NOTICES
Preventable Serious Adverse Events in Nonpublic and County Nursing Facilities
[44 Pa.B. 5939]
[Saturday, September 13, 2014]The purpose of this notice is to announce the issuance of the following final bulletin by the Department of Public Welfare (Department) under section 4(d) of the Preventable Serious Adverse Events Act (Act 1) (35 P. S. § 449.94(d)). In addition, the Department intends to amend its methods and standards for payment of Medical Assistance (MA) to nonpublic and county nursing facilities for preventable serious adverse events (PSAE) beginning October 1, 2014.
Background
The Department announced its intent to issue a bulletin addressing PSAEs in nonpublic and county nursing facilities at 40 Pa.B. 6042 (October 16, 2010). In developing this proposed bulletin, the Department consulted representatives of the nursing facility trade associations, representatives of individual nursing facilities and the Long-Term Care Delivery System Subcommittee of the Medical Assistance Advisory Committee (LTC Subcommittee). There were 35 commentator responses to the proposed bulletin during the 30-day public comment period.
Subsequent to the publication of the proposed bulletin, the Centers for Medicare and Medicaid Services (CMS) published a final rule at 76 FR 32816 (June 6, 2011) that included, among other things, the addition of 42 CFR 447.26 (relating to prohibition on payment for provider-preventable conditions). This new Federal regulation requires that no MA will be paid for provider-preventable conditions (PPC) as defined in 42 CFR 447.26. The PPCs are divided into two parts, health care-acquired conditions and other provider-preventable conditions (OPPCs). OPPCs apply to nursing facilities. The three mandatory OPPCs (wrong surgical or other invasive procedure performed on a patient; surgical or other invasive procedure performed on the wrong body part; surgical or other invasive procedure performed on the wrong patient) are included in the Commonwealth's currently approved State Plan effective July 1, 2011. The State Plan will be amended so that nonpublic and county nursing facility payment policies and procedures for the three mandatory OPPCs align with the PSAEs for nonpublic and county nursing facilities. All other PSAE events listed in Appendix A will be considered ''additional OPPCs'' for nonpublic and county nursing facilities under the Commonwealth's State Plan.
In addition, the Department met with the nursing facility trade associations again in 2012, 2013 and 2014 for further discussion and review and comment on the final bulletin. The Department considered those comments and Federal regulations in developing the following final bulletin.
Public Comment—Discussion of Comments and Major Changes
Following is a summary of the major comments received within the public comment period following publication of the proposed bulletin and the Department's response to those comments.
PSAEs—Criteria
Numerous commentators contended that the definition and criteria of a PSAE is broad and subjective and determining if an event is a PSAE is not a task that will be easily accomplished. Commentators requested the Department provide specific examples of PSAEs like the screening codes, ICD-9 and E-codes, found in MA Bulletin 01-07-11, Preventable Serious Adverse Events, which addresses PSAEs in acute care hospitals. In addition, several commentators questioned what constitutes a system failure and what is within the control of a nursing facility.
Response
An event qualifies as a PSAE if it was preventable, serious, within the control of the nursing facility and a result of an error or other system failure within the nursing facility. Each nursing facility has policies and procedures in place to assure appropriate resident treatment and safety based on Nationally accepted standards of care, such as The Joint Commission, the National Quality Forum, the Centers for Disease Control and Prevention (CDC) and the CMS. The nursing facility is responsible for the development, review and revision of individual resident care plans and for the actions of staff. If an event occurs, because of a breakdown in the nursing facility's policies or procedures or because the nursing facility fails to follow the individual resident's care plan while providing care for the resident, this would constitute a system failure.
Hospitals are very dependent on Diagnosis Related Groups and ICD-9 codes for billing. E-codes permit the classification of environmental events, circumstances and conditions as the cause of injury, poisoning and other adverse effects. The specificity required for hospitals made defining their PSAEs by code easier. Nursing facilities, however, are not required to use ICD-9 codes and E-codes as extensively. For any incident or accident, the nursing facility is required to investigate the circumstances internally for the Quality Assurance process. For instance, if a resident is given insulin intended for the roommate with resultant unconsciousness and hospitalization, the event may be a PSAE, but no code would be used by a nursing facility.
