Supporting Statement – Part A
QECP Annual Report Workbook Submission Requirement for Qualified Entities under
ACA Section 10332
(CMS-10589;OMB 0938-1309)
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.
Section 105 of the Medicare Access and Reauthorization Act of 2015 (MACRA) expands how qualified entities will be allowed to use and disclose data under the qualified entity program consistent with other applicable laws, including information, privacy, security, and disclosure laws. This collection focuses on the expansion of qualified entities. This collection covers the requirement that a qualified entity must submit an annual report to CMS. In addition, this collection covers the requirement that a qualified entity must have a qualified entity data use agreement (QE DUA) or non-public analyses agreement in place with an authorized user prior to providing or selling data or analyses to that authorized user.
We are requesting reinstatement with no change approval from OMB for currently approved CMS-10589 collection. We were delayed submitting the package as we waited for the 2019 workbook to be provided from our contractor.
The Patient Protection and Affordable Care Act (ACA) was enacted on March 23, 2010 (Pub. L. 111-148). ACA amends section 1874 of the Social Security Act by adding a new subsection (e) to make standardized extracts of Medicare claims data under Parts A, B, and D available to qualified entities to evaluate the performance of providers of services and suppliers. It also provides for annual reporting requirements that the qualified entity annual report must be completed annually, as required by the program’s Final Rule (42 CFR Part 401, Subpart G, Section 719).
Section 105 of MACRA provides for additional annual reporting requirements if a qualified entity chooses to provide or sell analyses and/or data to authorized users. It also requires a qualified entity to enter into a data use agreement or non-public analyses agreement with an authorized user prior to providing or selling data or selling a non-public analyses.
The information from the collection will be used by CMS to determine whether a qualified entity continues to meet the qualified entity certification requirements under section 10332 of the Affordable Care Act and Section 105 of MACRA. In addition, it will ensure that certain privacy and security requirements are met when qualified entities provide or sell data or sell non-public analyses that contains individually identifiable beneficiary information to authorized users.
Annual reports currently are submitted electronically. With recent upgrade to our customer relations management (CRM) tool, QEs will provide information and upload information in the CRM.
The QE DUA and non-public analyses agreement may be collected electronically but there is no requirement on the qualified entity on how they collect these from the authorized users.
This information collection does not duplicate any other effort and the information cannot be obtained from any other source.
No special considerations are given to small businesses. The same information is needed to assess the qualifications of all organizations.
Data are collected once at the time of annual report as required by statute.
There is no requirement around the frequency of the collection for the QE DUA or non-public analyses agreement other than a QE must execute either a QE DUA or non-public analyses agreement with an authorized user prior to providing or selling data or analyses to that authorized user. Such agreements are created on an as-needed basis.
There are no special circumstances that would require an information collection to be conducted in a manner that requires respondents to:
Report information to the agency more often than quarterly;
Prepare a written response to a collection of information in fewer than 30 days after receipt of it; Submit more than an original and two copies of any document;
Retain records, other than health, medical, government contract, grant-in-aid, or tax
records for more than three years;
Collect data in connection with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study,
Use a statistical data classification that has not been reviewed and approved by OMB;
Include a pledge of confidentiality that is not supported by authority established in statute or regulation that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
Submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
8. Federal Register/Outside Consultation
The 60 day Federal Register Notice is published to the Federal Register (85 FR 12305) on 03/02/2020.
No comments were received during the comment period.
The 30 day Federal Register Notice is published to the Federal Register (86 FR 1503) on 01/08/2021.
There are no payments/gifts to respondents. Respondents are required to submit this in order to remain compliant with the QE program requirements.
We pledge privacy to the extent allowed by law. The applications will be kept secure. No proprietary data or information will be disclosed outside the Government and will not be duplicated, used, or disclosed – in whole or in part – for any purpose other than to evaluate the application. Files containing the applications or information from these forms will be safeguarded in accordance with Departmental standards and National Institute of Standards and Technology (NIST) Special Publication 800-53, Recommended Security Controls for Federal Information Systems and Organizations which limits access to only authorized personnel. The safeguards shall provide a level of security as required by Office of Management and Budget (OMB) Circular No. A-130 (revised), Appendix III – Security of Federal Automated Information Systems.
11. Sensitive Questions
No sensitive questions are part of this information collection.
