MediSpend’s Advisory Services team recently 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, Connecticut’s new sales representative disclosure requirements and an update on the Italian Sunshine Act.

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. Perhaps the most notable change includes a mandatory payment context field added to the reporting template for all payments attributed to teaching hospitals. 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. Companies should decide how they will handle this field moving forward prior to submission in March.

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.

Connecticut

The Connecticut Governor signed Public Act 23-171 which became effective on October 1, 2023. Sections 3 through 6 of the Act require pharmaceutical manufacturers that employ pharmaceutical sales representatives to register with the Department of Consumer Protection. Applicable pharmaceutical representatives include “any person, including, but not limited to, a sales representative, who markets, promotes or provides information regarding a legend drug for human use to a prescribing practitioner and is employed or compensated by a pharmaceutical manufacturer.”

The Act requires that beginning October 1, no pharmaceutical manufacturer may have sales representatives acting on their behalf without having registered with the Department of Consumer Protection (DCP). Registrations expire on June 30 of each year and must be renewed annually. A list of current pharmaceutical sales representatives will be published online by the department.

In addition to the registration requirements, annual reporting requirements are included as part of the Act. Beginning July 1, 2024, and annually thereafter, each company shall provide the DCP with specific information regarding its pharmaceutical sales representatives. The information that must be provided on an annual basis includes:

  • the aggregate number of contacts the pharmaceutical sales representative had with prescribing practitioners and pharmacists
  • the specialty of each of those prescribing practitioners and pharmacists
  • whether any product samples, materials, or gifts of any value were provided to either a prescribing practitioner or a prescribing practitioners staff or to a pharmacist
  • an aggregate report of all free samples provided, by drug name and strength.

The DCP website states that more information will be posted to their page regarding the submission of the above information in the coming months.

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.

On August 17, 2023, the Ministry of Health published the draft decree and related regulations and launched a public consultation to gather comments and contributions from stakeholders, including manufacturers of health products, healthcare professionals and organizations. The draft decree reviewed the required data elements and provided whether each is included in the publication as well as a brief description of each required data point. One noteworthy requirement included the birthplace and birthdate of recipients of transfers of value. This is information that most pharmaceutical and medical device companies are not currently capturing as part of their busines practices. The consultation period was to remain open until September 24, 2023.

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. Stay tuned for additional information regarding Connecticut and Italy disclosure requirements and deadlines.

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

November 1, 2023