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Daily News

June 10, 2021

Congress should consider bipartisan policies to bolster home- and community-based services, Senate Finance Committee ranking Republican Mike Crapo (ID) said during a committee hearing on the HHS fiscal 2022 budget Thursday (June 10), but he is concerned that President Joe Biden’s proposal to invest $400 billion may come with labor reforms that could further harm the inpatient caregiving workforce.

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A lawsuit seeking to get rid of a two-tiered benefits system for Nebraska’s Medicaid expansion population has been put on hold after the state decided to end the tiered system last week.

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HHS Secretary Xavier Becerra told lawmakers Wednesday (June 9) the department might soon take steps to curb non-ACA-compliant plans, including short-term plans, that beneficiary advocates and Democratic lawmakers say are proliferating the markets and harming consumers, but he again deferred to Congress to lay a path for a potential public option.

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Moderna on Thursday (June 10) asked FDA to expand emergency use authorization for its COVID-19 vaccine to kids ages 12 to 17 after the two-dose mRNA vaccine was found to be 100% effective in teens. The vaccine is already authorized for use in adults ages 18 and up.

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The United States will purchase and donate half a billion doses of Pfizer’s COVID-19 vaccine to 92 low- and lower middle-income countries and the African Union through the end of 2021 and into the beginning of 2022, the Biden administration announced Thursday (June 10).

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June 09, 2021

The first part of the highly anticipated rulemaking on the surprise billing legislation enacted late last year is now under review by the White House Office of Management and Budget (OMB), surprising some stakeholders who expected CMS might miss early deadlines.

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The White House has asked HHS to lead a consortium comprising nearly a dozen federal agencies, the private sector and nonprofit entities charged with crafting a strategy to secure the pharmaceutical supply chain by boosting U.S. production, developing new manufacturing technologies, and increasing the resilience of U.S. and allied pharmaceutical production.

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The Biden administration committed to pay Merck $1.2 billion for 1.7 million courses of an investigational COVID-19 treatment, molnupiravir (MK-4482), on the condition that FDA at least grants the antiviral an emergency use authorization.

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HHS Secretary Xavier Becerra told senators Wednesday (June 9) the $24 billion in remaining provider relief will not be subject to the June 30 spending deadline when it’s distributed, but previous relief does have a deadline.

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Home- and community-based care stakeholders remain optimistic that Congress will pass President Joe Biden’s proposal to spend $400 billion on Medicaid home care as the White House shifts its infrastructure talks toward reaching a deal with a bipartisan group of senators that reportedly includes Sen. Rob Portman (R-OH), an HCBS supporter, and others who have backed home care before.

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World Trade Organization members agreed this week to move ahead with text-based talks on proposals aimed at improving the international pandemic response -- both a waiver of some intellectual property obligations and an alternative from the European Union -- with the United States calling for the final product to focus directly on access to vaccines.

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Regulatory experts say the development of booster vaccines for COVID-19 raises key regulatory and approval questions for FDA, namely whether the booster shots will be considered wholly new products and have to go through the standard biologics testing and approval process, and whether booster shots from one manufacturer can be mixed and matched with original vaccine regimens from another manufacturer.

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CMS on Wednesday (June 9) increased pay for at-home COVID-19 vaccination of Medicare beneficiaries from $40 to $75 per dose, meaning providers will receive about $70 more between the two vaccine doses.

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California Rep. Ro Khanna (D) and 24 Democratic colleagues on Tuesday (June 8) reintroduced legislation to create a waiver giving states access to federal funding and regulatory flexibility needed to support universal health care coverage.

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A coalition of beneficiary advocacy organizations is demanding CMS rescind an informal guidance released in April that recommends states consider allowing hours worked during the public health emergency to count toward certified nurse aide training hours.

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June 08, 2021

As key House lawmakers look at potentially crafting a public option that would compete with private insurers on the ACA exchanges, a county-backed health plan in Los Angeles that offers Medicaid and exchange plans is touting its own story as a potential model for certain markets.

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In a new supply chain report released Tuesday (June 8), the White House, HHS and FDA call for Congress to give FDA the power to collect information about drugs and drug ingredients moving through the U.S. supply chain, coming as the COVID-19 pandemic sheds light on several gaps in FDA’s ability to collect data on the availability of drug ingredients and respond to drug shortages.

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House Ways & Means ranking Republican Kevin Brady (TX) suggested President Joe Biden’s fiscal 2022 budget ignores a need to continue telehealth coverage after the COVID-19 public health emergency, but HHS Secretary Xavier Becerra told lawmakers Tuesday (June 8) he does not intend to go backwards on such coverage, although the department could use some help from Congress.

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Nearly 50 groups representing consumers, patients and workers are pressing the Biden administration to write a surprise billing rule that makes the qualifying payment amount, on which patient cost-sharing is based.

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HHS Secretary Xavier Becerra told House Ways & Means Committee members Tuesday (June 8) his department will provide some flexibility on the June 30 provider relief spending deadline, but he offered few other details on an extension that hospitals, providers and lawmakers have been advocating for.

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