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Daily News

October 06, 2020

Medicare Payment Advisory Commission members are worried about the Medicare hospice program’s integrity and are considering recommending hospice rates be set based on time or the patient’s malady after MedPAC staff showed hospice costs are increasing, patients are staying longer and there are more live discharges.

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The European Medicines Agency on Tuesday (Oct. 6) began its rolling review of Pfizer and BioNTech’s COVID-19 vaccine, marking EMA’s second rolling review of a vaccine in the past week; the agency began reviewing AstraZeneca’s vaccine on Oct. 1.

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October 05, 2020

CMS Administrator Seema Verma on Monday (Oct. 5) said the agency will reach out to providers about new flexibility surrounding the Medicare provider relief loans, as laid out in the newly signed continuing resolution to keep the government open through Dec. 11.

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CMS Administrator Seema Verma on Monday (Oct. 5) said the agency will reach out to providers about new flexibility surrounding the Medicare provider relief loans, as laid out in the newly signed continuing resolution to keep the government open through Dec. 11.

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The key insurance lobbies say that they’re still reviewing CMS’ directive on how they should report the billions in risk corridor reimbursements they’re getting from the Judgment Fund due to a Supreme Court decision, but sources suggest the guidance will be strongly opposed by at least some plans.

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Over the weekend, President Donald Trump’s doctors revealed the president was put on a five-day course of remdesivir, hours after he was given a dose of Regeneron Pharmaceutical’s investigational COVID-19 antibody cocktail, REGN-COV2, though the company told Inside Health Policy there are currently no data on combined use of the drugs.

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The Advanced Medical Technology Association wants CMS to review all its Medicare regulations to find ways to increase coverage of and beneficiary access to digital health technology, learning from its eased regulatory approach during the pandemic.

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FDA’s risk mitigation programs for fentanyl and extended-release opioids are not suited to quickly address the opioid crisis, according to the HHS Office of Inspector General, which released a report Tuesday (Sept. 29) recommending the agency improve the programs.

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Worried the current skilled nursing facility value-based purchasing program isn’t performing as expected, Medicare Payment Advisory Commission members reviewed a possible replacement that would eliminate the so-called cliff effect and reward providers for taking in more patients with social risk factors.

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The Medicare Payment Advisory Commission appeared largely supportive of a recommendation to modify Medicare Advantage benchmarks after staff said current benchmarks create higher payments to MA plans and significant benchmark cliffs across regions.

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October 02, 2020

President Donald Trump’s physician Sean Conley announced that the president took a single dose of an experimental antibody cocktail, along with vitamin supplements, after being diagnosed with COVID-19 early Friday (Oct. 2) morning, and the president is now heading to Walter Reed hospital where the White House says he will stay for a few days out of an abundance of caution.

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During a congressional hearing Friday (Oct. 2), HHS Secretary Alex Azar defended the Trump administration’s involvement in public health agency decisions, including White House efforts to alter or block reports and guidances, asserting that some of the actions taken are “perfectly normal” and that lawmakers are over-reacting.

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A new Bipartisan Policy Center report on the opioid crisis says the federal government should do a better job using its opioid funds to target at-risk groups and should revisit Medicaid practices that restrict access to treatment.

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Three House Democrats introduced a bill to penalize laboratories that take longer than three days to provide coronavirus test results and to reward fast turnarounds.

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Pfizer CEO Albert Bourla on Thursday (Oct. 1) urged people to stop talking about potential COVID-19 vaccines in political terms and instead focus on the science, echoing similar pleas from former FDA chiefs, doctors and public health experts, some of whom recently criticized politicians and company CEOs, including Bourla, for talking about vaccine timelines.

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October 01, 2020

House Democrats late Thursday passed their $2.2 trillion revised HEROES bill, which includes Affordable Care Act subsides for the unemployed, increased federal matching funds for Medicaid and additional money for providers, after they failed to reach a deal with the White House, but House Speaker Nancy Pelosi (D-CA) told reporters the talks will continue.

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Six Senate Republicans, including several in tight races, joined Democrats’ failed move Thursday (Oct. 1) to block the administration from continuing its Supreme Court battle to shoot down the Affordable Care Act, further highlighting the GOP’s vulnerability when it comes to the ACA’s most popular provision just a day after Republicans’ effort to pass their own bill claiming to protect people with preexisting conditions fell short.

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The European Medicines Agency announced Thursday (Oct. 1) that its human medicines committee has begun reviewing the first batch of data from AstraZeneca’s COVID-19 vaccine clinical trial, coming as reports reveal that the U.S. trial of the vaccine remains on hold while FDA expands its safety investigation into a serious adverse event experienced by a trial participant in the United Kingdom.

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FDA on Wednesday (Sept. 30) authorized OralDNA Labs’ oral rinse COVID-19 diagnostic test, which the company asserts could help resolve supply chain bottlenecks, coming as FDA officials express concern about potential supply shortages heading into flu season.

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AstraZeneca and Sanofi moved forward Thursday (Oct. 1) with their highly contentious plans to limit the availability of 340B pricing for drugs at certain contract pharmacies -- and were promptly slammed by 340B hospitals -- but it appears Novartis has yet to put its contract pharmacy policy into effect as the company’s CEO told House lawmakers the drug maker is still collecting data from hospitals.

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