ERVIC ?37. 53.0 or AND HUMAN SERVICES 5 OFFICE OF INSPECTOR GENERAL ?a ha \xzwuxo'mx, m: 2020] JAN 16 2020 TO: Seema Verma, M.P.H. Administrator Centers for Medicare Medicaid Services FROM: Christi A. Grimm WW Principal Deputy InSpector General SUBJECT: OIG Final Report: Did Not Fully Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Bene?ciaries With Developmental Disabilities, A?03?l7?00202 Attached, for your information, is an advance copy of our final report on critical incidents involving Medicaid bene?ciaries with developmental disabilities. We will issue this report to the State Department of Health within 5 business days. If you have any questions or comments about this report, please do not hesitate to call me, or your staff may contact Brian P. Ritchie, Assistant Inspector General for Audit Services, at (410) 786-7104 or through email at Brian.Ritchie@oig.hhs.gov. or Nicole Freda, Regional Inspector General for Audit Services, Region at (215) 861?4497 or through email at Nicole.Freda@oig.hhs.gov. Please refer to report number A?03?l7?00202. Attachment IRVICE kb? 5.0 DEPARTIVIENT OF HEALTH AND HUMAN SERVICES OFFICE OF INSPECTOR GENERAL 45? 4?62, x? OFFICE OF AUDIT SERVICES, REGION 801 MARKET STREET, SUITE 8500 PHILADELPHIA, PA 19107-3134 JAN 1 7 2020 Report Number: Ms. Teresa D. Miller Secretary Department of Human Services PO. Box 2675 Harrisburg, PA 17105-2675 Dear Ms. Miller: Enclosed is the US. Department of Health and Human Services (HHS), Of?ce of Inspector General (01G), ?nal report entitled Did Not Fully Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Bene?ciaries With Developmental Disabilities. We will forward a copy of this report to the HHS action of?cial noted on the following page for review and any action deemed necessary. The HHS action of?cial will make ?nal determination as to actions taken on all matters reported. Section 8M of the Inspector General Act, 5 U.S.C. App., requires that OIG post its publicly available reports on the OIG website. Accordingly, this report will be posted at If you have any questions or comments about this report, please do not hesitate to contact Charles Hubbs, Assistant Regional Inspector General for Audit Services, at (202) 815?1540 or through email at Charles.Hubbs@Loig.hhs.gov. Please refer to report number in all correspondence. Sincerely, Wit [ka Nicole Freda Regional Inspector General for Audit Services Enclosure Page Teresa D. Miller Direct Reply to HHS Action Of?cial: Ms. Jackie Glaze Acting Director Regional Operations Group Consortium for Medicaid and Children?s Health Operations Centers for Medicare Medicaid Services 233 North Michigan Avenue, Suite 600 Chicago, IL 60601 Department of Health and Human Services OFFICE OF INSPECTOR GENERAL PENNSYLVANIA DID NOT FULLY COMPLY WITH FEDERAL AND STATE REQUIREMENTS FOR REPORTING AND MONITORING CRITICAL INCIDENTS INVOLVING MEDICAID BENEFICIARIES WITH DEVELOPMENTAL DISABILITIES Inquiries about this report may be addressed to the Office of Public Affairs at Public.Affairs@oig.hhs.gov. Christi A. Grimm Principal Deputy Inspector General January 2020 A-03-17-00202 Office of Inspector General https://oig.hhs.gov The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as amended, is to protect the integrity of the Department of Health and Human Services (HHS) programs, as well as the health and welfare of beneficiaries served by those programs. This statutory mission is carried out through a nation-wide network of audits, investigations, and inspections conducted by the following operating components: Office of Audit Services The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting audits with its own audit resources or by overseeing audit work done by others. Audits examine the performance of HHS programs and/or its grantees and contractors in carrying out their respective responsibilities and are intended to provide independent assessments of HHS programs and operations. These assessments help reduce waste, abuse, and mismanagement and promote economy and efficiency throughout HHS. Office of Evaluation and Inspections The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide HHS, Congress, and the public with timely, useful, and reliable information on significant issues. These evaluations focus on preventing fraud, waste, or abuse and promoting economy, efficiency, and effectiveness of departmental programs. To promote impact, OEI reports also present practical recommendations for improving program operations. Office of Investigations The Office of Investigations (OI) conducts criminal, civil, and administrative investigations of fraud and misconduct related to HHS programs, operations, and beneficiaries. With investigators working in all 50 States and the District of Columbia, OI utilizes its resources by actively coordinating with the Department of Justice and other Federal, State, and local law enforcement authorities. The investigative efforts of OI often lead to criminal convictions, administrative sanctions, and/or civil monetary penalties. Office of Counsel to the Inspector General The Office of Counsel to the Inspector General (OCIG) provides general legal services to OIG, rendering advice and opinions on HHS programs and operations and providing all legal support for OIG’s internal operations. OCIG represents OIG in all civil and administrative fraud and abuse cases involving HHS programs, including False Claims Act, program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG also negotiates and monitors corporate integrity agreements. OCIG renders advisory opinions, issues compliance program guidance, publishes fraud alerts, and provides other guidance to the healthcare industry concerning the anti-kickback statute and other OIG enforcement authorities. Notices THIS REPORT IS AVAILABLE TO THE PUBLIC at https://oig.hhs.gov Section 8M of the Inspector General Act, 5 U.S.C. App., requires that OIG post its publicly available reports on the OIG website. OFFICE OF AUDIT SERVICES FINDINGS AND OPINIONS The designation of financial or management practices as questionable, a recommendation for the disallowance of costs incurred or claimed, and any other conclusions and recommendations in this report represent the findings and opinions of OAS. Authorized officials of the HHS operating divisions will make final determination on these matters. Report in Brief Date: January 2020 Report No. A-03-17-00202 Why OIG Did This Audit We have performed audits in several States in response to a congressional request concerning deaths and abuse of people with developmental disabilities living in group homes. Federal waivers permit States to furnish an array of home and community-based services to Medicaid beneficiaries with developmental disabilities so that they may live in the community and avoid institutionalization. The Centers for Medicare & Medicaid Services (CMS) requires States to implement an incident reporting system to protect the health and welfare of the Medicaid beneficiaries receiving waiver services. Our objective was to determine whether Pennsylvania complied with Federal waiver and State requirements related to 24-hour reportable incidents that involve Medicaid beneficiaries with developmental disabilities residing in community-based settings. How OIG Did This Audit Our audit covered 2015 and 2016. We reviewed medical claims for beneficiaries residing in community-based settings who had acute-care hospital stays and emergency room visits with diagnosis codes that we determined to be indicative of high risk for suspected abuse or neglect. We also reviewed 24-hour reportable incident reports that were submitted to Pennsylvania’s incident reporting system. Pennsylvania Did Not Fully Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities What OIG Found Pennsylvania did not fully comply with Federal Medicaid waiver and State requirements for reporting and monitoring 24-hour reportable incidents involving Medicaid beneficiaries with developmental disabilities who resided in community-based settings. Specifically, Pennsylvania did not (1) ensure that community-based providers reported thousands of 24-hour reportable incidents within required timeframes, (2) ensure that community-based providers and county and regional investigators analyzed and investigated all beneficiary deaths, and (3) ensure that community-based providers referred all suspicious deaths to law enforcement. Pennsylvania did not have adequate controls to detect unreported 24-hour reportable incidents and did not have controls in place to ensure that all beneficiary deaths were investigated and that all suspicious deaths were referred to law enforcement. Therefore, Pennsylvania did not fulfill participant safeguard assurances it gave to CMS to ensure the health, welfare, and safety of the 18,770 Medicaid beneficiaries with developmental disabilities covered by the Medicaid waiver in our audit. What OIG Recommends and Pennsylvania Comments We recommend that Pennsylvania improve its controls regarding the reporting and monitoring of 24-hour reportable incidents involving Medicaid beneficiaries with developmental disabilities residing in community-based settings. We made specific recommendations for these controls. Pennsylvania concurred with six of our seven recommendations and described corrective actions that it plans to take or has already taken, but it did not concur with our recommendation that it record the 24-hour reportable incidents noted in our report. Instead, Pennsylvania stated that it plans to focus on recording unreported emergency room visits and hospital stays that contain diagnoses indicative of high risk for suspected abuse or neglect and take remedial action as appropriate. We agree that Pennsylvania should prioritize recording unreported incidents that contain diagnoses indicative of high risk for suspected abuse or neglect but maintain that all unreported 24hour reportable incidents must be reported. The full report can be found at https://oig.hhs.gov/oas/reports/region3/31700202.asp. TABLE OF CONTENTS INTRODUCTION ............................................................................................................................... 1 Why We Did This Audit ....................................................................................................... 1 Objective ............................................................................................................................. 1 Background ......................................................................................................................... 1 Developmental Disabilities Assistance and Bill of Rights Act of 2000 .................... 1 Medicaid Home and Community-Based Services Waiver ...................................... 2 Community-Based Providers’ Reporting Requirements for 24-Hour Reportable Incidents .............................................................................. 3 How We Conducted This Audit ........................................................................................... 5 FINDINGS ......................................................................................................................................... 6 Community-Based Providers Did Not Report Thousands of 24-Hour Reportable Incidents to the State Agency ....................................................................... 7 Unreported Emergency Room Visits....................................................................... 7 Unreported Acute-Care Hospital Stays ................................................................... 9 The State Agency Did Not Ensure That Community-Based Providers and County and Regional Investigators Analyzed and Investigated All Beneficiary Deaths ............. 