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Advocacy

Regulatory

NATCO educates regulators of donation and transplantation through meetings and comments to regulatory agencies. NATCO and its members advocate for changes concerning donation and transplantation for the benefit of patients and organization. The NATCO Board of Directors, Committees and Taskforces work with regulatory counsel to provide education and recommendations.

 

Availability of DRAI Addenda to Assist with Screening for Risk of Zika Virus Infection

 

To assist with screening donors for risk of Zika virus (ZIKV) infection an addendum and relevant flowcharts are available for use with any of the three Uniform Donor Risk Assessment Interview (DRAI) forms, and they are adaptable for use with any DRAI form style. Separate tools have been created for a “Deceased Donor” and for a “Living Donor – Delivery Mother – Birth Tissue.” Documents can be accessed at these links on the AATB website:

 

Zika Virus (ZIKV) Infection Addenda and Flowcharts

 

Deceased Donor (ZIKV)

 

Living Donor – Delivery Mother – Birth Tissue (ZIKV)

 

The tools for a “Deceased Donor” assist with developing policies and procedures to screen a deceased donor of organs, tissues or eyes for risk of infection with ZIKV, and use “as is” is encouraged.  The following guidance information was referenced to develop the tools:

 

 

 

A separate addendum and set of flowcharts should be used when screening a living donor who is a delivery mother of birth tissue (e.g., placenta).  Both sets of tools meet expectations described in the immediate guidance issued by FDA/CBER on March 1, and their recommendations should be implemented by March 29, 2016. 

 

NOTE: As knowledge is gained regarding risk of ZIKV infection associated with donation of organs, tissues or eyes, be aware that updates to the addenda and/or the flowcharts can occur.

 

Contact Scott Brubaker if you have questions after careful reviewing all documents and published guidance.

 

 

Ebola Virus Updates

The Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC) and Office of the Assistant Secretary for Preparedness and Response (ASPR) continues to work with other U.S. government agencies, the World Health Organization (WHO), and other domestic and international partners in an international response to the current Ebola outbreak in West Africa. This document summarizes key messages about the outbreak and the response. It will be updated as new information becomes available and distributed regularly.

ASPR continues to provide Ebola information for healthcare professionals and healthcare settings on its website.  Information is organized for EMS providers, clinicians and healthcare professionals, hospitals and healthcare facilities, and healthcare coalitions.  Audio replays and transcripts from recent Ebola webinars and national calls for healthcare professionals and healthcare settings are also available here and updated as additional information comes available. 

Additionally, on October 24, the CDC published Interim Guidance for Emergency Medical Services (EMS) Systems and 9-1-1 Public Safety Answering Points (PSAPs) for Management of Patients with Known or Suspected Ebola Virus Disease in the United States. It can be found at: http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-emergency-medical-services-systems-911-public-safety-answering-points-management-patients-known-suspected-united-states.html

On October 24, the Interagency Board published Recommendations on the Selection and Use of Personal Protective Equipment for First Responders Against Ebola Exposure Hazards.  It can be found at:

https://iab.gov/Uploads/IAB%20Ebola%20PPE%20Recommendations_10%2024%2014.pdf

 

 

Availability of DRAI Addendum to Assist with Screening for Risk of Ebola Virus Disease

To assist with screening for risk of Ebola Virus Disease (EVD), a one-page addendum and relevant flowcharts are now available for use with any of the three Uniform Donor Risk Assessment Interview (DRAI) forms, and they are adaptable for use with any DRAI form style. The documents are found at this link on the AATB website:

Ebola Virus Disease Addendum and Flowcharts 

These tools can assist with developing policies and procedures to screen for risk of infection with Ebola Virus, and use is encouraged. 

A background document is also available at the link above. It contains notes developed from meetings of AATB’s Tissue Transmitted Diseases Advisory Group (TTDAG), a subgroup of the Physicians’ Council, and comments received from members of the DRAI Stakeholder Review Group.  The background document describes,  “An addendum provides the opportunity to discontinue use if screening for EVD risk changes and is determined to no longer be relevant.”

A Uniform DRAI Documents link has been established on the AATB website, and a new folder has been added that contains flowcharts for questions on the Uniform DRAI Adult Donor form. Accessing that link should automatically download the zipped folder.

Contact Scott Brubaker if you have questions after reading all documents and reviewing published guidance.

 


 

In February 2014, The Centers for Medicare & Medicaid Services (CMS) proposed changes to Medicare Parts C and D that would have eliminated immunosuppressive drugs as one of the six protected drug classes. NATCO submitted comments to CMS opposing this action, citing that timely access to immunosuppressant’s is essential for patients with transplanted organs and that restricting access to these life-saving medications could lead to increased rates of organ rejection, patient suffering and ultimately even death.
We expressed our concerns with CMS and others, and I am happy to report that the proposed change was withdrawn.

See NATCO's comments that led to the withdrawal.

 

The Centers for Medicare and Medicaid Services (CMS) which administers the Medicare and Medicaid programs implemented a set of regulations for the certification of transplant centers. In order for a transplant center to be certified, the center must meet the Conditions of Participation. These conditions were published on March 30, 2007 with an effective date of June 28, 2007. Transplant programs that were previously Medicare-approved prior to June 28, 2007 were all required to apply for continued participation to CMS by December 26, 2007. Once a center is re-approved they will be required to be surveyed every 3 years by CMS.
CMS is the largest payer in the United States for transplant service. Transplant centers must be certified by CMS for each organ type. In the past, Medicare certification was based on meeting certain volume and patient and/ or graft survival requirements.