PSAEs—Events
The Department received numerous comments inquiring if a particular event listed in Appendix A in a specific set of circumstances would be considered a PSAE. In addition, commentators asked for certain events to be eliminated or modified in Appendix A, as some stated that these events may be unpreventable even under the best of circumstances and when given proper medical care. Others asked for further clarification of the events listed. In addition, a commentator stated that Act 1 is one in a series of similar legislation that affect patient safety and provider accountability and recommended that the PSAE list be combed to eliminate redundant reviews covered under the act of July 20, 2007 (P. L. 331, No. 52), regarding health care-associated infections, and other legislation. Also, a few commentators asked if certain events were on the list of PSAEs for hospitals. Another commentator requested that when the National Quality Forum serious reportable events (SRE) in health care list is updated that the Department consider reconvening the stakeholder workgroup to compare the National Quality Forum SREs list to the Department's PSAE list for nursing facilities and modify as deemed appropriate.
Response
The Department recognizes that not every event listed in Appendix A will be a PSAE. The Department cannot list every possible set of circumstances that would result in an event being a PSAE. The Department will consider if the event listed in Appendix A was: (1) preventable; (2) serious; (3) within the control of the nursing facility; and (4) a result of an error or other system failure within the nursing facility.
All four of these criteria must be met for the event to be considered a PSAE. The list of PSAEs was developed in accordance with the requirements of Act 1. The Department will consult with representatives of the nursing facility trade associations, representatives of individual nursing facilities and the LTC Subcommittee and provide a 30-day public comment period prior to any future modifications to the list of events.
After considering all the viewpoints, the National Quality Forum SREs list as of November 4, 2013, and in consultation with a panel of physicians representing the Department, the LTC Subcommittee, the Pennsylvania Health Care Association and the Pennsylvania Association of County Affiliated Homes, Appendix A has been modified with major changes as follows:
The following events were deleted from the proposed PSAE events list:
• Under Surgical Events, (1)(D) Unintended retention of a foreign object in a resident after surgery or other procedure.
• Under Care Management Events:
o (4)(B) Severe allergic reaction.
o (4)(C) A hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products.
o (4)(E) Catheter-associated Urinary Tract Infection.
o (4)(F) An event related to spinal manipulative therapy.
o (4)(G) Vascular catheter-associated infection.
o (4)(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.
• Under Environmental Events, (5)(B), An event relat- ed to a fall (fractures/dislocations/intracranial injuries/crush injuries/burns) while being cared for in a nursing facility.
The following event was added under Care Management Events—''resident death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results.''
The Department also made several modifications to the events list. The surgical events were modified to mirror the Federal regulation in 42 CFR 447.26(b)(v). The Department also added ''resident death or serious injury'' at the beginning of most events.
Under Patient Protection Events relating to suicide, the Department added ''or self-harm that results in serious injury'' and relating to elopement deleted ''for more than four hours'' for a disappearance. Under Care Management Events relating to ulcers, the Department added ''any preventable'' before Stage 3, ''unstageable'' before pressure ulcers and ''/presentation'' after ''admission.''
Under Environmental Events, relating to oxygen or other gas delivered to a patient, the Department added ''no gas'' to the list and relating to restraints added ''physical'' before restraints.
Under Potential Criminal Events the following changes were made: for the event relating to sexual assault added ''abuse/'' before ''assault'' and ''within or on the grounds of a nursing facility'' after ''resident'' and for the event relating to physical assault added ''within or on the grounds of a nursing facility'' after ''battery.''
The scope of this bulletin does not include hospitals. Two MA Bulletins (01-07-11, Preventable Serious Adverse Events and 01-08-11, Preventable Serious Adverse Events) were issued for hospitals on January 14, 2008, and November 26, 2008. Another MA Bulletin (01-12-30, Provider Preventable Conditions) was issued for multiple providers including hospitals on June 15, 2012. These MA Bulletins are available on the Department's web site at http://www.dpw.state.pa.us/publications/bulletinsearch/index.htm.
Identification and Review of a PSAE and Services Required to Correct or Treat a PSAE—Appeals
A commentator questioned how the Bureau of Hearings and Appeals (BHA) will interact with the Department regarding decision processes and how many appeals are anticipated. Two commentators asked what the time frame is for filing an appeal. Another commentator recommended the Department better define the review and adjudication process that will be followed in addressing alleged violations.
Response
The Department will include appeal information in the final notification letter likewise found within nursing facility audit and rate letters. If the nursing facility does not agree with the Department's determination, the nursing facility may appeal to the BHA under 55 Pa. Code Chapter 41 (relating to Medical Assistance provider appeal procedures). The appeal must be filed within 33 days of the date of the final notification letter. The Department anticipates the number of confirmed PSAEs to be minimal; therefore, costs and the number of appeals should also be minimal.
