In response to an overwhelming outpouring of stakeholder comments, CMS redefined its Open Payment reporting rules to specifically exclude the vast majority of CME payments, including speaker-related payments and tuition support for attendees, so long as they follow CME guidelines and are, therefore, not directed by a commercial supporter. Although CMS deleted the section of a previous rule that defined a limited CME reporting exclusion for CME payments for certain accredited programs, the new rule sets reasonable criteria for determining which CME-related payments need not be reported.
FOR IMMEDIATE RELEASE
Contact: Andrew Rosenberg, (202) 247-6301, arosenberg@thornrun.com
On October 31st, CMS announced that the section of last year’s Open Payments rule that created a special CME exemption was eliminated. In its place, CMS provided redefined and pre-existing reporting rules that specifically exclude CME payments, including speaker-related payments and tuition support for attendees, so long as they are not directed by a commercial supporter and otherwise do not meet the definition of an indirect payment under§403.904(i)(1).
The CME Coalition applauds this new approach.
Specifically, CMS clarifies that where "an applicable manufacturer or applicable GPO provides funding to support a continuing education event [and] does not require, instruct, direct, or otherwise cause the continuing education event provider to provide the payment … to a covered recipient, the [commercial supporter] is not required to report the payment.” (Final Rule at page 595) Importantly, CMS specifically declares under the Final Rule that such indirect CME-supporting transfers of value are not reportable, even if the commercial supporter subsequently discovers the identity of the covered recipient “because the payment or other transfer of value did not meet the definition of an indirect payment.”
“As a practical matter, because the standards for commercial support inherent in most accredited CME already prohibit commercial supporters from paying speakers directly, suggesting speakers (e.g., providing a list), or otherwise controlling the nature or content of the educational program, there will not be any necessity to report CME payments under the Sunshine Act for most accredited CME programs,” stated CME Coalition Senior Advisor Andrew Rosenberg. “Therefore the CME Coalition applauds CMS for clarifying these important rules in such a manner.”
Furthermore, CMS addressed another important concern of CMS stakeholders by making it clear that physician attendees of CME programs need not be reported to Open Payments for the value of their educational experience, so long as the commercial supporter does not "instruct, direct, or otherwise cause the subsidized tuition fee for a continuing education event to go to a specific physician attendee.” (Final Rule at pages 595-596). The CME Coalition looks forward to working with CMS to assist the agency in drafting sub-regulatory guidance regarding tuition fees provided to physician attendees, which the agency expects not to be reported.
These clarifications by CMS address the chief concerns of the CME Coalition and over 98% of the commenters to the public record who called on the Agency to maintain a strong CME exemption to the reporting requirements.
About the CME Coalition
The CME Coalition’s 30+ member organizations represent a broad collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in the US health care system. Its member organizations provide, manage and support the development of healthcare continuing education programs that impact more than 500,000 physicians, nurses and pharmacists annually. Graduation from medical school and completion of residency training are the first steps in a career-long educational process for physicians. To take advantage of the growing array of diagnostic and treatment options, physicians must continually update their technical knowledge and practice skills. CME is a mainstay for such learning.
FOR IMMEDIATE RELEASE
Contact: Andrew Rosenberg, (202) 247-6301, arosenberg@thornrun.com
On October 31st, CMS announced that the section of last year’s Open Payments rule that created a special CME exemption was eliminated. In its place, CMS provided redefined and pre-existing reporting rules that specifically exclude CME payments, including speaker-related payments and tuition support for attendees, so long as they are not directed by a commercial supporter and otherwise do not meet the definition of an indirect payment under§403.904(i)(1).
The CME Coalition applauds this new approach.
Specifically, CMS clarifies that where "an applicable manufacturer or applicable GPO provides funding to support a continuing education event [and] does not require, instruct, direct, or otherwise cause the continuing education event provider to provide the payment … to a covered recipient, the [commercial supporter] is not required to report the payment.” (Final Rule at page 595) Importantly, CMS specifically declares under the Final Rule that such indirect CME-supporting transfers of value are not reportable, even if the commercial supporter subsequently discovers the identity of the covered recipient “because the payment or other transfer of value did not meet the definition of an indirect payment.”
“As a practical matter, because the standards for commercial support inherent in most accredited CME already prohibit commercial supporters from paying speakers directly, suggesting speakers (e.g., providing a list), or otherwise controlling the nature or content of the educational program, there will not be any necessity to report CME payments under the Sunshine Act for most accredited CME programs,” stated CME Coalition Senior Advisor Andrew Rosenberg. “Therefore the CME Coalition applauds CMS for clarifying these important rules in such a manner.”
Furthermore, CMS addressed another important concern of CMS stakeholders by making it clear that physician attendees of CME programs need not be reported to Open Payments for the value of their educational experience, so long as the commercial supporter does not "instruct, direct, or otherwise cause the subsidized tuition fee for a continuing education event to go to a specific physician attendee.” (Final Rule at pages 595-596). The CME Coalition looks forward to working with CMS to assist the agency in drafting sub-regulatory guidance regarding tuition fees provided to physician attendees, which the agency expects not to be reported.
These clarifications by CMS address the chief concerns of the CME Coalition and over 98% of the commenters to the public record who called on the Agency to maintain a strong CME exemption to the reporting requirements.
About the CME Coalition
The CME Coalition’s 30+ member organizations represent a broad collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in the US health care system. Its member organizations provide, manage and support the development of healthcare continuing education programs that impact more than 500,000 physicians, nurses and pharmacists annually. Graduation from medical school and completion of residency training are the first steps in a career-long educational process for physicians. To take advantage of the growing array of diagnostic and treatment options, physicians must continually update their technical knowledge and practice skills. CME is a mainstay for such learning.
