Results of Widespread Prepayment Probe Review of Spinal Orthoses (HCPCS L0631 and L0637)

Review Results

Jurisdiction D DME MAC Medical Review Department completed a widespread prepayment probe review of HCPCS codes L0631 and L0637. This review was initiated based on reason for review by CERT analysis.

The L0631 review involved 101 claims of which 96 were denied. This resulted in an overall error rate of 96%.

The L0637 review involved 100 claims of which 80 were denied. This resulted in an overall error rate of 80%.

Primary documentation errors that resulted in denial of claims

  • 24% of L0631 claims received a denial as Criteria 1 not met.
  • 14% of L0637 claims received a denial as Criteria 1 not met.

The beneficiary’s medical records did not indicate the LSO order as reasonable and medically necessary as described in LCD 11459.

A lumbar-sacral orthosis is covered when it is ordered for one of the following indications:

  1. To reduce pain by restricting mobility of the trunk; or
  2. To facilitate healing following an injury to the spine or related soft tissues; or
  3. To facilitate healing following a surgical procedure on the spine or related soft tissue; or
  4. To otherwise support weak spinal muscles and/or a deformed spine.
  • 23% of L0631 claims received a denial as documentation does not support medical necessity for the item requested.
  • 13% of L0637 claims received a denial as documentation does not support medical necessity for the item requested.

The beneficiary’s medical records did not justify the LSO as medically reasonable and necessary.

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

  • Beneficiary’s medical record submitted does not have sufficient objective documentation to validate beneficiary use of a LSO as reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the function of a malformed body member.
  • According to the supplier manual the provision of an identical or nearly identical item may be replaced when a new physician order and/or new CMN, when required, is needed to reaffirm the medical necessity of the item.  The useful lifetime of a spinal orthosis is no less than 5 years.  Medical record documentation must validate the need for a new or replaced spinal orthosis.
  • 14% of L0637 claims received a denial as no proof of delivery submitted.
  • 7% of L0631 claims received a denial as invalid proof of delivery.

L0637 – No proof of delivery submitted.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. For medical review purposes, POD serves to assist in determining correct coding and billing information for claims submitted for Medicare reimbursement. Regardless of the method of delivery, the contractor must be able to determine from delivery documentation that the supplier properly coded the item(s) submitted for Medicare reimbursement and that the item(s) are intended for, and received by, a specific Medicare beneficiary.

L0631 – Requirements for proof of delivery.

Delivery Directly to Beneficiary
POD record must include:

  • Beneficiary’s name
  • Delivery address
  • Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)
  • Quantity delivered
  • Date delivered
  • Beneficiary (or designee) signature and date of signature.

The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiary or designee. In instances where the supplies are delivered directly by the supplier, the date the beneficiary received the DMEPOS supply must be the date of service on the claim.

If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim.

  • 12% of L0631 claims received a denial as no documentation received.

A large number of suppliers failed to respond to our request for records. 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 NSC.

  • 12% of L0637 claims received a denial as billing requirements not met.

Billing Requirements

Part A Covered SNF or Hospital Stay

  • Payment for spinal orthosis is included in payment to hospital or SNF if:
    1. The orthosis is provided to a patient prior to an inpatient hospital admission or Part A covered SNF stay; and
    2.  Medical necessity for the orthosis begins during the hospital or SNF stay (e.g., after spinal surgery).
  • Or:
    1. Orthosis is provided to a patient during an inpatient hospital or Part A covered SNF stay prior to the day of discharge; and
    2. Patient uses the item for medically necessary inpatient treatment or rehabilitation.

DME MAC submitted claim

  • Payment for spinal orthosis delivered to patient in hospital or Part A covered SNF stay is eligible for coverage by DME MAC if:
    1. The orthosis is medically necessary for a patient after discharge from a hospital or Part A covered SNF stay; and
    2. The orthosis is provided to the patient within two days prior to discharge home; and
    3. The orthosis is not needed for inpatient treatment or rehabilitation, but is left in the room for the patient to take home.

Going Forward

Based on high error rate, Noridian Administration Services will close this probe review and begin a widespread targeted review on HCPCS codes L0631 and L0637.

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