Top Non-Affirmation Reasons for Orthotics - JA DME

The Jurisdiction A, DME MAC, Medical Review Department conducts Prior Authorization (PA) reviews for select durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items per the CMS. The quarterly non-affirmation results from January 2025 - March 2025 pertaining to medical necessity and replacement criteria are as follows:

Top Reasons for Orthoses Non-Affirmation:

• Medical record documentation does not support the beneficiary has had a recent injury or a surgical procedure on the knee(s). Refer to Local Coverage Determination L33318 and Policy Article A52465.
  • This accounts for 16% of the non-affirmations.
• Medical record documentation does not demonstrate an objective description of joint laxity. Refer to Local Coverage Determination L33318 and Policy Article A52465.
  • This accounts for 14% of the non-affirmations.
• Documentation does not include verification that the equipment was lost, stolen, or irreparably damaged in a specific incident. Refer to Medicare Claims Processing Manual 100-04, Chapter 20, Section 50 & Standard Documentation Requirements A55426.
  • This accounts for 9% of the non-affirmations.
• Medical record documentation does not demonstrate a change in the patient's medical condition necessitating a different item. Refer to Medicare Claims Processing Manual 100-04, Chapter 20, Section 50 & applicable Local Coverage Determination/Policy Article.
  • This accounts for 8% of the non-affirmations.

Educational Resources

Suppliers billing Medicare should be familiar with the documentation requirements and utilization parameters. Visit the Orthotics webpage to access coverage documents (Local Coverage Determination (LCD), Policy Article, National Coverage Determination (NCD)); documentation letters, forms, and checklists; reviews; tips; tools; resources; related articles; and educational events and tutorials, if applicable.

Suppliers can view resources related to applicable HCPCS codes, submitting PA requests, documentation requirements, educational resources and CMS Resources via the Required Prior Authorization Programs webpage.

Noridian provides education via supplier workshops, training opportunities, and presentations. See the CMS Internet Only Manual (IOM), Publication 100-08, Medicare Program Integrity Manual, Chapter 3 information about probe/error validation reviews.

LCD and Policy Education

COVERAGE CRITERIA

A knee immobilizer without joints (L1830), or a knee orthosis with adjustable knee joints (L1832, L1833), or a knee orthosis, with an adjustable flexion and extension joint that provides both medial-lateral and rotation control (L1843, L1845, L1851, L1852), are covered if the beneficiary has had recent injury to or a surgical procedure on the knee(s). Refer to the diagnoses listed in the Groups 2 or 4 ICD-10 Codes in the LCD-related Policy Article.

Medicare does not cover an orthotic device dispensed to a beneficiary prior to the time at which the beneficiary undergoes the procedure that makes necessary the use of the device. Moreover, the need for the device cannot be clearly established until the procedure that makes its use possible is successfully performed.

For codes L1832, L1833, L1843, L1845, L1850, L1851 and L1852, knee instability must be documented by examination of the beneficiary and objective description of joint laxity (e.g., varus/valgus instability, anterior/posterior Drawer test).

Claims for L1832, L1833, L1843, L1845, L1850, L1851 or L1852 will be denied as not reasonable and necessary when the beneficiary does not meet the above criteria for coverage. For example, they will be denied if only pain or a subjective description of joint instability is documented.

REPLACEMENT

The definition of replacement is found in the CMS Benefit Policy Manual (Internet-only manual 100-02), Chapter 15, Section 110.2.C. That section generally defines replacement as the provision of an entire identical or nearly identical item when it is lost, stolen or irreparably damaged.

Beneficiary owned items or a capped rental item may be replaced in cases of loss or irreparable damage. Irreparable damage may be due to a specific accident or to a natural disaster (e.g., fire, flood). Contractors may request documentation confirming details of the incident (e.g., police report, insurance claim report).

Replacement of items due to irreparable wear takes into consideration the Reasonable Useful Lifetime (RUL) of the item. The RUL of DME is determined through program instructions. In the absence of program instructions, carriers may determine the RUL, but in no cases can it be less than 5 years. If the item has been in continuous use by the beneficiary on either rental or purchase basis for its RUL, the beneficiary may elect to obtain a replacement.

Replacement of equipment which the beneficiary owns or is purchasing or is a capped rental item is covered in cases of loss, or irreparable damage or wear, and when required because of a change in the patient's condition subject to the following provisions. Expenses for replacement required because of loss or irreparable damage may be reimbursed without a physician's order when, in the DME MAC’s judgment, the equipment as originally ordered, considering the age of the order, still fills the patient's medical needs. However, claims involving replacement equipment necessitated because of wear or a change in the patient's condition must be supported by a current physician's order.