11 The State Agency Did Not Ensure That Provider Employees and Administrators Referred All Suspicious Deaths to Law Enforcement ..................................................... 14 The State Agency Did Not Have Adequate Controls To Ensure Compliance With Federal Medicaid Waiver and State Requirements .............................................. 15 RECOMMENDATIONS ................................................................................................................... 16 STATE AGENCY COMMENTS ......................................................................................................... 17 OFFICE OF INSPECTOR GENERAL RESPONSE ................................................................................ 18 APPENDICES A: Audit Scope and Methodology ..................................................................................... 19 B: Related Office of Inspector General Reports................................................................ 21 C: Federal Waiver and State Requirements ...................................................................... 22 D: Unreported Emergency Room Visit Diagnosis Codes................................................... 27 Pennsylvania Did Not Fully Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) E: Unreported Acute-Care Hospital Stay Diagnosis Codes ............................................... 29 F: State Agency Comments ............................................................................................... 31 Pennsylvania Did Not Fully Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) INTRODUCTION WHY WE DID THIS AUDIT We have performed audits in several States1 in response to a congressional request concerning deaths and abuse of people with developmental disabilities living in group homes. This request was made following nation-wide media coverage of deaths of individuals with developmental disabilities involving abuse, neglect, or medical errors. In Pennsylvania, individuals with developmental disabilities may reside in community-based settings such as group homes, shared living arrangements, and private family homes (collectively known as “community-based providers”). As required by its Medicaid Home and Community-Based Services (HCBS) Waiver, the Pennsylvania Department of Human Services (State agency) has specified types of events—including alleged abuse and neglect—that must be reported to the State agency for review and followup action by an appropriate authority. Pennsylvania’s waiver application contains two categories that must be reported to the State agency within 24 hours of incident occurrence (collectively referred to in this report as “24-hour reportable incidents”). The waiver application further categorizes these events as either “critical incidents” or “incidents.” OBJECTIVE Our objective was to determine whether the State agency complied with Federal Medicaid waiver and State requirements for reporting and monitoring 24-hour reportable incidents that involve Medicaid beneficiaries with developmental disabilities residing in community-based settings. BACKGROUND Developmental Disabilities Assistance and Bill of Rights Act of 2000 As defined by the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (the Disabilities Act),2 “developmental disability” means a severe, chronic disability that is attributable to a mental impairment, a physical impairment, or a combination of both; is evident before the age of 22 and likely to continue indefinitely; and results in substantial limitations in three or more of these major life areas: self-care, receptive and expressive language, learning, mobility, self-determination, capacity for independent living, and economic self-sufficiency. Federal and State Governments have an obligation to ensure that public funds are provided to residential, institutional, and community-based providers that serve individuals with 1 See Appendix B for related Office of Inspector General reports. 2 P.L. No. 106-402 (October 30, 2000). Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 1 developmental disabilities. Further, these providers must meet minimum standards to ensure the care they provide does not involve abuse, neglect, sexual exploitation, or violations of legal and human rights (the Disabilities Act § 109(a)(3)). Medicaid Home and Community-Based Services Waiver The Social Security Act (the Act) authorizes the Medicaid HCBS Waiver program (the Act § 1915(c)). The program permits a State to furnish an array of home and community-based services that assist Medicaid beneficiaries to live in the community and avoid institutionalization. Waiver services complement or supplement the services that are available to participants through the Medicaid State plan and other Federal, State, and local public programs and the support that families and communities provide. Each State has broad discretion to design its waiver program to address the needs of the waiver’s target population. Pennsylvania currently has several HCBS waiver programs for people with developmental disabilities. This audit includes only those beneficiaries covered by the consolidated waiver program.3 States must give certain assurances to the Centers for Medicare & Medicaid Services (CMS) to receive approval for an HCBS waiver, including that necessary safeguards have been taken to protect the health and welfare of the beneficiaries receiving services (42 CFR § 441.302). This waiver assurance requires the State to give specific information regarding its plan or process related to participant safeguards, which includes whether the State operates a critical event or incident reporting system (HCBS consolidated waiver, Appendix G-1). In its consolidated waiver and its own regulations, the State agency stated that it has a critical event or incident reporting system. The State agency retains authority over the administration and implementation of the consolidated waiver program. Within the State agency, the Office of Developmental Programs (ODP) is responsible for developing and distributing policies, procedures, and rules related to consolidated waiver operations and for coordinating with other State and local agencies. During 2015 and 2016, Pennsylvania claimed $4.1 billion ($2.2 billion Federal share) to provide 18,770 individuals with needed comprehensive support services under the consolidated waiver. 3 During our audit period, the consolidated waiver population consisted of beneficiaries with intellectual disabilities, which is a subset of developmental disabilities. After our audit period, the consolidated waiver’s eligibility criteria was expanded to include certain beneficiaries with other developmental disabilities. For the purposes of this report, we refer to beneficiaries who have an intellectual disability, or both an intellectual disability and a physical disability, as having developmental disabilities. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 2 Community-Based Providers’ Reporting Requirements for 24-Hour Reportable Incidents The HCBS waiver states that the State agency must specify types of critical events or incidents, including alleged abuse, neglect, and exploitation, that must be reported for review and followup action by an appropriate authority (HCBS consolidated waiver, Appendix G-1(b)). Pennsylvania’s consolidated waiver application contains two categories, “critical incidents” or “incidents,” that must be reported to the State agency within 24 hours of occurrence.4 Examples of critical incidents include abuse, neglect, death, and certain emergency room visits and hospitalizations. Examples of incidents include missing persons, fire, law enforcement activity, and all non-critical-incident emergency room visits and hospitalizations. Both critical incidents and incidents must be reported in the State agency’s incident reporting system,5 but there are different investigation requirements for critical incidents and incidents. The consolidated waiver specifies that community-based providers must report both critical incidents and incidents to the State agency within 24 hours of their occurrence or discovery.6 Community-based providers must complete incident reports7 for all 24-hour reportable incidents. These finalized incident reports must correctly categorize the 24-hour reportable incident; indicate if proper safeguards were in place; indicate if any necessary corrective action either has taken or will take place; and indicate if critical incidents of abuse, neglect, or exploitation were reported to the proper authority as required by Pennsylvania law8 (HCBS consolidated waiver, Appendix G-1(d)). In addition, critical incidents must also be investigated by an ODP-certified investigator in accordance with established timelines and standards. When an ODP-certified investigator completes the investigation, he or she enters the summary into the State agency’s incident 4 The consolidated waiver and State regulations also include a category of incidents that must be reported within 72 hours. However, we limited our review to only those incidents that must be reported within 24 hours of occurrence. When we use the term “incident” in this report, we are referring only to those incidents that must be reported within 24 hours of occurrence. 5 Before 2016, the State agency’s incident reporting system was the Home and Community Services Information System (HCSIS). On January 4, 2016, the State agency transitioned to the Enterprise Incident Management (EIM) system. The State agency maintains separate databases for HCSIS incidents and EIM incidents. We analyzed data from both systems and refer to the systems collectively as “the incident reporting system.” 6 State regulations at 55 Pennsylvania Code section 6000.922 also specify categories that must be reported in the State agency’s incident reporting system within 24 hours after occurrence. 7 These reports are known as “incident reports” regardless of whether the event is a critical incident or an incident. 8 Incident reports include a conclusion section in which investigators document whether the 24-hour reportable incident resulted from abuse or neglect or whether there were additional referrals to adult or child protective services. Detail must also be provided that describes exactly what happened during the incident, including all relevant details prior to, during, and after the incident. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 3 reporting system, and the provider then completes and finalizes the report within 30 days of the occurrence of the critical incident (HCBS consolidated waiver, Appendix G-1(d)). Incidents, however, do not require an investigation by an ODP-certified investigator. The consolidated waiver states that incidents are subject to review by ODP and an administrative entity.9 Table 1 on the following page shows the types and number of incidents recorded in the incident reporting system10 during calendar years (CYs) 2015 and 2016 (audit period). The waiver generally classifies beneficiary deaths as critical incidents, which must be reported within 24 hours of occurrence or discovery, investigated by an ODP-certified investigator in accordance with ODP’s established timelines and standards, and entered as an incident in the incident reporting system. In addition, State regulations at 55 Pennsylvania Code section 6000.922(a)(2) require all deaths to be reported within 24 hours, while 55 Pennsylvania Code section 6000.925 indicates that the death of an individual receiving services from a provider must be investigated by the provider and ODP or by the Pennsylvania Department of Health with county participation as requested by ODP. In addition to these requirements, the Pennsylvania Adult Protective Services Act, which applies to adults between the ages of 18 and 59, and the Pennsylvania Older Adults Protective Services Act, which applies to adults ages 60 and older, specify that when deaths are suspicious, the community-based provider must immediately make an oral report to appropriate law enforcement officials. Within 48 hours of making the oral report, the community-based provider must submit a written report to appropriate law enforcement officials.11 9 An administrative entity is a county mental health or intellectual disability program or a nongovernmental entity that has a signed agreement with ODP to perform operations and administrative functions related to the consolidated waiver. 