There’s not enough oversight to ensure hospitals and other providers aren’t double-dipping on prescription drug discounts through the 340B and Medicaid Drug Rebate Programs, according to the U.S. Government Accountability Office (GAO). To lessen that risk, the GAO recommended that the Centers for Medicare & Medicaid Services ensure that state Medicaid programs have written policies and procedures that specify the extent to which covered entities can use 340B drugs for Medicaid beneficiaries, are designed to effectively identify if 340B drugs were used and, if so, how they should be excluded from Medicaid rebate requests. The GAO also is advising the Health Resources and Services Administration (HRSA) to assess covered entities' compliance with state Medicaid policies regarding the use and identification of 340B drugs as part of its audit process. In addition, the HRSA should require covered entities to work with affected drug manufacturers on repaying duplicate discounts in Medicaid managed care, the GAO said.
The U.K.’s National Institute for Health and Care Excellence (NICE) passed on Johnson & Johnson’s Spravato (esketamine) nasal spray, citing uncertainties over its clinical and cost-effectiveness even as a third-line therapy for treatment-resistant depression. Noting a lack of evidence comparing Spravato with all relevant treatment options, NICE concluded that the estimates of the drug’s cost-effectiveness likely would be much higher than what the National Health Service usually considers value for money. The concern extended beyond the cost of the drug itself, as putting the nasal spray into clinical practice would require changes in the structure and delivery of depression treatment. “Estimates of the costs of providing the clinical service for esketamine were highly uncertain, as are the costs of repeated courses of the drug,” said Meindert Boysen, director of NICE’s center for health technology evaluation.
It’s not just drug companies and distributors being investigated in the U.S.-wide crackdown on opioid marketing. Practice Fusion Inc., a San Francisco-based developer of electronic health records (EHR) software, agreed to pay a total of $145 million to resolve criminal and civil investigations involving kickbacks. In resolving the criminal investigation, Practice Fusion admitted “that it solicited and received kickbacks from a major opioid company in exchange for utilizing its EHR software to influence physician prescribing of opioid pain medications,” according to the U.S. Department of Justice. The civil settlements involved allegations that Practice Fusion accepted kickbacks from more than a dozen drug companies in exchange for implementing clinical decision support alerts in its EHR software that were designed to increase prescriptions for their drugs and causing the submission of false claims to federal health care programs. In a separate case, Alexandru Burducea, a New York doctor, was sentenced Jan. 27 in federal court to 57 months in prison in connection with a scheme to prescribe Insys Therapeutics Inc.’s Subsys, a potent fentanyl-based spray, in exchange for bribes and kickbacks from the manufacturer. Burducea, who pleaded guilty last year, is one of five New York doctors convicted in the bribery conspiracy.
With cancer drugs being promoted more in TV ads, the FDA is proposing a study to determine whether disclosing information about common endpoints that support a drug’s cancer indication helps consumers understand the drug’s efficacy. The study also will test whether consumers adequately comprehend indication statements when portions of the indication are presented only in superimposed text while other information is being conveyed in the audio, according to a notice scheduled for publication in the Jan. 29, 2020, Federal Register. Comments on the proposed research should be submitted to Docket No. FDA-2019-N-2313 by Feb. 28, 2020.