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Hospital Insurance ForumThe Impact of ACOs on Liability

March 17-20, 2013

Michael R. CallahanKatten Muchin Rosenman LLPChicago, [email protected]

61046583

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The Changing Healthcare Landscape

Consolidation of market• Hospital mergers• Practice acquisitions

Provider margins are under attack• Reductions in Medicare/Medicaid reimbursement • Higher costs• Private payer reductions

New models of provider integration are emerging• Co-management arrangements• Patient centered medical home• ACOs

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The Changing Healthcare Landscape (cont’d)

Shift from “Volume to Value” as a basis of reimbursement

• Pay for performance

• ACO quality metrics

• Value Based Purchasing

• Reduced or denied reimbursement for:

Hospital acquired conditions

Never events – (Billing Medicare for a never event is considered a false claim)

Readmissions within 30 days

Joint Commission/NCQA Accreditation Standards

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Never Events

• Surgery on wrong body part

• Surgery on wrong patient

• Wrong surgery on a patient

• Death/disability associated with use of contaminated drugs

• Patient suicide or attempted suicide resulting in disability

• Death/disability associated with medication error

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Hospital Acquired Conditions

• Foreign object left in patient after surgery

• Death/disability associated with intravascular air embolism

• Death/disability associated with incompatible blood

• Stage 3 or 4 pressure ulcers after admission

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Key Features of an ACO

An organization of healthcare providers that agrees to be accountable for the quality, cost, and overall care of Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to it.

For ACO purposes, “assigned” means those beneficiaries for whom the professionals in the ACO provide the bulk of primary care services.

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Key Features of an ACO (cont’d)

Goal of coordinated care:

• Ensure that patients (especially chronically ill) get the right care at the right time.

• At the same time, avoid duplication of services and prevent medical errors.

When an ACO successfully delivers high-quality care and spends more wisely, it will share in the savings it achieves for the Medicare program.

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Key Features of an ACO (cont’d)

Medicare offers several ACO programs:

• Medicare Shared Savings Program: Provides an option for Medicare providers to become an ACO which bases reimbursement and the possibility of receiving an additional portion of Medicare revenue tied to satisfying required quality outcome measures.

• Advance Payment Program: Supplementary incentive program for selected participants in the Shared Savings Program.

• Pioneer ACO Mode: Designed for early adopters of coordinated care. (No longer accepting applications).

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ACOs Currently Participating in Shared Savings Initiatives As of July 1, there are over 250 Accountable Care Organizations

(ACOs) in 40 States and Washington, D.C.

• This total includes:

− 32 ACOs participating in the testing of the Pioneer ACO Model by the Center for Medicare and Medicaid Innovation (Innovation Center) announced last December, and

− 6 Physician Group Practice Transition Demonstration organizations that started in January 2011.

Providers participating in Medicare shared savings initiatives care for more than 4.4 million beneficiaries.

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ACO Standards and Quality Metrics

Demonstrate it meets patient-centeredness criteria, as determined by the Secretary

Quality assurance program must establish internal performance standards for quality, costs and outcomes improvements and hold ACO providers accountable, including termination

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ACO Standards and Quality Metrics (cont’d)

Consistent with the overall purpose of the Affordable Care Act, the intent of the Shared Savings Program is to achieve high-quality health care for patients in a cost-effective manner. As part of CMS’s goal to provide better care for individuals, defined as “safe, effective, patient-centered, timely, efficient, and equitable,” the regulations propose:

• Measures to assess the quality of care furnished by an ACO;

• Requirements for data submission by ACOs;• Quality performance standards

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• Incorporation of reporting requirements under the Physician Quality Reporting System; and

• Requirements for public reporting by ACOs. ACOs that do not meet quality performance thresholds for all

measures would not be eligible for shared savings, regardless of how much per capita costs were reduced.

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ACO Standards and Quality Metrics ACO Quality measures are in four domains:

• Patient/caregiver experience (7)• Care coordination/patient safety (6)• Preventive health (8) and,• At-risk populations (12): includes 6 measures for diabetes (5

scored as a single composite), 1 for hypertension, 2 for IVD, 1 for heart failure, and 2 for CAD

• EHR adoption by PCPs will be included as a quality measure in the Care Coordination/Patient Safety domain and will be given double weight in scoring

Changes over time:• CMS can specify higher standards and/or new measures to

improve quality of care

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Patient experience survey:

• CMS will pay to administer patient experience surveys (CAHPS) in 2012 and 2013

• Beginning in 2014, ACOs must select an approved survey vendor to administer the survey and report results to CMS

Alignment with PQRS reporting

• Use of GPRO tool to report ACO measures qualifies you for the physician quality reporting bonus payments – good example of alignment and reinforcing incentive for ACO

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Examples of Quality Standards (cont’d)

Value Based Purchasing Program Measures

• Starting in October, 2012, will reward hospitals based on the quality of inpatient acute care services provided and not just on the quality delivered.

