Major Developments in O&P Research Priorities, Policies and Funding

NAAOP’s roots center on the issue of O&P research and development. In 1987, a small group of O&P leaders believed the field needed to develop a funding stream for O&P research activity and NAAOP’s predecessor organization, the American State of the Art Prosthetic Association, was born. The organization focused on introduction of the Claude Pepper Act for Amputees, which was eventually merged into the National Institutes of Health (NIH) Reauthorization Act of 1990. That law created a program at NIH known as the National Center for Medical Rehabilitation Research (NCMRR). The mission of the center is to “conduct and support medical rehabilitation research, including orthotic and prosthetic research and development.” The center has supported O&P research ever since, primarily through the Small Business Innovation Grant (SBIR) program, but also through more traditional NIH grants usually secured by large research universities.

NIH: Recently, twenty five years after passage of this law, NIH held a two-day rehabilitation research conference where nearly 500 people participated. O&P research priorities were discussed in the context of rehabilitation science. O&P research was clearly at the table and held its own in a manner that could not have been imagined 25 years ago. This conference will help NIH update its research priorities, which have not been updated since 1993. This conference and the research plan update were, in part, prompted by advocacy by the Disability and Rehab-ilitation Research Coalition (DRRC), a 43-member coalition in which NAAOP participates.

Interagency Committee on Disability Research (ICDR): DRRC was also successful in getting Congress to direct another federal entity, the ICDR, to develop a government-wide strategic plan for rehabilitation, disability and independent living. That broader effort is being conducted simultaneously with the NIH research plan process. Within the next few months, the federal government is expected to have two major documents that prioritize, coordinate, and elevate the stature of rehabilitation and disability research, with a meaningful focus on O&P research.

Evidence-Based Medicine: This is critical in that all of health care is moving at a rapid pace toward evidence-based medicine and evidence-based practice. A sufficient evidence base will be necessary in the future to secure coverage of O&P services that are often taken for granted today, and the research efforts of today will help pave the way to this. The O&P community has been proactive about evidence development for some time. Two research foundations were established by AOPA and the Academy. AOPA secured a large federal appropriation to fund O&P research through the Department of Defense, and the Academy developed consensus around a set of O&P research priorities as well as other efforts.

Washington Meetings with Research Agencies: The timing, therefore, could not be better for the next Alliance activity planned for mid-June. O&P researchers and Alliance leaders will meet with the heads of five different federal agencies responsible for funding O&P research over a two-day period. The agencies include NIH, ICDR, the National Science Foundation, the Department of Defense, and the Veterans Administration. The goal of the meetings is to further develop relationships with these funding agencies and exchange information on priorities and research portfolios. NAAOP will continue to keep you apprised of developments in this area.

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Spring Brings Fever Pitch to O&P Policy Developments

There is no shortage of O&P issues on which NAAOP and its Alliance partners are actively engaged including publication of regulations on BIPA Section 427, separation of O&P from DME, implementation of prior authorization, the draft LCD for Lower Limb Prostheses, and the Administration’s proposal to expand competitive bidding to all O&P patient care. Recently, there has been major progress on moving our agenda. Former Senator Bob Kerrey, an amputee himself, has personally invested himself in preserving access to prosthetic/orthotic care and his support is helping to focus Congress and CMS on our priorities.

BIPA Section 427: The Benefits Improvement and Protection Act of 2000 (BIPA) included Section 427, which prohibits the Medicare program from paying for custom orthotics and prosthetics unless they are provided by qualified practitioners and suppliers. A supplier can qualify by being O&P licensed or accredited by ABC, BOC or an accreditor whose standards are “essentially equivalent.” The problem is that CMS never implemented this section of the law through regulation. NAAOP and the O&P Alliance have been fighting for years to get these regulations issued. But finally, the proposed regulations on BIPA 427 are pending at the White House, the final step before being issued for public comment. Once issued, we will analyze and respond forcefully to these regulations. The link between qualifications and Medicare payment of custom O&P care remains a priority of the profession, especially in the age of alternative payment models.

LCD Moratorium Legislation Introduced: On Monday, April 25th, Congresswomen Renee Ellmers (R-NC) and Jan Schakowsky (D-IL) introduced H.R. 5045, the Preserving Access to Modern Prosthetic Limbs Act of 2016. This bipartisan bill would impose a moratorium on issuance of the draft LCD, or any part thereof, until at least July 2017, instruct CMS and its contractors to remove the draft LCD from their websites, and clarify that CMS has authority to oversee the development of LCDs. NAAOP worked alongside AOPA and the Alliance organizations to get this bill introduced and strongly supports passage of the bill.

Veterans Access to Provider of Choice: Senator Burr and Senator McCain are promoting legislation to allow veterans to access private providers, outside of the VA system, on a permanent basis. NAAOP met with Senator Burr’s office to help ensure that his bill applies to veteran choice of prosthetists/orthotists. NAAOP submitted specific language to amend the bill, which would accomplish one of the key goals in H.R. 3408, the Injured and Amputee Veterans Bill of Rights. We will continue to update the profession as developments occur.

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Help Impose a Moratorium on Medicare’s Draft Lower Limb Prosthetic LCD – Ask Your Representative to Co-Sponsor H.R. 5045 Today!

H.R. 5045, introduced by Reps. Ellmers (R-NC) and Schakowsky (D-IL), addresses the July 2015 Medicare Administrative Contractor (DME MAC) proposed draft LCD for prosthetic limbs (DL 33787) that would completely rewrite the coverage rules for prosthetic limb care for Medicare beneficiaries with limb loss. The new coverage policy was so restrictive that it would have sent amputees back to a 1970’s level of care. This draft LCD was not based on any credible evidence, would seriously restrict access to modern prosthetic limbs, and was widely criticized by patients, prosthetists, physicians and numerous beneficiary and clinical organizations. Under these proposed policies, beneficiaries would be eligible for prosthetic limbs that are functionally outdated, less durable and less safe.
H.R. 5045 is bipartisan legislation that would:

  1. Place a moratorium on issuance of this draft LCD (or any part of it) until spring of 2017, after a new administration is in office;
  2. Instruct CMS and the DME MACs to remove the draft LCD from their websites to eliminate the risk of private insurers adopting this misguided coverage policy; and,
  3. Clarify that CMS does, in fact, have the authority to provide guidance and oversight of LCDs developed by Medicare Administrative Contractors.
  4. safe.

Ask your Member of Congress to Co-Sponsor H.R.5045 and help protect access to modern prosthetic care for Medicare beneficiaries and others with limb loss. You may contact your Member of Congress at this link:

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O&P Policy Forum and Separation of O&P from DME

NAAOP, in conjunction with the O&P Alliance, submitted formal comments last week on the proposed federal regulations to create a definition of the term “orthotics and prosthetics” in the Uniform Glossary of Medical Terms. This definition will be separate and distinct from the term, “Durable Medical Equipment.” The Uniform Glossary is a collection of commonly used insurance and medical terms that is intended to help inform the general public about its insurance plans and insurance options. Defining O&P separately from DME does not guarantee coverage of all O&P care in private insurance policies, but it will help consumers understand these benefits and will alert them to potential coverage, and coverage limitations and exclusions.

Not only will this separate O&P definition increase awareness of orthotics and prosthetics in private insurance, but it essentially breaks the connection between O&P and DME in these health plans. If the final rule is consistent with the proposed rule, strong arguments will exist to no longer apply DME limitations and exclusions on O&P services. And once consumers better understand what constitutes O&P care, they are likely to pressure plans into defining coverage under this benefit. While this victory does not impact the Medicare program, it represents the achievement of a long-standing goal that NAAOP has been waging, both independently and in concert with the O&P Alliance, since 2009, during Congress’ consideration of the ACA.

Please ATTEND the O&P Policy Forum

The O&P Policy Forum is fast approaching and NAAOP joins its Alliance partners in strongly encouraging leaders in the O&P profession to attend. AOPA spearheads the O&P Policy Forum each year and the Alliance organizations have promoted it for the past several years. It is a key opportunity for the O&P community to come to Washington, learn about the policies that impact the O&P professionals, and advocate on behalf of themselves and their patients.

This year, the Policy Forum will include an opportunity to help write legislation that can make a real difference. We are honored that Former U.S. Senator Bob Kerrey, himself a lower limb amputee, will participate in the forum by leading the effort to draft a bill, and will help advocate this bill on Capitol Hill. Your presence at the Policy Forum has never been more important!

