On October 7, 2021, five years after issuing initial draft guidance on its enforcement approach for hospitals and health system pharmacy compounding under section 503A of the Food, Drug, and Cosmetic Act (the “Act”), the U.S. Food and Drug Administration (“FDA”) released revised draft guidance (“Draft Guidance”) that provides increased flexibility to hospitals and health systems that compound drugs for patients within their facilities before receiving patient-specific prescriptions.
Most notably, the Draft Guidance removes the “one-mile radius” provision (as previously
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Hall, Render, Killian, Heath & Lyman, P.C.
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New Texas Exemptions to a COVID Vaccine Mandate
By Hall Render
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 held religious belief, observance or practice) and broader than would be required under the Americans with Disabilities Act (for disabilities). Accordingly, employers, who have mandated…
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Provider Relief Fund Updates: Application Deadline for Additional Funding Approaching as Phase One Reporting Continues
By Hall Render
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 for funding from the PRF Phase 4 General Distribution and American Rescue Plan (“ARP”) Rural Distribution is due October 26, 2021;
- Providers should immediately begin
PREP Act Eligibility Expanded for Pharmacists, Pharmacy Technicians and Interns Administering COVID-19 Therapeutics
By Hall Render
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. More specifically, it extends PREP Act liability protections to pharmacists who order/administer along with qualified pharmacy technicians and interns who, under the supervision of a…
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Texas Expands Sexual Harassment Protections
By Hall Render
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 employees were subject to the federal or state fair employment laws addressing sexual harassment. SB 45 extends coverage of the state laws to employers with…
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Biden Administration’s Revitalization of Gender-Based Protections Under Section 1557 of the ACA – What Do the Continuing Challenges Mean for Your Organization?
By Hall Render
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 on the basis of: (i) gender identity; (ii) sex stereotyping; and (iii) pregnancy, including termination of pregnancy, childbirth and related medical conditions. However, as we…
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Webinar Q&A: COVID-19 Vaccination Strategies for Health Care Employers
By Hall Render
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 redact any identifying names/information within these questions and answers. Please click here for the full summary of all questions we received following the webinar and…
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Teaching Physician and Teaching Hospital Changes in the Proposed 2022 Medicare Part B Payment Policies Rule
By Hall Render
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 describes how these proposals could limit teaching hospitals’ and teaching physicians’ options for assigning outpatient and office evaluation and management codes for patient encounters, as…
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