule of well-child visits, they were less likely to have an avoidable hospital- ization at a later time. 45 A third type of benefit from some pre- ventive services is cost savings. Increasing the provision of preventive services is ex- pected to reduce the incidence or severity of illness, and, as a result, reduce expendi- tures on treatment of illness. For example, childhood vaccinationshave generally been found to reduce such expenditures by more than the cost of the vaccinations themselves and generate considerable ben- efits to society. Researchers at the Centers for Disease Control and Prevention (CDC) studying the economic impact of DTaP (diphtheria and tetanus toxoids and acel- lular Pertussis), Td (tetanus and diphtheria toxoids), Hib (Haemophilus influenzatype b), IPV (inactivated poliovirus), MMR (measles, mumps and rubella), Hepatitis B and varicella routine childhood vaccines found that every dollar spent on immuniza- tionsin2001wasestimatedtosave$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 Prior- ities 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 rec- ommends 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 counsel- ing should decrease obesity and its related costs. If providers are able to proactively identify and monitor obesity in child pa- tients, they may reduce the incidence of adult health conditions that can be expen- sive to treat, such as diabetes, hyperten- sion, and adult obesity. 50 One recent study estimated that a one-percentage-point re- duction in obesity among twelve-year-olds 39 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.pdfand Janet Currie et. al., “Has Public Health Insurance forOlder Children Reduced Disparities in Access to Care and Health Outcomes?”,JournalofHealthEconomics, Volume 27, Issue 6, pages 1567–1581 (Dec. 2008). With early childhoodinterventions, 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 d ays-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 R eform 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 f or 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). 41 Bloom B, Cohen RA. Summary health statistics for U.S. children: National Health Interview Survey, 2006. Vital Health Stat 2007;10(234). Available athttp://www.cdc.gov/nchs/nhis.htm. 42 University of Pennsylvania 2007:http://www.upenn.edu/pennnews/news/childhood-obesity-indicates-greater-risk-school-absenteeism-university-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.” Pediatrics122.1 (2008). 44 Moonie,Sheniz,DavidA.Sterling,LarryFiggs,andMarioCastro. “Asthma Status and Severity Affects Missed School Days.”Journal of School Health76.1 (2006): 18–24. 45 Bye, “Effectiveness of Compliance with Pediatric PreventativeCare Guidelines Among Medicaid Beneficiaries.” 46 Fangjun 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 Medicine2005; 159(12): 1136–1144. The estimates of the costs savings are based on current immunization levels. The incremental impact of increasing immunization rates is likely to be smaller, but still significant and positive. 47 MaciosekMV,CoffieldAB,EdwardsNM,CoffieldAB,FlottemeschTJ,GoodmanMJ, Solberg LI. Priorities among effective clinical preventive services: Results of a Systematic Review and Analysis.AmJPrevMed2006; 31(1):52–61. 48 Solberg LI, Maciosed, MV, Edwards NM,Khanchandani HS, and Goodman MJ. Repeated tobacco-use screening and intevention in clinical practice: Healthimpact and cost effectiveness. American Journal of Preventive Medicine. 2006;31(1). 49 Congressional 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 Institute of Health, U.S. Department of Health and Human Services (2007),available at http://www.nhlbi.nih.gov/meetings/workshops/child-obesity/index.htm. 2010–35 I.R.B.283August 30, 2010 would save $260.4 million in total medical expenditures. 51 A full quantification of the cost sav- ings from the extension of coverage of preventive services in these interim final regulations is not possible, but to illus- trate the potential savings, an assessment of savings from obesity reduction was con- ducted. According to the CDC, in 2008, 34.2 percent of U.S. adults and 16.9 per- cent of children were obese (defined as having a body mass index (BMI) of 30.0 or greater). 52 Obesity is associated with in- creased risk for coronary heart disease, hy- pertension, 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 in- dividual 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 servicesboth 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 employ- ees with employer-sponsored insurance from a small (< 200 employees) employer do not currently have coverage for weight lossprograms,comparedto38percentat 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 physicianpractice patterns, in which relatively few individuals who are obese receive physician recommendations for dietary counseling. In one study of pa- tients 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 ex- pected to increase the take-up rate of coun- seling 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 cov- ered 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 dedi- cated to combating the obesity epidemic. In the absence of data on take-up of counseling among patients who are re- ferred 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 fol- low 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 with- out weight loss coverage is estimated to be 29 percent. 59 It is assumed that obese individuals have health care costs 39 per- cent 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 ef- fect. 61 Assuming midpoint reduction of six percent of body weight, the BMI for an individual taking up such an interven- tion would fall by six percent as well, as height would remain constant. Based on the aforementioned McKinsey Global In- stitute 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 approx- imately five percent. This parameter for cost reduction is subject to considerable uncertainty, given the wide range of po- tential weight loss strategies with varying degrees of impact on BMI, and their inter- connectedness 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 illustra- tive calculation of the total dollar reduction in premiums, and dividing by total premi- ums for the affected population allows for an estimate of the reduction in average pre- 51 Ibid. 52 Centers for Disease Control and Prevention. “Obesity and Overweight.” 2010.http://www.cdc.gov/nchs/fastats/overwt.htm. 53 Agency for Healthcare Research and Quality (AHRQ).“Screening for Obesity in Adults.” December 2003.http://www.ahrq.gov/clinic/3rduspstf/obesity/obesrr.pdf. 54 Thorpe, 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 canincur nearly twice the annual health care costs of normal-weight adults.” 2007. 55 Congressional 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. 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 58 Molly E. Waring, PhD, Mary B. Roberts, MS, Donna R. Parker, ScD and Charles B.Eaton, MD, MS. “Documentation and Management of Overweight and Obesity inPrimary Care,”The Journal of the American Board of Family Medicine 22(5): 544–552 (2009). 59 This 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 andPrevention data.. U.S. Census Bureau. “Current Population Survey (CPS) Table Creator.” 2010.http://www.census.gov/hhes/www/cp- stc/cps_table_creator.html. Centers for Disease Control and Prevention. “Obesity and Overweight.” 2010.http://www.cdc.gov/nchs/fastats/overwt.htm. 60 McKinsey Global Institute Analysis provided to CEA. 61 Agency for Healthcare Research and Quality (AHRQ). “Screening for Obesity in Adults.” December 2003. p. 4.http://www.ahrq.gov/clinic/3rduspstf/obesity/obesrr.pdf. August 30, 20102842010–35 I.R.B. miums across the entire affected popula- tion. Doing so results in a potential pri- vate premium reduction of 0.05 percent to 0.1 percent from lower health care costs due to a reduction in obesity for enrollees in non-grandfathered plans. This does not account for potential savings in Medicaid, Medicare, or other health programs. A fourth benefit of these interim fi- nal regulations will be to distribute the cost of preventive services more equitably across the broad insured population. Some Americans in plans affected by these reg- ulations 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 cer- tain 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 regula- tions. Reductions in out-of-pocket costs are expected to be largest among people in age groups in which relatively expensive preventive servicesare most likely to be recommended. 