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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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CMS-9949-F 27 including standards related to guaranteed availability with respect to certain eligible individuals and guaranteed renewability for all individuals. Part 153 outlines standards related to the reinsurance and risk corridors programs. Part 154 outlines standards related to the disclosure and review of rate increases. Part 155 outlines standards related to the operations and functions of an Exchange, including standards related to non-discrimination, accessibility, and enforcement remedies; standards applicable to the consumer assistance functions performed by Navigators, non-Navigator assistance personnel, and certified application counselors; standards related to eligibility appeals; standards related to exemptions; standards related to quality reporting; and standards related to SHOP. Part 156 outlines health insurance issuer responsibilities, including EHB prescription drug standards; the methodology for calculating the annual limit on costsharing for years after 2014; minimum certification standards; standards for recognition of certain types of coverage as minimum essential coverage; quality standards for QHPs; and other QHP issuer responsibilities. Part 158 outlines standards related to the MLR program, including standards related to treatment of ICD-10 conversion costs, standards related to adjustments for issuers affected by the HHS transitional policy and issuers that incurred costs due to the technical issues during the implementation of the Exchanges, and standards related to MLR reporting and rebate calculations in States with merged individual and small group markets.

III. Provisions of the Proposed Regulations and Analysis and Responses to Public Comments The proposed rule titled, “Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond,” was published in the Federal Register on March 21, 2014 (79 FR 15808), with comment period ending April 21, 2014 (referred to in this

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proposed rule. Comments represented a wide variety of stakeholders, including but not limited to States, tribes, tribal organizations, health plans, consumer groups, employer groups, healthcare providers, industry experts, and members of the public.

Some comments were general public comments on the Affordable Care Act and the government’s role in health care, but not specific to the proposed rule. We have not addressed such comments, and others that are not directly related to the proposed rule, because they are outside the scope of this final rule.

In this final rule, we provide a summary of each proposed provision, a summary of and responses to the public comments received, and the provisions we are finalizing.

Comment: Some commenters were concerned that the 30-day comment period did not provided sufficient opportunity for public review and comment on the proposed rule. One commenter stated that the proposed rule included many distinct policy issues, each of which should be addressed in separate rulemaking.

Response: HHS provided a 30-day comment period, which is consistent with the Administrative Procedure Act and the policy established by the Assistant Secretary for Administration (ASA) and the Office of Management and Budget (OMB). Additionally, HHS discussed nearly all of the proposed policies in the preamble to the HHS Notice of Benefit and Payment Parameters for 2015 final rule published on March 11, 2014 (79 FR 13744).9 HHS believes that interested stakeholders had adequate opportunity to provide comment on the policies established in this final rule.

A. Part 144 – Requirements Relating to Health Insurance Coverage

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See the discussion in section III.C.1.b, “Product Discontinuance and Uniform Modification of Coverage Exceptions to Guaranteed Renewability Requirements.” B. Part 146—Requirements for the Group Health Insurance Market

1. HIPAA Opt-Out Provisions for Plan Sponsors of Self-Funded, Non-Federal Governmental Plans (§146.180) We proposed to codify the requirement that self-funded, non-Federal governmental plans may no longer elect to be exempt from (“opt out of”) requirements of title XXVII of the PHS Act related to limitations on preexisting condition exclusion periods; requirements for special enrollment periods; and prohibitions on health status discrimination. Self-funded, non-Federal governmental plans may, however, continue to opt-out of requirements related to benefits for newborns and mothers; parity in mental health and substance use disorder benefits; required coverage for reconstructive surgery following mastectomies; and coverage of dependent students on a medically necessary leave of absence.

We also proposed to streamline the submission process by requiring that opt-out elections be submitted electronically in a format specified by the Secretary in guidance. We solicited comment on these proposals, including ways to improve the electronic submission process.

The proposed rule provided a special effective date for self-funded, non-Federal governmental plans maintained pursuant to a collective bargaining agreement ratified before March 23, 2010 (the date of enactment of the Affordable Care Act) that had opted out of the requirement categories which are no longer available for exemption. These collectively bargained plans may continue to be exempt from the requirements until the first plan year

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The effect of the Affordable Care Act amendments on the HIPAA opt-out provisions was discussed in previous CMS guidance released on September 21, 2010.10 We noted that under the current regulations, plan sponsors of collectively bargained plans may submit one opt-out election for all group health plans subject to the same collective bargaining agreement. We solicited comment on whether the plan sponsor in such circumstances should be required to list all plans subject to the agreement. We also solicited comment on whether a single opt-out submission should be permitted in the case of multiple group health plans not subject to collective bargaining.

Comment: One commenter supported a requirement that plan sponsors of collectively bargained plans must list in their opt-out election all group health plans subject to the collective bargaining agreement.

Response: We establish this requirement in new paragraph (b)(1)(ix) of §146.180.

Sponsors of group health plans not subject to collective bargaining will continue to be required to file a separate election for each group health plan.

We solicited comments on whether the regulation should be modified to allow plan sponsors of multiple group health plans not subject to collective bargaining to submit one election for all of its group health plans. We did not receive any comments on this issue;

accordingly, we are adding regulation text to clarify the current requirement that a separate election must be filed for each group health plan not subject to collective bargaining.

