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 “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.
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 Remove General Ownership Records: AM and Applicable GPO Data Collection and Submission
CMS-10495 - Supporting Statement A (CMS-1751-P version 5).docx
Remove General Ownership Records: AM and Applicable GPO Data Collection and Submission