News & Analysis as of

Proposed Regulation Department of Health and Human Services (HHS)

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

Wyrick Robbins Yates & Ponton LLP

Addressable No More: HHS Proposes Significant Changes to HIPAA Security Rule

On December 27, 2024, the Department of Health and Human Services (“HHS”) proposed substantial revisions to the 20-year-old HIPAA Security Rule. Comments on the proposal will be due within sixty days of its publication in the...more

Mintz - Health Care Viewpoints

Telehealth Update: DEA/HHS Temporary Rule, Medicare Coverage of Telehealth Services, Potential for Increased Oversight, and What...

Telehealth companies and other industry stakeholders have had a watchful eye towards the end of 2024 and the impending “telehealth cliff” as COVID-era Drug Enforcement Agency (DEA) flexibilities and Medicare expanded...more

Proskauer Rose LLP

How Expanded Birth Control Coverage May Affect Employers

Proskauer Rose LLP on

The U.S. Departments of Labor, Treasury, and Health and Human Services proposed regulations last month that would expand group health plans' required coverage of preventive services and contraceptives. Originally published...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+

McDermott+ Check-Up: September 20, 2024

McDermott+ on

Senate Judiciary Human Rights and the Law Subcommittee Holds Hearing on Georgia Abortion Ban. The field hearing examined how Georgia’s abortion ban impacts women’s health, and featured patient and physician witnesses. ...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 Will & Emery

Six Wishes for the Forthcoming Final Regulations Under MHPAEA

McDermott Will & Emery on

On July 1, 2024, the US Department of Labor (DOL) submitted final regulations to the Congressional Budget Office (CBO), implementing the Mental Health Parity and Addiction Equity Act (MHPAEA) as most recently amended by the...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

Hall Benefits Law

HHS Issues Proposed Rule on Nondiscrimination in Health Programs and Activities

Hall Benefits Law on

The U.S. Department of Health and Human Services (HHS) has issued a proposed rule entitled “Nondiscrimination in Health Programs and Activities.” The proposed rule, designed to advance health equity and protect people from...more

McDermott Will & Emery

DOJ Proposes to Reschedule Marijuana (Cannabis) to Schedule III

McDermott Will & Emery on

On May 21, 2024, the US Department of Justice (DOJ) published the highly anticipated notice of proposed rulemaking (NPRM) to reschedule marijuana (cannabis) from a Schedule I controlled substance to Schedule III, taking the...more

Latham & Watkins LLP

US AI Standards Take Shape: Key 180-Day Developments Following White House AI Executive Order

Latham & Watkins LLP on

Companies should consider how new AI risk standards may align to their operations and whether to comment on the draft standards to shape their development. On April 29, 2024, the White House announced that several federal...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

ArentFox Schiff

NYS Insurance Regulators to Health Insurers: Ensure Your Networks Are Adequate

ArentFox Schiff on

On February 21, Superintendent Adrienne A. Harris of the New York State Department of Financial Services (DFS) unveiled a proposed regulation, 11 NYCRR 38. If adopted, this regulation, would establish network adequacy...more

Jones Day

HHS Releases Cybersecurity Performance Goals to Enhance Cybersecurity for Health Care and Public Health Sectors

Jones Day on

The Department of Health and Human Services ("HHS") has released voluntary cybersecurity performance goals for the health care and public health sectors, which outline an increasingly standardized regulatory approach and...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Health Care Compliance Association (HCCA)

OCR Ends Year With Settlements That Tread Old Ground, Says New Rules Are Coming—Someday

If the penultimate enforcement settlement of 2023 issued by the HHS Office for Civil Rights (OCR) sounds familiar, that’s with good reason. And the last one of the year should ring some bells, too....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

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...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 Will & Emery

Discerning Congressional Purpose from the Proposed MHPAEA Regulations Comment Letters

McDermott Will & Emery on

We continue our investigation of proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) issued by the US Departments of Labor, Health and Human Services and the Treasury (the Departments)...more

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