01-021 Diabetic Test Strips (DTS) and No Response Providers – Notification of Medical Review

Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review of Part B Durable Medical Equipment (DME) claims billed on dates of service from January 1, 2019 through June 30, 2019. Claims with excess units for DTS paid over and above the expected Medicare policy limits will be selected for review.

It is the supplier’s responsibility to obtain from the ordering practitioner, as much documentation from the patient’s medical record as necessary, to be sure that coverage criteria for an item is met. If the practitioner does not send the requested documentation to the supplier, the supplier may not receive payment from Medicare for provided items.

Failure to supply medical records upon request may be indicative of a Medicare vulnerability. If a practitioner doesn’t respond to a supplier’s request for documentation to support the DTS billed, CMS is concerned that the practitioner may also have other services that are not supported by documentation. Therefore,we are now auditing those practioners’ claims for evaluation and management services.

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.

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 will complete medical record review on claims in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

HCPCS
A4253: Blood Glucose Test or Reagent Strips for Home Blood Glucose Monitor, per 50 strips/1 unit

A4259: Lancets, per box of 100/1 unit

Access related project details below.

Documentation Requirements

Below is a list of specific documentation requirements that will be included in each ADR to obtain the necessary documentation to perform the review. Documentation requested has been made specific to assist the provider in collecting and submitting pertinent information to decrease provider burden.

  1. Written verbal/dispensing order
  2. Detailed written order
  3. All pertinent medical record documentation for diabetic test strips and lancets, including, but not limited to:
    1. Diagnosis
    2. Treatment regimen
  4. Documentation to support coverage for quantities of diabetic test strips and lancets that exceed the usual utilization*, including, but not limited to:
    1. Provider notes
    2. Testing logs or other documentation that supports frequency of blood glucose testing to support utilization greater than policy limits
  5. Refill request for diabetic test strips and lancets provided on a recurring basis to validate the quantity of diabetic test strips on hand have been nearly exhausted
  6. Advanced Beneficiary Notice (if applicable)
  7. Any and all other documentation to support the item(s) billed

*  Usual utilization, as defined in the Local Coverage Determination, means up to 100 DTS and 100 lancets every three months for a non-insulin-dependent beneficiary and up to 300 DTS and 300 lancets every three months for an insulin-dependent beneficiary.

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 Nov 18, 2019