Forensic Analysis in Drug Litigation Finds Most Errors Occur with Commonly Used Therapies and Practices

In previous columns, we have explored various ways in which the historical basis for pharmacy and therapeutics (P&T) committees’1 accreditation requirements and litigation matters have driven the need for sound P&T committees within health care entities. The importance of rational drug-use policy was covered in this column in 20172 and the topic has gained additional exposure as a result of recent Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) initiatives. FDA Commissioner Scott Gottlieb accelerated the approval of generic drugs, new chemical entities, and biologic drug approvals during 2018, resulting in a significant increase in the number of available products on the market.3–5 CMS Commissioner Sumer Verma has put out a Request for Information Notice seeking public comment regarding the appropriateness of some Medicare-approved accrediting organizations (AOs) offering fee-based consultative services to Medicare-participating providers and suppliers that they also accredit as part of their business model—i.e., the Joint Commission and others.6 Beyond cost-sharing or changing reimbursement rates for drugs, Verma has reiterated the role of managed care-associated P&T drug-product selection rules in determining coverage in Medicare programs (parts B, C, D).7 Open in a separate window F. Randy Vogenberg