5.Costs and Transfers The changes in how plans and is- suers cover the recommended preventive services resulting from these interim fi- nal regulations will result in changes in covered benefits and premiums for in- dividuals in plans and health insurance coverage subject to these interim final reg- ulations. 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 coin- surance, deductibles, and copayments, divides the costs of health services be- tween 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 individ- uals are sensitive to prices for health ser- vices. 62 Evidence that consumers change their utilization of preventive services is available from CDC researchers who stud- ied out-of-pocket costs of immunizations for 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 asso- ciated with a 0.07 percent decrease in utilization. 63 Along with new costs of induced uti- lization, 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 in- crease 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 house- hold spending on health care, which are scaled to levels consistent with the CMS projections of the National Health Expen- diture Accounts. 64 This data is combined with data from the Employer Health Ben- efits 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 cov- ered expenses, benefits, premiums, and induced utilization of services resulting from changes in the characteristics of the plan. The analysis of changes in cover- age is based on the average per-person covered expenses and insurance benefits. The average covered expense is the total charge for covered services; insurance benefits are the part of the covered ex- penses 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 premi- ums will be the same. This is based on two assumptions: (1) that administrative costs included in the premium will increase pro- portionally with the increase in insurance benefits; and (2) that the increases in in- surance benefits will be directly passed on to the consumer in the form of higher premiums. These assumptions bias the es- timates of premium changes upward. Us- ing this model, the Departments assessed: (1) changes in cost-sharing for currently covered and utilized services, (2) changes in services covered, and (3) induced uti- lization 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 particu- lar 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 De- partments 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 62 See 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. 63 See e.g., Noelle-Angelique Molinariet. al., “Out-of-Pocket Costs of Childhood Immunizations: A Comparison by Type of Insurance Plan,”Pediatrics, 120(5) pp. 148–156 (2006). 64 The 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_Na- tionalHealthAccountsHistorical.asp. 2010–35 I.R.B.285August 30, 2010 (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 preven- tive 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 gen- erous benefits for preventive services than group health plans. However, the evidence base for current coverage and cost shar- ing 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 stan- dard practice within employer-sponsored health insurance plans. 67 BC/BS covers most of the preventive services listed in the Task Force and Advisory Commit- tee recommendations, and most of the preventive services listed in the compre- hensive 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 pro- viding the services, and then spread these new costs across the total insured popu- lation. The Departments estimated that adding coverage for genetic screening and depression screening would increase insur- ance benefits an estimated 0.10 percent. Adding lead testing, autism testing, and oral health screening would increase in- surance benefits by an estimated 0.02 per- cent. This results in a total average in- crease in insurance benefits on these ser- vices of 0.12 percent, or just over $4 per insured person. This increase represents a mixture of new costs and transfers, depen- dent on whether beneficiaries previously would have purchased these services on their own. It is also important to remem- ber that actual plan impacts will vary de- pending on baseline benefit levels, and that grandfathered healthplans will not experi- ence any impact from these interim final regulations. The Departments expect the increase to be larger in the individual mar- ket because coverage of preventive ser- vices in the individual market is less com- plete 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 cover- age for health services. For this analysis, the Departments used the model to esti- mate the induced demand (the increased use of preventive services). The model uses a standard actuarial formula for in- duction 1/(1+alpha*P), where alpha is the “induction parameter” and P is the aver- age 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 elas- ticity of demand from the RAND Health Insurance Experiment and other economic studies. 70 Removing cost sharing for pre- ventive services lowers the direct cost to consumers of using preventive services, which induces additional utilization, esti- mated with the model above to increase covered expenses and benefits by approx- imately $17, or 0.44 percent in insurance benefits in group health plans. The Depart- ments expect a similar but larger effect in the individual market, although these esti- mates are highly uncertain. The Departments calculated an estimate of the average impact using the informa- tion from the analyses described above, using estimates of the number of individ- uals 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-grandfa- thered 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 men- tioned earlier, this assumption biases the estimates of premium change upward. b.Sensitivity analysis As discussed previously, there is sub- stantial uncertainty associated with the es- timates presented above. To address the uncertainty in the group market, the De- partments first varied the estimated change to underlying benefits, to address the par- ticular uncertainty behind the estimate of baseline coverage of preventive services in the group market. The estimate for the per person annual increase in insurance ben- efits from adding coverage for new ser- 65 The 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. 66 The Blue Cross Blue Shield standard option plan documentation is available online athttp://fepblue.org/benefitplans/standard-option/index.html. 67 Frey A, Mika S, Nuzum R, and Schoen C. “Setting a National Minimum Standard forHealth 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-a-National-Minimum-Standard-for-Health- Benefits.aspx. 68 The 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 follow-up. 69 Lead, autism, and oral health screening are from the HRSA comprehensive guidelines. 70 Standard formula best described in “Quantity-Price Relationships in Health Insurance”, Charles L Trowbridge, Chief Actuary, Social Security Administration (DHEW Publication No. (SSA)73–11507, November 1972).. August 30, 20102862010–35 I.R.B. vices is approximately $4. The Depart- ments considered the impact of a smaller and larger addition in benefits of approxi- mately $2 and $6 per person. To consider the impact of uncertainty around the size of the behavioral change (that is, the utiliza- tion of more services when cost sharing is eliminated), the Departments analyzed the impact on insurance benefits if the behav- ioral change were 15 percent smaller and 15 percent larger. In the individual market, to accommo- date the greater uncertainty relative to the group market, the Departments considered the impact of varying the increase in ben- efits 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 non-grandfathered plans, the Depart- ments’ low-end is a few tenths of a percent lower than the mid-range estimate of ap- proximately 1.5 percent, and the high-end estimate is a few tenths of a percent higher. Grandfathered health plans are not sub- ject to these interim final regulations and therefore would not experience this pre- mium change. 