August 31, 2015
Stacey Brennan, M.D.
DME MAC Medical Director
National Government Services
8115 Knue Road
Indianapolis, Indiana 46250
Submitted Electronically to: DMAC_DRAFT_LCD_Comments@anthem.com
Re: Proposed Draft LCD on Lower Limb Prostheses (DL33787)
Dear Dr. Brennan:
The Center for Medicare Advocacy (Center) appreciates the opportunity to provide the following comments regarding the proposed draft LCD on lower limb prostheses (DL 33787). The Center, founded in 1986, is a national, non-profit, non-partisan law organization that works to ensure fair access to Medicare and quality health care. The staff of the Center provides education, legal assistance, research and analysis on behalf of older people and people with disabilities, particularly those with long-term conditions. The Center’s health policy positions are based on its experience of annually assisting thousands of individuals and their families with Medicare coverage and appeal issues. Additionally, when necessary, the Center provides beneficiaries with class action representation to address broad patterns and practices that inappropriately deny access to Medicare and necessary care.
As an overarching principle, we urge you to rescind the proposed draft LCD immediately. We believe that:
- The proposed draft LCD unfairly and illegally restricts Medicare coverage;
- The OIG report recommendations, upon which the proposed draft LCD is purportedly based, does not support the proposed draft LCD provisions;
- The proposed draft LCD violates individuals’ Civil Rights as established pursuant to Section 504 of the Rehabilitation Act of 1973, as amended, and 45 C.F.R. Part 85;
- As a matter of ethics and good conscience, and in the interest of programmatic integrity, the proposed draft LCD should be eliminated.
- Pursuant to the Affordable Care Act, the proposed draft LCD must advance patient-centered planning and self-direction and provide individuals with maximum independence and control to fully participate in community life.
The following comments support these assertions.
1. The proposed draft LCD unfairly and illegally restricts Medicare coverage.
- Medicare coverage is available for services and items considered 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 (“The 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 documentation provided by the referring physician. CMS, Medicare Program Integrity Manual (PIM), Pub. No. 100-08, ch.5, § 5.2.1, §5.2.4. The referring physician works with a supplier to determine the most appropriate prostheses and its Healthcare Common Procedure Coding System (HCPCS) code(s). (HCPCS for lower limb prostheses are defined from L5000 to L5999.)
The draft proposed LCD ignores Medicare’s mandate to provide coverage to improve the functioning of a malformed body member. At best, the draft proposed LCD purports to “maintain” “immediately previous” functioning. What is more likely is that the draft proposed LDC will result in worsening the functioning of individuals needing lower limb prostheses by covering only ill-fitting alternatives. Clearly, nothing in the LCD wording or intent allows for the functional improvement of a malformed body member.
- PIM § 13.7.1 states that LCDs should be based on the strongest evidence available and may not take cost into account. The proposed draft LCD arbitrarily eliminates coverage, creates higher risk of complications for prostheses wearers, adds discriminatory and offensively ignorant prerequisites, and inexplicably removes the expertise of licensed and certified prosthetists from consideration.
2. The OIG report recommendations, upon which the proposed draft LCD is purportedly based, does not support the proposed draft LCD provisions.
In August 2011, the Department of Health and Human Services Office of the Inspector General (OIG), issued a report titled, Questionable Billing By Suppliers of Lower Limb Prostheses. In that report, as background, the OIG stated that “Medicare also requires that suppliers follow local coverage determination policies, which provide guidelines for determining the beneficiary’s potential functioning level…”(emphasis added). Contrary to this directive, the proposed draft LCD does not consider potential functioning.
In the report findings, the OIG stated that one reason for finding inappropriate Medicare payments was “the claims did not include any information about the beneficiaries’ potential functional level when it was required…”. Again, potential functioning is seen as a critical component of the process in the OIG report. It makes no sense, and conflicts with the OIG report, for the proposed draft LCD to attempt to eliminate potential functioning as a criteria in prostheses evaluation.
Also in the OIG report, the four DME MACs were criticized for not having claims processing edits for all requirements. Some beneficiaries had not seen their referring doctors in over 5 years, some were not documented appropriately, and some had no history of an amputation or missing limb.
