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Manatt, Phelps & Phillips, LLP

Harnessing Claims Data to Address Today's Healthcare Challenges

State All Payer Claims Databases (APCDs) can provide users with broad insights about the health of our populations and the performance of our health care system, across payers (insurers) and over time, and may be used to: ...more

Health Care Compliance Association (HCCA)

[Event] 2025 Board & Compliance Committee Conference - February 24th - 25th, Phoenix, AZ

The Board & Compliance Committee Conference is designed specifically to educate board members on best practices and recommendations for establishing and maintaining an effective compliance program. The OIG-HHS will discuss...more

Holland & Knight LLP

CMS Finalizes the IOTA Model

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The Centers for Medicare & Medicaid Services (CMS) released the Final Rule implementing the Increasing Organ Transplant Access Model (IOTA Model) on Nov. 26, 2024. This mandatory payment model introduces financial incentives...more

Bradley Arant Boult Cummings LLP

Goin’ Down South: How the Southeastern U.S. Became the Current Hotbed of Cannabis Activity

Part of the reason we started a Cannabis Industry team at a Southeastern-based law firm before any Southeastern state had adopted a marijuana program was because we had a hunch that the expansion of cannabis would eventually...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical...more

Parker Poe Adams & Bernstein LLP

New York Court Ruling Highlights Risks of Noncompete and Non-Solicitation Restrictions in Health Care

A federal court in New York recently allowed a lawsuit against a major anesthesia provider to proceed. The case, brought by an upstate New York hospital, claims that the anesthesia provider’s use of restrictive employment...more

McDermott Will & Emery

Post-Election Outlook: Issues to Watch for Pharmacy Industry Stakeholders

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The 2024 election results will create significant tailwinds for Republican legislative and regulatory priorities in US Congress, federal agencies, and state houses across the country. This On the Subject considers the outlook...more

BakerHostetler

Supreme Court Hears FDA’s Flavored Vape Case

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On Monday, the Supreme Court heard oral arguments in a pivotal case that examines the Food and Drug Administration’s (FDA) authority to regulate flavored e-cigarettes. At the heart of the debate are the agency’s denials of...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Draft Guidance for Industry Regarding Accelerated Approval for Drugs and Biologics

On December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat...more

Husch Blackwell LLP

HHS Publishes Nursing Facility ICPG

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In November 2024, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published the Industry-Specific Compliance Program Guidance for Skilled Nursing Facilities and Nursing Facilities (Nursing...more

Stevens & Lee

New Jersey Expands Hospital at Home Program

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Providing medical care in a patient’s home has become increasingly popular with both providers and patients since the COVID-19 pandemic. Stevens & Lee previously blogged about the CMS Acute Hospital Care at Home Individual...more

Husch Blackwell LLP

Massachusetts Joins National Nurse Licensure Compact

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On November 20, 2024, Massachusetts Governor Maura Healy signed into law new legislation that brings Massachusetts into the Nurse Licensure Compact. This law aims to address the critical issue of nursing shortages by...more

Parker Poe Adams & Bernstein LLP

Mandatory COVID Testing Did Not Violate Employee's Religious Beliefs

Lawsuits challenging employers' authority to require measures intended to prevent COVID-19 infections continue to wend their way through the federal judiciary. Last month, the Seventh Circuit Court of Appeals rejected a claim...more

Seyfarth Shaw LLP

The Week in Weed: December 2024

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Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week looks a lot like our last post – updates on the DEA re-scheduling process and on the Nebraska ballot...more

Hendershot Cowart P.C.

Novo Nordisk Urges FDA to Ban Compounded Semaglutide – What Weight-Loss Clinic Owners Need to Know

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Novo Nordisk, the manufacturer of Ozempic and Wegovy, has petitioned the Food and Drug Administration (FDA) to add semaglutide, the active ingredient in Wegovy and Ozempic, to the "Demonstrable Difficulties for Compounding"...more

Proskauer - Law and the Workplace

New York Releases Guidance on Paid Prenatal Leave Law Taking Effect January 1, 2025

The New York State Department of Labor (NYDOL) has issued informal guidance regarding the Paid Prenatal Leave benefit that will be available to New York employees beginning January 1, 2025.  The guidance includes general...more

Manatt, Phelps & Phillips, LLP

Preparing State I/DD Systems for Implementation of the Medicaid Access Final Rule

This spring, the Centers for Medicare & Medicaid Services (CMS) finalized a highly anticipated rule that, among other things, updates program standards and processes for Medicaid home- and community-based services (HCBS),...more

Holland & Knight LLP

Holland & Knight Health Dose: December 3, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott+

ACO REACH: What Recent Performance Results Could Mean for the Model’s Future

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Decisions, decisions, decisions. The Centers for Medicare & Medicaid Services (CMS) under the Trump Administration will have its hands full making decisions about Center for Medicare and Medicaid Innovation (CMMI) models...more

Sheppard Mullin Richter & Hampton LLP

New York Paid Prenatal Leave Begins Next Year – What Employers Need to Know

Beginning on January 1, 2025, all New York employers will be required to provide eligible employees with 20 hours of paid prenatal leave (“Paid Prenatal Leave”) during any 52-week period for health care services during or...more

Fox Rothschild LLP

New York State Releases FAQs on New Prenatal Leave Mandate

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The New York Department of Labor (NYDOL) recently added a frequently asked questions (FAQs) section to its prenatal leave webpage, providing additional insight into the department’s interpretation of a new state law that...more

Brooks Pierce

OIG Recommends Changes to HIPAA Audit Program to Strengthen Data Protections, Implications for Regulated Entities

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The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is required by law to perform periodic audits of covered entities and business associates to ensure their compliance with HIPAA Security Rule...more

McCarter & English, LLP

DEA Begins Hearings on Cannabis Rescheduling

Earlier this week, the Drug Enforcement Administration (DEA) held a preliminary hearing as part of the ongoing process to determine whether cannabis should be reclassified from Schedule I to Schedule III of the Controlled...more

Wiley Rein LLP

Section 111 Bulletin: Mitigating Medicare Section 111 Reporting Risks - With Civil Money Penalties on the Line, Are You Certain...

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Under a long anticipated Centers for Medicare & Medicaid Services (CMS) final rule that took effect in October, casualty insurers face risks of incurring Civil Money Penalties (CMPs) if they fit the Section 111 definition of...more

Jackson Lewis P.C.

Florida Healthcare Provider Faces $1.19M HIPAA Penalty Following Independent Contractor Breach

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A healthcare provider delivering pain management services in Florida and other states faces a $1.19 million civil monetary penalty from the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR)....more

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