Prior to
publication of the final rule, the agency should provide to OMB a
summary of all comments received on the proposed information
collection and identify any changes made in response to these
comments.
Inventory as of this Action
Requested
Previously Approved
03/31/2021
36 Months From Approved
03/31/2021
179,048
0
179,048
1,143,241
0
1,143,241
0
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.
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. These estimates also reflect
the one-time burden associated with the changes proposed in the FY
2020 PFS proposed rule to adjust the nature of payment categories
and the addition of the device identifier. This burden is outlined
below and is reflected in the overall burden calculation above. The
proposed 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 proposed categories. We also expect that all entities would
need to make minor, one-time adjustments to their submission
processes. For the proposed 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.
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 Dispute and Resolution Correction
CMS-10495 - Supporting Statement A (NPRM version 7).docx
Standardizing Data on Reported Products