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Regulatory tracking

Aimed primarily at decreasing the number of uninsured Americans and reducing the overall costs of health care, the Affordable Care Act represents the most significant government expansion and regulatory overhaul of the U.S. health care system since the passage of Medicare and Medicaid in 1965. A change this significant cannot be executed in 906 pages. That’s why, since the passage of the law in March 2010, tens of thousands of pages of ACA-related rules have been published in the Federal Register.

Don’t have time to read through all those rules? Find summaries below.

If you're looking for regulations related to specific topics, enter keywords into the search box to narrow down the options.

Insurance reforms and exchanges

Proposed Rule: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2015

(Comments Due 12/26/13)

This proposed rule sets forth payment parameters and oversight provisions related to the risk adjustment, reinsurance and risk corridors programs; cost-sharing parameters and cost-sharing reductions; and user fees for Federally Facilitated Exchanges (FFEs).

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Final Rule: Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act

(Effective 1/13/14 with Exceptions)

This document contains final rules implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, which requires parity between mental health or substance use disorder benefits and medical/surgical benefits with respect to financial requirements and treatment limitations under group health plans and group and individual health insurance coverage.

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Final Rule: Program Integrity – Exchange, Premium Stabilization Programs and Market Standards

(Effective 12/30/13)

This final rule outlines financial integrity and oversight standards with respect to Affordable Insurance Exchanges, qualified health plan (QHP) issuers in Federally Facilitated Exchanges (FFEs), and States with regard to the operation of risk adjustment and reinsurance programs.

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Proposed Rule: Program Integrity – Exchange, SHOP, Premium Stabilization Programs

(Comments Due 7/19/2013)

This proposed rule sets forth financial integrity and oversight standards with respect to Affordable Insurance Exchanges; qualified health plan (QHP) issuers in Federally Facilitated Exchanges (FFEs); and States with regard to the operation of risk adjustment and reinsurance programs. It also proposes additional standards with respect to agents and brokers.

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Final Rule: Shared Responsibility for Not Maintaining Minimum Essential Coverage

(Effective 8/30/2013)

This document contains final regulations on the requirement to maintain minimum essential coverage enacted by the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, as amended by the TRICARE Affirmation Act and Public Law 111-173.

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Final Rule: Coverage of Certain Preventive Services under the ACA

(Effective 8/30/2013)

This document contains final regulations on the requirement to maintain minimum essential coverage enacted by the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, as amended by the TRICARE Affirmation Act and Public Law 111-173.

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Proposed Rule: Information Reporting for Affordable Insurance Exchanges

(Comments Due 9/3/2013)

This document contains proposed regulations relating to requirements for Affordable Insurance Exchanges (Exchanges) to report information relating to the health insurance premium tax credit enacted by the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010.

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Final Rule: Patient Protection and Affordable Care Act: Miscellaneous Minimum Essential Coverage Provisions

(Effective 8/26/13)

This final rule implements certain functions of the Affordable Insurance Exchanges (Exchanges). These specific statutory functions include determining eligibility for and granting certificates of exemption from the individual shared responsibility payment described in section 5000A of the Internal Revenue Code.

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Final Rule: Establishment of Exchanges and Qualified Health Plans; Small Business Health Options Program

(Effective 7/1/2013)

This final rule amends existing regulations regarding triggering events and special enrollment periods for qualified employees and their dependents and implements a transitional policy regarding employees’ choice of qualified health plans (QHPs) in the SHOP.

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Interim Final Rule with Comment Period: Pre-Existing Condition Insurance Plan Program

(Comments Due 7/22/13)

This interim final rule with comment period sets the payment rates for covered services furnished to individuals enrolled in the Pre-Existing Condition Insurance Plan (PCIP) program administered directly by HHS beginning with covered services furnished on June 15, 2013. This interim final rule also prohibits facilities and providers who, with respect to dates of service beginning on June 15, 2013, accept payment for most covered services furnished to an enrollee in the federally administered PCIP from charging the enrollee an amount greater than the enrollee’s out-of-pocket cost for the covered service as calculated by the plan.

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Proposed Rule: Minimum Value of Eligible Employer-Sponsored Plans and Other Rules Regarding the Health Insurance Premium Tax Credit

(Comments Due 7/2/13)

These proposed regulations affect individuals who enroll in qualified health plans (QHPs) through Affordable Insurance Exchanges (Exchanges) and claim the premium tax credit, and exchanges that make QHPs available to individuals and employers. These proposed regulations also provide guidance on determining whether health coverage under an eligible employer-sponsored plan provides minimum value and affect employers that offer health coverage and their employees.

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Proposed Rule: Standards for Navigators and Non-Navigator Assistance Personnel

(Comments Due 5/6/13)

This proposed rule would create conflict-of-interest, training and certification, and meaningful access standards applicable to Navigators and non-Navigator assistance personnel in Federally Facilitated Exchanges (FFEs), including State Partnership Exchanges, and to non-Navigator assistance personnel in State-based Exchanges that are funded through federal Exchange Establishment grants.

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Final Rule: Establishment of the Multi-State Plan Program for the Affordable Insurance Exchanges

(Effective 5/10/13)

The Office of Personnel Management (OPM) is issuing a final rule establishing the Multi-State Plan Program (MSPP). The purpose of this regulation is to outline the process by which OPM will establish and administer the MSPP, as well as to establish standards and requirements for MSPs and MSPP issuers.

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Proposed Rule: Ninety-Day Waiting Period Limitation and Technical Amendments to Certain Health Coverage Requirements under the Affordable Care Act

(Comments Due 5/20/13)

These proposed rules implement the 90-day waiting period limitation under section 2708 of the Public Health Service Act, which states that a group health plan shall not apply any waiting period that exceeds 90 days. The accompanying proposed conforming amendments make changes to existing requirements such as preexisting condition limitations and other portability provisions added by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) because they have become moot or need amendment due to new market reform protections under the Affordable Care Act.

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Proposed Rule: Establishment of Exchanges and Qualified Health Plans; Small Business Health Options Program

(Comments Due 4/1/13)

This proposed rule would amend existing regulations regarding triggering events and special enrollment periods for qualified employees and their dependents and would implement a transitional policy regarding employees’ choice of qualified health plans (QHPs) in the Small Business Health Options Program (SHOP).

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Final Rule: Benefit and Payment Parameters for 2014

(Effective 4/30/13)

This final rule provides further detail and parameters related to: the risk adjustment, reinsurance and risk corridors programs; cost-sharing reductions; user fees for a Federally Facilitated Exchange (FFE); advance payments of the premium tax credit; a Federally Facilitated Small Business Health Option Program; and the medical loss ratio program.

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Final Rule: Health Insurance Market Rules; Rate Review

(Effective 4/29/13)

This final rule implements the Affordable Care Act’s policies related to fair health insurance premiums, guaranteed availability, guaranteed renewability, risk pools and catastrophic plans.

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Final Rule: Essential Health Benefits

(Effective 4/26/13)

This rule outlines exchange and issuer standards related to coverage of essential health benefits and actuarial value.

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Proposed Rule: Coverage of Certain Preventive Services Under the Affordable Care Act

(Comments Due 4/8/13)

These proposed rules would amend the authorization to exempt group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) with respect to the requirement to cover contraceptive services.

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Proposed Rule: Shared Responsibility Payment for Not Maintaining Minimum Essential Coverage

(Comments Due 5/2/13)

These proposed regulations provide guidance on the liability for the shared responsibility payment for not maintaining minimum essential coverage.

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Proposed Rule: Exchange Functions – Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions

(Comments Due 3/18/13)

This proposed rule would implement certain functions of the Affordable Insurance Exchanges. These specific statutory functions include determining eligibility for and granting certificates of exemption from the shared responsibility payment for not maintaining minimum essential coverage as described in section 5000A of the Internal Revenue Code.

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Proposed Rule: Shared Responsibility for Employers Regarding Health Coverage

(Comments Due 3/18/13)

This document contains proposed regulations providing guidance under section 4980H of the Internal Revenue Code with respect to the shared responsibility for employers regarding employee health coverage.

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Public coverage programs

Final Rule: 2014 Medicare Hospital OPPS and ASC

(Effective 1/1/14 with Exceptions)

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2014 to implement applicable statutory requirements and changes arising from our continuing experience with these systems.

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Final Rule: 2014 Physician Fee Schedule

(Effective 1/1/14 with Exceptions)

This major final rule with comment period addresses changes to the physician fee schedule, clinical laboratory fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services.

