News & Views: 11/10 - 11/16

November 17, 2020

Maryland Federal District Court dismissed the Federal False Claims Act (FCA) alleging Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP).

Forest Laboratories argued that CMS guidance and statutes are unclear surrounding stacked Medicaid rebates; it is unclear if discounts to different customers must be stacked to determine the best price. While CMS added a preamble to their MDRP regulations in 2016 to address stacking, it did not clear any of the ambiguity. The revision addressed multiple rebates paid to a PBM which impact the cost at the pharmacy level and provides a discount to the pharmacy, rather than discounts given to two different customers that do not affect one another. To review the case, click here.

The Supreme Court heard arguments to overturn the Affordable Care Act in California v Texas.

No matter their official ruling, President-elect Biden has stated he will still work to protect the ACA and lower drug costs. To review the impact this case has on prescription drug prices, click here.

A researcher from Washington University discussed the future of drug pricing policy based on the election results in a recent Health Affairs blog post.

The post highlighted President Trump’s failed attempts to lower prescription drug prices, most notably the series of drug related executive orders. It is likely that President-elect Biden will use some of HHS Secretary Azar’s policies as a starting point for his own policy reform, especially if Republicans continue to control the Senate. To review the full post, click here.

The Institute for Clinical and Economic Review (ICER) conducted a second review of Remdesivir pricing as a COVID-19 treatment.

ICER evaluates COVID-19 treatments based on “cost recovery” for the manufacturer and typical “cost-effectiveness” of health benefits and costs in the healthcare system. The updated review has no change to the cost recovery, but new data indicates remdesivir has no survival benefits, although it does reduce costs of care by lowering rate of progression to additional respiratory supportive care. Based on the new data, ICER priced remdesivir treatments at $2,470 for hospitalized patients experiencing moderate-to-severe cases and $70 for mild cases. To review the complete update, click here.

Gilead Sciences filed a lawsuit against multiple networks of healthcare providers in Florida who have been profiting off of Gilead’s free-drug program.

The defendants, which include dozens of clinics, prescribers, laboratories, and pharmacies, have been recruiting homeless adults to sign up for Gilead’s free-drug program, where the recruits then receive PrEP prescriptions so that the prescribers can pocket the refunds from Gilead Sciences. It is also being alleged that the prescribers are buying these medicines back from their recruits and selling them on the black market to profit even more. To review the case, click here.

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