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    Additional Analysis on the CMS Final Rule Regarding Supplier Enrollment, Accreditation Requirements, DMEPOS Competitive Bidding, and Medicare Prior Authorization

    Wednesday, Dec 03, 2025

    Agency for Healthcare Research and Quality Releases its Draft Systematic Review of Lower Limb Prostheses Research

    The Agency for Healthcare Quality Research (AHRQ), in conjunction with a contractor known as an Evidence-based Practice Center, has released a draft systematic review of current scientific literature that address the use of lower limb prostheses in the United States.  The Systematic review was originally announced in September of 2016 with a request for additional comments in December of 2016 on the “key questions” that would be used in the systematic review.  AOPA provided significant comments on the systematic review itself as well as on the key questions issue.

    While the complete systematic review document is 440 pages and is currently under review by AOPA, the abstract of the systematic review indicates the following:

    • 92 studies were identified that assessed performance characteristics of lower limb prostheses
    • 29 of the 92 studies were deemed valid and reliable by the researchers
    • 19 of the 29 studies were generally applicable to Medicare aged populations
    • 11-22% of amputees abandon their lower limb prosthesis within one year of delivery
    • Unilateral trans-femoral amputees are twice as likely to abandon their prosthesis than unilateral trans-tibial amputees
    • Currently, there is not evidence to support the selection of specific components for patient subgroups to maximize ambulation, function, and quality of life or to minimize abandonment or limited use
    While AOPA supports the need to review the current research that addresses lower limb prostheses, we do not agree with much in the conclusions, and particularly its final abstract conclusion noted above, as there is clear evidence, apparently not considered by AHRQ or its contractor to support specific components for patient subgroups for maximizing favorable patient outcomes.  It is important to recognize that the draft systematic review did not include recent research by the RAND Corporation and the health economics firm Dobson DaVanzo that specifically studied both the clinical and cost effectiveness of the provision of higher technology prosthetic limbs, despite AOPA’s having submitted BOTH preliminary findings of both studies before the December, 2016 AHRQ deadline, as well as the final study results of both being submitted to AHRQ as soon as the first became available seven (7) weeks ago.  It is particularly unfortunate to see a purportedly current literature review be deficient in not reflecting the latest determinative scientific findings.

    AOPA will be preparing extensive comments on the draft systematic review and encourages its members to review the document and provide comments as appropriate.

    AOPA Holds Press Event on the “Amputee Tech Gap” 

    On October 19, AOPA hosted a press event at the National Press Club in Washington DC, to share the important research from the RAND Corporation on the economic value of advanced prosthetics.

    Dr. Soren Mattke from RAND presented the findings of this recently published research that concluded that microprocessor knees are associated with improvements in physical function and reductions in falls and osteoarthritis, and that the economic benefits are in line with commonly accepted criteria for good value for money by U.S. payers.

    Dr. Ken Kaufman, PhD of the Mayo Clinic, shared his research on health outcomes for those living with limb loss, including the cost of care broken down by K-level, and the costs of falls, and the large number of amputees who never receive a prescription for a prosthesis. Prosthetic users Christopher Allen and Peggy Chenoweth discussed how they have benefited from advanced technology in their everyday lives.

    The video was livestreamed on Facebook and is now available to view. The Power Point presentations used are available upon request.

    About the RAND Corporation study 
    Due to recent advances in technologies, prosthetic knees allow for more-dynamic movements and improve user quality of life, but payers question their value for money. To explore this issue, RAND simulated the differential clinical outcomes and costs of microprocessor-controlled knees (MPKs) compared with non-MPKs (NMPKs). They conducted a literature review of the clinical and economic impacts of prosthetic knees, convened technical expert panel meetings, and implemented a simulation model over a ten-year time period for unilateral transfemoral Medicare amputees with Medicare Functional Classification Levels of 3 and 4.

    They found that compared with NMPKs, MPKs are associated with sizeable improvements in physical function and reductions in incidences of falls and osteoarthritis. The simulation results show that over a ten-year time period, compared with NMPKs, MPKs are associated with an incremental cost of $10,604 per person and an increase of 0.91 quality-adjusted life years per person, resulting in an incremental cost of $11,606 per quality-adjusted life year gained. The results suggest that the economic benefits of MPKs are in line with commonly accepted criteria for good value for money and with those of other medical devices that are currently covered by U.S. payers.

    Read the RAND Study.

    This study is just part of AOPA’s commitment to advancing O&P research. See all of AOPA’s Research Initiatives.

