Category Archives: Dept of Health and Human Services (HHS)

After criticism, HHS directs $25B in CARES funding to Medicaid providers, safety net hospitals

Posted on by • Posted in American Hospital Association (AHA), Coronavirus, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Economic Crisis, Economic Stimulus, Financially Distressed, Hospital, Medicaid, Medicaid Childrens Health Insurance Program (CHIP), Rural Hospital, Safety Net Hospitals, Safety-Net Providers, The CARES Act • Leave a comment

https://www.healthcaredive.com/news/after-criticism-hhs-directs-25b-in-cares-funding-to-medicaid-providers-s/579496/

Dive Brief:

  • HHS announced Tuesday it will deliver $25 billion to providers and hospitals that serve the nation’s most vulnerable patients, or those with Medicaid and Children’s Health Insurance Program coverage. Of that, $15 billion will go to providers that primarily serve Medicaid and CHIP patients while the other $10 billion is reserved for safety net hospitals that usually operate on razor-thin margins. A total of 758 safety net hospitals will receive direct deposits, and the administration noted that many of these facilities are operating in the red with an average profit margin of -7%.
  • Not all Medicaid providers received Coronavirus Aid, Relief, and Economic Security funding from the initial general distribution. This targeted allocation is designed to make up for that by distributing money to the remaining 38% of Medicaid and CHIP providers who were left out of the first tranche.
  • These Medicaid providers will receive at least 2% of reported gross patient revenue, but could receive more depending on how many patients they serve. HHS will make a final determination once providers start submitting data to the relief portal.

Dive Insight:

The industry has been clamoring for HHS to target funding to Medicaid providers amid the COVID-19 pandemic and the downturn in business, noting these organizations are already on fragile ground.

Last week the American Hospital Association pleaded for the administration to release $50 billion more for all hospitals, with $10 billion reserved for providers with a heavy caseload of Medicaid patients.

HHS answered the hospital lobby’s call — in part. HHS will distribute funds to safety net providers — more than AHA asked for — but disclosed no plans Tuesday to broaden that funding to all hospitals. America’s Essential Hospitals, which represents safety net providers, had also called for the quick release of targeted funding.

“Our goal for all these distributions has been to get the money to the providers who need it most as soon as possible,” Eric Hargan, HHS deputy secretary, said Tuesday during a call with reporters.

However, some have been critical of how the administration decided to allocate the first few waves of funding.

Congress has earmarked a total of $175 billion in funding for providers through two pieces of legislation, including the CARES Act.

To get the money out the door quickly, the first tranche was sent to providers based on the Medicare fee-for-service business, and later on the net patient service revenue.

These formulas put certain providers at an advantage, which tend to be for-profit hospitals with higher-margins, or those who were already well off heading into the pandemic, according to a recent Kaiser Family Foundation analysis.

This targeted funding was not swift, one reason for the delay was the challenge in getting a list of Medicaid providers from the states to validate and authenticate those who came to the portal to apply for funds, according to a senior HHS official.​

Still, providers that have already received funds have noted that it comes with its own set of headaches. Some have decided to return the funds as navigating the legal and compliance issues may not be worth the hassle.

Though, that’s likely not the case for these safety net hospitals and providers.

 

 

 

 

Private equity lands $1.5B in Medicare loans

Posted on by • Posted in 2020 Election Issues, Accountability, Coronavirus, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Economic Crisis, Economic Stimulus, Health Policy, Medicare, Medicare Advance Payments, Oversight, Private Equity, Venture Capital • Leave a comment

https://www.beckershospitalreview.com/finance/private-equity-lands-1-5b-in-medicare-loans.html?utm_medium=email

One-Click To Private Equity Yields Up To 9%

Private equity companies have borrowed at least $1.5 billion from HHS through two programs intended to provide funding to healthcare providers facing financial damage due to the COVID-19 pandemic, according to Bloomberg‘s analysis of more than 40,000 loans disclosed by HHS. 

