Coverage of Certain Preventive Services Under the Affordable Care Act, 51092-51101 [2014-20252]

Download as PDF 51092 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 54 [TD–9690] RIN 1545–BM38 DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Parts 2510 and 2590 RIN 1210–AB67 DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Parts 147 [CMS–9939–IFC] RIN 0938–AR42 Coverage of Certain Preventive Services Under the Affordable Care Act Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Interim final rules. AGENCY: This document contains interim final regulations regarding coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women’s preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). As authorized by the current regulations, and consistent with the HRSA Guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. Additionally, under current regulations, accommodations are available with respect to the contraceptive coverage mstockstill on DSK4VPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), and student health insurance coverage arranged by eligible organizations that are institutions of higher education, that effectively exempt them from this requirement. The regulations establish a mechanism for separately furnishing payments for contraceptive services on behalf of participants and beneficiaries of the group health plans of eligible organizations that avail themselves of an accommodation, and enrollees and dependents of student health coverage arranged by eligible organizations that are institutions of higher education that avail themselves of an accommodation. These interim final regulations augment current regulations in light of the Supreme Court’s interim order in connection with an application for an injunction in Wheaton College v. Burwell, 134 S. Ct. 2806 (2014) (Wheaton order). These interim final regulations provide an alternative process that an eligible organization may use to provide notice of its religious objections to providing contraceptive coverage, while preserving participants’ and beneficiaries’ (and enrollees’ and dependents’) access to coverage for the full range of Food and Drug Administration (FDA)-approved contraceptives, as prescribed by a health care provider, without cost sharing. Effective date: These interim final regulations are effective on August 27, 2014. Comments: Written comments on these interim final regulations are invited and must be received by October 27, 2014. DATES: Written comments may be submitted to the Department of Labor as specified below. Any comment that is submitted will be shared with the Department of Health and Human Services and the Department of the Treasury, and will also be made available to the public. Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments may be posted on the Internet and can be retrieved by most Internet search engines. No deletions, modifications, or redactions will be made to the comments received, as they are public records. Comments may be submitted anonymously. ADDRESSES: PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 Comments, identified by ‘‘Preventive Services,’’ may be submitted by one of the following methods: Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Mail or Hand Delivery: Office of Health Plan Standards and Compliance Assistance, Employee Benefits Security Administration, Room N–5653, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, Attention: Preventive Services. Comments received will be posted without change to www.regulations.gov and available for public inspection at the Public Disclosure Room, N–1513, Employee Benefits Security Administration, 200 Constitution Avenue NW., Washington, DC 20210, including any personal information provided. FOR FURTHER INFORMATION CONTACT: David Mlawsky, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), at (410) 786–1565; Amy Turner or Beth Baum, Employee Benefits Security Administration (EBSA), Department of Labor, at (202) 693–8335; Karen Levin, Internal Revenue Service (IRS), Department of the Treasury, at (202) 927–9639. Customer Service Information: Individuals interested in obtaining information from the Department of Labor concerning employment-based health coverage laws may call the EBSA Toll-Free Hotline at 1–866–444–EBSA (3272) or visit the Department of Labor’s Web site (www.dol.gov/ebsa). Information from HHS on private health insurance coverage can be found on CMS’s Web site (www.cms.gov/cciio), and information on health care reform can be found at www.HealthCare.gov. SUPPLEMENTARY INFORMATION: I. Background The Patient Protection and Affordable Care Act (Pub. L. 111–148) was enacted on March 23, 2010. The Health Care and Education Reconciliation Act of 2010 (Pub. L. 111–152) was enacted on March 30, 2010. These statutes are collectively known as the Affordable Care Act. The Affordable Care Act reorganizes, amends, and adds 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 Affordable Care Act adds section 715(a)(1) to the Employee Retirement Income Security Act of 1974 (ERISA) and section 9815(a)(1) to the Internal Revenue Code (Code) to incorporate the provisions of part A of E:\FR\FM\27AUR1.SGM 27AUR1 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES title XXVII of the PHS Act into ERISA and the Code, and to make them applicable to group health plans and health insurance issuers providing health insurance coverage in connection with group health plans. The sections of the PHS Act incorporated into ERISA and the Code are sections 2701 through 2728. Section 2713 of the PHS Act, as added by the Affordable Care Act and incorporated into ERISA and the Code, requires that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage provide coverage of certain specified preventive services without cost sharing, including under paragraph (a)(4), benefits for certain women’s preventive health services as provided for in comprehensive guidelines supported by the Health Resources and Services Administration (HRSA). On August 1, 2011, HRSA adopted and released guidelines for women’s preventive health services (HRSA Guidelines) based on recommendations of the independent Institute of Medicine. As relevant here, the HRSA Guidelines include all Food and Drug Administration (FDA)-approved contraceptives, sterilization procedures, and patient education and counseling for women with reproductive capacity, as prescribed by a health care provider (collectively, contraceptive services).1 Except as discussed later in this section, non-grandfathered group health plans and health insurance coverage are required to provide coverage consistent with the HRSA Guidelines without cost sharing for plan years (or, in the individual market, policy years) beginning on or after August 1, 2012.2 Interim final regulations implementing section 2713 of the PHS Act were published on July 19, 2010 (75 FR 41726) (2010 interim final regulations). On August 1, 2011, the Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) amended the 2010 interim final regulations to provide HRSA with authority to exempt group health plans established or maintained by certain religious employers (and group health insurance 1 The HRSA Guidelines exclude services relating to a man’s reproductive capacity, such as vasectomies and condoms. 2 Interim final regulations published by the Departments on July 19, 2010, generally provide that plans and issuers must cover a newly recommended preventive service starting with the first plan year (or, in the individual market, policy year) that begins on or after the date that is one year after the date on which the new recommendation is issued. 26 CFR 54.9815–2713T(b)(1); 29 CFR 2590.715–2713(b)(1); 45 CFR 147.130(b)(1). VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 coverage provided in connection with such plans) from the requirement to cover contraceptive services consistent with the HRSA Guidelines (76 FR 46621) (2011 amended interim final regulations).3 On the same date, HRSA exercised this authority in the HRSA Guidelines to exempt group health plans established or maintained by these religious employers (and group health insurance coverage provided in connection with such plans) from the HRSA Guidelines with respect to contraceptive services.4 The 2011 amended interim final regulations specified that, for purposes of this exemption, a religious employer was one that: (1) Has the inculcation of religious values as its purpose; (2) primarily employs persons who share its religious tenets; (3) primarily serves persons who share its religious tenets; and (4) is a nonprofit organization described in section 6033(a)(1) and (a)(3)(A)(i) or (iii) of the Code. Section 6033(a)(3)(A)(i) and (iii) of the Code refers to churches, their integrated auxiliaries, and conventions or associations of churches, as well as to the exclusively religious activities of any religious order. Final regulations issued on February 10, 2012, adopted the definition of religious employer in the 2011 amended interim final regulations without modification (2012 final regulations).5 Contemporaneous with the issuance of the 2012 final regulations, HHS, with the agreement of the Departments of Labor and the Treasury, issued guidance establishing a temporary safe harbor from enforcement of the contraceptive coverage requirement by the Departments for group health plans established or maintained by certain nonprofit organizations with religious objections to contraceptive coverage (and group health insurance coverage provided in connection with such plans).6 The guidance provided that the 3 The 2011 amended interim final regulations were issued and effective on August 1, 2011, and published in the Federal Register on August 3, 2011 (76 FR 46621). 4 HRSA subsequently amended the HRSA Guidelines to reflect the simplified definition of ‘‘religious employer’’ contained in the July 2013 final regulations, 78 FR 39870 (July 2, 2013) (discussed below), effective August 1, 2013. 5 The 2012 final regulations were published in the Federal Register on February 15, 2012 (77 FR 8725). 6 Guidance on the Temporary Enforcement Safe Harbor for Certain Employers, Group Health Plans, and Group Health Insurance Issuers with Respect to the Requirement to Cover Contraceptive Services Without Cost Sharing Under Section 2713 of the Public Health Service Act, Section 715(a)(1) of the Employee Retirement Income Security Act, and Section 9815(a)(1) of the Internal Revenue Code; originally issued on February 10, 2012, and reissued on August 15, 2012 and June 28, 2013; PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 51093 temporary enforcement safe harbor would remain in effect until the first plan year beginning on or after August 1, 2013. At the same time, the Departments committed to rulemaking to achieve the goals of providing coverage of recommended preventive services, including contraceptive services, without cost sharing, while simultaneously ensuring that certain additional nonprofit organizations with religious objections to contraceptive coverage would not have to contract, arrange, pay, or refer for such coverage. On March 21, 2012, the Departments published an advance notice of proposed rulemaking (ANPRM) that described and solicited comments on possible approaches to achieve these goals (77 FR 16501). On February 6, 2013, following review of the comments on the ANPRM, the Departments published proposed regulations at 78 FR 8456 (proposed regulations). The regulations proposed to simplify and clarify the definition of ‘‘religious employer’’ for purposes of the religious employer exemption. The regulations also proposed accommodations for group health plans established or maintained or arranged by certain nonprofit religious organizations with religious objections to contraceptive coverage (and group health insurance coverage provided in connection with such plans). These organizations were referred to as ‘‘eligible organizations.’’ The regulations proposed that, in the case of an insured group health plan established or maintained by an eligible organization, the health insurance issuer providing group health insurance coverage in connection with the plan would be required to assume sole responsibility for providing contraceptive coverage to plan participants and beneficiaries without cost sharing, premium, fee, or other charge to plan participants or beneficiaries or to the eligible organization or its plan. The Departments proposed a comparable accommodation with respect to student health insurance coverage arranged by available at: http://www.cms.gov/CCIIO/Resources/ Regulations-and-Guidance/Downloads/preventiveservices-guidance-6-28-2013.pdf. The guidance clarified, among other things, that plans that took some action before February 10, 2012, to try, without success, to exclude or limit contraceptive coverage were not precluded from eligibility for the safe harbor. The temporary enforcement safe harbor was also available to student health insurance coverage arranged by nonprofit institutions of higher education with religious objections to contraceptive coverage that met the conditions set forth in the guidance. See Student Health Insurance Coverage, 77 FR 16457 (Mar. 21, 2012). E:\FR\FM\27AUR1.SGM 27AUR1 mstockstill on DSK4VPTVN1PROD with RULES 51094 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations eligible organizations that are institutions of higher education. In the case of a self-insured group health plan established or maintained by an eligible organization, the proposed regulations presented potential approaches under which the third party administrator of the plan would provide or arrange for a third party to provide contraceptive coverage to plan participants and beneficiaries without cost sharing, premium, fee, or other charge to plan participants or beneficiaries or to the eligible organization or its plan. An issuer (or its affiliate) would be able to offset the costs incurred by the third party administrator and the issuer in the course of arranging and providing such coverage by claiming an adjustment in the Federally-facilitated Exchange (FFE) user fee. The Departments received over 400,000 comments (many of them standardized form letters) in response to the proposed regulations. After consideration of the comments, the Departments published final regulations on July 2, 2013 at 78 FR 39870 (July 2013 final regulations). The July 2013 final regulations simplified and clarified the definition of religious employer for purposes of the religious employer exemption and established accommodations for health coverage established or maintained or arranged by eligible organizations. A contemporaneously re-issued HHS guidance document extended the temporary safe harbor from enforcement of the contraceptive coverage requirement by the Departments to encompass plan years beginning on or after August 1, 2013, and before January 1, 2014. This guidance included a form to be used by an organization during this temporary period to self-certify that its plan qualified for the temporary enforcement safe harbor. In addition, HHS and the Department of Labor (DOL) issued a self-certification form, EBSA Form 700, to be executed by an organization seeking to be treated as an eligible organization for purposes of an accommodation under the July 2013 final regulations. This self-certification form was provided for use with the accommodation under the July 2013 final regulations, after the expiration of the temporary enforcement safe harbor (that is, for plan years beginning on or after January 1, 2014). On June 30, 2014, the Supreme Court ruled in the case of Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014), that, under the Religious Freedom Restoration Act of 1993 (RFRA), the requirement to provide contraceptive coverage could not be VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 applied to the closely held for-profit corporations before the Court because their owners had religious objections to providing such coverage, and because the Government’s goal of guaranteeing coverage for contraceptive methods without cost sharing could be achieved in a less restrictive manner by offering such closely held for-profit entities the accommodation the Government already provided to religious nonprofit organizations with religious objections to contraceptive coverage. After describing this accommodation, the Court concluded that the accommodation ‘‘does not impinge on the plaintiffs’ religious belief that providing insurance coverage for the contraceptives at issue here violates their religion, and it serves HHS’ stated interests equally well.’’ 134 S. Ct. at 2782. The Departments are publishing elsewhere in this edition of the Federal Register a notice of proposed rulemaking (NPRM) that proposes possible amendments to the definition of the term ‘‘eligible organization’’ to include closely held for-profit entities with religious objections to contraceptive coverage, in light of the Hobby Lobby decision. On July 3, 2014, the Supreme Court issued an interim order in connection with an application for an injunction pending appeal in Wheaton College v. Burwell, 134 S. Ct. 2806 (2014), in which the plaintiff challenged under RFRA the requirement in the July 2013 final regulations that an eligible organization invoking the accommodation send EBSA Form 700 to the insurance issuer or third party administrator. The Court’s order stated that, ‘‘[i]f the [plaintiff] informs the Secretary of Health and Human Services in writing that it is a nonprofit organization that holds itself out as religious and has religious objections to providing coverage for contraceptive services, the [Departments of Labor, Health and Human Services, and the Treasury] are enjoined from enforcing against the [plaintiff]’’ certain provisions of the Affordable Care Act and related regulations requiring coverage without cost sharing of certain contraceptive services ‘‘pending final disposition of appellate review.’’ 134 S.Ct. at 2807. The order stated that Wheaton College need not use EBSA Form 700 or send a copy of the executed form to its health insurance issuers or third party administrators to meet the condition for this injunctive relief. Id. The Court also stated that its interim order neither affected ‘‘the ability of the [plaintiff’s] employees and students to obtain, without cost, the full range of PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 FDA approved contraceptives,’’ nor precluded the Government from relying on the notice by the plaintiff ‘‘to facilitate the provision of full contraceptive coverage under the Act.’’ Id. The Court’s order further stated that it ‘‘should not be construed as an expression of the Court’s views on the merits’’ of the plaintiff’s challenge to the accommodations. Id. The Departments are issuing these interim final regulations in light of the Supreme Court’s interim order in Wheaton concerning notice to the Federal government that an eligible organization has a religious objection to providing contraceptive coverage, as an alternative to the EBSA Form 700 method of self-certification, and to preserve participants’ and beneficiaries’ (and, in the case of student health insurance coverage, enrollees’ and dependents’) access to coverage for the full range of FDA-approved contraceptives, as prescribed by a health care provider, without cost sharing. II. Overview of the Interim Final Regulations These interim final regulations amend the Departments’ July 2013 final regulations to provide an alternative process for the sponsor of a group health plan or an institution of higher education to provide notice of its religious objection to coverage of all or a subset of contraceptive services, as an alternative to the EBSA Form 700 method of self-certification. These interim final regulations continue to allow eligible organizations to use EBSA Form 700, as set forth in the July 2013 final regulations and guidance.7 The alternative process permitted by these interim final regulations is consistent with the Wheaton order. It provides that an eligible organization may notify HHS in writing of its religious objection to coverage of all or a subset of contraceptive services. The notice must include the name of the eligible organization and the basis on which it qualifies for an accommodation; its objection based on sincerely held religious beliefs to providing coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable); the plan name and type (i.e., whether it is a student health insurance plan within the 7 The EBSA Form 700 is available at: http://www. dol.gov/ebsa/pdf/preventiveserviceseligible organizationcertificationform.pdf. When using the EBSA 700, the self-certification form is provided directly to each third party administrator or issuer of the plan. E:\FR\FM\27AUR1.SGM 27AUR1 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES meaning of 45 CFR 147.145(a) or a church plan within the meaning of ERISA section 3(33)); and the name and contact information for any of the plan’s third party administrators and health insurance issuers.8 A model notice to HHS that eligible organizations may, but are not required to, use is available at: http://www.cms.gov/cciio/resources/ Regulations-and-Guidance/index.html# Prevention. If there is a change in any of the information required to be included in the notice, the organization must provide updated information to HHS. As with the process established in the July 2013 final regulations, nothing in this alternative notice process requires a government assessment of the sincerity of the religious belief underlying the eligible organization’s objection. The notice to HHS, and any subsequent updates, should be sent electronically to: marketreform@cms.hhs.gov, or by regular mail to: Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 200 Independence Avenue SW., Washington, DC 20201, Room 739H. The content required for the notice represents the minimum information necessary for the Departments to determine which entities are covered by the accommodation, to administer the accommodation, and to implement the policies in the July 2013 final regulations. When an eligible organization that establishes or maintains or arranges a self-insured plan subject to ERISA provides such a notice to HHS, DOL (working with HHS) will send a separate notification to each third party administrator of the ERISA plan. DOL’s notification will inform each third party administrator of the eligible organization’s religious objection to funding or administering some or all contraceptive coverage and will designate the relevant third party administrator(s) as plan administrator under section 3(16) of ERISA for those contraceptive benefits that the third party administrator would otherwise manage. The DOL notification will be an instrument under which the plan is operated and shall supersede any earlier designation. In establishing and implementing this alternative process, DOL is exercising its broad rulemaking 8 Church plans are exempt from ERISA pursuant to ERISA section 4(b)(2). As such, a third party administrator of a self-insured church plan cannot become the plan administrator by operation of 29 CFR 2510.3–16, although such third party administrators may voluntarily provide or arrange separate payments for contraceptive services and seek reimbursement for associated expenses under the process set forth in 45 CFR 156.50. VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 authority under Title I of ERISA, which includes the ability to interpret and apply the definition of a plan administrator under ERISA section 3(16)(A). If an eligible organization that establishes or maintains an insured health plan provides a notice to HHS under this alternative process, HHS will send a separate notification to the plan’s health insurance issuer(s) informing the issuer(s) that HHS has received a notice under § 2590.715–2713A(c)(1) and describing the obligations of the issuer(s) under § 2590.715–2713A. Issuers remain responsible for compliance with the statutory and regulatory requirement to provide coverage for contraceptive services to participants and beneficiaries, and to enrollees and dependents of student health plans, notwithstanding that the policyholder is an eligible organization with a religious objection to contraceptive coverage that will not have to contract, arrange, pay, or refer for such coverage. Other questions have arisen regarding the requirement to provide coverage for contraceptive services without cost sharing and the accommodations for eligible organizations. In what has been described as the ‘‘non-interference provision,’’ the July 2013 final regulations provided that eligible organizations that establish or maintain self-insured group health plans ‘‘must not, directly or indirectly seek to interfere with a third party administrator’s arrangements to provide or arrange for separate payments for contraceptive services’’ and ‘‘must not, directly or indirectly, seek to influence a third party administrator’s decision to make any such arrangements.’’ 