News & Views: 12/8 - 12/14

December 15, 2020

The Supreme Court issued an 8-0 ruling in favor of the Arkansas law in Rutledge v. Pharmacy Care Management.

The law requires PBMs to reimburse pharmacies for generic drugs and allows pharmacies to challenge PBM reimbursement rates or refuse to dispense any drugs that they would lose money from due to low PBM reimbursements. This ruling sets a precedent for more than 40 other states to enforce PBM regulation through increased payments to independent pharmacies. The court unanimously voted against ERISA preemption, which they historically vote in favor of. To read the opinion of the Court, click here.

California Attorney General Xavier Becerra is one of the leading attorneys general in the most recent letter to HHS Secretary Azar in defense of the 340B program.

Twenty-nine attorneys general have written a letter urging Secretary Azar to levy large fines against the major manufacturers who are choosing to limit their participation in the 340B program. Becerra, President-elect Biden’s nominee for HHS secretary has fought for 340B discounts in the past and 340B advocates are hopeful he will continue to do so as the nominee for HHS Secretary. To read the letter, click here.  

A 340B administrative dispute resolution rule was published in the Federal Registrar.

The rule was originally requested in the Affordable Care Act but has been delayed for years. The rule creates an administrative panel to resolve disputes on overcharging, duplicate discounts, or diversion.  While stakeholders, such as 340B Health, are optimistic about the rule, it may not do enough, especially to deal with the manufacturers who have already restricted their participation in the program. To read the final rule, click here.

  • The Ryan White Clinics for 340BAccess v Azar lawsuit was filed in October 2020 to compel the administration to publish the rule. To review the complaint, click here.

The first COVID-19 vaccine has been approved for emergency use by the FDA and has begun to be distributed across the United States.

The FDA issued the first emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. Currently, the vaccine is only authorized for adults over the age of 16. The first round of shipments is expected to reach the vaccine sites by Wednesday (December 16), which will allow health care workers and seniors to receive the first dose of the vaccine in the following days and weeks.  To read the FDA press release, click here.

The Milliman consulting firm published a report on PBM pricing practices in Florida’s Statewide Medicaid managed Care (SMMC) program.

The report shows that concealed PBM markups have cost Florida Medicaid an estimated$113 million, due to practices such as spread pricing. The report also found that Florida PBMs made an average of $8.64 per claim with spread pricing, whereas they would only make $1.45 with a pass-through arrangement. To read the full report, click here.

  • To read the news release from the Florida Pharmacy Association, click here.

Researchers from Warren Alpert Medical School and the University of California San Francisco published their examination of the recent changes in drug list prices and the amounts paid by patients and insurers in JAMA.

This study looked at 14.4 million pharmacy claims by 1.8million patients under 65 years old between 2010-2016. Over the seven-year period, drug list prices more than doubled, even though manufacturer discounts and rebates increased. The rebates were also associated with even higher increases in patient out-of-pocket costs and insurer payments, according to the study. To read the full study, click here.

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