The following topics will be covered in detail in the November edition of the newsletter:
- US Federal & State disclosure timeline
- US Updates
- US CMS Updates
- EU & global disclosure requirements for; Indonesia, Portugal
- EU & Global disclosure timeline
- EU & Global Updates
- EU – Italian Sunshine Act FAQ
- Details on a community run website around the Italian Sunshine Act.
- Compliance Commentary.
We are fast approaching the end of 2023. Manufacturers will start to get busy with complying with transparency reporting deadlines.
To assist you, we have provided a calendar which provides a list of the transparency reporting deadlines and licence/certifications under the US State & Federal requirements. Further details on the process and requirements will be contained in the newsletter edition, prior to when the deadline is due. Some of which have already been covered in the previous editions of our monthly newsletters.
Wednesday, November 15, 2023, was the cut-off date to make corrections to undisputed records and to remove any previous requests for delay in publication in order for those changes to be reflected in the January 2024 Open Payments data refresh.
Corrections to records in response to active disputes can still be made through to December 31, 2023, to be included in the January data refresh. CMS will publish a refresh of the Open Payments data in January 2024.
CMS has recently updated its published data on settlements made under the Voluntary Self-Referral Disclosure Protocol. These settlements are as a result of providers disclosing actual or potential violations of the federal physician self-referral prohibition (Stark Law).
The self-referral disclosure protocol was established in the Affordable Care Act and providers are required to submit all information on actual or potential violations to CMS.
There does appear to be a significant increase in the number of disclosures CMS settled in 2022 (104) compared to the number of settlements made in 2021 (27), although the amount made in settlement appears to be consistent with the figures from 2021.
The Office of Inspector General (OIG) has released a General Compliance Program Guidance (GCPG). The GCPG is a reference guide for the health care compliance community and other health care stakeholders. The HHS-OIG emphasises on 7 elements of an effective compliance program.
Moving on to some FDA updates, the FDA has released a draft guidance document, Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers.
The FDA is asking for stakeholders to submit comments by December 24, 2023, to ensure that the agency considers the comments before it begins work on the final version of the guidance.
Moving across to the Global updates; the only transparency reporting disclosure for the month of November is Indonesia and Portugal; which are due on a monthly basis. We have outlined the requirements for these countries in the newsletter and have provided an International transparency reporting deadline Calander.
The Italian Sunshine Act remains to be of an interest to many. We have compiled an FAQ bank which is detailed in our newsletter. There is also a useful website around the latest updates on the Italian Sunshine Report which is of use for those who wish to ensure they are kept up to speed with the latest developments.
We are still conducting one-on-one meetings to deep dive into the Italian Sunshine Act. Anyone interested is encouraged to contact us to schedule a meeting.