Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action

As of May 3, 2013
ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE Compliance, grandfathered health plans, claims, internal appeals and external review, dependent coverage of children, out-of-network emergency services, and highly compensated employees Grandfathered health plans, dental and vision benefits, rescissions, preventive health services, and ACA effective date for individual health insurance policies Exemption for group health plans with less than two current employees Grandfathered Health Plans HIPAA nondiscrimination and wellness program rules, and the Mental Health Parity and Addiction Equity Act of 2008 Grandfathered Health Plans Exchanges Summary of Benefits and Coverage (SBC) Exchanges REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY HHS, DOL, IRS

ACA Implementation FAQs I

FAQs I

Sep. 20, 2010

HHS, DOL, IRS FAQs II Oct. 8, 2010

ACA Implementation FAQs II

ACA Implementation FAQs III ACA Implementation FAQs IV

FAQs III FAQs IV

Oct. 12, 2010 Oct. 28, 2010

HHS, DOL, IRS HHS, DOL, IRS HHS, DOL, IRS

ACA Implementation FAQs V

FAQs V

Dec. 22, 2010 HHS, DOL, IRS CCIIO HHS, DOL, IRS CCIIO

ACA Implementation FAQs VI Affordable Insurance Exchanges: Questions and Answers ACA Implementation FAQs VII State Exchange Implementation Questions and Answers

FAQs VI FAQs FAQs VII FAQs

Apr. 1, 2011 July 11, 2011 Nov. 17, 2011 Nov. 29, 2011

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Page 1

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE Automatic Enrollment, Employer Shared Responsibility, and Waiting Periods REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE Feb. 9, 2012 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION FAQs from Employers Regarding Automatic Enrollment, Employer Shared Responsibility, and Waiting Periods Questions and Answers Related to Annual Limit Waivers Frequently Asked Questions on the Essential Health Benefits Bulletin ACA Implementation FAQs VIII ACA Implementation FAQs IX Frequently Asked Questions on the Draft Blueprint for Exchanges Exchange Establishment Cooperative Agreement Funding FAQs ACA Implementation FAQs X Exchange Establishment Cooperative Agreement Funding FAQs Exchange Blueprint FAQs Medical Device Excise Exchanges, Market Reforms and Medicaid Increased Medicaid Payment for Primary Care Questions and Answers

COMMENT DUE DATE

AGENCY HHS, DOL, IRS

FAQs

FAQs EHB Summary of Benefits and Coverage (SBC) Summary of Benefits and Coverage (SBC) Exchange Blueprint ACA § 1311(a) PHS Act §2715 ACA § 1311(a) ACA § 1311(a) IRC § 4191 FAQs FAQs VIII FAQs IX FAQs FAQs FAQs X FAQs FAQs FAQs FAQs HCERA §1202 Questions & Answers

Feb. 10, 2012 Feb. 17, 2012 March 19, 2012 May 11, 2012 May 16, 2012

CCIIO CCIIO HHS, DOL, IRS HHS, DOL, IRS CCIIO CCIIO

June 29, 2012 Aug.7, 2012 Nov. 9, 2012 Nov. 9, 2012 Dec. 5, 2012 Dec. 10, 2012 Dec. 21, 2012 CCIIO IRS CMS CMS CCIIO CCIIO

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Page 2

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE ACA § 1512; PHS Act § 2711; IRC § 4376 REGULATION TYPE OR ACTION FAQs XI Questions & Answers PHS Act §§ 2707(b), 2713 Expatriate group health insurance coverage Premium assistance through Medicaid CO-OP Program FAQs XII FAQs XIII FAQs FED. REG. PUBLICATION DATE, VOLUME, PAGE Jan. 24, 2013 Feb. 6, 2013 Feb. 20, 2013 March 8, 2013 March 29, 2013 HHS, DOL, IRS HHS, DOL, IRS EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Affordable Care Act Implementation FAQs XI Medicaid and CHIP ACA Implementation Questions and Answers ACA Implementation FAQs XII ACA Implementation FAQs XIII Medicaid and the Affordable Care Act: Premium Assistance FAQs Questions and Answers on Consumer Operated and Oriented Plan Program Contingency Fund Questions and Answers Regarding the MLR Final Rule and 2012 Annual Reporting Form QHP Webinar Series Frequently Asked Questions (FAQs) #1 QHP Webinar Series Frequently Asked Questions (FAQs) #2 QHP Webinar Series Frequently Asked Questions (FAQs) #3 QHP Webinar Series Frequently Asked Questions (FAQs) #4

COMMENT DUE DATE

AGENCY HHS, DOL, IRS CMS

CMS CCIIO

Q&A

April 4, 2013

CCIIO
MLR Q&A April 4, 2013

QHPs QHPs

FAQs #1 FAQs #2

April 8, 2013 April 9, 2013 April 11, 2013 April 18, 2013

CMS CMS CMS CMS

QHPs FAQs #3 QHPs FAQs #4

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Page 3

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE QHPs REGULATION TYPE OR ACTION FAQs #5 § 2715 PHS Act (SBC) QHPs FAQs #6 QHPs FAQs #7 QHPs FAQs #8 Availability of the 75 percent federal match for maintenance and operations, systems issues regarding communication between the Federally-Facilitated Marketplace and Medicaid, and further policy guidance regarding the use of section 1115 demonstrations April 23, 2013 CMS April 24, 2013 April 23, 2013 FAQs XIV FED. REG. PUBLICATION DATE, VOLUME, PAGE April 18, 2013 April 23, 2013 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION QHP Webinar Series Frequently Asked Questions (FAQs) #5 ACA Implementation FAQs XIV QHP Webinar Series Frequently Asked Questions (FAQs) #6 QHP Webinar Series Frequently Asked Questions (FAQs) #7 QHP Webinar Series Frequently Asked Questions (FAQs) #8

COMMENT DUE DATE

AGENCY

CMS
HHS, DOL, IRS

CMS CMS

Affordable Care Act Questions and Answers

CMCS Informational Bulletin

April 25, 2013

CMS

Questions and Answers Related to the Health Insurance Market Reforms ACA Implementation FAQs XV QHP Webinar Series Frequently Asked Questions (FAQs) #9

Q&As FAQs XV QHPs FAQs #9

April 26, 2013 April 29, 2013 April 30, 2013

CCIIO HHS, DOL, IRS CMS

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Page 4

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE QHPs REGULATION TYPE OR ACTION FAQs #10 FED. REG. PUBLICATION DATE, VOLUME, PAGE April 30, 2013 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION QHP Webinar Series Frequently Asked Questions (FAQs) #10

COMMENT DUE DATE

AGENCY

CMS

Prepared by Greenberg Traurig, LLP.

Page 5

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Patient Protection and Affordable Care Act; Health § 1001 (PHS Act §§ 2701, Nov. 26, 2012 Proposed Rule Dec. 26, 2012 Insurance Market Rules; Rate 2702, 2703, 2723 and 2794) 77 Fed. Reg. 70583 Review Apr. 29, 2013, except 45 CFR Patient Protection and 147.103 and the Affordable Care Act; Health § 1001 (PHS Act §§ 2701, Feb. 27, 2013 Final Rule amendments to 45 Insurance Market Rules; Rate 2702, 2703, 2723 and 2794) 78 Fed. Reg. 13405 CFR part 154 are Review effective on March 29, 2013 Preexisting Conditions § 1001 (2704); § 1001 Interim Final Rule 75 Fed. Reg. 123, Exclusions; Lifetime & Annual (2711); § 1001 (2712); § & Request for 37188 Aug. 27, 2010 Aug. 27, 2010 Limits; Rescission; Patient 1001 (2719A) Comments June 28, 2010 Protections Process for Obtaining Waivers Guidance Released Sept. 3, § 1001 (2711(a)(2)) Sept. 23, 2010 of Annual Limits Requirements Memorandum 2010 Waivers of Annual Limits Supplemental § 1001 (2711(a)(2)) Nov. 5, 2010 Requirements Guidance Consumer Notices on Waivers Supplemental § 1001 (2711(a)(2)) Dec. 9, 2010 of Annual Limits Requirements Guidance Sale of New Business by Supplemental § 1001 (2711(a)(2)) Dec. 9, 2010 Issuers Receiving Waivers Guidance Annual Limit Waivers Fact Sheet Consumer Notices and Sale of § 1001 (2711(a)(2)) Letter to Consumer New Business Groups Annual Limit Waiver Form § 1001 (2711(a)(2)) Dec. 8, 2010 Application Instructions

BINDER 1 TAB #

AGENCY

HHS

HHS

1 2 2 2 2 2 2

IRS; EBSA; HHS HHS

OCIIO OCIIO

Prepared by Greenberg Traurig, LLP.

Page 6

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Approved Applications for Approved Waiver of Annual Limits § 1001 (2711(a)(2)) Dec. 3, 2010 Applications Requirements Concluding the Annual Limit June 17, 2011 Waiver Application Process Supplemental CMS Supplemental § 2711 PHS Act September 22, 2011 Guidance Guidance (CCIIO 2011 - 1D) Exemption for Health Reimbursement Arrangements Aug. 19, 2011 Aug. 19, 2011 § 2711 PHS Act Guidance that are Subject to PHS Act CCIIO 2011 - 1E Section 2711 Patient Protections § 1001 (2719A) Fact Sheet Interim Final Rule July 19, 2010 Preventive Services § 1001 (2713 PHS Act) & Request for 75 Fed. Reg. 137, Sept. 17, 2010 Sept. 17, 2010 Comments 41726 Recommended Preventive Services § 1001 (2713 PHS Act) Preventive Services 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 Technical § 1001 (2713 PHS Act) Feb. 10, 2012 Cost Sharing Under Section Guidance 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

BINDER 1 TAB #

AGENCY

2

CCIIO

CCIIO

2 3 3

IRS; EBSA; HHS IRS; EBSA; HHS

CCIIO

Prepared by Greenberg Traurig, LLP.

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Feb. 15, 2012 § 1001 (2713 PHS Act) Final Rules April 16, 2012 Services under Patient 77 Fed. Reg. 8725 Protection and Affordable Care Act Advance Notice Of Certain Preventive Services March 21, 2012 § 1001 (2713 PHS Act) Proposed June 19, 2012 Under the Affordable Care Act 77 Fed. Reg. 16501 Rulemaking Coverage of Certain Preventive Feb. 6, 2013 Services Under the Affordable § 1001 (2713 PHS Act) Proposed Rule April 8, 2013 78 Fed. Reg. 8456 Care Act Request for Information Dec. 28, 2010 Regarding Value-Based Request for 75 Fed. Reg. 248, Dec. 28, 2010 Feb. 28, 2011 Insurance Design in Connection Information 81544 with Preventive Care Benefits Interim Final Rule May 13, 2010 Dependent Coverage of § 1001 (2714) & Request for 75 Fed. Reg. 92, Aug. 11, 2010 July 12, 2010 Children to Age 26 Comments 27122 Dependent Coverage of § 1001 (2714) Fact Sheet Children to Age 26 Dependent Coverage of § 1001 (2714) FAQs June 29, 2010 Children to Age 26 Group Health Plans and Health Insurance Issuers Relating to Subtitles A and C of title I Interim Final Rules Aug. 3, 2011 Coverage of Preventive ACA (§ 715(a)(1) ERISA; § With Request For 76 Fed. Reg. 149, August 1, 2011 Services under Patient 9815(a)(1) IRC; §§ 2701 Comments 46621 Protection and Affordable Care 2728 PHS Act) Act

BINDER 1 TAB #

AGENCY

IRS, HHS, EBSA

IRS; EBSA; HHS IRS; EBSA; HHS IRS; EBSA; CCIIO IRS; EBSA; HHS

3

4 4 4

HHS, EBSA, IRS

Prepared by Greenberg Traurig, LLP.

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS HRSA's Women's Preventive Subtitles A and C of title I Services: Required Health Plan ACA (§ 715(a)(1) ERISA; § Aug. 3, 2011 Guidelines Coverage 9815(a)(1) IRC; §§ 2701 2728 PHS Act) Providing Clear and Consistent Information to Consumers § 2715 PHS Act Fact Sheet August 17, 2011 about Their Health Insurance Coverage Summary of Benefits and Notice Of Aug. 22, 2011 Coverage and Uniform § 2715 PHS Act Proposed 76 Fed. Reg. 162, Oct. 21, 2011 Glossary Rulemaking 52442 Summary of Benefits and Coverage and Uniform Aug. 22, 2011 Glossary: Templates, Solicitation Of § 2715 PHS Act 76 Fed. Reg. 162, Oct. 21, 2011 Instructions, and Related Comments 52475 Materials under Public Health Service Act § 2715 PHS Act Guidance For Summary of Benefits, Coverage Compliance And and Uniform Glossary: Notice Of Feb. 14, 2012 Templates, Instructions, and Availability Of Feb. 14, 2012 77 Fed. Reg. 8706 Related Materials; and Templates, Guidance for Compliance Instructions, And Related Materials. Summary of Benefits, Coverage § 2715 PHS Act Feb. 14, 2012 Final Rule Feb. 14, 2012 and Uniform Glossary 77 Fed. Reg. 8668 Corrected Summary of Benefits § 2715 PHS Act Guidance May 11, 2012 and Coverage Template Corrected Sample Completed § 2715 PHS Act May 11 Guidance SBC

BINDER 1 TAB #

AGENCY

HRSA

CCIIO HHS, EBSA, IRS

HHS, EBSA, IRS

HHS; IRS; EBSA

HHS; IRS; EBSA CCIIO, EBSA CCIIO, EBSA

Prepared by Greenberg Traurig, LLP.

Page 9

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS HHS Guidance on Inputs for § 2715 PHS Act May 11 Guidance Coverage Example Calculator Medical Loss Ratio § 1001 (2718 PHS Act) § 1001 (2718 PHS Act) Medical Loss Ratio § 1001 (2718 PHS Act) Medical Loss Ratio Fact Sheet § 1001 (2718 PHS Act) Medical Loss Ratio § 1001 (2718 PHS Act) Medical Loss Ratio Submission of 2011 Quarterly Reports of MLR Data by Issuers of “Mini-med” and Expatriate Plans § 2718 PHS Act Technical Guidance May 19, 2011 June 30, 2011 CCIIO Technical Guidance for State Submission of Request for MLR Adjustment Technical Correction to Interim Final Rule Request for Information Apr. 14, 2010 75 Fed. Reg. 71, 19297 Regulatory Impact Analysis Technical Appendix Interim Final Rule with Request for Comments Nov. 22, 2010 May 14, 2010.

BINDER 1 TAB #

AGENCY

CCIIO IRS EBSA HHS OCIIO

4

Dec. 1, 2010 75 Fed. Reg. 230, 74864 Jan. 31, 2011 Jan. 1, 2011 HHS

OCIIO Dec. 30, 2010 75 Fed. Reg. 250, 82277

Jan. 1, 2011

HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Agency Information Collection § 1001 (2718 PHS Act) Activities; Proposals, May 31, 2011 Submissions, and Approvals: Comment Request 76 Fed. Reg. 104, June 30, 2011 Request for Adjustment to the 31337 Medical Loss Ratio Standard for a State’s Individual Market Extension of Time to Comply Extended to any with MLR Requirements taxable year (Filling Out Part V, Section B beginning in 2010 June 11, 2011 of Schedule H, Hospitals in IRS § 9106 (§ 2718 PHS Act) Notice and the first taxable IRS Notice 2011-51 Announcement 2011-37) year beginning after December 31, 2010. Federal Employees Health Interim Final Rule June 23, 2011 Benefits Program: New § 9106 (§ 2718 PHS Act) with Request for 76 Fed. Reg. 121, August 22, 2011 July 25, 2011 Premium Rating Method for Comments 36857 Most Community Rated Plans Questions and Answers Technical July 18, 2011 Regarding the Medical Loss § 1001 (2718 PHS Act) Guidance 76 Fed. Reg. 137 Ratio Interim Final Rule Medical Loss Ratio Rebate Interim Final Rule Dec. 7, 2011 Requirements for Non-Federal § 1001 (2718 PHS Act) with Request for 76 Fed. Reg. 235, Jan. 3, 2012 Governmental Plans Comments 76596 Medical Loss Ratio Dec. 7, 2011 Requirements under the Patient Final Rule with § 1001 (2718 PHS Act) 76 Fed. Reg. 235, Jan. 3, 2012 Protection and Affordable Care Comment Period 76574 Act CCIIO Technical Guidance: Questions and Answers § 1001 (2718 PHS Act) Guidance February 10, 2012 Regarding the Medical Loss Ratio Interim Final Rule

BINDER 1 TAB #

AGENCY

CMS

CCIIO HHS

HHS

CCIIO

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Page 11

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Memo to Insurance Companies: Medical Loss Ratio Annual § 2718 PHS Act Guidance March 30, 2012 Reporting Procedures Annual MLR and Rebate April 3, 2012 § 2718 PHS Act Notice May 3, 2012 Calculation Report 77 Fed. Reg. 20023 CCIIO Technical Guidance: Questions and Answers § 2718 PHS Act Guidance April 20, 212 Regarding the Medical Loss Ratio Regulation Memo to Insurance Companies: Guidance for Medical Loss Guidance Ratio Annual Reporting Form; § 2718 PHS Act May 15, 2012 Memo to Insurance Companies: Guidance Guidance for Medical Loss Ratio Notices of Rebates Health Insurance Issuers May 16, 2012; Implementing Medical Loss May 16, 2012 corrections are Ratio (MLR) Under the Patient § 2718 PHS Act Rule 77 Fed. Reg. 28788 applicable on Protection and Affordable Care January 1, 2011 Act; Correcting Amendment Medical Loss Ratio Requirements Under the Patient May 16, 2012 § 2718 PHS Act Final Rule June 15, 2012 Protection and Affordable Care 77 Fed. Reg. 28790 Act CCIIO Technical Guidance: Questions and Answers § 2718 PHS Act Guidance May 24, 2012 Regarding the Medical Loss Ratio Reporting Form

BINDER 1 TAB #

AGENCY

CCIIO CMS CCIIO

CCIIO

HHS

HHS

CCIIO

Prepared by Greenberg Traurig, LLP.

