The FDA has announced a Class II recall of 59 lots of Baxter Revaclear 300 Dialyzer, Product Code 114745L, and 3 lots of Baxter Revaclear 400 Dialyzer, Product Code 114746L, totaling 1.3 million units. These HD dialyzers may leak blood during dialysis because there is potential for fibers in the dialyzer to rupture. For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=173325 for the Revaclear 300, and https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=173326 for the Revaclear 400.
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.
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.
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.
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
The National Forum of ESRD Networks has introduced or updated several Medical Advisory Council (MAC) Toolkits. Two new Kits include the Transplant Toolkit and the Medication Conversion Toolkit. The Transitions of Care Toolkit was updated in mid-April. Find them all at http://esrdnetworks.org/resources/toolkits/mac-toolkits-1, along with the existing Home Dialysis Toolkit, Medical Directors Toolkit, QAPI Toolkit, Medication Reconciliation Toolkit, Catheter Reduction Toolkit, Vaccination Toolkit, and Assurance of Diabetes Care Coordination Toolkit.
May is Mental Health Month. Raise awareness by talking about mental health conditions. Recommend appropriate preventive services, including the Initial Preventive Physical Examination, Annual Wellness Visit, and Depression Screening.
For More Information:
- Medicare Preventive Services Educational Tool
- Initial Preventive Physical Examination Booklet
- Annual Wellness Visit Booklet
- Centers for Disease Control and Prevention Mental Health website
Visit the Preventive Services website to learn more about Medicare-covered services.
Approximately 60 million Americans or roughly 1 in 5 live in rural areas, with nearly every state having a rural county. CMS recognizes the significant obstacles faced by patients and providers in rural areas and places an unprecedented priority on improving the health of these Americans, including the introduction of the first Rural Health Strategy. In the last year, CMS took several steps to improve rural health:
- Expanded access to telehealth and other virtual services across the Medicare program
- Proposed to increase the wage index of rural and other low wage index hospitals through the Inpatient Prospective Payment System (IPPS) proposed rule: CMS is seeking input on several approaches for accomplishing this
- Proposed to remove urban-to-rural hospital reclassifications from the calculation of the rural floor wage index value through the IPPS proposed rule
- Announced the CMS Primary Care First Initiative, a new set of payment models for primary care practices and other providers: Seeking public comment on the Direct Contracting: Geographic Population-Based Payment model option
- Developing a new innovative model for rural communities that will offer a pathway for stakeholder coalitions to invest collectively in increasing access and improving rural health care delivery
See the full text of this excerpted CMS Blog (issued May 8).
The FDA has announced a recall of Medcomp 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422. For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=171580.
The National Kidney Foundation 2019 Spring Clinical Meetings (SCM19) present a unique opportunity for renal health care providers to learn new developments related to all aspects of nephrology. An important objective of SCM19 is to present the latest insights into CKD care through a combination of interesting courses, practical workshops, thought-provoking symposia and insightful debates. SCM19 will be held May 8-12, 2019 in Boston MA. In-person registration is allowed, but many registration fees are discounted if you register online before May 6.
Extra-cost pre-conference course topics on May 8 include dialysis success, vascular access, ultrasound, supportive care, and updates on new developments in transplant, critical care, and glomerular disease. Extra-cost lunch workshop topics will include vascular access, electrolytes, hyponatremia, glomerular disease, reproductive health, hypertension, communication, and board review. For those unable to attend in person, live-streamed conference sessions will be available on burnout, obesity, safety, fluid management, opioids, social media, diabetes, community, lifestyle interventions, palliative care, and KDOQI update.
For more information and registration, see https://www.kidney.org/spring-clinical.
CMS and NKF will present a May 22, 2019 webinar on on Population Health Strategies for Kidney Disease Risk Reduction, at noon PST. Nephrologists, dialysis facility medical directors and renal care providers are invited and encouraged to attend. The NKF CKD Change Package will be introduced, systematic strategies for improving identification and management of CKD will be described, and a population health strategy for registry function, QI, and patient engagement for people living with CKD will be presented. Register for the webinar at https://meetings-cms.webex.com/meetings-cms/onstage/g.php?MTID=e06e8b0a5642756b1b7a7e0998d0eeeb8. Find the NKF CKD Change Package at https://www.kidney.org/sites/default/files/02-11-8036_JBI_CKD_ChangePackV17.pdf.
Register now for a free one-hour webinar with continuing education
This World Kidney Day, CDC and the Making Dialysis Safer for Patients Coalition invite you to a webinar presenting the infection risks associated with different vascular access types. Discussion will include strategies and recommendations for successful catheter reduction to prevent bloodstream infections.
Webinar: Making Dialysis Safer for Patients: Optimal Vascular Access
Date: Thursday, March 14, 2019
Time: 2:00 – 3:00 PM EDT
Registration: Click Here to Register (at no cost)
Join us this World Kidney Day for a presentation on “Incident Vascular Access and Risk of Bloodstream Infection Among New ESRD Patients Receiving Hemodialysis” followed by a conversation about achieving optimal vascular access for patient safety.
Sophia Kazakova, MD, MPH, PhD; Division of Healthcare Quality Promotion, CDC.
• Vandana Dua Niyyar, MD, FASN, FNKF, FASDIN; Professor of Medicine, Division of Nephrology, Emory University.
• Tracy Jonelis, MD; Chief of Nephrology, Kaiser Permanente Northern California, San Francisco Medical Center
Priti Patel, MD, MPH and Ibironke Apata, MD; Division of Healthcare Quality Promotion, CDC.
Continuing Education: Accredited for physicians, nurses, pharmacists, certified health educators, public health professionals and other health professions.
Audio: Please note the audio for this webinar will come through your computer speakers. During the webinar, please ensure that your speakers are turned on and the volume is up. Thank you.