Noridian Healthcare Solutions, LLC, (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid (CMS), has conducted post-payment review of claims for Medicare Part B billed on dates of service from January 1, 2021, through December 31, 2022. Below are the review results:

Background

Medicare Part B covers carotid artery testing in certain circumstances for select indications. Non-invasive vascular studies done for screening purposes (i.e., without signs or symptoms of disease) are considered not reasonable and necessary, and are therefore non-covered by Medicare.

Inappropriate screening/testing is an ongoing area of focus for the Office of the Inspector General (OIG) and its work. A prior project done by the SMRC identified a claims error rate of 52% for Current Procedural Terminology (CPT) code 93880, “duplex scan of extracranial arteries; complete bilateral study”.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and medical record review activities on carotid artery screening. The SMRC performed medical record review on supporting documentation, to determine if select Part B claims for carotid artery screening were 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

• Non-Response to the ADR
  • The requested records were not received. Refer to 42 CFR 424.5(a)(6), Social Security Act 1862(a)(1)(A), Social Security Act 1833(e). The Medicare Program Integrity Manual (PIM) Pub. 100-08, Chapter 3, Section 3.2.3.8 requires providers 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 from the provider to support the claim as requested by the additional documentation request (ADR).
• Diagnosis Code Billed
  • The documentation does not support the diagnosis code billed. Refer to Internet Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 3. The documentation submitted did not include signs and/or symptoms to support the diagnosis billed for the carotid artery screening. For example, I65.23 “Occlusion and stenosis of bilateral carotid arteries,” is a covered diagnosis code on five billing and coding LCAs utilized, however documentation frequently indicated the providers billed this code without having documentation to validate a history of stenosis, prior to the carotid artery screening.
• Medical Necessity
  • The documentation submitted does not support medical necessity as listed in coverage requirements in the National Coverage Determination or Local Coverage Determination. Refer to Social Security Act 1862, Internet Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2. The documentation submitted did not support a covered diagnosis or did not include signs and/or symptoms to support the diagnosis billed for the carotid artery screening. For example, a claim was billed indicating the beneficiary had a carotid bruit, however the medical record documentation did not support the beneficiary had a bruit noted within the history of present illness or history and physical.

References

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(m) (4) (F) Special Payment Rules for Particular Items and Services
• §1842(p) (4) Provisions Relating to the Administration of Part B
• §1861(ddd) (1) Additional Preventive Services; Preventive Services
• §1861(s) (2) (K) Miscellaneous Provisions (Definitions of Services, Institutions, etc.)
• §1862(a) (1) (A) Exclusion from Coverage and Medicare as a Secondary Payer
• §1879(a) (1) Limitation on Liability of Beneficiary where Medicare Claims are Disallowed
• §1893(f) (7) (A) (B) (i-iv), (h) (4) (B) Medicare Integrity Program

42 Code of Federal Regulations (CFR)

• §410.32 Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions
• §410.33 Independent diagnostic testing facility
• §410.64 Additional Preventative Services
• §411.15(k)(1) Particular services excluded from coverage
• §424.5(a)(6) Basic Conditions

Federal Register

• Final Rule Volume 85, 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) 85 FR 19230. Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC). Effective March 1, 2020. Retrieved from CMS-1744-IFC.
• Interim Final Rule with Comments (IFC), 5531. 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-5531-IFC. Effective March 1, 2020. Retrieved from CMS-55341-IFC

Public Law

• Coronavirus Aid, Relief, and Economic Security Act. Title III- Supporting America’s Health Care System in the Fight Against the Coronavirus. Subtitle D-Finance Committee, §§ 3710. Medicare Hospital Inpatient Prospective Payment System add-on Payment for Covid-19 Patients During Emergency Period. § 3711. Increasing Access to Post-Acute Care During Emergency Period. January 3, 2020. Retrieved from BILLS-116hr748enr.pdf (congress.gov)
• Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020). § 101. Telehealth Services During Certain Emergency Periods Act of 2020. Retrieved from PUBL123.PS (congress.gov)
• Public Health Service Act, 2021, § 319(e). Telehealth Enhancements for Emergency Response. Enacted June 25, 2022. Retrieved from COMPS-8773.pdf (govinfo.gov)
• Robert T. Stafford Disaster Relief and Emergency Assistance Act, Pub. L. No. 100-707, 102 Stat. 4689 (1988), Codified as Amended 42. U.S.C. § 5121. Disaster Relief and Emergency Assistance Amendments. May 2021. Retrieved from Stafford Act, as Amended – FEMA P-592 vol. 1 May 2021

