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Daily News

January 07, 2021

HHS Assistant Secretary Brett Giroir said the department is “very confident” an improved congressional COVID-19 testing system will be in place in time for President-Elect Joe Biden’s inauguration, coming after FDA warned earlier this week that the test currently used by members of Congress could be faulty.

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Democrats will take control of the Senate starting Jan. 20, shifting power on the Senate health and appropriations committees that drive key health care policies, and sources speculate the result could be increased appropriations and COVID-19 response funding for FDA and passage of landmark marijuana decriminalization legislation that could hand FDA a new regulatory role.

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CMS Administrator Seema Verma on Thursday (Jan. 7) again announced the agency is withdrawing the Medicaid Fiscal Accountability Regulation, this time saying the 2020 year-end legislation that included supplemental pay transparency provisions would help achieve the proposed rule’s goals.

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A pharmaceutical prescribing expert tells Inside Health Policy that FDA ignored its own data when it warned earlier this week that allowing patients to go longer than the authorized three to four weeks between COVID-19 vaccine inoculations is not supported by current scientific evidence.

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January 06, 2021

HHS late Tuesday evening (Jan. 5) indicated it planned to exempt distilleries and other small businesses that supplied hand sanitizer during the COVID-19 public health emergency from FDA’s over-the-counter monograph user fee program.

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Democratic control of the Senate sets up a debate between the liberal and moderate wings of the party over how to curb drug prices, but the bigger obstacle to drug pricing legislation could be a Republican filibuster, unless Democrats pay for Bidencare policies with drug pricing measures in budget-neutral legislation that they could pass with a simple majority using a budget process called budget reconciliation.

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Lobbyists and stakeholders are urging the incoming Biden administration to tackle health care changes through an administrative lens, coming as the courts face pressure to watch how the new administration acts on key policies before moving on cases involving regulations like the public charge rule.

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Democratic leaders of congressional health committees Tuesday called for the Trump administration to scrap its last-minute proposal to let states rely on web-based brokers instead of healthcare.gov or a state-based exchange for ACA plan enrollment, noting those and other controversial policies in the draft 2022 exchange rule are likely to be revamped by the incoming Biden administration.

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President-elect Joe Biden’s promise to freeze Trump administration proposed rules could also delay a few drug-pricing rules that the Trump administration recently finished but that have not taken effect, and it would be much easier for Biden administration officials to overturn final rules if Democrats win back the Senate and invoke the Congressional Review Act.

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January 05, 2021

Providers and plans agreed on two things in comments on CMS’ rule meant to streamline the prior authorization process: the timeline of 17 days over the holidays to comment on the proposal was too short and the rule could further burden providers and plans as they would have to manage new technology and competing priorities during a pandemic.

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Device manufacturers hope FDA will draft guidance laying out strict requirements for device servicers in 2021 after deregulation of third-party servicers was discussed in 2020 due to the COVID-19 public health emergency.

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FDA drug center director Janet Woodcock, who last May joined the Trump administration’s Operation Warp Speed initiative and recused herself from FDA’s COVID-19 product review decisions, will take on a new role at FDA -- principal medical adviser to FDA chief Stephen Hahn.

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Industry lawyers say it is unclear how FDA will handle on-site facility inspections as the COVID-19 health emergency spills into 2021 and sponsors of COVID-19 vaccines and therapeutics that received emergency use authorization move toward full approvals.

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January 04, 2021

FDA announced late Monday evening (Jan. 4) that changing the doses for authorized COVID-19 vaccines is not backed by scientific evidence and could pose health risks despite recent suggestions by a top Operation Warp Speed official that some of the vaccines could be safely administered in half-doses.

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The incoming Biden administration must immediately offer tax relief to Americans who may be on the hook to repay the government for Affordable Care Act subsidies, open a special enrollment period and clarify who is responsible for covering COVID-19 testing for public health purposes, Democratic state insurance commissioners say in a recent letter.

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New Jersey insurance regulators shut down two related companies they allege were illegally operating a health care sharing ministry (HCSM) and are warning consumers that plans available outside of the state’s insurance exchange may not be offering comprehensive coverage.

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FDA forecasts plans in its latest unified agenda to propose seven new rules, none of which have been included in previous agendas.

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The drug and device industries are pushing back against FDA’s plans to finalize a rule this month that will amend the definition of “intended use,” alleging the rule would violate the First and Fifth Amendments.

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December 31, 2020

The Urban Institute finds in a new analysis that coupling a Medicare buy-in with enhanced ACA tax credits would lead to the largest coverage gains.

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Pharmaceutical Research and Manufacturers of America says the Health Resources and Services Administration rushed the 340B administrative dispute resolution regulation without thinking through the consequences and the changes in the 340B landscape between 2016 and 2020, making it a faulty regulation.

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