Registration, Attestation, Assumptions Document and Data Retention Requirements for Open Payments

ICR 201311-0938-023

OMB: 0938-1237

Federal Form Document

ICR Details
0938-1237 201311-0938-023
Historical Active
HHS/CMS 20949
Registration, Attestation, Assumptions Document and Data Retention Requirements for Open Payments
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 04/29/2014
Retrieve Notice of Action (NOA) 11/18/2013
CMS will seek comments on its dispute resolution information collections before resubmitting them to OMB for review.
  Inventory as of this Action Requested Previously Approved
04/30/2017 36 Months From Approved
231,867 0 0
1,613,307 0 0
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.

PL: Pub.L. 111 - 148 6002 Name of Law: Affordable Care Act
  
PL: Pub.L. 111 - 148 6002 Name of Law: Affordable Care Act

Not associated with rulemaking

  78 FR 43887 07/22/2013
78 FR 67150 11/08/2013
Yes

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 231,867 0 231,867 0 0 0
Annual Time Burden (Hours) 1,613,307 0 1,613,307 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new information collection request.

$0
No
No
Yes
No
No
Uncollected
William Parham 4107864669

  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.
11/18/2013


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