AXON’S PHYSICIAN PAYMENT SUNSHINE ACT COMPLIANCE OVERVIEW
On August 1, 2013, the first reporting period under the Physician Payment Sunshine Act began. The commencement of that reporting period has caused field research and expert network companies to focus more closely on complying with the Sunshine Act's requirements, and to consider deploying new protocols for the conduct of market research. In the process, a number of critical questions have arisen, among both the manufacturers and their research consultants. The PMRG, CASRO and MRA have addressed the questions they consider to be most urgent in the following alert http://www.pmrg.org/Portals/0/Govt%20Affairs/PHYSICIAN%20PAYMENT%20SUNSHINE%20ACT%20ALERT%20082913.pdf.
In summary Axon Advisors adheres to the statutory language that clearly excludes from the reporting requirement any research in which physician research participants are paid by Axon and their identities are not disclosed to the study sponsor.
Pursuant to the ethical codes of CASRO and MRA, Axon may not report the physicians' identities (or identifying information) to the manufacturers without first disclosing to the physicians that such reporting will occur and what it will be used for - i.e., public posting on the Internet with honoraria amounts. Thus, regardless of the reason for reporting physician identities to the manufacturers, it would be a clear violation of our industry codes were we to turn over the identifying information of physician research participants after the completion of the data collection in cases where prior consent had not been obtained. Clearly, identifying information is not required to be turned over in any double-blinded study. It is less clear whether this applies to single-blinded studies as well, and the research companies and pharmaceutical companies may not be aligned on the interpretation of the statutory language. PMRG, CASRO and MRA are actively seeking such clarification and advise in the meantime that if a client has requirements to turn over identifying information of physicians involved in single-blinded studies (where the sponsor is blinded), that requirement should be clearly communicated by the client at the outset of the project, so that Axon can disclose this requirement to the physicians prior to their participation. Otherwise, Axon cannot turn over this information, as it would be a violation of our market research standards – while nonetheless remaining in adherence to the statutory language of the Sunshine Act.
Axon Advisors is committed to keeping abreast of the latest in Federal and State compliance as it relates to our services, and we want to make sure that you have the necessary information from Axon to meet compliance requirements on your end.
An excerpt of the guidance issued by the PMRG, CASRO and MRA is copied below:
PMRG, CASRO AND ESOMAR'S PHYSICIAN PAYMENT SUNSHINE ACT ALERT
Excerpted from a Legislative Update by the PMRG, CASRO and MRA: http://www.pmrg.org/Portals/0/Govt%20Affairs/PHYSICIAN%20PAYMENT%20SUNSHINE%20ACT%20ALERT%20082913.pdf.
A. Background: The Sunshine Act.
• Purpose and Mandate.
The Sunshine Act, enacted by Congress in March 2010 as part of the Patient Protection and Affordable Care Act, requires pharmaceutical and medical device manufacturers to report to the federal government many types of payments that they make to physicians. The government will, in turn, publicly post those payments and the names of the individual recipients on the Internet. The purpose of the law is to create greater transparency around manufacturer-physician relationships, so as to minimize any undue influence on physicians' prescribing behavior. The first reports must be filed in March 2014, for payments made between August and December 2013.
• Successful Efforts to Exclude Pharmaceutical Market Research from Reporting Requirements.
PMRG - with the support of CASRO and MRA - worked closely with the drafters of the Sunshine Act in Congress to ensure that typical market research honoraria would not have to be reported. Our concern was that reporting and publicizing the physicians' identities could: (a) reduce the pool of willing respondents, thereby adversely impacting both the cost and the quality and efficacy of research, to the detriment of our industry and health care consumers; (b) threaten the candor of responding physicians, as a result of disclosure of their identities to research sponsors, thereby (again) impeding the quality and efficacy of the research, to the detriment of our industry and consumers; and (c) contravene the very purposes of the Sunshine Act, by - for the first time in the history of market research - enabling manufacturers to routinely know the identities of those physicians whom they were paying, thus creating new opportunities for influencing prescribing behavior.
We also explained to the drafters that typical market research poses no risk of undue influence on prescribing behavior, in that, pursuant to CASRO and MRA ethical codes, (1) the manufacturers don't know the identities of the physicians who participate as respondents in the research and thus are unable to market directly to them as a result of the research, and (2) the researchers themselves are forbidden from marketing to research subjects.
To our great satisfaction, Congressional staff appreciated all of those observations; and as a consequence, a provision was inserted in the Sunshine Act excluding market research honoraria from the reporting obligations. The exclusion, written at PRMG's suggestion and with its material input, appears in the official compilation of federal laws at 42 USC 1320a-7h(e)(10)A, where the statute defines the types of payments that are and are not subject to the reporting requirements, as follows:
The term "payment or other transfer of value" ... does not include a transfer of anything of value that is made indirectly to a covered recipient through a third party in connection with an activity or service in the case where the applicable manufacturer is unaware of the identity of the covered recipient. (Emphasis added.)
