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) › § 9047 - Medical exceptions approval process requirements and procedures

(a) If the health insurance organization or issuer that provides prescription drug benefits and manages this benefit through the use of a formulary or through the application of a dose restriction that causes a prescription for a particular drug not to be covered for the number of doses prescribed, or step therapy requirement that causes a particular drug not be covered until the requirements of that management process have been met, the health insurance organization or issuer shall establish and maintain a medical exceptions process that allows covered persons or enrollee, or their authorized representatives, to request approval for:
(1) A prescription drug that is not covered based on the formulary;
(2) continued coverage of a particular prescription drug whose coverage the health insurance organization or issuer shall discontinue from the formulary for reasons other than safety or because the prescription drug cannot be supplied or has been withdrawn from the market by the drug's manufacturer, or
(3) an exception to a management process that causes a prescription drug to not be covered until the step therapy requirement is satisfied or not be covered at the prescribed number of doses.
(b)
(1) A covered person or enrollee, or his/her authorized representative, may only file a written request under this section if the prescribing provider has determined that the requested prescription drug is medically necessary to treat the covered person or enrollee's disease or medical condition because:
(A) There is no prescription drug listed on the formulary that is a clinically acceptable alternative to treat the covered person or enrollee's disease or medical condition.
(B) The prescription drug alternative listed on the formulary or required in accordance with step therapy requirements:
(i) Has been ineffective in the treatment of the covered person or enrollee's disease or medical condition or, based on clinical, medical, and scientific evidence and the known relevant physical or mental characteristics of the covered person or enrollee and known characteristics of the drug regimen, is likely to be ineffective or adversely affect the drug's effectiveness or patient compliance; or
(ii) has caused or, based on clinical, medical, and scientific evidence, is likely to cause an adverse reaction or other harm to the covered person or enrollee, or
(iii) the covered person or enrollee was at the top level of a step therapy under another health plan, so that it would be unreasonable to start in a lower step therapy level.
(C) The doses available under a dose restriction for the prescription drug has been ineffective in the treatment of the covered person or enrollee's disease or medical condition or, based on clinical, medical, and scientific evidence and the known relevant physical or mental characteristics of the covered person or enrollee and known characteristics of the drug regimen, is likely to be ineffective or adversely affect the drug's effectiveness or patient compliance.
(2)
(A) The health insurance organization or issuer may require the covered person or enrollee, or his/her authorized representative, to provide a written certification from the prescribing provider of the determination made under clause (1).
(B) The health insurance organization or issuer may require the written certification to include only the following information:
(i) The name, group or contract number, subscriber number.
(ii) Patient history.
(iii) The primary diagnosis related to the requested prescription drug that is the subject of the medical exception request.
(iv) The reason:
(I) Why the formulary drug is not acceptable for that particular patient;
(II) if the medical exception request involves a step therapy requirement, why the prescription drug required is not acceptable for that particular patient, or
(III) if the medical exception request involves a dose restriction, why the available number of doses for the prescription drug is not acceptable for that particular patient.
(v) The reason why the prescription drug that is the subject of the medical exception request is needed for the patient or, if the medical exception request involves a dose restriction, why an exception to the dose restriction is needed for that particular patient.
(c)
(1) Upon receipt of a medical exception request made pursuant to this section, the health insurance organization or issuer shall ensure that the request is reviewed by appropriate healthcare professionals who, depending on the health condition for which the medical exception is requested, in reaching a decision on the request, shall take into account the specific facts and circumstances that apply to the covered person or enrollee for whom the request has been made using documented clinical review criteria that:
(A) Are based on solid clinical, medical, and scientific evidence, and
(B) if available, appropriate practice guidelines, which may include generally accepted practice guidelines, evidence-based practice guidelines, practice guidelines developed by the health insurance organization or issuer's Pharmacy and Therapeutics Committee, or any other practice guidelines developed by the federal government or by national or professional medical or pharmacist societies, boards, and associations.
(2) The healthcare professionals designated by the health insurance organization or issuer to review the medical exceptions request shall ensure that the decision reached on such request is consistent with the benefits and exclusions under the covered person or enrollee's health plan. The healthcare professionals designated to review medical exception requests shall have experience in the management of prescription drugs. Such determinations shall be duly stated in a report, which shall include the qualifications of the healthcare professionals who made such determination.
