On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Fill ‘Er Up: OIG Approves Gasoline Discounts Based on Prescription Drug Co-Pays
Specifically, the OIG found that under the beneficiary inducement CMP, the program satisfies all three requirements of the retailer rewards exception. Under PPACA, retailer awards are not “remuneration” within the meaning of the CMP if the rewards: 1) consist of coupons, rebates or other rewards from retails; 2) are offered or transferred on terms equal to those available to the general public regardless of health insurance status; and 3) are not tied to the provision of other items or services reimbursable under Federal health care programs. See Section 1128A(i)(6)(G) of the Social Security Act. The OIG found that the Loyalty Card program would satisfy all three elements as the rewards were offered by a supermarket operator to all of its customers; the awards are offered on equal terms for all customers; and the customers redeem the rewards for gasoline, an item not reimbursable under Federal health care programs, and earn the discounts on all purchases without any disparate treatment of or additional reward for prescription purchases.
The OIG further found a minimal risk of fraud and abuse under the anti-kickback statute as the rewards program would not pose a risk of steering beneficiaries to the supermarket operator’s stores and pharmacy because prescription fills are not required or rewarded differently under the program, and there was a low risk of overutilization or increased costs to Federal health care programs because the rewards would be earned on already prescribed drugs without any reduction in the beneficiary’s cost-sharing amounts.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017