Benjamin Daniels

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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…
In response to the opioid crisis, the Drug Enforcement Administration (DEA) is cracking down on pharmacies, pharmacists, and prescribers by leveraging an old enforcement weapon: revocation of controlled substance registrations. The DEA actively revived this enforcement mechanism in February and March of 2018 when it arrested 29 people and revoked 147 controlled substance registrations throughout the country.1 Revocations carry the harsh consequence of preventing pharmacies, pharmacists, and prescribers from dispensing or prescribing federally controlled substances,…
Co-Author: Nina Zhang, Stephenson Acquisto & Colman This article addresses the high-level challenges of tackling drug pricing policy related to prices that seniors and government programs pay, as well as the potential effects that the Trump administration’s policy efforts could have on those prices.1 Starting in January 2019, the Centers for Medicare & Medicaid Services (CMS) will provide Medicare Advantage plans—private health insurance plans that provide Medicare benefits to 20 million Medicare beneficiaries (a third…
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:…
On November 30, 2018, the Centers for Medicare & Medicaid Services (CMS) published 83 Fed. Reg. 62152, which proposes changes to Medicare Part D (prescription drug benefit) and drug plans offered by Medicare Advantage (managed care) in an effort to reduce out-of-pocket costs for beneficiaries. The proposed rule is part of the Trump Administration’s  four part strategy to effectuate its “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs,” published in May 2018. The…
On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet published (or leaked), the title of the rule itself is rather transparent: Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of a New Safe Harbor Protection (Proposed Rule).…