(d)
(1) The medical exceptions process under this section shall require the health insurance organization or issuer to make a decision on a request made and provide notice of the decision to the covered person or enrollee, or his/her authorized representative, as quickly as the covered person or enrollee’s particular medical condition requires, but in no event later than seventy-two (72) hours after the date of receipt of the request, or the date of receipt of the certification, if required by the health insurance organization or issuer pursuant to subsection (b)(2), whichever is later. In the case of controlled drugs, such term shall not exceed thirty-six (36) hours.
(2)
(A) If the health insurance organization or issuer fails to make a decision on the request and provide notice of the decision within the aforementioned time:
(i) The covered person or enrollee shall be entitled, for a term of thirty (30) days, to the supply of the prescription drug that is the subject of the request and, as the supply is requested or prescribed, in the case of step therapy, for the term established in the coverage.
(ii) the health insurance organization or issuer shall make a decision on the medical exception request prior to the covered person or enrollee's completion of the supply.
(B) If the health insurance organization or issuer fails to make a decision on the medical exception request and provides notice of such decision prior to the covered person or enrollee's completion of the supply, the health insurance organization or issuer shall maintain coverage on the same terms on an ongoing basis, as long as the prescription drug continues to be prescribed for that covered person or enrollee and is considered safe for the treatment of his/her disease or medical condition, unless the applicable benefit limits have been exhausted.
(e)
(1) Whenever a medical exception request made under this section is approved, the health insurance organization or issuer shall provide coverage for the prescription drug that is the subject of the request and not require the covered person or enrollee to request approval under this section for a refill or anew prescription to continue using the prescription drug after the refills for the initial prescription have been exhausted. All of the foregoing shall be subject to the terms of the prescription drugs coverage under the health plan, provided:
(A) That the covered person or enrollee's prescribing provider continues to prescribe such prescription drug to treat the same disease or medical condition, and
(B) the prescription drug continues to be considered safe for treating the covered person or enrollee's disease or medical condition.
(2) The health insurance organization or issuer shall not establish a special formulary tier, co-payment, or other cost-sharing requirement that is applicable only to prescription drugs approved through medical exception requests.
(f)
(1) Any denial of a medical exception request made by a health insurance organization or issuer:
(A) Shall be notified to the covered person or enrollee or, if applicable, to his/her authorized representative, in writing or electronically, if the covered person or enrollee has agreed to receive information in this manner;
(B) shall be notified electronically to the prescribing provider or, upon request, in writing, and
(C) may be appealed by filing a grievance pursuant to the chapter on Health Insurance Organization or Issuer Grievance Procedures of this Code.
(2) The denial shall, in a manner that is comprehensible to the covered person or enrollee or, if applicable, his/her authorized representative, set forth:
(A) The specific reasons for the denial;
(B) a reference to the evidence or documentation, including the clinical review criteria practice guidelines, and clinical, medical, and scientific evidence considered in reaching the decision to deny the request;
(C) instructions for requesting a written statement of the clinical, medical, or scientific rationale for the denial, and
(D) a description of the process and procedures that must be followed for filing a grievance to appeal the denial pursuant to the chapter on Health Insurance Organization or Issuer Grievance Procedures of this Code, including anytime limits applicable to those procedures.
(g) A health insurance organization or issuer shall not be required to establish a medical exception request process or to comply with the provisions of subsections (b), (c), (d), (e)(1), and (f) of this section if such health insurance organization or issuer:
(1) Has an expedited utilization review process as provided in the chapter on Utilization Review and Benefit Determination of this Code, and
(2) allows covered persons or enrollees, or their authorized representatives, to use this process to seek approval for coverage of a prescription drug that is not covered because of formulary or other management process.
(h) This section shall be construed to allow a covered person or enrollee to use the medical exceptions process set forth herein to request coverage for a prescription drug that is categorically included from coverage under the covered person or enrollee’s health plan.
History —Aug. 29, 2011, No. 194, § 4.070, eff. 180 days after Aug. 29, 2011; July 10, 2013, No. 55, § 4, eff. 30 days after July 10, 2013.