PURPOSE: This rule establishes the MO HealthNet payment policy for services provided by acute care hospitals or ambulatory surgical centers that result in a preventable serious adverse event or hospital or ambulatory surgical center-acquired condition, errors in medical care that are clearly identifiable, preventable, and serious in their consequences for patients.

1. (1) Definitions.

   1. (A) Adverse event. A discrete, auditable, and clearly defined occurrence as identified by the National Quality Forum in its list of serious adverse events in health care, as of December 15, 2008, (and as further defined by the criteria and implementation guidance of Table 1 of the National Quality Forum’s publication “Serious Reportable Events in Healthcare: 2006 Update” which is available at http://www.qualityforum.org/publications/reports/sre_2006.asp) or an event identified by the Centers for Medicare and Medicaid Services, as of December 15, 2008, that leads to a negative consequence of care resulting in an unintended injury or illness which was preventable.
   2. (B) Preventable. An event that reasonably could have been anticipated and avoided by the establishment and implementation of appropriate policies, procedures, and protocols by a hospital or ambulatory surgical center or by staff conformance to established hospital or ambulatory surgical center policies, procedures, and protocols.
   3. (C) Serious. An adverse event that results in death or loss of a body part, disability, or loss of bodily function lasting more than seven (7) days or, for a hospital patient, the loss of bodily function is still present at the time of discharge from a hospital.
   4. (D) Healthcare facility. For purposes of the regulation shall mean a hospital or ambulatory surgical center. 13 CSR 70-15

2. (2) Payment to hospitals or ambulatory surgical centers enrolled as MO HealthNet providers for care related only to the treatment of the consequences of a serious adverse event will be denied or recovered by the MO HealthNet Division when such serious adverse event is determined to:

   1. (A) Be preventable;
   2. (B) Be within the control of the hospital or ambulatory surgical center;
   3. (C) Have occurred during an inpatient hospital admission, outpatient hospital surgery care, or care in an ambulatory surgical center;
   4. (D) Have resulted in serious harm; and

   5. (E) Be included on the National Quality Forum list of Serious Reportable Events as of December 15, 2008, or the Centers for Medicare and Medicaid Services list of Medicare Hospital-Acquired Conditions (HCAs), non-payable by Medicare as of December 15, 2008. The National Quality Forum list of serious reportable events as of December 15, 2008, includes:

      1. 1. Surgery performed on the wrong

body part;

1. 2. Surgery performed on the wrong

patient;

1. 3. Wrong surgical procedure on a

patient;

1. 4. Foreign object left in a patient after

surgery or other procedure;

1. 5. Intraoperative or immediately post-

operative death in a normal health patient;

1. 6. Patient death or serious disability

associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility;

1. 7. 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;

1. 8. Patient death or serious disability

associated with intravascular air embolism that occurs while being cared for in a healthcare facility;

1. 9. Infant discharged to the wrong per-

son;

1. 10. Patient death or serious disability

associated with patient elopement (disappearance) for more than four (4) hours;

1. 11. Patient suicide, or attempted suicide

resulting in serious disability, while being cared for in a healthcare facility;

1. 12. Patient death or serious disability

associated with a medication error (error involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration);

1. 13. Patient death or serious disability

associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products;

1. 14. Maternal death or serious disability

associated with labor or delivery on a lowrisk pregnancy while being cared for in a healthcare facility;

1. 15. Patient death or serious disability

associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility;

1. 16. Death or serious disability

(Kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates;

1. 17. Stage 3 or 4 pressure ulcers acquired

after admission to a healthcare facility;

1. 18. Patient death or serious disability

due to spinal manipulative therapy;

1. 19. Patient death or serious disability

associated with an electric shock while being cared for in a healthcare facility;

1. 20. Any incident in which a line desig-

nated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances;

1. 21. Patient death or serious disability

associated with a burn incurred from any source while being cared for in a healthcare facility;

1. 22. Patient death associated with a fall

while being cared for in a healthcare facility;

1. 23. Patient death or serious disability

associated with the use of restraints or bedrails while being cared for in a healthcare facility;

1. 24. Any instance of care ordered by or

provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider;

1. 25. Abduction of a patient of any age; or
2. 26. Sexual assault on a patient within or

on the grounds of a healthcare facility.

1. (3) A MO HealthNet participant shall not be liable for payment for an item or service related to a serious adverse event or hospital or ambulatory surgical center-acquired condition or the treatment of consequences of a serious adverse event or hospital or ambulatory surgical center-acquired condition that would have been otherwise payable by the MO HealthNet Division.
2. (4) MO HealthNet payment denials will be calculated by the MO HealthNet Division based on the facts of each serious adverse event. The calculation of the denial of payment will be reviewed by the MO HealthNet director. The final decision of the division regarding the denial of payment shall be subject to review by the Administrative Hearing Commission pursuant to the provisions of 208.156, RSMo. Such payment limitation shall only apply to the hospital or ambulatory surgical center where the adverse event occurred and shall not apply to care provided by other hospitals should the patient subsequently be transferred or admitted to another hospital for needed care.
3. (5) Hospitals or ambulatory surgical centers enrolled as MO HealthNet providers and paid under the Medicare Inpatient Prospective Payment System (IPPS) shall include the “Present on Admission” (POA) indicator on the UB 04 when submitting claims for payment beginning thirty (30) days after publication of this rule in the Missouri Code of State Regulations. Hospitals or ambulatory surgical centers enrolled as MO HealthNet providers and not paid under the Medicare Inpatient Prospective Payment System (IPPS) shall include the “Present on Admission”
4. (POA) indicator on the UB 04 when submitting claims for payment beginning July 1, 2010. The POA indicator shall be coded as instructed by the Centers for Medicare and Medicaid Services.
5. (6) On or before January 1, 2010, all hospitals or ambulatory surgical centers enrolled as MO HealthNet providers shall have a contract to participate with a federally-designated Patient Safety Organization (PSO) as defined in the federal Patient Safety and Quality Improvement Act of 2005. The hospital or ambulatory surgical center shall report the occurrence of a serious reportable event and the root cause of the event to the PSO and participate in PSO-related improvement strategies as set forth in the contract.

AUTHORITY: section 208.201, RSMo Supp. 2008.* Original rule filed Nov. 17, 2008, effective June 30, 2009.

*Original authority: 208.201, RSMo 1987, amended 2007.