NOTICES
DEPARTMENT OF
PUBLIC WELFARE
Preventable Serious Adverse Events in Nonpublic and County Nursing Facilities Purpose of Notice
[40 Pa.B. 6042]
[Saturday, October 16, 2010]The purpose of this notice is to announce that the Department of Public Welfare (Department) intends to issue the following proposed bulletin under 35 P. S. § 449.94(d) (relating to nursing facility preventable serious adverse events bulletin).
Public Comment
Interested persons are invited to submit written comments regarding the bulletin to the Department at the following address: Commonwealth of Pennsylvania, Department of Public Welfare/Department of Aging, Office of Long-Term Living, 555 Walnut Street, 5th Floor, Harrisburg, PA 17101-1919, Attention: Yvette Sanchez-Roberts. Comments received within 30 days will be reviewed and considered in developing the final bulletin.
Persons with a disability who require an auxiliary aid or service may submit comments using the Pennsylvania AT&T Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).
MICHAEL P. NARDONE,
Acting SecretaryFiscal Note: 14-NOT-661. No fiscal impact; (8) recommends adoption.
PROPOSED PSAE BULLETIN SUBJECT
Preventable Serious Adverse Events in Nonpublic and County Nursing Facilities
PURPOSE
The purpose of this bulletin is to identify Preventable Serious Adverse Events (PSAEs) for nursing facilities that are enrolled in the Medical Assistance (MA) Program and to notify those facilities how they may fulfill the obligations not to knowingly seek payment from the MA Program for PSAEs or for services required to correct or treat PSAEs. This bulletin also describes the MA Program's payment policies relating to PSAEs.
SCOPE
This bulletin applies to all MA-enrolled county and non-public (general, hospital-based, and special rehabilitation) nursing facilities.
BACKGROUND/INTRODUCTION
In June of 2009, the General Assembly enacted the Preventable Serious Adverse Events Act. Act of June 10, 2009, P. L. 1, No. 1, codified at, 35 P. S. §§ 449.91—449.97 (''Act 1''). Act 1 prohibits health care providers, including nursing facilities, from knowingly seeking payment from a health payor or patient (1) for a preventable serious adverse event (''PSAE''); or (2) for any services required to correct or treat the problem created by a PSAE. In addition, Act 1 also requires a health care provider that unknowingly receives payment for services associated with a PSAE or for the services to correct the PSAE to immediately notify the health payor or patient and refund the payment within 30 days of discovery or receipt of payment, whichever is later.
Act 1 defines a PSAE as ''[a]n event that occurs in a health care facility that is within the health care provider's control to avoid, but that occurs because of an error or other system failure and results in a patient's death, loss of body part, disfigurement, disability or loss of bodily function lasting more than seven days or still present at the time of discharge from a health care facility.'' Act 1 also specifies that PSAEs ''shall be included on the list of reportable serious adverse events adopted by the national quality forum or in a bulletin as provided under this act.''
Act 1 directs the Department of Public Welfare (''the Department'') to issue a PSAE bulletin for nursing facilities, and specifies that ''[f]or a nursing facility, preventable serious adverse events shall be those listed in [the] bulletin.'' As required by Act 1, this bulletin lists the events. The bulletin also highlights the criteria that must be satisfied in order for an event to be classified as a PSAE. In developing this bulletin, the Department consulted representatives of the nursing facility trade associations, representatives of individual nursing facilities and the Long-Term Care Subcommittee of the Medical Assistance Advisory Committee.
PSAEs
The events listed in Appendix A qualify as a PSAE if all of the following criteria are satisfied:
1. The event was preventable. To be preventable, the event could have been anticipated and prepared for, but, nonetheless, occurred because of an error or other system failure; and
2. The event was serious. The event is serious if the event subsequently results in death or loss of body part, disfigurement, disability or loss of bodily function lasting more than seven days or still present at the time of discharge from a nursing facility; and
3. The event was within the control of the nursing facility. Control means that the nursing facility had the power to avoid the error or other system failure; and
4. The event occurred as a result of an error or other system failure within the nursing facility.
The Department may modify the list of PSAEs identified in Appendix A and its payment policies and procedures in the future. Before making any modification to the PSAEs, the Department will consult with representatives of the nursing facility trade associations, representatives of individual nursing facilities, and the Long Term Care Subcommittee of the Medical Assistance Advisory Committee. The Department will also provide for a 30-day public comment period.
