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March 05, 2021 | Daily News

Every member of the Medicare Payment Advisory Commission said Friday (March 5) they support recommendations that Medicare Part B cover all vaccines, without cost sharing for preventive vaccines, and that Medicare pay doctors 103% of wholesale acquisition cost to administer preventive vaccines, although they have yet to vote on the proposals.

March 05, 2021 | Daily News

Infectious disease experts stress the importance of applying the same urgency to pediatric COVID-19 vaccine trials and vaccination efforts that has been applied to adult studies and vaccinations in order to achieve the herd immunity needed to reopen the United States.

March 04, 2021 | Daily News

Congress’ investigative arm warned Wednesday (March 3) that FDA needs to prepare for a large backlog of foreign inspections in future years due to its decision to stop onsite reviews during the pandemic and rely on alternative inspection options, and it asked FDA to study whether the alternative tools have worked in place of traditional inspections.

March 04, 2021 | Daily News

Pediatricians say vaccine developers need to make information about their COVID-19 clinical trials more accessible, especially to historically underrepresented minority groups, to encourage parents to enroll their children in trials now taking place to study the vaccines’ effects on children.

March 04, 2021 | Daily News

Given that up to 38% of all prescriptions and 56% of oncology prescriptions are written for off-label uses, Congress could consider asking HHS to study how drug prices and reimbursement influence off-label prescribing and patient safety, the Congressional Research Service suggests.

March 04, 2021 | Daily News

Rep. Buddy Carter (R-GA) said during a recent Energy & Commerce Committee hearing that pharmacy benefits manager audits are deterring some pharmacists from administering coronavirus vaccines.

March 03, 2021 | Daily News

Senate Democrats are falling in line with House-passed pandemic relief funding for FDA and HHS, proposing $500 million for FDA review, development and postmarketing surveillance of COVID-19 medical products; $47.8 billion for HHS’ test-and-trace work; and $6 billion for HHS to secure the vaccine, therapeutics and ancillary medical products supply chains, according to their latest draft of relief legislation floated Wednesday (March 3).

March 03, 2021 | Daily News

Senate Democrats delayed by one year, till 2024, the removal of the cap on Medicaid inflation rebates included in their draft pandemic relief package, according to language circulating Wednesday (March 3).

March 02, 2021 | Daily News

HHS is paying Merck $268.8 million to make Johnson & Johnson’s newly authorized coronavirus vaccine to help J&J meet its production goals and help the administration reach the goal of supplying enough doses to vaccinate every American by the end of May.

March 02, 2021 | Daily News

A proposal to waive a selection of World Trade Organization intellectual property obligations is “misguided,” the U.S. Chamber of Commerce argued on Tuesday, calling it “a distraction” from the broader vaccine access push.

March 02, 2021 | Daily News

The Centers for Disease Control and Prevention’s panel of vaccine advisers on Monday (March 1) debated whether only a single dose of the two-dose COVID-19 vaccines is needed for people who have already been infected with the SARS-CoV-2 virus.

March 02, 2021 | Daily News

Studies show that postponing the second dose of the two-dose mRNA COVID-19 vaccines beyond their currently recommended dosing regimens left some people less protected against SARS-CoV-2 variants, an official from the Centers for Disease Control and Prevention revealed during a meeting of CDC’s vaccine advisers on Monday (March 1).

March 02, 2021 | Daily News

Merck will make Johnson & Johnson’s newly authorized coronavirus vaccine to help J&J meet its production goals, a White House official confirmed.

February 28, 2021 | Daily News

The Centers for Disease Control and Prevention’s vaccine advisers emphasized a need for the government and other health officials to quash any concerns that Johnson & Johnson’s one-shot COVID-19 vaccine is inferior to the two other FDA-authorized vaccines from Pfizer and Moderna by clearly communicating that none of the vaccines have been compared head to head.

February 27, 2021 | Daily News

FDA granted emergency use authorization to Johnson & Johnson’s one-shot COVID-19 vaccine Saturday (Feb. 27), just one day after the agency’s panel of vaccine advisers unanimously endorsed the shot.

February 27, 2021 | Daily News

The Biden administration on Friday (Feb. 26) updated and partially reversed Trump administration guidance on insurers’ responsibilities for covering COVID-19 testing, clarifying that non-grandfathered group health plans must fully cover diagnostic testing even if the patient is asymptomatic, except when done for public health surveillance or return-to-work mandates.

February 26, 2021 | Daily News

Members of FDA’s vaccine advisory panel signaled they’re concerned about messaging and logistical issues that could come up later down the road, should Johnson & Johnson move its one-dose COVID-19 vaccine into a more-effective two-dose vaccine.

February 26, 2021 | Daily News

A majority of House lawmakers from both parties are telling HHS to fine drug companies that deny 340B discounts to hospitals for drugs dispensed by contract pharmacies and to make drug companies pay hospitals back for discounts that were withheld.

February 26, 2021 | Daily News

FDA’s vaccine advisers unanimously agreed that the benefits of Johnson & Johnson’s one-shot COVID-19 vaccine outweigh its risks for people who are at least 18 years old, with all 22 members of the agency’s advisory committee expressing support for emergency use authorization.

February 26, 2021 | Daily News

FDA will work to rapidly authorize Johnson & Johnson’s one-shot COVID-19 vaccine, acting agency commissioner Janet Woodcock and biologics center director Peter Marks announced shortly after the agency’s panel of vaccine advisers unanimously agreed that the benefits of shot outweigh its risks for people who are at least 18 years old.

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