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»  Posts By   September 2017 

Need for Heightened Vigilance Illustrated by Pharmaceutical Manufacturer Mallinckrodt’s Settlement with DEA for $35 Million Based on Suspicious Orders

In an unprecedented settlement, Mallinckrodt, LLC, one of the largest pharmaceutical manufacturers of generic oxycodone, has agreed to pay Federal Drug Enforcement Agency (DEA) $35 million to settle allegations that they violated certain provisions of the Controlled Substance Act (CSA). The allegations included that Mallinckrodt failed to meet its obligations to detect and notify the DEA of suspicious orders of controlled substances, such as oxycodone, (a drug at the height...

DEA Clarifies Its Guidance Regarding Pharmacies Forwarding Unfilled Electronic Prescriptions

The Drug Enforcement Administration (DEA) recently clarified for pharmacists its guidance regarding forwarding unfilled electronic prescriptions (EPCS) for controlled substances. In an email from Loren Miller, an Associate Section Chief of the Drug Enforcement Administration, to Carmen Catizone, CEO of the National Association of Boards of Pharmacy (NABP), Loren stated, "The DEA published information in the preamble of the notice of proposed rulemaking (NPRM) on EPCS, 73 FR 36722, and...

340B Final Rule Pushed Back Once Again to July 2018

The Department of Health and Human Services (HHS) has once again delayed the 340B final rule which would penalize pharmaceutical manufacturers that knowingly overcharge hospitals beyond the ceiling price for drugs purchased through the program. HHS has now decided to delay the final rule until July 2018. Filed on August 17, 2017, HHS states that the delay has been proposed in order to allow more time to consider alternative and...

Pharmacy Membership Programs Offering Discounts May Be Legal According to a Recent OIG Opinion

In a recent advisory opinion, the Office of the Inspector General (OIG) opined that a retail pharmacy chain, which also operates health care clinics, could offer discounts to Medicare and Medicaid beneficiaries without those discounts constituting prohibited remuneration. The retail pharmacy chain had asked the OIG if it would permit the pharmacy to operate a paid membership program ("Benefit Program") allowing participation by Federal health care program beneficiaries. The retail...

Physician Billing: Defending the “Impossible Day” Case

A Newark, New Jersey, pediatrician was recently sentenced to 3 years in state prison for submitting fraudulent claims to the Medicaid program. At trial, the federal government focused on the fact that the physician’s bills alleged she worked for more than 24 hours in a day. This is yet another example of the government's increased efforts at targeting physicians who work an "impossible day."  Federal prosecutors rely upon an aggregation...