Topic
Diagnostic Testing
41 published works
Health Industry Washington Watch
CMS Proposes Permanent Virtual Direct Supervision of Diagnostic Tests
By Thomas W. Greeson, Paul W. Pitts, James F. Hennessy, Smita Patil, Liyun Huang, Matthew Loughran
On July 14, 2025, the Centers for Medicare & Medicaid Services (“CMS”) issued the proposed Medicare Physician Fee Schedule Rule for Calendar Year (“CY”) 2026. Building on the temporary flexibility…
Trends in Transformation
FDA Publishes FAQs Around Its Recent Laboratory Developed Tests Final Rule
Linda Malek and Jason Johnson are partners in Crowell’s Health Care and Privacy & Cybersecurity Groups, and have a particular focus on advising clients on compliance issues related to clinical…
Healthcare Law Blog
FemTech Meets DiagnosTech: A Discussion with Deirdre O’Neill
By Michael Sutton, Sara Shanti, Phil Kim
Emerging technologies are prompting a revolution in women’s healthcare through advanced diagnostic testing. In the sixth episode of Sheppard Mullin's Health-e Law Podcast, Deirdre O'Neill, Chief Commercial & Legal Officer…
Health Care and Life Sciences
Unpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA
This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The answer is that, on average, the…
The FCA Insider
Free FQHC COVID-19 Testing Approved by OIG
By Timothy Fry
As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about…
Immuno-Innovation
A Glimmer of Light for Immunotherapy Diagnostic Method Patents
Antibody-based serology tests and PCR tests for coronavirus are being approved at a breakneck pace by the U.S. Food and Drug Administration under newly relaxed guidelines. As recently as May…
Healthcare Law Insights
Missouri Encourages COVID-19 Diagnostic Testing but Urges Caution with Serological/Antibody Testing
By Lorinda Holloway, Tamar Hodges RN, JD
Due to expanded COVID-19 diagnostic testing availability, the Missouri Department of Health and Senior Services (MDHSS) is encouraging providers to test both symptomatic and asymptomatic individuals, if the clinician’s medical…
Healthcare Law Insights
CMS Doubles Payment for Diagnostic Lab COVID-19 Testing
By Wakaba Tessier, Erica M. Ash
On April 14, 2020, CMS released a ruling that will increase the reimbursement for tests conducted to detect SARS–CoV–2 (the diagnosis of the virus that causes COVID–19) for tests utilizing…
Law and the Workplace
EEOC Updates Its COVID-19 Guidance
By Caralyn M. Olie, Harris Mufson
On June 17, 2020, the EEOC issued additional, revised technical assistance to employers, specifically addressing necessary considerations for employers that have employees returning to the workplace who are at higher…
Health Law Diagnosis
Departments of Labor, Health and Human Services, and the Treasury Issue FAQ guidance on the FFCRA, the CARES Act, and other health coverage issues related to COVID-19
On April 11, 2020 the U.S. Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments) issued guidance in the form of frequently asked questions…