Sunshine Act will bring COI data headaches

Financial COI data will be made public

Get ready, IRBs — data collection for financial conflicts of interest (FCOIs) is about to get more complicated.

The Physician Payment Sunshine Act — a provision of the Affordable Care Act — will mean pharmaceutical, medical device, biological, and medical supply manufacturers will begin disclosing to CMS the payments they make to physicians and teaching hospitals (Medicare, Medicaid, Children’s Health Insurance Programs Transparency Reports and Reporting of Physician Ownership or Investment Interests: 42 CFR Parts 402 and 403). CMS will then make the data available to the public at large. All payments will be made public, even if a product never received FDA approval, clearance, or licensure.

Beginning August 1st of this year, the industry will begin collecting information on payments made to physicians and teaching hospitals. The payment data will be submitted to CMS by the end of March 2014. After March 2014, CMS will alert affected teaching hospitals and individuals that the information is available for a 45-day review period and a 15-day reconciliation period. The information will then be made public in September 2014, repeated on a calendar year basis. It will include all payments or transfers of value made to a physician or teaching hospital.

All this information will likely cause massive headaches for IRBs, says David Blake, PhD, JD, vice president, chief compliance and privacy officer of Cedars-Sinai Medical Center in West Hollywood, CA.

“There’s bound to be some discrepancy between what’s getting publicly reported and what’s being disclosed,” he says. “There may also be confusion about payments to institutions that may benefit individuals and payments to individuals that may benefit institutions; and then how all of this might or might not actually affect research.”

Blake gives an example scenario: An investigator could receive a federal grant for testing of a particular pharmaceutical company’s new drug. The investigator might report that she has had no significant financial interests (SFIs) with this company for the previous 12 months (as required under the new Public Health Service COI regulations). CMS then may release data that the investigator received a consulting fee from the same pharmaceutical company but for a different drug, say 13 or 14 months prior. Since the information falls outside the required reporting timeline, the investigator had no specific obligation to report this consulting fee. With public reporting, however, it is quite possible that the previous financial interest could receive the attention of regulators, the media, or other body, questioning whether the non-disclosed previous payment could now compromise his or her research. Sorting out how to handle this and similar scenarios could prove to be a nightmare for a research institution.

Another issue that IRBs will face, Blake says, is being inundated with financial information that may not be material or relevant. “There will be a massive amount of data that might be inconsequential,” he says. “IRBs will be flooded with information about very small payments that the IRBs may not care about, but they will have to sift through it all to see if individual researchers have any serious financial relationships amid all the small payment reported.” For instance, a doctor may have 100 payments in the $25 range, but just a few larger payments. “They would still have to sort through all of the small-payment information to see if there’s anything larger that could present a conflict,” he says. At this point, it’s not clear if CMS can deliver all the payment data provided to them by companies in a form that will be easily managed by research institutions.

Blake does not see the new regulations as necessarily the result of a demonstrated increase in the negative effects of financial relationship on clinical trials. “There’s no clear evidence of an increased negative impact of outside financial relationships on clinical trials. I question whether things are much worse now that, say, 10 years ago,” he says. Instead, he says, there is a marked increase in concern from politicians, regulators, the media, and some within academic medicine regarding possible negative effects.

“What has increased more recently is the management challenge in dealing with federal regulations, in particular dealing with the review of outside interests,” he says. “There’s an increased level of scrutiny at the federal and institutional level regarding these outside relationships. It’s not necessarily the case that outside relationships necessarily adversely affected research — there’s an understandable concern that it might happen. Whether the new regulatory requirements and increased public scrutiny are justified given the real possibility of adverse effects is the question.”

The new regulatory requirements include updated SFI guidelines from the National Institutes of Health, which lowers the SFI threshold to $5,000 from $10,000. The regulations also define different types of SFIs. (For more information, see box below.)

In order to deal with the increased information from the Sunshine Act, Blake advises that IRBs develop a clear threshold for what they would consider to be a possible SFI, and clear policies for what information will need further evaluation. The IRB should also have a solid plan in place for managing possible FCOIs or SFIs, rather than just requiring further disclosure.

“A challenging issue is whether an outside interest can usually be best managed by simply requiring that the interest be further disclosed to research subject.” Blake says. “I think that simply requiring further disclosures of interest are not in and of themselves an adequate management, partly because it’s not clear what a research subject would make of those disclosures. I would think for a layperson — especially if they are suffering some condition and the experimental treatment is showing promise — it would be hard to determine if outside interest disclosed to me is a good thing or bad thing.”

At Cedars-Sinai Medical Center, the IRBs have a separate committee to review outside interests. Some financial interests require nothing more than a simple disclosure in the consent process, while greater interests could require the investigator be excluded from certain areas of the study, such as subject recruitment or data analysis and review. “The guidelines are spelled out in detail in policies and in the research COI committee that monitors these relationships,” Blake says.

 

Updated regulations clarify interests to be disclosed

In 2011, the National Institutes of Health released updated regulations to define significant financial interests. The regulations read as follows:

• “With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).

“Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available).”

• “With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).”

• “Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available).”

Read more about the regulations at http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf.