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More Losses than Gains? OIG Declines to Approve Certain Medicare Advantage Gainsharing Arrangements in Advisory Opinion 24-08

On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more

CMS Finalizes New Mandatory Value-Based Payment Initiative: The Transforming Episode Accountability Model

On August 28, as part of its Fiscal Year 2025 Hospital Inpatient Prospective Payment System (IPPS) Final Rule, the Centers for Medicare & Medicaid Services (CMS) finalized the Transforming Episode Accountability Model (TEAM)...more

The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more

CMS Proposes New Mandatory Value-Based Payment Initiative: The Transforming Episode Accountability Model

The Centers for Medicare & Medicaid Services (CMS) recently proposed the Transforming Episode Accountability Model (TEAM) – a new, mandatory, episode-based alternative payment model in the Fiscal Year 2025 Hospital Inpatient...more

12th Annual Healthcare Fraud & Abuse Review - A Critical Resource for Healthcare Providers

We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

2024 Healthcare Private Equity Outlook & Trends

W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more

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

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

Labs Take Note: In a New Opinion, OIG Reminds Us that Fair Market Value Payments Can Still Violate the Anti-Kickback Statute

On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more

Extension Extended: DEA Continues Telemedicine Prescription Flexibilities Through 2024

On October 6, the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule providing for a second temporary extension of its COVID-19 telemedicine...more

FDA Takes Definitive Step Toward the Regulation of LDTs

On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more

OIG Approves Gift Cards to Promote Patient Compliance with a Preventive Screening Measure

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion 23-03, approving a proposal by the manufacturer of a colorectal cancer screening test and its wholly owned...more

Payment Due: HRSA Seeks Repayment of Provider Relief Funds for Non-Compliance

The Health Resources and Services Administration (HRSA) is seeking repayment of Provider Relief Fund (PRF) payments from providers who failed to submit the required report(s) on their use of the funds. Recipients were...more

CY 2023 Medicare Physician Fee Schedule: Clinical Laboratory Update

On November 2, 2022, Centers for Medicare & Medicaid Services (CMS) filed its final rule implementing changes to the Medicare Physician Fee Schedule for CY 2023 (Final Rule). Embedded within this Final Rule are important...more

CY 2023 Medicare Physician Fee Schedule: Big Strides for Behavioral Health

On November 2, 2022, the Centers for Medicare & Medicaid Services (CMS) filed its Medicare Physician Fee Schedule (PFS) final rule (Final Rule) for calendar year (CY) 2023. CMS finalized several noteworthy updates specific to...more

Recent Updates to CLIA Proficiency Testing and Proposed Changes to Fees, Sanctions, and Other Requirements

This client alert highlights recent regulatory developments from the Centers for Medicare & Medicaid Services (CMS) relevant to clinical laboratories. CMS is implementing or considering implementing several updates to the...more

No Surprises Act: New Regulations Improve Dispute Resolution Process for Providers

On August 19, the federal government issued a final rule addressing certain aspects of the No Surprises Act (NSA). The NSA was enacted in December 2020 to protect commercially insured patients from receiving surprise medical...more

OIG Declines to Approve Lab’s Payment of Specimen Collection Fees to Hospitals

On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more

Research Using De-Identified Specimens: A Reminder from FDA

On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more

First Installment of Surprise Billing Regulations Released

On July 1, the Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (Departments) jointly issued interim final rules (IFR) implementing certain aspects of the No Surprises Act...more

CMS Advisory Opinion Provides Flexibility Under Stark for Group Practice Structures Involving Wholly-Owned Physician Practice...

The Centers for Medicare & Medicaid Services (CMS) recently issued Advisory Opinion No. CMS-AO-2021-01, clarifying that physician groups that furnish designated health services (e.g., laboratory, imaging) through wholly-owned...more

HHS Updates Provider Relief Fund Reporting Guidance and Timelines

After months of quiet introspection, on June 11, 2021, the U.S. Department of Health and Human Services (HHS) released long-awaited updated Post-Payment Notice of Reporting Requirements, which outlines updated reporting...more

Looking through the Scope: 5 Key Diligence Considerations When Buying a GI Practice

Private equity investors’ interest in gastroenterology (GI) practices continues to remain strong, despite some headwinds that GI practices have experienced as a result of the COVID-19 pandemic and further investment in this...more

FDA Creates New Pathway for Authorization of COVID-19 Screening Tests

On March 17, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) all took steps to improve access to COVID-19 screening. HHS...more

American Rescue Plan Act of 2021: Healthcare Highlights

Yesterday, President Biden signed into law the American Rescue Plan Act of 2021 (Act), which narrowly passed the U.S. Senate (50 – 49) and House of Representatives (220 – 211) earlier this week. The Act provides for $1.9...more

The No Surprises Act Passed and (Surprise!) Healthcare Providers are Leery of its Impact

After a drawn-out drafting-and-review process, the hotly contested No Surprises Act (Act) has made its way into law after being tucked into the 5,500+ pages of the Consolidated Appropriations Act, 2021, signed into law on...more

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