Fees in Clinical Trial Pacts Can Affect ‘Sunshine'Rule Compliance

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By Jeannie Baumann

March 15 — Clinical trial agreement language can affect how research-related payments from drug and device companies are reported under a federal law, a Johns Hopkins research administrator said March 14.

Mont Brownlee, director of the Johns Hopkins Medicine Office of Research Administration, told a health lawyers group that with the Open Payments program, research payments fall under a “completely different paradigm” than payments provided to physicians in a clinical setting. He cited language in the Open Payments rule that says manufacturers must report payments related to each research protocol once as a single transaction, instead of listing line-item research payments to each investigator.

When reporting research-related payments, Brownlee said, information should include the:

  • total amount of the payment;
  • name of the drug, device or biological product;
  • name of the research study; and
  • names of the principal investigator or investigators, along with their national provider identifier, license information, specialty and primary business address.

    There's an option to include the information on the context of the research as well as the ClinicalTrials.gov identifier number.

    The Centers for Medicare & Medicaid Services said in the preamble to its final rule that, “We believe that the recipient of the payment could include individual principal investigators, teaching hospitals, nonteaching hospitals or clinics. We intend for the principal investigator(s) to include the individual(s) conducting the research or providing the services on behalf of the research institution.”

    The rule also says that the total research payment should include “the aggregated amount of any payments for services included in the written agreement/research protocol, including any costs associated with patient care, including diagnostics, exams, and laboratory expenses. The payment amount should not include any payments for activities which are separate or segregable from the written agreement or research protocol or are paid through a method different than that of the research,” the CMS said in the Federal Register notice containing the rule (78 Fed. Reg. 9,458, Feb. 8, 2013).

    Individual Investigators Avoid Stigma

    “The guidance in the Federal Register commentary along with the rule is not especially super clear, but I think it makes it pretty clear” that any research-related costs that have been included in the clinical trials agreement can be included in the total research costs, Brownlee said. The clinical trial agreement is a legally binding document that outlines the scope of work that's required by all parties.

    “If you can write it into your clinical trials agreement or your protocol, then it is reportable as research,” Brownlee said. This way, the database reports the aggregated costs under the entire protocol instead of listing a single physician as taking in a large amount of money from a drug company.

    “So my faculty love it that we include travel to investigator meetings in the clinical trial agreement as a line item because then they don’t get reported on personally for that,” he said.

    Brownlee said he also writes publication fees into the clinical trial agreements.

    “You can amend your CTA later on and put that stuff in if you forgot it,” he said. “But it keeps it in the research agreement, and it keeps it in the big payments” report for the entire protocol.

    Established under Section 6002 of the Affordable Care Act (Pub. L. No. 111-148), the Open Payments program requires manufacturers of drugs, devices and other medical supplies and group purchasing organizations to report certain payments to physicians or teaching hospitals that exceed $10.21. The program is commonly referred to as the sunshine law, in reference to the Physician Payments Sunshine legislation that Sen. Charles E. Grassley (R-Iowa) introduced a few times before his bill was rolled into the 2010 ACA .

    $6.49 Billion in Payments

    The CMS, which runs Open Payments, reported last summer that drug and device manufacturers made $6.49 billion in payments to physicians and teaching hospitals over the course of 2014 .

    “So if you’re from a health system, you’re probably experiencing a huge volume of Sunshine disclosures in connection with everything but research. But research is handled in a completely different fashion. It’s on a different reporting template. It’s subject to different rules,” Brownlee said.

    The Open Payment rule adopted a broad definition of research, he said, that includes pre-clinical studies, clinical research in all four phases and investigator-initiated studies.

    The rule covers “everything basically under the sun” in terms of research, he said.

    Brownlee made his remarks as part of a panel on clinical trial agreements during the American Health Lawyers Association annual conference on legal issues affecting academic medical centers and teaching hospitals.

    To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

    To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com

    For More Information

    More information on the Open Payments program is available at https://www.cms.gov/openpayments/.

    The CMS final rule is at https://www.cms.gov/OpenPayments/Downloads/Affordable-Care-Act-Section-6002-Final-Rule.pdf.

    More information on the AHLA conference is at http://bit.ly/1P8KJWL.