Policy & Regulation
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Permission granted by BioNTech SE
Mayo, Epic and Cerner teaming to create digital COVID-19 vaccine passport
The hope of the Vaccination Credential Initiative is to form a standard for credentials to be made in an interoperable and accessible format.
By Ron Shinkman • Jan. 15, 2021 -
Kendall Davis/Industry Dive/Healthcare Dive, data from Marc Nozell
Former FDA chief Kessler tapped as top Biden adviser for COVID-19 response
David Kessler, who served in both the first Bush and Clinton administrations, will be joined by former acting Medicare head Andy Slavitt in a revamped effort from the new administration.
By Jonathan Gardner • Jan. 15, 2021 -
Trendline
Social determinants of health
The focus on social determinants of health has only increased as the COVID-19 pandemic has devastated the United States.
By Healthcare Dive staff -
Getty Images
CMS finalizes prior authorization rule payers slam as 'half-baked'
Insurers face the biggest impact from the rule and America's Health Insurance Plans blasted it as "a series of empty promises" and "shabbily and hastily constructed" in a Friday statement.
By Rebecca Pifer • Jan. 15, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
US pushes for wider use of 'underutilized' COVID-19 antibody drugs as pandemic worsens
A $2.6 billion deal with Regeneron this week is part of a renewed effort by government officials to bolster uptake of the treatments, which haven’t gained traction.
By Ben Fidler • Jan. 15, 2021 -
Hospital buy-ups of physician practices under fresh FTC scrutiny
The agency sent orders to UnitedHealthcare, Anthem, Aetna and Cigna, among others, seeking patient claims data in what several economists cheered as a major move to probe healthcare mergers.
By Samantha Liss • Jan. 15, 2021 -
Samantha Liss/Healthcare Dive
'Really difficult nut to crack': MedPAC torn over telehealth regs post-COVID-19
Members were wary of making any concrete near-term policy changes, suggesting instead industry be allowed to test drive new telehealth regulations after the pandemic without baking them in permanently.
By Rebecca Pifer • Jan. 15, 2021 -
iStock: zoranm
Sponsored by AppointmentPlus3 ways to tame the vaccine administration chaos
In this fast-paced, changing-by-the-minute environment, it’s important for those in charge of administering the vaccine to take a moment and think about ways to improve and add efficiency to the process.
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UpperEdge
FDA issues action plan for regulating AI in medical devices
The proposal brings the agency a step closer to draft guidance for regulating the fast-evolving field of artificial intelligence and machine learning-based software in medical devices.
By Susan Kelly • Jan. 14, 2021 -
ACA plan enrollment for 2021 ticked up slightly
Of the total, 23% of consumers were new and the rest renewed coverage. Repeat consumers who actively chose a new plan and those who were automatically re-enrolled both increased.
By Shannon Muchmore • Jan. 14, 2021 -
CMS breakthrough rule cheered as tailwind for Abbott, J&J and Medtronic
The final rule enables developers of FDA-designated breakthrough products to get Medicare coverage for some 60 million beneficiaries on the day they win approval.
By Nick Paul Taylor • Jan. 13, 2021 -
Samantha Liss, Healthcare Dive
OpinionCare navigation during COVID-19 and beyond
The industry needs to quickly come up with a way to prevent and mitigate enduring health issues for COVID-19 survivors as well as catch up on deferred care for other conditions, Harvard Medical School's Sanjay Basu argues.
By Sanjay Basu • Jan. 12, 2021 -
Dollar Photo Club
CMS audits small slice of hospitals for price transparency, probes complaints
Compliance is "frustratingly incomplete," said Niall Brennan, CEO of the Health Care Cost Institute. A paltry $300 daily fine may not be enough to force facilities to reveal the information.
By Samantha Liss • Jan. 11, 2021 -
Courtesy of Novavax, Australian Broadcasting Corporation
AHA to HHS: Feds need to take charge in COVID-19 vaccine rollout
The plea coming less than two weeks before the Biden administration takes over suggests the urgency. "As this rollout rapidly evolves, it is absolutely critical that effective situational, real-time leadership is provided nationally."
By Ron Shinkman • Jan. 08, 2021 -
Brian Tucker / Healthcare Dive
Tennessee approved for first Medicaid block grant program
The waiver is approved for 10 years. The incoming Biden administration could attempt to roll it back, but the state would be able to challenge such a move.
By Shannon Muchmore • Jan. 08, 2021 -
HHS finalizes regulatory review rule, though more lenient than proposed
When pitched in November, the idea sparked concern among providers and other groups fearing it would inject more uncertainty into the industry, and heap additional administrative burden onto HHS.
By Rebecca Pifer • Jan. 08, 2021 -
Retrieved from Gage Skidmore/Flickr.
With Democratic trifecta, Biden could shore up ACA
"A lot can be done with a simple majority vote in the Senate," Kaiser Family Foundation's Larry Levitt said on Twitter.
By Shannon Muchmore • Jan. 07, 2021 -
Not enough time, not enough clarity: Payers push back on CMS prior authorization rule
Following publication on the Federal Register, industry groups had only 17 days to review the rule and draft comments — a major source of concern, insurers said.
By Rebecca Pifer • Jan. 06, 2021 -
Permission granted by University of Maryland School of Medicine
FDA says changing coronavirus vaccine dosing could put 'public health at risk'
In an unusual statement, FDA chief Stephen Hahn and top official Peter Marks opposed altering vaccination regimens without further evidence, calling proposals to do so "premature."
By Ben Fidler • Jan. 05, 2021 -
CMS should tweak wage index adjustment to help rural hospitals, OIG says
The report, issued following a federal audit, found rural hospitals had the highest concentration of low-wage providers. Of all hospitals in the bottom quartile of area wage indexes, 53% were operating in rural areas.
By Rebecca Pifer • Jan. 04, 2021 -
AHA seeks emergency relief to block enforcement of price transparency rule
Imminent enforcement "will force overburdened hospitals to divert resources that hospitals desperately need to respond to the surge of COVID-19 cases and successfully roll out the vaccines," the hospital lobby argued.
By Samantha Liss • Dec. 23, 2020 -
Getty
CMS finalizes rule to ease value-based arrangements for prescription drugs
The changes, effective in 2022, overhaul existing regulations that stymied value-based payments in a bid to expand access to new, expensive drugs like gene therapies, the agency said.
By Rebecca Pifer • Dec. 22, 2020 -
ACA exchange enrollment for 2021 holds steady
About a quarter signed up for a plan for the first time — amid historic job losses — while the rest were returning customers or people who were automatically re-enrolled.
By Shannon Muchmore • Dec. 21, 2020 -
Moderna
Moderna's first FDA clearance brings the US a second coronavirus vaccine
The FDA's emergency authorization of the biotech's shot bolsters an immunization campaign in the U.S. that's just beginning.
By Ben Fidler • Dec. 18, 2020 -
CMS greenlights direct contracting model for Medicaid MCOs, dual eligibles
The possibility of shared savings may spur managed care companies to make new investments in coordinated care to ultimately curb costs in Medicare fee-for-service, the agency said.
By Samantha Liss • Dec. 18, 2020 -
Moderna
FDA panel endorses Moderna's coronavirus vaccine
A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the agency within days.
By Ned Pagliarulo • UPDATED: Dec. 17, 2020 at 6:02 p.m.
