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Daily News

June 29, 2020

The hospice lobby told Inside Health Policy on Monday (June 29) that HHS signaled to the group an extension of the public health emergency declaration is likely as a growing number of provider groups join hospitals’ calls to HHS to extend the declaration before its expiration on July 25.

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A wide-ranging group of providers are asking lawmakers to fix what they say is an oversight that could cost them about 20% of their Paycheck Protection Program and COVID-19 provider relief funds due to taxes.

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House Energy & Commerce Committee Chairman Frank Pallone (D-NJ) wants HHS to send all state and local COVID-19 testing plans to Congress by July 6.

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The Pew Charitable Trusts calls for FDA to provide more regulatory clarity and predictability for 503B compounders, among a slew of recommendations in a compounding report issued Monday (June 29).

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The Trump administration is allowing employers to provide stand-alone telehealth coverage to part-time or seasonal or other workers not eligible for group coverage without fear of non-compliance, a move celebrated by telehealth stakeholders who’ve been lobbying the administration and Congress on the issue.

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The Trump administration has secured 500,000 treatment courses of Gilead’s experimental COVID-19 drug remdesivir, and hospitals will pay no more than $3,200 per average treatment course, HHS and Gilead announced Monday morning (June 29).

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June 26, 2020

Pfizer plans to base the price of its coronavirus vaccine candidate on prices of existing vaccines and anticipates offering bulk discounts, Pfizer Chairman and CEO Albert Bourla said Friday (June 26), but he expects the company to make a profit from the vaccine.

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The Centers for Disease Control and Prevention for the first time since the start of the pandemic presented evidence that pregnant women, particularly Hispanic and black pregnant women, may be at increased risk for severe COVID-19 illness, although the agency said data gaps still exist.

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Pfizer Chair and CEO Albert Bourla said the company anticipates it will have safety and efficacy data from phase 3 trials of its COVID-19 vaccine available by the fall, perhaps as early as September, in time for a potential FDA approval or authorization in October.

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HHS will continue to support five COVID-19 testing sites in Texas for another 14 days, the department announced Friday (June 26), yielding to state leaders’ criticism that the federal government was going to abandon testing just as coronavirus cases in the region increased.

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HHS will ship what’s left of Gilead’s remdesivir to the latest COVID-19 hotspots on June 29, and with that the federal government will deplete its supply of the investigational drug.

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A broad telehealth task force seeks input as it develops long-term recommendations to build on the use of telehealth during the COVID-19 pandemic -- including what criteria should be used to decide which telehealth regulations should be continued once the pandemic ends.

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Democratic Reps. Bill Pascrell, Jr. (NJ) and Katie Porter (CA) are concerned about provider relief fund transparency after HHS said provider relief recipients do not need to submit a separate quarterly report to the department or the Pandemic Response Accountability Committee.

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After having reworked certain innovation center models in light of COVID-19,[/node/115262], Center for Medicare and Medicaid Innovation Director Brad Smith said during a virtual summit Wednesday (June 24) the center hopes to release new models later this year.

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FDA’s Oncology Center of Excellence introduced a new pilot project that will make patient-reported data from cancer treatment trials publicly available to patients and their providers.

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FDA last week told labs they could combine and test multiple patient COVID-19 diagnostic test samples using a new “pooling” technique laid out by the agency in a set of updated testing templates, coming just days before National Institute of Allergy and Infectious Diseases Director Anthony Fauci told The Washington Post that health officials were having “intense discussions” about pivoting to the new testing approach.

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The Trump administration in its opening Supreme Court brief in the high-profile challenge to the Affordable Care Act again asks that the ACA’s coverage mandate be ruled unconstitutional and not severable from the rest of the law, and still seeks a narrower remedy that would save some portions of the law that don’t harm the two Texan plaintiffs.

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June 25, 2020

CMS on Thursday (June 25) revealed that more 892,000 people in states that use healthcare.gov have signed up through an existing special enrollment period, or about 188,000 more than during the same time frame in 2019.

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Beneficiary advocates, family and nursing home staff told lawmakers at a heated House Ways & Means Committee hearing Thursday (June 25) that an increased focus on testing and oversight in nursing homes is needed after CMS said more than 29,000 residents died of COVID-19.

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CMS on Thursday (June 25) proposed to permanently expand home health telehealth options, initially approved for use during the COVID-19 pandemic, as part of its proposed 2021 home health pay rule, and the rule also would implement new wage index calculations while capping cuts that could be tied to those calculations.

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