Prosthetic Limb LCD: How a Genuine Threat Can Motivate an Entire Field
October 2015 Issue
By now, you are likely aware of the Proposed/Draft Local Coverage Determination (LCD) for Lower Limb Prostheses (DL-33787) issued by the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) on July 16. Seldom has a threat of this magnitude confronted the O&P community, including practitioners, O&P practices, manufacturers, suppliers, and especially patients. But in times like these, you either fail to mount an effective response or you band together and work like never before to defend your ground. In this instance, the O&P field has risen to the occasion, working in coordination and cooperation toward a common goal: rescinding the LCD for Lower Limb Prostheses.
Overview of the LCD
The Draft LCD amounts to a complete rewrite of Medicare coverage, coding, and payment policy for lower-limb prostheses. It would dramatically restrict access to the current standard of prosthetic care not only for Medicare beneficiaries, but also for veterans, and, as recent events are already revealing, for all individuals with limb loss covered by insurance. It is not an exaggeration to say the Draft LCD would send people with amputations back in time to a 1970s standard of care and slam the brakes on the incredible success story that prosthetic care in this country has become. The most disconcerting aspect of the Draft LCD is that it is based on virtually no evidence-which is the primary requirement for development of an LCD. It appears to have been motivated by little more than a desire to save Medicare money in the short term, with no real concern for the implications it would have on patient care.
Background of O&P Medicare Policy
The Draft LCD came as a surprise to the field, both in terms of the scope of what it proposed to do with the Medicare lower-limb prosthetic benefit and the impact of the changes. Before its release, the major O&P organizations, working individually and through the O&P Alliance, were engaged in a longstanding effort to finally have the Centers for Medicare & Medicaid Services (CMS) issue proposed regulations implementing Section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA), which links provider qualifications with the right to bill the Medicare program for custom orthoses and prostheses. A final regulation on prior authorization of certain types of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), including lower-limb prostheses, has also been pending with CMS.
In addition, the Alliance had collaborated with the American Academy of Physical Medicine and Rehabilitation as well as the Amputee Coalition to affirmatively establish that the clinical notes of appropriately credentialed prosthetists and orthotists are considered part of the Medicare patient's record for purposes of determining medical necessity. The LCD impacts all three of these existing O&P priorities in various ways.
Response From the O&P Community
If there is any silver lining in the issuance of the Draft LCD, it is that responding to it brought together the O&P community like never before. The Washington-based O&P associations played their parts by educating the field about the pending threat and encouraging responses to it, but it was the grassroots reaction from practitioners and patients that made the difference. People with limb loss from across the country mobilized to defend access to modern prosthetic care and underscored the unique and critically important relationship that prosthetists and patients develop over time. Rather than just fighting to preserve access to a set of prosthetic devices, the response to the Draft LCD highlighted the distinct difference between O&P care and the provision of durable medical equipment and demonstrated the manner in which O&P care constitutes a lifelong healthcare relationship between the patient and practitioner.
A number of strategies were employed to raise awareness of the threat and develop effective messaging that would impact the policymakers. Virtually every O&P sector played an active role in responding to the Draft LCD. Practitioners and O&P clinic owners rallied their colleagues and patients. Hanger Clinic, Austin, Texas, commissioned a series of written critiques of the Draft LCD's proposed policies, and manufacturers and suppliers coordinated their responses through an ad hoc coalition. Patients from across the country, led by the Amputee Coalition, promoted access to the care they rely on to be functional and independent.
O&P accreditors, educators, and researchers all contributed in important ways to comprehensively address the evidence base, to promote the importance of responding through the public comment period, and to raise important issues of quality care and provider qualifications. Given the magnitude of the threat, the entire field responded proactively and cooperatively, strengthening the ability of the field to defend access to O&P care in the future.
Petition to Rescind the Draft LCD
A White House "We the People" petition was launched by the National Association for the Advancement of Orthotics and Prosthetics (NAAOP) on July 31 asking President Obama to rescind the Draft LCD. The goal was to obtain 100,000 signatures in 30 days, which would obligate the president to respond to the petition's request. NAAOP also established www.SaveProsthetics.org, a website to serve as a focal point and portal to respond to the petition and submit comments on the Draft LCD. The website has links to the Amputee Coalition, the O&P Alliance organizations, www.MobilitySaves.org, and many other resources to learn about and respond to the Draft LCD.
All members of the O&P Alliance (American Orthotic & Prosthetic Association (AOPA), American Academy of Orthotists and Prosthetists (the Academy), American Board for Certification in Orthotics, Prosthetics and Pedorthics (ABC), Board of Certification/ Accreditation (BOC), and NAAOP), as well as the Amputee Coalition, greatly contributed to the entire effort to oppose the LCD, and especially the promotion of the petition. Many other organizations, including the Brain Injury Association of America and the trade association representing rehabilitation hospitals, also heavily promoted the petition during the first two weeks of August. There were even reports that people with limb loss were setting up kiosks in rehabilitation hospitals to help people sign the petition on the spot. On August 17, the goal of achieving 100,000 signatures on the petition was achieved. The White House has until mid-October to issue a formal response.
Public Comment Hearing
The drafters of the proposed LCD, the DME MAC medical directors, provided an opportunity via a public meeting on August 26 for the public to comment on the set of policies. As the day drew near, demand far exceeded the size of the selected venue-a hotel ballroom in Maryland-and the DME MACs were forced to move the meeting to a room that seated 400 people and accommodated many more by teleconference. The room was full, and the phone lines contained hundreds of participants, many wanting to offer oral remarks; however, the number of speakers was capped at 50. The testimony that was given came from across the O&P spectrum.
