Payment, ownership, and investment information for subsequent calendar years will need to be reported by the 90th day of the following calendar year. Manufacturers will have 180 days to begin complying with the data collection and reporting requirements upon a product becoming covered under the regulations.
The penalties to applicable manufacturers and GPOs for failure to comply with the new regulations can be up to $150,000 per year, and up to $1 million for knowing violations. While CMS stated that it does not have empirical data to estimate the financial benefit of the PPSA, CMS estimates it will cost all manufacturers a total of over $205 million dollars in the first year to establish the infrastructure and staff support necessary to implement the final rule.
Action Steps
The final rule provides clarification and detail lacking in the proposed rule, and CMS has begun posting fact sheets and other information regarding the National Physician Payment Transparency Program (OPEN PAYMENTS). Yet there are still further implementation steps that CMS will need to take, including the mechanism for physicians to register with CMS to receive updates regarding the OPEN PAYMENTS program. In the meantime, rheumatologists should review their existing relationships with industry to determine if they are engaged with applicable manufacturers and, if so, what will appear publicly. The records maintained by rheumatologists of all payments or transfers of value will be extremely important. Rheumatologists should mark their calendars and make sure that they are given the opportunity to review the data submitted to CMS in order to avoid the publication of inaccurate information that can be viewed by patients, colleagues, the media, and other departments/agencies of the government.
Steven M. Harris, Esq., is a nationally recognized health care attorney and a member of the law firm McDonald Hopkins, LLC. He may be reached at [email protected].
