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Advisory Opinions

Gardner Law

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

Gardner Law on

Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

Hinshaw & Culbertson - Health Care

OIG Advisory Opinion 25-02 Integrates Community Health Center Social Support Services with Primary Care Referral Programs

The U.S. Department of Health and Human Services (HHS) Office of Inspector General ("OIG") issued Advisory Opinion No. 25-02 ("Opinion") on April 4, 2025, regarding a Health Center proposal to link social support services to...more

Sheppard Mullin Richter & Hampton LLP

CFPB Withdraws Dozens of Guidance Documents as Part of Deregulatory Push

On May 12, the CFPB formally withdrew nearly 70 guidance materials—including policy statements, advisory opinions, circulars, and interpretive rules—through a Federal Register notice issued by Acting Director Russell...more

Bricker Graydon LLP

Ohio Ethics Commission Clarifies Household Definition

Bricker Graydon LLP on

In Advisory Opinion 2025-01, the Ohio Ethics Commission (OEC) clarified when a public official or employee’s domestic partner crosses over to “family” for purposes of Ohio’s Ethics laws....more

Hudson Cook, LLP

Regulatory Reversal: CFPB's Withdrawal of Interpretive Guidance and Its Impact on the Rental Screening Industry

Hudson Cook, LLP on

On May 9, 2025, the Consumer Financial Protection Bureau (CFPB) formally withdrew dozens of interpretive rules, policy statements, advisory opinions, bulletins, and circulars issued over the past decade....more

Foley Hoag LLP - White Collar Law &...

Federal District Court Upholds HHS Advisory Opinion Blocking Fertility Assistance Program

A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...more

King & Spalding

Second Circuit Holds No FCA Violation Where Defendant Relied on Favorable OIG Advisory Opinions

King & Spalding on

On April 14, 2025, the Second Circuit issued a summary order holding that the relator failed to plead scienter, a necessary element under the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), where the defendant...more

King & Spalding

OIG Issues Favorable Advisory Opinion Permitting a Community Health Center to Refer Primary Care Services During Provision of...

King & Spalding on

On April 9, 2025, OIG posted Advisory Opinion No. 25-02, a favorable advisory opinion allowing a community health center operating under Section 330 of the Public Health Service Act (the Requestor) to ask individuals, to whom...more

Sheppard Mullin Richter & Hampton LLP

CFPB to Revoke Medical Debt Collection Advisory Opinion

On April 11, the CFPB filed a joint motion in the U.S. District Court for the District of Columbia indicating its intent to revoke an advisory opinion on medical debt collection. The Bureau requested a stay of litigation...more

Mintz - Health Care Viewpoints

OIG Issues Another Favorable Advisory Opinion on Patient Recruitment Efforts by Community Health Centers

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more

Parker Poe Adams & Bernstein LLP

Key Takeaways for Businesses From Recent South Carolina Department of Revenue Rulings

The South Carolina Department of Revenue (SCDOR) has had an active start to the year, issuing new administrative guidance that impacts a variety of businesses operating in the state. Each year, the department issues advisory...more

Orrick, Herrington & Sutcliffe LLP

CFPB to revoke its medical debt advisory opinion

On April 11, the CFPB stated in a court filing that it plans to revoke its advisory opinion on medical debt collection from October 1, 2024. The filing was a motion to the U.S. District Court for the District of Columbia and...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

ArentFox Schiff on

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

Baker Donelson

Relocation of Physician-Owned Hospitals: CMS Advisory Insights

Baker Donelson on

The Centers for Medicare and Medicaid Services (CMS) issued CMS Advisory Opinion No. CMS-AO-2025-1 on February 26, 2025, blessing the relocation of a physician-owned hospital. The hospital planned to relocate eight miles from...more

Bricker Graydon LLP

Ohio Ethics Commission Expands Definition of Family Member to Include Domestic Partners

Bricker Graydon LLP on

The Ohio Ethics Commission recently issued Advisory Opinion No. 2025-01, clarifying that domestic partners are now considered "family members" under Ohio's Ethics Law. This opinion marks a significant step in modernizing the...more

McGuireWoods LLP

CMS Opinion Offers Guidance on Relocation of Physician-Owned Hospitals

McGuireWoods LLP on

On Feb. 26, 2025, McGuireWoods successfully assisted a physician-owned hospital in obtaining a favorable advisory opinion from the Centers for Medicare & Medicaid Services (CMS) regarding its proposal to relocate the entire...more

Ballard Spahr LLP

CFPB revokes EWA advisory opinion

Ballard Spahr LLP on

The CFPB rescinded an advisory opinion that had described how one particular type of “earned wage” product did not involve the offering or extension of “credit” as that term is defined in the Truth in Lending Act and...more

Holland & Knight LLP

California Attorney General Issues New Legal Advisories on Artificial Intelligence

Holland & Knight LLP on

California Attorney General (AG) Rob Bonta issued two new Legal Advisories on Jan. 13, 2025, to provide further clarity on the application of California law(s) to businesses, including those in the healthcare industry, that...more

Orrick, Herrington & Sutcliffe LLP

CFPB rescinds previous opinion regarding how one EWA product was not a “loan”

On January 15, the CFPB issued an advisory opinion rescinding its 2020 advisory opinion on earned wage access (EWA) products. As previously covered by InfoBytes, the CFPB’s 2020 advisory opinion stated that a certain EWA...more

Troutman Pepper Locke

CFPB Rescinds 2020 Advisory Opinion on Earned Wage Access Products

Troutman Pepper Locke on

As part of a flurry of last minute regulatory activity by the Biden administration’s Consumer Financial Protection Bureau (CFPB or Bureau), on January 15, the CFPB published an advisory opinion in the Federal Register...more

King & Spalding

OIG Issues a Favorable Advisory Opinion to a Pharmaceutical Manufacturer Regarding Free Transportation, Lodging and Support for...

King & Spalding on

On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients...more

King & Spalding

DOJ Issues Final Rule Restricting Foreign Access to U.S. Data

King & Spalding on

The rule imposes substantial new diligence, reporting, cybersecurity, and auditing obligations on companies. On December 27, 2024, the U.S. Department of Justice (“DOJ”) issued a final rule implementing Executive Order...more

Bracewell LLP

Will FARA Get a Facelift? DOJ Proposes Updated Regulations for the First Time in 15 Years

Bracewell LLP on

After years of suggesting that modifications were in the works, the Department of Justice recently proposed drastic changes to the Foreign Agents Registration Act (FARA) that would, among other things, profoundly limit one of...more

Hinch Newman LLP

DOJ Issues Rule Addressing Threat Posed by Foreign Adversaries’ Access to Americans’ Sensitive Personal Data

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On Friday, December 27, 2024, the Justice Department issued a final rule to address “urgent national security risks posed by access to U.S. sensitive personal and government-related data from countries of concern and covered...more

Sheppard Mullin Richter & Hampton LLP

Navigating Gainsharing Pitfalls in Value-Based Models

As the shift toward value-based care continues to transform the healthcare industry, hospitals and health systems are increasingly utilizing incentive-based physician compensation structures. Incentive-based compensation...more

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