Regulations and Guidance

• Consumer Support and Information
  • External Appeals
  • Summary of Benefits and Coverage and Uniform Glossary
• Content Requirements for Healthcare.gov
• Pre-Existing Condition Insurance Plan (PCIP)
• Early Retiree Reinsurance Program (ERRP)
• Affordable Insurance Exchanges
• State Innovations
• Consumer Operated and Oriented Plans Program
• Health Market Reforms
  • Annual Limits
  • Association Coverage
  • Coverage for Young Adults
  • Grandfathered Plans
  • Medical Loss Ratio
  • Patient’s Bill of Rights
  • Prevention
  • Review of Insurance Rates
  • Student Health Plans
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Consumer Support and Information   

External Appeals  

Regulations:

• July 23, 2010
  OCIIO-9993-IFC: Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Internal Claims and Appeals and External Review Processes Under the Patient Protection and Affordable Care Act (PDF – 257 KB)
• June 22, 2011
  CMS-9993-IFC2: Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims and Appeals and External Review Processes
• July 26, 2011
  CMS-9993-CN: Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims and Appeals and External Review Processes; Correction (PDF - 184 KB)

Guidance:

• August 26, 2010
  Notice: Availability of Interim Procedures for Federal External Review and Model Notices Relating to Internal Claims and Appeals and External Review Under the Patient Protection and Affordable Care Act (PDF – 60KB)
• August 26, 2010
  Technical Guidance: Interim Procedures for Federal External Review Relating to Internal Claims and Appeals and External Review For Health Insurance Issuers in the Group and Individual Markers and under the Patient Protection and Affordable Care Act (PDF – 51 KB) 
• September 1, 2010
  Technical Guidance: Issuers in the Individual Market to Establish County Level Estimates Pertaining to the Culturally and Linguistically Appropriate Standards Set Forth in the Internal Claims and Appeals and External Review Processes under the Patient Protection and Affordable Care Act (PDF – 26 KB)
• September 20, 2010
  Guidance: Interim Procedures for Internal Claims and Appeals under the Patient Protection and Affordable Care Act (PDF – 29 KB)
• September 23, 2010
  Technical Guidance: Interim Procedures for Federal External Review Relating to Internal Claims and Appeals and External Review under the Patient Protection and Affordable Care Act for Self-Insured Non-Federal Government Health Plans  (PDF – 17 KB)
• March 18, 2011
  Technical Guidance: Extension of Non-Enforcement Period Relating to Certain Interim Procedures for Internal Claims and Appeals under the Patient Protection and Affordable Care Act
• June 22, 2011
  Technical Release 2011-02: Guidance on External Review for Group Health Plans and Health Insurance Issuers Offering Group and Individual Health Coverage, and Guidance for States on State External Review Processes (PDF – 381 KB)
• June 22, 2011
  Technical Guidance- June 22, 2011:  Updated Instructions for Calculating County Level Estimates Pertaining to the Culturally and Linguistically Appropriate Standards Set Forth in the Internal Claims and Appeals and External Review Processes under the Affordable Care Act (PDF - 54 KB)
• June 22, 2011
  Technical Guidance- June 22, 2011:  Instructions  For Self-Insured Nonfederal Governmental Health Plans and Health Insurance Issuers Offering Group and Individual Health Coverage on How To Elect a Federal External Review Process (PDF – 46 KB)

Summary of Benefits and Coverage and Uniform Glossary

Regulations:

• August 22, 2011
  CMS-9982-P: Summary of Benefits and Coverage and the Uniform Glossary
• February 14, 2012
  CMS-9982-F: Summary of Benefits and Coverage and Uniform Glossary

Guidance:

• August 22, 2011
  Notice: Summary of Benefits and Coverage and Uniform Glossary - Templates, Instructions, and Related Materials under the Public Health Service Act
• February 14, 2012
  Summary of Benefits and Coverage and Uniform Glossary - Templates, Instructions, and Related Materials, and Guidance for Compliance

Content Requirements for Healthcare.gov  

Regulations:

• May 5, 2010
  Health Care Reform Insurance Web Portal Requirements (PDF – 368 KB)

Guidance:

• May 3, 2010
  Memorandum: User Access and Authorization for the Health Insurance Oversight System

Pre-Existing Condition Insurance Plan (PCIP)  

Regulations:

• July 30, 2010
  OCIIO–9995­–IFC: Pre-Existing Condition Insurance Plan Program (PDF – 198 KB)

Guidance:

• October 6, 2010
  Guidance: The Pre-Existing Condition Insurance Plan Program and Newborn Coverage (PDF – 105 KB)
• December 28, 2010
  Guidance: Portability of Coverage, Enrollee Notices, and Third Party Payments (PRD – 57 KM)
• February 17, 2011
  Guidance: Eligibility for Children under Age 19 in the Federally-Administered Pre-Existing Condition Insurance Plan (PDF – 166 KB)
• March 23, 2011
  Guidance: Pre-Existing Condition Insurance Plan Eligibility and Access to Other Creditable Coverage (PDF – 145 KB)
• May 31, 2011
  Guidance: PCIP Premium and Benefit Revisions (PDF – 31 KB)
• May 31, 2011
  Guidance: Question and Answer Regarding Anti-Dumping Provisions Related to the Pre-Existing Condition Insurance Plan Program (PDF – 13 KB)

Early Retiree Reinsurance Program (ERRP)  

Regulations:

• May 5, 2010
  Early Retiree Reinsurance Program (PDF – 132 KB)
• December 13, 2011
  CMS-9996-N2: Early Retiree Reinsurance Program Notice regarding Incurred Claims Date (PDF - 142 KB)

Affordable Insurance Exchanges  

Regulations:

• July 15, 2011
  CMS-9989-P:Establishment of Exchanges and Qualified Health Plans (PDF - 425 KB)
• July 15, 2011
  CMS-9975-P: Standards Related to Reinsurance, Risks Corridors and Risk Adjustment (PDF - 281 KB)
• July 15, 2011
  CMS-9989-P2: Preliminary Regulatory Impact Analysis: Establishment of Exchanges and Qualified Health Plans (CMS-9989-P) and Standards Related to Reinsurance, Risk Corridors and Risk Adjustment (CMS-9975-P) (PDF – 204 KB)
• August 17, 2011
  CMS-9974-P: Exchange Functions in the Individual Market: Eligibility Determinations; Exchange Standards for Employers  (PDF - 319 KB)
• August 17, 2011
  CMS-2349-P: Medicaid Program; Eligibility Changes under the Affordable Care Act of 2010 (PDF - 394 KB)
• August 17, 2011
   REG-131491-10: Health Insurance Premium Tax Credits (PDF - 247 KB)
• September 30, 2011
  Patient Protection and Affordable Care Act:  Establishment of Exchanges and qualified Health Plans and Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment:  Extension of Comment Period (PDF - 143 KB)

Guidance:

• November 3, 2010
  Guidance: Exchange and Medicaid Information Technology (IT) Systems (PDF -110 KB)
• November 18, 2010
  Guidance: Initial Guidance to States on Exchanges
• May 31, 2011
  Guidance: Guidance for Exchange and Medicaid Information Technology (IT) Systems: Version 2.0 (PDF – 401 KB)
• November 29, 2011
  State Exchange Implementation Questions and Answers (PDF – 135 KB)
• December 16, 2011
  Essential Health Benefits Bulletin (PDF - 104 KB)
• January 25, 2012
  Essential Health Benefits: Illustrative List of the Largest Three Small Group Products by State (PDF – 135 KB)
• February 17, 2012
  Frequently Asked Questions on the Essential Health Benefits Bulletin (PDF – 88 KB)
• February 24, 2012
  Actuarial Value and Cost-Sharing Reductions Bulletin (PDF - 123 KB)

State Innovations 

Regulations:

• March 10, 2011
  Application, Review, and Reporting Process for Waivers for State Innovation
• February 22, 2012
  CMS-9987-F: Application, Review, and Reporting Process for Waivers for State Innovation

Consumer Operated and Oriented Plans Program 

Regulations:

• June 23, 2010
  Establishment of the Consumer Operated and Oriented Plan (CO-OP) Advisory Board
• July 20, 2011
  Establishment of the Consumer Operated and Oriented Plan (CO-OP) Program
• December 13, 2011
  CMS-9983-F: Patient Protection and Affordable Care Act, Establishment of Consumer Operated and Oriented Plan (CO-OP) Program (PDF - 244 KB)
• February 10, 2012
  IRS Revenue Procedures Published in the Federal Register For Tax-Exempt 501(c)(29) Qualified Nonprofit Health Insurance Issuers

Health Market Reforms  

Annual Limits  

Regulations:

• June 28, 2010
  OCIIO–9994–IFC: Patient Protection and Affordable Care Act: Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, and Patient Protections

Guidance:

