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Regional Hospital System and Two Physicians Pay More Than $69 Million to Settle False Claims Act, Involving Allegations of...

On March 29, 2023, the U.S. District Court for the Eastern District of Michigan granted the parties’ joint stipulation for dismissal in U.S. ex. rel. Godsholl v. Covenant Healthcare, following three settlements of the...more

HHS Language Access Progress Report – OCR Will Hold Providers to the “Highest Bar”

On May 24, 2023, the U.S. Department of Health and Human Services (HHS) released its first Language Access Annual Progress Report (the Report) reflecting on its advancements since the 2022 HHS Equity Action Plan (Equity Plan)...more

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

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

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

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

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

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

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

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

HHS Draws Curtain on the Healthcare Regulatory SUNSET Final Rule

On May 27, 2022, the U.S. Department of Health and Human Services (HHS) announced it was withdrawing the Securing Updated Necessary Statutory Evaluations Timely final rule (SUNSET final rule), which was originally set to take...more

OIG Permits Healthcare Organization’s Smartphone Loan Program For Telehealth Services

On April 22, 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion (no. 22-08) (the “Advisory Opinion”) approving a healthcare organization loaning...more

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

May 18 Deadline to Request Late Reporting for Provider Relief Fund Period 2 - The U.S. Department of Health and Human Services (HHS) announced a deadline extension for providers that received $10,000 or more in the second...more

California Court: Fair Market Value Payments May Not Avert Anti-Kickback Liability

In February 2022, the U.S. District Court for the Central District of California denied a defendant’s motion to dismiss a qui tam action alleging that the defendant had violated the federal Anti-Kickback Statute (AKS). In its...more

District Court Adopts Middle of the Road Approach in Determining Causation in Anti-Kickback Statute-Based False Claims Act Case

The U.S. District Court for the District of Maryland recently weighed in on the appropriate causation standard when evaluating whether a claim “result[s] from” a violation of the Anti-Kickback Statute sufficient to constitute...more

Key Regulatory Topics for Women's Health Businesses

Regulatory considerations continue to be an area women’s health businesses must address, as discussed during an April 14, 2022, webinar presented by McGuireWoods healthcare lawyers Kayla Marty and Tim Fry. Prevalent areas of...more

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