Think about the challenges: The draft Lower Limb LCD, competitive bidding, prior authorization, and the list goes on and on. Come learn about these policies and bring your advocacy to your representatives in Washington. We strongly encourage you to attend and hope to see you in D.C. in late April.

O&P Policy Forum and Legislative Writing “Congress”
Tuesday, April 26th and Wednesday, April 27th (Arrive Monday night, April 25th)
Marriott Metro Center, Washington, D.C.
For more information, contact NAAOP or AOPA directly.

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Separation of O&P from DME in Private Health Plans

On February 26, 2016, three federal agencies responsible for regulating the Affordable Care Act announced a proposal to add a new definition of the term “orthotics and prosthetics” to the “Uniform Glossary of Coverage and Medical Terms” (“Uniform Glossary”), separate and distinct from the definition of durable medical equipment (“DME”). This had been a goal of NAAOP as well as the O&P Alliance since 2008, even before passage of the ACA.

The Uniform Glossary is a collection of standard definitions of medical and insurance terms that assist individuals in understanding their private health insurance options. The document is written at an elementary level, so as to be understood by the vast majority of the public. Inclusion in the Uniform Glossary does not guarantee coverage of orthotic and prosthetic (O&P) services but it does help consumers understand what constitutes O&P coverage and assists them in comparing and contrasting levels of such coverage across competing health plans. It also formally signals separate treatment from durable medical equipment (DME) in private health plans.

A new definition of orthotics and prosthetics in the Uniform Glossary will stimulate consumers to ask questions about the extent of private plan coverage of O&P care. It can be used to argue that DME caps of one sort or another do not apply to orthotic and prosthetic services, and it may prompt health plans to collect better data on O&P benefits and better define coverage of this important benefit.

Orthotics and Prosthetics Definition
The proposed regulation adopts a version of a definition that NAAOP and the Alliance recommended in numerous comment letters over the past six years, since enactment of the Affordable Care Act. The new definition of orthotics and prosthetics, as proposed in the Uniform Glossary, is as follows:

• Orthotics and Prosthetics: Leg, arm, back, and neck braces, and artificial legs, arms, and eyes, and external breast prostheses incident to mastectomy resulting from breast cancer. These services include: adjustments, repairs, and replacements required because of breakage, wear, loss, or a change in the patient’s physical condition.

Comments to this proposed definition are due on March 28, 2016, and NAAOP and the O&P Alliance will strongly support its adoption in the final Uniform Glossary. We may even offer some refinements to the definition, but the proposal to add this separate definition of orthotics and prosthetics is an important victory and should be strongly supported by the entire O&P profession and the larger rehabilitation and disability community. This will have an impact on all private insurance plans, not just ACA plans, and it will also strengthen the policy arguments for further separation of O&P from DME in both the Medicare and Medicaid programs.

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BREAKING NEWS: Three New Developments Impact the O&P Community

Three new developments impacting the orthotic and prosthetic profession occurred on February 9th that NAAOP would like you to know immediately:

1. Rehabilitation Research Bill Advances in Senate Committee: On February 9th, the Senate Health Education Labor and Pensions (HELP) Committee reported favorably on a bipartisan bill introduced by Senators Kirk (R-IL) and Bennet (D-CO) to advance rehabilitation research, including O&P research and development, at the National Institutes of Health (NIH). The bill would enhance coordination and improve the stature and visibility of this research at NIH’s 27 Institutes and Centers, particularly in the National Center for Medical Rehabilitation Research (NCMRR). NCMRR’s mission includes O&P research and development. This occurred in 1990 after extensive lobbying efforts by NAAOP to increase O&P research funding at NIH. This is the first major piece of legislation to address the NCMRR at NIH since that time and should spark additional attention at NIH in this area. The bill now goes to the full Senate for consideration. A companion House bill has already been introduced by Congressman Langevin (D-RI) and Congressman Harper (R-MS)

2. DC Appeals Court Ruling Offers Hope to Providers on ALJ Backlog: The D.C. Circuit Court of Appeals issued an important opinion in the American Hospital Association’s administrative law judge (ALJ) delay lawsuit. The D.C. Circuit reversed the district court’s decision and determined that the court has jurisdiction over this case because HHS has a clear duty to issue ALJ decisions in 90 days, and “escalation” to the next level of administrative review is not an adequate remedy for HHS’s failure to issue ALJ decisions in a timely manner. The court remanded the case to the district court for it to consider whether to compel HHS to comply with the deadline in light of the worsening ALJ backlog. The decision gives some hope to Medicare providers, including O&P practices, that the intolerable delay in ALJ appeals will begin to be resolved, but the court did not yet actually step in and solve the problem. A decision by the district court is expected late this year.

