Legal Status
Health Care Reform
The Patient Protection and Affordable Care Act (PPACA) was signed into law on March 23, 2010. That law, along with the Health Care and Education Reconciliation Act of 2010 and related measures is being implemented by Federal agencies to reform certain aspects of the private health insurance industry and public health insurance programs, including increasing insurance coverage of pre-existing conditions and expanding access to insurance. The implementing agencies include the various agencies of the Department of Health and Human Services, the Department of Labor, the Internal Revenue Service, and others.
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Confidentiality of Substance Use Disorder Patient Records
The Department of Health and Human Services (HHS) is issuing this final rule to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations and facilitate information exchange within new health care models while addressing the legitimate privacy concerns of patients seeking treatment for a substance use...
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Considerations in Demonstrating Interchangeability With a Reference Product; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations in Demonstrating Interchangeability With a Reference Product.'' This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product (proposed interchangeable product or...
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Department of Labor Federal Civil Penalties Inflation Adjustment Act Annual Adjustments for 2017
The U.S. Department of Labor (Department) is publishing this final rule to adjust for inflation the civil monetary penalties assessed or enforced in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990 as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Inflation...
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Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures
This final rule revises the procedures that the Department of Health and Human Services (HHS) follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and...
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International Entrepreneur Rule
This final rule amends Department of Homeland Security (DHS) regulations to implement the Secretary of Homeland Security's discretionary parole authority in order to increase and enhance entrepreneurship, innovation, and job creation in the United States. The final rule adds new regulatory provisions guiding the use of parole on a case-by-case...
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Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies
This final rule revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care...
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Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities
This final rule amends the regulations relating to exclusion authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS or the Department). The final rule incorporates statutory changes, early reinstatement provisions, and policy changes, and clarifies existing regulatory provisions.
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Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations
This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud,...
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Standards for Accessible Medical Diagnostic Equipment
The Architectural and Transportation Barriers Compliance Board (Access Board or Board) is issuing accessibility standards for medical diagnostic equipment. The standards for medical diagnostic equipment (MDE Standards) contain minimum technical criteria to ensure that medical diagnostic equipment, including but not limited to, examination...
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340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This...
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Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR)
This final rule implements three new Medicare Parts A and B episode payment models, a Cardiac Rehabilitation (CR) Incentive Payment model and modifications to the existing Comprehensive Care for Joint Replacement model under section 1115A of the Social Security Act. Acute care hospitals in certain selected geographic areas will participate in...
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Affirmative Action for Individuals With Disabilities in Federal Employment
The Equal Employment Opportunity Commission (EEOC or Commission) is issuing its final rule to amend the regulations that require federal agencies to engage in affirmative action for individuals with disabilities. These changes clarify the obligations that the Rehabilitation Act of 1973 imposes on federal agencies, as employers, that are over and...
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Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates Under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital; Correction and Extension of Comment Period
This document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 14, 2016, entitled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement...
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Access to Federal Employees Health Benefits (FEHB) for Employees of Certain Indian Tribal Employers
This final rule makes Federal employee health insurance accessible to employees of certain Indian tribal entities. Section 409 of the Indian Health Care Improvement Act (codified at 25 U.S.C. 1647b) authorizes Indian tribes, tribal organizations, and urban Indian organizations that carry out certain programs to purchase coverage, rights, and...
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including...
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Updating the HRSA-Supported Women's Preventive Services Guidelines
Effective December 20, 2016, the Health Resources and Services Administration (HRSA) updated the HRSA-supported Women's Preventive Services Guidelines for purposes of health insurance coverage for preventive services that address health needs specific to women based on clinical recommendations from the Women's Preventive Services Initiative....
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Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2016
Publication of the Unified Agenda of Regulatory and Deregulatory Actions and the Regulatory Plan represent key components of the regulatory planning mechanism prescribed in Executive Order 12866, ``Regulatory Planning and Review'' (58 FR 51735) and incorporated in Executive Order 13563, ``Improving Regulation and Regulatory Review'' issued on...
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Regulatory Agenda
The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
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Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2018; Amendments to Special Enrollment Periods and the Consumer Operated and Oriented Plan Program
This final rule sets forth payment parameters and provisions related to the risk adjustment program; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. It also provides additional guidance relating to standardized options; qualified health...
Showing 1-20 of 2055 results since 1994. View 2035 more results.
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