Policy & Regulation

Medical device makers get more flexibility with value-based care in Stark, anti-kickback final rules

The changes include two safe harbor pathways and "allow you to do things that otherwise might violate the kickback statute or the Stark Law. So, that is always welcome in the industry," one lawyer said.

By Ricky Zipp • Nov. 25, 2020

COVID-19 is making it harder for some middle income patients to pay premiums, deductibles: report

The economic impact from COVID-19 could make it harder for workers to pay for their share of employee-sponsored healthcare coverage, a survey from The Commonwealth Fund found.

By Ron Shinkman • Nov. 24, 2020

Explore the Trendline➔

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

In last minute agenda push, Trump admin rolls back Stark, anti-kickback rules

The final regs issued Friday are slated to take effect Jan. 19, one day before President-elect Joe Biden is inaugurated. A new administration could still change them, though experts called that unlikely.

By Rebecca Pifer • Nov. 23, 2020

Trump admin pushes last-ditch plan to lower drug prices

The American Hospital Association blasted one measure it said will significantly cut reimbursement for coming "in the middle of a pandemic with cases at record levels, and with less than six weeks’ notice."

By Jonathan Gardner , Ned Pagliarulo • Nov. 20, 2020

Deep Dive

Hospitals scramble to get ready for coronavirus vaccines

From ultra-cold storage capabilities to extra security staff, facilities are bracing now for their role in distribution of an eventual vaccine.

By Shannon Muchmore • Nov. 19, 2020

Is Amazon's pharmacy foray disruptive? Experts disagree.

Analysts are split on the impact of the e-commerce giant finally entering the space in full force. Either way, it's unwelcome news for heavyweights like CVS and Walgreens.

By Samantha Liss • Nov. 18, 2020

FDA OKs first fully at-home COVID-19 test as US cases surge

Though the test is expected to be available nationally by early spring through healthcare providers, it will first be made available in the "near future" to patients of Sutter Health in Northern California and Cleveland Clinic Florida.

By Greg Slabodkin • Nov. 18, 2020

Moderna's vaccine can last for weeks in a refrigerator, expanding an edge on rivals

Pharmacies and doctor's offices should be able to store Moderna's shot on site, a crucial advantage for the mass immunization challenge that lies ahead.

By Jonathan Gardner • Nov. 17, 2020

Moderna says vaccine prevents COVID-19 in large study as virus surges

The results, on par with those reported by Pfizer and BioNTech last week, come as health systems nationwide scramble to prepare for eventual distribution of shots that healthcare workers will be among the first to get.

By Ben Fidler • Nov. 16, 2020

What we know about Pfizer's coronavirus vaccine distribution plan

The pharmaceutical company plans to ship vials directly from manufacturing plant to point of vaccination in a supply chain model it described as flexible and just in time.

By Matt Leonard • Nov. 12, 2020

Abbott COVID-19 tests at center of squabble between Trump administration, states

HHS testing czar Brett Giroir said the federal government is halting shipments of tests to eight states until the diagnostics already sent to governors are distributed and used. At least one state pushed back on his assertions.

By Greg Slabodkin • Nov. 11, 2020

Eli Lilly wins FDA emergency clearance for COVID-19 antibody drug

The Food and Drug Administration cleared the company's synthetic antibody treatment, but short supplies and logistical challenges could limit its initial impact.

By Ben Fidler • Nov. 10, 2020

Top picks for who could run HHS, CMS under Biden

Former Obama adviser and ACA architect Ezekiel Emanuel as well as high-profile state officials like New Mexico Governor Michelle Lujan Grisham are among those considered likely advisers.

By Rebecca Pifer • Nov. 10, 2020

Deep Dive

5 issues hospitals want Biden to tackle in his first 100 days

Taming the COVID-19 pandemic, which threatens to overwhelm the sector's resources, is the No. 1 ask. Rolling back limits to Medicaid and sustaining COVID-19-spurred telehealth reimbursement are also on the list. 

By Samantha Liss , Rebecca Pifer • Nov. 10, 2020

The Affordable Care Act before the US Supreme Court

The ACA has been in peril before, including before the country's highest court. But with a newly seated conservative justice, the decade-old law faces another major challenge. Here's a roundup of Healthcare Dive's coverage.

By Samantha Liss • Nov. 10, 2020

COVID-19 could depress 2021 Medicare Advantage payments, analysis suggests

Consultancy Avalere also warned that MA plans should brace for dealing with chronically ill enrollees whose health has declined due to foregoing care during the pandemic and could require more services in the long term.

By Ron Shinkman • Nov. 09, 2020

Biden names COVID-19 experts, calls pandemic top priority for transition

His plan calls for using the Defense Production Act to increase production of PPE, ramping up testing availability, creating a racial and ethnic disparities task force and restoring the U.S. role in the World Health Organization.

By Shannon Muchmore • Nov. 09, 2020

Coronavirus vaccine from Pfizer, BioNTech prevents COVID-19, early results show

The results, from a large Phase 3 trial that began in late July, cap off a dizzying eight months of research, into which scientists at Pfizer and German drug developer BioNTech compressed what's normally a yearslong process.

By Jonathan Gardner • Nov. 09, 2020

Healthcare helped Democrats usher in 2018's blue wave. This year it hasn't delivered a decisive win.

"Clearly, the ACA message wasn't the salient issue of the election as it seemed to be in 2018, but we did see healthcare playing a big role," Chris Sloan, a principal at consultancy Avalere, said.

By Samantha Liss • Nov. 06, 2020

Biden faces a divided Congress, stifling chance for more progressive health policies

Former Vice President Joe Biden won the U.S. presidency, the Associated Press and all the major networks said, after votes were tallied in Pennsylvania on Saturday.

By Shannon Muchmore • UPDATED: Nov. 7, 2020 at 2:31 p.m.

CMS finalizes rejection of Baxter, Outset dialysis device add-on payments

The broader, now final, end-stage renal disease rule is meant to support use of equipment and supplies for at-home dialysis treatment.

By Nick Paul Taylor • UPDATED: Nov. 3, 2020 at 9:52 a.m.

What healthcare issues are driving voters to the polls on Election Day?

While the economy has topped the list of concerns in some national surveys, the Affordable Care Act's Medicaid expansion and pre-existing condition protections are also key issues on voters' minds.

By Hailey Mensik • Nov. 03, 2020

Healthcare Dive's 2020 election coverage

The outcome of the presidential race and control of the Senate were still unknown. Polling showed healthcare issues were top of mind for many as they cast their vote.

CMS set to bump MA rates for 2022 in win for payers

The agency is also proposing to rely entirely on encounter data to calculate patient risk scores in 2022, a move that has been opposed by commercial insurers.

By Samantha Liss • Nov. 02, 2020

CMS clears Georgia bid to nix Healthcare.gov, decentralizing ACA marketplace

If implemented, the state would be the first with no government-run website to enroll in ACA plans, decentralizing marketplace functions among a few private insurers. Some call it an illegal move that would push thousands off the rolls.

By Rebecca Pifer • Nov. 02, 2020