CMS-R-305 - Supporting State B [rev 11-25-2016 by OSORA PRA]]

CMS-R-305 - Supporting State B [rev 11-25-2016 by OSORA PRA]].docx

External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364 (CMS-R-305)

OMB: 0938-0786

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Supporting Statement - Part B

External Quality Review (EQR) of Medicaid Managed Care, EQR Protocols, and Supporting Regulations in 42 CFR 438.350, 438.352, 438.354, 438.356, 438.358, 438.360, 438.362, 438.364, and 438.370

CMS-R-305, OMB 0938-0786


Collection of Information Employing Statistical Methods - The eight currently approved protocols were drafted in 2010 by Provider Resources, Inc. and the National Commission for Quality Assurance with the intention of providing updated guidance to states, their contractors that are not managed care organizations (MCOs), prepaid inpatient health plans (PIHPs), prepaid ambulatory health plans (PAHPs), primary care case management (PCCM) entities (described in §438.310(c)(2)), or external quality review organizations (EQROs) hired by states on how to properly conduct three mandatory and five optional EQR activities listed in 42 CFR 438.358. The regulations required the initial drafting and promulgation of these protocols in 2003; the 2012 revision incorporated changes in law and quality practices since the original version was published. The revised EQR Protocols received OMB approval in September 2012 for a three-year period, which expired September 30, 2015. On May 19, 2015, OMB renewed this PRA package without change; the current expiration date is May 31, 2018.


There are no proposed changes at this time to the EQR protocols. We anticipate revision of these protocols within the next three years to reflect changes related to CMS-2390-F (including the new mandatory EQR-related activity (network adequacy validation) and the new optional EQR-related activity (plan rating)) and changes in quality review and measurement processes since 2012.


  1. No revisions to the protocols are proposed at this time. States and/or their contractors are not required to follow these protocols exactly, but are required to use “methods consistent with the Protocols.” Taken together, the protocols could be considered to be a textbook on statistical methods in health care quality control. Often, several statistically valid methods are offered to states and/or their contractors conducting a specific EQR task. The protocols offer general statistical guidelines for states and/or their contractors to apply and do not dictate specifics. The forty states and territories which utilize MCOs, PIHPs, or PAHPs are therefore required to submit Medicaid EQR technical reports.


  1. Procedures for collection - See answer to number one and the enclosed Protocols. Currently states submit final EQR technical reports to CMS via email.


  1. Methods to maximize response rates and address non-response - The CMS proactively reaches out to states to solicit annual report submission. Following initial outreach, the CMS conducts state-specific follow-up to address non-response. We work with states and/or their contractors to improve compliance and address requests for technical assistance.


  1. Tests of procedures or methods undertaken - See answer to number one and the enclosed protocols.


  1. Individuals consulted - As indicated, these protocols were written by Provider Resources, Inc. and the National Commission for Quality Assurance, but are now the responsibility of the Division of Quality and Health Outcomes (DQHO) in CMS. The designated contact for DQHO is Barbara Dailey located at S2-08-28, telephone number (410) 786-9012.


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