Page 12

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS CCIIO Technical Guidance: Questions and Answers § 2718 PHS Act Guidance May 30, 2012 Regarding the Medical Loss Ratio Reporting Requirements Agency Information Collection Activities; Proposals, Submissions, and Approvals: § 2718 PHS Act Notice Dec. 4, 2012 Feb. 4, 2013 Annual MLR and Rebate Calculation Report and MLR Rebate Notices Memo to Insurance Companies: Guidance for 2012 Medical § 2718 PHS Act Notice March 29, 2013 Loss Ratio Annual Reporting Form Memo to Insurance Companies: Announcement Regarding § 2718 PHS Act Notice March 29, 2013 Training for 2012 Medical Loss Ratio Reporting Period Interim Final Rules July 23, 2010 Internal Claims & Appeals & § 1001 (2719) & Request for 75 Fed. Reg. 141, Sept. 23, 2010 Sept. 23, 2010 External Review Comment 43330 Internal Claims & Appeals & § 1001 (2719) Fact Sheet July 22, 2010 External Review Availability of Interim Procedures for Federal External Aug. 26, 2010 Review & Model Notices 75 Fed. Reg. 165, Relating to Internal Claims & § 1001 (2719) Notice 52597 Appeals & External Review under the Patient Protection & Affordable Care Act

BINDER 1 TAB #

AGENCY

CCIIO

CMS

CCIIO

CCIIO

5 5

IRS; EBSA; HHS

6

IRS; EBSA; HHS

Prepared by Greenberg Traurig, LLP.

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Federal External Review Technical Release Process for Self-Insured Group § 1001 (2719) Interim Procedures Aug. 23, 2010 Health Plans Model Notices: Adverse Benefit Determination, Final Released Sept. 20, Internal Adverse Benefit § 1001 (2719) Model Notices 2010 Determination, Final External Review Decision Technical Guidance for Interim Procedures for Federal External Review Relating to Internal Interim Procedures Released August Claims and Appeals and § 1001 (2719) / Technical 23, 2010 External Review for Health Guidance Insurance Issuers in the Group and Individual Markets Technical Guidance for Issuers in Individual Market to Establish County Level Estimates Pertaining to the Technical Posted Sept. 1, Culturally and Linguistically § 1001 (2719) Guidance 2010 Appropriate Standards Set Forth in the Internal Claims and Appeals and External Review Processes Agency Information Collection Activities; Submission for OMB Review; Comment Request; Affordable Care Act May 2, 2012 § 1001 (2719) Notice June 1, 2012 Internal Claims and Appeals 77 Fed. Reg. 26046 and External Review Procedures for NonGrandfathered Plans

BINDER 1 TAB #

AGENCY

7

EBSA

8

EBSA

9

EBSA

10

OCIIO

DOL

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Enforcement Grace Period for Compliance with Certain New Released Sept. 20, § 1001 (2719) Technical Release Provisions with Respect to 2010 Internal Claims and Appeals Revised Model Notice of Released Sept. 20, § 1001 (2719) Model Notice Adverse Benefit Determination 2010 Interim Enforcement Safe Harbor for Plans Subject to the Technical Released Sept. 23, § 1001 (2719) Federal External Review Guidance 2010 Process Interim Procedures for Internal Technical § 1001 (2719) Sept. 20, 2010 Claims and Appeals Guidance Nov. 17, 2010 Federal External Review Request for § 1001 (2719) 75 Fed. Reg. 221, Dec. 8, 2010 Process Information 70160 Extension of Non-Enforcement Period Relating to Certain Interim Procedures for Internal Technical Release § 1001 (2719 PHS Act) Guidance Mar. 18, 2011 Claims and Appeals under the 2011-01 Patient Protection and Affordable Care Act

BINDER 1 TAB #

AGENCY

11 12 13

EBSA EBSA OCIIO OCIIO HHS; EBSA

DOL, HHS, IRS

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Page 15

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Guidance on External Review Transition period for Group Health Plans and until January Health Insurance Issuers 1, 2012 for State Offering Group and Individual external review Health Coverage, and Guidance process for States on State External June 22, 2011 implementation; Review Processes § 1001 (2719 PHS Act) Technical Release Technical Release and (2) a set of 2011-02 temporary standards for NAIC-similar processes that will apply until January 1, 2014. Updated Instructions for Calculating County Level Estimates Pertaining to the Culturally and Linguistically Technical Appropriate Standards Set § 1001 (2719 PHS Act) June 22, 2011 2011 Guidance Forth in the Internal Claims and Appeals and External Review Processes under the Affordable Care Act Instructions for Self-Insured Nonfederal Governmental Health Plans and Health Insurance Issuers Offering Technical § 1001 (2719 PHS Act) June 22, 2011 January 1, 2012 Group and Individual Health Guidance Coverage on How to Elect a Federal External Review Process.

BINDER 1 TAB #

AGENCY

HHS, IRS, TREAS

CMS

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Affordable Care Act: Working with States to Protect § 1001 (2719 PHS Act) Fact Sheet June 22, 2011 Consumers Group Health Plans and Health Amendment To § 1001 (2719 PHS Act; § June 24, 2011 Insurance Issuers: Internal Interim Final Rules 715(a)(1) ERISA; § 76 Fed. Reg. 122, July 25, 2011 July 22, 2011 Claims and Appeals and With Request For 9815(a)(1) IRC) 37208 External Review Processes Comments External Appeals: Determinations of External § 1001 (2719 PHS Act) Fact Sheet August 3, 2011 Appeals Review Processes Proposed Extension of Information Collection Request Submitted for Public Comment; Feb. 23, 2012 Affordable Care Act Internal § 1001 (2719 PHS Act) Notice April 23, 2012 77 Fed. Reg. 10781 Claims and Appeals and External Review Procedures for Non-Grandfathered Plans 2012 County Data for Culturally and Linguistically Appropriate Services

BINDER 1 TAB #

AGENCY

CCIIO HHS, IRS, TREAS CCIIO

EBSA

§ 1001 (2719 PHS Act)

Fact Sheet

March 9, 2012

CCIIO

HHS-Administered Federal External Review Process

§ 1001 (2719 PHS Act)

Fact Sheet

June 19, 2012

CCIIO

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Application of Individual and Group Market Requirements under Title XXVII of the Public § 1001 (Title XXVII PHS Guidance September 1, 2011 Health Service Act when Act) Insurance Coverage Is Sold to, or through, Associations Agency Information Collection Activities; Proposals, Submissions, and Approvals: Income and Eligibility Jan. 4, 2012 Verification System (IEVS) § 1001 (2719 PHS Act) Notice March 5, 2012 77 Fed. Reg. 291 Reporting and Supporting Regulations Contained in 42 CFR 431.17, 431.306, 435.910, 435.920, and 435.940-960 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Early Retiree Reinsurance Program Survey of Plan Sponsors; Affordable Care Act Jan. 11, 2013 § 1001 (2719 PHS Act) Notice Feb. 11, 2013 Internal Claims and Appeals 78 Fed. Reg. 2408 and External Review Procedures for Nongrandfathered Group Health Plans and Issuers and Individual Market Issuers

BINDER 1 TAB #

AGENCY

CCIIO

CMS

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Extension of the Transition Period for the Temporary NAIC-Similar State External Review Process under the Affordable Care Act Agency Information Collection Activities: Proposed Collection; Comment Request: Information Collection Requirements for Compliance with Individual and Group Market Reforms under Title XXVII of the Public Health Service Act 5 Premium Rate Review Process Agency Information Collection Activities; Proposals, Submissions, and Approvals: Consumer Assistance Program Grants Rate Increase Disclosure and Review Rate Increase Disclosure and Review Rate Increase Disclosure and Review

BINDER 1 TAB #

AGENCY

§ 1001 (2719 PHS Act)

Notice

March 15, 2013

January 1, 2016

CCIIO

§ 1001 (PHS Act §§ 2723, 2761)

Notice

Nov. 21, 2012 77 Fed. Reg. 69846

January 22, 2013

CMS

§ 1003 (2794 PHS Act)

Request for Information

Apr. 14, 2010, 75 Fed. Reg. 71, 19335 July 27, 2012 77 Fed. Reg. 44241 Dec. 23, 2010 75 Fed. Reg. 246, 81004 December 21, 2010 May 23, 2011 76 Fed. Reg. 99, 29964

May 14, 2010

HHS

§ 1002

Notice

Sept. 25, 2012

CMS

§ 1003 (2794 PHS Act) § 1003 (2794 PHS Act) § 1003 (2794 PHS Act)

Notice of Proposed Rulemaking Letter to Insurance Commissioners Final Rule

OCIIO

July 18, 2011

CMS (CCIIO)

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION EFFECTIVE PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE OF DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION REGULATION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE A - IMMEDIATE IMPROVEMENTS IN HEALTH COVERAGE FOR ALL AMERICANS Agency Information Collection Activities; Proposals, June 01, 2011 Submissions, and Approvals: § 1003 (2794 PHS Act) Notice 76 Fed. Reg. 105, June 27, 2011 Rate Increase Disclosure and 31613 Review Reporting Requirements Agency Information Collection Activities; Proposals, Submissions, and Approvals: Rate Review Grants to States § 1003 (2794 PHS Act) Notice July 22, 2011 August 22, 2011 and Territories Cycle I and II Funding Opportunity Announcement Application and Reporting Rate Increase Disclosure and Sept. 6, 2011 Review § 1003 (2794 PHS Act) Final Rule 76 Fed. Reg. 172, Nov. 1, 2011 54969 Emergency Clearance: Public Information Collection Oct. 12, 2011 Requirements Submitted to the § 1003 (2794 PHS Act) Notice 76 Fed. Reg. Oct. 21, 2011 Office of Management and 63302 Budget (OMB)

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AGENCY

CMS

HHS

CMS

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT TOPIC OF REGULATION ACT SECTION TYPE OR DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE B - IMMEDIATE ACTIONS TO PRESERVE & EXPAND COVERAGE July 30, 2010 Pre-Existing Condition § 1101 Interim Final Rule Sept. 28, 2010 Insurance Plan Program 75 Fed. Reg. 146, 45014 Guidance on Portability of Pre-Existing Condition § 1101 Coverage, Enrollee Dec. 28, 2010 Insurance Plan Program Notices, and Third Party Payments Pre-Existing Condition Guidance on § 1101 Oct. 6, 2010 Insurance Plan Program Newborn Coverage Pre-Existing Condition Solicitation Insurance Plan Program - State § 1101 Cover Letter May 10, 2010 High Risk Pool Model Contract Pre-Existing Condition Aug. 30, 2012 § 1101 Final Rule Insurance Plan Program 77 Fed. Reg. 52614 Agency Information Collection Activities: Submission for OMB Review; Comment Sept. 21, 2012 Request - Pre-Existing § 1101 Notice Oct. 22, 2012 77 Fed. Reg. 58558 Condition Insurance Plan (PCIP) Authorization to Share Personal Health Information PCIP Authorization to Share Apr. 4, 2013 § 1101 Notice May 6, 2013. Personal Health Information 78 Fed. Reg. 20320 May 5, 2010 Interim Final Rule Early Retiree Reinsurance § 1102 with Comment June 4, 2010. Program 75 Fed. Reg. 86, Period 24450

BINDER 1 TAB #

EFFECTIVE DATE OF REGULATION

AGENCY

1

July 30, 2010

HHS

Aug. 30, 2012

HHS

CMS

CMS June 1, 2010 OCIIO

2

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # 3 4 ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 1102 § 1102 § 1102 ACA REGULATION TYPE OR ACTION Application Instructions Notice FED. REG. PUBLICATION DATE, VOLUME, PAGE Posted July 2, 2010 Posted June 29, 2010 Apr. 5, 2011 76 Fed. Reg. 65, 18766 June 28, 2011 76 Fed. Reg. 124, 37813 Dec. 13, 2011 76 Fed. Reg. 239, 77537 July 28, 2011 EFFECTIVE DATE OF REGULATION June 1, 2010 June 1, 2010

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

ERRP Program Application ERRP Program Application Instructions ERRP Program - Cessation of Applications (5/5/11) Agency Information Collection Activities; Proposals, Submissions, and Approvals: Early Retiree Reinsurance Program (ERRP) Early Retiree Reinsurance Program

OCIIO OCIIO CMS

§ 1102 ACA

Notice

CMS

§ 1102 ACA

Notice

Dec. 9, 2011 Notice reiterates and formalizes our expectation that a sponsor will use ERRP reimbursement funds as soon as possible, but not later than December 31, 2014 April 19, 2013 June 4, 2010 May 10, 2010

CMS

Early Retiree Reinsurance Program

§ 1102 ACA

Notice

Mar. 21, 2012 77 Fed. Reg. 16551

CMS

Early Retiree Reinsurance Program (Termination) 5 5 Health Care Reform Insurance Web Portal Requirements Health Care Reform Insurance Web Portal Requirements

§ 1102 ACA § 1103 § 1103

Notice Interim Final Rule with Comment Period Fact Sheet

Apr. 23, 2013 78 Fed. Ref. 23936 May 5, 2010 75 Fed. Reg. 86, 24470

CMS HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Agency Information Collection Activities: Submission for OMB Review; Comment Request -Health Care Reform Insurance Web Portal Requirements 45 CFR part 159 Health Care Reform Insurance Web Portal Requirements User Access and Authorization for the Health Insurance Oversight System Health Care Reform Insurance Web Portal Requirements Administrative Simplification: Adoption of Operating Rules for Eligibility for Health Plan and Health Care Claim Status Transactions Administrative Simplification: Adoption of Operating Rules for Eligibility for Health Plan and Health Care Claim Status Transactions Administrative Simplification: Adoption of Standards for Health Care Electronic Funds Transfers and Remittance Advice

COMMENT DUE DATE

AGENCY

§ 1103

Notice

Aug. 15, 2012 77 Fed. Reg. 48986

Sept. 13, 2012

CMS

5

§ 1103

Memorandum

May 3, 2010 Aug. 26, 2011 76 Fed. Reg. 166, 53474 July 08, 2011 76 Fed. Reg. 131, 40458 July 08, 2011 76 Fed. Reg. 131, 40458 September 6, 2011

§§ 1103 and 10102 ACA

Notice Interim Final Rule With Comment Period

Sept. 26, 2011

CMS

§1104 ACA

June 30, 2011

HHS

§ 1104 ACA

Rule

September 6, 2011

June 30, 2011

HHS

§ 1104 ACA

Rule

Jan 10, 2012 77 Fed. Reg. 1556

January 10, 2012

HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Administrative Simplification: Adoption of a Standard for a Unique Health Plan Identifier; Addition to the National Provider Identifier Requirements; and a Change to the Compliance Date for ICD10-CM and ICD-10-PCS Medical Data Code Sets