10 This table contains every incident type that a provider can report in the incident reporting system. This includes both critical incidents and incidents. The incident reporting system does not distinguish between critical incidents and incidents in its listing of primary incident types. 11 Pennsylvania Adult Protective Services Act § 501(b); Pennsylvania Older Adults Protective Services Act § 701(b). Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 4 Table 1: Number and Type of Incidents Reported in the Incident Reporting System for Calendar Years 2015 and 2016 Primary Incident Type* Number of Incidents Emergency Room Visit 24,149 Medication Error 22,226 Individual To Individual Abuse 10,650 Hospitalization 8,160 Neglect 6,369 Restraint 5,279 Abuse 5,273 Optionally Reportable Event 3,581 Law Enforcement Activity 2,958 Injury Requiring Treatment Beyond First Aid 2,524 Psychiatric Hospitalization 2,098 Misuse of Funds 1,536 Rights Violation 1,215 Death 654 Missing Person 469 Emergency Closure 141 Fire 66 Reportable Disease 53 Suicide Attempt 43 Total 97,444 * Incidents also have secondary incident types; however, they are categorized in this table according to primary incident type. The provider determines the primary incident type for reporting purposes; for each primary incident type, the incident reporting system automatically generates a list of options from which the provider selects the secondary incident type. HOW WE CONDUCTED THIS AUDIT We extracted from the Pennsylvania Medicaid Management Information System (MMIS) claim records for 28,627 emergency room visits and 5,709 acute-care hospital stays that the State agency paid on behalf of Medicaid beneficiaries with developmental disabilities who were eligible for the consolidated waiver and had a claim during CYs 2015 and 2016. We compared these 28,627 emergency room visits and 5,709 acute-care hospital stays to the incident reporting system databases to determine if these visits and stays were reported to the State agency as 24-hour reportable incidents.12 To determine whether community-based providers reported these 24-hour reportable incidents to the State agency, we also reviewed 1,162 emergency room visits and 510 12 Emergency room visits and acute-care hospital stays can be either critical incidents or incidents depending on the circumstances. However, in either case, all emergency room visits and acute-care hospital stays must be reported in the State agency’s incident reporting system within 24 hours of their occurrence. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 5 acute-care hospital stays with at least 1 of 97 diagnosis codes that we determined to be indicative of high risk for suspected abuse or neglect. We also reviewed incident reports that were submitted to the State agency through the State agency’s incident reporting system to determine if the State agency followed Federal and State requirements regarding 24-hour reportable incident reporting and monitoring. To determine whether community-based providers analyzed and investigated all beneficiary deaths, we judgmentally sampled 13 of the 654 beneficiaries who had an incident report during our audit period with the primary incident type listed as death. We reviewed the critical incident reports surrounding the 13 deaths and compared that information to hospital medical records. For those 13 beneficiaries, we also reviewed any previous 24-hour reportable incidents that were reported in the incident reporting system. We conducted this performance audit in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives. Appendix A contains details of our audit scope and methodology. Appendix C contains details about the Federal waiver and State requirements. FINDINGS The State agency did not fully comply with Federal Medicaid waiver and State requirements for reporting and monitoring 24-hour reportable incidents involving Medicaid beneficiaries with developmental disabilities who resided in community-based settings. Specifically, the State agency did not: • ensure that community-based providers reported all 24-hour reportable incidents to the State agency within required timeframes, • ensure that community-based providers and county and regional investigators analyzed and investigated all beneficiary deaths, and • ensure that community-based providers referred all suspicious deaths to law enforcement. The State agency did not fully comply with Federal Medicaid waiver and State requirements for reporting and monitoring 24-hour reportable incidents because it did not have adequate internal controls in place to detect unreported 24-hour reportable incidents and did not have controls in place to ensure that all beneficiary deaths were investigated and that all suspicious deaths were referred to law enforcement. Therefore, the State agency did not fulfill various participant safeguard assurances it gave to CMS in its consolidated waiver. The State agency Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 6 also failed to demonstrate that it ensured the health, welfare, and safety of the 18,770 Medicaid beneficiaries with developmental disabilities covered by the consolidated waiver. COMMUNITY-BASED PROVIDERS DID NOT REPORT THOUSANDS OF 24-HOUR REPORTABLE INCIDENTS TO THE STATE AGENCY Community-based providers in Pennsylvania are required to report to the State agency 24-hour reportable incidents involving Medicaid beneficiaries with developmental disabilities (HCBS consolidated waiver, Appendix G-1(b)). As part of its oversight, the State agency is required to compile 24-hour reportable incident data and analyze these data to identify patterns and trends to prevent reoccurrences of 24-hour reportable incidents (Appendix G-1(e); Appendix G: Quality Improvement: Health and Welfare; Appendix H). All emergency room visits and acute-care hospital stays are either critical incidents or incidents depending on the circumstances13 surrounding the visits or stays and must be reported in the State agency’s incident reporting system within 24 hours of their occurrence. Unreported Emergency Room Visits Community-based providers did not report to the State agency all 24-hour reportable incidents involving emergency room visits for Medicaid beneficiaries with developmental disabilities covered by the consolidated waiver. By comparing Medicaid claims for emergency room visits to the emergency room visits reported in the State agency’s incident reporting system, we determined that 18,880 emergency room visits were not reported. Of the 1,162 claims that included diagnoses indicative of high risk for suspected abuse or neglect, community-based providers failed to report 307. Figure 1 on the following page shows these 307 unreported emergency room visits by diagnosis code category.14 13 See Appendix C for the circumstances that dictate whether an emergency room visit or acute-care hospital stay is a critical incident or an incident. 14 Appendix D contains descriptions of the 61 diagnosis codes associated with unreported emergency room visits. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 7 Figure 1: High-Risk Diagnosis Code Categories in Unreported Emergency Room Visits State agency officials stated that the State agency relies on community-based providers to report 24-hour reportable incidents. Current controls to detect unreported 24-hour reportable incidents consist of State agency visits and annual provider monitoring by administrative entities. However, these controls did not detect the 18,880 emergency room visits that we found were not reported, and State agency officials did not indicate that the State agency had any other controls to ensure that community-based providers report 24-hour reportable incidents within 24 hours. Because the State agency did not detect that these 24-hour reportable incidents had not been reported, it was not always able to take prompt action to protect beneficiaries’ health, safety, and rights. A Representative Example of Emergency Room Visits Not Reported by the Community-Based Provider A beneficiary with developmental disabilities who lived alone in an apartment but had 24-hour home-care services was admitted to an emergency room twice. The first emergency room visit was not reported within 24 hours of the incident, and the second emergency room visit was not reported at all. The medical record from the first emergency room visit documented that the beneficiary called 911 and stated that she wanted to commit suicide. The beneficiary was brought to the emergency room, where the medical record noted self-inflicted facial lacerations that the beneficiary said resulted from a Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 8 suicide attempt. The medical record also documented that the beneficiary was pinching her arm and stabbing a pencil into her chest. The emergency room physician diagnosed the beneficiary with a suicide attempt and suicidal ideation. Even though the home-care services provider was at the hospital, the home-care services provider waited 63 days to report the emergency room visit. The incident report stated only that the beneficiary was admitted, treated, and discharged home. The incident report did not contain any explanation for what occurred before, during, and after the beneficiary was taken to the emergency room. A State agency reviewer concluded that the incident report should have included an explanation for the delay in reporting the emergency room visit and that home-care services provider should have taken corrective action to ensure that all staff understood the requirements for reporting 24-hour reportable incidents within required timeframes. Twelve days after the first emergency room visit was reported, the beneficiary was admitted to the emergency room again for a suicide attempt. The second emergency room visit was not reported in the incident reporting system. Because both of the emergency room visits met the State agency’s definition of a 24-hour reportable incident, the community-based provider should have reported each in the State’s incident reporting system within 24 hours of occurrence. Because of the delay in reporting the first emergency room visit, the State agency could not review it in a timely manner and ensure prompt corrective actions were taken. Because the second emergency room visit was not reported, the State agency could not review it and ensure prompt corrective actions were taken or identify patterns of beneficiary care. Unreported Acute-Care Hospital Stays Community-based providers did not report to the State agency all 24-hour reportable incidents involving acute-care hospital stays for Medicaid beneficiaries with developmental disabilities. By comparing Medicaid claims for acute-care hospital stays to the acute-care hospital stays reported in the incident reporting system, we determined that 2,078 stays had not been reported. 15 To determine if the most serious acute-care hospital stays were being reported, we selected acute-care hospital stay claims with at least 1 of 97 diagnosis codes that we determined to be indicative of high risk for suspected abuse or neglect. Of the 510 stays that included diagnoses 15 OIG has developed A Resource Guide for Using Diagnosis Codes in Health Insurance Claims To Help Identify Unreported Abuse or Neglect, A-01-19-00502. The guide explains OIG’s approach to using claims data to identify incidents of potential abuse or neglect and also provides technical information to support OIG’s private and public sector partners with analyzing their own claims data to help combat abuse and neglect. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 9 indicative of high risk for suspected abuse or neglect, community-based providers failed to report 167. Figure 2 shows these 167 unreported acute-care hospital stays by diagnosis code category.16 Figure 2: High-Risk Diagnosis Code Categories in Unreported Acute-Care Hospital Stays State agency officials stated that the State agency relies on community-based providers to report 24-hour reportable incidents. Current controls to detect unreported 24-hour reportable incidents consist of State agency visits and annual provider monitoring by administrative entities. However, these controls did not detect the 2,078 acute-care hospital stays that we found had not been reported, and the State agency officials did not indicate that the State agency had any other controls to ensure that community-based providers report 24-hour reportable incidents within 24 hours. Because the State agency did not detect that these 24-hour reportable incidents had not been reported, it was not always able to take prompt action to protect beneficiaries’ health, safety, and rights. 16 Appendix E contains descriptions of the 32 diagnosis codes associated with unreported acute-care hospital stays. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 10 A Representative Example of Acute-Care Hospital Stays Not Reported by the Community-Based Provider A beneficiary with developmental disabilities had two unreported acute-care hospital stays following a reported critical incident of abuse. The two hospital stays took place at two different hospitals on two consecutive days. During the first hospital stay, the beneficiary was diagnosed with dehydration, and during the second hospital stay, the beneficiary was diagnosed with bedsores and recurrent dislocation of the pelvis. Less than two weeks before these unreported acute-care hospital stays, the beneficiary was released from the hospital after a reported 24-day hospitalization. The medical record for this 24-day hospitalization stated that the beneficiary’s mother pushed the beneficiary, who was in a wheelchair, to a park and left the beneficiary there unattended for 5 days. According to the medical record, law enforcement found the beneficiary covered by a tarp, leaves, and sticks and bound so that the beneficiary could not communicate. Law enforcement brought the beneficiary to the hospital, where he was diagnosed with adult nutritional neglect and assault (criminal neglect). The medical record also documented that the beneficiary’s mother had previously attempted to drown him by leaving him in a bathtub with the water running. Because both of the unreported acute-care hospital stays met the State agency’s definition of a 24-hour reportable incident, the community-based provider should have reported each acute-care hospital stay in the incident reporting system within 24 hours of occurrence. However, because the acute-care hospital stays were not reported, the State agency could not record or investigate them and could not implement possible corrective actions and identify patterns of beneficiary care. THE STATE AGENCY DID NOT ENSURE THAT COMMUNITY-BASED PROVIDERS AND COUNTY AND REGIONAL INVESTIGATORS ANALYZED AND INVESTIGATED ALL BENEFICIARY DEATHS The death of a beneficiary covered by the consolidated waiver is generally a critical incident and must therefore be reported in the incident reporting system and investigated. (HCBS consolidated waiver, Appendix G(b)). In addition, State regulations at 55 Pennsylvania Code section 6000.922(a)(2) requires all deaths to be reported within 24 hours, and 55 Pennsylvania Code section 6000.925 indicates that deaths must be investigated when an individual is receiving services from a provider. Of the 13 beneficiary deaths in our judgmental sample, 1 involved potential abuse or neglect. For this case, the community-based provider’s investigation originally determined that the beneficiary’s death did not involve abuse or neglect. However, the initial investigation was Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 11 based on incomplete information. The State agency reopened the investigation after reviewing the case at our request. In addition, community-based providers and county and regional investigators did not investigate a significant number of deaths: community-based providers did not investigate 80 deaths, and county and regional investigators did not investigate 94 deaths. (See Table 2.) We also found differences between the results of provider investigations and the results of county and regional investigations. Additionally, many community-based provider and county or regional investigations left the conclusion section of the incident report blank. Table 2: Analysis of Death Investigations Results of Investigations Into Provider County or Regional Beneficiary Death Investigation Investigation Neglect Abuse and Neglect No Abuse or Neglect Conclusion Blank No Investigation Total 11 1 510 52 80 654 12 1 240 307 94 654 If a community-based provider investigation or county or regional investigation concludes that deaths did not involve abuse or neglect based on incomplete information or if an investigator does not document conclusions on incident reports, there is a possibility that beneficiary deaths involving abuse or neglect could be overlooked and not referred to law enforcement in accordance with the Pennsylvania law.17 For the beneficiary death in our sample that may have involved abuse or neglect, had the initial investigation taken into account the beneficiary’s previous 24-hour reportable incidents we describe below, the investigation might have come to a different conclusion and the community-based provider might have referred the case to law enforcement. The Incomplete Investigation Into a Beneficiary Death A community-based provider reported the death of a beneficiary with a developmental disability. The beneficiary had two wound care clinic visits and five reported 24-hour reportable incidents in the 3-month period before the beneficiary’s death. In February, 3 months before the beneficiary’s death, the beneficiary was seen by a hospital’s outpatient wound care clinic for surgical evaluation of multiple bed sores as well as a stage IV pressure ulcer. In the medical record, the attending physician expressed “significant concerns with this patient in the 17 Pennsylvania Adult Protective Services Act § 501(b); Pennsylvania Older Adults Protective Services Act § 701(b). Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 12 environment that she is currently living in, due to multiple pressure ulcer development. [The beneficiary] is in a group home and appears to need more skilled nursing care than is able to be provided through [the group home].” The following month, in March, the beneficiary had a second wound care clinic visit. In the medical record, the attending physician noted that “based on the patient’s current health status and present living conditions, I feel that [the beneficiary’s] health issues are becoming overly difficult for non-skilled nursing caregivers to be able to provide. It is my recommendation that [the beneficiary] be considered for placement in a skilled nursing facility.” In addition to these wound care clinic visits, this beneficiary also had five 24-hour reportable incidents that were reported in the incident reporting system in the 3 months before the beneficiary’s death. Specifically, in February, the beneficiary had two reported 24-hour reportable incidents: • an (undetermined) injury requiring treatment beyond first aid and • a failure by the group home to provide needed care. In March, the beneficiary had three reported 24-hour reportable incidents: • a hospital stay, • a failure by the group home to provide needed care, and • an emergency room visit. Separate provider investigations of these 24-hour reportable incidents confirmed neglect in the “failure to provide needed care” 24-hour reportable incidents. In April, the community-based provider reported the death of the beneficiary. The provider investigated the death to determine if the beneficiary received timely and adequate care before death but did not document a conclusion to its investigation. A regional investigation concluded that the death was “not confirmed for abuse or neglect.”18 Investigations for this death did not take into account the beneficiary’s previously reported 24-hour reportable incidents. If the investigators had 18 The State agency noted that a conclusion of “not confirmed for abuse or neglect” is an assertion that the critical incident is not a founded case of abuse or neglect. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 13 considered previous 24-hour reportable incidents, medical history, and doctor’s notes, they may have decided that this case resulted from abuse or neglect, which would have triggered an additional investigation into the group home. While reviewing this case at our request, the State agency discovered evidence that warranted reopening the investigation into the beneficiary’s death. THE STATE AGENCY DID NOT ENSURE THAT PROVIDER EMPLOYEES AND ADMINISTRATORS REFERRED ALL SUSPICIOUS DEATHS TO LAW ENFORCEMENT In addition to the provider’s requirement to report deaths to the State agency, Pennsylvania requires a provider’s employee or administrator who has reasonable cause to suspect that a death is suspicious to immediately contact law enforcement officials to make an oral report. Within 48 hours of making the oral report, the employee and the administrator must submit a joint written report to appropriate law enforcement officials (Pennsylvania Adult Protective Services Act § 501(b); Pennsylvania Older Adults Protective Services Act § 701 (b)). Of the 13 death cases in our judgmental sample that met the criteria for referral to law enforcement, 2 cases were not referred. One case had provider and regional investigations that confirmed neglect, but law enforcement officials and the Office of the Attorney General were not notified as required by Pennsylvania law.19 Therefore, neither the district attorney nor the Attorney General investigated the death. After we asked about the case, the State agency reported the death to the district attorney’s office. For the other case, the State agency reopened its investigation after reviewing the case at our request. A Representative Example of a Suspicious Death Not Reported to Law Enforcement A beneficiary died after being removed from life support. The written description of the critical incident in the incident reporting system stated that the beneficiary was eating lunch and began choking. The cause of death on the death certificate was anoxic brain injury, cardiorespiratory arrest, and aspiration with upper respiratory obstruction. A provider investigation concluded that the beneficiary’s death was the result of neglect. The State agency agreed with this determination and confirmed that the beneficiary’s care was not managed properly. The regional investigator stated that she communicated directly with a provider quality improvement manager who expanded the provider investigation summary to document more information on the circumstances surrounding the critical incident. According to this expanded summary, the beneficiary grabbed 19 ACT 28/26 (Pennsylvania Statutes, Title 18, section 2713), requires the State agency to report abuse or neglect of a care-dependent person to the Office of the Attorney General or local law enforcement. Under ACT 28/26, the Attorney General and district attorneys have the authority to investigate the alleged abuse or neglect. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 14 a plate of pureed grilled cheese and began eating very quickly while the staff member’s back was turned. The beneficiary’s individual service plan stated that the beneficiary was to have direct staff supervision while eating. The beneficiary was also to eat slowly and have sips of water every three bites because the beneficiary was at risk for choking. The expanded summary stated that it appeared that there was insufficient direction regarding foods that may be less than ideal for pureeing. Both the provider investigation and the regional investigation confirmed neglect. However, neither law enforcement nor the district attorney’s office was contacted regarding the case. Because this case was not referred to law enforcement for further review and investigation, the State agency did not ensure that other Medicaid beneficiaries with developmental disabilities were adequately protected from similar future 24-hour reportable incidents involving neglect by this community-based provider. As a result of our questioning why the case was not referred to the district attorney’s office, the State agency referred this case to law enforcement in July 2018. The State agency referral indicated that the provider was suspected of neglecting an individual in its care, which resulted in the individual’s death. THE STATE AGENCY DID NOT HAVE ADEQUATE CONTROLS TO ENSURE COMPLIANCE WITH FEDERAL MEDICAID WAIVER AND STATE REQUIREMENTS The State agency did not comply with Federal Medicaid waiver and State requirements for reporting and monitoring 24-hour reportable incidents because internal controls were not sufficient to ensure that providers reported all 24-hour reportable incidents. The State agency relies on community-based providers to report all 24-hour reportable incidents in the incident reporting system. The State agency’s only controls for detecting unreported 24-hour reportable incidents were quarterly support coordinator20 visits for each beneficiary covered by the consolidated waiver, annual State agency licensing inspections, and annual administrative entity provider-monitoring activities. During their visits, support coordinators and State agency officials should review event logs to determine if all 24-hour reportable incidents have been reported. However, not all community-based providers have event logs, and the support coordinators and State agency licensing personnel did not disclose any steps the State agency or the providers had taken to identify 24-hour reportable incidents that may not have been logged. Additionally, administrative entities conduct annual provider-monitoring activities that review a sample of 20 Support coordinators are employed by Supports Coordination Organizations that have contracts with the State agency. Each support coordinator works to locate, coordinate, and monitor needed services and supports for waiver participants. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 15 individual records at each provider. As part of the record review, the administrative entities determine whether all 24-hour reportable incidents have been reported. However, this control did not detect the 18,880 emergency room visit claims and 2,078 acute-care hospital stay claims that we found had not been reported. Current controls only address identifying 24-hour reportable incidents after they have gone unreported. The State agency officials did not indicate that the State agency had any other controls to ensure that community-based providers report all 24-hour reportable incidents within 24 hours of their occurrence. One control that would improve the percentage of 24-hour reportable incidents that are reported would be the State agency’s conducting a routine reconciliation of the 24-hour reportable incidents in the incident reporting system with Medicaid claims data in MMIS. A routine reconciliation would allow the State agency to identify claims that should have been reported as 24-hour reportable incidents. Such a reconciliation might also provide the State agency with information about patterns of reporting behavior and beneficiary care at community-based providers. The State agency also did not have controls in place to ensure that all beneficiary deaths were investigated. Nor were there controls in place to ensure that the State agency referred all suspicious deaths to law enforcement. Accordingly, the State agency did not fulfill numerous participant safeguard assurances it gave to CMS to ensure the health, welfare, and safety of the Medicaid beneficiaries with developmental disabilities covered by the consolidated waiver (18,770 for the audit period) (42 CFR § 441.302(a)). RECOMMENDATIONS We recommend that the Pennsylvania Department of Human Services improve its controls regarding the reporting and monitoring of 24-hour reportable incidents involving Medicaid beneficiaries with developmental disabilities residing in community-based settings. Specifically, we recommend that the Pennsylvania Department of Human Services: • record the unreported 24-hour reportable incidents noted in this report; • work with community-based providers on how to identify and report all 24-hour reportable incidents; • work with community-based providers to ensure that all community-based providers’ staff understand the requirements for reporting 24-hour reportable incidents within required timeframes; Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 16 • develop a policy to periodically match Medicaid emergency room visit and acute-care hospital stay claims to 24-hour reportable incidents recorded in the incident reporting system; • work with community-based providers to ensure that administrative reviews and investigations are conducted and reported appropriately and consider all previous 24-hour reportable incidents related to the beneficiary; • ensure community-based providers analyze, investigate, and report to the State all beneficiary deaths; and • send a written report of death to law enforcement or the district attorney’s office when a death is determined to be suspicious or when abuse or neglect is suspected. STATE AGENCY COMMENTS In written comments on our draft report, the State agency did not concur with our first recommendation but concurred with the remaining six recommendations. The State agency outlined the corrective actions that it has taken and plans to take to address those six recommendations. The State agency did not concur with our recommendation that the State agency record the unreported 24-hour reportable incidents noted in this report. Although it said that it understood the basis for the recommendation, it stated that adopting the recommendation would require significant effort and resource investment and would have minimal impact on health and safety outcomes for current waiver participants. The State agency further noted that, given the amount of time since the incidents occurred, it is unlikely that the State agency would be able to perform critical investigative activities, such as locating witnesses and gathering the documentary evidence necessary to determine whether abuse or neglect had occurred. Instead, the State agency stated that it plans to focus its efforts on recording all unreported emergency room visits and hospital stays that had diagnoses indicative of high risk for suspected abuse or neglect and take remedial action as appropriate. The State agency began this process after we brought the issue to its attention. The State agency stated that it analyzed several high-risk incidents that we identified as unreported and found that these high-risk incidents had been reported. According to the State agency, these incidents appeared to us to be unreported because the date of the incident and the date of the claim were not an exact match. The State agency also indicated that some claims for emergency room visits did not meet the criteria for required reporting because the incidents did not occur during the provision of a provider-delivered service in accordance with 55 Pa. Code section 6000.911. Additionally, the State agency noted that it found that some claims identified as unreported emergency room visits occurred at treatment facilities located at the same service location as an emergency room but were not emergencies that were Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 17 required to be reported. For these reasons, the State agency requested that we reconsider the characterization of our finding that thousands of incidents were unreported. In its comments, the State agency also noted an inaccuracy in the draft report that we corrected. The State agency’s comments are included in their entirety as Appendix F. OFFICE OF INSPECTOR GENERAL RESPONSE After reviewing the State agency’s comments, we maintain that the facts of our report are valid. We agree that the State agency should prioritize recording the unreported 24-hour reportable incidents that contain diagnoses indicative of high risk for suspected abuse or neglect. However, we maintain that all unreported 24-hour reportable incidents must be reported to establish an accurate beneficiary history, which may indicate that changes to a beneficiary’s care setting are necessary. We acknowledge that some of the 18,800 unreported emergency room visits could have been followup visits, assessments, and visits to the emergency room in lieu of visits to a primary care provider. However, all 18,800 were coded as emergency room visits, and the State agency did not determine how many of the coded emergency room visits may have been miscategorized. We also acknowledge that, under certain limited circumstances the incident date and claim date may not have been an exact match, and therefore some of the 24-hour reportable incidents that we classified as unreported may have been reported. However, the State agency did not provide evidence as to how many of these 24-hour reportable incidents were reported on a date other than the emergency room claim date. Therefore, we have not changed the characterization of our finding that thousands of incidents were unreported. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 18 APPENDIX A: AUDIT SCOPE AND METHODOLOGY SCOPE During CYs 2015 and 2016, the State agency provided consolidated waiver services to 18,770 Medicaid beneficiaries with developmental disabilities and received 97,444 incident reports involving these 18,770 beneficiaries from community-based providers and other mandated reporters. Of the 18,770 beneficiaries, 14,099 had at least one 24-hour reportable incident recorded. MMIS claim records showed that the State agency paid for a total of 28,627 emergency room visits and 5,709 acute-care hospital stays on behalf of Medicaid beneficiaries with developmental disabilities who were eligible for the consolidated waiver during CYs 2015 and 2016. For this same period, the State agency conducted 16,140 critical incident investigations on behalf of beneficiaries covered by the consolidated waiver. We selected 1 of 97 diagnosis codes that we determined to be indicative of high risk for suspected abuse or neglect and reviewed 1,162 emergency room visits and 510 acute-care hospital stays that contained at least one of those diagnosis codes. In performing our audit, we established reasonable assurance that the claims data contained in the MMIS were accurate. We did not review the overall internal control structure of the State agency. We limited our internal control review to obtaining an understanding of the State agency’s policies and procedures related to 24-hour reportable incidents. We performed our fieldwork at the State agency office in Harrisburg, Pennsylvania. METHODOLOGY To accomplish our audit objective, we: • reviewed applicable Federal waiver and State requirements; • held discussions with CMS officials to gain an understanding of the HCBS waiver for beneficiaries with developmental disabilities residing in community-based settings; • held discussions with officials from various Pennsylvania agencies to gain an understanding of Pennsylvania’s policies and procedures related to the mandatory reporting of potential abuse and neglect of beneficiaries with developmental disabilities; • obtained from the State agency a computer-generated file of eligibility information on all 18,770 Medicaid beneficiaries with developmental disabilities covered by the consolidated waiver and residing in community-based settings during 2015 and 2016; • obtained from MMIS a computer-generated file containing claims for emergency room visits and acute-care hospital stays during CYs 2015 and 2016 for Medicaid beneficiaries with developmental disabilities covered by the consolidated waiver; Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 19 • obtained from the incident reporting system database 97,444 incident reports from CYs 2015 and 2016 submitted on behalf of beneficiaries covered by the consolidated waiver; • obtained from the incident reporting system databases 16,140 investigation reports of 24-hour reportable incidents from CYs 2015 and 2016 submitted on behalf of beneficiaries covered by the consolidated waiver; • matched the MMIS medical claims data (28,627 emergency room visits) for beneficiaries covered by the consolidated waiver to the incident reporting system databases to determine which claims for emergency room visits did not have corresponding 24-hour reportable incidents reported in the incident reporting system; • matched the MMIS medical claims data (5,709 acute-care hospital stays) for beneficiaries covered by the consolidated waiver to the incident reporting system databases to determine which claims for acute-care hospital stays did not have corresponding 24-hour reportable incidents reported in the incident reporting system; • identified 1,162 emergency room visit claims that had 1 or more of the 97 diagnosis codes indicative of high risk for potential abuse or neglect (Appendix D); • identified 510 acute-care hospital stay claims that had 1 or more of the 97 diagnosis codes indicative of high risk for potential abuse or neglect (Appendix E); • contacted hospitals and obtained and reviewed hospital medical records for 52 judgmentally selected beneficiary emergency room visits and 12 judgmentally selected acute-care hospital stays associated with 1 or more of the 97 diagnosis codes that indicated an increased risk of abuse or neglect; • reviewed incident reporting system data for 654 critical incidents involving beneficiary deaths and specifically reviewed incident reports and other supporting documentation for 13 judgmentally sampled critical incidents involving beneficiary deaths to determine if the State agency followed Federal waiver and State requirements regarding critical incident reporting for critical incidents involving beneficiary deaths; and • discussed the results of our audit with State agency officials. We conducted this performance audit in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 20 APPENDIX B: RELATED OFFICE OF INSPECTOR GENERAL REPORTS Report Title A Resource Guide for Using Diagnosis Codes in Health Insurance Claims To Help Identify Unreported Abuse or Neglect Alaska Did Not Fully Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities Ensuring Beneficiary Health and Safety in Group Homes Through State Implementation of Comprehensive Compliance Oversight Maine Did Not Comply With Federal and State Requirements for Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities Massachusetts Did Not Comply With Federal and State Requirements for Critical Incidents Involving Developmentally Disabled Medicaid Beneficiaries Connecticut Did Not Comply With Federal and State Requirements for Critical Incidents Involving Developmentally Disabled Medicaid Beneficiaries Review of Intermediate Care Facilities in New York With High Rates of Emergency Room Visits by Intellectually Disabled Medicaid Beneficiaries Report Number Date Issued A-01-19-00502 7/23/2019 A-09-17-02006 6/10/2019 Joint Report 1/17/2018 A-01-16-00001 8/9/2017 A-01-14-00008 7/13/2016 A-01-14-00002 5/25/2016 A-02-14-01011 9/28/2015 Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 21 APPENDIX C: FEDERAL WAIVER AND STATE REQUIREMENTS MEDICAID HOME AND COMMUNITY-BASED SERVICES WAIVER States must provide certain assurances to CMS to receive approval for an HCBS waiver,21 including that necessary safeguards have been taken to protect the health and welfare of the beneficiaries of the service (42 CFR § 441.302). The State agency must provide CMS with information regarding these participant safeguards in its HCBS waiver, Appendix G, Participant Safeguards. A State must provide assurances regarding three main categories of safeguards: • response to critical events or incidents (including alleged abuse, neglect, and exploitation); • safeguards concerning restraints and restrictive interventions; and • medication management and administration. The HCBS consolidated waiver, Appendix G-1, Participant Safeguards: Response to Critical Events or Incidents, G-1(b), “State Critical Event or Incident Reporting Requirements” This section of the waiver states that the entities required to report 24-hour reportable incidents are identified and defined in the ODP Bulletin and regulations, and that these entities include employees, contracted agents and volunteers for waiver service providers, administrative entities, and ODP staff. Participating beneficiaries and their families must notify the provider or support coordinator, when they feel it is appropriate, regarding any health and safety concerns related to a service or support received. ODP requires reporting of 24-hour reportable incidents in the incident reporting system whether the person who witnessed or first discovered the 24-hour reportable incident is an employee, contractor, or volunteer. To facilitate reporting, there are toll-free phone and email options for reporting of 24-hour reportable incidents by volunteers, families, or other community members. This section of the waiver also defines both critical incidents and incidents. It states that the following are critical incidents: • abuse; • death; 21 Three different versions of the consolidated waiver were in effect during the period of this audit. Any material differences between these waivers are noted in this report. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 22 • emergency room visit resulting from unexplained injury, staff-to-individual injury, injury resulting from individual-to-individual abuse, or injury resulting from restraint; • hospitalization resulting from accidental injury, unexplained injury, staff-to-individual injury, injury resulting from individual-to-individual abuse, or injury resulting from restraint; • individual-to-individual sexual abuse; • injury requiring treatment beyond first aid resulting from staff-to-individual injury, individual-to-individual abuse, or restraint; • misuse of funds; • neglect; and • rights violation. The following are incidents: • suicide attempt; • emergency room visit that does not involve unexplained injury, staff-to-individual injury, injury resulting from individual-to-individual abuse, or injury resulting from restraint; • hospitalization that does not involve accidental injury, unexplained injury, staff-toindividual injury, injury resulting from individual-to-individual abuse, or injury resulting from restraint; • psychiatric hospitalization; • individual-to-individual abuse that does not involve sexual abuse; • missing person; • injury requiring treatment beyond first aid that does not involve staff-to-individual injury and that is not the result of individual-to-individual abuse; • disease that is reportable to the Department of Health; • fire; • law enforcement activity; and • emergency closure of a facility or home. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 23 The HCBS consolidated waiver, Appendix G-1, Participant Safeguards: Response to Critical Events or Incidents, G-1(d) “Responsibility for Review of and Response to Critical Events or Incidents” This section of the waiver states that ODP receives and evaluates reports on each type of critical incident. When a critical incident is recognized or discovered, the provider must take prompt action to protect the beneficiary and must file an incident report in the incident reporting system within 24 hours. ODP reviews beneficiary records through the administrative entity, which is required to ensure that the provider files an incident report and takes appropriate action if a critical incident has not been reported. ODP also requires providers to separate victims from alleged perpetrators when the victim's health and safety are jeopardized. Separation may include reassigning, suspending, or terminating the alleged perpetrator. This section of the waiver also provides details about ODP’s policy on incident management and investigations. According to the waiver, ODP policy on incident management states that the administrative entity and ODP regional office must evaluate incident reports within 24 hours of submission to ensure that the provider took prompt action to protect the beneficiary’s health, safety, and rights; the provider notified the beneficiary’s family of the critical incident within 24 hours unless otherwise indicated in the individual support plan; and the provider initiated an investigation by assigning the case to a certified investigator. The provider may also be required to meet other notification requirements related to the Older Adults Protective Services Act and Child Protective Services Law. This section of the waiver also states that ODP certifies its investigators and requires that only those certified by ODP conduct investigations of critical incidents. ODP requires certified investigators to participate in 4 days of training in investigatory procedures. ODP only certifies investigators who successfully complete the training and pass a final examination. Investigators must be recertified every 3 years. When a certified investigator completes an investigation, he or she enters the summary in the incident reporting system. The provider then completes and finalizes the report within 30 days of the critical incident, and the incident reporting system sends an electronic alert notifying ODP and the administrative entity of the finalized report. The administrative entity evaluates all finalized reports within 30 days and approves the report if it meets certain requirements related to the protection of the participant’s health, safety, and rights through proper resolution of the critical incident. After resolution of the critical incident, the administrative entity will continue to work with and monitor the provider to ensure appropriate adherence to the established policies. ODP staff evaluates approved reports within 30 days and, if satisfactory, closes the incident report. The HCBS consolidated waiver, Appendix G-1, Participant Safeguards: Response to Critical Events or Incidents, G-1(e) “Responsibility for Oversight of Critical Incidents and Events,” Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 24 Appendix G: Participant Safeguards, Quality Improvement: Health and Welfare, and Appendix H: Quality Improvement Strategy These sections of the waiver state that the State agency is responsible for the oversight of and response to critical incidents and events. This oversight includes the collection and compilation of reported 24-hour reportable