2023 Laws of Puerto Rico › TITLE TWENTY-SIX - Insurance (§§ 101 — 10377) › Subtitle 3 - Puerto Rico Health Insurance Code (§§ 9001 — 10377) › Chapter 102 - Prescription Drug Management (§§ 9041 — 9052) › § 9043 - Definitions

For purposes of this chapter:
(a) Prior authorization.— Means the process of obtaining prior approval from a health insurance organization or issuer, required under the terms of a health plan, for coverage of a prescription drug.
(b) Pharmacy and Therapeutics Committee.— Means a committee or equivalent body that is comprised of individuals who are either employed by or under contract with the health insurance organization or issuer, which shall be composed of an odd number of members. The members of the Pharmacy and Therapeutics Committee shall be healthcare professionals, such as physicians and pharmacists, who have knowledge and expertise in:
(1) Clinically appropriate prescribing, dispensing, and monitoring of outpatient prescription drugs, and
(2) drug use review, evaluation, and intervention.
If there were any representatives of the pharmacy benefits manager, the health insurance organization, or issuer among the members of the Pharmacy and Therapeutics Committee, the same shall only contribute with operations and logistic considerations, but shall not vote on issues related to adding or excluding prescription drugs from the formulary.
(c) Clinical review criteria.— Mean the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a healthcare organization or issuer to determine medical necessity and appropriateness of healthcare services.
(d) Medical or scientific evidence.— Means evidence found in any of the following sources:
(1) Peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts.
(2) Peer-reviewed medical literature, including literature related to therapies reviewed and approved by a qualified institutional review board, biomedical compendia, and other medical literature that meets the criteria of the National Institutes of Health's Library of Medicine for indexing in Index Medicus (Medline) and Elsevier Science Ltd. for indexing in Excerpta Medica (EMBASE).
(3) Medical journals recognized by the Secretary of Health and Human Services of the United States Government under the Federal Social Security Act.
(4) The following standard reference compendia:
(A) The American Hospital Formulary Service-Drug Information.
(B) Drug Facts and Comparisons.
(C) The American Dental Association Accepted Dental Therapeutics.
(D) The United States Pharmacopeia-Drug Information.
(5) Findings, studies, or research conducted by or under the auspices of Federal government agencies and federal research institutes recognized in the United States of America, including:
(A) The Agency for Healthcare Research and Quality.
(B) The National Institutes of Health.
(C) The National Cancer Institute.
(D) The National Academy of Sciences.
(E) The Centers for Medicare and Medicaid Services (CMS).
(F) The Food and Drug Administration (FDA).
(G) Any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of healthcare services.
(6) Any other medical or scientific evidence that is comparable to the sources listed in clauses (1)–(5) above.
(e) Categorical exclusion.— Means an express determination by a health plan not to provide coverage for a prescription drug, identifying the same by its scientific or brand name.
(f) Formulary.— Means a list of prescription drugs that has been developed by a health insurance organization or issuer or its designee, which is regularly evaluated to add or exclude prescription drugs, and which the health insurance organization or issuer or its designee references in determining pharmacy coverage.
(g) Prescription drug.— Means a drug that has been approved or regulated and that the Food and Drug Administration (FDA) has allowed to be marketed, and which the laws of Puerto Rico and the United States requires to be dispensed only through a prescription order.
(h) Prescription drug order or Prescription.— Means an order from a licensed, certified or otherwise legally authorized prescriber to a pharmacist for a prescription drug to be dispensed.
(i) Prescriber.— Means any healthcare professional legally authorized to issue prescription drug orders.
(j) Pharmaceutical Benefit Management Procedure or “PBMP” includes any of the following:
(1) A formulary;
(2) dose restrictions and quantity limits;
(3) prior authorization requirements, or
(4) step therapy requirements.
(k) Grievance.— Means a written complaint requesting a remedy submitted by or on behalf of a covered person or enrollee, for the actions or determinations of a health insurance organization or issuer regarding:
(1) The availability, delivery, or quality of healthcare services, including a complaint regarding an adverse determination made pursuant to utilization review;
(2) claims payment, handling, or reimbursement for healthcare services, or
(3) matters pertaining to the contractual relationship between a covered person or enrollee and a health insurance organization or issuer.
(l) Authorized representative.— Means:
(1) A person to whom the covered person or enrollee has given express written consent to represent him/her in requesting a medical exception pursuant to this chapter.
(2) A person authorized by law to provide substituted consent for a covered person or enrollee.
(3) A family member of the covered person or enrollee, or the healthcare professional who is treating such covered person or enrollee, when he/she is unable to provide consent.
(4) A healthcare professional who treats or dispenses prescription drugs to the covered person or enrollee, in order to request a medical exception on the latter's behalf, pursuant to the chapter.
(m) Dose restriction.— Means imposing a restriction on the number of doses of a prescription drug that will be covered during a specific time period.
(1) Dose restriction does not include:
(A) A restriction set forth in the coverage that limits the number of doses of a prescription drug that will be covered during a specific time period; or
(B) a restriction on the number of doses of a prescription drug when it has been withdrawn from the market by the drug's manufacturer or it cannot be supplied.
(n) Generic substitution.— Means the substitution of a generic version of a brand name prescription drug that has the same active ingredients, strength, and intended use as the brand name prescription drug, whose therapeutic equivalence has been recognized by the Food and Drugs Administration (FDA), and is coded as such in the Approved Drug Products with Therapeutic Equivalence Evaluations, better known as the “Orange Book”.
(o) Step therapy.— Means a type of protocol that specifies the sequence in which different prescription drugs for a given medical condition are to be prescribed.
History —Aug. 29, 2011, No. 194, § 4.030, eff. 180 days after Aug. 29, 2011.