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.
In an effort to keep all
aspects of the same data collection under one OMB control number,
CMS is proposing to combine OMB control number 0938-1173 and OMB
control number 0938-1237 under the same OMB control number. The
total number of hours (3,925,518) in the existing 0938-1173 will
decrease significantly as a result of decreasing the number of
respondents and the time associated with the Open Payments Portal.
The existing ICR overestimated burden considerably; however, due to
more reliable data provided by the Open Payments system, CPI has
been able to provide more accurate data versus relying on best
guest assumptions. Start-up burden has been removed from 0938-1173
(Registration, Review and Disputes) and from 0938-1237 (Open
Payments Portal) as well. CMS is proposing to decrease the overall
burden hours by -1,956,056 hours. The burden estimates related to
registration (Applicable Manufacturer, Applicable GPO, Physician
and Teaching Hospital) has decreased as the initial registration
process has already been completed by the majority of Applicable
Manufacturers and GPOs and physicians and hospitals interested in
reviewing data. Once the initial registration is completed, no
repeated registration is required. Thus registration is a one-time
burden and does not recur on an annual basis; however, some
registration burden is still included due to the fact that some new
entities may need to register. Additionally, since the program
inception, Open Payments has made a number of improvements to the
system interface and user materials that streamline the
registration process for users. Those improvements have
significantly decreased the registration burden on users. The
estimated number of such entities is much smaller than in the
initial years of the program. The estimated burden of record
retention, dispute resolution and correction (teaching hospitals
and physicians) has been revised as it was discovered that
participation in the review, dispute, and correction process by
physicians and hospitals was much lower than originally estimated.
Participation in this process is entirely voluntary for physicians
and hospitals. The number of records disputed during the first 3
years of the program, was also much lower than originally
estimated. Lastly, the burden of the review, dispute and correction
process was decreased for those who participate in it by usability
refinements to the system and user documentation making the process
less burdensome. Estimates of burden for attestation and
assumptions document for applicable manufacturers and GPOs changed
due to methodology refinements based on the actual operational
program data rather than best guest projections used in the
previous set of estimates developed before the program’s start and
also due to technical system refinements that streamlined the
attestation and assumptions document submission process.
$0
No
No
No
Yes
No
No
Uncollected
Jamaa Hill 301 492-4190
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.
Form CMS-10495 AM and Applicable GPO (Data submission)
CMS-10495 - 2016-Data-Submission-Data-Mapping-Doc.xlsx
CMS-10495 - Open-Payments-User-Guide 2018.pdf
CMS-10495 - Supporting Statement AFinal.docx
AM and Applicable GPO (Data submission)