America's Blood Centers and its members work to protect the rights of donors, patients, community blood centers, and hospitals. We do this by helping to shape new laws, policies and standards of care through:
- Grassroots advocacy at the local level
- Congressional advocacy in Washington, D.C.
- Coalition building with stakeholders on specific issues
- Ongoing coordination and cooperation with other blood organizations
- Tracking legislative issues of concern to blood centers
America's Blood Centers uses a combination of legislative advocacy and grassroots outreach to help its members strengthen local relationships with elected officials while forging a national identity for community blood centers.
Legislative Issues Affecting Community
Medical Device Excise Tax and Blood Centers
The Affordable Care Act (ACA) of 2010 imposes a 2.3 percent excise tax on manufacturers, suppliers, and importers of medical devices, as a way of raising $20 billion over 10 years to help fund the expansion of Medicaid services to the poor. The tax will be imposed starting in 2013 at the point of sale and, except for some devices in common use by consumers (such as hearing aids), most medical devices are affected. Obviously, medical device manufacturers will be forced to pass on the tax in the form of higher prices or as a line item tax on sales invoices.
Not-for-profit blood centers annually purchase approximately $1.5 billion worth of medical devices to ensure the safety and availability of the nation's blood supply. These items include blood collection devices such as blood bags, devices used in blood processing such as apheresis machines and centrifuges, blood center computers' software systems, and blood screening tests. A rough calculation suggests that the tax could cost blood centers some $11.5 million a year, if passed directly onto customers by manufacturers.
By imposing this financial burden on blood centers, Congress has stepped back from the nation's long-standing commitment to a safe and available blood supply. Not-for-profit community blood centers are unique healthcare providers in that they must purchase these medical devices to meet Food and Drug Administration testing protocols and regulatory requirements to ensure the safety of the blood supply. In a fiscal environment that is already constrained for small, community-based, not-for-profit institutions, an added tax would compromise blood centers' continued efforts to ensure the safety and integrity of the nation's blood supply. This tax would force blood centers to consider which safety measures to prioritize, and may force centers to eliminate certain critical measures entirely.
Congress has long recognized the special role played by not-for-profit community blood centers. In the Pension Protection Act of 2006, Congress specifically exempted "qualified blood collection organizations" from paying excise taxes on fuel, tires and vehicles purchased for the purpose of collecting, storing, or transporting blood and on electronic communications used for the purpose of recruiting blood donors. Congress should continue this protection to ensure the safety and availability of the nation's blood supply.
To avoid this unfair and unwise burden, Congress should exempt medical devices sold to not-for-profit community blood centers from any excise tax on medical devices. To help ensure the continued availability and safety of the nation's blood supply, please ask your local Congressman or Senator to introduce or support a bill that explicitly exempts not-for-profit community blood centers from the excise tax on medical devices.
Medical Malpractice Reform and Blood Centers
America's blood supply has never been safer. Blood for transfusions in the U.S. is provided by volunteer donors who donate at nonprofit, charitable blood centers, including members of America's Blood Centers and blood collection facilities run by the American Red Cross. Through our efforts and those of the FDA, transfusion-related infections such as HIV and hepatitis are now extremely rare, and blood safety increases yearly.
All states have some sort of "blood shield" statute. Though there is little uniformity in how these statutes are enforced from state to state, they all were enacted to recognize the special nature of blood. They shield blood centers from strict liability lawsuits as long as the blood center adheres to Food and Drug Administration rules and guidelines for the collection, testing, processing, and distribution of blood.
Still, in the very rare instance in which a patient contracts a transfusion-borne illness, the nonprofit, charitable blood center is still typically sued, even if it took all possible measures in compliance with FDA regulations. In fact, judgments in medical malpractice lawsuits can be so high that they can greatly exceed the insurance a blood center is able to carry. As a result, a ruling in just one case can be enough to force a blood center into bankruptcy - which could render it unable to provide blood and blood products to the patients whose lives depend on them.
To stem the tidal wave of litigation against doctors, hospitals, corporations, and nonprofit organizations that in recent years have driven up healthcare costs, legislatures across the nation have been passing healthcare liability reform measures. The House of Representatives has also passed a number of bills designed to curb out-of-control litigation abuses by capping jury awards.
During the past decade, the House of Representatives has on several occasions passed a bill that would provide protections to healthcare providers and the providers of medical products. H.R. 5, introduced in January 2011 and passed by the House in early 2012, protects the healthcare delivery system from excessive liability by capping non-economic damages at $250,000. Among other provisions, the bill exempts healthcare providers who prescribe or dispense FDA-approved drugs, medical products, or devices from being named a party in a lawsuit. The bill also exempts manufacturers, distributors or suppliers of medical products that are subject to FDA approval from being named party to a suit.
America's Blood Centers urges lawmakers to include blood centers as beneficiaries of any medical malpractice reform legislation at the federal or state levels. In 2008, the American Medical Association approved a resolution to advocate for the inclusion of blood centers in all medical malpractice reform bills.
H.R. 5 has the support of dozens of associations such as the American Medical Association and the American Hospital Association. America's Blood Centers has supported H.R. 5, though it finds the protections in the bill inadequate for blood centers. One reason is that blood is regarded by all state laws as a service, not a product, and that in some 10 states, either by statute or case law, blood centers are considered healthcare organizations or healthcare providers. Thus, blood centers need to be explicitly included in the "healthcare provider" definition in H.R. 5 and any other medical liability reform legislation.
To clearly cover blood centers under any healthcare liability reform legislation, a "healthcare provider" should be defined as any entity required by federal laws or regulations to be licensed, registered, or certified to provide healthcare services, including a blood center possessing a license from the FDA.
If blood centers are not recognized as healthcare providers for healthcare liability reform purposes, two of the parties likely to be sued - the hospital and the physician - would get the benefits of the legislation, but the blood center - which is almost always a nonprofit, charitable entity that charges service fees only sufficient to cover its costs - would not.
Please urge your federal lawmaker to support healthcare liability legislation that explicitly gives blood centers the same protections as doctors and hospitals.
Federal Health IT Initiative and Blood Centers
Advances in health information technology, especially from the use of electronic health records, are slowly spreading through the nation's healthcare system, pushed along by the Obama administration.
The American Recovery and Reinvestment Act (ARRA) of 2009, also known as the stimulus act, includes several HIT (Health Information Technology) grant programs. Title XIII of ARRA contains most of the Health Information Technology provisions, including grant programs, technical assistance, and hospital and eligible provider incentives. Section 13101 defines "health care provider" to explicitly include blood centers. However, blood centers have been stymied in applying for HIT funding.
America's Blood Centers has repeatedly advocated on behalf of members at meetings of the Health IT Policy Committee, which reports to the Office of the National Coordinator of Health IT (ONC). Staff also submitted comments asking that "transfusion services" be added to the definition of "meaningful use of health IT," which is a major criterion for qualifying for funding. Our staff, assisted by America's Blood Centers' member blood centers and our Capitol Hill representatives, submitted comments to ONC and the Centers for Medicare and Medicaid Services (CMS) on a proposed rule on EHR (Electronic Health Record) incentive programs, as well as on an ONC Interim Final Rule that sets out standards, implementation specifications, and certification criteria for EHR technology.
However, the CMS final rule rejected arguments from America's Blood Centers by making it clear that eligibility is limited to direct Medicare and Medicaid billers, such as hospitals and physician groups, and a list of Medicaid "eligible professionals." The rule includes this explanation: "Additionally, professionals who do not participate in either Medicaid or Medicare are also not eligible for incentives due to the statutory requirements associated with each program."
America's Blood Centers represents community blood centers that are implementing IT systems that will support processes to track blood from donor to patient. For example, Our Appropriate Inventory Management (AIM) program helps manage the available blood supply while lowering the risk of transfusion complications and lowering the cost of blood transfusions. The system is in use by an ever-growing number of hospitals.
We were also a key player in the development of an IT interface standard for blood centers based on an existing standard already used by hospitals. In February 2012, after a two-year development project, Health Level Seven (HL7) International published an implementation guide to extend the HL7 standard used by hospitals into the blood center environment. HL7 Version 2.6 Implementation Guide: Blood Bank Donation Service (U.S. Realm) Release 1 is now available on the HL7 website. Once implemented by blood centers and their software vendors, the blood banking specification should enable speedy and accurate data exchanges between blood center devices and systems, and eventually between blood centers and transfusion centers, thereby reducing transfusion errors and improving patient safety.
America's Blood Centers has also developed a data warehouse system that will help hospitals benchmark blood use with other hospitals, show which blood products are being used and for what conditions, and monitor disease markers in blood donors as early public warnings of national disease trends.
With the help of our member community blood centers, America's Blood Centers has also been on the forefront of the development and implementation of new radio frequency identification and bar-coded labeling systems that aim to reduce the number of transfusion errors and transfusion-transmitted infections in the hospital setting.
Clearly, blood transfusion and the provision of blood products are "meaningful uses" of health IT. Please ask your federal lawmakers to encourage the Centers for Medicare and Medicaid Services to recognize transfusion medicine professionals as certified users of health IT, and enable blood centers, with or without the hospitals they supply, to become eligible for discretionary funding contained in ARRA.
House Resolution 220
In October 2006, the U.S. House of Representatives adopted House Resolution 220 (H. Res 220) (PDF 25KB), which honors America's Blood Centers and its members' for their commitment to ensuring the adequacy and safety of half of the nation's blood supply, as well as for the critical roles they play in disaster response and preparedness and infectious disease research.
The resolution also noted that our community blood center members provide hospitals and their patients with much of the nation's tissue, bone marrow, cord blood, and stem cell services. It also recognized the important research they do in infectious disease detection and prevention, conducting the majority of blood-related studies supported by the federal government. New York Blood Center invented hepatitis B vaccine and solvent-detergent plasma sterilization.
America's Blood Centers also has taken a leadership role in educating young people about the importance of donating blood, which is a hallmark of good citizenship. Among its accomplishments is a series of popular educational videos called My Blood, Your Blood, including a Spanish version. The high school module won a Telly award for excellence in video education.
Since the 9/11 World Trade Center tragedy, our members have supported and developed with the Departments of Homeland Security and Health and Human Services proposals to ensure rapid response and adequate blood support in the case of a national disaster or act of terrorism. Among other initiatives, America's Blood Centers is prepared to deploy a developed "hub-and-spoke" system to rapidly respond to any military requirement for blood to support our troops.
Prescription Drug Marketing Act
In 1994, the Food and Drug Administration proposed a rule to implement a provision of the Prescription Drug Marketing Act (PDMA) providing that "a person cannot simultaneously be a 'health care entity' and a retail pharmacy and wholesale distributor." This created unintended problems for many of our community blood center members that both (a) provide health care and (b) distribute blood-related products, especially blood derivatives.
In 1999, the FDA published its intent to make this a final rule. Accordingly, in 2000 America's Blood Centers filed formal comments asking for a revision so as "not to prohibit blood centers from simultaneously acting as health care entities and wholesale drug distributors.") While it considered the issue, FDA postponed the effective date of the final rule to December 1, 2006.
In April 2004 comments to the FDA and in ongoing discussions with FDA officials, we continued to urge that blood centers be permitted to distribute all blood-related drugs, including plasma derivatives and their recombinant counterparts, oxygen carriers, and empty blood bags with anticoagulant.
Finally, in October 2008, FDA ended a more than 14-year struggle initiated by America's Blood Centers by publishing a final rule allowing blood centers to continue to distribute blood-related drugs as long as state regulatory requirements are met. Today, some 22 of its members continue to sell $450 million a year in derivatives.
Producer Price Index
In 2005, after years of negotiations between America's Blood Centers' leadership, the Centers for Medicare and Medicaid Services (CMS) and the Bureau of Labor Statistics (BLS), the BLS decided to add blood and organ products to its Producer Price Index (PPI).
This index category measures the price change associated with providing a specific set of services related to the collection, storage, and distribution of blood and blood products and the storage and distribution of body organs.
In May 2009, CMS issued a proposed rule, later finalized, that for the first time provided a separate line item for blood costs in the hospital Inpatient Prospective Payment System. The rule took effect in October 2010. The figure is based in part on blood and organ banks cost data from the PPI that are used in the "market basket" for hospital-based services.
Changes in these cost data affect the National Adjusted Operating Standardized Amount, or baseline payment, that hospitals receive for Medicare-covered inpatient treatment. The payments thus more accurately reflect the actual costs associated with transfusions and transplants.