QECP Annual Report Workbook Submission Requirement and QE DUA and Non-public Analyses Agreement Requirement for Qualified Entities under ACA Section 10332 and MACRA Section 105 (CMS-10589)

Forms and Documents

Document Name	Status
Form CMS-10589 Reporting Form and Instruction	New
CMS-10589_Supporting Statement Part A.doc Supporting Statement A	2016-02-19

IC Document Collections

IC ID	Document Title	Status
220190	Reporting Form and Instruction	New
220188	Processing and Maintenance	New
220186	Legal Review	New
220185	DUA and non-public analyses agreement Development	New

ICR Details

OMB Control No: 0938-1309	ICR Reference No: 201602-0938-009
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: QECP Annual Report Workbook Submission Requirement and QE DUA and Non-public Analyses Agreement Requirement for Qualified Entities under ACA Section 10332 and MACRA Section 105 (CMS-10589)
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: 06/14/2016
	Date Received in OIRA: 02/19/2016
Terms of Clearance: OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates.

	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 10332 of the Patient Protection and Affordable Care Act (ACA) requires the Secretary to make standardized extracts of Medicare claims data under Parts A, B, and D available to “qualified entities” for the evaluation of the performance of providers of services and suppliers. The statute provides the Secretary with discretion to establish criteria to determine whether an entity is qualified to use claims data to evaluate the performance of providers of services and suppliers. After consideration of comments from a wide variety of stakeholders during the public comment period, CMS established “Medicare Program; Availability of Medicare Data for Performance Measurement” (hereinafter called the Final Rule and referred to as the Medicare Data Sharing Program). It was published in the Federal Register on December 7, 2011 (42 CFR, Part 401, Subpart G). To implement the requirements outlined in the legislation, the Centers for Medicare and Medicaid Services (CMS) established the Qualified Entity Certification Program (QECP). The Qualified Entity Certification Program (QECP) was established to implement the Final Rule. One of the requirements in the Final Rule is that QEs must submit annual reports to CMS containing specific data elements. Section 105 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) provides for additional annual reporting requirements if a qualified entity chooses to provide or sell analyses and/or data to authorized users. This form is the official annual report workbook that QEs must complete to comply with this requirement.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 10332 Name of Law: Affordable Care Act
   PL: Pub.L. 114 - 110 105 Name of Law: Medicare Access and CHIP Reauthorization Act of 2015
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 10332 Name of Law: Affordable Care Act
PL: Pub.L. 114 - 110 105 Name of Law: Medicare Access and CHIP Reauthorization Act of 2015

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AS66	Proposed rulemaking	81 FR 5397	02/02/2016

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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: 4

IC Title	Form No.	Form Name
Reporting	CMS-10589	QECP Annual Report Workbook
DUA and non-public analyses agreement Development
Legal Review
Processing and Maintenance

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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: $206,488

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: 02/19/2016

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