NIH is testing the antiviral drug's safety and efficacy against COVID-19.
Gilead Sciences, Inc. has asked the federal government to rescind orphan drug designation for remdesivir, an antiviral drug that could be used to fight COVID-19.
"Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation."
Orphan drug designation is granted by the FDA for rare diseases that affect fewer than 200,000 people nationwide.
Remdesivir was originally designed by Gilead to treat Ebola and Marburg viruses.
The drug maker said Wednesday it "is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation."
Gilead's about-face on the orphan drug status comes as pressure was mounting on the drug maker to rescind the designation, which would have given Gilead a seven-year marketing monopoly.
A group of 50 public advocacy groups rapped Gilead for rushing to get the orphan designation earlier this month while there were fewer than 200,000 known COVID-19 cases in the United States.
"This is an unconscionable abuse of a program designed to incentivize research and development of treatments for rare diseases,” the advocates said in a letter sent Wednesday to Gilead CEO Daniel O'Day.
"COVID-19 is anything but a rare disease. Calling COVID-19 a rare disease mocks people's suffering and exploits a loophole in the law to profiteer off a deadly pandemic."
"Making the claim to special orphan status even more outrageous is the fact that the public already has largely paid for remdesivir's development through at least $60 million in grants and innumerable contributions from federal scientists. America, and the world, has the right to expect better from Gilead," the letter said.
The National Institutes of Health announced Wednesday that it would begin testing remdesivir to determine if it could be used safely and effectively to treat the coronavirus.
However, new estimates from federal actuaries do not project the cost implications of the coronavirus pandemic.
National health spending growth is expected to average 5.4% annually through 2028, outstripping the growth of the gross domestic product by 1.1 percentage points, reaching nearly $6 trillion a year, and consuming nearly 20% of the economy by then, according to federal actuaries.
"As it has over the past several decades, health spending is expected to grow, on average, more rapidly than the rest of the economy," said Sean Keehan, an economist at CMS and lead author of the study, which was published today in Health Affairs.
However, the new estimates released today by the independent Office of the Actuary at the Centers for Medicare and Medicaid Services come with a critical caveat: They provide no cost estimates for the ongoing coronavirus pandemic.
A new analysis from FAIR Health estimates that the total costs for all hospitalized COVID-19 patients may range from a low of $362 billion in charges and $139 billion in estimated in-network amounts to a high of $1.449 trillion in charges and $558 billion in estimated in-network amounts.
The CMS actuaries' report projects healthcare spending growth to be driven primarily by healthcare sector wage growth, and an expected rebound in the prices for medical services and goods. Personal health care prices are expected to increase at an average rate of 2.4% during 2019–28 and to account for 43% of the total projected growth in personal health care spending over the period, CMS said.
“The government is projected to pay a larger share (nearly half) of the nation’s total health bill by 2028, as the baby boomers continue aging into Medicare and the program’s beneficiaries consume $1 out of every $4 spent on healthcare," Keehan said. "Policy makers and other stakeholders will undoubtedly continue to monitor these trends and their implications for the health sector, federal and state budgets, and the economy as a whole."
"This acceleration in price growth largely reflects faster expected growth in health-sector wages and follows the unusually slow rate of personal health care inflation observed in 2014–18, when price growth for medical goods and services was 1.2% and represented 25% of expenditure growth," the audit said.
For the decade ahead, Medicare's annual spending growth of 7.6% will outstrip Medicaid (5.5%) and private health insurance (4.8%) mostly because of higher enrollment throughout the decade as retiring baby boomers transition to Medicare, along with a 2.5% increases in medical goods prices through 2027.
COVID-19 Cost Estimates Vary Widely
The wide variance in the FAIR Health estimates depend on the incidence rate and severity of the infection in the U.S. population, with projections that 66 million to 198 million Americans may become infected with the virus, and that from 4.9 million to 19.8 million of them may require inpatient stays.
The total average charge per COVID-19 inpatient stay is estimated at $73,300 and the total average estimated in-network amount per commercially insured patient at $38,221, the analysis said.
Uncertainty ahead
Cori Uccello, a senior fellow at theAmerican Academy of Actuaries, said the sudden and unforeseen onset of the coronavirus pandemic is wreaking havoc on cost projections.
"The pandemic and policy responses to it are evolving rapidly, bringing uncertainty to how total national health spending will be affected and how costs of care for 2020 will compare to what insurers anticipated when they set premium rates for the year," Uccello said.
"That uncertainty also applies to 2021 health spending projections, even as insurers are currently developing 2021 premiums," she said.
