In California Workers’ Compensation Law, there are many rules and regulations that apply to the dispensing of medications. The authorization of the medication is driven by a multitude of issues. The starting point in authorization is what type of medication is being provided and for what reason. This article, in brief, will discuss the language of medications within the workers’ compensation system. Reading this may provide some insight into why or why not you are getting your medications.
What is the basis for providing medications within workers’ compensation?
Labor Code provides that “Drugs prescribed or dispensed to treat a work related injury or illness fall within Labor Code section 4600’s definition of “medical treatment” and are subject to the relevant provisions of the MTUS, including the MTUS Treatment Guidelines, provisions relating to the presumption of correctness, and the methods for rebutting the presumption and for substantiating medical necessity where the MTUS Treatment Guidelines do not address the condition or injury.”
What is MTUS?
MTUS is an abbreviation for Medical Treatment Utilization Schedule.
Are there any terms as far as the method of delivery of medication that are of importance to an Injured Worker?
Yes. California Regulations specifically describe and identify the means upon which drugs are provided.
Administer means the direct application of a drug or device to the body of the patient by injection, inhalation, ingestion, or other means. Regs.
Dispense means that 1) the furnishing of a drug upon a prescription from a physician or other health care provider acting within the scope of his or her practice, or 2) the furnishing of drugs directly to a patient by a physician acting within the scope of his or her practice. Regs
Outpatient Use is a term used “if it is dispensed to be taken, applied, or self-administered by the patient at home or outside of a clinical setting, including “take home” drugs dispensed at the time of discharge from a facility. “Home” includes an institutional setting in which the injured worker resides, including but not limited to, an assisted living facility.” Regs.
What are Prescription Drugs?
A “Prescription Drug” means any drug whose labeling states “Caution: Federal law prohibits dispensing without prescription,” “Rx only,” or words of similar import. Regs
What are Brand Name Medications?
Brand Name Medications are medications that are from the initial manufacturer of the product.
Per the California Regulation 9792.27.1, a Brand Name Drug” means a drug that is produced or distributed under an FDA original New Drug Application (NDA) or Biologic License Application (BLA) approved by the FDA. It also includes a drug product marketed by any cross-licensed producers or distributors operating under the same NDA or BLA.
What is a Combination Drug?
A Combination Drug means a fixed dose combination of two or more active drug ingredients into a single dosage form that is FDA-approved for marketing. Regs.
What is a Generic Drug?
Generic Medications are a copy of brand name drugs.
Per the FDA, Generic Medications provide the same dosage, intended use, effects, side effects, route of administration, risks, safety and strength as the original drug. As defined by the government, they are ”a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.” They are required by the Food and Drug administration to be as safe and as effective as the brand name drug.
Generic drugs become available to be sold and distributed when either the patent & exclusivity protection ends, or the patent owner waives its rights, and FDA requirements are met.
Generally, Generic drugs are more economical than the brand name drugs. Therefore, Insurance Companies want to encourage
While Generic drugs are essentially the same as the brand name drug, some patients report better results when using the brand name of the product.
Generic Drug means a drug that is produced or distributed under an FDA Abbreviated New Drug Application (ANDA) approved by the FDA. A generic drug may be substituted for a therapeutic equivalent brand name drug pursuant to applicable state and federal laws and regulations. Regs
Is there a preference in California Workers’ Compensation Law to prescribe Generic Drugs?
Yes. Labor Code Section 4600.1, requires the provision of generic drugs.
Are there exceptions to providing Generic Drugs?
Yes. Labor Code Section 4600.1(b) provides that (b) A person or entity is not required to dispense a generic drug equivalent under either of the following circumstances: (1) When a generic drug equivalent is unavailable or (2) When the prescribing physician specifically provides in writing that a non-generic drug must be dispensed.
How does a Physician prescribe a Brand Name Drug in lieu of a Generic?
Yes. “[i]f a physician prescribes a brand name drug when a less costly therapeutically equivalent generic drug exists, and writes “Do Not Substitute” or “Dispense as Written” on the prescription in conformity with Business and Professions Code section 4073, the physician must document the medical necessity for prescribing the brand name drug in the patient’s medical chart and in the Doctor’s First Report of Injury (Form 5021) or Progress Report (PR-2.) The documentation must include the patient-specific factors that support the physician’s determination that the brand name drug is medically necessary. The physician must submit a Request for Authorization and obtain authorization through prospective review before the brand name drug is dispensed.” Regs.
