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HHS Dear Colleague Letter Outlines Nondiscrimination Requirements for Medical Schools

On May 6, 2025, the U.S. Department of Health and Human Services (HHS) issued a Dear Colleague Letter on Nondiscrimination Requirements for Medical Schools on the Basis of Race, Color, and National Origin pursuant to Students...more

Fourth Circuit Upholds OIG Advisory Opinion Process

On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services,...more

Second Circuit Joins Other Circuits with AKS One Purpose Test

On December 27, 2024, the United States Court of Appeals for the Second Circuit decided United States ex rel. Camburn v. Novartis Pharmaceuticals Corporation and joined a growing list of federal circuit courts that have...more

Ounce of Prevention: Are You Providing Free Translators for Individuals with Limited English Proficiency?

Applicable Provider Types: All - Is Your Entity in Compliance? Recent regulatory language makes clear that most healthcare providers must provide free translators or interpreters for patients with limited English...more

Eight Healthcare Provider Requirements From Updated Section 1557 Nondiscrimination Rule

On May 6, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) published their final rule on nondiscrimination in the Federal Register...more

OIG’s New Compliance Guidance: 10 Action Items and Six Themes for Providers

On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued the General Compliance Program Guidance (GCPG) for healthcare providers and other industry stakeholders. The GCPG...more

A Failed Constitutional Challenge to the AKS Safe Harbor Provision – More to come?

This past summer, in United States v. Booker, a North Carolina district court ruled against a challenge to the constitutionality of Congress’s delegation of authority to promulgate safe harbors to the Anti-Kickback Statue...more

$12M Default Judgment Results from Purchasing Prescriptions

A large damage award serves as a significant reminder to file an appearance in a False Claims Act (FCA) case. In late August of 2022, the Government filed suit against AZ Diabetic and the owner, Hisham Zaghal (Zaghal),...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

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

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

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

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

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

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

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

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

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

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

Provider Relief Fund Reporting Guidance: HHS Grants Reporting Grace Period Until Nov. 30 for Provider Relief Fund

HHS Grants Reporting Grace Period Until Nov. 30 for Provider Relief Fund - The U.S. Department of Health and Human Services (HHS) recently announced a 60-day grace period to allow providers to comply with the Provider...more

Provider Relief Fund Reporting Guidance

Any healthcare provider that received at least $10,000 from the Provider Relief Fund (described further below) during the first half of 2020 must report on its use of those funds by Sept. 30, 2021. To facilitate these...more

Provider Relief Fund Reporting Guidance

Healthcare providers will have 90 days, beginning July 1, 2021, to report on funds they received in the first half of 2020 from the Public Health and Social Services Emergency Fund (Provider Relief Fund)....more

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