• Under the VBP Program, CMS will pay acute care inpatient prospective payment system (IPPS) hospitals value-based incentive payments for meeting minimum performance standards for certain quality measures with respect to a performance period designated for each fiscal year.

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• Clinical Process of Care Measures

− Acute myocardial infarction

Primary PCI received within 90 minutes of hospital arrival

− Heart Failure

Discharge Instructions

− Pneumonia

Blood cultures performed in ED prior to initial antibiotic received in hospital

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• Survey Measures

− Communication with Nurses

− Communication with Doctors

− Responsiveness of Hospital Staff

− Pain Management

− Communication About Medicines

− Cleanliness and Quietness of Hospital Environment

− Discharge Information

− Overall Rating of Hospital

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Delivery of Accountable Care

SpecialtyCare

PrimaryCare Ambulatory

Hospitaland ED

SkilledNursing

NursingHome

HomeHealthPatients

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Summa’s Service Area

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The Integrated Delivery System

Hospitals

Inpatient Facilities• Tertiary/Academic Campus• 4 Community Hospitals• 1 Affiliate Community Hospital• 2 JV Hospitals with Physicians

Outpatient Facilities• Multiple ambulatory sites• Locations in 3 Counties

Service Lines• Cardiac, Oncology, Neurology,

Ortho, Surgery, Behavioral Health, Women’s, Emergency, Seniors

Key Statistics• 2,000+ Licensed Beds• 62,000 IP Admissions• 45,000 Surgeries• 660,000 OP Visits• 229,000 ED Visits• 5,000 Births• Over 220 Residents

MultipleAlignment Options• Employment• Joint Ventures• EMR• Clinical Integration• Health Plan

Summa Physicians, Inc.• 265 Employed Physician

Multi-Specialty Group

Summa Health Network• PHO with over 1,000

physician members• EMR/Clinical Integration

Program

Geographic Reach• 17 Counties for

Commercial• 18 Counties for Medicare• 55-hospital Commercial

provider network • 41-hospital Medicare

provider network• National Accounts in 2

States

155,000Total Members• Commercial Self Insured• Commercial Fully Insured• Group BPO/PSN• Medicare Advantage• Individual PPO

Physicians Health Plan Foundation

System FoundationFocused On:• Development• Education• Research• Innovation• Community Benefit• Diversity• Government Relations• Advocacy

Net Revenues: Over $1.6 BillionTotal Employees: Nearly 11,000

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Impact on Board and Corporate Responsibility Traditional corporate duties

• Duty of care

• Duty of loyalty

Must act in good faith as would an ordinary prudent person and in a manner which they reasonably believe is in the best interests of the corporation

• Business judgment rule

Doctrine of Corporate Negligence

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Impact on Board and Corporate Responsibility (cont’d)

Medicare Conditions of Participation (42 C.F.R. Section 482.12)

The Joint Commission Hospital Accreditation Standards (See LD.01.03.01)

“Resources for Health Care Board of Directors on Corporate Responsibility and Health Care Quality (Joint White Paper of OIG/AHLA (2007))

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Corporate Responsibility in Health Care Quality In 2007 the OIG and AHLA collaborated on a publication titled

“Resource for Health Care Boards of Directors on Corporate Responsibility and Health Care Quality”

Was published “for the specific purpose of identifying the role and responsibility of corporate boards and management with respect to its fiduciary obligations to meet its charitable mission and legal responsibilities to provide health care quality services”

Cites to key questions reflective of standards against which hospital boards will be measured

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Corporate Responsibility in Health Care Quality (cont’d)

What are the goals of the organization’s quality improvement program?

What metrics and benchmarks are used to measure progress towards each of the performance goals? How is each goal specifically linked to management accountability?

How does the organization measure and improve the quality of patient/resident care? Who are the key management and clinical leaders responsible for these quality and safety programs?

