News & Analysis as of

Department of Health and Human Services (HHS) Federal Register

Quarles & Brady LLP

Never Say Never Again: HHS Signals the Return of HIPAA Audit Program

Quarles & Brady LLP on

On February 12, 2024, the U.S. Department of Health and Human Services (“HHS”) published a notice in the Federal Register regarding reinstatement of the Health Information Portability and Accountability Act of 1996 (“HIPAA”)...more

Jones Day

HHS-OIG Issues Long-Anticipated General Compliance Program Guidance for All Health Care Stakeholders

Jones Day on

In Short - The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more

Jackson Lewis P.C.

U.S. Department of Transportation Allows Oral Fluid Drug Testing

Jackson Lewis P.C. on

The U.S. Department of Transportation (DOT) published new regulations in the Federal Register on May 2, 2023 that will allow covered employers to use oral fluid testing for drugs. While the new rules technically become...more

ArentFox Schiff

New Law Eases Federal Restrictions on Medical Marijuana Research and Cultivation

ArentFox Schiff on

The Medical Marijuana and Cannabidiol Research Expansion Act (MMCREA) became law last Friday. The bipartisan legislation will roll back federal restrictions on medical marijuana research and the cultivation of research-grade...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 31, Number 43. Proposed Part 2 Rule Brings It Closer to HIPAA, Including Enforcement,...

A proposed HHS regulation on the Confidentiality of Substance Use Disorder (SUD) Patient Records under 42 C.F.R. Part 2 would bring it further in line with HIPAA, which is somewhat of a double-edged sword, attorneys say....more

Stevens & Lee

HHS Proposes Updates to “Part 2” Regulations on Substance Abuse Record Confidentiality

Stevens & Lee on

On Nov. 28, 2022, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) and the Office for Civil Rights (“OCR”), both agencies within the U.S. Department of Health and Human Services (“HHS”), provided...more

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

Bass, Berry & Sims PLC on

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

King & Spalding

Departments Issue Final No Surprises Act Dispute Resolution Rule and Other Guidance

King & Spalding on

On August 19, 2022, the Departments of Health and Human Services, Labor, and the Treasury (the Departments) issued a long-awaited final rule (the Final Rule) on the Independent Dispute Resolution (IDR) Process under the No...more

King & Spalding

HHS Withdraws Two Trump Administration Rules Limiting the Agency’s Use of Guidance Documents in Civil Enforcement Actions

King & Spalding on

On Friday, July 22, 2022, HHS issued a final rule (Final Rule), rescinding two regulations issued at the end of the Trump Administration on December 7, 2020, and January 14, 2021, that would have significantly altered the...more

Husch Blackwell LLP

Employment Considerations for Long Term Care Facilities under the Biden-Harris Administration

Husch Blackwell LLP on

In direct response to the significant challenges experienced by long term care (LTC) facilities throughout the COVID-19 pandemic, the Biden-Harris Administration announced its commitment to improving safety and quality of...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

McGlinchey Stafford

Employer Primer on COVID-19 Vaccination Policies

McGlinchey Stafford on

The Supreme Court is currently considering the validity of two rules promulgated by federal agencies in the past months regarding vaccines and testing in the workplace. Whether those rules—OSHA’s Emergency Temporary Standard...more

Sheppard Mullin Richter & Hampton LLP

Back to the Future: 2023 Payment Rule Would Revert Nondiscrimination and Guaranteed Availability Provisions to Pre-Trump Forms,...

Today HHS published the Notice of Benefit and Payment Parameters for 2023 proposed rule in the Federal Register. The annual rulemaking details changes to qualified health plans (“QHPs”), QHP issuers, and the ACA’s exchanges...more

King & Spalding

HHS Proposes Repeal of Two Trump Administration Rules on Guidance, Enforcement, and Adjudication Procedures

King & Spalding on

On October 20, 2021, HHS published in the Federal Register a proposal to repeal two final rules issued during the Trump administration. The final rules up for repeal are the “Department of Health and Human Services Good...more

Cozen O'Connor

HHS, Treasury And Labor Release First Set Of Surprise Billing Rules

Cozen O'Connor on

The United States Departments of Health and Human Services, Treasury and Labor released interim final rules (“Rules”) regarding the “No Surprises Act” (“Act”) yesterday. The Rules are effective beginning on January 1, 2022....more

King & Spalding

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

King & Spalding on

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...more

Husch Blackwell LLP

Health And Human Services Extends Comment Deadline For Proposed Rule On HIPAA Privacy To May 6, 2021

Husch Blackwell LLP on

You may recall on December 10, 2020 we wrote about the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announcement of a proposed rule that would revise the Health Insurance Portability and...more

Husch Blackwell LLP

Holiday Confusion For The Over-The-Counter Drug Industry: FDA Announces OTC Fee Schedule That HHS Quickly Withdraws

Husch Blackwell LLP on

On December 29, 2020, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice the 2021 fee schedule for its Over-the-Counter Monograph Drug User Fee Program. That user fee program was an addition...more

Arnall Golden Gregory LLP

What's Old is Not New Again . . . HHS Rescinds FDA's Unapproved Drug Initiative Program

On November 20, 2020, the United States Department of Health and Human Services (HHS) issued a Federal Register notice to: (1) withdraw the Food and Drug Administration’s (FDA) Compliance Policy Guide (CPG) Sec. 440.100...more

King & Spalding

Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements

King & Spalding on

Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more

McDermott Will & Emery

OIG Penalties Expand to Grant and Contract Fraud

McDermott Will & Emery on

On April 21, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a proposed rule that would amend its civil money penalty (CMP) regulations to address a 21st Century Cures Act...more

Vedder Price

HIPAA Civil Penalty Annual Limits Plummet

Vedder Price on

Recognizing that different levels of culpability warrant different annual civil penalty limits, the Department of Health and Human Services adopted a notification April 23, 2019, to be published in the Federal Register April...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

Baker Donelson

New Horizons Calling for Action Under Home Health Agency Final Rule

Baker Donelson on

On November 13, 2018, CMS/HHS published in the Federal Register the Home Health Final Rule. 83 FR 56406 (Nov. 13, 2018). We provided an overview of the proposed rule in Payment Matters on September 14, 2018. Home health...more

Robinson+Cole Data Privacy + Security Insider

New HHS Secretary Delays Effective Date of Part 2 Final Rule

We previously reported that the 30 year old regulations (last updated in 1987) relating to the disclosure of substance abuse treatment information has been updated by SAMHSA to bring it into the modern world of electronic...more

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