Orders have always been an area of contention because there are so many opinions about what is required. If you look at history, guidance has been all over the place. For example, you can take the Documentation Guidelines from 95 & 97 and look at the General Principles of Medical Record Documentation, and the # states, “If not documented, the rationale for ordering diagnostic and other ancillary services should be easily inferred.” Medicare has some other requirements for ordering and certifying that include things like having an individual National Provider Identifier (NPI), being enrolled in Medicare in either an “approved” or an opt-out status, or being of an eligible specialty type. If you are an opt-out provider, you can still order or certify for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS), Clinical Laboratory Services, Imaging Services, and Home Health Services. In section 3.3.2.1.2 –DMEPOS Orders of Chapter 3 of the Program Integrity Manual (PIM), there are specific requirements for the ordering and/or certifying of DMEPOS.

Requirements For Ordering Laboratory Services

When it comes to laboratory services, there are some very specific requirements that have to be met. Take for example the Fact Sheet Produced by CGS – they break it down into multiple parts: “All DMEPOS items require a Standard Written Order (SWO) from the treating practitioner as a condition of payment. Medicare contractors shall consider the totality of the medical record when reviewing for compliance of the SWO elements. This will allow contractors to account for the dynamic nature of electronic medical record documentation systems, and give them additional discretion when they believe the entirety of the record demonstrates compliance with our order requirements. For example, a contractor may nonetheless support payment when an order has a missing or flawed element that is clearly documented elsewhere in the record. Contractors acting as a secondary reviewer shall grant deference to the initial reviewer’s discretion if such an initial decision resulted in a reasonably prudent decision that aligns with Medicare coverage and coding instructions.”

Prior to Ordering ANY Lab Services:

  • Document your diagnosis (why the patient needs the test ordered), not just the ICD-10 code. The reason must be documented CLEARLY in the medical records.
  • Document and sign in the medical record comments that support the physician/practitioner’s intent to order tests (e.g. “order Lab”, “check blood”, “repeat urine”).
  • Medicare coverage extends to tests ordered by a licensed provider (for example-MD, DO, NP). The physician or other eligible professional who is treating the beneficiary MUST order all diagnostic laboratory tests. Tests not ordered by the physician or eligible professional are not considered reasonable and necessary.
  • All diagnostic laboratory tests must be ordered for the treatment of the individual patient.

Requisitioning/Placing Order:

  • Use either the lab portal of the respective lab or one of the processes listed below.
  • A written document signed by the treating physician/eligible professionals, which is hand-delivered, mailed, or faxed to the testing facility; Although no signature is required on orders for clinical diagnostic tests paid on the basis of the clinical laboratory fee schedule, the physician fee schedule, or for physician pathology services, documentation in the medical record must show intent to order and medical necessity for the testing.
  • A telephone call by the treating physician/eligible professional or his/her office to the testing facility; If the order is communicated via telephone, both the treating physician/ eligible professional or his/her office and the testing facility must document the telephone call in their respective copies of the beneficiary’s medical records.
  • Electronic mail can be sent to the testing facility by the treating physician/eligible professional or his/her office.

Routine Orders:

Routine orders are for services and treatments that apply to patients with the same or similar medical condition(s). These frequently called “routine, protocol or standing orders” are based on an assessment of a given condition in patients with medical illness or injury.

  • Medicare defines any order(s) that does not specifically address an individual patient’s unique illness, injury, or medical status, as not reasonable and necessary.
  • As required by law, Medicare does not accept such “standing orders” as supporting medical necessity for the individual patient.
  • Services related to population-based or condition-based orders are not reimbursable.

Recurring Orders:

Reimbursement of tests or services provided under a standing order for a recurring or serial evaluation is subject to medical necessity review.

  • All such orders must be written for a specific patient, and each instance of the test or service must be necessary.
  • Each result must be reviewed with appropriate action taken by the treating physician, including any appropriate change in the frequency or duration of testing.

Laboratory Orders:

Preprinted orders are not covered by Medicare. However, preprinted or electronic lists of potential orders are permitted if the provider individually affirms, defines, or otherwise modifies each component as appropriate for an individual patient’s clinical circumstances. Standing orders for recurring diagnostic tests may be appropriate when all of the following conditions are met:

  • Each ordered test must be appropriate and necessary for the treatment of the individual patient on a specific date of service
  • The frequency and number of repeated testing must not be greater than medically necessary.
  • The diagnosis must be indicated for each test with sufficient clarity to permit accurate ICD-10-CM coding to the highest level of specificity.
  • The treating physician must review each test result, making any indicated adjustments in frequency and number of repeated studies.
  • All lab tests must be reviewed and documentation must support that the appropriate clinical action was taken.

Signature Requirements for Orders:

If the signature is missing from an order, ACs, MACs, PSCs, ZPICs and CERT shall disregard the order during the review of the claim. There are some circumstances for which an order does not need to be signed. For example, orders for clinical diagnostic tests are not required to be signed. The rules in 42 CFR 410 and the Medicare Benefit Policy Manual, chapter 15, section 80.6.1, state that if the order for the clinical diagnostic test is unsigned, there must be medical documentation by the treating physician (e.g., a progress note) that he/she intended the clinical diagnostic test be performed. This documentation showing the intent that the test be performed must be authenticated by the author via a handwritten or electronic signature.

In Chapter 3 of the Program Integrity Manual, there are again varying requirements for orders as well as exceptions. For the full section refer to 3.3.2.4 – Signature Requirements (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/pim83c03.pdf). I want to focus on one of the exceptions, number two (2): “There are some circumstances for which an order does not need to be signed. For example, orders for some clinical diagnostic tests are not required to be signed. The rules in 42 CFR 410 and Pub.100-02 chapter 15, Section 80.6.1 state that if the order for the clinical diagnostic test is unsigned, there must be medical documentation (e.g., a progress note) by the treating physician that he/she intended the clinical diagnostic test be performed. This documentation showing the intent that the test be performed must be authenticated by the author via a handwritten or electronic signature.” 

Further, in section I of the aforementioned section the PIM goes on to state, “In addition, MACs, CERT and UPICs have the discretion to add language to their ADRs stating that the provider is encouraged to review their documentation prior to submission, to ensure that all services and orders are signed appropriately. In cases where a reviewer finds a note with a missing or illegible signature, the ADR may inform the provider that it should submit a signature log or signature attestation as part of the ADR response.”

The last section (Medicare Program Integrity Manual Chapter 6 – Medicare Contractor Medical Review Guidelines for Specific Services) outlines a variety of “order” requirements for Skilled Nursing Facilities (SNF), Home Health Services, and other types of services where orders are required. When it comes to orders, make sure you dot the I’s and cross the T’s!

Laboratory Compliance Services From DoctorsManagement

Delving into the intricacies of laboratory service orders can be a daunting task, given the multitude of requirements involved. Recognizing the complexities involved, our team is here to assist you in crafting a tailored laboratory compliance program that not only aligns with your specific needs but also adheres to CLIA regulations. Our commitment is to simplify the process for you, ensuring that your laboratory operations not only meet industry standards but also operate seamlessly within the framework of compliance. Contact us to learn more!

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