Recently, MediSpend’s Advisory Services team presented a webinar on emerging transparency updates and requirements for pharmaceutical and medical device manufacturers. Notable updates included changes to the Centers for Medicare & Medicaid Services (CMS) Open Payments reporting, Oregon’s new sales representative disclosure requirements, the Italian Sunshine Act and the Chilean Chamber of Pharmaceutical Innovation (CIF) disclosure obligations.

CMS Open Payments Updates

Numerous updates to the Open Payments program were included as part of the 2022 Physician Fee Schedule which went into effect for data capture beginning January 1, 2023, to be included in the March 2024 report. Among other changes, a mandatory payment context field has been added to the reporting template for teaching hospitals for both general and research payments. Examples of data that may be provided include, “the check number or electronic wire number for the payment, the related department of the hospital, or other pieces of relevant information.” This field will only be visible to the teaching hospital disputing the reported information.

Reporting entities will have the ability to attest in the Open Payments portal that they do not have any reportable records to disclose for that year. Additionally, the 2023 updates disallow record deletions without a substantial reason. A new required field titled “Reason for Deletion” will be added to the delete attested record functionalities in the Open Payments system with a list of reasons to choose from. Options include incorrect covered recipient, duplicate record and check was void or not cashed among others.

A full list of CMS changes as well as guidance for each can be found under the Reporting Entities tab on the Open Payments Resources page.

Oregon

Senate Bill 763 was finalized in June of 2022, which requires pharmaceutical representatives who do business within the state of Oregon to acquire a license from the Department of Consumer and Business Services. The application includes a cost of $750 and proof of at least 10 hours of professional education. Licenses are to be renewed each year for the same fee with proof of an additional five hours of continuing education. In addition to obtaining a license, an annual reporting requirement is due each April, with the first report being April 1, 2023. Information to be disclosed includes the following:

  • A list of healthcare professionals (HCPs) within the state that the licensee has contacted, along with their NPI or Oregon state license number
  • The number of times the licensee contacted each HCP
  • The location and duration of each contact
  • The pharmaceutical products promoted
  • Any product samples, materials, gifts or other compensation provided to the HCP and the value

Italy

On May 31, 2022, the Italian Parliament approved Law 62/2022, also known as the Italian Sunshine Act, which entered force on June 26, 2022. The new rules become fully enforceable when the Ministry of Health establishes a Telematic Public Register for disclosures. In accordance with the Law, the Ministry of Health was given six months to establish the register from the date of entry into force. The date of commencement of operation of the registry will be announced with publication in the Official Gazette.

MediSpend is committed to providing our clients with the most up-to-date information, and we are working in conjunction with outside counsel, industry leaders and life science manufacturers regarding the latest Italian Sunshine Act updates. Stay tuned for additional information in a future MediSpend webinar when the Ministry has completed their requirements.

Chile

The CIF, the trade association in Chile, has implemented a Code of Conduct that contains transparency obligations for member companies. Report requirements differ depending on the covered recipient and the transfer of value. Member companies must report transfers of value on a quarterly basis within three months following the end of each quarter. The first report was due in June for all January to March transactions.

To stay up to date on industry knowledge, subscribe to MediSpend Perspectives to receive updates from our MediSpend Advisory Services team. MediSpend Advisory Services is led by a team of experienced attorneys and compliance professionals to assist life sciences companies with the development and implementation of policies and procedures that facilitate compliance with global healthcare laws, regulations and codes of conduct.

 

Lauren Howe
Director of Compliance Solutions

February 16, 2023