3. President’s Budget Proposes to Expand Competitive Bidding to ALL O&P Care: For the first time, the President’s budget for FY 2017, released yesterday, proposes to expand DMEPOS competitive bidding to include ALL PROSTHETICS AND ORTHOTICS, in addition to a number of other types of DMEPOS. The proposal is expected to save $38 billion over ten years. This is bad news in that NAAOP and the O&P Alliance organizations will have to mount a strong defense against this proposal, but it is important to put this development into perspective. Competitive bidding for anything more than off-the-shelf orthotics is currently illegal, so Congress would have to pass a law authorizing CMS to expand it to all O&P care. This is the last year of the current President’s budget. The budget represents a grab-bag of policies that the administration throws out to gather reaction, and to pad the savings they can achieve in order to pay for their other proposed priorities. In this calendar year, there is no chance this proposal will become law absent titanic developments in Congress, which are not expected. Congressional Republicans declared the budget “Dead on Arrival” and have shown no interest in this specific proposal. NAAOP will work with its Alliance partners to strongly oppose this proposal, but it is certainly not immanent.

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PRESS STATEMENT Contact: Peter Thomas
February 10, 2016
(202) 466-6550


Washington, D.C.: The National Association for the Advancement of Orthotics and Prosthetics (NAAOP) applauded the Senate HELP Committee for favorably reporting out of committee yesterday a modified version of legislation entitled, the “Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act,” S. 800, introduced last year by Senator Mark Kirk (R-IL) and Senator Michael Bennet (D-CO). The bill now goes to the full Senate for consideration and, hopefully, passage.

S. 800 is designed to improve, coordinate, and enhance medical rehabilitation research at the National Institutes of Health (NIH). The National Center for Medical Rehabilitation Research (NCMRR) is the lead agency within NIH that funds rehabilitation science. NCMRR’s mission is to conduct and support rehabilitation research, “including orthotic and prosthetic research and development.” O&P research is the only specifically referenced type of rehabilitation research in the 1990 law that created the NCMRR. The 1990 law was the product of compromise legislation spearheaded by NAAOP’s predecessor organization, the American State of the Art Prosthetic Association.

S. 800 is supported by a wide coalition of consumer, clinical and research organizations, including NAAOP, the American Academy of Orthotists and Prosthetists (AAOP) and the Amputee Coalition.

NAAOP commended Senators Kirk and Bennet as well as HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) for including in the bill many of the recommendations made by the Blue Ribbon Panel on Medical Rehabilitation Research established by NIH in December 2012. We are particularly supportive of the provisions in the bill designed to enhance strategic coordination within the Director’s office at NIH and with other agencies to update and streamline medical rehabilitation and O&P research priorities. We also support the provisions in the bill which specify that the Research Plan must be updated every five years following a scientific conference or workshop; provide for progress reports; and include a definition of medical rehabilitation research that reflects the importance of an individual’s ability to improve their functional status after illness or injury.

“We urge the full Senate to pass S. 800 and send the bill to the House of Representatives to enact H.R. 1631 as revised by the Senate bill,” stated David McGill, President of NAAOP. “Enactment of this legislation will send a powerful message that our Nation can and must improve the evidence base of medical rehabilitation, including orthotic and prosthetic care, so that individuals with limb loss and other orthopedic conditions can return to work, live as independently as possible, and have a high quality of life.”

Peter Thomas, NAAOP General Counsel stated, “NIH has devoted the vast majority of its attention and resources to technology-based O&P research and development over the years, primarily through the Small Business Innovation Research (SBIR) grant program. We intend to build on this bill’s passage to prompt NIH to conduct and support O&P research that is more clinically focused and patient centered.”

