Compliance

CAP Files Amicus Brief in Support of No Surprises Act Lawsuit

The College of American Pathologists warns the No Surprises Act will further drive more physicians out of their patients’ health plan networks.

Compliance

FDA Updates Serology Templates for Covid-19 Test Developers

The two new templates offer recommendations on what to include in emergency use authorization requests for serology tests.

Compliance

CMS Posts New Covid-19 Testing Requirements for Labs, Nursing Homes

A memo recommends that facilities conducting patient lab tests use authorized detection antigens to prevent the spread of covid-19 in nursing homes.

FDA Proposes to Reclassify Two Types of Hepatitis C Virus Diagnostic Tests

Apr 8, 2020 | Compliance, Infectious Diseases, Lab Management, Molecular Diagnostics

If the agency’s proposed reclassification is finalized, devices of this type may go through the 510(k) pathway for clearance instead of the premarket approval (PMA) pathway.

Digital Pathology Association Commends CMS for Waiving Restrictions on Remote Pathology Diagnoses

Mar 31, 2020 | Compliance, Covid 19, Emerging & Zoonotic Diseases, Infectious Diseases, Lab Management

The waiver will provide temporary relief from federal regulations requiring pathologists to render primary diagnoses onsite at healthcare facilities.

CMS Issues Change Request for HCPCS Codes

Mar 12, 2020 | Compliance, Covid 19, Emerging & Zoonotic Diseases, Infectious Diseases, Lab Management

CMS has issued a change request to inform Medicare administrative contractors about new HCPCS codes that are subject to and excluded from CLIA edits.

HHS Finalizes Historic Rules to Provide Patients More Control of Their Health Data

Mar 11, 2020 | Compliance, Information Technology

Final rules require access to health information, spur innovation, and aim to end information blocking.

FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19

Mar 9, 2020 | Compliance, Covid 19, Emerging & Zoonotic Diseases, Infectious Diseases

FDA and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.

FDA Issues Clinical Laboratory Improvement Amendments-Related Final Guidances

Mar 8, 2020 | Compliance

FDA has recently issued two guidance documents for developers of in vitro diagnostics.

Illumina Files Patent Infringement Suits against BGI in Sweden and the United Kingdom

Jan 10, 2020 | Compliance, Molecular Diagnostics

Illumina has filed two additional patent infringement suits relating to BGI’s sequencing products. Related patent suits are pending in Denmark, Germany, Switzerland, Turkey and the United States.

MSBiosuite Bioinformatics Platform Tackles NGS Data Analytics

Nov 5, 2019 | Compliance, Research

The Cloud-based solution automates the analysis of next-generation sequencing data for liquid biopsy and FFPE workflows.

Inside Track: Expanding Consumer Genomic Testing

Aug 2, 2019 | Compliance

AMP President Victoria M. Pratt, PhD, discusses the association’s updated position statement on consumer genomic testing.

Planning for PAMA

Apr 15, 2019 | Compliance, Lab Management

Now is the time to make sure that hospital executives are fully educated about details of the Protecting Access to Medicare Act of 2014.

Data Collection under PAMA

Apr 15, 2019 | Compliance, Lab Management

Laboratories that meet CMS criteria must collect their private payor data for the first half of 2019, and report it to CMS no later than March 31, 2020.