6.Alternatives considered Several provisions in these interim final regulations involved policy choices. One was whether to allow a plan or issuer to im- pose cost sharing for an office visit when a recommended preventive service is pro- vided in that visit. Sometimes a recom- mended preventive service is billed sepa- rately 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 preven- tive service as recommended by the guide- lines. Therefore, if the preventive service is billed separately from the office visit, it is the preventive service that has cost shar- ing waived, not the entire office visit. A second policy choice was if the pre- ventive service is not billed separately from the office visit, whether these in- terim final regulations should prohibit cost sharing for any office visit in which any recommended preventive service was ad- ministered, 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 pri- mary 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 con- dition 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 con- sumers 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 reg- ulations provide that a plan or issuer is not required to provide coverage for recom- mended preventive services delivered by an out-of-network provider. The plan or is- suer may also impose cost sharing for rec- ommended preventive services delivered by an out-of-network provider. The De- partments considered that requiring cover- age 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 allow- ing differences in cost sharing in- and out- of-network enables plans to encourage use of in-network providers. Allowing zero cost sharing for out of network providers could reduce providers’ incentives to par- ticipate in insurer networks. The Depart- ments decided that permitting cost shar- ing for recommended preventive services provided by out-of-network providers is the appropriate option to preserve choice of providers for individuals, while avoid- ing potentially larger increases in costs and transfers as well as potentially lower qual- ity care. C.Regulatory Flexibility Act—Department of Labor and Department of Health and Human Services The Regulatory Flexibility Act (5 U.S.C. 601et seq.) (RFA) imposes cer- tain 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. 551et 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 pro- mulgate 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 sec- tions into ERISA section 715 and Code section 9815. Moreover, under Section 553(b) of the APA, a general notice of proposed rule- making is not required when an agency, for good cause, finds that notice and pub- lic comment thereon are impracticable, un- necessary, or contrary to the public inter- est. These interim final regulations are ex- empt from APA, because the Departments made a good cause finding that a general notice of proposed rulemaking is not nec- essary earlier in this preamble. Therefore, the RFA does not apply and the Depart- ments are not required to either certify that the rule would not have a significant eco- nomic impact on a substantial number of small entities or conduct a regulatory flex- ibility analysis. Nevertheless, the Departments care- fully 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 2010–35 I.R.B.287August 30, 2010 of Health and Human Services, for pur- poses of the Department of the Treasury, it has been determined that this Treasury de- cision is not a significant regulatory action for purposes of Executive Order 12866. Therefore, a regulatory assessment is not required. It has alsobeen determined that section 553(b) of the APA (5 U.S.C. chap- ter 5) does not apply to these interim fi- nal 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 Bulletin. Pur- suant to section 7805(f) of the Code, these temporary regulations have been submit- ted to the Chief Counsel for Advocacy of the Small BusinessAdministration for comment on their impact on small busi- nesses. 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 Paper- work Reduction Act of 1980 (44 U.S.C. 3501et 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 Regula- tory Enforcement Fairness Act of 1996 (5 U.S.C. 801et seq.) and have been trans- mitted to Congress and the Comptroller General for review. G.Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (Public Law 104–4) requires agen- cies 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 sub- ject to the Unfunded Mandates Reform Act because they are being issued as interim fi- nal regulations. However, consistent with thepolicyembodiedintheUnfundedMan- dates Reform Act, these interim final reg- ulations 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 Af- fordable Care Act. HFederalism Statement—Department of Labor and Department of Health and Human Services Executive Order 13132 outlines fun- damental principles of federalism, and requires the adherence to specific criteria by Federal agencies in the process of their formulation and implementation of poli- cies 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 consulta- tion 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 impli- cations, because they have direct effects on the States, the relationship between the national government and States, or on the distribution of power and responsibili- ties among various levels of government. However, in the Departments’ view, the federalism implications of these interim fi- nal 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 stan- dards. In general, through section 514, ERISA supersedes State laws to the extent that they relate to any covered employee ben- efit plan, and preserves State laws that regulate insurance, banking, or securities. While ERISA prohibits States from regu- lating a plan as an insurance or investment company or bank, the preemption provi- sions 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 (in- cluding 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 ex- cept 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 require- ments on health insurance issuers that are more restrictive than the Federal law. In compliance with the requirement of Executive Order 13132that agencies ex- amine closely any policies that may have federalism implications or limit the policy making discretion of the States, the De- partments have engaged in efforts to con- sultwithandworkcooperativelywithaf- fected State and local officials, including attending conferencesof the National As- sociation 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 require- ments. Throughout the process of devel- oping these interim final regulations, to the extent feasible within the specific preemp- tion provisions of HIPAA as it applies to the Affordable Care Act, the Departments have attempted to balance the States’ in- terests in regulating health insurance is- suers, and Congress’ intent to provide uni- form minimum protections to consumers in every State. By doing so, it is the De- partments’ 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 in- terim final regulations, the Departments certify that the Employee Benefits Secu- rity Administration and the Centers for Medicare & Medicaid Services have com- August 30, 20102882010–35 I.R.B. plied 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 recom- mended 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 reg- ulations 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 guide- lines that went into effect at some point later than September 23, 2009. Those ser- vices 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 Septem- ber 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 athttp://www.Health- Care.gov/center/regulations/preven- tion.htmlspecifically identifies those ser- vices and the relevant dates. The materials athttp://www.HealthCare.gov/center/reg- ulations/prevention.htmlwill 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 is- sued 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 partic- ular 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 Com- mittee on Heritable Disorders in Newborns and Children. 