Kyle Faget

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In February, the Department of Justice (DOJ) successfully leveraged a new weapon to target pharmacies as it battles the nation’s opioid crisis. The new approach utilizes court-ordered temporary restraining orders (TROs) that result in an immediate suspension of a pharmacy’s ability to dispense controlled substances at the outset of a Drug Enforcement Administration (DEA) registration revocation process. A TRO prevents the suspect pharmacies from dispensing any medications until the DEA and the DOJ proceed through…
Momentum and support continues to build for telehealth commercial coverage laws across the United States, designed to ensure that covered members of health insurance plans can enjoy the full scope of their medical benefits – whether in-person or virtually.  Last summer, the Massachusetts Legislature considered a sweeping telehealth bill that would have instituted certain requirements for insurance coverage.  (Read our critique of that bill here.)  Although the 2018 legislative session ended before the…
On January 31, 2019, the United States Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) announced a proposed rule, which would eliminate certain drug rebates and encourage direct discounts for federal beneficiaries.  Specifically, the rule would:…
Justice Reed O’Connor’s recent decision, Texas et al. v. U.S. et al., No. 4:18-cv-00167-O (E.D. Tex. Dec. 14, 2018), to strike down the entire Patient Protection and Affordable Care Act, 42 U.S.C. § 18001 et seq. (2010) (the ACA) as unconstitutional not only threatens to dismantle health coverage for millions of Americans and protections for people with pre-existing conditions, but the decision could also invalidate the Biologics Price Competition and Innovation Act (BPCIA) of 2009,…
In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research conducted or supported by participating federal departments and agencies.[1]  Compliance with the revised Common Rule is expected on January 21, 2019.[2]