    Press about the Event so far:

     

    O&P Edge– RAND Study: Far Fewer Falls With MPKS
    Medscape– Modern Prosthetic Knees Cut Falls, Morbidity, Mortality in Amputees (login required)
    Rehab Management – Amputees Are Being Denied Access to Higher-Tech Prostheses, Resulting in Preventable Injury and Death, Per RAND Study
    NJTV PBS – Prosthetics tech gap costs money and lives according to report
    Healthcare Business Daily News- Payors less inclined to cover high-tech prosthetics for amputees

    RAND Corporation Study: “Tech Gap” Puts U.S. Amputees At Greater Risk Of Injury, Death As Medicare, Private Payers Deny Access To Newer Artificial Limbs

    Denial of Access to New Microprocessor-Controlled Knees Seen As Resulting in Preventable Falls, Deaths; Forcing Amputees to Use Riskier 1970s Technology Seen As Saving Little Money Over Lifetime.

    WASHINGTON, D.C. – U.S. amputees are facing a “tech gap” in which Medicare and private health insurers deny access to new microprocessor-controlled knees (MPKs) that are only slightly more expensive over a lifetime and considerably safer in terms of preventable injuries and deaths than the alternative “1970s-style” artificial lower limbs. Those are among the key findings of a major new report issued today by the RAND Corporation and available online from the American Orthotics & Prosthetics Association (AOPA) at: https://bit.ly/randstudy.

    Every week in the U.S., more than 3,500 people undergo a transfemoral amputation. Of the 185,000 new amputee patients each year, an estimated 25-30 percent receive a prosthetic leg and knee.

    However, fewer and fewer U.S. amputees are getting access to the new, safer technology and, instead, find themselves confined to the older and more dangerous 1970s-style tech. The RAND Corporation study notes that Medicare total payments for prosthetics declined 15 percent during the 2010-14 period despite advances in technologies. (Private insurers have historically taken their cues from Medicare as to possible cuts in coverage.)

    The RAND Corporation study shows that 26 percent of patients who received more advanced prosthetic limbs with MPK will fall per year as opposed to 82 percent of patients with the older non-MPK limbs. There are 14 fall-related deaths per 10,000 patient years for non-MPK amputees, and three fall-related deaths per 10,000 patient years for the MPK amputees, which means up to 11 lives per 10,000 patient years could be saved through wider MPK usage. The data show only 38 falls per 10,000 patient years resulting in injuries suffered by users of the higher-tech MPK versus 182 falls per 10,000 patient years for non-MPK amputees.

    Dr. Soeren Mattke, managing partner, Health Care Practice, RAND Corporation, Boston, MA, said: “Due to recent advances in technologies, prosthetic knees and feet allow for more dynamic movements and improve user quality of life, but payers have recently started questioning their value for money … the microprocessor controlled knee is associated with sizeable improvement in physical function and reductions in incidences of falls and osteoarthritis …The results suggest that the incremental cost of MPK is in line with commonly accepted criteria for good value for money and with the incremental cost of other medical devices that are currently covered by U.S. payers.”

    Kenton Kaufman, PhD, Department of Biomedical Engineering, Mayo Clinic, Rochester, MN., said: “Even if an amputee with the older technology avoids death due to a fall, he or she may suffer very serious consequences from a fall-related injury. The average additional cost in the six months following a fall can be substantial. The cost for individuals requiring an emergency department visit is about $18,000. For patients who had to be hospitalized, this extra expense is over $25,000. We know our cost estimate underestimates the true cost of a fall, because we didn’t include indirect costs, such as lost wages, caregiving expenses and transportation costs.”

    Dr. Kaufman was summarizing the findings of a new Mayo Clinic research published in July 2017. See: https://newsnetwork.mayoclinic.org/discussion/prosthetic-knee-type-may-determine-cost-of-care-foramputees/?utm_source=facebook&utm_medium=sm&utm_content=post&utm_campaign=mayoclinic&geo=national&placementsite=enterprise&mc_id=us&cauid=100502&linkId=39637813.

    Michael Oros, CPO and president, American Orthotic & Prosthetic Association, and CEO, Scheck & Siress, Chicago, Illinois, said: “This is not a case of amputees wanting to have access to new technology just because it is new. To the contrary, new tech versus old tech can be a life-anddeath issue for an amputee. The RAND Corporation study we are helping to release today shows that there is a much higher risk of injury or death when Medicare and private payers refuse to permit access to the only slightly more expensive new generation of artificial knee and lower limb. And there is a huge quality of life issue here. Amputees who are stuck with the 1970s style tech tend to be less mobile in addition to being more vulnerable to risk of injury or death.”

    In the summer of 2015, AOPA led a national campaign to oppose a Medicare rule that would have placed even more restrictions on both access to these very MPK devices and more sharply reduced the quality of current-technology care provided to amputees in the federal program. In that case, the Association opposed a draft proposal that remains in doubt. See: AOPA AC News Conference on LCD Policy.

