CMS Revises Several Regulations in Appendix PP

The Centers for Medicare & Medicaid (CMS) released a Quality, Safety & Oversight Group (QSO) Memo on November 18, 2024. QSO-25-07-NH incorporates revised Appendix PP regulations including Admission, Transfer & Discharge, Chemical Restraints/Unnecessary Psychotropic Medication, Resident Assessment, Quality of Life and Quality of Care, Administration, Quality Assurance Performance Improvement (QAPI), Infection Prevention and Control, and other areas including clarifications and technical corrections have also been made throughout Appendix PP. The memo lists an effective date of February 24, 2025, and surveyor resources will be finalized and released on that date as well. Advanced copies are currently available and included in the memo. The revised guidance is outlined below.

Admission, Transfer, and Discharge:

F-Tags 622 – 626 and F660 – F661 were removed with two new regulations being added under F627 – Inappropriate Transfers and Discharges and F628 – Transfer and Discharge Process.

The regulatory language under F627 combines the regulatory language from the former F622 – F626. Changes include revisions in the intent and interpretative guidance.

The intent of the regulation is to address inappropriate discharges by ensuring:

• Policies are developed and implemented which allow residents to return to the nursing home following hospitalization or therapeutic leave.
• Ensuring that the nursing home does not transfer or discharge a resident in an unsafe manner such as to a location that is unable to meet their needs, does not provide needed support and resources, or does not meet the resident’s preferences and therefore should not have occurred.
• Ensuring the discharge planning process addresses each resident’s discharge goals and needs.

The interpretative guidance directs surveyors to begin determining compliance in offsite preparation and instructs the team coordinator (TC) to contact the local ombudsman and inquire if there are specific residents that they have received complaints about regarding potential inappropriate discharges. Evidence of noncompliance may include, but is not limited to:

• Evidence does not support the basis for discharge such as:
  • Discharge based on the inability to meet the resident’s need without evidence of attempts to meet the needs, or an assessment indicating what needs could not be met.
  • Discharge based on improvement in the resident’s health such that services are no longer needed, however, documentation indicates the resident’s health did not improve or actually declined.
  • Discharge based on the failure to pay, however, there is a lack of evidence that the nursing home offered the resident to pay privately or apply for medical assistance or that the resident refused to pay or have Medicare or Medicaid pay for services.
  • The discharge occurred despite an appeal which is pending and a lack of documentation to support that the failure of discharge would endanger the health or safety of others in the nursing home.
  • When evidence in the medical record shows the resident was not allowed to return following hospitalization or leave without a valid basis for discharge.
  • When there is no evidence that the nursing home considered the care giver’s availability, capacity, or capability to perform necessary care following discharge.
  • The post-discharge care plan did not address the resident’s limitations in ability to provide care for themselves.

Nursing homes must ensure that if the resident is being discharged based on the nursing home’s inability to meet the resident’s needs an assessment of the resident’s status must be completed at the time of the proposed return to the nursing home or there cannot be a determination of the nursing home’s inability to meet the resident’s needs or that the health and safety of other individuals would be endangered.

If a resident has appealed their discharge and obtained a favorable ruling, the resident or their representative may choose to report the discharge as a compliant to the State Survey Agency (SSA). However, the SSA cannot take survey action, citing noncompliance exclusively based on the ruling of the hearing. Surveyors must identify in a compliant survey if other noncompliance was present, citing the appropriate tag and scope and severity. In addition, if the resident was discharged and it was determined that the discharge location was not to a location or setting that is able to meet their health or safety needs, the plan of correction should state that the nursing home will either, readmit the resident until a safe and compliant discharge can be completed or coordinate a transfer of the resident to another setting that will be safe.

Violations of F627 would generally be cited at the severity of a harm or immediate jeopardy level when using the reasonable person approach in considering psychosocial outcomes as well as the likelihood for serious physical harm resulting from an unsafe discharge. For citations at any level of scope and severity, if the discharged resident’s health and/or safety is threatened in the setting they are currently located, the plan of correction should state that either the nursing home will readmit the resident until a safe and compliant discharge can be completed or coordinate a transfer of the resident to another setting where they will be safe. Substantial compliance should not be achieved until one of these two items is complete (and all other noncompliance has been corrected).

F628 is a new regulation that includes information required for documentation of transfers and discharges. The regulatory language includes what information must be communicated to the receiving location, the notice before a transfer (including notifying the LTC Ombudsman of the transfer), timing of transfer and discharge notices, notice of closure, bed hold information, and discharge summaries. The regulatory language previously was incorporated into several regulations.

The intention of this regulation is to ensure that the nursing home adheres to all applicable components of the process for transferring or discharging a resident which include documentation and information conveyed to the receiving provider, the notice of the transfer or discharge, notice of bed-hold policy, and completing the discharge summary. The interpretative guidance included in this regulation only included minor technical and wording changes.

Chemical Restraints/Unnecessary Psychotropic Medications:

Previous regulations regarding chemical restraints were found under F605 and Unnecessary Psychotropic Medications under F758 while regulatory language for F758 applied to both F757 (Unnecessary Medications pertaining to all categories of medications except psychotropics) and F758. Regulatory language for F758 was moved to F605 under the Freedom from Abuse, Neglect, and Exploitation subsection. Despite the regulatory language appearing to be revised as indicated in red font, the language is the same as previously incorporated in F758.

The intent of this regulation was revised to indicate that the requirements are to ensure residents only receive psychotropic medications when other nonpharmacological interventions are clinically contraindicated. Also, residents must only remain on psychotropic medications when a gradual dose reduction and behavioral interventions have been attempted and/or deemed clinical contraindicated. Additionally, medications should only be used to treat resident’s medical symptoms and not used for discipline or staff convenience, which would be deemed a chemical restraint. The regulations and guidance are not intended to supplant the judgment of a practitioner in consultation with staff, the resident and their representative. Rather, are intended to ensure psychotropic medications are used only when a practitioner determines that medication(s) are appropriate to treat a specific, diagnosed condition and they are beneficial to the resident based on monitoring and documentation of response.

Several definitions were merged into the one interpretative guidance, for example indication for use was previously just under F605 and not F758. Key changes in the interpretative guidance include:

• If the surveyor identifies that a medication has caused symptoms consistent with prolonged sedation that is not addressed such as excessive sleeping, withdrawal, decreased activity participation, noncompliance is cited at a minimum of a harm level.
• Convenience definition was revised and now states “the unnecessary administration of a medication that causes (intentionally or unintentionally) a change in a resident’s behavior such that the resident is subdued and/or requires less effort from staff. Therefore, if a medication causes symptoms consistent with sedation, it may take less effort to meet the resident’s behavioral needs, which meets the definition of convenience.”

A new section was added on the resident’s right to be informed. In accordance with regulations included in the resident’s rights subsection, residents have the right to be informed of and participate in their treatment. Prior to initiating or increasing a psychotropic medication, the resident, family, and/or resident representative must be informed of the benefits, risks, alternatives for the medication, including any black box warnings for antipsychotic medications, in advance of such initiation or increase. The resident has the right to accept or decline the initiation or increase of a psychotropic medication. To demonstrate compliance, the record must include documentation that the resident or representative was informed in advance of the risks and benefits of the proposed care, the treatment alternatives or other options and was able to choose the option they prefer. A written consent form may serve as evidence of a resident’s consent, but other types of documentation are also acceptable. If the resident/representative was not informed, noncompliance should be cited under F552.

Professional Standards and Medical Director:

Updates were made to both F658 (Professional Standards) and F841 (Medical Director) related to physicians and other practitioners adhering to policies on diagnosing and prescribing medications, the coordination of care, and implementation of resident care policies.

F658 includes new interpretative guidance outlining a proper diagnosis of mental disorders including the diagnosis that must be based on evidence-based criteria and professional standards such as using the current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) and are supported by documentation in the resident’s medical record. The supporting documentation should include, but is not limited to, the resident’s physical, behavioral, mental, psychosocial status, and comorbid conditions. The record should also rule out other physiological effects such as substance use, other medical conditions, indications of distress, changes in functional status, resident complaints, behaviors, symptoms. The documentation can also reference the Preadmission Screening and Resident Review (PASARR) evaluation.

The resident’s medical record must include:

• Documentation indicating the resident had symptoms, disturbances, or behaviors and for the period of time consistent with the DSM criteria.
• Documentation from the diagnosing provider indicating the diagnosis was given based on a comprehensive assessment such as a physician’s visit.
• Documentation from the diagnosing provider indicating that symptoms, disturbances, or behaviors are not attributable to the effects of a substance or another medical condition.
• Documentation regarding the effect the disturbance is having on the resident’s function including interpersonal relationships or self-care in comparison to their level of function prior to the onset.

Examples of insufficient documentation would include:

• Schizophrenia or other diagnosis is only mentioned as an indication in medication orders without supporting documentation.
• The addition of, or request to a practitioner of schizophrenia or other diagnosis without supporting documentation.
• A practitioner’s note or transfer summary stating a history of schizophrenia or another diagnosis without supporting documentation confirming the diagnosis with a previous practitioner or family and the nursing home did not have evidence that a practitioner conducted a comprehensive evaluation.
• A diagnosis list or practitioner’s note including schizophrenia or another diagnosis without supporting documentation.
• A nurse documenting schizophrenia or other diagnosis in the medical record without supporting practitioner documentation.

