Bill of Health

OCTOBER 11, 2023

The selections feature topics ranging from a review of the regulatory consequences of the FDA’s accelerated approval of eteplirsen, to a comparison of the safety and effectiveness of generic and brand-name fluticasone-salmeterol for COPD, to an analysis of free speech challenges to Medicare drug price negotiation under the Inflation Reduction Act.

Patient Advocacy 144

Patient Advocacy Medicare Medicare FDA 144

Health Populi

JANUARY 7, 2019

This week’s heart-and-food tech announcements at #CES2019 coincide with an FDA recall on a popular drug prescribed to treat hypertension (high blood pressure). An important example of this self-care approach is the evidence-based Ornish food regimen which is reimbursed by Medicare (as a form of cardiac rehabilitation).

FDA 67

FDA Patient Advocacy Medicare Medicare 67

The Digital Health Corner

NOVEMBER 28, 2016

Digital health technology has seen an incredible growth in the last few years, fueled by a combination of consumerization of wearable technologies, ubiquity of mobile devices, proliferation of technology incubators, attention by government health and regulatory agencies and involvement of large companies heretofore not focused on healthcare.

Public Health 68

Public Health Health Services Administration Patient Advocacy Governance 68

Health Law Advisor

JULY 21, 2023

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced its proposed “Transitional Coverage for Technologies” (TCET) pathway—the Biden administration’s highly anticipated take on a mechanism to expedite coverage for certain devices designated by the U.S. Food and Drug Administration (FDA) as breakthrough devices. [1]

FDA 52

FDA Medicare Medicare Patient Advocacy 52