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A Las Vegas counseling and mental health care provider has been fined more than $1 million and placed on three years of probation after fraudulently billing Medicaid...We Care Behavioral Health Agency LLC was convicted on a gross misdemeanor charge of intentional failure to maintain adequate records...(the agency) didn’t keep documentation on when or which billed services it actually provided to Medicaid recipients

The House of Representatives...voted....to pass Sen. Ron Johnson’s, R-Wis., Right to Try legislation, sending the bill to President Donald Trump’s desk. The vote is the culmination of a multi-year campaign...which aims to provide access to unapproved drugs under review at the Food and Drug Administration to patients facing life-threatening illnesses with no further options...The bill covers a much broader population than an earlier House-passed version. The president has been a vocal advocate...it may have unintended effects and potentially hinder FDA’s authority without changes...Conservative groups including Freedom Partners and Americans for Prosperity backed the effort, calling attention to the fact that 40 states have passed versions of Right to Try, a strategy employed by Goldwater to drum up momentum for the bill...The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current expanded access process...The Senate’s bill would allow unproven therapies to be given to patients without FDA notification for up to a full year and would not establish any standards for informed consent...

Nevada health officials are examining how the state could license consultants who transfer mentally ill people to unregulated group homes, a step prompted by a Las Vegas Review-Journal investigation that highlighted the death of a suicidal woman after she was placed in an unsupervised residence...“This story has been really motivating for people,” said Julie Kotchevar, deputy director at the Nevada Department of Health and Human Services. “It’s certainly been motivating for me to make sure it doesn’t happen again.”...Kotchevar presented lawmakers with an idea: Broaden the state statute that governs “referral agencies” to require anyone doing that type of work to obtain a license. Currently, state law requires a license only for businesses that refer patients to “residential facilities for groups.”

The House is set to take up a controversial “right-to-try” bill next week — and if it passes, the Food and Drug Administration will have to work harder to protect patients than it would if a different version of the legislation were advancing, Commissioner Scott Gottlieb told STAT...right-to-try legislation aims to give terminally ill patients a different pathway to access experimental treatments that are not FDA approved...“In terms of making sure that it balances [access to experimental drugs] against appropriate patient protections, I think the Walden bill gives us less work to do,” Gottlieb said. “With the Johnson bill, we’d have to do a little bit more … in guidance and perhaps in regulation to achieve some of those goals, and I think those are the goals that Congress wants us to achieve.”

Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher...The entire life sciences industry is committed to reducing animal testing, and all organizations are looking at how this can be done effectively...The study analyzed 1,637,449 adverse events (AEs) reported for both humans and the five most commonly used animals in US Food and Drug Administration and European Medicines Authority regulatory documents for 3,290 approved drugs and formulations...published in the Journal of Regulatory Toxicology and Pharmacology...We already know that animal testing has some predictive capabilities for humans but there has never been a study on this broad scale before to look at the level of exact concordance...Of the study’s key results...the species most frequently used in toxicology (rat and dog)...are performing well with regard to identifying adverse events in humans...also...the negative predictive value is low for many adverse events...no findings in animal often does not mean that no adverse events will occur in humans...some effects observed in some animal species do not imply high risk for humans...The analysis allows a researcher to estimate the human risk implied by a given observed effect in an animal...With access to this kind of information, researchers can design safer clinical trials in the future...

Hospitals that joined the 340B Drug Pricing Program at its onset provided more uncompensated care and low-profit services to patients than those who joined in its later years, according to a new research letter published in JAMA from researchers at Vanderbilt University and the University of Chicago...Allan Coukell and Sean Dickson...write...that policymakers would be "well served by greater transparency on hospitals' use of 340B revenues," but warn that reductions in 340B eligibility will lead to a transfer from Medicare spending on 340B hospitals to increased revenue for drug manufacturers...In January, a final rule went into effect that cut drug payments to 340B hospitals by almost 30%. The American Hospital Association and other groups are currently suing the U.S. Department of Health and Human Services over the rule. Earlier this month, the U.S. Court of Appeals for the District of Columbia Circuit heard oral arguments for the case...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Samantha DiGrande, Welcome to This Week in Managed Care from the Managed Markets News Network

Nicole Grassano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Nicole Grassano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.