2010–35 I.R.B.289August 30, 2010 August 30, 20102902010–35 I.R.B. 2010–35 I.R.B.291August 30, 2010 August 30, 20102922010–35 I.R.B. 2010–35 I.R.B.293August 30, 2010 August 30, 20102942010–35 I.R.B. 2010–35 I.R.B.295August 30, 2010 August 30, 20102962010–35 I.R.B. 2010–35 I.R.B.297August 30, 2010 August 30, 20102982010–35 I.R.B. 2010–35 I.R.B.299August 30, 2010 August 30, 20103002010–35 I.R.B. 2010–35 I.R.B.301August 30, 2010 August 30, 20103022010–35 I.R.B. 2010–35 I.R.B.303August 30, 2010 VI. Statutory Authority The Department of the Treasury tem- porary regulations are adopted pursuant to the authority contained in sections 7805 and 9833 of the Code. 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 Hu- man Services interim final regulations are adopted pursuant to the authority con- tained 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. Steven T. Miller, Deputy Commissioner for Services and Enforcement, Internal Revenue Service. ApprovedJuly 8, 2010. Michael F. Mundaca, Assistant Secretary oftheTreasury(TaxPolicy). Signed this9thday ofJuly, 2010. Phyllis C. Borzi, Assistant Secretary Employee Benefits Security Administration Department of Labor. OCIIO–9992–IFC 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 un- der 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.Begin- ning 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 copay- ment, coinsurance, or deductible) with re- spect 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 Ad- visory Committee on Immunization Prac- tices of the Centers for Disease Control and Prevention with respect to the individ- ual involved (for this purpose, a recom- mendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is con- sidered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention, and a recommen- dation is considered to be for routine use if it is listed on the Immunization Schedules of the Centers for Disease Control and Pre- vention); (iii) With respect to infants, children, and adolescents, evidence-informed pre- ventive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Admin- istration; and (iv) With respect to women, to the ex- tent not described in paragraph (a)(1)(i) of this section, evidence-informed preven- tive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Ad- ministration. (2)Office visits— (i) If an item or ser- vice 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 re- spect 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 ser- vice, then a plan or issuer may not impose cost-sharing requirements with respect to the office visit. (iii)Ifanitemorservicedescribedin 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 cost-sharing 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 in-network 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 recommen- dations 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.InthisExample 1, the plan may not impose any cost-sharing requirements with re- spect to the separately-billed laboratory work of the cholesterol screening test. Because the office visit is billed separately from the cholesterol screening test, the plan may impose cost-sharing requirements for the office visit. Example 2.(i)Facts. Same facts asExample 1. As the result of the screening, the individual is diag- nosed with hyperlipidemia and is prescribed a course August 30, 20103042010–35 I.R.B. of treatment that is not included in the recommenda- tions under paragraph (a)(1) of this section. (ii)Conclusion. In thisExample 2, because the treatment is not included in the recommendations un- der 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 in-network health care provider to discuss recurring abdominal pain. During the visit, the individual has a blood pressure screen- ing,whichhasineffectaratingofAorBinthecur- rent recommendations of the United States Preven- tive Services Task Force with respect to the individ- ual. The provider bills the plan for an office visit. (ii)Conclusion.InthisExample 3, the blood pres- sure 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 sec- tion. Therefore, the plan may impose a cost-sharing requirement for the office visit charge. Example 4.(i)Facts. A child covered by a group health plan visits an in-network pediatrician to re- ceive 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 thisExample 4,theservice was not billed as a separate charge and was billed as part of an office visit. Moreover, the primary pur- pose for the visit was to deliver items and services described as part of the comprehensive guidelines supported by the Health Resources and Services Ad- ministration. Therefore, the plan may not impose a cost-sharing requirement with respect to the office visit. (3)Out-of-network providers.Noth- ing in this section requires a plan or is- suer that has a network of providers to provide benefits for items or services de- scribed in paragraph (a)(1) of this section that are delivered by an out-of-network provider. Moreover, nothing in this sec- tion 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 sec- tion that are delivered by an out-of-net- work 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 Ad- ministration, or from denying coverage for items and services that are not recom- mended 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 Fed- eral 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 consid- ered 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 de- termining the application of this section to grandfathered health plans (providing that these rules regarding coverage of pre- ventive health services do not apply to grandfathered health plans). (e)Expiration date. This section ex- pires on July 12, 2013 or on such earlier dateasmaybeprovidedinfinalregula- tions or other action published in theFed- eral Register. DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Chapter XXV 29 CFR Part 2590 is amended as fol- lows: 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.Begin- ning 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 copay- ment, coinsurance, or deductible) with re- spect 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 2010–35 I.R.B.305August 30, 2010 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 Ad- visory Committee on Immunization Prac- tices of the Centers for Disease Control and Prevention with respect to the individ- ual involved (for this purpose, a recom- mendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is con- sidered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention, and a recommen- dation is considered to be for routine use if it is listed on the Immunization Schedules of the Centers for Disease Control and Pre- vention); (iii) With respect to infants, children, and adolescents, evidence-informed pre- ventive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Admin- istration; and (iv) With respect to women, to the ex- tent not described in paragraph (a)(1)(i) of this section, evidence-informed preven- tive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Ad- ministration. (2)Office visits— (i) If an item or ser- vice 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 re- spect 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 ser- vice, then a plan or issuer may not impose cost-sharing requirements with respect to the office visit. (iii)Ifanitemorservicedescribedin 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 cost-sharing 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 in-network 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 choles- terol screening test. (ii)Conclusion.InthisExample 1,the plan may not impose any cost-sharing re- quirements with respect to the separately- billed laboratory work of the cholesterol screening test. Because the office visit is billed separately from the cholesterol screening test, the plan may impose cost- sharing requirements for the office visit. Example 2.