MediSpend’s legal experts recently presented a webinar shedding light on the recent transparency updates within the life science industry. The presentation covered key topics, such as updates to CMS’ Open Payments reporting, various state considerations and the newly issued OIG General Compliance Program Guidance. Notably, the webinar highlighted recent developments in compliance regulations in both Italy and the United Kingdom.

Italian Sunshine Act

While there have been no significant updates to the status of the Italian Sunshine Act since our last Legislative Watch Update webinar, it remains a hot topic in the life sciences industry.

As many are aware, on May 31, 2022, the Italian Parliament approved Law 62/2022, also known as the Italian Sunshine Act, which entered into force on June 26, 2022. The new rules become fully enforceable once the Ministry of Health (MOH) establishes the Telematic Public Register for disclosures known as Transparent Healthcare – Sanità Trasparente. Originally, the MOH was given six months to establish the Register from the date of entry into force.

On August 17, 2023, the MOH published the draft decree and related technical regulations and launched a public consultation to gather comments and contributions from stakeholders, including manufacturers of health products, healthcare professionals and organizations (HCP/Os). The consultation period remained open until August 17, 2023. The Italian Sunshine Act is not yet applicable because the website of the Italian MOH, where data should be published, is not yet ready.

United Kingdom Proposed Sunshine Act

In accordance with the United Kingdom’s Health and Care Act of 2022, on August 17, 2023, the MOH published the draft decree and related technical regulations and launched a public consultation to gather comments and contributions from stakeholders, including manufacturers of health products and HCP/Os.

In September, the UK Department of Health and Social Care (DHSC) launched a public consultation for comments and questions regarding proposed new legislation that would make it a legal requirement to disclose financial and other benefits flowing from pharmaceutical or medical device companies to HCPs and HCOs. The proposed Sunshine Act has a significantly broader scope than the current requirements of the Association of the British Pharmaceutical Industry (ABPI) and would also include suppliers of generic and unbranded medicines, medical devices, and “borderline” products, such as some cosmetics, and foods for special medical purposes that are purchased by healthcare systems. Obligations would apply to “every manufacturer and commercial supplier […] as well as their subsidiaries and parent businesses.”

Reportable recipients would include any registered HCP or any hospital, trust, clinic, health board, pharmacy or surgery, whether in the public or private sector. The Proposal states that reports would be due to be published on the company’s website annually within 6 months of the end of the reporting period.

OIG Compliance Program Guidance

In November 2023, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG), a 90-page comprehensive reference guide about federal laws, compliance programs and other available OIG resources. This Guidance represents the first comprehensive update since 2008 and replaces existing, fragmented and out-of-date guidance. While much of the guidance is not new, it does reinforce past statements and incorporates insights from past Corporate Integrity Agreements and enforcement actions.

The OIG structured the guidance as a broad resource for compliance for healthcare industry stakeholders and entities, new entrants and entities tangential to the traditional healthcare industry. Healthcare entities should remain flexible and adaptable and right-size their compliance program depending on their organization’s size and needs. The OIG continues emphasize on the seven fundamental elements of an effective compliance program and updated those elements to focus on governance, quality and integration. For perhaps the first time in a formal guidance document, the OIG directly linked compliance to quality and patient safety.

Starting in 2024, the OIG will begin issuing Industry Segment-Specific Compliance Program Guidance (ICPGs) for various participants in the healthcare industry. These ICPGs will be tailored to fraud and abuse risks for each industry subsector. Additionally, these ICPGs will be periodically updated as newly identified risk areas and compliance measures arise. For more information, please find the OIG’s guidance document here.

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 science 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

Jay Ward
Director of Life Science Solutions

 

Feb. 2, 2024