Insurance Companies Want Blood for Drug

*The Angry Moms have hidden Lucy’s name and location out of concern that it will negatively affect her access to clozapine.

Lucy* has been taking clozapine for more than 20 years. It is the only medication that works for her serious symptoms of schizophrenia. In August 2024, she went to her clinic’s on-site Genoa pharmacy to pick up her monthly clozapine prescription. Instead, the Genoa pharmacist handed her a rejected claim form.

Lucy’s Medicare plan would not cover the prescription cost because the REMS Dispense Authorization (RDA) number hadn’t been submitted with the pharmacy claim. The RDA is a unique code generated by clozapine’s Risk Evaluation and Mitigation Strategy (REMS). The RDA is intended to ensure a “safe use” condition before authorizing the pharmacy to release the clozapine prescription. The Genoa pharmacy had not received an Absolute Neutrophil Count (ANC) blood test result, so they sent Lucy for another blood draw, with overnight processing, and told her to come back the next day.

The barriers to clozapine treatment are profound: transportation, prescriber refusal, phlebotomy challenges, lab order mix-ups, denied blood draws for unpaid balances, “bad sticks,” data entry delays, pharmacist inexperience, controlled substance mentality, REMS program confusion, non-participating pharmacies, liability fears, restricted distribution… and now the insurance provider wants blood too?

Will the “No blood, No drug” policy ever end?

In fact, those are the exact words Lucy’s clinical nurse used when they sent her home with no clozapine: “No blood, no drug.” Neither the pharmacy nor the clinical team thought to ask if Lucy had any extra clozapine to ensure her medication therapy was not interrupted while her ANC result was pending. She was offered no antipsychotic substitution, no anticholinergic mitigations, and no re-titration instructions for the imminent interruption. The Genoa pharmacist seemed genuinely confused when Lucy made a fuss.

The Angry Moms did some investigation into why Lucy went home empty-handed. We have discovered some major problems:

• Medicare’s refusal to cover Lucy’s clozapine without an RDA number negates the FDA’s “enforcement discretion,” which expressly states that pharmacists may dispense clozapine without an RDA. This Medicare policy directly conflicts with the FDA’s current position, and both low-income and disabled populations are more likely to be affected.

  
  

• The duplicative prescriber requirement of ANC entry alongside a monthly Patient Status Form (PSF) means PSFs are frequently expired, regardless of patient testing status. No RDA is granted in this case. Even though "dispense rationales" may be used to override the PSF expiration to obtain the RDA, there is a limit of three per year, and most pharmacists don't understand the process.

  
  

• The REMS program formally allows a 37-day window to complete the monthly testing requirements (rightly so because blood test results can take several days), but the “dispense rationale” only specifies a 30-day window. By nature, PSF expiration conditions are much more likely to occur during the 7-day grace period.

  
  

• Pharmacists frequently confuse the RDA number received from the REMS as being tied to ANC rather than PSF status; often, the pharmacist won't even request the RDA until they have the ANC result in hand. This is how Genoa treated Lucy’s prescription.

With The Angry Mom's help, Lucy contacted the REMS agency to determine exactly why Genoa sent her home empty-handed. We discovered:

• Lucy had a passing ANC test exactly 30 days prior, and the PSF was current on the day of the denied prescription.

  
  

• The pharmacy should NOT have refused to dispense Lucy’s clozapine, and she did not need an ANC result at that moment. Genoa was applying an unnecessary additional requirement of having an ANC result before requesting an RDA.

  
  

• An RDA would have been approved during Lucy’s August visit if the pharmacist had requested it.

  
  

• The pharmacist would have been authorized to dispense the full 30 days’ supply.

  
  

• The pharmacy made Lucy come to the clinic twice on two different days, needlessly, because they refused to dispense her clozapine until the ANC was available the following day.

  
  

• The prescriber could have easily and justifiably signed off Lucy’s PSF with the missing ANC value by selecting the “extrinsic factors” option. Still, even in that case, Genoa’s requirement to have an ANC result would have likely blocked the prescription.

  
  

• Lucy had to use a day of "stockpile" to avoid missing doses.

  
  

• Lucy’s Medicare plan is ready to accept the costs and consequences of interrupted clozapine treatment: rebound psychosis, cholinergic rebound, catatonia, worsening disability, and an imminent hospitalization, rather than align with the FDA’s “enforcement discretion” policy.

  
  

• Lucy’s clinical team and the Genoa pharmacy are also willing to accept these risks and consequences rather than follow the current clozapine REMS procedures.

Most readers won’t understand this complex saga of Lucy and her blocked clozapine prescription unless, of course, you already live this nightmare.

Now, imagine that you have schizophrenia and that your life depends on understanding all of this.

The Angry Moms