On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an effort to ensure that participants in CMS programs have no-cost access to any forthcoming Food and Drug Administration (FDA or Agency) authorized or approved COVID-19 vaccine. The IFR governs any vaccine that is licensed by FDA under a Biologics License Application (BLA), or, significantly, receives an Emergency Use Authorization (EUA) from the…

Just two business days before the first of many critical components of the new 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) were set to take effect, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) issued an advanced copy of an interim final rule with comment period (the “Interim Final Rule”) extending the compliance dates…

On October 5, 2020, the White House issued President Trump’s Executive Order on Saving Lives Through Increased Support for Mental- and Behavioral-Health Needs (the “Executive Order”), which seeks to provide federal support to address mental and behavioral health concerns arising from the COVID-19 pandemic. The Executive Order acknowledges the exacerbating effects that the COVID-19 pandemic has had on mental and behavioral health conditions due to “stress from prolonged lockdown orders, lost employment, and social isolation,”…

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information. In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), settled five costly investigations with HIPAA-regulated parties for potential violations of the HIPAA right of access…

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 VBC; provides an assessment of key lessons learned from early state and federal experiences in implementing VBC reforms, as well…

On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1]  Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial.  FDA recognizes this information as important because by integrating patients’ voices throughout the total product lifecycle, concepts important to patients can be considered in the…

The October 3, 2019 Executive Order 13890 (“EO 13890”), entitled “Executive Order on Protecting and Improving Medicare for our Nation’s Seniors,” directs the Secretary of Health and Human Services to “propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients.”  EO 13890 explicitly requests that the Secretary make coverage of breakthrough medical devices widely available, and clarify the application of coverage standards.  In response, on September 1, 2020, the…