01-109 Lumbar-Sacral Orthoses Notification of Medical Review
Noridian Healthcare Solutions, LLC, (Noridian) as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid Services (CMS), is conducting post-payment review of claims for select Medicare Durable Medical Equipment (DME) lumbar-sacral orthoses (LSO) billed with dates of service from January 1, 2021, through December 31, 2022. This notification includes the reasons for the review, documentation that will be requested in the Additional Documentation Request (ADR) letter, and resources providers/suppliers may wish to consult when submitting claims.
A lumbar-sacral orthoses, is a back brace that can either be off-the shelf (OTS), custom fitted, or custom-fabricated. OTS LSO braces are prefabricated braces that may or may not require minimal self-adjustment for fitting at the time of delivery. Custom fitted LSO braces are prefabricated braces that requires more than minimal self-adjustment for fitting at the time of delivery requiring a qualified practitioner or an individual with specialized training to make those adjustments.
The 2022 Comprehensive Error Rate Testing (CERT) report identified an improper payment rate of 51.7% for LSO, with a projected improper payment of $78,264,550; in 2021, the improper payment rate was 44.2%, with a projected improper payment of $76,454,328; and in 2020 the improper payment rate was 35.8% with a projected improper payment of $177,244,008.
The Office of Public Affairs in the Department of Justice (DOJ) issued a news release dated May 16, 2022, stating four orthotic brace suppliers in Dallas, Texas were convicted in a $6.5 million kickback scheme. Approximately $12.5 million was billed to Medicare for unnecessary braces. In addition, on April 9, 2019, the OIG alerted the public concerning a fraud scheme targeting Medicare recipients to get free or no-cost back and knee braces. Also, on October 25, 2019, the Federal Trade Commission (FTC) issued a consumer alert on scammers targeting Medicare recipients for free or low-cost back and knee braces.
On March 9, 2023, CNBC published an article “Inside the minds of criminals: How to brazenly steal $100 billion from Medicare and Medicaid” discussed how easy Medicare and Medicaid are being targeted by criminals to conduct fraud schemes. Also, it was identified these fraud schemes are costing taxpayers more than $100 billion a year.
In January 2023, Noridian completed research on Healthcare Common Procedure Coding System (HCPCS) code L0631 (Lumbar-sacral orthosis (LSO), sagittal control, with rigid anterior and posterior panels, posterior extends from sacrococcygeal junction to t-9 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise.) The SMRC identified utilization for L0631 peaked at nearly $2.5 million in quarter two of 2021 and showed an increase from $1.5 million to nearly $2 million by the end of the second quarter of 2022.
Reason for Review
The SMRC is tasked to perform data analysis and conduct medical record reviews on claims billed with HCPCS code L0631 billed with DOS January 1, 2021, through December 31, 2022.
The SMRC will conduct medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.
Claim Sample Detail
|L0631||Lumbar-sacral orthosis, sagittal control, with rigid anterior and posterior panels, posterior extends from sacrococcygeal junction to t-9 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise|
Access related project details below.
Below is a list of specific documentation requirements that will be included in each ADR to obtain the necessary documentation to perform the review.
Providers/suppliers are requested to submit each of the Documentation Requirements outlined below, if and as applicable to the claim on review.
