As discussed in our June Insight, earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s regulatory authority. Such a rule would be FDA’s first comprehensive attempt to impose its authority over LDTs since its 2014 draft guidance, which FDA ultimately chose not to finalize, and comes after several failed congressional legislative attempts to do the same.
In this episode of the Diagnosing Health Care Podcast: 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 considerations, including how the varying options for collection could impact a model.
How do these factors combine to create a roadmap for companies navigating the direct access testing industry?
In this episode of the Diagnosing Health Care Podcast: 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 reimbursement and related compliance requirements?
In this episode of the Diagnosing Health Care Podcast: What are the various factors impacting stakeholders in the direct access testing industry?
By the end of this four-part series on direct access laboratory testing, listeners will have gained insight into how to navigate the complex regulatory and legal regimes that govern the process of making lab tests available directly to patients and understand the aspects that will dictate how their operations should be structured.
In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software.
How has this document caused confusion for industry? How can companies respond?
In this episode of the Diagnosing Health Care Podcast: The Dobbs v. Jackson Women’s Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the nation with respect to abortion services.
What additional implications are there for certain aspects of clinical trials and research?
On this episode, Epstein Becker Green attorneys Kate Heffernan, Marylana Helou, and Megan Robertson discuss how the changing state laws and regulations post-Dobbs may impact clinical research in different ways for different stakeholders.
It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.
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