Only Medicare has the power to create the necessary market demand to bring critically needed and newly developed bionics technology to the mass market. It was thus shocking when in 2015, CMS, through its Medicare Administrative Contractors issued a proposed Local Coverage Determination (LCD) for Lower Limb Prosthetics, which if adopted, would have drastically reduced access to new prosthetics technology. The proposed LCD (DL33787) was a comprehensive re-write of Medicare’s entire lower limb prosthetic benefits package.
The reaction to the LCD was immediate and intense. Peter Rosenstein, a former Executive Director of the American Academy of Orthotists and Prosthetists (AAOP), commented that it “would send Medicare beneficiaries, and eventually all amputees in this country, back to 1970’s technology and result in poorer functional outcomes.” He also commented that “it would dramatically reduce beneficiary access to the current standard of prosthetic care.” One common criticism from a variety of sources was that the LCD was “based on virtually no evidence to support it.”
Some of the lowlights of the LCD:
- It would have set limits on the type and functionality of a prosthetic based on an evaluation of the amputee’s current cognitive, cardio-pulmonary, and neuro-muscular control at the time of the evaluation, thereby significantly limiting access to higher functional level componentry for patients who were progressing through the rehab process. It also limited reimbursement to amputees with certain common health issues such as high blood pressure and asthma.
- The LCD would have limited access to higher quality prosthetics if the patient’s records revealed that Medicare was paying for another form of mobility aid (cane, crutches, walker, etc.) despite the fact that bilateral amputees often use an assistive device for balance purposes and many amputees utilize mobility devices for nighttime bathroom access.
- The LCD would have eliminated higher quality prosthetics by consolidating multiple codes for specialized prosthetics into single, generic codes which according to The O&P Alliance, would have “eliminate[d] coverage of multiple prosthetic knees, feet and ankles that have undergone years of development, coding assignment, and widespread use by Medicare beneficiaries, causing them to live with prosthetic technology that is outdated and not consistent with the current standard of care.”
In November 2015, after a preliminary review of the public comments, CMS announced it was not intending to pursue the draft LCD and was convening a multidisciplinary workgroup in 2016 to develop a consensus statement to inform Medicare policy by reviewing the available clinical evidence that defines best practices in the care of amputees. CMS announced that the work group would be composed of clinicians, researchers, policy specialists, and patient advocates from different federal agencies. Nevertheless, CMS never identified the members of the working group, has never published any of its work or comments, it is unknown where they are in the process or when they intend to publish and never withdrew the LCD from its website.
In April 2016 AOPA, representing over 150 O&P providers descended on Capital Hill in a major lobbying effort. A bipartisan bill was sponsored that would place a moratorium on insurers from using the LCD as a basis for making decisions and directing CMS to remove it from its website. Thereafter, prosthetist Tom Watson sent a letter to Senator Mitch McConnell in which he recounted these recent lobbying efforts and explained that certain insurance carriers including Cigna and United had used the LCD to justify removing insurance coverage for vacuum pump technology for prosthetic sockets.
Mr. Watson advised Senator McConnell that a further bill was necessary to address three acute needs: 1) directing CMS to treat prosthetics separately from other durable medical equipment; 2) to make reimbursement for a particular prosthetic solely dependent on the recommendations of medical necessity from the patient’s own prosthetist through prescription; and 3) that custom prosthetics and orthotics be deemed inappropriate for inclusion in competitive bidding.
In May 2016 McConnell sent Watson’s letter along with his own to Andrew Slavitt, the Acting Administrator of CMS, asking him 1) whether CMS intended to rescind the LCD; 2) to identify the members of the working group; 3) state whether any stakeholders from the prosthetics industry (users or makers) were participating; and 4) asking CMS to report on the topics which the group had discussed.
While no response from Mr. Slavitt issued, in June 2016, as a result of these efforts, language was inserted into a Committee report in connection with the 2017 Senate Labor/HHS Appropriations Bill instructing CMS to consult with clinicians, patients and prosthetist groups before releasing any new or revised version of the LCD.
CMS and legislators in Washington must now definitely act to bring fair and equitable treatment to America’s disabled. This country should spend the same tax-payer’s dollars to make amputees whole as it does to make whole those with advanced organ disease. In so doing, it would usher in an era where bionics become commonplace and accessible to everyone, a world where the concept of disability will increasingly become an anachronism. It will also put an end to an increasingly discriminatory system that does not provide equal medical care and treatment to amputees.