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Daily News

July 06, 2020

Dozens of House and Senate lawmakers from both parties are urging HHS to send additional CARES Act funding to children’s hospitals, which they say have not received the same financial support as other providers that are struggling due to the COVID-19 pandemic.

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Trump administration officials told a Senate Appropriations panel that reported moves by several COVID-19 vaccine and drug developers to eliminate “march-in” language from their contracts with HHS should not lead to price gouging.

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The House Appropriations agriculture subcommittee on Monday (July 6) agreed by voice vote to send a draft fiscal 2021 FDA funding bill to the full committee that would give FDA an increase of $40.8 million dollars over fiscal 2020 funding levels, for a total of $3.21 billion in discretionary funding, yet slightly less than the increase proposed by the White House.

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The House Appropriations Committee late Monday (July 6) released a $96.4 billion draft fiscal year 2021 HHS funding bill that is $1.5 billion more than the 2020 enacted level and $11.1 billion above the president’s budget request.

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CMS on Monday (July 6) proposed new Medicare add-on payments for innovative dialysis equipment that can be used in the home as part of its proposed end-stage renal disease pay rule.

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The country is still facing national shortages of personal protective equipment and N95 masks are not expected to meet demand until September, an administration official revealed at a hearing held by the House Select Subcommittee on the Coronavirus Crisis late last week.

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The Supreme Court’s 7-2 ruling in a case over illegal robocalls is seen by legal experts as a boon for the ACA supporters, as the court found that an unconstitutional provision can be severed from the remaining law, which is a key question the justices will consider in California v. Texas.

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FDA on Monday (July 6) announced its plans to launch a two-phase study assessing how consumer and health care provider perceptions of a prescription drug are affected by certain disclosures in promotional materials, including information about a product’s biosimilar status and whether a drug may have additional clinical benefit based on secondary endpoints.

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A bipartisan group of 35 senators are asking CMS and HHS to assist them in codifying and expanding the telehealth flexibilities offered by the administration during the pandemic.

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July 02, 2020

Senate Finance Committee Chair Chuck Grassley on Thursday (July 2) re-introduced drug pricing legislation that is structurally unchanged from the version passed by Finance last summer, but none of the Democrats who previously voted for it are co-sponsors.

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Hospitals and providers are looking to the future, calling for a permanent emergency fund for hospitals in case of future emergencies, an investment in public health surveillance and medical supplies, and permanent flexibility to offer telehealth services in recent letters to Congress.

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HHS officials told senators on Thursday (July 2) that clinical trial data from diverse populations, including racial and ethnic minorities, pregnant and lactating women, and children, will help inform the government’s COVID-19 vaccine distribution plan and ensure the vaccine is appropriately distributed among those in need.

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A bipartisan group of senators on Thursday (July 2) introduced legislation to waive eligibility requirements next year for any previously eligible hospital in the 340B program, citing challenges faced by these hospitals during the COVID-19 pandemic that might make them ineligible moving forward.

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The medical cost trend for commercial and self-insured employer-sponsored insurance in 2021 will be highly dependent on the pandemic, which is why analysts at PwC are basing estimates on three potential utilization scenarios with outcomes ranging from a 4% to a 10% increase in per capita costs for medical services and drugs.

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FDA this year will once again attempt to clarify the types of evidence that should be considered when determining a product’s intended use.

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FDA plans to issue a handful of new regulations this year that will clarify new minimum age requirements for purchasing tobacco, amend the agency’s good guidance practices, and set agricultural water standards, according to the agency’s newly issued Spring 2020 Unified Agenda, which was published Tuesday (June 30).

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FDA officials detailed the agency’s long-expressed intention to usher in a new food safety era by using emerging tools like artificial intelligence and blockchain to create a more traceable system.

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Dexamethasone, an inexpensive generic drug, can’t be substituted for Gilead’s higher-priced remdesivir when treating hospitalized coronavirus patients, doctors and analysts say, because the two drugs treat patients at different stages of COVID-19.

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July 01, 2020

Health care advocates are celebrating Oklahoma voters’ move to defy state leadership and expand Medicaid under the Affordable Care Act, which is expected to provide health care to about 200,000 Sooners.

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A CMS official on Wednesday (July 1) hinted that an upcoming physician pay rule may contain provisions to make permanent waived restrictions in telehealth and encouraged stakeholders to comment on the rule once it’s proposed.

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