The members of the Contact Lens Institute (CLI) seek to support the needs of the optometry community, often through their respective professional and medical associations. In connection with these efforts, a number of questions have arisen from time to time regarding the various types of funding requests submitted to members as well as some of the related reporting requirements under the Open Payments “Sunshine” Law.
The definitions and discussion provided in this guidance provide some clarity around the types of requests CLI members receive, as well as some insights into relevant considerations under the AdvaMed Code of Ethics on Interactions with Health Care Providers and related guidance under that Code.
Please note that this guidance is not specific to any individual member, all of whom retain autonomy in their funding processes, requirements, and decisions.
Typically, funding can be categorized into three types of support including promotional sponsorships, educational grants and charitable contributions. Additionally, companies may be asked to provide support in several other ways, including providing meals, in-kind services, educational materials, and other items. We will focus on the funding categories.
Requests for a commercial sponsorship may be requested for promotional opportunities at local, regional or national meetings, or for a healthcare related organization. This type of sponsorship may include but is not limited to:
Supporting Third-Party Educational Conferences – Bona fide independent, educational, scientific, and policymaking conferences promote scientific knowledge, medical advancement and the delivery of effective health care. These typically include conferences sponsored by national, regional, or specialty medical associations and conferences sponsored by accredited continuing medical education providers. Companies may support these conferences in various ways: companies may provide a grant to the conference sponsor to reduce conference costs. They may also provide grants to a training institution or the conference sponsor to allow attendance by medical students, residents, fellows, and others who are Health Care Professionals in training. Companies may provide grants when: (1) the gathering is primarily dedicated to advancing objective scientific and educational activities and discourse; and (2) the training institution or the conference sponsor selects the attending Health Care Professionals who are in training.
Such grants should be paid only to organizations with a genuine educational function and may be used to reimburse only the legitimate expenses for bona fide educational activities. Such grants also should be consistent with applicable standards established by the conference sponsor and the accrediting body for the educational activity. The conference sponsor should independently control and be responsible for the selection of program content, faculty, educational methods, and materials.
Faculty Expenses. Companies may make grants to conference sponsors for reasonable honoraria, travel, lodging, and modest meals for health care professionals who are bona fide conference faculty members.
A company may make monetary or medical technology donations for charitable purposes, such as supporting indigent care, patient education, public education, or the sponsorship of events where the proceeds are intended for charitable purposes. Charitable donations should be motivated by bona fide charitable purposes and should be made only to bona fide charitable organizations or, in rare instances, to individuals engaged in genuine charitable activities for the support of a bona fide charitable mission. Charitable donations should not be tied to, or conditioned upon, the purchase or recommendation of a Company product by the organization or its supporters. Companies should exercise diligence to ensure the bona fide nature of the charitable organization or charitable mission.
The main purpose of the law is to provide patients with enhanced transparency into the relationships their health care providers have with life science manufacturers, including medical technology companies. The Sunshine Law requires that payments and transfers of value made by life science manufacturers to “Physicians” and “Teaching Hospitals” be reported. Under the Sunshine Law, “physicians” include doctors of medicine and osteopathy, dentists, podiatrists, optometrists and licensed chiropractors. The program is administered by the Centers for Medicare and Medicaid Services (CMS), and is now known as the Open Payments program.
There are numerous ways in which CLI companies compensate physicians, academics and healthcare professionals for their time, expertise and intellectual property, in connection with the development of new technologies, the improvement of existing technologies, and training and education of other health care professionals in the safe and effective use of medical technology, among other beneficial services.
These arrangements fuel advances in medical technology, and improve medical care and the quality of healthcare available to patients and consumers. Specific examples under the Sunshine Nature of Payment Categories include Consulting Fees, Honoraria, Education, Research, Royalty or license, and Direct compensation for serving as a faculty or a speaker.
Under the Open Payments program, CLI members are required to report certain value transfers made by them through third parties if the Company directs, instructs, “or otherwise causes” (e.g., through an agreement) the third party to make such a transfer. These are known as “indirect payments.” This includes suppliers that facilitate speaker programs or advisory boards, provide meals at company sponsored events, or distribute educational items such as text books. Additionally, value transfers provided through organizations that provide continuing medical education are reportable.
The Advanced Medical Technology Association (“AdvaMed”) represents companies that develop, produce, manufacture, and market medical products, technologies and related services and therapies used to diagnose, treat, monitor, manage and alleviate health conditions and disabilities (“Medical Technologies”) in order to enable patients to live longer and healthier lives. AdvaMed is dedicated to the advancement of medical science, the improvement of patient care, and, in particular, the contributions that high quality, innovative Medical Technologies make toward achieving these goals.
AdvaMed recognizes the obligation to facilitate ethical interactions between Companies and those individuals or entities involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Companies’ Medical Technologies in the United States.
AdvaMed recognizes that Health Care Professionals’ first duty is to act in the best interests of patients. Companies can serve the interests of patients through beneficial collaborations with Health Care Professionals. To ensure that these collaborative relationships meet high ethical standards, they must be conducted with appropriate transparency and in compliance with applicable laws, regulations and government guidance. AdvaMed recognizes the obligation to facilitate ethical interactions between Companies and Health Care Professionals in order to ensure that medical decisions are based on the best interests of the patient. The ethical principles that govern these interactions are reflected in the AdvaMed Code of Ethics.
It is important that Companies typically have different internal processes for each type of funding and requests from organizations should be sent by type and not combined. As mentioned previously, the CLI Companies are all committed to meet the reporting requirements under Open Payments.
When requesting funds, consider the reporting implications that these requests might have on companies required to report under Open Payments, such as the CLI Companies, as well as the data gathering that would be required of your organizations to meet these reporting requirements.
Currently, the requirements for Continuing Education programs (CE) for optometrists are the same as non CE programs. This is because COPE accredited programs are not exempt from Open Payment as per CMS.
As you submit requests for funding, consider the following:
The following are criteria that may be evaluated to determine if a value transfer needs to be reported:
If it is determined that a value exchange will be provided as part of the commercial support, the following information will need to be provided by the respective Professional and Medical Society: