Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

The GAO has issued a report entitled "Prescription Drug Control: DEA Has Enhanced Efforts to Combat Diversion, but Could Better Assess and Report Program Results." The GAO notes that the DEA has expanded resources and targeted investigation strategies to collaborate with state and local entities and enhance the effectiveness of its drug diversion investigations. Among other things, the GAO highlights the expansion of the DEA’s use of Tactical Diversion Squads to investigate criminal diversion, which has enabled the DEA to more than triple its number of regulatory investigations between FYs 2009 and 2010. While DEA has taken steps to ensure that investigators follow policies and procedures for such investigations, the GAO believes it could better assess how its efforts are reducing the diversion of prescription drugs. The GAO therefore recommends that DEA reassess the program’s performance measures to better link them to the goal of reducing diversion.

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The OIG has issued a report entitled “Oversight of the Prescriber Identifier Field in Prescription Drug Event Data for Schedule II Drugs." Based on an audit of Prescription Drug Event (PDE) records for Schedule II drugs, the OIG found that approximately 228,000 PDE records with invalid prescriber identifiers accounted for about $20.6 million in gross drug costs in 2007. The OIG recommends that CMS take steps to ensure that Part D plan sponsors include a valid Drug Enforcement Administration number on all PDE records involving Schedule II drugs. CMS did not concur with the OIG’s recommendations, citing the need to ensure that Medicare beneficiaries have access to critical medications. 

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On June 29, 2010, the Drug Enforcement Administration (DEA) published a notice requesting public comment on whether revisions to the DEA regulations are feasible and warranted to facilitate residents of long-term care facilities to receive controlled substance medications, while adhering to the framework of the Controlled Substances Act. Comments will be accepted until August 30, 2010.

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On March 31, 2010, the Drug Enforcement Administration (DEA) issued an interim final rule with comment period allowing practitioners to write prescriptions for controlled substances electronically and permitting pharmacies to receive, dispense, and archive these electronic prescriptions. The DEA lists a number of expected benefits to the rule. First, the policy will give pharmacies, hospitals, and practitioners “the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing.” In addition, the rule is expected to reduce paperwork for DEA registrants who dispense controlled substances and potentially reduce prescription forgery. Moreover, the regulations may reduce prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Finally, the rule is expected to help pharmacies and hospitals integrate prescription records into other medical records more directly, which may increase efficiency and potentially reduce the time patients wait to have their prescriptions filled. While the rule is effective June 1, 2010, comments will be accepted until that date. Note that this rule has been classified as a major rule subject to Congressional review; the DEA will publish a subsequent Federal Register document if the effective date is changed or the rule is withdrawn as a result of the Congressional Review.

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