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Requirements for Non-Prescribing California Associates
(Including Guidelines for the Development and Operation of Standing Orders)
These guidelines do not constitute legal advice. These guidelines are Policy that Your Hormones, Inc. has established based on interpretation of the Federal Registry, Department of Health and Human Services OIG Compliance Program Guidance for Clinical Laboratories [1] and the Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations [2]. Associates are encouraged to seek their own legal advice on such matters.
California State health law does not allow the testing of specimens collected or mailed from California without a written order from a healthcare professional licensed to prescribe in California (M.D.; N.D.; D.C.; D.O.; N.P.; and L.Ac.). Any Associate residing or practicing into the state of California (such as consulting with clients who reside in California), who is not a healthcare professional licensed to prescribe in California is a Non-Prescribing California Associate. Each Non-Prescribing California Associate must fulfill these Requirements for Non-Prescribing California Associates.
If you are not a healthcare professional licensed to prescribe in California, you agree not to recommend, promote, order, or advise or allow the testing of specimens collected or mailed from California unless you meet one of the two following requirements:
1) Have a specific lab order for each client/patient/customer from a healthcare professional licensed to prescribe in California; OR,
2) Have a Standing Order for the lab tests from a healthcare professional licensed to prescribe in California that meets the following criteria: a) Standing Order must be by a healthcare professional licensed to prescribe in California, such as an (M.D.; N.D.; D.C.; D.O.; N.P.; or L.Ac.; b) Standing Order must indicate the circumstances in which the standing order will apply, such as a list of symptoms; c) Standing Order must legibly include the name and contact information of the Associate who is authorized to use the Standing Order; d) Standing Order must legibly include the name and contact information of the healthcare professional licensed to prescribe in California who is issuing the Standing Order; e) Standing Order must be signed and dated by both the healthcare professional licensed to prescribe in California and the Non-Prescribing California Associate; f) Standing Order must contain include the following statement above the signatures: “We the undersigned take full responsibility for complying with all applicable laws, ordinances, rules, regulations, orders, licenses, permits, judgments, decisions, and other requirements of any governmental authority that has jurisdiction over us.”; g) Standing Order is valid for one year from the date of signature, and must be renewed/resubmitted each year; and h) a photocopy or exact reproduction of the Standing Order is provided to Your Hormones, Inc.
The Standing Orders Template may be used as a model.
Associates using Standing Orders should be aware of the following statement from the Federal Register:
“Standing orders in and of themselves are not usually acceptable documentation that tests are reasonable and necessary. Accordingly, the insurer may reject standing orders as evidence that a test is reasonable and necessary. Medicare contractors can and may require additional documentation to support the medical necessity of the test.” [3]
Realizing that most insurance companies follow Medicare guidelines, it should be noted that standing orders do not guarantee that a patient will receive reimbursement for the test when they submit a bill to the insurance company. For all intents and purposes, patients should be advised that the tests must be paid for by the patient, and insurance reimbursement is not guaranteed.
THESE GUIDELINES DO NOT CONSTITUTE LEGAL ADVICE. THESE GUIDELINES ARE POLICY THAT YOUR HORMONES, INC. HAS ESTABLISHED BASED ON INTERPRETATION OF THE FEDERAL REGISTRY, DEPARTMENT OF HEALTH AND HUMAN SERVICES OIG COMPLIANCE PROGRAM GUIDANCE FOR CLINICAL LABORATORIES AND THE DIRECT ACCESS TESTING (DAT) AND THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) REGULATIONS. ASSOCIATES ARE ENCOURAGED TO SEEK THEIR OWN LEGAL ADVICE ON SUCH MATTERS.
[2] https://www.cms.gov/CLIA/Downloads/directaccesstesting.pdf, located at: https://www.cms.gov/clia/. Archived copy: http://yourhormones.com/documents/directaccesstesting.pdf
[3] Federal Register, DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Compliance Program Guidance for Clinical Laboratories, Compliance Program Elements, Section A. Subsection 4. Reliance on Standing Orders. http://oig.hhs.gov/authorities/docs/cpglab.pdf. Archived copy, emphasizing Section A. Subsection 4.: http://yourhormones.com/documents/cpglab.a4.pdf
Documents of the Your Hormones Healthcare Professional Associate Program:
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