Consumers spoke compellingly of personal experiences with advances in prosthetic limb care and the impact the Draft LCD would have on their abilities to remain active, functional, independent, and, in some instances, employed. Multiple speakers emphasized that the proposal would quickly bleed into the private sector, affecting even those individuals not covered by Medicare. Physicians spoke about the way in which the restrictions in coverage would tie the hands of the rehabilitation team when treating people with amputations. Therapists spoke about diminished outcomes that would result from the Draft LCD and the lack of evidence for the proposed changes. Practitioners spoke about the impact on the care they provide daily to patients, the absurdity of some of the proposed changes from a provider perspective, and the likelihood that the Draft LCD would cost Medicare more in the long term, not less. The public hearing offered the DME MAC medical directors compelling reasons to dramatically modify the Draft LCD.
Immediately following the public hearing, more than 100 people with amputations traveled from the hearing to Washington and protested the Draft LCD in front of the building that houses the U.S. Department of Health and Human Services (HHS), which oversees CMS and the DME MACs. Protesters donned T-shirts, displayed placards, marched in procession, and chanted slogans designed to raise awareness of the Draft LCD and to get the HHS secretary's attention to rescind the policy. AOPA, many dozens of Amputee Coalition members, other individuals with amputations, and supporters were instrumental in making this rally, which garnered wide media attention, a success. Participants traveled from as far away as Alaska to make their voices heard. Among them were Adrianne Haslet-Davis, a Boston Marathon bombing survivor, who served as an eloquent spokesperson during the public hearing, and Jordan Thomas, CNN Hero and president of the Jordan Thomas Foundation, which donates prosthetic limbs to children in need.
High-Level Medicare Meeting
The day's events were highlighted by a high-level meeting in which HHS and CMS leaders met with eight representatives of the O&P community, including five people who use lower-limb prostheses. The meeting was held in the deputy secretary's conference room while the rally continued on the street within earshot. CMS Acting Administrator Andy Slavitt hosted the meeting and, after the group's presentation on the problems associated with the Draft LCD, expressed "serious concern" with the proposed policies. Slavitt and CMS' Chief Medical Officer Patrick Conway, MD, promised a thorough review of the policy and discussions with the DME MAC medical directors to ensure the policy is driven by the evidence base, not cost savings. In fact, they confirmed that CMS was prohibited from considering cost savings when developing LCDs.
Public Comments Written
The flurry of LCD activity in August culminated with a major push to submit written comments to the DME MAC medical directors by the August 31 deadline. The O&P Alliance submitted a 138-page detailed response to the Draft LCD on behalf of its five member organizations. Although the DME MACs have not thus far agreed to post all comments to the policy, as CMS is obligated to do with respect to proposed regulations, it is clear that the Medicare contractors received thousands of comment letters from patients, prosthetists, physicians, therapists, researchers, educators, and many other prosthetic-care stakeholders. It is the DME MACs' task to review those comments and to make a decision whether to rescind the Draft LCD and start anew, or to simply modify the proposed policy to reflect the public comments and the evidence base brought to their attention through the public comment process.
Research and Evidence Base
The Draft LCD was released without any evidence in support of its major proposed changes. In response, AOPA sent a letter requesting evidentiary support for the Draft LCD. The DME MACs subsequently released a bibliography that was highly suspect. Numerous citations were not considered evidence-based medicine, and those articles that met the CMS-adopted standard of evidence were 20, 30, and, in one case, 50 years old. In fact, key O&P researchers cited in the bibliography jointly co-authored a letter disavowing the use of their studies as evidence for the Draft LCD. The letter stated that their research did not support the Draft LCD and, in some cases, the results of the studies demonstrated the opposite of what the LCD proposed.
The Media Identifies With the Absurdity of the Proposed Policy
Nearly 400 television newscasts and newspaper articles throughout the country picked up on the problematic LCD, the rally organized to protest it, and the reaction from the O&P community. AOPA and the Amputee Coalition hosted a press briefing that accelerated the media attention on this story, while high-profile people with amputations attracted major media players to the issue. For instance, former senator Bob Kerrey, who has a transtibial amputation, offered to help when he learned about this Draft LCD, generally through his prosthetist, and eventually, more specifically, through NAAOP. Kerrey volunteered his voice and time to the cause, becoming a major, unpaid spokesman on this issue. He wrote a compelling, personal letter to the HHS secretary requesting rescission of the proposed policy and participated in the press briefing. His advocacy was critical to gaining traction within CMS on this issue.
The End Game
As the White House ponders its response to the petition to rescind the LCD and the DME MACs review and consider thousands of pages of written comments, efforts continue to press CMS to start from scratch and base any new LCD for Lower Limb Prostheses on sound evidence. The importance of having CMS rescind the policy was highlighted by recent news that United Healthcare announced that it will no longer cover "elevated vacuum" technology, consistent with Medicare's Draft LCD, effective October 1. Without an outright rescission of the proposed policy, the O&P field can expect more of this to occur. The O&P community, therefore, has no choice but to remain vigilant in opposing the Draft LCD.
Peter W. Thomas, JD, is general counsel for NAAOP. Thomas also serves as counsel to the O&P Alliance and is a bilateral transtibial amputee.