United Spinal Position Papers define where we stand on the issues that impact on people with spinal cord injuries and diseases.
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).
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.
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.
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.
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.
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, 2017 policy change which applies 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, 2017 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).
Without basic data concerning the size and makeup of people with neurological diseases, researchers are working at a distinct disadvantage. Additional epidemiological data on the neurological disease populations could lead to new treatment targets, better clinical understanding of diseases, and eventually new treatments and cures. The Advancing Research for Neurological Diseases Act will collect this essential data.
The Advancing Research for Neurological Diseases Act allows the Secretary of the Department of Health and Human Services (HHS) to establish a centralized data collection system within the Centers for Disease Control and Prevention (CDC) to collect and aggregate data on the epidemiology of neurological diseases. This data will provide a foundation for evaluating and understanding aspects of neurological diseases, (both CDC and NIH include spinal cord injury/disease SCI/D in their categorization of neurologic diseases including multiple sclerosis, Parkinson’s disease) such as:
• The natural history of neurological diseases;
• Demographics, such as age, race, ethnicity, sex, geographic location, and family history;
• Geographic clusters of diseases;
• Diagnosis and progression markers;
• Risk factors that may be associated with certain neurological diseases;
• Disease burden;
• Outcomes measures; and
• Research for the prevention, detection, management, and development of therapies
The Secretary of the Department of Health and Human Services will have the ultimate discretion to decide what types of data to collect and how it will be collected. Data can be drawn from existing databases, including but not limited to: Medicare, State Medicaid Programs, the Department of Veterans Affairs, and State and local registries. This data will be made available to other agencies and researchers.
The bill requires that privacy and security protections be at least as stringent as those required by the Health Insurance Portability and Accountability (HIPAA), de-identifying personal information and eliminating the possibility of privacy breaches.
REQUEST TO POLICYMAKERS
Co-sponsor S.849, Advancing Research for Neurological Diseases Act of 2015 that would create a centralized data collection system and the Centers for Disease Control and Prevention to track and collect data on the epidemiology of neurological diseases. Lead Senate sponsors: Sen. Johnny Isakson (R-GA) and Sen. Chris Murphy (D-CT).
In March, Senators Mark Kirk (R-Il.) and Michael Bennet (D-CO) and Congressmen Jim Langevin (D-RI) and Gregg Harper (R-MS) introduced companion bills (S. 800; H.R. 1631) to improve, coordinate, and enhance medical rehabilitation research at the National Institutes of Health (NIH).
The legislation builds upon the conclusions and recommendations of an NIH Blue Ribbon Panel on Medical Rehabilitation Research which issued a comprehensive report in January 2013. The panel concluded that rehabilitation research is not thriving at NIH and that reforms are needed to assist people with injuries, illnesses, disabilities and chronic conditions maximize their health and their ability to function, live independently, and return to work if possible.
This broad range of topics not only includes research efforts to find cures for those of us with neurological disorders and disease, but to enhance the quality of the daily lives of each of us given our current neurological conditions. By applying the latest technologies to our challenges and opportunities including the Internet, universal design and growth in smart applications, existing research holds many concrete promises for the spinal cord injury/disease (SCI/D) population.
United Spinal Association has played a leading role in the dialogue with the National Institutes of Health to ensure that the medical and rehabilitation needs of individuals with spinal cord injury and other neurologic conditions are understood and incorporated into NIH research priorities.
• Focuses on creating greater links within NIH to help coordinate rehabilitation research across Institutes and Centers to streamline rehabilitation research priorities and maximize the current federal investment in this area of research.
• Involves the Office of the NIH Director in coordination activities, raising the stature of rehabilitation science across the NIH’s 27 Institutes and Centers.
• Calls for a Rehabilitation Research Plan to be updated every five years following a scientific conference or workshop. The existing research plan has not been updated since 1993.
• Provides for an annual progress report; ties co-funding of medical rehabilitation research projects to the Research Plan, and includes a definition of medical rehabilitation research to ensure consistent tracking of rehabilitation research across NIH.
• Is bipartisan, has been fully vetted with NIH officials, and there is continued dialogues in support of this bill with rehabilitation research organizations, clinical associations and disability and consumer groups
• is expected to have no budgetary impact.
REQUEST TO POLICYMAKERS
United Spinal Association urges Congress to pass S. 800 / H.R. 1631, Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act. Senate sponsors: Sen. Mark Kirk (R-IL) and Sen. Michael Bennet (D-CO). House sponsors: Rep. James Langevin (D-RI 2nd) and Rep. Gregg Harper (R-MS 3rd).
• Specifying in both general and specific terms that discrimination which has the effect of denying people with disabilities a real choice in how they receive services and supports is against the law;
• assuring that states and LTSS insurance providers deliver services and supports in a manner that allows individuals with disabilities to live in the most integrated setting, have maximum control over their services and supports, and lead an independent life;
• establishing a comprehensive planning requirement that includes enforceable benchmarks;
• requiring public entities to address the need for affordable, accessible, integrated housing that is independent of service delivery; and
• establishing stronger, targeted enforcement mechanisms.
DIA’s definition of discrimination is modeled on Title III of the ADA:
“No public entity or LTSS insurance provider shall deny an individual with an LTSS disability who is eligible for institutional placement, or otherwise discriminate against that individual in the provision of, community-based long-term services and supports that enable the individual to live in the community and lead an independent life.”
• DIA requires that regulations from Department of Justice and Department of Health and Human Services be released within one year after the legislation is signed into law. It then requires that all public entities and LTSS insurance providers complete a self-evaluation within six months after the regulations are released.
• Within one year of the regulations being released, state and local governments must submit a transition plan to address the issues identified in the self-evaluation and achieve the purpose of this legislation. Every plan must address these issues as soon as practicable, but public entities have up to 10 years to complete the plan. The legislation also creates new targeted enforcement mechanisms to ensure timely development and implementation of these transition plans.
• This bill prohibits states or local governments that provide institutional placements for individuals with disabilities who need long-term assistance with daily living activities or health-related tasks, and prohibits insurance providers that fund such long-term services, from denying community-based services that would enable such individuals, as an alternative to institutionalization, to live in the community and lead an independent life.
• DIA will ensure that people with spinal cord injuries and other conditions are able to exercise real choice in where they wish to receive attendant services, assistance with health related tasks or other services that enable a person with a disability to live in the community and lead an independent life.
REQUEST TO POLICYMAKERS
Co-sponsor S.2427 Disability Integration Act of 2015 that creates the right of all people with disabilities to live in the community and supports the integration, equality, and civil rights of people with disabilities. Senate sponsors: Sen. Charles Schumer (D-NY).