Supporting Statement Part A
Annual Early and Periodic Screening, Diagnostic and Treatment (EPSDT) Participation Report (CMS-416/OMB# 0938-0354)
and Supporting Statutory Language
Contained in 1902(a)(43)(D) of the Social Security Act

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 and Medicaid Services (CMS) is responsible for administering the EPSDT program and uses the annual reports to evaluate the program’s effectiveness in improving the health of Medicaid eligible children.  The report also is used to provide data to the Congress and the public on the health of Medicaid children.

CMS is requesting an extension 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 dental services, and also changes the instructions to improve the capture of eligible children referred for corrective treatment.  CMS also updated the instructions to reflect the change from the ICD-9 code set to ICD-10 codes, as required by the Health Insurance and Portability Act of 1996.

(On October 1, 2014, the International Classification of Diseases, or ICD-9 code sets that are used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets.  States will submit the EPSDT Report using the ICD-10 code set beginning with the due date of April 1, 2016, based on data from the federal fiscal year October 1, 2014 through September 30, 2015.)

Two tables are incorporated into the instructions to assist states in completing Form CMS-416:
Table 1 was added to the instructions to assist states in identifying medical codes related to specific dental codes so that they can capture all allowable data for the services provided.

Table 2 was added to the instructions to assist states in converting from ICD-9 codes to ICD-10 codes for reporting on line 14 – Total Number of Screening Blood Lead Tests.  There are many more ICD-10 codes that correspond to the ICD-9 codes, so this will help states to determine the most appropriate codes for reporting purposes.

State reporting requirements for Form CMS-416 are currently approved under OMB number 0938-0354 until December 31, 2013.

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

2.	Information Users

States submit the CMS-416: Annual EPSDT Participation Report to CMS’ Center for Medicaid and CHIP Services (CMCS).  The baseline 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, and vision 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 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.

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.

7.	Special Circumstances

No special circumstances exist which require completion of this section of the supporting statement.

8.	Federal Register/Outside Consultations

The 60-day Federal Register notice published on August 9, 2013 (78 FR 48687). Comments were received. A summary of the comments and our response has been attached to this package. While the form has not changed, the form’s instructions have been revised. 

Prior to the 30-day Federal Register notice, CMS presented information to and solicited feedback from the CMS Oral Health Technical Advisory Group (OTAG) on the revised CMS-416 instructions. The OTAG members represent states, territories, dental consultants, and dental associations, and all represented parties are welcome to listen to the discussion and consult with respective OTAG members.

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 questions of a sensitive nature in this data collection.

12.	Estimate of Hour Burden and Cost to Respondents

The estimate of burden includes time for reviewing instructions, searching/gathering data, and completing the form.  The estimate was derived from a sample of states and has not changed.  It has been updated to correct the amount of salary for a GS 12, step 1 that is used in the calculation.

Record Keeping Burden
56 State entities x 1 report annually x 9 hours	=	504

Reporting Burden
56 State entities x 1 report annually x 19 hours	=	1,064

TOTAL ANNUAL BURDEN HOURS	1,568

The estimate of annualized cost to state governments is $13,548 (25 percent of the total costs ($54,190).  The State employee hourly wage figure is computed as 80 percent of a GS-12 step 1, annual salary, plus 20 percent retirement/insurance.  The State cost is computed as follows:

$74,872 x 80 percent = $59,898 + 11,980 (20% retirement/insurance) =
$71,878 divided by 2,080 hours per year = $34.56 per hour.

$34.56 per hour x 1,568 hours per year = $54,190 per year.

$54,190 x 25 percent (state share) = $13,548.

13.	Total Costs as a Result of Data Collection

There are no start-up costs associated with this information collection because the Medicaid EPSDT program 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
The estimate of annualized cost to the Federal Government is $57,114. The cost estimate is computed as follows:

	75 percent (Federal share) of the states’ total costs	=		$40,643	
	Data entry, analysis, and inquiry responses		=	+ 16,471	
	(GS-13/8 x .15 FTE)				
	Total Federal Costs			$ 57,114	

15.	Changes in Burden and/Program Changes

No additional burden is estimated because the changes include only clarification of instructions to improve accuracy of the data and conversion of ICD-9 codes to ICD-10 codes. States are able to run ad hoc reports from the MMIS systems and are already collecting all of the data.

We are also correcting our cost estimate, based on the General Services (GS) pay schedule for 2013 (frozen at 2010 levels). The result of this correction resulted in a slight increase in cost to the state and federal governments.

16.	Publication and Tabulation Data

This information will be posted on the CMS website.  No other publication is planned.

17.	Display of Expiration Date

CMS requests approval to not display the expiration date for OMB approval on the CMS-416 form or instructions.  The form is referenced in the State Medicaid Manual, and this would make it necessary for CMS to reissue those pages of the manual with each OMB approval.

18.	Exception to Certification Statement

Not applicable. There are exceptions.

B.	Collections of Information Employing Statistical Methods

CMS does not intend to collect information employing statistical methods.