Identification and Review of a PSAE and Services Required to Correct or Treat a PSAE—Existing Departmental Reviews
One commentator stated that it is unclear when claims reviews, utilization management reviews and Department integrity reviews will occur. Another commentator contended that the bulletin duplicates some of the utilization medical reviews of the resident assessments submitted by each nursing facility.
Response
This bulletin does not change the routine of these existing reviews. Further, PSAE reviews will not duplicate reviews completed by staff in the Division of Nursing Facility Field Operations. They may coincidentally review the same resident record; however, the review criteria are different. When Field Operations reviews a resident assessment, they are looking to see if the documentation in the resident's clinical record supports the Minimum Data Set (MDS) item response. When the PSAE team reviews a record, they will be looking to see if an adverse event is a PSAE. On occasion, Field Operations has made a referral to the Department of Health (DOH) or the Ombudsman regarding quality care issues (for example, suspected abuse) after discussion with the nursing facility.
Identification and Review of a PSAE and Services Required to Correct or Treat a PSAE—Reporting
Commentators stated that the method to report a PSAE is not identified. Another commentator questioned if PSAE reporting should apply for a resident in a nursing facility whose care is being paid for by private pay, Medicare or other third-party payment.
Response
Instructions for reporting a PSAE will be posted on the Department's web site at http://www.dpw.state.pa.us/provider/doingbusinesswithdpw/longtermcarecasemixinformation/index.htm. PSAE reporting applies to any resident receiving MA.
Identification and Review of a PSAE and Services Required to Correct or Treat a PSAE—Residents' Rights
Commentators asserted that the bulletin fails to recognize that residents often make choices that are not in their best interest medically, including the right to refuse professional intervention.
Response
The Department agrees that residents have rights and can make their own choices assuming they have decision making capacity; thus, nursing facilities should ensure that residents' decisions are documented on their care plans in the event a PSAE review occurs.
Identification and Review of a PSAE and Services Required to Correct or Treat a PSAE—Review Determination Process
A few commentators recommended that the review process be included as an appendix to the PSAE bulletin. One commentator asserted that facilities should have the ability to discuss Department findings before a final determination is rendered. A commentator asked who is responsible when determining that an event qualifies as a PSAE, whether it is done by a person, committee, panel or physician. Another commentator suggested the Department have an arbitrary panel of geriatricians review PSAEs, because from a provider's perspective, a Medical Director hired by the Commonwealth may be in conflict with the overall determination.
Response
The nursing facility's representative will have an opportunity to discuss the initial findings with the Department before a final notification letter is sent as referenced in the PSAE review and determination process posted on the Department's web site at http://www.dpw.state.pa.us/provider/doingbusinesswithdpw/longtermcarecasemixinformation/index.htm. All potential PSAEs will be investigated by a panel of physicians to include a review of the resident's care plans and whether the established care plans were followed. The Department will review events from a quality control perspective, as a result of care protocols including those supported by The Joint Commission, the National Quality Forum, the CDC and the CMS. The PSAE review process will be posted on the Department's web site. The Department will notify all nursing facilities when revisions to the review process have been posted on its web site. As with other instances regarding an audit, review or survey, a provider may appeal if the provider does not agree with the Department's determination.
Claims—Bed Hold
One commentator requested clarification on whether the bed hold requirement is 15 days or if it is held indefinitely if a PSAE occurs. Another commentator asked how the bed hold calculations would be impacted.
Response
The hospital bed hold requirement is 15 days per hospitalization whether a PSAE is identified or not. In accordance with 55 Pa. Code § 1187.104(b)(1)(i) (relating to limitations on payment for reserved beds), a resident receiving nursing facility services is eligible for a maximum of 15 consecutive reserved bed days per hospitalization. The final bulletin does not infringe on the bed hold occupancy percentage calculation.
Claims—Billing
The Department received numerous comments about billing procedures and billing questions for a specific set of circumstances. Commentators questioned submissions and processing in PROMISe, computer programming changes, billing to Medicare and Medicaid, billing after a hospital stay, services for a PSAE and comorbidity, Case Mix Index (CMI) changes, MA-11 reporting requirements and the procedures for resident assessments. Several commentators recommended that the Department include billing procedures in the final bulletin or post the procedures on the Department's web site. A few commentators expressed concerns with Medicaid rates not being current and the potential for incorrect billing.
