Never Events: Case Study 1

Flaws and Disorder: Never Event Unit Jason Davis Global Excel Management Adam V. Russo, Esq. The Phia Group, LLC Stacy M. Borans, MD Advanced Medical Strategies Never Events: Case Study 1 59 year old male with morbid obesity BMI 60 Admitted November 2008 for Laparoscopic gastric bypass Co-Morbid Conditions: Asthma HTN Sleep Apnea DJD

Never Events: Case Study 1 Taken to OR on 11/17/08 Procedure Note: Laparoscopic examination with termination of procedure secondary to equipment malfunction Right arm comes off table Patient slides down table Bed unable to be maintained in supine position Patient eventually repositioned by 4 staff members Never Events: Case Study 2 November 2007-Cedars Sinai Med. Center Newborn Twins admitted due to staph infections for IV antibiotics Heparin flush given to keep IV line clear Dose given was 10,000 units Dose Required was 10 units

Never Events: Case Study 2 Pharmacy Tech-larger dose bottles placed in same bin as smaller dose bottles Floor Nurse-did not check labels on heparin retrieved from bin Babies transferred to ICU Required close monitoring due to extensive bleeding Definitions: Never Event adverse consequence of care results in unintended injury or illness; indicative of a problem in a health facility s safety systems; and important for public credibility or public accountability.

Definitions: Never Event Must meet the following criteria: Unambiguous clearly identifiable and measurable, and thus feasible to include in a reporting system; Usually preventable recognizing that some events are not always avoidable, given the complexity of health care; Serious resulting in the death or loss of a body part, disability, or more than transient loss of a body function, Never Events: Surgical Events Surgery performed on the wrong body part Surgery performed on the wrong patient Wrong surgical procedure performed on a patient Unintended retention of a foreign object in a patient after surgery or other procedure Intraoperative or immediately postoperative death in an ASA Class I patient

Never Events: Surgical Events E876.5 Performance of inappropriate operation 998.4 Foreign body, accidentally left during procedure, not elsewhere classified. 998.7Acute reaction to foreign substance accidentally left during a procedure. Never Events: Drug/Device Events Patient death/serious disability associated with: the use of contaminated drugs, devices or biologics provided by the healthcare facility The improper use or function of a device in patient care intravascular air embolism that occurs while being cared for in a healthcare facility (999.1)

Never Events: Management Events Patient death or serious disability associated with: a medication error hemolytic reaction due to the administration of ABO/HLA incompatible blood or blood products labor or delivery in a low-risk pregnancy hypoglycemia Never Events: Management Events Patient death or serious disability associated with: failure to identify and treat hyperbilirubinemia in neonates spinal manipulative therapy electric shock or elective cardioversion burn incurred from any source a fall the use of restraints or bedrails

Never Events: Management Events Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility Artificial insemination with the wrong donor sperm or wrong egg Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances Never Events: Other Events Infant discharged to the wrong person Patient death or serious disability associated with patient disappearance Patient suicide, or attempted suicide, resulting in serious disability while being cared for in a healthcare facility

Never Events: Other Events Care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider Abduction of a patient of any age Sexual assault on a patient Death/significant injury of a patient or staff member resulting from a physical assault Definitions: Hospital Acquired Condition Reasonably preventable condition Not present or identifiable at the time of hospital admission Present on Discharge Typically fall into categories: High volume High cost

CMS Hospital Acquired Conditions (continued) Identified through the ICD-9-CM Object inadvertently left in after surgery (998.4 & 998.7) Air embolism (999.1) Blood incompatibility (999.6) Catheter associated urinary tract infection Pressure ulcer (decubitus ulcer)-stage III/IV (707.23 & 707.24) Vascular catheter associated infection (999.31) Surgical site infection- Mediastinitis (infection in the chest) after coronary artery bypass graft surgery CMS Hospital Acquired Conditions (continued) Certain types of falls and trauma Surgical site infections following certain elective procedures, including certain orthopedic surgeries, and bariatric surgery for obesity Certain manifestations of poor control of blood sugar levels Deep vein thrombosis or pulmonary embolism following total knee replacement and hip replacement procedures