Internet-Only Manual (IOM), Medicare National Coverage Determination Manual (NCD), Publication (Pub.) 100-03

• Chapter (Ch). 1, Part 1, §20.17 Noninvasive Tests of Carotid Function

IOM, Medicare Benefit Policy Manual (MBPM), Pub. 100-02

• Ch. 6, §20.4 Outpatient Diagnostic Services
• Ch. 15, §80 Requirements for Diagnostic X-ray, Diagnostic laboratory, and other Diagnostic tests
• Ch. 16, §20 General Exclusions from Coverage

IOM, Medicare Claims Processing Manual (MCPM), Pub. 100-04

• Ch.13, §10.1 Billing Part B Radiology Services and Other Diagnostic Procedures
• Ch 23, §20.9 National Correct Coding Initiative (NCCI)
• Ch. 30, §30.2 Healthcare Provider or Supplier Knowledge and Liability

IOM, Medicare Program Integrity Manual (MPIM), Pub. 100-08

• Ch. 3, §3.2.3.2 Time Frames for Submission
• Ch. 3, §3.2.3.3 Third-party Additional Documentation Request
• Ch. 3, §3.2.3.4 Additional Documentation Request Required and Optional Elements
• Ch. 3, §3.2.3.8 No Response or Insufficient Response to Additional Documentation Requests
• Ch. 3, §3.3.2.1 Documents on which to Base a Determination
• Ch. 3, §3.3.2.4 Signature Requirements
• Ch. 3, §3.6.2.2 Reasonable and Necessary Criteria
• Ch. 3, §3.6.2.3 Limitation of Liability Determinations
• Ch. 3, §3.6.2.4 Coding Determinations
• Ch. 5, §5.9 Documentation in the Patient’s Medical Record
• Ch. 13, §13.5.4 Reasonable and Necessary Provisions in LCDs

CMS Coding Policies

• NCCI Policy Manual for Medicare Services, Effective January 1, 2020. Chapter 11, Section I. Cardiovascular Services

Local Coverage Determination (LCD)

• L33627 Non-Invasive Vascular Studies
• L33695 Non-Invasive Extracranial Arterial Studies
• L34045 Non-Invasive Vascular Studies
• L35397 Non-Invasive Cerebrovascular Arterial Studies
• L35448 Independent Diagnostic Testing Facility (IDTF)
• L35753 Non-Invasive Cerebrovascular Studies

Local Coverage Article (LCA)

• A52992 Billing and Coding: Non-Invasive Cerebrovascular Arterial Studies
• A53252 Billing and Coding: Independent Diagnostic Testing Facility (IDTF)
• A56697 Billing and Coding: Non-Invasive Vascular Studies
• A56758 Billing and Coding: Non-Invasive Vascular Studies
• A57592 Billing and Coding: Non-Invasive Cerebrovascular Studies
• A57670 Billing and Coding: Non-Invasive Extracranial Arterial Studies

Other

• Medicare Learning Network, MLN Matters SE1419. Medicare Signature Requirements – Educational Resources for Health Care Professionals. Revised June 25, 2020
• Medicare Learning Network, MLN Matters 905364. Complying with Medicare Signature Requirements. April 2022
• Medicare Learning Network, MLN Matters MM6563. Billing for Services Related to Voluntary Uses of Advance Beneficiary Notices of Noncoverage (ABNs). Effective April 1, 2010
• Medicare Learning Network, MLN Matters MLN909060. Independent Diagnostic Testing Facilities (IDTF). October 2022

Last Updated Jun 7, 2024