Bill to reform delivery of specialty medicines placed on suspense file, awaits further fiscal analysis

Senate Bill 958, also known as the Medication and Patient Safety Act of 2022, was placed on the Senate Suspense File earlier this month at its Senate Appropriations Committee hearing.

 

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The bill, sponsored by Sens. Monique Limon (D–Santa Barbara) and Anthony Portantino (D–La Canada Flintridge), would restrict health plans from requiring or incentivizing patients to have infused or injected specialty medications supplied by a vendor, which is often specified by the health plan, to the patient or to the patient’s physician, rather than maintained at the location where the infused or injected medication will be administered. This process is known as “white bagging.”

The bill specifically stipulates that numerous conditions must be met in order for these medications to be supplied by a vendor specified by the health plan, including that the drug choice or dose does not depend on the enrollee’s same-day clinical presentation, and that the vendor delivers the drug within the time period needed by the enrollee. The vendor would also be required to ensure that the drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.

Limon says the ultimate goal of this bill is to ensure that patients with complex and life threatening illnesses who need specialty medications administered by a doctor or nurse, such as chemotherapy, can receive the necessary medication in a safe and timely manner. 

“White bagging can result in significantly delayed treatment, which may put the patient’s health at risk,” she said at a Senate Health Committee Meeting in April. “For example, if the same-day test requires a different strength or different medication, then the medical provider must reorder the medication and reschedule the appointment. Requiring a patient to wait for the health plan to arrange to have the medication shipped or needing to reschedule the whole appointment because the medication was not correct or did not arrive on time not only causes undue stress, but is detrimental to the success of the overall treatment plan.”

Limon also emphasized that the bill does not completely prohibit the current practice of health plans requiring hospitals and physicians to order specialty medications from a third-party pharmacy, but rather sets appropriate safeguards to ensure patient safety and prevent delayed and suboptimal care, patient distress, and unnecessary hospital admissions.

Opponents of the bill, including the California Association of Health Plans and the Association of California Life and Health Insurance Companies, say the specialty pharmacies that are providing these medications are used only for prescription drugs that may be safely delivered to the physician, and that they are on the hook for the cost of these very expensive drugs due to any spoilage or delays, and so therefore are incentivized to handle these drugs with care.

Opponents say they also object to the bill’s provision that allows a provider to unilaterally initiate the patient-specific exception process to white bagging without approval from the patient. According to the bill, this exception process is initiated when the treating health care provider tells the health plan that, in the provider’s reasonable medical judgment, it is unsafe or inappropriate for the enrollee to receive the medication from the plan’s preferred vendor based on characteristics such as the drug’s profile and stability, and required storage and preparation conditions. 

The opponents maintain that, due to the significant cost difference between drugs provided by the specialty pharmacy and those provided by the hospital or physician’s office, providers should not be permitted to make unilateral requests to “protect their profits.”

The bill now awaits its suspense hearing, after which it will either move on to the Senate Floor for further consideration or be held in committee and under submission.