News & Analysis as of

CLIA Laboratories

ArentFox Schiff

CMS Revises Survey Prioritization and Resumes Enforcement Activities

ArentFox Schiff on

On August 17, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Guidance Memorandum (Guidance) setting forth revised state survey agency priorities as well as providing information regarding the resumption...more

Fox Rothschild LLP

PA ASC Guidance Requires CLIA Certification For COVID-19 Testing

Fox Rothschild LLP on

On May 23, 2020, the PA Department of Health (DOH) revised its guidance for ambulatory surgical facilities (ASFs) to require ASFs that intend to provide COVID-19 testing to patients and staff to hold the appropriate CLIA...more

Chambliss, Bahner & Stophel, P.C.

Medicare Reimbursement of Pharmacy-Based COVID-19 Testing

On May 8, 2020, CMS issued guidance clarifying how pharmacies and other suppliers can obtain waivers to allow them to temporarily enroll as independent clinical diagnostic laboratories for the purpose of providing COVID-19...more

Mintz - Health Care Viewpoints

Florida Repeals Laboratory Licensure Requirements Effective July 1st

Thousands of laboratories nationwide will be happy to hear that Florida, which licenses in-state as well as out-of-state laboratories, has repealed its laboratory licensure requirements. As of July 1, 2018, laboratories...more

Mintz

What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

Mintz on

Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

Mintz - Health Care Viewpoints

OCR Delays Required Changes to Notices of Privacy Practices for Laboratories

The HHS Office of Civil Rights (OCR) has granted certain clinical laboratories a temporary reprieve from the requirement to update their Notices of Privacy Practices (NPPs) by September 23, 2013, the deadline imposed by the...more

Bradley Arant Boult Cummings LLP

CMS Issues Proposed Rule to Reform "Unnecessary, Obsolete, or Excessively Burdensome" Medicare Participation Standards

On February 4, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to reform Medicare regulations that CMS views as unnecessary, obsolete, and/or excessively burdensome on hospitals and health care...more

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