Uccello said factors affecting health spending include the ultimate hospitalization rate for COVID-19, access to COVID-19 treatments, and the degree to which increased spending for patients with COVID-19 will be offset by deferments or cancellations of nonessential services.
"These factors can vary by insurance market and geographic area," she said.
For example, Uccello said that if COVID-19-related costs are concentrated in 2020, 2021 health spending might be affected only minimally.
However, if COVID-19 incidence and related costs are expected to continue into 2021, premiums for 2021 could be affected as well.
CMS says the waivers will give state governments more flexibility to respond to the epidemic.
The federal government on Monday approved 1135 Medicaid waiversfor 11 states batting the coronavirus epidemic.
The 1135 waiver allows the Centers for Medicare & Medicaid Services to waive some requirements in Medicare, Medicaid, and CHIP that give state Medicaid agencies flexibility and remove red tape that can hamper access to needed services.
President Donald Trump on March 13 granted CMS emergency powers to expedite the waivers.
"Thanks to the decisive leadership of President Trump during this emergency, CMS has been able to swiftly remove barriers and cut red tape for our state partners," CMS Administrator Seema Verma said in a media release. "These waivers give a broad range of states the regulatory relief and support they need to more quickly and effectively care for their most vulnerable citizens.”"
The waiver: streamlines provider enrollment processes; allows care to be provided in alternative settings in unlicensed facilities if a licensed facility is evacuated; waives prior authorization requirements; suspends some nursing home screening requirements to provide necessary administrative relief; and extends deadlines for appeals and state fair hearing requests.
The newly approved waiver states are: Alabama, Arizona, California, Illinois, Louisiana, Mississippi, New Hampshire, New Jersey, New Mexico, North Carolina, and Virginia.
Federal Court issues temporary restraining order against website offering fake COVID-19 vaccine.
A website selling bogus "Coronavirus Medical Kits" to rattled consumers is the first company to be slapped with a civil fraud complaint by the Department of Justice.
A federal judge in Austin, Texas issued a temporary restraining order on the website"coronavirusmedicalkit.com," which claims to offer consumers access to World Health Organization vaccine kits in exchange for a shipping charge of $4.95, which consumers would pay by entering their credit card information on the website.
"You just need to add water, and the drugs and vaccines are ready to be administered," the website said.
"There are two parts to the kit: one holds pellets containing the chemical machinery that synthesizes the end product, and the other holds pellets containing instructions that tell the drug which compound to create. Mix two parts together in a chosen combination, add water, and the treatment is ready."
DOJ said that "in fact, there are currently no legitimate COVID-19 vaccines and the WHO is not distributing any such vaccine."
U.S. District Judge Robert Pitman issued a temporary restraining order requiring that the registrar of the fraudulent website – who was not named by DOJ -- immediately block public access to it.
However, the website was still operational at mid-morning Monday.
The action follows U.S. Attorney General William Barr's announcement this weekend that DOJ would prioritize investigations of illegal conducted related to the pandemic.
In court papers filed Saturday, federal prosecutors accused the website of "engaging in a wire fraud scheme seeking to profit from the confusion and widespread fear surrounding COVID-19."
"The Department of Justice will not tolerate criminal exploitation of this national emergency for personal gain," said Assistant Attorney General Jody Hunt of the Department of Justice's Civil Division.
CMS says the waiver will give state governments more flexibility to respond to the epidemic.
Washington, one of the hardest hit states for the coronavirus, on Thursday became the second state in as many days to receive an 1135 Medicaid waiver from the federal government help fight the pandemic.
The 1135 waiver allows the Centers for Medicare & Medicaid Services to waive some requirements in Medicare, Medicaid, and CHIP that give state Medicaid agencies flexibility and remove red tape that can hamper access to needed services.
The waiver: streamlines provider enrollment processes; allows care to be provided in alternative settings in unlicensed facilities if a licensed facility is evacuated; waives prior authorization requirements; suspends some nursing home screening requirements to provide necessary administrative relief; and extends deadlines for appeals and state fair hearing requests.
"I recognize that Governor (Jay) Inslee and his team are working around the clock to respond to the escalating crisis in Washington State," CMS Administrator Seema Verma said in a media release.
"We are committed to stripping away any red tape that gets in the way of states or providers effectively managing this public health emergency," she said.
The streamlined review process for the waiver, which Verma said was submitted by Washington on March 15, came just days after President Donald Trump declared a national emergency on March 13.
