POLICIES AND PROCEDURE MANUAL

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POLICIES AND PROCEDURE MANUAL Policy: MP209 Section: Medical Benefit Policy Subject: Medical Error Never Events, Hospital Acquired Conditions, and Hospital Readmission Review I. Policy: Medical Error Never Events, Hospital Acquired Conditions, and Hospital Readmission Review II. Purpose/Objective: To provide a policy of coverage regarding Medical Error Never Events, Hospital Acquired Conditions, and Hospital Readmission Review III. Responsibility: A. Medical Directors B. Medical Management IV. Required Definitions 1. Attachment a supporting document that is developed and maintained by the policy writer or department requiring/authoring the policy. 2. Ehibit a supporting document developed and maintained in a department other than the department requiring/authoring the policy. 3. Devised the date the policy was implemented. 4. Revised the date of every revision to the policy, including typographical and grammatical changes. 5. Reviewed the date documenting the annual review if the policy has no revisions necessary. V. Additional Definitions Medical Necessity or Medically Necessary means Covered Services rendered by a Health Care Provider that the Plan determines are: a. appropriate for the symptoms and diagnosis or treatment of the Member's condition, illness, disease or injury; b. provided for the diagnosis, and the direct care and treatment of the Member's condition, illness disease or injury; c. in accordance with current standards of good medical treatment practiced by the general medical community. d. not primarily for the convenience of the Member, or the Member's Health Care Provider; and e. the most appropriate source or level of service that can safely be provided to the Member. When applied to hospitalization, this further means that the Member requires acute care as an inpatient due to the nature of the services rendered or the Member's condition, and the Member cannot receive safe or adequate care as an outpatient. Medicaid Business Segment Medical Necessity shall mean a service or benefit that is compensable under the Medical Assistance Program and if it meets any one of the following standards: (i) The service or benefit will, or is reasonably epected to, prevent the onset of an illness, condition or disability.

(ii) (iii) The service or benefit will, or is reasonably epected to, reduce or ameliorate the physical, mental or development effects of an illness, condition, injury or disability. The service or benefit will assist the Member to achieve or maintain maimum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for members of the same age. DESCRIPTION: The intent of this policy is to implement a strategy to monitor for a safe environment for medical services that minimizes avoidable risks to patients and to hold the member and payer/employer financially harmless for the event and its sequelae. If patient harm occurs, and upon quality review the facility and/or provider(s) could have reasonably avoided said harm, Health Plan may withhold payment for part or all services related to the event and its sequelae. The National Quality Forum, a nonprofit national coalition of physicians, hospitals, businesses and policy makers, published a list of events that they termed never events (NE). These incidents represent Serious Reportable Events (SRE s), etremely rare medical errors and hospital acquired conditions (HACs) that are largely preventable and should never happen to a patient. This policy also outlines the guidelines for determining the appropriateness of a return hospitalization following a prior discharge to the same hospital or hospital system to ensure optimal quality of care outcomes for members. PROCESS: Geisinger Health Plan (the Plan): Requires the acute care inpatient facility to be responsible for reporting Hospital Acquired Conditions (HACs) as defined by CMS to Geisinger Health Plan. Will monitor Serious Reportable Events (SREs)/HACs through case management, member complaints, claims review, and other channels. The report will include the following information: o Member name o Medical record number o Date of birth o Date of event o Inpatient or outpatient status at time of event o Discharge date or date of epiration o Provider name o Description of event Geisinger Health Plan follows CMS guidelines for reporting POA indicators. Applicable facilities are required to submit POA indicators for all product lines. The Present on Admission (POA) Indicator requirement applies to all inpatient acute care hospitals with the following eceptions: Critical Access Hospitals (CAHs) Long-term Care Hospitals (LTCHs) Cancer Hospitals Children's Inpatient Facilities Rural Health Clinics Federally Qualified Health Centers Religious Non-Medical Health Care Institutions Inpatient Psychiatric Hospitals Inpatient Rehabilitation Facilities All cases will have a quality investigation according to Quality Improvement Policy 08, Medical Care/Public Concern and Never Event Policy Reserves the right to partially or totally withhold payment for all provider costs associated with the never event at its discretion, based on the severity of the incident. All cases will be referred to the Medical Error/Payment Determination Committee. The Payment Review and Determination shall be made consistent with the intent of this Policy and with recognition of the following variables: o The timing of the occurrence of the SRE/HAC, within the patient s episode of care; o The specific roles as well as clinical and procedural requirements of the providers involved in the patient s episode of care (e.g. surgeons, anesthesiologists, hospital-based physicians and nursing staff, etc.); o Patient behavior. It may result in the following actions: Full Denial of Payment

Partial Denial of Payment - Based on DRG assignment reflecting the Present on Admission indicators. NEVER EVENT CATAGORIES: Event HAC NE Surgical Events: (includes endoscopies and other invasive procedures) Surgery or other invasive procedure performed on the wrong body part (ecludes emergent situations that precludes obtaining informed consent) Surgery or other invasive procedure performed on the wrong patient Wrong surgical procedure or other invasive procedure performed on a patient (ecludes emergent situations that precludes obtaining informed consent) Unintended retention of a foreign object in a patient after surgery or other invasive procedure Intraoperative or immediately post-operative (within 24 hrs) death in an ASA Class I patient Care Management Events: Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration) Patient death or serious disability associated with unsafe administration of blood products Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a health care facility Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy Patient death or serious disability due to spinal manipulative therapy Patient death or serious disability associated with hypoglycemia, or manifestations of poor glycemic control, the onset of which occurs while the patient is being cared for in a healthcare facility Death or serious disability associated with failure to identify and treat hyperbilirubinemia in neonates Stage 3 or 4 pressure ulcers acquired after admission/ presentation to a healthcare Catheter-associated urinary tract infection Surgical site infection mediastinitis after coronary artery bypass graft (CABG) surgery Surgical site infection after total knee replacement Surgical site infection after laparoscopic gastric bypass or laparoscopic gastroenteroscopy Deep vein thrombosis/pulmonary thrombosis Vascular catheter associated infection Artificial insemination with the wrong donor sperm or donor egg Patient death or serious disability associated with a fall while being cared for in a healthcare facility Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results Product/Device Events:

Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a healthcare facility Environmental Events: Patient or staff death or serious disability associated with an electric shock* in the course of a patient care process in a healthcare Any incident in which systems designated for oygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toic substances Patient death or serious disability associated with a burn incurred from any source in the course of a patient care process in a healthcare Patient death or serious injury associated with the use of restraints or bedrails while being cared for in a healthcare Patient Protection Events: Patient suicide, or attempted suicide (occurring after admission) resulting in serious disability, while being cared for in a healthcare Patient death or serious disability associated with patient elopement (ecludes mentally competent adults) Discharge or release of a patient/resident of any age, who is unable to make decisions, to other than an authorized person Potential Criminal Events: Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider Abduction of a patient/resident of any age Seual abuse/assault on a patient or staff member within or on the grounds of the healthcare Death or serious injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of the healthcare Radiologic Events: Death or serious injury of a patient or staff associated with the introduction of a metallic object into an MRI area HOSPITAL READMISSION REVIEW Geisinger Health Plans reserves the right to review hospital readmissions - defined as any admission occurring within 30 days of the date of discharge from the same hospital or hospital system for the same or similar diagnosis or a related diagnosis to determine if the readmission could have reasonably been prevented by optimization of any of the following factors: Provision of care during the initial admission Discharge planning Post-discharge follow-up Coordination of care between inpatient and outpatient care teams

A readmission may be considered to be clinically related to the initial admission if any of the following scenarios are supported in the medical record: Recurrence or continuation of the condition responsible for the initial admission; or Surgical procedures required to treat the recurrence or continuation of the condition responsible for the initial admission; or Medical complications caused by, or for which the quality of care during the initial admission is implicated; or Surgical procedures resulting from a medical complications caused by or for which the quality of care during the initial admission is implicated; or Eacerbation or decompensation of a chronic medical condition for which there is a reasonable epectation that optimal care during or immediately following the initial admission could have prevented. Readmissions that are determined to be clinically related to the initial admission and preventable will not be reimbursed. The following readmission types are not considered to be preventable, and therefore are not subject to non-payment rules: Planned readmissions for repetitive or ongoing treatment Initial discharge was against medical advice that is documented in the medical record. Readmissions caused by end-stage disease processes Readmissions that occur more than 30 days after the initial admission. Readmissions for planned elective surgery REFERENCES: https://www.thehealthplan.com/providers/medpolicies/reimbursement/pnm43.pdf CMS Final Rule for Serious Preventable Events. http://www.cms.hhs.gov National Quality Forum. Serious Reportable Events in Healthcare. 2011 Update http://www.google.com/url?url=http://www.qualityforum.org/publications/2011/12/sre_2011_final_report.asp&rct=j&frm =1&q=&esrc=s&sa=U&ei=4y-PU-iLDasASqqYHwCg&ved=0CB0QFjAB&usg=AFQjCNE90mmC8ZaTfnicpOlAV_FH9NJO4Q Agency for Healthcare Research and Quality (AHRQ). Eliminating serious, preventable, and costly medical errors - never events. http://psnet.ahrq.gov/resource.asp?resourceid=3816 Centers for Medicare and Medicaid. Medical Benefit Policy Manaual Chapter 1, Sections 10 and 120, and Chapter 16, Section 180. This policy will be revised as necessary and reviewed no less than annually. Devised: 4/08 Revised: 8/08 Added CMS Hospital Acquired Conditions; 6/14 (Revised process and events) 5/15 (add hospital readmission review), 3/16 Reviewed: 06/09, 4/10, 4/11, 4/12, 4/13, 4/14, 3/17, 2/18