CMS recently issued updated Open Payments Frequently Asked Questions (FAQs). The FAQs are revised periodically to reflect the most up to date program requirements. This latest revision both added and removed FAQs, and also included some general edits.
The following FAQs were added: #2014, #2015, #2016, #2017, #2018, #2019, #2020, #2021 and #2022. Each new FAQ is reproduced in full below. They provide additional guidance regarding topics such as archived reporting years, salaries paid to covered recipients, reporting of device identifiers, valuing long-term device loans, debt forgiveness, and the definition of Nurse Practitioner.
Additionally, the following FAQs have been removed from the FAQ document “due to being no longer applicable, redundant with another FAQ, or of low utility” (according to CMS):
- #8161 (describing non-reportable educational materials),
- #8360 (clarifying the retraction or resubmission of entire reports, or corrections, retractions or additions to a group of records),
- #8972 (confirming that CMS will not issue advisory opinions exempting applicable manufacturers or applicable group purchasing organizations from reporting requirements),
- #8978 (regarding manufacturers of dental alloys),
- #9002 (regarding dental schools affiliated with universities and health care institutions not listed on CMS’ teaching hospital list),
- #9130 (explaining the removal of research as a nature of payment category),
- #9134 (clarifying whether Federal, state, and local taxes withheld from a physician owner or inventory are considered reportable payments or other transfers of value),
- #10246 and #11002 (answering why CMS changed certain aspects of the Finale Rule at Part 403, subpart I),
- #11638 (regarding payments to a continuing education organization),
- #12368 (regarding the calculation of the number of payments received by a physician),
- #12394 (describing how CMS will ensure Open Payments information remains user-friendly for consumers),
- #22569 (identifying the content required for reporting ownership and investment interests).
Even now, almost a decade after the Open Payments program final rule was first implemented, questions continue to arise regarding the types of payments and transfers of value that are reportable and how companies must report them. These updated FAQs certainly provide helpful guidance as companies navigate federal transparency obligations, but additional questions may remain.
Reed Smith will continue monitoring developments involving the Open Payments program. Please reach out to the authors of this post or the Reed Smith attorneys with whom you regularly work for more information or guidance on these changes.
Full Text of New FAQs
Question: What is the process for archiving data? Why are only the most recent seven years of data available on the Open Payments Search Tool?
Answer: Data publication occurs for 5 years from the time the program year data is first published. After a program year reaches its fifth full year (including data publication and data refresh) of publication, the program year is closed and archived. “Closed” means that the specific program year will no longer be eligible for edits and no new records may be submitted. Archiving is completed based on the program year of the record, so for example, if a Program Year 2021 record is updated in 2023, it will still be archived with Program Year 2021 records. Following the closing of a program year, it is archived. Archived program years are not displayed or searchable on the Open Payments Search Tool. Archived program years are available for download via the Open Payments Archived Dataset Download page.
Final Rule Changes
Question: At the start of Program Year 2021, why did changes occur, and what were they, to the nature of payment categories?
Answer: At the start of Program Year 2021, CMS’s Open Payments team made several reporting changes in response to feedback that CMS received from industry stakeholders. These 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.
The changes made were that 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.” Further, the following additional Nature of Payments categories were added: “Debt forgiveness,” “Long-term medical supply or device loan,” and “Acquisitions.”
Data Submission / Attestation
Question: Should reporting entities report the salary paid to covered recipients who are on the payroll?
Answer: The salary paid to a bona fide employee of the reporting entity is not required to be reported. The final rule states that “covered recipient means— (1) Any physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, or certified nurse-midwife who is not a bona fide employee of the applicable manufacturer that is reporting the payment.” An employee is an individual who is considered to be “employed by” or an “employee” of an entity if the individual would be considered to be an employee of the entity under the usual common law rules applicable when determining the employer-employee relationship (as applied for purposes of section 3121(d)(2) of the Internal Revenue Code of 1986).
Question: How should a long-term medical supply or device loan be valued?
Answer: CMS does not dictate how the valuation of a device loan is set. The reporting entity should make a reasonable determination. Reporting entities are encouraged to use the assumptions document for the purpose of explaining reporting methodologies and noting any unique reporting circumstances when completing data submissions.
Question: Should the entire Universal Device Identifier (UDI) of the device be provided, i.e., expiry and lot number, or is just the general UDI sufficient?
Answer: In the Open Payments System, only the DI portion of the UDI needs to be reported. This is mentioned in the instructions document which states that if the device has a unique device identifier (UDI), then the device identifier (DI) portions of it must be reported, as applicable. This is a new field labelled as “Primary Device Identifier” in the Open Payments System on the Associated Related Products page. The Primary DI information is available in the reference data “List of Medical Device or Medical Supply Names and Primary Device Identifier,” which is available for download on the Open Payments Resources page.
Question: Since the Primary Device Identifier (DI) is a unique 14-digit string that varies by different sizes and components even for the same brand name, do you have any guidelines for selecting which representative DI to assign to a brand name?
Answer: The reporting entity is responsible for determining the most appropriate DI for the record. 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.” 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. This reference data includes medical device and medical supply name and Primary Device Identifier information for all the medical devices and medical supplies listed annually through December 31st in the Food and Drug Administration (FDA) Global Unique Device Identification Database Directory (GUDID). An active list of devices is located on the Access GUDID website at https://accessgudid.nlm.nih.gov/download.
Question: Does CMS validate product brand names against device identifiers (DIs)? Will records fail if these do not match?
Answer: Open Payments System validation checks whether the combination of the Primary DI and the marketed name of the medical device/supply name match. 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 may then correct the information or proceed with reporting the payment. The records will not fail and they are able to be sent to final submission despite the presence of a warning. Users will be able to submit the Primary DI data and validation starting in the Open Payments System beginning in calendar year 2022.
Question: For debt forgiveness, should a reporting entity report the full write-off amount, or, if given to a collection agency, only report the amount that is returned?
Answer: For any debt collection write-off, the entire amount written off should be reported regardless of whether a collection agency is involved.
Question: Is a Nurse Practitioner (NP) a type of advanced practice nurse? Do you have a formal definition of an NP?
Answer: The regulation at 42 C.F.R. §403.902 defines a nurse practitioner as 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 the 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.