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

Forms and Documents

Document Name	Status
Form CMS-10495 AM and Applicable GPO (Assumptions Document) Form and Instruction	New
Form CMS-10495 AM and Applicable GPO (Attestation) Form and Instruction	New
Form CMS-10495 Teaching Hospitals (Registration) Form and Instruction	New
Form CMS-10495 Physicians (Registration) Form and Instruction	New
Form CMS-10495 AM and Applicable GPO (Registration) Form and Instruction	New
CMS-10495 Crosswalk of Revisions.pdf Supplementary Document	2013-11-13
CMS-10495_Response to 60-day Public Comments.pdf Supplementary Document	2013-11-13
CMS-10495_Supporting_Statement_Part_A 4 29 14.docx Supporting Statement A	2014-04-29

IC Document Collections

IC ID	Document Title	Status
211456	AM and Applicable GPO (Assumptions Document) Form and Instruction	New
211455	AM and Applicable GPO (Attestation) Form and Instruction	New
211454	AM and Applicable GPO (Record Retention) Instruction	New
209365	Teaching Hospitals (Registration) Form and Instruction	New
209364	Physicians (Registration) Form and Instruction	New
209363	AM and Applicable GPO (Registration) Form and Instruction	New

ICR Details

OMB Control No: 0938-1237	ICR Reference No: 201311-0938-023
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: 20949
Title: Registration, Attestation, Assumptions Document and Data Retention Requirements for Open Payments
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/29/2014
	Date Received in OIRA: 11/18/2013
Terms of Clearance: 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
Expiration Date	04/30/2017	36 Months From Approved
Responses	231,867	0	0
Time Burden (Hours)	1,613,307	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 6002 Name of Law: Affordable Care Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 6002 Name of Law: Affordable Care Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 43887	07/22/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 67150	11/08/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
AM and Applicable GPO (Registration)	CMS-10495	AM and AGPO Registration
Physicians (Registration)	CMS-10495	Physician Registration
Teaching Hospitals (Registration)	CMS-10495	Teaching Hospitals Registration
AM and Applicable GPO (Record Retention)
AM and Applicable GPO (Attestation)	CMS-10495	Attestation
AM and Applicable GPO (Assumptions Document)	CMS-10495	Assumptions

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 11/18/2013

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