COMPLIANCE WITH ACT 1:
Under Act 1, an MA-enrolled nursing facility may not knowingly seek payment for a PSAE, or for any services required to correct or treat a PSAE.
1. Identification and Review of a PSAE and Services Required to Correct or Treat a PSAE
a. Responsibilities of the Nursing Facility
To comply with Act 1, whenever an event listed in Appendix A occurs in a nursing facility, the nursing facility must determine whether the event meets the PSAE criteria specified above. If the event meets those criteria, the event is a PSAE. If the nursing facility concludes that a PSAE has occurred, the nursing facility may not submit a claim for the event or for any services required to correct or treat a PSAE. If a nursing facility discovers that it has inadvertently submitted a claim and received payment from the MA Program or an MA recipient for a PSAE or services required to correct or treat a PSAE, the nursing facility must refund the payment within 30 days of the discovery of the event or receipt of the payment, whichever is later. The Department will consider a nursing facility as meeting obligations if the facility follows the guidelines in Section 2 below.
b. Authority of the Department
The Department may identify potential PSAEs or the services required to correct or treat PSAEs and seek recovery of money through its exiting claims review process, its utilization management review process, or its program integrity review process. See 55 Pa. Code §§ 1101.71, 1101.77 and 1101.83.
With both facility-reported PSAEs and Department-identified PSAEs, the Department will determine whether the event meets the criteria of a PSAE; the duration of the PSAE; whether services were required to correct or treat the PSAE; the duration of the services to correct or treat the PSAE; and the amount of MA payments associated with the PSAE or with the services to correct or treat the PSAE. Once the event has been either self-reported or identified, the Department will notify the nursing facility, in writing, that it has initiated its review. As part of its review, the Department may request documentation from the facility concerning the facility's policies and/or procedures, the resident and/or the event. Based on its review, the Department may recover or adjust MA payments or return money already refunded by the nursing facility. The Department's review process, including how the Department's physicians will be used in the case review and the opportunities that a nursing facility's designated staff will have to interact with the Department through the review process is available on the DPW website. The Department will notify all nursing facilities when revisions to the review process have been posted on the DPW website.
The Department will send a written notice of its determination to the nursing facility. In the event of an adverse determination, the Department's notice to the nursing facility will outline the reasons for the determination and whether the Department will recover or adjust MA payments. If the nursing facility does not agree with the Department's determination, the nursing facility may appeal to the Bureau of Hearings and Appeals pursuant to 55 Pa. Code Chapter 41.
2. Guidelines Relating to PSAEs and Services to Correct or Treat the PSAE
a. Claims relating to PSAEs
The Department pays MA-enrolled nursing facilities for services provided to MA-eligible persons through a prospective per diem rate and other additional payments (e.g., for hospital reserve days and for exceptional durable medical equipment). 55 Pa. Code Chapters 1187 and 1189. With respect to those payments, an MA-enrolled nursing facility may not knowingly submit a claim or otherwise receive payment for a PSAE. In those instances where a PSAE occurs on a single day, the nursing facility may not submit a claim for payment of the resident care portion of the MA per diem rate. For certain PSAEs, such as a PSAE-identified Stage 3 or Stage 4 decubitus ulcer, the PSAE may occur over multiple days, Because Act 1 prohibits a nursing facility from knowingly seeking payment for a PSAE, in those instances where the PSAE occurs over several days, the nursing facility may not submit a claim or otherwise receive payment of the resident care portion of the MA per diem rate for any day that the PSAE occurs.
