Prehospital Blood Transfusion: Paving the Way for Reimbursement and Policy Reform

Exsanguination remains the leading cause of preventable deaths among trauma victims, with nearly half of these patients dying in the prehospital setting. And data shows for every one-minute delay in prehospital resuscitation there is a two percent increase in the odds of 30-day mortality.

While the use of pre-hospital blood products is widespread within the deployed Department of Defense trauma system and has been proven lifesaving, a limited number of civilian pre-hospital systems have implemented prehospital transfusion programs.

Low-titer O whole blood (LTOWB) was created by an Armed Services Blood Program collecting blood from donors who have had an antibody titer test showing that they have low levels of anti-A and anti-B antibodies.

Two significant barriers to getting prehospital blood implemented nationwide: reimbursement of blood products and scope of practice.

A grassroots effort led by various experts is in the infancy stage of forming the Prehospital Blood Transfusion Initiative Coalition (PHBTIC).

Among them is Randall Schaefer, DNP, RN, ACNS-BC, CEN, CEO, Schaefer Consulting, and Bill Skillman, Velico Medical's senior vice president.

Velico Medical is a medical technology company behind the design of a dry plasma manufacturing system to equip blood centers to produce dry plasma products for transfusion.

The on-demand plasma rehydrates in minutes at the point of medical care, including pre-hospital use.

What is the PHBTIC?

PHBTIC was established to build a multidisciplinary, industry-wide collaborative initiative to establish reimbursement coverage from government and commercial payors for prehospital blood transfusions and ensure prehospital blood transfusion is included appropriately in the prehospital ground and air EMS clinical scope of practice in all U.S. states and jurisdictions.

It includes the development of a reimbursement proposal to the Centers for Medicare and Medicaid Services (CMS) and prehospital blood policy recommendations to Congress and the National Association of State EMS Officials addressing the scope of practice inconsistencies.

The Coalition also will address U.S. strategic preparedness as it pertains to blood availability in the field for everyday trauma and mass casualty events as well as implement an educational support program for EMS related to prehospital transfusions.

PBHTIC will coordinate with the National Association of Emergency Medical Technicians, National Association of EMS Physicians, National Association of State EMS Officials, American Ambulance Association, Americas Blood Centers (ABC), and the American Red Cross.

Introducing Bood in Pre-Hospital Settings

Schaefer was an Army trauma nurse who helped oversee clinical care in Iraq, Syria, Turkey, and Jordan for 20 years.

In Iraq, “when we blew through our blood supply, we turned to walking donors and started using fresh whole blood. We started seeing improvement clinically in patients as they were getting this special blood,” Schaefer says.

After the military, Schaefer was hired by the Southwest Texas Regional Advisory Council – designated by the Texas Department of State Health Services to develop, implement, and maintain the regional trauma and emergency healthcare system for 22 counties.

Leveraging her Army experience, Schaefer engaged in discussions with South Texas Blood & Tissue Center staff about using blood in the pre-hospital setting on the civilian side.  She rolled it out to 18 helicopter bases and 20 South Texas agencies.

Setting up a model that could be quickly standardized meant considering clinical training, logistics, and operations – making pre-hospital blood manageable for the EMS agencies helped make it fiscally viable.

San Antonio may run between 45 and 55 ambulances every shift and while there could be a bag of blood on every ambulance, “we chose not to because that was not being a good steward of a product that has a lifecycle that's expensive,” Schaefer says.

The decision was made to put it on the supervisor's vehicles.

“Doing that model allowed us to roll it out to the far stretches of south Texas, with helicopters that are three hours away from a level one trauma center,” she adds.

Advocacy for Prehospital Blood

Her advocacy for prehospital blood led to her involvement on a national level with PHBTIC.

“We have made tremendous progress over the last five years, but still have a long way to go,” she says. “Progressive EMS agencies like the San Antonio Fire Department are leading the efforts to implement prehospital blood. The implementation in other metropolitan areas has been slower.”

However, pre-hospital blood implementation is taking off in rural areas such as the Blue Ridge Mountain region of North Carolina.

A recent position statement from the American College of Surgeons Committee on Trauma, the American College of Emergency Physicians, and the National Association of EMS Physicians recommended all patients with signs of hemorrhagic shock should receive blood products whenever available.

