CMS-416 - Supporting Statement A [rev 02-23-2017 by OSORA PRA]

Supporting Statement Part A

Annual Early and Periodic Screening, Diagnostic and Treatment (EPSDT) Participation Report and Supporting Statutory Language

Contained in 1902(a)(43)(D) of the Social Security Act

CMS-416, OMB 0938-0354

Background

Section 1902 (a)(43)(D) of the Social Security Act (the Act) requires States to report annually by age group and basis of Medicaid eligibility for medical assistance, information relating to Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) services provided under the State plan. The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the EPSDT benefit, in partnership with states, and uses the annual reports to evaluate the benefit’s effectiveness in meeting the health care needs of Medicaid eligible children. The report also is used to provide data ^{to the Congress and the public on} the use of health care services by Medicaid children.

CMS is requesting a revision of the EPSDT reporting requirements on form CMS-416: Annual EPSDT Participation Report (EPSDT Report). There are no changes to the report itself, but CMS has taken this opportunity to include clarifications to the instructions for certain lines on the reporting form, primarily related to lead screenings (Line 14), including definitions for the Categorically Needy (CN) and Medically Needy (MN) line items and clarification of provider types for reporting on the dental lines (Lines 12a-12g).

Section 2700.4 of the State Medicaid Manual (SMM) contains form CMS-416, instructions for completion of the form, and the required PRA disclosure statement.

^A. Justification

1. Need and Legal Basis

The authority for requiring states to submit the EPSDT annual report is section 1902 (a)(43)(D) of the Act. This is a national report that CMS is required to produce and publish on a yearly basis. This report is compiled with the data submitted to CMS by each state on their yearly CMS-416 report. The information is used to assess the effectiveness of state EPSDT programs, including the provision of required dental Services to eligible children. CMS has experienced that reporting by states on the form CMS-416 can be uneven and inaccurate. CMS regularly receives inquiries from staff responsible for reporting the data. Those inquiries often evidence confusion about how to interpret the instructions. It is important that the data CMS receives from the states on the form CMS-416 be complete and accurate, and that the instructions be followed consistently across all states. To this end, CMS has clarified instructions and developed training modules to provide an opportunity for more in- depth training about the instructions as well as context around the EPSDT benefit and the importance of the data CMS collects.

2. Information Users

States submit the EPSDT Report to CMS’ Center for Medicaid and CHIP Services (CMCS). The data collected is used to assess the effectiveness of state EPSDT programs in reaching eligible children, by age group and basis of Medicaid eligibility, who are provided initial and periodic child health screening services, referred for corrective treatment, and receiving dental, and lead screening services. The information gathered from this report, permits federal and state managers to evaluate the effectiveness of the EPSDT law on the basic aspects of the program.

3. Information Technology

CMS developed a uniform electronic form by which states must report the required data. All states and territories use a Medicaid Management Information Systems (MMIS) from which the data is extracted, based on programing according to the CMS-416 instructions. The state extracts the data and inputs it into the electronic CMS form, and then submits the report via email to the CMS EPSDT mailbox.

In addition, CMS produced six Form CMS-416 Dental Data Reporting learning tools, recorded as YouTube videos. The videos aim to support states in improving the quality of the data they report to CMS on the Form CMS-416.

4. Duplicate Information

CMCS is the only CMS component collecting this EPSDT data. Therefore, there is no duplication.

5. Small Business

This collection of information does not involve small businesses or other small entities.

6. Less Frequent Collection

Section 1902 (a)(43)(D) of the Act requires the annual reporting by states of the EPSDT data. Less frequent collection does not provide adequate/current data necessary for response to Congressional and public inquiries. States that do not provide the Form CMS-416 by the annual deadline are considered out of compliance with the authorizing statute.

7. Special Circumstances

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 Consultations

The 60-day notice published in the Federal Register on October 31, 2016 (81 FR 75406). CMS received two public comments via e-mail. The comments and our response are attached to this package. No revisions are being made to this package as a result of the comments.

9. Payments or Gifts

There is no provision for any payment or gift to respondents associated with this reporting requirement.

10. Confidentiality

Because no personal identifying information is collected in the report, there is no issue of confidentiality with respect to the data submitted by the state. The data collected on the report is available for public review.

11. Sensitive Questions

There are no sensitive questions associated with this collection. Specifically, the collection does not solicit questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

12. Estimate of Hour Burden and Cost to Respondents

1. Wage Estimates

The following costs are based on the U.S. Bureau of Labor Statistics’ May 2015 National Occupational Employment and Wage Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm).

Occupation Title	Occupation Code	Mean Hourly Wage	Fringe Benefit (at 100%)	Adjusted Hourly Wage
Computer and Information Analyst	15-1120	$43.56/hr	$43.56/hr	$87.12/hr

We are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

2. Burden Estimates

^a. Training Videos

There are six (6) YouTube videos available as supplements to the instructions.