"Florida is acutely focused on eliminating unnecessary barriers on our healthcare providers who are on the front lines serving our communities most impacted by COVID-19," Florida Governor Ron DeSantis said in a media release.
CMS says it expects other states to apply for the waiver.
New report shows some states and counties lag far behind in the availability of hospital beds.
Nearly two-thirds of the nation’s estimated 728,000 hospital beds already are occupied, according to a new report from the Urban Institute that provides a county-level view of bed capacity.
"As federal, state and local policymakers prepare for large increases in demand for inpatient hospital care, they need to understand the variation in bed capacity across states and communities—which will likely not match the spread of the virus," said Kathy Hempstead, senior policy adviser at the Robert Wood Johnson Foundation, which funded the study.
"Now is the time to identify contingency plans," she said.
The report, and an accompanying interactive county-level map, show that bed availability per 1,000 people varies a great deal across urban and rural areas, states, and counties across the nation.
The Urban Institute analysis estimates that in 2018, the United States had 728,000 medical and surgical hospital beds available to the public, or 2.2 hospital beds per 1,000 population. However, only 36% of these beds were unoccupied on a typical day, leaving just 0.8 unoccupied beds per 1,000 people.
The report cites experts who are urging hospitals to improve capacity by: creating internal rapid-response groups; transferring equipment to ICUs; prioritizing non-COVID-19-related patients; cancelling elective surgeries; speeding discharges; using military aid; and finding alternative spaces such as halls, conference rooms, and amphitheaters to increase capacity.
RWJF wants policymakers and local officials to use the map to identify regions with the greatest capacity challenges.
CommonSpirit's announcement is in line with a national push by hospital stakeholders and policy experts to improve access and affordability for coronavirus testing and treatment.
Chicago-basedCommonSpirit Health announced this week that it will suspend billing for patients undergoing tests and treatments at its 142 hospital and 700 other care venues in 21 states.
"The last thing our patients should worry about if they experience symptoms characteristic of this coronavirus is the cost of seeking care, CommonSpirit CEO Lloyd H. Dean said Tuesday in a media release.
"While we cannot yet know how COVID-19 will spread in the days and weeks ahead, our care sites will remain available to our communities," Dean said. "The most important thing now is for people who experience symptoms of the coronavirus to contact their health care provider and seek medical care if directed to do so."
CommonSpirit's announcement is in line with a national push by hospital stakeholders and policy experts to improve access and affordability for coronavirus testing and treatment.
Earlier this month, several states announced that they would waive some costs for coronavirus testing to address concerns that the access to care would be cost-prohibitive for poor and uninsured people.
CMS says the waiver will give state governments more flexibility to respond to the epidemic.
Florida this week became the first state to be approved for a Section 1135 waiver to respond to the COVID-19 national emergency, the Centers for Medicare & Medicaid Services said.
"Florida is acutely focused on eliminating unnecessary barriers on our healthcare providers who are on the front lines serving our communities most impacted by COVID-19," Florida Governor Ron DeSantis said in a media release.
On Friday, President Donald Trump granted CMS emergency powers to waive some requirements in Medicare, Medicaid, and CHIP under Section 1135 authority, to give state governments more flexibility to respond to the epidemic.
The waiver: streamlines provider enrollment processes; allows care to be provided in alternative settings in unlicensed facilities if a licensed facility is evacuated; waives prior authorization requirements; suspends some nursing home screening requirements to provide necessary administrative relief; and extends deadlines for appeals and state fair hearing requests.
While Florida is the first state to receive the 1135 waiver, CMS said it expects to review waiver requests from other states.
"CMS is committed to removing all unnecessary administrative and bureaucratic barriers that may hinder an effective response to this public health emergency, and I have directed my team to expeditiously process these requests," CMS Administrator Seema Verma said.
The U.S. House this is expected to take up an emergency spending bill for the coronavirus, but sequestration relief is not part of the package.
Hospital stakeholders have urged Congress to suspend the upcoming 2% Medicare cuts mandated under the sequestration "for at least the duration of the coronavirus pandemic."
"This action alone will provide immediate, significant relief across-the-board, and will signal continued Congressional support for the hard work that lies ahead for all of us," the American Hospital Association, the Association of American Medical Colleges, and the Federation of American Hospitals said Sunday in a joint letter to Senate Majority Leader Mitch McConnell and House Speaker Nancy Pelosi.
"Suspending the sequester and restoring those payments will provide a much-needed jolt of confidence not just for hospitals, but for physicians, post-acute providers, Medicare Advantage plans and so many others who rely on Medicare as a trusted partner," the letter said.