(i)Facts. Same facts asEx- ample 1. As the result of the screening, the individual is diagnosed with hyperlipi- demia and is prescribed a course of treat- ment that is not included in the recommen- dations under paragraph (a)(1) of this sec- tion. (ii)Conclusion.InthisExample 2,be- cause 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 in-network health care provider to discuss recurring abdominal pain. During the visit, the individual has a blood pressure screen- ing, 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.InthisExample 3,the blood pressure screening is provided as part of an office visit for which the pri- mary purpose was not to deliver items or services described in paragraph (a)(1) of this section. Therefore, the plan may im- pose a cost-sharing requirement for the of- fice 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 comprehen- sive 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 sec- tion. The provider bills the plan for an office visit. (ii)Conclusion.InthisExample 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 re- quirement with respect to the office visit. (3)Out-of-network providers.Noth- ing in this section requires a plan or is- suer that has a network of providers to provide benefits for items or services de- scribed in paragraph (a)(1) of this section that are delivered by an out-of-network provider. Moreover, nothing in this sec- tion 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 sec- tion that are delivered by an out-of-net- work 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 additionto 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 Ad- ministration, or from denying coverage for items and services that are not recom- mended 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 August 30, 20103062010–35 I.R.B. 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.Aplanor 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 Fed- eral 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 consid- ered to be current. (d)Applicability date. The provisions of this section apply for plan years be- ginning on or after September 23, 2010. See§2590.715–1251 of this Part for de- termining the application of this section to grandfathered health plans (providing that these rules regarding coverage of preven- tive health services do not apply to grand- fathered health plans). DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Subtitle A For the reasons stated in the preamble, the Department of Health and Human Ser- vices 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 USC 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.Begin- ning 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 Ad- visory Committee on Immunization Prac- tices of the Centers for Disease Control and Prevention with respect to the individ- ual involved (for this purpose, a recom- mendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is con- sidered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention, and a recommen- dation is considered to be for routine use if it is listed on the Immunization Schedules of the Centers for Disease Control and Pre- vention); (iii) With respect to infants, children, and adolescents, evidence-informed pre- ventive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Admin- istration; and (iv) With respect to women, to the ex- tent not described in paragraph (a)(1)(i) of this section, evidence-informed preven- tive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Ad- ministration. (2)Office visits— (i) If an item or ser- vice 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 re- spect 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 ser- vice, then a plan or issuer may not impose cost-sharing requirements with respect to the office visit. (iii)Ifanitemorservicedescribedin 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 cost-sharing 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 in-network 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 choles- terol screening test. (ii)Conclusion.InthisExample 1,the plan may not impose any cost-sharing re- quirements with respect to the separately- billed laboratory work of the cholesterol screening test. Because the office visit is billed separately from the cholesterol screening test, the plan may impose cost- sharing requirements for the office visit. Example 2.(i)Facts. Same facts asEx- ample 1. As the result of the screening, the individual is diagnosed with hyperlipi- demia and is prescribed a course of treat- 2010–35 I.R.B.307August 30, 2010 ment that is not included in the recommen- dations under paragraph (a)(1) of this sec- tion. (ii)Conclusion.InthisExample 2,be- cause 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 in-network health care provider to discuss recurring abdominal pain. During the visit, the individual has a blood pressure screen- ing, 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.InthisExample 3,the blood pressure screening is provided as part of an office visit for which the pri- mary purpose was not to deliver items or services described in paragraph (a)(1) of this section. Therefore, the plan may im- pose a cost-sharing requirement for the of- fice 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 comprehen- sive 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 sec- tion. The provider bills the plan for an office visit. (ii)Conclusion.InthisExample 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 re- quirement for the office visit charge. (3)Out-of-network providers.Noth- ing in this section requires a plan or is- suer that has a network of providers to provide benefits foritems or services de- scribed in paragraph (a)(1) of this section that are delivered by an out-of-network provider. Moreover, nothing in this sec- tion 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 sec- tion that are delivered by an out-of-net- work 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 Ad- ministration, or from denying coverage for items and services that are not recom- mended 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 (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 Fed- eral 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 consid- ered to be current. (d)Applicability date. The provisions of this section apply for plan years (in the individual market, for policy years) begin- ning 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 re- garding coverage of preventive health ser- vices do not apply to grandfathered health plans). (Filed by the Office of the Federal Register on July 14, 2010, 11:15 a.m., and published in the issue of the Federal Register for July 19, 2010, 75 F.R. 41726) August 30, 20103082010–35 I.R.B. Part III. Administrative, Procedural, and Miscellaneous 26 CFR 601.105: Examination of returns and claims for refund, credit, or abatement; determination of tax liability. Rev. Proc. 2010–29 SECTION 1. PURPOSE This revenue procedure provides the domestic asset/liability percentages and domestic investment yields needed by for- eign life insurance companies and foreign property and liability insurance compa- nies to compute their minimum effectively connected net investment income under section 842(b) of the Internal Revenue Code for taxable years beginning after December 31, 2008. Instructions are pro- vided for computing foreign insurance companies’ liabilities for the estimated tax and installment payments of estimated tax for taxable years beginning after Decem- ber 31, 2008. For more specific guidance regarding the computation of the amount of net investment income to be included by a foreign insurance company on its U.S. in- come tax return, see Notice 89–96, 1989–2 C.B. 417. For the domestic asset/liability percentage and domestic investment yield, as well as instructions for computing for- eign insurance companies’ liabilities for estimated tax and installment payments of estimated tax for taxable years beginning after December 31, 2007, see Rev. Proc. 2009–34, 2009–34 I.R.B. 258. SECTION 2. CHANGES DOMESTICASSET/LIABILITY PERCENTAGES FOR 2009. The Secre- tary determines the domestic asset/liability percentage separately for life insurance companies and property and liability in- surance companies. For the first taxable year beginning after December 31, 2008, the relevant domestic asset/liability per- centages are: 138.5 percent for foreign life insurance companies, and 193.4 percent for foreign property and liability insurance companies. .02 DOMESTIC INVESTMENT YIELDS FOR 2009. The Secretary is required to prescribe separate domestic in- vestment yields for foreign life insurance companies and for foreign property and liability insurance companies. For the first taxable year beginning after December 31, 2008, the relevant domestic investment yields are: 5.2 percent for foreign life insurance companies, and 4.2 percent for foreign property and li- ability insurance companies. .03 SOURCE OF DATA FOR 2009. The section 842(b) percentages to be used for the 2009 tax year are based on tax re- turn data following the