Because pharmaceutical market research payments are typically made by the research companies rather than the manufacturer-sponsors, and to physicians whose identities are unknown to the manufacturer-sponsors, those payments meet the statutory exclusion criteria. When the law was enacted, that exclusion was widely regarded within the pharmaceutical market research industry as having saved the industry from debilitating consequences.
Importantly, the exclusion, as written, clearly applies to both double-blind research, where neither the manufacturer nor the physician knows the other's identity, and to single-blind research, where the manufacturer doesn't know the identities of the physician participants but the participants may know, or might infer, the identity of the manufacturer.
B. The CMS Final Rule.
In February 2013, the Centers for Medicare and Medicaid Services ("CMS") - a unit of the Department of Health and Human Services - announced its Final Rule interpreting and implementing the Sunshine Act. (The text of the Final Rule appears in the codification of federal regulations at 42 CFR Parts 402 and 403.)
Among the topics included in that announcement was CMS's response to comments that it had received regarding how the Final Rule would address aspects of the exclusion from reporting, including how manufacturer's knowledge of the identity of physicians would be assessed for purposes of determining if the exclusion applied. In the context of that discussion, CMS stated, at p. 9490:
[I]f a payment meets the definition of an indirect payment or other transfer of value in [42 C.F.R.] §403.902, then the payment can only be excluded from the reporting requirements if the applicable manufacturer did not "know" the identity of the covered recipient, as defined in [42 C.F.R.] §403.902. . . . . For example, an applicable manufacturer may hire a market research firm to conduct a double-blinded market research study, which includes paying physicians $50 for responding to a set of questions. The applicable manufacturer clearly intends a portion of the payment to be provided to physicians, but given that the reason for the third party's involvement is specifically to maintain the anonymity of the respondents and sponsor, we do not intend this to be considered a reportable indirect payment or other transfer of value.
While that excerpt contains some errors in its characterization of market research, PMRG was heartened when the Final Rule was promulgated to see that CMS had expressly recognized the exclusion from reporting of market research honoraria.
C. Concerns and Suggestions.
Unfortunately, some members of the industry have focused on CMS's reference in the example to "a double-blinded market research study," and have been prompted to question whether single-blind research honoraria are likewise excluded from the statutory reporting requirement as expressed under the Final Rule. We strongly believe that they are. CMS's use of the phrase "a double-blinded market research study" in its example was unfortunate, and was incidental to the test that the example was presumably being used to illustrate - the lack of manufacturer knowledge of the physicians' identities. We simply do not believe that the phrase was intended, either expressly or implicitly, to limit the reporting exclusion to double-blind research honoraria.
Nonetheless, we understand that, in a good faith effort to comply with the Final Rule, some manufacturers are considering requiring their research consultants to disclose, for public reporting on the Internet, the identities of the physicians who receive honoraria in single-blind research studies.
PMRG, CASRO and MRA are deeply concerned about the effects of the industry acting on the basis of what we believe is a misinterpretation of the Final Rule. It would effectively vitiate most of the benefit of the reporting exclusion that Congress enacted, to the detriment of market research and ultimately, the delivery of sound health care solutions. Accordingly, for the benefit of our members, the associations are seeking a confirmation from CMS that the reference to double-blind research is mere commentary and an "example" - not a statutory or regulatory requirement - and that both double-blind and single-blind honoraria are exempt from reporting. We will advise our members if and when that confirmation materializes.
We meanwhile urge that our members adhere to the statutory language that clearly excludes from the reporting requirement any research in which physician research participants are paid by an intermediary (i.e., a market research firm) and their identities are not disclosed to the study sponsor. Both of those criteria are routinely met by conventional market research.
It is important to reiterate:
• The Sunshine Act is clear, on its face, that honoraria for physicians' participation in such research are excluded from the reporting requirement.
• CMS, as a regulatory agency of the executive branch of the federal government, is not lawfully able to supersede an act of Congress, even if it wished to do so.
We would like to remind our members that, pursuant to the ethical codes of CASRO and MRA, research companies may not report the physicians' identities (or identifying information) to the manufacturers without first disclosing to the physicians that such reporting will occur and what it will be used for - i.e., public posting on the Internet with honoraria amounts - even if that disclosure could chill research participation and increase recruiting costs. Thus, regardless of the reason for reporting physician identities to the manufacturers, it would be a clear violation of our industry codes were a market research company to turn over the identifying information of physician research participants after the completion of the data collection in cases where prior consent had not been obtained.