Registration, Attestation, Dispute Resolution and Correction, Assumptions Document and Data Retention Requirements for Open Payments (CMS-10495)

ICR 202112-0938-008

OMB: 0938-1237

Federal Form Document

ICR Details
0938-1237 202112-0938-008
Received in OIRA 202102-0938-019
HHS/CMS CPI
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 05/05/2022
  Requested Previously Approved
36 Months From Approved 07/31/2024
78,166 78,812
1,945,756 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.

PL: Pub.L. 111 - 148 6002 Name of Law: Affordable Care Act
  
PL: Pub.L. 111 - 148 6002 Name of Law: Affordable Care Act

0938-AU42 Final or interim final rulemaking 86 FR 64996 11/19/2021

  86 FR 39104 07/23/2021
86 FR 64996 11/19/2021
Yes

16
IC Title Form No. Form Name
AM (Assumptions Document) CMS-10495 Assumptions
AM (Attestation) CMS-10495 Attestation
AM (Data Collection and Submission) CMS-10495, CMS-10495 Open Payments User Guide ,   General-Research-Ownership Submission Data Elements and Screen Shots
AM (Record Retention)
AM (Registration) CMS-10495 Registration
Applicable GPO (Assumptions Document) CMS-10495 Assumptions
Applicable GPO (Attestation) CMS-10495 Attestation
Applicable GPO (Data Collection and Submission) CMS-10495, CMS-10495 Open Payments User Guide ,   General-Research-Ownership Submission Data Elements Screen Shots
Applicable GPO (Record Retention)
Applicable GPO (Registration) CMS-10495 Registration
Dispute Resolution and Correction (AM) CMS-10495, CMS-10495 Review and Dispute Screen Shots ,   Review and Dispute Email Notifications
Dispute Resolution and Correction (Physicians) CMS-10495, CMS-10495 Review and Dispute Screen Shots ,   Review and Dispute Email Notifications
Dispute and Resolution Correction (Teaching Hospitals) CMS-10495, CMS-10495 Review and Dispute Screen Shots ,   Review and Dispute Email Notifications
GPO Dispute and Resolution Correction CMS-10495, CMS-10495 Review and Dispute Screen Shots ,   Review and Dispute Email Notifications
Modifying Nature of Payment Categories
Physicians (Registration) CMS-10495 Registration
Standardizing Data on Reported Products
Teaching Hospitals (Registration) CMS-10495 Registration

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 78,166 78,812 0 2,554 -3,200 0
Annual Time Burden (Hours) 1,945,756 1,897,790 0 113,205 -65,239 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Our correction adds 78 respondents, reduces responses by 3,044, and adds 46,702 hours Although the CY 2022 Physician Fee Schedule (PFS) final rule (CMS-1751-F, RIN: 0938-AU42) does not change the number of respondents, it adds 2,398 responses and 1,263 hours. The new provisions will be implemented for data collection in 2023 and reporting in 2024. See section 15 of the Supporting Statement for details.

$23,045,117
No
    No
    No
Yes
No
No
No
Mitch Bryman 410 786-5258 [email protected]

  No

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.
05/05/2022


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