Monday, May 6, 2024

MolDx Publishes Major Guidance Document: When Pathologists Can Order Molecular Tests

Famously, CMS has a regulation (42 CFR 410.32) that tests must be ordered by a physician who is treating a patient for a particular disorder.  However, CMS provides some exceptions where pathologists (or radiologists) can adjust orders or, for pathologists, implement orders necessary to complete a case.   (The example provided is seeing possible bacteria and running a special stain).  

(For additional clarification, see Medicare Benefits Manual 80.6, and the original Fed Reg creation of 410.32 at 10/31/1997, 62 FR 59048).

MolDx has published an important public policy article about when a pathologist can order molecular tests.  Find the article here:

  • The article  is very important because of the need for timely molecular testing in conditions such as cancer.  
  • The guidance also has important guidance that a test order form and its clinical information is "part of the medical record" for audit purposes.
  • Rather than summarize the guidance, I will cut/paste below.   
    • Articles get updated, so always check the current version online..




Documentation requirements for laboratory services require that services be ordered by a treating physician as defined in IOM 100-02 Chapter 15 §80.6.1 and meet other criteria set in 42CFR§410.32(b). Further clarifications were made in ICN MLN909221, December 2020.

In view of these requirements, this contractor provides the following supplemental clarifying information:

  • Pathologists may order molecular diagnostic services when they fall under exemptions to the “treating physician” requirements as defined in the Medicare Benefits Manual 100-02 Chapter 15 sections 80.6.3, 80.6.4, or 80.6.5. Most commonly, pathologists may order molecular diagnostic tests when performing diagnostic services from a sample submitted to them without a specific test order. In such instances, the pathologist must meet all the criteria listed in section 80.6.5. This includes ensuring the service is reasonable and necessary, the results are communicated, and that the pathologist documents why the service was performed in their report. 
    • A pathologist may also order additional testing as defined in the above exemptions after the completion of an ordered service (molecular pathology or other pathology service) when that service is medically necessary and a delay in the performance of the test would have an adverse effect on the care of the beneficiary.
  • Test requisition forms are part of the medical record. When requisition forms include complete information validating medical necessity, such as qualifying clinical information that demonstrate test coverage criteria are met, the requisition form may be sufficient to determine if the service is reasonable and necessary without other medical information from the ordering provider. 
    • If the requisition form does NOT contain sufficient and relevant clinical information to determine if the service is reasonable and necessary for the intended patient, the requisition form is NOT considered sufficient to meet reasonable and necessary requirements and additional documentation may be required to fulfil this criteria.
  • A “wet signature” is NOT required for clinical diagnostic tests and electronic signatures are acceptable if they confer an attestation that the physician is placing the order. A signature is also not required on orders for clinical diagnostic tests paid on the basis of the clinical lab fee schedule, the physician fee schedule, or for physician pathology services (IOM 100-02 Chapter 15 §80.6.1), provided that there is other evidence in the medical record that there is intent to place an order. 
    • However, it should be understood by providers that the most common reason for improper payment upon review is insufficient documentation, and it is best practice to ensure there is a signed order in place.
My own reading of this topic (including original Fed Reg documents) was more narrow and conservative.  But the MolDx announcement and interpretation is better health policy.  

I collated some sources on this topic here
Nerd note.  CMS updated its signature rules in 5/2024, CR13556.