News & Analysis as of

Department of Health and Human Services (HHS) Comment Period Covered Entities

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

Quarles & Brady LLP on

The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

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On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

Faegre Drinker Biddle & Reath LLP

Proposed HIPAA Security Rule Updates — Implications for Covered Entities and Their Information Security Programs

On January 6, 2025, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking (Proposed Rule) updating the Health Insurance Portability and...more

Fisher Phillips

PEOs Need to Prepare for Increased Cybersecurity Requirements Thanks to Proposed HIPAA Security Rule Revisions

Fisher Phillips on

With the HIPAA Security Rule set to undergo a massive overhaul to boost cybersecurity protections, PEOs need to take note. After all, as stewards of worksite employee and client company data – and as sponsors of group health...more

Fisher Phillips

Proposed Updates to HIPAA Security Rule Would Require Entities to Adopt Enhanced Cybersecurity Measures

Fisher Phillips on

The HIPAA Security Rule may soon undergo a big overhaul that would better defend healthcare data from cybersecurity threats – and require much more from covered entities when it comes to establishing and maintaining defenses....more

Holland & Knight LLP

Big Changes Proposed for the HIPAA Security Rule

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) has issued an unpublished Notice of Proposed Rulemaking (NPRM) that strengthens the Health Insurance Portability and Accountability Act (HIPAA) Security Rule and, if...more

Foley Hoag LLP - Security, Privacy and the...

HHS Office for Civil Rights Proposes Measures to Strengthen Cybersecurity in Health Care Under HIPAA

The Department of Health and Human Services (HHS) has proposed significant modifications to the HIPAA Security Rule and the HITECH Act in an attempt to strengthen cybersecurity protections for electronic protected health...more

Bass, Berry & Sims PLC

Proposed Changes to HIPAA Privacy Rule Strengthening PHI Protections for Reproductive Health Care Information Have Broad...

Bass, Berry & Sims PLC on

On April 13, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a Notice of Proposed Rulemaking (NPRM) to amend the HIPAA Privacy Rule, 45 C.F.R. Part 160 and Part 164, Subparts A...more

Holland & Knight LLP

HHS Proposes HIPAA Changes to Protect Reproductive Health Information

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The U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rule Making (Proposed Rule) on April 12, 2023, proposing amendments to the Health Insurance Portability and...more

McDermott Will & Schulte

HHS Goes Back to the Drawing Board on the 340B ADR Process

Citing “policy and operational challenges” with the current 340B Administrative Dispute Resolution (ADR) Process, the US Department of Health and Human Services (HHS) has issued a new Proposed Rule to modify the current ADR...more

Health Care Compliance Association (HCCA)

Awaiting New Leader, OCR Collects NPRM Feedback, Closes Breach, 14th Access Case

Report on Patient Privacy 21, no. 2 (February 2021) - Unless an extension is granted or the notice of proposed rulemaking (NPRM) is withdrawn, covered entities (CEs) and business associates (BAs) have until late March to...more

Proskauer - Employee Benefits & Executive...

HHS Proposes to Narrow Scope of Nondiscrimination Regulations under Affordable Care Act

The U.S. Department of Health and Human Services (HHS) recently proposed regulations that scale back nondiscrimination protections under Section 1557 of the Affordable Care Act (ACA). The new regulations, proposed on May 24,...more

Harris Beach Murtha PLLC

OCR Issues Anticipated RFI on HIPAA Modifications

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The Request for Information on Modifying HIPAA Rules to Improve Coordinated Care is slated for publication in the federal register tomorrow. The Department of Health and Human Services’ Office for Civil Rights (OCR) issued an...more

Foley & Lardner LLP

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

Foley & Lardner LLP on

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

Balch & Bingham LLP

Nondiscrimination in Health Programs and Activities: Proposed Rules from HHS

Balch & Bingham LLP on

...So, why did HHS need over five years to propose the set of rules published September 8? Here are a few highlights. For brevity’s sake, we omit foreign language service requirements, disability accommodation, compliance...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

King & Spalding on

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

McDermott Will & Emery

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

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