Showing: 1 - 2 of 2 RESULTS

FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’

While Congress mandated earlier this year that Medicare cover the cost of administering a licensed vaccine, the requirement did not include drugs authorized under emergency-use designations. That’s raised the prospect that millions of people could be forced to pay out of pocket unless Congress were to adopt a quick fix.

HHS officials over the past month thought they found a solution, with Charrow arguing that the FDA should make clear that emergency authorization of a Covid-19 vaccine is equal to a “pre-licensure,” and should be covered by Medicare as a result, the officials said.

But Hahn firmly opposed the idea, amid concerns that failing to stick to the FDA’s technical language would erode the agency’s credibility and open it up to accusations that it’s allowing politics to influence its role in the Trump administration’s vaccine hunt.

“Hahn is hell bent against any modification of definitions, because it would be viewed as a politicization of science,” one senior administration official said, adding that while Hahn has so far rebuffed the proposal, some believe the White House could still get involved and demand changes.

Of particular concern, the official said, is that referring to a Covid-19 vaccine as having won a “pre-licensure” would be conflated with the shot being fully licensed by the FDA – a level of regulatory approval that signals the vaccine has met significantly higher standards for safety and effectiveness, and one the agency does not expect to grant to any vaccine candidates any time soon.

President Donald Trump has already spent months contradicting his own health officials involved in the complicated vaccine development process, claiming repeatedly that a viable vaccine is just around the corner and could be delivered faster than the end-of-year target agreed upon by the officials.

Suddenly changing how the FDA labels an eventual coronavirus vaccine could further muddle the situation, FDA officials worried, sparking confusion and deepening distrust of its work toward authorizing a vaccine.

In a statement, an FDA spokesperson pointed to “important substantive differences” between an emergency use authorization and the more stringent process required to seek full licensure of a vaccine.

“There is no such thing as ‘pre-licensure’ or ‘pre-approval’ under the laws FDA administers,” the spokesperson said.

An HHS spokesperson said that its Centers for Medicare and Medicaid Services is still exploring coverage options for vaccines authorized under an emergency use designation. And two administration officials downplayed the “pre-licensure” concept as an “academic discussion” about safety and effectiveness that never rose to the level of HHS Secretary Alex Azar.

But in talks with Hahn over the past several weeks, HHS officials presented the “pre-licensure” relabeling as the simplest and quickest way to close the Medicare coverage loophole, officials familiar with the conversations said.

The move would also prevent the Trump administration from having to rely on Congress to pass a legislative fix – a path that could get bogged down in gridlock on Capitol Hill.

“They’re trying to get creative – Congress is in disarray and they want a solution

WellCare of Nebraska Will Rebrand as Healthy Blue in January, Reflecting a New Alliance With Blue Cross and Blue Shield of Nebraska

Members’ health plan benefits and services will remain the same.

Community Care Health Plan of Nebraska, Inc. (dba WellCare of Nebraska), which is an Anthem Inc. company and leading managed care provider of health benefits for Nebraska’s Heritage Health Medicaid program, along with Blue Cross and Blue Shield of Nebraska (BCBSNE), the largest health insurer in Nebraska, have received approval to enter into an alliance to collaboratively serve Medicaid beneficiaries across the state.

In support of this venture, the Nebraska health plan known as WellCare will be rebranded as Healthy Blue to reflect the strength of its new alliance with BCBSNE, as well as to extend brand stability and recognition of the Blue Cross and Blue Shield name to its Heritage Health Medicaid members. This name change will take effect on Jan. 1, 2021.

“Through this joint venture, we are bringing together proficiency in building best-in-class Medicaid programs with expertise that comes from being the state’s oldest and largest health insurer,” said Tim Meyers, health plan president. “We both have a shared interest in addressing the unique needs of Nebraska’s Medicaid beneficiaries and alleviating Nebraska’s most pressing health issues. Through our shared mission, we are confident that we will succeed in building healthier, stronger communities across our state.”

Approximately 83,000 health plan members, who participate in the state’s Heritage Health Medicaid program, will be notified through the mail to inform them of the change to their health plan’s name. Members should expect to receive new Healthy Blue member ID cards with the Blue Cross and Blue Shield logo before January 1, 2021. Existing WellCare of Nebraska member ID cards should be used through the end of 2020.

Members will also continue to receive the same healthcare benefits and have access to their established primary care providers, specialists and care centers. This rebrand will not have any impact on BCBSNE health plan members or providers.

“We have been here for millions of Nebraskans throughout their health journeys and believe that ensuring care access and equity is fundamental to the health and well-being of our communities,” said Steve Grandfield, president and chief executive officer of BCBSNE. “In collaboration with a fellow industry leader, we look forward to equipping more people across our state with the power and peace of mind a Blue card provides.”

When the name change takes effect on Jan. 1, 2021, the current member website will be redirected to a new Healthy Blue website, and members should begin using the new customer service phone numbers printed on their Healthy Blue ID cards. Current members who do not receive their new Healthy Blue ID cards by Jan. 1, or those who have questions may contact member services at 855-599-3811 (TTY 877-247-6272), Monday – Friday, 8:00 a.m. – 5:00 p.m. CST, or visit myhealthybluene.com.

About Community Health Plan of Nebraska, Inc.

Community Care Health Plan of Nebraska, Inc. (“CCHPN”), an Anthem Inc. company that is formally known as WellCare of Nebraska, Inc., is a managed healthcare provider committed to