    Download PDF Version

    VA Proposed Rule Includes Troubling Provision Restricting Veterans’ Ability to Receive Care from Their Chosen Provider

    The October 16, 2017 Federal Register included a proposed rule published by the Department of Veterans Affairs (VA) that intends to “reorganize and update the current regulations related to prosthetic and rehabilitative items, primarily to clarify eligibility for prosthetic and other rehabilitative items and services, and to define the types of items and services available to eligible veterans.  While the 48 page proposed rule will require some time to be reviewed completely, there is a provision in the proposed rule that is of immediate concern to AOPA.

    Page 29 of the proposed rule includes a provision regarding how prosthetic, orthotic, and other rehabilitative services will be delivered to veterans.  The proposed language states the following:

    “VA will determine whether VA or a VA-authorized vendor will furnish authorized items and services under § 17.3230 to eligible veterans. When VA has the capacity or inventory, VA directly provides items and services to veterans. However, VA also may use, on a case-by case basis, VA authorized vendors to provide greater access, lower cost, and/or a wider range of items and services. We would clarify in regulation that this administrative business decision is made solely by VA to eliminate any possible confusion as to whether a veteran has a right to request items or services generally, or to request specific items or services from a provider other than VA, and to clarify for the benefit of VA-authorized vendors that VA retains this discretion as part of our duty to administer this program in a legally sufficient, fiscally responsible manner.”

    This language, if finalized, will significantly restrict the ability of a veteran to see the VA contracted provider of their choice for prosthetic and orthotic care and must be addressed immediately.  AOPA, its Board of Directors, and its VA Committee are reviewing this proposed change in VA policy, which appears to be almost completely contrary to longstanding VA policy regarding veteran provider choice and the intent of the Veteran’s Access, Choice, and Accountability Act of 2014 which empowered Veterans to take a more active role in assuring their ability to receive convenient and timely care, whether through the VA directly or through the private sector.

    Anticipating an AOPA position in opposition to this proposal, look for instructions as to how AOPA members can engage and mobilize patients on this important new proposed direction for prosthetic and orthotic care for Veterans.

    The full text of the proposed rule may be viewed by clicking VA Proposed Rule

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    Short-Term Health Insurance, End of Subsidies Paid to Health Insurers—What Does It Mean to You and Your Patients?

    On October 12, President Trump undertook a non-legislative overhaul of the country’s healthcare insurance program, and some significant administrative ‘repeal’ of the Affordable Care Act. Two major executive actions comprise this effort:

    (1) clearing the path for sale of “short-term” insurance plans that do not have full ACA essential health benefits and other rules, at lower rates for healthy individuals, as well as clearing the path for sale of insurance through ‘association plans’ that will include sale of insurance across rate lines without meeting state license laws (parity laws from one state may not apply to plans sold by an out-of-state carrier who operates in a state that does not have parity rules). At peak, there were only about 100,000 Americans enrolled in these short-term plans, so immediate effect will probably not be dramatic. That said, this does initiate a segmenting of the market, incentivizing some healthy persons not to participate in the state-level insurance exchanges under ACA, but to gravitate to these cheaper, less robust short-term plans. If this snowballed to having much larger number of people in short-term plans it would tend to shift the risk pool in the exchanges in the direction of the unhealthier Americans, likely de facto giving them some characteristics of higher risk pools. Indirectly, persons with pre-existing conditions could find themselves relegated to the exchanges and their insurance rates would probably increase across the board without the balance of exchange participation by healthier individuals.

    (2) The administration will stop providing the $7 billion in annual, so-called CSR subsidies to health insurers to help cover the co-pays and deductibles of lower income individuals. This is facilitated because of legal challenges where one federal district court deemed these subsidies illegal. Ending the subsidies creates some hard decisions for insurers. They may: (1) continue the credits for co-pays/deductibles without collecting any off-setting subsidy payments which would result in little change in policyholder experience in the short run (some insurers already issued major hikes in 2018 rates, likely anticipating that the subsidy payments would end); (2) thirty-two states will allow insurers to levy a surcharge to offset the loss of subsidies and thereby increasing the premiums (low cost insureds will be eligible for larger tax credits essentially offsetting these larger premiums so they won’t have too much pressing them to drop coverage), or (3) with subsidies unavailable, insurers are permitted to withdraw from the 2018 ACA insurance exchanges in each state over the next few weeks before annual enrollment in the ACA plans begins.

    There is a timing disconnect. It will take a substantial amount of time for folks at HHS and CMS to write and implement the many new rules that will be needed to effectuate the short-term plans and association plans. So, these short-term plans will probably not be available for months or perhaps up to a year, even as the subsidy situation could push many folks from their current plans. Providers will want to take more special care that patients are enrolled and paid in their plans before delivering care. It’s important to recognize that, at least in the near term, these changes will impact only a portion of the health insurance market. In the short term; employer-based plans, Medicare, Medicaid, and VA, will remain unaffected—though in the longer term the premiums for these plans may change.

