CMS posts new Open Payments thresholds, MedTech Europe revises its Code, California deals with two new pharmaceutical laws, and multiple settlements are announced for one “unlucky” pharmaceutical company…in this Friday the 13th edition of the Compliance News in Review.
Be careful what you wish for, Freaky Friday (a.k.a. Friday the 13th) has arrived. Steer clear of those sidewalk cracks, black cats, and broken mirrors! We prefer to focus more on the “Friday” part of the date stamp rather than the “13th.” Whether you’re working for the weekend, or just counting down the minutes until it officially begins, we offer the latest edition of the Compliance News in Review to help you whittle away the hours until the superstitions have subsided.
Change doesn’t have to always be scary. MedTech Europe, a joint venture of EucoMed and European Diagnostic Manufacturers Association, changed its Code of Ethical Business Practice. Changes include the phasing out of direct sponsorship for HCPs to attend medical conferences; enhanced transparency of educational grants; and new guidelines for demonstration products and samples. In addition, starting in 2018, members will only be able to provide educational grant support for meetings that have been vetted by the organization.
The “lucky” numbers for the Open Payments reporting thresholds for 2018 have been posted by CMS. The small payments, or de minimis threshold, was raised to $10.49, and the annual aggregate threshold was raised to $104.90.
California passed two new laws affecting the pharmaceutical industry. First, SB 17 requires health plans and insurers to report information about drug pricing. The information will be compiled into a report showing how drug pricing effects health insurance premiums. The law also requires drug manufacturers to notify purchasers 90 days in advance if a drug’s wholesale acquisition cost (WAC) is going to increase.
AB 265 prohibits prescription drug manufacturers from offering assistance to lower out of pocket costs, if a lower-cost generic equivalent drug is available. Exceptions include the discounts required under an FDA Risk Evaluation and Mitigation Strategy (REMS); single-tablet drug regimens for the treatment of HIV or AIDS that are as effective as a multi-tablet regimen; and completion of step therapy or prior authorization requirements for a branded drug, as mandated by the individual’s health coverage.
Time to start throwing copious amounts of salt over the shoulder at Aegerion. The company pled guilty and pay over $35 million to settle criminal and civil charges that it violated the FDCA, HIPAA, and the False Claims Act. According to the Department of Justice, Aegerion did not follow the proper Risk Evaluation and Mitigation Strategy when educating prescribers about the rare cholesterol condition its drug was approved to treat. The government also claimed the company filed a misleading REMS report and promoted the drug for the general treatment of high cholesterol, all in violation of the FDCA.
Aegerion also resolved civil charges it violated the False Claims Act. The company allegedly shared misleading information about its drug, altered or falsified statements of medical necessity or prior authorization to federal healthcare programs, and defrayed the copay obligations of patients in federal healthcare programs, which is a violation of the Anti-Kickback Statute.
Following the settlement, the patient assistance organization involved, Patient Services, Inc. (PSI), acknowledged it received a subpoena from the DOJ. PSI said it had cooperated with the government in the case. The organization said it operates “under guidelines set by the U.S. Health and Human Services Office of the Inspector General and does not funnel funds for manufacturers.”
Some “strange magic” leads to a $13 million FCPA settlement for Alere to resolve charges it violated the FCPA. The company allegedly paid bribes to meet its revenue targets. According to the SEC, company subsidiaries in India and Colombia used distributors or consultants to make improper payments to foreign officials. The agency said the company failed to maintain adequate internal controls to prevent the payments and recorded the payments incorrectly.
With that, we close out this superstitious edition of the Compliance News in Review. Thanks for reading! Stay safe out there as you navigate the potholes and pitfalls that allegedly lurk in shadows, and no matter what, don’t walk under that ladder!