Medicare currently reimburses ambulance services through bundled payments under a fee schedule, which varies in amount based on service level. The model is followed by most health care insurers nationally, PHBTIC notes.

But payment rates for existing service levels do not account for and are far too low to accommodate the cost of providing blood transfusions in the field, the coalition notes.

Implementing Pre-Hospital Blood Banks

“The blood bank has a very strict set of rules and lots of compliance,” she says. “EMS, pre-hospital, military, we do too. But we are more comfortable with risk because we live in a risky world every single day. One of my roles has been trying to help bring these two different worlds together so that we can get blood out there.”

EMS agencies enter a vendor relationship with a blood center, which supplies the product and pays for it, Schaefer says.

More than 60,000 deaths per year in the U.S. are attributed to hemorrhaging, says Skillman, adding “If you look at people with abdominal bleeds, intracranial bleeds, postpartum hemorrhage, that number goes up substantially…tens of thousands of people.”

The idea for the coalition was to “build a big tent” that includes blood collectors, trauma surgeons, hospital transfusion services, and EMS trade associations, Skillman says.

“We’re working to unify the regulations across the country to get it down to the paramedic level,” says Skillman of the scope of practice focus. Other initiatives include strategic preparedness assessments and extensive community education and outreach to prepare for program initiation and execution.

With bundled payments, any costs for advances and medical innovations are largely absorbed by the agency, especially since they can’t do line item billing, Schaefer says,

“When you take something like pre-hospital blood, in a best-case scenario, an agency will have that bag of blood for 32 days. At the end of 32 days, if it's not used, it has to be discarded. The agencies are eating that cost and the cost of blood varies across the country,” Schaefer says, adding the average cost of LTOWB is about $550.

“Some agencies are only getting it for 14 days,” she adds. “That gets very expensive. We know that EMS is in a state of crisis. They’re barely able to meet their operating costs now.”

Schaefer says in South Texas, a rotation system was utilized. Blood donations from the South Texas Blood & Tissue Center are sent to an EMS agency for 14 days. If it’s not used in that time period, it is sent back to the South Texas Blood & Tissue Center where it undergoes a quick quality check and then sent to a local Level 1 trauma center where it has a greater chance of being utilized.

“The agencies are only charged if they use that blood on a patient or for some reason they aren't able to return it because it went out of a temperature range or some other event happens,” she adds. “That cuts the cost down for the EMS agencies.”

A Look at the Impact So Far

A similar model of return privileges is showing success in other areas of the country.

In the best case scenario, CMS would authorize the reimbursement of the blood product as they do in hospitals to help the agencies offset those costs, says Schaefer.

Skillman says efforts are underway to raise about $200,000 to pay for strategy and policy consultants and lobbyists to help the coalition get in front of Congress.

Schaefer says there are efforts in states that have successfully lobbied their state legislature to get waivers to do pre-hospital blood implemented at the paramedic level, such as in Georgia, Colorado, and Florida.

The coalition is tracking 115 ground EMS agencies throughout the U.S. that are currently carrying pre-hospital blood, she says, adding one challenge is there is no centralized reporting.

Pre-hospital blood will help address some of the disparities in health care, says Schaefer.

“In the urban areas, there tends to be more penetrating trauma and that is often associated with minority groups or folks who don't have access to health care,” she adds. “On the flip side, 60 percent of the country lives in rural areas greater than an hour from a trauma center.

“We're in a state of crisis not only with our EMS in the rural area but also hospitals are shutting down left and right. Pre-hospital blood on an ambulance might be that lifesaving bridge as EMS has to transport further and further to get to a hospital.”

Schaefer says there exists a pre-conceived notion that pre-hospital blood is used primarily for stabbings and shootings, but in fact, it is used for all patient types, including pregnant women who were hemorrhaging to death and saved by pre-hospital blood. In some rural settings, up to 90 percent is used for medical and non-trauma patients.

“We’re all headed towards the same goal in decreasing that patient mortality,” says Schaefer says “We just have to synergize our efforts to get there.”

“It goes beyond medical as a personal impact on the folks delivering the service,” Skillman says.

“Folks in EMS suffer from a lot of frustration and anxiety. When they deliver that whole blood, oftentimes they see immediate results in the patient. It makes them feel really good about the work that they do and being able to save a life.”