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CMS Again Settles Record Stark Self-Disclosures in 2023

The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2023 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark...more

Ounce of Prevention: Are Independent Contractor Agreements Signed?

Applicable Provider Types: All - Is Your Entity in Compliance? Financial relationships with an independent contractor in a position to make or influence referrals of federal healthcare program business can implicate...more

Lessons for Providers and Practice Entities: Ophthalmology Groups Pay Millions to Settle Co-Management, Optometrist Relationship...

Recently, two ophthalmology practice groups — Kleiman Evangelista Eye Centers of Texas (KEEC) and SouthEast Eye Specialists, PLLC (SEES) — reached large settlements with the U.S. government over allegations that the groups’...more

HHS Advisory Opinion Approves Profit-Based Bonus Plan for Bona Fide Physician Employees

On Oct. 13, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-07 approving a multispecialty physician practice’s proposal to pay bonuses to each of its...more

CMS Settles Record Number of Stark Self-Disclosures

The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2021 and 2022 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law...more

Private Equity in Healthcare – An Updated Review of Selected Niche Investment Areas

Since mid-2022, the macro acquisition environment has faced the challenges of inflation and increasing interest rates, among a variety of other headwinds. Global deal flow is down from its 2021 peak. Yet, as this white paper...more

U.S. Supreme Court Clarifies DOJ’s Authority to Dismiss Whistleblowers’ False Claims Act Suits, Questions Constitutionality of Qui...

In United States ex rel. Polansky v. Executive Health Resources, Inc., the U.S. Supreme Court recently resolved a circuit split[1] by holding that in a False Claims Act (“FCA”) action (1) the Government may seek dismissal of...more

Supreme Court Clarifies the False Claims Act’s Knowledge Requirement, Eliminating a Potential Defense for Government Contractors...

On June 1, 2023, the Supreme Court unanimously ruled in favor of whistleblower plaintiffs (referred to as “relators”) in consolidated False Claims Act (“FCA”) cases in a decision that clarified the application of the FCA’s...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

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

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

Stark Law 2020 Settlements Return to Pre-2019 Trend

The Centers for Medicare & Medicaid Services (CMS) recently announced 2020 settlements concerning past violation or potential violations of the physician self-referral law (the Stark Law) and the number and value of such...more

CMS statement clarifies agency’s view that the Stark Law final rule is effective

Industry publication BVWire quoted a statement from the Centers for Medicare & Medicaid Services (CMS) that gives healthcare providers more certainty to rely on the much heralded final rule modernizing the physician...more

Fraud and Abuse Rules Part V: Easing Stark Law Compliance

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the regulations to the Physician Self-Referral Law (Stark Law), the federal...more

Fraud and Abuse Rules Part IV: Final Changes to Existing and New Anti-Kickback Statute Safe Harbors

As discussed in a prior McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute...more

Fraud and Abuse Rules Part III: New Value-Based Arrangement Protections

As discussed in a previous McGuireWoods alert, the Department of Health and Human Services (HHS) published final rules, effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law (Stark Law), the...more

Omnibus Appropriations Package – 15 Key Provisions for Healthcare Providers

Passed by Congress Dec. 21, 2020, and signed by President Donald Trump Dec. 27, 2020, the $1.4 trillion omnibus Consolidated Appropriations Act, 2021 (H.R. 133), includes numerous statutory provisions that directly affect...more

Stark Law and Anti-Kickback Statute Reform: Six Key Insights for Private Equity Healthcare Affiliations

Two new healthcare fraud and abuse final rules, effective Jan. 19, 2021, may increase flexibility for private equity firms exploring opportunities in the healthcare space as well as private equity-backed healthcare platforms...more

HHS Finalizes Stark Law, AKS Changes to Reduce Burdens on Healthcare Providers

On Nov. 20, 2020, the U.S. Department of Health and Human Services (HHS) published two long-awaited final rules significantly amending the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and...more

HHS Extends Timeline to finalize Stark Law Changes and CMP Inflation Rule

In the last two weeks, the U.S. Department of Health and Human Services (HHS) published two notices in the Federal Register delaying the publication of certain final fraud and abuse rule reforms for up to a full year. First,...more

COVID-19 – New Regulatory Flexibilities for Durable Medical Equipment Suppliers

On April 29, 2020, the Centers for Medicare & Medicaid Services (CMS) updated its guidance regarding several emergency waivers related to Medicare and Medicaid policy and regulatory revisions, which were originally issued on...more

CMS Issues Explanatory Guidance on Stark Law Blanket Waivers During COVID-19 Pandemic

On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance on the scope and application of the blanket waivers to the Physician Self-Referral Law (Stark Law) issued by the Department of Health and...more

COVID-19: Consolidated Medicare Telehealth Expansion Update

On March 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFC). This alert is part of a series of alerts discussing the IFC provisions and comprehensive actions...more

OIG Follows the Stark Law COVID-19 Waivers for Anti-Kickback Statute

On April 3, 2020, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) issued a policy statement announcing that the OIG will exercise its enforcement discretion not to impose...more

Emergency Declaration Waivers, Interim Rule for Medicare Home Health and Hospice Providers Amid COVID-19

On March 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFC). This alert is part of a series of alerts discussing the IFC provisions and comprehensive actions...more

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