CMS Hospital Acquired Conditions Catheter associated urinary tract infection 996.64: Infection and inflammatory reaction due to indwelling urinary catheter Also excludes the following from acting as a CC/MCC: 112.2: Candidiasis of other urogenital sites 590.10: Acute pyelonephritis without lesion of renal medullary necrosis 590.11: Acute pyelonephritis with lesion of renal medullary necrosis 590.2: Renal and perinephric abscess 590.3: Pyeloureteritis cystica 590.80 Unspecified pyelonephritis 590.81: Pyelitis or pyelonephritis in diseases classified elsewhere 595.0: Acute cystitis 597.0: Urethral abscess 599.0: Urinary tract infection, site not specified CMS Hospital Acquired Conditions Mediastinitis after CABG: 519.2 Requires Procedure Codes: 36.10-36.19 Correlates with (aorto) coronary bypass, internal mammary bypass or other bypass anastomosis for heart revascularization

CMS Hospital Acquired Conditions Falls and Trauma include: fractures, dislocations, intracranial injury, crushing injury, burn and other unspecified effects of external causes: 800-829: Fracture code range 830-839: Dislocation code range 850-854: Intracranial injury code range 925-929: Crushing injury code range 940-949: Burns code range 991-994: Other and unspecified effects of external causes code range CMS Hospital Acquired Conditions Orthopedic Procedures: 996.67: Infection and inflammatory reaction due to other orthopedic device and implant graft. 998.59 (other post-op infection) and: 81.01-81.08, 81.23-81.24, 81.31-81.83, 81.83, 81.85

CMS Hospital Acquired Conditions Bariatric Procedures: Principal diagnosis 278.01(morbid obesity) 998.59 (other post-op infection) and: 44.38 44.39 44.95 CMS Hospital Acquired Conditions Poor Glycemic Control: 249.10-249.11: Secondary Diabetes with Ketoacidosis 249.20-249.21: Secondary Diabetes with Hyperosmolarity 250.10 250.13: Diabetic Ketoacidosis 250.20 250.23: Nonketotic Hyperosmolar Coma 251.0: Hypoglycemic Coma

CMS Hospital Acquired Conditions DVT/Pulmonary Embolism: 415.11: Iatrogenic pulmonary embolism and infarction 415.19: Other pulmonary embolism and infarction 453.40: Venous embolism and thrombosis of unspecified deep vessels of lower extremity 453.41: Venous embolism and thrombosis of deep vessels of proximal lower extremity 453:42: Venous embolism and thrombosis of deep vessels of distal lower extremity Requires Associated Procedure code: 00.85-0.87, 81.51-81.52, or 81.54 CMS Hospital Acquired Conditions Identify if a condition was Present on Admission Select the correct POA indicator for each diagnosis code http://www.cdc.gov/nchs/datawh/ftpserv/ftpicd9/icdguide07.pdf http://www.cms.hhs.gov/hospitalacqcond. There are five POA indicator reporting options: Y, N, W, U, and 1. located in field 67 of the UB-04 and in segment K3 in the 2300 loop, data element K301 for the 8371 electronic submission.

CMS Hospital Acquired Conditions Y: Condition present on admission N: Condition was not present on admission W: Provider has determined, based on data and clinical judgment, that it is not possible to document when the onset of the condition occurred U: Medical record documentation is insufficient to determine whether the condition was present at time of admission 1: Unreported/not used, thus exempt from reporting States that prohibit balance billing: Delaware Georgia Indiana Maine Massachusetts Minnesota Oregon New Hampshire Pennsylvania South Carolina Vermont Washington

Discussion Topics Never Events Usual & Customary Analysis Reasonableness Defining Clean Claims Good and Bad Plan Language Definitions Never Events Services, supplies, care and/or treatment that results from errors in medical care that are clearly identifiable, preventable, and serious in their consequence for patients. It is imprudent to address Never Events in your plan document or policy. As a new issue, there is no concrete definition agreed upon by the industry. This can result in considerable confusion when determining what is payable, and what is actually a Never Event. Due to uncertainty, administrators and carriers should be more creative when addressing situations that may constitute Never Events. Many employers are asking what TPA is doing about using plan assets to pay for things that were medical errors, or resulted from medical errors.