Response
The Department will post billing instructions on its web site at http://www.dpw.state.pa.us/provider/doingbusinesswithdpw/longtermcarecasemixinformation/index.htm pertaining to submission of claims relating to PSAEs and claims relating to services to correct or treat a PSAE as referenced in the final bulletin. Section 2 of the final bulletin (relating to guidelines: claims relating to PSAEs and to services to correct or treat the PSAE) provides minimum claims guidelines for compliance with Act 1. For example, a claim may not be submitted for a PSAE involving an MA resident and if a claim is incorrectly billed, a claim adjustment may be processed by the Department. In addition, the day of the event and hospital reserve bed days related to a PSAE shall be recorded as a private pay and other day for purposes of Pennsylvania's Nursing Facility Assessment Program and as a noncovered day or days on the resident census. Also, exceptional durable medical equipment costs related to a PSAE shall be reported as nonallowable costs on the cost report. The Department does not anticipate that any computer programming changes related to the billing process will be necessary for nursing facility providers or the Department. In addition, the requirements for submitting a resident assessment have not changed.
Claims—Eligibility
A commentator asked whether the bulletin is strictly for Medicaid residents or if it pertains to Medicare dual eligible and managed care providers as well. Some commentators asked how the county nursing facilities and State veterans homes would adjust the resident care portion of their rate since their rates are calculated differently than the nonpublic nursing facilities.
Response
This bulletin only applies to MA residents, including MA managed care and dual eligibles, within general, hospital-based, special rehabilitation and county nursing facilities.
In addition, the final bulletin does not direct a nursing facility to adjust the resident care portion of the MA per diem rate related to a PSAE or for services to correct or treat a PSAE.
Claims—Estimate
A commentator asked for an estimate of the number of PSAE claims expected within the first few years of implementation.
Response
The Department anticipates the number of confirmed PSAEs to be minimal, but currently cannot provide future projections on PSAE claims.
Claims—Payment Reduction
A commentator supported the proposed provision that only the resident care portion of the MA payment will be affected rather than the full per diem amount. In time, the commentator hopes that this approach may be refined for determining what a facility should or should not be paid. A commentator also recommended PSAEs fall under the process similar to the imposition of a civil monetary penalty or overpayment recoupment. As a result, it would keep the process simple, avoids costly computer programming for either the provider or the Commonwealth and avoids patient day reconciliation issues on audits.
Response
The Department agrees and will continue discussions with the nursing facility trade associations looking for opportunities to improve the methodology. Under section 3 of Act 1 (35 P. S. § 449.93), a health care provider may not knowingly seek payment from a health payor or patient for a PSAE or any services required to correct or treat the problem created by a PSAE. In addition, 42 CFR 447.26 also directs the payment policy for PPCs which impacts OPPCs and PSAEs. No MA will be paid for PPCs. The final bulletin reflects significant changes to the guidelines related to claims thus simplifying the process for PSAE-related claims. Also, the Department does not anticipate any computer programming changes related to the billing process will be necessary for nursing facility providers or the Department. In addition, the final bulletin does not change the requirements for reporting patient days on the cost report.
Claims—Refunds by Provider
Several commentators claimed that 30 days is not sufficient time to resolve and administer PSAE refunds, both for the provider and the Department. One commentator asserted that it is unfair to require a facility to refund money prior to a PSAE review process. Another commentator contended that the Department is holding providers to a higher than reasonable standard and asked whether there are additional penalty provisions when at first an incident does not qualify as a PSAE, but then at a later date the Department cites the event as a PSAE.
Response
The Department disagrees. Once a nursing facility concludes that a PSAE has occurred, section 3(b) of Act 1 requires that payment shall be refunded within 30 days of discovery or receipt of payment for a PSAE or services to correct or treat a PSAE, whichever is later. The bulletin does not increase standards for quality nursing home care and does not address any additional penalty provisions.
Claims—Refunds by the Department
A commentator requested a retrospective reimbursement within 15 days if the Department determines the PSAE did not occur. Another commentator stated that the timing of reimbursement payments is unclear.
Response
Retrospective reimbursements will be processed when the nursing facility submits a claim adjustment. The usual time frame for the processing of claim adjustments is 30 days.
Duration of Payment—Clinical Reviews and Redetermination
Several commentators stated that nursing facilities should be allowed to request a clinical review any time it is necessary, instead of every 90 days. The commentators asked for more flexibility and requested a clinical review be permitted whenever the facility's Medical Director or the resident's attending physician determines that the resident's condition warrants a clinical review. A commentator stated that if a resident's higher CMI is no longer due to the PSAE, the payment restriction should be retroactive to the date of the facility's written request for a clinical review. Another commentator questioned how the Department will determine if the post-PSAE score is attributable to reasons other than the PSAE and if the facility will be reimbursed at a higher rate if the resident's health condition is not related to a PSAE. One commentator contended that trying to figure out decline, preventable or not, is extremely difficult to determine as it is a normal part of the aging trajectory. A commentator asked if an algorithm exists for determining a significant change on the MDS. One commentator requested the Department clarify the standards to be used to identify the duration for which the facility will see a reduction in payment for the event.