The Medicare loans were made to hospitals, clinics and treatment centers controlled by private equity firms through two programs administered by CMS: the Advance Payments Program and the Accelerated Payments Program. Those programs were expanded earlier this year to help offset the financial impact of COVID-19.

HHS approved loans totaling more than $60 million to subsidiaries of companies owned by private equity firm KKR, which has roughly $58 billion of cash to invest, according to Bloomberg. Healthcare facilities owned by private equity firm Apollo Global Management received $500 million in loans, and Cerberus Capital Management’s Steward Health Care System received roughly $400 million in loans. Steward physicians announced June 2 that they’re acquiring the health system from Cerberus.

CMS Administrator Seema Verma said the goal of the programs was to get funds to healthcare providers as quickly as possible. The loan applications did not include questions about beneficial ownership of the healthcare companies seeking loans. 

“We don’t look into ownership, what we look into is are they Medicare-enrolled providers,” Ms. Verma told Bloomberg.

Access the full Bloomberg article here.

 

 

 

Administration Wants To Cut Back A Billion-Dollar Healthcare Program. Hospitals Say Now Is A Really Bad Time.

Posted on by • Posted in 2020 Election Issues, American Hospital Association (AHA), Center for Medicare and Medicaid Services (CMS), Dept of Health and Human Services (HHS), District Court of Appeals, Financially Distressed, Government Accountability Office, Health Policy, Health System, Hospital, Hospital Industry, Lawsuit, Medicare 340B Drug Discount Program, Pandemic, Pharmaceutical Industry, Safety Net Hospitals, Safety-Net Providers, Vulnerable Populations • Leave a comment

https://www.buzzfeednews.com/article/zoetillman/trump-medicare-cuts-hospitals-coronavirus-lawsuits?mkt_tok=eyJpIjoiTVRRd00yUmpZbUV3TVRVeiIsInQiOiJTZ0piR2wyRnBZOU5jR3N2TTNzd3Vrb040dHA5K0hVT0lQRm82YnFkVlNVVko4QlVRU0Z0SVVTQWxZUXJmWTZFTVBqaVh0N1JRWHFJTmg2dkNDb0hQTjBYYmxyUnphMEVGSmhwN0NJWUE3V0FFa2FIenJRZTJjWmliSWZKRVwvcU8ifQ%253D%253D

340B Drug Pricing Program: What Is it, How Does It Work?

The Trump administration has been fighting in court with public and nonprofit hospitals since 2017 over a plan to slash the reimbursement rates for drugs prescribed to Medicare patients.

In 2018, Park Ridge Health, a not-for-profit healthcare network in western North Carolina that serves a large population of lower-income patients, delayed plans to buy a new CT scanner for stroke patients.

The Trump administration had drastically scaled back a federal drug reimbursement program that benefitted public and not-for-profit hospitals. Park Ridge, now called AdventHealth Hendersonville, stood to lose $3.3 million per year, the hospital’s chief financial officer wrote in a court affidavit, and it wasn’t just the CT scanner on the line — that money went toward a variety of services for elderly and poor patients, including new cancer treatment facilities, women’s healthcare, and partnerships with nonprofits on issues like prescription drug abuse.

Park Ridge and other hospitals have been battling with the administration in court for three years over a plan to slash by nearly 30% the reimbursement rate that hospitals get for certain drugs prescribed to Medicare patients. The hospitals won the first round. The US Court of Appeals for the DC Circuit heard arguments in November and has yet to rule, and for now the cut is still in effect. In the meantime, the Centers for Medicare & Medicaid Services (CMS) is exploring another way to make the cut if they lose the case, over the objection of hospitals.

The litigation predates the coronavirus pandemic, but the stakes are higher as hospitals nationwide lose tens of billions of dollars weekly while nonessential services and elective surgeries are on hold because of the ongoing crisis.

