Policy & Regulation: Page 2

FDA appoints first medical device cybersecurity chief

University of Michigan professor Kevin Fu will serve a one-year term as acting cyber director at the Center for Devices and Radiological Health. Experts fear the chaos of the pandemic creates the perfect storm for hackers to exploit.

By Greg Slabodkin • Feb. 04, 2021

Low Medicare EKG rate a potential setback for device makers

Wall Street analysts questioned whether the lower-than-expected rates are final and what the prospects are for renegotiation. Shares of market leader iRhythm fell over 32% on Friday.

By Ricky Zipp • UPDATED: Feb. 1, 2021 at 10:28 a.m.

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Labor

While labor strife among healthcare workers is hardly new, the COVID-19 pandemic brought new issues to the table, including re-use of personal protective equipment and other safety measures.

By Healthcare Dive staff

Medicare buy-in for older adults could cut health costs, increase coverage value: Urban Institute

A Medicare buy-in is not a specific prong of President Joe Biden's health policy agenda, but there are currently two proposals in Congress designed to build upon the ACA.

By Rebecca Pifer • Feb. 03, 2021

Biden administration awards $231M to increase US production of at-home, OTC COVID-19 test

Australian company Ellume will use the funding to establish a U.S. manufacturing facility that is projected to increase production capacity by 640,000 tests per day by December.

By Susan Kelly • Feb. 02, 2021

How might Xavier Becerra operate as HHS Secretary?

The nominee has made headlines since leaving the House of Representatives, in part by leading blue state efforts to defend the ACA. Less high-profile, perhaps, were his efforts to block major hospital mergers in California.

By Ron Shinkman • Feb. 01, 2021

Vaccine makers prepare response as coronavirus mutations raise alarms

So far, both Pfizer's and Moderna's vaccines appear to work against more transmissible variants, but preparation is underway for the day they don't.

By Jonathan Gardner • Feb. 01, 2021

Novavax vaccine prevents COVID-19 in studies, but less effective against new variants

The drugmaker is already discussing an authorization with health authorities in the U.K., and plans to begin talks with the FDA and other regulators, too.

By Jonathan Gardner • Jan. 29, 2021

J&J says single dose of coronavirus vaccine 66% effective in large trial

The vaccine's efficacy was higher in the U.S., but lower in Latin America and South Africa, where new, more infectious virus variants are circulating.

By Ned Pagliarulo • Jan. 29, 2021

Payers welcome reopening of ACA marketplaces

Healthcare.gov will be open for a special enrollment period from Feb. 15 through May 15, though advocates say robust outreach and marketing efforts need to be coupled with the move.

By Samantha Liss • Jan. 28, 2021

Biden campaign cyber chief named federal CISO

Cybersecurity veterans praised the appointment, highlighting Chris DeRusha's extensive government and private sector experience.

By David Jones • Jan. 28, 2021

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

Q&A

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

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 • 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

Deep Dive

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

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.

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