Never Events If a payer wants to exclude these types of charges, the administrator must retain discretionary authority to determine whether this exclusion will apply based upon information presented to the administrator, and they must ensure that their plan language allows them to do so. An estimated 98,000 patients die each year due to preventable medical errors. This presents an enormous financial cost. Between 2002 and 2004 the Centers for Medicare and Medicaid Services (CMS) paid more than $9.3 billion in claims associated with medical errors. If the self-funded industry and TPAs do nothing, they will lose their clients to the fully insured market. A growing number of insurers such as Aetna, Cigna, and Wellpoint are reacting to Never Events, and in so doing signal to payers the savings opportunity available to those that react. Usual and Customary (U&C) Plans cannot afford to ignore dubious provider billing practices Must review claims to ensure the amounts being charged come within the definition of U&C in strict accordance with their plan terms. Upgrade plan documents to include the best U&C language possible. This results in a strong right to monitor claims for U&C, and which provisions leave the Plan helpless in the face of excessive charges. Review claims to ensure the amounts being charged come within both the definition of U&C and Medical Necessity, in strict accordance with their plan terms. Most if not all Plans will limit U&C to charges roughly equivalent to those charges billed by similar providers, providing similar services, in a similar locale.

Usual and Customary (U&C) Similarly, medical necessity is determined by simply asking what other medical providers in the area might do. The problem is that in many geographic areas, sample sizes used as a basis for comparison are small or even non-existent. When deciding whether a treatment or charge is customary or necessary, relying solely on industry practices is a mistake. Administrators have the right to consider other sources of information, such as Medicare cost to charge ratios, average wholesale prices (AWP) for prescriptions and/or manufacturer s retail pricing (MRP) for supplies. Plan administrators should exercise their discretionary authority by considering multiple sources of information. Reasonableness Unlike U&C limitations, which relate to the amount charged, Reasonableness relates to the basis for the charge. In other words, the amount charged is irrelevant. What is relevant is the service being charged for. For some time, payers have examined charges only to determine whether the amount charged is usual and customary. While payers frequently review claims for medical necessity, and to ensure they are not excluded by the Plan, rarely if ever do payers examine claims to determine whether the service for which they are being charged is reasonable. Self-funded benefit plans have the right to pay only for reasonable charges and reasonable treatments.

Reasonableness If Provider s error causes additional treatments to become necessary, that Medical Provider should supply those additional treatments for free. In other words, Medical Providers should be expected to perform tasks without mistake, and if a mistake is made, should not benefit from that mistake by charging others fees for their costly errors. Ensure that your plan language allows recovery of claims paid for unreasonable charges by providers. Assert your right to recover these funds based upon the applicable plan language and law. There are many situations where payment of charges may be unreasonable and the applicable plan document may substantiate efforts to pursue a refund if claims are paid. Strengthen your right to reclaim funds used to pay unreasonable bills. Defining Clean Claims A clean claim is one that includes relevant details and documentation adequate to determine whether the claim is actually payable by the Plan. State and Federal laws exist which assign deadlines to claims administrators once a clean claim is received; but that begs the question - what is a clean claim? The definition of a clean claim varies. PPO network agreements, for instance, often define a clean claim as merely one that adequately fills a HCFA or UB-92 form. What is often forgotten are data elements, legibleness, accuracy, and complete details. Medicare defines it as one that has no defect, impropriety, lack of required substantiating documentation or particular circumstance requiring special treatment that prevents timely payment. 42 C.F.R. 422.500.