incidents. Specifically, the State agency should analyze aggregate incident data to develop reports that identify patterns and trends to prevent reoccurrences of 24-hour reportable incidents. The HCBS consolidated waiver, Appendix G, Participant Safeguards, Quality Improvement: Health and Welfare, (a)(i), “Methods for Discovery: Health and Welfare,” (a) “Sub-Assurances” This section of the waiver states that the State agency must demonstrate on an ongoing basis that it identifies, addresses, and seeks to prevent instances of abuse, neglect, exploitation, and unexplained death.22 The State agency must review deaths to determine the number and percentage of deaths by cause of death, and determine the number and percent of deaths examined according to State protocols. PENNSYLVANIA STATUTES Older Adults Protective Services Act (Act 79 of 1987, P.L. 381) Chapter 7, “Reporting Suspected Abuse by Employees,” codified at 35 P.S. §§ 10225.101-10225.5102 For participating beneficiaries age 60 and older, Pennsylvania’s Older Adults Protective Services Act specifies that a provider’s employee or administrator who has reasonable cause to suspect that a beneficiary is the victim of sexual abuse, serious physical injury or serious bodily injury, or that a death is suspicious, must immediately contact appropriate law enforcement officials to make an oral report. Within 48 hours of making the oral report, the provider’s employee and administrator must submit a written report to appropriate law enforcement officials. Adult Protective Services Act (Act 10 of 2010, P.L. 484) Chapter 5, “Reporting Suspected Abuse by Employees,” codified at 35 P.S. §§ 10210.101-10210.704 For participating beneficiaries between the ages of 18 and 59, this act mandates that a provider’s employee or administrator who has reasonable cause to suspect that a beneficiary is the victim of sexual abuse, serious injury, or serious bodily injury, or has reasonable cause to suspect that a death is suspicious, must immediately contact the appropriate law enforcement officials to make an oral report. Within 48 hours of making the oral report, the provider’s employee and administrator must submit a joint written report to appropriate law enforcement officials. 22 The version of the consolidated waiver effective through July 22, 2015, states that the State agency, on an ongoing basis, identifies, addresses, and seeks to prevent the occurrence of abuse, neglect, and exploitation. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 25 ACT 28/26 (Pennsylvania Statutes, Title 18, section 2713) This statute requires the State agency to report abuse or neglect of a care-dependent person to the Office of the Attorney General or to local law enforcement. PENNSYLVANIA REQUIREMENTS REGARDING REPORTABLE INCIDENTS 55 Pa. Code § 6000.921, Categories of incidents This section of the Pennsylvania Code states that there are different categories of incidents that must be reported in the incident reporting system. There are categories of incidents that must be reported within 24 hours and other categories of incidents that must be reported within 72 hours. For the incidents that require reporting within 24 hours, the first section of the incident report must be completed in the incident reporting system within 24 hours of the incident’s occurrence. This first section includes individual and provider demographics, incident categorization, actions taken to protect the health and safety of the beneficiary, and a description of the incident. The final section of the incident report includes additional information about the incident, any required investigation, and any corrective actions taken. The final section must be completed within 30 days of recognition or discovery of the incident. This section also states that providers, support coordination entities, counties, and ODP must be vigilant in reporting to law enforcement any incident in which there is a suspected crime. 55 Pa. Code § 6000.922, Incidents to be reported within 24 hours, and § 6000.931, Multiple categories and sequences These sections list the categories of incidents to be reported within 24 hours, define each category, and provide a suggested sequence for reporting incidents that can be classified as belonging in multiple categories. Section 6000.931 also states that if a death, hospitalization, psychiatric hospitalization, emergency room visit, or injury requiring treatment beyond first aid is the result of a medication error or the use of a restraint, a report is to be initiated within 24 hours using the corresponding primary category. 55 Pa. Code § 6000.925, Categories of incidents to be investigated This section identifies reportable incidents to be investigated by the provider, the county, and ODP. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 26 APPENDIX D: UNREPORTED EMERGENCY ROOM VISIT DIAGNOSIS CODES Category Accidents/Safety Diagnosis Code 9331 9661 9691 9712 9752 9778 9779 9941 E9108 T184XXA T192XXA T5692XA V714 Description Foreign body in larynx Poisoning by hydantoin derivatives Poisoning by phenothiazine tranquilizers Poisoning by sympathomimetics Poisoning by skeletal muscle relaxants Poisoning by drugs or medicinal substance Poisoning by other unspecified drug or medicinal substance Drowning and nonfatal submersion Other accidental drowning or submersion Foreign body in colon, initial encounter Foreign body vulva or vagina, initial encounter Toxic effect of unspecified metal, intentional self-harm, initial encounter Observation following other accident (car) Bodily Injury 9592 9597 70722 70723 70724 80701 81000 81342 81500 81601 82525 92320 92401 92411 92420 95919 L89153 L89323 Injury to shoulder and upper arm Injury to knee, leg, ankle, foot Pressure ulcer stage II Pressure ulcer stage III Pressure ulcer stage IV Closed fracture to hip Closed fracture to unspecified part of clavicle Closed fracture radius distal end Closed fracture to hand Closed fracture to fingers Fractured toes Contusion of hand Contusion to hip Contusion of knee Contusion of foot Injury to the trunk Pressure ulcer of sacral region, stage 3 Pressure ulcer of left buttock, stage 3 Domestic Violence 99581 99583 Adult physical abuse Adult sexual abuse Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 27 Category Diagnosis Code E9682 E9688 E9804 E9889 T7411XA T7611XA T7621XA Description Assault by striking by blunt or thrown object Assault by other specified means Poisoning by other specified drugs and medicinal substances, undetermined whether accidentally or purposely inflicted Injury by unspecified means, undetermined whether accidentally or purposely inflicted Adult physical abuse, confirmed, initial encounter Adult physical abuse, suspected, initial encounter Adult sexual abuse, suspected, initial encounter Head Injury 920 8730 9100 87342 87343 87344 87349 95901 95909 Contusion to face, scalp or neck Open wound to scalp Abrasion/friction burn to head Open wound to forehead Open wound to lip Open wound to jaw Open wound to face and other sites Head injury, unspecified Injury of face or neck 5070 79902 Pneumonitis due to inhalation of food or vomitus Hypoxemia—lack of oxygen Other Medical Conditions Suicide E9503 E9588 T1491 X781XXA Suicide and self-inflicted poisoning by tranquilizers and other psychotropic agents Suicide and self-inflicted injury by other specified means Suicide attempt Intentional self-harm by knife, initial encounter Assault E9600 Y00XXXA Y040XXA Y041XXA Y042XXA Y048XXA Unarmed fight or brawl Assault by blunt object initial encounter Assault by unarmed brawl or fight, initial encounter Assault by human bite, initial encounter Accidental striking against or bumped into by another person, initial encounter Assault by other bodily force, initial encounter Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 28 APPENDIX E: UNREPORTED ACUTE-CARE HOSPITAL STAY DIAGNOSIS CODES Category Diagnosis Code Accidents/Safety 9331 9351 9941 99584 E9108 T184XXA Diagnosis Description T56892A Y0703 Foreign body in larynx Foreign body in esophagus Drowning and nonfatal submersion Adult neglect (nutritional) Other accidental drowning or submersion Foreign body in colon, initial encounter Poisoning by iminostilbenes, intentional self-harm, initial encounter Poisoning by other antiepileptic and sedative-hypnotic drugs, intentional self-harm, subsequent encounter Poisoning by selective serotonin reuptake inhibitors, intentional self-harm, initial encounter Poisoning by other antipsychotics and neuroleptics, intentional self-harm, initial encounter Toxic effect of other metals, intentional self-harm, initial encounter Male partner, perpetrator of maltreatment and neglect 9597 70722 70723 70724 80701 81000 82525 L89153 L89323 S61451A Injury to knee, leg, ankle, foot Pressure ulcer stage II Pressure ulcer stage III pressure ulcer stage IV Closed fracture to hip Closed fracture to unspecified part of clavicle Fractured toes Pressure ulcer of sacral region, stage 3 Pressure ulcer of left buttock, stage 3 Open bite of right hand, initial encounter T421X2A T426X2D T43222A T43592A Bodily Injury Head Injury 920 9100 95901 Contusion to face, scalp or neck Abrasion/friction burn to head Head injury, unspecified 5070 79902 Pneumonitis due to inhalation of food or vomitus Hypoxemia—lack of oxygen Other Medical Condition Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 29 Category Suicide Diagnosis Code E9504 E9588 X76XXXS Diagnosis Description Suicide and self-inflicted poisoning by other specified drugs and medicinal substances Suicide and self-inflicted injury by other specified means Intentional self-harm by smoke, fire and flames, subsequent encounter Assault E9684 T7601XA Assault by criminal neglect Adult neglect or abandonment, suspected, initial encounter Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 30 APPENDIX F: STATE AGENCY COMMENTS TH OF PENNSYLVANIA DEPARTMENT OF HUMAN SERVICES OCT 18 2019 Ms. Nicole Freda Reg ional Inspector General for Audit Services Department of Health and Human Services Office of Inspector General Office of Aud it Services, Region Ill 801 Market Street, Suite 8500 Philadelphia, Pennsylvania 19107 Dear Ms. Freda: The Department of Human Services (OHS) has received the draft report number A-03-17-00202 titled "Pennsylvan ia Did Not Fully Comply With Federal and State Requirements for Critical Incidents Involving Med icaid Beneficiaries With Developmental Disab ilities". The objective of this audit was to determ ine whether the Pennsylvan ia Department of Human Services (State agency) complied w ith Federal Medicaid waiver and State requ irements for reporting and monitoring 24-hour reportable incidents that involve Medicaid beneficiaries w ith developmental disab ilities residing in communit y-based settings. We first want to comment on a couple of items in the report before respond ing to the individual recommendations. W e noted one statement in the draft report that isn't completely accurate, and we wanted to bring this to your attention: The last full paragraph on page 15 of the draft report states: "The State agency's only control for detecting unreported 24-hour reportable incidents consisted of 3 State agency v isits each quarter or 12 visits each year for each beneficiary covered b y the consol idated waiver. During these v isits, State agency officials review event logs to determine if all 24-hour reportable incidents have been reported." Supports Coordination Organizations are the entit ies that conduct the quarterly visits and review event logs to determ ine if all 24-hour reportable incidents have been reported. The State agency conducts annual licensing inspections where event logs and other on-site documentation (e.g. med ical records, medical v isit or d ischarge summaries, daily progress notes, event logs, etc.) are reviewed to detect unreported critical incidents. P.O. Box 2675 I Deputy Secretary for Administration Harrisburg , PA 17 105 I 717.787.34 22 I Fax 717.772. 