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News Briefs: Dept. of Justice to appeal 340B ruling | January 13, 2022

New drugs are becoming less expensive to bring to market and more profitable at launch, according to a new Deloitte Ltd. white paper. “Cost to bring an asset to market has declined over the past three years, as peak sales forecasts increase,” the report says. “The combined cohort’s average cost to develop an asset was $2,006 million, a decrease of $370 million from 2020....This decrease in 2021 compared to 2020 is due mainly to the overall increase in the number of assets in the late-stage pipeline.” However, the report also notes that this figure is “an increase of $710 million from 2013.” In addition, the cycle time for drug development has increased, especially since the start of the pandemic.

New Hampshire is the latest state to settle its suit against Centene Corp, accepting $21 million from the Medicaid-focused carrier. More than a dozen states have sued the health insurer, accusing Centene of mismanaging their Medicaid programs’ pharmacy benefits. As with the other settlements, in the New Hampshire agreement Centene denied it was liable for any wrongdoing or violations of federal or state statute. The insurer has paid out more than $241 million in settlements with Arkansas, Illinois, Kansas, Mississippi and Ohio out of the $1.25 billion it set aside earlier this year to settle such suits.

What Will Be Impact of Allowing Abortion Pill to be Mail-Ordered?

Earlier this month, as the debate over legal abortion in the U.S. intensified, the FDA removed a requirement that the pregnancy-ending drug mifepristone be dispensed only in clinics, medical offices and hospitals. That move will effectively open the door for “certified prescribers or pharmacies” in states that haven’t already banned the practice to dispense mifepristone by mail.

Experts tell AIS Health, however, that there are more questions than answers about how those loosened regulations will ultimately affect patient access to the controversial drug, as well as how industry players such as health plans and PBMs will be affected.

Provider Lawsuit Could Tie Up Surprise Billing Regulations

The U.S.’s two largest health care provider groups, the American Medical Association (AMA) and the American Hospital Association (AHA), sued the Biden administration on Dec. 9, asking a federal court to block regulations officials developed to implement the No Surprises Act, parts of which will come into effect on Jan. 1. Health care attorneys tell AIS Health that the suit may hinge on the providers’ allegation that federal officials stretched their legal authority too far beyond the Act’s original intent — and that the providers might win.

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News Briefs: Cigna settles $27.6 million PBM lawsuit with Kansas | Dec. 9, 2021

Centene Corp. will pay the state of Kansas $27.6 million, the fifth such settlement reached between the insurer and state Medicaid programs. More than a dozen states have sued the health insurer, accusing Centene of mismanaging their Medicaid programs’ pharmacy benefits. The insurer has paid out $214 million in settlements with Arkansas, Illinois, Mississippi and Ohio out of the $1.25 billion it set aside earlier this year to settle such suits. According to a press release from the office of Republican Kansas Attorney General Derek Schmidt, “In the settlement, Centene guarantees that it will improve transparency by providing the state with access to all data necessary to track pharmaceutical transactions, from the point of sale through reimbursement.” Centene is in the process of consolidating its $30 billion in pharmacy spend and hopes to bid out that business to one vendor in 2022.

TeamHealth Wins One Battle in Ongoing War With UnitedHealth

A jury recently found UnitedHealthcare underpayed Nevada emergency care subsidiaries of TeamHealth Inc. in out-of-network billing scenarios — and it’s the first of several ongoing suits between the two health care firms to wrap up. Experts say that the No Surprises Act, which comes into effect next month, will fix some of the issues raised in the lawsuit, but also point out that settling out-of-network billing disputes remains a matter of leverage.

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Recent MA Coding Complaints Signal DOJ’s ‘Evolving Expectations’

The risk adjustment system used to pay Medicare Advantage plans continues to face intensifying scrutiny from the federal government, with the Dept. of Justice (DOJ) intervening in multiple False Claims Act (FCA) complaints and the HHS Office of Inspector General focusing on retrospective chart reviews and high-risk diagnosis codes. Now, attorneys say health care providers should be on high alert as well. While prior DOJ complaints-in-intervention have focused largely on MAOs conducting “one-way” chart reviews, more recent lawsuits focus on the use of “addenda” — information retroactively added to a patient’s medical record — which one law firm says indicates a new area of scrutiny.