Fraud, Waste, and Abuse

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Permissibility of Pharmaceutical Copayment Coupon Programs Under ACA
Bloomberg BNA’s Health Care Fraud Report by Kevin G. McAnaney (August, 2013).

In this article, Washington lawyer Kevin G. McAnaney, former chief of the Industry Guidance Branch, Office of Counsel to the HHS Inspector General, explains that the use of copay coupons in connection with federally-subsidized health insurance plans under the Accountable Care Act (ACA) would likely violate federal anti-kickback laws.

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Combatting the Prescription Painkiller Epidemic: A National Prescription Drug Reporting Program
Emory University School of Law Legal Studies Research Paper Series, Research Paper No. 13-246 by Joanna Shepherd (June, 2013).

In this paper, Professor Shepherd suggests that a national prescription drug reporting program building on existing pharmacy benefit manager (PBM) networks could be significantly more effective than existing state Prescription Drug Monitoring Programs in detecting prescription drug abuse.

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Myths and Realities of Medication Waste in Medicare Part D
Pharmaceutical Care Management Association Report prepared by Visante (March, 2013).

This report refutes the assertions that medication wastage is: 1) a significant problem in Medicare Part D; 2) more prevalent in mail-service than retail pharmacy; and 3) is largely caused by how a drug is dispensed. It concludes that: 1) less than 1% of medications are “wasted” in Medicare Part D; 2) two-thirds of wastage occurs among prescriptions dispensed by drugstores; and 3) wastage is largely due to discontinuation of therapy, switching to a different drug, changing dosage, death, and other reasons unrelated to how patients fill prescriptions.

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Prescription Drug Monitoring Programs
Congressional Research Service (July 10, 2012).

This Congressional Research Service report provides an overview of state prescription drug monitoring programs (PDMPs) — electronic databases of prescriptions dispensed for controlled substances. Information collected by PDMPs may be used to support access to and legitimate medical use of controlled substances; identify or prevent drug abuse and diversion; facilitate the identification of prescription drug-addicted individuals and enable intervention and treatment; outline drug use and abuse trends to inform public health initiatives; or educate individuals about prescription drug use, abuse, and diversion as well as about PDMPs.

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Drug Pricing:  Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement
GAO Report to Congressional Committees (September, 2011)

In this report, GAO finds that the Health Resources and Services Administration (HRSA), which is responsible for administering the section 340B discount drug program, has provided inadequate oversight of the program and cannot ensure that covered entities and drug manufacturers are in compliance with program requirements – such as the requirement that entities transfer drugs purchased at 340B prices only to eligible patients.  GAO finds that HRSA relies on participant self-policing to ensure program compliance, but has not issued guidance with the necessary level of specificity to provide clear direction, making it possible for participants to interpret the guidance in ways inconsistent with the agency’s intent.

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Drug Offenses: Maximum Fines and Terms of Imprisonment for Violation of the Federal Controlled Substances Act and Related Laws
Congressional Research Service (August 2011).

This Congressional Research Service Report provides a chart showing the maximum fines and terms of imprisonment that may be imposed as a consequence of conviction for violation of the federal Controlled Substances Act (CSA) and other drug supply and drug demand related laws.

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Legal Issues Relating to the Disposal of Dispensed Controlled Substances
Congressional Research Service (October 19, 2010).

This Congressional Research Service report reviews the legal issues governing disposal of dispensed controlled substances, summarizes the federal Controlled Substances Act, and discusses 111th Congress legislation.

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Other Reports and White Papers

 

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