How are the organization’s quality assessment and improvement processes integrated into overall corporate policies and operations? Are clinical quality standards supported by operational policies? How does management implement and enforce these policies? What internal controls exist to monitor and report on quality metrics?

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Does the board have a formal orientation and continuing education process that helps members appreciate external quality of patient safety requirements? Does the board include members with expertise in patient safety and quality improvement issues?

What information is essential to the board’s ability to understand and evaluate the organization’s quality assessment and performance improvement programs? Once these performance metrics and benchmarks are established, how frequently does the board receive reports about the quality improvement effort?

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Are human and other resources adequate to support patient safety and clinical quality? How are proposed changes in resource allocation evaluated from the perspective of clinical quality and patient care? Are systems in place to provide adequate resources to account for differences in patient acuity and care needs?

Do to the organization’s competency assessment and training, credentialing and peer review processes adequately recognize the necessary focus on clinical quality and patient safety issues?

How are these “adverse patient events” and other medical errors identified, analyzed, reported and incorporated into the organization’s performance improvement activities? How do management and the board address quality deficiencies without unnecessarily increasing the organization’s liability exposure?

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Quality Enforcement Efforts

False Claims Act• The OIG has identified that its principal enforcement tools include

allegations of violations of the False Claims Act, use of corporate integrity agreements, including the use of external quality of care monitors, as well as civil fines and, in extreme circumstances, exclusion from the Medicare program

• The OIG has made the following statement:

“To hold responsible individuals accountable and to protect additional beneficiaries from harm, the OIG excludes from participation in federal health care programs individuals and entities whose conduct results in poor care. In enforcement actions against corporate entities, . . . OIG places particular emphasis on high level officials, such as owners and chief executive officers. . . .”

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Quality Enforcement Efforts (cont’d)

• Grand Jury indicted a Michigan hospital based on its failure to properly investigate medically unnecessary pain management procedures performed by a physician on the medical staff.

• A California hospital paid $59.5 million to settle a civil False Claims Act allegation that the hospital inadequately performed credentialing and peer review of cardiologists on its staff who perform medically unnecessary invasive cardiac procedures.

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• In a settlement with Tenet Health Care Corporation and pursuant to a Corporate Integrity Agreement, a hospital board was required to:

− Review and oversee the performance of the compliance staff.

− Annually review the effectiveness of the compliance program.

− Engage an independent compliance consultant to assist the board and review an oversight of tenant’s compliance activities.

− Submit a resolution summarizing its compliance efforts with the CIA and federal health care program requirements, particularly those relating to delivery of quality care.

• A Pennsylvania hospital recently entered into a $200,000 civil False Claims Act settlement to resolve substandard care allegations related to the improper use of restraints.

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Rogers v. Azmat (2010)• DOJ interviewed in a False Claims Act lawsuit alleging that Satilla

Regional Medical Center and Dr. Najam Azmat submitted claims for medical substandard and unnecessary services to Medicare and Medicaid . The complaint alleges, among other things, that the defendants submitted claims for medical procedures performed by Dr. Azmat in Satilla’s Heart Center that the physician was neither qualified nr properly credentialed to perform. As a result, at least one patient died and others were seriously injured.

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• The complaint states that Satilla placed Dr. Azmat on staff even after learning that the hospital where he previously worked had restricted his privileges as a result of a high complication rate on his surgical procedures. The complaint also states that after Dr. Azmat joined the Satilla staff, the hospital management allowed him to perform endovascular procedures in the hospital’s Heart Center even though he lacked experience in performing such procedures and did not have privileges to perform them.

• The complaint further states that the nurses in Satilla’s Heart Center recognized that Dr. Azmat was incompetent to perform endovascular procedures and repeatedly raised concerns with hospital management. Despite the nurse’s complaints and Dr. Azmat’s high complication rate, Satilla’s management continued to allow him to perform endovascular procedures and to bill federal health care programs for these services.

