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
08/02/2021
Requested
Previously Approved
36 Months From Approved
07/31/2024
81,210
78,812
1,899,053
1,897,790
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.
This 2021 iteration reflects five changes proposed in the CY 2022 Physician Fee Schedule (PFS) Proposed Rule (CMS-1751-P, RIN: 0938-AU42). The rule proposes to clarify existing Open Payments requirements, as well as add provisions that program stakeholders have requested and we agree would improve the quality of the data. We propose the following revisions effective for data collection beginning in CY 2023 and reporting in CY 2024: (1) adding a mandatory payment context field for records to teaching hospitals (+772 hr) ; (2) adding the option to recertify annually even when no records are being reported (+120 hr); (3) disallowing record deletions without a substantiated reason (+80 hr); (4) requiring entities to update their contact information (+15 hr); and (5) removing the option to submit and attest to general payment records with an âOwnershipâ Nature of Payment category. We believe these changes will all have minimal burden, but will increase the usability of the data, address concerns we have heard from stakeholders, and give reporting entities sufficient time to prepare for changes to their data collection and reporting procedures (+276 hr).
Section 12 of our active Supporting Statement estimates total time of 1,897,790 hours. The correct total should have been 1,832,551, a difference of 65,239 hours.
Overall, we estimate an increase of 1,263 hours.
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.
Remove General Ownership Records: AM and Applicable GPO Data Collection and Submission