Category Archives: Medications (Staff)

More March-April Events

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March EQRS Newsletter Available at https://mycrownweb.org/2024/03/march-2024-newsletter-now-available/, with information on the 2744 ESRD Annual Survey, March 14 EOCT Town Hall, Care Compare Update, New EQRS Dashboard Reports, New EQRS Medication Reconciliation Reporting Field, ESRD QIP Information, How to Route Questions, and ESRD Data Submission Deadlines.

March 14, 2024:

March 16, 2024: Comment Deadline for Medicare Part D Guidance Part 2 – Guidance to help Medicare Part D enrollees manage drug costs, PART 2. Find details at https://www.cms.gov/files/document/medicare-prescription-payment-plan-draft-part-two-guidance.pdf.

April 16-17, 2024: CMS NTP Understanding Medicare 2-Day Webinar – Find more information and register at https://cmsnationaltrainingprogram.cms.gov/live-events.

March 19, 2024: CMS EQRS New User Training – Find details and register at https://mycrownweb.org/pcw_lems/march-2024-new-user-training/.

Final CMS Guidance to help Medicare Part D enrollees manage drug costs – https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-03-07-mlnc#_Toc160622795.

Current Medicare Status of Blood Tests for Organ Transplant Rejection – https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-03-07-mlnc#_Toc160622796.

FDA Warning – Rings/Watches Not Accurate Glucose Monitors

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The FDA has warned that “Smart” Rings and Watches that do not pierce the skin do not accurately measure blood sugar (glucose), even if they claim to do so. For people with diabetes, inaccurate blood glucose measurements can lead to errors in diabetes management, including taking the wrong dosage of medications that can quickly lead to mental confusion, coma, or death, within hours of the error.

For details, recommendations, and further instructions, see https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication. Some smart watches are capable of reading remote signals from other implanted or skin-piercing devices that do accurately report blood sugar. The Warning does not apply to these.

3/1 CY2025 Part D Revisions

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CMS has released Advanced Notice of revised Medicare Part D drug coverage Payment Policies, and will accept comments on the revisions until March 1, 2024. Find details at https://www.cms.gov/newsroom/fact-sheets/2025-medicare-advantage-and-part-d-advance-notice-fact-sheet (sections 17ff) and https://www.cms.gov/files/document/draft-cy-2025-part-d-redesign-program-instruction.pdf. 

A Fact Sheet on the draft Redesign Program Instructions (https://www.cms.gov/files/document/draft-cy2025-part-d-redesign-program-instruction-fact-sheet.pdf) summarizes the changes as:

  • A newly defined standard Part D benefit design consisting of three phases: annual deductible, initial coverage, and catastrophic coverage;
  • The lower annual out-of-pocket threshold of $2,000;
  • The sunset of the Coverage Gap Discount Program and establishment of the
    Manufacturer Discount Program; and
  • Changes to the liability of enrollees, sponsors, manufacturers, and CMS in the new
    standard Part D benefit design.

The changes respond to the provisions of the Inflation Reduction Act of 2022. The CY2025 Advanced Notice also applied to Medicare Advantage Plans.

CDC HAN Alert re RSV Respiratory Virus

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CDC has published a Health Alert Network Advisory (HAN) on a surge of RSV or Respiratory Syncytial Virus in the Southeastern US. Find the HAN bulletin at https://emergency.cdc.gov/han/2023/han00498.asp. RSV is different from Flu and COVID (and the “common cold”). “Syncytial,” pronounced something like “SIN-see-teal,” means that a whole mass of single-nucleus cells have merged into one big multinucleated cell. Like Flu and COVID, RSV can be serious or even fatal for vulnerable populations.

As people begin to make holiday travel plans, it is important to be aware of specific illnesses they may encounter. Some patients have family from the Southeastern US that may be coming here, or they may be planning to travel themselves, in which case they should talk to their healthcare provider about their individual risks. Although the spread of RSV has not increased here yet, the health advisory contains helpful information about new adult RSV vaccines that are available, and guidance for healthcare providers on how to care for at-risk individuals over the age of 60.

See also https://nwrnbulletins.wordpress.com/2023/09/06/9-19-cdc-call-re-flu-covid-rsv-vaccines/.

Medicare Notes re Part B Insulin and Continuing Insurance After Transplant

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The February 16, 2023 issue of the CMS mlnconnects online newsletter contains two notes of interest to ESRD patients and practitioners:

More January+ News and Events

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CMS News: ESRD/AKI Billing, Cognitive Assessment, Drug Prices

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Todays MLN Matters bulletin from CMS includes articles on:

Find the full bulletin at https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership-email-archive/2023-01-12-mlnc#_Toc124335724.

MLN Mattrs: Medicare Part B-ID Transplant Drugs

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CMS has published an MLN Matters bulletin on the New Medicare Part B Immunosuppressant Drug Benefit that’s available starting January 1, 2023, commonly known as Medicare Part B-ID or PBID. Find the bulletin at https://www.cms.gov/files/document/mm12804-new-medicare-part-b-immunosuppressant-drug-benefit.pdf. See also https://nwrnbulletins.wordpress.com/2022/12/01/cms-advice-to-transplant-patients-on-coverage/.

CMS Advice to Transplant Patients on Coverage

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CMS has issued a short bulletin informing patients about their Options when their 36-month ESRD Medicare coverage expires after a transplant. Options include other kinds of health insurance and the new Immunosuppressive Drug Benefit, Medicare Part B-ID, that takes effect January 1, 2023. CMS will send a letter explaining these Options to recipients whose coverage is about to end. Find the bulletin at https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-12-01-mlnc#_Toc120707505. The bulletin includes a link to more detail for healthcare providers at https://www.cms.gov/partbid-provider, and directs patients to https://www.medicare.gov/basics/end-stage-renal-disease#:~ for a short description of Part B-ID.

FDA Warning on Prolia/denosumab re Risk of Severe Hypocalcemia

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Prolia (denosumab) by Amgen: Drug Safety Communication – FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis. Preliminary results from an internal FDA study investigating hypocalcemia in dialysis patients treated with the osteoporosis medicine Prolia (denosumab) show a substantial risk with serious outcomes, including hospitalization and death. Because of the frequency and seriousness of these risks, the FDA is alerting health care professionals and patients about them and is continuing to evaluate this potential safety issue with Prolia use in patients with advanced kidney disease, particularly those on dialysis. The FDA will communicate the final conclusions and recommendations when the review is completed and there is more information to share. Prolia works by blocking a protein called RANK (receptor activator of nuclear factor kappa beta) and helps prevent bone cells called osteoclasts from breaking down bone in the body. A health care professional administers Prolia by injection once every six months. Find the full FDA Notice at https://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-amgen-drug-safety-communication-fda-investigating-risk-severe-hypocalcemia-patients.