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Legislative Updates


Medicare at a Threshold Part 3

By Robert "Bob" Weiss, M.S.
Insurance and Legislation Committee

Previous columns in LYMPHLink [Vol. 22, No. 2 April-June and No. 3 July-Sept 2010] have outlined the three-pronged approach being taken over the last decade to achieve meaningful coverage of the treatment of lymphedema. The reader is referred to those earlier columns for a more complete background on NLN's efforts in this area.

Washington Lobby Trip May 26-7, 2010 — In late May a team of 12 volunteer advocates comprising patients (upper and lower, primary and secondary lymphedema), therapists, orthotists, therapist instructors and a garment manufacturer visited and lobbied on Capitol Hill. Our lobby team included Bob Weiss, NLN Legislative Chair and author of the original bill which became H.R. 4662, Heather Ferguson who was instrumental in obtaining a lymphedema treatment mandate in North Carolina and who is spearheading the efforts to pass the Medicare bill introduced by Congressman Larry Kissell, and Michael Cannon, Product Manager of Medi-USA who so ably organized the Washington trip. The team visited a number of representatives and senators, and held an extremely successful congressional staff briefing. We had seven new co-sponsors sign up immediately following the trip.

NLN Industry Advisory Committee (IAC) Briefing June 10, 2010. — In June Saskia Thiadens asked Bob Weiss and Michael Cannon to get together with Jerry Mattys, Chairman of the IAC, to brief the Committee on the bill provisions and status, benefits to industry, potential problems, plans going forward, and to answer any questions and receive suggestions from the Committee members. It is NLN's intent to keep the lines of communications open and to address the concerns of all stakeholders. A second industry tele-conference will be scheduled in the near future to reach more industry stakeholders who are not members of the IAC.

Contemplated Changes to the Bill Provisions — It is an unfortunate reality that many stakeholders had been reluctant to review a draft bill and spend time in proposing changes before the bill became "real" and was introduced in Congress. Now that the bill has been introduced we have been receiving many comments and proposals for change. We take all comments seriously and are collecting them for possible inclusion in the Congressional markup when that occurs. Some of the changes to H.R. 4662 that will be proposed are the following:

    • Removal of designated compression garment covered compression range. Any compression determined by the treating physician and therapist will be covered;
    • Addition of Physicians and certain Nurses who have received specialized lymphedema training to those reimbursed for provision of lymphedema treatment so long as this is within their scope of license. References to Massage Therapists will be removed, but The Secretary of the Department of Health and Human Services will be given the discretion, without additional legislation, of naming other health professionals who can be reimbursed for lymphedema services;
    • The requirement that a medical worker must have specialized lymphedema training will be retained in the bill, however specification of specific lymphedema training and certification requirements [i.e. LANA levels and 135 hours] for Physical Therapists and Occupational Therapists are removed since these specialized requirements are the province of the State Licensing Boards, and not the Federal government;
    • The Secretary will be given the authority to reimburse new lymphedema diagnostic and treatment protocols or new technologies as supporting evidence becomes available;
    • Changes to requirements for prescribing sequential pneumatic compression devices have been made which place the burden on the Physician or Referrer to not only provide information on medical necessity for such a device, but to prescribe the specific characteristics required to treat the individual patient's diagnosed lymphedema and existing co-morbidities. This will help eliminate the practices of automatically downgrading device requests based on cost and policy instead of patient medical need and the provision of devices more elaborate than is medically required.

Final Technology Assessment (TA) Diagnosis and Treatment of Secondary Lymphedema — The final draft of the technical assessment commissioned by the Agency for Healthcare Research and Quality (AHRQ) was issued May 28, 2010. The conclusions of the final TA were identical to those of the draft -- that "there is no evidence to suggest an optimal diagnostic testing protocol, an optimal frequency or duration of treatment, the most efficacious treatment combinations (including the use of maintenance therapy), the length of time for which persons should be tested or treated for lymphedema, and whether certain tests or treatments may benefit some types of patients more than others." The treatment of lymphedema is a multimodal, multi-phase therapy which comprises manual lymph drainage to reduce swelling by stimulating the lymphatics, compression to prevent re-swelling, exercise with compression to facilitate decongestion and skin care to maintain skin integrity. Any attempt to selectively institute one modality to the exclusion of the others may result in partial and ineffective treatment for this chronic, ever changing, and progressive medical condition.

It is hoped that MEDCAC has heard the testimony of the medical experts at the November 2009 open meeting, factors in the broader goals of evidence-based medicine, and considers the vast amount of clinical evidence and consensus recommendations of expert panels, in coming up with a patient-centered recommendation for lymphedema coverage. It is not the function of CMS/Medicare to determine the optimal diagnosis or treatment programs. That is precisely the function of the treating physician and therapist. The function of Medicare is to cover any diagnostic or treatment protocol determined to be effective on some subset of lymphedema patients – the selection for any particular patient to be made by a physician on the basis of the patient's presentation.

Summary — There is no doubt that we are gathering momentum. At the time of writing this column Congressman Kissell had 46 co-sponsors to H.R. 4662 and we have gained the support and endorsement of over 40 organizations and coalitions, including Susan G. Komen for the Cure Advocacy Alliance, Living Beyond Breast Cancer, the Breast Cancer Network of Strength, Colon Cancer Alliance and the Lance Armstrong Foundation, LIVESTRONG. This is truly a patient healthcare bill.

We need your help to keep the momentum and pass our comprehensive lymphedema law. Patients must continue to write their Senators to request that they introduce a Senate companion to H.R. 4662, and write their Representatives to urge them to sign up as co-sponsors to the bill. Links, sample letters and information can be obtained on our website http://www.lymphedematreatmentact.org/. Healthcare professionals contact Dr. Clifford Goodman, Chairperson of the MEDCAC and urge that the evidence base for the measurement and treatment protocols not be limited to randomized clinical trials, but be expanded to include medical consensus of specialty groups and the vast amount of clinical and patient data which demonstrates the efficacy of CDT protocols. Dr. Goodman may be reached through Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, E-mail: Maria.Ellis@cms.hhs.gov.

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