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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

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

OIG Approves Physician-Owned Medical Device Company With Several Safeguards

On April 20, 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion (no. 22-07) regarding physician ownership of a medical device company that manufactures...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

COVID Nursing Home Patient Safety Failures Not Actionable under FCA in New York

In Conte v. Kingston NH Operations LLC, 2022 U.S. Dist. LEXIS 21686, *1, 2022 WL 356753, a New York District court granted a defendant’s motion to dismiss an employee’s false claims allegations under the False Claims Act (the...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

CMS Continues Implementation of No Surprises Act With IDR Portal and FAQs

The No Surprises Act (NSA) went into effect Jan. 1, 2022, with the goal of protecting consumers from unexpected medical bills. The NSA places numerous obligations on certain healthcare providers, facilities and providers of...more

District Court finds that AKS Violations are Per Se Material

Last month, the Central District of California granted the government’s affirmative motion for partial summary judgment in U.S. v. Reliance Medical Sys., 2022 WL 524062 (C.D. Cal. Feb. 2, 2022). The Reliance Medical case...more

Provider Relief Fund Reporting Guidance: Looming Deadlines to Report Provider Relief Fund Period 2 Payments and COVID-19 Vaccine...

Looming Deadlines to Report Provider Relief Fund Period 2 Payments and COVID-19 Vaccine Claims - The U.S. Department of Health and Human Services (HHS) reporting portal remains open only through March 31, 2022, at 11:59...more

Eye Care Practice Settles with Government for Employing Excluded Individual

On March 18, the Department of Justice (“DOJ”) and the Connecticut Attorney General announced that a Connecticut eye care practice and its owners had agreed to pay $192,699 to resolve allegations that the practice improperly...more

Court Strikes HHS No Surprises Act’s Independent Dispute Resolution Procedures

On Feb. 23, 2022, the U.S. District Court for the Eastern District of Texas granted a motion for summary judgment in favor of the Texas Medical Association and Dr. Adam Corley, striking down a portion of an interim final rule...more

Seventh Circuit Clarifies Pleading Standard for Anesthesiologist’s False Claims Action

The Seventh Circuit recently reversed a lower court’s ruling that an amended complaint in a qui tam lawsuit filed under the False Claims Act (FCA) alleging fraudulent anesthesiology billing practices failed to meet the...more

Will 2022 Be The Year? OIG’s 25 Top Recommendations to Reduce Healthcare Fraud

Every year the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) releases an annual Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Unimplemented Recommendations. HHS...more

Court Allows Superseding Indictment Twelve Days Before Trial, Failing to Find Prosecutorial Vindictiveness

In U.S. v. Georges, 2021 WL 3887183 (S.D. Oh. Aug. 30, 2021), a federal court recently dismissed a defendant’s motion to dismiss a superseding indictment, denying her claim of prosecutorial vindictiveness related to multiple...more

CMS Vaccine Mandate Enforcement Begins — Understanding the Three Deadlines

On Jan. 13, 2022, the U.S. Supreme Court permitted the Centers for Medicare & Medicaid Services (CMS) to enforce its interim final rule requiring many Medicare- and Medicaid-certified providers and suppliers to vaccinate...more

Supreme Court Upholds CMS Vaccine Mandate: Next Steps for Healthcare Providers

Update (Jan. 15, 2022): After the Jan. 14, 2022, publication of this alert, the Centers for Medicare & Medicaid Services issued updated guidance to State Survey Agency directors providing 30 days (by Feb. 13) for facilities...more

What’s Next for Employers After the Supreme Court’s Vaccine Rulings?

Update (Jan. 15, 2022): After the Jan. 14, 2022, publication of this alert, the Centers for Medicare & Medicaid Services issued updated guidance to State Survey Agency directors providing 30 days (by Feb. 13) for facilities...more

Stop and Go — Supreme Court Halts Some (but Not Other) Employee Vaccine Mandates

On Jan. 13, 2022, the U.S. Supreme Court granted an emergency request for relief regarding one of the two Biden administration COVID-19 employee vaccine mandates on appeal before the Court...more

Provider Relief Fund Reporting Guidance: HHS to Reopen Provider Relief Fund Period 1 Reporting Dec. 13–20

HHS to Reopen Provider Relief Fund Period 1 Reporting Dec. 13-20 - The U.S. Department of Health and Human Services (HHS) reporting portal includes a new statement appearing to give providers an additional week in...more

Transaction Considerations and Regulatory Updates for Hospital Executives: Five Key Takeaways

Hospitals and health systems continue to navigate an environment in flux, one consistently impacted by a significant amount of transactional and regulatory activity. During a Nov. 2, 2021, webinar titled “Key Transaction...more

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