COMMENT DUE DATE

AGENCY

§ 1104 ACA

Proposed Rule

April 17, 2012 77 Fed. Reg. 22950

May 17, 2012

HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE C PART 1- HEALTH INSURANCE MARKET REFORMS § 1201 (2704 PHS Act) Interim Final Rule & Request for Comments Questions and Answers June 28, 2010 75 Fed. Reg. 123, 37188 Oct. 13, 2010 Aug. 27, 2010 Aug. 27, 2010

BINDER 1 TAB #

TOPIC OF REGULATION

EFFECTIVE DATE OF REGULATION

AGENCY

IRS EBSA HHS OCIIO

1

Preexisting Condition Exclusions Preexisting Condition Exclusions - Enrollment of Children Under 19 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Wellness Program Study: Assessing the Impact of Workplace Health and Wellness Programs Guidance on 90-Day Waiting Period Under Public Health Service Act § 2708 Incentives for Nondiscriminatory Wellness Programs in Group Health Plans Ninety-Day Waiting Period Limitation and Technical Amendments to Certain Health Coverage Requirements Under the Affordable Care Act

§ 1201 (2705 PHS Act)

Notice

July 12, 2011 76 Fed. Reg. 133, 40913

August 12, 2011

HHS

§ 1201 (2708 PHS Act)

IRS Notice 201259 Proposed Rule

August 31, 2012 Nov. 26, 2012 77 Fed. Reg. 70619

September 30, 2012 January 25, 2013

IRS, HHS, DOL IRS, HHS, DOL

§ 1201 (2708 PHS Act)

§ 1201 (2708 PHS Act)

Proposed Rules

Mar. 21, 2013 78 Fed. Reg. 17313

May 20, 2013

IRS, HHS, DOL

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION June 14, 2010 Except that certain amendments are effective July 12, 2010

BINDER 1 TAB #

TOPIC OF REGULATION Grandfathered Plans

COMMENT DUE DATE

AGENCY

IRS EBSA HHS

(Retiree Plans) 2 (Collectively Bargained Plans) (Good Faith Compliance) Grandfathered Plans § 1251 § 1251

Interim Final Rule & Proposed Rule

June 17, 2010 75 Fed. Reg. 116, 34538

Aug. 16, 2010

Fact Sheet IRS Amendment to Interim Final Rules Nov. 17, 2010 75 Fed. Reg. 221, 70114

Grandfathered Plans

§ 1251

Dec. 17, 2010

Nov. 15, 2010

EBSA HHS

Grandfathered Plans - Group Health Plans and Health Insurance Coverage Rules Relating to Status as a Grandfathered Health Plan Under the Patient Protection and Affordable Care Act

§ 1251

Notice of Proposed Rulemaking

Nov. 17, 2010 75 Fed. Reg. 221, 70159

Dec. 17, 2010

IRS

IRS Grandfathered Plans § 1251 Fact Sheet on Regulation Amendment Memo on Amendments to HIPAA Opt-Out Provision Comment Request EBSA HHS Opt-Out Elections Disclosure and Recordkeeping § 1251 ACA § 1251 ACA Sep. 21, 2010 May 27, 2011 July 26, 2011 Various HHS / OCIIO CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE 76 Fed. Reg. 103, 30942 EFFECTIVE DATE OF REGULATION

BINDER 1 TAB #

TOPIC OF REGULATION Requirements for Grandfathered Health Plans under the Affordable care Act

COMMENT DUE DATE

AGENCY

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS TITLE I SUBTITLE D § 1302(b) § 1302(b) Bulletin Notice Dec. 16, 2011 Jan. 25, 2012 January 31, 2012

BINDER 1 TAB #

TOPIC OF REGULATION

EFFECTIVE DATE OF REGULATION

AGENCY

1

Essential Health Benefits Bulletin Essential Health Benefits: Illustrative List of the Largest Three Small Group Products by State Frequently Asked Questions on the Essential Health Benefits Bulletin

CCIIO CCIIO

§ 1302(b)

FAQs

Feb. 17, 2012 Please send comments on AV: ActuarialValue@ cms.hhs.gov and cost-sharing reductions: CostSharingRedu ctions@cms.hhs.g ov

CCIIO

Actuarial Value and CostSharing Reductions Bulletin

§§ 1302(d)(2); 1402

Bulletin

Feb. 24, 2012

HHS

Patient Protection and Affordable Care Act; Data Collection To Support Standards Related to Essential Health Benefits; Recognition of Entities for the Accreditation of Qualified Health Plans

§ 1302; § 1311

Proposed rule

June 5, 2012 77 Fed. Reg. 33133

July 5, 2012

HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Patient Protection and Affordable Care Act; Data Collection To Support Standards Related to Essential Health Benefits; Recognition of Entities for the Accreditation of Qualified Health Plans Essential Health Benefits: List of the Largest Three Small Group Products by State Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation Planning & Establishment of State Level Exchanges

COMMENT DUE DATE

AGENCY

§ 1302; § 1311

Final Rule

July 20, 2012 77 Fed. Reg. 42658

Aug. 20, 2012

HHS

§ 1302

Fact Sheet

July 2, 2012

CCIIO

§ 1302

Proposed Rule

Nov. 26, 2012 77 Fed. Reg. 70643

Dec. 26, 2012

HHS

§ 1302

Final Rule

Feb. 25, 2013 78 Fed. Reg. 12833 Aug. 3, 2010

Apr. 26, 2013

HHS

§§ 1311-24

Request for Comments Initial Guidance to States on Exchanges Cover Letter on Initial Guidance

OCIIO Oct. 4, 2010 CMS

75 Fed. Reg. 148, 45584

Health Insurance Exchanges

§§ 1311-24

Nov. 18, 2010

HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION Guidance for Exchange and Medicaid IT Systems Cover Memo to States from OCIIO and CMS on IT for Exchanges and Medicaid FOA Announcement for “Early Innovator” Grants for Developing Exchange IT Systems Fact Sheet Award FAQs Process FAQs §§ 1311-24 ACA Planning and Establishment Grant FAQs § 1311 ACA Comment Request Apr. 15, 2011 76 Fed. Reg. 73, 21371 June 14, 2011 OCIIO CMS FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Health Insurance Exchanges

§§ 1311-24

Nov. 3, 2010

OCIIO CMS

Health Insurance Exchanges Health Insurance Exchanges State Planning and Establishment Grants Limited Competition for State Planning and Establishment Grants for the Affordable Care Act's Exchanges

§§ 1311-24

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Agency Information Collection Activities; Proposals, Submissions, and Approvals: Extension of a currently approved collection, Cooperative Agreement to Support Establishment of StateOperated Health Insurance Exchanges

COMMENT DUE DATE

AGENCY

§ 1311 ACA

Comment Request

Apr. 29, 2011 76 Fed. Reg. 83, 24032

June 28, 2011

CMS

Exchange Regulation Overview Fact Sheet Affordable Insurance Exchange Basics Small Business Fact Sheet States Fact Sheet Health Plans Fact Sheet Patient Protection and Affordable Care Act: Establishment of Exchanges and Qualified Health Plans § 1311 ACA Proposed Rule July 15, 2011 76 Fed. Reg. 136, 41866 September 28, 2011 HHS

Establishment of Exchanges and Qualified Health Plans

§ 1311 ACA

July 11, 2011

CCIIO

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION Affordable Insurance Exchange Overview Fact Sheet Exchange Eligibility and Employer Standards Medicaid, CHIP and the Affordable Care Act Health Insurance Premium Tax Credits and the Affordable Care Act Patient Protection and Affordable Care Act: Exchange Functions in the Individual Market: Eligibility Determinations; Exchange Standards for Employers Affordable Insurance Exchanges: State Partnership Model Essential Health Benefits Bulletin Fact Sheet Aug. 17, 2011 76 Fed. Reg. 159, 51202 FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Establishment of Exchanges and Qualified Health Plans

§ 1311 ACA

August 12, 2011

CCIIO

§ 1311 ACA

Proposed Rule

Oct. 31, 2011

HHS

§ 1311 ACA § 1311 ACA

Fact Sheet Fact Sheet

Sept. 19, 2011 Dec. 16, 2011

CCIIO

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 1311 ACA REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE Mar. 2, 2012 77 Fed. Reg. 12847 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Cooperative Agreement to Support Establishment of the Affordable Care Act’s Health Insurance Exchanges Affordable Insurance Exchanges Final Rule: Choices, Competition and Clout for States Draft Exchange Blueprint General Guidance on Federallyfacilitated Exchanges Agency Information Collection Activities; Proposals, Submissions, and Approvals: Agent/broker data collection in Federally Facilitated Health Insurance Exchanges fordable Insurance Exchanges: Update and Upcoming Implementation Forums Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers Regulations Pertaining to the Disclosure of Return Information To Carry Out Eligibility Requirements for Health Insurance Affordability Programs

COMMENT DUE DATE

AGENCY

Notice

May 1, 2012

CMS

§ 1311 ACA § 1311 ACA § 1311 ACA

Fact Sheet Guidance Guidance

Mar. 12, 2012 May 16, 2012 May 16, 2012 CCIIO CCIIO

§ 1311 ACA

Notice

Feb. 7, 2013 78 Fed. Reg. 9056

April 8, 2013

CMS

§ 1311 ACA

Fact Sheet

May 16, 2012

CCIIO

§ 1311 ACA

Final Rule, Interim Final Rule

March 27, 2012 77 Fed. Reg. 18310

May 11, 2012

May 29, 2012

HHS

§ 1311 ACA

NPRM and Notice of Public Hearing

April 30, 2012 77 Fed. Reg. 25378

July 30, 2012

IRS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 1311 REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE May 18, 2012 77 Fed. Reg. 29645 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Cooperative Agreement to Support Establishment of the Affordable Care Act’s Health Insurance Exchanges Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers; Correction Request for Domains, Instruments, and Measures for Development of a Standardized Instrument for Use in Public Reporting of Enrollee Satisfaction With Their Qualified Health Plan and Exchange

COMMENT DUE DATE

AGENCY

Notice

June 18, 2012

CMS

§ 1311

Rule

May 29, 2012 77 Fed. Reg. 31513

May 29, 2012

HHS

§ 1311

Notice

June 21, 2012 77 Fed. Reg. 37409

June 29, 2012.

HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Agency Information Collection Activities; Proposals, Submissions, and Approvals: Data Collection to Support Eligibility Determinations and Enrollment for Employees in the Small Business Health Options Program; Data Collection to Support Eligibility Determinations for Insurance Affordability Programs and Enrollment through Affordable Insurance Exchanges, Medicaid and Children’s Health Insurance Program Agencies

COMMENT DUE DATE

AGENCY

§ 1311(b)

Notice

Jan. 29, 2013 78 Fed. Reg. 6109

Feb. 28, 2013

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Agency Information Collection Activities; Proposals, Submissions, and Approvals: Initial Plan Data Collection to Support Qualified Health Plan (QHP) Certification and Other Financial Management and Exchange Operations; Data Collection to Support Eligibility Determinations and Enrollment for Employees in the Small Business Health Options Program; Data Collection to Support Eligibility Determinations and Enrollment for Small Businesses in the Small Business Health Options Program; Data Collection to Support Eligibility Determinations for Insurance Affordability Programs and Enrollment through Affordable Insurance Exchanges, Medicaid and Children’s Health Insurance Program Agencies Recognition of Entities for the Accreditation of Qualified Health Plans Request for Information regarding Health Care Quality for Exchanges

COMMENT DUE DATE

AGENCY

§§ 1311-24 ACA

Notice(s)

July 06, 2012 77 Fed. Reg. 40064

Sept. 4, 2012

CMS

§ 1311 ACA § 1311 ACA

Notice Notice

Nov. 26, 2012 77 Fed. Reg. 70163 Nov. 27, 2012 77 Fed. Reg. Dec. 27, 2012

November 20, 2012

HHS CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Agency Information Collection Activities: Submission for OMB Review; Comment Request: Initial Plan Data Collection to Support Qualified Health Plan (QHP) Certification and Other Financial Management and Exchange Operations State Health Insurance Marketplaces (List of Conditionally Approved Exchanges) Guidance on State Partnership Exchange Conditional Approval of StateBased Exchanges Draft 2014 Letter to Issuers on Federally-facilitated and State Partnership Exchanges Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Small Business Health Options Program Recognized Accrediting Entities Data Collection

COMMENT DUE DATE

AGENCY

§§ 1311-24 ACA

Notice

Nov. 21, 2012 77 Fed. Reg. 69846

Dec. 21, 2012

CMS

§§ 1311-24 ACA §§ 1311-24 ACA §§ 1311-24 ACA §§ 1311-24 ACA

Notice Notice Notice Notice

Dec. 20, 2012 Jan. 3, 2013 Jan. 3, 2013 Mar. 1, 2013 Mar. 15, 2013

CCIIO CCIIO CCIIO CCIIO

§§ 1311-12 ACA

Proposed Rule

Mar. 11, 2013 78 Fed. Reg. 15553 Mar. 14, 2013 78 Fed. Reg. 16270

April 1, 2013

HHS

§ 1311 ACA

Notice

April 15, 2013

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE §§ 1311-24 ACA REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE Apr. 5, 2013 78 Fed. Reg. 20581 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Patient Protection and Affordable Care Act; Exchange Functions: Standards for Navigators and Non-Navigator Assistance Personnel Agency Information Collection Activities: Proposed Collection; Comment Request: Cooperative Agreement to Support Navigators in Federallyfacilitated and State Partnership Exchanges 2014 Letter to Issuers on Federally-facilitated and State Partnership Exchanges Using Section 1311(a) Funding for Marketing Activities in a Plan Management State Partnership Marketplace or Federally-facilitated Marketplace Progress Continues in Building Exchanges – Marketplace Timeline Helping Consumers Apply & Enroll Through the Marketplace Marketplace Consumer Application CMCS Informational Bulletin: Model Eligibility Application and Guidance on State Alternative Applications

COMMENT DUE DATE

AGENCY

Proposed Rule

May 6, 2013

HHS

§§ 1311-24 ACA

Notice

Apr. 12, 2013 78 Fed. Reg. 21957

June 11, 2013

CMS

§§ 1311-24 ACA

Notice

Apr. 15, 2013

CCIIO

§§ 1311-24 ACA

Guidance

April 22, 2013

CCIIO

§§ 1311-24 ACA §§ 1311-24 ACA §§ 1311-24 ACA §§ 1311-24 ACA

Timeline Guidance Guidance Guidance

April 22, 2013 April 23, 2013 April 30, 2013 April 30, 2013

CCIIO CCIIO CCIIO CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE §§ 1311-24 ACA § 1322 ACA § 1322 ACA REGULATION TYPE OR ACTION Guidance Notice Announcing Establishment Notice of Meeting FED. REG. PUBLICATION DATE, VOLUME, PAGE May 1, 2013 June 23, 2010 75 Fed. Reg. 120, 35816 Dec. 28, 2010 75 Fed. Reg. 248, 81612 Dec. 8, 2011 Dec. 13, 2011 76 Fed. Reg. 239, 77392 July 20, 2011 76 Fed. Reg. 139, September 16, 2011 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Role of Agents, Brokers, and Web-brokers in Health Insurance Marketplaces Consumer Operated and Oriented Plan (CO-OP) Advisory Board Consumer Operated and Oriented Plan (CO-OP) Advisory Board New Federal Loan Program Helps Nonprofits Create Customer-Driven Health Insurers Patient Protection and Affordable Care Act; Establishment of Consumer Operated and Oriented Plan Patient Protection and Affordable Care Act: Establishment of Consumer Operated and Oriented Plan Program Agency Information Collection Activities; Proposals, Submissions, and Approvals: Consumer Operated and Oriented (CO-OP) Program CO-OP Awardees Announced

COMMENT DUE DATE

AGENCY

CCIIO OCIIO Dec. 28, 2010 OCIIO

§ 1322 ACA

Fact Sheet

CCIIO

§ 1322 ACA

Final Rule

Feb. 13, 2012

HHS

§ 1322 ACA

Proposed Rule

HHS

§ 1322 ACA § 1322 ACA

Notice Fact Sheet

Aug. 5, 2011 76 Fed. Reg. 151, 47591 June 22, 2012

Oct. 4, 2011

CMS CCIIO

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION 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 Application for Recognition as a 501(c)(29) Organization State Flexibility to Establish Basic Health Program: Request for Information State Innovation Waivers Application, Review and Reporting Process (ACOs) Application, Review, and Reporting Process for Waivers for State Innovation OPM Request For Information: Multi-State Plan Nationwide Insurance Plans Offered Through Exchanges Establishment of the MultiState Plan Program for the Affordable Insurance Exchanges

COMMENT DUE DATE

AGENCY

§ 1322 ACA

Notice

Sept. 30, 2011 76 Fed. Reg. 190, 60788

Oct. 31, 2011

HHS

Temporary regulation § 1322(h)(1) ACA Revenue Procedure 2012-11 § 1331 ACA § 1332 ACA § 1332 ACA Notice Proposed Rule Final Rule

Feb. 7, 2012 77 Fed. Reg 6005 Sept. 14, 2011 76 Fed. Reg. 178, 56767 March 14, 2011 76 Fed. Reg. 49, 13553 Feb. 27, 2012 77 Fed. Reg. 11700 June 16, 2011 OPM35-11-R-0001

Feb. 7, 2012

IRS

Oct. 31, 2011 May 13, 2011 Apr. 27, 2012

CMS HHSS Treasury HHS Treasury

§ 1334 ACA

Request for Information

August 2, 2011

OPM

§ 1334 ACA

Proposed Rule

Dec. 5, 2012 77 Fed. Reg. 72581

January 4, 2013

OPM

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 1334 ACA § 1341 §§ 1341, 1342, 1321 ACA REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE Mar. 11, 2013 78 Fed. Reg. 15559 July 11, 2011 July 15, 2011 76 Fed. Reg. 136, 41930 September 28, 2011 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Establishment of the MultiState Plan Program for the Affordable Insurance Exchanges Reinsurance, Risk Corridors and Risk Adjustment Fact Sheet Standards Related to Reinsurance, Risk Corridors and Risk Adjustment 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 Request for Information Regarding the Reinsurance Program Under the Affordable Care Act Reinsurance, Risk Corridors and Risk Adjustment Final Rule Fact Sheet Patient Protection and Affordable Care Act; Standards Related to Reinsurance, Risk Corridors and Risk Adjustment Bulletin on the Risk Adjustment Program: Proposed Operations by the Department of Health and Human Services

COMMENT DUE DATE

AGENCY

Final Rule Fact Sheet Proposed Rule

May 10, 2013

OPM CCIIO HHS

§ 1341 ACA

Notice

Sept. 30, 2011 76 Fed. Reg. 60788

Oct. 31, 2011

HHS

§ 1341

Request For Information Fact Sheet

Jan. 30, 2012 77 Fed. Reg. 4534 March 16, 2012 March 23, 2012 77 Fed. Reg. 17220

February 29, 2012

CMS

§ 1341

CCIIO

§ 1341

Final Rule

May 22, 2012

HHS

§ 1341

Guidance

May 1, 2012

CCIIO

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 1341 REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE May 17, 2012 77 Fed. Reg. 29235 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Patient Protection and Affordable Care Act; Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment; Correction Bulletin on the Transitional Reinsurance Program: Proposed Payment Operations by the Department of Health and Human Services Agency Information Collection Activities; Proposals, Submissions, and Approvals: Standards Related to Reinsurance, Risk Corridors and Risk Adjustment Risk Adjustment Meeting-May 7, 2012 and May 8, 2012 HHS Notice of Benefit and Payment Parameters for 2014 Patient Protection and Affordable Care Act: Amendments to the HHS Notice of Benefit and Payment Parameters for 2014 Patient Protection and Affordable Care Act: HHS Notice of Benefit and Payment Parameters for 2014 Technical Fact Sheet: HHS Notice of Benefit and Payment Parameters for 2014

COMMENT DUE DATE

AGENCY

Final Rule; Correction

May 22, 2012

HHS

§ 1341

Guidance

May 31, 2012

CCIIO

§§ 1341, 1342

Notice

Jan. 25, 2013 78 Fed. Reg. 5457 April 11, 2012 77 Fed. Reg. 21775 Dec. 7, 2012 77 Fed. Reg. 73117 Mar. 11, 2013 78 Fed. Reg. 15541

March 26, 2013

CMS

§ 1343 § 1343

Notice Proposed Rule Interim Final Rule With Comment

May 7 - 8, 2012 Dec. 31, 2012

HHS CMS

§ 1343

April 30, 2013

April 30, 2013

CMS

§ 1343 § 1343

Final Rule

Mar. 11, 2013 78 Fed. Reg. 15409 Mar. 11, 2013

April 30, 2013

CMS

Guidance

CCIIO

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 1 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 1343 § 1343 Notice January 15, 2013 CCIIO REGULATION TYPE OR ACTION Notice FED. REG. PUBLICATION DATE, VOLUME, PAGE January 15, 2013 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Model Algorithm Instructions for the Proposed HHS Risk Adjustment Model Technical Details on the Proposed HHS Risk Adjustment Model

COMMENT DUE DATE

AGENCY

CCIIO

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION PAGE RELATED STATUTE TITLE I - QUALITY, AFFORDABLE HEALTH CARE FOR ALL AMERICANS Title I Subtitle E Part I - Premium Tax Credits and Cost-Sharing Reduction §1401 §1401 §§ 1402, 1412 §§ 1413, 1414, 2001, 2002, 2101, 2201, 2001, 10201 § 1341 Fact Sheet Notice of Proposed Rulemaking Notice Proposed Rule August 12, 2011 Aug. 17, 2011 76 Fed. Reg. 159, 50931 IRS Notice 2011-36 Aug. 17, 2011 76 Fed. Reg. 159, 51148 March 23, 2012 77 Fed. Reg. 17220 April 26, 2012 April 26, 2012 May 23, 2012 77 Fed. Reg. 30377 Feb. 1, 2013 78 Fed. Reg. 7264 Mar. 11, 2013 78 Fed. Reg. 15407 August 21, 2012 May 23, 2012 Feb. 1, 2013 May 10, 2013 June 11, 2012 June 17, 2011 Oct. 31, 2011 Oct. 31, 2011

BINDER 1 TAB #

TOPIC OF REGULATION

EFFECTIVE DATE OF REGULATION

AGENCY

Treasury Department fact sheet on health insurance premium tax credit Health Insurance Premium Tax Credit Employer Shared Responsibility Medicaid Programs: Eligibility Changes under the Affordable Care Act of 2010 Patient Protection and Affordable Care Act; Standards Related to Reinsurance, Risk Corridors and Risk Adjustment Minimum Value of an Employer-Sponsored Health Plan Verification of Access to Employer-Sponsored Coverage Bulletin Health Insurance Premium Tax Credit Health Insurance Premium Tax Credit Proposed Collection; Comment Request for Regulation Project: Health Insurance Premium Tax Credit

IRS IRS IRS CMS

Final Rule IRS Notice 201231 Guidance Rule Final Rule Notice And Request For Comments

May 22, 2012

HHS

§ 1401 § 1411 § 1412; IRC 36B § 1412; IRC 36B § 1412; IRC 36B

IRS CCIIO IRS IRS IRS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 1412; IRC 36B REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE May 3, 2013 78 Fed. Reg. 25909 EFFECTIVE DATE OF REGULATION

BINDER 1 TAB #

TOPIC OF REGULATION Health Insurance Premium Tax Credit: Minimum Value of Eligible Employer-Sponsored Plans and Other Rules

COMMENT DUE DATE

AGENCY

Proposed Rule

July 2, 2013

IRS

1 2

Small Business Health Care Tax Credit Small Business Health Care Tax Credit Shared Responsibility Payment for Not Maintaining Minimum Essential Coverage Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions Shared Responsibility Payment for Not Maintaining Minimum Essential Coverage; Correction Request for Comments on Reporting of Health Insurance Coverage Request for Comments on Health Coverage Affordability Safe Harbor for Employers (Section 4980H)

§ 1421 § 1421

Title I Subtitle E Part II - Small Business Tax Credit Released May 17, Notice 2010 Released Sept. 7, Draft Form 2010 Title I Subtitle G - Miscellaneous Provisions Proposed Rule Feb. 1, 2013 78 Fed. Reg. 7314

Sept. 1, 2010

Mar. 30, 2010

IRS IRS

§1501 (IRC 5000A)

May 2, 2013

IRS

§1501 (IRC 5000A)

Proposed Rule

Feb. 1, 2013 78 Fed. Reg. 7348

Mar. 18, 2013

HHS

§1501 (IRC 5000A) §1502(a)

Correction IRS Notice 201231 Notice

Mar. 29, 2013 78 Fed. Reg. 19155 April 26, 2012 Sept. 1, 2011 Notice 2011-73 June 11, 2012

IRS IRS

§ 1513 (4980H IRC)

Dec. 13, 2011

IRS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 1513 (4980H IRC) REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

BINDER 1 TAB #

TOPIC OF REGULATION Determining Full-Time Employees for Purposes of Shared Responsibility for Employers Regarding Health Coverage (§ 4980H) Shared Responsibility for Employers Regarding Health Coverage Request for Comments on Reporting by Applicable Large Employers on Health Insurance Coverage Under EmployerSponsored Plans Procedures for Handling of Retaliation Complaints under Section 1558 of Affordable Care Act Student Health Insurance Student Health Insurance

COMMENT DUE DATE

AGENCY

IRS Notice 201258

August 31, 2012

September 30, 2012

IRS, HHS, DOL

§ 1513 (4980H IRC)

Proposed Rule

Jan. 2, 2013 78 Fed. Reg. 217

Mar.18, 2013

IRS

§ 1514

IRS Notice 201233

April 26, 2012

June 11, 2012

IRS

§ 1558 § 1560(c) § 1560(c)

Interim Final Rule Proposed Rule Final Rule

Feb. 27, 2013 78 Fed. Reg. 13222 Feb. 11, 2011 76 Fed. Reg. 7767 Mar. 21, 2012 77 Fed. Reg. 16453

April 29, 2013 Apr. 12, 2011

February 27, 2013

DOL CMS

April 20, 2012

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE TITLE II - ROLE OF PUBLIC PROGRAMS § 2001 § 2006 Report § 4106 § 10202 Medicaid Program; Increased Federal Medical Assistance Percentage Changes Under the Affordable Care Act of 2010 Medicaid Programs: Eligibility Changes under the Affordable Care Act of 2010 Medicaid Program; Eligibility Changes Under the Affordable Care Act of 2010 Conversion of Net Income Standards to MAGI Equivalent Income Standards Informational Bulletin: MAGIBased Eligibility Verification Plans §§ 2001(a)(3)(B), 10201(c) §§ 1413, 1414, 2001, 2002, 2101, 2201, 2001, 10201 §§ 1413, 1414, 2001, 2002, 2101, 2201, 2001, 10201 ACA §§ 2002, 2101 ACA §§ 2002, 2101 Final Rule With Request For Comments Proposed Rule Final Rule; Interim Final Rule SMDL Bulletin Apr. 2, 2013 78 Fed. Reg. 19917 Aug. 17, 2011 76 Fed. Reg. 159, 51148 Mar. 23, 2012 77 Fed. Reg. 17144 Dec. 28, 2012 Jan. 21, 2013 March 20, 2013 June 3, 2013 June 3, 2013 CMS Released Sept. 9, 2010

BINDER 2 TAB #

TOPIC OF REGULATION

COMMENT DUE DATE

EFFECTIVE DATE OF REGULATION

AGENCY

1

Medicaid: The Federal Medical Assistance Percentage (FMAP)

Mar. 23, 2010

CRS

Oct. 31, 2011 Jan. 1, 2014

CMS CMS CMS CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing Medicaid Programs: Alternative Benefit Plan; Eligibility Notices, Fair Hearing , Appeal Processes, and Other Provisions; Correction Adjustments for DisasterRecovery States to the Fourth Quarter of Fiscal Year 2011 and Fiscal Year 2012 Federal Medical Assistance Percentage (FMAP) Rates for Federal Matching Shares for Medicaid and Title IV–E Foster Care, Adoption Assistance and Guardianship Assistance Programs

COMMENT DUE DATE

AGENCY

§§ 1411, 1413, 2001, 2002, 2004, 2101, 2201, 2202, 2303, and 10201

Proposed Rule

Jan. 22, 2013 78 Fed. Reg. 4593

Feb. 21, 2013 (Per Correction below)

CMS

§§ 1411, 1413, 2001, 2002, 2004, 2101, 2201, 2202, 2303, and 10201

Notice

Jan. 30, 2013 78 Fed. Reg. 6275

Feb. 21, 2013

CMS

§ 2006

Notice

Dec. 22, 2010 75 Fed. Reg. 245, 80502

July 1, 2011

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2013 Through September 30, 2014 Hospice Care for Children in Medicaid and CHIP Medicaid Program; Community First Choice Option Medicaid Program; Community First Choice Option Medicaid Program; State Plan Home and Community-Based Services, 5-Year Period for Waivers, Provider Payment Reassignment, and Setting Requirements for Community First Choice Medicaid Program; State Plan Home and Community-Based Services, 5-Year Period for Waivers, Provider Payment Reassignment, and Setting Requirements for Community First Choice; Correction

COMMENT DUE DATE

AGENCY

§ 2001, 2006, 10201

Notice

Nov. 30, 2012 77 Fed. Reg. 71420

October 1, 2013 and ending September 30, 2014

CMS

2

§ 2302 § 2401 § 2401

Guidance Proposed Rule Final Rule

Released Sept. 9, 2010 Feb. 25, 2011 76 Fed. Reg. 38, 10736 May 07, 2012 77 Fed. Reg. 26828

CMS Apr. 26, 2011 July 6, 2012 CMS CMS

§§ 2401; 2601

Proposed Rule

May 03, 2012 77 Fed. Reg. 26362

June 4, 2012

CMS

§§ 2401; 2601

Proposed Rule

May 03, 2012 77 FR 26232

July 2, 2012

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 2403 § 2501, 2503, 3301(d)(2) (SSA 1927) § 2503(a) Proposed Rule AMP REGULATION TYPE OR ACTION Notice Proposed Rule FED. REG. PUBLICATION DATE, VOLUME, PAGE Sept. 28, 2011 76 Fed. Reg. 188, 60050 Feb. 2, 2012 77 Fed. Reg. 5318 Sept. 3, 2010 75 Fed. Reg. 171, 54073 Oct. 4, 2010 CMS EFFECTIVE DATE OF REGULATION Before September 30, 2011 through April 15, 2013 April 2, 2012

TOPIC OF REGULATION Medicaid Program: Money Follows the Person Rebalancing Demonstration Program Medicaid Program; Covered Outpatient Drugs Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs

COMMENT DUE DATE

AGENCY

CMS CMS

3

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE TITLE II - ROLE OF PUBLIC PROGRAMS § 2602 Request For Information May 16, 2011 76 Fed. Reg. 94, 28196

BINDER 2 TAB #

TOPIC OF REGULATION

COMMENT DUE DATE

EFFECTIVE DATE OF REGULATION

AGENCY

Medicare and Medicaid Programs; Opportunities for Alignment Under Medicaid and Medicare Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Proposed Changes; Considering Changes to the Conditions of Participation for Long Term Care Facilities Initial Core Set of Health Quality Measures for MedicaidEligible Adults Initial Core Set of Health Quality Measures for MedicaidEligible Adults

July 11, 2011

CMS

§§ 2602, 2702, 3008(a), 3008(b), 3204, 3301, 6005, 6405(c), 10328

Proposed Rule

Oct. 11, 2011 76 Fed. Reg. 196, 63018

Dec. 12, 2011

CMS

§ 2701

Notice with Comment Period

Dec. 30, 2010 75 Fed. Reg. 250, 82397 Jan. 4, 2012 77 Fed. Reg. 286

March 1, 2011

HHS

§ 2701

Final Notice

Jan. 4, 2012

HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION Effective Nov 5, 2012, with the exception of the definition of “meaningful EHR user” in § 495.4 and the provisions in § 495.6(f), § 495.6(g), § 495.8, § 495.102(c), and part 495 subpart D, which are effective September 4, 2012. Show citation box Mar. 18, 2011

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Medicare and Medicaid Programs; Electronic Health Record Incentive ProgramStage 2

§ 2701

Final Rule

Sept. 4, 2012 77 Fed. Reg. 53967

CMS

Medicaid Program; Payment Adjustment for ProviderPreventable Conditions Including Health Care-Acquired Conditions Advancing Interoperability and Health Information Exchange

§ 2702

Proposed Rule

Feb. 17, 2011 76 Fed. Reg. 33, 9283

CMS

§ 2703

Notice With Comment; Request For Information

Mar. 7, 2013 78 Fed. Reg. 14793

April 22, 2013

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE § 3001(a) Final Rule May 6, 2011 76 Fed. Reg. 88, 26490

TOPIC OF REGULATION

EFFECTIVE DATE OF REGULATION

AGENCY

Medicare Program; Hospital Inpatient Value-Based Purchasing Program Medicare Programs: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates Medicare Programs: Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates; Corrections Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates, etc. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal

July 1, 2011 These changes would be applicable to discharges occurring on or after October 1, 2011

CMS

§§ 3001, 3004, 305, 3124, 3401, 10324, 3401, 10319, 1105, 3125, 10314, 1109

Proposed Rule

May 5, 2011 76 Fed. Reg. 78, 25879

June 20, 2011

CMS

§§ 3001, 3004, 3025, 3124, 3401, 10324, 3401, 10319, 3125, 10314, 1109 ACA

Proposed Rule; Corrections

June 14, 2011 76 Fed. Reg. 114, 34633

CMS

§§ 3001, 3004, 3025, 3124, 3401, 10324, 10319, 10314, 1109, 5503 ACA

Final Rule

Aug 18, 2011 76 Fed. Reg. 160, 51476

Oct. 1, 2011

CMS

§§ 3001, 3004, 3025, 3124, 3401, 10324, 10319, 10314, 1109, 5503 ACA

Notice

Sept. 26, 2011 76 Fed. Reg. 186, 59263

Oct. 1, 2011

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Year 2012 Rates; Hospitals' FTE Resident Caps for Graduate Medical Education Payment; Corrections Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2012; Changes in Size and Square Footage of Inpatient Rehabilitation Units and Inpatient Psychiatric Units

§ 3004 ACA

Proposed Rule

Apr. 29, 2011 76 Fed. Reg. 83, 24214

June 21, 2011

CMS

Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2013

§ 3004 ACA

Notice

July 30, 2012 77 Fed. Reg. 44618

For IRF discharges occurring on or after October 1, 2012 and on or before September 30, 2013 (FY 2013).

