Articles and Blogs

On October 7, 2021, five years after issuing initial draft guidance on its enforcement approach for hospitals and health system pharmacy compounding under section 503A of the Food, Drug, and Cosmetic Act (the “Act”), the U.S. Food and Drug Administration (“FDA”) released revised draft guidance (“Draft Guidance”) that provides increased flexibility to hospitals and health... READ MORE

On Monday, October 11, Texas Governor Greg Abbott issued Executive Order GA-40, requiring that employers provide exemption from any COVID-19 mandate for reason of personal conscience, religious belief or for medical reason, including prior recovery from COVID-19. These exemptions are broader than those required under Title VII of the Civil Rights Act (for sincerely... READ MORE

The Department of Health and Human Services Health Resources and Services Administration (“HRSA”) released multiple key Provider Relief Fund (“PRF”) updates over the past four weeks, which include opening a new application for additional PRF funding. The new funding application process and other updates are discussed in more detail below. Practical Takeaways The applications... READ MORE

On September 14, 2021, HHS issued a ninth amendment (the “Ninth Amendment”) to the Declaration for medical countermeasures against COVID-19 (the “Declaration”) under the Public Readiness and Emergency Preparedness Act (“PREP Act”). This Amendment expands the scope of authority for licensed pharmacists along with qualified pharmacy technicians and interns relative to FDA-approved COVID-19 therapeutics.... READ MORE

Effective September 1, 2021, employers in Texas are subject to two significant amendments to the state employment law: SB 45 and HB 21 to the Texas Labor Code expand sexual harassment protections for employees in essentially all workplaces. More Employers Can Now Expect to Receive Legal Challenges Previously, only employers with 15 or more... READ MORE

Section 1557 of the Affordable Care Act (“Section 1557”) prohibits discrimination on the basis of race, color, national origin, sex, age or disability by any health program or activity that receives federal financial assistance. In 2016, HHS promulgated a Final Rule (“2016 Rule”) that interpreted discrimination on the “basis of sex” to include discrimination... READ MORE

Hall Render recently hosted a webinar on July 12, Effectively Navigating the Changing Landscape: COVID-19 Vaccination Strategies for Health Care Employers. The following includes a selection of audience questions that our attorneys received during and after the webinar. We made a few additional modifications to avoid duplicate questions and responses and also decided to... READ MORE

On July 23, 2021, CMS published its proposal for changes to its Medicare Part B payment policies for calendar year 2022, including proposed changes for teaching physician billing. In addition, in the same proposed rule, CMS published a proposal to modify the reporting relating to teaching hospitals under the Open Payments system. This article... READ MORE