Your plan denied your medication: the medical exception and its 48 hours

The law describes three things a plan does that block you: the formulary, the list of covered drugs; the dose limit, which covers less than you were prescribed; and step therapy, which requires you to fail first on another drug before covering the one your physician wants. The medical exception is the door against all three. It only applies if the prescriber determines the requested drug is medically necessary because there is no clinically acceptable alternative on the formulary; or because the alternative has been ineffective, or is very likely to be per the clinical evidence, or has caused or is very likely to cause an adverse reaction or other harm; or because you were already at a more advanced step in another plan’s step therapy, making it unreasonable to start again at a lower step.

Every covered or insured person whose plan provides prescription drug benefits and manages them with a formulary, dose limits or step therapy. The request may be made by the covered person or their personal representative, and must be in writing. Two limits the law sets expressly: the medical exception procedure cannot be used to request coverage of a drug categorically excluded from your plan, and it does not apply in the same way if the insurer has an expedited utilization review procedure and lets you use it to request approval of a drug not covered because of the formulary or another management procedure.

• That the prescriber determines the requested drug is medically necessary for one of the reasons the law lists.Verified against the official source
• That the request be in writing, made by the covered person or their personal representative.Verified against the official source

• The prescriber’s certification, if the insurer requires it. The law limits what it may ask for: name, group or contract number and subscriber number; patient history; related primary diagnosis; the reason the formulary drug is not acceptable for that patient; and the reason the requested drug is needed.

1. 1

   Step 1: Request the medical exception in writing

   The request is made by you or your personal representative, and must be in writing. It may be for a drug not on the formulary, for continued coverage of one the plan will drop for reasons other than health or manufacturer supply, or for an exception to step therapy or the dose limit. Date everything: the law’s deadlines run from receipt of the request, or of the medical certification if the insurer asks for it, whichever comes later.

2. 2

   Step 2: Have your physician write the exact reason

   The law lists the valid reasons and the certification should use those words: that there is no drug on the formulary that is a clinically acceptable alternative; that the formulary alternative or the one required by step therapy has been ineffective, or per the clinical evidence is very likely to be, or that its efficacy or your adherence will be affected; that it has caused or is very likely to cause an adverse reaction or other harm; that you were already at a more advanced step of step therapy in another plan; or that the dose available under the limit has been or likely will be ineffective.

3. 3

   Step 3: Demand the temporary coverage from day one

   This is the part that keeps you from going without treatment. The insurer, the PBM or any entity delegated pharmacy administration must provide immediate temporary coverage for the initial prescription during the request process and until it notifies its final determination in writing, when the physician states in writing that the drug is medically necessary. It must pay the pharmacy for that initial prescription while it adjudicates, and the pharmacy may bill electronically: the insurer must accept the electronic bill and may not require a paper invoice as a condition of payment.

4. 4

   Step 4: Count the 48 hours — or the 24

   The determination is notified with the urgency your medical condition requires, and in no case may it exceed forty-eight (48) hours from receipt of the request, or of the certification if the insurer asked for it, whichever is later. For controlled drugs, the term must not exceed twenty-four (24) hours. If they miss it: you are entitled for thirty (30) days to the supply of the drug requested, and the insurer must make the determination before you finish what was supplied. And if it still does not decide before you run out, it must maintain coverage on the same terms and continuously while the drug keeps being prescribed to you and is considered safe for your condition.

5. 5

   Step 5: If it is approved, they cannot price it up

   Once the exception is approved, the insurer provides coverage and may not require you to seek approval again for a refill or a new prescription of the same drug, as long as it keeps being prescribed for the same condition and is still considered safe. And there is an express prohibition: the insurer shall not establish a special formulary tier, copay or other cost-sharing requirement applicable only to drugs approved through medical exceptions.

6. 6

   Step 6: If it is denied, demand the denial say why

   The denial is notified to you in writing, or electronically if you agreed to receive it that way, and also to the prescriber. The law requires it to state, understandably: the specific reasons; references to the evidence or documentation, including the clinical review criteria, practice guidelines and the clinical, medical and scientific evidence considered; instructions on how to request a written statement of the clinical justification; and a description of the process to file a grievance and appeal, with its deadlines. A denial that does not say those things is incomplete under the text.

The request goes to your insurer or to whoever administers your pharmacy benefit. To appeal, the Code itself points to its Chapter on Internal Grievance Procedures of Health Insurance Organizations. If the problem persists, the Office of the Insurance Commissioner regulates insurers and the Office of the Patient Advocate receives claims. A note for anyone on the Government Health Plan: Act 142-2020 ordered ASES to adopt these same amendments by regulation so they apply equally to the Government Plan, and subjected non-compliance to the same Code sanctions.

• Looking for the rules in Act 142-2020: its substantive sections are "omitted" and live in Article 4.070 of the Health Insurance Code.
• Leaving the pharmacy without medication: the law requires immediate temporary coverage while the exception is decided.
• Not dating the request or the medical certification, which is where the 48 or 24 hours run from.
• Accepting a denial that gives no specific reasons and does not explain how to appeal.
• Letting them charge a special copay for a drug approved by exception, which the law prohibits.
• Not demanding that manufacturer coupons and discounts count toward your out-of-pocket maximum.
• Requesting the exception for a drug your plan categorically excludes: the law says that is not the procedure.

These are the government pages this guide is based on.

• Oficina del Comisionado de Seguros (OCS)

  OCS

  bvirtualogp.pr.gov

• Office of the Insurance Commissioner

  OCS

  ocs.pr.gov

• File your claim — Patient Advocate

  OPP

  www.opp.pr.gov