Defining Clean Claims Victoria C. Bunce, Director of Research and Policy with the Council for Affordable Health Insurance, posted an article regarding clean claims and prompt payment laws. At times the provider submits incomplete information, leaves off salient data, miscodes procedures, or even makes a mistake in the patient s name, time of treatment or medical condition. When this happens, the insurer has to recheck the information and needs the right to challenge a bill. Some states have passed - and others have begun considering - legislation undermining that right. The new laws obligate an insurer to pay even questionable bills or face a heavy fine. Supporters of legislation define a clean claim as a completed standard claim form, regardless of whether it includes all of the information the insurer needs to determine its liability. Critics contend that when a claim appears incomplete or otherwise inaccurate, the insurer cannot always tell right away whether or to what extent it is liable for the claim. Good Plan Language The Plan should: Define reasonableness Exclude unreasonable charges Limit the Maximum Allowable Charge to reasonable charges Allow the Plan to pursue refunds of claims that were wrongfully paid Have discretionary authority Charges are not considered Reasonable or eligible for payment (exceed the Maximum Allowable Charge) when they result from provider error or preventable facility-acquired conditions through the use of evidence-based guidelines - not limited to CMS guidelines.

Good Plan Language The Plan reserves the right to identify charges that are not Reasonable and thus not eligible for payment by the Plan. Plan may pay benefits that are later found to be greater than the Maximum Allowable Charge. Plan has right to seek refunds from providers that submit charges to the Plan that are not deemed reasonable or eligible expenses. Plan may recover overpayment from source to which it was paid or from the party on whose behalf the charges were paid. Bad Language Usual, Customary, and Reasonable Charge is a charge which is not higher than the usual charge made by the provider of the care or supply and does not exceed the usual charge made by most providers of like service in the same area. No mention of Federal preemption or ERISA (where applicable) No discretionary authority assertion or weak assertion No definition of a clean claim No definition of reasonable charges, or reasonable is not separate from U&C No right, or weak right, to medical bill review and precertification The Phia Group, LLC Copyright 1999-2009

Bad Language No right to deny for errors or excessive charges No coordination with Medicare, Medicaid, and First-Party Policies of Auto Insurance U&C focused only on the amount charged and what providers in an area charge, without defining what an area must consist of (allowing one provider to determine what U&C is in rural areas) Subrogation provisions that fail to address lack of cooperation, first party funds, death, bankruptcy, minors, constructive trust, equitable liens, etc. Plans with no ability to seek recovery for claims paid in error, OPs, duplicate payments or in excess of plan provisions from either the provider or the participant. Reasonable Charge The Plan will only pay fees that are for services or supplies which are necessary for the care and treatment of illness or injury not caused by the treating provider. Determination that fees are reasonable will be made by the Plan Administrator, taking into consideration unusual circumstances or complications requiring additional time, skill and experience in connection with a particular service or supply. This determination will consider, but will not be limited to, the findings and assessments of the following entities: The National Medical Associations, Societies, and organizations; and The Food and Drug Administration. To be reasonable, fees must be in compliance with generally accepted billing practices for unbundling or multiple procedures. Services, supplies, care and/or treatment that results from errors in medical care that are clearly identifiable, preventable, and serious in their consequence for patients, are not reasonable.

Maximum Allowable Charge Maximum Allowable Charge(s) will be the lesser of: The Usual and Customary amount, Reasonable Charges The allowable charge specified under the terms of the Plan, The negotiated rate established in a contractual arrangement with a provider, or The actual billed charges for the covered services The Plan will reimburse the actual charge billed if it is less than the Usual and Customary amount. The Plan has the discretionary authority to decide if a charge is Reasonable, Usual and Customary. The Maximum Allowable Charge will not include any identifiable billing mistakes including upcoding, duplicate charges, and charges for services not performed.