The Pulse

As we start off 2025, it is important to review any changes that will take place with regards to CMS surveys and other regulatory updates. The CMS has updated the survey guidance and revised the State Operations Manual that will be effective as of February 24, 2025. Surveyors will begin using the new guidance for all surveys as of the above effective date. The goal is to streamline the survey process and eliminate overlapping citations. The following are some of the guidances that have been revised. Your team should review and ensure that changes in your processes have been made to maintain compliance with new standards.
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Admission/Transfer/Discharge

• Tags F622-F626, F660-661 will be deleted, and revisions were made to noncompliant transfers and discharges.
• Tag F627 for Inappropriate transfers and discharges along with tag F628 for the transfer and discharge process will be the new citations with the goal to better identify where transfers and discharges were not carried out to meet resident rights and regulatory requirements. Changes were also made to verbiage requirements of admission agreements where certain language around payment guarantees cannot be included.
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Chemical Restraints/Unnecessary Use of Psychotropic Medication

• The former F758 tag for unnecessary use of psychotropics has been incorporated into F605 to streamline and strongly advise facilities to prevent the unnecessary use of psychotropics.
• The guidance is revised to include situations where medications are used to cause sedation as unnecessary. The resident must be informed and included in the initiation or increase of psychotropic medication and has the right to accept or decline the medication.
• The F757 tag for unnecessary medications has been revised to include only non- psychotropic medications to avoid confusion and separation of the types of medications.
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Professional Standards and Medical Director

• Clarification regarding medical director responsibilities was added and F841 now includes implementation of resident care policies, participation in the quality assessment and assurance committee, and addressing issues related to coordination of medical care and active involvement in conducting facility assessments.
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Accuracy/Coordination/Certification

• Modifications to guidance related to minimum data set (MDS) assessments accuracy and documentation.
• New instructions include investigating if proper documentation supporting a medical condition specifically where a resident is receiving an antipsychotic medication. The documentation should comply with the facility policy and regulatory requirements.
• Due to this revision, F642 (coordination/certification of assessment) is being deleted and added to F641 (accuracy of assessment) for better clarity.
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QAPI/QAA Improvements

• New guidance was added to include health equity when collecting and monitoring data.
• Facilities should consider factors that affect health equity and outcomes of their resident population specifically when creating their QAPI program priorities.
• QAPI now should also include interviewing the medical director.
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Infection Prevention and Control

• Use of Enhanced Barrier Precautions for Prevention of multidrug-resistant organisms is now included as part of deficiency- F880.
• COVID-19 immunization is now included with requirements for facilities to educate residents and staff on the benefits and potential side effects of the vaccine.

Final Rule CMS 3442-Final
The minimum staffing standards final ruling was confirmed on April 22, 2024, thereby holding nursing homes accountable for staffing to provide safe and quality care for residents living in such facilities. This final rule has new comprehensive minimum nurse staffing requirements with the goal to reduce risks to residents, reduce medication errors, and improve on quality care. The ruling and implementation is outlined below:

The CMS final rule outlines the following requirements around staffing:

• Total nurse staffing standard of 3.48 hours per resident day
  • RN hours per resident day = 0.55 hours
  • Direct nurse aid hours per resident day = 2.45 hours
  • Any nurse staff (RN/LPN/LVN/AIDE) hours per resident day = 0.48 hours
• Must have an RN on site 24 hours a day, seven days a week to provide skilled nursing care.
• Limited possible exemptions for facilities that may qualify (ie rural location, or unique workforce challenges being identified) after completing a CMS Facility survey.
• Facilities must utilize their new facility assessment tools to determine if more hours than the minimum standard needs to be set based on factors specific to that facility’s resident criteria.
• States must report compensation for workers – percent of Medicaid payments that are spent on compensation for care workers and support staff delivering patient care.

Facility Assessment Requirements:
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• Include behavioral health needs while care planning for residents.
• Look at each resident’s specific needs rather than aa general resident population.
• Nursing home leadership must provide input – including but not limited to administrator, DON, medical director, direct care staff.
• Include feedback from residents and family members.
• Develop a staffing plan to maximize staff retention and recruitment.

CMS Implementation Plan:
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• Staggered implementation timeline of the minimum staffing and the 24/7 RN requirements based on geographic locations –
  • Phase 1 – facilities must meet the facility assessment requirements within 90 days (July 2024)
  • Phase 2 – facility must meet the 3.48 HPRD and the 24/7 RN requirements within 2 hours (by April 2026)
  • Phase 3 – facilities must meet the specific breakdown of HPRD to meet the 0.55 RN and 2.45 Nurse Aide HPRD requirements (April 2027)

Nationwide Drug Shortages Record High
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During the first quarter of 2024 alone there have been over 320 drug shortages, a ten-year record high. Most of these shortages are older generic products, with half being injectable medications. The generic medications can only compete with pricing, so likely a supply vs demand issue played a role in these shortages. The generic shortages do not affect the drug companies, because the cost to produce these medications is so low which is why there is not real drive to address the shortages quickly.

Many clinics and hospitals are completely out of certain medications causing disruptions in patient care. The FDA is looking at different tools that can be utilized to increase supply, including an expedited review of a supplement. Many of the shortages began years ago but were exacerbated by COVID-19 and we are now seeing the effects of the pandemic on supply. HHS will be looking at wholesalers and drug purchasing to identify disruptions in the supply chain.They are seeing how corporate control of drugs affects the end user, the patient.

As 2024 gets underway, it's time to prepare for any new guidelines that take effect this year and reflect on the areas that were identified in 2023 that need the most improvement.