“If [hospitals] lost that money now, it would make an already dire financial situation worse,” Lindsay Wiley, director of the Health Law and Policy Program at American University Washington College of Law, wrote in an email to BuzzFeed News.

Hospitals that serve a high proportion of lower-income patients can buy outpatient drugs at a discounted price through what’s known as the 340B program. Until 2017, these hospitals were reimbursed by the federal government for drugs prescribed to Medicare patients at a higher rate than the discounted price the hospitals paid.

The CMS announced in 2017 that it was slashing the reimbursement rate from 6% above the average price of the drugs to 22.5% below the average cost. The agency said the program gave hospitals an incentive to overprescribe drugs and cost patients more money, and shouldn’t provide a windfall to subsidize other services.

Hospitals that opposed the change argued that they had put money earned through the program — which can run in the millions of dollars for a hospital each year — into services for poor and underserved communities, as Congress intended.

The CMS estimated that cutting the reimbursement rate for the drugs would reduce the amount of money paid to hospitals by $1.6 billion in 2018 alone. Scaling back that funding would actually increase the rates paid by the government for other services for Medicare patients — the payment system has to be “budget neutral” — but Park Ridge and other hospitals that took the administration to court said they still expected net losses of millions of dollars.

Many hospitals that participate in the 340B program “are in the red to begin with,” said Maureen Testoni, president and CEO of 340B Health, a membership group for hospitals and health systems that participate.

“So on top of that, you add this pandemic and all the financial turmoil that this has caused,” Testoni said. The pandemic has highlighted “how critical [hospitals] are … and what an important role they play. And, financially, they’re not in a situation where they can play that role when they have this big financial reduction.”

While waiting for the DC Circuit to rule, the CMS is exploring ways to move forward with the rate cut even if it loses. Last month, the agency launched a survey to collect data from 340B hospitals that the CMS says would address the issues that led the lower court judge to rule against the government. Hospitals opposed the survey and asked the agency to at least delay it, saying they’d have to divert resources that are already stretched thin during the pandemic to respond.

“Now is not the time to distract hospitals’ attention from the vital job at hand to complete a CMS survey on drug acquisition costs. By launching the survey with no notice on April 24 and providing less than three weeks to respond, CMS is creating an unnecessary burden on hospitals at the worst possible moment,” Testoni wrote in a May 4 letter to the agency. The agency didn’t respond.

Representatives of hospitals involved in the lawsuits declined interview requests, citing the pending litigation. The American Hospital Association, a lead plaintiff, declined an interview request but sent a statement:

“The COVID-19 pandemic has created the greatest financial crisis in history for America’s hospitals and health systems, with our field losing over $50 billion each month. While it is too soon to have precise data on the full impact of this pandemic, the unlawful Medicare cuts that we are contesting in federal court have added significantly to the financial pressure all hospitals face,” the group said.

A spokesperson for the Department of Health and Human Services did not return a request for comment. In court, the Justice Department has argued that the district court judge lacked authority to review the rate cut at all, and that even if he could, the government had the power to bring the rate in line with what the available data showed hospitals were paying for the drugs.

“[O]vercompensation for some drugs or treatments means reduced payments for other drugs and treatments, and correcting overcompensation permits more equitable distribution of limited funds,” Justice Department lawyers argued in the government’s brief to the DC Circuit. “The result of bringing the Medicare payment amount for 340B drugs into alignment with average acquisition cost was therefore the redistribution of the anticipated $1.6 billion in savings, resulting in a 3.2% increase in the Medicare payment rates for non-drug items and services.”

Congress created the 340B program in 1992. Healthcare providers eligible for the program can buy outpatient drugs at discounted rates from pharmaceutical companies. When hospitals prescribe those drugs to patients covered by Medicare — the federal insurance program for people who are over the age of 65 or have disabilities — they submit claims to the government for reimbursement.