Response
After careful consideration of the comments and further discussion with the nursing facility trade associations, the Department made significant changes to the bulletin, including deleting section 2(b)(v) in the proposed bulletin (relating to duration of payment restrictions). Section 2(b) in the final bulletin (relating to claims relating to services to correct or treat a PSAE) provides minimum guidelines for purposes of determining the value of claims relating to services to correct or treat problems caused by the PSAE.
Duration of Payment—Payment Standards
Some commentators stated the duration of payment standards for nursing facilities are inconsistent with those of acute care hospitals, as acute care hospitals are not penalized beyond the time period of the PSAE or the treatment of the PSAE. One commentator requested clarification regarding the time limit for a review. A few commentators asked the Department to identify the duration for which the facility will see a reduction in payment and suggested changing the time limit from using its best efforts to complete the process within 30 days to no longer than 30 days, while another commentator believes the 30-day process is too long.
Response
The Department agrees that circumstances relating to a PSAE in an acute care hospital are significantly different than in a nursing facility regarding payment and rate setting; therefore, the bulletin reflects this difference.
Further, as mentioned previously, the Department made significant changes to the bulletin, including deleting section 2(b)(v) in the proposed bulletin (relating to duration of payment restrictions). Section 2(b) in the final bulletin provides minimum guidelines for purposes of determining the value of claims relating to services to correct or treat problems caused by the PSAE.
Fiscal Impact
One commentator asked if any cost analysis data was completed to determine whether there is a fiscal impact. Several commentators also remarked that the bulletin indicates no fiscal impact to the Commonwealth, but believe there will be resulting from added care staff, appeals, education, trainings and meetings. Commentators are also concerned that there will be a financial burden due to an increase in administrative costs to comply with the requirement to not ''knowingly seek payment for a PSAE, or for any services required to correct or treat a PSAE,'' as well as for the additional requirement to recalculate Resource Utilization Group (RUG) scores after the PSAE or if hospitalized.
Response
The provisions of this bulletin should not increase the nursing facility's staff time. Participating nursing facilities are required to address quality assessments and assurances as an established requirement of participation in the MA Program. The Department is authorized to request and review medical and fiscal records, including a facility's policies and procedures, under 55 Pa. Code §§ 1101.71 and 1187.22(9) (relating to utilization control; and ongoing responsibilities of nursing facilities), section 1402(b) of the Public Welfare Code (62 P. S. § 1402(b)) and 42 CFR Part 483 (relating to requirements for states and long term care facilities). The DOH licensure regulations also include provisions for quality assurance and patient safety. In addition, section 3 of Act 1 directs the payment policy for PSAEs. A health care provider may not knowingly seek payment from a health payor or patient for a PSAE or any services required to correct or treat the problem created by a PSAE. See section 3(a) of Act 1. The bulletin does not require any additional resident assessment requirements or the recalculation of the RUG scores.
Department functions related to PSAEs will be handled by the existing staff complement.
General—Care Protocols and Policies
One commentator recommended the Department develop a list of care protocols and policies, create a list of best practices and make the information available to nursing facility providers to help minimize potential PSAEs.
Response
The nursing facility is responsible for developing a care plan that is appropriate for the resident's con- ditions and needs and reflects the resident's choices regarding their care. For example, the Resident Assessment Instrument (RAI) manual contains care protocols and current practices and is available on the CMS's web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/MDS30RAIManual.html. The RAI manual is currently used by nursing facilities to assist with the development of policies and procedures that assure appropriate resident treatment and safety. A nursing facility is responsible to determine the root cause and review their protocols, processes, policies and procedures and revise as necessary to prevent recurrences if there is an incident, accident or event involving a resident. As a courtesy, references pertaining to care protocols and current practices that can be used to assist nursing facilities with the development of policies and procedures will be posted on the Department's web site at http://www.dpw.state.pa.us/provider/doingbusinesswithdpw/longtermcarecasemixinformation/index.htm.
General—Compliance
Commentators expressed concerns over compliance with the Health Insurance Portability and Accountability Act (HIPAA) and corporate compliance regulations during the review process.
Response
The Department issued the PSAE bulletin in accordance with Act 1. The bulletin does not infringe on HIPAA provisions or jeopardize compliance with HIPAA requirements and compliance with Federal participation requirements.