• September 3, 2010
  OCIIO Sub-Regulatory Guidance: Process for Obtaining Waivers of the Annual Limits Requirements of PHS Act Section 2711 (PDF – 48 KB)
• November 5, 2010
  OCIIO Supplemental Guidance: Waivers of the Annual Limits Requirements (PDF – 61 KB)
• December 9, 2010
  OCIIO Supplemental Guidance: Consumer Notices on Waivers of the Annual Limits Requirements (PDF – 53 KB)
• December 9, 2010
  OCIIO Supplemental Guidance: Sale of New Business by Issuers Receiving Waivers (PDF – 55 KB)
• June 17, 2011
  CCIIO Supplemental Guidance (CCIIO 2011 – 1D): Concluding the Annual Limit Waiver Application Process  (PDF – 76 KB)
• August 19, 2011
  CCIIO Supplemental Guidance (CCIIO 2011 - 1E):  Exemption for Health Reimbursement Arrangements that are Subject to  PHS Act Section 2711 (PDF - 44 KB)

Association Coverage

Guidance:

• September 1, 2011
  CCIIO Technical Guidance: Application of Individual and Group Market Requirements under Title XXVII of the Public Health Service Act when Insurance Coverage Is Sold to, or through, Associations  (PDF  – 56 KB)

Coverage for Young Adults  

Regulations:

• May 13, 2010
  OCIIO – 4150 – IFC: Group Health Plans and Health Insurance Issuers Relating to Dependent Coverage of Children to Age 26 Under the Patient Protection and Affordable Care Act (PDF – 178 KB)

Guidance:

• October 13, 2010
  Q&A: Enrollment of Children Under 19 Under the New Policy That Prohibits Pre-Existing Condition Exclusions

Grandfathered Plans  

Regulations:

• June 17, 2010
  OCIIO–9991–IFC: Interim Final Rules for Group Health Plans and Health Insurance Coverage Relating to Status as a Grandfathered Health Plan Under the Patient Protection and Affordable Care Act (PDF – 258)
• November 15, 2010
  OCIIO–9991–IFC2:  Amendment to the Interim Final Rules for Group Health Plans and Health Insurance Coverage Relating to Status as a Grandfathered Health Plan Under the Patient Protection and Affordable Care Act

Medical Loss Ratio  

Regulations:

• December 1, 2010
  OCIIO–9998–IFC: Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act (PDF – 2 MB) 
• Technical Appendix
  Interim Final Rule for Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements under the Patient Protection and Affordable Care Act (PDF – 300 KB)
• Technical Correction (December 30, 2010)
  Technical Correction to the Medical Loss Ratio Interim Final Rule (PDF – 59 KB)
• December 7, 2011
  CMS-9998-FC: Medical Loss Ratio Requirements under the Patient Protection and Affordable Care Act
  CMS-9998-IFC2: Medical Loss Ratio Rebate Requirements for Non-Federal Governmental Plans

Guidance:

• December 17, 2010
  OCIIO Technical Guidance: Process for a State to Submit a Request for Adjustment to the Medical Loss Ratio Standard of PHS Act Section 2718 (PDF – 35 KB)
• April 26, 2011
  CCIIO Technical Guidance: Submission of 2011 Quarterly Reports of MLR Data by Issuers of “Mini-med” and Expatriate Plans (PDF – 26 KB)
• May 13, 2011
  CCIIO Technical Guidance: Questions and Answers Regarding the Medical Loss Ratio Interim Final Rule (PDF – 52 KB)
• May 19, 2011
  CCIIO Technical Guidance: Deadline for Submission of 2011 First Quarter MLR Data by Issuers of “Mini-med” and Expatriate Plans (PDF – 26 KB)
• July 18, 2011
  CCIIO Technical Guidance: Questions and Answers Regarding the Medical Loss Ratio Interim Final Rule (PDF – 66 KB)
• February 10, 2011
  CCIIO Technical Guidance: Questions and Answers Regarding the Medical Loss Ratio Interim Final Rule (PDF - 94 KB)

Patient’s Bill of Rights  

Regulations:

• June 28, 2010
  OCIIO–9994–IFC: Patient Protection and Affordable Care Act: Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, and Patient Protections

Guidance:

• September 3, 2010
  OCIIO Sub-Regulatory Guidance: Process for Obtaining Waivers of the Annual Limits Requirements of PHS Act Section 2711

Prevention  

Regulations:

• July 19, 2010
  OCIIO–9992–IFC: Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act
• August 3, 2011
  CMS-9992-IFC2: Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (PDF - 201 KB)
• February 10, 2012
  CMS-9992-F:  Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act (PDF – 152 KB)

Guidance:

• July 19, 2010
  Recommendation: Recommendations of the U.S. Preventive Service Task Force
• August 1, 2011
  Guidelines: HRSA's Women's Preventive Services: Required Health Plan Coverage Guidelines
• February 10, 2012
  CCIIO Technical Guidance:  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 (PDF - 59 KB)

Review of Insurance Rates 

Regulations:

• December 23, 2010
  OCIIO–9998–IFC: Rate Increase Disclosure and Review; Proposed Rule (PDF – 215 KB)
• May 19, 2011
  CMS-9999-FC: Rate Increase Disclosure and Review; Final Rule (PDF - 282 KB)
• September 6, 2011
   CMS-9999-F: Rate Increase Disclosure and Review: Definitions of Individual Market and Small Group Market (PDF - 526 KB)

Student Health Plans 

Regulations:

• February 11, 2011
  CMS–9981–P: Student Health Insurance Coverage (PDF – 250 KB)

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Guidance:

• March 1998
  Program Memorandum: Agent Commissions and Application Processing Delays (PDF - 87 KB)
• June 1999
  Program Memorandum: Applicability of the Health Insurance Portability and Accountability Act of 1996 to Secondary Coverage and Continuing Coverage (PDF - 157 KB)
• June 1999
  Program Memorandum: Issues Related to Eligible Individual Status Under the Health Insurance Portability and Accountability Act of 1996 (PDF 130 KB)
• September 1999
  Program Memorandum: Group Size Issues Under Title XXVII of the Public Health Service Act (PDF - 136 KB)
• March 2000
  Program Memorandum: Imposing Nonconfinement Clause on Eligible Individuals (PDF -68 KB)
• June 2000
  Program Memorandum: Issue Related to Eligible Individual Status Under Section 2741(b) of the Public Health Service Act (PDF -122 KB)
• June 2000
  Program Memorandum: The Relationship of Certain Types of State Laws to the Application of the Guaranteed Availability Requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in the Small Group Market
• August 2000
  Program Memorandum: State “succeeding carrier” or “extension of benefits” laws and an issuer’s obligation under HIPAA to enroll an eligible individual who is disabled.
• November 2000
  Program Memorandum: Guaranteed Availability Under Title XXVII of the Public Health Service Act – Applicability of Group Participation Rules
• November 2000
  Program Memorandum: Circumstances Under which Health Insurance Regulated as “Individual” Coverage Under State Law is Subject to the Group Market Requirements of The Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• March 2001
  Program Memorandum: Guaranteed Renewability of Conversion Policies
• August 2001
  Program Memorandum: Identifying Federally Eligible Individuals in states Electing to Use Alternative mechanisms to Comply with Guaranteed Availability Requirements under Title XXVII of the PHS Act
• March 2002
  Program Memorandum: How to Apply the “Product Withdrawal” and “Market Exit” Exceptions of the Guaranteed Renewability Requirements of Title XXVII of the PHS Act
• August 2002
  Program Memorandum: Application of Group and Individual Market Requirements Under Title XXVII of the Public Health Service (PHS) Act When Insurance Coverage is Sold To, or Through Associations
• August 2002
  Program Memorandum: The Obligation Health Insurance Issuers Have to Association Members and Associations Under Title XXVII of the PHS Act With Respect to Guaranteed Renewability of Coverage
• September 2002
  Program Memorandum: Characteristics of Bona Fide Associations, and How Selling Coverage Exclusively Through Them Affects an Issuer’s Guaranteed Availability Obligations Under Title XXVII of the PHS Act
• September 2002
  Program Memorandum: How Selling Coverage Exclusively Through Bona Fide Associations Affects and Issuer’s Guaranteed Renewability Obligations Under Title XXVII of the PHS Act
• March 2004
  Program Memorandum: HIPAA Enforcement Is Not Preempted by COBRA; Non-HIPAA-Related State Insurance Law is Not Preempted by Public Sector COBRA
• June 2004
  Program Memorandum: Federal Eligibility Under HIPAA After Group Health Plan Termination
• March 2005
  Program Memorandum: Coverage through a Foreign Government, the U.S. Government, and a State Children’s Health Insurance Program, is Creditable Coverage for Purposes of Identifying Eligible Individuals under HIPAA
• June 2005
  Program Memorandum: Benefit Exclusions that Cannot be Applied to Eligible Individuals Under HIPAA Individual Market Provisions
• May 2008
  Program Memorandum: Circumstances Under Which Supplemental Health Insurance Coverage Satisfies the Requirements for Excepted Benefits Under Section 2791(c) of the Public Health Service Act