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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 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 published in the Federal Register.


45 CFR Parts 144, 146, 147, 148, 153, 154, 155, 156, and 158


RIN 0938-AS02

Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards

for 2015 and Beyond

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

ACTION: Final rule.

SUMMARY: This final rule addresses various requirements applicable to health insurance issuers, Affordable Insurance Exchanges (“Exchanges”), Navigators, non-Navigator assistance personnel, and other entities under the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, the rule establishes standards related to product discontinuation and renewal, quality reporting, non-discrimination standards, minimum certification standards and responsibilities of qualified health plan (QHP) issuers, the Small Business Health Options Program, and enforcement remedies in Federally-facilitated Exchanges. It also finalizes: a modification of HHS’s allocation of reinsurance collections if those collections do not meet our projections; certain changes to allowable administrative expenses in the risk corridors calculation; modifications to the way we calculate the annual limit on cost sharing so that we round this parameter down to the nearest $50 increment; an approach to index the required contribution used to determine eligibility for an exemption from the shared responsibility CMS-9949-F 2 payment under section 5000A of the Internal Revenue Code; grounds for imposing civil money penalties on persons who provide false or fraudulent information to the Exchange and on persons who improperly use or disclose information; updated standards for the consumer assistance programs; standards related to the opt-out provisions for self-funded, non-Federal governmental plans and related to the individual market provisions under the Health Insurance Portability and Accountability Act of 1996 including excepted benefits; standards regarding how enrollees may request access to non-formulary drugs under exigent circumstances; amendments to Exchange appeals standards and coverage enrollment and termination standards; and time-limited adjustments to the standards relating to the medical loss ratio (MLR) program. The majority of the provisions in this rule are being finalized as proposed.




For general matters and matters related to Parts 144, 146, 147, 148 and 154: Jacob Ackerman, (301) 492-4179.

For matters related to reinsurance, under Part 153: Adrianne Glasgow, (410) 786-0686.

For matters related to risk corridors, under Part 153: Jaya Ghildiyal, (301) 492-5149.

For matters related to non-interference with Federal law and non-discrimination standards, and Navigator, non-Navigator assistance personnel, and certified application counselor program

–  –  –

For matters related to civil money penalties for noncompliant consumer assistance entities, under Part 155, subpart C: Emily Ames, (301) 492-4246.

For matters related to enrollment of a qualified individual, under Part 155, subpart E: Jack Lavelle, (410) 786-0639.

For matters related to civil money penalties for false or fraudulent information or improper use of information, under Part 155, subpart C; exemptions under Part 155, subparts D and G, and matters related to eligibility appeals, under Part 155, subparts F and H: Christine Hammer, (301) 492-4431.

For matters related to special enrollment periods under Part 155, Subpart E: Spencer Manasse, (301) 492-5141.

For matters related to the Small Business Health Options Program, under Part 155, subpart H:

Christelle Jang, (410) 786-8438.

For matters related to the required contribution percentage for affordability exemptions, under Part 155, subpart G: Ariel Novick, (301) 492-4309.

For matters related to cost sharing, under Part 156, subpart B: Pat Meisol, (410) 786-1917.

For matters related to quality standards, under Parts 155 and 156: Nidhi Singh Shah, (301) 492-5110.

For matters related to enforcement remedies, under Part 156: Cindy Yen, (301) 492-5142.

For matters related to minimum essential coverage, under Part 156, subpart G: Cam Clemmons, (410) 786-1565.

For all other matters related to Parts 155 and 156: Leigha Basini, (301) 492-4380.

For matters related to the medical loss ratio program, under Part 158: Julie McCune,

–  –  –


Electronic Access This Federal Register document is also available from the Federal Register online database through Federal Digital System (FDsys), a service of the U.S. Government Printing Office. This database can be accessed via the internet at http://www.gpo.gov/fdsys.