We will continue to accept opt-out elections via U.S. Mail or facsimile until December 31, 2014. During this time, opt-out elections will continue to be accepted by mail to: Centers for

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Medicare & Medicaid Services (CMS), Center for Consumer Information and Insurance Oversight (CCIIO), Attn: HIPAA Opt-Out, 200 Independence Avenue, SW, Room 733H-02, Washington, DC 20201. Elections may also continue to be submitted via facsimile at 301-492For elections submitted via U.S. mail, CMS will continue to use the postmark on the envelope in which the election is submitted to determine that the election is timely filed. If the latest filing date falls on a Saturday, Sunday, or a State or Federal holiday, CMS accepts a postmark or a fax on the next business day. Questions regarding the opt-out process can be submitted to CMS at HIPAAOptOut@cms.hhs.gov. CMS’s Center for Consumer Information and Insurance Oversight makes publicly available on its website a list of self-funded, nonFederal governmental plans that have submitted an opt-out election and the PHS Act provisions subject to the election.11 Summary of Regulatory Changes We are finalizing the revisions proposed in §146.180 of the proposed rule, with the following modifications. In paragraph (b), we add paragraph (b)(1)(ix) to state that, in the case of plan sponsor submitting one opt-out election for multiple group health plans subject to the same collective bargaining agreement, the opt-out election must list each group health plan subject to the agreement. Also in paragraph (b), we add paragraph (b)(1)(x) to state that, in the case of a plan sponsor submitting more than one opt-out election for plans that are not collectively bargained, a separate opt-out election must be submitted for each such plan. In paragraph (c)(3), we delete the special rule for timely filing with respect to opt out elections submitted by U.S. mail, and instead specify a special rule for timely filing that applies to

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electronic filings. The special rule indicates that, if the latest filing date falls on a Saturday, Sunday, or a State or Federal holiday, CMS accepts filings submitted the next business day.

C. Part 147—Health Insurance Reform Requirements for the Group and Individual Health Insurance Markets Guaranteed Availability and Guaranteed Renewability of Coverage (§§147.104 and 147.106) a. No Effect on Other Laws We proposed that nothing in the guaranteed availability requirements should be construed to require an issuer to offer coverage where other Federal laws operate to prohibit the issuance of such coverage. Similarly, we proposed that nothing in the guaranteed renewability requirements should be construed to require an issuer to renew or continue in force coverage for which continued eligibility would otherwise be prohibited under applicable Federal law. We offered several examples of statutory exceptions to the guaranteed availability and renewability requirements in the preamble to the proposed rule (78 FR 15815-6), and noted that only Federal law, not State law, can create such exceptions. We solicited comment on these clarifications, as well as other clarifications that may be helpful.

Additionally, we proposed a technical correction in §147.104(b)(1)(i) to delete duplicate regulatory text added in earlier rulemaking.12 We also proposed other minor regulatory revisions in paragraph (b)(1)(i) for clarity.

Comment: Some commenters recommended the final rule enumerate all current Federal prohibitions on the sale of health insurance coverage that would create exceptions to the guaranteed availability and renewability requirements.

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Response: We believe it is neither appropriate nor practical to outline every specific exception to the guaranteed availability and renewability requirements and that a general rule of construction provides sufficient guidance to stakeholders.

Comment: One commenter sought clarification on situations where issuers offering coverage through an Exchange can sell coverage to individuals who are enrolled in Medicare and recommended that HHS add additional questions within the eligibility application to prevent individuals from receiving advance payments of the premium tax credit (APTC) who are also enrolled in Medicare.

Response: Section 1882(d)(3) of the Social Security Act (the “Medicare anti-duplication provision”) prohibits the sale of an individual market insurance policy that duplicates Medicare benefits to anyone known to be entitled to benefits under Part A (receiving free Part A) or enrolled in Part B or Premium Part A. This prohibition applies to individual health insurance coverage sold both through and outside an Exchange. This final rule clarifies that this prohibition creates an exception to the guaranteed availability provision where the prohibition would be violated by a sale.

While the Medicare anti-duplication provision prohibits the sale or issuance of a policy, it does not provide for discontinuance or non-renewal of a policy already issued, such as when an individual covered by an individual market policy becomes covered by Medicare. As stated in the individual market regulations at 45 CFR 148.122(b)(2), implementing the HIPAA guaranteed renewability provision, Medicare eligibility or entitlement is not a basis for non-renewal or termination of individual health insurance coverage. For ease of reference we are adding §147.106(g)(2) of this final rule, which repeats the regulatory language in §148.122(b)(2). We

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availability or renewability regulations prohibits an issuer from coordinating benefits under an individual health insurance policy with Medicare benefits in the case of a beneficiary. HHS will consider including questions in the FFE enrollment application to address this issue.

Summary of Regulatory Changes We are finalizing the proposed provisions with the following modification. We add §147.106(g)(2) to restate the standard under the HIPAA guaranteed renewability regulations at §148.122(b)(2) that Medicare eligibility or entitlement is not a basis for non-renewal or termination of an individual's health insurance coverage in the individual market.

b. Product Discontinuance and Uniform Modification of Coverage Exceptions to Guaranteed Renewability Requirements We proposed standards to define whether certain modifications to coverage constitute “uniform modifications” within the meaning of the PHS Act. These provisions were proposed in the guaranteed renewability regulations at 45 CFR 146.152, 147.106, and 148.122. Under the proposed rule, they would apply to issuers offering health insurance coverage in the group and individual markets, including both grandfathered and non-grandfathered health plans.

Specifically, we proposed that a modification made by an issuer solely pursuant to applicable Federal or State law would be considered a modification of the same product, and offered several examples of changes in response to Federal law that would constitute a modification of coverage.

We further proposed that if an issuer makes changes to the health insurance coverage for a product that are not pursuant to applicable Federal or State law, the modifications would also be considered a uniform modification of coverage if the resulting product meets all of the

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 The product is offered as the same product type (for example, preferred provider organization (PPO) or health maintenance organization (HMO));



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