What you need to know about the Sunshine Act

AADA urges passage of bill exempting CME from Sunshine Act

AADA, along with more than 100 medical societies, is encouraging Congress to pass legislation that would exempt certain Continuing Medical Education (CME) publications from reporting requirements under the Physician Payments Sunshine Act. If passed, the law would provide a clarification, noting that physicians will have access to the most up-to-date medical evidence and materials. Under the current regulations, educational materials, medical textbooks and scientific journals are subject to reporting requirements, potentially delaying physician uptake of the latest medical advances. The bill allows for more rapid provider access to peer-reviewed publications, which helps physicians to adopt the latest evidence-based medicine for patient care. Read the AADA's letter of support.

Commonly referred to as the Sunshine Act, the National Physician Payment Transparency Program was established as part of the Patient Protection and Affordable Care Act (ACA) and is intended to create greater transparency about the financial relationships between drug and device manufacturers and health care providers.

As part of the Centers for Medicare and Medicaid Services' (CMS) Open Payments program, industry is required to track and report payments to physicians and teaching hospitals beginning Aug. 1, 2013. However, dermatologists are also advised to track payments they receive from industry for verification purposes.

CMS will post the information that industry provides on the Open Payments public website, which anyone will be able to access on Sept. 30, 2014. Those in industry who do not comply can face penalties of $1 million or more. Expand the menu items below to learn more about this program.

Sunshine Act

Who is required to report?

Under the Open Payments program the following entities are required to report payments or items of value:

  • Manufacturers of drugs, devices, biologics, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program.
  • Manufacturers and group-purchasing organizations must disclose physician ownership or investment interests.

What are they required to report?

The following list details the compensation or gifts that are reportable under the program:

  • Consultations
  • Lectures
  • Research projects
  • Education
  • Honoraria
  • Gifts
  • Entertainment
  • Food and beverages
  • Travel and lodging
  • Charitable contributions
  • Royalties/licenses
  • Current or prospective ownership or investment interests
  • Grants and compensation (For serving as faculty or a speaker for an unaccredited and non-certified CME program, or an accredited or certified CME program under certain circumstances.)

A proposed change to the Sunshine Act requirements in the 2015 Medicare Fee Schedule proposed rule would also make payments made to speakers for Continuing Medical Education (CME) services reportable. Previously, accredited or certified continuing education payments to speakers were not required to be reported.

What is exempt?

Exemptions include the following items that do not need to be reported:

  • A transfer of value less than $10, unless the aggregated amount transferred exceeds $100 annually.
  • Product samples intended for patient use.
  • Patient education materials that directly benefit patients.
  • The loan of a device for a trial period not to exceed 90 days for the purpose of evaluation.
  • Items or services provided under a contractual warrant, where the terms of the warranty are set forth in the purchase or lease agreement.
  • Discounts, including rebates.
  • In-kind items used for the provision of charity care.
  • CME activities, offered by Accreditation Council for Continuing Medical Education (ACCME) accredited providers that comply fully with ACCME’s standards for commercial support and that meet the definition of “indirect payments.”

What should you do?

Track payments

Beginning in August 2013, dermatologists should keep a list of all payments they receive, disclose the companies they receive them from as required, and document for their own records details about services rendered. To aid in this effort, CMS has established a help desk for physician inquiries. Physicians may email their questions to openpayments@cms.hhs.gov. CMS also has developed a free app that physicians may use to track this information on their mobile devices. Information about how to download the app on Android and Apple devices is available here.

Register for Open Payments

Dermatologists should register with CMS so they can review their payment data for accuracy. The site includes registration instructions. Physicians can register starting June 1.

NOTE: Physicians may encounter significant delays when registering for the Open Payments site. Additionally, once registered, physicians may receive an error message if there is no information published about the physician. To confirm there is no information to review, or to report problems with the site, physicians are encouraged to email openpayments@cms.hhs.gov.

Dispute inaccuracies

Physicians will have a 45-day period in which to review the data before it goes public and dispute any inaccuracies. Dermatologists should verify their information in the National Plan and Provider Enumeration System (NPPES) to ensure they are being identified correctly.

Additionally, physicians will need to work with the applicable manufacturer or group-purchasing organization to make corrections. After the initial 45-day period, the manufacturers will have an additional 15 days to submit corrections. If the dispute is not resolved on or before the 15-day period, CMS will publish the information but will label it as disputed.

Note: It is important for physicians to review and dispute any inaccuracies in the Open Payment data to ensure that the physician’s relationship are not misrepresented to the public.

Review information from the Academy about Medicare enrollment and documentation here.

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