The Patient Protection and Affordable
Care Act (ACA) was enacted on March 23, 2010. Section 6409 of the
ACA requires the Secretary of the Department of Health and Human
Services, in cooperation with the Inspector General of the
Department of Health and Human Services, to establish a Medicare
self-referral disclosure protocol ("SRDP") that sets forth a
process to enable providers of services and suppliers to
self-disclose actual or potential violations of the physician
self-referral statute (Section 1877 of the Social Security Act,
"Section 1877"). We believe that in order to effectively
self-disclose an actual or potential violation, the SRDP must
require health care providers of services or suppliers to submit
all information necessary for CMS, on behalf of the Secretary, to
analyze the actual or potential violation of Section 1877 of the
Act. Therefore, in accordance with Section 6409(a)(1), this
information collection request sets forth the specific information
related to the actual or potential violation(s) and the related
financial analysis that must be furnished by health care providers
of services and suppliers as part of their voluntary disclosure
submission to participate in the SRDP The collection may seek
additional financial documentation and other information as the
Secretary considers appropriate to establish the amount due and
owing for the violation. Section 6409(b), gives the Secretary of
HHS the authority to reduce the amount due and owing for all
violations of Section 1877. In establishing such amount due and
owing for the violation, the Secretary may consider: the nature and
extent of the improper or illegal practice; the timeliness of the
self-disclosure; the cooperation in providing additional
information related to the disclosure; and such other factors as
the Secretary considers appropriate.
In accordance with
Section 6409 of The Patient Protection and Affordability Care Act
(ACA), the Secretary of HHS, in cooperation with the Inspector
General of HHS, is tasked with establishing a self-referral
disclosure protocol to enable health care providers of services and
suppliers to disclose an actual or potential violation of section
1877 of the Social Security Act. The Self-Referral Disclosure
Protocol must be established by September 23, 2010 and information
must be published on CMS' website instructing relevant stakeholders
how to disclose actual or potential violations pursuant to the
Protocol. Due to the urgency and the short time frames associated
with this requirement, CMS does not have sufficient time to follow
the notice and comment periods associated with the usual OMB
approval process. Therefore, we are requesting an emergency review
and approval for this information collection request.
US Code:
42
USC 1395nn Name of Law: Limitation on Certain Physician
Referrals
PL:
Pub.L. 111 - 148 6409 Name of Law: Medicare self-referral
disclosure protocol.
PL: Pub.L. 111 - 148 6409 Name of Law:
Medicare self-referral disclosure protocol.
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.
Financial Review