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
The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more
This week, the Ninth Circuit considers whether COVID-testing providers have a private right of action for reimbursement and considers a landlord’s standing to challenge a COVID-related eviction moratorium. SALOOJAS, INC....more
In April 2022, CMS announced an initiative to pay for Medicare beneficiaries to receive free OTC COVID-19 test kits. Specifically, Medicare established a demonstration project to pay various eligible healthcare providers to...more
On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency Use Authorizations...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
This is a supplement to our January 16, 2022 article titled “Free over-the-counter COVID test (if you can find them)” on the new requirements related to health plans providing free over-the-counter COVID tests. Last...more
The COVID-19 pandemic has caused an enormous need for testing and has spawned the creation of new labs and specimen collection agencies to (try to) meet that need. In 2020 alone, Medicare spent $1.5 billion on COVID-19 tests....more
On December 2, 2021, President Biden announced that federal agencies would soon issue guidance regarding the availability of coverage/reimbursement from group health plans and health insurance carriers for individuals who...more
At the start of the COVID-19 pandemic, each state and the federal government announced various states of public health emergencies which enabled them to suspend or modify various laws, rules, and regulations to accommodate...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
The Canadian Agency for Drugs and Technologies in Health (CADTH) published an interesting new report on January 29, 2021 about Health Technology Trends to Watch. The report identifies the following list of emerging trends...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 CMS, DOL and Treasury Departments recently and jointly issued FAQs about how group health plans are required to cover COVID-19 Diagnostic Testing without cost-sharing. The guidance makes clear that private group health...more
FDA has been monitoring the emergence of novel coronavirus mutations and variants and their potential for impacting the results of currently authorized COVID-19 tests. On February 22, FDA issued a new Guidance for...more
At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and...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
Clinical laboratories across the country have ramped up their diagnostic testing capabilities to meet the critical need for COVID-19 testing, which is essential to mitigating the spread of the virus. Many labs are responding...more
On December 15, 2020, the U.S. Food and Drug Administration (FDA) finally issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home...more
Out-of-network providers appear to be inflating the price of COVID-19 diagnostic and antibody tests, according to a recent America’s Health Insurance Plans (AHIP) survey. The October 2020 survey reports that out-of-network...more
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
Since early this year, the COVID-19 virus substantially affects our daily life. Testing for the presence of or past exposure to the virus is an essential aspect of combatting the COVID-19 outbreak and a number of companies...more
Seit Monaten wird die Frage kontrovers diskutiert, ob Probenentnahme-Sets zur Feststellung einer SARS-CoV-2 Infektion oder entsprechender Antikörper an jedermann abgegeben werden dürfen oder nicht....more
For months now there has been ongoing controversial debate about whether or not specimen-collecting kits for the detection of a SARS-CoV-2 infection or related antibodies may be furnished to members of the general public. ...more
On July 24, 2020, the U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use...more