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Daily News

June 17, 2021

Public Citizen has asked HHS Secretary Xavier Becerra to remove or request resignations from acting FDA chief Janet Woodcock and agency officials Patrizia Cavazzoni and Billy Dunn due to their role in the controversial approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab), a decision sparking new calls for a permanent FDA leader and refueling debate over whether Woodcock is right for that role.

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A bipartisan, bicameral group of lawmakers are pushing a revised version of their legislation to spur development of new antibiotics through a subscription-style reimbursement model for antimicrobial drugs.

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The U.S. District Court for the District of Delaware on Wednesday (June 16) rejected the Biden administration’s request to dismiss AstraZeneca’s lawsuit challenging HHS’ effort to stop drug maker restrictions on 340B discounts on drugs dispensed via contract pharmacies, as the judge said the statue is vague on the issue.

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The Supreme Court today ruled 7-2 that the GOP states and two Texans challenging the Affordable Care Act ‘s constitutionality do not have standing and dismissed the case. Justice Steven Breyer wrote the decision, and Justice’s Samuel Alito and Neil Gorsuch dissent.

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CivicaScripts will contract with drug manufacturer Catalent to make low-priced versions of expensive generic drugs, and the company is partnering with Anthem, which operates affiliated health plans that provide health coverage to more than 43 million Americans, Civica Rx announced Wednesday (June 16).

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The topic of government drug price controls did not come up at the meeting Wednesday (June 16) between Senate Majority Leader Chuck Schumer (D-NY) and members of the Budget Committee, Sen. Tim Kaine said after exiting the meeting.

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June 16, 2021

Colorado and Nevada enacted legislation creating a standardized health plan and a public option, respectively, that will compete with private insurers on exchanges; New York health plans take issue with legislation on mail-order pharmacies and other recently passed bills; and several states have published their 2022 proposed rates for the individual and small group markets.

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The American Medical Association House of Delegates on Tuesday (June 15) adopted new policies that call for reducing clinician burden posed by peer-to-peer prior authorization, coming just a few weeks after the CMS budget justification document affirmed that CMS plans to increase the number of items and services subject to prior authorization.

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More than 20 House Republicans, including several members of the GOP Doctors Caucus, wrote to HHS Secretary Xavier Becerra Tuesday (June 15) urging him to invest in and pursue vigorous new research and development of COVID-19 therapies, including those that can help with variants, coming amid reports the agency has no further plans to look into new COVID-19 therapeutic candidates.

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President Joe Biden’s proposal to invest $400 billion in home- and community-based services would boost funding for social determinants of health within the HCBS program, and some health care stakeholders are optimistic the investment could be a step towards broader social determinants funding.

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Sen. Tim Scott (R-SC) reportedly plans to introduce a bill Wednesday (June 16) that aims to bring medical product manufacturing to the United States and prevent shortages by providing a tax incentive for products made in certain U.S. areas and creating a new approval pathway for advanced manufacturing technologies.

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The Federation for American Hospitals (FAH) on Tuesday offered three recommendations for the surprise billing rulemaking: The administration should ensure adequate stakeholder engagement, avoid policies that would create de facto benchmarks based on qualified payment amounts or advantage health plans over providers, and ensure notice and consent provisions allow exceptions for providers unable to comply.

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Stakeholders on Tuesday (June 15) praised legislation that aims to improve the benchmarking process for accountable care organizations by taking an organization’s beneficiaries out of the calculation of a regional benchmark.

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The U.S. government has purchased an additional 200 million doses of Moderna’s COVID-19 vaccine, which the company says potentially could be used to vaccinate children or as booster shots.

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June 15, 2021

HHS hints in its latest regulatory agenda that a proposed exchange rule now under White House review will extend the open enrollment period for the 2022 benefit year, although it's unclear for how long.

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FDA on Monday (June 14) launched a Generic Drug Cluster through which the world’s leading regulatory agencies will address generic drug development and increase scientific alignment.

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A drug industry official on Tuesday (June 15) joined lawmakers in touting legislation that would increase funding for FDA’s and the National Institutes of Health’s nonprofit foundations.

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House Appropriations Committee Chair Rosa DeLauro (D-CT) on Tuesday (June 15) released the schedule for marking up fiscal 2022 spending bills, with the committee planning to take up FDA’s appropriations starting next week and HHS’ appropriations in July.

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A bipartisan bill to eliminate cost-sharing for vaccines covered under Medicare Part D and another to improve provider reimbursement for administering no-cost vaccines to children were hailed as necessary steps to vaccinating the American public during a House Energy & Commerce Committee health subcommittee hearing on Tuesday (June 15).

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FDA drug center Director Patrizia Cavazzoni told members of the Biotechnology Innovation Organization that the agency wants to rethink its advisory committee processes, including loosening up conflict of interest rules and removing “some of the emotional” undertones that have been present in recent committee meetings.

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