August 5, 2013
As required by the Physician Payments Sunshine Act, certain drug, device and biologicals manufacturers have begun tracking payments to physicians and will be reporting these payments to CMS next year. CMS will make the information available in a public, searchable database. Physicians should understand the rules and make sure that their information is accurate.
As of August 1st, certain manufacturers of drugs, medical devices and biologicals are tracking their payments to physicians, as required by the Physician Payments Sunshine Act (Sunshine Act), which is part of the Affordable Care Act. They will report payments and other items of value worth more than $10, as well as certain ownership interests held by physicians and immediate family members, to CMS annually. Reporting may begin immediately, on a voluntary basis, and must begin by next January. CMS will post the information, by physician, on a public, searchable website.
CMS published the final regulations implementing the Act on February 1, 2013, and we summarized the rule in an Alert dated February 18th. We refer readers to that Alert for information on the “applicable manufacturers,” the definition of “covered products,” the form and nature of payments and other “transfers of value” that must be reported and reportable ownership and investment interests held directly or indirectly by physicians and their immediate family members. In the Alert, we said that we would “watch for guidance from CMS on how physicians might register, review and, if necessary challenge their information.” The purpose of today’s Alert is to bring you up to date on registering with CMS and reviewing and challenging the information on your financial relationships with manufacturers.
The Act imposes reporting responsibilities on manufacturers and group purchasing organizations (GPOs) only. It does not preclude payments to physicians, nor require any action of physicians. Voluntary participation is encouraged, however. Anesthesiologists and pain specialists should consider the following suggestions from CMS’ Open Payments Fact Sheet for Physicians:
- Become familiar with the information that will be reported about physicians.
- Keep records of all payments and other transfers of value received from applicable manufacturers or applicable GPOs.
- Register with CMS and subscribe to the list serve to receive updates regarding the program. [CMS will provide information on registering through a portal later this year.]
- Look at the information applicable manufacturers and applicable GPOs submitted on physician’s behalf.
- Work with applicable manufacturers and applicable GPOs to make sure the information submitted about is correct.
The following timeline indicates approximately when you can expect to take these actions:
Under the terms of the Sunshine Act, physicians will have a minimum of 45 days to review their own consolidated payments and transfers reports and to make corrections before the reports are released to the public. Additionally, physicians will have up to two years to dispute reports even after these are made public. The fact that the information is in dispute will be noted in the public database. CMS will not mediate any disputes.
The American Medical Association (AMA) offers a number of resources in its Sunshine Act toolkit, including a set of Top Tips to Ensure Accurate Reporting. Physicians are advised to:
- Ensure that all financial and conflict-of-interest disclosures required by employers or other entities are current and are updated regularly, as those entities may compare their information with that posted on the future public website.
- Make sure your professional information and specialty designation are correct. Check that your National Provider Identifier (NPI) appears correctly in the NPI enumerator database. Manufacturers will use NPIs to confirm identities.
- Ask manufacturers’ representatives to provide information on payments and transfers in advance for verification and correction, if appropriate, before submitting the information to CMS. “If you ask for a pre-submission review,” according to the CMS Fact Sheet cited above, “there is a better chance that the information sent to us about you is accurate and complete.”
- If you hold any ownership interests in a manufacturer or GPO (other than publicly traded stock), ask what they intend to report.
CMS has created an app that allows physicians to capture and collect information on payments or other transfers from manufacturers. The OPEN PAYMENTS Mobile for Physicians app can be downloaded for free from the iOS Apple™ Store and the Google Play™ Store, as can a complementary app for health care industry users. The AMA suggests that physicians “urge your industry contacts to use the app so you will be able to capture the information you need to ensure accurate reporting.”
In addition to the extensive guidance posted on its website, CMS plans to hold a National Provider Call on the Sunshine Act (Open Payments) titled "OPEN PAYMENTS – Policy Updates on Payments and the Physician Resource Toolkit on" August 8th at 1:30 pm Eastern Standard Time. Click here to register for the call. There is also an April 24th webinar on Physicians Preparing for the Sunshine Act: What You Need to Know and How to Prepare archived on the AMA website.
Whether the Sunshine Act will prevent health companies from gaining inappropriate influence over research, education and clinical decisions, and whether it will stop physicians from attending valuable continuing education sessions that involve a meal paid for by a pharma company (buffet meals are not generally reportable) remain to be seen. We will observe the implementation over the next year and keep our readers informed of developments and new resources.
With best wishes,
Tony Mira
President and CEO