Sections §401.718(c) and §401.716(b)(2)(ii) require a qualified entity to enter into a QE DUA with an authorized user prior to providing or selling data or selling a non-public analyses that contains individually identifiable beneficiary information. §401.713(d) requires specific provisions in the QE DUA. §401.716(c) requires a qualified entity to enter into a non-public analyses agreement with the authorized user as a pre-condition to providing or selling de- identified analyses. We estimate that it will take each qualified entity a total of 40 hours to develop the QE DUA and non-public analyses agreement. Of the 40 hours, we estimate it will take a professional/technical services employee with an hourly labor cost of $85.63 a total of 20 hours to develop both the QE DUA and non-public analyses agreement and estimate that it will require a total of 20 hours of legal review at an hourly labor cost of $104.50 for both the QE DUA and non- public analyses agreement. We also estimate that it will take each qualified entity 2 hours to process and maintain each QE DUA or non-public analyses agreement with an authorized user by a professional/technical service employee with an hourly labor cost of $85.63. While there may be two different staff positions that perform these duties (one that is responsible for processing the QE DUAs and/or non-public analyses agreement and one that is responsible for maintaining the QE DUA and/or non-public analyses agreement), we believe that both positions would fall under the professional/technical services employee labor category with an hourly labor cost of $85.63. This would mean that to develop each QE DUA and non-public analysis agreement, the burden cost per qualified entity would be $3,803 with a total estimated burden for all 15 qualified entities of $57,039. This does not include the two hours to process and maintain each QE DUA.
We estimate that each qualified entity would need to process and maintain 70 QE DUAs or non-public analyses agreements as some authorized users may receive both datasets and a non- public analyses and would only need to execute one QE DUA. We estimate that it will take each qualified entity 2 hours to process and maintain each QE DUA or non-public analyses agreement. This would mean the burden cost per qualified entity to process and maintain 70 QE DUAs or non-public analyses agreements would be $11,988 with a total estimated burden for all 15 qualified entities of $79,823. While we anticipate that the requirement to create a QE DUA and/or non-public analyses agreement will only be incurred once by a qualified entity, we believe that the requirement to process and maintain the QE DUAs and/or non-public analyses will be an ongoing cost. A qualified entity is required to submit an annual report to CMS under §401.719(b). §401.719(b)(3) and (4) provide for additional reporting requirements if a qualified entity chooses to provide or sell analyses and/or data to authorized users. The burden associated with this requirement is the time and effort necessary to gather, process, and submit the required information to CMS. There are currently 31 qualified entities; however we estimate that number will increase to 35. Some qualified entities may not want to bear the risk of the potential assessments and have been able to accomplish their program goals under other CMS data sharing programs, therefore some qualified entities may not elect to provide or sell analyses and/or data to authorized users. As a result, we estimate that 15 qualified entities will choose to provide or sell analyses and/or data to authorized users, and therefore, would be required to comply with these additional reporting requirements. We further estimate that it would take each qualified entity 50 hours to gather, process, and submit the required information. We estimate that it will take each qualified entity 34 hours to gather the required information, 15 hours to process the information, and 1 hour to submit the information to CMS. We believe a professional or technical services employee of the qualified entity with an hourly labor cost of $85.63will fulfill these additional annual report requirements. We estimate that 35 qualified entities will need to comply with this requirement and that the total estimated burden associated with this requirement is $149,852. We based the hourly labor costs on those reported by the Bureau of Labor Statistics (BLS) at http://data.bls.gov/pdq/querytool.jsp?survey=ce for this labor category. We used the rate for 2019 and added 100 percent for overhead and fringe benefit costs.
Table 1: Collection of Information
Regulation Section(s) |
OMB Control No. |
Number of Respondents |
Number of Responses per responden |
Burden per Respons e (hours) |
Total Annual Burden (hours) |
Hourly Labor Cost of Reporting ($)* |
Total Labor Cost of Reporting ($) |
Total Cost ($) |
§401.718, §401.716, and §401.713 (DUA and non- public analyses agreement Development) |
0938-1309 |
15 |
1 |
20 |
300 |
85.63 |
25,689 |
25,689 |
§401.718 and §401.716 (Legal Review) |
0938-1309 |
15 |
1 |
20 |
300 |
104.50 |
31,350 |
31,350 |
§401.718 and §401.716 (Processing and Maintenance) |
0938-1309 |
15 |
70 |
2 |
2,100 |
85.63 |
179,823 |
179,823 |
§401.719(b) |
0938-1309 |
15 |
1 |
50 |
750 |
85.63 |
64,222 |
64,222 |
Total |
|
15 |
|
|
3,450 |
|
|
301,084 |
*The values listed are based on 100 percent overhead and fringe benefit calculations.
Note: There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 1.
There are no capital costs associated with the annual report or the QE DUA or non-public analyses agreement.
It is estimated that CMS costs for managing the information collection will include one-eighth full time equivalent at the GS-13 step 4 level with an annual fully loaded salary of $112,930 and $31,202 in contractor support, for a total of $144,132.
There have been updates to the BLS labor categories and the government salaries, which have increased since the last information collection submission. The contractor costs have decreased due to the new electronic submission process.
Publication/Tabulation Dates
There are no publication/tabulation dates associated with this collection.
Expiration Date
CMS will display the expiration date and OMB control number as indicated.
There are no exceptions to the certification statement.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Medicare Data Sharing Program - Supporting Statement Part A |
| Subject | Medicare Data Sharing Program - Supporting Statement Part A |
| Author | CMS |
| File Modified | 0000-00-00 |
| File Created | 2021-01-12 |