General—Resident Outcomes
A commentator contested that the proposed PSAE bulletin does not focus on improved resident outcomes, but instead towards more unnecessary paperwork.
Response
In an effort to improve quality of care, Act 1 was enacted on June 10, 2009. Act 1 directed the Department to issue a PSAE bulletin for nursing facilities, which was developed in accordance with this act. See section 4 of Act 1.
The final bulletin includes a list of events, based on those adopted by the National Quality Forum, which occur in a health care facility and are within the health care provider's control to avoid. If a PSAE occurs, nursing facilities should take appropriate actions when there is an incident, accident or event involving a resident. The facility should determine the root cause of the event and review their protocols, processes, policies and procedures and revise as necessary to prevent recurrences. The Department expects the number of PSAEs to be minimal; however, if a potential PSAE is identified, paperwork is a necessity for the review and determination process. Under 55 Pa. Code §§ 1101.71 and 1187.22(9), section 1402(b) of the Public Welfare Code and 42 CFR Part 483, the Department is authorized to request and review medical and fiscal records, including policies and procedures, from the facility.
General—Litigations and Consequences
Commentators asserted that PSAEs will put a burden on facilities, expose them to lawsuits and create a time-consuming process. Another commentator asked if the information requested will be used for any consequences or targeting.
Response
Under section 3(d) of Act 1, ''Any information provided to any health payor or health care provider, in compliance with subsections (b) and (c), shall not be discoverable or admissible in any civil or administrative action related to the act of March 20, 2002 (P. L. 154, No. 13), known as the Medical Care Availability and Reduction of Error (Mcare) Act.''
General—Services to MA Residents
A few commentators questioned whether these new procedures contain flaws that jeopardize services to MA individuals and seniors, potentially inhibiting their access to long-term care. In addition, several commentators expressed concern that consumers may be denied access to care because of their likelihood to develop an event. Another commentator suggested that there may be costs to consumers as a result of the bulletin. One commentator claimed their costs will soar because hospitals will not be able to find placement for residents with histories of falls, infections and wounds. A commentator contended that the Department needs to deal with problem facilities directly. Another commentator asserted that the bulletin is being used to penalize facilities and not as an enhancement to quality.
Response
The Department disagrees. Under section 4 of Act 1, the Department is required to issue a PSAE bulletin for nursing facilities that specifies PSAEs. The bulletin does not specifically direct or recommend any preclusion for admission and does not affect access decisions by nursing facilities. In addition, the event must meet all four PSAE criteria. The Department will review the records of the nursing facility to determine if the event was preventable, serious, within the control of the nursing facility and a result of an error or other system failure within the nursing facility.
General—Stakeholder Guidance
Commentators suggested that further reviews and additional meetings be held to stay in constant communication, to share data related to retrospective reviews and screening methodologies and to fully incorporate the stakeholders' suggestions because opportunities were missed relating to such issues as billing, quality assurance, collaborative effort, Appendix A and self-reporting, among others.
Response
The Department agrees it is important to be transparent with its stakeholders. The Department held numerous meetings with stakeholders regarding the proposed bulletin and has carefully considered all public comments received in response to the proposed bulletin. The Department will continue to review the National Quality Forum list to determine if the bulletin should be revised. Before making any PSAE modifications, the Department will consult with representatives of the nursing facility trade associations, representatives of individual nursing facilities and the LTC Subcommittee. Further, under section 7(c) of Act 1 (35 P. S. § 449.97(c)), any modifications to the bulletin require a 30-day comment period. The Department intends to monitor the program and share data as appropriate with both providers and the nursing facility trade associations by means of the LTC Subcommittee.
General—Training
Several commentators requested that the Department provide education and technical training to providers. A commentator stated that most nurses do not have the training or desire to understand Medicaid and CMI, but instead are focused on communication and resident needs. Other commentators stated the importance of allocating a sufficient implementation time frame. Also, commentators questioned the costs associated with training.
Response
The Department will provide training and a provider helpline is available at (800) 932-0939 for technical assistance. Training information will be e-mailed to nonpublic and county nursing facility providers by the Bureau of Quality and Provider Management. Further, the DOH licensure regulations include provisions for quality assurance and patient safety.
Fiscal Impact
There is no cost to MA recipients as a result of this bulletin. The costs associated with this bulletin apply to MA nursing facility providers. The fiscal impact is specific to the PSAE within a specific MA nursing facility. The nursing facility will not be paid for the PSAE or for services required to correct or treat the problem created by a PSAE.
