Healthcare Law Blog

Shaping the World of Healthcare Law

The Office of the Inspector General (“OIG”) recently issued Advisory Opinion 22-08 (the “Advisory Opinion”), concluding that the provision of limited use smartphones by a federally qualified health center (“FQHC”) to existing, low-income patients (the “Arrangement”) lacked the intent required to violate the federal Anti-Kickback Statute (“AKS”)[1] and was not likely to generate remuneration

On June 29, 2022, the Centers for Medicare and Medicaid Services (CMS) announced it issued significant changes to surveyor guidance for Long Term Care (LTC) facility health, quality and safety standards.[1] 

Some of the changes reflect clarifications to requirements that become effective during Phase 2 of the revised Requirements for Participation for LTC facilities

The AHLA’s Annual Meeting held June 27-29 in Chicago reunited healthcare attorneys across the country. The diverse group of attendees were eager not only to reconnect in-person, but also to process the changes that the now-easing pandemic has brought to all corners of the healthcare industry. The conference presenters grappled in real-time with the transitory

Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here. EKRA prohibits, among other things, the exchange of remuneration for referrals of patients or patronage to a clinical laboratory, or an individual’s use of

As telehealth services surged in response to the COVID-19 pandemic, unique compliance challenges likewise developed in unexpected ways. Recognizing these challenges, the Office of Civil Rights (“OCR”) indicated that it would exercise its enforcement discretion by declining to impose penalties against covered health care providers for instances of good faith noncompliance with the requirements of

On April 29, 2022, the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”).  CMS promotes the Final Rule as advancing “CMS’ strategic vision of expanding access to affordable health care

As of April 11, 2022, the Health Resources & Services Administration (“HRSA”) is now offering providers who missed the original Provider Relief Fund (“PRF”) reporting deadlines the opportunity to request the ability to report in compliance with the PRF Terms and Conditions. Request submissions for Reporting Period 1 are due by Friday, April 22,

On February 24, 2022, the Centers for Medicare & Medicaid Services (CMS) announced its redesign of the Global and Professional Direct Contracting Model (GPDC), which now will be called the Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model.
The REACH Model builds on CMS’s ten years of experience with accountable care

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Acknowledging that the COVID-19 emergency will not last forever, the FDA’s recent draft guidances propose a 180-day transition path