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Daily News

June 15, 2021

Centene is paying $143 million total to settle with Ohio and Mississippi over allegations that the health insurer used pharmacy benefit schemes to overcharge the states, and Centene is setting aside an additional $1.1 billion to settle with other states over similar allegations.

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FDA’s Spring 2021 regulatory agenda indicates the agency could release as soon as this month its long-awaited proposed rule to establish an over-the-counter category of hearing aids and lay out safety, labeling and manufacturing standards for the devices, coming as key lawmakers press HHS to get the regulation out.

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June 14, 2021

A bipartisan infrastructure proposal from Congress is unlikely to include home- and community-based services investments, a GOP aide confirmed to Inside Health Policy Monday (June 14).

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FDA will move forward with finalizing a controversial rule that aims to clarify what kind of evidence the agency will consider when determining a product’s intended use, the agency reveals in its Spring 2021 regulatory agenda published Friday (June 11).

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FDA over the next year plans to finalize several food-related rules, including one that will allow the agency to recognize accreditation bodies that will authorize certain labs to perform food analyses, the agency says in its Spring 2021 regulatory agenda published Friday (June 11).

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Center for Medicare and Medicaid Innovation Director Liz Fowler told stakeholders there needs to be uniformity across payers -- including CMS -- in how to gauge their health equity efforts and make them successful.

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FDA hopes that its new strict enforcement plans that kicked in this month coupled with a landmark court ruling will get stem cell clinics to comply with agency standards, an agency official said.

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Medicaid expansion is gaining traction in Wyoming, even passing the Wyoming House of Representatives earlier this year, but with a July special session to discuss the policy now off the table and concerns among state lawmakers about using Medicaid funding to pay for abortion care, roadblocks remain.

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HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure on Monday (June 14) announced that more than 1.24 million people signed up for coverage through healthcare.gov from the Feb. 15 launch of the special enrollment period through May 31, and about one-third of Americans who have either enrolled or returned to the exchange to access new tax credits since April 1 have plans costing $10 or less due to the American Rescue Plan.

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June 11, 2021

FDA’s vaccine advisers failed to reach an agreement Thursday (June 10) on whether COVID-19 vaccines should be authorized for emergency use in pediatric populations, namely those ages 6 months to 12 years, or whether pediatric indications should go through the full vaccine licensure process.

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The date that provider relief recipients received the COVID-19 aid will determine which spending deadline they must meet, HHS announced Friday (June 11), stopping short of a complete extension of the June 30 deadline while still giving providers, hospitals and lawmakers much of the flexibility they had sought.

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Some Democratic senators told HHS Secretary Xavier Becerra during committee hearings this week they were pleased to see large increases in funding to tackle opioid and substance use disorder in the fiscal 2022 budget request, but they asked for additional support on funding cliffs and opioid production solutions.

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The Biden administration has asked HHS to study whether new reimbursement policies could be used to shore up domestic supplies of critical medicines, including the possibility of new federal payment policies that hike profit margins for certain generic sterile injectables and cancer drugs, procurement guarantees and flexible acquisition policies.

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In a bid to increase availability of Johnson & Johnson’s COVID-19 vaccine, FDA on Friday (June 11) announced it will allow two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore to be released for use in the United States or exported to other countries, despite several quality control and facility management issues at the facility.

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Democrats are considering adding Medicare drug price negotiation to the president’s American Families Plan and using budget reconciliation to pass it separately from the infrastructure bill, if a bipartisan deal is struck on infrastructure, drug and consumer lobbyists said.

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June 10, 2021

HHS Secretary Xavier Becerra agreed with Senate Finance Chair Ron Wyden (D-OR) that Congress should revisit the Affordable Care Act’s affordability threshold for employer-sponsored coverage, currently set at around 10% of income, so that it aligns with current policy on the exchanges.

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The Biden administration’s proposed budget goes against the last six years of precedent by not increasing the children’s hospital graduate medical education levels from this year’s enacted budget, Senate Appropriations subcommittee on HHS ranking Republican Roy Blunt (MO) said during a budget hearing Wednesday (June 9).

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Acting FDA Commissioner Janet Woodcock told lawmakers Thursday (June 10) that FDA intends to have its domestic facility inspection program upgraded and fully running again by the end of summer 2021 for the first time since inspections were halted due to the COVID-19 pandemic.

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The 2022 medical cost trend for commercial and self-insured employers will 6.5%, or slightly lower than 2021 yet still somewhat higher than the recent pre-pandemic rate, PwC’s Health Research Institute (HRI) predicts in its annual report dubbed Medical Cost Trend: Behind the Numbers.

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FDA released the final version of its rule modernizing the standard of identity for yogurt on Wednesday (June 9) after HHS highlighted the rule as high priority in its semi-annual regulatory agenda.

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