(a) No provider shall submit a claim to the department or its fiscal intermediaries for the dispensing or furnishing of a controlled drug, a dangerous drug, or a dangerous device, or a drug or device requiring a written order or prescription for the drug or device to be covered under the Medi-Cal program or for the performance of a clinical laboratory test or examination, unless the provider’s records contain an order authorized by Section 4019 of the Business and Professions Code, or a prescription, including an electronic transmission prescription, signed by the person lawfully authorized by his or her practice act to prescribe or order the dispensing or furnishing of that drug or device to, or for the performance of a clinical laboratory test or examination that meets the federal CLIA standard for test requisition as set forth in Section 493.1241 of Title 42 of the Code of Federal Regulations upon, a Medi-Cal beneficiary, except the following:

1. (1) Providers who are physicians, clinics, hospitals, or other nonpharmacists and who are legally authorized to dispense or furnish drugs or devices directly to their patients, may in lieu of the requirements of this subdivision include a notation in their patients’ medical charts reflecting they have dispensed or furnished the drug or device directly to the patient as authorized by the Business and Professions Code.
2. (2) Anatomical pathology examinations may be ordered by physicians by notation within the patients medical record during inpatient or outpatient surgery provided that these examinations comply with federal CLIA requirements. Any claims made contrary to this section shall be subject to recovery as overpayments.
3. (3) If obtaining a biological specimen is required in order that a test or examination occurs on a periodic basis within an established provider-patient relationship or the furnishing or dispensing of drugs or devices occurs on a periodic basis within an established provider-patient relationship, the provider shall only be required to retain the order or requisition upon obtaining the biological specimen necessary for the initial test or examination or initial furnishing or dispensing of the drug or device, so long as an appropriate record of each test or examination, or furnishing or dispensing, is entered in the patient’s chart.

(b) For purposes of this section:

1. (1) “Signed” shall include a signature that meets the conditions of the Electronic Signature in Global and National Commerce Act (15 U.S.C. Sec. 7001).
2. (2) “Controlled substance” shall mean any substance listed in Chapter 2 (commencing with Section 11053) of Division 10 of the Health and Safety Code.
3. (3) “Dangerous drug” or “dangerous device” has the same meaning as in Section 4022 of the Business and Professions Code.

4. (4) “Drug or device” means:

   1. (A) “Drug,” as defined in Section 4025 of the Business and Professions Code.
   2. (B) “Device,” as defined in Section 4023 of the Business and Professions Code.
   3. (C) Pharmaceuticals, medical equipment, medical supplies, orthotics and prosthetics appliances, and other product-like supplies or equipment.
5. (5) “Prescription” has the same meaning as in Section 4040 of the Business and Professions Code.
6. (6) “Electronic transmission prescription” includes both image and data prescriptions.
7. (7) “Electronic image transmission prescription” means any prescription order for which a facsimile of the order is received by a pharmacy or other appropriate provider from a licensed prescriber and that is reduced to writing and processed by the pharmacy or other appropriate provider in accordance with applicable provisions of the Business and Professions Code, including Section 4070.
8. (8) “Electronic data transmission prescription” means any prescription order, other than an electronic image transmission prescription, that is electronically transmitted from a licensed prescriber to a pharmacy or other appropriate provider and which is reduced to writing and processed by the pharmacy or other appropriate provider in accordance with applicable provisions of the Business and Professions Code, including Section 4070. The use of commonly used abbreviations shall not invalidate an otherwise valid prescription.
9. (9) “Clinical laboratory test or examination” means the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data that may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual.

(c) Notwithstanding any other provision of law, the director may, without taking regulatory action pursuant to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, implement, interpret, or make specific this section by means of a provider bulletin or similar instruction. The department shall notify and consult with interested parties and appropriate stakeholders in implementing, interpreting, or making specific the provisions of this section, including all of the following:

1. (1) Notifying provider representatives of the proposed action or change. The notice shall occur at least 10 business days prior to the meeting provided for in paragraph (2).
2. (2) Scheduling at least one meeting with interested parties and appropriate stakeholders to discuss the action or change.
3. (3) Allowing for written input regarding the action or change.
4. (4) Providing at least 30 days’ advance notice on the effective date of the action or change.