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«Department of Health and Human Services has submitted this rule to the Office of the Federal Register. The official version of the rule will be ...»

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The size threshold for “small” business established by the SBA is currently $35.5 million in annual receipts for health insurance issuers. See ‘‘Table of Small Business Size Standards Matched To North American Industry Classification System Codes,’’ effective July 23, 2013, U.S. Small Business Administration, available at http://www.sba.gov.

CMS-9949-F 351 Federally required training or completing continuing education or recertification in FFEs.

Further, the cost burden related to continuing education and recertification, and recordkeeping will generally be considered an allowed cost that will be covered by the Navigator grants for the FFEs, and these grant funds may be drawn down as the grantee incurs such costs. The costs associated with these proposals may also be covered by other compensation provided by an Exchange, such as payments through contracts to non-Navigator assistance personnel. Though it is very likely that all costs associated with these proposals will be largely covered by affected entities’ and individuals’ funding sources, HHS cannot guarantee that all such costs will be covered because of the possibility of budget limitations applicable to the FFE in any given period, and because there may be variations in how State Exchanges provide funding for these programs. To the extent that all such costs will not be covered by these funding sources, other outside sources may also be available to cover unfunded costs that remain. Costs incurred by designated certified application counselor organizations related to continuing education and recertification and recordkeeping are expected to be low. In some circumstances funds from sources outside of the Exchange, including Federal funds such as Health Resources and Services Administration (HRSA) grants to health centers, or private or State funds may be available to cover certified application counselor costs.

E. Unfunded Mandates Reform Act Section 202 of the Unfunded Mandates Reform Act (UMRA) of 1995 requires that agencies assess anticipated costs and benefits before issuing any final rule that includes a Federal mandate that could result in expenditure in any one year by State, local or tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for

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UMRA does not address the total cost of a final rule. Rather, it focuses on certain categories of cost, mainly those “Federal mandate” costs resulting from--(1) imposing enforceable duties on State, local, or tribal governments, or on the private sector; or (2) increasing the stringency of conditions in, or decreasing the funding of, State, local, or tribal governments under entitlement programs.

This final rule includes mandates on State governments and the private sector. Issuers, non-Navigator assistance personnel, certified application counselors and Exchanges are expected to incur costs of approximately $13 million in 2014 and approximately $85 million in 2015 onwards to comply with the provisions of this final rule. However, beginning in 2015, issuers in the individual market will experience a reduction in costs of approximately $26 million due to the discontinuation of the certification of creditable coverage. Consistent with policy embodied in UMRA, this final rule has been designed to be the least burdensome alternative for State, local and tribal governments, and the private sector while achieving the objectives of the Affordable Care Act.

F. Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications.

Since States are the primary regulators of health insurance coverage, State laws will continue to apply to health insurance coverage and the business of insurance. A State’s authority to pass and implement additional State requirements that affect programs established under the provisions of title I of the Affordable Care Act is not unlimited, however, but extends

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provisions of title I of the Affordable Care Act, including but not limited to those provisions which provide authority for functions of an Exchange, such as the application assistance provided by Navigator programs, non-Navigator programs and certified application counselor programs.

The final rule provides that non-Navigator assistance personnel subject to §155.215, and certified application counselors must meet any licensing, certification or other standards prescribed by the State so long as such standards do not prevent the application of the provisions of title I of the Affordable Care Act, within the meaning of section 1321(d) of the Affordable Care Act. The final rule also includes a non-exhaustive list of non-Federal requirements applicable to Navigators, non-Navigator assistance personnel subject to §155.215, and certified application counselors that, in HHS’s view, prevent the application of the provisions of title I of the Affordable Care Act, within the meaning of section 1321(d) of the Affordable Care Act.

They include non-Federal requirements that require referrals to entities or individuals not required to provide impartial information or act in a consumer’s best interest; non-Federal requirements that prevent Navigators, non-Navigator assistance personnel subject to §155.215, or certified application counselors from providing services to all individuals seeking assistance;

non-Federal requirements that prevent these assisters from providing information regarding substantive benefits or comparative benefits of different health plans; non-Federal requirements that facially, or as applied, make it impossible to fulfill required duties; non-Federal standards that would, as applied or as implemented in a State, prevent an Exchange’s implementation of the programs for Navigators, non-Navigator personnel subject to §155.215 and certified application counselors consistent with Federal requirements; and non-Federal requirements that

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Navigators in the Exchange to be licensed agents and brokers. These provisions provide HHS’s interpretation of how the preemption standard that Congress established in section 1321(d) of the Affordable Care Act applies to this non-exhaustive list of non-Federal requirements for these assister programs.

