View Information Collection Request (ICR) Package

OMB Control No: 0938-1237	ICR Reference No: 201911-0938-008
Status: Historical Active	Previous ICR Reference No: 201707-0938-018
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: Approved with change	Conclusion Date: 09/03/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/21/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	36 Months From Approved	03/31/2021
Responses	78,812	0	179,048
Time Burden (Hours)	1,897,790	0	1,143,241
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.

Authorizing Statute(s): PL: Pub.L. 111 - 148 6002 Name of Law: Affordable Care Act

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 6002 Name of Law: Affordable Care Act

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT72	Final or interim final rulemaking	84 FR 62998	11/15/2019

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 40482	08/14/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 62998	11/15/2019
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	78,812	179,048	-100,236
Annual Time Burden (Hours)	1,897,790	1,143,241	754,549
Annual Cost Burden (Dollars)	0	0	0

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: 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.

Annual Cost to Federal Government: $0

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

View ICR - OIRA Conclusion