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Proposed Rule: FY 2014 IPPS – Changes to Certain Cost Reporting Procedures (DSH)

(Comments Due 11/29/2013)

In the fiscal year (FY) 2014 inpatient prospective payment systems (IPPS)/long-term care hospital (LTCH) PPS final rule, CMS established the methodology for determining the amount of uncompensated care payments made to hospitals eligible for the disproportionate share hospital (DSH) payment adjustment in FY 2014 and a process for making interim and final payments.

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Final Rule with comments: OPPS and ASC Payment Changes FY14

(Effective 1/1/14 with Exceptions) (Comments Due 1/27/14)

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2014 to implement applicable statutory requirements and changes arising from our continuing experience with these systems.

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Final Rule: Medicaid, CHIP, Health Insurance Marketplace

(Effective 10/1/2013 and 1/1/2014)

This final rule finalizes new Medicaid eligibility provisions; finalizes changes related to electronic Medicaid and the Children’s Health Insurance Program (CHIP) eligibility notices and delegation of appeals; revises CHIP rules relating to the substitution of coverage to improve the coordination of CHIP coverage with other coverage; and amends requirements for benchmark and benchmark-equivalent benefit packages.

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Final Rule: MLR Requirements for MA and Medicare Prescription Drug Program

(Effective 7/22/13)

This final rule implements new medical loss ratio (MLR) requirements for the Medicare Advantage Program and the Medicare Prescription Drug Benefit Program established under the Patient Protection and Affordable Care Act.

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Proposed Rule: IPPS FY 2014 Rates

(Comments Due 6/25/13)

This proposed rule would make payment and policy changes under the Medicare inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals as well as for certain hospitals and hospital units excluded from the IPPS.

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Final Rule with request for comments: Increased Federal Medical Assistance Percentage Changes under the Affordable Care Act of 2010

(Comments Due 6/3/13) (Effective 6/3/13)

This final rule concerns the technical aspects of applying the appropriate FMAP to the expenditures of individuals in the new adult group who are either newly eligible or, if not, meet the criteria for the increased expansion state FMAP.

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Proposed Rule: Medicare Program; Part B Inpatient Billing in Hospitals

(Comments Due 5/17/13)

This proposed rule would revise Medicare Part B billing policies when a Part A claim for a hospital inpatient admission is denied as not medically reasonable and necessary. When Part A payment cannot be made for a hospital inpatient claim because the inpatient admission is determined not reasonable and necessary, CMS proposes that Medicare should pay for all the Part B services (except for services that specifically require an outpatient status) that would have been reasonable and necessary had the beneficiary been treated as a hospital outpatient rather than admitted as an inpatient.

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Ruling: Medicare Hospital Insurance (Part A) and Medicare Supplementary Medical Insurance (Part B)

(Effective 3/13/13)

This notice announces a CMS Ruling that establishes a policy that revises the current policy on Part B billing following the denial of a Part A inpatient hospital claim by a Medicare review contractor on the basis that the inpatient admission was determined not reasonable and necessary. This revised policy is intended as an interim measure until CMS can finalize a policy to address the issues raised by the Administrative Law Judge and Medicare Appeals Council decisions going forward.

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Proposed Rule: Medicaid, Children’s Health Insurance Programs and Exchanges

(Comments Due 2/13/13)

This rule reflects new statutory eligibility provisions, proposes changes to provide states more flexibility to coordinate Medicaid and CHIP eligibility notices, appeals and other related administrative procedures with similar procedures used by other health coverage programs authorized under the Affordable Care Act.

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Proposed Rule: Regulatory Provisions to Promote Program Efficiency, Transparency and Burden Reduction

(Comments Due 4/8/13)

This proposed rule would reform Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

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Delivery system reform

Proposed Rule: Community Health Needs Assessments for Charitable Hospitals

(Comments Due 7/5/13)

This document contains proposed regulations that provide guidance to charitable hospital organizations on the community health needs assessment (CHNA) requirements and related excise tax and reporting obligations. These proposed regulations also clarify the consequences for failing to meet these and other requirements for charitable hospital organizations. These regulations will affect charitable hospital organizations.

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Provider and plan payment changes

Proposed Rule: State Medicaid DSH Allotment Reductions

(Comments Due 7/12/13)

The statute, as amended by the Affordable Care Act, requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually from fiscal year (FY) 2014 through FY 2020.

