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Kelly Kearney

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On August 1, 2023, the U.S. Food & Drug Administration (“FDA”) and the Drug Enforcement Administration (“DEA”) issued a joint letter to all Americans to provide a status update regarding the ongoing shortage of prescription stimulants. Stimulants fall under the purview of both FDA and DEA because they are controlled substance drugs. Both agencies recognize the important role of prescription stimulants when it comes to the treatment of conditions such as attention-deficit/hyperactivity disorder (“ADHD”), binge eating disorder, and narcolepsy.

According to the letter, the agencies are working closely with manufacturers and other members of the drug supply chain to address these shortages, which are the result of two main factors—manufacturing delays and an increased demand for the stimulants.…

Continue Reading FDA and DEA seek to ameliorate the shortage and misuse of stimulants

On February 4, 2022, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a favorable advisory opinion on a proposal by a nonprofit children’s hospital to enter into an arrangement with two individual donors, who intend on making a testamentary gift to the hospital that would be used to reduce and subsidize costs incurred by patients.

The OIG indicated it would not impose administrative sanctions, despite the fact that the proposed arrangement would not fall squarely within any safe harbor under the federal Anti-Kickback Statute (“AKS”) or exception to the definition of “remuneration” for purposes of the beneficiary inducement prohibition (“Beneficiary Inducement CMP”).

Arrangement created restricted endowment fund

Under the proposed arrangement, the hospital would be the beneficiary to a restricted endowment fund established through a testamentary gift from two donors. The fund would be used to subsidize bills for families with children who have an established care relationship with the hospital’s physicians and who receive services provided by the hospital’s programs.…

Continue Reading OIG approves arrangement involving a testamentary gift to a nonprofit hospital to reduce costs for pediatric patients

The 2019 Novel Coronavirus pandemic (“COVID-19”) introduced several unfamiliar hardships adversely impacting the long-term care industry, especially for nursing homes.  Acknowledging these hardships, the Centers for Medicare & Medicaid Services (“CMS”) enacted several temporary emergency blanket waivers effective March 1, 2020, lending flexibility to nursing homes in their COVID-19 response efforts.  Since that time, according…

With 2020 coming to a close, businesses are looking ahead to 2021 and evaluating how they can stay open while keeping their employees and patrons safe.  In an effort to resolve this seemingly open question, just this week, the National Institutes of Health (“NIH”) unveiled an innovative online mechanism that may give businesses the tools…

On September 15, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance to state Medicaid directors on how to advance value-based care (VBC) across their health care systems, with an emphasis on Medicaid populations, and how to share pathways for adoption­ of such approaches.  Within the 33-page letter, CMS highlights the merits of…

As technology has advanced over the years, there has been a corresponding push for virtual visits with health care providers.  In fact, many state boards of medicine and other regulatory agencies have sought to amend regulations and guidances to make telehealth a reality for patients across the U.S.  However, despite the technical allowance for telehealth,…