The final rule establishes Federal standards to determine whether coverage modifications constitute the continuance of an existing product in a market within a State for coverage offered both through and outside of an Exchange in the individual and small group markets. Some States may have different definitions of what changes to a health insurance product constitute modifications and what changes constitute terminations and re-filings of new products. The definitions finalized in this rule will preempt any conflicting State definitions. The guaranteed renewability sections of the PHS Act provide in pertinent part that a uniform modification of coverage must be “consistent with State law.” We interpret this statutory language as governing the extent or type of modifications that may legally be made under State law. As discussed in the preamble to the final rule published on February 27, 2013 under section 2703 of the PHS Act (78 FR 13419), State laws that prevent issuers from uniformly modifying coverage to comply with Federal law requirements would, in effect, prevent the application of such requirements and therefore be preempted. States, however, have the flexibility to broaden the scope of two of the criteria for what is considered a uniform modification, but not narrow its scope.

Some States already have requirements for and publicly report health plan quality and outcomes data, and we want to encourage State flexibility and innovation, consistent with the Affordable Care Act. In addition to prominently displaying quality rating information for each QHP, as calculated by HHS in accordance with the QRS, a State Exchange may display

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In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have Federalism implications or limit the policymaking discretion of the States, HHS has engaged in efforts to consult with and work cooperatively with affected States. HHS has consulted with stakeholders on policies related to the operation of Exchanges, including the SHOP and the premium stabilization programs. HHS has held a number of listening sessions with State representatives to gather public input. HHS consulted with State representatives through regular meetings with the NAIC and regular contact with States through the Exchange Establishment grant and Exchange Blueprint approval processes.

Throughout the process of developing this final rule, HHS has attempted to balance the States’ interests in regulating health insurance issuers and other entities, such as Navigators, nonNavigator assistance personnel, and certified application counselors with creating a Federal baseline for protecting the consumers’ interests. By doing so, it is HHS’ view that it has complied with the requirements of Executive Order 13132. Under the requirements set forth in section 8(a) of Executive Order 13132, and by the signatures affixed to this rule, HHS certifies that the CMS Center for Consumer Information and Insurance Oversight has complied with the requirements of Executive Order 13132 for the attached final rule in a meaningful and timely manner.

G. Congressional Review Act This final rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), which specifies that before a rule can take effect, the Federal agency promulgating the rule shall submit to each

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List of Subjects 45 CFR part 144 Health care, Health insurance, Reporting and record keeping requirements.

45 CFR Part 146 Health care, Health insurance, Reporting and recordkeeping requirements.

45 CFR Part 147 Health care, Health insurance, Reporting and recordkeeping requirements, State regulation of health insurance.

45 CFR Part 148 Administrative practice and procedure, Health care, Health insurance, Penalties, Reporting and recordkeeping requirements 45 CFR Part 153 Administrative practice and procedure, Adverse selection, Health care, Health insurance, Health records, Organization and functions (Government agencies), Premium stabilization, Reporting and recordkeeping requirements, Reinsurance, Risk adjustment, Risk corridors, Risk mitigation, State and local governments.

45 CFR Part 154 Administrative practice and procedure, Claims, Health care, Health insurance, Health plans, Penalties, Reporting and recordkeeping requirements.

45 CFR Part 155 Administrative practice and procedure, Health care access, Health insurance, Reporting

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payments of premium tax credit, Administration and calculation of advance payments of the premium tax credit, Plan variations, Actuarial value.

45 CFR Part 156 Administrative appeals, Administrative practice and procedure, Administration and calculation of advance payments of premium tax credit, Advertising, Advisory Committees, Brokers, Conflict of interest, Consumer protection, Cost-sharing reductions, Grant programshealth, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, American Indian/Alaska Natives, Individuals with disabilities, Loan programs-health, Organization and functions (Government agencies), Medicaid, Payment and collections reports, Public assistance programs, Reporting and recordkeeping requirements, State and local governments, Sunshine Act, Technical assistance, Women, and Youth.

45 CFR Part 158 Administrative practice and procedure, Claims, Health care, Health insurance, Health plans, Penalties, Reporting and recordkeeping requirements, Premium revenues, Medical loss

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For the reasons set forth in the preamble, the Department of Health and Human Services

amends 45 CFR parts 144, 146, 147, 148, 153, 154, 155, 156, and 158 as set forth below:


1. The authority citation for part 144 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.

2. Section 144.103 is amended by adding new definitions of “plan” and “product” in

alphabetical order to read as follows:

§144.103 Definitions.

* * * * * Plan means, with respect to an issuer and a product, the pairing of the health insurance coverage benefits under the product with a metal tier level (as described in sections 1302(d) and (e) of the Affordable Care Act) and service area. The product comprises all plans offered within the product, and the combination of all plans offered within a product constitutes the total service area of the product.

* * * * * Product means a discrete package of health insurance coverage benefits that a health insurance issuer offers using a particular product network type within a service area.

* * * * *


3. The authority citation for part 146 continues to read as follows:

Authority: Secs. 2702 through 2705, 2711 through 2723, 2791, and 2792 of the PHS Act (42 U.S.C. 300gg-1 through 300gg-5, 300gg-11 through 300gg-23, 300gg-91, and 300gg

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The revision and addition read as follows:

§146.152 Guaranteed renewability of coverage for employers in the group market.

* * * * *

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* * * * * (4) Termination of product. The issuer is ceasing to offer coverage in the market in accordance with paragraph (c) or (d) of this section and applicable State law.

* * * * *

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