This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon, Inc. The motion to dismiss relates to claims made by the whistleblowers under 31 U.S.C.§ 3729(a)(1)(G) (“. . . knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit money or property to the Government, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government . . .”). Specifically, the relators allege that Cephalon promoted its drugs Provigil and Nuvigil for off-label purposes and paid unlawful kickbacks to health care professionals, and failed to report this conduct in violation of its 2008 corporate integrity agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (OIG).
Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and transfers of value related to continuing medical education (CME). As we previously discussed, there has been confusion in the industry regarding CMS’ changes to reporting requirements for CME beginning in January 1, 2016, which were implemented as part of the 2015 Medicare Physician Fee Schedule. In sum, CMS reiterated that it expects applicable manufacturers to report payments and other transfers of value related to CME if the payment or transfer of value meets the definition of “indirect payment” and the manufacturer “knows or finds out the identity” of the physician speakers and/or attendees within the reporting year or by the end of the second quarter of the following reporting year. “Indirect payment” is defined as “a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient.”
There remains some concern among industry regarding its obligation to identify physician speakers and attendees. Although CMS uses in several instances the “knows or finds out the identity of” language, one FAQ uses slightly different and potentially more problematic language – “knows or can determine the identity of the covered recipient.”
CMS also released last week another round of Open Payment FAQs primarily related to its June 30, 2015 release of data. The new FAQs are the following:
UCLA Health announced today that it was the victim of a cybersecurity attack. The press report disseminated by UCLA Health noted there is evidence that computer systems containing sensitive personal data and health data was accessed; however, at this time UCLA Health maintains that no personal or health data itself was accessed or acquired. It is estimated that 4.5 million individuals may have potentially been involved in the attack. Continue reading
As we discussed here, the government continues to improve its use of data analytics to identify and prevent fraud, waste, and abuse in the health care industry. This week, the Centers for Medicare & Medicaid Services (CMS) announced that its Fraud Prevention System (FPS) has identified and prevented $820 million in improper Medicare payments in its first three years of operation. CMS stated that the FPS “helps to identify questionable billing patterns in real time and can review past patterns that may indicate fraud”, which allows CMS to, among other things, revoke provider payments, withdraw provider enrollment in Medicare, and/or refer appropriate matters to law enforcement for further investigation.
The Office of Inspector General (OIG) recently certified the “positive return on investment” from the FPS and recommended its continued operation, although the OIG determined that it was not feasible at this time to expand the FPS program to Medicaid and the Children’s Health Insurance Program (CHIP). Also last month, several members of Congress asked the Government Accountability Office (GAO) to provide additional information regarding the GAO’s review of the FPS, including expansion of the program to Medicaid and CHIP.
Policy and Medicine published today an interesting infographic prepared by Open Payments Analytics regarding the 2014 Open Payments data, which contains 11.41 million payments and other transfers of value totaling $6.49 billion from applicable manufacturers to physicians and teaching hospitals. One key takeaway from the infographic is applicable manufacturers are spending significant resources to track and report de minimis payments and transfers of value to covered recipients. For example:
- 9 million food and beverage interactions were reported at an average of $23.80 per instance
- Gifts accounted for 0.45% of the reported spend
- 49% of physicians in the database received less than $100 total
JAMA: Study Shows “Significant Positive Progress” in Managing Conflicts of Interest Among IRB Members, But More Work Needed
JAMA Internal Medicine published a report this week titled, Industry Relationships Among Academic Institutional Review Board Members: Changes From 2005 Through 2014, which is an update to a similar study conducted in 2005. The study found that although there were no significant changes in the percentage of institutional review board (IRB) members with an industry relationship, the number of respondents who stated that they always disclose industry relationships increased significantly from 54.9% in 2005 to 80.0% in 2014. IRB members also reported a decrease in instances where they felt another IRB member did not properly disclose a financial relationship and pressure from their institution or department to approve a protocol. Nevertheless, there was not a significant change among the number of IRB members who voted on protocols in which they had a conflict of interest, leading the study authors to conclude that additional work is needed to ensure that IRB members are educated on what constitutes a conflict of interest and to deter IRB members from inappropriately voting on protocols in which they have a conflict.