Medical Policy

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Lymphedema Treatment Act

Medicare pays for lymphedema compression treatment items. The items and services included in this benefit category are defined in section 1861(s)(2)(JJ) of the Social Security Act (the Act), and further defined in Medicare regulations at 42 Code of Federal Regulations (CFR) 410.36(a)(4).

The benefit includes medically necessary treatment items for each affected body part, including:

• Standard and custom fitted, gradient compression garments, including those for daytime and nighttime, which offer different levels of compression
• Compression bandaging systems and supplies provided during the initial decongestion phase and maintenance phases of treatment
• Gradient compression wraps with adjustable straps
• Necessary accessories for gradient compression garments and wraps, including:
  • Aids for putting on and taking off (donning and doffing) items for different body parts, like lower limb butlers or foot slippers that help patients put on compression stockings
  • Fillers
  • Lining
  • Padding
  • Zippers

Medicare pays for both standard and custom fitted gradient compression garments. Custom fitted compression garments are garments that are uniquely sized and shaped to fit the exact dimensions of the affected extremity or part of the body of an individual, to provide accurate gradient compression to treat lymphedema. This is defined in section 145 of chapter 15 of the Medicare Benefit Policy Manual (CMS Pub. 100-2).

Certain laws, regulations, and Medicare program manuals are often mentioned on this page, and you can locate them by going to the “Related Links” section.

Question:

Are there any limits to how many lymphedema compression treatment garments an individual with Medicare can get?

Answer:

Medicare pays for compression garments as follows:

• Daytime: 3 garments per affected body part every 6 months
• Nighttime: 2 garments per affected body part every 2 years

Diabetic Shoe LCD

Therapeutic Shoes and inserts are covered under the Therapeutic Shoes for Individuals with Diabetes benefit (Social Security Act §1861(s)(12)). In order for a beneficiary’s equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

For an item addressed in this policy to be covered by Medicare, a Standard Written Order (SWO) must be communicated to the supplier prior to claim submission. If the supplier bills for an item without first receiving the SWO, the item will be denied as statutorily noncovered.

The Certifying Physician is defined as a doctor of medicine (M.D.) or a doctor of osteopathy (D.O.) who is responsible for diagnosing and treating the beneficiary’s diabetic systemic condition through a comprehensive plan of care. The certifying physician may not be a podiatrist or clinical nurse specialist. Consequent to the M.D. or D.O. restriction, a nurse practitioner (NP) and a physician assistant (PA) may not serve in the role of the certifying physician, unless practicing “incident to” the supervising physician’s authority, as described below.

NPs or PAs providing ancillary services as auxiliary personnel could meet the “incident to” requirements in their provision of therapeutic shoes to beneficiaries with diabetes if all of the following criteria are met:

1. The supervising physician has documented in the medical record that the patient is diabetic and has been, and continues to provide, the patient follow-up under a comprehensive management program of that condition; and,
2. The NP or PA certifies that the provision of the therapeutic shoes is part of the comprehensive treatment plan being provided to the patient; and,
3. The supervising physician must review and verify (sign and date) all of the NP or PA notes in the medical record pertaining to the provision of the therapeutic shoes, acknowledging their agreement with the actions of the NP or PA.

In states where the NP may practice independently, the NP’s employment situation would require compliance with Medicare “incident to” rules in order to serve as the certifying physician. Please refer to the applicable A/B MAC for further information.

The Prescribing Practitioner is the person who actually writes the order for the therapeutic shoe, modifications and inserts. This practitioner must be knowledgeable in the fitting of diabetic shoes and inserts. The prescribing practitioner may be a podiatrist, M.D., D.O., physician assistant, nurse practitioner, or clinical nurse specialist. The prescribing practitioner may be the supplier (i.e., the one who furnishes the footwear).

The Supplier is the person or entity that actually furnishes the shoe, modification, and/or insert to the beneficiary and that bills Medicare. The supplier may be a podiatrist, pedorthist, orthotist, prosthetist or other qualified individual. The Prescribing Practitioner may be the supplier. The Certifying Physician may only be the supplier if the certifying physician is practicing in a defined rural area or a defined health professional shortage area.

Therapeutic shoes, inserts and/or modifications to therapeutic shoes are covered if all of the following criteria are met:

1. The beneficiary has diabetes mellitus (Reference diagnosis code section below); and
2. The certifying physician has documented in the beneficiary's medical record one or more of the following conditions: 
   1. Previous amputation of the other foot, or part of either foot, or
   2. History of previous foot ulceration of either foot, or
   3. History of pre-ulcerative calluses of either foot, or
   4. Peripheral neuropathy with evidence of callus formation of either foot, or
   5. Foot deformity of either foot, or
   6. Poor circulation in either foot; and
3. The certifying physician has certified that indications (1) and (2) are met and that he/she is treating the beneficiary under a comprehensive plan of care for his/her diabetes and that the beneficiary needs diabetic shoes. For claims with dates of service on or after 01/01/2011, the certifying physician must:
   • Have an in-person visit with the beneficiary during which diabetes management is addressed within 6 months prior to delivery of the shoes/inserts; and
   • Sign the certification statement (refer to the Policy Specific Documentation Requirements section below) on or after the date of the in-person visit and within 3 months prior to delivery of the shoes/inserts.

1. Prior to selecting the specific items that will be provided, the supplier must conduct and document an in-person evaluation of the beneficiary. (Refer to the Policy Specific Documentation Requirements section below.)
2. At the time of in-person delivery to the beneficiary of the items selected, the supplier must conduct an objective assessment of the fit of the shoe and inserts and document the results. A beneficiary’s subjective statements regarding fit as the sole documentation of the in-person delivery does not meet this criterion.

If criteria 1-5 are not met, the therapeutic shoes, inserts and/or modifications will be denied as noncovered. When codes are billed without a KX modifier (see Policy Specific Documentation Requirements section below), they will be denied as noncovered.

In order to meet criterion 2, the certifying physician must either:

1. Personally document one or more of criteria a – f in the medical record of an in-person visit within 6 months prior to delivery of the shoes/inserts and prior to or on the same day as signing the certification statement; or
2. Obtain, initial, date (prior to signing the certification statement), and indicate agreement with information from the medical records of an in-person visit with a podiatrist, other M.D or D.O., physician assistant, nurse practitioner, or clinical nurse specialist that is within 6 months prior to delivery of the shoes/inserts, and that documents one of more of criteria a – f.

The requirement that the in-person visit(s) be within 6 months prior to delivery of the shoes/inserts is effective for claims with dates of service on or after 1/1/2011.

Note: The certification statement is not sufficient to meet the requirement for documentation in the medical record.

Depending on the items ordered, both the evaluation and delivery could occur on the same day if the supplier had both a sufficient array of sizes and types of shoes/inserts and adequate equipment on site to provide the items that meet the beneficiary’s needs. Both components of the visit (criteria 4 and 5 above) must be clearly documented.

For claims with dates of service on or after 1/1/2011, there must be an in-person visit with the prescribing practitioner within 6 months prior to delivery of the shoes/inserts.

For beneficiaries meeting the coverage criteria, coverage is limited to one of the following within one calendar year (January – December):

• One pair of custom molded shoes (A5501) (which includes inserts provided with these shoes) and 2 additional pairs of inserts (A5512, A5513, or A5514); or
• One pair of depth shoes (A5500) and 3 pairs of inserts (A5512, A5513, or A5514) (not including the non-customized removable inserts provided with such shoes).