Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Sunday, December 7, 2014
Express Scripts suit over compounded drugs signals future
Payers and PBMs have not excluded reimbursement pathways for compounds when there are no approved alternatives. Creating policy that would indiscriminately pay for chemicals that cannot be verified as fit for their intended use through a reasonable patient-risk-and-harm mitigating mechanism would be reckless. Even purported DMF-holding chemicals may be inappropriately handled in distribution chains, and they may be used to compound dosage forms for routes of administration not covered under the DMF.
While it may be less expensive to pay for drugs made from scratch in facilities licensed to dispensing of drugs than to pay for drugs produced according to federal standards, there are alternative ways to meet access and affordability goals that do not transfer an added burden of risk to patients.
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Payers and PBMs have not excluded reimbursement pathways for compounds when there are no approved alternatives. Creating policy that would indiscriminately pay for chemicals that cannot be verified as fit for their intended use through a reasonable patient-risk-and-harm mitigating mechanism would be reckless. Even purported DMF-holding chemicals may be inappropriately handled in distribution chains, and they may be used to compound dosage forms for routes of administration not covered under the DMF.
While it may be less expensive to pay for drugs made from scratch in facilities licensed to dispensing of drugs than to pay for drugs produced according to federal standards, there are alternative ways to meet access and affordability goals that do not transfer an added burden of risk to patients.
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