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Daily News

June 16, 2020

CMS hasn’t given Congress Medicare data on COVID-19 outcomes broken down by race that the agency has been promising for months, and House Energy & Commerce Chair Frank Pallone (D-NJ) is threatening to force the agency to provide that data.

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The House’s select subcommittee on coronavirus on Tuesday (June 16) launched a probe into CMS’ response to and prevention of COVID-19 outbreaks in nursing homes following agency reports earlier this month that 32,000 nursing home residents have died.

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FDA is reworking its process for reviewing clinical trial data as part of Operation Warp Speed’s efforts to accelerate development of COVID-19 vaccines, senior Trump administration officials said Tuesday (June 16).

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Democratic health care leaders Monday (June 15) blasted HHS Secretary Alex Azar and CMS Administrator Seema Verma for ignoring their constitutional obligation to respond to Congressional inquiries on special enrollment periods and the lawmakers said if the officials fail to reply by Friday (June 19) to series of questions first asked in April, the lawmakers will consider “additional measures."

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FDA on Monday (June 15) authorized the first game-based medical device for treatment of attention deficit hyperactivity disorder in adolescents.

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Congressional Medicare advisers released Monday (June 15) their report to Congress that recommends capping seniors’ annual drug costs, making plans pay a larger share of seniors' drug costs before the catastrophic phase and increasing drug companies’ share of catastrophic costs.

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The Information Technology & Innovation Foundation, a non-profit think tank that focuses on public policy and innovation, is concerned the Trump administration’s latest push to “Buy American” could have unintended consequences on the medical product supply chain, despite the administration’s assertions that it could help ease American reliance on foreign drug production.

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June 15, 2020

FDA said Monday (June 15) that hydroxychloroquine and chloroquine inhibit remdesivir’s effectiveness against COVID-19 so remdesivir should not be combined with either of the drugs.

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The Supreme Court’s 6-3 ruling in Brockton v. Clayton County that discrimination on the basis of sex extends to gender identity and sexual orientation under Title VII of the Civil Rights law pertaining to employment will at the very least bolster the various lawsuits that transgender and other advocates have pledged over HHS’ non-discrimination rule released Friday (June 12), legal sources say.

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A group of bipartisan senators, led by Sen. Brian Schatz (D-HI), want telehealth provisions included in previous COVID-19 emergency legislation to be made permanent, as some provider groups turn to Congress to make statutory changes to allow for expanded telehealth flexibilities after the pandemic.

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FDA on Monday (June 15) revoked the emergency use authorization it issued in March to allow use of chloroquine and hydroxychloroquine to treat hospitalized COVID-19 patients.

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The nation’s largest health insurance exchange said Friday (June 13) that 155,000 people have enrolled in health coverage via California’s COVID-19 emergency special enrollment period since March 20, a sign-up pace that is two times higher than the same time period last year.

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Senate Finance Committee leaders are pressing HHS to be more transparent on how much individual providers have received in COVID-19 funding from both Medicare loans and provider relief funding grants, saying the information released so far has been “incomplete and fragmented, giving only a limited view into how much each provider has received.”

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June 12, 2020

The Trump administration on Friday (June 12) finalized its controversial reinterpretation of the Affordable Care Act’s section 1557 by removing non-discrimination protections for transgender individual, axing certain language requirements and narrowing the scope of the rule’s overall non-discrimination provisions to exclude entities not engaged in health care or getting federal dollars, including short-term plans.

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FDA chief Stephen Hahn applauded drug companies and the U.S. government for working together in an unprecedented way to carry out an all-of-America approach to pandemic response, but he also stressed that drug makers choosing not to participate in the government’s public-private partnerships will still have an “equal shot” when it comes to approval of drugs or vaccines to fight COVID-19.

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The head of a global partnership formed to promote vaccines for pandemics says the United States should play a bigger role in global efforts to fund and develop a COVID-19 vaccine by coordinating its investments with international research and development efforts, like the World Health Organization’s Access to COVID-19 Tools Accelerator.

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HHS gave states less than a week to compile and send two years of state Medicaid provider data, including banking information, so the department could distribute provider relief funds to providers serving low-income communities, according to stakeholders.

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Stakeholders continue to call for some of the relaxed telehealth requirements to be continued after the pandemic, with some turning their focus towards Congress, while beneficiary advocates caution against moving too quickly to make certain telehealth aspects permanent.

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June 11, 2020

House Democratic leaders have set the week of July 4 to bring to the floor a legislative package that aims to improve the Affordable Care Act, House Speaker Nancy Pelosi (D-CA) and Majority Whip Steny Hoyer (D-MD) revealed at separate events Wednesday (June 10).

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FDA on Thursday (June 11) approved Mylan’s injectable insulin glargine product Semglee following myriad patent disputes between Mylan and Sanofi-Aventis.

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