In 2016 and now in early 2017, state legislatures and regulatory boards continue to enact laws and rules setting telemedicine practice standards. Such standards generally include clarifying the definition of telemedicine as well as providing standards related to prescribing in an online setting, patient informed consent, treatment of medical records generated during a telemedicine encounter, … Read more
As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C) Subcommittee on Health. That hearing focused on the UFAs specific to generic drugs and biosimilar biological products. Since then, Congress … Read more
In the alphabet soup that is health and FDA law and policy (if you don’t know what we mean, are you sure you should be reading this blog?), one acronym that doesn’t get a lot of respect is “UFA.” This is the first is a series of blog posts that aim to educate and inform … Read more
On Wednesday, March 8, James B. Comey, Director of the FBI, was at Boston College to deliver the keynote address for the inaugural Boston Conference on Cyber Security (BCCS 2017). Director Comey addressed various industry, cyber security, FBI, law enforcement and military experts in attendance regarding current cyber threats to both industry and government assets and the … Read more
In the coming weeks, it is highly likely that House Republicans will come forward with Medicaid financing reform proposals, such as block grant or a per capita cap proposal, or some combination of both. How should these proposals be evaluated? The best way to understand these proposals is through the equation A x B = … Read more
As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support approvals of new indications for previously approved drugs, and to support or fulfill post-approval study requirements. This directive to apply … Read more
More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil Monetary Penalty … Read more
The U.S. Court of Appeals for the 2nd Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing, http://www.ca2.uscourts.gov/decisions. Given the number of off-label marketing cases pursued by the government in recent years, this decision could have major repercussions. But it is important to recognize the limits of the … Read more
On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released the final rule for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The final rule marks the most significant reform to our health care system since the enactment of the Affordable Care Act in 2010, providing Medicare incentives to reward quality and value—not volume—through … Read more
On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released the final rule for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The final rule marks the most significant reform to our health care system since the enactment of the Affordable Care Act in 2010, providing Medicare incentives to reward quality and value—not volume—through … Read more