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Category: Government


FDA gives Quest EUA for their at-home sample collection kit for COVID-19 testing; Plans to produce 500k units by end of June

William Feuer CNBC Author Healthcare HandoutPosted on May 29, 2020May 29, 2020Categories Commercial Labs, COVID-19, FDATags Quest Diagnostics Go Deeper
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Trump Administration bungled distribution of initial remdesivir doses; Gave doses to hospitals that were lacking ICUs, patients, or the ability to store it properly

Yasmeen Abutaleb, Josh Dawsey, Lena Sun, Laurie McGinley The Washington Post Author Healthcare HandoutPosted on May 28, 2020May 28, 2020Categories COVID-19, Biotech, Government Go Deeper
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Experts say Medicare's new $35 copay cap for insulin is hardly a win as it applies only to insulin, doesn't change actual prices, and will drive premiums up, all while giving drug companies political cover

Bob Herman Axios Author Healthcare HandoutPosted on May 28, 2020May 28, 2020Categories CMS Go Deeper
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Relaxed regulations and improved payments lead to Medicare telehealth visits exploding from 11,000 per week in March to 1.3M in a week in April

Rebecca Pifer Healthcare Dive Author Healthcare HandoutPosted on May 28, 2020May 28, 2020Categories Medicare Advantage, CMS Go Deeper
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FDA says it abruptly shut down Gates-backed Seattle coronavirus study for lacking EUA, institutional review board ethics approvals

Erin Brodwin STAT Author Healthcare HandoutPosted on May 27, 2020May 27, 2020Categories COVID-19, FDA Go Deeper
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CDC now saying antibody tests shouldn't be used for determining individual immunity; In certain scenarios 'less than half of those testing positive will truly have antibodies'

Tommy Beer Forbes Author Healthcare HandoutPosted on May 27, 2020May 27, 2020Categories COVID-19, Commercial Labs, Government Go Deeper
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CMS announces 1,750 insurance plans have agreed to cap insulin costs for Medicare Advantage and Part D members at $35/month; Drugmakers have also agreed to the plan

Robert King Fierce Healthcare Author Healthcare HandoutPosted on May 26, 2020May 26, 2020Categories Medicare Advantage, CMS Go Deeper
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Philips gets FDA 510(K) clearance for Biosensor BX100; Disposable chest patch that lets providers remotely monitor patient heart and respiratory rates

Elise Reuter MedCityNews Author Healthcare HandoutPosted on May 26, 2020May 26, 2020Categories FDATags Philips Go Deeper
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CMS expands Medicare Advantage telehealth rules to allow plans to include more specialists to meet network adequacy standards; Also allows ESRD patients to enroll in MA plans

Laura Dyrda Becker's Hospital Review Author Healthcare HandoutPosted on May 22, 2020May 22, 2020Categories CMS, Medicare Advantage, Telehealth
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HHS begins distributing CARES grants to skilled nursing facilities; Each SNF will receive $50K plus $2.5K per bed

Rachel Cohrs Modern Healthcare Author Healthcare HandoutPosted on May 22, 2020May 22, 2020Categories Nursing Homes/SNF, COVID-19, Government Go Deeper
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Stericycle predicts a surge in medical device recalls starting in Q3 as FDA Emergency Use Authorizations and enforcement-discretion end

Alia Paavola Becker's Hospital Review Author Healthcare HandoutPosted on May 21, 2020May 21, 2020Categories Medical Devices, FDATags Stericycle
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FCC has approved telehealth infrastructure grants amounting to $33M across 89 providers, but has only actually distributed funds to one provider

Rebecca Pifer Healthcare Dive Author Healthcare HandoutPosted on May 20, 2020May 20, 2020Categories Telehealth, Government
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Analysis: How medical supply chains work, and how federal response to supply chain troubles in times of pandemic can be improved

Anand Devaiah, Michael Wijaranakula, Chinmay Kommuru, Rena M. Conti Health Affairs Author Healthcare HandoutPosted on May 20, 2020May 20, 2020Categories Supply Chain, COVID-19, Government
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FDA partners with Aetion to launch real-world evidence study for COVID-19 diagnostics and treatments

Matthew Herper STAT Author Healthcare HandoutPosted on May 19, 2020May 19, 2020Categories FDA, COVID-19, ResearchTags Aetion
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CMS says nursing homes should stay closed to visitors until they have no new COVID-19 cases for 28 days and should test workers weekly

Bruce Japsen Forbes Author Healthcare HandoutPosted on May 19, 2020May 19, 2020Categories CMS, COVID-19, Nursing Homes/SNF
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Study shows more ACOs are led by physician groups than hospitals, with new growth driven by physician groups; Argues future regulation and model development should focus on physician needs

David Muhlestein, Tianna Tu, Carrie H. Colla American Journal of Managed Care Author Healthcare HandoutPosted on May 18, 2020May 18, 2020Categories ACO, Government, Hospitals, Insurance
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White House pushing Congress to require hospitals and insurers to disclose negotiated prices in future COVID-19 relief bills

Jennifer Jacobs, Shira Stein Bloomberg Author Healthcare HandoutPosted on May 16, 2020May 16, 2020Categories Hospitals, Government, Insurance
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FDA abruptly orders Seattle Coronavirus Assessment Network, a Gates-backed initiative to do broad coronavirus testing, to stop performing tests and reporting results pending review

Mike Baker The New York Times Author Healthcare HandoutPosted on May 15, 2020May 15, 2020Categories FDA, COVID-19
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Trump administration to rework Strategic National Stockpile of drugs and medical supplies; Increasing supplies to 90 days, smoothing communication between agencies, more closely monitoring shelf-life

Michael Brady Modern Healthcare Author Healthcare HandoutPosted on May 15, 2020May 15, 2020Categories Supply Chain, Government
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HHS makes $5M available for studies evaluating health care system response to COVID-19

Release HHS Author Healthcare HandoutPosted on May 15, 2020May 15, 2020Categories Government, COVID-19
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Analysis: By distributing CARES Act relief funds according to patient revenue, HHS gave more than 2x the relief funds on a per-bed basis to hospitals that earn more revenue from private insurers

Karyn Schwartz Kaiser Family Foundation Author Healthcare HandoutPosted on May 14, 2020May 14, 2020Categories Government, COVID-19, Hospitals
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Trump administration to name Moncef Slaoui, former GSK vaccine head, to be 'therapeutics czar'; Will lead government efforts to speed COVID-19 vaccine development

Dan Diamond Politico Author Healthcare HandoutPosted on May 13, 2020May 13, 2020Categories COVID-19, Government, PharmaTags GlaxoSmithKline
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IRS gives employers ability to allow employees to change health benefits elections outside enrollment periods; Includes dropping coverage, adding family members, switching plans

Margot Sanger-Katz, Ron Lieber The New York Times Author Healthcare HandoutPosted on May 13, 2020May 13, 2020Categories Insurance, Government
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Analysis: As of May 2, 27 million have lost employer sponsored insurance; 79% of those are eligible for subsidized coverage through Medicaid or subsidized exchange plans

Rachel Garfield, Larry Levitt, Gary Claxton, Anthony Damico Kaiser Family Foundation Author Healthcare HandoutPosted on May 13, 2020May 13, 2020Categories Insurance, CMS, COVID-19
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Doctor on Demand to start offering services to Medicare Part B FFS beneficiaries; Assuming telehealth regulations will remain loosened post-pandemic

Katie Jennings Forbes Author Healthcare HandoutPosted on May 13, 2020May 13, 2020Categories Telehealth, CMSTags Doctor on Demand
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CMS circulates draft guidelines for reopening nursing homes; Industry says they're too vague, while experts say it's too soon to reopen

Anna Wilde Mathews, Jon Kamp The Wall Street Journal Author Healthcare HandoutPosted on May 11, 2020May 11, 2020Categories Nursing Homes/SNF, CMS, COVID-19
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HHS outlines plan for remdesivir distribution: drug supply will be given over to states, whose health departments will distribute to hospitals based on determinations of need

Release HHS Author Healthcare HandoutPosted on May 9, 2020May 13, 2020Categories COVID-19, GovernmentTags Gilead
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KHN investigation shows many hospitals receiving HHS relief funds have been recently fined, including one that received $67M in bailouts and owes a $40M penalty June 1 due to a recent antitrust judgement

Rachana Pradhan, Fred Schulte Kaiser Health News Author Healthcare HandoutPosted on May 9, 2020May 9, 2020Categories Hospitals, Government
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At least three recently bankrupt hospitals have sued for access to the SBA Paycheck Protection Program to pay their staffs and keep doors open

Bob Herman Axios Author Healthcare HandoutPosted on May 9, 2020May 9, 2020Categories Hospitals, COVID-19, Government
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CMS issues new rules for insurance exchanges including tweaks to special enrollment periods, redeterminations of eligibility for financial help, and how prescription drug rebates count towards OOP maximums and MLR totals

Shelby Livingston Modern Healthcare Author Healthcare HandoutPosted on May 8, 2020May 8, 2020Categories Insurance, Government
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FDA pulls approval for 60+ mask makers in China after discovering products don't meet safety standards

Austen Hufford, Mark Maremont The Wall Street Journal Author Healthcare HandoutPosted on May 7, 2020May 7, 2020Categories FDA, Supply Chain Go Deeper
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FDA grants EUA for Sherlock Biosciences' CRISPR-based coronavirus test; First CRISPR product through the FDA

Alaric DeArment MedCityNews Author Healthcare HandoutPosted on May 7, 2020May 13, 2020Categories Biotech, COVID-19, FDA, GovernmentTags Sherlock Biosciences Go Deeper
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FDA reverses course, will now require coronavirus antibody tests to receive emergency use authorization; Only 12 tests have been authorized so far, 250+ are pending

Berkeley Lovelace Jr., William Feuer CNBC Author Healthcare HandoutPosted on May 4, 2020May 4, 2020Categories FDA, COVID-19, Government
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Analysis: AI tools and technologies will challenge established regulatory frameworks, as well as the authority of physicians

Anthony Weiss, Luke Sato, Barak D. Richman Health Affairs Author Healthcare HandoutPosted on May 4, 2020May 4, 2020Categories Artificial Intelligence, Government
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CMS issues interim rule to remove spending associated with COVID patients from performance calculations for ACOs

Michael Brady Modern Healthcare Author Healthcare HandoutPosted on May 1, 2020May 1, 2020Categories ACO, CMS, COVID-19
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Health insurers are telling investors they're largely untroubled by the pandemic, while their lobbying group, AHIP, is asking Congress for relief funds

Isaac Arnsdorf ProPublica Author Healthcare HandoutPosted on May 1, 2020May 1, 2020Categories Insurance, COVID-19, Government Go Deeper
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CMS announces new rules to extend telehealth coverage & boost payment rates; Also relaxing rules to make it easier to get coronavirus testing

Paige Minemyer Fierce Healthcare Author Healthcare HandoutPosted on April 30, 2020April 30, 2020Categories CMS, Government
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Analysis: The "innovation premium" Americans pay in the form of higher prescription drug prices doesn't provide clear benefits, should be studied more deeply

Richard G. Frank, Jerry Avorn, Aaron S. Kesselheim Health Affairs Author Healthcare HandoutPosted on April 30, 2020April 30, 2020Categories Pharma, Government
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Analysis: Government and private insurers must act to alleviate unprecedented & systemic financial pressures facing independent practices

Michael L. Barnett, Ateev Mehrotra, Bruce E. Landon NEJM Author Healthcare HandoutPosted on April 30, 2020April 30, 2020Categories COVID-19, Government, Insurance, Small Practices
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Pear Therapeutics launches digital therapeutic for schizophrenia during FDA emergency period; Therapy is combination of digital interventions, medication, and physician supervision

Laura Lovett Mobihealthnews Author Healthcare HandoutPosted on April 30, 2020April 29, 2020Categories Digital Therapeutics, Digital Health, Government
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Analysis: How the Amish health care system produces comparable results to the American system at a fraction of the cost

Scott Alexander Slate Star Codex Author Healthcare HandoutPosted on April 29, 2020April 29, 2020Categories Government, Insurance, Public Health
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National Institutes of Health facilitating challenge for innovators to win funding for rapid coronavirus testing technologies; winners will receive funding from NIH and commercialization support from industry experts

Katie Jennings Forbes Author Healthcare HandoutPosted on April 29, 2020April 29, 2020Categories Government, COVID-19
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OIG report finds major operational, technical issues in VA rollout of new Cerner EHR system

Christopher Jason EHRIntelligence Author Healthcare HandoutPosted on April 29, 2020April 29, 2020Categories EHR, Government
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Analysis of the Supreme Court's ruling on risk corridors and what happens now: the effect on MLRs, who will receive funds, and other impacts of the decision

Katie Keith Health Affairs Author Healthcare HandoutPosted on April 28, 2020April 28, 2020Categories Government, Health Policy, Insurance
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California fines more than a dozen drug makers for not providing drug pricing data; Fines reached a total of $17.5M, mostly in 2020

Ed Silverman STAT Author Healthcare HandoutPosted on April 28, 2020April 28, 2020Categories Pharma, Government
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CMS suspends advance payments to providers, is reevaluating accelerated payments for hospitals

Tina Reed Fierce Healthcare Author Healthcare HandoutPosted on April 27, 2020April 27, 2020Categories Government, COVID-19, Hospitals, Small Practices
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CVS will offer coronavirus testing at 1,000 locations; More retailers expected to follow suit after Trump administration meeting

Angelica Lavito Bloomberg Author Healthcare HandoutPosted on April 27, 2020April 27, 2020Categories COVID-19, Government, Retail Healthcare
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Supreme Court rules commercial health insurers are owed $12B in payments from government; Ruling settles legal uncertainty around the ACA's risk corridor program

Shannon Muchmore Healthcare Dive Author Healthcare HandoutPosted on April 27, 2020April 27, 2020Categories Government, Insurance
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Some of $50 billion CARES Act provider grants went to closed hospitals

Rachel Cohrs Modern Healthcare Author Healthcare HandoutPosted on April 27, 2020April 27, 2020Categories Government, COVID-19, Hospitals
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Longread: What the Coronavirus Crisis Reveals About American Medicine

Siddhartha Mukherjee The New Yorker Author Healthcare HandoutPosted on April 27, 2020April 27, 2020Categories Public Health, Government
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Healthcare Handout Everything worth knowing in healthcare tech and business.
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