F841 includes revisions of the medical director’s responsibilities for the nursing home. These updates include:

• Implementation of resident care policies, such as ensuring that the nursing home staff and other practitioners adhere to policies on diagnosing and prescribing medications including intervening when care is inconsistent with current professional standards of care.
• Addressing issues related to the coordination of medical care and implementation of resident care policies identified in the QAPI activities.
• Active involvement in the process of conducting the facility assessment.
• Administrative decisions including recommending, developing, and approving policies related to resident care which includes the resident’s physical, mental and psychosocial well-being.

Accuracy/Coordination/Certification:

F642 which relates to the coordination of the Minimum Data Set (MDS), certification, accuracy, and penalties for falsification of the MDS were moved to F641 and F642 was deleted.

F641 includes new information in the interpretative guidance outlining inaccurate MDS coding based on diagnoses that lack supporting documentation based on the criteria in the DSM. While several other regulations include language regarding inaccurate diagnoses, this regulation relates to the nursing home coding it in the MDS. The guidance also directs surveyors to report concerns identified that constitute a pattern of inaccurate MDS coding to the appropriate licensure board. There is also a statement included in the investigative procedures that direct survey staff to report concerns when they believe the individual coding the inaccurate information knew it was inaccurate to the Office of Inspector General (OIG) for investigating possible falsification of the MDS assessment.

An additional new section containing information on certifying accuracy and completion is included in the interpretative guidance including that each individual assessor is responsible for certifying the accuracy of responses relative to the resident’s condition and discharge or entry status. These assessments must be dated the day they complete their portion of the assessment. Information previously included in the interpretative guidance in F642 is now included in F64 such as the use of electronic signatures and backdating completion dates.

Significant Change in Condition:

The interpretative guidance for F637 was revised slightly to include current language from Section GG of the MDS when identifying a significant change in the resident’s performance in Activities of Daily Living (ADLs).

Quality Assurance:

F867 interpretive guidance was updated in the QAPI regulations to incorporate health equity reports for nursing home providers. The revised QAPI guidelines include incorporating indicators of health equity into the QAPI program. Examples are outlined in the interpretative guidance including considering feedback related to health equity concerns such as addressing needs of individuals with disabilities, limited English proficiency, or different cultural or ethnic preferences. In addition, data can be incorporated while monitoring various measures to identify if there are increased concerns with problem-prone areas as the relate to sub-populations including race, sexual orientation, socioeconomic status, or preferred language.

CPR:

The language included in the interpretative guidance of F678 was updated to reflect current standards of practice with CPR instruction. The guidance states that staff must maintain current CPR certification for a health care provider through a CPR provider whose training includes a hands-on session either physically or virtually instructor-led setting in accordance with accepted professional standards.

Pain Management:

The interpretative guidance included in F697 was updated to define acute, subacute, and chronic pain and that opioid treatment to address pain needs to be individualized for each resident . When starting Opioid therapy, clinicians may consider prescribing immediate release opioids instead of long-acting or extended release. The update also includes references to F552 and identifying the risks of opioid use whenever prescribed by the physician.

Physical Environment:

Interpretative guidance was updated at F918 to clarify when nursing homes must meet compliance with each resident having access to a bathing facility in their room. The requirement for having each resident bedroom with its own bathroom consisting of at least a sink and commode/toilet includes:

• Approval for construction after November 28, 2016
• Newly certified after November 28, 2016
• A change of ownership that results in a new initial certification after November 28, 2016
• A nursing home whose provider agreement was terminated by CMS and a new provider is working to reenroll in the Medicare program as a newly certified nursing home after November 28, 2016

Nursing homes that meet the above criteria must also meet the requirement that resident rooms accommodate no more than two individuals. This includes a clarification regarding Jack & Jill type bathrooms where two residents have individual living space but share a bathroom. Noncompliance would exist if one of those rooms had more than one resident in it though.

Infection Control:

F880 was updated to include language on Enhanced Barrier Precautions (EBP) as outlined in the QSO-24-08-NH memo issued on March 20, 2024.

COVID-19 Immunization:

F887 was also added to Appendix PP incorporating the requirements to screen, educate, offer, and assist with administering COVID-19 vaccination to residents and staff as previously outlined in QSO-21-19-NH on May 11, 2021.

LeadingAge Iowa will provide resources based on some of the significant changes made to the interpretative guidance and notify members when they are available.