26 CFR 54.9815–2713A(b)(1)(iii); 29 CFR 2590.715–2713A(b)(1)(iii). The Departments interpret the July 2013 final regulations solely as prohibiting the use of bribery, threats, or other forms of economic coercion in an attempt to prevent a third party administrator from fulfilling its independent legal obligations to provide or arrange separate payments for contraceptive services. Because such conduct is generally unlawful and is prohibited under other state and federal laws, and to reduce unnecessary confusion, these interim final regulations delete the language prohibiting an eligible organization from interfering with or seeking to influence a third party administrator’s decision or efforts to provide separate payments for contraceptive services. PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 51095 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 Treasury, Labor, and HHS (collectively, the Secretaries) to promulgate any interim final rules that they determine are appropriate to carry out the provisions of chapter 100 of the Code, part 7 of subtitle B of title I of ERISA, and part A of title XXVII of the PHS Act, which include PHS Act sections 2701 through 2728 and the incorporation of those sections into ERISA section 715 and Code section 9815. In addition, under Section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq.), a general notice of proposed rulemaking is not required when an agency, for good cause, finds that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest. The provisions of the APA that ordinarily require a notice of proposed rulemaking do not apply here because of the specific authority granted by section 9833 of the Code, section 734 of ERISA, and section 2792 of the PHS Act. However, even if these provisions of the APA were applicable, the Secretaries have determined that it would be impracticable and contrary to the public interest to delay putting the provisions in these interim final regulations in place until a full public notice and comment process is completed. As discussed earlier, the Departments are issuing these interim final regulations in light of the Supreme Court’s order in Wheaton College concerning notice to the Federal government that an eligible organization has a religious objection to providing contraceptive coverage, as an alternative to the EBSA Form 700, and to preserve participants’ and beneficiaries’ (and, in the case of student health insurance coverage, enrollees’ and dependents’) access to coverage for the full range of FDA-approved contraceptive services, as prescribed by a health care provider, without cost sharing. That order was issued and was effective on July 3, 2014. In order to provide other eligible organizations with an option equivalent to the one the Supreme Court provided to Wheaton College on an interim basis, regulations must be published and available to the public as soon as possible. Delaying the availability of the alternative process in order to allow for a full notice and comment period would delay the ability of eligible organizations to avail themselves of this alternative process and could delay women’s access to contraceptive E:\FR\FM\27AUR1.SGM 27AUR1 51096 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations coverage without cost sharing, thereby compromising their access to necessary contraceptive services. Issuing interim final regulations provides the public with an opportunity to comment on whether these regulations affording this alternative should be made permanent or subject to modification without delaying the effective date of the regulations. For the foregoing reasons, the Departments have determined that it would be impracticable and contrary to the public interest to engage in full notice and comment rulemaking before putting these interim final regulations into effect, and that it is in the public interest to promulgate interim final regulations. For the same reasons, the Departments have determined, consistent with section 553(d) of the APA (5 U.S.C. 553(d)), that there is good cause to make these interim final regulations effective immediately upon publication in the Federal Register. IV. Economic Impact and Paperwork Burden mstockstill on DSK4VPTVN1PROD with RULES A. Executive Orders 12866 and 13563— Department of Health and Human Services and Department of Labor Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, and public health and safety effects; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Section 3(f) of Executive Order 12866 defines a ‘‘significant regulatory action’’ as an action that is likely to result in a regulation: (1) Having an annual effect on the economy of $100 million or more in any one year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities (also referred to as ‘‘economically significant’’); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President’s priorities, or VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 the principles set forth in the Executive Order. A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in any one year), and an ‘‘economically significant’’ regulatory action is subject to review by the Office of Management and Budget (OMB). These interim final regulations are not likely to have economic impacts of $100 million or more in any one year, and therefore do not meet the definition of ‘‘economically significant’’ under Executive Order 12866. 1. Need for Regulatory Action These interim final regulations amend the Departments’ July 2013 final regulations to provide an alternative process for an eligible organization to provide notice of its religious objection to coverage of all or a subset of contraceptive services. 2. Anticipated Effects The Departments expect that these interim final regulations will not result in any additional burden on or costs to the affected entities. These interim final regulations do not change the fundamental ability of an eligible organization to exempt itself from contracting, arranging, paying, or referring for contraceptive coverage. Instead, the regulations merely provide alternative means for eligible organizations to provide notice of their religious objection to coverage of all, or a subset of, contraceptive services. B. Special Analyses—Department of the Treasury For purposes of the Department of the Treasury, it has been determined that this rule is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the APA does not apply to these regulations. Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), it is hereby certified that this rule will not have a significant economic impact on a substantial number of small entities This certification is based on the fact that the temporary regulations will not result in any additional costs to affected entities but will provide an alternative means for eligible organizations to provide notice of their religious objection to providing coverage of all, or a subset of, contraceptive services. Pursuant to section 7805(f) of the Code, these temporary regulations have been submitted to the Chief Counsel for Advocacy of the Small Business PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 Administration for comment on their impact on small business. C. Paperwork Reduction Act— Department of Health and Human Services Under the Paperwork Reduction Act, an agency may not conduct or sponsor, and an individual is not required to respond to, a collection of information unless it displays a valid OMB control number. These interim final regulations contain an information collection request (ICR) that is subject to review by the Office of Management and Budget (OMB). A description of these provisions is given in the following section with an estimate of the annual burden. Average labor costs (including fringe benefits) used to estimate the costs are calculated using data available from the Bureau of Labor Statistics. Each organization seeking to be treated as an eligible organization under these interim final regulations must either use the EBSA Form 700 method of self-certification or provide notice to HHS of its religious objection to coverage of all or a subset of contraceptive services. Specifically, these interim final regulations continue to allow eligible organizations to notify an issuer or third party administrator using EBSA Form 700, as set forth in the July 2013 final regulations. In addition, these interim final regulations permit an alternative process, consistent with the Supreme Court’s interim order in Wheaton College, by which an eligible organization may notify HHS of its religious objection to coverage of all or a subset of contraceptive services. HHS is aware, based on litigation, that there are approximately 122 eligible organizations that would now have the option to provide notice to HHS, rather than provide a self-certification to TPAs and/or issuers. In order to complete this task, HHS assumes that clerical staff for each eligible organization will gather and enter the necessary information and send the self-certification to the issuer or third party administrator as appropriate, or send the notice to HHS.9 HHS assumes that a compensation and benefits manager and inside legal counsel will review the self-certification or notice to HHS and a senior executive would execute it. HHS estimates that an eligible organization would spend approximately 45 minutes (30 minutes of clerical labor at a cost of $30 per hour, 10 minutes for a compensation 9 For purposes of this analysis, the Department assumes that the same amount of time will be required to prepare the self-certification and the notice to HHS. E:\FR\FM\27AUR1.SGM 27AUR1 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations and benefits manager at a cost of $102 per hour, 5 minutes for legal counsel at a cost of $127, and 5 minutes by a senior executive at a cost of $121) preparing and sending the self-certification or notice to HHS and filing it to meet the recordkeeping requirement. Therefore, the total annual burden for preparing and providing the information in the self-certification or notice to HHS will require approximately 50 minutes for each eligible organization with an equivalent cost burden of approximately $53 for a total hour burden of 102 hours with an equivalent cost of $6,430. As the Department of Labor and the Department of Health and Human Services share jurisdiction they are splitting the hour burden so each will account for 51 burden hours. HHS estimates that each self-certification or notice to HHS will require $0.49 in postage and $0.05 in materials cost (paper and ink) and the total postage and materials cost for each selfcertification or notice sent via mail will be $0.54. For purposes of this analysis, HHS assumes that all self-certifications or notices to HHS will be mailed. The total cost burden for the selfcertifications or notices to HHS is approximately $66. As the Department of Labor and the Department of Health and Human Services share jurisdiction they are splitting the cost burden so each will account for $33 of the cost burden. mstockstill on DSK4VPTVN1PROD with RULES D. Paperwork Reduction Act— Department of Labor and Department of the Treasury Under the Paperwork Reduction Act, an agency may not conduct or sponsor, and an individual is not required to respond to, a collection of information unless it displays a valid OMB control number. In accordance with the requirements of the PRA, the EBSA Form 700 ICR has been approved by OMB under control number 1210–0150. These interim final regulations amend the ICR by providing an alternative process consistent with the Wheaton order, as discussed earlier in this preamble. The Department of Labor submitted an ICR in order to obtain OMB approval under the PRA for the regulatory revision. The request was made under emergency clearance procedures specified in regulations at 5 CFR 1320.13. In response, OMB approved the ICR under control number 1210–0150 through January 31, 2015. A copy of the information collection request may be obtained free of charge on the RegInfo.gov Web site at http:// www.reginfo.gov/public/do/PRA ViewICR?ref_nbr=201408-1210-001. VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 This approval allows respondents temporarily to utilize the additional flexibility these final regulations provide, while the Department seeks public comment on the collection methods—including their utility and burden. Contemporaneously with the publication of these interim final regulations, the Department of Labor published a notice elsewhere in today’s issue of the Federal Register informing the public of their intention to extend the OMB approval. Consistent with the analysis in the HHS PRA section above the Department expects that each of the estimated 122 organizations will spend approximately 50 minutes in preparation time and incur $0.54 mailing cost to satisfy the requirements. The DOL information collections in this rule are found in 29 CFR 2510.3–16 and 2590.715–2713A and are summarized as follows: Type of Review: Revised Collection. Agency: DOL–EBSA. Title: Coverage of Certain Preventive Services Under the Affordable Care Act. OMB Numbers: 1210–0150. Affected Public: Private Sector— businesses or other for profits. Total Respondents: 61 (combined with HHS total is 122). Total Responses: 61 (combined with HHS total is 122). Frequency of Response: On occasion. Estimated Total Annual Burden Hours: 51 (combined with HHS total is 102 hours. Estimated Total Annual Burden Cost: $33 (combined with HHS total is 66). E. Regulatory Flexibility Act— Department of Labor and Department of Health and Human Services The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) imposes certain requirements with respect to Federal rules that are subject to the notice and comment requirements of section 553(b) of the APA (5 U.S.C. 551 et seq.) and that are likely to have a significant economic impact on a substantial number of small entities. Under Section 553(b) of the APA, a general notice of proposed rulemaking is not required when an agency, for good cause, finds that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest. These interim final regulations are exempt from APA’s prior notice and comment requirement because the Departments made a good cause finding that a general notice of proposed rulemaking is not necessary earlier in this preamble. Therefore, the RFA does not apply and the Departments are not required to either certify that the rule would not have a significant economic PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 51097 impact on a substantial number of small entities or conduct a regulatory flexibility analysis. Nevertheless, the Departments carefully considered the likely impact of the rule on small entities in connection with their assessment under Executive Order 12866. The Departments do not expect that these interim final regulations will have a significant economic effect on a substantial number of small entities, because they will not result in any additional costs to affected entities. Instead, the regulations merely provide an alternative means for eligible organizations to provide notice of their religious objection to coverage of all, or a subset of, contraceptive services. F. Unfunded Mandates Reform Act For purposes of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4), as well as Executive Order 12875, these interim final regulations do not include any federal mandate that may result in expenditures by state, local, or tribal governments, nor do they include any federal mandates that may impose an annual burden of $100 million, adjusted for inflation, or more on the private sector.10 G. Federalism—Department of Health and Human Services and Department of Labor Executive Order 13132 outlines fundamental principles of federalism, and requires the adherence to specific criteria by federal agencies in the process of their formulation and implementation of policies that have ‘‘substantial direct effects’’ on states, the relationship between the federal government and states, or the distribution of power and responsibilities among the various levels of government. Federal agencies promulgating regulations that have these federalism implications must consult with state and local officials, and describe the extent of their consultation and the nature of the concerns of state and local officials in the preamble to the regulation. These interim final regulations do not have any Federalism implications, since they only provide an eligible organization with an alternative process to provide notice of its religious objection to coverage of all or a subset of contraceptive services. V. Statutory Authority The Department of the Treasury temporary regulations are adopted 10 In 2014, that threshold level is approximately $141 million. E:\FR\FM\27AUR1.SGM 27AUR1 51098 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations pursuant to the authority contained in sections 7805 and 9833 of the Code. The Department of Labor regulations are adopted pursuant to the authority contained in 29 U.S.C. 1002(16), 1027, 1059, 1135, 1161–1168, 1169, 1181– 1183, 1181 note, 1185, 1185a, 1185b, 1185d, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Public Law 104–191, 110 Stat. 1936; sec. 401(b), Public Law 105– 200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Public Law 110–343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Public Law 111–148, 124 Stat. 119, as amended by Public Law 111–152, 124 Stat. 1029; Secretary of Labor’s Order 1– 2011, 77 FR 1088 (Jan. 9, 2012). The Department of Health and Human Services regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg–63, 300gg–91, and 300gg–92), as amended; and Title I of the Affordable Care Act, sections 1301– 1304, 1311–1312, 1321–1322, 1324, 1334, 1342–1343, 1401–1402, and 1412, Pub. L. 111–148, 124 Stat. 119 (42 U.S.C. 18021–18024, 18031–18032, 18041–18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31 U.S.C. 9701). Signed this 20th day of August 2014. John Dalrymple, Deputy Commissioner for Services and Enforcement, Internal Revenue Service. List of Subjects ■ Signed this 20th day of August 2014. Phyllis C. Borzi, Assistant Secretary, Employee Benefits Security Administration, Department of Labor. Dated: August 19, 2014. Marilyn Tavenner, Administrator, Centers for Medicare & Medicaid Services. Approved: August 20, 2014. Sylvia M. Burwell, Secretary, Department of Health and Human Services. DEPARTMENT OF THE TREASURY Internal Revenue Service Accordingly, 26 CFR part 54 is amended as follows: PART 54—PENSION EXCISE TAXES Paragraph 1. The authority citation for part 54 continues to read, in part, as follows: ■ Authority: 26 U.S.C. 7805. * * * Par. 2. Section 54.9815–2713A is amended by revising paragraphs (b), (c)(1), and (c)(2)(i) introductory text, and adding paragraph (f), to read as follows: 26 CFR Part 54 Excise taxes, Health care, Health insurance, Pensions, Reporting and recordkeeping requirements. § 54.9815–2713A Accommodations in connection with coverage of preventive health services. 29 CFR Part 2510 * Employee benefit plans, Pensions. 29 CFR Part 2590 Continuation coverage, Disclosure, Employee benefit plans, Group health plans, Health care, Health insurance, Medical child support, Reporting and recordkeeping requirements. 45 CFR Part 147 Health care, Health insurance, Reporting and recordkeeping requirements, State regulation of health insurance. mstockstill on DSK4VPTVN1PROD with RULES Mark J. Mazur, Assistant Secretary of the Treasury (Tax Policy). * * * * (b) [Reserved]. For further guidance, see § 54.9815–2713AT(b). (c) Contraceptive coverage—insured group health plans. (1) [Reserved]. For further guidance, see § 54.9815– 2713AT(c)(1). (2) * * * (i) [Reserved]. For further guidance, see § 54.9815–2713AT(c)(2)(i) introductory text. * * * * * (f) [Reserved]. For further guidance, see § 54.9815–2713AT(f). ■ Par. 3. Section 54.9815–2713AT is added to read as follows: § 54.9815–2713AT Accommodations in connection with coverage of preventive health services (temporary). (a) [Reserved]. For further guidance, see § 54.9815–2713A(a). (b) Contraceptive coverage—selfinsured group health plans. (1) A group health plan established or maintained by an eligible organization that provides benefits on a self-insured basis complies VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 for one or more plan years with any requirement under § 54.9815– 2713(a)(1)(iv) to provide contraceptive coverage if all of the requirements of this paragraph (b)(1) are satisfied: (i) The eligible organization or its plan contracts with one or more third party administrators. (ii) The eligible organization provides either a copy of the self-certification to each third party administrator or a notice to the Secretary of Health and Human Services that it is an eligible organization and of its religious objection to coverage of all or a subset of contraceptive services. (A) When a copy of the selfcertification is provided directly to a third party administrator, such selfcertification must include notice that obligations of the third party administrator are set forth in 29 CFR 2510.3–16 and this section and under § 54.9815–2713A. (B) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization and the basis on which it qualifies for an accommodation; its objection based on sincerely held religious beliefs to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable); the plan name and type (i.e., whether it is a student health insurance plan within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of ERISA section 3(33)); and the name and contact information for any of the plan’s third party administrators and health insurance issuers. If there is a change in any of the information required to be included in the notice, the organization must provide updated information to the Secretary of Health and Human Services. The Department of Labor (working with the Department of Health and Human Services), will send a separate notification to each of the plan’s third party administrators informing the third party administrator that the Secretary of Health and Human Services has received a notice under paragraph (b)(1)(ii) of this section and describing the obligations of the third party administrator under 29 CFR 2510.3–16 and this section and under § 54.9815–2713A. (2) If a third party administrator receives a copy of the self-certification from an eligible organization or a notification from the Department of Labor, as described in paragraph (b)(1)(ii) of this section, and agrees to enter into or remain in a contractual relationship with the eligible E:\FR\FM\27AUR1.SGM 27AUR1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations organization or its plan to provide administrative services for the plan, the third party administrator shall provide or arrange payments for contraceptive services using one of the following methods— (i) Provide payments for contraceptive services for plan participants and beneficiaries without imposing any costsharing requirements (such as a copayment, coinsurance, or a deductible), or imposing a premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries; or (ii) Arrange for an issuer or other entity to provide payments for contraceptive services for plan participants and beneficiaries without imposing any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), or imposing a premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries. (3) If a third party administrator provides or arranges payments for contraceptive services in accordance with either paragraph (b)(2)(i) or (ii) of this section, the costs of providing or arranging such payments may be reimbursed through an adjustment to the Federally-facilitated Exchange user fee for a participating issuer pursuant to 45 CFR 156.50(d). (4) A third party administrator may not require any documentation other than a copy of the self-certification from the eligible organization or notification from the Department of Labor described in paragraph (b)(1)(ii) of this section. (c) Contraceptive coverage—insured group health plans—(1) General rule. A group health plan established or maintained by an eligible organization that provides benefits through one or more group health insurance issuers complies for one or more plan years with any requirement under § 54.9815– 2713(a)(1)(iv) to provide contraceptive coverage if the eligible organization or group health plan provides either a copy of the self-certification to each issuer providing coverage in connection with the plan or a notice to the Secretary of Health and Human Services that it is an eligible organization and of its religious objection to coverage for all or a subset of contraceptive services. (i) When a copy of the selfcertification is provided directly to an issuer, the issuer has sole responsibility for providing such coverage in accordance with § 54.9815–2713. An issuer may not require any further VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 documentation from the eligible organization regarding its status as such. (ii) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization and the basis on which it qualifies for an accommodation; its objection based on its sincerely held religious beliefs to coverage of some or all contraceptive services, as applicable (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable); the plan name and type (i.e., whether it is a student health insurance plan within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of ERISA section 3(33)); and the name and contact information for any of the plan’s third party administrators and health insurance issuers. If there is a change in any of the information required to be included in the notice, the organization must provide updated information to the Secretary of Health and Human Services. The Department of Health and Human Services will send a separate notification to each of the plan’s health insurance issuers informing the issuer that the Secretary of Health and Human Services has received a notice under paragraph (c)(1) of this section and describing the obligations of the issuer under this section and under § 54.9815– 2713A. (2) Payments for contraceptive services. (i) A group health insurance issuer that receives a copy of the selfcertification or notification described in paragraph (b)(1)(ii) of this section with respect to a group health plan established or maintained by an eligible organization in connection with which the issuer would otherwise provide contraceptive coverage under § 54.9815– 2713(a)(1)(iv) must— (ii) [Reserved]. For further guidance, see § 54.9815–2713A(c)(2)(ii). (d) [Reserved]. For further guidance, see § 54.9815–2713A(d). (e) [Reserved]. For further guidance, see § 54.9815–2713A(e). (f) Expiration date. This section expires on August 22, 2017 or on such earlier date as may be provided in final regulations or other action published in the Federal Register. DEPARTMENT OF LABOR Employee Benefits Security Administration For the reasons stated in the preamble, the Department of Labor amends 29 CFR parts 2510 and 2590 as follows: PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 51099 PART 2510—DEFINITION OF TERMS USED IN SUBCHAPTERS C, D, E, F, G, AND L OF THIS CHAPTER 4. The authority citation for part 2510 is revised to read as follows: ■ Authority: 29 U.S.C. 1002(2), 1002(16), 1002(21),1002(37), 1002(38), 1002(40), 1031, and 1135; Secretary of Labor’s Order 1–2011, 77 FR 1088 (Jan. 9, 2012); Sec. 2510.3–101 also issued under sec. 102 of Reorganization Plan No. 4 of 1978, 43 FR 47713, 3 CFR, 1978 Comp., p. 332 and E.O. 12108, 44 FR 1065, 3 CFR, 1978 Comp., p. 275, and 29 U.S.C. 1135 note. Sec. 2510.3–102 also issued under sec. 102 of Reorganization Plan No. 4 of 1978, 43 FR 47713, 3 CFR, 1978 Comp., p. 332 and E.O. 12108, 44 FR 1065, 3 CFR, 1978 Comp., p. 275. Sec. 2510.3–38 is also issued under sec. 1, Pub. L. 105–72, 111 Stat. 1457. 5. Revise the heading for part 2510 to read as set forth above. ■ 6. Section 2510.3–16 is amended by revising paragraph (b) and adding a new paragraph (c) to read as follows: ■ § 2510.3–16 Definition of ‘‘plan administrator.’’ * * * * * (b) In the case of a self-insured group health plan established or maintained by an eligible organization, as defined in § 2590.715–2713A(a) of this chapter, if the eligible organization provides a copy of the self-certification of its objection to administering or funding any contraceptive benefits in accordance with § 2590.715–2713A(b)(1)(ii) of this chapter to a third party administrator, the self-certification shall be an instrument under which the plan is operated, shall be treated as a designation of the third party administrator as the plan administrator under section 3(16) of ERISA for any contraceptive services required to be covered under § 2590.715–2713(a)(1)(iv) of this chapter to which the eligible organization objects on religious grounds, and shall supersede any earlier designation. If, instead, the eligible organization notifies the Secretary of Health and Human Services of its objection to administering or funding any contraceptive benefits in accordance with § 2590.715– 2713A(b)(1)(ii) of this chapter, the Department of Labor, working with the Department of Health and Human Services, shall separately provide notification to each third party administrator that such third party administrator shall be the plan administrator under section 3(16) of ERISA for any contraceptive services required to be covered under § 2590.715–2713(a)(1)(iv) of this chapter to which the eligible organization objects on religious grounds, with E:\FR\FM\27AUR1.SGM 27AUR1 51100 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations respect to benefits for contraceptive services that the third party administrator would otherwise manage. Such notification from the Department of Labor shall be an instrument under which the plan is operated and shall supersede any earlier designation. (c) A third party administrator that becomes a plan administrator pursuant to this section shall be responsible for— (1) Complying with section 2713 of the Public Health Service Act (42 U.S.C. 300gg–13) (as incorporated into section 715 of ERISA) and § 2590.715–2713 of this chapter with respect to coverage of contraceptive services. To the extent the plan contracts with different third party administrators for different classifications of benefits (such as prescription drug benefits versus inpatient and outpatient benefits), each third party administrator is responsible for providing contraceptive coverage that complies with section 2713 of the Public Health Service Act (as incorporated into section 715 of ERISA) and § 2590.715–2713 of this chapter with respect to the classification or classifications of benefits subject to its contract. (2) Establishing and operating a procedure for determining such claims for contraceptive services in accordance with § 2560.503–1 of this chapter. (3) Complying with disclosure and other requirements applicable to group health plans under Title I of ERISA with respect to such benefits. PART 2590—RULES AND REGULATIONS FOR GROUP HEALTH PLANS 7. The authority citation for part 2590 is revised to read as follows: ■ Authority: 29 U.S.C. 1027, 1059, 1135, 1161–1168, 1169, 1181–1183, 1181 note, 1185, 1185a, 1185b, 1185d, 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. 12(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 1–2011, 77 FR 1088 (January 9, 2012). 8. Section 2590.715–2713A is amended by revising paragraphs (b), (c)(1), and (c)(2)(i) introductory text to read as follows: mstockstill on DSK4VPTVN1PROD with RULES ■ § 2590.715–2713A Accommodations in connection with coverage of preventive health services. * * * * * (b) Contraceptive coverage—selfinsured group health plans—(1) A group health plan established or maintained by an eligible organization that provides benefits on a self-insured basis complies VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 for one or more plan years with any requirement under § 2590.715– 2713(a)(1)(iv) to provide contraceptive coverage if all of the requirements of this paragraph (b)(1) are satisfied: (i) The eligible organization or its plan contracts with one or more third party administrators. (ii) The eligible organization provides either a copy of the self-certification to each third party administrator or a notice to the Secretary of Health and Human Services that it is an eligible organization and of its religious objection to coverage of all or a subset of contraceptive services. (A) When a copy of the selfcertification is provided directly to a third party administrator, such selfcertification must include notice that obligations of the third party administrator are set forth in § 2510.3– 16 of this chapter and this section. (B) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization and the basis on which it qualifies for an accommodation; its objection based on sincerely held religious beliefs to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable); the plan name and type (i.e., whether it is a student health insurance plan within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of ERISA section 3(33)); and the name and contact information for any of the plan’s third party administrators and health insurance issuers. If there is a change in any of the information required to be included in the notice, the organization must provide updated information to the Secretary of Health and Human Services. The Department of Labor (working with the Department of Health and Human Services), shall send a separate notification to each of the plan’s third party administrators informing the third party administrator that the Secretary of Health and Human Services has received a notice under paragraph (b)(1)(ii) of this section and describing the obligations of the third party administrator under § 2510.3–16 of this chapter and this section. (2) If a third party administrator receives a copy of the self-certification from an eligible organization or a notification from the Department of Labor, as described in paragraph (b)(1)(ii) of this section, and agrees to enter into or remain in a contractual relationship with the eligible organization or its plan to provide administrative services for the plan, the PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 third party administrator shall provide or arrange payments for contraceptive services using one of the following methods— (i) Provide payments for contraceptive services for plan participants and beneficiaries without imposing any costsharing requirements (such as a copayment, coinsurance, or a deductible), or imposing a premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries; or (ii) Arrange for an issuer or other entity to provide payments for contraceptive services for plan participants and beneficiaries without imposing any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), or imposing a premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries. (3) If a third party administrator provides or arranges payments for contraceptive services in accordance with either paragraph (b)(2)(i) or (ii) of this section, the costs of providing or arranging such payments may be reimbursed through an adjustment to the Federally-facilitated Exchange user fee for a participating issuer pursuant to 45 CFR 156.50(d). (4) A third party administrator may not require any documentation other than a copy of the self-certification from the eligible organization or notification from the Department of Labor described in paragraph (b)(1)(ii) of this section. (c) * * *(1) General rule. A group health plan established or maintained by an eligible organization that provides benefits through one or more group health insurance issuers complies for one or more plan years with any requirement under § 2590.715– 2713(a)(1)(iv) to provide contraceptive coverage if the eligible organization or group health plan provides either a copy of the self-certification to each issuer providing coverage in connection with the plan or a notice to the Secretary of Health and Human Services that it is an eligible organization and of its religious objection to coverage for all or a subset of contraceptive services. (i) When a copy of the selfcertification is provided directly to an issuer, the issuer has sole responsibility for providing such coverage in accordance with § 2590.715–2713. An issuer may not require any further documentation from the eligible organization regarding its status as such. E:\FR\FM\27AUR1.SGM 27AUR1 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations (ii) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization and the basis on which it qualifies for an accommodation; its objection based on its sincerely held religious beliefs to coverage of some or all contraceptive services, as applicable (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable); the plan name and type (i.e., whether it is a student health insurance plan within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of ERISA section 3(33)); and the name and contact information for any of the plan’s third party administrators and health insurance issuers. If there is a change in any of the information required to be included in the notice, the organization must provide updated information to the Secretary of Health and Human Services. The Department of Health and Human Services will send a separate notification to each of the plan’s health insurance issuers informing the issuer that the Secretary of Health and Human Services has received a notice under paragraph (c)(1) of this section and describing the obligations of the issuer under this section. (2) * * * (i) A group health insurance issuer that receives a copy of the selfcertification or notification described in paragraph (c)(1)(ii) of this section with respect to a group health plan established or maintained by an eligible organization in connection with which the issuer would otherwise provide contraceptive coverage under § 2590.715–2713(a)(1)(iv) must— * * * * * DEPARTMENT OF HEALTH AND HUMAN SERVICES For the reasons stated in the preamble, the Department of Health and Human Services amends 45 CFR part 147 as follows: PART 147—HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS 9. The authority citation for part 147 continues to read as follows: mstockstill on DSK4VPTVN1PROD with RULES ■ Authority: Secs 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg–63, 300gg–91, and 300gg–92), as amended. 10. Section 147.131 is amended by revising paragraphs (c)(1) and (c)(2)(i) introductory text to read as follows: ■ VerDate Mar<15>2010 17:33 Aug 26, 2014 Jkt 232001 § 147.131 Exemption and accommodations in connection with coverage of preventive health services. * * * * * (c) * * * (1) General rule. A group health plan established or maintained by an eligible organization that provides benefits through one or more group health insurance issuers complies for one or more plan years with any requirement under § 147.130(a)(1)(iv) to provide contraceptive coverage if the eligible organization or group health plan provides either a copy of the selfcertification to each issuer providing coverage in connection with the plan or a notice to the Secretary of Health and Human Services that it is an eligible organization and of its religious objection to coverage for all or a subset of contraceptive services. (i) When a self-certification is provided directly to an issuer, the issuer has sole responsibility for providing such coverage in accordance with § 147.130. An issuer may not require any further documentation from the eligible organization regarding its status as such. (ii) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization and the basis on which it qualifies for an accommodation; its objection based on its sincerely held religious beliefs to coverage of some or all contraceptive services, as applicable (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable); the plan name and type (i.e., whether it is a student health insurance plan within the meaning of § 147.145(a) or a church plan within the meaning of ERISA section 3(33)); and the name and contact information for any of the plan’s third party administrators and health insurance issuers. If there is a change in any of the information required to be included in the notice, the organization must provide updated information to the Secretary of Health and Human Services. The Department of Health and Human Services will send a separate notification to each of the plan’s health insurance issuers informing the issuer that the Secretary of Health and Human Services has received a notice under paragraph (c)(1) of this section and describing the obligations of the issuer under this section. (2) * * * (i) A group health insurance issuer that receives a copy of the selfcertification or notification described in paragraph (c)(1)(ii) of this section with respect to a group health plan established or maintained by an eligible PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 51101 organization in connection with which the issuer would otherwise provide contraceptive coverage under § 147.130(a)(1)(iv) must— * * * * * [FR Doc. 2014–20252 Filed 8–22–14; 3:30 pm] BILLING CODE 4830–01– 4510–29–P; 4120–01–P; 6325– 64–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG–2014–0686] Annual Marine Events in the Eighth Coast Guard District, Sabine River; Orange, TX Coast Guard, DHS. Notice of enforcement of regulation. AGENCY: ACTION: The Coast Guard will enforce Special Local Regulations for the Southern Professional Outboard Racing Tour (S.P.O.R.T.) boat races to be held on the Sabine River in Orange, TX from 3 p.m. on September 19, 2014, through 6 p.m. on September 21, 2014. This action is necessary to provide for the safety of the participants, crew, spectators, participating vessels, nonparticipating vessels and other users of the waterway. During the enforcement period, the Coast Guard Patrol Commander will enforce restrictions upon, and control the movement of, vessels in the zone established by the Special Local Regulation. DATES: The regulation in 33 CFR 100.801 will be enforced from 3 p.m. to 6 p.m. on September 19, 2014; and from 9 a.m. to 6 p.m. on September 20 and 21, 2014. FOR FURTHER INFORMATION CONTACT: If you have questions on this notice of enforcement, call or email Mr. Scott Whalen, U.S. Coast Guard Marine Safety Unit Port Arthur, TX; telephone 409– 719–5086, email scott.k.whalen@ uscg.mil. SUPPLEMENTARY INFORMATION: The Coast Guard will enforce Special Local Regulation for the annual S.P.O.R.T. boat races in 33 CFR 100.801 (Table 3, Line 5) on September 19, 2014, from 3 p.m. to 6 p.m. and on September 20 and 21, 2014, from 9 a.m. to 6 p.m. This Special Local Regulation encompasses all waters of the Sabine River south of latitude 30°05′33″ N and waters north of latitude 30°05′45″ N North American Datum (NAD 83). Under the provisions of 33 CFR 100.801, a vessel may not enter the SUMMARY: E:\FR\FM\27AUR1.SGM 27AUR1

