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Daily News

June 03, 2020

CMS on Wednesday (June 3) said, due to the COVID-19 pandemic, it will extend some innovation center models, including the Next Generation Accountable Care Organizations, while delaying the start date for others.

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Hydroxychloroquine does not prevent coronavirus infections, according to research findings published Wednesday (May 3) in the New England Journal of Medicine.

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The National Association of Insurance Commissioners (NAIC) seeks more guidance from CMS on how to deal with potential risk corridor payments, as well as on which COVID-19 tests should be covered and how they should be financed, as the regulators gear up to review filings for 2021 rates.

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Congressional leaders from both parties wrote to HHS Secretary Alex Azar on Wednesday (June 3) pressing him to immediately distribute emergency relief money from the CARES Act to Medicaid-dependent providers.

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The Congressional Research Service says Congress could rein in FDA’s broad discretionary authority over vaccine clinical trial policies by legislating how the agency and Institutional Review Boards approach clinical trial designs and reviews for the current COVID-19 pandemic, as well as for future emergencies.

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CMS tells Inside Health Policy that extending many of the newly waived restrictions on telehealth beyond the pandemic would require Congress to step in, despite the president’s executive order aimed at making some COVID-19 regulatory waivers permanent.

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During a Senate hearing on Tuesday (June 2), the head of Congress’ oversight arm’s health division called FDA out for what she asserts are significant problems with the way the agency manages its foreign drug inspection program, and she questioned the agency’s decision to halt foreign inspections during the COVID-19 pandemic.

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A federal appeals court is grappling with whether states are required to reimburse Medicaid managed care plans for a controversial Obamacare tax -- and, if they aren’t, whether the federal government must pay back nearly $500 million to six states that challenged the regulatory regime surrounding the tax.

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June 02, 2020

Democrats continued to emphasize a need for the federal government to take the lead on the COVID-19 testing supply at a House Energy & Commerce subcommittee hearing where three governors, including two Democrats and one Republican, testified Tuesday (June 2) on their states’ responses to the pandemic.

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Third-party medical device servicers want Congress, FDA and CMS to ensure that, post-COVID-19, servicers will still be able to obtain critical device servicing materials, including equipment manuals and training, access to which has increased during the pandemic thanks to collaboration between servicers and device makers.

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Former Vice President Joe Biden said the widespread protests across the country during an uncontrolled pandemic demonstrate why the United States should extend health coverage to more Americans via a public option and not eliminate the Affordable Care Act, as the Trump administration says it wants to do.

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Fifteen carriers want to sell plans in Washington state’s exchange, including two new entrants, and the insurers have proposed to decrease their rates by nearly 2%, insurance commissioner Mike Kreidler announced Monday (June 1).

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June 01, 2020

CMS on Monday (June 1) said it will withhold some CARES Act funds from states that fail to follow oversight requirements on infection control after the agency released public data showing that almost 26,000 nursing home residents have died of COVID-19.

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HHS signaled additional payments could be coming for some high-impact areas that missed the April 10 application deadline, in updated frequently asked questions that clarifies how CMS is disbursing and overseeing the CARES Act provider relief fund.

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HHS recently updated its provider relief fund website to confirm it will base $50 billion in COVID-19 relief funding on providers’ share of overall 2018 patient revenue, rather than on 2019 Medicare revenue.

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FDA chief Stephen Hahn has asked agency officials to look into whether some of the more flexible and novel approaches FDA has taken to respond to COVID-19, including allowing remote clinical trial visits, using real-world evidence to make certain regulatory decisions and streamlining lab test approvals, could be applied more broadly and on a more permanent basis.

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FDA has created a voluntary online form through which certain FDA-regulated food facilities can report a temporary stop or significant slowdown in production during the COVID-19 pandemic, as well as request help from the agency on how to safely continue or restart food production.

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Some states are using lottery-like systems to allocate remdesivir to hospitals as an ethical way to ration supplies of the only drug shown to help treat COVID-19, according to interviews with several state health officials.

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May 31, 2020

The nation’s largest health insurer, UnitedHealthcare, will extend its policy of providing treatment for COVID-19 without cost-sharing through July 24, a spokesperson tells Inside Health Policy.

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May 29, 2020

CMS on Friday (May 29) proposed changes to the risk adjustment data validation program for exchange plans (HHS-RADV) based on feedback the agency received from a recent white paper and other conversations with stakeholders.

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