Starting in 2006, Congress gave the CMS two options to set the drug reimbursement rate. It could rely on what hospitals were actually paying to buy drugs if it had “statistically sound survey data” or, if that wasn’t available, the average sales price of the drugs. If the agency used the second, alternative option, Congress set a default rate: the average sales price plus 6%.

In the summer of 2017, the Trump administration announced a plan to change the rate. Under the new rule, the Medicare agency said it would pay the average sales price of drugs minus 22.5%. That rate would come closer to matching the discounted rate hospitals were paying through the 340B program, the agency said.

Hospitals don’t have to track or disclose how they use money saved through the program. Kelly Cleary, who spent three years as the chief legal officer for the CMS, said hospitals had provided examples of how they were using the funds to expand services into underserved areas and provide free or low-cost care.

“The money was going toward a purpose that was consistent with their mission,” said Cleary, who was involved in the CMS’s effort to change the rate and defend it in court. She returned to private practice last month as a partner at the law firm Akin Gump Strauss Hauer & Feld.

The chief financial officer for the Henry Ford Health System, which serves patients in Detroit and Jackson, Michigan, wrote in a court affidavit that even if the cut meant that reimbursement rates increased for other Medicare services, the hospital network still expected to lose around $8.5 million by the end of 2018 — money that had gone toward services for patients with low incomes, such as free and low-cost medications, a free community clinic, and mobile health units.

The margin between what the Henry Ford Health System paid for drugs through the 340B program and what it received back from Medicare helped hospitals in that network provide care for “underserved and indigent populations … that would otherwise be financially unsustainable,” the officer wrote.

In support of the rate cut, the CMS pointed to a 2015 report by the Government Accountability Office that showed hospitals participating in the program had an incentive to prescribe more drugs than hospitals that weren’t in the program, and that meant higher copayments for Medicare patients who were prescribed more drugs or higher-priced drugs. The agency concluded hospitals were receiving too much of a net financial benefit.

“While we recognize the intent of the 340B Program,” the agency wrote in a November 2017 notice in the Federal Register, “we believe it is inappropriate for Medicare to subsidize other activities.”

It’s a position that aligned the government with the pharmaceutical industry, which argued that some hospitals had abused the program. Drugmakers pointed out that even with a cut to the reimbursement rate, the healthcare providers would still get the benefit of discounted drugs. A representative of PhRMA, a membership group for the pharmaceutical industry, declined an interview request, but sent BuzzFeed News a copy of comments the group submitted in support of the cut.

“PhRMA is concerned that the 340B program continues to grow rapidly and without patient benefits, thus increasingly departing from its purpose and statutory boundaries,” the group wrote. “This growth in the 340B program creates market-distorting incentives that affect consumer prices for medicines, shift care to more expensive hospital settings, and accelerate provider market consolidation.”

Hospitals that supported the program, meanwhile, said the proposal punished providers who work with vulnerable patients, and they urged the CMS to focus its efforts instead on bringing down drug costs.

The agency disputed that the plan was punitive and said that “lowering the price of pharmaceuticals is a top priority” but was outside the scope of what it was considering at the time.

Hospitals and hospital associations began suing the administration shortly after the rule became final in November 2017. They argued that the CMS had come up with the new rate using a process that Congress hadn’t approved. The agency admitted that it didn’t have the “statistically sound” survey data on what hospitals were actually paying for the drugs — the first method Congress had laid out — so instead it used an estimate of average purchase costs compiled by the Medicare Payment Advisory Commission, an agency that advises Congress.

The problem with the government’s approach, the hospitals argued, was that Congress had said the CMS could either use survey data on purchase costs or the average sales price of the drugs, but not a hybrid of the two. Congress had given the CMS authority to “adjust” rates, but cutting the reimbursement rate by nearly 30% was more than just an adjustment, the hospitals said.

