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Legislative Updates


About H.R. 4662 Rep. Larry Kissell's Lymphedema Diagnosis & Treatment Cost Saving Act of 2010
Update: Jan - March, 2011

 By Robert (Bob) Weiss, MS, LE Legislative Advocate

The information I presented in my 2010 NLN Conference presentation is a plain language statement as to where we seem to be at the moment. It is not the language of the bill, which will not exist until the final suggested changes are accepted by Congressman Kissell, and he sends our suggestions to the Congressional legal counsel (bill writer). That statement was meant to convey the following ideas:

• Anyone who treats a lymphedema patient must have specialized lymphedema training;
• Specification of specific training and certification levels is not appropriate in a bill to change the Social Security Act;
• Specific levels and certification requirements are the jurisdiction of State Licensing Boards.

I have been serving as a moderator of sorts, collecting comments and proposed changes, negotiating and explaining, and synthesizing a bill which will be in the best interests of lymphedema patients. The final content and wording are at the discretion of the bill sponsor, Representative Kissell.

1. THE REAL BILL— The only "reality" at this point is the current wording of the bill. What we must do is to create a "new reality" which would be implemented when the bill is re-introduced. The new wording must consider the framework of law as well as the sometimes-conflicting needs of the affected stakeholders. I am still struggling to reconcile these aspects and welcome your participation in the process.

1. THE REAL BILL— The only "reality" at this point is the current wording of the bill. What we must do is to create a "new reality" which would be implemented when the bill is re-introduced. The new wording must consider the framework of law as well as the sometimes-conflicting needs of the affected stakeholders. I am still struggling to reconcile these aspects and welcome your participation in the process.

1A. BILL HISTORY— It was about nine years ago that I was first told by the then-Director of the Medicare Coverage and Analysis Group that the proposed changes that were submitted by NLN and me to improve the treatment of lymphedema patients would not be made and that Medicare coverage of treatment of lymphedema was adequate. Only through a change in the law would the Centers for Medicare and Medicaid Services (CMS—then called HCFA) change their policies. I took them up on their challenge and set out on the journey to write such a law.

My proposed bill, ultimately picked up by Representative Larry Kissell of North Carolina, re-drafted by a Congressional Legislative Counsel, and introduced in the House of Representatives as H.R. 4662, was written by first identifying the deficiencies in current Medicare treatment of lymphedema, secondly looking at the microstructure of Medicare law and CMS policy, and then crafting the changes that had to be implemented to provide comprehensive quality treatment for lymphedema patients.

1B. BILL OBJECTIVES— The Medicare coverage problems the bill attempts to rectify include:

• Non coverage of compression bandages and garments;
• Limitation of reimbursement for lymphedema treatment to PTs and OTs to the exclusion of other qualified healthcare providers;
• No training or competency requirements for the therapists who treat lymphedema;
• No training or competency requirements or reimbursement for garment fitters;
• No reimbursement for therapist time for bandaging and patient education;
• Annual limitation of therapy treatment;
• Down-coding of physician requests for lymphedema sequential compression devices.

The bill does not remove any rights that now exist. H.R. 4662 only affects Medicare reimbursement.

1C. BILL STRUCTURE AND ORIGINS— The complexity of H.R. 4662 directly flows from the complexity of Medicare statutes. This bill was written eight years ago and circulated to patients, manufacturers, therapists, and physicians for comments. Each year I solicited comments about desirable changes to incorporate. Every one of the constructive comments submitted to me were studied and considered for incorporation. Many were included, and the reasons for non-exclusion were discussed with the submitter. The text that became H.R. 4662 was based on the 9th version of the original bill.

This legislation has not been in any way crafted by special interest groups or profit-making groups, although their inputs were certainly solicited along with the inputs of patients, therapists, and physicians. After the bill was introduced, I started to receive comments and suggestions for changes. To date, I have addressed constructive comments and suggested changes from over 50 stakeholders, and I believe I have personally answered all of them, explaining why I could or could not incorporate each suggested change. Many suggestions were based on misunderstanding of the bill, reactions to private communications about the bill but not based on the actual bill text, lack of understanding of Medicare law and the history of previous attempts to bring about change, or blatant special interests not necessarily in the interest of patients.

As a result of these discussions, I have come up with a number of desirable changes to the bill version that was introduced in Congress and a number of other not-so-desirable changes that were necessitated by the realities of federal and state laws. The potential changes to the current text were listed in LymphLink Vol. 22, No. 4, October-December, 2010.

I continue to encourage specific suggestions until the bill is reintroduced next Congressional Session. For that is the cycle of Congressional legislation. A bill goes to the committee(s) of jurisdiction and perhaps one in ten emerges to be voted on the floor of Congress. Bills commonly are re-introduced many times before they emerge from committee and are voted upon. Meanwhile, we have the opportunity to optimize and craft them so as to make them acceptable to as many stakeholders as possible without removing its benefits to the patient. That process is ongoing right now for H.R. 4662 IH.

2. LEGAL FRAMEWORK— The Social Security Act (the Act) that governs Medicare delineates in rather broad terms the conditions for provision and payment for medical services. Coverage criteria are couched in terms of functional requirements and not specific treatment procedures or item descriptions. Those details are left for the further definition of CMS, which was given the responsibility by Congress to implement the broad requirements of the Act.

The licensing of healthcare professionals is a State right and not a Federal right. Licensing requirements, scope of license, and disciplinary responsibilities are the responsibility of State Professional Boards and are not properly the province of federal law, and specifically of the Act. That being said, Medicare does use a federal regulation to define the professionals who can be reimbursed for services provided to Medicare beneficiaries and bill Medicare for those services [see Code of Federal Regulations 42 C.F.R. §484.4 Personnel Qualifications, or "42CFR484.8"]. This regulation, part of the section of the Act on Home Health Services, has been incorporated by reference to physical and occupational services provided in other settings, most notably in conjunction with services "incident to a physician's professional services".

3. MEDICARE REIMBURSEMENT FOR LYMPHEDEMA SERVICES OF LICENSED MASSAGE THERAPISTS (LMTs) "INCIDENT TO THE SERVICES OF A PHYSICIAN"— A change in the Medicare 2005 Fee Schedule terminated the practice of granting qualified massage therapists and registered nurses the right to provide lymphedema services "incident to a physician's professional services". Bills were introduced by Wyoming Senator Thomas and New York Representative Towns in 2006 to allow this practice, but the bills died in committee.

The possibility of changing 42 C.F.R. 484.4 to include Licensed Massage Therapists (LMTs) as qualified lymphedema therapists has been discussed with AMTA, but this organization has offered no help in defining the specific training and certification an LMT must have to assure adequate medical training to be able to provide lymphedema services. Furthermore, I was informed by this organization that although a licensed massage therapist is qualified to perform MLD without specialized training (not true!), compression bandaging, garment fitting, and decongestion exercises are not in an LMT's training or scope of license.

In light of these problems, I was forced to conclude that my long-term efforts to add qualified massage therapists to the lymphedema bill were futile at this point and could jeopardize the other achievable goals of the bill. The proper groundwork has not been done yet to achieve this goal. Further work needs to be done to bring LMTs with specific training in lymphedema treatment into the provisions of the bill.

4. MEDICARE REIMBURSEMENT FOR LYMPHEDEMA SERVICES OF LYMPHEDEMA TRAINED REGISTERED NURSES, PHYSICIANS, OSTEOPATHS— The addition of certain licensed medical staff who have completed lymphedema training and are certified to provide lymphedema treatment will be retained in the bill. A "lymphedema therapist", defined for the purposes of meeting Medicare requirements for treatment of lymphedema, would be any healthcare provider who/whom is licensed to practice in the State as a PT, OT, Physician, RN, OD, or PA and who/whom has taken adequate specialized training in lymphedema management and who/whom has been certified to be competent to provide lymphedema services.

5. THERAPIST TRAINING AND COMPETENCE— Medicare will reimburse ANY licensed PT or OT for lymphedema services within their scope of license, irrespective of any specialized competence in lymphedema protocols.

While it may not be appropriate to include training levels and certification levels in a Federal bill, it would be appropriate to indicate the intent that any therapist who provides lymphedema treatment to a Medicare Beneficiary must have special training and be certified in the protocols of lymphedema therapy, leaving open for HHS and State Licensing Boards to decide what constitutes "adequate training" and who determines "competence". In my mind, any progress that will be made with respect to training requirements for lymphedema therapists will have to be done through a change to 42CFR484.4.

Passage of a bill with this kind of wording should be a trigger to the State Licensing Boards that they have to develop a set of requirements to define "adequate training" and method of certification. The provisions above will, for the first time, impose the requirement for at least some specialized training for therapists who treat lymphedema, albeit perhaps not immediately to the generally accepted levels. This is, in itself, a significant forward step. We must work with CMS after passage of this Medicare bill to change 42CFR484.4 appropriately.

In seeking good legislation, we must evaluate not only what we would like in the ideal world. We must consider what may be achievable now in the real world that will take us, step by step, toward that ideal. It is short-sighted to scuttle the bill that will bring payment for bandages, garments, and devices for all lymphedema sufferers because we couldn't go all the way and impose therapist standards. And we will need the support of all stakeholders if we are to succeed. Disagreement among stakeholders will surely result in legislators backing away from a bill that does not have the full support of its proponents. They depend on us to assure them that the bill will benefit the patients.

My door is always open for further discussion.

Robert "Bob" Weiss, M.S.
NLN LE Legislative Advocate

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