News & Analysis as of

False Claims Act (FCA) Rulemaking Process

Foley & Lardner LLP

ORI Proposes New Rulemaking for Research Misconduct Regulations

Foley & Lardner LLP on

On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more

Venable LLP

FTC Issues New Rulemaking Proceedings on Customer Reviews and “Junk Fees”

Venable LLP on

​​​​​​​Last week at its monthly open meeting, the Federal Trade Commission (FTC) unveiled two new rulemaking proceedings: the first deals with deceptive customer reviews and endorsements and the second with so-called junk...more

McDermott Will & Emery

Healthcare Enforcement Quarterly Roundup - Q4 2019

In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more

Morgan Lewis

Protecting Your Investment: Insights For 2020

Morgan Lewis on

Investors and investment managers around the globe are seeing increasing rules and regulations on how they can deploy their money, how they can advertise their services, and how they have to report to regulators. ...more

Akin Gump Strauss Hauer & Feld LLP

False Claims Act - Year In Review: Five Decisions That Will Affect the Future of FCA Litigation - The Salcido Report: False Claims...

Key Points: - False Claims Act plaintiff cannot use discovery to satisfy Fed. R. Civ. P. 9(b). - Payment of fair market value is a dispositive defense in FCA actions alleging a violation of the Anti-Kickback Statute. ...more

Seyfarth Shaw LLP

In Case You Missed It: Guidance on Health Care Fraud Enforcement and Compliance

Seyfarth Shaw LLP on

The Houston Bar Association and the University of Houston Law Center Health Law & Policy Institute partnered to host the “Guidance on Health Care Fraud Enforcement and Compliance - A Conversation with HHS Counsel and Other...more

Polsinelli

CMS Outlines New Standard for Challenging Medicare Payment Denials, Echoing Brand Memo on Force of Sub-Regulatory Guidance

Polsinelli on

On October 31, 2019, the Office of General Counsel for the U.S. Department of Health and Human Services (HHS) issued an important memo from Kelly M. Cleary, CMS Chief Legal Officer, and Brenna E. Jenny, Deputy General...more

Bricker Graydon LLP

CMS proposes new Stark Law exception for limited remuneration to a physician

Bricker Graydon LLP on

On October 9, 2019, the Centers for Medicare and Medicare Services (CMS) released proposed changes to the regulations interpreting the Physician Self-Referral Law (Stark Law), including a new proposed exception for limited...more

Bricker Graydon LLP

CMS proposes to change the way group practices can pay profit shares to physicians under Stark Law

Bricker Graydon LLP on

Part of the Centers for Medicare and Medicaid Services’ (CMS) proposed changes to the regulations interpreting the Physician Self-Referral Law (the “Stark Law”), released on October 9, 2019, include changes to the special...more

Bricker Graydon LLP

CMS proposes to recalibrate the scope and application of the Stark regulations

Bricker Graydon LLP on

As part of the long-awaited proposed changes “to modernize and clarify” the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) released on October 9, 2019, the Centers for Medicare and Medicaid...more

Bricker Graydon LLP

CMS proposes changes to and clarifications of key Stark Law terms

Bricker Graydon LLP on

Part of the Centers for Medicare and Medicaid Services’ (CMS) proposed changes “to modernize and clarify” regulations interpreting the Physician Self-Referral Law (the “Stark Law”), released on October 9, 2019, contain...more

Akerman LLP - Health Law Rx

Possible Changes to Stark Law in 2019

Last summer The Centers for Medicare and Medicaid Services (CMS) solicited input on potential amendments to the federal Physician Self-Referral Law (the Stark Law)....more

Epstein Becker & Green

Reimbursement Issues Worth Noting: Administrative Law and False Claims Act Implications

Epstein Becker & Green on

News of two distantly related reimbursement issues with administrative law and False Claims Act (“FCA”) implications is worth noting....more

Mintz - Health Care Viewpoints

The 2014 Overpayment Rule is Vacated: How We Got Here and Key Takeaways

Medicare Advantage Organizations (MAOs) have been hailing a federal judge’s recent ruling to vacate the 2014 Overpayment Rule. But, how did we get here? And what does it really mean for MAOs? ...The Medicare Advantage...more

Ruder Ware

Changes in Federal Enforcement Cases and the Stark Law May Benefit Health Care Providers

Ruder Ware on

Some recent changes in federal law and in federal agency interpretation of federal law may both clarify and relieve some regulatory obligations of health care providers. Lessening Dependence on Federal Agency...more

McDermott Will & Emery

Guidance on Guidance: DOJ Limits Use of Agency Guidance Documents in Civil Enforcement Cases

McDermott Will & Emery on

In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...more

Jones Day

DOJ Limits the Use of Agencies' Guidance Documents in Civil Enforcement Actions

Jones Day on

The Department of Justice ("DOJ") recently issued a memorandum limiting the ability of its litigators to use agency guidance documents in civil enforcement actions against private parties. The memo expands on a directive...more

Sheppard Mullin Richter & Hampton LLP

“Brand Memo” Prohibits US DOJ From Converting Agency Guidance Into Binding Legal Obligations In Civil Enforcement Actions

On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum (the “Brand Memo”) limiting the use of agency guidance documents in affirmative civil enforcement cases. The memorandum builds on Attorney...more

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