As of November 2023, the top 10 F-Tags include:

1. F812 Food Procurement, Store/Prepare/Serve Sanitary
2. F880 Infection Prevention and Control
3. F689 Free of Accident Hazards/Supervision/Devices
4. F656 Develop/Implement Comprehensive Care Plan
5. F761 Storage of Drugs & Biologicals
6. F684 Quality of Care
7. F695 Respirator/Tracheostomy Care and Suctioning
8. F677 ADL Care Provided for Dependent Residents
9. F657 Care Plan Timing and Revision
10. F584 Safe/Clean/Comfortable/Homelike Environment

Tips on How to Prepare for Survey:

• Standards Review: Review the most current CMS standards to identify and list what
  is needed to be done to meet those standards within your facility.
• Previous Survey Deficiencies: Review previous surveys over the last three years
  and look at citations and the plan of corrections and monitoring of those plans.
• Mock Surveys, Audits: Set up a mock survey with your team and utilize your
  consultant pharmacist for med cart audits, drug labeling audits, medication
  administration.
• Survey Readiness Binder: Collect all the documents, policies/procedures that you
  know surveryors would want to review, so all documents are in one convenient
  location.

SpecialtyRx Account Executives can also assist in some aspects of survey preparation with regards to med cart audits, medication storage, and ensuring emergency kits are intact and within expiration dates.
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MDS 3.0 Changes to Resident Assessment Instrument as of October 1, 2023

Latest MDS 3.0 v 1.18.11 as of October 1, 2023 – The main focus is the resident’s voice, direct resident interview and goals of individualized care plans. Below is a quick reminder of some of the changes that took place in October 2023:

• Section A: Reconciled medications will have a new documentation requirement which will impact SNF quality measure (QM). The goal is to transfer the reconciled medication list from the SNF to ensure continuity of care and minimize risks to patient.
• Section G (Functional Status): is retired and replaced with Section GG – Functional Abilities and Goals.
• Section D: New and Improved Review of Resident Mood Data – Important piece that can significantly increase your Part A payment rate based on the Mood severity score. It is to your benefit to make sure your care team is educated on how to correctly conduct mood assessments.
• Section J: New Pain Interview – allowing information to come directly from resident for a better individualized care plan.
• Section N: Medications – revised coding instructions and updates to Drug Regimen Review (DRR) as listed below:
  1. Medications Received has been replaced by High-Risk Drug classes. The goal is for nursing staff to be educated and identify high risk drug classes. This will allow the team to better understand the medication and what to monitor since side effects can impact a resident’s quality of life, health and safety.
     • Asks for a 7 day look-back IF resident took a medication by drug class
     • Indication for use as the pharmacological indication should be documented, not how medication is being used.
     • 2 new high risk medication classes – Antiplatelet and hypoglycemic have been added.
  2. Antipsychotic Medication Review now includes Gradual Dose Reduction (GDR) which is part of the CMS guideline requirement
  3. Drug Regimen Review: added coding tips around Adverse Drug Reaction (ADR) distinguishing it from “side effect”.
     • Purpose is to identify if a DRR was performed, and clinically significant issues identified and addressed

CMS Form 671 and Form 672 as of October 22, 2023

Survey-related forms were changed based on the upcoming changes to the MDS. Due to Section G being removed from the MDS, fields on the CMS-672 form can no longer be completed, and these MDS-based fields are not used as part of the survey process any longer, anyway. Facilities do not have to complete fields F79-F145 and surveyors do not need to populate F79-93 in the survey system. The following should still be completed:

• Census Information (F75-F78)
• Ombudsman Information (F146-F147)
• Medication Error Rate (F148)

As of October 22, 2023, the above fields were relocated from the CMS-672 to the CMS- 671. The CMS-672 has been removed.

Looking Ahead into 2024 – Prepare for the Future!

Upcoming Quality Measure changes to the CMS five-star rating to look for in 2024 are as follows:

Staffing Measure Changes
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• The staffing rating methodology is going to be revised. CMS believes this will incentivize providers to submit accurate staffing data beginning April 2024, and those who fail to submit data or submit erroneous data will be penalized in the form of the lowest score available related to turnover measures. Previously if reporting was not done, facility was excluded, and CMS star rating score was not impacted.
• The new measures will be posted starting July 2024. The associated staffing rating thresholds will also be revised to maintain the same overall points distribution for impacted staffing measures.

Quality Measure Changes
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• CMS will freeze the following 4 QM around resident short and long stays starting in April 2024 due to MDS changes with removal of Section G and transition to the new section GG.
  • Quality Measures (QM) changes will be made over time. Starting in October 2024, the Short-Stay functionality Quality Measure will be replaced with the new cross-setting functionality. The Long-Stay QMs will remain frozen until January 2025 to allow for data related to the equivalent measures to be collected.

Another New MDS 3.0 Version in the Works
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The MDS (minimum data set) 3.0 RAI (resident assessment instrument) will again be updated to V1.19.1 effective October 1, 2024. The key differences to expect:

1. Updates to the new GG section: removal of discharge goals
2. Section N: High-risk drug classes – new addition of Anticonvulsants
3. Section O: New item addition – Resident’s Covid-19 vaccination status is up to date

There are a lot of changes to Nursing Homes on the way – starting this summer and proceeding into the following year! SpecialtyRx will keep you informed and give reminders as changes go into effect. We know you are focused on daily patient care and SpecialtyRx is your long-term partner with the same goals and values. Together, we can prioritize the needs of our patients!