Registration, Attestation, Dispute Resolution and Correction, Assumptions Document and Data Retention Requirements for Open Payments (CMS-10495)
Revision of a currently approved collection
No
Regular
Approved with change
09/03/2020
11/21/2019
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
03/31/2021
36 Months From Approved
03/31/2021
78,812
0
179,048
1,897,790
0
1,143,241
0
0
0
Section 6002 of the Affordable Care Act added section 1128G to the Social Security Act (Act), which requires applicable manufacturers and applicable group purchasing organizations (GPOs) of covered drugs, devices, biologicals, or medical supplies to report annually to CMS certain payments or other transfers of value to physicians and teaching hospitals, as well as, certain information regarding the ownership or investment interests held by physicians or the immediate family members of physicians in such entities. Specifically, applicable manufacturers of covered drugs, devices, biologicals, and medical supplies are required to submit on an annual basis the information required in section 1128G(a)(1) of the Act about certain payments or other transfers of value made to physicians and teaching hospitals (collectively called covered recipients) during the course of the preceding calendar year. Similarly, section 1128G(a)(2) of the Act requires applicable manufacturers and applicable GPOs to disclose any ownership or investment interests in such entities held by physicians or their immediate family members, as well as information on any payments or other transfers of value provided to such physician owners or investors. Applicable manufacturers must report the required payment and other transfer of value information annually to CMS in an electronic format. The statute also provides that applicable manufacturers and applicable GPOs must report annually to CMS the required information about physician ownership and investment interests, including information on any payments or other transfers of value provided to physician owners or investors, in an electronic format by the same date. This information collection request includes the Registration, Attestation, Assumptions Document and Data Retention Requirements this program.
In this 2019 iteration, the cost estimates reflect more current salary figures and doubles all BLS wage estimates to account for fringe benefits and overhead costs. Previously we applied a 3 percent increase to account for change over time and fringe benefits. The 100% increase is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Therefore, we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. This burden estimate also includes revised figures for the estimated number of records and for the number of applicable manufacturers and applicable GPOs, teaching hospitals, and physicians to reflect current trends.
The estimates also reflect the one-time burden associated with the changes made in the CY 2020 PFS rule to adjust the nature of payment categories and the addition of the device identifier.
The nature of payment category changes would modify the nature of payment categories and provide more options for applicable manufacturers and GPOs to capture the nature of the payment made to the covered recipient. To accommodate this change, we project that reporting entities would need to update their system to incorporate the categories. We also expect that all entities would need to make minor, one-time adjustments to their submission processes.
For the change related to device identifiers, we estimate that approximately 850 entities (approximately 53 percent of an assumed 1,600) would need to report at least one record with a device identifier and that 450 of those entities do not already collect the device identifier. We also assume that the remaining 750 entities not planning to submit a device identifier would have a small amount of burden associated with updating their submission processes.
These changes in the CY 2020 PFS pertain to data collected in 2021 that will be submitted in 2022. Minor adjustments to the collection materials such as the submission-mapping document will be made for versions to be used for Program Year 2021 and beyond to reflect the changes from the CY 2020 PFS final rule.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form CMS-10495 General-Research-Ownership Submission Data Elements Screen Shots
CMS-10495 Change Summary 2019.xlsx
CMS-10495 - Supporting Statement A (2019 CMS-1715-F version 5) CLEAN.docx
Response to Comments.pdf
Standardizing Data on Reported Products