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Daily News

July 02, 2020

The medical cost trend for commercial and self-insured employer-sponsored insurance in 2021 will be highly dependent on the pandemic, which is why analysts at PwC are basing estimates on three potential utilization scenarios with outcomes ranging from a 4% to a 10% increase in per capita costs for medical services and drugs.

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FDA this year will once again attempt to clarify the types of evidence that should be considered when determining a product’s intended use.

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FDA plans to issue a handful of new regulations this year that will clarify new minimum age requirements for purchasing tobacco, amend the agency’s good guidance practices, and set agricultural water standards, according to the agency’s newly issued Spring 2020 Unified Agenda, which was published Tuesday (June 30).

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FDA officials detailed the agency’s long-expressed intention to usher in a new food safety era by using emerging tools like artificial intelligence and blockchain to create a more traceable system.

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Dexamethasone, an inexpensive generic drug, can’t be substituted for Gilead’s higher-priced remdesivir when treating hospitalized coronavirus patients, doctors and analysts say, because the two drugs treat patients at different stages of COVID-19.

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July 01, 2020

Health care advocates are celebrating Oklahoma voters’ move to defy state leadership and expand Medicaid under the Affordable Care Act, which is expected to provide health care to about 200,000 Sooners.

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A CMS official on Wednesday (July 1) hinted that an upcoming physician pay rule may contain provisions to make permanent waived restrictions in telehealth and encouraged stakeholders to comment on the rule once it’s proposed.

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HHS expects that an additional 5 million COVID-19 point-of-care tests will come onto the market this month, which should bring the total number of available point-of-care tests to 10 million, Assistant Secretary for Health Brett Giroir told reporters on Wednesday (July 1).

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HHS Assistant Secretary for Health Brett Giroir told reporters Wednesday (July 1) that large-scale batch testing for COVID-19 likely will be in place and “very mature” by the time colleges reopen in August and September.

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The American Hospital Association wants CMS to make pandemic-related waivers around telehealth, nurse practitioners and discharge planning permanent while delaying, suspending or reconsidering other rules and certain waivers.

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The Republican attorneys general of Ohio and Montana, who hold a different stance than the GOP AGs seeking to throw out the entire Affordable Care Act and the Democrats who argue the law’s individual mandate is still constitutional, are asking the Supreme Court for time to explain their position during oral arguments.

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Senate Finance Committee Chair Chuck Grassley plans to introduce “in the coming days” an updated version of his drug pricing legislation, and the Iowa Republican now blames Democrats, who voted for his bill in committee, for not negotiating on changes.

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The Pharmaceutical Research and Manufacturers of America on Tuesday (June 30) sued to block a Minnesota law, slated to take effect today, that aims to make insulin affordable.

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June 30, 2020

FDA on Tuesday (June 30) released guidance stating a coronavirus vaccine should demonstrate at least 50% efficacy in placebo-controlled trials, meaning it will prevent disease or decrease severity in at least half of the people vaccinated.

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Senators on both side of the aisle raised concern with White House Coronavirus Task Force members that employees and students who must take COVID-19 tests to return to work or school could get stuck with large bills due to the Trump administration’s recent guidance.

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In a new guidance released Tuesday (June 30), FDA urges vaccine sponsors to include diverse populations in all stages of COVID-19 vaccine clinical trials. The agency is especially focused on ensuring trials include racial and ethnic minorities, elderly individuals, people with comorbidities and pregnant women.

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The United States over the weekend committed $545 million for COVID-19 relief efforts as part of Global Citizen and the European Commission’s campaign to coordinate development of COVID-19 tests, treatments and vaccines and ensure equitable access around the world.

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Four long overdue Medicaid guidance documents meant to help states tackle the nation’s opioid crisis are still missing, months after CMS and HHS officials promised the House Energy & Commerce health subcommittee in early March they’d get the guidance out sometime this spring.

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Two Republican committee leaders on Monday (June 29) asked the HHS Office of the Inspector General to investigate whether five states violated federal guidance by asking nursing homes to accept COVID-19 positive patients.

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June 29, 2020

The House on Monday (June 29) passed 234-179 legislation to expand the Affordable Care Act’s ACA’s tax credits, incentivize Medicaid expansion and reverse Trump administration policies that chipped away at the law, and Democrats fully paid for the package using legislation to reduce prescription drug prices via government negotiation.

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