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Clinical Updates

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Updates to Asthma Management Guidelines
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August 2025

Updates to Asthma Management Guidelines

May 6th was World Asthma Day, and SpecialtyRx is here to give you all the latest updates around Asthma guidelines!

The Global Asthma Initiative (GINA) has updated its guidelines for 2025. Some ofthe key changes include looking at additional biomarkers for Type 2 inflammation,additional risk factors for severe exacerbation in adults, including environmentalfactors and air quality that they are exposed to, and the impact of extreme weather.The diagnosis criteria have also been updated for clarity because variability insymptoms and expiratory airflow are two distinct characteristics of Asthma.Additionally, a reference to a calculator of peak expiratory flow variability was alsoadded.

Treatment recommendations for adults are in two treatment tracks for better clarity,and due to poor access to some preferred combination inhaled products. The mainkey difference is the medication that is used for symptom relief. Track one maintainsan"as needed" inhaled corticosteroid (ICS) - formoterol combination product such asSymbicort or Dulera as the preferred treatment approach. Formoterol substantiallyreduces the risk of severe exacerbations and systemic corticosteroid exposure ascompared to short-acting beta agonists (SABA) based regimens. Also, thecombination products provide a simpler regimen and better overall compliance.

Track 2 uses the alternative approach of “as needed” SABA or as needed ICS-SABA(ie, Airsupra -combo product or albuterol and a steroid inhaler separately), which maybe a good option for patients with controlled stable asthma and no exacerbations. Itis recommended to ensure the patient is good with medication adherence beforeusing one of these suggested products.

The U.S. Department of Veterans Affairs (VA) and Department of Defense alsoreleased updated clinical practice guidelines for Asthma in March 2025. Like the GINAguidelines, the VA also makes strong recommendations for the use of ICS incombination with a long-acting beta agonist (LABA) such as formoterol as both acontroller and reliever for those with uncontrolled asthma.

Lastly, the latest studies show that the use of Proton Pump Inhibitors (PPI) has beenassociated with increased asthma incidence. While PPIs are used to manage GERD,which itself can also worsen symptoms of asthma, the use of PPIs may not be thebest option in asthma patients. If there are residents who are on PPIs and seem tocontinue having asthma that is uncontrolled, consider switching to an H2-receptorantagonist such as famotidine or ranitidine.

Asthma is a chronic condition that can affect many residents in the nursing homesetting. Proper management by identifying triggers, educating residents and staff,and having up-to-date knowledge of new and preferred treatment options can begreatly beneficial in better controlling and reducing asthma exacerbations in theelderly.

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New COVID-19 Vaccine 2024-25 Formulation
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August 2025

New COVID-19 Vaccine 2024-25 Formulation

On June 5, 2024, the Vaccines and Related Biological Products Advisory Committee (VRBAC) and FDA panel met and unanimously voted for the JN.1 strain for the new fall 2024-25 COVID-19 vaccine formulation. A week later, based on updated data, the FDA asked the vaccine manufacturers to focus on the KP.2 and KP.3 strains of the JN.1 lineage as they are becoming the more dominant strains. It is anticipated that the change requested by the FDA will not cause any delays in the manufacturing of the new formulations.

The vaccine manufacturers (Pfizer, Moderna) expect the new vaccine will be available mid to late August, while Novavax anticipates a slightly later release in September but still in time to begin the fall vaccine administrations once the final approval is received by the FDA. The current COVID-19 2023-24 vaccine is still approved for administration, likely for the remainder of the summer, however, production of the 2023-24 formulation has stopped as manufacturers gear for the new formulation.

Currently, Pfizer has stopped shipping all 2023-24 from Pfizer direct. Going forward, additional doses of Pfizer and Moderna may be obtained through regular wholesalers or vendors IF they have any more stock remaining. Once the 2023-24 is completely depleted from all Vendors, facilities should wait until the new formulation is available early fall.

Facilities are encouraged to review all patients who did not receive any vaccine or dose of the 2023-24 formula and administer it as a priority for those patients. For all others who have already received at least one dose of the 2023-24 formula in recent months, it may be beneficial to wait for the new formulation at the discretion of the healthcare provider and facility protocol.

The ACIP and CDC advisory group made official recommendations on June 27, 2024, for who should get the new vaccine in the fall. They continue to support vaccination against Covid-19 with one dose of the new 2024-25 formulation in all individuals ages 6 months and older irrespective of whether they were previously vaccinated for COVID-19.

