Last week’s historic executive order (EO) on the development and use of artificial intelligence (AI) is teeming with urgency, both in caution and optimism, to keep pace with the technological advancements. The EO addresses the duality of AI—its promising utility and disconcerting risks—across a range of public and private sectors, including healthcare. Below are five key takeaways from the EO for the healthcare industry.Continue Reading AI’s Executive Order and Its Key Healthcare Implications
On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment
Continue Reading Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets
On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released the annual Physician Fee Schedule final rule (“Final Rule”) which, among other things, aimed to further President Trump’s October 3, 2019 Executive Order #13890 on “Protecting and Improving Medicare for Our Nation’s Seniors” (the “EO”) by expanding the use of proven alternatives like telehealth services to Medicare beneficiaries even after the conclusion of the COVID-19 Public Health Emergency (the “Pandemic”).
Continue Reading Permanent Expansion of Medicare Telehealth Services
On Thursday, August 6, 2020 President Trump signed an Executive Order, mandating that certain drugs and medical supplies purchased by federal agencies, including the Department of Health and Human Services, Department of Defense, and Department of Veteran’s Affairs must be US-manufactured (the “Buy American Order” or the “Order”). The list of “essential medicines, medical countermeasures and critical input” that fall under this Order will be determined by the Food and Drug Administration (“FDA”). The Order also calls on the FDA to conduct a greater amount of unannounced inspections of overseas drug plants to ensure that production of drugs is compliant with safety standards and to encourage more advanced drug manufacturing techniques.
Continue Reading President Trump’s Executive Order Mandating the Purchase of U.S. Drugs Evokes Criticism
On August 3, 2020, President Trump signed Executive Order 13941 (the “Executive Order”) which expands access to certain telehealth services post-pandemic. The Executive Order focuses on telehealth access for individuals living in rural areas and implements the following mechanisms:
Continue Reading It’s Official: Telehealth Benefits Have Been Expanded For Medicare Beneficiaries
On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”). One order – which has received the most negative reaction from the pharmaceutical industry – would create a “most-favored nation” policy to limit the price Medicare Part B pays for certain drugs to the lowest price paid in another Organization for Economic Cooperation and Development country. The White House did not release the text of this order on Friday and stated that it would not take effect until August 24, or at all if pharmaceutical companies can offer an alternative proposal to substantially reduce drug prices or if Congress acts.
Continue Reading A Shot Across the Bow of the Pharmaceutical Industry: President Trump Issues a Quartet of Executive Orders on Drug Pricing that Might Eventually (OR NEVER?) Take Effect
On June 24, 2019, President Trump signed an executive order that purports to create a more transparent health care market for both patients and providers. The order attempts to decrease the prevalence of opaque pricing, while increasing the amount of health care data available to health care users and stakeholders alike.
The executive order lays out a series of deadlines by which regulations, proposals and recommendations must be completed that intend to generate: (i) more informed patient choices, (ii) enhanced health care analytics, and (iii) greater financial options for individual payment.
Continue Reading More Data. More Choices. Better Care? New Executive Order Relies on Market Principles to Improve American Healthcare