March 29, 2013
By Amy Kaufman*
Industry and Physicians Join Together to Develop Guiding Principles
American Medical News (3/25) reports that trade groups for pharmaceutical companies, device manufacturers, medical schools, and clinical research organizations are standing by physicians to defend the value of collaborative relationships between industry and the medical profession. Given that federal law will require industry to start tracking payments to physicians later this year, a coalition of stakeholders is developing principles to guide collaboration so that the tracking—and reporting—of payments will not have a chilling effect. According to Mary Grealy, the president of the Healthcare Leadership Council, "[i]f this whole issue of physician-industry collaboration is not handled in the appropriate way, it could inhibit innovation."
Nurses Lobby for Less Supervision
The Washington Post (3/24) reports that nurses are lobbying for legislation in 11 states that would permit nurses with a master's degree or higher "to order and interpret diagnostic tests, prescribe medications and administer treatments without physician oversight." Organizations such as the American Association of Retired Persons, as well as social workers and health policy experts, support the nurses' efforts; however, some physicians' groups have clearly expressed their opposition. Currently, many states' laws vary on this issue, with states like Maryland allowing minimal physician supervision and others like Virginia requiring more stringent supervision. If these proposals are successful, the number of states that allow nurses to practice without any physician supervision will increase from 16 to 30.
Representative McDermott urges HHS to Extend Safe Harbor for EHRs
Modern Healthcare (3/28) reports that Representative Jim McDermott (D-WA) wrote a letter to Greg Demske, Chief Counsel to the U.S. Department of Health & Human Services' (HHS') Inspector General, asking him to extend the safe harbor provision that protects certain donations of electronic health records (EHRs) under the federal Anti-Kickback Statute (AKS). According to the letter, the safe harbor that HHS has established "encourages collaboration among providers, yet also contains rigorous requirements that providers must meet in order to protect the Medicare and Medicaid programs from the few unscrupulous providers who would donate electronic health record software in exchange for referrals." Earlier this year, the Federation of American Hospitals also showed support for renewing the EHR safe harbor. The safe harbor under the AKS and the relevant exception under the federal Stark Law are set to expire on December 31.
Supreme Court Considers "Pay-for-Delay" Arguments
Competition Policy International (3/27) reports that, during Monday's oral arguments in Federal Trade Commission v. Actavis, Inc., the Justices on the U.S. Supreme Court appeared to suggest that the Court might permit lawsuits against drug makers for pay-for-delay agreements in the future. Prior to the Supreme Court's grant of certiorari, the Eleventh Circuit dismissed the Federal Trade Commission's (FTC's) claim that pay-for-delay agreements are unfair methods of competition that violate
Section 5 of the FTC Act. Under these agreements, brand-name drug makers pay generic drug makers to delay bringing competitor drugs to market. According to FTC, there were 40 pay-for-delay deals in the industry in 2012. Several companies have been sued for these arrangements in the past, "despite their arguments that the agreements are valid patent settlements."
*We would like to thank Amy E. Kaufman, Esquire (Patton Boggs LLP, Washington, DC), for providing this week's update.