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.
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.
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 Applicable GPO (Data Collection and Submission)
CMS-10495 - Supporting Statement A (CMS-1751-F version 20).docx
Standardizing Data on Reported Products