If the resident is transferred to a hospital or other institution as a result of the PSAE, then the nursing facility may not submit a claim to the Department, or otherwise receive payment, to reserve the resident's nursing facility bed during the resident's absence (the nursing facility remains obligated to reserve the bed in accordance with federal and state requirements).
b. Claims Relating to Services to Correct or Treat a PSAE
Nursing facilities may use the following guidance to fulfill their obligation under Act 1 not to seek payment for services required as a result of a PSAE. Nonetheless, the Department will determine whether the actual value of subsequent services needed to correct or treat the PSAE is more or less than the payment adjustment made by the nursing facility.
A nursing facility may fulfill its obligation under Act 1 to not seek payment for services required as a result of a PSAE by comparing certain resident Case Mix Index (''CMI'') scores and by reducing the resident care portion of the MA per diem rate and the patient pay amount by any percent increase in those scores. Which CMI scores are compared to determine whether there was any increase will depend on whether the resident is hospitalized or transferred as a result of the PSAE. Furthermore, to reduce the resident care component, the CMI scores should be calculated using the RUG III 5.12 44 Grouper and related CMI table.
i. No Hospitalization or Transfer
In the event that the resident is not transferred, the resident's CMI score based on the assessment immediately following the PSAE (''post-PSAE CMI score'') should be compared to the resident's CMI score from the resident assessment immediately prior to the occurrence of the PSAE (''pre-PSAE CMI score''). If the post-PSAE CMI score is higher than the pre-PSAE score, then the resident care portion of the MA per diem rate and the patient pay amount may be reduced by the percentage increase in the scores (i.e., (post-PSAE CMI score minus pre-PSAE CMI score) divided by pre-PSAE CMI score). If the post-PSAE CMI score is equal to or lower than the pre-PSAE CMI score, then there will be no reduction in the MA per diem rate as result of the PSAE.
ii. Hospitalization—Medicare is Payor of First Resort Upon Admission to the Same Nursing Facility
In the event of hospitalization due to a PSAE, Medicare may be the payor of first resort upon the resident's return to the nursing facility; therefore, consideration must be given to both the Medicare coinsurance payment and to the MA per diem rate when MA resumes payments. With respect to the Medicare coinsurance, if the resident's CMI score based upon the readmission assessment (''readmission CMI score'') is greater than the resident's pre-PSAE CMI score, then the Department will not pay the Medicare coinsurance payment. If the Department does not pay the nursing facility for the Medicare coinsurance, in this circumstance, the nursing facility may not bill the resident. If the readmission CMI score is not higher, then the nursing facility may seek payment from the Department for the Medicare coinsurance payment. Payment of Medicare coinsurance is subject to 55 Pa. Code §§ 1101.64, 1187.102, and 1189.102.
When MA resumes payment, the resident's CMI score based on the resident assessment immediately after MA resumes payment may be compared to the pre-PSAE CMI score. If the former is greater than the latter, then the resident care portion of the MA per diem rate and the patient pay amount should be reduced by the percentage increase in those two scores. If the scores are equal or the pre-PSAE CMI is the greater of the two, then there will be no reduction in the MA per diem rate as a result of the PSAE.
iii. Hospitalization or Transfer—Medicare is not Payor of First Resort upon Admission to the Same Nursing Facility
When the MA Program pays for the resident's stay immediately upon return to the same nursing facility from another institution, then the readmission CMI score should be compared to the pre-PSAE CMI score. If the former is greater than the latter, then the resident care portion of the MA per diem rate and the patient pay amount should be reduced by the percentage increase in those two scores. If the scores are equal or the pre-PSAE CMI score is the greater of the two, then there will be no reduction in the MA per diem rate as a result of the PSAE.
iv. Durable Medical Equipment
In any circumstance, the nursing facility may not seek any payment through an exceptional durable medical equipment (DME) grant for equipment or services required to correct or treat a problem created by a PSAE.
v. Duration of the Payment Restrictions
The duration of the payment restrictions (prohibition or reduction) should also be based on the afore-mentioned CMI scores. If a payment restriction is imposed, then the payment restriction should continue until the resident's CMI score upon reassessment under normal procedures is equal to or less than the pre-PSAE CMI score or until the Department determines that resident's higher post-PSAE CMI score is attributable to reasons other than the PSAE.