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Increased enforcement

• 2012 OIG Work Plan

− Reliability of hospital-reported quality measures data

− Hospital admissions with conditions coded as “present-on-admission” and accuracy of “present on admissions” indicators

− Review of Medicaid payments for HACs and never events

− Acute-care inpatient transfers to inpatient hospice care

− Safety and quality of surgeries and procedures in surgicenters and hospital outpatient departments

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- Quality of care and safety of residents and quality of post-acute care for nursing homes

- Hospital reporting of adverse events

- Hospital same-day readmissions

- Hospitalizations and re-hospitalization of nursing home residents

- Review effectiveness of PSO programs

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• January, 2012 OIG Report: “Hospital Incident Reporting Systems Do Not Capture Most Patient Harm”

- All hospitals have incident reporting systems to capture events and are heavily relied on to identify problems

- These systems provide incomplete information about how events occur

- Of the events experienced by Medicare beneficiaries, hospital incident reporting systems only captured an estimated 14% due to events that staff did not perceive as reportable or were simply not reported

- Accrediting bodies only review incident reports and outcomes but not the methods used to track errors and adverse events

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Enhanced Exposure to Malpractice and Corporate Negligence Liability (cont’d)

Hospital, along with its medical staff, is required to exercise reasonable care to make sure that physicians applying to the medical staff or seeking reappointment are competent and qualified to exercise the requested clinical privileges. If the hospital knew or should have known that a physician is not qualified and the physician injures a patient through an act of negligence, the hospital can be found separately liable for the negligent credentialing of this physician [Doctrine of Corporate Negligence]

Doctrine also applies to managed care organizations such as PHOs and IPAs

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Enhanced Exposure to Malpractice and Corporate Negligence Liability

Emphasis on Pay for Performance (“P4P”) and expected or required quality outcomes as determined by public and private payors

Adverse Events, HACs, ACO metrics, value based purchasing standards can arguably be used as standards of care – all are increasing

Greater transparency to general public via hospital rankings, published costs and outcomes, accreditation status, state profiling of physicians, etc.

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Some questions associated with this duty:

• How are core privileges determined?

• Based on what criteria does hospital grant more specialized privileges?

• Are hospital practices and standards consistent with those of peer hospitals?

• Were any exceptions to criteria made and, if so, on what basis?

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• Has each of your department’s adopted criteria which they are measuring as part of FPPE or OPPE obligations such as length of stay patterns or morbidity and mortality data?

• Has system incorporate VBP, ACO metrics, P4P, and peer metrics into its credentialing/privileging procedure?

• Is system asking for quality score cards generated by other providers?

• Is information being collected, evaluated and reported back to each provider?

• Are meetings set up with providers to review quality score cards and are reasonable remedial measures being taken?

• Are you tracking performance throughout the system?

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Challenges to Decision to Exclude/ Terminate Based on Poor Performance

Because the failure of a provider to meet a quality metrics standard now has a direct adverse impact on a hospital’s or system’s reimbursement, provider’s failure to adjust and improve performance requires imposition of remedial measures which can include termination from managed care plans, participation in one or more delivery sites or from the medical staff

Physician performance and impact on cost containment also must come under closer scrutiny and will result in similar remedial action even if quality is acceptable

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Challenges to Decision to Exclude/ Terminate Based on Poor Performance (cont’d)

The legal challenges to adverse membership decision include:

• Antitrust

− Exclusive contracts for hospital based services – system prevails

− Exclusive contracts for non-hospital based services

− Challenges are not likely to succeed by what impact on current providers?

− Must have strong quality/economic grounds on which to support Board decision

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- Exclusive contract through employment – same as above

- Exclusive contract for ED coverage – coverage is a duty and therefore challenge is not likely to be successful

- Adoption of conflict of interest or similar policy that bars new applicants or terminates existing providers from membership if they have a financial, economic or employment relationship with a competing entity

- Easier to implement, enforce and defend for initial applicants if supported by objective facts

- Application to existing “medical staff” versus “ACO staff” members is much more difficult. At a minimum a hearing needs to be provided (See Murphy vs. Baptist Hospital)

- Challenges to credentialing/privilege decisions

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Recommendation• All exclusive/recruitment/development plans should be Board driven and

Board decision albeit with physician involvement

• Any physician participation should be in the form of a “recommendation” and not a veto or final decision

• Decisions should be based on objective and quantifiable information fully reviewed and vetted

• Decisions and standards should be implemented, where possible, through medical staff bylaws, rules, regs, or policies or board policies

• Any adopted policy must evaluate impact on prospective and current members on medical and allied staffs

• Need to incorporate standards into employment/independent contractor agreements

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Title VII Claims• Title VII makes it “an unlawful employment practice for an

employer . . . To discriminate against any individual with respect to his compensation, terms, conditions, or privileges of employment because of such individual’s race, color, religion, sex or national origin.” (42 U.S.C. § 2000e – 2(a)(1))

