The High Cost of Low Quality
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1 The High Cost of Low Quality Measuring the Economic Impact of Inadequate Quality of Care Goals of the Presentation Pose the Question: Is Quality of Care a concern for Compliance Officers? Attempt to Identify the Quality + Compliance + Risk Management Connection Discuss measurements of inadequate Quality of Care Provide information that may influence: Administration / Board recognition of inadequate quality Physician / staff recognition of quality concerns Organizational movement toward a culture of improved quality, improved patient safety, and improved compliance
2 Can Quality be Federally Mandated? Medicare Conditions of Participation (CoP): Patient Rights 64 FR 36069, 1999 Quality Assessment, Performance Improvement 48 FR 3435, 2003 Authentication of Verbal Orders 42 CFR (c)(1) False Statements Concerning Health Care (18 USC 1035) Schemes to defraud health care programs (18 USC 1347) Patient Safety and Quality Improvement Act, 2005 (42 U.S.C. 299c-21) Can Quality Be State Regulated? Medicaid Compliance Program Budget Reconciliation Act of 2005 (effective 1/1/2007) mandates States set up Medicaid Compliance Programs Mirror of Federal Medicare Compliance Program managed by HHS OIG since HIPAA 1996 State False Claims Act mirrors Federal False Claims Act (fines of $5,500 - $11,000 plus double and treble penalties per false claim filed) State gets to keep 10% of all recoveries Mandated training, education from payees receiving $5M per year in Medicaid funds
3 Can the OIG Require Quality? Tenet Healthcare and Physicians CIA 9/27/2006 First CIA to directly link quality performance to deferred FCA prosecution 23 of 66 pages include discussion of quality measures to some degree Fraud Prevention and Detection page Quality functions must demonstrate effectiveness, not just existence Tenet CIA Quality Requirements Chief Medical Officer, Clinical Quality Department, clinical quality staff and officers Clinical Audits of Physicians, medical care Improved Physician Credentialing Improved Physician Privileging Improved Physician Peer Review Evidence Based Medicine Programs Standards of Clinical Excellence Utilization Management and review Quality Metrics
4 Can the OIG Prosecute Quality? Redding Hospital and Physicians, 2005 Lack of medical necessity for cardiac procedures, Qui Tam case Prosecutors noted 13 medical malpractice lawsuits against involved Physicians noted between 1988 and 2002 Fines, penalties, and incarceration Can the OIG Prosecute Quality? United Memorial Hospital and Physicians, 2003 Inadequate quality of care related to pain management and anesthesia services Improper sterile technique; failure of patients to improve; high volume of procedures; patient complaints Deferred Prosecution Agreement
5 Public Perception: Quality Red Flags JAMA 2005:...patient safety system progress is slow...and is cause for great concern. NIH Public Education Campaign 2007: 120 patient deaths per day due to medical errors more than are due to MVA s, breast cancer, or AIDS State Regulation: Mandatory serious event reporting in 24 of 50 States USA TODAY Cover Story: Physician Shortage 2/26/
6 More Quality Concerns AMA, 2005: Physician shortfalls nationwide by , ,000 fewer Physicians than needed by an aging population USA Today front page feature 2/26/2008 Boomer Boom: Beginning 1/1/2007, one Baby Boomer turns 65 every 7 seconds National Nursing Staff Shortage Expanding Role of Mid-Level Providers USA TODAY: Changing Face of Healthcare 2/26/08 54% Drop in number of General Practice Physicians,
7 What is Quality Federal perception Quality of care needs attention Some Quality issues = negligence and fraud Federal and State regulation moving toward mandated quality Public perception Quality of care is poor Wait time is intolerable Facilities are crowded Most patients willing to bring suit if injury + communications failure occurs Healthcare Organization perception Quality is good Errors occur The Economic Impact of Poor Compliance Easy to Measure Office of Inspector General (OIG) Semiannual Report to Congress, 2007 $43 Billion total savings and recoveries this period $39 Billion Implemented Actions $1.9 Billion Audit Receivables $2.18 Billion Investigative Receivables 3308 Individuals / Entities Excluded from Participation 447 Criminal Actions 262 Civil Actions
