News & Analysis as of

Healthcare Final Rules New Regulations

Katten Muchin Rosenman LLP

Have You Done Your Part to Comply with Part 2 Changes?

Important changes are coming to 42 CFR Part 2 (Part 2), which deals with the confidentiality of patients’ substance use disorder (SUD) records. On April 16, 2024, the US Department of Health and Human Services (HHS) published...more

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

McDermott Will & Emery

Section 1557 Patient Care Decision Support Tools, Anti-Discrimination Compliance: 12 Things to Consider

McDermott Will & Emery on

In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

McDermott+

Digesting the Huge Buffet of CMS Regs: Highlights from the CY 2025 PFS Final Reg

McDermott+ on

While we all are focused on the election results, let’s take a quick break to digest some regs and eggs. The Centers for Medicare & Medicaid Services (CMS) “spoiled” all of us in the health policy world with a huge buffet of...more

Health Care Compliance Association (HCCA)

New ORI Misconduct Rule Offers ‘Thoughtful’ Revisions in Wake of Highly Criticized NPRM

Now that the HHS Office for Research Integrity (ORI) has published its final rule revising 2005 regulations governing misconduct, compliance officials could be engaging in three activities simultaneously: checking to see if...more

McDermott+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

McDermott+ on

Biden Administration Issues Final Reg on Mental Health Parity Requirements McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts....more

Epstein Becker & Green

Medical Diagnostic Equipment Accessibility Regulations Announced by DOJ Under Title II of ADA

Epstein Becker & Green on

To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for...more

McDermott Will & Emery

HHS Final Section 1557 Nondiscrimination Regulations: Gender-Affirming Care and the Role of Carriers Under ASO Arrangements

On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press release, fact sheet, FAQs) (final regulations) reinterpreting Section 1557 of the Affordable Care Act (ACA), which prohibits...more

McDermott Will & Emery

Ten Takeaways From Long-Awaited Section 1557 Nondiscrimination Protections

On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press release, fact sheet, FAQs) reinterpreting Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the...more

McDermott Will & Emery

Trending in Telehealth: January 4 – 15, 2024

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott+

REGS & TURKEY LEGS: The Regs We’re Thankful For

McDermott+ on

It’s Thanksgiving week, so instead of eating eggs with your regs, you should sit back, relax and reflect on the regs you are thankful for as you eat your turkey legs (or whatever you enjoy on Thanksgiving). Many of the...more

Bass, Berry & Sims PLC

Behavioral Health: Momentum Continues in the CY 2024 Medicare Physician Fee Schedule

Bass, Berry & Sims PLC on

On November 16, the Centers for Medicare & Medicaid Services (CMS) published its Medicare Physician Fee Schedule (PFS) final rule for calendar year 2024 (PFS Final Rule). According to the CMS press release, the PFS Final Rule...more

Bass, Berry & Sims PLC

CMS Extends Virtual Direct Supervision Through 2024

Bass, Berry & Sims PLC on

On November 2, the Centers for Medicare & Medicaid Services (CMS) extended virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather than in-person presence)...more

Proskauer - Health Care Law Brief

CMS Corrects Inadvertent Omissions in Recent Stark Law Regulatory Amendments, Clarifies Reach of the Prohibition Related to...

Earlier this month, the Centers for Medicare and Medicaid Services (CMS) released its final rules for the 2022 Medicare Physician Fee Schedule (PFS Final Rule) and 2022 Medicare Hospital Outpatient Prospective Payment System...more

Foley Hoag LLP - Medicaid and the Law

MACPAC Releases Status Update on 2014 HCBS Final Rule

We’ve written previously about the the 2014 final regulation issued by the Obama administration making significant updates to the requirements for the qualities of settings eligible for reimbursement for Medicaid...more

Foley & Lardner LLP

Beneficiary Assignment Under the MSSP Final Rule

Foley & Lardner LLP on

This is the fourth post in Health Care Law Today’s series on the final rule. This post addresses how CMS assigns beneficiaries to an ACO participating in the MSSP. In the MSSP ACO Final Rule, CMS finalized new...more

King & Spalding

CMS Issues Pared-Down Final Rule on Medicare Part D and Medicare Advantage

King & Spalding on

CMS recently issued a Final Rule with respect to the Medicare Part D and Medicare Advantage programs (the “Final Rule”) implementing certain Affordable Care Act provisions. The Final Rule follows a January 10, 2014 Notice of...more

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