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Complex AKS/Stark Complaint Survives Rule 9(b) Particularity Challenge – A Guide for FCA Complaints

In U.S. v. Genesis Global Healthcare, 2023 WL 3656925 (S.D. Ga. May 25, 2023), a Georgia district court denied three (3) Motions to Dismiss the Second Amended Complaint filed in a qui tam action brought by relators under the...more

Home Cooking: Washington Transfers Venue to Court in State

Earlier this year, the U.S. District Court for the Western District of Oklahoma granted Washington state’s motion to intervene to transfer venue to the Western District of Washington in James Siegel, M.D. v. Novo Nordisk,...more

Temporary Allies: Opposing Parties Successfully Sue VA for FCA-related Discovery

A Kansas federal court recently ruled against the United States Department of Veterans Affairs (VA) in litigation arising out of a discovery dispute brought by the relator and defendant in a separate, pending FCA action. See...more

CMS Ends COVID-19 Vaccine Mandate for Medicare- and Medicaid-Certified Providers and Suppliers

On June 5, 2023, the Centers for Medicare & Medicaid Services (CMS) published a final rule in the Federal Register that withdraws COVID-19 vaccination mandates for certain providers’ staff members and withdraws long-term care...more

Providers Must Offer Effective Communication for Hearing-Impaired or Face ‘Robust Enforcement’

The U.S. government entered into two recent settlements with healthcare providers who allegedly denied deaf and hearing-impaired patients or their caregivers auxiliary aids for effective communication. These settlements...more

A View From the Top: Bill Drehkoff of Heart & Vascular Partners

The interview below is part of a McGuireWoods series featuring interviews with C-suite leadership of private equity-backed portfolio companies. To recommend a leader for a future interview, email Holly Buckley at...more

HRSA Allows Post-May 11 Provider Relief Fund Spending, Adds Two Reporting Periods

Most healthcare providers received Provider Relief Fund (PRF) payments (as described in greater detail in a previous McGuireWoods client alert) from the Health Resources and Services Administration (HRSA) earlier in the...more

End of an Era: White House Ends Many Federal COVID-19 Vaccine Requirements

On May 1, 2023, the White House announced it would end the COVID-19 vaccine requirements for federal employees, federal contractors and international air travelers effective May 11, the same day the federally declared...more

CMS Publicly Releases Ownership Data for Medicare-Certified Hospice and Home Health Agencies

On April 20, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the release of ownership data for all Medicare-enrolled hospice and home health agencies. This release is consistent with the Department of...more

Subsector Snapshots — Why Investor Interest Is Ballooning in Cardiology

The growing cardiology subsector is one of the most sought-after and competitive specialties for healthcare investors. Stemming from an aging population and growing obesity demographic trends, demand for cardiovascular...more

End of COVID-19 Emergency: Legal Implications for Healthcare Providers

On Jan. 30, 2023, President Joe Biden announced that the COVID-19 public health emergency (PHE) will end May 11, 2023. Under the PHE, the federal government implemented a range of modifications and waivers impacting Medicare,...more

Outdated Medicare Enrollment Data? Caution: CMS Verifying Ownership

In recent weeks, the Centers for Medicare & Medicaid Services (CMS) has been contacting certain Medicare-enrolled providers and suppliers (hereinafter “providers”) to verify that their ownership information, as reported in...more

OIG to Expand Informal Guidance with New FAQs

The Office of Inspector General (OIG) has announced that it is expanding the topics it considers for new Frequently Asked Questions (FAQs) submitted by healthcare stakeholders. OIG will now answer general questions about the...more

Pharmaceutical Suppliers Beware: Expect Increased Scrutiny of Average Wholesale Pricing Methodology and Marketing “The Spread”

A Texas federal court recently denied a pharmaceutical supplier’s motion to dismiss claims brought by a whistleblower under the federal False Claims Act (FCA) alleging violations of the Anti-Kickback Statute (AKS) and...more

Provider Relief Fund Reporting Guidance: Provider Relief Fund Late Reporting Requests for Extenuating Circumstances Accepted April...

Two Weeks Left: Approaching Deadline to Report Period 4 Provider Relief Fund Payments - Most healthcare providers received Provider Relief Fund (PRF) funding (as described in greater detail in a previous McGuireWoods...more

CMS Streamlines Stark Law Self-Disclosures

The Centers for Medicare & Medicaid Services recently announced updates to the voluntary self-referral disclosure protocol (SRDP), including revisions to streamline SRDP submissions. Providers and suppliers may report and...more

Key Takeaways From the 2023 Healthcare Private Equity and Finance Conference

McGuireWoods recently held its 19th Annual Healthcare Private Equity and Finance Conference (HCPE Conference) at The Ritz-Carlton in Chicago. The HCPE Conference drew registration of more than 1,000 professionals from private...more

Medicare Accelerated Payment Fraud Leads to Criminal Conviction

Government investigators focus on pandemic-related fraud has culminated in a recent criminal conviction As announced by the Department of Justice (DOJ), on Friday, January 13, 2023, a federal jury convicted a Colorado...more

Physicians and Their Employers Must Notify California Patients About Open Payments Database

Under a new California law, effective Jan. 1, 2023, physicians and their employers must begin notifying their California patients during a patient’s initial visit of the Open Payments database, and documenting such notice in...more

CMS Issues ESRD Prospective Payment System Final Rule for 2023

Rule Addresses Rate Increases, Outlier, Add-On and ETC Model Payments, Oral-Only Drugs and QIP Reporting - On Oct. 31, 2022, the Centers for Medicare & Medicaid Services issued a final rule implementing an increase in...more

OIG Weighs in on Practices Funding Continuing Education Programs for Their Referral Sources

On June 29, 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 22-14 regarding an ophthalmology practice’s proposed options to fund continuing education (CE)...more

Court Strikes No Surprises Act’s Dispute Resolution Process for Air Ambulance Providers

On July 26, 2022, Judge Jeremy D. Kernodle of the U.S. District Court for the Eastern District of Texas set aside a portion of the interim final rule implementing the No Surprises Act’s (NSA) independent dispute resolution...more

Seventh Circuit Suggests High Standard Under the FCA Whistleblower Retaliation Provision

Last month, the U.S. Court of Appeals for the Seventh Circuit affirmed summary judgement against an employee-whistleblower who had claimed that her former employer retaliated against her in violation of the False Claims Act’s...more

Potential Anti-Kickback Prosecution Does Not Give Blanket Fifth Amendment Protection in a Medical Malpractice Suit

An Ohio Court of Appeals recently weighed in on the proper protocols one must take in order to successfully assert one’s Fifth Amendment Constitutional Right against self-incrimination in relation to a discovery request in a...more

CMS Considers Streamlined Physician Group Stark Law Self-Disclosures

On June 9, 2022, the Centers for Medicare & Medicaid Services announced an opportunity for the public to comment through Aug. 8, 2022, on its voluntary self-referral disclosure protocol (SRDP). The voluntary SRDP is a way to...more

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