Labs Not for the Treatment of ESRD FAQs

Lab Orders: Medical Necessity Documentation, Paneling and Protocols - FAQs

I.       Not for the Treatment of ESRD – Medical Necessity Documentation

What labs are considered “Not for the Treatment of ESRD”?

As referenced in Medicare Benefit Policy Manual, Chapter 11, the distinction of what is considered to be a renal dialysis laboratory test is a clinical decision determined by the ESRD patient’s ordering practitioner. If a laboratory test is ordered “for the treatment of ESRD,” then the laboratory test is considered a renal dialysis laboratory test and part of the Medicare PPS (bundled) rate.  Conversely, if a laboratory test is order “not for the treatment of ESRD” the laboratory test it is not a renal dialysis laboratory test and may be paid separately by CMS. 

CMS has offered limited guidance on what physicians should consider “for the treatment ESRD” or “not for the treatment of ESRD.” Ordering physicians should consider the following questions when ordering laboratory services for ESRD patients:

  •          Is the laboratory test being ordered for the treatment of the ESRD or as a part of the dialysis treatment?
  •          Or is the test being ordered for the diagnosis or treatment of another condition other than ESRD?

Why are we asking for this documentation?

During a CMS education outreach program, DaVita Labs was made aware of an increased focus on medical necessity documentation for clinical laboratory tests.  This education outreach program was conducted by DaVita Labs’ Medicare Administrative Contractor (the “MAC”), the regional contractor that processes claims for CMS.

The MAC is requiring the ordering physician to provide the following information in the medical record as documentation of medical necessity for each test:

  •          Clinical justification for the order;
  •          A signed lab order;
  •          Documentation that:
    • The result was reviewed by the physician; and
    • How the lab result was used in the treatment of the patient’s condition.

DaVita Kidney Care and DaVita Labs have been working with the MAC, our physicians, as well as our partners in the lab industry, to ensure that both appropriate documentation and appropriate expectations about physician documentation are understood by all parties.

In the spirit of continuous improvement, DaVita Labs, in partnership with OCMO, has produced a tool in OneView and OneView Mobile to support ordering physicians’ ability to provide the medical necessity documentation required by the MAC.

  • Where does a physician document whether a lab is “for the treatment of ESRD” or “not for the treatment of ESRD?”

Documenting that a lab is for or not for the treatment of ESRD is done within Snappy by the care team member entering the order. The physician’s designation of “for the treatment of ESRD” or “not for the treatment of ESRD” will appear on the order to be signed by the physician in OneView.

Please note: when reviewing orders prior to signature, if the physician disagrees with the designation he/she can dispute the order through the standard disputed process.

What type of documentation is needed for the OneView tools that supplements the existing medical necessity documentation for labs?

The ability to review and document on labs that were ordered Not for the Treatment of ESRD is available in OneView and OneView Mobile.

Physicians can access the Labs Not for the Treatment of ESRD queue, where they may select “Reviewed, No Change [in Care Plan]” or “Reviewed, Changed Care Plan” for the lab results that are presented in the queue.  In addition, a comment box is offered to give physicians the ability to document how labs ordered Not for the Treatment of ESRD were used in the treatment of the patient’s condition. Please note that any changes to the care plan must be directly communicated to the DaVita Care Team.

What happens if I refuse to document?

If you refuse to document in accordance with DaVita’s Medical Staff Bylaws, you may be referred for Peer Review.  Section 2.2.2 (f) of DaVita’s Bylaws states that a credentialed physician will:

Prepare and complete within 30 days of creation (or sooner, as required by DaVita and/or Facility policy): 2728 forms, care plans, IDT notes, and any other medical records or Facility-required documentation for his or her patients. This includes diagnosis and applicable comorbidities/ICD-10 codes on laboratory tests, and orders for services outside of standard dialysis (e.g., additional days of dialysis/MFD).

II.   Lab Panels

How do I order a lab panel?

Labs are ordered by physicians based on their independent, clinical judgment.  While DaVita’s Office of the Chief Medical Officer (OCMO) recommends certain labs, it is always up to the physicians to determine which labs to order for the care of their patients.  Labs may be ordered individually or as part of a lab panel (for instance, the monthly composite lab set or the lab set of iron, iron saturation, ferritin).

One example of a lab panel for an in-center hemodialysis patient is the Monthly Composite Panel w/o Ca/Phos, which includes:

Albumin AST (SGOT) CO2 (bicarbonate) Potassium
Alkaline Phosphates Chloride LDH Protein, total

Physicians should be aware that some tests may be included on multiple panels.  As a result, physicians should consider ordering individual lab tests rather than duplicating tests by ordering multiple panels that include the same test(s).

III.            Protocols

How are DaVita Protocols developed?

Protocols are developed by OCMO and the DaVita Clinical Enterprise team in conjunction with our physician council.  Protocols are intended to provide physicians with tools that allow them to give their patients high quality of care that is aligned with current industry best practices; however, it is always up to the physician’s independent, clinical judgment to determine the most appropriate care for their patients, including whether to order specific labs, lab panels, or protocols.

How are DaVita protocols made available to clinicians?

Once a protocol has been developed, it is shared with our facilities.  The Governing Body at each facility must approve the protocol for use to make the protocol available to all credentialed providers for ordering.

Can physicians alter or customize protocols?

Physicians can always alter the orders for their patient, at any time, based on their independent, clinical judgment.  You may choose to order any lab or group of labs at any frequency that you feel is appropriate for your patients, as well as to change the frequency of, or discontinue, existing lab orders.  

What labs are included in DaVita protocols?

DaVita has a number of protocols that include labs.  One example is the hepatitis C screening protocol.

It is worth mentioning the Hep C protocol in detail.  The Hep C protocol was developed under the guidance of OCMO to reflect the recommendations of KDIGO and the CDC. These recommendations are designed to reflect the need for close monitoring of patients designated as “at high risk for contracting hepatitis.” The recommendations include:

  •          Yearly hepatitis C antibodies; and
  •          Monthly ALT measurements to look for changes in liver function which may point towards hepatitis seroconversion.  

Please note: If ALT is designated by the physician as “not for the treatment of ESRD” when ordered as part of the Hep C protocol, then as referenced above, documentation will be required to document the physician’s review of the lab results and how the lab was used in the treatment of the patient’s condition.  

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