Clearly those issues need to be addressed by the contractors, but it is wrong for the draft proposed LCD to remove multiple HCPCS for knees, feet, and ankles; to remove potential for function; and to require an unnecessary and outdated “hoop-jumping” rehabilitation program to qualify for a permanent prosthetic limb. It is equally intolerable to eliminate proper fitting of the device; to not allow a person to use a cane, crutches, or walker; to require the “appearance of a natural gait”; to make someone go through strength, capacity, intelligence, posture, and control testing like a “trick pony”; and, to eliminate coverage for expert prosthetists. The OIG report never contemplated these narrow, harmful, pain-producing, and independence-robbing strategies.
3. The proposed draft LCD violates individuals’ Civil Rights as established pursuant to Section 504 of the Rehabilitation Act of 1973, as amended, and 45 C.F.R. Part 85.
45 C.F.R. Part 85 was promulgated under the authority of section 504 of the Rehabilitation Act of 1973, as amended, which prohibits discrimination on the basis of handicap in programs or activities conducted by Federal Executive Agencies. This regulation covers all programs and activities conducted by the Department of Health and Human Services, including the Medicare Program.
45 C.F.R. § 85.21(a) describes general prohibitions against discrimination. It prohibits the 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 that “The 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;”.
The unduly restrictive requirements of the proposed draft LDC, the lack of coverage for potential improvement, and the inability to obtain reasonable and necessary care by denying expert analysis and covering only ill-fitting prostheses are all in violation of 45 C.F.R. Part 85. Individuals in need of prostheses have been discriminated against pursuant to the proposed draft LCD.
4. As a matter of ethics and good conscience, and in the interest of programmatic integrity, the proposed draft LCD should be eliminated.
The public outcry against this proposed draft LCD has been loud and clear. The fact that it was proposed, and in the hurtful form that it was, shocks the conscience. Rather than embrace the advancements that have been made to keep people who need prosthetic devices active, vital, and independent, this proposed draft LCD wants to take away those advances and take away the potential to function that has already been denied to beneficiaries in need of prostheses.
CMS should encourage technology in prostheses coverage, and in all future Medicare coverage, to enhance beneficiaries’ health care outcomes, patient-centered care, self-direction, and to promote Medicare’s fiscal solvency by encouraging more independent living. CMS should bear in mind the following realities:
- The technologies of today will not be the technologies of the future. A successful Medicare program must have the flexibility to embrace efficient and effective changes that strengthen program integrity.
- Accessibility to quality health care is essential to health and well-being and promotes community integration.
- Technology ensures an individual can direct his or her own care.
- Monitoring of functions through technology provides the opportunity for an individual’s safe and secure independence.
- Beneficiaries want, and are entitled to, the ability to be in control of their own lives and enjoy the maximum level of independence in safety and security.
(From the Institute of Medicine and National Research Council Forum on Aging, Disability and Independence workshop on Fostering Independence, Participation, and Health Aging Through Technology. Published by the National Academies of Sciences, 2013, ISBN 978-0-309-28517-9)
5. Pursuant to the Affordable Care Act, the proposed draft LCD must advance patient-centered planning and self-direction and provide individuals with maximum independence and control to fully participate in community life.
In June 2014, HHS issued important guidance on implementing Section 2402(a) of the Affordable Care Act. This provision of the law requires the Secretary to ensure all states develop systems that are designed to respond to the changing needs of beneficiaries, maximize independence, support self-direction, and achieve a more consistent and coordinated approach to the administration of policies and procedures across programs providing home and community based services and supports (HCBS).
The Secretary’s guidance states that patient-centered planning “creates a space of empowerment – a level playing field – that allows for consideration of personal preferences as well as health and safety needs, without unnecessarily restricting freedoms. The best person-centered planning helps people to live better lives, with support to do the things most important to them.”
The Secretary’s guidance includes standards for self-direction. Self-direction allows the person maximum control over his or her HCBS including the amount, duration, and scope of services and supports, as well as choice of providers, which may include family or friends….Consistent with the philosophy of independent living, self-direction embraces the values of freedom, authority, autonomy, and responsibility to allow the person to fully participate in community life with the necessary supports.
We strongly urge CMS to consider the health care needs and well-being of beneficiaries who comprise the population of prostheses users. We appreciate the opportunity to submit these comments. For additional information, please contact Kathy Holt, Associate Director, at email@example.com or 860-456-7790.
Judith Stein, J.D.
Kathy Holt, M.B.A, J.D.