On April 12, 2022, the Centers for Medicare and Medicaid Services (CMS) announced a revised version of the Open Payments Frequently Asked Questions (FAQs). While the revision includes some minor grammatical changes, CMS also removed a handful of FAQs and added nine new FAQs.
In the revised FAQs, CMS notes that salaries paid to a bona fide employee of the reporting entity is not required to be reported.
CMS also addressed questions about how a long-term medical supply or device loan should be valued, noting that it does not dictate how the valuation of a device loan is set and that it is up to the reporting entity to make a “reasonable determination.”
Additionally, CMS stated that when it comes to the Universal Device Identifier (DI), only the DI portion of the UDI needs to be reported. There is a new field labelled as “Primary Device Identifier” in the Open Payments System on the Associated Related Products page.
CMS also added an FAQ concerning whether the agency has any guidelines for selecting which representative DI to assign to brand names. CMS noted that the reporting entity holds that responsibility – in the Open Payments System, the Primary DI is validated against the reference data in the “List of Medical Device or Medical Supply Names and Primary Device Identifier.” CMS states that it is sufficient if the Primary DI and device/supply name match the information in the reference data stated in the List of Medical Device or Medical Supply Names and Primary Device Identifier.
CMS noted that it does validate whether the combination of the Primary DI and the marketed name of the medical device/supply name match upon submission. However, should the combination of the Primary DI and the medical device/supply name not match, and should the information not match what is given in the reference data “List of Medical Device or Medical Supply Names and Primary Device Identifier,” the Open Payments System will return a warning to the user. The user then has the option of either correcting the information or proceeding with reporting the payment as input. The records will not fail and they can be sent to final submission.
CMS also clarified in the revised FAQs that for any debt collection write-off, the entire amount of the write-off should be reported irrespective of whether a collection agency is involved.
One of the new FAQs covers the process for archiving data and answers why only the most recent seven years of data are available on the Open Payments Search Tool. CMS noted that data publication occurs for five years from the time the program year data is first published. Once program year reaches its fifth full year (including data publication and data refresh) of publication, the program year is closed and archived, which means the specific program year will no longer be eligible for edits and no new records may be submitted. Additionally, archiving is done based on the program year of the record, so for example, if a Program Year 2021 record is updated in 2023, it will be archived with Program Year 2021 records. While archived program years are not displayed or searchable on the Open Payments Search Tool, they are available for download via the Open Payments Archived Dataset Download page.
CMS also added an FAQ that defines a Nurse Practitioner, which is a nurse practitioner who performs such services as such individual is legally authorized to perform (in the State in which the individual performs such services) in accordance with State law (or the State regulatory mechanism provided by State law), and who meets such training, education, and experience requirements (or any combination thereof) as the Secretary may prescribe in regulations. If an advanced practice nurse meets the requirements of a Nurse Practitioner (which might vary from state to state) in the Regulations at 42 CFR 403.902, then presumably they would qualify as a Nurse Practitioner. However, this will be an individual case-by-case determination.
Final Rule Changes
One of the FAQs covered the changes that occurred at the Start of Program Year 2021. CMS noted that the reporting changes were made in response to feedback that CMS received from industry stakeholders. The changes were made in an effort to: 1) reduce ambiguity when reporting payments classified as forgiven debts; 2) accurately reflect the value long-term medical supply or device loans; 3) capture acquisition-related transactions such as buyout payments made to covered recipients in relation to the acquisition of a company in which the covered recipient has an ownership interest; and 4) simplify the reporting of payments related to medical education.
Essentially, the two medical education Nature of Payment categories, “Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing medical education program” and “Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program” were consolidated to the single category of “Medical education programs.” Additionally, new Nature of Payments categories were added to include: “Debt forgiveness,” “Long-term medical supply or device loan,” and “Acquisitions.”
As indicated above, CMS also removed several FAQs as they were either no longer applicable, redundant, or of low utility. Only a selection of removed FAQs are included here. A full explanation can be found in the linked document below.
CMS removed the FAQ that covered which items/materials were considered educational materials and not reportable transfers of value. CMS removed an FAQ on continuing medical education that seemed contradictory with other guidance.
Review, Dispute, and Correction
CMS also removed the FAQ discussing whether applicabl05e manufacturers or applicable group purchasing expected to resubmit an entire report with corrections and/or updates or should a resubmitted report only reflect the changes from the originally submitted report (i.e., corrected or previously missed payments or transfers of value)?
CMS removed the FAQ stating it would not issue advisory opinions exempting applicable manufacturers or applicable group purchasing organizations from Open Payments reporting requirements.
CMS also removed an FAQ regarding a manufacturer of dental alloys considered an applicable manufacturer and an FAQ focused on dental schools that do not match the name or address provided in the CMS teaching hospital list.
CMS also removed the FAQ that discussed why research was removed as a nature of payment category option from the general data specification.
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Posted by Centers for Medicare and Medicaid Services (CMS)