George Breece, NAAOP’s founding Executive Director, said “Since our inception, NAAOP has been an organization committed to greater funding and support for O&P research. We are pleased to join nearly 40 other national organizations in strongly supporting S. 800 and look forward to seeing the bill enacted this year.”

The DRRC is a coalition of nearly 40 national non-profit organizations committed to improving the science of rehabilitation and disability. The DRRC seeks to maximize the return on the federal investment in rehabilitation and disability research with the goal of optimizing the health and function and quality of life of persons with injuries, illnesses, disabilities, and chronic conditions.

DRRC Member Organizations

National Association for the Advancement Orthotics & Prosthetics
American Academy of Orthotists & Prosthetists
Amputee Coalition
American Academy of Physical Medicine & Rehabilitation
American Congress of Rehabilitation Medicine
American Occupational Therapy Association
American Physical Therapy Association
American Speech-Language-Hearing Association
Association of Academic Physiatrists
Brain Injury Association of America
American Academy of Neurology
American Association of People with Disabilities
American Association on Health and Disability
American Foundation for the Blind
American Medical Rehabilitation Providers Association
American Music Therapy Association
American Therapeutic Recreation Association
Association of Rehabilitation Nurses
Association of University Centers on Disabilities
Child Neurology Foundation
Child Neurology Society
Christopher and Dana Reeve Foundation
Disability Rights Education and Defense Fund
Lakeshore Foundation
March of Dimes
Mental Health America
National Alliance for Caregiving
National Association of Rehabilitation Research Training Centers
National Association of State Head Injury Administrators
National Association of Veterans’ Research and Education Foundations
National Council on Independent Living
National Multiple Sclerosis Society
Paralyzed Veterans of America
RESNA, Rehabilitation Engineering and Assistive Technology Society of North America
The Arc
Uniform Data System for Medical Rehabilitation
United Spinal Association

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O&P Policy Priorities Command Your Presence

January has been a month of introspection for the O&P community as leaders in the profession have come together to discuss policy priorities and the path that lies ahead.

Medicare Lower Limb LCD: NAAOP and its Alliance partners will soon meet with CMS to discuss their plans for the Work Group being convened to study and recommend a consensus statement on lower limb prostheses. The Draft LCD was placed on hold by CMS last fall but it is not clear what will occur when the Work Group makes its recommendations. By law, the Work Group is comprised of federal employees only, so stakeholder input by the O&P and rehabilitation communities is critical as the Work Group deliberates on this important issue.

Prior Authorization of Prostheses: The final rule on prior authorization MAY impact as many as 84 lower limb prosthetic codes, but CMS will issue additional guidance before implementing this program. NAAOP and the Alliance members will continue to work with CMS as it determines which prosthetic codes, if any, will be subject to prior authorization and how they will implement this new process. Our first approach is to dissuade CMS from imposing prior authorization on prosthetic limbs and components at all. This new process is supposed to be targeted to Medicare benefits that are over-utilized, but recent Medicare data suggests a significant decrease in Medicare spending for prosthetic care in the past several years. If CMS does impose prior authorization on certain prostheses, we will stress to them that delays and denials are unacceptable for patient care and that transition to this new system must be as seamless as possible.

Injured and Amputee Veterans Bill of Rights: Please email us by clicking on “Contact NAAOP” on our website,, to let us know your current experience with the Veteran Administration as you try to provide services to veterans in need of prostheses. Congresswoman Ellmers (R-NC) intends to soon reintroduce the Injured and Amputee Veterans Bill of Rights, which has been a long-standing priority of NAAOP. We need to hear your current experience in treating veteran patients. Do you confront barriers in gaining access to veterans in need of prosthetic care? Do you have an O&P contract with the VA? Do you experience long delays in gaining approval to provide prosthetic care to veterans? Please let us know your current experience with VA prosthetic care as we finalize our policy proposals to address problems and concerns in the O&P field.