US District Judge Rudolph Contreras in Washington, DC, sided with the hospitals. In a December 2018 opinion, he wrote that the rate cut’s “magnitude and its wide applicability inexorably lead to the conclusion” that the agency had “fundamentally altered” what Congress had spelled out.

The judge stopped short of blocking the rule and ordering the government to reimburse hospitals for the difference between the previous rate and the CMS’s new, lower rate, however, writing that it was “likely to be highly disruptive.” He noted that the payment system had to stay budget neutral, which meant the money would need to come from another source, a “quagmire that may be impossible to navigate” given how much money the government paid out of Medicare each year. He asked for more briefing on what the agency should do to fix the problem, but that issue was put on hold as the administration took the case to the DC Circuit.

A three-judge DC Circuit panel heard arguments on Nov. 8 and has yet to release a decision. In the meantime, hospitals have continued to file lawsuits as their claims for reimbursement at the previous, higher rate are rejected; earlier this month, a hospital system in Jacksonville, Florida, which is part of the University of Florida, filed a new suit in federal court in Washington. And the CMS is going ahead with its survey over the objections from hospitals.

“The pandemic amplifies the significance of this policy, but the fact remains that there were winners and losers with the policy and it’s always going to be a zero-sum game,” Cleary said. “If the court rules against the agency and the agency is forced to walk back the policy, that stands to negatively impact thousands of hospitals.”

Wiley, of American University, told BuzzFeed News that even before the pandemic, the fight over the 340B program highlighted how hospitals and drugmakers were “actively throwing each other under the bus” in the broader debate about who was to blame for the high cost of prescription drugs and what the federal government should do about it.

“Which stakeholders voters perceive to be the heroes of the pandemic response could affect health reform and reimbursement politics for years to come,” she wrote.

 

 

 

Cartoon – Are you Socially Distancing or in Denial?

Posted on by • Posted in 2020 Election Issues, Accountability, Cartoon, Centers for Disease Control & Prevention (CDC), Coronavirus, Credibility, Crisis, Crisis Management, Denial, Dept of Health and Human Services (HHS), Economic Crisis, Economy Reopening, Expectations, False Claims Act, Health Policy, Infection Control, Infection Control Plan, Infectious Virus, Leadership Cares, Leadership Trust, Mortality, National Strategy, Pandemic, Partisanship, Public Health, Public Safety, Social Distancing, Transparency, Trust, Truth, Uncertainty, Undermining, Wishful Thinking • Leave a comment

Weekly Humorist

Medicaid Providers At The End Of The Line For Federal COVID Funding

Posted on by • Posted in 2020 Election Issues, Dept of Health and Human Services (HHS), Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Health Policy, Medicaid, Medicaid Childrens Health Insurance Program (CHIP), Medicaid Expansion, Personal Protective Equipment (PPE), Safety Net Hospitals, Safety-Net Providers • Leave a comment

https://khn.org/news/medicaid-providers-at-the-end-of-the-line-for-federal-covid-funding/

Medicaid Providers At The End Of The Line For Federal COVID ...

Casa de Salud, a nonprofit clinic in Albuquerque, New Mexico, provides primary medical care, opioid addiction services and non-Western therapies, including acupuncture and reiki, to a largely low-income population.

And, like so many other health care providers that serve as a safety net, its revenue — and its future — are threatened by the COVID-19 epidemic.

“I’ve been working for the past six weeks to figure out how to keep the doors open,” said the clinic’s executive director, Dr. Anjali Taneja. “We’ve seen probably an 80% drop in patient care, which has completely impacted our bottom line.”

In March, Congress authorized $100 billion for health care providers, both to compensate them for the extra costs associated with caring for patients with COVID-19 and for the revenue that’s not coming in from regular care. They have been required to stop providing most nonemergency services, and many patients are afraid to visit health care facilities.

But more than half that money has been allocated by the Department of Health and Human Services, and the majority of it so far has gone to hospitals, doctors and other facilities that serve Medicare patients. Officials said at the time that was an efficient way to get the money beginning to move to many providers. That, however, leaves out a large swath of the health system infrastructure that serves the low-income Medicaid population and children. Casa de Salud, for example, accepts Medicaid but not Medicare.