same methodology used for the 2008 year. SECTION 3. APPLICATION—ESTIMATED TAXES To compute estimated tax and the in- stallment payments of estimated tax due for taxable years beginning after Decem- ber 31, 2008, a foreign insurance com- pany must compute its estimated tax pay- ments by adding to its income other than net investment income the greater of (i) its net investment income as determined un- der section 842(b)(5), that is actually ef- fectively connected with the conduct of a trade or business within the United States for the relevant period, or (ii) the mini- mum effectively connected net investment income under section 842(b) that would re- sult from using the most recently available domestic asset/liability percentage and do- mestic investment yield. Thus, for install- ment payments due after the publication of this revenue procedure, the domestic as- set/liability percentages and the domestic investment yields provided in this revenue procedure must be used to compute the minimum effectively connected net invest- ment income. However, if the due date of an installment is less than 20 days after the date this revenue procedure is published in the Internal Revenue Bulletin, the as- set/liability percentages and domestic in- vestment yields provided in Rev. Proc. 2009–34 may be used to compute the mini- mum effectively connected net investment income for such installment. For further guidance in computing estimated tax, see Notice 89–96. SECTION 4. EFFECTIVE DATE This revenue procedure is effective for taxable years beginning after December 31, 2008. SECTION 5. DRAFTING INFORMATION The principal author of this revenue procedure is Sheila Ramaswamy of the Office of Associate Chief Counsel (In- ternational). For further information re- garding this revenue procedure, contact Sheila Ramaswamy at (202) 622–3870 (not a toll-free call). 2010–35 I.R.B.309August 30, 2010 Part IV. Items o fGeneralInterest Notice of Prop osed Rulemaking by Cross-Refere nce to Temporary Re gulations Requirement for Group Health Plans and Hea lth Insurance Issuers to P rovide Coverage of Preventi ve Services under the Patien tProtectionand Affordabl eCareAct REG–12039 1–10 AGENCY: In ternal Revenue Service (IRS), Tr easury. ACTION: No tice of proposed rulemaking by cross- reference to temporary regula- tions. SUMMARY: Elsewhere in this issue of the Bulletin , the IRS is issuing temporary reg- ulations (T.D. 9493) under the provisions of the Pa tient Protection and Affordable Care Act (the Affordable Care Act) regard- ing prev entive health services. The IRS is issui ng the temporary regulations at the same tim e that the Employee Benefits Se- curity Administration of the U.S. Depart- ment of Labor and the Office of Consumer Inform ation and Insurance Oversight of the U.S . Department of Health and Hu- man Ser vices are issuing substantially sim- ilar i nterim final regulations with respect to gro up health plans and health insur- ance c overage offered in connection with a group health plan under the Employee Re- tirem ent Income Security Act of 1974 and the P ublic Health Service Act. The tempo- rary regulations provide guidance to em- ploy ers, group health plans, and health in- sura nce issuers providing group health in- sura nce coverage. The text of those tem- por ary regulations also serves as the text of t hese proposed regulations. DAT ES: Written or electronic comments and requests for a public hearing must be rec eived by October 18, 2010. ADD RESSES: Send submissions to: CC: PA:LPD:PR(REG–120391–10), room 5205, Int ernal Revenue Service, P.O. Box 7604, BenFranklinSta- tion, Washing ton, DC 20044. Sub- missions may b e hand-delivered to: CC:PA:LPD:PR (REG–120391–10), Courier’s De sk, Internal Revenue Ser- vice, 1111 Co nstitution Avenue, NW, Washington D C 20224. Alternatively, taxpayers ma y submit comments elec- tronically via the Federal eRulemaking Portal atht tp://www.regulations.gov(IRS REG–120391 –10). FOR FURTHER INFORMATION CONTACT: Co ncerning the regula- tions, Kar en Levin at 202–622–6080; concernin g submissions of com- ments,Ric hard A. Hurst at Richard.A .Hurst@irscounsel.treas.gov. SUPPLEMEN TARY INFORMATION: Backgroun d and Explanation of Provision s The tempor ary regulations published elsewher e in this issue of the Bulletin add §54.9815 –2713T to the Miscellaneous Ex- cise Tax R egulations. The proposed and temporar y regulations are being published as part o f a joint rulemaking with the De- partmen t of Labor and the Department of Healt h and Human Services (the joint rulemak ing). The text of those temporary regulat ions also serves as the text of these propos ed regulations. The preamble to the tem porary regulations explains the tempor ary regulations and these proposed regula tions. Specia lAnalyses It has b een determined that this notice of prop osed rulemaking is not a signifi- cant re gulatory action as defined in Exec- utive Order 12866. Therefore, a regula- tory a ssessment is not required. It has also been d etermined that section 553(b) of the Admin istrative Procedure Act (5 U.S.C. chapt er 5) does not apply to these regu- lati ons, and because the regulation does not i mpose a collection of information re- quir ement on small entities, the Regula- tory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Interna l Revenue Code, this regula- tion has been s ubmitted to the Chief Coun- sel for Advoca cy of the Small Business Administrati on for comment on its impact on small busin ess. Comments and Requests for a Public Hearing Before these proposed regulations are adopted as final regulations, consideration will be given to any written comments (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS. Comments are specifi- cally requested on the clarity of the pro- posed regulations and how they may be made easier to understand. All comments will be available for public inspection and copying. A public hearing may be sched- uled if requested in writing by a person that timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place for the hearing will be published in the Federal Register. Draftin g Information The principal author of these proposed regulations is Karen Levin, Office of the Division Counsel/Associate Chief Coun- sel (Tax Exempt and Government Enti- ties), IRS. The proposed regulations, as well as the temporary regulations, have been developed in coordination with per- sonnel from the U.S. Department of Labor and the U.S. Department of Health and Hu- man Services. ***** Propo sed Amendments to the Regul ations Accordingly, 26 CFR part 54 is pro- posed to be amended as follows: PART 54—PENSION EXCISE TAXES Para graph 1. The authority citation for part 54 is amended by adding an entry in nume rical order to read in part as follows: Auth ority: 26 U.S.C. 7805 * * * Sect ion 54.9815–2713 also issued un- der 2 6 U.S.C. 9833. * * * August 30, 20103102010–35 I.R.B. Par. 2. Section 54.9815–2713 is added to read as follows: §54.9815–2713 Coverage of preventive health services. [The text of proposed §54.9815–2713 is the same as the text of paragraphs (a) through (c) of §54.9815–2713T published elsewhere in this issue of the Bulletin]. Steven T. Miller, Deputy Commissioner for Services and Enforcement. (Filed by the Office of the Federal Register on July 14, 2010, 11:15 a.m., and published in the issue of the Federal Register for July 19, 2010, 75 F.R. 41787) 2010–35 I.R.B.311August 30, 2010 Definition of Terms Revenue rulings and revenue procedures (hereinafter referred to as “rulings”) that have an effect on previous rulings use the following defined terms to describe the ef- fect: Amplifieddescribes a situation where no change is being made in a prior pub- lished position, but the prior position is be- ingextendedtoapplytoavariationofthe fact situation set forth therein. Thus, if an earlier ruling held that a principle ap- plied to A, and the new ruling holds that the same principle also applies to B, the earlier ruling is amplified. (Compare withmodi- fied,below). Clarifiedis used in those instances where the language in a prior ruling is be- ing made clear because the language has caused, or may cause, some confusion. It is not used where a position in a prior ruling is being changed. Distinguisheddescribes a situation where a ruling mentions a previously pub- lished ruling and points out an