Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards; Updates To State Innovation Waiver (Section 1332 Waiver) Implementing Regulations

by the Treasury Department and the Health and Human Services Department on 12/04/2020.

This proposed 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 includes proposed changes related to special enrollment periods; Navigator program...

Acquisition Regulations; Buy Indian Act; Procedures for Contracting

by the Indian Health Service on 11/10/2020.

The United States Department of Health and Human Services (HHS) is proposing to issue regulations guiding implementation of the Buy Indian Act, which provides IHS with authority to set-aside procurement contracts for Indian-owned and controlled businesses.

Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage

by the Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department on 07/15/2020.

This document is a notice of proposed rulemaking regarding grandfathered group health plans and grandfathered group health insurance coverage that would, if finalized, amend current rules to provide greater flexibility for certain grandfathered health plans to make changes to certain types of cost-sharing requirements without causing a loss of...

Transparency in Coverage

by the Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department on 11/27/2019.

These proposed rules set forth proposed requirements for group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information upon request, to a participant, beneficiary, or enrollee (or his or her authorized representative), including an estimate of such individual's cost- sharing liability...

Request for Information Regarding State Relief and Empowerment Waivers

by the Treasury Department and the Health and Human Services Department on 05/03/2019.

This request for information (RFI) solicits public comment on ideas for innovative programs and waiver concepts that states could consider in developing a 1332 waiver plan. The Department of the Treasury and the Centers for Medicare & Medicaid Services in the Department of Health and Human Services (collectively, the Departments) are seeking...

Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage

by the Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department on 02/25/2019.

This document is a request for information regarding grandfathered group health plans and grandfathered group health insurance coverage. Given the limited information available regarding such coverage, the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the Departments) are issuing this...

Health Reimbursement Arrangements and Other Account-Based Group Health Plans

by the Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department on 10/29/2018.

This document sets forth proposed rules to expand opportunities for working men and women and their families to access affordable, quality healthcare through proposed changes to regulations under various provisions of the Public Health Service Act (PHS Act), the Employee Retirement Income Security Act (ERISA), and the Internal Revenue Code...

Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period

by the Homeland Security Department, the Agriculture Department, the Energy Department, the National Aeronautics and Space Administration, the Commerce Department, the Consumer Product Safety Commission, the Social Security Administration, the Agency for International Development, the Housing and Urban Development Department, the Labor Department, the Defense Department, the Education Department, the Veterans Affairs Department, the Environmental Protection Agency, the Health and Human Services Department, the National Science Foundation, and the Transportation Department on 04/20/2018.

In a final rule published on January 19, 2017, federal departments and agencies made revisions to the Federal Policy for the Protection of Human Subjects (hereafter the ``2018 Requirements''). The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The 2018...

Short-Term, Limited-Duration Insurance

by the Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department on 02/21/2018.

This rule contains proposals amending the definition of short- term, limited-duration insurance for purposes of its exclusion from the definition of individual health insurance coverage. This action is being taken to lengthen the maximum period of short-term, limited- duration insurance, which will provide more affordable consumer choice for...

Compliance With Title X Requirements by Project Recipients in Selecting Subrecipients

by the Health and Human Services Department on 09/07/2016.

This document seeks comment on the proposed amendment of Title X regulations specifying the requirements Title X projects must meet to be eligible for awards. The amendment precludes project recipients from using criteria in their selection of subrecipients that are unrelated to the ability to deliver services to program beneficiaries in an...

World Trade Center Health Program; Petition 013-Autoimmune Disease; Finding of Insufficient Evidence

by the Health and Human Services Department on 09/01/2016.

On April 4, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 013) to add ``relapsing remitting multiple sclerosis (autoimmune)'' to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 013 is...

New Animal Drugs for Use in Animal Feed; Category Definitions

by the Food and Drug Administration on 08/24/2016.

The Food and Drug Administration (FDA, the Agency, we) proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability of medicated feeds...

Good Laboratory Practice for Nonclinical Laboratory Studies

by the Food and Drug Administration on 08/24/2016.

The Food and Drug Administration (FDA) is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products...

Request for Information: Inappropriate Steering of Individuals Eligible for or Receiving Medicare and Medicaid Benefits to Individual Market Plans

by the Centers for Medicare & Medicaid Services on 08/23/2016.

This request for information seeks public comment regarding concerns about health care providers and provider-affiliated organizations steering people eligible for or receiving Medicare and/or Medicaid benefits to an individual market plan for the purpose of obtaining higher payment rates. CMS is concerned about reports of this practice and is...

World Trade Center Health Program; Amendments to Definitions, Appeals, and Other Requirements

by the Health and Human Services Department on 08/17/2016.

In 2011 and 2012, the Secretary, Department of Health and Human Services (HHS), promulgated regulations designed to govern the World Trade Center (WTC) Health Program (Program), including the processes by which eligible responders and survivors may apply for enrollment in the Program, obtain health monitoring and treatment for WTC-related health...

340B Drug Pricing Program; Administrative Dispute Resolution

by the Health and Human Services Department on 08/12/2016.

The Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The proposed rule sets forth...

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Correction

by the Centers for Medicare & Medicaid Services on 08/10/2016.

This document corrects a technical error in the proposed rule that appeared in the July 15, 2016 Federal Register (81 FR 46162-46476) entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D...

Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model

by the Centers for Medicare & Medicaid Services on 08/03/2016.

Health and Human Services Grants Regulation

by the Health and Human Services Department on 07/13/2016.

This notice of proposed rulemaking (NPRM) proposes changes to the Department of Health and Human Services' (HHS) adoption of the Office of Management and Budget's (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (``Uniform Administrative Requirements'') published on December 19, 2014 (79 FR...

Submission of Food and Drug Administration Import Data in the Automated Commercial Environment

by the Food and Drug Administration on 07/01/2016.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the...