2490 I www.dhs.pa.gov Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 31 Nicole Freda 2 Find ing one, Commun ity-Based Providers Did Not Report Thousands of 24-H our Reportable Incidents to the State Agency, on pages 7 through 11 of the draft report includes statements that the auditors determined that 18,880 emergency room visits and 2,078 acute-care hosp ital stays had not been reported. We understand that incidents were discovered as not reported; however, following our analysis of the high-risk incidents that were identified as unreported in the draft report, we found that a majority of these incidents were in fact reported but the date of the incident report and the date of the claim were not an exact match. For example, the incident report was dated as July 1, 2015 at 10:00 PM , but the em erg ency room visit, or hospital stay claim was dated July 2, 2015, because that is when adm ission or treatment occurred. There were also claims for emergency room visits that did not meet the criteria to requ ire reporting by a provider because the incidents did not occur during the provision of a provider delivered service in accordance with 55 Pa. Code§ 6000.911 (b), which states: "the provider is to report all categories of incidents and complete an investigation as necessary whenever services or supports are: (1) Rendered at the provider's site, (2) Provided in a commun ity environment, other than an individual's home, wh ile the individual is the responsibility of an employee, contracted agent or volunteer, or (3) Provided in an individual's own home or the home of his fam ily, while an employee, contracted agent or volunteer is providing services in the home." In add ition , we found that many claims identified as unreported emergency room visits occurred at treatment facilities at the same service location as an emergency room. Such visits were likely scheduled follow-up treatment or assessments resulting from a prior reported incident or a primary care physician visit. For example, a physician may recommend a swallowing study, which is then performed at a service location collocated with an em erg ency room. Scheduled follow-up treatment and assessments are not considered "emergencies" and not requ ired to be reported in accordance with 55 Pa. Code§ 6000.922 (a) (5), which states "Emergency room visit. The use of a hospital emergency room. Th is includes situations that are clearly "emergencies" as well as those when an individual is directed to an emergency room in lieu of a visit to the Primary Care Physician (PCP) or as the result of a visit to the PCP. The use of an emergency room by an ind ividual's PCP, in place of the physician's office, is not reportable." We respectfully request that you reconsider the characterization of th is finding given the number of incidents that were not requ ired to be reported and the number of incidents that were reported within the requ ired 24-hour timeframe, but where the 24hour period spanned two calendar days as described above. Our responses to the specific recommendations are below: Office of Inspector General (OIG) Recommendation 1: We recommend that the Pennsylvan ia Department of Human Services record the unreported 24-hour reportable incidents noted in this report. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 32 Nicole Freda 3 Department of Human Services (DHS) Response: OHS does not concur with this recommendation. While we understand the basis for the recommendation, adopting it would requ ire a significant level of effort and resource investment that will have m inim al impact on improving health and safety outcomes for current waiver participants. Given the amount of time since the incidents occurred, it is unlikely that we would be able to perform critical investigative activit ies such as locating witnesses and gathering documentary evidence necessary to make a conclusive determination about whether abuse or neglect occurred and by extension what, if any, corrective actions are necessary. Instead, we intend to focus our efforts on recording all unreported incidents of emergency room visits and hospital stays that contain diagnoses indicative of high­ risk for suspected abuse or neglect and take remedial action as appropriate. Please note that we initiated th is process as soon as it was brought to our attention by the auditors. As noted above, many of these incidents were in fact reported or did not meet criteria for reporting. OIG Recommendation 2: We recommend that the Pennsylvania Department of Hum an Services work with commun ity-based providers on how to identify and report all 24-hour reportable incidents. DHS Response: OHS concurs w ith this recommendation. We are revising our incident management policy to align with the recommendations outlined in the OIG, Admin istration for Comm unity Living, and Office of Civil Rights January 2018 joint report titled "Ensuring Beneficiary Health and Safety in Group Homes Through State Implementation of Comprehensive Compliance Oversight" (Joint Report) and other recogniz ed national best practices. The revised policy emphasiz es the need for stronger recogn ition of reportable incidents by front-line staff and provides detailed definitions of each incident type to minim ize confusion about what constitutes a reportable incident. In addition, training to raise awareness of the need to rule out abuse and neglect and ensure reporting to law enforcement, protective service entities, and other oversight entities is under development. OIG Recommendation 3: We recommend that the Pennsylvan ia Department of Human Services work w ith community-based providers to ensure that all community-based providers' staff understand the requirements for reporting 24-hour reportable incidents w ithin required timeframes. DHS Response: OHS concurs with th is recommendation. We are in the process of promulgating regulations that require commun ity- based p rovider staff to complete annual competency-based training specific to incident recognition, timely reporting of incidents, state protective service laws, and mandatory reporting requ irements. We are also working on the development of statewide training in these areas to ensure compliance with the regulations. In addition, community-based providers are required to trend and analyz e data related to t imel iness and identify improvement strategies to ensure incidents are reported within requ ired timeframes. Incident reporting system ­ generated reports are available to accompl ish these requirements. Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 33 Nicole Freda 4 OIG Recommendation 4: We recommend that the Pennsylvan ia Department of Human Services develop a policy to periodically match Med icaid emergency room visit and acute-care hosp ital stay claims to 24-hour reportable incidents recorded in the incident reporting system. DHS Response: OHS concurs w ith this recommendation. We have begun reviewing Medicaid emergency room visit and acute-care hospital stay claims to identify ind ividuals w ith certain high-risk diagnosis codes such as those associated w ith pressure ulcers and chok ing incidents. In add ition, we are working to obtain and include Medicare claims data in this analysis, given that many individuals with intellectual disabil ities or autism have both Med icare and Medicaid. Once identified, the findings w ill be used for targeted interventions, outreach, and training to provider agencies, individuals, and caregivers. OHS has also begun develop ing protocols and technology enhancements to embed emergency room visit and acute-care hosp ital claim data into oversight and monitoring activities to better identify unreported incidents. OIG Recommendation 5: We recommend that the Pennsylvan ia Department of Human Services work with commun ity-based providers to ensure that adm inistrative reviews and investigations are conducted and reported appropriately and consider all previous 24-hour reportable incidents related to the beneficiary. DHS Response: OHS concurs with this recommendation. We have enhanced the overall adm inistrative review process for provider investigations to provide gu idance and stronger emphasis on the reviewer's obligation to: Rule out abuse and neglect for all incidents reviewed; Ensure appropriate authorities have been notified; and, Develop robust corrective actions that not only prevent a recurrence to the ind ividual beneficiary but prevent recurrence to all individual beneficiaries. In addition, DH S developed an adm inistrative review manual and continues to enhance the investigator's curriculum to align w ith nationally recogn ized best practices and the recommendations outlined in the Joint Report. OIG Recommendation 6: We recommend that the Pennsylvania Department of Human Services ensure community-based providers analyze, investigate, and report to the State all beneficiary deaths. DHS Response: OHS concurs with this recommendation. In May 2017, as a result of reviewing other OIG audit reports, we modified policies and the incident reporting system to requ ire investigations for all Home and Community-Based Waiver Services (HCBS) beneficiary deaths. Prior to th is change, only deaths that occu rred in a provider-operated setting were required to be investigated. In addition, in 2018, OHS enhanced its mortality review process and imbedded th is within the incident reporting system. This enables medical staff to more easily analyze the factors that surround Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 34 Nicole Freda 5 each beneficiary's death, and as appropriate, send a written report to local law enforcement or the Pennsylvania Attorney General's Office when suspicious deaths are discovered, or the death is the result of abuse or neglect. This also enables med ical staff to more easily trend beneficiary deaths to identify patterns and develop preventative measures, targeted train ing, and techn ical assistance initiatives. OIG Recommendation 7: We recommend that the Pennsylvania Department of Human Services send a written report of death to law enforcement or the district attorney's office when a death is determined to be suspicious or when abuse or neglect is suspected. DHS Response: OHS concurs w ith th is recommendation. We recently updated reporting protocols and training to contain a stronger emphasis on notifications to law enforcement when warranted. In addition, in 2018, the incident reporting system was enhanced to include prompts for incident management reviewers to better collect and track follow-up actions planned or being conducted (i.e. notifying law enforcement, licensing entities, the Pennsylvania Department of State, etc.) when abuse or neglect is confirmed or when a death is determ ined to be suspicious. In add ition, protocols were developed to ensure state staff notify the Pennsylvania Attorney General's Office immediately when there is reasonable suspicion of abuse or neglect or when a death is determined to be suspicious. These protocols were developed in conjunction with the Pennsylvan ia Attorney General's Office's Med icaid Fraud Control Un it. Thank you for the opportunity to respond to this draft report. If you have any questions or concerns regarding th is response, please contact Mr. David R. Bryan , Manager, Audit Resolution Section, Bureau of F inancial Operations, at 717-783-7217, or via email at davbryan@pa.gov. Sincerely, Carolyn K. Ellison Deputy Secretary for Administration Shared Services for Health and Human Services c: Mr. Charles Hubbs, Assistant Reg ion al Inspector General Mr. David R. Bryan Pennsylvania Did Not Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-03-17-00202) 35