News & Analysis as of

CLIA Health Care Providers

Mintz - Health Care Viewpoints

FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to Stakeholders

The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding...more

Alston & Bird

Health Care Week in Review: House Passes Minibus, HHS Releases Public Inquiry on Private Equity in Health Care

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Foley Hoag LLP

United States v. Elizabeth Holmes and Ramesh Balwani

Foley Hoag LLP on

I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more

Roetzel & Andress

COVID Laboratory Testing Investigations

Roetzel & Andress on

On this episode of the HealthLaw HotSpot, host Ericka Adler, Roetzel shareholder and Health Law Practice Group Leader, is joined by fellow Roetzel attorney Christina Kuta to discuss laboratory testing investigations related...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

Oberheiden P.C. on

Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

Foley & Lardner LLP

COVID-19 At-Home Tests: Do CLIA Requirements Apply and what do Health Care Providers Need to Know?

Foley & Lardner LLP on

Demand for COVID-19 tests, including over-the-counter at-home tests, has soared with the surge of the Omicron variant of the COVID-19 virus. However, health care providers, employers, and individuals have lacked clarity on if...more

Mintz - Health Care Viewpoints

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

Bass, Berry & Sims PLC

Penalties for COVID-19 Reporting Failures and Other New CMS Rules on Mandatory Testing and Ordering Limits

Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more

McDermott Will & Emery

Healthcare’s Next Normal: CMS Directs States to Resume Routine Surveys and Enforcement

McDermott Will & Emery on

On August 17, 2020, the Centers for Medicare and Medicaid Services (CMS) announced in a memo to State Survey Agency Directors (QSO-20-35-ALL) the resumption of certain routine surveys and inspections of healthcare providers...more

Maynard Nexsen

Federal Distribution of Point-of-Care COVID-19 Testing Instruments for Nursing Homes Begins This Week

Maynard Nexsen on

The U.S. Department of Health and Human Services (HHS) announced on July 14, 2020 that it is distributing rapid point-of-care diagnostic test instruments and tests to all 15,400 nursing homes throughout the country to...more

Faegre Drinker Biddle & Reath LLP

CMS Offers Guidance On Expedited CLIA Certification

Laboratories that perform tests on human materials for the purpose of diagnosis are considered laboratories under the Clinical Laboratory Improvement Amendments (CLIA) and must receive CLIA certification. Basic elements of...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

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

On January 2, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule entitled, Confidentiality of Substance Use Disorder Patient Records. The final rule makes changes to the SAMHSA...more

Robinson+Cole Health Law Diagnosis

The Joint Commission Relaxes Process for Credentialing Independent Pathologists

Effective January 3, 2018, The Joint Commission (TJC) has revised its standards to no longer require TJC-accredited hospitals, critical access hospitals, and ambulatory care organizations to credential and privilege...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

On November 27, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Pediatric Information for X-ray imaging Device Premarket Notifications. The guidance outlines FDA’s rationale regarding information that...more

Foley & Lardner LLP

Navigating the Diagnostic Commercialization Process

Foley & Lardner LLP on

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

K&L Gates LLP

Potential Stark Changes Ahead

K&L Gates LLP on

On July 15, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published proposed regulations governing policies and payments made under the Physician Fee Schedule for calendar year 2016 (the “Proposed Rule”). In...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

19 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide