United Spinal Position Papers define where we stand on the issues that impact on people with spinal cord injuries and diseases.

Our Positions

Complex rehab technology (CRT) refers to products and services, including medically necessary individually configured manual and power wheelchair systems, adaptive seating systems, alternative positioning systems, and other mobility devices that require evaluation, fitting, design, adjustment and programming. CRT is designed to meet the specific and unique medical and functional needs of an individual with primary diagnoses resulting from a congenital disorder, progressive or degenerative neuromuscular disease, or from an injury or trauma.

The U.S. Congress has acknowledged that complex rehab power wheelchairs are unique and different from standard durable medical equipment (DME). In 2008, it passed legislation exempting these products from inclusion in Medicare’s new Durable Medical Equipment (DME) competitive acquisition program recognizing that such inclusion would jeopardize access to this technology for individuals with disabilities and chronic medical conditions for whom it is medically necessary. However, separate recognition of CRT was not established at that time. The Centers for Medicare and Medicaid Services (CMS) has recognized the unique nature of other unique products and services and has created a separate and distinct classification for orthotics and prosthetics (O&P), i.e. custom braces and artificial limbs.

CRT is unique and differs significantly from standard DME in the following ways:
CRT is used by individuals with disabilities and chronic conditions who have medical conditions significantly different from those experienced by the traditional elderly population in Medicare. This population tends to qualify for Medicare based on their disability and not their age including individuals diagnosed with cerebral palsy, muscular dystrophy, multiple sclerosis, spinal cord injury, amyotrophic lateral sclerosis (Lou Gehrig’s disease), and spina bifida.

• CRT requires a broader range of services and specialized personnel than those required for standard DME – an interdisciplinary team consisting of, at minimum, a physician, a physical therapist/occupational therapist, and a rehab technology professional (RTP) –certified by the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA). Devices in this category require a technology assessment (review of individual’s medical and functional needs) completed by a certified RTP employed by a CRT company. The CRT company is also required to repair the equipment it provides.
• This bill requires a home evaluation of the individual’s functional mobility needs to include a technology assessment, measuring, fitting, simulations and trials, a mixing and matching of products from different manufacturers, significant training and education, refitting and ongoing additional modifications.
• The Medicare program has established quality standards that all DME companies must meet to qualify for the Medicare program. Under this benefit, additional and more rigorous quality standards will be in place with which CRT companies must comply including the fact that suppliers must be accredited by an independent accreditation organization demonstrating that they comply with the enhanced quality standards.
• Under this bill, CRT would be covered for people transitioning from skilled nursing facilities to the home and community. This bill exempts CRT products from Medicare’s ‘in-the-home’ rule which covers mobility devices only if used inside a person’s home. The exemption rightly allows people to use their mobility devices to remain active members of their community.

Medicare currently does not have unique coverage for the more complex needs of individuals with disabilities and chronic medical conditions that require medically necessary individually configured products and services. We believe the creation of a separate recognition of CRT will result in decreased Medicare expenditures by averting hospitalizations due to conditions such as severe pressure sores and blood clots. In the interest of quality healthcare and optimal functionality for individuals with disabilities and chronic medical conditions, recognition of a separate category for CRT is needed.

REQUEST TO POLICYMAKERS
Co-sponsor H.R. 1516/S. 1013, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 that will create separate recognition for complex rehab technology. House co-sponsors: Rep. Jim Sensenbrenner (R-5th WI)]/Rep. Joseph Crowley (D-14th NY). Senate sponsors: Sen. Thad Cochran (R-MS)/Sen. Charles Schumer (D-NY).

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BACKGROUND
Catheters are essential prosthetic medical supplies used by individuals living with spinal cord injuries and disorders, spina bifida, urinary incontinence, serious bladder impairment (neurogenic bladder), and other urinary medical conditions. For example, individuals with a neurogenic bladder have no bladder function control, and these individuals are at extremely high risk for severe infection to both bladder and kidneys. These infections often lead to otherwise avoidable emergency room visits, hospitalization and even death.

Ostomy medical supplies are used by individuals living with colorectal cancer, bladder cancer, Crohn’s disease, ulcerative colitis, birth defects, and other intestinal or urinary medical conditions. People living with an ostomy have undergone surgery to remove their bladder or part of their bowel which impairs their ability to store and eliminate bodily waste. They have a surgically-created opening (stoma) in their abdomen for the discharge of waste. People use ostomy pouches on a daily basis and often for the rest of their lives to help restore the critical function of storing and removing bodily waste. Ostomy and related medical supplies are also necessary in cases of severe abdominal or pelvic trauma as a result of an accident including those sustained during military service.

A proposal in the President’s FY2017 Budget expands the competitive bidding program to additional categories, including ostomy and urological supplies. This decision will limit access to prosthetic supplies which need to be clinically prescribed, selected, and/or adjusted and fitted for individuals by specially trained health care professionals based on the unique medical and physical needs of each person in relation to their disease or condition. The incorrect catheters or ostomy supplies can put individuals at risk of severe skin damage, infection, hospitalization and possibly death. Since ostomy and urological medical supplies restore the lost functions of waste storage and elimination, they are defined in the Social Security Act as prosthetics .

Medicare, and other payers, need to ensure that individuals have access to the catheters and ostomy supplies prescribed for their use to avoid life-threatening infection and increased health care costs. Ostomy and urological products are clinically prescribed by health care professionals and finding the right product to address both clinical and lifestyle needs can take time and requires continual adjustment over the course of an individual’s life. There are approximately 450,000 people living with an ostomy in the United States and approximately a total of 400,000 people living with a spinal cord injury and with spina bifida in the United States.

REQUEST TO POLICYMAKERS
Prescribed products such as urological and ostomy supplies should continue to be excluded from the current competitive bidding program under Medicare for the following reasons:
• They are products prescribed by medical professionals to address a Medicare beneficiary’s life-sustaining medical needs, not a one-size-fits-all, off-the-shelf, or over-the-counter generic product.
• They require continual services from a health care professional for selection, fitting, training on use, adjustment, and to mitigate risk associated with health care conditions and clinical complexities that arise.
• The wrong prosthetic supply can result in severe skin damage, infection and illness resulting in hospitalization and increased health care costs.
• Ostomy and urological prosthetic supplies are not used with other durable medical equipment but rather function on their own, replacing a bodily function.
• A 2004 evaluation and report by the U.S. Department of Health and Human Services concluded that urological supplies were not well-suited for competitive bidding because there was insufficient potential for Medicare savings.

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1Title XVIII, §1861(s)(8) of the Social Security Act defines prosthetics as those which replace all or part of an internal body organ, including colostomy bags and supplies directly related to colostomy care, and replacement of such devices.
2Final Report to Congress: Evaluation of Medicare’s Competitive Bidding Demonstration for Durable Medical, Equipment, Prosthetics, Orthotics and Supplies; 2004; Office of the Secretary, Department of Health and Human Services.

United States House of Representatives
Congressional Bipartisan Disabilities Caucus

Co-Chairs: Rep. Jim Langevin (D-RI 2nd), Rep. Gregg Harper (R-MS 3rd)

The Bipartisan Disabilities Caucus (BDC) was formed in the 107th Congress and serves as a groundbreaking forum for Members of Congress and their staff to discuss the many issues affecting people with disabilities. The primary purpose of the Caucus is to inform, educate and raise awareness on issues affecting people with disabilities.

It is estimated that one in five Americans is living with a disability. Most Americans will experience a disability at some point during their lives, either personally or within their families. As advances in public health, medical treatment, and technology enable people to live longer lives and survive once-fatal diseases, the likelihood of their developing a disability increases. It is crucial that we continue our work to create a more accessible and inclusive society for people with disabilities. The Caucus has been a leading force in the House of Representatives in promoting measures to accomplish this goal.

Bipartisan

REQUEST TO REPRESENTATIVES
Are you a member of the Caucus? If NOT, please join the Bipartisan Disabilities Caucus now and demonstrate your support for people with disabilities.

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The Affordable Care Act (ACA), signed into law in 2010, established new regulatory authority for the Food and Drug Administration (FDA) to review and approve biosimilar versions of FDA approved biologic medicines (biosimilar products are similar but not identical to the original biologic product). The ACA lays out basic standards that must be met including that the biosimilar is “highly similar” to an already-approved biological product. The law also gives FDA authority to find a biosimilar to be “interchangeable” which requires a significantly higher standard confirming that it will achieve the same clinical result in any given patient. The law left many important details about biosimilar approval standards to the FDA to develop.

United Spinal Association endorses Biotechnology Industry Organization’s biosimilar principles which designate that substitions of biosimilar products can only occur when the FDA has designated a biosimilar product as interchangeable; the prescribing physician should be able to prevent substitution in light of the patient’s medical treatment and history; the prescribing physician should be notified of the substitution – even though interchangeable biologics will be “expected” to produce the same clinical result, patients could react very differently to an interchangeable product. The patient, or the patient’s authorized representative, should, at a minimum, be notified of the substitution. The pharmacist and the physician should keep records of the substitution – many biologic medicines are used to treat chronic conditions that can change over time so it is important for a patient’s treatment team to have records that document how and when a patient was treated with biologic therapies.

The ACA permits manufacturers of biosimilars to rely on clinical trial data from the original biologic as long as several conditions are met (such as if the FDA deems the biosimilar product to be similar in structure with no clinically meaningful differences to the innovator product). However:

  • biologic medicines are unique and complex proteins that are made from highly specialized and purified living cells.
  • biosimilars are not identical “generic” versions of the innovator biologic medicines they seek to copy because they are made from different cell lines and different manufacturing processes.
  • biosimilars may provoke immune responses that differ from biologic medicines that can only be understood with adequate human clinical trials.

REQUEST TO POLICYMAKERS

  • The FDA is expected to publish proposed guidance for public comment this year related to key aspects of implementation of the biosimilars law. The Federal Trade Commission (FTC) may also issue a report with advisory recommendations regarding the naming and marketing of biosimilars, but the FTC has no direct jurisdiction. Please hold oversight hearings on this important process and urge the FDA to release guidance as soon as possible that ensure patient safety, patient access to the right biologic medicines, patient choice and full transparency.
  • Choice should be at the center of any decision to substitute or switch therapies and should only be decided by the patient and provider. Patient choice needs to be preserved and regulatory decisions must be based on sound science.
  • Biosimilar regulations must put patient safety first. Policymakers and regulators must address appropriate patient safety and efficacy concerns as they relate to decisions around interchangeability, clinical indications, labeling, naming and substitution.

o Particular attention must be given to assure that rigorous clinical testing proves that a biosimilar works safely in each and every condition or disease for which it is approved to be prescribed, as well as in each distinct group of patients with that disease.

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Complex rehab wheelchairs and essential components are used by a segment of wheelchair users with significant disabilities such as ALS, cerebral palsy, multiple sclerosis, muscular dystrophy, spinal cord injury and traumatic brain injury. For these wheelchair users, the chair is not complete, usable or even safe without the appropriate complex rehab technology components included. Medicare is planning on implementing a payment policy change on January 1, 2016 which will result in these vital components becoming more difficult to acquire.

This specialized equipment is provided through a clinical team model and requires extensive evaluation, configuration, fitting, adjustment, or programming. These individuals have the highest level of disabilities and require individually configured complex rehab wheelchairs and critical wheelchair components to meet their medical needs and maximize their function and independence. Complex rehab components are not mere cup-holders or convenience items but include such items as seating and positioning systems and specialty wheelchair controls. These are medically necessary and integral to the complex rehab wheelchair being functional and useful to an individual living with a significant disability such as SCI in order to maintain their independence and participation in society.

The current payment policy for complex rehab wheelchair components must be maintained and Medicare’s January 1, 2016 policy change which will apply competitive bid pricing for standard wheelchair components to complex rehab wheelchair components must be canceled based on the following:

• Complex rehab wheelchair components need additional adjustment and fitting and rely on higher-credentialed technicians for those services.
• Medicare is inappropriately using pricing information obtained through its competitive bidding program for standard wheelchair components and applying that pricing to complex rehab wheelchair accessories that were not part of the competitive bidding program.
• This policy change is in violation of Congressional intent when it passed Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) which excluded complex rehab power wheelchairs and components from the competitive bidding program.
• This policy change is contrary to Medicare policy after MIPPA which states components (called accessories by Medicare) on complex rehab manual wheelchairs are paid at established fee schedule amounts.
• Medicare is using extremely limited information from a sample size of 174 power wheelchairs in nine cities. Medicare plans to apply this inadequate, 7 year old data to complex rehab wheelchair components used on a national universe of over 15,000 complex rehab power wheelchairs.
• The negative consequences will spread to include other people with disabilities who are covered by Medicaid and private health insurance plans since many insurance payers follow Medicare policy.

In order to avoid major access problems for people with significant disabilities whom rely on specialized features and accessories, Medicare must rescind its planned January 1, 2016 payment policy change regarding critically needed components used on complex rehab wheelchairs.

REQUEST TO POLICYMAKERS
Co-sponsor and pass H.R. 3229/S. 2196 to protect access to complex rehab wheelchairs and essential components required by people with disabilities. House sponsors: Rep. Lee Zeldin (R-NY); Senate sponsors: Sen. Robert Casey (D-PA), Sen. Rob Portman (R-OH), Sen. Thad Cochran (R-MS), Sen. Charles Schumer (D-NY).

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