December 8 – 14, 2008 is National Influenza Vaccination Week.
The Centers for Disease Control and Prevention (CDC) has announced the week of December 8-14, 2008, as National Influenza Vaccination Week. This week-long event is designed to raise awareness of the importance of continuing influenza (flu) vaccination, as well as foster greater use of flu vaccine in December, January, and beyond. Since flu activity typically does not peak until February or later, December and January still provide good opportunities to offer flu shots. This year, Thursday, December 11th, is designated as Seniors' Vaccination Day. The Centers for Medicare & Medicaid Services (CMS) needs your help to ensure that people with Medicare get their flu shots. Please use this week long event as an opportunity to place greater emphasis on flu prevention. If you have Medicare patients who have not yet received their annual flu shots, we ask that you encourage these patients to protect themselves from the seasonal flu and serious complications arising from the flu virus by recommending that they take advantage of the flu shot benefit covered by Medicare. And remember, health care professionals and their staff are also at risk for contracting and spreading the flu virus, so don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot -- Not the Flu!
NOTE: - Influenza vaccine plus its administration are covered Part B benefits. Influenza vaccine is NOT a Part D covered drug.
For More Information
Health care professionals and their staff can learn more about Medicare’s coverage of the flu vaccine and other Medicare Part B covered vaccines and related provider education resources created by CMS, by reviewing Special Edition MLN Matters article SE0838 located at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0838.pdf on the CMS website.
For more information about National Influenza Vaccination Week, please visit the Centers for Disease Control and Prevention’s website, http://www.cdc.gov/flu/nivw/
Tuesday, December 9, 2008
Thursday, December 4, 2008
CrownWEB is Nearly Here
The following announcement is being mailed and faxed to Administrators of all dialysis facilities in Florida. If you are not the correct person to receive this email, we ask that you forward it to the correct individual(s).
CROWNWeb is Nearly Here
The implementation date for the electronic data submission required by the new Conditions for Coverage is just around the corner. CROWNWeb is the application designated by CMS to meet this requirement.
How Do I Get Access to CROWNWeb?
Every facility (whether they are an independent, a regional chain or part of a large dialysis organization) will need to identify their Security Administrator and Backup Security Administrator for CROWNWeb. This will be the person responsible for assigning roles and scope within the CROWNWeb application for other users at your facility. To designate your facility’s Security Administrator you need to fill out the CROWNWeb Authentication Service (CAS) Account Form. This is an online form available at https://www.qualitynet.org/crown/registration_form.pdf. The form must be either TYPED directly into the online form and printed; or printed as a blank form and TYPED on a typewriter. No hand written forms can be accepted. The printed form must then be signed by both the person designated as the Security Administrator and their manager and notarized. The original notarized form, not a fax or copy, should be sent to the Network office no later than December 15. If your facility does not designate a Security Administrator, your facility will not be able to submit data electronically to CMS and will unable to comply with new Conditions for Coverage for electronic data submission.
NOTE: The CAS form requires signatures from three different people. Do NOT sign as your own manager and neither you nor your manager may notarize the form.
Important Date to Remember:
12/15/2008
DEADLINE for submitting Notarized CAS form for CROWNWeb access
This date applies to VISION users also.
CROWNWeb is Nearly Here
The implementation date for the electronic data submission required by the new Conditions for Coverage is just around the corner. CROWNWeb is the application designated by CMS to meet this requirement.
How Do I Get Access to CROWNWeb?
Every facility (whether they are an independent, a regional chain or part of a large dialysis organization) will need to identify their Security Administrator and Backup Security Administrator for CROWNWeb. This will be the person responsible for assigning roles and scope within the CROWNWeb application for other users at your facility. To designate your facility’s Security Administrator you need to fill out the CROWNWeb Authentication Service (CAS) Account Form. This is an online form available at https://www.qualitynet.org/crown/registration_form.pdf. The form must be either TYPED directly into the online form and printed; or printed as a blank form and TYPED on a typewriter. No hand written forms can be accepted. The printed form must then be signed by both the person designated as the Security Administrator and their manager and notarized. The original notarized form, not a fax or copy, should be sent to the Network office no later than December 15. If your facility does not designate a Security Administrator, your facility will not be able to submit data electronically to CMS and will unable to comply with new Conditions for Coverage for electronic data submission.
NOTE: The CAS form requires signatures from three different people. Do NOT sign as your own manager and neither you nor your manager may notarize the form.
Important Date to Remember:
12/15/2008
DEADLINE for submitting Notarized CAS form for CROWNWeb access
This date applies to VISION users also.
Wednesday, December 3, 2008
FDA: Innohep (tinzaparin sodium injection)
Innohep (tinzaparin sodium injection)
FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.
In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.
Read the complete MedWatch 2008 Safety summary, including a link to the FDA Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep
FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.
In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.
Read the complete MedWatch 2008 Safety summary, including a link to the FDA Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep
Friday, November 21, 2008
Medicare Publishes New Information on Quality of Care at Dialysis Facilities
Medicare Publishes New Information on Quality of Care at Dialysis Facilities
Changes to Web Site Will Help Consumers Compare Care and Make
Informed Health Care Choices
The Centers for Medicare & Medicaid Services (CMS) today announced important additions to the Dialysis Facility Compare consumer Web site (http://www.medicare.gov/dialysis) that will give consumers even better insight into the quality of care provided by their local dialysis patient facilities.
The improvements include two new quality measures that demonstrate how well dialysis patients are treated for anemia (low red blood cell count) as well as updated information that will help patients better understand survival rates by facility.
To view the entire Press Release, please see: http://www.cms.hhs.gov/apps/media/press_releases.asp
Thursday, November 20, 2008
Notice: ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)
The kidney community uses a variety of products and resources to ensure the health and safety of patients and healthcare professionals. The United States Food and Drug Administration (FDA) issues alerts and notifications when these products and resources are unsafe or being recalled.
As directed by CMS, the KCER Coalition issues notices on FDA recalls via email and this website for the kidney community. To join the email list, please email sburris@nw7.esrd.net.
November 6, 2008
ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)
Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.
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