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 Medicare Part B carotid artery screening billed on 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 and suppliers may wish to consult when submitting claims.

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 will perform medical record review on supporting documentation, to determine if select Part B claims for carotid artery screening were reasonable and necessary. The SMRC will conduct medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.

Table 2-Claim Sample Detail

Access related project details below.

• Documentation Requirements
• References

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.
Providers and suppliers are requested to submit each of the Documentation Requirements outlined below, if and as applicable to the claim on review:

1. NOTE: It is the responsibility of the billing provider to obtain and forward for review all documentation from the ordering/referring provider that confirm all medical necessity criteria have been met.
2. Physician/Non-Physician (NPP) order or evidence of intent to order.
3. Documentation supporting the diagnosis code(s) required for the item(s) billed.
4. Progress notes from the referring provider describing and supporting the covered indication along with signs and symptoms for diagnosis code(s).
5. Diagnostic tests, radiologic reports, lab results, pathology reports, and other pertinent test results and interpretations along with comparison with prior relevant studies with both normal and abnormal findings.
6. Documentation to support National Coverage Determination (NCD), Local Coverage Determination (LCD) and/or Policy Article.
7. Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services).
8. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC).
9. Any other supporting documentation.
10. 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.

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 8, 2023