Dear CHOP Provider:

In an effort to comply with guidance promulgated by the Office of Inspector General (“OIG”) of the Department of Health and Human Services and the requirements of federal, state, and private health plans, The Children's Hospital of Philadelphia (“CHOP”) and the Department of Pathology and Laboratory Medicine (“CHOP Clinical Laboratories”) are providing you with this Annual Notice to Physicians and Nurse Practitioners. This Notice delineates the guidelines and policies used by CHOP Clinical Laboratories when submitting claims. Your compliance with these guidelines and policies is vital because any individual who knowingly causes a false claim to be submitted may be subject to sanctions or remedies under civil, criminal and administrative law.

Clinical Consultant: The Pathologist-in-Chief and Chair, Department of Pathology and Laboratory Medicine, Dr. Robert Doms, or a member of the Laboratory staff, is available to assist with all laboratory testing questions. The Laboratory phone number is 215-590-5221.

Medical Necessity: As a provider, you are responsible to document medical necessity for each test in the permanent patient medical record and to provide a written order with ICD10 code(s) or narrative diagnosis for any test(s) for which you instruct the CHOP Clinical Laboratories to perform and for which CHOP will seek reimbursement. You may order only those tests, including tests that are components of Organ or Disease Panels or Order Sets, that you believe are medically necessary for patient diagnosis and treatment because federal, state, and commercial health plans will pay only for tests that are reasonable and necessary to treat or diagnose an individual patient. National Correct Coding Initiative (NCCI) and Medically Unlikely Edits (MUE) will apply and may result in charges to your patient.

Organ or Disease Oriented Panels: Only Organ or Disease Oriented Panels that are recognized by the American Medical Association in its CPT Manual (CPT codes 80048-80076) may be billed. They should only be ordered when all components of the panel are medically necessary. A valid diagnosis code or narrative diagnosis must be provided for each AMA-approved panel ordered. A list of the Organ or Disease Oriented Panels can be found here(PDF).

Order Sets and Pricing: All Order Sets must be ordered separately except for those contained in Organ or Disease Oriented Panels. Each component of an Order Set must be medically necessary and is billed separately. Order Set pricing is based on the cost of each component included in a test panel, and individual tests or profiles are never priced below cost. You may not provide tests to patients or potential patients free of charge or at below cost either as a professional courtesy or to secure additional business. In accordance with CHOPs Discounts and Reductions in Patient/Family Financial Obligations Policy A-2-5, CHOP does not provide discounted services or professional courtesy based on a patients relationship to any CHOP physician or any other provider. Panels are paid and billed only when all components are medically necessary. ORDER SETS.1.1.2024 

Medical Assistance Reimbursement Fee Schedule: Pennsylvania Medical Assistance and New Jersey Medicaid reimburse laboratory services based upon published fee schedules. You may access these online here for Pennsylvania+ or here for New Jersey+.

Reflex Laboratory Tests: Reflex testing may be performed without a specific written order when the results of initial testing are positive or outside normal parameters and indicate that a second, related test is medically necessary. The CHOP Clinical Laboratories Lab Requisition is designed to permit reflex testing only when medically necessary. Please contact the Laboratory if you have any questions about reflex tests.

Required Information: Please use standard laboratory requisitions, a copy of which is available on request. The following information is required on all laboratory requisitions:

• Patient demographic information (name or unique patient identifier, gender, date of birth) 
• Physician name, written or electronic signature and ordering location 
• Indications for testing, including ICD-10 diagnosis code or narrative description 
• Test(s) to be performed 
• Date and, if appropriate, time and/or source of specimen 

Standing Orders: A standing order directs the laboratory to perform a particular test(s) in connection with an extended course of treatment at specified intervals for a defined time period without having to submit a new requisition form each time. Standing orders must be renewed annually in writing or in the hospital ordering system (EPIC). For patients with a documented diagnosis of Cystic Fibrosis the standing order will be no more than five years old. When requesting a standing order, please provide the “Required Information” outlined above in addition to:

• Start/Stop day, month and year 
• Frequency the test is to be performed, such as "every two weeks." The use of the phrase as the occasion arises, or as necessary" (PRN/prn) is not an acceptable frequency. 

Calculated Test Results: Laboratory calculation tests cannot be billed when the calculation is derived from an underlying test. Underlying tests used in the calculation will be billed. 

Screening Tests: Payors, including Medical Assistance, generally do not cover routine screening tests other than those authorized under the Early and Periodic Screening, Diagnostic, and Treatment Program.

Referred Tests: Any laboratory test that must be sent to a reference lab for testing may only be sent to labs that are CLIA-certified or otherwise approved by CMS (e.g., COLA-accredited).

Patient Privacy (HIPAA): Under the Health Insurance Portability and Accountability Act (HIPAA), CHOP is a health care provider and a covered entity. It is our policy to comply with the letter and intent of the HIPAA privacy and security standards. A copy of the CHOP Notice of Privacy Practices can be found here. https://at.chop.edu/general-counsel/compliance-privacy/privacy/Shared%20Documents/hipaa_npp.pdf

Thank you for your time and anticipated cooperation. Please feel free to contact the Laboratory directly if you have any questions.

Sincerely,

Robert Doms, MD, PhD
Pathologist-in-Chief and Chair, Department of Pathology and Laboratory Medicine
The Children's Hospital of Philadelphia

Published: 7/1/2024