The viewing time of the videos ranges from 11 minutes to 38 minutes. The content of the videos is largely based on the form CMS-416 instructions.

Viewing the videos is entirely voluntary. They are intended to support states and their contractors to more accurately and completely report dental data to CMS using the form CMS-416.

The estimate of burden includes time for one individual to view all six (6) of the supplemental videos. This is a one-time burden per staff member. It is unknowable how many, if any, staff members each state or contractor might ask to view the videos. Thus the burden is expressed in terms of one individual per state.

As demonstrated below, the viewing time of the videos ranges from 11 minutes to 38 minutes. The content of the videos is largely based on the form CMS-416 instructions.

Module	Viewing Time
1	0:10:58
2	0:29:14
3	0:27:57
4	0:37:41
5	0:32:31
6	0:31:47
TOTAL	2.75 hr/person

In aggregate we estimate 154 hours (2.75 hr/person x 56 states and territories) at a cost of $13,416.48 (154 hours x $87.12/hr).

For one (1) person in each state agency to view all six (6) videos, we estimate $239.58 (2.75 hours x $87.12/hr).

Using the supplemental YouTube videos is entirely voluntary. They are intended to support states and their contractors to more accurately and completely report data to CMS using the form CMS-416.

b. Form CMS-416

Reporting

1,092 hours = 56 State entities x 1 report annually x 19.5 hours

$95,135 per year = $87.12/hr x 1,092 hr

Recordkeeping

532 hours = 56 State entities x 1 report annually x 9.5 hours

$46,347 per year = $87.12/hr x 532 hr

3. Summary of Annual Burden Estimates

Requirement	Respondents	Responses	Burden per Response (hours)	Total Annual Burden (hours)	Labor Cost of Reporting	Total Cost ($)	Adjusted Cost*
Training	56	56	2.75	154	$87.12/hr	13,417	3,354
CMS-416 (Reporting)	56	56	19.5	1,092		95,135	23,784
CMS-416 (Recordkeeping)			9.5	532		46,347	11,587
Total	56	112	varies	1,778	$87.12/hr	154,899	38,725

*The cost is adjusted by 25 percent to account for the state share.

3. Information Collection Instruments and Supporting Documents

• Form CMS-416, “Annual EPSDT Participation Report.”

States submit the CMS-416: Annual EPSDT Participation Report to CMS’ Center for Medicaid and CHIP Services (CMCS). The data collected is used to assess the effectiveness of state EPSDT programs in reaching eligible children, by age group and basis of Medicaid eligibility, who are provided initial and periodic child health screening services, referred for corrective treatment, and receiving dental, hearing, lead screening services. This assessment is coupled with the state’s results in attaining the participation goals set for the state. The information gathered from this report permits federal and state managers to evaluate state effectiveness in implementing the EPSDT benefit.

• Form CMS-416, “Instructions for Completing Form CMS-416: Annual Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Participation Report.”

Section 2700.4 of the State Medicaid Manual (SMM) contains the CMS-416 form as well as instructions for completing the form.

• There are six (6) supplemental YouTube videos covering the following topics:

Title: Module 1: Overview of the Early and Period Screening, Diagnostic, and Treatment (EPSDT) Benefit

Description: Module 1 covers the history, goals, and basic requirements of the Early and Period Screening, Diagnostic, and Treatment (EPSDT) benefit, and provides a general overview of the Form CMS-416 and the Oral Health Initiative.

URL: https://youtu.be/O3cYN7z3q0M

Time: 10:58

Title: Module 2: Form CMS-416 Overview

Description: Module 2 provides information about how to submit the Form CMS- 416 and how to get help, familiarizes the audience with the partners and processes involved with collecting and reporting Form CMS-416 data, and introduces the general principles of data quality.

URL: https://youtu.be/BUQqLAzfaK4

Time: 29:14

Title: Module 3: Form CMS-416 Specifications – Lines 1a and 1b

Description: Module 3 addresses Lines 1a and 1b of the Form CMS-416, determining the correct age range when classifying eligibles, and provides some data quality checks for these lines.

URL: https://youtu.be/IzuxSdy4LO8

Time: 27:57

Title: Module 4: Form CMS-416 Specifications – Lines 12a through 12e

Description: Module 4 addresses a number of issues related to Lines 12a through 12e on the Form CMS-416, the difference between oral health and dental services, determining the correct age range when classifying eligibles, and provides some data quality checks for these lines.

URL: https://youtu.be/qub-h-E5BcE

Time: 37:41

Title: Module 5: Form CMS-416 Specifications – Lines 12f and 12g

Description: Module 5 addresses a number of issues related to Lines 12f and 12g on the Form CMS-416, the difference between oral health and dental services, determining the correct age range when classifying eligibles, and provides some data quality checks for these lines.