CMS

Agency Information Collection Activities: Proposed Collection; Comment Request - Hospice Quality Reporting Program

§ 3004 ACA

Notice

June 4, 2012 77 Fed. Reg. 32977

August 3, 2012

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Agency Information Collection Activities: Submission for OMB Review; Comment Request

§ 3004 ACA

Notice

Aug. 13, 2012 77 Fed. Reg. 48158

For the data collection period starting October 1, 2012, through December 31, 2012, and continuing on a calendar year thereafter October 1, 2011

CMS

Medicare Program: Hospice Wage Index for Fiscal Year 2012 Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2012 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2012; Changes in Size and Square Footage of Inpatient Rehabilitation Units and Inpatient Psychiatric Units; Correction Agency Information Collection Activities; Proposals, Submissions, and Approvals: Hospice Voluntary Quality Data Reporting Program

§§3004; 3401 ACA

Rule

§ 3004 ACA

Final Rule

Aug 4, 2011 76 Fed. Reg. 150, 47302 Aug. 5, 2011 76 Fed. Reg. 151, 47836

CMS

Oct. 1, 2011

CMS

§ 3004 ACA

Notice

Sept. 26, 2011 76 Fed. Reg. 186, 59256

Oct. 1, 2011

CMS

§ 3004 ACA

Notice

Sep. 2, 2011 76 Fed. Reg. 171, 54776

Nov. 1, 2011

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE § 3021 ACA Notice of Meeting May 19, 2011 76 Fed. Reg. 97, 28988 May 20, 2011 76 Fed. Reg. 98, 29249 June 08, 2011 76 Fed. Reg. 110, 33306 All teams must register by Monday, June 20, 2011 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Meetings: Medicare Program; Accelerated Development Sessions for Accountable Care Organizations - June 20, 21, and 22, 2011 Medicare Program; Pioneer Accountable Care Organization Model: Request for Applications Medicare Program; Pioneer Accountable Care Organization Model, Request for Applications; Correction Medicare Program; Pioneer Accountable Care Organization Model: Extension of the Submission Deadlines for the Letters of Intent and Applications Meetings: Medicare Program; Accountable Care Organization Accelerated Development Learning Sessions

CMS

§ 3021 ACA

Notice

June 20, 2011

CMS

§ 3021 ACA

Correction Notice

July 19, 2011

CMS

§ 3021 ACA

Notice Of Extension Of Deadlines

June 14, 2011 76 Fed. Reg. 114, 34712

Pioneer ACO Model letters of intent - June 30, 2011; apps August 19, 2011 Meeting Date: Thursday, September 15, 2011, 8 a.m to 5 pm., pacific daylight time (p.d.t): Friday, September 16, 2011, 8 a.m. to 5 p.m. (p.d.t).

CMS

§ 3021 ACA

Notice

Aug. 12, 2011 76 Fed. Reg. 156, 50224

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Bundled Payments for Care Improvement Initiatives

§ 3021 ACA

Notice

Aug. 25, 2011 76 Fed. Reg. 165, 53137

Bundled Payments for Care Improvement Initiatives

§ 3021 ACA

Notice

Oct. 4, 2011 76 Fed. Reg. 192, 61365

Interested organizations must submit a nonbinding letter of intent by September 22, 2011 for Model 1 and November 4, 2011 for Models 2 through 4; Applications must be received on or before October 21, 2011 for Model 1 and March 15, 2012 for Models 2 through 4. For Model 1 of the initiative: (1) The letter of intent will be due on or before October 6, 2011; and (2) the application will be due on or before November 18, 2011 Nov. 15, 2011

CMS

CMS

Medicare Program; Comprehensive Primary Care Initiative

§ 3021 ACA

Notice

Oct. 3, 2011 76 Fed. Reg. 191, 61103

CMS

Prepared by Greenberg Traurig, LLP.

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE § 3022 ACA Request for Information Nov. 17, 2010 75 Fed. Reg. 221, 70165 Apr. 19, 2011 76 Fed. Reg. 75, 21894 April 18, 2011 2011-16 I.R.B. 652 Apr. 7, 2011 76 Fed. Reg. 67, 19528 Apr. 7, 2011 76 Fed. Reg. 67, 19655 Jun. 6, 2011 Dec. 3, 2010 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Accountable Care Organizations and the Medicare Shared Saving Program ACOs - Antitrust Policy Statement

CMS

§ 3022 ACA

Guidance

FTC, DOJ

IRS Notice of Tax Treatment of Shared Savings Accountable Care Organizations and the Medicare Shared Saving Program Medicare Programs: Waiver Designs in Connection with the Medicare Shared Savings Program and the Innovation Center Tax-Exempt Organizations Participating in the Medicare Shared Savings Program through Accountable Care Organizations Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations

§ 3022 ACA

Guidance

IRS

§ 3022 ACA

Notice of Proposed Rulemaking

CMS

§ 3022 ACA

Guidance

CMS, OIG

§ 3022 ACA

Fact Sheet

October 20, 2011

IRS

§ 3022 ACA

Final Rule

Nov. 2, 2011 76 Fed. Reg. 212, 67802

Jan. 1, 2011

CMS

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Page 6

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE Nov. 2, 2011 § 3022 ACA Notice 76 Fed. Reg. 212, 68012 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Medicare Program: Advanced Payment Model

Medicare Program: New Application Deadline for Advance Payment Model

§ 3022 ACA

Notice

Nov. 30, 2011, 76 Fed. Reg. 230, 74067

Application Submission Deadlines for the Advance Payment Model: Apps for the performance period beginning on April 1, 2012 will be accepted from January 3, 2012 through February 1, 2012. Jan. 1, 2011 Nov. 2, 2011

CMS

Final Waivers in Connection With the Shared Savings Program Meetings: Medicare Program; Accountable Care Organization Accelerated Development Learning Sessions Statement of Antitrust Enforcement Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program Tax-Exempt Organizations Participating in the Medicare Shared Savings Program

§ 3022 ACA

Interim Final Rule with Comment Period Meeting

Nov. 2, 2011 76 Fed. Reg. 212, 67992 Oct. 28, 2011 76 Fed Reg. 209, 66931

CMS, OIG

§ 3022 ACA

CMS

§ 3022 ACA

Guidance; Final Policy Statement

FTC, DOJ

§ 3022 ACA

Fact Sheet

Oct. 20, 2011 FS-2011-11

IRS

Prepared by Greenberg Traurig, LLP.

Page 7

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

through Accountable Care Organizations Additional guidance for Medicare Shared Savings Program Accountable Care Organization (ACO) applicants Medicare Program: Independence at Home Demonstration Program

§ 3022 ACA

Memorandum

March 16, 2012 Dec. 21, 2011 76 Fed. Reg. 32568 December 21, 2011

March 16, 2012

CMS

§ 3024 ACA

Notice

CMS Proposals will be accepted on a rolling basis. Acceptable applicants will be awarded on an ongoing basis as funds permit.

Medicare Program: Solicitation for Proposals for Medicare Community-based Care Transitions Program

§ 3026 ACA

Notice

Apr. 15, 2011 76 Fed. Reg. 73, 21372

CMS

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Community-based Care Transitions Program (CCTP) Implementation and Monitoring

§ 3026 ACA

Notice

July 22, 2011 76 Fed Reg. 141, 44009

September 20, 2011

CMS

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Page 8

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE Supporting information to request a temporary code due to CMS on or before Sep 6, 2011 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Medicare Program: Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration; Extension of Deadline

§ 3113 ACA

Notice

Aug 10, 2011 76 Fed. Reg. 153,

CMS

Medicare: Changes to Hospital Outpatient PPS & CY 2011 Payment Rates 1 Medicare: Changes to Ambulatory Surgical Center PPS & CY 2011 Rates

§§ 3121, 3138, 4103, 4104, 10324(b) Proposed Rule § 3401(i) & (k)

Aug. 3, 2010 75 Fed. Reg. 148, 46170 Aug. 31, 2010 Jan. 1, 2011 CMS

Nov. 22, 2010 Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year §§ 3202-06, 3208-09, 3303, 3308-10, 3312 § 1102 §§ 4103-05 §§ 3202-06, 3208-09, 3303, 3308-10, 3312 § 1102 Proposed Rule Correction of Proposed Rule 75 Fed. Reg. 22, 71190 Jan. 21, 2011 75 Fed. Reg. 22, 71064 Jan. 1, 2011 Jan. 1, 2012 (with some exceptions) June 6, 2011, unless otherwise specified in the rule. CMS

Final Rule

Apr. 15, 2011 76 Fed. Reg. 73, 21432

CMS

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Page 9

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE §§ 4103-05 § 3205 Final Rule Sept. 1, 2011 76 Fed. Reg. 107, 54600 Oct 31, 2011 CMS EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

2012 and Other Proposed Changes Medicare Program: Medicare Advantage and Prescription Drug Benefit Programs Medicare Program: Hospital Outpatient Prospective Payment System and CY 2011 Payment Rates; Ambulatory Surgical Center Payment System and CY 2011 Payment Rates; Payments to Hospitals for Graduate Medical Education Costs; Physician Self-Referral Rules and Related Changes to Provider Agreement Regulations; Payment for Certified Registered Nurse Anesthetist Services Furnished in Rural Hospitals and Critical Access Hospitals Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical Center Payment; Hospital Value-Based Purchasing Program; Physician Self-Referral; and Patient Notification Requirements in Provider Agreements Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and

§§ 3121, 3138, 4103, 4104, 10324(b) § 3401(i) & (k) §§ 1301 §§ 5503, 5504, 5505, 5506 § 6001

Jan. 1, 2011 (except for the amendment to 42 CFR 412.113 (c)(2)(i)(A), which is effective on Dec. 2, 2010, and certain retroactive amendments.)

Final Rule, Interim Final Rule

Jan. 3, 2011

CMS

§§3001; 3006; 3121; 3137; 3138; 3401; 4104; 6001; 7101; 10317; 10324; 10406

Final Rule With Comment Period

Nov. 30, 2011 76 Fed. Reg. 230, 74122

Jan. 3, 2012

Jan. 1, 2012

CMS

§§3001; 3006; 3121; 3137; 3138; 3401; 4104; 6001; 7101; 10317; 10324; 10406

Final rule with comment period

Nov. 15, 2012 77 Fed. Reg. 68209

Jan 1., 2013

Jan 1., 2013

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Electronic Reporting Pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; Revision to Quality Improvement Organization Regulations Medicare: Payment Policies Under the Physician Fee Schedule & Other Revisions to Part B for CY 2011 Corrections to Medicare: Payment Policies Under the Physician Fee Schedule & Other Revisions to Part B for CY 2011 Medicare: Payment Policies Under the Physician Fee Schedule & Other Revisions to Part B for CY 2011 Medicare Program: Five Year Review of Work Relative Value Units Under the Physician Fee Schedule Medicare: Amendment to Payment Policies Under the Physician Fee Schedule & Other Revisions to Part B for §§ 3002, 3003, 3007, 310205, 3017, 3108, 3111, 3114, 3122, 3134-36, 3139, 3401, 4103, 4104, 5501, 6003, 6410, 10501(i)(3) §§ 3002, 3003, 3007, 310205, 3017, 3108, 3111, 3114, 3122, 3134-36, 3139, 3401, 4103, 4104, 5501, 6003, 6410, 10501(i)(3) §§ 3002, 3003, 3007, 310205, 3017, 3108, 3111, 3114, 3122, 3134-36, 3139, 3401, 4103, 4104, 5501, 6003, 6410, 10501(i)(3) § 3134 July 13, 2010 75 Fed. Reg. 133, 40040

2

Proposed Rule

Aug. 24, 2010

Jan. 1, 2011

CMS

3

Correction of Proposed Rule

Aug. 26, 2010 75 Fed. Reg. 165, 52487

Jan. 1, 2011

CMS

Final Rule

Nov. 29, 2010 75 Fed. Reg. 73170 June 6, 2011 76 Fed Reg. 108, 32410 Jan. 10, 2011 76 Fed. Reg. 6, 13366

Jan. 3, 2011

Jan. 1, 2011

CMS

Proposed Rule

Final Rule

Jan. 10, 2011

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE Jan. 11, 2011 Correction of Final Rule 76 Fed. Reg. 7, 1670 Jan. 1, 2011 CMS EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

CY 2011 Medicare: Payment Policies Under the Physician Fee Schedule & Other Revisions to Part B for CY 2011; Corrections Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of NonRandom Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of NonRandom Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013 Agency Information Collection Activities: Submission for OMB Review; Comment Request - Medicare Advantage Quality Bonus Payment Demonstration

§ 3134

Proposed Rule

July 30, 2012 77 Fed. Reg. 44721

Sept. 4, 2012

CMS

§§ 3002; 3104; 3105; 3134; 3135; 4104; 4105; 6407; 10311; 10331

Final Rule with Comment Period

Nov. 16, 2012 77 Fed. Reg. 68891

Jan 1, 2013

Jan. 1, 2013 (Jul. 1, 2013)

CMS

§ 3201

Notice

Sept. 17, 2012 77 Fed. Reg. 57090

Nov. 16, 2012

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

4

Medicare: Hospital Inpatient Value-Based Purchasing Program Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Proposed Changes; Considering Changes to the Conditions of Participation for Long Term Care Facilities Medicare: Inpatient Rehabilitation Facility Prospective Payment System for Federal FY 2011 (CMS-1344-N) Inpatient Rehabilitation Facility Prospective Payment System for Federal FY 2011-Correction Medicare Program: Hospice Wage Index for Fiscal Year 2012 Medicare Program; Hospice Wage Index for Fiscal Year

§ 3301

Proposed Rule

Jan. 13, 2011 76 Fed. Reg. 9, 2454

March 8, 2011

Oct. 1, 2012

CMS

§§ 2602, 2702, 3008(a), 3008(b), 3204, 3301, 6005, 6405(c), 10328

Proposed Rule

Oct. 11, 2011 76 Fed. Reg. 196, 63018

Dec. 12, 2011

CMS

July 22, 2010 § 3401 Notice 75 Fed. Reg. 140, 42836 Nov. 16, 2010 75 Fed. Reg. 220, 70013 Aug. 4, 2011 76 Fed. Reg. 150, 47836 July 27, 2012 77 Fed. Reg. Oct. 1, 2010 CMS

§ 3401

Notice

Oct. 1, 2010

CMS

§ 3401(g) § 3132(a)

