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15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to enforce premarket review requirements for COVID-19 laboratory developed tests (LDTs). This prior policy, which waived premarket review requirements aimed at increasing broad public access to COVID-19 tests, was generally consistent with the FDA’s historical stance allowing laboratories to not seek approval of LDTs. With the policy announced by the Trump administration, laboratories again began offering their tests prior to or without an emergency use authorization (EUA) after the test was validated and a notification was provided to the FDA. While this policy expedited the availability of tests, the FDA contends that the policy also led to some poorly-performing tests being offered prior to FDA review. Notably, this prior policy did not apply to at-home or point of care collection tests, which have always required FDA review.
Continue Reading HHS Again Requires FDA Premarket Review for COVID-19 Tests

On August 19, 2021, Connecticut Governor Ned Lamont issued Executive Order No. 13C (the “Order”) to expand access to COVID-19 vaccination information for patients and providers (and school nurses) as public health authorities continue to promote vaccination efforts, implement recommendations for vaccine booster shots, and as schools adopt COVID-19 control measures for returning students and

On December 7, 2020, Connecticut Governor Ned Lamont signed Executive Order No. 9Q (the “Order”) in anticipation of the approval of COVID-19 vaccines. The Order addresses and expands COVID-19 vaccine administration, establishes flu vaccine reporting requirements for pharmacists, and limits out-of-network charges for administration of authorized COVID-19 vaccines. Specifically, the Order:
Continue Reading In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting

On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that clinicians participating in the Quality Payment Program (QPP) can earn credit in the Merit-based Incentive payment system (MIPS) by attesting to a new COVID-19 Clinical Trials improvement activity based on participation in a clinical trial and reporting information. Clinicians who may earn this MIPS credit include physicians, physician assistants, nurse practitioners and others. MIPS is one of two options for clinicians to participate in Medicare’s QPP, and requires clinicians to report certain quality, cost and other data to Medicare. A clinician’s Medicare reimbursement may be reduced if the clinician does not meet certain quality and performance measures.
Continue Reading CMS Announces Merit-Based Incentive Payment for Clinicians Participating in COVID-19 Clinical Trial

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder (SUD) confidentiality regulations at 42 C.F.R. Part 2 (Part 2) with the needs of providers and patients, and to “facilitate the provision of well-coordinated care” for individuals with SUD.
Continue Reading Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to Facilitate Provision of Coordinated Care

The Advanced Medical Technology Association (AdvaMed) has revised its U.S. Code of Ethics for Interactions with Health Care Professionals, with updates that take effect January 1, 2020. Until then, the current AdvaMed Code remains in effect.

Continue Reading AdvaMed Revises Code of Ethics on Interactions with Health Care Professionals

On November 6, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a proposed arrangement comprised of substantial donations that were earmarked for biomedical research purposes, made by a charitable trust (“Trust”) to a public-private medical research institute (“Research Institute”). The Research Institute had been formed by a health care system (“Health Care System”) and a public university (“University”). In addition, one of the Trustees planned to make a separate, individual donation to the Research Institute, through the University’s foundation, under substantially identical terms.
Continue Reading OIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System Having Ongoing Business Relationships with Trustee-Owned Long-Term Care Facilities

On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as well as modifying certain regulations applicable to data from US-sited investigations. The Final Rule does not go into effect until February 21, 2019 – a full year after promulgation.  The FDA also issued guidance in the form of Frequently Asked Questions (FAQ) addressing the new regulations.  In the FAQ document, the FDA explained its rationale that more research and marketing applications and submissions are being submitted that are supported by foreign investigations and that it was seeking to make its requirements more uniform.
Continue Reading FDA Amends Regulations for Acceptance of Data from Foreign and Domestic Investigation for Medical Devices

The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical research studies conducted at a non-profit medical center.  In the advisory opinion, the OIG reiterated its longstanding concern about routine waivers of Medicare beneficiary cost-sharing amounts in the absence of financial hardship, and noted this can lead to liability under the anti-kickback statute (AKS).  The research studies were conducted utilizing protocols under the Medicare Coverage with Evidence Development (CED) framework and involved a wound care system used to treat chronic, non-healing wounds.

Continue Reading New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

In May 2017, the U.S. Court of Appeals for the Third Circuit relied on the “heightened materiality standard” endorsed by the U.S. Supreme Court in its 2016 Escobar decision in dismissing a False Claims Act (FCA) whistleblower suit filed against pharmaceutical giant Genentech related to its billion dollar cancer drug Avastin. In Escobar, the Supreme Court upheld the validity—“at least in some circumstances”—of the “implied false certification” theory of FCA liability, and provided that this theory can attach where at least two conditions are met: a defendant must (1) make a specific representation on a claim for payment to the government, and (2) fail to disclose noncompliance with a material requirement for payment, which failure renders that representation a “misleading half-truth” (even if the representation is true on its face).
Continue Reading Third Circuit Recognizes Escobar “Heightened Materiality Standard” in Dismissal of False Claims Act Case Tied to Avastin