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Daily News

July 08, 2020

The White House Office of Management and Budget last week completed its review of FDA’s draft guidance on quality considerations for clinical research on cannabis.

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July 07, 2020

The Democratic leaders of key congressional health committees say recent Trump administration guidance that says insurers are not required to cover COVID-19 testing for surveillance or return to work screenings clashes with congressional intent.

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HHS’ lead COVID-19 testing official says social distancing, wearing a mask and good hygiene will do more to stop the pandemic in the United States than testing, coming as leading congressional Democrats allege a lack of administration leadership and faulty policies have caused tests to be rationed and prevented widespread testing of asymptomatic individuals.

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The Association for Behavioral Health and Wellness called on CMS to continue to allow telehealth flexibilities for behavioral health services beyond the pandemic, but to also closely study the efficiency of such services, in a letter sent to CMS Administrator Seema Verma on Monday (July 6).

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The Department of Justice has been entering into agreements to pay out potentially billions of dollars to insurers who have sued over the Affordable Care Act’s risk corridors program, in the wake of the Supreme Court’s April ruling that the government is statutorily obligated to make the payments.

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Novavax will receive $1.6 billion from HHS to make its COVID-19 vaccine candidate, and Regeneron Pharmaceuticals will receive $450 million to scale up production of its antibody candidate, HHS announced on Tuesday (June 7).

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Federal guidance calls for nursing home staff to be tested for COVID-19 at least once a week, but most nursing homes are waiting so long for results that testing is not an effective way to control the coronavirus’ spread and facilities also can’t afford to test everyone, an American Health Care Association survey of its members found.

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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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