Yesterday, the Supreme Court issued a unanimous decision holding that the scienter element of the False Claims Act (“FCA”) is met if a defendant subjectively knew his or her claims were false and submitted them anyway. See United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway. The Court’s ruling was narrow and avoided the more challenging—and common—issues raised during oral argument (which we previously discussed here).
Continue Reading Supreme Court Clarifies that Subjective (Not Objective) Knowledge of Falsity of Claim Dictates False Claims Act Liability

The Florida Legislature recently amended the Florida Electronic Health Records Exchange Act (the “Act”) to prohibit certain health care providers utilizing certified electronic health record technologies from storing qualified electronic health records[1] outside of the United States, its territories, or Canada.[2] Significantly, the prohibition also extends to qualified electronic health records that are stored through a third-party or subcontracted computing facility or cloud service provider.[3]…
Continue Reading Florida Bans Offshoring of Certain Patient Information

Texas is joining a growing number of states in passing comprehensive privacy legislation intended to safeguard consumer personal data.[1] Specifically, the Texas Data Privacy and Security Act (the “Act”) adds protections for consumers[2] and their personal data, which includes any information that is linked or reasonably linkable to an identified or identifiable individual.[3]…
Continue Reading Texas is Making Moves on a Comprehensive Consumer Privacy Law

With the Medicare Comprehensive Error Rate Testing program projected error rate for skilled nursing facilities (SNFs) showing a significant increase in 2022 (15.1%, up from 7.9% in 2021), the Centers for Medicare and Medicaid Services (CMS) has instructed each of its Medicare Administrative Contractors (MACs) that review SNF Medicare claims to initiate a five-claim probe and educate medical review for each SNF in the MAC’s jurisdiction.
Continue Reading CMS Takes Steps to Lower SNF Medicare Payment Error Rates

As an update to our previous post, on Monday, May 15, 2023, California Governor Gavin Newsom signed into law Assembly Bill 112 (“AB 112”), which is designed to provide critical relief to qualified struggling hospitals across the state. AB 112 creates the $150 million Distressed Hospital Loan Program, which is intended to provide zero-interest cash flow loans to qualified not-for-profit and public hospitals experiencing financial distress, as well as qualified government entities representing hospitals that closed after January 1, 2022. Hospitals across California, particularly those in underserved areas or serving vulnerable populations, have been hit hard by rising costs,…
Continue Reading Update to: A Lifeline Amidst Turbulent Times: California Lawmakers Approve Emergency Loans for Struggling Hospitals

On May 1, 2023, the Centers for Medicare and Medicaid Services (“CMS”) announced two investigations of hospitals that failed to offer necessary stabilizing care to a pregnant individual experiencing an emergency medical condition (“EMC”), in violation of the Emergency Medical Treatment and Labor Act (“EMTALA”). The U.S. Department of Health and Human Services (“HHS”) released a public statement and a letter to hospitals and provider associations, emphasizing the obligations of Medicare-participating hospitals’ under EMTALA, including stabilizing treatment, like abortion care, or an appropriate transfer. These investigations represent the first EMTALA enforcement action related to abortion emergency care since the…
Continue Reading EMTALA and Pregnancy Care Remains a Federal Enforcement Priority

Recently, we were invited to speak on a panel at the Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. We spoke about the federal information blocking rules, and highlighted how some actors are still engaging in conduct that the rules were intended to discourage, in part due to the lack of enforcement rules.
Continue Reading Laboratory and Pathology Information Blocking Concerns

This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan Haight Act (“RHA”) promulgated during the COVID-19 Public Health Emergency (“PHE”). This is notable as access to care, including mental health and substance abuse treatment, remains a crucial industry focus, especially as the transition to the post-PHE has begun.
Continue Reading DEA and SAMHSA Extend Tele-Prescribing Flexibilities

The Department of Health and Human Services Office of Inspector General (OIG) recently announced changes to its process for informing healthcare industry stakeholders of new or updated Compliance Program Guidance (CPG). Historically, sector-specific CPG has been published in the Federal Register. Going forward, the OIG will publish all current and updated CPG on its website.
Continue Reading OIG’s Modernization of Compliance Program Guidance: What to Expect

On March 24, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), in which it decided not to impose sanctions on an Arrangement to provide prepaid gift cards to patients for certain preventative screening tests (the “Arrangement”).
Continue Reading New OIG Opinion Permits Gift Cards to Beneficiaries in Limited Circumstances

On March 30, Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas issued a decision in Braidwood Management Inc. v. Becerra (“Braidwood”), invalidating the Affordable Care Act’s (“ACA’s”) mandate requiring health plans and health insurers offering health insurance coverage to provide coverage for preventative care services recommended by the U.S. Preventive Services Task Force (“USPSTF”). The case was pursued by religious individuals and businesses that asserted that they were harmed by being required to pay for health insurance coverage which included services that they do not want to cover on religious grounds.
Continue Reading Navigating the Wild West of the New ACA Preventative Care Ruling

Summary: California lawmakers have greenlighted emergency loans to support struggling hospitals facing financial challenges across the state. These loans will serve as a critical lifeline, helping eligible hospitals stabilize operations and navigate through turbulent times. Assembly Bill 112, passed by the California Senate and Assembly and expected to be signed by California Governor Gavin Newsom, establishes the Distressed Hospital Loan Program and the Distressed Hospital Loan Program Fund, which are designed to provide interest-free cashflow loans to not-for-profit hospitals, public hospitals in significant financial distress, and governmental entities representing a closed hospital (i.e., a hospital that closed after January 1, 2022). Understanding…
Continue Reading A Lifeline Amidst Turbulent Times: California Lawmakers Approve Emergency Loans for Struggling Hospitals

The growth of private equity and other financial sponsor investments in the health care industry has led many states across the country to adopt expansive oversight authority over health care transactions. With the enactment of New York State’s budget for the State Fiscal Year 2023-2024, signed into law on May 3, 2023, the movement for more oversight in New York is coming this summer.
Continue Reading New Notice and Public Disclosure Requirements for Material Health Care Transactions in New York