Final Rule Notice

Oct. 1, 2011 Oct. 1, 2012

CMS CMS

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Page 13

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE 44242 § 3401(h) ACA; § 1881(b)(14) SSA Proposed Rule July 08, 2011 76 Fed. Reg. 131 August 30, 2011 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

2013 Medicare Program: Changes to End-Stage Renal Disease Prospective Payment System for CY 2012, etc. Medicare Program; End-Stage Renal Disease Prospective Payment System and Quality Incentive Program; Ambulance Fee Schedule; Durable Medical Equipment; and Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Bad Debt Reductions for all Medicare Providers Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Bad Debt Reductions for All Medicare Providers Medicare: Home Health Prospective Payment System Rate Update for CY 2011; Changes in Certification

CMS

§ 3401 (h) Final Rule §§ 3105 and 10311

Nov. 10, 2011 76 Fed. Reg. 218, 70228

Jan. 1, 2012

CMS

§ 3401 ACA

Proposed Rule

July 11, 2012 77 Fed. Reg. 40951

Aug. 31, 2012

CMS

§ 3401 ACA

Final Rule

Nov. 9, 2012 77 Fed. Reg. 67449

Jan. 1, 2013

CMS

5

§ 3131 - Payment Adjustments for Home Health Care

Proposed Rule

July 23, 2010 75 Fed. Reg. 141, 43236

Sept. 14, 2010

Jan. 1, 2011

CMS

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Page 14

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE § 3401(e) - Market Basket Updates § 3132 - Hospice Reform § 6407(a) - Face-to-Face Encounter Required For Home Health Eligibility Certification § 3131 - Payment Adjustments for Home Health Care § 3401(e) - Market Basket Updates § 3132 - Hospice Reform § 6407(a) - Face-to-Face Encounter Required For Home Health Eligibility Certification § 3131 - Payment Adjustments for Home Health Care § 3401(e) - Market Basket Updates § 3132 - Hospice Reform § 6407(a) - Face-to-Face Encounter Required For Home Health Eligibility Certification § 3131 - Payment Adjustments for Home Health Care § 3401(e) - Market Basket Updates EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Requirements for Home Health Agencies & Hospices (CMS-1510-P)

Home Health Prospective Payment System Rate Update for CY 2011; Changes in Certification Requirements for Home Health Agencies and Hospices

Final Rule

Nov. 17, 2010 75 Fed. Reg. 221, 70372

Jan. 1, 2011

CMS

Home Health Prospective Payment System Rate Update for CY 2011; Changes in Certification Requirements for Home Health Agencies and Hospices

Correction

Dec. 8, 2010 75 Fed. Reg. 235, 76293

Jan. 1, 2011

CMS

Home Health Prospective Payment System Rate Update for CY 2011; Changes in Certification Requirements for Home Health Agencies and

Final Rule

Dec. 27, 2010 75 Fed. Reg. 247, 81138

Jan. 1, 2011

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE § 3132 - Hospice Reform § 6407(a) - Face-to-Face Encounter Required For Home Health Eligibility Certification §3131(b) ACA §3131(b) ACA Proposed Rule Final Rule July 12, 2011 76 Fed. Reg. 133, 40988 Nov. 4, 2011, 76 Fed. Reg. 214, 68526 September 6, 2011 Jan. 1, 2012 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Hospices

Home Health Prospective Payment System Rate Update for Calendar Year 2012 Home Health Prospective Payment System Rate Update for Calendar Year 2012 Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2013, Hospice Quality Reporting Requirements, and Survey and Enforcement Requirements for Home Health Agencies Medicare Program: Home Health Prospective Payment System Rate Update for Calendar Year 2013, Hospice Quality Reporting Requirements, and Survey and Enforcement Requirements for Home Health Agencies Surveys of Physicians and Home Health Agencies to Assess Access Issues for Specific Medicare Beneficiaries

CMS CMS

§§ 3004; 3131; 3401(e); 6111

Proposed Rule

July 13, 2012 77 Fed. Reg. 41547

Sept. 4, 2012

CMS

§§ 3004; 3131; 3401(e); 6111

Final Rule

Nov. 8, 2012 77 Fed. Reg. 67067

Jan. 1, 2013

CMS

§3131(d) ACA

Notice

June 27, 2012 77 Fed. Reg. 38298

July 27, 2012

CMS

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Page 16

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

6

7

as Defined in Section 3131(d) of the ACA Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long- Term Care Hospital Prospective Payment System Changes and FY2011 Rates; Provider Agreements and Supplier Approvals; and Hospital Conditions of Participation for Rehabilitation and Respiratory Care Services; Medicaid Program: Accreditation for Providers of Inpatient Psychiatric Services Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the LongTerm Care Hospital Prospective Payment System Changes and FY 2011 Rates; Provider Agreements and Supplier Approvals; and Hospital Conditions of Participation for Rehabilitation and Respiratory Care Services; Medicaid Program: Accreditation for Providers of Inpatient Psychiatric Services; Corrections Hospital Outpatient Prospective

§§ 3106, 3123, 3124, 3125, 3128, 3137, 3141, 3401

Final Rules and Interim Final Rule

Aug. 16, 2010 75 Fed Reg. 157, 50042

Sept. 28, 2010

Oct. 1, 2010; except for amendments to § 412.2(c)(5), (c)(5)(iii), and (c)(5)(iv); §§ 412.405; 412.521(b)(1); 412.540; 412.604(f); 413.40(c)(2) , (c)(2)(iii), and (c)(2)(iv), that apply to services furnished on or after June 25, 2010.

CMS

Oct. 1, 2010 §§ 3106, 3123, 3124, 3125, 3128, 3137, 3141, 3401 Correction 75 Fed. Reg. 190, 60640 Oct. 1, 2010 CMS

§§ 3004; 3006; 3121; 3137;

Proposed Rule

July 30, 2012

Sept. 4, 2012

CMS

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Page 17

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE 3138; 3401; 4104; 10301; 10317; 10324 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Electronic Reporting Pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; Quality Improvement Organization Regulations Accountable Care Organizations and the Medicare Shared Savings Program Medicare Program; Extension of the Payment Adjustment for Low-volume Hospitals and the Medicare-dependent Hospital (MDH) Program Under the Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals for Fiscal Year 2013 Eligibility for a Medicare Prescription Drug Subsidy Amendments to Regulations Regulations Regarding IncomeRelated Monthly Adjustment Amounts to Medicare Beneficiaries’ Prescription Drug Coverage Premiums Inpatient Psychiatric Facilities Prospective Payment System -

§ 3022

Request for Information

CMS Dec. 3, 2010 HHS March 4, 2013; Applicability dates: The provisions described in this notice are applicable for discharges on or after October 1, 2012 and on or before September 30, 2013. Feb. 28, 2011 Jan. 1. 2011

§§3125, 10314

Notice Of Extension

Mar. 7, 2013 78 Fed. Reg. 14689

CMS

§ 3304

Interim Final Rules with Request for Comments Interim Final Rule with Request for Comments Final Rule

Dec. 29, 2010 75 Fed. Reg. 249, 81843 Dec. 7, 2010 75 Fed. Reg. 234, 75884 76 Fed. Reg. 88, 26433

SSA

§ 3308

Feb. 7, 2011

Dec. 7, 2010

SSA

§ 3401(f); 5506; 10322

July 1, 2011

CMS

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Page 18

Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 2continued to Binder 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, DUE DATE AMENDED) OR OTHER ACTION VOLUME, RELATED STATUTE PAGE TITLE III - IMPROVING THE QUALITY & EFFICIENCY OF HEALTH CARE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Update for Rate Year Beginning July 1, 2011 (RY 2012) Inpatient Psychiatric Facilities Prospective Payment System Update for Rate Year Beginning July 1, 2011 (RY 2013) § 3401(f); 10319(e); 1105(d) HCERA Aug. 7, 2012 77 Fed. Reg. 47223 Effective for discharges occurring on or after October 1, 2012 through September 30, 2013

Notice

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Title IV - Prevention of Chronic Disease & Improving Public Health July 14, 2011 § 4002 ACA (§§ 311 and Notice 76 Fed. Reg. 135, 317(k)(2) PHS Act) 41501 Aug. 23, 2011 § 4002 ACA Notice 76 Fed. Reg. 163, Aug. 23, 2011 52663 § 4002 ACA § 4002 ACA Notice § 4002 ACA Notice § 4002 ACA Notice Notice Sep. 2, 2011 76 Fed. Reg. 171, 54772 Sept. 27, 2011 76 Fed. Reg. 187, 59703 Sept. 27, 2011 76 Fed. Reg. 187, June 15, 2012 77 Fed. Reg. 35981 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

1

Notice of Intent To Award Affordable Care Act (ACA) Funding, EH09-907 CDC Notice of Intent To Award Affordable Care Act Funding, DP-09-001 Notice of Intent To Award Affordable Care Act Funding, Funding Opportunity Announcement CDC-RFADP08-805 Notice of Intent To Award Affordable Care Act (ACA) Funding, RFA-TP-08-001 Notice of Intent To Award Affordable Care Act (ACA) Funding - PERLC program Notice of Intent To Award Affordable Care Act (ACA) Funding, HM10-1001 Proposed Data Collections Submitted for Public Comment and Recommendations: Targeted Surveillance and Biometric Studies for Enhanced Evaluation of Community Transformation Grants Voluntary Registration by Authorized Officials of NonCovered Retail Food Establishments & Vending

July 14, 2011

CDC CDC

Sep. 2, 2011

CDC CDC

Sept. 30, 2011 CDC Sept. 30, 2011 CDC July 2, 2012

§ 4201 ACA

Notice

April 18, 2012 77 Fed. Reg. 23263

April 17, 2012

CDC

§ 4205 ACA

Notice

July 23, 2010 75 Fed. Reg. 141, 43182

FDA Oct. 21, 2010 HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Title IV - Prevention of Chronic Disease & Improving Public Health EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

2

3

Machine Operators Electing to Be Subject to the Menu & Vending Machine Labeling Requirements Established by Section 4205 of the ACA Questions & Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection & Affordable Care Act of 2010 Questions & Answers Regarding the Effect of Section 4205 of the Patient Protection & Affordable Care Act of 2010 on State & Local Menu & Vending Machine Labeling Laws Agency Information Collection Activities; Proposed Collection; Comment Request; Restaurant Menu Labeling: Registration for Small Chains Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Food Labeling; Calorie Labeling of Articles of Food in Vending Machines

§ 4205 ACA

Draft Guidance Announced

Aug. 25, 2010 75 Fed. Reg. 164, 52426

Oct. 12, 2010

Mar. 23, 2010

FDA

§ 4205 ACA

Guidance Announced

Aug. 25, 2010 75 Fed. Reg. 164, 52427

Mar. 23, 2010

FDA

§ 4205 ACA

Notice

Nov. 4, 2010 75 Fed. Reg. 213, 67978 April 6, 2011 76 Fed. Reg. 66, 19192 April 6, 2011 76 Fed. Reg. 66, 19238

Jan. 3, 2011

FDA

§ 4205 ACA

Proposed Rule

June 6, 2011

FDA

§ 4205 ACA

Proposed Rule

June 6, 2011

FDA

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION COMMENT ACT SECTION TYPE OR DATE, VOLUME, DUE DATE AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Title IV - Prevention of Chronic Disease & Improving Public Health Extension of Comment Period May 24, 2011 76 Fed Reg. 100, 30051 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

AGENCY

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment Period Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Correction Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Correction Proposed Data Collection Standards: Race, Ethnicity, Primary Language, Sex, and Disability Status Required by the Affordable Care Act Reasonable Break Time for Nursing Mothers

§ 4205 ACA

July 5, 2011

FDA

§ 4205 ACA

Correction

May 24, 2011 76 Fed Reg. 100, 30050 June 27, 2011 76 Fed. Reg. 123, 37291 June 30, 2011 76 Fed. Reg. 126, 38396 Dec. 21, 2010 75 Fed. Reg. 244, 80073 August 1, 2011

FDA

§ 4205 ACA

Correction Notice Of Availability; Request For Comments Request for Information

FDA

§ 4302 ACA

HHS

§ 4702 ACA

Feb. 22, 2011

DOL

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Title V - Health Care Workforce Aug. 3, 2010 §§ 5503, 5504, 5505, 5506 Proposed Rule 75 Fed. Reg. 148, 46170 Aug. 31, 2010 CMS EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

SEE TAB 1 IN TITLE III BINDER

Proposed Changes Relating to Payments to Hospitals for Direct Graduate Medical Education (GME) & Indirect Medical Education (IME) Costs Payments to Hospitals for Direct Graduate Medical Education (GME) & Indirect Medical Education (IME) Costs Children’s Hospitals Graduate Medical Education Payment Program (CHGME Payment Program) Medicare Program; Solicitation for Proposals for the Medicare Graduate Nurse Education Demonstration-Deadline Extension Designation of Medically Underserved Populations and Health Professional Shortage Areas: Negotiated Rulemaking Committee Meeting

§§ 5503, 5504, 5505, 5506

July 1, 2010 Final Rule July 1, 2011 Jan. 14, 2011 76 Fed. Reg. 10, 2697 May 18, 2012 77 Fed. Reg. 29647

§§ 5503, 5504, 5505, 5506

Comment Request

March 15, 2011

HRSA

§5509

Notice

May 25, 2012

CMSrei

§ 5602 ACA

Proposed Rule; Notice of Meeting

Aug. 26, 2011 76 Fed. Reg. 166, 53377

Sept. 15, 2011

HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Title VI - Transparency & Program Integrity § 6001 ACA Proposed Rule Aug. 3, 2010 75 Fed. Reg. 148, 46170 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

SEE TAB 1 IN TITLE III BINDER

Changes to Physician SelfReferral Rules & Related Changes to Provider Agreement Regulations Changes to Physician SelfReferral Rules & Related Changes to Provider Agreement Regulations Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical Center Payment; Hospital Value-Based Purchasing Program; Physician Self-Referral; and Provider Agreement Regulations on Patient Notification Requirements Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests

Aug. 31, 2010

CMS

§ 6001 ACA

Final Rule

Sept. 23, 2011

CMS

§ 6001 ACA

Proposed Rule

July 18, 2011 76 Fed. Reg. 137, 42170

August 30, 2011

CMS

§ 6002 ACA

Final Rule

Feb. 8, 2013 78 Fed. Reg. 9457

April 9, 2013

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION Mostly March 23, 2011 §§ 6401, 6402, 6501 Proposed Rule Sept. 23, 2010 Nov. 16, 2010 Some March 23, 2010 Some March 23, 2012 § 6402(a) § 6301 Proposed Rule Notice Of Proposed Rulemaking Notice Of Public Hearing. Proposed Rule Feb. 16, 2012 77 Fed. Reg. 9179 April 17, 2012 77 Fed. Reg. 22691 April 16, 2012 July 16, 2012 CMS IRS CMS

TOPIC OF REGULATION Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers Medicare Program; Reporting and Returning of Overpayments Fees on Health Insurance Policies and Self-Insured Plans for the Patient-Centered Outcomes Research Trust Fund Fees on Health Insurance Policies and Self-Insured Plans for the Patient-Centered Outcomes Research Trust Fund; Hearing Cancellation Fees on Health Insurance Policies and Self-Insured Plans for the Patient-Centered Outcomes Research Trust Fund National Practitioner Data Bank National Practitioner Data Bank National Practitioner Data Bank; Correction

COMMENT DUE DATE

AGENCY

1

§ 6301

77 Fed. Reg. 47573

Aug. 9, 2012

Aug. 8, 2012

IRS

§ 6301 § 6403 § 6403 § 6403

Final Rule Notice of Proposed Rulemaking Final Rule Final Rule; Correction

Dec. 6, 2012 77 Fed. Reg. 72721 Feb. 15, 2012 77 Fed. Reg. 9138 Apr. 5, 2013 18 Fed. Reg. 20473 May 3, 2013 78 Fed. Reg. 25858 April 16, 2012

Dec. 6, 2012

IRS HHS

May 6, 2013 May 6, 2013

HHS HHS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 6403 REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE Apr. 8, 2013 78 Fed. Reg. 20929 July 12, 2011 76 Fed. Reg. 133, 41032 Dec. 27, 2010 75 Fed. Reg. 247, 81278 Sept. 16, 2011 75 Fed. Reg. 180, 57808 Feb. 24, 2012 77 Fed. Reg. 11127 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request Medicaid Program; Face-toFace Requirements for Home Health Services: Policy Changes and Clarifications Related to Home Health Development of a Recovery Audit Contractor Program for the Medicare Part C and D Programs Medicaid Program; Recovery Audit Contractors Medicaid Program; Announcement of Medicaid Recovery Audit Contractors (RACs) Contingency Fee Update Medicaid and Children's Health Insurance Programs: Disallowance of Claims for FFP and Technical Corrections Medicaid and Children's Health Insurance Programs; Disallowance of Claims for FFP and Technical Corrections

