Lunchtime Seminar Series Medical Studies Act and Patient

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Lunchtime Seminar Series Medical Studies Act and Patient Safety Act March 27, 2019 Michael

Lunchtime Seminar Series Medical Studies Act and Patient Safety Act March 27, 2019 Michael R. Callahan Katten Muchin Rosenman LLP Chicago +1. 312. 902. 5634 michael. callahan@kattenlaw. com 138291708 v 2 Karen Kies De. Grand Donohue Brown Mathewson & Smyth LLC Chicago +1. 312. 422. 0910 karen. degrand@dbmslaw. com

Factors/Questions to be Assessed in Determining Whether Either Privilege Applies § Does the healthcare

Factors/Questions to be Assessed in Determining Whether Either Privilege Applies § Does the healthcare provider seek state and/or federal privilege protections? § What is the scope of protected activities? -- peer review, quality improvement, incident reports, root cause analysis, adverse events? § What corporate entities, licensed facilities, licensed health care practitioners or others are protected under state/federal laws? § What committees or organizational construct receives the statutory protections? § Is the privilege applicable in light of a facility’s bylaws, rules, regs and/or policies? § Can privileged information be shared across the healthcare system without waiving the privilege? 1

Factors/Questions to be Assessed in Determining Whether Either Privilege Applies (cont'd) § How does

Factors/Questions to be Assessed in Determining Whether Either Privilege Applies (cont'd) § How does applicable case law affect statutory interpretation? § What is the impact, if any, of mandated adverse event reporting obligations? § Do state statutory privileges apply to federal claims filed in federal court, i. e. , antitrust, discrimination? § Can CMS, IDPH and The Joint Commission access the privileged information? 2

Summary of Illinois Medical Studies Act § Medical Studies Act • 735 ILCS 5/8

Summary of Illinois Medical Studies Act § Medical Studies Act • 735 ILCS 5/8 -2101 - All information, interviews, reports, statements, memoranda, recommendations, letters of reference or other third party confidential assessments of a health care practitioner’s professional competence, or other data. - Allied medical societies, health maintenance organizations, medical organizations under contract with health maintenance organizations or with insurance or other health care delivery entities or facilities. - Their agents, committees of ambulatory surgical treatment centers or post-surgical recovery centers or their medical staffs, or committees of licensed or accredited hospitals or their medical staffs. 3

Summary of Illinois Medical Studies Act (cont'd) - Including Patient Care Audit Committees, Medical

Summary of Illinois Medical Studies Act (cont'd) - Including Patient Care Audit Committees, Medical Care Evaluation Committees, Utilization Review committees, Credential Committees and Executive Committees, or their designees (but not the medical records pertaining to the patient), used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donations. - Shall be privileged, strictly confidential and shall be used only for medical research, the evaluation and improvement of quality care, or granting, limiting or revoking staff privileges or agreements for services. - Information can be used in disciplinary hearings and subsequent judicial review. 4

Summary of Illinois Medical Studies Act (cont'd) - Some opinions interpret the privilege broadly,

Summary of Illinois Medical Studies Act (cont'd) - Some opinions interpret the privilege broadly, but information produced for a different purpose, i. e. , risk management, may not be protected even if used by a peer review committee. - Although the Medical Studies Act references “medical organizations” under contract with HMOs or other healthcare delivery entities or facilities, surgicenters and hospitals, the appellate court has not extended protections to nursing homes or pharmacies. - Decisions of the Second District of the Appellate Court have limited the application of the privilege protections to materials and discussions generated after an event or investigation has been initiated by an identified peer review committee and only if used exclusively for peer review/quality activities. 5

Summary of Illinois Medical Studies Act (cont'd) - Protections cannot be waived if used

Summary of Illinois Medical Studies Act (cont'd) - Protections cannot be waived if used for statutory purposes. - Information arguably can be shared throughout the healthcare system among controlled affiliates as well as specific physician information if authorized. - Privilege does not apply to federal claims brought in federal court. 6

Complete view of an operational Health Care System ACO/CIN COO CFO re rm ce

Complete view of an operational Health Care System ACO/CIN COO CFO re rm ce i sp Ho ng Lo Te Ca e ar CMO re e C t Ac m s Ho Po ut a e. C ) l(s ita sp Ho CNO cie en e s ar er d C i Ag v y ns r h o a s alt Pr t im icia e s y r i H r P ys ial ic lla h l i c c b P e HO n u p P P A S Payer Partners 7 COO s

Genesis of Patient Safety and Quality Improvement Act of 2005 § Purpose: To create

