The sweeping "Hospitals Without Walls" initiative take effect immediately and allows hospitals to bill Medicare for services in unconventional settings.
The Trump Administration has suspended regulatory barriers and will now allow hospitals to clear precious bed capacity by triaging non-COVID-19 patients in thousands of ambulatory surgery centers, rehab hospitals, and even hotels and college dorms.
The sweeping "Hospitals Without Walls" initiative takes effect immediately, will last through the duration of the pandemic, and allows hospitals to bill Medicare and other government payers for providing these services in unconventional settings, the Centers for Medicare & Medicaid Services announced Monday.
"Front line healthcare providers need to be able to focus on patient care in the most flexible and innovative ways possible," CMS Administrator Seema Verma said.
"This unprecedented temporary relaxation in regulation will help the healthcare system deal with patient surges by giving it tools and support to create non-traditional care sites and staff them quickly," she said.
Martie Ross, managing principal of Knoxville, Tenn.-based PYA, says the guidance is meant to give providers wide latitude to manage through the COVID outbreak.
“They have really stripped out a lot of regulatory requirements applicable simply to relieve as much administrative burden as possible,” Ross says. “CMS goes a step further to expand the definition of a hospital. They're really trying to enable hospitals to use other facilities as are appropriate.”
Verma said the temporary waivers will give local health systems and hospitals the option of tapping into community-based healthcare venues and provide greater flexibility to respond to the COVID-19 pandemic as they see fit.
For example, the waiver allows health systems to bill government payers for home-based, or drive-through COVID-19 testing in order to limit exposure for both patients and providers, and to ease the strained supply of personal protective equipment.
The telehealth provisions allow for providers to get reimbursement for services that had been previously blocked, including those that involve simple phone calls between provider and patient, Ross says.
“It's not technically tele-health reimbursement,” Ross says. “They just turned on the telephonic evaluation of management codes. CMS had been staunchly refusing to do now for the last five years.”
Last week, America’s Health Insurance Plans said commercial plans would match CMS's waivers for Medicare beneficiaries in areas where in-patient capacity is under strain.
An Array Analytics study released Wednesday found that health systems across the country could boost ICU hospital bed capacity by 21% if ASCs were utilized, and that leveraging ASCs would boost medical-surgical bed capacity by 8% nationwide.
Under the waiver, ASCs could contract with local healthcare systems to provide hospital services, or they can enroll and bill as hospitals during the emergency declaration as long as they follow their state’s emergency pandemic preparedness plan.
The waiver also allows ASCs and other care venues to administer services usually provided by hospitals such as cancer procedures, and trauma and other essential surgeries.
The Ambulatory Surgical Care Association, the lobbying arm for more than 5,800 ASCs across the nation, said Monday that it is still reviewing the waiver. However last week, ASCA CEO Bill Prentice said "our best suggestion would be to keep those patients out of the hospital that is dealing with a pandemic and shift that care to places like ambulatory surgery centers."
"We could be the outflow for necessary surgery that's still going to happen over the next few months," Prentice told HealthLeaders. "Hernias are still going to become strangulated. People are still going to tear their ACLs. People are going to be uncontrollable pain use. Let's use surgery centers as a an off-campus site for that work to do so the hospitals can focus on dealing with a pandemic."
Suspending the rules will allow hospitals to support physician practices by transferring medical equipment, including items used for telehealth, and providing meals and childcare for healthcare workers, CMS said.
HealthLeaders' Jim Molpus contributed to this report.
The task force wants hospitals to report COVID-19 testing data and provide daily reports on bed capacity and supplies.
Vice President Mike Pence has asked the nation's hospitals to provide federal monitors with a daily report on "in-house" coronavirus testing results, other pandemic surveillance data, and bed capacity.
"The data will help us better understand disease patterns and develop policies for prevention and control of health problems related to COVID-19," said Pence, who is leading the White House Coronavirus Task Force.
Specifically, the task force wants hospitals to report COVID-19 testing data to the Department of Health and Human Services, and provide daily reports on bed capacity and supplies to the Centers for Disease Control and Prevention National Healthcare Safety Network COVID-19 Patient Impact and Hospital Capacity Module.
The data request will not include information that could identify patients.
The task force is already collecting data from public and private health labs, but not from in-house hospital labs.
"The nation's nearly 4,700 hospitals have access to testing data that's updated daily," Centers for Medicare & Medicaid Services Administrator Seema Verma said. "This data will help us better support hospitals to address their supply and capacity needs, as well as strengthen our surveillance efforts across the country.
Ashley Thompson, the American Hospital Association's vice president for public policy, said the hospitals already are "being asked to submit data to many entities, including local and state authorities being."
"We have urged that the federal government streamline these efforts to ensure hospitals can remain focused on patient care," she said.
"During this unique period in which we are dealing with a national emergency, we will urge our members to report the data needed by the federal government to support epidemiological surveillance and public health decision making as this effort evolves," she said.
The temporary layoffs at the Lexington, Kentucky-based health system will affect 8% of its 6,000 employees, who were given the news on Friday.
Appalachian Regional Healthcare is temporarily furloughing 500 employees across its 13 hospitals in eastern Kentucky and southern West Virginia as part of a focus on essential services for an expected surge in COVID-19 patients.