Effective Date
This final bulletin is effective October 1, 2014, and is contingent upon approval of a related State Plan Amendment by the CMS.
Public Comment
Interested persons are invited to submit written comments regarding this bulletin to the Department of Public Welfare, Office of Long-Term Living, Bureau of Policy and Regulatory Management, Attention: Marilyn Yocum, P. O. Box 8025, Harrisburg, PA 17105-8025. Comments received within 30 days will be reviewed and considered for any subsequent revision of the 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).
BEVERLY D. MACKERETH,
SecretaryFiscal Note: 14-NOT-896. No fiscal impact; (8) recommends adoption.
FINAL 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.
SCOPE
This bulletin applies to MA-enrolled county and non-public (including hospital-based and special rehabilitation) nursing facilities.
BACKGROUND/INTRODUCTION
In 2009, the General Assembly enacted legislation that imposed payment restrictions on health care providers when a PSAE occurs. See Act of June 10, 2009 (P. L. 1, No. 1), codified at 35 P. S. §§ 449.91—449.97 (Act 1). As a general principle, a health care provider may not knowingly seek payment from a health payor or from a patient for a PSAE or for any corrective services. 35 P. S. § 449.93(a). Additionally, if the health care provider unknowingly seeks payment for the PSAE or for any corrective services and, later, discovers the issue, then the provider is further obligated to notify the health payor or patient and to pay a refund. 35 P. S. § 449.93(c). The phrase ''health payor'' includes the MA Program. With respect to the MA Program specifically, Act 1 directs the Department of Public Welfare (''the Department'') to issue a bulletin that contains a list of PSAEs for nursing facilities. 35 P. S. §§ 449.94(a) and 449.97(g).
Subsequent to the codification of Act 1, the Centers for Medicare and Medicaid Services (CMS) published a final rule at 76 FR 32816 (June 6, 2011) that includes, among other things, the addition of 42 CFR § 447.26 (relating to prohibition on payment for provider-preventable conditions). These new Federal regulations require that no Medical Assistance will be paid for ''provider-preventable conditions'' (PPCs) as defined in 42 CFR § 447.26. The PPCs are divided into two parts, health care-acquired conditions and other provider-preventable conditions (OPPCs). OPPCs apply to nursing facilities. The three mandatory OPPCs (wrong surgical or other invasive procedure performed on a patient; surgical or other invasive procedure performed on the wrong body part; surgical or other invasive procedure performed on the wrong patient) are included in the Commonwealth's currently approved State Plan effective July 1, 2011. The State Plan will be amended so that all other PSAE events listed in Appendix A will be considered additional OPPCs for nonpublic and county nursing facilities for purposes of the Commonwealth's State Plan.
This bulletin sets forth guidance for purposes of nursing facility compliance with Act 1 and 42 CFR § 447.26 as it relates to the MA Program. If an MA-enrolled nursing facility follows the guidelines in this bulletin, then the Department will consider the MA-enrolled nursing facility as having met its obligations to the Department under Act 1. However, the nursing facility should not construe satisfactions of the guidelines as compliance with other requirements under Act 1 or any other law.
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.
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 7 days or still present at the time of discharge from a nursing facility.
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.
4. The event occurred as a result of an error or other system failure within the nursing facility.
The Department may modify both the list of PSAEs identified in Appendix A and its payment policies and procedures in the future subject to receiving an approved State Plan Amendment. 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 Delivery System Subcommittee of the Medical Assistance Advisory Committee. The Department will also provide for a 30-day public comment period.
COMPLIANCE WITH ACT 1:
1. Identification and Review of a PSAE and of the Services Required to Correct or Treat a PSAE
a. Responsibilities of the Nursing Facility
As a general principle, a health care provider may not knowingly seek payment from a health payor or from a patient for a PSAE or for any corrective services. 35 P. S. § 449.93(a). Therefore, whenever an event listed in Appendix A occurs in a nursing facility, the nursing facility must independently determine whether the event satisfies the PSAE criteria specified above and whether it has complied with the requirements of Act 1.
If the nursing facility concludes that the event constitutes a PSAE, the nursing facility may not submit a claim for payment of services associated with the PSAE or for payment of any services required to correct or treat the PSAE.
If the nursing facility discovers that payment has unknowingly been sought for a PSAE or for services required to correct or treat problems created by the PSAE, then the nursing facility shall immediately notify the MA Program. Information relating to such reports can be found on the Department's website.
In the event that the nursing facility received payment for the PSAE or for any services that were required to correct or treat the problems created by the PSAE, then the nursing facility shall refund any payment received within 30 days of discovery or receipt of payment, whichever is later.
