Public Health Emergency

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On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA requirement that off-site, outpatient facilities be (1) listed as reimbursable on the hospital’s Medicare Cost Report (MCR) prior to participating in the 340B Program; and (2) registered and listed in the Office of Pharmacy Affairs Information System (OPAIS) prior to participating in the 340B Program.Continue Reading HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

Below is an excerpt of an article  published in the May 2023 issue of  Health Law Connections, the member magazine of the American Health Law Association. Kate and Conor were assisted on this article by Health Law Group intern Paul Sevigny.

COVID-19 has driven increased telehealth access and technology-based health care services.

The Office of Inspector General (OIG) recently issued two notable compliance updates, of which health care organizations should take note as the COVID-19 public health emergency ends and regulatory compliance activities ramp up.Continue Reading OIG Compliance Updates

On April 11, 2023 – one month in advance of the end of the COVID-19 public health emergency (PHE) on May 11, 2023 – the federal Office for Civil Rights (OCR) confirmed that various Notifications of Enforcement Discretion issued under HIPAA during the PHE will expire at the end of the day on May 11, 2023.Continue Reading OCR Reminder: Pandemic-Era HIPAA Flexibilities Will End May 11, 2023

The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers, legislative changes, and flexibilities that have been established during the PHE. The government previously announced that the PHE will expire at the end of the day on May 11, 2023. CMS is providing this guidance as part of efforts to ease the transition for health care providers, patients, and other industry stakeholders away from pandemic-era policies and practices tied to PHE authorities. CMS emphasizes that many of the waivers and flexibilities are or will become permanent or extended, and others are intended to end on or soon following May 11, 2023.

Below please find a summary of key guidance provided by CMS in the Fact Sheet and in related CMS PHE guidance documents issued recently:Continue Reading CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency

Excerpt of a contributed article published in Medical Economics on August 13, 2020.

The public health emergency (PHE) caused by the COVID-19 pandemic has resulted in systemic changes throughout the nation’s health care system. Almost overnight, health systems, providers and the government were forced to collaborate to ‘stand up’ field hospitals, testing sites, and quarantine…

On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (the “Interim Rule”) in the Federal Register, setting forth additional regulatory waivers and other changes to healthcare regulations and policies in response to the COVID-19 public health emergency (PHE). At a high level, the Interim Rule encompasses topics including expansion of telehealth, support for and expansion of COVID-19 testing, allowing certain licensed professionals to practice at the top of their licenses, Medicare payments for teaching hospitals, changes to the Medicare Shared Savings Program regarding financial methodologies, and application and risk assumption deadlines for accountable care organizations, among other changes. CMS has also updated provider-specific fact sheets on recent waivers and flexibilities, available here. Below are highlights from the Interim Rule.  Providers are encouraged to read all applicable sections of the Interim Rule in their entirety here. Comments may be submitted to CMS within 60 days of the date of publication in the Federal Register.
Continue Reading CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

The U.S. Department of Health and Human Services (HHS) has used its authority to waive certain provisions of HIPAA in response to Hurricane Harvey.  HHS previously declared a public health emergency in Texas and Louisiana related to the hurricane and its aftermath.  
Continue Reading HHS Issues Limited Waiver of HIPAA Sanctions Post-Hurricane Harvey