News & Analysis as of

Reporting Requirements Compliance False Claims Act (FCA)

Foley Hoag LLP - White Collar Law &...

New Massachusetts Healthcare Law Targets Private Equity, REITs, and MSOs; Expands State False Claims Act

On January 8, 2025, Governor Maura Healey signed House Bill 5159 into law, toughening the rules and increasing the risks for private equity (PE) companies, real estate investment trusts (REITs), and management services...more

Verrill

Massachusetts Enacts Largest Health Care Transactions and Financial Oversight Legislation In a Decade, Private Investors and...

Verrill on

Health care sector stakeholders take notice: On January 8, 2025, Massachusetts Governor Healy signed sweeping new health care legislation with transactional, financial, and ongoing operational compliance ramifications for...more

Proskauer - Health Care Law Brief

CMS Publishes Final Rule, Effective January 1, 2025, Addressing the Requirements for Reporting and Returning Overpayments

The standard for an “identified overpayment” under Medicare Parts A–D now aligns with section 1128J(d)(4)(A) of the Social Security Act, which incorporates by reference the Federal False Claim Act’s (the “FCA”) “knowledge”...more

Foley & Lardner LLP

Massachusetts: New Year, New Law — Governor Signs “An Act enhancing the market review process” (House Bill No. 5159)

Foley & Lardner LLP on

On January 8, 2025, Governor Maura Healey signed into law H.B. 5159, “an Act enhancing the market review process.” This new law promises sweeping reform to reshape how health care businesses operate and grow...more

McDermott Will & Emery

Massachusetts H.5159 Seeks to Reshape Private Equity in Healthcare

McDermott Will & Emery on

On December 30, 2024, both the Massachusetts House of Representatives and the Massachusetts Senate enacted House Bill 5159 (H.5159), and Governor Maura Healey signed it on January 8, 2025. The bill seeks to strengthen...more

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

Bass, Berry & Sims PLC on

On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The...more

Burr & Forman

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

Burr & Forman on

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

Ropes & Gray LLP

Massachusetts Passes Act Implementing Broad Oversight into For-Profit Investment in Health Care

Ropes & Gray LLP on

On January 8, 2025, Massachusetts Governor Maura Healey signed House Bill 5159, An Act Enhancing the Market Review Process (the “Act”) into law, effective April 8, 2025. The Act is a compromise redraft of the separate health...more

Mintz - Health Care Viewpoints

It’s Been a Long Time Coming: Massachusetts Health Care Market Review 2.0

The latest entrant in a national wave of policymakers enacting health care market oversight laws that have a significant impact on providers and investors, Massachusetts Governor Maura Healey has signed into law House Bill...more

Troutman Pepper Locke

New Year, New Liability for Private Equity

Troutman Pepper Locke on

Private equity firms and health care companies operating in Massachusetts will now face enhanced liability risks following the recent passage and enactment of legislation regulating private equity investment in Massachusetts...more

Whiteford

Navigating New Medicare Overpayment Rules and Practical Tips to Comply

Whiteford on

On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) finalized the Medicare regulations interpreting the federal 60-day overpayment refund requirement (the Overpayment Statute) for Medicare Parts A and B as...more

Mitratech Holdings, Inc

DOJ Unveils Whistleblower Rewards Program: What Every Business Needs to Know

The Department of Justice has launched the Corporate Whistleblower Awards Pilot Program to fight corporate crime. See how it impacts your organization. The U.S. The Department of Justice (DOJ) has just rolled out the...more

Clark Hill PLC

Incident Reporting: The Newly Proposed Cybersecurity Requirements

Clark Hill PLC on

Last month the Federal Acquisition Regulatory (FAR) Council announced a major proposal regarding cybersecurity incident reporting and information. Comments currently are now due by February 2, 2024....more

Health Care Compliance Association (HCCA)

NSF Suspends 18 Awards, Receives Repayments Related to Foreign Ties, Research Misconduct

One university lost 14 awards; another, four. An investigator was suspended governmentwide. A public institution paid back more than $850,000, while two others returned nearly a million dollars....more

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

Goodwin on

​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

Bradley Arant Boult Cummings LLP

Inside DOJ’s New Cyber-Fraud Initiative

The Department of Justice (DOJ) recently announced the launch of the Civil Cyber-Fraud Initiative, which will utilize the False Claims Act (FCA) to pursue cybersecurity-related fraud by government contractors and grant...more

King & Spalding

Heightened Focus on Foreign Influence in Academia

King & Spalding on

Department of Education Report Warns that Academic Institutions Are Failing to Meet Compliance Obligations in Fight Against Foreign Influence Last month the Department of Education (“DOE” or “Department”) released an...more

Pillsbury Winthrop Shaw Pittman LLP

Fraud and the Risk of FCA Litigation in the Time of COVID-19

The $1.4 trillion set aside for loans to small, medium and large businesses in the CARES Act stimulus package makes compliance more crucial than ever for U.S. companies. Any entity that receives government funds may face...more

Cadwalader, Wickersham & Taft LLP

In Closely Watched Case, Federal Court Upholds the Government’s Position on Provider Mandate to Report and Return Medicare and...

The Patient Protection and Affordable Care Act (“PPACA”), signed into law on March 23, 2010, included a provision (the “Report and Refund Mandate”), broadly requiring health care providers, suppliers, Part D plans and managed...more

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