Agencies

[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Rules and Regulations]
[Pages 51092-51101]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20252]



[[Page 51092]]

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DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 54

[TD-9690]
RIN 1545-BM38

DEPARTMENT OF LABOR

Employee Benefits Security Administration

29 CFR Parts 2510 and 2590

RIN 1210-AB67

DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Parts 147

[CMS-9939-IFC]
RIN 0938-AR42


Coverage of Certain Preventive Services Under the Affordable Care 
Act

AGENCY: Internal Revenue Service, Department of the Treasury; Employee 
Benefits Security Administration, Department of Labor; Centers for 
Medicare & Medicaid Services, Department of Health and Human Services.

ACTION: Interim final rules.

-----------------------------------------------------------------------

SUMMARY: This document contains interim final regulations regarding 
coverage of certain preventive services under section 2713 of the 
Public Health Service Act (PHS Act), added by the Patient Protection 
and Affordable Care Act, as amended, and incorporated into the Employee 
Retirement Income Security Act of 1974 and the Internal Revenue Code. 
Section 2713 of the PHS Act requires coverage without cost sharing of 
certain preventive health services by non-grandfathered group health 
plans and health insurance coverage. Among these services are women's 
preventive health services, as specified in guidelines supported by the 
Health Resources and Services Administration (HRSA). As authorized by 
the current regulations, and consistent with the HRSA Guidelines, group 
health plans established or maintained by certain religious employers 
(and group health insurance coverage provided in connection with such 
plans) are exempt from the otherwise applicable requirement to cover 
certain contraceptive services. Additionally, under current 
regulations, accommodations are available with respect to the 
contraceptive coverage requirement for group health plans established 
or maintained by eligible organizations (and group health insurance 
coverage provided in connection with such plans), and student health 
insurance coverage arranged by eligible organizations that are 
institutions of higher education, that effectively exempt them from 
this requirement. The regulations establish a mechanism for separately 
furnishing payments for contraceptive services on behalf of 
participants and beneficiaries of the group health plans of eligible 
organizations that avail themselves of an accommodation, and enrollees 
and dependents of student health coverage arranged by eligible 
organizations that are institutions of higher education that avail 
themselves of an accommodation. These interim final regulations augment 
current regulations in light of the Supreme Court's interim order in 
connection with an application for an injunction in Wheaton College v. 
Burwell, 134 S. Ct. 2806 (2014) (Wheaton order). These interim final 
regulations provide an alternative process that an eligible 
organization may use to provide notice of its religious objections to 
providing contraceptive coverage, while preserving participants' and 
beneficiaries' (and enrollees' and dependents') access to coverage for 
the full range of Food and Drug Administration (FDA)-approved 
contraceptives, as prescribed by a health care provider, without cost 
sharing.

DATES: Effective date: These interim final regulations are effective on 
August 27, 2014.
    Comments: Written comments on these interim final regulations are 
invited and must be received by October 27, 2014.

