On April 23, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a new COVID-19 toolkit. While the toolkit is directed to the states, it should serve the American telehealth community as a focal point for the...more
The Federal Communications Commission (“FCC”) has opened the COVID-19 Telehealth Program Application portal and is now accepting applications for the COVID-19 Telehealth Program (the “Telehealth Program”). Authorized by the...more
In a March 24th letter to all of the nation’s Governors, Secretary Alex Azar of the Department of Health and Human Services (“HHS”) called upon states to take immediate action to loosen regulations that present obstacles to...more
As the novel coronavirus outbreak continues, the federal government and commercial health insurers have taken significant steps to increase Americans’ access to treatment and testing. In the past week, the federal government...more
On June 1, 2019, the United States Pharmacopeia (“USP”) published the final revisions to its pharmaceutical sterile compounding standards (“chapter <797>”). Chapter <797> sets forth standards for the preparation of compounded...more
The regulation of pharmacies at the state level might not be what Justice Louis Brandeis had in mind as an example of a “laboratory of democracy,” but for pharmacists and consumers, state-level policy-making can have...more
On Wednesday, the Department of Health and Human Services (“HHS”) reversed course in its delay of implementing fines against drug manufacturers that intentionally overcharge 340B providers. In a notice of proposed rulemaking,...more
On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded...more