State Medicaid directors say that without immediate funding, many of the health facilities that serve Medicaid patients could close permanently. More than a month ago, bipartisan Medicaid chiefs wrote the federal government asking for immediate authority to make “retainer” payments — not related to specific care for patients — to keep their health providers in business.

“If we wait, core components of the Medicaid delivery system could fail during, or soon after, this pandemic,” wrote the National Association of Medicaid Directors.

So far, the Trump administration has not responded, although in early April it said it was “working rapidly on additional targeted distributions” for other providers, including those who predominately serve Medicaid patients.

In an email, the Centers for Medicare & Medicaid Services said officials there will “continue to work with states as they seek to ensure continued access to care for Medicaid beneficiaries through and beyond the public health emergency.”

CMS noted that states have several ways of boosting payments for Medicaid providers, but did not directly answer the question about the retainer payments that states are seeking the authority to make. Nor did it say when the funds would start to flow to Medicaid providers who do not also get funding from Medicare.

The delay is frustrating Medicaid advocates.

“This needs to be addressed urgently,” said Joan Alker, executive director of Georgetown University’s Center for Children and Families in Washington, D.C. “We are concerned about the infrastructure and how quickly it could evaporate.”

In the administration’s explanation of how it is distributing the relief funds, Medicaid providers are included in a catchall category at the very bottom of the list, under the heading “additional allocations.”

“To not see anything substantive coming from the federal level just adds insult to injury,” said Todd Goodwin.

He runs the John F. Murphy Homes in Auburn, Maine, which provides residential and day services to hundreds of children and adults with developmental and intellectual disabilities. He said his organization — which has already furloughed almost 300 workers and spent more than $200,000 on COVID-related expenses including purchases of essential equipment such as masks and protective equipment that will not be reimbursable — has not been eligible for any of the various aid programs passed by Congress. It gets most of its funding from Medicaid and public school systems.

The organization has tapped a line of credit to stay afloat. “But if we’re not here providing these services, there’s no Plan B,” he said.

Even providers who largely serve privately insured patients are facing financial distress. Dr. Sandy Chung is CEO of Trusted Doctors, which has about 50 physicians in 13 offices in the Northern Virginia suburbs around Washington, D.C. She said about 15% of its funding comes from Medicaid, but the drop off in private and Medicaid patients has left the group “really struggling.”

“We’ve had to furlough staff, had to curtail hours, and we may have to close some locations,” she said.

Of special concern are children because Medicaid covers nearly 40% of them across the county. Chung, who also heads the Virginia chapter of the American Academy of Pediatrics, said that vaccination rates are off 30% for infants and 75% for adolescents, putting them and others at risk for preventable illnesses.

The biggest rub, she added, is that with the economy in free fall, more people will qualify for Medicaid coverage in the coming weeks and months.

“But if you don’t have providers around anymore, then you will have a significant mismatch,” she said.

Back in Albuquerque, Taneja is working to find whatever sources of funding she can to keep the clinic open. She secured a federal loan to help cover her payroll for a couple of months, but worries what will happen after that. “It would kill me if we’ve survived 15 years in this health care system, just to not make it through COVID,” she said.

