Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, conducted post-payment review of claims for Medicare Part B Durable Medical Equipment (DME) billed on dates of service from January 1, 2019 through June 30, 2019. Claims with excess units of diabetic test strips (DTS) paid over and above the expected Medicare policy limits were reviewed. Below are the review results:

Background

Over the years, the Office of Inspector General (OIG) has found that an area vulnerable to fraud, waste, and abuse is the ordering and dispensing of DTS. The report OEI-01-11-00330 dated August 2013, titled “Inappropriate and Questionable Medicare Billing for Diabetes Test Strips” supports these findings.

The prior SMRC, in 2015 and 2016, performed a DTS medical review project and the findings supported additional review and education on the DTS Medicare benefit.

A diabetic beneficiary uses a glucose meter to test the level of glucose in their blood. The meter uses the DTS to perform these readings. Medicare covers up to 100 DTS every three months for a non-insulin-dependent beneficiary. Medicare covers up to 100 DTS per month or up to 300 DTS every three months for the insulin-dependent beneficiary. Any Medicare coverage for the DTS over specified limits needs to meet coverage criteria for medically necessary and needs the required supporting documentation found in the physician/practitioner’s records. The supplier is responsible to obtain from the physician/practitioner the supporting documentation from the beneficiary’s medical record to ensure coverage criteria has been met. If the supplier is unable to the medical records/supporting documentation upon request, this causes a hardship on the supplier as this creates an inability to collect the proper Medicare reimbursement.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and conduct medical review. Noridian  completed medical record review on claims in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

• Insufficient Documentation
  • The CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.9 states, “For any DMEPOS item to be covered by Medicare, the patient’s medical record must contain sufficient documentation of the patient’s medical condition to substantiate the necessity for the type and quantity of items ordered and for the frequency of use or replacement (if applicable).” In addition, CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.10 provides guidance that the supplier must obtain as much documentation, as needed, to support coverage criteria of the item(s) billed. The submitted documentation did not include medical records, from the prescribing physician, to support coverage criteria.
• Refill Requirements
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.8 requires suppliers to contact the beneficiary, prior to dispensing a refill, to ensure the requested items remain reasonable and necessary, confirm any changes to the order and assess need for a replacement. The submitted documentation did not include a valid refill request.

References/Resources

• Social Security Act (SSA), Title XVIII, §1833(e). Payment of Benefits
• SSA, Title XVIII, §1862(a)(1)(A). Exclusions from Coverage and Medicare as Secondary Payer
• SSA, Title XVIII, §1879(a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
• 42 Code of Federal Regulations (C.F.R.) 410.38(1). Durable Medical Equipment: Scope and Conditions
• 42 C.F.R. 424.5(a)(6). Basic Conditions
• 42 C.F.R. 424.57(c)(12). Special Payment Rules for Items Furnished By DMEPOS Suppliers and Issuance of DMEPOS Supplier Billing Privileges
• CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 110. Durable Medical Equipment – General
• CMS IOM, Publication 100-02, Medicare Claims Processing Manual, Chapter 20, Section 10.2. Coverage Table for DME Claims
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8. No Response or Insufficient Response to Additional Documentation Requests
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.4. Signature Requirements
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 4, Section 4.26. Supplier Proof of Delivery Documentation Requirements
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 4, Section 4.26.1. Proof of Delivery and Delivery Methods
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.1. Physician Orders
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.2. Verbal and Preliminary Written Orders
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.3. Detailed Written Orders
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.7. Requirement of New Orders
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.8.Refills of DMEPOS Items Provided on a Recurring Basis
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.7. Documentation in the Patient’s Medical Record
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.8. Supplier Documentation
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.9. Evidence of Medical Necessity
• Local Coverage Determination (LCD) L33822. Glucose Monitors. Effective October 1, 2015-present
• Local Coverage Article A52464. Glucose Monitor. Effective October 1-2015-present
• Local Coverage Article A55426. Standard Documentation Requirements for All Claims Submitted to DME MACS. Effective January 1, 2017-present

Last Updated Apr 5, 2021