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MedMemos: Medications That Need Glucose Monitoring
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August 2025

MedMemos: Medications That Need Glucose Monitoring

One of the most common disease states in Long Term Care is Diabetes Mellitus Type 2. We always focus on obtaining glycemic control for these patients. However, often we forget that some of the most common classes of medications used to treat other disease states in diabetic patients, can disrupt the glucose levels. This may require extra monitoring of glucose levels or an adjustment of diabetic medications. Below are five commonly-used medication classes that should be reviewed when prescribing for your diabetic resident:

1. Glucocorticoids

Medications such as prednisone or methylprednisolone are some of the most commonly known offenders of affecting glycemic control in diabetics and even causing new onset diabetes or steroid induced diabetes. Management of glucose depends on duration of glucocorticoid therapy, and how well the patient’s glucose was controlled prior to initiating therapy.

Tips:

  • Metformin can help in managing glucose for short duration of glucocorticoid therapy.
  • Initiation of a short acting insulin or NPH might be the preferred option for patients
    with uncontrolled diabetes.
  • Use of continuous glucose monitoring devices is also particularly helpful for
    uncontrolled diabetes.
  • If glucocorticoids are tapered off, the diabetic treatments should also be adjusted as
    needed to ensure hypoglycemia does not occur.

2. Antipsychotics

Many drugs in this class can cause weight gain as a common side effect. As we know, obesity is a risk factor in contributing to or developing diabetes. Antipsychotics can also lead to insulin resistance. Some antipsychotics that more commonly affect glucose are Clozapine, Olanzapine, and Haloperidol. Alternatively, Ziprasidone is known to have less effects on glucose.

Tips:

  • The best approach with antipsychotics is to use ones that have less weight gain or the
    “third-generation antipsychotics” which include:
  • Abilify (Aripiprazole) – has the most coverage of FDA approved indications
  • Rexulti (Brexpiprazole)
  • Vraylar (Cariprazine)
  • Caplyta (Lumateperone)

3. Diuretics

Specifically, thiazide diuretics are a common first line therapy and adjunct in the management of high blood pressure. Some thiazide diuretics are Metolazone and Hydrochlorothiazide. Thiazide diuretics can also cause increased glucose levels in addition to affecting electrolyte levels such as potassium (hypokalemia). Studies show that hypokalemia due to thiazide diuretics can cause diabetes and reduce insulin sensitivity.

Tips:

  • Consider low dose diuretic since the side effect is dose dependent - a low dose
    thiazide may not cause hypokalemia and therefore reduce risk of diabetes.
  • Potassium levels should be monitored and manage hypokalemia with potassium
    supplements.

4. Statins

It is likely that your diabetic resident has other comorbidities such as high cholesterol which require treatment with statins. Statins are also on the list of medications that can reduce insulin secretion and sensitivity. In diabetics, statins may increase the hemoglobin A1C slightly. However, if you look at the risk vs benefit of statin therapy vs the development of diabetes, statin therapy should be initiated as the benefit to prevent cardiovascular disease and can outweigh risks with hyperglycemia.

Tips:

  • Monitoring of blood glucose and diabetic medication dose adjustments can be
    effective.
  • Atorvastatin has been linked to a greater effect on hemoglobin A1C levels.
  • Pitavastatin is associated with lower risk of new onset diabetes (but not the best data
    on cardiovascular risk reduction).
  • Pravastatin and Lovastatin are other low potency options for statins.

5. Beta Blockers

Beta blockers are commonly used for high blood pressure, coronary artery disease, and heart failure. Metoprolol and atenolol are associated with increasing hemoglobin A1C but also associated with increased risk of hypoglycemia. It is also important to keep in mind that beta blockers can mask the symptoms of hypoglycemia.

Tips:

  • Blood glucose monitoring can be beneficial especially with hypoglycemia risk.
  • Availability of Glucagon for managing hypoglycemic episode.
  • Education on managing hypoglycemia is important for diabetic patients that are
    taking Metoprolol or Atenolol.
  • Consider Carvedilol, Nebivolol, and Labetalol which show less effects on glucose.

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Regulatory Recap
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August 2025

Regulatory Recap

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.

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

  • 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

  • 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

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!

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Minimum Staffing Standards for Long Term Care Facilities
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August 2025

Minimum Staffing Standards for Long Term Care Facilities

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:

  • 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:

  • 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

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.

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CMS Revised Long Term Care Survey Guidance
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August 2025

CMS Revised Long Term Care Survey Guidance

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.

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.

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.

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.

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.

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.

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.