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Healthcare Proposed Regulation

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

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

Manatt, Phelps & Phillips, LLP

Energy and Commerce Chair Releases Framework with Recommendations to Overhaul NIH

On June 14, House Energy and Commerce Committee (E&C) Chair Cathy McMorris Rodgers published a “framework for discussion” proposing reforms to the National Institutes of Health (NIH)....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

Sheppard Mullin Richter & Hampton LLP

California is Capping Health Care Cost Increases – Starting at 3.5% in 2025

As we previewed last year regarding SB 184 and the establishment of the California Office of Health Care Affordability (OHCA), California now has taken a significant regulatory step aimed at restraining growth in health care...more

McDermott+

CMS Finalizes Major Reforms to Medicaid, Part 2: Medicaid Managed Care Reg

McDermott+ on

Medicaid Regs Part 2! Last week, Regs & Eggs took a deep dive into the Ensuring Access to Medicaid Services final reg, one of two regs that the Centers for Medicare & Medicaid Services (CMS) released to add new requirements...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

Manatt, Phelps & Phillips, LLP

Manatt Health: Health AI Policy Tracker

The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more

Health Care Compliance Association (HCCA)

Privacy Briefs: April 2024

The Cybersecurity and Infrastructure Agency (CISA) is seeking comment on a proposed rule to implement reporting requirements for critical infrastructure entities, including health care entities, on cyberattacks and ransomware...more

McDermott+

CMMI Proposes New Mandatory Episode-Based Payment Model

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) released the Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed regulation. This 1,900+ page annual reg updates Medicare payments and policies...more

Paul Hastings LLP

CISA Proposes Sweeping Cybersecurity Incident Reporting for U.S. Companies

Paul Hastings LLP on

On March 27, 2024, the Cybersecurity & Infrastructure Security Agency (“CISA”) released proposed regulations requiring expansive new cybersecurity incident and ransomware payment reporting across sixteen “critical...more

Bass, Berry & Sims PLC

AI a Target of California Regulation Drafting

Bass, Berry & Sims PLC on

While generative artificial intelligence (AI) apps – such as Chat-GPT, Google Gemini, and Stable Diffusion – are capturing the national spotlight, many businesses are using other forms of machine learning, algorithms, and...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

Harris Beach PLLC

OIG’s Favorable Advisory Opinion: Physician Consulting Firm’s Gift Cards to its Clients for Referring New Physician Practices

Harris Beach PLLC on

This favorable OIG opinion relates to Requestor who provides consulting services to physician practices and the Requestor’s proposed arrangement (“Proposed Arrangement”) to offer its current physician practice customers...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

Health Care Compliance Association (HCCA)

Privacy Briefs: January 2024

New York has released proposed cybersecurity regulations for hospitals. The regulations, which were published in The State Register on Dec. 6 and will undergo a 60-day public comment period ending on Feb. 5, are designed to...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

Sheppard Mullin Richter & Hampton LLP

OHCA Published Near-Final Draft of Regulations Requiring Notice and Review of Material Healthcare Transactions in 2024

In the final days of November, the Office of Health Care Affordability (OHCA) published three updates related to its proposed regulations regarding the review of certain healthcare transactions in California: 1. the...more

Polsinelli

Office of Health Care Affordability Publishes Near-Final Regulations on Health Care Transaction Notice Requirements

Polsinelli on

On Tuesday, November 28, 2023, California’s Office of Health Care Affordability (“OHCA”) published its latest version of the proposed regulations requiring advanced notice of certain health care transactions in California for...more

McDermott Will & Emery

Final Comment Period Anticipated Next Week for Emergency Regulations on California’s New Healthcare Transaction Notice Law

McDermott Will & Emery on

On November 28, 2023, California’s Office of Health Care Affordability (OHCA) published a notification of proposed emergency regulatory action indicating that OHCA is planning to submit the proposed regulations to the Office...more

Mintz - Health Care Viewpoints

California Further Revises Proposed Regulations for the Pre-Closing Review of Health Care Transactions and Notifies Stakeholders...

California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care transactions beginning January 1, 2024. As further explained in our previous post, subject to...more

Robinson+Cole Data Privacy + Security Insider

New York Governor Proposes Cybersecurity Regulations for NY Hospitals

On November 13, 2023, Governor Kathy Hochul released proposed cybersecurity regulations applicable to all hospitals located within the state of New York. The Governor has included $500 million in grant funding in her FY24...more

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