DEPARTMENT: Regulatory Compliance Support / POLICY DESCRIPTION: LABORATORY - Reflex Tests
PAGE: 1 of 3 / REPLACES POLICY DATED: 4/6/98; 3/1/99, 1/1/02, 5/15/03, 3/1/04, 5/1/04 (GOS.LAB.010)
EFFECTIVE DATE: March 6, 2006 / REFERENCE NUMBER: REGS.LAB.010
SCOPE: All Company-affiliated hospitals performing and/or billing laboratory services. Specifically, the following departments:
Laboratory
Health Information Management
Medical Staff
Administration
Information Systems
PURPOSE: To establish guidelines regarding laboratory reflex testing in accordance with Medicare, Medicaid, and other payer requirements.
POLICY: Laboratory reflex testing must be approved by the Medical Staff on an annual basis as evidenced in the Medical Executive Committee minutes. Only those tests documented as approved by the Medical Executive Committee may be reflexed. Laboratory reflex testing must be medically necessary. Physicians must be informed of those tests that are reflexed and be given the option to order the test without the reflex test.
PROCEDURE:
1.  Laboratory personnel must consult with the Medical Director, Pathologist(s), or Clinical Consultant to determine the tests and criteria for reflex testing. All reflex testing must be reviewed and approved by the Medical Staff via the facility’s Medical Executive Committee on an annual basis. The following questions should be considered and presented to the Medical Executive Committee when determining which tests should be reflexed:
·  Is the reflex test required by accrediting agencies (e.g., College of American Pathologists) or by federal or state mandates (e.g., CLIA)?
·  Is the reflex test considered “good medical practice,” providing accurate clinical information to the physicians?
·  Does the reflex test incur an additional charge, or is it included in the initial test charge?
·  Is the ordering physician clearly given the option to order a test with, as well as without, the reflex test being performed?
·  Has the ordering physician been informed about reflex tests and criteria through the lab requisition, bi-annual acknowledgment and subsequent change notices?
2.  The specific reflex test documentation and Medical Executive Committee approval must be reflected in the annual Medical Executive Committee meeting minutes.
3.  The facility must implement the following processes for reflex testing:
a.  Inform all credentialed and contracted physicians of the reflex tests and criteria via the following mechanisms:
·  Obtain a signed acknowledgment at least once every two years during the credentialing process. A form similar to Attachment A may be used to satisfy the acknowledgment requirement. The Reflex Testing Acknowledgment must be accompanied by a listing of the reflex tests that defines the initial tests, reflex criteria and reflex tests. It is also strongly recommended that this listing include the CPT code utilized for billing and the Medicare Fee Schedule amount for the reflex test.
·  Notify credentialed and contracted physicians of changes to the approved reflex tests and criteria that occur prior to the next acknowledgment due date. Refer to Attachment B for a sample notification form. The Reflex Testing Notification must be accompanied by a listing of the reflex tests that defines the initial tests, reflex criteria and reflex tests. It is also strongly recommended that this listing include the CPT code utilized for billing and the Medicare Fee Schedule amount for the reflex test.
·  Design the facility’s laboratory requisition to clearly indicate which tests may be reflexed and provide an option for the ordering physician to select the test without the reflex test.
b.  Establish an annual monitoring process that includes review of the medical necessity of reflex tests and criteria, Medical Executive Committee approval process, laboratory requisition design and implementation of the acknowledgment and notification process.
4.  Laboratory personnel must educate all staff associates responsible for ordering, testing, charging, or billing laboratory services on the contents of this policy.
The Facility Ethics and Compliance Committee is responsible for the implementation of this policy within the facility.
DEFINITION:
Reflex Testing: Testing performed subsequent to initial test results, and used to further identify significant diagnostic information required for appropriate patient care. Testing performed as a step necessary to complete a physician's order is not considered reflex testing. The CBC with auto diff is the only example of a test that is "reflexed" but is not considered a reflex test for billing purposes, i.e., the results of the auto diff indicate a manual diff needs to be performed.
Examples of billable reflex tests (when the appropriate processes outlined in this policy have been implemented) are organism identification and susceptibility studies reflexed on positive cultures, organism typing reflexed on certain organism identification, red cell antibody identification reflexed on positive screening tests and titers reflexed on positive screening tests.
REFERENCES:
OIG Model Lab Compliance Plan (March 1997)
National Correct Coding Policy Manual for Part B Carriers, 3rd Edition 1997
The Office of Inspector General’s Compliance Program Guidance For Clinical Laboratories
(August 1998), p. 13

2/2006

Attachment A

SAMPLE REFLEX TESTING ACKNOWLEDGMENT

PURPOSE:

The purpose of this Reflex Testing acknowledgment is to ensure that our physicians understand when reflex tests will be performed and how they will be billed to Medicare.

POLICY:

______Hospital’s Laboratory will automatically perform reflex tests according to the criteria in the attached list when all three of the following conditions are met, unless your order specifically states that you do not want the reflex test performed:

1.  An initial test has been performed as ordered;

2.  The initial test result meets the criteria for the reflex test; and

3.  The hospital’s Medical Executive Committee has approved those tests and criteria.

BILLING OF REFLEX TESTS:

The hospital bills for medically necessary reflex tests according to the CPT code listed on the attachment. The Medicare fee schedule amount is listed with each CPT code.

ACKNOWLEDGMENT AND APPROVAL:

By signing this acknowledgment, you acknowledge that you have reviewed the attachment and agree that, whenever the initial test ordered meets the reflex criteria, the corresponding reflex test will be performed, reported and billed.

If in the case of an individual patient, you consider the reflex test unnecessary, you must order the initial test without the reflex. With the exception of those tests required by law, you may order any test without the reflex option.

We recommend that you utilize the hospital laboratory requisition in order to clearly indicate the tests that you want performed.

This acknowledgment may be terminated at any time with written notice to the laboratory director.

Notification of any additions or modifications to reflex tests will be communicated via the Notification of Additions or Modifications for Reflex Testing form as they are approved by the Medical Executive Committee.


Physician Signature: ______Date: ______

Attachment to REGS.LAB.010

Attachment B

SAMPLE Notification of Additions

or Modifications for Reflex Testing

PURPOSE:

The purpose of this Reflex Testing notification is to ensure that our physicians understand when reflex tests will be performed and how they will be billed to Medicare.

POLICY:

______Hospital’s Medical Executive Committee has approved additions/modifications to the hospital’s reflex testing protocol. Due to these changes, the laboratory will automatically perform reflex tests according to the chart below when all three of the following conditions are met:

1.  An initial test has been performed as ordered;

2.  The initial test result meets the criteria for the reflex test; and

3.  The hospital’s Medical Executive Committee has approved those tests and criteria.

The physician will always have the option to order any initial test without the reflex test with the exception of those tests required by law.

BILLING OF REFLEX TESTS:

The hospital bills for medically necessary reflex tests according to the CPT code listed on the attachment. The Medicare fee schedule amount is listed with each CPT code.

Contact Person: Laboratory Director

Facility Address: Music City Hospitals address

Phone: Laboratory Director’s phone number

E-mail: Laboratory Director’s e-mail address

Attachment to REGS.LAB.010