"In this time of unprecedented uncertainty, this was not an easy decision to make," ARH Vice President of Human Resources Sonya Bergman said in a media release. "The temporary furloughs are in the best interest of the health of our employees and the community."
The furloughs will affect 8% of ARH’s 6,000 employees, who were given the news on Friday, Bergman said.
"As healthcare providers, we are on the front lines of the COVID-19 pandemic and need to do everything we can to ensure we have the right clinical resources in place, including staff, supplies and equipment, to prepare for a COVID-19 patient surge," she said.
Layoffs are being announced daily across the nation, as health systems grapple with the double-whammy of losing precious dollars from government-mandated postponed or cancelled elective surgeries, and by estimates that treating COVID-19 will be a money loser.
Bergman said ARH has seen a 30% decrease in its overall business operations from a decline in patient volumes and the closure of elective services because of the pandemic.
"When it is safe for our employees to resume work as normal and patient volumes return, we plan to restore services and bring these employees back," she said.
CMS says the waivers will give states more flexibility to respond to the coronavirus pandemic.
The federal government announced Friday that 34 states have been granted expedited 1135 Medicaid waiversso far in the ongoing fight against the coronavirus epidemic.
The emergency provision 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 expedited waiver process was part of a national emergency declaration issued earlier this month by President Donald Trump.
“These waivers allow states to make extraordinary adjustments to their Medicaid programs to meet the unprecedented demands of this emergency," CMS Administrator Seema Verma said in a media release.
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.
CMS said that the average review and negotiation period usually required for 1135 waivers has been reduced from months to an average of six days after a request is submitted, owing to a streamlined application process.
So far, the states granted the 1135 waiver are: York, Colorado, Hawaii, Idaho, Massachusetts, Maryland, Connecticut, Delaware, Minnesota, Pennsylvania, Wyoming, Iowa, Indiana, Rhode Island, Kansas, Kentucky, Missouri, Oregon, North Dakota, South Dakota, Oklahoma, Alabama, California, New Hampshire, New Mexico, New Jersey, Arizona, Virginia, North Carolina, Mississippi Louisiana, Illinois, Washington and Florida.
CMS has also approved eight state requests to invoke emergency flexibilities in their programs that care for the elderly and people with disabilities in their homes and communities.
The funding is part of a massive $2 trillion emergency stimulus package unanimously passed by the Senate late Wednesday.
The American Hospital Association is cheering the Senate's approval of a historic $117 billion stimulus package for the nation's besieged hospitals but warns that more resources will be needed to fight the coronavirus pandemic.
"While this legislation is an important first step forward, more will need to be done to deal with the unprecedented challenge of this virus," AHA President and CEO Rick Pollack said.
"We will continue to work with Congress to make sure providers on the front lines – hospitals, physicians and nurses – remain prioritized for future federal assistance as the COVID-19 pandemic spreads," he said.
The funding is part of a massive $2 trillion emergency stimulus package unanimously passed by the Senate late Wednesday. The House is expected to vote on the bill on Friday, and President Donald Trump has said he will sign the bill.
The 880-page bill includes: emergency funds for hospitals; a delay for the Medicaid Disproportionate Share Hospital cut; temporary elimination of the Medicare sequester; and a Medicare diagnosis-related group add-on payment.
AHA estimated the value of the stimulus package for hospitals at $117 billion, of which $100 billion is earmarked for healthcare-related expenses or lost revenues attributed to COVID-19.
Specifically, the stimulus would:
Eliminate the $4 billion in Medicaid DSH cuts this year, and reduce the cut for fiscal year 2021 to $4 billion from $8 billion. The FY 2021 cuts would be delayed until Dec. 1, 2020. No additional cuts would be added after FY 2025.
Eliminate the Medicare sequester from May 1 through Dec. 31;
Provide a 20% add-on to the DRG rate for patients with COVID-19, applied to patients treated at inpatient prospective payment system hospitals;
Allow hospitals to receive an advance on future Medicare payments.
Increase the amount most hospitals could receive based on prior payments to 100% (from 70%). Critical access hospitals would be eligible for up to 125%. Hospitals would have four months until recoupment, and one year or longer before repayment.
Provide flexibility for post-acute care providers to increase capacity without penalties during the emergency period.
Waive the "50% Rule," for long-term care hospitals, and the site-neutral payment policy.
Waive the three-hour rule for inpatient rehabilitation facilities.
In addition, for-profit and not-for-profit hospitals with fewer than 500 employees would be eligible for up to $10 million in emergency loans to pay for salaries, healthcare and other employee-related expenses benefits that could be eventually forgiven if no layoffs occur during the emergency period.
Bruce Siegel, MD, president and CEO of America's Essential Hospitals, said the emergency funding gives safety net hospitals "breathing room," but that more aid may soon be needed.
"Time will tell how far this funding will go and how much more our hospitals will need," he said. "We will continue to work with Congress and the administration to ensure we answer those questions and consider how to ease regulatory challenges, such as the pending Medicaid Fiscal Accountability Regulation, that would severely constrain safety-net funding just when it’s needed most."
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.