If the nursing facility's Medical Director or the resident's attending physician concludes and documents in the resident's medical record that the resident's higher CMI is no longer a result of the PSAE, the nursing facility may request in writing that the Department conduct a clinical review to determine whether the PSAE-related rate reduction should continue. Likewise, if there is a change in a resident's medical condition unrelated to the PSAE which results in a higher CMI, as determined by the nursing facility's Medical Director or the attending physician, the nursing facility may request that the Department conduct a clinical review and redetermination. The nursing facility shall include the resident's medical record and any other supporting documentation with their request.
The Department will use its best efforts to complete its review and make a determination of all such requests within 30 days of receipt of the resident's medical record and any other supporting documentation from the facility.
The Department will send a written notice of the results of its review to the nursing facility. If the Department determines that the resident's CMI score is no longer the result of the PSAE, then the payment reduction shall cease effective on the date determined by the Department that the PSAE-related services are (were) no longer the cause of the higher CMI. If the Department determines that the resident's higher CMI score is the result of the PSAE, the payment reduction will continue. If the nursing facility does not agree with the Department's determination, the nursing facility may appeal to the Bureau of Hearings and Appeals pursuant to 55 Pa. Code Chapter 41.
Whether or not the facility files an appeal, the facility may ask the Department to conduct a clinical review and redetermination once every 90 days.
Appendix A
Preventable Serious Adverse Events (''PSAEs'') for
Nursing Facilities Enrolled in the Medical Assistance ProgramIf an event listed below occurs in a nursing facility, then the event is a PSAE when all of the following criteria are satisfied:
1. The event was preventable. To be preventable, the event could have been anticipated and prepared for, but, nonetheless, occurred because of an error or other system failure; and
2. The event was serious. The event is serious if the event subsequently results in death or loss of body part, disfigurement, disability or loss of bodily function lasting more than seven days or still present at the time of discharge from a nursing facility; and
3. The event was within the control of the nursing facility. Control means that the nursing facility had the power to avoid the error or other system failure; and
4. The event is the result of an error or other system failure within the nursing facility.
1. Surgical Events
A. Surgery performed on the wrong body part
B. Wrong surgical procedure performed on a resident
C. Surgery performed on the wrong resident
D. Unintended retention of a foreign object in a resident after surgery or other procedure
2. Product or Device Events
A. An event associated with the use of contaminated drugs, devices or biologics provided by the nursing facility
B. An event associated with the use or function of a device in resident care in which the device is used or functions other than as intended
C. An intravascular air embolism that occurs while being cared for in a nursing facility
3. Resident Protection Events
A. Resident suicide or attempted suicide
B. Resident elopement (disappearance for more than four hours)
4. Care Management Events
A. A medication error (such as, errors involving the wrong drug, wrong dose, wrong resident, wrong time, wrong rate, wrong preparation, or wrong route of administration)
B. Severe allergic reaction
C. A hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products
D. Stage 3 or 4 pressure ulcers acquired after admission to the nursing facility
E. Catheter-associated Urinary Tract Infection
F. An event related to spinal manipulative therapy
G. Vascular catheter-associated infection
H. An event related to hyper- or hypoglycemia (Diabetic ketoacidosis, Nonketotic hyperosmolar coma, Diabetic coma, Hypoglycemic coma) the onset of which occurs while the resident is being cared for in a nursing facility.
5. Environmental Events
A. A burn incurred from any source while being cared for in a nursing facility
B. An event related to a fall (fractures/dislocations/intracranial injuries/crush injuries/burns) while being cared for in a nursing facility
C. An electric shock while being cared for in a nursing facility
D. Any incident in which a line designated for oxygen or other gas to be delivered to a resident contains the wrong gas or is contaminated by toxic substances
E. An event associated with the use of restraints or bedrails while being cared for in a nursing facility.
6. Criminal Events and Unlawful Activities
A. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider.
B. Abduction of a resident
C. Sexual assault on a resident
D. A physical assault (that is battery).
[Pa.B. Doc. No. 10-1975. Filed for public inspection October 15, 2010, 9:00 a.m.]
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