News & Analysis as of

Final Rules Enforcement Department of Health and Human Services (HHS)

ArentFox Schiff

HIPAA Reproductive Privacy Rule Takes Effect Amid Legal and Political Uncertainties

ArentFox Schiff on

As of December 23, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) must comply with new reproductive health care privacy...more

BakerHostetler

Healthcare Providers Beware: Finalized Disincentives Sharpen the Teeth of Information Blocking Rule

BakerHostetler on

On June 24, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the 21st...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Sheppard Mullin Richter & Hampton LLP

Increased Scrutiny into Agents & Brokers in the Medicare Advantage Space

Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed...more

White & Case LLP

United States Expands and Strengthens Enforcement of Antidumping and Countervailing Duty Laws

White & Case LLP on

On March 25, 2024, the US Department of Commerce (“DOC”) published a final rule revising substantive and procedural aspects of antidumping duty (“ADD”) and countervailing duty (“CVD”) investigations. The changes enter into...more

King & Spalding

Congressmembers Send Letter to Departments Raising Provider Concerns with No Surprises Act Implementation

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On March 18, 2024, thirty-nine (39) members of the United States House of Representatives sent a letter urging federal agencies to finalizing rulemaking regarding the implementation of the No Surprises Act. The letter,...more

Holland & Knight LLP

HHS Publishes Final Rule Governing Healthcare Conscience Protections

Holland & Knight LLP on

On Jan. 11, 2024, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) published its 2024 Final Rule governing healthcare conscience protections, "Safeguarding the Rights of Conscience as...more

Davis Wright Tremaine LLP

Old Rule, New Tricks: HHS Finalizes Most Substantial Changes to Substance Use Disorder Confidentiality Rule in Decades

The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more

King & Spalding

HHS Issues New Nondiscrimination Final Rule to Protect Conscience Rights

King & Spalding on

n January 9, 2024, the HHS Office for Civil Rights (OCR) announced a final rule, entitled “Safeguarding the Rights of Conscience as Protected by Federal Statutes” (the 2024 Final Rule). The 2024 Final Rule clarifies the...more

Health Care Compliance Association (HCCA)

Final Rule Increases Fines for Grant Fraud, Codifies OIG Authority to Sanction Awardees

Report on Research Compliance Volume 20, no 8 (August 2023) With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more

Davis Wright Tremaine LLP

Information Blocking Enforcement Is Here – Are You Ready?

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced its final rule (the Enforcement Rule) implementing the information blocking penalties created by the 21st Century Cures Act...more

Mintz - Health Care Viewpoints

OIG, HHS Publish Information Blocking CMP Final Rule, Enforcement Priorities

Though there has been much speculation and commentary among industry stakeholders, the Office of Inspector General (OIG) and the Office of the National Coordinator for Health Information Technology (ONC) have not yet begun...more

BakerHostetler

Steep Penalties for Information Blocking Finalized

BakerHostetler on

On June 27th, Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) posted its final rule (Final Rule), which amends the OIG’s civil monetary penalty (CMP) regulations to implement the...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 23, Number 2. ONC’s Tripathi: HIPAA Doesn’t Impede Sharing, Requirements Under Info Blocking...

Report on Patient Privacy Volume 23, no 2 (February 2023) When Micky Tripathi’s mom was recently transferred to a rehab facility to recover from a broken hip, the hospital, “right in front of me…printed off her record,...more

McDermott Will & Emery

HHS Issues Proposed Rule Under Section 1557 of the Affordable Care Act: Nondiscrimination in Health Programs and Activities

On August 4, 2022, the US Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM or proposed rule) to reinterpret section 1557 of the Affordable Care Act (ACA), which prohibits...more

Mintz - Health Care Viewpoints

ONC Publishes Report, Commentary on Information Blocking Rule Claims Trends

The Office of the National Coordinator for Health Information Technology (ONC) published noteworthy information blocking claim submission trends to date in its recent Information Blocking Claims: By the Numbers post on the...more

King & Spalding

OIG Publishes New Procedural Process for Advisory Opinions

King & Spalding on

On January 6, 2022, OIG issued a final rule (Final Rule) that will update the process and procedures that govern advisory opinions in early 2022. The Final Rule will be effective 30 days after its publication in the Federal...more

Goodwin

HHS, Labor, and Treasury Departments Defer Enforcement of Transparency in Coverage and No Surprises Act Requirements

Goodwin on

The No Surprises Act and Transparency in Coverage final rules go into effect January 1, 2022. Implemented as Titles I and II of Division BB of the Consolidated Appropriations Act, these rules are intended to protect patients...more

King & Spalding

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

King & Spalding on

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

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