• This provision applies to acts of discrimination, such as termination, and acts that create a hostile work environment

• As a general rule, independent members of the medical staff, even practice groups with an exclusive contract with the hospital, are not deemed to be “employees” under Title VII

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• However, in Solomon v. Our Lady of Victory Hospital (Western District, N.Y., No. 1:99-cv-48 (4/3/12) a federal district court, on remand from the Second Circuit, held that although Dr. Solomon was an independent member of the medical staff, the fact that she was subject to a supervision under hospital’s quality assurance program and required to undergo a three month re-education program and mentoring program presented a genuine issue of material fact as to whether she should be treated as an employee under the thirteen factor test enunciated by the U.S. Supreme Court in Community for Creative Non-Violence v. Reid (490 U.S. 730 (1989))

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• Second Circuit had held that while hospital policies that merely reflected professional and governmental standards that when imposed, establish an employer/employee relationship under Title VII, these standards as applied to Dr. Solomon may have been driven by maximizing revenue and/or in retaliation for her complaints of harassment

• Although the hospital argued that its policies and review of plaintiff’s cases were driven, if not required by, state and federal law, because the plaintiff argued that her cases were subjected to greater scrutiny due to her complaints about sexual harassment, there was a genuine issue of material fact as to whether the extent of the hospital’s control of her performance as to allow the Title VII claim to go forward

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Recommendations• Systems need to incorporate quality utilization metrics into bylaws,

rules, regs, policies and contracts and continuously update

• Standards need to be uniformly applied to independents and employees

• Need to address whether termination of employed provider does or does not trigger a hearing under the bylaws

Joint Commission takes the position that termination of the medical staff membership and clinical privileges of an employed physician requires that they be entitled to hearing rights if based on a Data Bank reportable event

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So Now What?

Compliance plans need to be updated or prepared which reflect the provider’s commitment to improving quality as per the areas identified by the OIG

Even if not seeking ACO certification at this time, hospital should review the ACO final rules as a future standard on which private and public reimbursement and standards of care will be based

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So Now What? (cont’d)

A failure to comply with ACO, VBP and other developing standards, including a pattern of HACs and Never Events, may also have a direct or indirect impact on provider responsibilities:

• Accreditation standards

• Doctrine of corporate negligence and related civil liability theories

• DOJ/OIG expectations on board responsibility for delivering quality health care services which could trigger False Claims Act exposure (Azmat case)

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Providers therefore need to incorporate these quality metrics and standards into their policies and procedures

Standards need to be developed that track performance and ensure that they are communicated to providers and then monitored for compliance

Providers need to receive periodic reports regarding their individual and comparative performances

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Remedial action plans need to be developed that are designed to assist providers in meeting standards but can include the ability to suspend or terminate participation

Performance results should be taken into consideration at the time of appointment, reappointment and contract renewal, and some internal administrative process/fair hearing for participants who are excluded should be provided

It is important that provider evaluate its processes and procedures, reports, analyses, etc., so as to maximize available confidentiality and immunity protections under state and federal law (e.g., participation in a Patient Safety Organization under Patient Safety and Quality Improvement Act of 2005).

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1. Is or can an ACO be a health care entity for HCQIA query, reporting and immunity purposes?

2. Under what circumstances can an ACO be considered a “provider” under the Patient Safety Act for purposes of participating in a patient safety organization?

3. Is an ACO eligible for or what criteria must be met in order to qualify for state confidentiality/immunity protections?

4. What risks, if any, are there if different credentialing/privileging/peer review standards are developed for ACOs versus hospitals?

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5. Can an ACO be held liable under negligent credentialing/corporate negligence/apparent agency or related liability principles?

6. How does an ACO best incorporate/implement ACO quality metrics, value based purchasing and similar quality standards as part of its credentialing/privileging/ peer review procedures?

7. Does the sharing of peer review, credentialing or otherwise protected information by and between a hospital/ACO and other providers in the ACO adversely affect confidentiality protections? What are ways to structure information sharing arrangements

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in order to maximize confidentiality protections?

8. How will an ACO balance the requirement to provide quality and utilization data to payers against the need or preference to keep certain information confidential?

9. Should hearing procedures be the same for ACOs and hospitals or should and can they be more streamlined? Can they be modified and still maintain HCQIA and other immunity protections?

