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Federal Trade Commission’s GoodRx Settlement: Not Just a $1.5 Million Penalty
March 8, 2023 | Blog | By Lara Compton, Pat Ouellette
The Federal Trade Commission (FTC) recently kicked off enforcement of its Health Breach Notification Rule (Breach Rule) by taking aim at GoodRx’s use of tracking technologies (e.g. pixels) and the sharing of consumer health data for advertising purposes. According to Samuel Levine, director of the FTC's Bureau of Consumer Protection, the FTC “is serving notice that it will use all of its legal authority to protect American consumers' sensitive data from misuse and illegal exploitation." Bottom line, HIPAA applicability may no longer be as significant of a factor when it comes to the risk presented by collecting, using, disclosing, and maintaining identifiable health information (IHI).
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Telehealth Update: DEA Issues Long-Awaited Proposed Rule on Prescribing Controlled Substances via Telehealth
March 3, 2023 | Blog | By Ellen Janos, Cassandra Paolillo
With just over two months before the COVID-19 Public Health Emergency (PHE) expected expiration on May 11, 2023, the Drug Enforcement Agency (DEA) has finally announced its proposed rule on prescribing controlled substances via telehealth. This post provides continued coverage of telehealth updates and dissects what this DEA's proposed rule could entail.
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New York Proposes Regulatory Review and Approval of Material Health Care Entity Transactions
March 1, 2023 | Blog | By Jean D. Mancheno, Pamela Polevoy, Lara Compton
On February 1, 2023, New York Governor Kathy Hochul announced the Fiscal Year 2024 New York State Executive Budget (the Executive Budget). One component of the Executive Budget’s Health and Mental Hygiene Article VII Legislation is a proposal to require certain “health care entities” to obtain approval from the New York State Department of Health (DOH) prior to consummating a material transaction.
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CMS Proposes New Disclosure of Ownership Regulations for Nursing Facilities - Top Five Takeaways for Private Equity Firms and REITs
February 21, 2023 | Blog | By Lauren Moldawer, Karen Lovitch
Private equity ownership of health care providers is unquestionably under scrutiny by federal and state regulators. States are passing laws that either directly or indirectly target PE health care transactions. This post highlights the top five takeaways related to the proposed regulations for private equity companies or real estate investment trust ownership.
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Health Care Deal Structures: What Will the Deal Look Like?
February 15, 2023 | Blog | By Pamela Polevoy, Deborah Daccord, Cody Keetch
Deal structure is the foundation of a health care transaction. This post offers practical tips and hypothetical case studies for laying the groundwork for a successful health care transaction.
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FDA’s Digital Health High Notes from 2022
February 13, 2023 | Blog | By Benjamin Zegarelli
There has been a lot of discussion of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023, but we should also take a moment to review last year’s actions and policy updates on digital health from the Food and Drug Administration (FDA). The year 2022 marked the conclusion of the five-year Software Precertification Pilot Program and the release of the final Clinical Decision Support Software guidance, among other things (both described below); however, major digital health policy updates and announcements were few and far between. In this post, we summarize the agency’s key actions in the digital health space in 2022.
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EnforceMintz Newsletter — Quick Hits
February 9, 2023 | Blog | By Karen Lovitch
EnforceMintz — 2022 Saw the Expansion of EKRA Outside of the Addiction Treatment Setting
February 9, 2023 | Blog | By Kathryn Edgerton
EnforceMintz — With Telemedicine Here to Stay, Enforcement Agencies Continued their Scrutiny
February 9, 2023 | Blog | By Karen Lovitch
EnforceMintz — Significant 2022 Regulatory and Policy Developments
February 9, 2023 | Blog | By Samantha Kingsbury
EnforceMintz — Despite Some Setbacks, Enforcement Authorities Continue to Focus on the Opioid Supply Chain
February 9, 2023 | Blog | By Grady Campion
EnforceMintz — 2022 Teed Up Two False Claims Act Issues That the Supreme Court Is Poised to Answer in 2023
February 9, 2023 | Blog | By Samantha Kingsbury, Kevin McGinty
EnforceMintz — The Pandemic May Be Ending, But Fraud Prosecutions Will Keep Coming
February 9, 2023 | Blog | By Cory S. Flashner
EnforceMintz — Medicare Advantage Remains a Top Enforcement Priority
February 9, 2023 | Blog | By Brian Dunphy
Operation Nightingale: Fraudulent Nursing Diploma Scheme and Its Implications on Health Care
February 6, 2023 | Blog | By Sophia Temis
The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently partnered with various law enforcement agencies in a multi-state enforcement action aimed at uncovering a nursing degree fraud scheme: Operation Nightingale. This blog post discusses the related enforcement actions surrounding the fraud scheme and the broader implication on healthcare.
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New Group Practice Information Form for the Stark Law’s Self-Referral Disclosure Protocol
February 2, 2023 | Blog | By Rachel Yount
The Stark Law’s Self-Referral Disclosure Protocol (SRDP) will include a new Group Practice Information Form for physician practices to report any noncompliance arising from not fully satisfying the Stark Law’s definition for a “group practice,” effective March 1, 2023. The Centers for Medicare & Medicaid Services (CMS) intends for the changes to reduce regulatory burden and streamline the disclosure process.
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Garland Memo May Provide White Collar Defendants Increased Opportunity for Negotiation While Updated Corporate Enforcement Policy Highlights the Importance the Department of Justice Places on Self-Disclosure, Cooperation, and Remediation
February 2, 2023 | Blog | By Eoin Beirne, Edmund P. Daley, Nick A. LaPalme
Supreme Court Justices Agree to Hear Second FCA Issue This Term
January 19, 2023 | Blog | By Samantha Kingsbury, Kevin McGinty
As many of our readers are likely aware, last week the Supreme Court agreed to hear a second False Claims Act (FCA) issue this term. Having previously accepted and heard argument on a case concerning the government’s authority to dismiss an FCA whistleblower case after declining to intervene, the Court has now granted certiorari to hear two cases addressing what constitutes a “knowing” violation of the FCA. Hanging in the balance is the fate of two lower court decisions that endorsed a powerful defense to FCA liability.
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CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard
January 17, 2023 | Blog | By Laurence Freedman, Jane Haviland
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims Act (FCA) and the Civil Monetary Penalties Law. Though this proposal purportedly ensures that a lack of “reasonable diligence” cannot create civil liability, it would create significant confusion as to how CMS expects providers and Medicare Advantage organizations (MAOs) to “identify” and quantify potential overpayments before triggering the 60-day period to refund them. The proposed rule, if adopted, would likely become part of the framework for the Department of Justice and Department of Health & Human Services’ Office of Inspector General when evaluating potential liability for the alleged failure to return overpayments.
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Telehealth Update: PHE Extended Through April 2023, But Some Key Telehealth Flexibilities Will Stick Around Longer
January 12, 2023 | Blog | By Ellen Janos, Cassandra Paolillo
The COVID-19 Public Health Emergency (PHE), which was originally declared nearly three years ago, has been renewed through April 2023. As we’ve previously covered, the PHE allowed federal and state regulators to relax certain telehealth requirements, which has led to a rapid expansion in the availability of telehealth services. The Biden Administration has committed to provide at least 60 days’ notice prior to terminating the PHE or allowing it to expire, but several news outlets are reporting that this could be the final extension.
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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