COMMENT DUE DATE

AGENCY

Notice

May 1, 2013

HRSA

§ 6407 ACA

Proposed Rule

September 12, 2011

CMS

§ 6411 ACA

Request for Information Final Rule

Feb. 25, 2011

§ 6411 ACA

Jan 1, 2012

CMS

§ 6411 ACA (SSA 1902(a)(42)(B))

Notice

March 26, 2012

CMS

§6506 ACA

Proposed Rule

Aug 3, 2011 76 Fed. Reg. 149 May 29, 2012 77 Fed. Reg. 31499

September 2, 2011

CMS

§6506 ACA

Final Rule

June 28, 2012

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Title VII - Improving Access to Innovative Medical Therapies §§7001; 7002; 7003 Notice March 13, 2012 77 Fed. Reg. 14809 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

1 2

Agency Information Collection Activities: Proposed Collection; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792 Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants; Availability Drug Pricing Program Manufacturer Civil Monetary Penalties Drug Pricing Program Administrative Dispute Resolution Process

May 14, 2012

FDA

§§7001; 7002; 7003

Notice

Apr. 1, 2013 78 Fed. Reg. 19492

May 31, 2013

FDA

§7102 ACA §7102 ACA

Proposed Rule and Sept. 20, 2010 Request for 75 Fed. Reg. 181, Comment 57230 Proposed Rule and Sept. 20, 2010 Request for 75 Fed. Reg. 181, Comment 57233 Title VIII - CLASS Act Title IX - Revenue Provisions Notice Released Oct. 12, 2010

Nov. 19, 2010 Nov. 19, 2010

HHS HHS

1

Interim Relief with Respect to Form W-2 Reporting of the Cost of Coverage of Group Health Insurance Under § 6051(a)(14) Interim Guidance on Informational Reporting to Employees of the Cost of Their Group Health Insurance Coverage § 6051(a)(14)

§ 9002 ACA

IRS

§ 9002 ACA

Guidance

IRS Notice 2011-28 Released March 29, 2011

July 18, 2011

IRS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 9002 ACA REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE IRS Notice 2012-9 Released Jan. 3, 2012 Released Sept. 3, 2010 Released Sept. 3, 2010 Dec. 27, 2010 Dec. 27, 2010 Jan. 1, 2011 Jan. 1, 2011 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Interim Guidance on Informational Reporting to Employees of the Cost of Their Group Health Insurance Coverage IRS Guidance Explaining 2011 Changes to Flexible Spending Arrangements IRS Revenue Ruling Regarding 2011 Changes to Flexible Spending Arrangements Guidance on Use of Debit Cards to Buy Prescribed OTC Medicines Health flexible spending arrangements not subject to $2,500 limit on salary reduction contributions for plan years beginning before 2013 and comments requested on potential modification of useor-lose rule. H.R. 4 - Comprehensive 1099 Taxpayer Protection and Repayment of Exchange Subsidy Overpayments Act Certain Filing Changes for TaxExempt Organizations Additional Requirements for Tax Exempt Hospitals

COMMENT DUE DATE

AGENCY

Guidance

IRS

2 3

§ 9003 ACA § 9003 ACA

Notice Revenue Ruling

IRS IRS

Notice 2011-5

January 15, 2011

IRS

§ 9005 ACA

Notice 2012-40

May 30, 2012

August 17, 2012

IRS

§ 9006 - REPEALED § 9007 ACA § 9007(a) ACA

Legislation Notice 2012-4 Notice 2010-39 January 15, 2012 July 22, 2010 IRS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 9007(a) ACA REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE July 7, 2011 IRS Notice 2011-52 June 26, 2012 77 Fed. Reg. 38147 Aug. 10, 2012 77 Fed. Reg. 47787 Oct. 16, 2012 77 Fed. Reg. 63287 Apr. 5, 2013 78 Fed. Reg. 20523 Nov. 7, 2012 July 5, 2013 June 2, 2011 December 5, 2012 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Notice and Request for Comments Regarding the Community Health Needs Assessment Requirements for Tax-exempt Hospitals Additional Requirements for Charitable Hospitals Additional Requirements for Charitable Hospitals; Correction Additional Requirements for Charitable Hospitals; Hearing Community Health Needs Assessments for Charitable Hospitals Annual Fee on Branded Prescription Drug Sales Annual Fee on Branded Prescription Drug Sales Branded Prescription Drug Fee (Temporary Guidance) Branded Prescription Drug Fee (Notice of Proposed Rulemaking) Branded Prescription Drug Fee; Hearing Branded Prescription Drug Fee; Correction

COMMENT DUE DATE

AGENCY

Notice

September 23, 2011 September 24, 2012.

IRS

§ 9007(a) ACA § 9007(a) ACA § 9007(a) ACA § 9007(a) ACA § 9008 ACA § 9008 ACA §§ 9008, 10404 ACA §§ 9008, 10404 ACA § 9008 ACA § 9008 ACA

Proposed Rule Proposed Rule Notice Notice Of Proposed Rulemaking Notice 2010-71 Notice 2011-92 Temporary Guidance Notice of Proposed Rulemaking Proposed Rule Proposed Rule

IRS IRS IRS IRS IRS IRS

Aug. 18, 2011 76 Fed. Reg. 160, 51245 Aug. 18, 2011 76 Fed. Reg. 160, 51310 Aug. 6, 2012 77 Fed. Reg. 46653 Aug. 13, 2012 77 Fed. Reg. 48111

Aug. 18, 2011

IRS IRS IRS IRS

Nov. 16, 2011 Nov. 9, 2012

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 9010 ACA REGULATION TYPE OR ACTION Notice Of Proposed Rulemaking And Notice Of Public Hearing Health Insurance Providers Fee; Correction Notice 2011-02 Notice Of Proposed Rulemaking Notice of proposed rulemaking and notice of public hearing Proposed Rule Cancellation Of Notice Of Public Hearing On Proposed Rulemaking Notice 2011-4 FED. REG. PUBLICATION DATE, VOLUME, PAGE Mar. 4, 2013 78 Fed. Reg. 14034 Mar. 22, 2013 78 Fed. Reg. 17612 IRS Notice 2011-02 Apr. 2, 2013 78 Fed. Reg. 19949 Dec. 5, 2012 77 Fed. Reg. 72268 Jan. 30, 2013 78 Fed. Reg. 6272 Mar. 22, 2013 78 Fed. Reg. 17612 The public hearing originally scheduled for April 4, 2013 at 10 a.m. is cancelled. Dec. 27, 2010 March 23, 2011 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY IRS

Health Insurance Providers Fee

June 3, 2013 IRS

Health Insurance Providers Fee; Correction Deduction for Compensation Paid by Certain Health Insurance Providers The $500,000 Deduction Limitation for Remuneration Provided by Certain Health Insurance Providers Rules Relating to Additional Medicare Tax Rules Relating to Additional Medicare Tax; Correction Rules Relating to Additional Medicare Tax; Hearing Cancellation Modification of Sec. 833 Treatment of Certain Health Organizations

§ 9010 ACA § 9014 ACA

IRS

§ 9014 ACA

July 1, 2013

IRS

§ 9015 ACA § 9015 ACA

March 5, 2013

IRS IRS

§ 9015 ACA

IRS

§ 9016 ACA

IRS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Extension of Interim Guidance on Modification of Section 833 Treatment of Certain Health Organizations

§ 9016 ACA

Notice 2012-37

May 26, 2012

Sept. 10, 2012

IRS

Notice 2010-45 Credits Qualified Therapeutic Discovery Project Program § 9023(a)ACA Grants Questions and Answers May 21, 2010 IRS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Title X (non-incorporated amendments) Notice of proposed rulemaking and Deb. 5, 2012 §1402(a)(1) notice of public 77 Fed. Reg. hearing. IRS Notice § 10101(d) ACA (2716) Request for Comments § 10108 - REPEALED § 10201(d) ACA Legislation Request for Comments Proposed Rule and Request for Comments Informational Bulletin Final Rule Released Sept. 20, 2010 Sept. 17, 2010 75 Fed. Reg. 180, 56946 Released Sept. 16, 2010 Feb. 27, 2012 77 Fed. Reg. 11678 Nov. 16, 2010 CMS Nov. 4, 2010 Sept. 23, 2010 IRS

BINDER 3 TAB #

TOPIC OF REGULATION

COMMENT DUE DATE

EFFECTIVE DATE OF REGULATION

AGENCY

Net Investment Income Tax Nondiscrimination Provisions Applicable to Insured Group Health Plans H.R. 1473 - Department of Defense and Full-Year Continuing Appropriations Act Discrimination in Favor of Highly Compensated Individuals Review and Approval Process for Section 1115 Demonstrations Review and Approval Process for Section 1115 Demonstrations Review and Approval Process for Section 1115 Demonstrations

IRS

March 11, 2011

1

2

§ 10201(i) ACA

§ 10201(i) ACA § 10201(i) ACA

Nov. 16, 2010 Apr. 27, 2012

CMS CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE Application Submission Deadline for the Advance Payment Model: Applications for the performance period beginning on January 1, 2013 will be accepted from August 1, 2012 through September 19, 2012.

AGENCY

Medicare Program; Announcement of a New Opportunity for Participation in the Advance Payment Model for Accountable Care Organizations (ACOs)

§ 10201(i) ACA (§1115 SSA)

Notice

June 26, 2012 77 Fed. Reg. 38066

CMS

Physician Group Practice Transition Demonstration (PGP–TD) Performance Assessment Tool (‘‘PAT’’) Floor on the Area Wage Adjustment Factor for Hospital Outpatient Department Services Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Disclosures of Ownership and Additional Disclosable Parties Information

§ 10307

Notice

May 18, 2012 77 Fed Reg 29645

June 18, 2012

C

§ 10324(b) ACA

Final Rule

Jan. 1, 2011

CMS

§ 10325 ACA

Proposed Rule

May 6,. 2011 76 Fed. Reg. 88, 26364

June 27, 2011

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE § 10325 ACA REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE Aug. 8, 2011 76 Fed. Reg. 152, 48486 Sept. 26, 2011 76 Fed. Reg. 186, 59265 Aug. 2, 2012 77 Fed. Reg. 46213 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012; Correction Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2013 Agency Information Collection Activities; Proposals, Submissions, and Approvals Standardized Pharmacy Notice: Your Prescription Cannot be Filled (f/k/a Medicare Prescription Drug Coverage and Your Rights) Physician Compare Medicare Program: Availability of Medicare Data for Performance Measurement Medicare Program: Availability of Medicare Data for Performance Measurement

COMMENT DUE DATE

AGENCY

Final Rule

Oct. 1, 2011

CMS

§ 10325 ACA

Notice

Oct. 1, 2011

CMS

§ 10325 ACA

Notice

Oct. 1, 2012

CMS

§ 10328 ACA

Comment Request

May 31, 2011 76 Fed. Reg. 104, 31338

August 1, 2011

CMS

Press Release § 10331(a) ACA Physician Compare Website Proposed Rule Final Rule Dec. 30, 2010 June 08, 2011 76 Fed. Reg. 110, 33566 Dec. 7, 2011 76 Fed. Reg. 235, 76542

§ 10332 ACA § 10332 ACA

August 8, 2011 Jan. 6, 2012

CMS CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE HCERA (non-incorporated amendments) HCERA § 1004(d) Notice Released Apr. 27, 2010 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

SEE TAB 1 IN TITLE III BINDER

Tax Treatment of Health Care Benefits Provided to Children Under 27 Medicare Program: Medical Loss Ratio Requirements for Medicare Advantage and Medicare Prescription Drug Benefit Programs Medicaid Program: Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration under the Vaccines for Children Program Changes to Hospital Outpatient PPS & CY 2011 Payment Rates Taxable Medical Devices

Mar. 30, 2010

IRS

HCERA § 1103

Proposed Rule

Feb. 22, 2013 78 Fed. Reg. 12427

Apr. 16, 2013

CMS

HCERA §1202

Final Rule

Nov. 6, 2012 77 Fed. Reg. 66669

Jan. 1, 2013

CMS

HCERA § 1301 - Community Mental Health Centers HCERA § 1405 (IRC § 4191)

Proposed Rule Notice Of Proposed Rulemaking Final Rule

Aug. 3, 2010 75 Fed. Reg. 148, 46170 Feb. 7, 2012 77 Fed. Reg. 6028 Dec. 7, 2012 77 Fed. Reg. 72924

Aug. 31, 2010 May 7, 2012

Jan. 1, 2011

CMS IRS

Taxable Medical Devices

HCERA § 1405 (IRC § 4191)

Dec. 7, 2012; applicable to sales of taxable medical devices after December 31, 2012.

IRS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3 TAB # ACA SECTION(S) IMPLEMENTED (PHS ACT SECTION AMENDED) OR OTHER RELATED STATUTE HCERA § 1405 (IRC § 4191) REGULATION TYPE OR ACTION FED. REG. PUBLICATION DATE, VOLUME, PAGE EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION Interim Guidance and Request for Comments; Medical Device Excise Tax; Manufacturers Excise Taxes; Constructive Sale Price; Deposit Penalties Taxable Medical Devices; Correction Taxable Medical Devices; Correction

COMMENT DUE DATE

AGENCY

Notice 2012-77

December 5, 2012 Mar. 13, 2013; applicable after December 31, 2012 Mar. 13, 2013; applicable after December 31, 2012

IRS

HCERA § 1405 (IRC § 4191)

Correcting Amendment Correcting Amendment

Mar. 13, 2013 78 Fed. Reg. 15878 Mar. 13, 2013 78 Fed. Reg. 15877

IRS

HCERA § 1405 (IRC § 4191)

IRS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation Apr. 15, 2010 75 Fed. Reg. 72, 19678 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

1

Medicare Program; Policy & Technical Changes to the MA & Medicare Prescription Drug Benefit Programs (CMS-4144-P) Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals & the Long-Term Care Hospital Prospective Payment System & Supplemental Proposed FY 2011 Rates; Effective Date of Provider Agreements Supplemental Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals & the Long-Term Care Hospital Prospective Payment System & Supplemental Proposed FY 2011 Rates: Corrections Supplemental Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care

MMA

Final Rule

June 7, 2010

CMS

2

SSA (Does not address the PPACA provisions that affect this proposed rule)

Proposed Rule

May 4, 2010 75 Fed. Reg. 85, 23852

June 18, 2010

Oct. 1, 2010

CMS

3

SSA

Correction of Proposed Rulemaking

July 2, 2010 75 Fed. Reg. 105, 30756

June 18, 2010

Oct. 1, 2010

CMS

4

SSA

Correction of Proposed Rulemaking

June 17, 2010 75 Fed. Reg. 116, 34612

June 18, 2010

Oct. 1, 2010

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

5

Hospitals & the Long-Term Care Hospital Prospective Payment System & Supplemental Proposed FY 2011 Rates: Corrections Modifications to the HIPAA Privacy, Security, & Enforcement Rules Under the Health Information Technology for Economic & Clinical Health Act Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules

HIPAA / HITECH Act

Notice of Proposed Rulemaking

July 14, 2010 75 Fed. Reg. 134, 40868

Sept. 13, 2010

Feb. 18, 2010 (Compliance Date: 180 days after enactment) March 26, 2013. Compliance date: Covered entities and business associates must comply with the applicable requirements of this final rule by September 23, 2013.

