PRESENTED AT 28 th Annual Health Law Conference April 21 22, 2016 Houston, Texas CMS Update: What is an SIA and How to Keep Your Hospital from Needing One Dodjie Guioa The University of Texas School of Law Continuing Legal Education 512.475.6700 utcle.org
Presented at: The University of Texas School of Law 28 th Annual Health Law Conference April 20, 21-22, 2016 Houston, Texas Summary of CMS Survey & Certification Processes and Authority Joy & Young, L.L.P. 2499 S. Capital of TX Hwy Ste A-101 Austin, TX 78746 hyoung@joyyounglaw.com 512.330.0228, ext. 2
Summary of CMS Survey & Certification Processes and Authority Joy & Young, L.L.P. April 21, 2016 Survey and Certification: General regulatory requirements: Providers must meet the Medicare conditions relevant to their type of operation or face termination of their provider agreement (42 C.F.R. 489.53(a)(3)). These conditions include: For providers: Conditions of Participation (CoPs) For a skilled nursing facility (SNF) or nursing facility (NF): Requirements For suppliers: Conditions for Coverage Hospital CoPs are found at 42 C.F.R. Part 482. Psychiatric hospitals must comply with two additional CoPs (42 C.F.R. 482.60-.62, Special Conditions of Participation on medical records and staffing), but these Special Conditions do not apply to general hospitals with psychiatric units. In addition to the core CoPs that all certified hospitals must meet, there are a number of CoPs for Optional Services such as, surgery, anesthesia, rehabilitation, etc. CMS provides guidance on the survey and certification process in its State Operations Manual (SOM) CMS Publication Number 100-07, located on the list of Internet-Only Manuals on the CMS website: http://www.cms.hhs.gov/regulations-and-guidance/guidance/manuals/internet- Only-Manuals-IOMs.html. Key SOM provisions relevant to hospitals include: Complaint survey process Sections 5000-5080 for all provider/supplier types Sections 5100-5160 for deemed providers/suppliers, so called because they are deemed to meet the relevant conditions through their accreditation (e.g., Joint Commission accreditation of hospitals) Sections 5200-5240 for non-deemed providing/supplier types besides SNFs/NFs Sections 5300-5390 for nursing homes Sections 5400-5480 for EMTALA violations Sections 5500-5590 for CLIA (laboratories) Procedures for termination actions (both involuntary and voluntary) Sections 3000-3005 and 3010-3049 The SOM Appendices contain detailed guidance on survey protocols, regulations, and the agency s interpretation of the regulations for various provider types. The key appendices for hospitals are: Appendix A: Hospitals Appendix AA: Psychiatric Hospitals (but not psychiatric units of a general hospital) Appendix I: Life Safety Code Appendix V: EMTALA Appendix Q: Determining Immediate Jeopardy (IJ) 1
The survey, certification, and enforcement rules are at 42 C.F.R. Part 488. Key players in the survey and certification process are: State Survey Agency (SA) Regulates, surveys, and enforces state licensing rules; Contracts with CMS to conduct surveys for Medicare certification and enforcement purposes. SA surveyors certify provider compliance or noncompliance to the CMS Regional Office responsible for oversight and regulation of the provider/supplier. CMS Regional Office (RO) Determines compliance and noncompliance with Medicare conditions; Provides notice to providers; Takes action to terminate provider agreements or other action to enable providers to come into compliance without termination, such as through a Systems Improvement Agreement (SIA), described in more detail below. Accrediting organization (AO) with deeming authority (such as The Joint Commission) Accredits provider in accordance with applicable standards; Conducts deemed status surveys of certain providers (such as hospitals) in the place of the SA. There are several types of Medicare surveys described in 42 C.F.R. Part 488 to determine a provider s substantial compliance with the applicable CoPs. Initial certification surveys are full surveys that review a hospital s compliance with all Medicare CoPs and the Life Safety Code. Validation Surveys are also full surveys. For ongoing monitoring, CMS authorizes a representative sample of validation surveys of deemed providers each year to confirm the performance and compliance of the applicable AOs. CMS also authorizes some validation surveys to follow a provider s accreditation survey. Complaint Surveys investigate a complaint and survey only the CoPs implicated by the complaint and by any noncompliance found during the survey. For accredited hospitals with deemed status, a complaint survey with findings of Condition-level noncompliance can result in loss of deemed status and a subsequent full survey. Resurveys follow findings of noncompliance with the CoPs and receipt of a plan of correction from the provider. The purpose of the resurvey is to determine whether the provider is back in compliance with the applicable CoPs. Surveys evaluate a provider s substantial compliance with the CoPs. A finding of substantial compliance depends on: [T]he manner and degree to which the provider or supplier satisfies the various standards within each condition. (42 C.F.R. 488.26(b)). But substantial compliance is in the eye of the regulator. 2
Find the full text of this and thousands of other resources from leading experts in over 30 legal practice areas in the UT Law CLE elibrary (utcle.org/elibrary) Title search: CMS Update: What is an SIA and How to Keep Your Hospital from Needing One Also available as part of the ecourse 2016 Health Law econference First appeared as part of the conference materials for the 28 th Annual Health Law Conference session "CMS Update: What is an SIA and How to Keep Your Hospital from Needing One"