    There are likely to be lawsuits challenging both of these steps. Both hospitals and health insurers will oppose these steps—hospitals because it will shift many more uninsured folks into emergency rooms, and increase uncompensated care (the expense of which falls on the hospitals), and insurers because, obviously, they want the subsidies. Look for attempts at legislation to stabilize insurance premiums.

    Clearly, a time of change has been initiated that will impact providers over coming months. Depending on how health insurers respond, the results could have our health care looking more like it did before the ACA was enacted: more lower income people uninsured; sicker people potentially paying higher premiums, no assured universal essential health benefits, more people seeking care in hospital emergency rooms listed as uncompensated care, but actually with the cost of their coverage subsidized by higher costs for paying patients and cost-shifting. Can the President do this on his own? We will need to wait through a few years and watch the results on a likely bevy of litigation that will begin to unfold. One enduring fact will be that so long as the Affordable Care Act remains the law, any executive actions taken and regulations enacted by one President will be subject to the prospect of complete reversal by another President.

    Stay tuned for what may be a somewhat turbulent ride. We’ll continue to keep AOPA members informed of significant developments.
    ##
    October 13, 2017

    AOPA and APMA Send Letter to CMS Administrator Regarding A5513 Coding

    On Friday, September 29, 2017 AOPA and the American Podiatric Medical Association (APMA) sent a joint letter to CMS Administrator Seema Verma expressing their concern about the recent DME MAC coding clarification for HCPCS code A5513.

    The coding clarification essentially states that in order to bill Medicare for a custom fabricated diabetic insert using HCPCS code A5513, a physical model of the patient’s foot must be created and that the insert must then be molded over the physical model of the foot.  The clarification further states that processes that use a “virtual” model to create a custom fabricated diabetic insert through direct milling or another manufacturing process do not meet the code language for A5513 and therefore must be billed using A9270 which is a HCPCS code used to describe statutorily non-covered services.

    The AOPA/APMA letter expresses the concern that the overly strict interpretation of the descriptor language for A5513 limits the use of advanced technologies such as direct milling and 3-D printing to produce diabetic inserts that may result in a more intimate fit for the patient, possibly leading to better outcomes.  The letter also states that the relatively small annual Medicare expenditure for custom diabetic inserts when compared to the overall Medicare expenditure for the treatment of diabetes mellitus is so minimal, that it seems unlikely that “splitting hairs” over such a minor issue will result in any real savings to the Medicare program but will have a negative impact on patient outcomes.

    The joint letter suggests that CMS can solve the issue by either instructing the DME MACs and PDAC to be less restrictive in their interpretation of the code language for A5513 or by asking the CMS HCPCS panel to consider a verbiage change that would allow providers to bill custom diabetic inserts as A5513 without the requirement that the inserts be molded to a physical model of the patient’s foot.

    Read the AOPA/APMA joint letter.

    CMS Withdraws BIPA 427 Proposed Rule

    On October 3, 2017, the Centers for Medicare and Medicaid Services announced that it has withdrawn the proposed rule that represented the first step in creating regulations that would implement the qualified provider provisions for prostheses and custom fabricated orthoses legislated in section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA).  The notice of withdrawal will be officially published in the October 4, 2017 Federal Register.

    According to the notice published by CMS the proposed rule is being withdrawn due to “the cost and time burdens that the proposed rule would create for many providers and suppliers, particularly the cost and burden for those providers and suppliers that are small businesses, and the complexity of the issues raised in the detailed public comments.”  CMS indicated that they received over 5,000 public comments regarding the proposed rule.

    AOPA is disappointed that CMS decided to withdraw the proposed rule that would finally create regulations to implement a law that was passed more than 17 years ago.  The withdrawal of the proposed rule once again exposes the Medicare population to no regulation regarding what qualifications are required to provide custom orthotic and prosthetic services.  While the proposed rule was far from perfect, as AOPA expressed in its public comments that were submitted to CMS, AOPA believed that issues that were of significant concern to several provider groups, who viewed the proposed rule as a threat to their ability to continue to provide services within their scope of practice, could have been addressed through changes to the final rule rather than through the complete withdrawal of the proposed rule.

    The combination of the recent administration change, including the new administration’s philosophy to reduce overall regulatory burden on businesses, the significant opposition from several high profile provider groups, and the restrictive language that would significantly limit certain providers from continuing to provided custom orthoses and prostheses appear to have led directly to the demise and subsequent withdrawal of the proposed rule.

    AOPA will continue to make every effort to ensure that all recipients of O&P care receive that care from folks who have been properly educated and trained in the fabrication, fit, and delivery of orthotic and prosthetic devices.

    View the CMS notice.