HHS

HIPAA / HITECH Act

Final Rule

Jan. 25, 2013 78 Fed. Reg. 5565

HHS

6

Hospice Wage Index FY 2011 (CMS-1523NC) Prospective Payment System & Consolidated Billing for Skilled Nursing Facilities for FY 2011 (CMS-1338-N)

SSA

Notice

July 22, 2010 75 Fed. Reg. 140, 42944 July 22, 2010 75 Fed. Reg. 140, 42886

Sept. 20, 2010

Oct. 1, 2010

CMS

7

SSA

Notice

Sept. 5, 2010

Oct. 1, 2010

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation SSA Notice Sept. 14, 2010 75 Fed. Reg. 177, 55801 July 28, 2010 75 Fed. Reg. 144, 44314 July 28, 2010 75 Fed. Reg. 144, 44590 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

8

9

10

11

Prospective Payment System & Consolidated Billing for Skilled Nursing Facilities for FY 2011 Correction Electronic Health Record Incentive Program (CMS-0033-F) Health Information Technology: Initial Set of Standards, Implementation Specifications, & Certification Criteria for Electronic Health Record Technology Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology Electronic Health Record Incentive Program Permanent Certification Program for Health Information Technology - Establishment Medicare Program: Legislative Changes to Provide Quality of Care to Children Rural Health Care Universal

Oct. 1, 2010

CMS

HITECH Act

Rule

Sept. 27, 2010

CMS

HITECH Act

Final Rule

Aug. 27, 2010

ONC

HITECH Act

Interim Final Rule and Request for Comments

Oct. 13, 2010 75 Fed. Reg. 197, 62686 Dec. 29 2010 75 Fed. Reg. 249, 81885 Jan. 7, 2011 76 Fed. Reg. 1262 July 30, 2010 75 Fed. Reg. 146, 44971 Aug. 9, 2010 75

Nov. 12, 2010

Oct. 13, 2010

ONC

HITECH Act HITECH Act CHIPRA National Broadband Plan

Correcting Amendment Final Rule Notice with Comments Notice of Proposed

Dec. 29, 2010 Feb. 7, 2011 Aug. 30, 2010 Sept. 8, 2010

CMS ONC CMS FCC

12 13

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation Rulemaking Fed. Reg. 152, 48236 Aug. 11, 2010 75 Fed. Reg. 154, 48816 Aug. 12, 2010 75 Fed. Reg. 155, 49215 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

14

Support Mechanism (FCC 10125) Medicaid Program & CHIP: Revisions to the Medicaid Eligibility Quality Control & Payment Error Rate Measurement Programs End-Stage Renal Disease Quality Incentive Program (CMS-3206-P)

CHIPRA

Final Rule

Sept. 10, 2010

CMS

15

MIPPA

Proposed Rule

Sept. 24, 2010 Jan. 1, 2011 (§ 413.174(f)(6) will be effective on Jan. 1, 2014 and § § 413.232(f) and 413.239(b) will be effective Nov. 1, 2010) Feb. 4, 2011 Nov. 12, 2010 Oct. 13, 2010

CMS

16

End-Stage Renal Disease Prospective Payment System (CMS-1418-F)

MIPPA

Final Rule

Aug. 12, 2010 75 Fed. Reg. 155, 49030

CMS

17

End-Stage Renal Disease Quality Incentive Program Maintenance Changes to Electronic Data Transaction Standards Part A Premiums for CY 2011 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement

Final Rule HIPAA Notice

Jan. 5, 2011 76 Fed. Reg. 3, 628 Oct. 13, 2010 75 Fed. Reg. 197, 62684 Nov. 9, 2010 75 Fed. Reg. 216, 68798

ONC

SSA

Notice

Jan. 1, 2011

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation Nov. 9, 2010 75 Fed. Reg. 216, 68790 Nov. 9, 2010 75 Fed. Reg. 216, 68799 Nov. 30, 2010 75 Fed. Reg. 229, 73972 Nov. 19, 2010 75 Fed. Reg. 223, 70831 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2011 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2011 Cost Limit for Providers Operated by Units of Government and Provisions To Ensure the Integrity of FederalState Financial Partnership Changes to the Hospital and Critical Access Hospital Conditions of Participation To Ensure Visitation Rights for All Patients Final FY 2009 and Preliminary FY 2011 Disproportionate Share Hospital Allotments, and Final FY 2009 and Preliminary FY 2011 Institutions for Mental Diseases Disproportionate Share Hospital Limits Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws Federal Tort Claims Act (FTCA) Medical Malpractice

SSA

Notice

Jan. 1, 2011

CMS

SSA

Notice

Jan. 1, 2011

CMS

Final Rule; Implementation of Court Orders

Nov. 30, 2010

CMS

Final Rule

Jan. 18, 2011

CMS

SSA, MMA

Notice

Jan. 3, 2011 76 Fed. Reg. 1, 148

4-Mar-11

CMS

Final Rule FSHCAA Notice of Proposed Rulemaking

Feb. 23, 2011 76 Fed. Reg. 36, 9968 Feb. 28, 2011 76 Fed. Reg. 39,

Mar. 25, 2011 Apr. 29, 2011

HHS HRSA

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As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation 10825 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Program Regulations: Clarification of FTCA Coverage for Services Provided to Non-Health Center Patients Compassionate Allowances for Autoimmune Disease Revisions to the Reductions and Increases to Hospitals' FTE Resident Caps for Graduate Medical Education Payment Purposes State Medicaid Fraud Control Units; Data Mining Medicare and Medicaid Programs; Civil Money Penalties for Nursing Homes Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2010 and Federal Fiscal Year 2011 Medicare, Medicaid, and Childrens Health Insurance Programs: 2011 Provider Enrollment Application Fee

SSA

Notice of Hearing

Mar. 10, 2011 76 Fed. Reg. 47, 13111 March 14, 2011 76 Fed. Reg. 49, 13515 Mar. 17, 2011 76 Fed. Reg. 52, 14637 Mar. 18, 2011 76 Fed. Reg. 53, 15105

Mar. 16, 2011

SSA

Sec. 203 Medicare & Medicaid Extenders Act of 2010

Interim Final Rule

Apr. 13, 2011

Mar. 14, 2011

CMS

Proposed Rule

May 16, 2011

OIG

1864(a) SSA

Final Rule

Jan. 1, 2012

CMS

Notice

Mar. 21, 2011 76 Fed. Reg. 54, 15316

Feb. 25, 2011

CMS

Notice

Mar. 23, 2011 76 Fed. Reg. 56, 16422

Mar. 23, 2011

CMS

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As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation April 4, 2011 76 Fed. Reg. 64, 18472 Apr. 6, 2011 76 Fed. Reg. 64, 18472 April 6, 2011 76 Fed. Reg. 66, 18930 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Medicare Program: Revisions to Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Suppliers Safeguards Medicare Programs: Changes to the End-Stage Renal Disease Prospective Payment System Transition Budget-Neutrality Adjustment Medicare Programs: Changes to the End-Stage Renal Disease Prospective Payment System Transition BudgetNeutrality Adjustment

Proposed Rule

June 3, 2011

CMS

Interim final rule with comment period Interim final rule with comment period

Jun. 3, 2011

CMS

June 6, 2011

April 1, 2011 Applicable for discharges on or after Oct. 1, 2010 and on or before Sept. 30, 2011. Certain hospitals that are not section 508/special exception providers, but that are located in areas affected by section 102 of the MMEA, are also identified in this notice, and will be paid based on the

CMS

Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Fiscal Year 2011 Final Wage Indices, etc.

Notice

Apr. 7, 2011 76 Fed. Reg. 67, 19365

CMS

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As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

revised wage index published in this notice for discharges on or after April 1, 2011 and on or before September 30, 2011. Request for Information Regarding Electronic Disclosure by Employee Benefit Plans Revised Medical Criteria for Evaluating Endocrine Disorders Proposed Establishment of a Federally Funded Research and Development Center Plan for Retrospective Review under Executive Order 13563 Revision of the Requirements for Constituent Materials FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities Disqualification of a Clinical Investigator Request for Information Final Rules Notice Notice Final Rule Apr. 7, 2011 76 Fed. Red. 67, 19285 Apr. 8, 2011 76 Fed. Reg. 68, 19692 Apr. 13. 2011 76 Fed. Reg. 71, 20673 Apr. 13. 2011 76 Fed. Reg. 71, 20568 Apr. 13. 2011 76 Fed. Reg. 71, 20513 Apr. 13. 2011 76 Fed. Reg. 71, 20588 Apr. 13. 2011 76 Fed. Reg. 71, 20575 June 6, 2011 EBSA

June 7, 2011 July 5, 2011 May 12, 2011 May 13, 2011

SSA CMS HHS FDA

Public Meeting

May 20, 2011

FDA

Proposed Rule

July 12, 2011

FDA

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation Apr. 14, 2011 Meeting 76 Fed. Reg. 72. 20989 Negotiated Rulemaking Committee meeting Apr. 14, 2011 76 Fed. Reg. 72. 20867 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

National Committee on Vital and Health Statistics Negotiated Rulemaking Committee Meeting on Designation of Medically Underserved Populations and Health Professional Shortage Areas Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser System for Aesthetic Use Agency Information Collection Activities: Proposed Collection; Comment Request: Medicaid Drug Rebate Program – Labelers Reconciliation of State Invoice (CMS-304) and Prior Quarter Adjustment Statement (CMS-304a) Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid Prevention Pressure Wedge Medicaid Program: Home and Community-Based Services Waivers

Apr, 27, 2011 Meetings will be held on May 18, 2011, 9:30 a.m. to 6 p.m.; May 19, 2011, 9 a.m. to 6 p.m.; and May 20, 2011, 9 a.m. to 3 p.m. May 16, 2011

HHS

HHS

Final Rule

Apr. 14. 2011 76 Fed. Reg. 72, 20840

FDA

Comment Request

Apr. 15, 2011 76 Fed. Reg. 73, 21370

May 16, 2011

CMS

Final Rule

Apr. 15, 2011 76 Fed. Reg. 73, 21237 Apr. 15, 2011 76 Fed. Reg. 73, 21311

May 16, 2011

FDA

Proposed Rule

June 14, 2011

CMS

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As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation Apr. 15, 2011 76 Fed. Reg. 73, 21950 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Medicaid Program: Enhanced Federal Funding for Medicaid Eligibility Determination and Enrollment Activities CMS: Statements of Organization, Functions, and Delegations of Authority Abolishment of the Office of External Affairs and Beneficiary Services and the establishment of the Office of Public Engagement and the Office of Communications. Agency Information Collection Activities; Proposals, Submissions, and Approvals: Healthcare Common Procedure Coding System (HCPCS) Medicare and Medicaid Programs: Changes Affecting Hospital and Critical Access Hospital Conditions of Participation: Telemedicine Credentialing and Privileging Medicare Program; Hospice Wage Index for Fiscal Year 2012 Exclusion of Orphan Drugs for SSA

Final Rule

April 19, 2011

CMS

Notice

Apr. 19, 2011 76 Fed. Reg. 75, 21908

CMS

Comment Request

Apr. 29, 2011 76 Fed. Reg. 83, 24034

May 31, 2011

CMS

Final Rule

May 5, 2011 76 Fed. Reg. 87, 25550 May 9, 2011 76 Fed. Reg. 89, 26731 May 20, 2011

July 5, 2011

CMS

Notice; Correction Final Rule

Apr. 14, 2011 July 19, 2011

CMS HRSA

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation 76 Fed. Reg. 98 29183 May 24, 2011 76 Fed. Reg. 100, 30199 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Certain Covered Entities Under 340B Program Proposed Extension of Information Collection Request Submitted for Public Comment: Consent to Receive Employee Benefit Plan Disclosure Electronically Agency Information Collection Activities; Proposals, Submissions, and Approvals: Independent Rural Health Center/Freestanding Federally Qualified Health Center Cost Report and Supporting Regulations 42 CFR 413.20 AND 42 CFR 413.24 HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical Health Act Agency Information Collection Activities: Submission for OMB Review; Comment Request: Medicare Demonstration Ambulatory Care Quality Measure Performance Assessment Tool (‘‘PAT’’)

Comment Request

July 25, 2011

EBSA

§ 1833(t)(6) SSA

Comment Request

May 27, 2011 76 Fed. Reg. 103, 30944

June 27, 2011

CMS

§13405(c) HITECH Act

NPRM

May 31, 2011 76 Fed. Reg. 104, 31426

August 1, 2011

HHS

§ 646 MMA

Comment Request

May 31, 2011 76 Fed. Reg. 104, 31339

June 30, 2011

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation §13405(c), § 13101 HITECH Act NPRM May 31, 2011 76 Fed. Reg. 104, 31426 June 01, 2011 76 Fed. Reg. 105, 31547 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical Health Act Medicare Program: Proposed Changes to Electronic Prescribing Incentive Program Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability Proposed Establishment of a Federally Funded Research and Development Center Medicare Program: Conditions of Participation for Community Mental Health Centers Medical Devices; Exception From General Requirements for Informed Consent Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall Regulations

August 1, 2011

HHS, OCR

§ 132 MIPPA Final Rule ‘‘Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans’’ (75 FR 59935)

Proposed Rule

July 25, 2011

CMS

Guidance

June 07, 2011 76 Fed. Reg. 109, 32863

September 28, 2011

FDA

Notice § 1832(a)(2)(J) SSA § 520(g)(3)(D) of the Federal Food, Drug, and Cosmetic Act § 701 FDCA Proposed Rule Final Rule

June 14, 2011 76 Fed. Reg. 114, 34713 June 17, 2011 76 Fed. Reg. 117, 35684 June 24, 2011 76 Fed. Reg. 122, 36989 June 29, 2011 76 Fed. Reg. 125, 38184

July 5, 2011 August 16, 2011 June 24, 2011

CMS CMS FDA

Notice

August 29, 2011

FDA

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation July 01, 2011 76 Fed. Reg. 127, 38552 EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Amendments to Regulations Regarding Major LifeChanging Events Affecting Income-Related Monthly Adjustment Amounts to Medicare Part B Premiums Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medicare Advantage Chronic Care Improvement Program and Quality Improvement Project Reporting Tools Requirements for Fee Disclosure to Plan Fiduciaries and Participants; Applicability Dates

Final Rule

July 1, 2011

SSA

§ 1852e(1), (2), (3)(a)(i) SSA

Notice

July 08, 2011 76 Fed. Reg. 131, 40370

September 6, 2011

CMS

§ 408(b)(2) ERISA

Final Rule

July 19, 2011 76 Fed. Reg. 138, 42539

The amendments made by this document are effective as of July 15, 2011 and the effective date for the interim final fiduciary-level fee disclosure rule published on July 16, 2010 (75 FR 41600) is delayed from July 16, 2011 to April 1, 2012. Sept. 2, 2011 Aug. 1, 2011 to July 31, 2014

EBSA

Medicare Program: Evaluation Criteria and Standards for Quality Improvement Program Contracts (10th Statement of

§ 1153(h)(2) SSA

Notice

Aug. 3, 2011 76 Fed. Reg. 149, 46814

CMS

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Work) Medicare Program: Evaluation Criteria and Standards for Quality Improvement Program Contracts (10th Statement of Work) Pilot Program for Parallel Review of Medical Products Medicare Program: Changes to the Ambulatory Surgical Centers Patient Rights Conditions for Coverage Medicare and Medicaid Programs: Reform of Hospital and Critical Access Hospital Conditions of Participation Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Draft Guidance for Industry on Notification to Food and Drug

§1153(h)(2) SSA

Aug 3, 2011 76 Fed. Reg. 149, 46814

September 2, 2011

August 1, 2011 to July 31, 2014

CMS

75 FR 57045

Notice

Executive Order 13563

Final Rule

Oct. 11, 2011 76 Fed. Reg. 196, 62808 Oct. 24, 2011 76 Fed. Reg. 205, 65886 Oct. 24, 2011 76 Fed. Reg. 205, Oct. 24, 2011 76 Fed. Reg. 205, Dec. 23

Nov. 10, 2011

FDA, CMS

Dec. 23, 2011

CMS CMS

Executive Order 13563

Proposed Rule

Dec. 23

CMS

Executive Order 13563

Proposed Rule

Notice Federal Food, Drug, and Cosmetic Act (FD Act)

Feb. 22, 2012 77 Fed. Reg. 10536 Feb. 27, 2012 77 Fed. Reg. 11550

April 23, 2012 Submit comments on the draft

FDA FDA

Notice

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Affordable Care Act (“ACA”) Implementation & Other Health Care Regulatory Action
As of May 3, 2013
BINDER 3continued to Binder 4 TAB # ACA SECTION(S) FED. REG. IMPLEMENTED (PHS REGULATION PUBLICATION ACT SECTION TYPE OR DATE, VOLUME, AMENDED) OR OTHER ACTION PAGE RELATED STATUTE Non-PPACA-Related Regulatory Implementation EFFECTIVE DATE OF REGULATION

TOPIC OF REGULATION

COMMENT DUE DATE

AGENCY

Administration of Issues That May Result in a Prescription Drug Shortage; Availability

guidance by May 29, 2012. Submit comments on the proposed collection of information by April 27, 2012.

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