The U.S. House this is expected to take up an emergency spending bill – estimated at more than $100 billion -- to offset the cost of paid sick leave, family leave, and expanded unemployment benefits. However, sequestration relief is not part of the package.
On Friday, President Donald Trump declared a national emergency and earmarked $50 billion to fight the coronavirus, on top of the $8.3 billion he pledged two weeks ago.
In an analysis issued this month, BDO International noted that many providers in the United States are under financial stress, and that the coronavirus could have a direct and lasting impact in the form of supply chain disruption and financial challenges as many hospitals curtail profitable elective surgeries until the epidemic subsides.
"For example, more than three-fourths (76%) of U.S. providers already have 60 days or less cash on hand, and nearly a quarter (23%) are concerned about government reimbursement risks, according to BDO’s Treating Healthcare Distress. "Variables like instability around the Affordable Care Act and uncertainty around incoming payments because of fluctuating deductibles and patient copays, meanwhile, will persist."
In their letter to Congressional leaders, the hospital stakeholders noted that the Medicare Payment Advisory Commission's semi-annual report this month found that Medicare payments to hospitals "fall far below the cost of care and have been deeply negative for well over a decade."
"The Medicare sequester, which reduces payments for most benefits by 2%, is a major contributor to these underpayments," the stakeholders wrote. "Indeed, MedPAC has argued against the Medicare sequester, "'because it reduces payments for all sectors by 2% without regard to payment adequacy.'"
Instead of the "arbitrary cuts," the stakeholders called for "the flexibility desperately needed to respond to the evolving demands of this pandemic."
AHA and other stakeholders say their "ability to respond to patients must not be prevented by arbitrary directives."
The nation's largest hospital associations are pushing back against a recommendation from U.S. Surgeon General Jerome Adams that providers "consider stopping elective surgeries" until the coronavirus threat subsides.
"Our ability to respond to patients must not be prevented by arbitrary directives," the American Hospital Association, the Federation of American Hospitals, the Association of American Medical Colleges, and the Children's Hospital Association said in a joint letter to Adams on Sunday.
"We are concerned about recent comments by government officials that could be interpreted as recommending that hospitals immediately stop performing “elective” surgeries without clear agreement on how we classify various levels of necessary care," the letter said.
The hospital lobby was responding to a tweet from Adams on Saturday that read: "Hospital & healthcare systems, PLEASE CONSIDER STOPPING ELECTIVE PROCEDURES until we can #FlattenTheCurve!"
Adams, in turn, was responding torecommendations from the American College of Surgeons, which on Friday advised its members to "thoughtfully review all scheduled elective procedures with a plan to minimize, postpone, or cancel electively scheduled operations, endoscopies, or other invasive procedures until we have passed the predicted inflection point in the exposure graph and can be confident that our health care infrastructure can support a potentially rapid and overwhelming uptick in critical patient care needs."
In their letter to Adams, the hospital lobby acknowledged that the coronavirus crisis "may require the curtailment of the least critical or time-sensitive hospital services, but any curtailment must be nuanced to meet the needs of all severely ill patients."
"Our patients will be best served by carefully evaluating and prioritizing gradients of "elective" care to ensure that the most time-sensitive medically necessary care can be delivered by physicians and hospitals," the letter read.
Some health systems are already cancelling elective procedures until the coronavirus threat subsides.
Northwell Health announced on Monday that it will cancel elective surgeries and procedures in its hospitals, but added that the guidelines will not apply to emergency surgeries
"With appropriate screening of patients and when deemed clinically necessary, some planned cases will continue to be performed," Northwell CMO David Battinelli, MD, said in a media release. "Patient care that may appear routine could, if canceled, result in significant negative impact on our patients' health."
On Sunday, Atlanta-based Emory Healthcare announced that it would postpone all inpatient and outpatient elective surgeries for the next two weeks, or longer if needed.
"We are currently contacting all patients and their physicians to alert them of this decision and to offer our support during this time when their cases are being postponed,"the health system said in a post on its website.
"While we adhere to the most stringent protocols to ensure infection prevention, we are taking this step to protect our patients and are working to support and preserve supplies, equipment and staffing for the most urgent and time-sensitive patient needs."
Dearborn, Michigan-based Beaumont Health announced Sunday that it "will begin limiting or reducing non-essential surgeries later this week, as the U.S. Surgeon General advised."
"As of right now, Beaumont will not require surgeons to cancel elective procedures on Monday, March 16. However, depending on the circumstances, we could start canceling non-essential surgeries beginning Tuesday, March 17," the health system said on its website.
