Therapeutic Shoes Quarterly Results of Targeted Probe and Educate Review

The Jurisdiction A, DME MAC, Medical Review Department is conducting a Targeted Probe and Educate (TPE) review of HCPCS code(s) A5500. The quarterly edit effectiveness results from January 2019 - March 2019 are as follows:

Based on dollars, the overall claim potential improper payment rate is 54%.

Top Denial Reasons

Educational Resources

It is important for suppliers to be familiar with the documentation requirements and utilization parameters as outlined in the Therapeutic Shoes Local Coverage Determination (LCD) L33369, Policy Article A52501 [PDF] and Standard Documentation Requirements Article A55426.

Suppliers can also review specific policy resources for Therapeutic Shoes to find information related to proper documentation requirements including a physician letter, documentation checklists, and FAQs.

Suppliers can also review a specific policy Documentation Checklist for Therapeutic Shoes on the Noridian website.

Noridian provides education via supplier workshops, training opportunities, and presentations.

Information about probe/error validation reviews may be found in CMS Internet Only Manual (IOM), Publication 100-08, Medicare Program Integrity Manual, Chapter 3.

Policy Education

Documentation does not support coverage criteria.

COVERAGE CRITERIA

The supplier must obtain a signed statement from the physician who is managing the beneficiary's systemic diabetes condition (i.e., the certifying physician) specifying that the beneficiary has diabetes mellitus, has one of conditions 2a-2f listed in the related Policy Article, is being treated under a comprehensive plan of care for his/her diabetes, and needs diabetic shoes. The certifying physician must be an M.D. or D.O and may not be a podiatrist, physician assistant, nurse practitioner, or clinical nurse specialist. The "Statement of Certifying Physician for Therapeutic Shoes" form is recommended. Whatever form is used must contain all of the elements contained on the recommended form attached to this LCD. This statement must be completed, signed, and dated by the certifying physician. A new Certification Statement is required for a shoe, insert or modification provided more than one year from the most recent Certification Statement on file.

For claims with dates of service on or after 01/01/2011, the certifying physician must sign
the certification statement (refer to the Documentation Requirements section of the related Local Coverage Determination) on or after the date of the in-person visit and within 3 months prior to delivery of the shoes/inserts.

There must be information in the medical records of the certifying physician that:

  1. Documents management of the beneficiary's diabetes; and
  2. Documents detailed information about the condition (2a-2f listed in the related Policy Article) that qualifies the beneficiary for coverage.

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: o Have an in-person visit with the beneficiary during which diabetes management is addressed within six months prior to delivery of the shoes/inserts; and
  4. Sign the certification statement (refer to the Documentation Requirements section of the related Local Coverage Determination) on or after the date of the in-person visit and within three months prior to delivery of the shoes/inserts.

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

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 six months prior to delivery of the shoes/inserts is effective for claims with dates of service on or after 1/1/2011.

Prior to selecting the specific items that will be provided, the supplier must conduct and document an in-person evaluation of the beneficiary.

The in-person evaluation of the beneficiary by the supplier at the time of selecting the items that will be provided must include at least the following:

  1. An examination of the beneficiary's feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications.
  2. For all shoes, taking measurements of the beneficiary's feet.
  3. For custom molded shoes (A5501) and inserts (A5513), taking impressions, making casts, or obtaining CAD-CAM images of the beneficiary's feet that will be used in creating positive models of the feet.

The in-person evaluation of the beneficiary by the supplier at the time of delivery must be conducted with the beneficiary wearing the shoes and inserts and must document that the shoes/inserts/modifications fit properly.

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.

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

Documentation was not received in response to the Additional Documentation Request (ADR) letter.

DOCUMENTATION REQUIREMENTS

Suppliers are in violation of Supplier Standard #28 when, upon request, they fail to provide requested documentation to a Medicare contractor. Medicare regulations (42 C.F.R 424.516[f]) stipulate that a supplier is required to maintain documentation for seven years from the date of service and, upon the request of CMS or a Medicare contractor, provide access to that documentation. Therefore, the consequences of failure to provide records may not only be a claim denial but also referral to the National Supplier Clearinghouse (NSC). The supplier standards can be found in 424 CFR Section 424.57(c).

Please remember, the documentation must be submitted within 45 days from the date on the ADR letter. Failure to provide the requested documentation within 45 days may result in a partial or complete denial of the claim. Submission information can be found on the ADR webpage of Noridian's website.

 

Last Updated Jul 18, 2019