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
On August 9, 2024, the U.S. Department of Justice published a final rule implementing new ADA requirements for accessible medical diagnostic equipment (MDE) used in hospitals, emergency departments, physicians’ offices,...more
As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more
Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more
Ontario has (finally!) made the call to community surgical and diagnostic centers for applications for new licences under the Integrated Community Health Services Centres Act, 2023 (the Act) to provide MRI and CT services. ...more
On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the...more
Cosmetic injections, such as Botox and dermal fillers, and weight-loss injections, such as Wegovy® and Ozempic®, are popular offerings at med spas, weight-loss clinics, and dermatology practices. But are they considered the...more
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
Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more
A new study shows that approximately 371,000 people die and 424,000 sustain permanent disabilities due to diagnostic error, including brain damage, blindness, loss of limbs or organs or metastasized cancer....more
It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more
Editor’s Note: In a new report prepared for The Commonwealth Fund, Manatt Health and its co-authors provide an actionable framework and strategies for how state-level policymakers can use Medicaid and the Children’s Health...more
The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer up to nine drug makers...more
A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection...more
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
When analyzing the life cycle of any health care product, a key component to consider is how much the product will cost and who will pay for it. What unique challenges do direct access tests (DATs) pose when it comes to...more
Joining hosts Matthew and Heather again is Mako Medical’s COO and co-founder, Josh Arant. After the medical diagnostic lab served a major role during the height of the pandemic, Mako is currently addressing the surges in flu,...more
CYBERSECURITY - Nineteen States Have Banned TikTok on Government-Issued Devices - Governors of numerous states have issued Executive Orders in the past several weeks banning TikTok from government-issued devices and...more
Attorneys across the nation have noticed an increase in the number of potential plaintiffs coming forward with a painful condition called complex regional pain syndrome (CRPS) that they believe resulted from needlestick...more
As part of its ongoing effort to crack down on health care-related COVID-19 fraud, the U.S. Justice Department has launched a nationwide coordinated law enforcement action that recently led to criminal charges against 21...more
ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of...more
The University of Washington announced that a team of researchers has developed a prothrombin time/international normalized ratio (PT/INR) blood clotting test that requires only a single drop of blood and a smartphone....more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
...The Personalized Medicine Coalition (“PMC”) recently published its 2020 Spring Newsletter that examines the landscape and outlook for personalized medicine as COVID-19 prompts new discussions about the effect of COVID-19...more