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Proposed LCD DL 33787 unfairly and illegally restricts Medicare coverage for, and discriminates against, Dr. Roger Catlin, an above-knee amputee who wears an elevated vacuum socket, micro-processor knee and energy storing foot.

Dr. Catlin breaks all assumptions the proposed LCD makes about his co-morbidities related to his functional potential. He ambulates independently, runs a tractor, walks over 300,000 documented steps a quarter and has documented variable cadence in his gait. Under the proposed LCD, his current prosthesis would be denied. It states he should not be a level 3+ ambulatory, thus Medicare would not cover his micro-processor knee, elevated vacuum suspension, nor energy storing foot.

The new criteria in the proposed LCD arbitrarily limits coverage, adds discriminatory prerequisites, and prohibits coverage to “improve the functioning of a malformed body member,” as required by law. It treats prostheses users like second class citizens, unentitled to proper fitting prosthetic limbs with components needed to achieve normal levels of function and independence. Dr. Catlin would have to “demonstrate the appearance of a natural gait” to qualify for coverage. Medicare has no such “natural gait appearance” requirement for those with natural limbs. The proposed LCD also violates Medicare’s “reasonable and necessary” standard by not considering expert opinions from licensed/certified prosthetists in the prosthetic device selection process.

The Law

45 C.F.R. § 85.21(a) “prohibits an agency from limiting a qualified individual with handicaps in the enjoyment of any right, privilege, advantage, or opportunity enjoyed by others receiving any aid, benefit or service.” 

45 C.F.R. § 85.21(b)(3)(i) states “[t]he agency may not directly or through contractual or other arrangements, utilize criteria or methods of administration the purpose or effect of which would subject qualified individuals with handicaps to discrimination on the basis of handicap.”

Medicare coverage is available for services and items “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” Social Security Act 1862(a)(1)(A), 42 U.S.C. § 1395y(a)(1)(A)(emphasis added). Whether a covered service or item is reasonable and necessary is determined through referring physician documentation. CMS, Medicare Program Integrity Manual (PIM), Pub. No. 100-08, ch.5, § 5.2.1, §5.2.4. The physician works with a supplier to determine the most appropriate prosthesis.

Application of the Law

The proposed LCD imposes limitations on people with lower limb prostheses that aren’t imposed on others. It limits coverage based on “current” functioning and does not allow consideration of potential functional improvement. It relegates those who use prostheses to outdated technology, far below accepted standards of care. It undermines coverage for people with disabilities.

The proposed LCD contains discriminatory criteria against people needing lower limb prostheses. It humiliates and strips away the dignity of people with disabilities. It imposes a subjective, discriminatory process of strength, capacity, intelligence, posture, and control testing to obtain an item based on how results compare to others. The opinions of expert prosthetists aren’t considered in the development of the plan of care. Proper fittings are disallowed as not reasonable or necessary in ways that other Medicare services would never be evaluated – as just “good enough.” It is a cruel, discriminatory basis for claim denials for people with disabilities, like Dr. Catlin.

The proposed LCD illegally prohibits reasonable and necessary Medicare coverage by not allowing functional improvement of a malformed body member. But, the statute deliberately includes the word, “improve” in this context. To take potential functioning away from someone, while restoring it to others, is discriminatory. We, therefore, ask that CMS rescind this proposed LCD.

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