Executive Summary
ASHP stands opposed to payer-mandated white bagging models that jeopardize optimal, safe, and effective medication use. Payer-mandated distribution models that require clinician-administered drugs to be dispensed exclusively via third-party specialty pharmacies threaten to compromise provider efforts to ensure patient safety and negatively impact pharmacists’ ability to validate medication integrity and maintain oversight of storage and handling.
ASHP believes that patients and providers must have choice in obtaining clinician-administered drugs, and that payers should not be permitted to unilaterally require methods of distribution that disrupt the patient experience and impair the provider’s ability to provide optimal patient care. The recommendations below outline measures needed to ensure clinician-administered drugs are dispensed in a manner that optimizes patient safety and enables the highest quality of care in all settings.
1. Define clinician-administered drugs
Effective policy must clearly establish which medications are subject to payer-mandated white bagging. An overly broad definition could result in unintended barriers that negatively affect patient access to self-administered medications. Conversely, an overly narrow definition may leave regulatory gaps that bad actors could continue to exploit at the expense of patient safety and quality of care.
Model legislative text:
"Clinician-administered drug" means an outpatient prescription drug other than a vaccine that:
(A) cannot reasonably be self-administered by the patient to whom the drug is prescribed or by an individual assisting the patient with the self-administration; and
(B) is typically administered:
(i) by a health care provider authorized under the laws of this state to administer the drug, including when acting under a physician ’s delegation and supervision; and
(ii) in a physician ’s office, hospital outpatient infusion center, or other clinical setting.
2. Require health plans to permit enrollees to obtain clinician-administered drugs directly from the administering facility on equal financial terms
Plans should be required to make clinician-administered drugs available directly from the administering provider on equal financial terms. Prohibited monetary advantage or penalty includes higher copayment, a reduction in reimbursement for services, or promotion of one participating pharmacy over another.
Model legislative text:
A health benefit issuer shall not:
(1) refuse to authorize, approve, or pay a participating provider for providing covered clinician-administered drugs and related services to covered persons;
(2) impose coverage or benefits limitations, or require an enrollee to pay an additional fee, higher copay, higher coinsurance, second copay, second coinsurance, or other penalty when obtaining clinician-administered drugs from a health care provider authorized under the laws of this state to administer clinician-administered drugs, or a pharmacy;
(3) interfere with the patient's right to choose to obtain a clinician-administered drug from their provider or pharmacy of choice, including inducement, steering, or offering financial or other incentives.
3. Permit any qualified specialty pharmacy to dispense clinician-administered drugs
In cases where administering providers choose to obtain clinician-administered drugs via a specialty pharmacy, providers should also be given freedom to obtain such drugs from any qualified specialty pharmacy on equal financial terms.
Model legislative text:
A health benefit issuer shall not:
(1) require clinician-administered drugs to be dispensed by a pharmacy selected by the health plan;
(2) limit or exclude coverage for a clinician-administered drug when not dispensed by a pharmacy selected by the health plan, if such drug would otherwise be covered;
(3) reimburse at a lesser amount clinician-administered drugs dispensed by a pharmacy not selected by the health plan;
(4) condition, deny, restrict, refuse to authorize or approve, or reduce payment to a participating provider for a clinician-administered drug when all criteria for medical necessity are met, because the participating provider obtains clinician-administered drugs from a pharmacy that is not a participating provider in the health benefit issuer’s network;
(5) require that an enrollee pay an additional fee, higher copay, higher coinsurance, second copay, second coinsurance, or any other form of price increase for clinician-administered drugs when not dispensed by a pharmacy selected by the health plan.
4. Prohibit plans from requiring brown bagging for any clinician-administered drug
Payers should not require any clinician-administered drug to be dispensed directly to a patient. There is strong clinical consensus that requiring patients to properly store and transport a drug to their clinician for administration jeopardizes patient safety.
Model legislative text:
A health benefit issuer shall not require a specialty pharmacy to dispense a clinician-administered medication directly to a patient with the intention that the patient will transport the medication to a healthcare provider for administration.
5. Prohibit plans from requiring home infusion and/or alternative sites of care for any clinician-administered drug
The decision whether or not to use home infusion should be made by providers and patients in cases where a provider and patient determine that drugs can be safely shipped, stored and administered in the patient’s home.
Model legislative text:
A health benefit issuer may offer, but shall not require:
(1) the use of a home infusion pharmacy to dispense clinician-administered drugs to patients in their homes or;
(2) the use of an infusion site external to a patient’s provider office or clinic.