Sixty-four patient organizations including the ALS Association, American Diabetes Association, and American Heart Association have petitioned the Centers for Medicare and Medicaid Services (CMS) to make an Open Payments reporting exemption for indirect payments made to voluntary health agencies (VHAs). The National Health Council (NHC) drove the initiative.
View the letter to CMS here
The letter states that the exemption should apply to VHAs as it does currently for continuing medical education (CME). “We respectfully urge you to create an exclusion under the Open Payments Program that would exempt reporting for indirect payments to VHAs in cases when an applicable manufacturer grants full and independent discretion to VHAs in selecting recipients for funding,” the letter states.
In bolstering its claim for an exemption, the associations pointed to CMS’ recent proposal to actually remove the CME exemption:
CMS recently relied on this argument with respect to exempting certain funding granted to a certified continuing medical education (CME) provider. Specifically, CMS states that if “an applicable manufacturer or applicable [group purchasing organization] provides funding to a continuing education provider, but does not either select or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program, CMS will consider those payments to be excluded from reporting …" and that “if an applicable manufacturer conveys ‘full discretion’ to the continuing education provider, those payments are outside the scope of the rule.’
To support research programs and other activities, VHAs will often pool funding from a variety of sources, including, but not limited to, manufacturers. Revenue from a particular grant or sponsorship is indistinguishable from revenue provided from other sources. Additionally, VHAs maintain full discretion in how the funding is allocated. While a VHA may receive funding for a specific grant program such as research, VHAs have rigorous processes in place to determine grant recipients within the program that are completely independent of the funders.
We followed the CME issue closely, and recently reported that over 800 comments were submitted in favor of CMS keeping the CME exemption.
The NHC further argued:
Requiring the disclosure of physicians who receive funding will create substantial administrative burden, as entire programs will need to be restructured to determine which researchers are receiving funding that came from a corporate sponsor as opposed to other sources of funding. If these programs are not restructured in such a fashion, VHAs will risk the loss of important funding streams, limiting their ability to fund research or conduct other activities that further their mission on behalf of the patients they serve."
Because VHAs maintain full discretion over whom they will fund, and corporate funders are unaware of the recipients of such funding, we urge CMS to implement an approach toward VHAs that is consistent with your rationale for exempting indirect payments for continuing medical education.
We are deeply troubled by the negative impact that the Open Payments Program can have on the ability of VHAs to fulfill their missions and goals by supporting research and other activities that are vital to furthering the understanding and development of treatments, cures, and services for the patients that they represent.
Discussions with VHAs have revealed that the sunshine rules are complex to comply with as each applicable manufacturer has their own interpretation of the rule. Because these transactions are hands off from the manufacturers, the leadership and others have a hard time understanding why CMS feels it is necessary to collect this information.