O&P Congress and Policy Forum: Please plan to attend this year’s O&P Policy Forum on April 26th and 27th in Washington, DC. The policy forum is an annual event where leaders in the O&P profession come to Washington, DC to learn about O&P policies and advocate on behalf of patients and the providers who serve them. While AOPA organizes the policy forum, all Alliance organizations participate in this event, including NAAOP. This year, former U.S. Senator BobKerrey, a long-time friend of NAAOP, will lead an “O&P Congress” where we will all help draft legislation to address O&P policy priorities. We will then bring this bill to our legislators and promote our key priorities. NAAOP hopes to see you there!

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Mixed Bag in Final Prior Authorization Regulations for DMEPOS

CMS issued final regulations on prior authorization of certain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) as 2015 came to a close. These regulations permit CMS to impose prior authorization requirements on a wide variety of DMEPOS that are “frequently subject to unnecessary utilization.” NAAOP participated with the O&P Alliance in submitting extensive comments to the proposed rule in July 2014 and met with CMS officials on this issue. Some of our comments were adopted in the final regulations and some were not, but in the end, prior authorization will be another tool that CMS and its contractors can use in the future to help control Medicare spending.

Not everyone in the O&P profession opposed prior authorization when it was proposed. Some see benefits to obtaining approval to provide an orthosis or prosthesis up front, before delivering care to a Medicare beneficiary and being denied for that claim. With the appeals process taking years to resolve disputes, there is an argument that prior authorization may bring additional certainty to the provision of orthoses and prostheses. But there are many drawbacks to prior authorization as well, and this is why NAAOP and the O&P Alliance raised serious objections to prior authorization during the comment period. There were some genuine victories in the final rule, namely:

  1. Prior authorization may be implemented gradually, with a select number of items identified on the “Master List” being exposed to prior authorization in the near term. It can also be implemented in certain regions of the country, rather than nationally for all billing codes.
  2. Once a billing code is subject to prior authorization, it need not be imposed for a full 10-year period, as the proposed rule stated. If certain conditions are met, it can be discontinued at any time; and,
  3. CMS recognizes that claims that have received prior authorization are subject to some protection from future auditing activity. There are exceptions for cases of suspected fraud and for CERT audits, which are mandated by federal law. While prior authorization is not a guarantee of Medicare payment, this is a significant concession by the government which was not included in the proposed rule.

Nonetheless, prior authorization will be permitted for the 135 DMEPOS items on the initial Master List, 84 of which are prosthetic codes. No orthotic codes appear on the list in 2016, but this may change in future years. If prior authorization is imposed on a code, all claims that do not have an affirmed prior authorization will be denied payment. The Master List will be automatically updated annually based on whether new billing codes have been identified in government reports (i.e., GAO, OIG and CERT reports) as being overutilized, and if these items exceed a payment threshold of $1,000. Denial of prior authorization is not appealable, but the provider can submit as many prior authorization requests as necessary to gain approval. Initial requests should be processed within 10 business days while resubmissions can take up to 20 days for a decision. CMS and its contractors will issue sub-regulatory guidance in the future to provide additional detail as to filing requests for prior authorization.

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2015 was a banner year for NAAOP and you can expect more of the same in 2016.

2015 was a banner year for NAAOP and, as a member of our association, you can expect more of the same in 2016. The year was defined by four major issues affecting the O&P profession:

  • NAAOP wrote to and met with the Secretary of the VA to advance protections for veterans in need of O&P care and continued to work toward adoption of the Injured and Amputee Veterans Bill of Rights;
  • NAAOP contributed to a major victory in February 2015 when CMS issued federal regulations clarifying that ACA health plans must cover rehabilitation “devices” as well as services, prompting New York State to expand its coverage of replacements and repairs of prostheses for the 2015-2016 benefit years, contrary to its one-limb-per-lifetime policy;
  • NAAOP played a leading role in working independently and through the O&P Alliance to oppose the Medicare Draft LCD for Lower Limb Prostheses, spearheading the White House “We the People” petition to rescind the Draft LCD and creating the webpage to galvanize opposition to the proposal; and,
  • NAAOP worked with rehabilitation organizations to promote O&P research and development, commenting on draft research priorities to be pursued by the National Institutes of Health and other federal agencies.

Your membership will enable NAAOP to continue to be on the front lines of these important issues and we cannot thank you enough for your support. We truly appreciate your financial contribution to NAAOP and your direct involvement in our collective O&P advocacy efforts.

Thank you again for your continued membership in NAAOP.

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