However, starting in 2021, the definition of covered beneficiary has been expanded to include five new types of providers: physician assistants; nurse practitioner; clinical nursing specialists; Certified Nurse Anesthesiologists and Assistant Anesthesiologists; and certified nurse midwives. If you do not want your data to be disclosed in accordance with the Sunshine Regulations, you must avoid payments or other transfers of value from Shionogi that fall within the scope of the report. If this is your intention, please inform your Shionogi representative. If, for a calendar year (January 1 to December 31), a small payment or other transfer of value is less than the minimum amount set out below, it is excluded from reporting requirements under open payments. However, if the amount transferred to, requested by or named on behalf of a covered beneficiary exceeds a total annual amount for the calendar year, any payment or other transfer of value must be reported. Email: [email protected] Call: +1.973.307.3383 Note from drug and medical device manufacturers: In the recently published Final Rule of the Medicare Physician Fee Schedule (Final Rule) for Calendar Year (CY) 2022, the Centers for Medicare & Medicaid Services (CMS) has made a number of important updates to the regulations of the Physician Payment Sunshine Act (Sunshine Act) and the related Open Payments reporting system, available on the CMS website. These revisions demonstrate CMS`s continued interest in improving both the integrity of the Sunshine Act reporting system and the agency`s ability to vigorously monitor the financial relationships between manufacturers and covered recipients. There has never been more at stake, as CMS updates reporting requirements in the context of a new wave of enforcement in this area by the Department of Justice (as discussed here). There are certain key thresholds that reporting units must meet.
These key reporting thresholds are adjusted annually based on the Consumer Price Index. CMS has developed a free smartphone app for Apple® and Android platforms. To protect the privacy of the data collected, the information is stored on a device and cannot be backed up to a cloud or other devices. Physicians should also encourage their industry contacts to use the app so they can enter the information needed to ensure accurate reporting. Open payments will have a large influx of more recipients. This significant increase, with more data requirements to report, could place a significant burden on organizations that do not have a robust collection and reporting system. Under the new guidelines, payment must be reported if an applicable manufacturer or group purchasing organization spends $11.05 or more on a “reportable activity” for a covered recipient between January 1, 2021 and December 31, 2021. This is an increase from $10.98 in 2020.
Even if the amount spent on a “reportable activity” is $11.04 or less, it must be reported if total payments exceed $110.40 in the 2021 calendar year. If the total amount exceeds $110.40 in 2021, all payments and other transfers of value must be reported to the covered recipient. The rule also corrects NDC reports. The 2015 Medicare Physician Fee Schedule Final Rule inadvertently removed a reference requiring NCDs to be reported for non-research payments. The rule specifies that payments for research and non-research must be reported. The new requirements, coupled with the reporting burden you already face, can have a significant impact on your business. You need tools that simplify and streamline. The Final Rule of the 2020 Medicare Physician Fee Schedule (Final Rule) covers the enactment of the provisions of the Support Act regarding unpaid payments. These changes will affect the 2021 data you report in 2022. Companies subject to the Sunshine Act should consider updates to policies, procedures and review plans based on updates to the final rules prior to the effective date of January 1, 2022. As CMS continues to refine its reporting obligations under the Sunshine Act, regulatees should also consider taking stock of their overall compliance infrastructure and training program on their aggregate expense tracking and reporting activities, and assessing whether strategic improvements are warranted to mitigate the risk of non-compliance.
The law requires the reporting of a payment or transfer of value to a covered beneficiary of $10 or more. If the cumulative value of all transfers to a specific covered beneficiary exceeds $100 in a calendar year, all transfers must be reported, even if the dollar value of each transfer is less than $10. Interactions or interactions between Shionogi and covered beneficiaries that do not involve payment or transfer of value do not require disclosure. The Sunshine Act aims to promote financial transparency regarding the relationship between manufacturers and health care providers by requiring manufacturers of certain drugs, devices, biologics and medical consumables reimbursed by CMS programs to report payments and other transfers of value to certain “covered beneficiaries,” with some exceptions. Covered beneficiaries include physicians, teaching hospitals, physician assistants, nurses and certain other health care providers. With this final rule, CMS aims to “increase the usability of the data” and “address concerns that [CMS] has heard from stakeholders.” The final rule will come into effect on January 1, 2022 and will apply to 2023 data collection and 2024 reporting.