ADDRESSES: Written comments may be submitted to the Department of Labor 
as specified below. Any comment that is submitted will be shared with 
the Department of Health and Human Services and the Department of the 
Treasury, and will also be made available to the public. Warning: Do 
not include any personally identifiable information (such as name, 
address, or other contact information) or confidential business 
information that you do not want publicly disclosed. All comments may 
be posted on the Internet and can be retrieved by most Internet search 
engines. No deletions, modifications, or redactions will be made to the 
comments received, as they are public records. Comments may be 
submitted anonymously.
    Comments, identified by ``Preventive Services,'' may be submitted 
by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.
    Mail or Hand Delivery: Office of Health Plan Standards and 
Compliance Assistance, Employee Benefits Security Administration, Room 
N-5653, U.S. Department of Labor, 200 Constitution Avenue NW., 
Washington, DC 20210, Attention: Preventive Services.
    Comments received will be posted without change to 
www.regulations.gov and available for public inspection at the Public 
Disclosure Room, N-1513, Employee Benefits Security Administration, 200 
Constitution Avenue NW., Washington, DC 20210, including any personal 
information provided.

FOR FURTHER INFORMATION CONTACT: David Mlawsky, Centers for Medicare & 
Medicaid Services (CMS), Department of Health and Human Services (HHS), 
at (410) 786-1565; Amy Turner or Beth Baum, Employee Benefits Security 
Administration (EBSA), Department of Labor, at (202) 693-8335; Karen 
Levin, Internal Revenue Service (IRS), Department of the Treasury, at 
(202) 927-9639.
    Customer Service Information: Individuals interested in obtaining 
information from the Department of Labor concerning employment-based 
health coverage laws may call the EBSA Toll-Free Hotline at 1-866-444-
EBSA (3272) or visit the Department of Labor's Web site (www.dol.gov/ebsa). Information from HHS on private health insurance coverage can be 
found on CMS's Web site (www.cms.gov/cciio), and information on health 
care reform can be found at www.HealthCare.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Patient Protection and Affordable Care Act (Pub. L. 111-148) 
was enacted on March 23, 2010. The Health Care and Education 
Reconciliation Act of 2010 (Pub. L. 111-152) was enacted on March 30, 
2010. These statutes are collectively known as the Affordable Care Act. 
The Affordable Care Act reorganizes, amends, and adds 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 Affordable Care Act adds section 
715(a)(1) to the Employee Retirement Income Security Act of 1974 
(ERISA) and section 9815(a)(1) to the Internal Revenue Code (Code) to 
incorporate the provisions of part A of

[[Page 51093]]

title XXVII of the PHS Act into ERISA and the Code, and to make them 
applicable to group health plans and health insurance issuers providing 
health insurance coverage in connection with group health plans. The 
sections of the PHS Act incorporated into ERISA and the Code are 
sections 2701 through 2728.
    Section 2713 of the PHS Act, as added by the Affordable Care Act 
and incorporated into ERISA and the Code, requires that non-
grandfathered group health plans and health insurance issuers offering 
non-grandfathered group or individual health insurance coverage provide 
coverage of certain specified preventive services without cost sharing, 
including under paragraph (a)(4), benefits for certain women's 
preventive health services as provided for in comprehensive guidelines 
supported by the Health Resources and Services Administration (HRSA). 
On August 1, 2011, HRSA adopted and released guidelines for women's 
preventive health services (HRSA Guidelines) based on recommendations 
of the independent Institute of Medicine. As relevant here, the HRSA 
Guidelines include all Food and Drug Administration (FDA)-approved 
contraceptives, sterilization procedures, and patient education and 
counseling for women with reproductive capacity, as prescribed by a 
health care provider (collectively, contraceptive services).\1\ Except 
as discussed later in this section, non-grandfathered group health 
plans and health insurance coverage are required to provide coverage 
consistent with the HRSA Guidelines without cost sharing for plan years 
(or, in the individual market, policy years) beginning on or after 
August 1, 2012.\2\
---------------------------------------------------------------------------

    \1\ The HRSA Guidelines exclude services relating to a man's 
reproductive capacity, such as vasectomies and condoms.
    \2\ Interim final regulations published by the Departments on 
July 19, 2010, generally provide that plans and issuers must cover a 
newly recommended preventive service starting with the first plan 
year (or, in the individual market, policy year) that begins on or 
after the date that is one year after the date on which the new 
recommendation is issued. 26 CFR 54.9815-2713T(b)(1); 29 CFR 
2590.715-2713(b)(1); 45 CFR 147.130(b)(1).
---------------------------------------------------------------------------

    Interim final regulations implementing section 2713 of the PHS Act 
were published on July 19, 2010 (75 FR 41726) (2010 interim final 
regulations). On August 1, 2011, the Departments of Health and Human 
Services (HHS), Labor, and the Treasury (collectively, the Departments) 
amended the 2010 interim final regulations to provide HRSA with 
authority to exempt group health plans established or maintained by 
certain religious employers (and group health insurance coverage 
provided in connection with such plans) from the requirement to cover 
contraceptive services consistent with the HRSA Guidelines (76 FR 
46621) (2011 amended interim final regulations).\3\ On the same date, 
HRSA exercised this authority in the HRSA Guidelines to exempt group 
health plans established or maintained by these religious employers 
(and group health insurance coverage provided in connection with such 
plans) from the HRSA Guidelines with respect to contraceptive 
services.\4\ The 2011 amended interim final regulations specified that, 
for purposes of this exemption, a religious employer was one that: (1) 
Has the inculcation of religious values as its purpose; (2) primarily 
employs persons who share its religious tenets; (3) primarily serves 
persons who share its religious tenets; and (4) is a nonprofit 
organization described in section 6033(a)(1) and (a)(3)(A)(i) or (iii) 
of the Code. Section 6033(a)(3)(A)(i) and (iii) of the Code refers to 
churches, their integrated auxiliaries, and conventions or associations 
of churches, as well as to the exclusively religious activities of any 
religious order. Final regulations issued on February 10, 2012, adopted 
the definition of religious employer in the 2011 amended interim final 
regulations without modification (2012 final regulations).\5\
---------------------------------------------------------------------------

    \3\ The 2011 amended interim final regulations were issued and 
effective on August 1, 2011, and published in the Federal Register 
on August 3, 2011 (76 FR 46621).
    \4\ HRSA subsequently amended the HRSA Guidelines to reflect the 
simplified definition of ``religious employer'' contained in the 
July 2013 final regulations, 78 FR 39870 (July 2, 2013) (discussed 
below), effective August 1, 2013.
    \5\ The 2012 final regulations were published in the Federal 
Register on February 15, 2012 (77 FR 8725).
---------------------------------------------------------------------------

    Contemporaneous with the issuance of the 2012 final regulations, 
HHS, with the agreement of the Departments of Labor and the Treasury, 
issued guidance establishing a temporary safe harbor from enforcement 
of the contraceptive coverage requirement by the Departments for group 
health plans established or maintained by certain nonprofit 
organizations with religious objections to contraceptive coverage (and 
group health insurance coverage provided in connection with such 
plans).\6\ The guidance provided that the temporary enforcement safe 
harbor would remain in effect until the first plan year beginning on or 
after August 1, 2013. At the same time, the Departments committed to 
rulemaking to achieve the goals of providing coverage of recommended 
preventive services, including contraceptive services, without cost 
sharing, while simultaneously ensuring that certain additional 
nonprofit organizations with religious objections to contraceptive 
coverage would not have to contract, arrange, pay, or refer for such 
coverage.
---------------------------------------------------------------------------

    \6\ Guidance on the Temporary Enforcement Safe Harbor for 
Certain Employers, Group Health Plans, and Group Health Insurance 
Issuers with Respect to the Requirement to Cover Contraceptive 
Services Without Cost Sharing Under Section 2713 of the Public 
Health Service Act, Section 715(a)(1) of the Employee Retirement 
Income Security Act, and Section 9815(a)(1) of the Internal Revenue 
Code; originally issued on February 10, 2012, and reissued on August 
15, 2012 and June 28, 2013; available at: http://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/preventive-services-guidance-6-28-2013.pdf. The guidance clarified, among other things, 
that plans that took some action before February 10, 2012, to try, 
without success, to exclude or limit contraceptive coverage were not 
precluded from eligibility for the safe harbor. The temporary 
enforcement safe harbor was also available to student health 
insurance coverage arranged by nonprofit institutions of higher 
education with religious objections to contraceptive coverage that 
met the conditions set forth in the guidance. See Student Health 
Insurance Coverage, 77 FR 16457 (Mar. 21, 2012).
---------------------------------------------------------------------------

    On March 21, 2012, the Departments published an advance notice of 
proposed rulemaking (ANPRM) that described and solicited comments on 
possible approaches to achieve these goals (77 FR 16501).
    On February 6, 2013, following review of the comments on the ANPRM, 
the Departments published proposed regulations at 78 FR 8456 (proposed 
regulations). The regulations proposed to simplify and clarify the 
definition of ``religious employer'' for purposes of the religious 
employer exemption. The regulations also proposed accommodations for 
group health plans established or maintained or arranged by certain 
nonprofit religious organizations with religious objections to 
contraceptive coverage (and group health insurance coverage provided in 
connection with such plans). These organizations were referred to as 
``eligible organizations.''
    The regulations proposed that, in the case of an insured group 
health plan established or maintained by an eligible organization, the 
health insurance issuer providing group health insurance coverage in 
connection with the plan would be required to assume sole 
responsibility for providing contraceptive coverage to plan 
participants and beneficiaries without cost sharing, premium, fee, or 
other charge to plan participants or beneficiaries or to the eligible 
organization or its plan. The Departments proposed a comparable 
accommodation with respect to student health insurance coverage 
arranged by

[[Page 51094]]

eligible organizations that are institutions of higher education.
    In the case of a self-insured group health plan established or 
maintained by an eligible organization, the proposed regulations 
presented potential approaches under which the third party 
administrator of the plan would provide or arrange for a third party to 
provide contraceptive coverage to plan participants and beneficiaries 
without cost sharing, premium, fee, or other charge to plan 
participants or beneficiaries or to the eligible organization or its 
plan. An issuer (or its affiliate) would be able to offset the costs 
incurred by the third party administrator and the issuer in the course 
of arranging and providing such coverage by claiming an adjustment in 
the Federally-facilitated Exchange (FFE) user fee.
    The Departments received over 400,000 comments (many of them 
standardized form letters) in response to the proposed regulations. 
After consideration of the comments, the Departments published final 
regulations on July 2, 2013 at 78 FR 39870 (July 2013 final 
regulations). The July 2013 final regulations simplified and clarified 
the definition of religious employer for purposes of the religious 
employer exemption and established accommodations for health coverage 
established or maintained or arranged by eligible organizations. A 
contemporaneously re-issued HHS guidance document extended the 
temporary safe harbor from enforcement of the contraceptive coverage 
requirement by the Departments to encompass plan years beginning on or 
after August 1, 2013, and before January 1, 2014. This guidance 
included a form to be used by an organization during this temporary 
period to self-certify that its plan qualified for the temporary 
enforcement safe harbor. In addition, HHS and the Department of Labor 
(DOL) issued a self-certification form, EBSA Form 700, to be executed 
by an organization seeking to be treated as an eligible organization 
for purposes of an accommodation under the July 2013 final regulations. 
This self-certification form was provided for use with the 
accommodation under the July 2013 final regulations, after the 
expiration of the temporary enforcement safe harbor (that is, for plan 
years beginning on or after January 1, 2014).
    On June 30, 2014, the Supreme Court ruled in the case of Burwell v. 
Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014), that, under the 
Religious Freedom Restoration Act of 1993 (RFRA), the requirement to 
provide contraceptive coverage could not be applied to the closely held 
for-profit corporations before the Court because their owners had 
religious objections to providing such coverage, and because the 
Government's goal of guaranteeing coverage for contraceptive methods 
without cost sharing could be achieved in a less restrictive manner by 
offering such closely held for-profit entities the accommodation the 
Government already provided to religious nonprofit organizations with 
religious objections to contraceptive coverage. After describing this 
accommodation, the Court concluded that the accommodation ``does not 
impinge on the plaintiffs' religious belief that providing insurance 
coverage for the contraceptives at issue here violates their religion, 
and it serves HHS' stated interests equally well.'' 134 S. Ct. at 2782. 
The Departments are publishing elsewhere in this edition of the Federal 
Register a notice of proposed rulemaking (NPRM) that proposes possible 
amendments to the definition of the term ``eligible organization'' to 
include closely held for-profit entities with religious objections to 
contraceptive coverage, in light of the Hobby Lobby decision.
    On July 3, 2014, the Supreme Court issued an interim order in 
connection with an application for an injunction pending appeal in 
Wheaton College v. Burwell, 134 S. Ct. 2806 (2014), in which the 
plaintiff challenged under RFRA the requirement in the July 2013 final 
regulations that an eligible organization invoking the accommodation 
send EBSA Form 700 to the insurance issuer or third party 
administrator. The Court's order stated that, ``[i]f the [plaintiff] 
informs the Secretary of Health and Human Services in writing that it 
is a nonprofit organization that holds itself out as religious and has 
religious objections to providing coverage for contraceptive services, 
the [Departments of Labor, Health and Human Services, and the Treasury] 
are enjoined from enforcing against the [plaintiff]'' certain 
provisions of the Affordable Care Act and related regulations requiring 
coverage without cost sharing of certain contraceptive services 
``pending final disposition of appellate review.'' 134 S.Ct. at 2807. 
The order stated that Wheaton College need not use EBSA Form 700 or 
send a copy of the executed form to its health insurance issuers or 
third party administrators to meet the condition for this injunctive 
relief. Id. The Court also stated that its interim order neither 
affected ``the ability of the [plaintiff's] employees and students to 
obtain, without cost, the full range of FDA approved contraceptives,'' 
nor precluded the Government from relying on the notice by the 
plaintiff ``to facilitate the provision of full contraceptive coverage 
under the Act.'' Id. The Court's order further stated that it ``should 
not be construed as an expression of the Court's views on the merits'' 
of the plaintiff's challenge to the accommodations. Id.
    The Departments are issuing these interim final regulations in 
light of the Supreme Court's interim order in Wheaton concerning notice 
to the Federal government that an eligible organization has a religious 
objection to providing contraceptive coverage, as an alternative to the 
EBSA Form 700 method of self-certification, and to preserve 
participants' and beneficiaries' (and, in the case of student health 
insurance coverage, enrollees' and dependents') access to coverage for 
the full range of FDA-approved contraceptives, as prescribed by a 
health care provider, without cost sharing.

