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:
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.
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:
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.
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.
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.
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.
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.
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.
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.
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:
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:
As of October 22, 2023, the above fields were relocated from the CMS-672 to the CMS- 671. The CMS-672 has been removed.
Upcoming Quality Measure changes to the CMS five-star rating to look for in 2024 are as follows:
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:
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!
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.
