Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 126: Josh Arant, COO, Mako Medical
Part I: COVID-19 Diagnostic Testing Coverage - On January 30, 2023, the Biden Administration announced that it intends for the National Emergency (NE) relating to the COVID-19 pandemic to end on May 11, 2023....more
On January 30, 2023, the Biden Administration announced that it intends for the National Emergency (“NE”) relating to the COVID-19 pandemic to end on May 11, 2023. Shortly after, the Secretary of the Department of Health and...more
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more
On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more
The Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2023 Medicare Physician Fee Schedule (PFS) Final Rule on Nov. 1, 2022, which impacts Medicare Part B payments starting on Jan. 1, 2023....more
Although businesses, schools, and the general population seem to be moving COVID-19 to the background, it’s still very much on the forefront of employer health plan administration. Health and Human Services (HHS)...more
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA warns...more
The US Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) on January 10 published much-anticipated FAQs implementing President Joseph Biden’s announcement last month to expand...more
According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath. Instead of relying on a lab, the...more
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more
Learning objectives: - Governmental/Payor Data Analytics - Impact of Yates Memo and Data Analytics - COVID-19 Evaluation and Management Coding and Documentation - COVID-19 Testing Coding and Documentation -...more
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...more
As COVID-19 testing continues to increase throughout the nation, providers and patients alike are faced with the issue of who is responsible for covering the cost of testing. Whether a payor will reimburse for a COVID-19 test...more
On May 7, 2020 Connecticut Governor Ned Lamont issued Executive Order 7KK allowing pharmacists to order COVID-19 tests....more
The Families First Coronavirus Response Act (Act), signed into law Wednesday, requires group health plans to provide coverage for coronavirus (COVID-19) diagnostic testing, including the cost of healthcare provider visits (as...more