essential difference between them. Modifiedis used where the substance of a previously published position is being changed. Thus, if a prior ruling held that a principle applied to A but not to B, and the new ruling holds that it applies to both A and B, the prior ruling is modified because it corrects a published position. (Compare withamplifiedandclarified, above). Obsoleteddescribes a previously pub- lished ruling that is not considered deter- minative with respect to future transac- tions. This term is most commonly used in a ruling that lists previously published rul- ings that are obsoleted because of changes in laws or regulations. A ruling may also be obsoleted because the substance has been included in regulations subsequently adopted. Revokeddescribes situations where the position in the previously published ruling is not correct and the correct position is beingstatedinanewruling. Supersededdescribes a situation where the new ruling does nothing more than re- state the substance and situation of a previ- ously published ruling (or rulings). Thus, the term is used to republish under the 1986 Code and regulations the same po- sition published under the 1939 Code and regulations. The term is also used when it is desired to republish in a single rul- ing a series of situations, names, etc., that were previously published over a period of time in separate rulings. If the new rul- ing does more than restate the substance of a prior ruling, a combination of terms is used. For example,modifiedandsu- persededdescribes a situation where the substance of a previously published ruling is being changed in part and is continued without change in part and it is desired to restate the valid portion of the previously published ruling in a new ruling that is self contained. In this case, the previously pub- lished ruling is first modified and then, as modified, is superseded. Supplementedis used in situations in which a list, such as a list of the names of countries, is published in a ruling and that list is expanded by adding further names in subsequent rulings. After the original rul- ing has been supplemented several times, a new ruling may be published that includes the list in the original ruling and the ad- ditions, and supersedes all prior rulings in the series. Suspendedis used in rare situations to show that the previous published rulings will not be applied pending some future action such as the issuance of new or amended regulations, the outcome of cases in litigation, or the outcome of a Service study. Abbreviations The fol lowing abbreviations in current use and for merly used will appear in material publis hedintheBulletin. A—Individual. Acq.—A cquiescence. B—Individual. BE—Beneficiary. BK—Bank . B.T.A.—Board of Tax Appeals. C—Individual. C.B.—Cu mulative Bulletin. CFR—Code of Federal Regulations. CI—City. COOP—Coo perative. Ct.D.—Court Decision. CY—County. D—Decede nt. DC—Dummy Corporation. DE—Donee. Del. Order —Delegation Order. DISC—Domestic International Sales Corporation. DR—Donor. E—Estate. EE—Employee. E.O.—Executive Order. ER—Emp loyer. ERISA—Employee Retirement Income Security Act. EX—Executor. F—Fiduc iary. FC—Foreign Country. FICA—Federal Insurance Contributions Act. FISC—Fo reign International Sales Company. FPH—Foreign Personal Holding Company. F.R.—Federal Register. FUTA—Fed eral Unemployment Tax Act. FX—Foreign corporation. G.C.M.—Chief Counsel’s Memorandum. GE—Grante e. GP—General Partner. GR—Grantor. IC—Insura nce Company. I.R.B.—Internal Revenue Bulletin. LE—Lessee. LP—Limited Partner. LR—Lessor. M—Minor. Nonacq.—No nacquiescence. O—Organization. P—Parent Corporation. PHC—Persona l Holding Company. PO—Possession of the U.S. PR—Partner. PRS—Pa rtnership. PTE—Prohibited Transaction Exemption. Pub. L.—Public Law. REIT—Re al Estate Investment Trust. Rev. Proc.—Revenue Procedure. Rev. Rul.—Revenue Ruling. S—Subsi diary. S.P.R.—Statement of Procedural Rules. Stat.—Statutes at Large. T—Target Corporation. T.C.—Tax Court. T.D.—Treasury Decision. TFE—Trans feree. TFR—Transferor. T.I.R.—Technical Information Release. TP—Taxpay er. TR—Trust. TT—Trustee. U.S.C.—Uni ted States Code. X—Corporation. Y—Corporation. Z—Corporat ion. August 30, 2010i2010–35 I.R.B. Numerical Finding List 1 Bulletins 2010–27 through 2010–35 Announcements: 2010-43, 2010-27 I.R.B.42 2010-44, 2010-28 I.R.B.54 2010-45, 2010-29 I.R.B.87 2010-46, 2010-29 I.R.B.87 2010-47, 2010-30 I.R.B.173 2010-48, 2010-32 I.R.B.234 2010-49, 2010-34 I.R.B.272 2010-50, 2010-33 I.R.B.260 2010-51, 2010-33 I.R.B.261 Notices: 2010-48, 2010-27 I.R.B.9 2010-49, 2010-27 I.R.B.10 2010-50, 2010-27 I.R.B.12 2010-51, 2010-29 I.R.B.83 2010-52, 2010-30 I.R.B.88 2010-53, 2010-31 I.R.B.182 2010-55, 2010-33 I.R.B.253 2010-56, 2010-33 I.R.B.254 2010-57, 2010-34 I.R.B.267 Proposed Regulations: REG-139343-08, 2010-33 I.R.B.256 REG-151605-09, 2010-31 I.R.B.184 REG-112841-10, 2010-27 I.R.B.41 REG-118412-10, 2010-29 I.R.B.85 REG-120391-10, 2010-35 I.R.B.310 REG-120399-10, 2010-32 I.R.B.239 Revenue Procedures: 2010-25, 2010-27 I.R.B.16 2010-26, 2010-30 I.R.B.91 2010-27, 2010-31 I.R.B.183 2010-28, 2010-34 I.R.B.270 2010-29, 2010-35 I.R.B.309 Revenue Rulings: 2010-18, 2010-27 I.R.B.1 2010-19, 2010-31 I.R.B.174 Tax Conventions: 2010-48, 2010-32 I.R.B.234 Treasury Decisions: 9486, 2010-27 I.R.B.3 9487, 2010-28 I.R.B.48 9488, 2010-28 I.R.B.51 9489, 2010-29 I.R.B.55 9490, 2010-31 I.R.B.176 9491, 2010-32 I.R.B.186 9492, 2010-33 I.R.B.242 Treasury Decisions— Continued: 9493, 2010-35 I.R.B.273 1 A cumulative list of all revenue rulings, revenueprocedures, Treasury decisions, etc., publishedin Internal Revenue Bulletins 2010–1 through 2010–26 is in Internal Revenue Bulletin 2010–26, dated June 28, 2010. 2010–35 I.R.B.iiAugust 30, 2010 Finding List of Current Actions on Previously Published Items 1 Bulletins 2010–27 through 2010–35 Notices: 2003-19 Revoked by Notice 2010-53, 2010-31 I.R.B.182 2009-47 Obsoleted by Rev. Proc. 2010-28, 2010-34 I.R.B.270 Revenue Procedures: 81-18 Obsoleted by Rev. Proc. 2010-27, 2010-31 I.R.B.183 2007-44 Modified by Notice 2010-48, 2010-27 I.R.B.9 2009-18 Obsoleted in part by Rev. Proc. 2010-25, 2010-27 I.R.B.16 2009-30 Superseded by Rev. Proc. 2010-26, 2010-30 I.R.B.91 Treasury Decisions: 9487 Corrected by Ann. 2010-50, 2010-33 I.R.B.260 1 A cumulative list of current actions on previously published items in Internal Revenue Bulletins 2010–1 through 2010–26 is in Internal Revenue Bulletin 2010–26, dated June 28, 2010. August 30, 2010iii2010–35 I.R.B. INDEX Internal Revenue Bulletins 2010–27 through 2010–35 The abbreviation and number in parenthesis following the index entry refer to the specific item; numbers in roman and italic type following the parenthesis refers to the Internal Revenue Bulletin in which the item may be found and the page number on which it appears. Key to Abbreviations: AnnAnnouncement CDCourt Decision DODelegation Order EOExecutive Order PLPublic Law PTEProhibited Transaction Exemption RPRevenue Procedure RRRevenue Ruling SPRStatement of Procedural Rules TCTax Convention TDTreasury Decision TDOTreasury Department Order EMPLOYEE PLANS Disaster relief, qualified plans (Notice 48) 27,9 Excise taxes on prohibited tax shelter transactions and related provisions (TD 9492) 33,242 Full funding, weighted average interest rates, segment rates for: July 2010 (Notice 52) 30,88 August 2010 (Notice 57) 34,267 Proposed regulations: 26 CFR 54.9815–2704, –2711, –2712, –2719A, added; re- quirements for group healthplans and health insurance issuers under the Patient Protection and Affordable Care Act relating to preexisting condition exclusions, lifetime and annual limits, rescissions, and patient protections (REG–120399–10) 32,239 26 CFR 54.9815–2713, added; rules relating to coverage of preventive health services (REG–120391–10) 35,310 Qualified plans: Alternative amortization schedules for single-employer plans under PRA 2010 (Notice 55) 33,253 Special funding rules for multiemployer plans under PRA 2010 (Notice 56) 33,254 Regulations: 26 CFR 1.6033–5, added; 1.6033–5T, removed; 53.4965–1 thru –9, added; 53.6071–1, revised; 53.6071–1T(g) & (h), removed; 54.6011–1, revised; 54.6011–1T(c) & (d), removed; 301.6011(g)–1, added; 301.6033–5, added; 301.6033–5T, removed; 602.101, amended; excise taxes on prohibited tax shelter transactions and related disclo- sure