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Medicare Compliance Regulatory Requirements

King & Spalding

The One Big Beautiful Bill Act Explained: A Detailed Review of Key Changes for the Healthcare Industry

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To offset the cost of other provisions in the bill, the One Big Beautiful Bill Act (OBBBA) includes significant reforms to Medicaid, Medicare, and Affordable Care Act (ACA) premium tax credits that are expected to result in...more

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

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In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Hendershot Cowart P.C.

Qlarant, Novitas Audits Escalate as Medicare Skin Substitutes Spending Hits $1.6 Billion, CMS Seeks Evidence of Clinical...

Hendershot Cowart P.C. on

The wound care industry faces unprecedented scrutiny as Medicare Part B expenditures for skin substitutes exceeded $1.6 billion in the fourth quarter of 2023 alone. The spending surge has triggered a wave of skin substitute...more

Dentons

Ep. 68 – Before You Audit—Why Pre-Audit Planning Matters

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If you’re preparing to launch an audit within your healthcare organization, pause for a moment and consider this: how well you plan before the audit begins can significantly affect the outcome—and your risk exposure. This...more

King & Spalding

OIG Releases Audit of Medicare Payments for Evaluation Management Services Billed on the Same Day as Eye Injections

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On May 27, 2025, HHS Office of Inspector General (OIG) issued a report outlining its finding that Medicare payments for evaluation management (E&M) services provided on the same day as eye injections were at risk for...more

Dentons

Ep. 59 – Treating Medicare Beneficiaries as a Cash-Based Practice

Dentons on

Cash-based practices, or providers who neither participate with nor bill insurers, are becoming increasingly common, especially in certain specialties such as primary care, women’s health, and mental health. While providers...more

McDermott Will & Schulte

OIG Nursing Facility Compliance Program Guidance: Renewed Focus on Fraud and Abuse

The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the...more

Whiteford

Client Alert: CMS Again Delays Updates to its Guidance to Surveyors for Long Term Care Facilities Under Appendix PP of the State...

Whiteford on

On March 10, 2025, the Centers for Medicare & Medicaid Services (“CMS”) announced a further delay in the implementation of proposed updates to its Guidance to Surveyors for Long-Term Care Facilities under Appendix PP of the...more

Paul Hastings LLP

OIG Issues Favorable Opinion on Pharmaceutical Manufacturer’s Free Product Program

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In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more

Whiteford

Ambulatory Surgery Center Trends in Regulation, Compliance, and Enforcement

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Ambulatory Surgery Centers (ASCs) are experiencing significant shifts in regulation, reimbursement, and operational practices. These changes are driven by evolving healthcare policies, technological advancements, and the...more

Mintz - Health Care Viewpoints

First Circuit Adopts “But-For” Causation Standard for False Claims Act Cases Based on Anti-Kickback Statute Violations

In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for”...more

Klein Moynihan Turco LLP

Current TCPA and Medicare Marketing Landscape

As our readers know, a recent federal court decision left the fate of the Federal Communications Commission’s (“FCC”) one-to-one consent rule under the Telephone Consumer Protection Act (“TCPA”) on life support, at best....more

Mintz

Mintz IRA Update — Duplicate Discounts Between the 340B Program & Medicare Drug Price Negotiation Program

Mintz on

The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more

Mintz - Health Care Viewpoints

PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team...more

Woodruff Sawyer

Reminder: RxDC Reporting Due June 1st

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With the 2024 reference year RxDC reporting deadline approaching in June, plan sponsors should re-familiarize themselves with the reporting requirements. The 2024 reference year RxDC Reporting Instructions have been released,...more

Sheppard Mullin Richter & Hampton LLP

May the Coverage Be With You: Navigating CMS’s Changes to the Health Insurance Marketplace

The Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) recently issued the final “HHS Notice of Benefit and Payment Parameters for 2026” (hereinafter referred to as the “Rule”)...more

Goldberg Segalla

CMS Issues Alert & WCMSA User Guide Update; Positive Changes Expedite Allocation Practice

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Beginning April 7, the Centers for Medicare & Medicaid Services (CMS) will eliminate its one-year waiting period for Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Amended Review requests. Instead, CMS will...more

McDermott Will & Schulte

Hospital Provider-Based Compliance: Top 10 Myths and Truths

Medicare reimbursement for hospital outpatient services has come under attack in recent years, with a focus on “site neutral” payment policies that would pay hospitals for outpatient services furnished in off-campus locations...more

Whiteford

Navigating Value-Based Care in Anesthesia: Enhancing Patient Outcomes Amid Legal Complexities

Whiteford on

Value-based care (VBC) is a healthcare delivery model that prioritizes patient outcomes over the volume of services provided. This approach aims to enhance the quality of care while controlling costs by incentivizing...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Genetic Testing

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more

Goodell, DeVries, Leech & Dann, LLP

Understanding CMS “Immediate Jeopardy” Investigations in Healthcare Facilities

When it comes to ensuring patient safety, healthcare facilities operate under a complex regulatory framework, including oversight from the Centers for Medicare & Medicaid Services (CMS). One of the more intense processes CMS...more

Baker Donelson

Upcoming Deadline to Apply for Medicare-Funded Residency Positions

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Teaching hospitals training over their graduate medical education (GME) caps have limited opportunities to receive additional funding from Medicare. ...more

Burr & Forman

Failure to Return Credit Balances (Especially to Medicare and Medicaid) Can Create Significant Liability

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Every health care provider has “credit balances,” which occur when a provider receives more money than it is owed for services rendered. Credit balances can be caused by a number of factors, including incorrect coding,...more

McCarter & English, LLP

Nursing Home Update

The federal government has made a variety of changes to federal requirements aimed at improving the quality of care at long-term care facilities across the country. In May 2024, the United States Department of Health and...more

Health Care Compliance Association (HCCA)

Early returns on MA plans’ two-midnight rule interpretations: A compliance nightmare

The Centers for Medicare and Medicaid Services (CMS) issued regulations applicable to Medicare Advantage (MA) plans—also commonly referred to as managed Medicare or Part C Medicare—in April 2023 (CMS 4201–F) that address,...more

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