Alliance for CEHP Hosts Sunshine Act Webinar: Sunshine Effects on CME Left Open; Attendee Meals at CME Events Still Up for Interpretation
The Alliance for Continuing Education in the Health Professions (CEHP) hosted a webinar to discuss federal perspectives on the implementation of the Sunshine Act. Dr. Shantanu Argawal, Medical Director at the Center for Program Integrity at the Centers for Medicare and Medicaid Services (CMS), outlined the objectives of the Sunshine Act, and addressed specific questions with respect to the Act’s exemption for accredited continuing medical education (CME) activities.
Dr. Argawal described the Sunshine Act as essentially a balance between the beneficial aspects of industry-physician relationships, which encourage discovery and development of new technologies that improve health care efficiently, and the potential conflicts of interest that could influence professional judgment. When compared to the narrow, technical focus of CMS’ last few webinars, the presentation started with a refreshing high-level discussion of the Sunshine Act, walking through the definitions of several crucial pieces of the complicated final rule.
SUNSHINE ACT FUNDAMENTALS:
The Sunshine Act, also referred to as Open Payments, requires applicable manufacturers and group purchasing organizations (GPOs) of the medical industry to collect and report to CMS data on transfers of value to covered recipients, as well as the ownership interests held by physician owners or investors and their family members. CMS will publish the submitted information on their website on September, 2014, and annually following. CMS cleared up the general uncertainty about whether physicians have to report anything. They do not. The medical industry is required to collect and report data. The civil penalties may only be leveled against industry.
Industry:
- Applicable Manufacturers: Entities that operate in the US and that either produce or prepare at least one drug, device, biological, or medical supply covered by Medicare/Medicaid/CHIP or operate under common ownership (5% ownership interest) and provide assistance and support to applicable manufacturers.
- Applicable Group Purchasing Organizations: Entities that operate in the US and that purchase, arrange for, or negotiate the purchase of covered drugs, devices, biologicals, or medical supplies.
Covered Recipients:
- Physicians: The physician category is not restricted to Doctors of Medicine. The list includes: Doctors of Medicine/Osteopathy, Dental Surgery/Dental Medicine, Podiatrists, Optometrists, and Chiropractors. Physicians with no relationship with CMS through reimbursement are included. Medical Residents are excluded from the definition, but CMS stated that Medical Fellows are included.
- Teaching Hospitals: CMS is required to provide an annual list of teaching hospitals included under the definition of “covered recipient,” which includes the hospitals that CMS has recorded as receiving a payment(s) under Medicare direct graduate medical education (GME), indirect medical education (IME) or psychiatric hospitals IME programs. Industry has been instructed in the 2013 program cycle to collect and report using an institution’s legal business name, and to report data separately for each legal business name, TIN, and address combination appearing on the list.
In addition to reporting on transfers of value to covered recipients, industry must also report information on physician owners or investors, and their family members, extending out to in-laws and spouses of grandparents or grandchildren.
What data must the industry collect?
CMS breaks it down into three categories: (1) General Payments, defined broadly as payments or other transfers of value not made in connection with research agreements, (2) Research Payments, the transfers of value made in connection with a research agreement, including medical research writing and/or publication, and (3)Ownership & Investment Interests. The program captures Direct Payments, transfers of value paid directly to physicians and teaching hospitals, such as when a physician sits down to lunch with a manufacturer. The program also captures Indirect Payments, where a manufacturer provides funding to intermediaries, which may then go to a physician. Finally, the programs captures data on payments designated by physicians or teaching hospitals to be paid to another party, such as a charity (Third Party Payments).
As stated above, industry—the applicable manufacturers and GPOs—are the ones required to collect and report the data. However, CMS urges physicians and teaching hospitals to monitor the submitted information before the public posting. Physicians and teaching hospitals will receive a notification when the reported information is ready for review and can enter into dispute resolution with the manufacturers if they disagree with the submissions or come across inaccuracies before CMS publishes the data. Industry members who submit incorrect or missing information run the risk of being audited and receiving civil fines.