II. Overview of the Interim Final Regulations

    These interim final regulations amend the Departments' July 2013 
final regulations to provide an alternative process for the sponsor of 
a group health plan or an institution of higher education to provide 
notice of its religious objection to coverage of all or a subset of 
contraceptive services, as an alternative to the EBSA Form 700 method 
of self-certification. These interim final regulations continue to 
allow eligible organizations to use EBSA Form 700, as set forth in the 
July 2013 final regulations and guidance.\7\
---------------------------------------------------------------------------

    \7\ The EBSA Form 700 is available at: http://www.dol.gov/ebsa/pdf/preventiveserviceseligibleorganizationcertificationform.pdf. 
When using the EBSA 700, the self-certification form is provided 
directly to each third party administrator or issuer of the plan.
---------------------------------------------------------------------------

    The alternative process permitted by these interim final 
regulations is consistent with the Wheaton order. It provides that an 
eligible organization may notify HHS in writing of its religious 
objection to coverage of all or a subset of contraceptive services. The 
notice must include the name of the eligible organization and the basis 
on which it qualifies for an accommodation; its objection based on 
sincerely held religious beliefs to providing coverage of some or all 
contraceptive services (including an identification of the subset of 
contraceptive services to which coverage the eligible organization 
objects, if applicable); the plan name and type (i.e., whether it is a 
student health insurance plan within the

[[Page 51095]]

meaning of 45 CFR 147.145(a) or a church plan within the meaning of 
ERISA section 3(33)); and the name and contact information for any of 
the plan's third party administrators and health insurance issuers.\8\ 
A model notice to HHS that eligible organizations may, but are not 
required to, use is available at: http://www.cms.gov/cciio/resources/Regulations-and-Guidance/index.html#Prevention. If there is a change in 
any of the information required to be included in the notice, the 
organization must provide updated information to HHS.
---------------------------------------------------------------------------

    \8\ Church plans are exempt from ERISA pursuant to ERISA section 
4(b)(2). As such, a third party administrator of a self-insured 
church plan cannot become the plan administrator by operation of 29 
CFR 2510.3-16, although such third party administrators may 
voluntarily provide or arrange separate payments for contraceptive 
services and seek reimbursement for associated expenses under the 
process set forth in 45 CFR 156.50.
---------------------------------------------------------------------------

    As with the process established in the July 2013 final regulations, 
nothing in this alternative notice process requires a government 
assessment of the sincerity of the religious belief underlying the 
eligible organization's objection. The notice to HHS, and any 
subsequent updates, should be sent electronically to: 
marketreform@cms.hhs.gov, or by regular mail to: Centers for Medicare & 
Medicaid Services, Center for Consumer Information and Insurance 
Oversight, 200 Independence Avenue SW., Washington, DC 20201, Room 
739H. The content required for the notice represents the minimum 
information necessary for the Departments to determine which entities 
are covered by the accommodation, to administer the accommodation, and 
to implement the policies in the July 2013 final regulations.
    When an eligible organization that establishes or maintains or 
arranges a self-insured plan subject to ERISA provides such a notice to 
HHS, DOL (working with HHS) will send a separate notification to each 
third party administrator of the ERISA plan. DOL's notification will 
inform each third party administrator of the eligible organization's 
religious objection to funding or administering some or all 
contraceptive coverage and will designate the relevant third party 
administrator(s) as plan administrator under section 3(16) of ERISA for 
those contraceptive benefits that the third party administrator would 
otherwise manage. The DOL notification will be an instrument under 
which the plan is operated and shall supersede any earlier designation. 
In establishing and implementing this alternative process, DOL is 
exercising its broad rulemaking authority under Title I of ERISA, which 
includes the ability to interpret and apply the definition of a plan 
administrator under ERISA section 3(16)(A).
    If an eligible organization that establishes or maintains an 
insured health plan provides a notice to HHS under this alternative 
process, HHS will send a separate notification to the plan's health 
insurance issuer(s) informing the issuer(s) that HHS has received a 
notice under Sec.  2590.715-2713A(c)(1) and describing the obligations 
of the issuer(s) under Sec.  2590.715-2713A. Issuers remain responsible 
for compliance with the statutory and regulatory requirement to provide 
coverage for contraceptive services to participants and beneficiaries, 
and to enrollees and dependents of student health plans, 
notwithstanding that the policyholder is an eligible organization with 
a religious objection to contraceptive coverage that will not have to 
contract, arrange, pay, or refer for such coverage.
    Other questions have arisen regarding the requirement to provide 
coverage for contraceptive services without cost sharing and the 
accommodations for eligible organizations. In what has been described 
as the ``non-interference provision,'' the July 2013 final regulations 
provided that eligible organizations that establish or maintain self-
insured group health plans ``must not, directly or indirectly seek to 
interfere with a third party administrator's arrangements to provide or 
arrange for separate payments for contraceptive services'' and ``must 
not, directly or indirectly, seek to influence a third party 
administrator's decision to make any such arrangements.'' 26 CFR 
54.9815-2713A(b)(1)(iii); 29 CFR 2590.715-2713A(b)(1)(iii). The 
Departments interpret the July 2013 final regulations solely as 
prohibiting the use of bribery, threats, or other forms of economic 
coercion in an attempt to prevent a third party administrator from 
fulfilling its independent legal obligations to provide or arrange 
separate payments for contraceptive services. Because such conduct is 
generally unlawful and is prohibited under other state and federal 
laws, and to reduce unnecessary confusion, these interim final 
regulations delete the language prohibiting an eligible organization 
from interfering with or seeking to influence a third party 
administrator's decision or efforts to provide separate payments for 
contraceptive services.

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 Treasury, Labor, and HHS 
(collectively, the Secretaries) to promulgate any interim final rules 
that they determine are appropriate to carry out the provisions of 
chapter 100 of the Code, part 7 of subtitle B of title I of ERISA, and 
part A of title XXVII of the PHS Act, which include PHS Act sections 
2701 through 2728 and the incorporation of those sections into ERISA 
section 715 and Code section 9815.
    In addition, under Section 553(b) of the Administrative Procedure 
Act (APA) (5 U.S.C. 551 et seq.), a general notice of proposed 
rulemaking is not required when an agency, for good cause, finds that 
notice and public comment thereon are impracticable, unnecessary, or 
contrary to the public interest. The provisions of the APA that 
ordinarily require a notice of proposed rulemaking do not apply here 
because of the specific authority granted by section 9833 of the Code, 
section 734 of ERISA, and section 2792 of the PHS Act. However, even if 
these provisions of the APA were applicable, the Secretaries have 
determined that it would be impracticable and contrary to the public 
interest to delay putting the provisions in these interim final 
regulations in place until a full public notice and comment process is 
completed.
    As discussed earlier, the Departments are issuing these interim 
final regulations in light of the Supreme Court's order in Wheaton 
College concerning notice to the Federal government that an eligible 
organization has a religious objection to providing contraceptive 
coverage, as an alternative to the EBSA Form 700, and to preserve 
participants' and beneficiaries' (and, in the case of student health 
insurance coverage, enrollees' and dependents') access to coverage for 
the full range of FDA-approved contraceptive services, as prescribed by 
a health care provider, without cost sharing. That order was issued and 
was effective on July 3, 2014.
    In order to provide other eligible organizations with an option 
equivalent to the one the Supreme Court provided to Wheaton College on 
an interim basis, regulations must be published and available to the 
public as soon as possible. Delaying the availability of the 
alternative process in order to allow for a full notice and comment 
period would delay the ability of eligible organizations to avail 
themselves of this alternative process and could delay women's access 
to contraceptive

[[Page 51096]]

coverage without cost sharing, thereby compromising their access to 
necessary contraceptive services. Issuing interim final regulations 
provides the public with an opportunity to comment on whether these 
regulations affording this alternative should be made permanent or 
subject to modification without delaying the effective date of the 
regulations.
    For the foregoing reasons, the Departments have determined that it 
would be impracticable and contrary to the public interest to engage in 
full notice and comment rulemaking before putting these interim final 
regulations into effect, and that it is in the public interest to 
promulgate interim final regulations. For the same reasons, the 
Departments have determined, consistent with section 553(d) of the APA 
(5 U.S.C. 553(d)), that there is good cause to make these interim final 
regulations effective immediately upon publication in the Federal 
Register.

IV. Economic Impact and Paperwork Burden

A. Executive Orders 12866 and 13563--Department of Health and Human 
Services and Department of Labor

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, and public 
health and safety effects; distributive impacts; and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility.
    Section 3(f) of Executive Order 12866 defines a ``significant 
regulatory action'' as an action that is likely to result in a 
regulation: (1) Having an annual effect on the economy of $100 million 
or more in any one year, or adversely and materially affecting a sector 
of the economy, productivity, competition, jobs, the environment, 
public health or safety, or state, local, or tribal governments or 
communities (also referred to as ``economically significant''); (2) 
creating a serious inconsistency or otherwise interfering with an 
action taken or planned by another agency; (3) materially altering the 
budgetary impacts of entitlement grants, user fees, or loan programs or 
the rights and obligations of recipients thereof; or (4) raising novel 
legal or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order.
    A regulatory impact analysis must be prepared for major rules with 
economically significant effects ($100 million or more in any one 
year), and an ``economically significant'' regulatory action is subject 
to review by the Office of Management and Budget (OMB). These interim 
final regulations are not likely to have economic impacts of $100 
million or more in any one year, and therefore do not meet the 
definition of ``economically significant'' under Executive Order 12866.
1. Need for Regulatory Action
    These interim final regulations amend the Departments' July 2013 
final regulations to provide an alternative process for an eligible 
organization to provide notice of its religious objection to coverage 
of all or a subset of contraceptive services.
2. Anticipated Effects
    The Departments expect that these interim final regulations will 
not result in any additional burden on or costs to the affected 
entities. These interim final regulations do not change the fundamental 
ability of an eligible organization to exempt itself from contracting, 
arranging, paying, or referring for contraceptive coverage. Instead, 
the regulations merely provide alternative means for eligible 
organizations to provide notice of their religious objection to 
coverage of all, or a subset of, contraceptive services.

B. Special Analyses--Department of the Treasury

    For purposes of the Department of the Treasury, it has been 
determined that this rule is not a significant regulatory action as 
defined in Executive Order 12866, as supplemented by Executive Order 
13563. Therefore, a regulatory assessment is not required. It also has 
been determined that section 553(b) of the APA does not apply to these 
regulations. Pursuant to the Regulatory Flexibility Act (5 U.S.C. 
chapter 6), it is hereby certified that this rule will not have a 
significant economic impact on a substantial number of small entities 
This certification is based on the fact that the temporary regulations 
will not result in any additional costs to affected entities but will 
provide an alternative means for eligible organizations to provide 
notice of their religious objection to providing coverage of all, or a 
subset of, contraceptive services. Pursuant to section 7805(f) of the 
Code, these temporary regulations have been submitted to the Chief 
Counsel for Advocacy of the Small Business Administration for comment 
on their impact on small business.

C. Paperwork Reduction Act--Department of Health and Human Services

    Under the Paperwork Reduction Act, an agency may not conduct or 
sponsor, and an individual is not required to respond to, a collection 
of information unless it displays a valid OMB control number. These 
interim final regulations contain an information collection request 
(ICR) that is subject to review by the Office of Management and Budget 
(OMB). A description of these provisions is given in the following 
section with an estimate of the annual burden. Average labor costs 
(including fringe benefits) used to estimate the costs are calculated 
using data available from the Bureau of Labor Statistics.
    Each organization seeking to be treated as an eligible organization 
under these interim final regulations must either use the EBSA Form 700 
method of self-certification or provide notice to HHS of its religious 
objection to coverage of all or a subset of contraceptive services. 
Specifically, these interim final regulations continue to allow 
eligible organizations to notify an issuer or third party administrator 
using EBSA Form 700, as set forth in the July 2013 final regulations. 
In addition, these interim final regulations permit an alternative 
process, consistent with the Supreme Court's interim order in Wheaton 
College, by which an eligible organization may notify HHS of its 
religious objection to coverage of all or a subset of contraceptive 
services. HHS is aware, based on litigation, that there are 
approximately 122 eligible organizations that would now have the option 
to provide notice to HHS, rather than provide a self-certification to 
TPAs and/or issuers.
    In order to complete this task, HHS assumes that clerical staff for 
each eligible organization will gather and enter the necessary 
information and send the self-certification to the issuer or third 
party administrator as appropriate, or send the notice to HHS.\9\ HHS 
assumes that a compensation and benefits manager and inside legal 
counsel will review the self-certification or notice to HHS and a 
senior executive would execute it. HHS estimates that an eligible 
organization would spend approximately 45 minutes (30 minutes of 
clerical labor at a cost of $30 per hour, 10 minutes for a compensation

[[Page 51097]]

and benefits manager at a cost of $102 per hour, 5 minutes for legal 
counsel at a cost of $127, and 5 minutes by a senior executive at a 
cost of $121) preparing and sending the self-certification or notice to 
HHS and filing it to meet the recordkeeping requirement. Therefore, the 
total annual burden for preparing and providing the information in the 
self-certification or notice to HHS will require approximately 50 
minutes for each eligible organization with an equivalent cost burden 
of approximately $53 for a total hour burden of 102 hours with an 
equivalent cost of $6,430.
---------------------------------------------------------------------------

    \9\ For purposes of this analysis, the Department assumes that 
the same amount of time will be required to prepare the self-
certification and the notice to HHS.
---------------------------------------------------------------------------

    As the Department of Labor and the Department of Health and Human 
Services share jurisdiction they are splitting the hour burden so each 
will account for 51 burden hours. HHS estimates that each self-
certification or notice to HHS will require $0.49 in postage and $0.05 
in materials cost (paper and ink) and the total postage and materials 
cost for each self-certification or notice sent via mail will be $0.54. 
For purposes of this analysis, HHS assumes that all self-certifications 
or notices to HHS will be mailed. The total cost burden for the self-
certifications or notices to HHS is approximately $66.
    As the Department of Labor and the Department of Health and Human 
Services share jurisdiction they are splitting the cost burden so each 
will account for $33 of the cost burden.

