Ethics, Advocacy, and Disclosure: The Sunshine Rule

SHM recently joined more than 30 organizations in the Council of Medical Specialty Societies (CMSS) in signing a letter to the Centers for Medicare & Medicaid Services (CMS) to affirm the importance of—and to voice concerns about—some provisions in the proposed Sunshine Rule for doctor-industry relationships.

Specifically, the letter highlights some critical distinctions in compensation for teaching Continuing Medical Education (CME) courses.

The Sunshine Rule was proposed in response to the adoption of the Physician Payments Sunshine Act in Section 6002 of the Affordable Care Act of 2010. The act requires gifts or payments to physicians from pharmaceutical and medical device manufacturers worth more than $10 to be reported publicly by manufacturers. CMS created the proposed rule to frame which situations and exchanges of value fall within and outside the reporting requirements. As part of the rulemaking process, CMS welcomed comments to help refine and develop the final rule.

The proposed rule asserts that the category of “Direct Compensation for Serving as a Faculty or as a Speaker for a Medical Education Program” be broadly understood to encompass any situation in which a manufacturer compensates physicians for speaking engagements. This includes certain indirect payments through a third-party like a CME provider. So if you serve as a faculty member sharing your expertise through accredited or certified CME, your service could be reportable if the provider received industry funding. This could happen even if you have no specific knowledge of the industry funder.

The CMSS letter identifies a distinction between promotional education programs and accredited or certified CME programs, noting that only the former implies a relationship between a physician and manufacturer. Accredited and certified CME programs, on the other hand, already are governed by the Standards for Commercial Support: Standards to Ensure the Independence of CME Activities, which includes guidance to ensure the independence of CME activities from industry funders. Industry grants do not pay accredited or certified CME faculty directly, but rather go to CME providers who organize and develop the programs. This clarification expressly acknowledges the established self-regulation and ethical guidelines of the CME programs. Importantly, the letter does support disclosure of compensation from promotional education programs directly sponsored by industry.

By signing on to this letter, SHM has expressed its support for greater transparency in relationships between physicians and industries, while illuminating areas of concern in the rule.

The Sunshine Rule illustrates some of the richness and complexity of policy initiatives, and highlights potential topics to broaden our conversation and involvement. These types of issues generate robust discussions about ethics and professionalism within the medical establishment.

Hospitalists can, and should, engage these debates both within SHM and from their unique vantage point within the hospital.

As a membership organization, SHM details our efforts at transparency in our relationship with industry partners at www.hospitalmedicine.org/industry.

SHM recently joined more than 30 organizations in the Council of Medical Specialty Societies (CMSS) in signing a letter to the Centers for Medicare & Medicaid Services (CMS) to affirm the importance of—and to voice concerns about—some provisions in the proposed Sunshine Rule for doctor-industry relationships.

Specifically, the letter highlights some critical distinctions in compensation for teaching Continuing Medical Education (CME) courses.

The Sunshine Rule was proposed in response to the adoption of the Physician Payments Sunshine Act in Section 6002 of the Affordable Care Act of 2010. The act requires gifts or payments to physicians from pharmaceutical and medical device manufacturers worth more than $10 to be reported publicly by manufacturers. CMS created the proposed rule to frame which situations and exchanges of value fall within and outside the reporting requirements. As part of the rulemaking process, CMS welcomed comments to help refine and develop the final rule.

The proposed rule asserts that the category of “Direct Compensation for Serving as a Faculty or as a Speaker for a Medical Education Program” be broadly understood to encompass any situation in which a manufacturer compensates physicians for speaking engagements. This includes certain indirect payments through a third-party like a CME provider. So if you serve as a faculty member sharing your expertise through accredited or certified CME, your service could be reportable if the provider received industry funding. This could happen even if you have no specific knowledge of the industry funder.

The CMSS letter identifies a distinction between promotional education programs and accredited or certified CME programs, noting that only the former implies a relationship between a physician and manufacturer. Accredited and certified CME programs, on the other hand, already are governed by the Standards for Commercial Support: Standards to Ensure the Independence of CME Activities, which includes guidance to ensure the independence of CME activities from industry funders. Industry grants do not pay accredited or certified CME faculty directly, but rather go to CME providers who organize and develop the programs. This clarification expressly acknowledges the established self-regulation and ethical guidelines of the CME programs. Importantly, the letter does support disclosure of compensation from promotional education programs directly sponsored by industry.

By signing on to this letter, SHM has expressed its support for greater transparency in relationships between physicians and industries, while illuminating areas of concern in the rule.

The Sunshine Rule illustrates some of the richness and complexity of policy initiatives, and highlights potential topics to broaden our conversation and involvement. These types of issues generate robust discussions about ethics and professionalism within the medical establishment.

Hospitalists can, and should, engage these debates both within SHM and from their unique vantage point within the hospital.

As a membership organization, SHM details our efforts at transparency in our relationship with industry partners at www.hospitalmedicine.org/industry.

SHM recently joined more than 30 organizations in the Council of Medical Specialty Societies (CMSS) in signing a letter to the Centers for Medicare & Medicaid Services (CMS) to affirm the importance of—and to voice concerns about—some provisions in the proposed Sunshine Rule for doctor-industry relationships.

Specifically, the letter highlights some critical distinctions in compensation for teaching Continuing Medical Education (CME) courses.

The Sunshine Rule was proposed in response to the adoption of the Physician Payments Sunshine Act in Section 6002 of the Affordable Care Act of 2010. The act requires gifts or payments to physicians from pharmaceutical and medical device manufacturers worth more than $10 to be reported publicly by manufacturers. CMS created the proposed rule to frame which situations and exchanges of value fall within and outside the reporting requirements. As part of the rulemaking process, CMS welcomed comments to help refine and develop the final rule.

The proposed rule asserts that the category of “Direct Compensation for Serving as a Faculty or as a Speaker for a Medical Education Program” be broadly understood to encompass any situation in which a manufacturer compensates physicians for speaking engagements. This includes certain indirect payments through a third-party like a CME provider. So if you serve as a faculty member sharing your expertise through accredited or certified CME, your service could be reportable if the provider received industry funding. This could happen even if you have no specific knowledge of the industry funder.

The CMSS letter identifies a distinction between promotional education programs and accredited or certified CME programs, noting that only the former implies a relationship between a physician and manufacturer. Accredited and certified CME programs, on the other hand, already are governed by the Standards for Commercial Support: Standards to Ensure the Independence of CME Activities, which includes guidance to ensure the independence of CME activities from industry funders. Industry grants do not pay accredited or certified CME faculty directly, but rather go to CME providers who organize and develop the programs. This clarification expressly acknowledges the established self-regulation and ethical guidelines of the CME programs. Importantly, the letter does support disclosure of compensation from promotional education programs directly sponsored by industry.

By signing on to this letter, SHM has expressed its support for greater transparency in relationships between physicians and industries, while illuminating areas of concern in the rule.

The Sunshine Rule illustrates some of the richness and complexity of policy initiatives, and highlights potential topics to broaden our conversation and involvement. These types of issues generate robust discussions about ethics and professionalism within the medical establishment.

Hospitalists can, and should, engage these debates both within SHM and from their unique vantage point within the hospital.

As a membership organization, SHM details our efforts at transparency in our relationship with industry partners at www.hospitalmedicine.org/industry.