What's in a number? Recommending practicality in the DATA 2000 patient limits.

According to the Substance Abuse and Mental Health Services Administration, 2.4 million individuals have an opioid use disorder (OUD). Yet, nearly 80 percent of them-more than 1.9 million people-do not receive treatment. Medication-assisted treatment (MAT), specifically with buprenorphine, has proven to be effective in treating patients with OUDs while also reducing costs to the healthcare system, criminal justice system, and workforce. Despite its effectiveness, barriers to MAT continue to exist. Consequently, many individuals must wait months, if not years, to receive treatment. This article analyzes the US Department of Health and Human Services' final rule (Final Rule) on MAT, common barriers to treatment, and the cost-benefit of treatment in light of the current opioid abuse epidemic. The article finds that while the Final Rule was a step in the right direction, it does not go far enough to adequately address the epidemic. Finally, the article proposes practical recommendations for increasing patient access to treatment for OUDs, including increasing the patient limit for highly qualified addiction treatment providers so that they can practice addiction medicine on a full-time basis and exempting buprenorphine products labeled by the US Food and Drug Administration for direct administration from the practitioner's patient limit.

Abuse-deterrent formulations: transitioning the pharmaceutical market to improve public health and safety.

This article evaluates abuse-deterrent formulations (ADFs) as a method to reduce prescription drug abuse while ensuring access to vital medications for individuals with legitimate need; assesses the pros and cons of ADFs and the current state of ADF adoption in the market; and develops policy recommendations to transition the market to ADFs. Although abuse-deterrent technology is still in its nascent stages, ADFs have been proven to reduce prescription drug abuse and its consequences, and even an incremental reduction in abuse can have a significant impact on the nation by reducing the costly social, physical, mental, and public health problems resulting from abuse. Federal ADF policy does not reflect the urgency of the prescription drug abuse epidemic and does not go far enough toward changing the status quo. Policies must be implemented to encourage innovation and a market shift toward ADFs by ensuring any generic medication that references a branded ADF demonstrates that it does not have abuse-deterrent properties inferior to the branded ADF product. Policies must also require federal prescription drug benefit plans to cover ADFs to ensure consumers have access to such medications.

Evaluating motives: Two simple tests to identify and avoid entanglement in legally dubious urine drug testing schemes.

OBJECTIVE: This article educates healthcare practitioners on the legal framework prohibiting abusive practices in urine drug testing (UDT) in medical settings, discusses several profit-driven UDT schemes that have resulted in enforcement actions, and provides recommendations for best practices in UDT to comply with state and federal fraud and anti-kickback statutes. METHODS: The authors carefully reviewed and analyzed statutes, regulations, adivsory opinions, case law, court documents, articles from legal journals, and news articles. RESULTS: Certain facts-driven UDT arrangements tend to violate federal and state healthcare laws and regulations, including Stark law, the anti-kickback statute, the criminal health care fraud statute, and the False Claims Act. CONCLUSIONS: Healthcare practitioners who use UDT can help ensure that they are in compliance with applicable federal and state laws by evaluating whether their actions are motivated by providing proper care to their patients rather than by profits. They must avoid schemes that violate the spirit of the law while appearing to comply with the letter of the law. Such a simple self-evaluation of motive can reduce a practitioner's likelihood of civil fines and criminal liability.

Pyrrolidine-5,5-trans-lactams. 5. Pharmacokinetic optimization of inhibitors of hepatitis C virus NS3/4A protease.

[reaction: see text] In this, the second of two Letters, the optimization of the pyrrolidine-5,5-trans-lactam template (exemplified by 1a) as a mechanism-based inhibitor of hepatitis C NS3/4A protease is described. "Right Box" analysis of cassette dosing screening pharmacokinetic data was used to rapidly categorize the compounds. GW0014 (compound 4d) emerged as the compound displaying an optimal balance of biochemical and replicon potency, along with low i.v. clearance in the dog.