The most recent 2013-2014 Sunshine Act Timeline:
SUNSHINE ACT & CONTINUING MEDICAL EDUCATION
Despite the clear summary of the Sunshine Act’s general goals, the presentation was elusive with regards to some of the Act’s effects on Continuing Medical Education (CME) programs.
Accrediting Bodies:
The Sunshine Act’s reach is expansive. As stated above, the program seeks to capture generally all transfers of value. The Sunshine Act provides an exception in the CME context, but the exception is limited. Compensation for speaking at a continuing education program is not required to be reported if the program meets the certification requirements and standards of one the five accrediting bodies identified in the final rule – ACCME, AOA, AAFP, AMA, or ADA. Furthermore, the manufacturer may not directly pay the physician speaker, and the manufacturer may not select the physician speaker nor provide the third party with a distinct set of individuals to be considered as speakers for the accredited of certified continuing education program.
AstraZeneca’s Pam Mason identified concerns about these requirements, namely that there are a number of medical specialties—including pharmacy, nursing, optometry and podiatry—that rely heavily upon CME, but whose programming is generally accredited by well-respected bodies not included in the list delineated in the Final Rule. Dr. Argawal responded that several accreditation organizations raised concerns with the certification requirements and that he “[sees] this as an area of inconsistency,” adding that CMS is working to devise a solution that will work for stakeholders and “meet the spirit of this transparency program.” Further, he said that CMS cannot simply augment the list in sub-regulatory guidance—a fix would require additional rulemaking. Dr. Argawal insinuated that an immediate solution to this issue should not be expected, adding that 2013 data will be reported under the current conditions, and 2014 data will have to be collected under the assumption that the Final Rule will stand.
Meals at CME Events:
Jacob Coverstone of the Alliance for Continuing Education in the Health Professions (ACEhp) spoke for many listeners when he asked Dr. Argawal to elaborate on the CMS’ position with respect to exemptions for attendee meals at accredited CME events. Despite guidance from CMS that meals at accredited CME events are exempt from the law’s reporting requirements, Dr. Argawal urged stakeholders to dwell on the essential elements of an education course. Because in his opinion meals are “not required components of the CME,” he reasoned, they would not be exempted.
With respect to the distinction between buffet style meals opposed to plated meals, Dr. Argawal added that CMS has “provided a definition as much as we can at this point in sub-regulatory guidance.” He continued, “We have tried to leave this open,” and indicated that additional guidance is unlikely in the near future, as to allow industry time to adapt to the guidance that has already been promulgated. Finally, while Dr. Argawal did not address the issue of meals at accredited CME events during his formal presentation, it is noteworthy that the issue was addressed in the following slide:
Mr. Coverstone also asked if CMS had come to a conclusion on the definition of a “large meeting” for the reporting exemption, which CMS had previously indicated would be ready this month. Dr. Agrawal said that while CMS has been working towards a specific definition, they are still soliciting feedback from industry on what they would consider a large event, noting that there is “quite a bit of heterogeneity.” He said that at some relatively “large” conferences, companies are able keep track of thousands of exhibits through electronic means, and so they may have a wildly different interpretation of “large” than smaller, less sophisticated organizations. Clarifying, Dr. Argawal said that while the definition is currently open to interpretation, it will be a “maturing process.”
In the roundtable discussion with Ms. Mason, Mr. Coverstone, and Damon Marquis, the Coalition for CEhp President, following the CMS presentation, the presenters fronted many questions about meals. They agreed that, under CMS’ interpretation, a meal is simply not a necessary component of the educational activity. This is not to say that meals are not allowed at CME events, but rather that a “common sense” approach should be in place to report meals provided to attendees.
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CMS concluded its presentation advising physicians and hospitals to track all interactions they have with industry involving payments or transfers of value to ensure accuracy. For CME providers and supporters the CME Coalition with the assistance of six attorneys from four seperate firms has developed a detailed sunshine act compliance guide and supplemental FAQ for implementing the Physician Payment Sunshine Act and CME. The discussion from CMS helped to validate the guide as good resource for CME providers and supporters.
Follow Policy and Medicine for future updates regarding the Sunshine Act.