Genesis of Patient Safety and Quality Improvement Act of 2005 § Purpose: To create a new, national healthcare paradigm focusing on information sharing to improve patient safety and elevate the quality of medical care. § Core principle: Voluntary reporting and analysis of patient events. § Provider participation is critical to supply data for identifying national trends and patient safety events so that remedial action may be recommended, and best practice information may be shared. Participating providers feed data that is essential to broad system analysis. § The information gathering occurs on a nationwide scale, dwarfing internal quality review at a single institution. § The goal of the privilege is to promote self reporting and analysis without exposing providers to the risk of liability inherent in reporting. § To balance competing interests, only specific information is privileged. 8

Summary of Patient Safety and Quality Improvement Act of 2005 § Privileged Patient Safety

Summary of Patient Safety and Quality Improvement Act of 2005 § Privileged Patient Safety Work Product • Any data, reports, records, memoranda, analyses (such as Root Cause Analyses), or written or oral statements (or copies of any of this material) which could improve patient safety, health care quality, or health care outcomes; and that: • Are assembled or developed by a provider for reporting to a patient safety organization (“PSO”) and are reported to a PSO, which includes information that is documented as within a patient safety evaluation system for reporting to a PSO, and such documentation includes the date the information entered the patient safety evaluation system; or • Are developed by a PSO for the conduct of patient safety activities; or • Which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system. 9

Summary of Patient Safety and Quality Improvement Act of 2005 (cont’d) § What types

Summary of Patient Safety and Quality Improvement Act of 2005 (cont’d) § What types of information can be considered for inclusion in the patient safety evaluation system for collection and reporting to the PSO, or treated as deliberations or analysis, if used to promote patient safety and quality? • Medical error or proactive risk assessments, root cause analysis • Risk Management – Not all activities will qualify such as claims management, but incident reports, investigation notes, interview notes, RCA notes, etc. , tied to activities within the patient safety evaluation system can be protected • Outcome/Quality—may be practitioner specific • Peer review • Relevant portions of Committee minutes for activities included in the patient safety evaluation system relating to improving patient quality and reducing risks • Deliberations or analysis • Unlike the MSA, privileged materials and information are not limited to committee work product unlike the MSA 10

Summary of Patient Safety and Quality Improvement Act of 2005 (cont’d) § What is

Summary of Patient Safety and Quality Improvement Act of 2005 (cont’d) § What is not patient safety work product? • Patient's medical record, billing and discharge information, or any other original patient or provider record • Information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system. Such separate information or a copy thereof reported to a PSO shall not by reason of its reporting be considered patient safety work product but the copy can be considered patient safety work product • Patient safety work product assembled or developed by a provider for reporting to a PSO but removed from a patient safety evaluation system is no longer considered patient safety work product if: - Information has not yet been reported to a PSO; and - Provider documents the act and date of removal of such information from the patient safety evaluation system 11

Summary of Patient Safety and Quality Improvement Act of 2005 (cont’d) • Reports that

Summary of Patient Safety and Quality Improvement Act of 2005 (cont’d) • Reports that are the subject of mandatory state or federal reporting or which are collected and maintained pursuant to state or federal laws may not be treated as patient safety work product - Illinois Adverse Health Care Reporting Law of 2005 – not yet implemented - “Never” events, e. g. , hospital acquired infections § What entities are covered under the Act? • All entities or individuals licensed under state law to provide health care services or which the state otherwise permits to provide such services, i. e. , hospitals, SNFs, physician groups, labs, pharmacies, home health agencies, etc. • A non-licensed corporate entity that owns, controls, manages or has veto authority over a licensed provider is considered a provider. 12

Complete view of an operational Health Care System ACO/CIN COO CFO re rm ce

Complete view of an operational Health Care System ACO/CIN COO CFO re rm ce i sp Ho ng Lo Te Ca e ar CMO re e C t Ac m s Ho Po ut a e. C ) l(s ita sp Ho CNO cie en e s ar er d C i Ag v y ns r h o a s alt Pr t im icia e s y r i H r P ys ial ic lla h l i c c b P e HO n u p P P A S Payer Partners 13 COO s

Illinois Appellate Opinion in Daley v. Ingalls Memorial Hospital, 2018 IL App (1 st)

Illinois Appellate Opinion in Daley v. Ingalls Memorial Hospital, 2018 IL App (1 st) 170891 § Application of Patient Safety Act in medical malpractice lawsuit – as a matter of first impression. § Factual background: The estate of a patient alleged that Ingalls Hospital and employees failed to adequately monitor the patient’s blood glucose levels. § Trial court overruled Ingalls’ objection to written discovery in which plaintiff sought documents it considered privileged under the Act, as established by affidavits of the hospital’s associate general counsel. § The appellate court reversed the trial court’s order requiring production of the documents which seemed to rely on a Medical Studies Act analysis to an assertion of privilege under the Patient Safety Act. 14

