Transparency Reports and Reporting of Physician Ownership or Investment Interests

Forms and Documents

Document Name	Status
Form CMS-10442 Applicable Manufacturers and Applicable GPOs Form and Instruction	New
PRA_6002_Supporting_Statement_-_Part_A1 (Dec11).doc Supporting Statement A	2012-07-12

IC Document Collections

IC ID	Document Title	Status
203245	Applicable Manufacturers and Applicable GPOs Form and Instruction	New

ICR Details

OMB Control No: 0938-1173	ICR Reference No: 201207-0938-002
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Transparency Reports and Reporting of Physician Ownership or Investment Interests
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: Comment filed on proposed rule	Conclusion Date: 08/15/2012
	Date Received in OIRA: 07/12/2012
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. 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
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Section 6002 of the Affordable Care Act requires applicable manufacturers of covered drugs, devices, biologicals and medical supplies to report annually to the Secretary all payments and other transfers of value to physicians and teaching hospitals (collectively, covered recipients). Section 6002 of the ACA also requires applicable manufacturers and applicable group purchasing organizations (GPOs) to report ownership and investment interests held by physicians or the immediate family members of physicians in such entities. The first reports are due on March 13, 2013 for payments and other transfers of value made, and ownership and investment interests held in CY 2012. We are proposing at section CFR 403.904 to require applicable manufacturers to report information on all payments or other transfers of value provided to covered recipients, and a document outlining the assumptions made when describing payments. We are also proposing in CFR 403.906 to require applicable manufacturers to report information regarding ownership and investment interests held by physicians or their family members, as well as any payments provided to such physicians.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 6002 Name of Law: Transparency Reports and Reporting of Physician Ownership or Investment Interests
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 6002 Name of Law: Transparency Reports and Reporting of Physician Ownership or Investment Interests

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AR33	Proposed rulemaking	76 FR 78742	12/19/2011

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Applicable Manufacturers and Applicable GPOs	CMS-10442	Reporting Templates

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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: $3,482,000

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: 07/12/2012

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