Pew Comments to FDA on Proposed Changes to Sunshine Act Reporting


On September 2, Pew submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to proposed regulations which would change reporting under the Physician Payment Sunshine Act. Pew supports the elimination of the continuing medical education exclusion, and urges CMS to implement the Sunshine Act in the best interest of consumers.

September 2, 2014

Marilyn Tavenner
Centers for Medicare & Medicaid Services
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Submitted electronically via: http://www.regulations.gov (CMS-2014-0094-0002)

Re: Other Provisions of the Proposed Regulations, Reports of Payments or Other Transfers of Value to Covered Recipients (Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015) (CMS-1612-P)

Dear Administrator Tavenner:

The Pew Charitable Trusts thanks the Centers for Medicare & Medicaid Services (CMS) for the opportunity to provide comments on the proposed rule regarding Other Provisions of the Proposed Regulations, Reports of Payments or Other Transfers of Value to Covered Recipients. Pew is an independent, non-profit organization that applies a rigorous analytical approach to improve public policy, inform the public, and stimulate civic life, including support for transparency of financial relationships between pharmaceutical and medical device makers and health care providers.

We support the elimination of the Continuing Medical Education (CME) Exclusion

The Sunshine Act provides long overdue tools for understanding the financial relationships between physicians and industry, and eliminating the Continuing Medical Education exclusion is an important step toward ensuring transparency in the payments that physicians receive from industry.

  1. CME payments are indirect payments, and they should be treated in the same way as all other indirect payments made to physicians, as described in §403.904(i)(1) of the rule. This section clarifies that indirect payments are excluded from reporting only in cases where the manufacturer is unaware of the identity of the covered recipient during the reporting year or by the end of the second quarter of the following year. Applying this same standard to CME would likely result in many CME payments being reported because accrediting agencies typically require full and public disclosure of the industry funder and the speaker before the course takes place. It would therefore be unusual by accreditor best practices for a company to not learn the identity of the recipient within the time frame specified by the regulation. Becoming aware of the recipient then triggers the requirement to report the payment.
  2. The CME industry continues to thrive, bolstered by a consistent trend toward non-commercial funding of continuing education courses for physicians and other health care providers. According to annual financial reports from the Accreditation Council for Continuing Medicare Education (ACCME), the proportion of CME supported by companies has fallen by almost half from 50 percent in 2007 to 26 percent in 2013. Meanwhile, support from non-commercial sources has increased steadily, with an average annual increase of 6 percent since 2005. According to the latest figures, more than 83 percent of all CME courses are now funded by non-commercial sources, such as physician registration fees, hospital budgets, and grants from a variety of non-profit agencies. Given these industry-wide trends, the reporting of industry CME payments is unlikely to affect the availability of medical education for doctors.1
  3. Eliminating the CME exemption would appropriately level the playing field within the medical education accreditation community. Without the rule change, the current regulation appears to endorse or support particular accrediting organizations, and places others at a disadvantage—which could in turn limit educational offerings for health professionals such as nurses or podiatrists.
  4. On the Open Payments website, CMS should clearly distinguish indirect CME payments from direct payments for educational or promotional talks. There have been anecdotal concerns expressed by physicians in academic medicine that ending the CME exemption could have the unanticipated consequence of creating the appearance of non-compliance with conflict of interest policies at their institutions. The root of this concerns stems from the fact that the majority of medical schools have policies in place that expressly forbid faculty from being directly paid by companies for promotional talks2, which will likely lead compliance officers in academic medicine to use the Open Payments website as a source of information to confirm compliance with such policies; consequently, those faculty who do not serve on industry speakers bureaus choose instead to teach accredited CME courses funded by industry because of their concern that, without the CME exemption, the honoraria they earn for such talks will be reported by the Open Payments Program. Unless these payments are clearly reported as indirect payments, compliance officers may wrongly conclude that faculty is violating conflict of interest policies. We therefore encourage CMS to allow the reporting of these payments so that indirect CME payments can be clearly distinguished from direct payments for promotional speaking.

We recommend that CMS require reporting of the marketed name for all covered and non-covered devices

We support the proposed rule change that would require applicable manufacturers to report the marketed name for all covered and non-covered drugs, devices, biologicals or medical supplies. This change will help ensure consistent reporting by both pharmaceutical product manufacturers and medical device manufacturers. The Open Payments program is designed to publicly display transfers of value from pharmaceutical and medical device manufacturers to covered recipients, including health care providers and teaching hospitals so that the financial relationships between industry and physicians are rendered transparent. The public – including researchers, journalists, and other consumers of the payment data – have a reasonable expectation that they will be able to employ typical search functions, including the ability to search for payments by brand name or marketed name of a particular product. The proposed rule change is not burdensome; the rule would still allow applicable manufacturers, in cases where the medical device does not have a marketed name, the option to report product category or therapeutic area in addition to reporting the marketed name.

We recommend that CMS perform data updates every six months during the initial two years of the Open Payments program

CMS has stated in regulations and other communications that payment disputes that have not been resolved after the 15 day dispute reconciliation and adjustment period will still be displayed on the Open Payments website, but that it will be noted that the payments are in dispute. Once the dispute is resolved, the applicable manufacturer or GPO will be responsible for transmitting updated data to CMS. CMS had previously stated its intention to update the publicly available data on an annual basis. However, due to the technical problems experienced during the initial physician review and dispute period in August, we urge CMS to consider semi-annual updates during the initial two years of the Open Payments program, and perhaps on a permanent basis. Data updates conducted on a more regular basis will help assuage concerns among affected stakeholders, including physicians and teaching hospitals that incorrect payment data may remain on display to the public for an extended period of time. More frequent updates will also provide consumers and researchers with relevant, detailed, and accurate payments information on a timely basis, as intended by statute. These supplemental updates would not require manufacturers to submit additional data beyond the data related to unresolved disputes, and therefore do not pose any additional reporting burdens that do not already exist.

In conclusion, as CMS prepares to launch the Open Payments website, we urge the agency to actively engage and educate the public and other stakeholders on the purpose, utility, and value of the Open Payments program. The website is required, by regulation, to contain payments data that is downloadable, easily searchable, and aggregated. We encourage CMS to meet those regulatory requirements on schedule so that the Open Payments program is consistent with the original Congressional intent to provide consumers and patients with clear and easy-to-understand information about the relationships between their health care providers and industry. 

CMS must also find a way to balance its commitment to the timely release of information with ensuring that the first payments data release on September 30th is as accurate and complete as possible. We urge CMS to be forthcoming regarding the status of the data that is released on September 30, including any limitations that may apply as well as a timeline for when consumers can expect updates to the information.

We thank the agency for its commitment to transparency and for ensuring that the Open Payments program is implemented in the best interest of consumers, as intended by Congress. 


Daniel J. Carlat, M.D.

1 Accreditation Council for Continuing Medical Education 2013 Annual Report. Available online: http://www.accme.org/sites/default/files/630_2013_Annual_Report_20140715_0.pdf.
2 American Medical Student Association Scorecard 2014. Available online: “Conflict of Interest Policies at Academic Medical Centers”, http://www.amsascorecard.org/

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