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Final Rule: 2013 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Centers (ASC)

(Effective 1/1/13)

Describes the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system.

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Final Rule: Increased Medicaid Payment for Primary Care

(Effective 1/1/13)

Under this provision, certain physicians (and other qualified practitioners) who provide eligible primary care services will be paid the Medicare rates in effect in calendar years (CY) 2013 and 2014 instead of their usual state-established Medicaid rates, which may be lower than federally established Medicare rates.

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Final Rule: CY2013 Physician Fee Schedule

(Effective 1/1/13)

This major final rule with comment period addresses changes to the physician fee schedule, payments for Part B drugs and other Medicare Part B payment policies to ensure that CMS payment systems are updated to reflect changes in medical practice and the relative value of services.

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Financing of health reform

Proposed Rule: Health Insurance Providers Fee

(Comments Due 6/3/13)

This document contains proposed regulations that provide guidance on the annual fee imposed on covered entities engaged in the business of providing health insurance for U.S. health risks. This fee is imposed by section 9010 of the Patient Protection and Affordable Care Act, as amended. The regulations affect persons engaged in the business of providing health insurance for U.S. health risks.

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Final Rule: Health Insurance Premium Tax Credit

(Effective 2/1/13)

These final regulations provide guidance to individuals related to employees who may enroll in eligible employer-sponsored coverage and who wish to enroll in qualified health plans (QHPs) through Affordable Insurance Exchanges and claim the premium tax credit.

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Proposed Rule: Rules Relating to Additional Medicare Tax

(Comments Due 3/5/13)

This document contains proposed regulations relating to Additional Hospital Insurance Tax on income above threshold amounts, as added by the Affordable Care Act.

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Compliance and transparency

Final Rule: Physicians’ Referrals to Health Care Entities … EHR Exception

(Effective 3/27/2014 w/exceptions)

This final rule revises the exception to the physician self-referral law that permits certain arrangements involving the donation of electronic health records items and services.

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Proposed Rule: HIPAA Privacy Rule and the NICS

(Comments Due 6/7/13)

Among the persons disqualified from possessing or receiving firearms under Federal law are individuals who have been involuntarily committed to a mental institution; found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been determined, through a formal adjudication process, to have a severe mental condition that results in the individuals presenting a danger to themselves or others or being incapable of managing their own affairs.

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Proposed Rule: Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships; Exception for Certain Electronic Health Records

(Comments Due 6/10/13)

This proposed rule would revise the exception to the physician self-referral prohibition for certain arrangements involving the donation of electronic health records items and services. Specifically, it would extend the sunset date of the exception, remove the electronic prescribing capability requirement and update the provision under which electronic health records technology is deemed interoperable.

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Final Rule: Transparency Reports and Reporting of Physician Ownership or Investment Interests

(Effective 4/9/13)

This final rule will require applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals.

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Final Rule: Modifications to the HIPAA Privacy, Security, Enforcement and Breach Notification Rules

(Effective 3/26/13)

This final rule strengthens the privacy and security protections established under the Health Insurance Portability and Accountability of 1996 Act (HIPAA) for individual’s health information maintained in electronic health records and other formats.

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Health information technology

Interim final rule with comment period: Health Information Technology: Revisions to the 2014 Edition Electronic Health Record Certification Criteria

(Effective 1/7/13)

This interim final rule with comment period replaces the Data Element Catalog (DEC) standard and the Quality Reporting Document Architecture (QRDA) Category III standard adopted in the final rule published on Sept. 4, 2012, in the Federal Register with updated versions of those standards.

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Other

Proposed Rule: Emergency Preparedness Requirements for Medicare and Medicaid Providers

(Comments Due 2/25/14)

This proposed rule would establish national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they adequately plan for both natural and man-made disasters, and coordinate with federal, state, tribal, regional and local emergency preparedness systems.

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Final Rule: Employer-based Wellness Programs

(Effective 8/2/13)

This document contains final regulations, consistent with the Affordable Care Act, regarding nondiscriminatory wellness programs in group health coverage.

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Proposed Rule: Incentive for Nondiscriminatory Wellness Programs in Group Health Plans

(Comments Due 1/25/13)

These proposed regulations would increase the maximum permissible reward under a health-contingent wellness program offered in connection with a group health plan (and any related health insurance coverage) from 20 percent to 30 percent of the cost of coverage.

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