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Daily News

March 30, 2021

A group of Democratic Representatives urged President Joe Biden to stick to his campaign trail proposal to allocate $450 billion to home- and community-based services in a letter sent Tuesday (March 30), a day before Biden is expected to release his “Build Back Better” plan.

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Only about 40% of hospitals that applied to be exempt from certain site-neutral provisions for off-campus departments were granted that exemption, but the American Hospital Association says CMS was too slow in conducting audits to affirm the requests so it should either reverse the denials to the remaining 60% or allow hospitals that were denied exceptions to appeal.

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The Biden administration is considering temporarily suspending intellectual property protections for COVID-19 vaccines and treatments to allow other countries to replicate existing vaccines for their own populations, but the idea faces opposition from the pharmaceutical industry, the European Union and other developed countries.

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Several state-based exchange will extend their special enrollment periods through Aug. 15 or beyond to better align with the federal government’s decision to keep healthcare.gov open longer so consumers can access the increased Affordable Care Act tax credits available under the American Rescue Plan.

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March 29, 2021

State and federal officials said the United States needs to work on standardizing and integrating public health data to improve health equity and the general public health infrastructure during the Office of the National Coordinator for Health Information Technology’s annual meeting Monday (March 29).

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America’s Physician Groups say the infrastructure package expected to be unveiled later this week would be the perfect vessel to allocate additional provider relief, and specifically targeted at physicians, especially those in primary care, whom they feel have been largely left out of previous distributions in favor of relief for hospitals.

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Novartis may give away its $475,000 cancer drug Kymriah to low-income patients who either don’t have insurance or have been denied access to the CAR T therapy by their insurer, according to an HHS Inspector General advisory opinion.

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A District Judge Friday (March 26) granted Georgia permission to intervene in a lawsuit challenging the Trump HHS approval of the state’s 1332 waiver that lets the state exit healthcare.gov and instead rely on agents and brokers to enroll consumers starting in 2022.

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March 26, 2021

Employers, health plan administrations and other stakeholders eagerly await guidance from HHS, Treasury and the Department of Labor on how the federal government will fully fund COBRA benefits that are now available April 1 under the American Rescue Plan.

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FDA watchers are split over how newly minted HHS Secretary Xavier Becerra will address the battle between FDA and the U.S. Department of Agriculture over which agency should have authority to regulate genetically engineered food animals.

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Proponents of FDA device regulation hope to see new HHS head Xavier Becerra reinstate FDA’s jurisdiction over laboratory-developed tests after the Trump HHS told the agency it no longer had the authority to regulate the tests.

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Stakeholders are urging CMS to quickly issue a flexible guidance on how and when states can use the American Rescue Plan’s 10 percentage point increase in federal Medicaid matching funds for home- and community-based services, with some asking for specific permission to spend on items including the direct support workforce and bolstering technology.

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The National Institutes of Health has kicked off a study of more than 12,000 college students and 25,000 of their closest contacts to figure out whether those vaccinated against COVID-19 can still get asymptomatic infection and, if so, whether they can transmit the infection to others, National Institutes of Allergy and Infectious Diseases Director Anthony Fauci announced Friday (March 26).

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Children’s health care advocates say their push to make the Children's Health Insurance Program permanent now goes beyond concerns that Congress will use the program as a bargaining chip: Depending on how the Supreme Court rules on the Affordable Care Act, the Congressional Budget Office score of the cost to renew CHIP could drastically increase when the program is up for renewal in 2027 from the last assessment of nearly budget neutral.

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March 25, 2021

Longtime Democratic operative Chris Jennings has joined the governance board of the Institute for Clinical and Economic Review, an independent organization that assesses drug values and that could become a key part of Democrats’ plan to control drug prices.

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The final 2022 Notice of Benefit and Payments Parameters is under review by the White House more than three months after the Trump administration finalized some of the most controversial pieces of the proposed rule before leaving office in January but left remaining policies for the Biden CMS.

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As providers and lobbyists anticipated, the Senate on Thursday (March 25) passed an extension of the Medicare sequester moratorium through the end of the year, but the legislation doesn’t include a House provision that would also head off additional sequester cuts created by the American Rescue Plan.

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FDA announced Thursday (March 25) that it has raised facility fees for its over-the-counter monograph user fee program to make up for the lack of revenue from non-traditional hand sanitizer manufacturers that temporarily entered the market provide sanitizer during the COVID-19 pandemic and were then carved out of the user fee program by the Trump administration.

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Providers called or faxed in their prior authorization requests 38% of the time even when given the option to submit them electronically, America’s Health Insurance Plans found in its electronic prior authorization pilot program, feeding into payers’ concerns that investing in an online platform for these authorizations won’t be worth it without provider buy-in.

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Germany’s drug pricing model, which makes drug companies justify prices to an independent panel, got a lot of attention Tuesday (March 23) at a Senate subcommittee hearing that highlighted the higher prices Americans pay for drugs compared to prices in the rest of the world.

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