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Daily News

June 08, 2021

The prospect of waiving certain provisions of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property garnered widespread support ahead of a Tuesday (June 8) TRIPS Council meeting and following a weekend endorsement from Asia-Pacific Economic Cooperation trade ministers.

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President Joe Biden’s budget proposes spending $17 million next year on the operations and oversight of the 340B drug discount program, $7 million more than this year, and the budget asks Congress to give HHS the authority to audit hospital records of how savings from the program are spent.

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The Biden administration is committing $60 million to develop technology that improves manufacturing of complex generic drugs, the White House announced Tuesday (June 8).

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June 07, 2021

The drug price watchdog ICER said FDA failed to protect patients by approving Aduhelm (aducanumab) because there isn’t enough evidence that the Alzheimer’s drug works yet there is evidence of serious side effects, and ICER said the drug is grossly overpriced.

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During weekend meetings, Asia-Pacific Economic Cooperation trade ministers agreed to support a temporary waiver of certain intellectual property protections on COVID-19 vaccines and treatments and committed to speeding up the flow of vaccines, according to a joint statement issued Saturday.

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HHS revealed Saturday (June 5) that as of February a record 31 million Americans were covered under the Affordable Care Act, including 11.3 million people who had effectuated exchange plans, 14.8 million newly eligible Medicaid enrollees, 1 million in the Basic Health Program and another 4 million previously eligible Medicaid beneficiaries who came out of the woodwork due to the ACA outreach.

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Women and children health care advocates are cheering growing interest among states in extending Medicaid postpartum coverage beyond the current 60 days -- most recently, a bill to extend postpartum coverage to six months is sitting on the Texas GOP governor’s desk while Florida Governor Ron DeSantis (R) signed Wednesday (June 2) legislation to extend coverage to one year after a woman gives birth.

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The European Union on Friday (June 4) proposed an alternative to the widely debated waiver of certain World Trade Organization intellectual property obligations -- of which the bloc remains critical -- outlining instead an initiative to limit export restrictions on COVID-19-related products, encourage expanded production of vaccines and facilitate intellectual property flexibilities, including issuing compulsory licenses.

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FDA and industry are in talks about how the agency can support scientific research around and issue guidance on biosimilar interchangeability, according to a summary of a recent biosimilars user fee meeting.

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FDA on Monday (June 7) approved Biogen’s Alzheimer’s drug Aduhelm (aducanumab) after months of contentious debate during which the agency’s own advisers spoke out against approving the drug, while patients and patient advocates pushed for approval.

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June 04, 2021

Center for Medicare and Medicaid Innovation Director Liz Fowler promised to keep Congress up to speed on what her center is up to one day after a bipartisan group of House lawmakers demanded she be transparent on how the agency determines demonstrations to be successful and work more closely with Congress and stakeholders on innovation efforts.

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CMS formally announced Friday (June 4) that it will make available $80 million in grant funding for navigators in states with a federally facilitated marketplace in the 2022 plan year.

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FDA officials say manufacturers of COVID-19 tests that are on the market under emergency use authorization should begin submitting applications to convert their EUAs to full approval so they can stay on the market after the COVID-19 public health emergency is over.

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A group of 20 health care and insurance plan organizations are asking HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure to allow Medicare Advantage plans to submit diagnoses from audio-only telehealth appointments for risk adjustment.

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As part of its program integrity strategy, CMS aims to increase Medicare medical claim reviews and is asking Congress for extra funding to allow more Qualified Independent Contractors to defend their decisions at the third level of appeals, according to the CMS fiscal 2022 budget justification.

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FDA has granted emergency authorization for a subcutaneous injection version of Regeneron’s COVID-19 antibody therapy -- a move the agency hopes will dramatically increase access since up to now patients could only get the treatment through IV infusions.

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Nursing homes estimate more than 1,600 skilled nursing facilities could close in 2021 and disrupt residents’ care if HHS doesn’t distribute the remaining provider relief and extend its deadline to spend the relief from June 30 to Dec. 30, 2022.

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CMS’ innovation center likely will take a different approach to the drug pricing favored-nation demo attempted by the Trump administration and now delayed by the courts, Center for Medicare and Medicaid Innovation Director Elizabeth Fowler said Thursday (June 3).

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June 03, 2021

Center for Medicare and Medicaid Innovation Director Liz Fowler said Thursday (June 3) her center is in the midst of a strategic review of its demonstrations and plans to make conscious choices on how it invests, move to more mandatory models and focus on beneficiaries’ meaningful care relationships.

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Creating a public option continues to be a priority for the Biden administration, Center for Medicare and Medicaid Innovation Director Liz Fowler said at a Health Affairs event Thursday (June 3), but she stressed that progress on the hot-button policy needs to come from Congress and that states must work through unanswered questions such as whether to base reimbursement on Medicare or something else, and how to maintain a level of competition.

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