- Standard Written Order (SWO)
- Documentation to support Local Coverage Determination (LCD) and Local Coverage Articles (LCAs)
- Medical record documentation to support the lumbar-sacral orthosis brace was ordered for one of the following indications:
- To reduce pain by restricting mobility of the trunk; or
- To facilitate healing following an injury to the spine or related soft tissues; or
- To facilitate healing following a surgical procedure on the spine or related soft tissue; or
- To otherwise support weak spinal muscles and/or a deformed spine
- Documentation that supports a certified orthotist or specialized trained individual performed custom fitting of the item and describes the custom fitting that was performed to fit the item to the individual beneficiary
- Documentation that provides sufficient information to verify the item provided was a product that has received coding verification review from the PDAC and is listed in the Product Classification List on the PDAC web site
- Medical record documentation to support continued need
- Proof of Delivery
- If the beneficiary has same or similar equipment, documentation indicating the reason new equipment is necessary
- Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services)
- Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
- Any other supporting/pertinent documentation
- If medical record documentation is submitted via esMD: Beneficiary identification, date of service, and provider of the service should be clearly identified on each page of the submitted documentation
- PLEASE NOTE: It is the responsibility of the supplier or provider to obtain all documentation from the ordering/referring provider to ensure medical necessity criteria have been met
Social Security Act (SSA), Title XI
- § 1135 Authority to Waive Requirements During National Emergencies
Social Security Act (SSA), Title XVIII
- § 1815(a) Payment to Providers of Services
- § 1833(e) Payment of Benefits
- § 1834(a) Payment for Durable Medical Equipment
- § 1862(a)(1)(A) Exclusion from Coverage and Medicare as a Secondary Payer
- § 1877(g) Blanket Waivers of Section 1877(G) of the Social Security Act Due to Declaration of COVID-19 Outbreak in the United States as a National Emergency
- § 1879(a)(1) Limitation on Liability of Beneficiary where Medicare Claims are Disallowed
42 Code of Federal Regulations (CFR)
- § 410.38 Durable medical equipment, prosthetics, orthotics and supplies (DMEPOS): Scope and conditions
- § 411.15(k)(1) Particular Services Excluded from Coverage
- § 414.200 Payment for Durable Medical Equipment and Prosthetic and Orthotic Devices
- § 414.240 Procedures for making benefit category determinations and payment determinations for new durable medical equipment, prosthetic devices, orthotics and prosthetics, surgical dressings, and therapeutic shoes and inserts
- §§ 424.5 and 424.5(a)(6) Basic Conditions, Sufficient Information
- § 424.57(c)(12) Special Payment Rules for Items Furnished by DMEPOS Suppliers and Issuance of DMEPOS Supplier Billing Privileges
- § 424.516(f) Additional provider and supplier requirements for enrolling and maintaining active enrollment status in the Medicare program
- Interim Final Rule with Comments (IFC), Volume (Vol.) 85, Number (No.) 66, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency. Effective March 1, 2020. Retrieved from 2020-06990.pdf (govinfo.gov)
- Interim Final Rule with Comments (IFC), Vol. 85, No. 214, Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program. CMS-1730-F, CMS-1744-IFC, and CMS-5531-IFC. Effective March 1, 2020. 2020-24146.htm (govinfo.gov)
IOM, Medicare Benefit Policy Manual (MBPM), Pub. 100-02
- Chapter (Ch.) 15, §§ 110 and 130, Durable Medical Equipment, and Leg, Arm, Back, and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes
- Ch. 16, § 20 Services not reasonable and necessary
IOM, Medicare Claims Processing Manual (MCPM), Pub.100-04
- Ch. 1 General Billing Requirements
- Ch. 20 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)
- Ch. 23, § 20.9 National Correct Coding Initiative (NCCI)
- Ch. 30, § 50 Advanced Beneficiary Notice (ABN) of Noncoverage
IOM, Medicare Program Integrity Manual (MPIM), Pub. 100-08
- Ch. 3 Verifying Potential Errors and Taking Corrective Actions
- Ch. 4, § 126.96.36.199 Supplier Proof of Delivery Documentation Requirements
- Ch. 5 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items and Services Having Special DME Review Considerations
- Ch. 13, § 13.5.4 Reasonable and Necessary Provisions in LCDs
Local Coverage Determination (LCD)
- L33790 Spinal Orthoses TLSO and LSO. Effective October 1, 2015
Local Coverage Article (LCA)
- A52500 Spinal Orthoses TLSO and LSO – Policy Article. Effective October 1, 2015
- A55426 Standard Documentation Requirements for All Claims Submitted to DME MACs. Effective January 1, 2017
Last Updated Oct 6, 2023