Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare & Medicaid Services (CMS), has conducted post-payment review of claims for Medicare Part B cryosurgery of the prostate billed on dates of service from January 1, 2020, through December 31, 2021. Below are the review results:

Background

Cryosurgery of the prostate gland, also known as cryosurgical ablation of the prostate (CAP), destroys prostate tissue by applying extremely cold temperature to reduce the size of the prostate. CAP is the primary treatment for localized prostate cancer, stages T1-T3.

Salvage therapy may be used when the patient has recurrent, localized prostate cancer, in addition to failing a trial of radiation therapy as their primary treatment, stage T2B or below, Gleason score less than 9, or Prostate Specific Antigen (PSA) less than 8 ng/ml.

For cryosurgery claims that meet medical necessity and are found to be payable, we note that, the ultrasonic guidance associated with this procedure will not be paid separately. Ultrasonic guidance associated with CAP is bundled into the payment for the surgical procedure.

The SMRC performed medical record review on select claims with Current Procedural Terminology (CPT) code 55873 (Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)) with diagnosis code C61, malignant neoplasm of the prostate.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and conduct medical record review of cryosurgery of the prostate claims. The SMRC performed medical record review on supporting documentation to determine if the cryosurgery of the prostate was reasonable and necessary.

The SMRC conducted medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

• Requested Records Not Received
  • Refer to Internet-only Manual Pub 100-08, Chapter 3, Section 3.2.3.8, 42 CFR 424.5(a)(6), Social Security Act 1862(a)(1)(A), Social Security Act 1833(e). The PIM 100-08, Chapter 3, Section 3.2.3.8 requires providers/suppliers to respond to requests for documentation within 45 calendar days of the additional documentation request for the dates of service under review. The documentation was not submitted or not submitted timely.
• Medical Necessity:
  • Refer to Social Security Act 1862, Internet Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2. “No payment may be made under Part A or Part B for any expenses incurred for items or services which, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” Documentation submitted did not support reasonable and necessary criteria was met.  The documentation supported that cryosurgery was performed as the primary treatment for prostate cancer. For salvage therapy, the documentation did not support a failed trail of radiation therapy.
• Incomplete and/or Insufficient Documentation:
  • Refer to 42 CFR 424.5(a)(6), Social Security Act 1862(a)(1)(A), Social Security Act 1833(e). Insufficient documentation to support the stage of the cancer failed radiation treatment prior to salvage cryosurgery of prostate therapy. Also, if the Cryosurgery of the prostate was for primary treatment or salvage therapy. The documentation did not include the stage of the prostate cancer, the course of treatment, any failed prior radiation treatment and if the treatment was primary or salvage therapy.

References/Resources

Title XVIII of the Social Security Act (SSA)

• § 1815(a). Payment to Providers of Service
• § 1833(e). Payment of Benefits
• § 1862(a)(1)(A). Exclusions from Coverage and Medicare as Secondary Payer
• § 1869(f)(1)(B). Determinations; Appeals
• § 1879 (a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
• § 1893(b). Provider Education and Technical Assistance

Title 42 of the Code of Federal Regulations (CFR)

• § 405.929. Post-Payment Review
• § 405.930. Failure to Respond to Additional Documentation Request
• § 411.15(k)(1). Particular Services Excluded from Coverage
• § 424.5(a)(6). Basic Conditions
• § 482.24. Condition of participation: Medical record services

Medicare National Coverage Determinations (NCD) Manual, Publication 100-03

• Ch. 1, § 230.9. Cryosurgery of Prostate

Medicare Benefit Policy Manual (MBPM), Publication 100-02

• Ch. 6, § 20. Outpatient Hospital Services

Medicare Claims Processing Manual (MCPM), Publication 100-04

• Ch. 18, § 50. Prostate Cancer Screening Tests and Procedures
• Ch. 23, § 20.9. National Correct Coding Initiative [NCCI]
• Ch. 30, § 50. Form CMS-R-131 Advance Beneficiary Notice of Noncoverage (ABN)
• Ch. 32, § 180. Cryosurgery of the Prostate Gland

Medicare Program Integrity Manual (MPIM), Publication 100-08

• Ch. 3, § 3.2.3.2. Time Frames for Submission
• Ch. 3 § 3.2.3.8. No Response or Insufficient Response to Additional Documentation Request
• Ch. 3, § 3.3.2.4. Signature Requirements
• Ch. 3, § 3.6.2.2. Reasonable and Necessary Criteria

Last Updated Oct 26, 2023