FDA approves first-of-its-kind lupus drug

Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year.

By Jacob Bell • Jan. 27, 2021

Biden invokes DPA to combat supply shortages, but experts say it's no 'magic wand'

The administration's strategy document notes that supply chains are facing shortages of several types of personal protective equipment and supplies related to COVID-19 vaccines and testing.

By Matt Leonard • Jan. 27, 2021

Moderna to study vaccine booster aimed at coronavirus variant

Laboratory tests indicated the biotech's shot would still protect against virus variants detected in the U.K. and South Africa, although the latter appeared to result in a weaker immune response.

By Ned Pagliarulo • Jan. 26, 2021

Biden to create new enrollment period for ACA exchanges

While most state-based exchanges created special enrollment periods earlier in the COVID-19 pandemic, CMS under former President Donald Trump resisted calls to do so as his administration fought the landmark law in the courts.

By Shannon Muchmore • Jan. 26, 2021

Biden gives OSHA 2 weeks to issue new coronavirus guidance

The president also asked the agency to reconsider its decision to skip emergency temporary standards.

By Kate Tornone • Jan. 25, 2021

ACLA seeks lab reimbursement changes as need for COVID-19 testing surges

Julie Khani, president of the American Clinical Laboratory Association, which includes Quest and LabCorp, called for eliminating testing coverage gaps and clarifications around what tests are paid for by insurers.

By Greg Slabodkin • Jan. 25, 2021

4 key trends for payers and providers in 2021

The COVID-19 crisis has led some providers to inquire about partnering or acquiring insurance assets as the pandemic exposed the risk of relying on fee-for-service models.

By Samantha Liss • Jan. 22, 2021

CMS expands transcatheter mitral coverage, boosting Abbott's MitraClip device

Wall Street analysts said the national coverage determination could triple the patient base eligible for the company's device that repairs leaky heart valves, adding fuel to a growing and under-penetrated market.

By Ricky Zipp • Jan. 22, 2021

Biden taps acting HHS, CMS heads, to launch COVID-19 testing board

The president also promptly rejoined the World Health Organization and issued a mask mandate on federal property in his first hours on the job.

By Shannon Muchmore • Jan. 21, 2021

Biden faces many healthcare challenges as he takes the helm at an unprecedented time

The former senator and vice president has been sworn in as the 46th president of the United States while the country grapples with one of the biggest health crises in its history.

Jan. 20, 2021

Biden's most ambitious health policy: a public option plan

"It could fundamentally change how healthcare is priced in the U.S.," said Cynthia Cox, vice president of the Kaiser Family Foundation.

By Samantha Liss • Jan. 20, 2021

Key members of the Biden healthcare team

Many officials in the administration will be focused solely on the U.S. response to the COVID-19 pandemic, which Biden has named as his top priority.

By Shannon Muchmore • Jan. 20, 2021

Here’s which Trump-era health policies Biden could roll back — without help from Congress

The nearest-term 2021 actions will likely center on bolstering the ACA and Medicaid, after the Trump administration made significant efforts to weaken the landmark law and change the direction of the social safety net program.

By Rebecca Pifer Parduhn • Jan. 20, 2021

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

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

CMS finalizes prior authorization rule payers slam as 'half-baked'

Insurers face the biggest impact from the rule. America's Health Insurance Plans blasted it as "a series of empty promises" and "shabbily and hastily constructed."

By Rebecca Pifer Parduhn • Jan. 15, 2021

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

'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 Parduhn • Jan. 15, 2021

3 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.

Jan. 15, 2021

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

Care 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

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