By Allison Shelton and Colleen Byrom, Brown & Fortunato, P.C. On July 23, 2020, the Department of Justice announced a $49 million settlement with Progenity, Inc. The settlement addressed claims that Progenity engaged in fraudulent billing practices and provided illegal kickbacks to physicians and their staff. Progenity is a biotechnology company based out of San Diego, California, that provides molecular and diagnostic testing services, such as prenatal testing, for genetic and chromosomal abnormalities. Claims against...

By Allison Shelton and Monique Pena, Brown & Fortunato, P.C. In a final rule published on June 19, 2020 (2020 Final Rule), the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) significantly reduced requirements placed on health care entities and narrowed OCR’s interpretations on prohibited discrimination. The 2020 Final Rule was adopted under Section 1557 of the Affordable Care Act which prohibits discrimination in health care on the basis of race,...

By Kelly T. Custer and Beth Anne Jackson, Brown & Fortunato, P.C.   Congress and CMS have issued round after round of sweeping regulatory waivers and rule changes to provide flexibility to the health care system as America grapples with COVID-19. These changes include provisions that make it remarkably easier for Medicare and Medicaid beneficiaries to access telehealth services. This article summarizes some of the changes and our thoughts on what telehealth will look like...

By Beth Anne Jackson and Kelly T. Custer, Brown & Fortunato, P.C.   Congress allocated $100 billion to the Public Health and Social Services Emergency Fund for provider relief (the Provider Relief Fund) in the CARES Act.  The Provider Relief Fund includes $50 billion dollars for general distribution and an additional $50 billion in special allocations.  The initial general distribution beginning April 10, 2020 of $30 billion resulted in payments proportionate to providers’ share of...

By Allison Shelton and Beth Anne Jackson, Brown & Fortunato, P.C. Amid the flurry of government actions, announcements, and other efforts to address the threat of COVID-19, the U.S. Department of Health and Human Services (HHS) released two final rules that will significantly impact the health care industry. On March 9, 2020, the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) issued companion...

By Beth Anne Jackson, Esq. and Allison Shelton, Esq. After a decision in Ciox Health Care LLC v. Alex Azar (Ciox) in January, health care providers will no longer be required to subsidize the provision of copies of medical records used by plaintiff attorneys to prove malpractice, personal injury and similar cases. The scheme was hatched after the Office of Civil Rights (OCR) published guidance in 2016 (Guidance) regarding patients’ ability to request that records...

By Elizabeth H. Jepson, Esq. and Beth Anne Jackson, Esq. In fiscal year 2019 (FY 2019), which ended September 30, 2019, the U.S. Department of Justice (DOJ) recovered over $2.6 billion in civil health care fraud actions.  This amount comprises the vast majority of the more than $3 billion recovered by DOJ in all civil fraud cases in FY 2019.  And early in January 2020, DOJ announced its first civil health care settlement of the...

By Allison Shelton and Elizabeth Jepson, Brown & Fortunato, P.C.   Health care providers typically have some discretion in determining whether an incident is reportable under the Health Insurance Portability and Accountability Act (HIPAA). However, providers should take care in exercising such discretion. As evidenced by a recent settlement between a hospital system and the Office for Civil Rights (OCR), a provider’s decision to not report an incident, may result in significant costs. Subject to certain exceptions,...

By Beth Anne Jackson and Elizabeth H. Jepson, Brown & Fortunato, P.C.   On November 15, 2019, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) issued two rules to increase pricing transparency and competition among hospitals, group health plans, and health insurance issuers.  The first rule was issued in final form (the 2020 Pricing Transparency Requirements), and the second was released as a proposed rule...

By Beth Anne Jackson and Allison D. Shelton, Brown & Fortunato, P.C.   On October 17, 2019, two agencies within the U.S. Department of Health and Human Services (HHS) finally proposed rules (Proposed Rules) intended to reduce the regulatory risk of value-based arrangements (VBAs) in health care. Specifically, the Centers for Medicare and Medicaid Services (CMS) proposed new exceptions to the physician self-referral law (Stark Law). Meanwhile, the Office of Inspector General (OIG) proposed changes...