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10. Will or should the standards for remedial/corrective action be different, i.e., should overutilization or failure to satisfy quality metric standards, which is turn can reduce shared savings or other forms of reimbursement, serve as a basis for action, including termination?

11. What should be the inter-relationship between ACO and medical staff/AHP membership and ACO membership? Should removal from one result in removal from the other?

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Patient Safety and Quality Improvement Act (PSQIA) Purpose

To encourage the expansion of voluntary, provider-driven initiatives to improve the quality and safety of health care; to promote rapid learning about the underlying causes of risks and harms in the delivery of health care; and to share those findings widely, thus speeding the pace of improvement.

• Strategy to Accomplish its Purpose

− Encourage the development of PSOs

− Establish strong Federal and greater confidentiality and privilege protections

− Facilitate the aggregation of a sufficient number of events in a protected legal environment.

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Long-Term Goals of the PSQIA Encourage the development of PSOs Foster a culture of safety through strong Federal and State

confidentiality and privilege protections Create the Network of Patient Safety Databases (NPSD) to

provide an interactive, evidence-based management resource for providers that will receive, analyze, and report on de-identified and aggregated patient safety event information

Further accelerating the speed with which solutions can be identified for the risks and hazards associated with patient care through the magnifying effect of data aggregation

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Who or What Does the Act Cover?

Provides uniform protections against certain disciplinary actions for all healthcare workers and medical staff members

Protects Patient Safety Work Product (PSWP) submitted by Providers either directly or through their Patient Safety Evaluation System (PSES) to Patient Safety Organizations (PSOs)

Protects PSWP collected on behalf of providers by PSOs, e.g., Root Cause Analysis, Proactive Risk Assessment

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PSO Approach & Expected Results

PSO

Immediate Warning System

Comparative Reports

New Knowledge

EducationalProducts

CollaborativeLearning

Surgicenter

HospitalPharmacy

Hospice

Home Health Care

Durable Medical Equipment

Long-Term Care Facility

Ambulatory Care Clinics

FQHC

Physician Groups

SNF

PSWP

PSWP

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Essential Terms of the Patient Safety Act

Patient Safety Evaluation System (PSES)

Patient Safety Work Product (PSWP)

Patient Safety Organization (PSO)

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Patient Safety Evaluation System(PSES)PSES Definition

Body that manages the collection, management, or analysis of information for reporting to or by a PSO (CFR Part 3.20 (b)(2))

• Determines which data collected for the PSO is actually sent to the PSO and becomes Patient Safety Work Product (PSWP)

• PSES analysis to determine which data is sent to the PSO is protected from discovery as PSWP

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Patient Safety Work Product(PSWP)

PSWP Definition

Any data, reports, records, memoranda, analyses (such as Root Cause Analyses (RCA)), 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 PSO and are reported to a PSO, which includes information that is documented as within a PSES for reporting to a PSO, and such documentation includes the date the information entered the PSES; 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 PSES

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What is NOT PSWP?

Patient's medical record, billing and discharge information, or any other original patient or provider information

Information that is collected, maintained, or developed separately, or exists separately, from a PSES. Such separate information or a copy thereof reported to a PSO shall not by reason of its reporting be considered PSWP

PSWP assembled or developed by a provider for reporting to a PSO but removed from a PSES and no longer considered PSWP if:

• Information has not yet been reported to a PSO; and

• Provider documents the act and date of removal of such information from the PSES

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What is Required?Establish and Implement a Patient Safety Evaluation System (PSES), that:

• Collects data to improve patient safety, healthcare quality and healthcare outcomes

• Reviews data and takes action when needed to mitigate harm or improve care

• Analyzes data and makes recommendations to continuously improve patient safety, healthcare quality and healthcare outcomes

• Conducts RCAs, Proactive Risk Assessments, in-depth reviews, and aggregate RCAs

• Determines which data will/will not be reported to the PSO

• Reports to PSO(s)

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PSO REPORTINGIdentification of

Patient Safety, Risk Managementor Quality event/concern

PSESReceipt and Response to Event/Concern,

Investigation & Data Collection

Needed forother uses?

Are neededreviews

finished?

“Do Not Report”?Is it flagged

“Do Not Report”?