D. Paperwork Reduction Act--Department of Labor and Department of the 
Treasury

    Under the Paperwork Reduction Act, an agency may not conduct or 
sponsor, and an individual is not required to respond to, a collection 
of information unless it displays a valid OMB control number. In 
accordance with the requirements of the PRA, the EBSA Form 700 ICR has 
been approved by OMB under control number 1210-0150. These interim 
final regulations amend the ICR by providing an alternative process 
consistent with the Wheaton order, as discussed earlier in this 
preamble. The Department of Labor submitted an ICR in order to obtain 
OMB approval under the PRA for the regulatory revision. The request was 
made under emergency clearance procedures specified in regulations at 5 
CFR 1320.13. In response, OMB approved the ICR under control number 
1210-0150 through January 31, 2015. A copy of the information 
collection request may be obtained free of charge on the RegInfo.gov 
Web site at http://www.reginfo.gov/public/do/
PRAViewICR?refnbr=201408-1210-001.
    This approval allows respondents temporarily to utilize the 
additional flexibility these final regulations provide, while the 
Department seeks public comment on the collection methods--including 
their utility and burden. Contemporaneously with the publication of 
these interim final regulations, the Department of Labor published a 
notice elsewhere in today's issue of the Federal Register informing the 
public of their intention to extend the OMB approval.
    Consistent with the analysis in the HHS PRA section above the 
Department expects that each of the estimated 122 organizations will 
spend approximately 50 minutes in preparation time and incur $0.54 
mailing cost to satisfy the requirements. The DOL information 
collections in this rule are found in 29 CFR 2510.3-16 and 2590.715-
2713A and are summarized as follows:
    Type of Review: Revised Collection.
    Agency: DOL-EBSA.
    Title: Coverage of Certain Preventive Services Under the Affordable 
Care Act.
    OMB Numbers: 1210-0150.
    Affected Public: Private Sector--businesses or other for profits.
    Total Respondents: 61 (combined with HHS total is 122).
    Total Responses: 61 (combined with HHS total is 122).
    Frequency of Response: On occasion.
    Estimated Total Annual Burden Hours: 51 (combined with HHS total is 
102 hours.
    Estimated Total Annual Burden Cost: $33 (combined with HHS total is 
66).

E. Regulatory Flexibility Act--Department of Labor and Department of 
Health and Human Services

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) imposes 
certain requirements with respect to Federal rules that are subject to 
the notice and comment requirements of section 553(b) of the APA (5 
U.S.C. 551 et seq.) and that are likely to have a significant economic 
impact on a substantial number of small entities. Under Section 553(b) 
of the APA, a general notice of proposed rulemaking is not required 
when an agency, for good cause, finds that notice and public comment 
thereon are impracticable, unnecessary, or contrary to the public 
interest. These interim final regulations are exempt from APA's prior 
notice and comment requirement because the Departments made a good 
cause finding that a general notice of proposed rulemaking is not 
necessary earlier in this preamble. Therefore, the RFA does not apply 
and the Departments are not required to either certify that the rule 
would not have a significant economic impact on a substantial number of 
small entities or conduct a regulatory flexibility analysis.
    Nevertheless, the Departments carefully considered the likely 
impact of the rule on small entities in connection with their 
assessment under Executive Order 12866. The Departments do not expect 
that these interim final regulations will have a significant economic 
effect on a substantial number of small entities, because they will not 
result in any additional costs to affected entities. Instead, the 
regulations merely provide an alternative means for eligible 
organizations to provide notice of their religious objection to 
coverage of all, or a subset of, contraceptive services.

F. Unfunded Mandates Reform Act

    For purposes of the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4), as well as Executive Order 12875, these interim final 
regulations do not include any federal mandate that may result in 
expenditures by state, local, or tribal governments, nor do they 
include any federal mandates that may impose an annual burden of $100 
million, adjusted for inflation, or more on the private sector.\10\
---------------------------------------------------------------------------

    \10\ In 2014, that threshold level is approximately $141 
million.
---------------------------------------------------------------------------

G. Federalism--Department of Health and Human Services and Department 
of Labor

    Executive Order 13132 outlines fundamental principles of 
federalism, and requires the adherence to specific criteria by federal 
agencies in the process of their formulation and implementation of 
policies that have ``substantial direct effects'' on states, the 
relationship between the federal government and states, or the 
distribution of power and responsibilities among the various levels of 
government. Federal agencies promulgating regulations that have these 
federalism implications must consult with state and local officials, 
and describe the extent of their consultation and the nature of the 
concerns of state and local officials in the preamble to the 
regulation.
    These interim final regulations do not have any Federalism 
implications, since they only provide an eligible organization with an 
alternative process to provide notice of its religious objection to 
coverage of all or a subset of contraceptive services.

V. Statutory Authority

    The Department of the Treasury temporary regulations are adopted

[[Page 51098]]

pursuant to the authority contained in sections 7805 and 9833 of the 
Code.
    The Department of Labor regulations are adopted pursuant to the 
authority contained in 29 U.S.C. 1002(16), 1027, 1059, 1135, 1161-1168, 
1169, 1181-1183, 1181 note, 1185, 1185a, 1185b, 1185d, 1191, 1191a, 
1191b, and 1191c; sec. 101(g), Public Law 104-191, 110 Stat. 1936; sec. 
401(b), Public Law 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 
512(d), Public Law 110-343, 122 Stat. 3881; sec. 1001, 1201, and 
1562(e), Public Law 111-148, 124 Stat. 119, as amended by Public Law 
111-152, 124 Stat. 1029; Secretary of Labor's Order 1-2011, 77 FR 1088 
(Jan. 9, 2012).
    The Department of Health and Human Services regulations are adopted 
pursuant to the authority contained in sections 2701 through 2763, 
2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-
91, and 300gg-92), as amended; and Title I of the Affordable Care Act, 
sections 1301-1304, 1311-1312, 1321-1322, 1324, 1334, 1342-1343, 1401-
1402, and 1412, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 
18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 
U.S.C. 36B, and 31 U.S.C. 9701).

List of Subjects

26 CFR Part 54

    Excise taxes, Health care, Health insurance, Pensions, Reporting 
and recordkeeping requirements.

29 CFR Part 2510

    Employee benefit plans, Pensions.

29 CFR Part 2590

    Continuation coverage, Disclosure, Employee benefit plans, Group 
health plans, Health care, Health insurance, Medical child support, 
Reporting and recordkeeping requirements.

45 CFR Part 147

    Health care, Health insurance, Reporting and recordkeeping 
requirements, State regulation of health insurance.

    Signed this 20th day of August 2014.
John Dalrymple,
Deputy Commissioner for Services and Enforcement, Internal Revenue 
Service.

Mark J. Mazur,
Assistant Secretary of the Treasury (Tax Policy).

    Signed this 20th day of August 2014.
Phyllis C. Borzi,
Assistant Secretary, Employee Benefits Security Administration, 
Department of Labor.

    Dated: August 19, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.

    Approved: August 20, 2014.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.

DEPARTMENT OF THE TREASURY

Internal Revenue Service

    Accordingly, 26 CFR part 54 is amended as follows:

PART 54--PENSION EXCISE TAXES

0
Paragraph 1. The authority citation for part 54 continues to read, in 
part, as follows:

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


0
Par. 2. Section 54.9815-2713A is amended by revising paragraphs (b), 
(c)(1), and (c)(2)(i) introductory text, and adding paragraph (f), to 
read as follows:


Sec.  54.9815-2713A  Accommodations in connection with coverage of 
preventive health services.

* * * * *
    (b) [Reserved]. For further guidance, see Sec.  54.9815-2713AT(b).
    (c) Contraceptive coverage--insured group health plans. (1) 
[Reserved]. For further guidance, see Sec.  54.9815-2713AT(c)(1).
    (2) * * *
    (i) [Reserved]. For further guidance, see Sec.  54.9815-
2713AT(c)(2)(i) introductory text.
* * * * *
    (f) [Reserved]. For further guidance, see Sec.  54.9815-2713AT(f).

0
Par. 3. Section 54.9815-2713AT is added to read as follows:


Sec.  54.9815-2713AT  Accommodations in connection with coverage of 
preventive health services (temporary).

    (a) [Reserved]. For further guidance, see Sec.  54.9815-2713A(a).
    (b) Contraceptive coverage--self-insured group health plans. (1) A 
group health plan established or maintained by an eligible organization 
that provides benefits on a self-insured basis complies for one or more 
plan years with any requirement under Sec.  54.9815-2713(a)(1)(iv) to 
provide contraceptive coverage if all of the requirements of this 
paragraph (b)(1) are satisfied:
    (i) The eligible organization or its plan contracts with one or 
more third party administrators.
    (ii) The eligible organization provides either a copy of the self-
certification to each third party administrator or a notice to the 
Secretary of Health and Human Services that it is an eligible 
organization and of its religious objection to coverage of all or a 
subset of contraceptive services.
    (A) When a copy of the self-certification is provided directly to a 
third party administrator, such self-certification must include notice 
that obligations of the third party administrator are set forth in 29 
CFR 2510.3-16 and this section and under Sec.  54.9815-2713A.
    (B) When a notice is provided to the Secretary of Health and Human 
Services, the notice must include the name of the eligible organization 
and the basis on which it qualifies for an accommodation; its objection 
based on sincerely held religious beliefs to coverage of some or all 
contraceptive services (including an identification of the subset of 
contraceptive services to which coverage the eligible organization 
objects, if applicable); the plan name and type (i.e., whether it is a 
student health insurance plan within the meaning of 45 CFR 147.145(a) 
or a church plan within the meaning of ERISA section 3(33)); and the 
name and contact information for any of the plan's third party 
administrators and health insurance issuers. If there is a change in 
any of the information required to be included in the notice, the 
organization must provide updated information to the Secretary of 
Health and Human Services. The Department of Labor (working with the 
Department of Health and Human Services), will send a separate 
notification to each of the plan's third party administrators informing 
the third party administrator that the Secretary of Health and Human 
Services has received a notice under paragraph (b)(1)(ii) of this 
section and describing the obligations of the third party administrator 
under 29 CFR 2510.3-16 and this section and under Sec.  54.9815-2713A.
    (2) If a third party administrator receives a copy of the self-
certification from an eligible organization or a notification from the 
Department of Labor, as described in paragraph (b)(1)(ii) of this 
section, and agrees to enter into or remain in a contractual 
relationship with the eligible

[[Page 51099]]

organization or its plan to provide administrative services for the 
plan, the third party administrator shall provide or arrange payments 
for contraceptive services using one of the following methods--
    (i) Provide payments for contraceptive services for plan 
participants and beneficiaries without imposing any cost-sharing 
requirements (such as a copayment, coinsurance, or a deductible), or 
imposing a premium, fee, or other charge, or any portion thereof, 
directly or indirectly, on the eligible organization, the group health 
plan, or plan participants or beneficiaries; or
    (ii) Arrange for an issuer or other entity to provide payments for 
contraceptive services for plan participants and beneficiaries without 
imposing any cost-sharing requirements (such as a copayment, 
coinsurance, or a deductible), or imposing a premium, fee, or other 
charge, or any portion thereof, directly or indirectly, on the eligible 
organization, the group health plan, or plan participants or 
beneficiaries.
    (3) If a third party administrator provides or arranges payments 
for contraceptive services in accordance with either paragraph 
(b)(2)(i) or (ii) of this section, the costs of providing or arranging 
such payments may be reimbursed through an adjustment to the Federally-
facilitated Exchange user fee for a participating issuer pursuant to 45 
CFR 156.50(d).
    (4) A third party administrator may not require any documentation 
other than a copy of the self-certification from the eligible 
organization or notification from the Department of Labor described in 
paragraph (b)(1)(ii) of this section.
    (c) Contraceptive coverage--insured group health plans--(1) General 
rule. A group health plan established or maintained by an eligible 
organization that provides benefits through one or more group health 
insurance issuers complies for one or more plan years with any 
requirement under Sec.  54.9815-2713(a)(1)(iv) to provide contraceptive 
coverage if the eligible organization or group health plan provides 
either a copy of the self-certification to each issuer providing 
coverage in connection with the plan or a notice to the Secretary of 
Health and Human Services that it is an eligible organization and of 
its religious objection to coverage for all or a subset of 
contraceptive services.
    (i) When a copy of the self-certification is provided directly to 
an issuer, the issuer has sole responsibility for providing such 
coverage in accordance with Sec.  54.9815-2713. An issuer may not 
require any further documentation from the eligible organization 
regarding its status as such.
    (ii) When a notice is provided to the Secretary of Health and Human 
Services, the notice must include the name of the eligible organization 
and the basis on which it qualifies for an accommodation; its objection 
based on its sincerely held religious beliefs to coverage of some or 
all contraceptive services, as applicable (including an identification 
of the subset of contraceptive services to which coverage the eligible 
organization objects, if applicable); the plan name and type (i.e., 
whether it is a student health insurance plan within the meaning of 45 
CFR 147.145(a) or a church plan within the meaning of ERISA section 
3(33)); and the name and contact information for any of the plan's 
third party administrators and health insurance issuers. If there is a 
change in any of the information required to be included in the notice, 
the organization must provide updated information to the Secretary of 
Health and Human Services. The Department of Health and Human Services 
will send a separate notification to each of the plan's health 
insurance issuers informing the issuer that the Secretary of Health and 
Human Services has received a notice under paragraph (c)(1) of this 
section and describing the obligations of the issuer under this section 
and under Sec.  54.9815-2713A.
    (2) Payments for contraceptive services. (i) A group health 
insurance issuer that receives a copy of the self-certification or 
notification described in paragraph (b)(1)(ii) of this section with 
respect to a group health plan established or maintained by an eligible 
organization in connection with which the issuer would otherwise 
provide contraceptive coverage under Sec.  54.9815-2713(a)(1)(iv) 
must--
    (ii) [Reserved]. For further guidance, see Sec.  54.9815-
2713A(c)(2)(ii).
    (d) [Reserved]. For further guidance, see Sec.  54.9815-2713A(d).
    (e) [Reserved]. For further guidance, see Sec.  54.9815-2713A(e).
    (f) Expiration date. This section expires on August 22, 2017 or on 
such earlier date as may be provided in final regulations or other 
action published in the Federal Register.

