MEDICARE

(Non)Coverage of Lymphedema Treatment

Medicare is administered by the Centers for Medicare and Medicaid Services (CMS) to interpret Titles XVIII and XIX of the Social Security Act (SSA) and to implement the requirements of the SSA through a series of publications. Local administration is through a network of Medicare Contractors selected by CMS who either use the national publications or create local policies further interpreting the national policy or creating policy when a national policy does not exist.

Every service covered by Medicare must be medically necessary and must fit into a "benefit category" defined in the SSA. A specific item is covered if it meets the criteria set up for the specific benefit category, and it is denied if it is deemed not to be medically required or if it does not meet the coverability requirements for its benefit category.

STEPS IN A MEDICARE APPEAL

1. There is a formal procedure for seeking reimbursement for funds already paid. You have 120 days to file an appeal. The steps are as follows:
1. Medicare-enrolled physician writes prescription for compression garment for treatment of lymphedema.
2. Medicare-enrolled Supplier fills prescription and files claim with Medicare DME Administrative Contractor (DME MAC)
3. DME MAC sends denial (Remittance Advice) to Supplier in about 1 week
4. Beneficiary receives denial on next quarterly Medicare Status Notice.
5. Either Beneficiary or Supplier files an appeal (Redetermination Request) with the DME MAC
6. DME MAC reiterates denial in a Redetermination Determination.
7. Beneficiary or Supplier appeals the Redetermination and files a Reconsideration Request with Qualified Independent Contractor (QIC)
8. QIC sends denial to whomever made the appeal.
9. Beneficiary or Supplier requests review by an Administrative Law Judge (ALJ)
10. ALJ makes final determination

BENEFICIARY/PATIENT RESPONSIBILITIES

You must purchase your garments from a Medicare-enrolled Supplier who is registered with the National Supplier Clearinghouse. Furthermore, the physician or non-physician practitioners who order or refer must be enrolled in the Medicare Provider Enrollment, Chain and Ownership System (PECOS) and must be of the type/specialty who are eligible to order/refer services for Medicare beneficiaries. The orderer/referrer and enrolled Supplier federal enrollment numbers must appear on the prescription and invoice for the prescribed item.

If Supplier is a Medicare Supplier: Garment supplier fills out an ABN and gives Beneficiary a copy. Beneficiary pays garment supplier and gets a receipt. Make sure that this is the latest version of Form CMS-R-131 (03/08). This is important since the Section (G) Options were in reverse order from earlier versions. The option to be chosen is the only one that states in bold "I can appeal to Medicare". Also make sure that the referrer's and Supplier's Medicare enrollment numbers ore on this form together with the Supplier's address and phone numer.

When the Supplier files the claim for the Beneficiary, they will file on a Form 1500. Ask that they fill out Item 27 Acceptance of Assignment with a "NO", and further place the note "Beneficiary refuses to assign benefits" in Item 19.

If supplier is not a Medicare Supplier or is a Medicare Supplier but refuses to file a claim then the Beneficiary may submit a CMS Form 1490 Patient's Request for Medical Payment to Medicare requesting reimbursement for the garments purchased, and attaches receipt which has a full description of the items. Reimbursement, if won, will be sent directly to the Beneficiary since Block 6 Authorization says "... and request payment of medical insurance benefits to me" just above beneficiary's signature".

Medicare will send the denial directly to the Supplier in the form of a Remittance Advice (RA). The Beneficiary is informed of the denial when it appears on the quarterly Medicare Summary Notice (MSN). After the headers on this form, the sentence "This is a summary of claims processed from ... to ...". Following this there should be a section labeled "Part B Medical Insurance—Unassigned Claims". In the last column "See Notes Section" there will be a series of code letters denoting the reason for the denial. There will also be detailed instructions for appealing the decision. There is a 120-day appeal period after which no appeal will be allowed.

Beneficiary then consults Bob Weiss [LymphActivist@aol.com] to proceed further, i.e., several more denials will usually be necessary before the appeal goes to an administrative law judge (ALJ). At this point I will need a copy of the MSN and I will either guide the beneficiary in the first appeal, or I will file it on behalf of the beneficiary. If you wish me to file as your representative you execute an Appointment of Representative CMS Form 1696.

• At this point if you have not furnished the following information to the Supplier, you should gather it and send it with the appeal. Absence of this information can jeopardize the appeal and provide administrative grounds for denial:
• Physician's prescription for items citing diagnosis of lymphedema
  • words like "for treatment of patient's lymphedema ICD-9 code xxx.x"
  • specific description of prescribed item, (e.g. wrist-to-axilla sleeve, compression class II, custom Elvarex)
• Letter of medical necessity signed by physician (could be written by therapist)
  • describe medical history
  • describe patient's recommended treatment plan
  • detailed description of garment(s), how and when they are used, medical efficacy in the treatment of lymphedema, any alternatives considered or tried
  • prognosis if garments are used
  • prognosis if garments are not worn
• Paid Invoice from Supplier with the following:
  • Supplier's name, address, Medicare Supplier Number
  • description of items
  • cost of items (shipping and handling included—not separate line item)
  • marked "paid" by beneficiary

This first appeal is called a "Redetermination", made to an "independent" Medicare Contractor called a DME Medicare Administrative Contractor or "DME MAC" for your region. After the DME MAC supports the denial, you indicate that you disagree with the decision and appeal by requesting a "Reconsideration" by a "Medicare Quality Independent Contractor" or QIC. Neither the DME MAC nor the QIC understands the concept of "benefit category", which is the mechanism in the Social Security Act that confers coverage. The next appeal is to an Administrative Law Judge (ALJ) which is the first hearing where you can get a "fair hearing" by an agency which is obliged and capable of looking at the law.

None of these appeals costs any more than the cost of making copies and postage. There is a 60-80% chance of a favorable determination by the ALJ. In the event that the ALJ renders an unfavorable decision then we will appeal to the Medicare Appeals Council, where I run about a 25% favorable rate.

The Supplier has little incentive to file your claim and appeal. The supplier receives a reduced amount of reimbursement from the retail price of the item, and if they are a Medicare-enrolled Supplier they are required to file a claim for something they know will be denied. So they will ask for payment in advance. So as long as they are filing on behalf of the beneficiary it is important for the beneficiary to refuse to "assign benefits" on the Form 1500. That way there will be no refunds necessary and the reimbursement check (minus deductibles and co-pay) will come directly to the Beneficiary.

(Thanks to therapist Kevern Hartmann for providing the framework for this piece and forcing me to research the appeal process. I would ask any reader who discovers any errors or changes o the process to contact me immediately. Please remember that I am not allowed to provide medical or legal advice. All I can do is to read the appropriate regulations and policies and tell you what my understanding is.

DOCUMENTATION REQUIREMENTS

(From Manual Lymphedema Drainage Therapy LCD Pennsylvania Highmark Medicare Services LCD Number Y-11C)

The medical record documentation maintained by the provider must clearly document the medical necessity of the services being performed.

• This document would need to include the following:
• a physician documented diagnosis of lymphedema
• a statement as to the ability of the patient/patient caregiver to follow through with the continuation of treatment on a long term home treatment plan.
• the medical necessity of each treatment
• history and physical which addresses the cause of the lymphedema and any prior treatment. It must also address the symptoms which necessitate treatment.
• measurement of body part/extremity prior to treatment
• a report showing the progress of the therapy which should contain measurements showing a reduction in size of the extremity. This should also address the response of the patient/patient caregiver to the education and their understanding and ability to take on some of the responsibilities of the treatment. This progress report must also address the expected outcome of the treatment as well as the expected duration of treatment.
• [added by R. Weiss, not in LCD] prognosis with treatment and without treatment, specifically relating undertreatment of lymphedema with an increased risk of infection, disability and lymphangiosarcoma.

APPROACH TO A MEDICARE APPEAL

The approach I have taken in appealing Medicare denials of lymphedema treatment are to show that: 1) the treatment service or item are medically necessary; 2) is it is part of a medically recommended treatment guideline and is prescribed by the patient's physician; and 3) it falls into a benefit category covered by the Social Security Act.

Specifically, I show that manual lymph drainage (MLD) performed by a specially-trained therapist in accordance with a physician-approved treatment plan determines the frequency and duration of the clinical treatment. The policies on treatment duration established for rehabilitative therapy do not apply to this medical procedure, and that the length of the treatment is determined by medical necessity.

Furthermore, I show that compression bandages, garments and devices fall into the "prosthetic devices" benefit category defined by §1861(s)(8) of the Social Security Act. CMS Publication 100-2, Chapter 15, §120 defines a prosthetic device as follows: "A. General.-- Prosthetic devices (other than dental) which replace all or part of an internal body organ (including contiguous tissue), or replace all or part of the function of a permanently inoperative or malfunctioning internal body organ are covered when furnished on a physician's order."

In this case the inoperative or malfunctioning internal body organ is the lymphatic system and the compression items replace all or part of its function.

There are no Medicare coverage determinations or policies dealing with compression bandages, garments or devices when used in the function of treating lymphedema, so Medicare Contractors (and healthcare insurers) select policies which deal with materials which look similar but are used in a different function, and apply the coverage criteria for the other use. They obviously fail and are denied.

Compression bandages are denied for home use because the benefit criteria they are placed into is "surgical dressings", which are non-durable supplies used in an in-patient procedure in conjunction with treatment of an open wound. This is hardly the function of a short-stretch bandage, tubular sleeve or gauze finger bandage in the treatment of lymphedema! My argument is that the assemblage of these diverse materials every night on the lymphedema patient's arm or leg is a prosthetic device which is assembled to the exact medical requirements at that time by a patient or an aide who has been instructed in the specific techniques. It makes no more sense to deny a bandage system because its components are not covered than it would be to deny a wheelchair because its wheels or axle are not separately covered. What matters is the function of this totality of parts in the treatment of lymphedema that determines coverability.

Compression garments are frequently denied either because they "are not medically necessary" or because they do not meet the requirements of "secondary surgical dressings". The first issue is easy to address by showing that these are different from "support stockings" which are worn as comfort or convenience items, not necessarily with physician's prescription. These are required for daily use as part of the medical standard of care of lymphedema. [reference to ISL, ACS, NLN consensus recommendations]

The second argument is more difficult to counter since 2006, when CMS moved the coding of compression stockings from the prosthetic devices category with HCPCS codes Lxxxx to the surgical dressing category with HCPCS codes Axxxx. The criteria for coverage of a compression stocking as a secondary surgical dressing is that it be used with one or more primary dressing in the treatment of an open venous stasis wound. Denied!

So my approach has been to show that compression garments and devices meet the prosthetic device requirements of the SSA, and are therefore not subject to the surgical dressing coverage criteria. So far eleven Medicare Administrative Law Judges have agreed and have ruled that the Medicare patients must be reimbursed for their garments (upper limbs and lower limbs).

APPEALING AN UNFAVORABLE MEDICARE DECISION

Compression is the mainstay of lymphedema treatment and denial of the medical materials which enable the patient to treat their lymphedema is tantamount to denial of medical treatment. And this is a breach of the insurance contract.

• Medicare offers five levels in the Part A and Part B appeals process. The levels, listed in order, are:
• Redetermination by the Fiscal Intermediary (FI), Medicare Contractor or DMEPOS Contractor
• Reconsideration by a Medicare Qualified Independent Contractor (QIC)
• Hearing by an Administrative Law Judge (ALJ)
• Review by the Medicare Appeals Council (MAC) within the Departmental Appeals Board
• Judicial review in U.S. District Court

1. I have had success with the following arguments:
1. Lymphedema is a diagnosable medical condition, not a symptom. (The medical record should note the appropriate ICD-9-CM diagnostic code for lymphedema, e.g. 457.0, 457.1 or 575.0)
2. The recognized medical treatment protocol for lymphedema from all causes, primary and secondary is complex decongestive therapy, the backbone of which is daily compression.
3. The physician's prescription attests to medical necessity of compression materials for this patient. (The prescription must have the diagnosis of lymphedema with the appropriate ICD-9-CM diagnostic code.)
4. Compression characteristics required for day and night are different, necessitating two different kinds of bandages/garments (i.e. elastic for active periods-daytime, exercise, and non-elastic for inactive periods-night time, watching TV, aircraft flights, etc.)
5. Daily use and need for frequent washing necessitates two sets of bandages and garments, every 4-6 months as required by wear-out and changes in patient's condition and measurements.
6. Compression when used to treat lymphedema meets the definition of "prosthetic devices and supplies" in Title XVIII section 1861(s)(8) of the Social Security Act as interpreted by Medicare in the Medicare Coverage Benefit Manual, Pub. 100-02, Chapter 15, section 120.
7. Compression bandages, garments and devices therefore are covered by Medicare and Medicaid as medically necessary prosthetic devices. They should also be covered in individual insurance contracts which include prosthetics and orthotics (not all contracts do).
8. Therefore, denial of the bandages, garments or devices which are prescribed by your physician for the treatment of diagnosed lymphedema constitutes a breach of contract and law.

APPEAL TIMELINES

(courtesy of Medicare Rights Center "Dear Marci" Column)

1. Your appeals timeline depends on three different factors:
1. What type of Medicare you have
2. How long ago the Medicare Summary Notice (MSN) was filed
3. Why you were "too busy"

If you have traditional Medicare (Part B), your appeal must be submitted within 120 days of the date on the MSN denying coverage.

If you receive your Medicare through a private plan, like an HMO or a PPO, you only have 60 days to submit your request for reconsideration. The plan then has 60 days to make a decision for post-service denials (but only 30 days for pre-service denials).

If the plan upholds the denial, the case is forwarded to an independent reviewer who must also make a decision to uphold or overturn the HMO's decision within 30 days for care or 60 days for payment. For more information on this independent reviewer, visit its web site listed in the Spotlight on Resources below.

• Medicare or your Medicare private plan (HMO or PPO) must accept a late filing of an appeal if you can show "good cause" of why you did not file an appeal on time. "Good cause" reasons are judged on a case-by-case basis. Therefore, there is no complete list of acceptable reasons for filing an appeal late, but some examples include the following:
• The coverage notice you are appealing was mailed to the wrong address;
• A Medicare representative gave you incorrect information about the claim you are appealing;
• You or a close family member you were caring for was ill, and you could not handle business matters;
• The person you are helping appeal a claim is illiterate, does not speak English or could not otherwise read or understand the coverage notice.

If you think you have a good reason for not appealing on time, send in your appeal with a clear explanation of why it is late.

Medicare Appeals — The Importance of Getting it to the Right Place at the Right Time!
(Courtesy CIGNA Government Services, Medicare DME MAC C, Part B ID & NC)

Over the past year, the Qualified Independent Contractor (QIC) Part B North (the processor of second — level appeals or reconsiderations) has consistently made a high rate of dismissal decisions. Based on data analysis, the driving factor in this high rate is that appellants, primarily providers, request reconsideration when a redetermination (first level appeal performed by CIGNA Government Services following the processing of the original claim) has not been completed.

While often the cause appears to be simply confusion over the steps of the appeals process and the parties involved, we have also noted that some providers are confusing written and telephone inquiry responses from CIGNA Government Services with official redetermination decisions. In accordance with current instructions, contractors are required to issue a written notice of redetermination. If you disagree with this decision, you may then file a reconsideration request in writing with the QIC.

Please remember......

Your first level appeal, a redetermination, is performed by the contractor who processed the original claim and those requests should be sent directly to CIGNA Government Services. Sending a first level appeal request to the QIC will result in a dismissal.

• You have 120 days from the date of receipt of the Remittance Advice to request a redetermination. You do not get extra days if you send it to the wrong entity (i.e. if you send it to the QIC and subsequently receive a dismissal for no redetermination, the 120 day clock is still ticking against the original claim process date).
• The Medicare Redetermination Notice (MRN) should specifically reference the date of the original decision, state a clear decision of favorable, partially favorable, unfavorable or dismissed, and advise of any further appeal rights with the QIC's address. Please review the entire MRN carefully.
• Your request for a second level appeal, a reconsideration, should be sent directly to the QIC at the address in the MRN, within 180 days of receipt of the notice. It is helpful if you include a copy of the redetermination decision.

Lastly, please be sure your request details specifically all the claims you are requesting an appeal on, including the beneficiary's name, the Medicare Health Insurance claim number, the dates of service at issue, the services at issue, your reason for appealing, the name and signature of the party or representative of the party, and the name of the contractor that made the redetermination.

WRITE A LETTER OF MEDICAL NECESSITY FOR YOUR DOCTOR TO SIGN

1. The reasoning in your physician's letter might be as follows:
1. Patient has diagnosed medical condition of lymphedema. This is not a symptom requiring symptomatic treatment, but a diagnosed chronic medical condition, ICD-9-CM code 457.0 or 457.1.
2. If not treated medically, the condition is permanent and progressive, and will degenerate in time. If not treated medically it will also place the patient in significant risk of rapid-onset infection, requiring antibiotic treatment in an emergency setting. And each infection further damages the lymphatic system making subsequent treatment more difficult and expensive.
3. Current medical standard of treatment of lymphedema is complex decongestive therapy, a multimodal treatment comprising ALL of the following modalities: a. MLD; b. Compression therapy; c. exercise; and d. skin care.
4. Compression therapy requires either wearing of bandage systems day and night or wearing bandages or non-elastic compression devices at night with a compression garment during the day.
5. The effectiveness of the therapy is a direct function of patient compliance, and if the patient is not helped to be compliant, treatment will fail.
6. Since compression garments are worn daily against the skin, they must be laundered every night, thereby necessitating the use of two garments simultaneously. Medical necessity governs the number of garments required, and anything short of 4 garments per year will probably not meet the treatment requirements for lymphedema according to current medical treatment standards.
7. The expected lifetime of the garments according to the manufacturer is 4-6 months. Daily use of these garments causes loss of elastic properties, and when the garment no longer provides the medically required compression (typically 30-50mmHg) they no longer serve their medical function and must be replaced. At this time the patient is re-measured and re-fitted to assure that the new garment is properly sized to account for the expected reduction in arm size.
8. Compression garments are not comfort or convenience items that are worn in the absence of a medically diagnosed condition. Rather, they are an essential and integral part of the standard of care for lymphedema, i.e. complex decongestive therapy.
9. The patient has already had manual lymph drainage by a qualified lymphedema therapist which has brought the diameter of her affected limb down from xxxx cm to yyyy cm. It is medically required for her to be measured and fitted for a compression garment of zzzz mmHg compression in order to maintain the gains achieved by physical therapy.

HELP AVAILABLE IN YOUR APPEAL

I help patients appeal denial of compression bandages, garments and devices. It is a lengthy process, taking 1-4 years, with not at all an assured outcome, but it is worth the trouble since I am using the successful cases to convince CMS to change their interpretation of the Social Security Act and to cover lymphedema treatment materials. Every claim filed adds to CMS's realization that there is a real problem that needs addressing, and every case won adds to the credibility of the prosthetic device interpretation of the federal statutes.

I do not charge any fees for the work I do. I expect that the patient therapist or provider to appeal the first denial, and when that appeal is upheld (and it will be) then I will help writing the Redetermination Request. For Medicare cases, when that is denied, I will ask to be designated the Authorized Representative and I will write and submit the Reconsideration Request for an "independent determination" by a Medicare Qualified Independent Contractor. I will at that time generate an evidence package for use at a Medicare Administrative Law Judge hearing. This is the first level of appeal at which we have a chance of winning the appeal and being reimbursed.

Contact me when you are denied reimbursement.

Robert Weiss, M.S.
Lymphedema Treatment Advocate
Email: LymphActivist@aol.com

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The above is solely the opinion of a lay patient advocate, and is not to be interpreted as legal or medical advice. Please consult a properly qualified professional before taking legal or medical action in your specific case.

Compiled February 26, 2008.
Revised December 3, 2009.
Revised April 14, 2010.

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© 2002 Robert Weiss, Porter Ranch, CA