Do not sendto PSO

Wait untilcompleted

Producereport for PSO

Submit to theAlliance PSO

Do not put is PSES(yet) or consider

removing from PSES

Information notprotected as PSWP

even if subsequentlyreported to PSO

NO NO

YES

YES

NO

YES

Justify Adverse Action– Peer Review– Personnel Review

Reporting to State, TJC

Evidence in court case

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Designing Your PSES

Events or Processes to be Reported

• Adverse events, sentinel events, never events, near misses, HAC, unsafe conditions, RCA, etc

Committee Reports/Minutes Regarding Events

• PI/Quality committee, Patient safety committee, Risk Management committee, MEC, BOD

Structures to Support PSES

• PI plan, safety plan, RM plan, event reporting and investigation policies, procedures and practices, grievance policies and procedures

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Event/Incident Reporting Policy Modify existing policies as needed to reflect the purpose of internal

event reporting is to …

• Improve patient safety, healthcare quality and patient outcomes

• Provide learning opportunity through reporting to a PSO

Include a process (through the PSES) for the removal of incidents from PSES or separate system for …

• Disciplinary action

• Just culture

• Mandatory state reporting

• Independent/separate peer review

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Questions To Answer When Developing PSES Policy

Who or What Committee(s)

• Collects data that will be reported to a PSO?

− Single source or multiple sites?

− Single department or organization wide event reporting?

• Analyzes data that will be reported to a PSO?

• Removes data from PSES prior to reporting to a PSO?

• Submits the data from the PSES to the PSO(s)?

− Committee or individual authorized submission?

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Questions To Answer When Developing PSES PolicyWhat data should be …

Collected to report to a PSO?

• Patient safety data, healthcare quality and outcomes data

* Data cannot be used for adverse disciplinary, versus remedial, employment action, mandated state reporting

Removed from PSES prior to reporting to a PSO?

• Criteria based or subjective case-by-case decision making

• Peer review information that could lead to disciplinary action

When is data …

• Reported to PSES?

• Removed from PSES?

• Reported to PSO?

* Each date must be documented

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How Does a Provider Determine Which Data Should Be Reported To A PSO?Criteria-based Prioritization

Suggested criteria

− Promotes culture of safety/improves care

− Impressions/subjective data that is not available in the medical record

− Information that could be damaging during litigation

− Not required to report elsewhere

− Required to report elsewhere, but data for reporting could be obtained from medical record

− Data will not be used to make adverse employment decisions

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Types of Data PSES May Collect and Report To The PSO Medical Error, FMEA or Proactive Risk Assessments, Root Cause

Analysis

Risk Management – incident reports, investigation notes, interview notes, RCA notes, notes rec’d phone calls or hallway conversations, notes from PS rounds

Outcome/Quality—may be practitioner specific, sedation, complications, blood utilization etc.

Peer Review

Committee minutes–Safety, Quality, Quality and Safety Committee of the Board, Medication, Blood, Physician Peer Review

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PA Patient Safety Authority: Reports Identify Trends

• Hidden sources of Latex in Healthcare Products

• Use of X-Rays for Incorrect Needle Counts

• Patient Identification Issues• Falls Associated with Wheelchairs• Electrosurgical Units and the Risk

of Surgical Fires• A Rare but Potentially Fatal

Complication of Colonoscopy• Fetal Lacerations Associated with

Cesarean Section• Medication Errors Linked to Name

Confusion• When Patients Speak-

Collaboration in Patient Safety• Anesthesia Awareness

• Problems Related to Informed Consent

• Dangerous Abbreviations in Surgery

• Focus on High Alert Medications• Bed Exit Alarms to Reduce Falls• Confusion between Insulin and

Tuberculin Syringes (Supplementary)

• The Role of Empowerment in Patient Safety

• Risk of Unnecessary Gallbladder Surgery

• Changing Catheters Over a Wire (Supplementary)

• Abbreviations: A Shortcut to Medication Errors

• Lost Surgical Specimens

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Steps to PSO Reporting Inventory Data Currently Collected

• Patient safety, quality of care, healthcare outcomes

Prioritize Data that will be submitted to a PSO and become PSWP; what data will do the most to support improving the culture of safety

Establish a system for data collection and review

• Standardized data collection will both enhance benchmarking comparisons and ultimately comply with AHRQ’s mandate for PSOs to collect standardized data; AHRQ’s “Common Formats” or another common format

• Agree to the processes that the PSES will follow to determine PSWP

Create appropriate policies: Event Reporting; PSES, PSO Reporting

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PSO Reporting Process

PSO

PSES

Administrative Quality Management

Committee

Medical ExecutiveCommittee

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