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 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.
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 Change Summary 2019.xlsx
CMS-10495 - Supporting Statement A (2019 CMS-1715-F version 5) CLEAN.docx
Response to Comments.pdf
Standardizing Data on Reported Products