Illinois Appellate Opinion in Daley v. Ingalls Memorial Hospital, 2018 IL App (1 st)

Illinois Appellate Opinion in Daley v. Ingalls Memorial Hospital, 2018 IL App (1 st) 170891 (cont'd) § Noting that the Act provides three ways for information to become patient safety work product, the court analyzed the hospital’s assertion that its documents were privileged under the “reporting pathway. ” Information may be considered patient safety work product under the reporting pathway if: • The information is developed by provider for the purpose of reporting to a PSO; • The information has the ability to improve patient safety and health care quality; • The information must be reported to a patient safety information (noting some leeway for “functional reporting”); and • The information contains the date of entry into the patient safety evaluation system. 15

Illinois Appellate Opinion in Daley v. Ingalls Memorial Hospital, 2018 IL App (1 st)

Illinois Appellate Opinion in Daley v. Ingalls Memorial Hospital, 2018 IL App (1 st) 170891 (cont'd) § Plaintiff opposed the classification of the documents as patient safety work product based on three arguments: • Plaintiff argued the information in the hospital’s reports should have been in the patient’s medical records and that the hospital was hiding important information to which the plaintiff was entitled. • Plaintiff challenged whether the documents contained information collected solely for the purposes of reporting to a patient safety organization. • Plaintiff argued that the information collected to satisfy a reporting requirement is not patient safety work product. 16

Illinois Appellate Opinion in Daley v. Ingalls Memorial Hospital, 2018 IL App (1 st)

Illinois Appellate Opinion in Daley v. Ingalls Memorial Hospital, 2018 IL App (1 st) 170891 (cont'd) § The appellate court disagreed with plaintiff’s arguments and noted that plaintiff had access the medical records to pursue their medical negligence claim, as was noted in Jenkins v. Wu, 102 Ill. 2 d 468, 479 (1984) in considering the Medical Studies Act. § The appellate court held that the Act preempted the circuit court’s production order. 17

Department of Financial & Professional Regulation v. Walgreen Co. , 2012 IL App (2

Department of Financial & Professional Regulation v. Walgreen Co. , 2012 IL App (2 d) 110452 § One other Illinois decision addresses the Patient Safety Act – Walgreens § In the context of the Department of Financial and Professional Regulation seeking to enforce administrative subpoenas regarding alleged medical errors involving pharmacists employed by Walgreens, the trial court held that the reports qualified as patient safety work product and dismissed the petition. § The Second District affirmed based on the findings that Walgreens maintained the reports in its patient safety evaluation system and transmitted them to a PSO. 18

Decisions of Other Jurisdictions § Kentucky v. Bunnell, 532 S. W. 3 d 658

Decisions of Other Jurisdictions § Kentucky v. Bunnell, 532 S. W. 3 d 658 (Ky. App. 2017). • Nothing in the Act or its implementing rules prohibits a hospital from incorporating data from an original medical record into its patient safety work product for purposes of analyzing a patient safety event as long as the hospital maintains the original record from which it derived the information. § Charles v. Southern Baptist Hospital of Florida, Inc. , 209 S. 3 d 1119 (Fla. 2017). • Reversing the appellate court’s holding that the Patient Safety Act preempted Amendment VII of the Florida Constitution. The court held that the Act did not preempt a Florida constitutional provision requiring the production of “adverse medical incident” reports and “original records” to patients. 19

Comparison of Medical Studies Act to the Patient Safety Act § Patient Safety Act

Comparison of Medical Studies Act to the Patient Safety Act § Patient Safety Act • The confidentiality and privilege protections afforded under the Act generally apply to reports, minutes, analyses, data, discussions, recommendations, etc. , that relate to patient safety and quality if generated or managed, or analyzed within the patient safety evaluation system, collected for reporting to a PSO, and reported to a PSO. • The scope of what patient safety activities can be protected, generally speaking, is broader than the activities and documents privileged under the MSA – not limited to committees. • The scope of which entities can seek protection is much broader – all licensed health care providers. 20

Comparison of Medical Studies Act to the Patient Safety Act (cont'd) • The privilege

