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Final Rules Disclosure Requirements Department of Health and Human Services (HHS)

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

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On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more

McDermott+

Breaking Down the New No Surprises Act FAQs Post-TMA III

McDermott+ on

On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...more

Harris Beach Murtha PLLC

"No Surprises Act" Ruling Favors Regulators, Insurers

Federal regulators recently won a large legal victory when the Fifth Circuit Court of Appeals upheld several provisions of the rule regulating Qualified Payment Amount (“QPA”) calculations under the No Surprises Act (the...more

Holland & Hart - The Benefits Dial

P-R-I-V-A-C-Y is Priceless to Me: The 2024 Privacy Rule

The Department of Health and Human Services issued a final rule amending the HIPAA privacy rules (“2024 Privacy Rule”). The 2024 Privacy Rule limits the use or disclosure of an individual’s PHI in connection with reproductive...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

Foley & Lardner LLP

HIPAA and Part 2 Harmonized: What Health Care Organizations Need to Know

Foley & Lardner LLP on

Substance Use Disorder (SUD) programs and HIPAA-regulated entities seeking to streamline their privacy and security practices and workflows received welcome news from the U.S. Department of Health & Human Services (HHS) last...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | November 2023 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...more

Quarles & Brady LLP

Key Considerations for Healthcare Providers Responding to Law Enforcement Requests

Quarles & Brady LLP on

Why is everyone talking about provider disclosures to law enforcement of late? The Senate Finance Committee authored a letter to Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS), outlining...more

Davis Wright Tremaine LLP

Ownership Transparency: The New Normal in Healthcare?

On November 17, 2023, the U.S. Department of Health and Human Services ("HHS") Centers for Medicare and Medicaid Services ("CMS") published a final rule (the "Final Rule") requiring Medicare skilled nursing facilities...more

McDermott Will & Emery

Private Equity and REITs, Take Note! CMS Finalizes Nursing Facility Ownership Disclosure Requirements

McDermott Will & Emery on

On November 17, 2023, the US Department of Health and Human Services (HHS) published a final rule requiring nursing facilities participating in Medicaid and skilled nursing facilities participating in Medicare to disclose...more

Dechert LLP

Dechert Cyber Bits - Issues 38

Dechert LLP on

SEC Finalizes Cybersecurity Disclosure Rules for Public Companies - On July 26, 2023, the Securities and Exchange Commission (“SEC”) voted to adopt new rules requiring public companies to make certain disclosures...more

Sheppard Mullin Richter & Hampton LLP

Final Rule Changes No Surprises Act Requirements

On Friday, August 26, 2022, the Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”), the Department of Labor’s Employee Benefits Security Administration and the Department of Treasury’s...more

Williams Mullen

Health Plan Transparency Requirements are Effective Now

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The Consolidated Appropriations Act, 2021 (“CAA” or the “Act”) includes several transparency requirements for health plans. Some of these requirements are already in effect for plan years beginning on or after January 1,...more

Bradley Arant Boult Cummings LLP

July 1 Deadline for Health Plan Website Disclosures

The Departments of Labor, Health and Human Services and the Treasury recently issued FAQs About Affordable Care Act Implementation Part 53 (FAQ), which provides additional guidance for non-grandfathered group health plans and...more

Verrill

You Are Here: A Mall Directory for Healthcare Transparency Requirements

Verrill on

The old adage “you can’t get where you’re going unless you know where you are” has never seemed more true than when applied to the current mélange of healthcare transparency guidance. Fortunately, a fading relic from...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

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

McAfee & Taft

New rule to impose price transparency requirements on group health plans

McAfee & Taft on

Yesterday, the U.S. Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury (the Departments) issued new final regulations that will impose price transparency requirements on...more

Mintz - Health Care Viewpoints

HHS Further Amends 42 CFR Part 2, Easing Some, But Not All, Burdens on Substance Use Disorder Treatment Providers

The U.S. Department of Health and Human Services (HHS) recently released a final rule further amending 42 CFR Part 2 regulations (Part 2) to allow greater sharing of patient records related to substance use disorder (SUD)...more

King & Spalding

HHS Issues Final Rule Requiring Disclosure of Partial Refills of Prescriptions to Help Curb Opioid Abuse

King & Spalding on

On January 23, 2020, HHS issued its final rule adopting a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D.0, National Council for Prescription Drug Programs...more

Ballard Spahr LLP

Health Care and Price Transparency: The Latest Summary

Ballard Spahr LLP on

Federal executive agencies recently published two rules, one final and one proposed, aimed at publicizing the various costs associated with health care. A final rule, promulgated by the Department of Health and Human Services...more

Bass, Berry & Sims PLC

Trump Administration Proposes Transparency Rule for Group Health Plans and Insurers

Bass, Berry & Sims PLC on

On November 15, 2019, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the Departments), unveiled a proposed rule (scheduled to be published on November...more

Proskauer - Employee Benefits & Executive...

Digging into the New HRA Regulations, Part 2 – ERISA Implications

New regulations issued by the Departments of Labor, Treasury, and Health and Human Services have expanded the use of health reimbursement accounts (“HRAs”) by allowing reimbursements for individual market insurance premiums....more

Mintz - Health Care Viewpoints

Pharmaceutical Companies Object to HHS Drug Pricing Disclosure Rule

Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule from...more

King & Spalding

CMS Issues Final Rule Requiring the Disclosure of Drug List Prices in Direct-to-Consumer Television Ads

King & Spalding on

The Final Rule Requires Manufacturers to Disclose List Prices of Prescription Drugs and Biological Products in Television Advertisements - On May 8, 2019, the U.S. Department of Health and Human Services (HHS or the...more

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