URL: https://youtu.be/n9tOl3ykN1A

Time: 32:31

Title: Module 6: Using Form CMS-416 Dental Data

Description: Module 6 covers how Form CMS-416 dental and oral health data are used to track progress on the CMS Oral Health Initiative, introduces the Principles of quality improvement (QI) in health care, and provides examples of state initiatives that used data to improve oral health quality and access.

URL: https://youtu.be/zHguFA0CX30

Time: 31:47

13. Capital Costs

There are no costs to states to use this set of videos. States will be able to access the videos using their existing systems.

There are no start-up costs associated with this information collection because the Medicaid EPSDT benefit has been in existence since 1967.

All states use the Medicaid Management Information System, a sophisticated mainframe system, to capture claims data, from which CMS-416 data can be collected. However, CMS does not mandate state data system types or data collection methodologies. Some states may use a different data system and/or a hybrid approach of claims data and managed care encounter data to collect the CMS-416 data. Therefore, it is necessary to estimate a range of operating and Maintenance costs for EPSDT data. These costs are estimated in a range of $3,000 to $15,000 annually.

14. Federal Costs

There is no cost to the federal government to deploy the videos or to support states to use them.

The annualized cost to the Federal Government is $133,711 which is computed as follows:

75 percent (Federal share) of the states’ total costs $116,174 = $154,899 x .75

Data entry, analysis, and inquiry responses (GS-13/8) $17,537 = $116,914 x .15 FTE

Note: $116,914/yr @ GS-13 step 8 for the Washington-Baltimore-Arlington locality (effective January 2017). See https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2017/DCB.pdf.

15. Changes in Burden and/Program Changes

Training Videos

The modules, which were initially interactive online tools, have been converted to YouTube videos, reducing the state burden to a state agency for one (1) person to complete all six (6) videos from 4.75 hours to 2.75 hours. ^{Using the videos is entirely voluntary. They are intended to support states} and their contractors to more accurately and completely report dental data to CMS.

Overall, the videos decrease the burden of hours from 266 hours (aggregate) for completing the modules to 154 hours (aggregate) viewing time.

CMS-416 (Form)

The changes to the Form CMS-416 include adding a line to provide the methodology for reporting Line 14 and adding the expiration date in the PRA disclaimer.

We have adjusted our per response burden by adding 0.5 hr/response for reporting and 0.5 hr/response for recordkeeping. In aggregate, we adjust our estimate from 1,568 hr to 1,624 hr.

CMS-416 (Instructions)

Changes to the instructions for completing the form include: Update to the FY in the header.

Modification of the bullet to clarify that data for Lines 3a – 14 (page 2): The population for which the data is reported on Lines 3a – Line 14 are children from Line 1b, that is unduplicated counts of individuals enrolled for at least 90 continues days during the reporting period.

Clarification of the definition/language for Categorically Needy and Medically Needy Eligibility Groups (page 2) to:

Categorically Needy (CN) and Medically Needy (MN) Eligibility Groups -- For purposes of reporting data on the CMS-416, children should be reported as medically needy (with or without spend down) or categorically needy (not medically needy) based on their status as of September 30th of the reporting federal fiscal year. If they weren’t enrolled in Medicaid on September 30th because their eligibility was terminated prior to that date, their status should be reported as of the date they were terminated.

Clarification of the definition/language under the important note (page 7):

IMPORTANT: Each dental line, Lines 12a-12g, collects information related to a type of dental service, a type of oral health service, or both. As described in Note B, this distinction relates to the type of provider who delivered the service. The instructions for each dental line specify the provider type(s) relevant to that line. It is important to pay close attention to this part of the instructions, and to report on each line only services delivered (rendered) by the type(s) of providers specified for that line.

Rendering provider type can usually be discerned from the claim form. For example: a child who received a fluoride varnish treatment (D1208) from a dentist should be reported on Line 12b, preventive dental service; a child who received a fluoride varnish treatment from a physician should be reported on Line 12f, oral health service.

Clarification of the instructions on Line 14 (page 9):

Clarifications to the instructions requesting that states provide the type of methodology used to report services under the lead screening line of the report with their submission.

16. Publication and Tabulation Data

The modules were previously housed on an Adobe Captivate web platform hosted by a CMS contractor, Mathematica Policy Research, Inc. but were converted to YouTube videos at the end of the contract to be compatible with Medicaid.gov. The videos are now available on CMS’ YouTube channel.

Data from state submissions of the form will be posted on the CMS website, Medicaid.gov. No other publication is planned.

17. Display of Expiration Date

The CMS-416 form and instruction display the expiration date.

18. Exception to Certification Statement

Not applicable. There are no exceptions.

B. Collections of Information Employing Statistical Methods

CMS does not intend to collect information employing statistical methods.

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