DEPARTMENT OF LABOR

Employee Benefits Security Administration

    For the reasons stated in the preamble, the Department of Labor 
amends 29 CFR parts 2510 and 2590 as follows:

PART 2510--DEFINITION OF TERMS USED IN SUBCHAPTERS C, D, E, F, G, 
AND L OF THIS CHAPTER

0
4. The authority citation for part 2510 is revised to read as follows:

    Authority:  29 U.S.C. 1002(2), 1002(16), 1002(21),1002(37), 
1002(38), 1002(40), 1031, and 1135; Secretary of Labor's Order 1-
2011, 77 FR 1088 (Jan. 9, 2012); Sec. 2510.3-101 also issued under 
sec. 102 of Reorganization Plan No. 4 of 1978, 43 FR 47713, 3 CFR, 
1978 Comp., p. 332 and E.O. 12108, 44 FR 1065, 3 CFR, 1978 Comp., p. 
275, and 29 U.S.C. 1135 note. Sec. 2510.3-102 also issued under sec. 
102 of Reorganization Plan No. 4 of 1978, 43 FR 47713, 3 CFR, 1978 
Comp., p. 332 and E.O. 12108, 44 FR 1065, 3 CFR, 1978 Comp., p. 275. 
Sec. 2510.3-38 is also issued under sec. 1, Pub. L. 105-72, 111 
Stat. 1457.


0
5. Revise the heading for part 2510 to read as set forth above.

0
6. Section 2510.3-16 is amended by revising paragraph (b) and adding a 
new paragraph (c) to read as follows:


Sec.  2510.3-16  Definition of ``plan administrator.''

* * * * *
    (b) In the case of a self-insured group health plan established or 
maintained by an eligible organization, as defined in Sec.  2590.715-
2713A(a) of this chapter, if the eligible organization provides a copy 
of the self-certification of its objection to administering or funding 
any contraceptive benefits in accordance with Sec.  2590.715-
2713A(b)(1)(ii) of this chapter to a third party administrator, the 
self-certification shall be an instrument under which the plan is 
operated, shall be treated as a designation of the third party 
administrator as the plan administrator under section 3(16) of ERISA 
for any contraceptive services required to be covered under Sec.  
2590.715-2713(a)(1)(iv) of this chapter to which the eligible 
organization objects on religious grounds, and shall supersede any 
earlier designation. If, instead, the eligible organization notifies 
the Secretary of Health and Human Services of its objection to 
administering or funding any contraceptive benefits in accordance with 
Sec.  2590.715-2713A(b)(1)(ii) of this chapter, the Department of 
Labor, working with the Department of Health and Human Services, shall 
separately provide notification to each third party administrator that 
such third party administrator shall be the plan administrator under 
section 3(16) of ERISA for any contraceptive services required to be 
covered under Sec.  2590.715-2713(a)(1)(iv) of this chapter to which 
the eligible organization objects on religious grounds, with

[[Page 51100]]

respect to benefits for contraceptive services that the third party 
administrator would otherwise manage. Such notification from the 
Department of Labor shall be an instrument under which the plan is 
operated and shall supersede any earlier designation.
    (c) A third party administrator that becomes a plan administrator 
pursuant to this section shall be responsible for--
    (1) Complying with section 2713 of the Public Health Service Act 
(42 U.S.C. 300gg-13) (as incorporated into section 715 of ERISA) and 
Sec.  2590.715-2713 of this chapter with respect to coverage of 
contraceptive services. To the extent the plan contracts with different 
third party administrators for different classifications of benefits 
(such as prescription drug benefits versus inpatient and outpatient 
benefits), each third party administrator is responsible for providing 
contraceptive coverage that complies with section 2713 of the Public 
Health Service Act (as incorporated into section 715 of ERISA) and 
Sec.  2590.715-2713 of this chapter with respect to the classification 
or classifications of benefits subject to its contract.
    (2) Establishing and operating a procedure for determining such 
claims for contraceptive services in accordance with Sec.  2560.503-1 
of this chapter.
    (3) Complying with disclosure and other requirements applicable to 
group health plans under Title I of ERISA with respect to such 
benefits.

PART 2590--RULES AND REGULATIONS FOR GROUP HEALTH PLANS

0
7. The authority citation for part 2590 is revised to read as follows:

    Authority:  29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-
1183, 1181 note, 1185, 1185a, 1185b, 1185d, 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. 12(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 1-2011, 77 FR 1088 (January 9, 
2012).


0
8. Section 2590.715-2713A is amended by revising paragraphs (b), 
(c)(1), and (c)(2)(i) introductory text to read as follows:


Sec.  2590.715-2713A  Accommodations in connection with coverage of 
preventive health services.

* * * * *
    (b) Contraceptive coverage--self-insured group health plans--(1) A 
group health plan established or maintained by an eligible organization 
that provides benefits on a self-insured basis complies for one or more 
plan years with any requirement under Sec.  2590.715-2713(a)(1)(iv) to 
provide contraceptive coverage if all of the requirements of this 
paragraph (b)(1) are satisfied:
    (i) The eligible organization or its plan contracts with one or 
more third party administrators.
    (ii) The eligible organization provides either a copy of the self-
certification to each third party administrator or a notice to the 
Secretary of Health and Human Services that it is an eligible 
organization and of its religious objection to coverage of all or a 
subset of contraceptive services.
    (A) When a copy of the self-certification is provided directly to a 
third party administrator, such self-certification must include notice 
that obligations of the third party administrator are set forth in 
Sec.  2510.3-16 of this chapter and this section.
    (B) When a notice is provided to the Secretary of Health and Human 
Services, the notice must include the name of the eligible organization 
and the basis on which it qualifies for an accommodation; its objection 
based on sincerely held religious beliefs to coverage of some or all 
contraceptive services (including an identification of the subset of 
contraceptive services to which coverage the eligible organization 
objects, if applicable); the plan name and type (i.e., whether it is a 
student health insurance plan within the meaning of 45 CFR 147.145(a) 
or a church plan within the meaning of ERISA section 3(33)); and the 
name and contact information for any of the plan's third party 
administrators and health insurance issuers. If there is a change in 
any of the information required to be included in the notice, the 
organization must provide updated information to the Secretary of 
Health and Human Services. The Department of Labor (working with the 
Department of Health and Human Services), shall send a separate 
notification to each of the plan's third party administrators informing 
the third party administrator that the Secretary of Health and Human 
Services has received a notice under paragraph (b)(1)(ii) of this 
section and describing the obligations of the third party administrator 
under Sec.  2510.3-16 of this chapter and this section.
    (2) If a third party administrator receives a copy of the self-
certification from an eligible organization or a notification from the 
Department of Labor, as described in paragraph (b)(1)(ii) of this 
section, and agrees to enter into or remain in a contractual 
relationship with the eligible organization or its plan to provide 
administrative services for the plan, the third party administrator 
shall provide or arrange payments for contraceptive services using one 
of the following methods--
    (i) Provide payments for contraceptive services for plan 
participants and beneficiaries without imposing any cost-sharing 
requirements (such as a copayment, coinsurance, or a deductible), or 
imposing a premium, fee, or other charge, or any portion thereof, 
directly or indirectly, on the eligible organization, the group health 
plan, or plan participants or beneficiaries; or
    (ii) Arrange for an issuer or other entity to provide payments for 
contraceptive services for plan participants and beneficiaries without 
imposing any cost-sharing requirements (such as a copayment, 
coinsurance, or a deductible), or imposing a premium, fee, or other 
charge, or any portion thereof, directly or indirectly, on the eligible 
organization, the group health plan, or plan participants or 
beneficiaries.
    (3) If a third party administrator provides or arranges payments 
for contraceptive services in accordance with either paragraph 
(b)(2)(i) or (ii) of this section, the costs of providing or arranging 
such payments may be reimbursed through an adjustment to the Federally-
facilitated Exchange user fee for a participating issuer pursuant to 45 
CFR 156.50(d).
    (4) A third party administrator may not require any documentation 
other than a copy of the self-certification from the eligible 
organization or notification from the Department of Labor described in 
paragraph (b)(1)(ii) of this section.
    (c) * * *(1) General rule. A group health plan established or 
maintained by an eligible organization that provides benefits through 
one or more group health insurance issuers complies for one or more 
plan years with any requirement under Sec.  2590.715-2713(a)(1)(iv) to 
provide contraceptive coverage if the eligible organization or group 
health plan provides either a copy of the self-certification to each 
issuer providing coverage in connection with the plan or a notice to 
the Secretary of Health and Human Services that it is an eligible 
organization and of its religious objection to coverage for all or a 
subset of contraceptive services.
    (i) When a copy of the self-certification is provided directly to 
an issuer, the issuer has sole responsibility for providing such 
coverage in accordance with Sec.  2590.715-2713. An issuer may not 
require any further documentation from the eligible organization 
regarding its status as such.

[[Page 51101]]

    (ii) When a notice is provided to the Secretary of Health and Human 
Services, the notice must include the name of the eligible organization 
and the basis on which it qualifies for an accommodation; its objection 
based on its sincerely held religious beliefs to coverage of some or 
all contraceptive services, as applicable (including an identification 
of the subset of contraceptive services to which coverage the eligible 
organization objects, if applicable); the plan name and type (i.e., 
whether it is a student health insurance plan within the meaning of 45 
CFR 147.145(a) or a church plan within the meaning of ERISA section 
3(33)); and the name and contact information for any of the plan's 
third party administrators and health insurance issuers. If there is a 
change in any of the information required to be included in the notice, 
the organization must provide updated information to the Secretary of 
Health and Human Services. The Department of Health and Human Services 
will send a separate notification to each of the plan's health 
insurance issuers informing the issuer that the Secretary of Health and 
Human Services has received a notice under paragraph (c)(1) of this 
section and describing the obligations of the issuer under this 
section.
    (2) * * * (i) A group health insurance issuer that receives a copy 
of the self-certification or notification described in paragraph 
(c)(1)(ii) of this section with respect to a group health plan 
established or maintained by an eligible organization in connection 
with which the issuer would otherwise provide contraceptive coverage 
under Sec.  2590.715-2713(a)(1)(iv) must--
* * * * *

DEPARTMENT OF HEALTH AND HUMAN SERVICES

    For the reasons stated in the preamble, the Department of Health 
and Human Services amends 45 CFR part 147 as follows:

PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND 
INDIVIDUAL HEALTH INSURANCE MARKETS

0
9. The authority citation for part 147 continues to read as follows:

    Authority:  Secs 2701 through 2763, 2791, and 2792 of the Public 
Health Service Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 
300gg-92), as amended.


0
10. Section 147.131 is amended by revising paragraphs (c)(1) and 
(c)(2)(i) introductory text to read as follows:


Sec.  147.131  Exemption and accommodations in connection with coverage 
of preventive health services.

* * * * *
    (c) * * * (1) General rule. A group health plan established or 
maintained by an eligible organization that provides benefits through 
one or more group health insurance issuers complies for one or more 
plan years with any requirement under Sec.  147.130(a)(1)(iv) to 
provide contraceptive coverage if the eligible organization or group 
health plan provides either a copy of the self-certification to each 
issuer providing coverage in connection with the plan or a notice to 
the Secretary of Health and Human Services that it is an eligible 
organization and of its religious objection to coverage for all or a 
subset of contraceptive services.
    (i) When a self-certification is provided directly to an issuer, 
the issuer has sole responsibility for providing such coverage in 
accordance with Sec.  147.130. An issuer may not require any further 
documentation from the eligible organization regarding its status as 
such.
    (ii) When a notice is provided to the Secretary of Health and Human 
Services, the notice must include the name of the eligible organization 
and the basis on which it qualifies for an accommodation; its objection 
based on its sincerely held religious beliefs to coverage of some or 
all contraceptive services, as applicable (including an identification 
of the subset of contraceptive services to which coverage the eligible 
organization objects, if applicable); the plan name and type (i.e., 
whether it is a student health insurance plan within the meaning of 
Sec.  147.145(a) or a church plan within the meaning of ERISA section 
3(33)); and the name and contact information for any of the plan's 
third party administrators and health insurance issuers. If there is a 
change in any of the information required to be included in the notice, 
the organization must provide updated information to the Secretary of 
Health and Human Services. The Department of Health and Human Services 
will send a separate notification to each of the plan's health 
insurance issuers informing the issuer that the Secretary of Health and 
Human Services has received a notice under paragraph (c)(1) of this 
section and describing the obligations of the issuer under this 
section.
    (2) * * * (i) A group health insurance issuer that receives a copy 
of the self-certification or notification described in paragraph 
(c)(1)(ii) of this section with respect to a group health plan 
established or maintained by an eligible organization in connection 
with which the issuer would otherwise provide contraceptive coverage 
under Sec.  147.130(a)(1)(iv) must--
* * * * *
[FR Doc. 2014-20252 Filed 8-22-14; 3:30 pm]
BILLING CODE 4830-01- 4510-29-P; 4120-01-P; 6325-64-P