Table of Contents I. Executive Summary II. Background

–  –  –

III. Provisions of the Proposed Regulations and Analysis and Responses to Public Comments A. Part 144 – Requirements Relating to Health Insurance Coverage B. Part 146 – Requirements for the Group Health Insurance Market 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)

–  –  –

b. Product Discontinuance and Uniform Modification of Coverage Exceptions to Guaranteed Renewability Requirements D. Part 148 – Requirements for the Individual Health Insurance Market

–  –  –

2. Fixed Indemnity Insurance in the Individual Health Insurance Market (§148.220) E. Part 153 – Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment under the Affordable Care Act

1. Provisions and Parameters for the Permanent Risk Adjustment Program

2. Provisions and Parameters for the Transitional Reinsurance Program

3. Provisions for the Temporary Risk Corridors Program (§153.500) F. Part 154 – Health Insurance Issuer Rate Increases: Disclosure and Review Requirements G. Part 155 – Exchange Establishment Standards and Other Related Standards under the Affordable Care Act

1. Subpart B – General Standards Related to the Establishment of the Exchange Non-Interference with Federal Law and Non-Discrimination Standards (§155.120)

2. Subpart C – General Functions of an Exchange a. Civil Money Penalties for Violations of Applicable Exchange Standards by Consumer Assistance Entities in Federally-Facilitated Exchanges (§155.206) b. Navigator, Non-Navigator Assistance Personnel, and Certified Application Counselor Program Standards (§§155.210, 155.215, and 155.225) c. Payment of Premiums (§155.240) d. Privacy and Security of Personally Identifiable Information (§155.260) e. Bases and Process for Imposing Civil Money Penalties for Provision of False or Fraudulent Information to an Exchange or Improper Use or Disclosure of Information

–  –  –

3. Subpart D – Exchange Functions in the Individual Market: Eligibility Determinations for Exchange Participation and Insurance Affordability Programs a. Verification Process Related to Eligibility for Insurance Affordability Programs (§155.320) b. Eligibility Redetermination During a Benefit Year (§155.330)

4. Subpart E – Exchange Functions in the Individual Market: Enrollment in Qualified Health Plans a. Enrollment of Qualified Individuals in a QHP (§155.400) b. Initial and Annual Open Enrollment Periods (§155.410) c. Special Enrollment Periods (§155.420) d. Termination of Coverage (§155.430)

5. Subpart F – Appeals of Eligibility Determinations for Exchange Participation and Insurance Affordability Programs a. General Eligibility Appeals Requirements (§155.505) b. Dismissals (§155.530) c. Employer Appeals Process (§155.555)

6. Subpart G – Exchange Functions in the Individual Market: Eligibility Determinations for Exemptions a. Required Contribution Percentage b. Options for Conducting Eligibility Determinations for Exemptions (§155.625)

7. Subpart H – Exchange Functions: Small Business Health Options Program a. Functions of a SHOP (§155.705)

–  –  –

c. SHOP Employer and Employee Eligibility Appeals Requirements (§155.740)

8. Subpart O – Quality Reporting Standards for Exchanges a. Quality Rating System (§155.1400) b. Enrollee Satisfaction Survey System (§155.1405) H. Part 156 – Health Insurance Issuer Standards under the Affordable Care Act, Including Standards Related to Exchanges

1. Subpart B – Essential Health Benefits Package a. Prescription Drug Benefits (§156.122) b. Cost-Sharing Requirements (§156.130)

2. Subpart C – General Functions of an Exchange a. QHP Issuer Participation Standards (§156.200) b. Enrollment Process for Qualified Individuals (§156.265)

3. Subpart G – Minimum Essential Coverage a. Other Coverage that Qualifies as Minimum Essential Coverage (§156.602) b. Requirements for Recognition as Minimum Essential Coverage for Types of Coverage Not Otherwise Designated Minimum Essential Coverage in the Statute or This Subpart (§156.604)

4. Subpart I – Enforcement Remedies in Federally-Facilitated Exchanges a. Available Remedies; Scope (§156.800) b. Bases and Process for Imposing Civil Money Penalties in Federally-Facilitated Exchanges (§156.805)