What are Compounded Drugs?
Compounded Drugs, per the FDA, are drugs that are manufactured through the “process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved.”
Per the FDA “[a] drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form. Practitioners in hospitals, clinics, and other health care facilities sometimes provide compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat them.”
Per the FDA, “Compounded drugs are not FDA-approved. This means that FDA does not verify the safety or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process for verification of safety, effectiveness, and quality. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed.”
Per the FDA, “Compounded drugs can serve an important medical need for patients, but they do not have the same safety, quality, and effectiveness assurances as approved drugs. Unnecessary use of compounded drugs unnecessarily exposes patients to potentially serious health risks.”
Per the FDA, “ because compounded drugs are not FDA-approved, FDA does not verify their safety, effectiveness, or quality before they are marketed. In addition, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much active ingredient. This can lead to serious patient injury and death.”
What are Physician-Dispensed Drugs?
Per a Study from The California Commission on Health and Safety and Workers’ Compensation are “Pharmaceuticals prescribed and dispensed by physicians are often referred to as “repackaged” drugs because they are purchased by re-labelers from manufacturers in large quantities (e.g., 1,000-10,000 tablets) relabeled, and repackaged into single prescriptions sizes (e.g., 15, 30, 60 tablets) appropriate for dispensing directly to patients.”
What are Special Fill Drugs?
Special Fill drugs have a higher risk profile than other medications. They include selected muscle relaxants, corticosteroids, and opioid analgesics. They may be urgently needed by the Injured Worker.
What are Perioperative Drugs?
Perioperative Drugs are those which are prescribe in connection with a surgical procedure. Perioperative may refer to the three phases of surgery: preoperative, peroperative, and postoperative.
Per the regulations, the perioperative period is defined as the period from 4 days prior to surgery to 4 days after surgery, with the day of surgery as “day zero.”
What is Off-Label use of Drugs?
“Off-label” means the medication is being used in a manner not specified in the FDA’s approved packaging label, or insert. Every prescription drug marketed in the U.S. carries an individual, FDA-approved label. This label is a written report that provides detailed instructions regarding the approved uses and doses, which are based on the results of clinical studies that the drug maker submitted to the FDA. See WebMd.
“Off-label use” means use of a drug for a condition, or in a dosage or method of administration, not listed in the drug’s FDA-approved labeling for approved use. Per Regs
What are Non Prescription Drugs or Over-the-Counter Drugs?
Per the Regs, a “Nonprescription Drug” or “Over-the-Counter Drug” (OTC drug) means a drug which may be sold without a prescription and which is labeled for use by the consumer without the supervision of a health care professional.
What is an OTC Monograph?
“OTC Monograph” means a monograph established by the FDA setting forth acceptable ingredients, doses, formulations, and labeling for a class of OTC drugs. Regs
What is a Therapeutic Equivalent?
A “therapeutic equivalent” is a drug designated by the FDA as equivalent to a Reference Listed Drug if the two drugs are pharmaceutical equivalents (contain the same active ingredient(s), dosage form, route of administration and strength), and are bioequivalent (comparable availability and rate of absorption of the active ingredient(s).) Drugs that the FDA considers to be therapeutically equivalent products are assigned a Therapeutic Equivalence Evaluation Code beginning with the letter “A” in the FDA publication “Orange Book: Approved Products with Therapeutic Equivalence Evaluations” which is available on the FDA website and accessible via a link provided on the department’s website. Reg
What is an Unlisted Drug?
An “Unlisted drug” means a drug that does not appear on the MTUS Drug List and which is one of the following: an FDA-approved or a nonprescription drug that is marketed pursuant to an FDA OTC Monograph. An “unlisted drug” does not include a compounded drug but does include a combination drug.
What are Exempt Drugs?
An “Exempt Drug” is a drug on the MTUS Drug List which is designated as being a drug that does not require authorization through prospective review prior to dispensing the drug, provided that the drug is prescribed in accordance with the MTUS Treatment Guidelines. The Exempt status of a drug is designated in the column with the heading labeled “Exempt / “Exempt / Non-Exempt.” Regs
If you would like a free consultation regarding workers compensation, please contact the Law Offices of Edward J. Singer, a Professional Law Corporation. They have been helping people in Central and Southern California deal with their worker’s compensation cases for 26 years. Contact us today for more information.
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