requirements, disclosure requirements with respect to prohibited tax shelter transactions, requirement of return and time for filing (TD 9492) 33,242 EMPLOYEE PLANS—Cont. 26 CFR 54.9801–2, –3, amended; 54.9815–2704T, –2711T, –2712T, –2719AT, added; 602.101(b), amended; require- ments for group health plans and health insurance issuers under the Patient Protection andAffordable Care Act relat- ing to preexisting condition exclusions, lifetime and annual limits, rescissions, and patient protections (TD 9491) 32, 186 26 CFR 54.9815–1251T, added; rules relating to status as grandfathered health plans for group health plans and health insurance coverage (TD 9489) 29,55 26 CFR 54.9815–2713T, added; rules relating to coverage of preventive health services (TD 9493) 35,273 Revocation of Notice 2003–19 (Notice 53) 31,182 Rules relating to coverage of preventive health services (TD 9493) 35,273; (REG–120391–10) 35,310 Rules relating to preexisting condition exclusions, lifetime and annual limits, rescissions, and patient protections (TD 9491) 32,186; (REG–120399–10) 32,239 Rules relating to status as grandfathered health plans for group health plans and health insurance coverage (TD 9489) 29,55; (REG-118412–10) 29,85 EMPLOYMENT TAX Examination of returns and claims for refund, credit or abate- ment, determination of correct tax liability (RP 27) 31,183 Revocation of Notice 2003–19 (Notice 53) 31,182 ESTATE TAX Revocation of Notice 2003–19 (Notice 53) 31,182 EXCISE TAX Examination of returns and claims for refund, credit or abate- ment, determination of correct tax liability (RP 27) 31,183 Excise taxes on prohibited tax shelter transactions and related provisions (TD 9492) 33,242 Guidance on section 5000B, indoor tanning services excise tax (TD 9486) 27,3; (REG–112841–10) 27,41 Proposed regulations: 26 CFR 40.0–1, amended; 40.6302(c)–1, amended; 49.0–3, added; 49.5000B–1, added; indoor tanning services excise tax (REG–112841–10) 27,41 26 CFR 54.9815–1251T, added; rules relating to status as grandfathered health plans for group health plans and health insurance coverage (REG-118412–10) 29,85 26 CFR 54.9815–2704, –2711, –2712, –2719A, added; re- quirements for group health plans and health insurance issuers under the Patient Protection and Affordable Care Act relating to preexisting condition exclusions, lifetime and annual limits, rescissions, and patient protections (REG–120399–10) 32,239 26 CFR 54.9815–2713, added; rules relating to coverage of preventive health services (REG–120391–10) 35,310 2010–35 I.R.B.ivAugust 30, 2010 EXCISE TAX—Cont. Regulations: 26 CFR 1.6033–5, added; 1.6033–5T, removed; 53.4965–1 thru –9, added 53.6071–1, revised; 53.6071–1T(g) & (h), removed; 54.6011–1, revised; 54.6011–1T(c) & (d), removed; 301.6011(g)–1, added; 301.6033–5, added; 301.6033–5T, removed; 602.101, amended; excise taxes on prohibited tax shelter transactions and related disclo- sure requirements, disclosure requirements with respect to prohibited tax shelter transactions, requirement of return and time for filing (TD 9492) 33,242 26 CFR 40.0–1, amended; 40.0–1T, added; 40.6302(c)–1, amended; 40.6302(c)–1T, added; 49.0–3T, added; 49.5000B–1T, added; 602.101, amended; indoor tanning services excise taxe (TD 9486) 27,3 26 CFR 54.9801–2, –3, amended; 54.9815–2704T, –2711T, –2712T, –2719AT, added; 602.101(b) amended; require- ments for group health plans and health insurance issuers under the Patient Protection and Affordable Care Act relat- ing to preexisting condition exclusions, lifetime and annual limits, rescissions, and patient protections (TD 9491) 32, 186 26 CFR 54.9815–1251T, added; rules relating to status as grandfathered healthplans for group health plans and health insurance coverage (TD 9489) 29,55 26 CFR 54.9815–2713T, added; rules relating to coverage of preventive health services (TD 9493) 35,273 Revocation of Notice 2003–19 (Notice 53) 31,182 Rules relating to coverage of preventive health services (TD 9493) 35,273; (REG–120391–10) 35,310 Rules relating to preexisting condition exclusions, lifetime and annual limits, rescissions, and patient protections (TD 9491) 32,186; (REG–120399–10) 32,239 Rules relating to status as grandfathered health plans for group health plans and health insurance coverage (TD 9489) 29,55; (REG-118412–10) 29,85 EXEMPT ORGANIZATIONS Excise taxes on prohibited tax shelter transactions and related provisions (TD 9492) 33,242 Regulations: 26 CFR 1.6033–5, added; 1.6033–5T, removed; 53.4965–1 thru –9, added 53.6071–1, revised; 53.6071–1T(g) & (h), removed; 54.6011–1, revised; 54.6011–1T(c) & (d), removed; 301.6011(g)–1, added; 301.6033–5, added; 301.6033–5T, removed; 602.101, amended; excise taxes on prohibited tax shelter transactions and related disclo- sure requirements, disclosure requirements with respect to prohibited tax shelter transactions, requirement of return and time for filing (TD 9492) 33,242 Revocation of Notice 2003–19 (Notice 53) 31,182 Revocations (Ann 44) 28,54;(Ann45)29,87; (Ann 47) 30,173; (Ann 49) 34,272 GIFT TAX Revocation of Notice 2003–19 (Notice 53) 31,182 INCOME TAX Corporations, section 382 treatment of prepaid income under built-in gain provisions of section 382(h) (TD 9487) 28,48; corrections (Ann 50) 33,260 Declaratory Judgment Suits (Ann 46) 29,87 Disciplinary actionsinvolving attorneys,certified public accoun- tants, enrolled agents, and enrolled actuaries (Ann 43) 27,42; (Ann 51) 33,261 Examination of returns and claims for refund, credit or abate- ment, determination of correct tax liability (RP 27) 31,183 Extended carryback of losses to or from a consolidated group (TD 9490) 31,176; (REG–151605–09) 31,184 Forms, 1097, 1098, 1099, 3921, 3922, 5498, 8935, and W-2G, requirements for filing electronically, 2010 revision (RP 26) 30,91 Information reporting under the amendments to section 6041 for gross proceeds paid and for payments to corporations (Notice 51) 29,83 Insurance companies: Effectively connected income (RP 29) 35,309 Safe harbor under sections 7702 and 7702A for contracts with a maturity date of 100, life insurance (RP 28) 34,270 Interest: Investment: Federal short-term, mid-term, and long-term rates for: July 2010 (RR 18) 27,1 August 2010 (RR 19) 31,174 Interest and penalty suspension provisions under section 6404(g) of the Internal Revenue Code (TD 9488) 28,51 Proposed Regulations: 26 CFR 1.1502–21, revised; extended carryback of losses to or from a consolidated group (REG–151605–09) 31,184 26 CFR 300.0 thru 300.8, amended; 300.9, added; user fees relating to enrollment and preparer tax identification num- ber (REG–139343–08) 33,256 Publication 1220, Specifications for Filing Forms 1097, 1098, 1099, 3921, 3922, 5498, 8935, and W-2G Electronically, 2010 revision (RP 26) 30,91 Qualified mortgage bonds (QMBs) and mortgage credit certifi- cate (MCCs), average area housing purchase price for 2010 (RP 25) 27,16 Regulations: 26 CFR 1.382–1, amended; 1.382–1T, added; 1.382–7, added; 1.382–7T, removed; built-in gains and losses under section 382(h) (TD 9487) 28,48; 1.382–2T, amended, correction (Ann 50) 33,260 26 CFR 1.1502–21, amended; 1.1502–21T, revised; 602.101, revised; extended carryback of losses to or from a consoli- dated group (TD 9490) 31,176 26 CFR 301.6404–0, –4, added; 301.6404–4T, removed; interest and penalty suspension provisions under section 6404(g) of the Internal Revenue Code (TD 9488) 28,51 August 30, 2010v2010–35 I.R.B. INCOME TAX—Cont. Revocation of Notice 2003–19 (Notice 53) 31,182 Revocations, exempt organizations (Ann 44) 28,54;(Ann45) 29,87; (Ann 47) 30,173;(Ann49)34,272 Section 382 limitation: Fluctuation in value, ownership changes (Notice 50) 27,12 Ownership changes, small shareholders (Notice 49) 27,10 Tax convention, U.S. –Greenland reciprocal exemption agree- ment (Ann 48) 32,234 User fees relating to enrollment and preparer tax identification numbers (REG–139343–08) 33,256 SELF-EMPLOYMENT TAX Revocation of Notice 2003–19 (Notice 53) 31,182 2010–35 I.R.B.viAugust 30, 2010 August 30, 20102010–35 I.R.B. 2010–35 I.R.B.August 30, 2010 August 30, 20102010–35 I.R.B. INTERNAL REVENUE BULLETIN The Introduction at the beginning of this issue describes the purpose and content of this publication. The weekly Internal Revenue Bulletin is sold on a yearly subscription basis by the Superintendent of Documents. 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