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 existing 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 (relating to utilization control; enforcement actions by the Department; and restitution and repayment).
With both facility-reported PSAEs and Department-identified PSAEs, the Department will determine whether the event meets the criteria of a PSAE and whether the guidelines of the bulletin have been satisfied.
In the event the Department initiates a review of an event, the Department will notify the nursing facility, in writing, that it has initiated its review. As part of its review, the Department may request medical and fiscal records, including policies and procedures, from the facility concerning the resident or the event, or both. 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 involved 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 Department's website at http://www.dpw.state.pa.us/provider/doingbusinesswithdpw/longtermcarecasemixinformation/index.htm.
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 under 55 Pa. Code Chapter 41 (relating to medical assistance provider appeal procedures).
2. Guidelines: Claims Relating to PSAEs and to Services to Correct or Treat the PSAE
The Department pays MA-enrolled nursing facilities for services provided to MA-eligible persons through a prospective per diem rate and other additional payments (for example, allowable cost payment related to Pennsylvania's Nursing Facility Assessment Program and supplemental payments in accordance with the Commonwealth's Medicaid State Plan). In the context of this payment system, the Department sets forth the following minimum claims guidelines for compliance with Act 1.
a. Claims relating to PSAEs
In those instances where a PSAE occurs, the nursing facility may not submit a claim for payment of the MA per diem rate for the day of the event and shall record the day as a non-covered day on the resident census. In addition, the nursing facility shall record the day of the event as a private pay and other day on the quarterly Resident Day Reporting Form (RDR Form) related to Pennsylvania's Nursing Facility Assessment Program. Further, the nursing facility shall not seek payment from any other payor source, including the resident, for the day of the event.
b. Claims Relating to Services to Correct or Treat a PSAE
For purposes of determining the value of claims relating to services to correct or treat problems caused by the PSAE, the nursing facility must satisfy the following minimum guidelines:
i. Hospital Reserve Bed Days
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 Medicaid participation requirements). The nursing facility shall record any PSAE-related hospital reserve bed days as non-covered days on the resident census. In addition, the nursing facility shall record those days as private pay and other days on the quarterly Resident Day Reporting Form (RDR Form) related to Pennsylvania's Nursing Facility Assessment Program.
ii. 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. In addition, the nursing facility shall report those exceptional DME costs as nonallowable costs on their cost report.
If an MA-enrolled nursing facility follows the guidelines in this bulletin, the Department will consider the nursing facility as having satisfied its Act 1-related obligations to the Department. Nonetheless, Act 1 specifically directs the health care providers to not knowingly seek payment for PSAEs and for corrective services. Therefore, the nursing facility remains obligated not to seek or to receive payments for the PSAE or for services to correct or treat problems caused by the PSAE, to provide appropriate notice and to refund applicable payments.
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.
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 7 days or still present at the time of discharge from a nursing facility.
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.
4. The event is the result of an error or other system failure within the nursing facility.
1. Surgical or Invasive Procedure Events
A. Wrong surgical or other invasive procedure performed on a patient
B. Surgical or other invasive procedure performed on the wrong body part
C. Surgical or other invasive procedure performed on the wrong patient
2. Product or Device Events
A. Resident death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the nursing facility
B. Resident death or serious injury associated with the use or function of a device in patient care, in which the device is used or functions other than as intended
C. Resident death or serious injury associated with intravascular air embolism that occurs while being cared for in a nursing facility
3. Patient Protection Events
A. Resident death or serious injury associated with resident elopement (disappearance)
B. Resident suicide, attempted suicide, or self-harm that results in serious injury, while being cared for in a nursing facility
4. Care Management Events
A. Resident death or serious injury associated with a medication error (such as, errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)
B. Any preventable Stage 3, Stage 4, and unstageable pressure ulcers acquired after admission/presentation to a nursing facility
C. Resident death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results
5. Environmental Events
A. Resident death or serious injury associated with an electric shock in the course of a patient care process in a nursing facility
B. Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or are contaminated by toxic substances
C. Resident death or serious injury associated with a burn incurred from any source in the course of a patient care process in a nursing facility
D. Resident death or serious injury associated with the use of physical restraints or bedrails while being cared for in a nursing facility
6. Potential Criminal Events
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 of any age
C. Sexual abuse/assault on a resident within or on the grounds of a nursing facility
D. Death or serious injury of a resident resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a nursing facility
[Pa.B. Doc. No. 14-1932. Filed for public inspection September 12, 2014, 9:00 a.m.]
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