–  –  –

d. Bases and Process for Decertification of a QHP Offered by an Issuer Through a Federally-Facilitated Exchange (§156.810)

5. Subpart L – Quality Standards a. Establishment of Standards for HHS-Approved Enrollee Satisfaction Survey Vendors for Use by QHP Issuers in Exchanges (§156.1105) b. Quality Rating System (§156.1120) c. Enrollee Satisfaction Survey (§156.1125) I. Part 158 – Issuer Use of Premium Revenue: Reporting and Rebate Requirements

1. Subpart A – Disclosure and Reporting a. ICD–10 Conversion Expenses (§158.150)

2. Subpart B – Calculating and Providing the Rebate a. MLR and Rebate Calculations in States with Merged Individual and Small Group Markets (§§158.211, 158.220, 158.231) b. Accounting for Special Circumstances (§158.221) c. Distribution of De Minimis Rebates (§158.243) IV. Provisions of Final Regulations V. Waiver of Delay in Effective Date VI. Collection of Information Requirements A. ICRs Regarding Recertification for Certified Application Counselors (§155.225) B. ICRs Regarding Consumer Authorization (§§155.210 and 155.215) C. ICRs Regarding Enrollee Satisfaction & Marketplace Surveys (§§155.1200, 156.1105, and 156.1125)

–  –  –

E. ICRs Regarding Quality Standards for Exchanges (§§155.1400 and 155.1405) F. ICR Regarding Medical Loss Ratio Requirements (§§158.150, 158.211, 158.220, 158.221, and 158.231) G. ICRs Regarding Civil Money Penalties (§§155.206 and 155.285) H. ICRs Regarding Fixed Indemnity Plans, Minimum Essential Coverage, Certifications of Creditable Coverage and HIPAA Opt-Out Election Notice, Notice of Discontinuation, Notice of Renewal (§§146.152, 146.180, 147.106, 148.122, 148.220, and 156.602) I. Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB) VII. Regulatory Impact Analysis

–  –  –

3. Anticipated Benefits, Costs and Transfers C. Regulatory Alternatives

1. Collecting ESS Data at the Product Level Instead of Each Product Per Metal Tier

2. Using Medicaid CAHPS® As Is Instead of Adding Additional and New Questions to the ESS

3. Collecting QRS Data for Each Product Per Metal Tier Instead of at the Product Level

4. Using the Medicare Advantage (MA) CAHPS® Instrument and Star System D. Regulatory Flexibility Act

–  –  –

I. Executive Summary Since January 1, 2014, qualified individuals and small employers have been able to obtain private health insurance through Affordable Insurance Exchanges, or “Exchanges” (also known as Health Insurance Marketplaces, or “Marketplaces”).1 The Exchanges provide competitive marketplaces where individuals and small employers can compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing power as large businesses.

Individuals who enroll in QHPs through individual market Exchanges may be eligible to receive premium tax credits to make health insurance purchased through an Exchange more affordable and cost-sharing reductions (CSRs) that lower out-of-pocket expenses for health care The word “Exchanges” refers to both State Exchanges, also called State-based Exchanges, and Federallyfacilitated Exchanges (FFEs). In this final rule, we use the terms “State Exchange” or “FFE” when we are referring to a particular type of Exchange. When we refer to “FFEs,” we are also referring to State Partnership Exchanges, which are a form of FFEs.

CMS-9949-F 12 services. The premium tax credits, combined with the new insurance reforms, have significantly increased the number of individuals with health insurance coverage. The premium stabilization programs– risk adjustment, reinsurance, and risk corridors– protect against adverse selection in the newly enrolled population. These programs, in combination with the MLR program and market reforms extending guaranteed availability (also known as guaranteed issue) protections, prohibiting the use of factors such as health status, medical history, gender, and industry of employment to set premium rates, will help to ensure that every American has access to high quality, affordable health insurance.

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