Month: June 2019

Warning: Medtronic MiniMed Insulin Pumps

The FDA has warned that certain Medtronic MiniMed Insulin Pump models are not protected from hackers, who could alter the insulin settings. Medtronic is replacing the inadequately protected pumps. For recommendations on protecting yourself while awaiting a replacement, a list of models and software versions involved, and more information, see https://www.fda.gov/medical-devices/safety-communications/certain-medtronic-minimed-insulin-pumps-have-potential-cybersecurity-risks-fda-safety-communication.

“Welcome to Medicare” Preventive Visit and Yearly “Wellness” Visits

Individuals new to Medicare should schedule a “Welcome to Medicare” preventive visit. Medicare Part B covers a FREE comprehensive screening within the first 12 months of having Part B.

Individuals who have had Medicare Part B for longer than 12 months can get a FREE yearly “Wellness” visit once every year to develop or update a personalized prevention plan.

Patients pay nothing if their doctor or other qualified health care provider accepts assignment. The Part B deductible doesn’t apply. However, patients may have to pay coinsurance, and the Part B deductible may apply, if doctors or other health care providers perform additional tests or services during the same visit that are not covered under the preventive benefits.

When making the appointment, patients should let the doctor’s office know a “Welcome to Medicare” preventive visit would like to be scheduled. It is also important to know what to bring to the “Welcome to Medicare” preventive visit.

The preventive visit includes a review of medical and social history related to the patient’s health, along with education and counseling about preventive services. It can also include:

  • Certain screenings, flu and pneumococcal shots, and referrals for other care, if needed.
  • Height, weight, and blood pressure measurements.
  • A calculation of your body mass index.
  • A simple vision test.
  • A review of your potential risk for depression and your level of safety.
  • An offer to talk with you about creating advance directives.
  • A written plan letting you know which screenings, shots, and other preventive services you need. Get details about coverage for screenings, shots, and other preventive services.

The yearly “Wellness” visit is designed to help prevent disease and disability based on current health and risk factors. Providers will ask patients to fill out a questionnaire, called a “Health Risk Assessment,” as part of this visit. It can also include:

  • A review of your medical and family history.
  • Developing or updating a list of current providers and prescriptions.
  • Height, weight, blood pressure, and other routine measurements.
  • Detection of any cognitive impairment.
  • Personalized health advice.
  • A list of risk factors and treatment options for you.
  • A screening schedule (like a checklist) for appropriate preventive services.
  • Advance care planning

By collaborating with physicians/practices that performs a comprehensive review of health status, the medical team at the dialysis clinic can be assured that patients have an established resource for healthcare issues that are not specifically related to ESRD. This is a great opportunity to coordinate care for essential services like immunizations, diabetes management and cardiac related issues, just to name a few.

Join CMS for a Public Webinar on Quality Measurement

CMS is pleased to invite the public to attend its upcoming webinar titled Measuring Quality to Improve Quality: Strengths and Challenges of Clinical Quality Measurement. The webinar will provide an engaging and informative overview of key concepts that go into its quality measures. Additionally, the presentation will review current CMS quality measures, explain how they are used, and how they fit into CMS’s quality goals, including the Meaningful Measures initiative.

The webinar will be offered twice in June, on Tuesday, June 25th, from 2:00-3:00pm EST (Register here) and Thursday, June 27th, from 2:00-3:00pm EST (Register here). Please register in advance if you can attend as space will be limited. CMS requests that interested individuals only register for the event they’re able to attend.  CMS looks forward to participant questions!

For questions, please contact MMSSupport@battelle.org.

Recall: Antibacterials Amikacin, Prochlorperazine

The FDA has announced the recall of one lot each of two antibacterials manufactured by Emcure Pharmaceuticals and distributed by Heritage Pharmaceuticals, because of non-sterility:

  • Amikacin Sulfate Injection USP 250mg/mL Lot# VEAC025 Expiry October 2019
  • Prochlorperazine Edisylate Injection USP 5mg/mL Lot# VPCA172 Expiry April 2020

For details see https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/heritage-pharmaceuticals-inc-issues-voluntary-nationwide-recall-amikacin-sulfate-injection-usp-1gm4.