DEA Forms 106 Must Be Submitted Online Only
The DEA has issued a final ruling that beginning July 24th, 2023, all DEA Forms 106 must be submitted online exclusively. This is a change from previously accepting paper submissions in addition to electronic submissions. This Rule also requires all submissions to be filed within 45 days after discovery of the theft or loss. This Rule does not affect the requirement that registrants are to also inform the DEA, in writing, of the theft or loss within one business day of discovery.
FTC Votes to Issue Statement Withdrawing Prior PBM Advocacy
The Federal Trade Commission voted unanimously on July 20, 2023 to issue a statement cautioning against reliance on prior advocacy statements and studies related to pharmacy benefit managers (PBMs) that no longer reflect current market realities.
The Commission’s statement warns against relying on nine advocacy letters published or issued between 2004 and 2014 that advocated against proposals to increase regulatory oversight and transparency of PBMs. The statement also cautions against reliance on a 2004 joint report with the Department of Justice and a 2005 FTC study, as these reports may no longer accurately reflect the current PBM industry.
The FTC is in the process of an ongoing study of the PBM industry that began in June 2022. The inquiry is aimed at shedding light on several practices that have drawn scrutiny in recent years including:
- fees and clawbacks charged to unaffiliated pharmacies;
- methods to steer patients towards pharmacy benefit manager-owned pharmacies;
- potentially unfair audits of independent pharmacies;
- complicated and opaque methods to determine pharmacy reimbursement;
- the prevalence of prior authorizations and other administrative restrictions;
- the use of specialty drug lists and surrounding specialty drug policies;
- the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.
