News & Analysis as of

Proposed Regulation Department of Health and Human Services (HHS) Regulatory Agenda

Bradley Arant Boult Cummings LLP

Top 10 takeaways from the new HIPAA security rule NPRM

On Jan. 6, 2025, the U.S. Department of Health and Human Services (HHS) proposed new regulations to enhance cybersecurity protections for electronic protected health information (ePHI) under the Health Insurance Portability...more

McDermott+

Regs Coming Through the End of the Year: Expect the Expected and the Unexpected

McDermott+ on

There could be an all-you-can-eat buffet of regs (and eggs) from now until the end of the year! As you may recall, a July 2024 Regs & Eggs blog post highlighted the spring 2024 “unified agenda” that listed all the regs...more

McDermott+

Reviews Are Mixed for Proposed Obstetrical Services CoP: Right Problem, Flawed Solution

McDermott+ on

As I mentioned last week, comments are in on major calendar year (CY) Medicare payment regulations. Besides the CY 2025 physician fee schedule, another big reg is the CY 2025 Outpatient Prospective Payment System (OPPS)...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

McDermott Will & Emery

Anticipating the MHPAEA Final Regulations: A Word About Network Composition

If our trade and industry sources have it right, we could see final regulations implementing the Mental Health Parity and Addiction Equity Act (MHPAEA), as most recently amended by the Consolidated Appropriations Act, 2021...more

McDermott+

Regs, Regs and More Regs: The Biden Administration Releases Spring 2024 Unified Agenda

McDermott+ on

We are in the midst of a storm of regulations that are being released by the Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services (HHS), including the Calendar Year (CY) 2025...more

McDermott Will & Emery

2024 Chart of Additional Healthcare Regulations

McDermott Will & Emery on

During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more

McDermott Will & Emery

Imported Drugs: (Possibly) Coming Soon to a State Near You

In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more

McDermott Will & Emery

The MHPAEA Proposed Rule: Scalability and the Plight of the Small(er) Self-Funded Plan

After a brief hiatus to discuss the pleading standards adopted by the US Court of Appeals for the Tenth Circuit in E.W. v. Health Net Life Insurance Company, we return to our examination of the comments submitted in response...more

McDermott+

Looking Forward: Top Policy Areas for 2024

McDermott+ on

Happy New Year! As we enter 2024, we want to lay out some of the main regulatory issues (both new and old) that McDermott+Consulting will be tracking over the next year. While these may evolve, we think they are still...more

McDermott Will & Emery

The Proposed MHPAEA Regulations: A Comment on the Comments

McDermott Will & Emery on

In our last post, we considered some of the comment letters submitted in response to proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) issued by the US Departments of Labor, Health and...more

McDermott+

New No Surprises Act Announcements Indicate Bumpy Road Ahead

McDermott+ on

The bumpy road toward implementing the No Surprises Act took another turn last Friday, October 6, 2023. The US Departments of Health and Human Services (HHS), Labor and the Treasury (collectively, the Departments) provided...more

McDermott Will & Emery

Special Report - HHS Proposes to Update Disability Nondiscrimination Regulations for First Time in Nearly 50 Years

McDermott Will & Emery on

Discrimination on the basis of disability has contributed to significant disparities in healthcare and child welfare. To address these disparities, the US Department of Health and Human Services (HHS) has proposed updated...more

Polsinelli

Unique Opportunity to Influence Anti-Kickback Statute Rules

Polsinelli on

Starting today, the industry has 75 days to provide input on the proposed rules published in the Federal Register regarding the future enforcement of the Anti-Kickback Statute (AKS). ...more

Hogan Lovells

HHS tackles barriers to value-based care: Part two – Substantial Stark Law regulatory revisions proposed

Hogan Lovells on

Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) proposed additional revisions to the Stark Law regulations (the...more

Latham & Watkins LLP

Drug Pricing and Payment Policy: Key 2018 Developments and Potential 2019 Changes and Challenges

Latham & Watkins LLP on

Following a number of drug pricing reforms implemented or proposed in 2018, 2019 likely will bring more action from HHS and Congress to reduce drug prices. Key Points: ..In 2018, the Administration implemented and...more

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