8 The Economic Impact of Poor Quality Difficult to Measure Juran Institute Study - Outmoded and Ineffective Procedures, 2002 (Two year study, 88 pages) 1 $390 Billion spent for poor quality care in the U.S. Overuse, Misuse, Waste = 30% of all Healthcare Spending, all payer sources CMS Study: US Government Medicare / Medicaid spending on Healthcare to = $4.1 Trillion by Juran Math: $1.23 Billion / year of Medicare / Medicaid spending wasted due to poor quality 1. CHARATAN, F., US REPORT BLAMES POOR QUALITY CONTROL FOR SOARING HEALTHCARE COSTS, BRITISH MEDICAL JOURNAL, VOLUME 324((7352); 1748, JUNE 22, HOFFMAN, E., KLEES, B., CURTIS, C., BRIEF SUMMARIES OF MEDICARE AND MEDICAID, NOVEMBER 1, 2007, PROJECTED EXPENDITURES, P.4; THE CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS), OFFICE OF THE ACTUARY; Medical Malpractice Claims as a measure of quality Ongoing PIAA Claims and Risk Study Physician-owned professional liability Insurers from across the United States Insure 60% of private practice Physicians, plus dentists, hospitals, and other practitioners 400,000 insured members The leading national database of reported malpractice claims, risk and exposure data 350,000 closed malpractice claims Data from present
9 PIAA Quality Data, ,877 Medical Malpractice Cases $3.4 Billion in indemnity payments Leading Allegations: Failure to supervise medical cases Medication Errors Unnecessary Procedures Failure to communicate with / instruct patients Medical Records documentation Inadequate facilities / equipment Unnecessary treatment Pharmacy Error Managed Care Referral Problems Premature Discharge Chasing the same rabbit Quality Improvement, Corporate Compliance, and Risk Management offices are focused on similar concerns in Healthcare organizations. OIG / DOJ / HHS investigative efforts are aimed at these same concerns
10 Conventional Thinking: Healthcare Risk Silos FACILITY SAFETY REGULATORY COMPLIANCE MEDICAL PERFORMANCE STAFF / RESIDENT SUPERVISION QUALITY IMPROVEMENT MEDICATION MANAGEMENT BOARD OF DIRECTORS ERRORS / OMISSIONS MEDICAL RECORDS EMPLOYEE SAFETY PATIENT SAFETY Reality: Overlapping Circles of Risk FACILITY SAFETY QUALITY IMPROVEMENT REGULATORY COMPLIANCE STAFF / RESIDENT SUPERVISION MEDICAL PERFORMANCE BOARD OF DIRECTORS ERR0ORS / OMISSIONS MEDICATION MANAGEMENT EMPLOYEE SAFETY PATIENT SAFETY MEDICAL RECORDS
11 Compliance, Quality, Liability, and Patient Safety: Four Related Phenomena 1. Regulatory Compliance through the Federal False Claims Act (FCA 1863) and the Health Insurance Portability and Accountability Act (HIPAA 1996) 2. Quality of Care Concerns and Compliance 3. Medical Malpractice Crisis Cycles 4. Patient Safety Movement The Essential 5: Risk Management 1. Medical Decision Making Physician treatment, diagnosis, procedure management Peer Review Process For New Physicians, Proctoring process 2. Clinical Support Systems Infection Control Medical Supplies and Medical Equipment Medication Management Clinical support staff training and competency
12 The Essential 5: Risk Management 3. Defensibility of Medical Records Physician Documentation Nursing or support staff documentation Record organization, privacy, and security Documentation / patient education and informed consent 4. Facility Safety Slip, trip and fall hazards Compliance with OSHA / CFR 29: Bloodborne Pathogens Infection control Maintenance and physical condition The Essential 5: Risk Management 5. Customer Service and Communications Appointment Scheduling Patient Registration and data collection Communications with patients all staff members Patient Physician communications Patient Education Informed Consent Diagnostic Test Result Tracking and Communication Medical Error Disclosure
13 The Top 13 Quality, Compliance, and Risk Management Exposures All Specialties, Failure to Supervise / Monitor medical cases 16,430 Medical Malpractice Cases $1.2 Billion indemnity payout 2. Medication Errors 9,326 Medical Malpractice Cases $369 Million indemnity payout 3. Unnecessary Procedures 6,702 Medical Malpractice Cases $382 Million indemnity payout Top 13 Combined Exposures Medical Records Documentation problems 6,702 Med-mal Cases $382 Million indemnity 5. Premature Discharge 2,625 Med-mal Cases $242 Million indemnity 6. Lack of adequate facilities / equipment 1,985 Med-mal Cases $217 Million indemnity
14 Top 13 Combined Exposures Improper Medical Case Management by Physicians 1,943 Med-mal cases $70 Million indemnity 8. Unnecessary Medical Treatment 1,693 Med-mal cases $118 Million indemnity 9. Breach of Confidentiality 918 Med-mal cases $8 Million indemnity Top 13 Combined Exposures Failure to Conform with Regulations / Statutes 902 Med-mal cases $68 Million indemnity 11. Pharmacy Error 355 Med-mal cases $18 Million indemnity 12. Managed Care Referral problems 276 Med-mal cases $15 Million indemnity
15 Top 13 Combined Exposures Failure to Communicate with or inform patients (Informed Consent and Patient Education) 4,771 Med-mal cases $118 Million indemnity
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