Comparison of Medical Studies Act to the Patient Safety Act (cont'd) • The privilege applies in both state and, for the first time, federal proceedings. • The protections are not waived under any circumstances. • PSA pre-empts state law – Daley v. Ingalls Memorial Hospital. • Non-provider corporate parent organization involved in patient safety activities as well as owned, controlled or managed provider affiliates can be included in a system-wide patient safety evaluation system and assert the privilege. • Patient safety work product can be shared among affiliated providers. • Patient safety work product is not admissible into evidence nor is it subject to discovery. • The provider’s and PSO’s patient safety evaluation system must be designed in accordance with the PSA. • The MSA and PSA are not mutually exclusive. A provider can assert both, depending on the documents claimed to be privileged. 21

Health Care Providers/Systems Participating in a PSO Ascension OSF HCA Lurie Children’s Universal Health

Health Care Providers/Systems Participating in a PSO Ascension OSF HCA Lurie Children’s Universal Health Services MAPS contracts with 81 hospitals/health systems AMITA Walgreens Advocate Aurora CVS Advent. Health Walmart Trinity Health Du. Page Medical Group Northwestern Medicine 22

Speaker Bio Michael R. Callahan, Partner- michael. callahan@kattenlaw. com Michael R. Callahan assists hospital,

Speaker Bio Michael R. Callahan, Partner- michael. callahan@kattenlaw. com Michael R. Callahan assists hospital, health system and medical staff clients on a variety of health care legal issues related to accountable care organizations (ACOs), patient safety organizations (PSOs), health care antitrust issues, Health Insurance Portability and Accountability Act (HIPAA) and regulatory compliance, accreditation matters, general corporate transactions, medical staff credentialing and hospital/medical staff relations. Michael's peers regard him as "one of the top guys […] for credentialing—he's got a wealth of experience" (Chambers USA). Additionally, his clients describe him as "always responsive and timely with assistance, " and say he is "informed, professional and extremely helpful" and "would recommend him without reservation" (Chambers USA). Michael's clients also commend his versatility, and say "He is willing to put on the hat of an executive or entrepreneur while still giving legal advice, " according to Chambers USA. He is a frequent speaker on topics including ACOs, health care reform, PSOs, health care liability and peer review matters. He has presented around the country before organizations such as the American Health Lawyers Association, the American Medical Association, the American Hospital Association, the American Bar Association, the American College of Healthcare Executives, the National Association Medical Staff Services, the National Association for Healthcare Quality and the American Society for Healthcare Risk Management. Michael was recently appointed as chair of the Medical Staff Credentialing and Peer Review Practice Group of the American Health Lawyers Association. He also was appointed as the public member representative on the board of directors of the National Association Medical Staff Services. He was an adjunct professor in De. Paul University's Master of Laws in Health Law Program, where he taught a course on managed care. After law school, he served as a law clerk to Justice Daniel P. Ward of the Illinois Supreme Court. 23

Speaker Bio Karen Kies De. Grand, Partner DONOHUE BROWN MATHEWSON &SMYTH LLC KAREN KIES

Speaker Bio Karen Kies De. Grand, Partner DONOHUE BROWN MATHEWSON &SMYTH LLC KAREN KIES DEGRAND leads the appellate practice of Donohue Brown Mathewson & Smyth LLC in Chicago. She has extensive experience representing clients before the appellate and supreme courts of Illinois, the Seventh Circuit Court of Appeals, and the appellate and supreme courts of Wisconsin and Indiana. In addition, she advises trial counsel regarding preservation of issues for appeal and handles post-trial proceedings. An experienced trial lawyer, Ms. De. Grand defends attorneys and physicians in a wide range of professional liability matters. She has defended attorneys in a variety of practice areas including criminal defense, domestic relations, transactional work, estate planning and tort litigation. Ms. De. Grand also has successfully defended product liability and employment actions and litigated business and insurance coverage disputes. She has guided her clients through insurance disputes involving contested interpretations of professional liability and commercial general liability policies. Ms. De. Grand, the firm’s managing partner, is a former President of the Appellate Lawyers Association and is included in the annual listing of “Super Lawyers” and “Leading Lawyers” in the area of appellate practice. In 2015 she was named to Leading Lawyers’ list of Top 10 Women in Civil Appellate, and in 2016 she was inducted into the American Academy of Appellate Lawyers, an organization with its membership limited to appellate lawyers with a minimum of 15 years of practice focusing substantially on appeals and possessing a reputation of recognized distinction as an appellate lawyer. Ms. De. Grand currently serves as a member of the Illinois Supreme Court’s Committee on Professional Responsibility. Ms. De. Grand received her law degree from the University of Illinois College of Law, where she served as an associate editor of the University of Illinois Law Review. She received her undergraduate degree in journalism from the University of Illinois, where she was awarded Bronze Tablet, the University’s highest recognition for academic excellence. 24