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View ICR - OIRA Conclusion

OMB Control No: 0938-1237	ICR Reference No: 202107-0938-014
Status: Historical Inactive	Previous ICR Reference No: 202102-0938-019
Agency/Subagency: HHS/CMS	Agency Tracking No: CPI
Title: Registration, Attestation, Dispute Resolution and Correction, Assumptions Document and Data Retention Requirements for Open Payments (CMS-10495)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 08/31/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/02/2021
Terms of Clearance: Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2024	36 Months From Approved	07/31/2024
Responses	78,812	0	78,812
Time Burden (Hours)	1,897,790	0	1,897,790
Cost Burden (Dollars)	0	0	0

Abstract: 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.

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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 “Ownership” 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.

Annual Cost to Federal Government: $23,045,117

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov