Dr. Lucille Beck
Chairwoman Buerkle, Ranking Member Michaud, and Members of the Subcommittee: thank you for the opportunity to speak about the Department of Veterans Affairs’ (VA) ability to deliver state-of-the-art care to Veterans with amputations. I am accompanied today by Joseph Webster, MD, Medical Director for VHA’s Amputation System of Care; Joseph Miller, Ph.D., National Program Director, Orthotic and Prosthetic Services, and Norbert Doyle, MBA, VHA’s Chief Procurement and Logistics Officer.
VA continually strives to improve our programs and we appreciate independent reviews that can validate our successes and offer recommendations for improvement. On March 8, 2012, VA’s Office of Inspector General (OIG) published a report on Prosthetic Limb Care in VA facilities. In this Report, OIG concluded that more than 99 percent of Veterans with a traumatic amputation who were discharged from active military duty had transitioned to VA care within 5 years of discharge. OIG also found that Veterans reported receiving excellent care at VA facilities, and that all required orthotic and prosthetic VA providers were appropriately certified; however, Veterans did express concern with the availability of care through fee basis or contract care. VHA concurred with OIG’s three recommendations: to consider the wide-ranging medical needs of traumatic amputees and adjust, if necessary, the delivery of appropriate health care services; to evaluate the needs of Veterans with traumatic upper limb amputation and improve their satisfaction; and to consider Veterans’ concerns with VA approval processes for fee basis and contract care for prosthetic services.
On the same day, OIG also published a report on the Management and Acquisition of Prosthetic Limbs. In this Report, OIG found that overpayment for prosthetic limbs was a systemic issue in each Veterans Integrated Service Network (VISN), and that internal controls needed to be strengthened to better control the process. VHA concurred with OIG’s recommendations in this report. OIG found that VA spent approximately $54 million on artificial limbs in fiscal year (FY) 2010, including total contracts to vendors valued at close to $49 million. VA acknowledges it could have saved $2.2 million, and has adopted practices to achieve greater savings.
Later that same month (March 30, 2012), OIG published a third report, an Audit of Prosthetics Supply Inventory Management. In this Report, OIG concluded that VA needs to strengthen management of prosthetic supply inventories at its medical centers and make better use of excess inventories. VHA concurred with OIG’s recommendations in this report, and has developed action plans to improve oversight and management processes to better ensure VHA delivers the quality care Veterans deserve while exercising responsible stewardship of prosthetics supplies.
My testimony today will first cover the range of services available to Veterans across our system of care, focusing specifically on demand and utilization of health care services, quality of care, gaps in service, and the ability for Veterans to access VA or contract care that best meets their needs. I will then describe the impact of procurement reform and suitability of acquisition and management policies in support of our clinical care objectives.
Demand for Quality Amputation and Prosthetic Care
VA’s Prosthetic and Sensory Aids Service is the largest and most comprehensive provider of prosthetic devices and sensory aids in the world. VA provides a full range of equipment and services, including artificial limbs, durable medical equipment, hearing aids, eyeglasses, ramps and vehicle modifications, and implantable devices, such as replacement hips or biological tissues. All enrolled Veterans may receive any prosthetic item prescribed by a VA clinician, without regard to service-connection, when it is determined to promote, preserve, or restore the health of the individual and is in accord with generally accepted standards of medical practice.
VA’s Prosthetic and Sensory Aids Service has a robust clinical staff of orthotists and prosthetists at more than 75 locations, and also partners with the private sector to provide custom fabrication and fitting of state-of-the-art orthotic and prosthetic (O&P) devices. Moreover, VA maintains local contracts with more than 600 accredited O&P providers to help deliver care closer to home. Commercial partners help fabricate and fit prosthetic limbs for Veterans across the country. When utilizing the services of these community partners, VA covers the full cost of the prescribed limb, as well as any repairs. In FY 2011, VA spent more than $108 million to purchase devices or services from more than 1,290 local business communities across the country.
VA promotes the highest standards of professional expertise for its workforce of more than 300 certified prosthetists, orthotists, and fitters. Each VA lab that is eligible for accreditation is accredited either by the American Board for Certification in Orthotics, Prosthetics, and Pedorthics, Inc. (ABC), the Board of Certification/Accreditation International (BOC), or both. This accreditation process ensures quality care and services are provided by trained and educated practitioners.
Since its creation in 2009, VA’s Amputation System of Care (ASoC) has expanded to deliver more accessible, high quality amputation care and rehabilitation to Veterans across the country. The ASoC utilizes an integrated system of VA physicians, therapists, and prosthetists working together to provide the best devices and state-of-the-art care. This System provides care through more than 375,000 clinical visits to more than 30,000 Veterans with limb loss, including more than 1,000 Veterans from Operations Enduring Freedom, Iraqi Freedom, and New Dawn (OEF/OIF/OND).
The ASoC consists of four levels of care. Seven (7) Regional Amputation Centers provide comprehensive rehabilitation care through an interdisciplinary team and serve as resources across the system through the use of tele-rehabilitation technologies. These Centers provide the highest level of specialized expertise in clinical care and technology and provide rehabilitation and consultation to patients with the most complex conditions. The seven locations include: Bronx, NY; Denver, CO; Minneapolis, MN; Palo Alto, CA; Richmond, VA; Seattle, WA; and Tampa, FL. Fifteen (15) Polytrauma Amputation Network Sites provide a full range of clinical and ancillary services to Veterans closer to home. One-hundred eleven (111) Amputation Rehabilitation Teams provide specialized outpatient amputation care, and 22 Amputation Points of Contact facilitate referrals and access to services. All sites in the ASoC are fully operational.
To support the continued delivery of high quality care, VA has developed a robust staff training program. We offer clinical education, technical education, and business process and policy education, in addition to specialty product training, to help our staff provide better services to Veterans. Clinical education describes the nature of the clinical environment and recommends ways to help maintain productive and positive outcomes in the clinical setting. Technical education trains providers in the nature of products, materials, and supplies, explaining how a microprocessor in a knee may work or how to harness advanced techniques for thermoforming plastics to improve the fit and comfort of the prosthetic socket. Finally, business process and policy education instructs providers how to help standardize processes in the clinical and health care environment to ensure consistent, quality care. Training is often available through facility-specific courses, monthly video tele-conferences, manufacturer-offered courses, educational seminars, curricula for independent study, and other forums. Further, VA has one of the largest orthotics and prosthetics residency programs in the Nation, with 18 paid residency positions at 11 locations across the country.
Research is another important element of VA’s amputation care program, with a number of research projects aimed at evaluating new prosthetic devices and improving clinical care. VA’s Office of Research and Development spent more than $13 million in FY 2011 on prosthetics and amputation health care research and is issuing Requests for Applications for studies to investigate a variety of upper limb amputation technologies and applications. VA also works with the Department of Defense (DoD) to support joint research initiatives to determine the efficacy and incorporation of new technological advances. Recent examples of this collaboration include:
- DEKA Arm, a robotic arm with fluid finger, wrist and elbow movements that is currently being deployed for home trials with 29 research subjects to provide data on the usefulness of this device in everyday life. This project began in April 2012.
- i-Walk Foot, which became commercially available in 2011; VA prosthetists have provided 57 units to date;
- Genium/X-2 Knee, which became commercially available in 2010; VA and DoD have been involved in the research and development of these products, which represent a significant advance in microprocessor prosthetic knee technology. VA has promoted training in this new technology, with more than 40 prosthetists, 25 physicians, and 35 physical therapists having completed training.
The partnership between VA and DoD extends further to provide a combined, collaborative approach to amputation care by developing a shared Amputation Rehabilitation Clinical Practice Guideline for care following lower limb amputation. VA is supporting DoD by collaborating on the establishment of the Extremity Trauma and Amputation Center of Excellence (EACE). The mission of the EACE encompasses clinical care, including outreach and clinical informatics, education, and research, and is designed to be the lead organization for policy, direction, and oversight in each of these areas. EACE is currently being implemented and will obtain initial operating capacity by the end of FY 2012. VA will provide four positions for the EACE, including the Deputy Director, Deputy Clinical Program Director, and Deputy Research Director.
Procurement Reform and Acquisition and Management Policies
Clinical care is an important part of our system to provide prosthetic devices to Veterans. Procurement, acquisition, and management policies reflect a complementary and essential piece of this system as well. VA is reforming its procurement practices to extract better prices and more competition in obtaining the devices and supplies Veterans need where appropriate. Title 38, United States Code (U.S.C.), section 8123, grants to VA broad authority to procure prosthetic appliances and services in any manner “the Secretary may determine to be proper without regard to any other provision of law.” When exercising this authority the Department may procure prosthetic appliances and necessary services required in the fitting, supplying, training, and use of prosthetic appliances by purchase, manufacture, contract, or in other manners as appropriate. This flexibility was granted to ensure that Veterans receive devices and supplies that are suitable for them and that meet their clinical needs. Many of the products VA purchases are either going to become a part of a Veteran or will be a critical part of their daily lives, helping them walk, work, and interact with their families. The §8123 authority permits VA to limit competition when physicians require specific devices or equipment to support patient care. Also, Federal Acquisition Regulation (FAR) and VA Acquisition Regulation (VAAR) authorize limiting competition under these circumstances. If the Secretary elects to use §8123 in this manner, all applicable FAR and VAAR requirements must still be followed.
When products are generally available and interchangeable, competitive procurements may be more appropriate. VA must comply with all applicable FAR and VAAR requirements in such procurements.
VHA is working to place appropriate limits on the use of the title 38 authority so that it secures fair and reasonable prices for products while still delivering state-of-the-art care, and so we can improve opportunities for Veteran-owned and small businesses. VHA is pursuing three strategies to extract cost savings while preserving high quality, patient-centered health care and appropriate clinical determinations. First, we are transferring purchasing authority from prosthetics purchasing agents to contracting specialists for any purchase above $3,000 (the micro-purchase threshold). VHA has notified the field that certified contracting specialists will be required to contract for these items. For items less than $3,000, micro-purchase requirements continue to apply. We conducted a pilot program to evaluate the impact of this change from January until March in Veterans Integrated Service Networks (VISN) 6, 11, and 20, and beginning this month, we are transitioning to national implementation. Second, VHA is pursuing a phased approach to standardize and define commodities for its products where appropriate. When we can purchase products, devices, or supplies that are generally available and interchangeable, we will comply with the FAR to ensure we are obtaining the best price possible. In the long term, VHA will develop a catalog of such items to facilitate better, more cost effective purchasing decisions. Again, we must balance this goal while still preserving clinical quality and patient care. Finally, VHA is updating policies and directives to better guide clinical and procurement staff on the proper use of §8123. These updates will allow us to more accurately and timely provide services to the benefit of Veterans.
VHA is also increasing its audits of purchases to identify best practices and conduct better oversight. As we gather more data on how these changes are working, we can continue to refine and enhance our programs. We are using new templates, checklists, and justifications to streamline and simplify our processes and improve communication between staff and leadership so we have a comprehensive view of our procurement activities. VHA will ensure proper controls are in place to review vendor quotes, purchase orders, and verify invoices and costs by developing a comprehensive database of all existing contracts. We will correct non-compliant contracts as required and evaluate contractor performance as required by the FAR, and institute collection activities when warranted for VA overpayments. To improve the guidance provided to certified prosthetists, we are developing contract templates, clearer guidance, and notices that will be disseminated later this summer to our VISN and facility contracting offices. VHA’s Service Area Organizations, which provide support, oversight, and guidance to our facilities, will review the award of every new prosthetic limb base contract to ensure price negotiations took place, and will review a random sample of delivery orders between May and September 2012, to ensure the base contracts include the correct prices. We will determine if base prices can be established following a system-wide review of non-Medicare classified limb items by the end of the fiscal year. In some circumstances, VHA may be better suited to fabricate items in-house. To better identify when we should pursue this approach, we will be contracting for an external review to assess how expanded use of in-house functions would impact patient satisfaction, capabilities, staffing, and Veterans’ needs.
Once VHA has procured devices and supplies, management of our inventories and resources is also essential. In the recently published OIG report auditing VHA’s prosthetics and supply inventory management practices, the OIG concluded VHA had made overpayments because of inefficiencies in our system and inadequate training and guidance. We appreciate OIG’s efforts and recommendations, and in response, we are better defining our policies and guidance to the field, improving our information technology (IT) systems to better track supplies, strengthening our training programs, and increasing oversight and audit functions. We have directed our facilities to reconcile physical inventories and take action to eliminate excess inventories without creating supply shortages. We are revising our standards for facilities to require at least one prosthetic supply inventory manager to become a certified VA Supply Chain Manager. A new, comprehensive IT system will be in place in 2015 to replace our existing inventory systems, but in the interim, we have issued a patch that will enhance the ability of the prosthetics package to interface with inventory management software, facilitating better information sharing. Through these steps, we will better utilize existing and available resources as we deliver prosthetic and amputation services and products to Veterans.
VA supports high quality amputation and prosthetics care by supporting ground-breaking research into new technologies, training a highly qualified cadre of staff, and pursuing accreditation of all eligible prosthetic laboratories in VA’s Amputation System of Care. We are improving our oversight and management of prosthetic purchasing and inventory management to better utilize the resources we have been appropriated by Congress as we serve America’s Veterans. High quality patient care is our top priority, but we understand we must pursue this objective in balance with other aims. These aims include: supporting Veteran-owned and service-disabled Veteran-owned small businesses, ensuring responsible fiscal stewardship of the funding provided to VA by Congress, and complying with all applicable laws and regulations in this regard. We appreciate the opportunity to appear before you today to discuss this important program. My colleagues and I are prepared to answer your questions.