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