 

 

 

 

Rick Bright, ousted director of vaccine agency, warns that administration lacks ‘centralized, coordinated plan’

Posted on by • Posted in 2020 Election Issues, Biomedical Advanced Research and Development Authority (BARDA), Chloroquine, Clinical Testing, Contact Tracing, Coronavirus, Credibility, Crisis, Crisis Management, Denial, Dept of Health and Human Services (HHS), Economic Crisis, Economic Recovery, Economic Stimulus, Economy Reopening, Emergency Preparedness, Health Policy, Hydroxychloroquine, Infection Control, Infectious Virus, Leadership Culture, Leadership Intent, Leadership Listens, Leadership Trust, National Strategy, Personal Protective Equipment (PPE), Scientists, Supply Chain, Transparency, Trust, Truth, Vaccination, Vaccine • Leave a comment

https://www.cnn.com/2020/05/14/politics/coronavirus-whistleblower-testimony/index.html?fbclid=IwAR0KfVp-njw8vqKFdaLbBC4r4NAx3KeS4rFg2vmFbSneW7PcqOwVYult9rc

Virus whistleblower tells lawmakers US lacks vaccine plan | Where ...

Rick Bright, the ousted director of a crucial federal office charged with developing countermeasures to infectious diseases, testified before Congress on Thursday that the US will face an even worse crisis without additional preparations to curb the coronavirus pandemic.

“Our window of opportunity is closing,” Bright said. “Without better planning, 2020 could be the darkest winter in modern history.”
Bright criticized the Trump administration for failing to implement a “standard, centralized, coordinated plan” to combat the virus and questioned its timeline for a vaccine. His testimony came a week after filing a whistleblower complaint alleging he was fired from his job leading the Biomedical Advanced Research and Development Authority for opposing the use of a drug frequently touted by President Donald Trump as a potential coronavirus treatment.
About an hour before Bright’s hearing, Trump tweeted that he had “never met” or “even heard of” Bright, but considers the NIH senior adviser a “disgruntled employee, not liked or respected by people I spoke to and who, with his attitude, should no longer be working for our government!”
Before the House Committee on Energy and Commerce’s health subcommittee, Bright urged the Trump administration to consider a number of actions, including increasing production of essential equipment and establishing both a national test strategy and a national standard of procurement of supplies. He calls on top officials to “lead” through example and wear face coverings and social distance.
Bright claimed that the administration missed “early warning signals” to prevent the spread of the virus. He said that he would “never forget” an email from Mike Bowen, the hearing’s other witness and the vice president of the medical supply company Prestige Ameritech, indicating that the US supply of N95, the respirator masks used by health care professionals, was at a perilous level.
“He said, ‘We’re in deep shit,'” testified Bright. “‘The world is.'”
Bright said he “pushed” that warning “to the highest levels” he could at Health and Human Services but received “no response.”
“From that moment, I knew that we were going to have a crisis for health care workers because we were not taking action,” said Bright. “We were already behind the ball.”
In his written statement, Bright blamed the leadership of HHS for being “dismissive” of his “dire predictions.” Bright wrote that he knew the US had a “critical shortage of necessary supplies” and personal protective equipment during the first three months of the year and prodded HHS to boost production of masks, respirators, syringes and swabs to no avail. He alleged that he faced “hostility and marginalization” from HHS officials after he briefed White House trade adviser Peter Navarro and members of Congress “who better understood the urgency to act.”
And he charged that he was removed from his post at BARDA and transferred to “a more limited and less impactful position” at NIH after he “resisted efforts to promote” the “unproven” drug chloroquine.
A Department of Health and Human Services spokesperson responded that it was “a personnel matter that is currently under review” but said it “strongly disagrees with the allegations and characterizations.”
Bright is seeking to be reinstated to his position as the head of BARDA. The Office of Special Counsel, which is reviewing Bright’s complaint, has determined that was a “substantial likelihood of wrongdoing” in removing him from his post, according to Bright’s attorneys.
Rep. Anna Eshoo, a California Democrat and the panel’s chairwoman, said Bright “was the right person, with the right judgment, at the right time.”
“We can’t have a system where the government fires those who get it right and reward those who get it completely wrong,” added Eshoo.
In his testimony, Bright also cast doubt on the Trump administration’s goal of manufacturing a vaccine in 12 to 18 months as overly optimistic, calling it “an aggressive schedule” and noting that it usually takes up to 10 years to make a vaccine.
“My concern is if we rush too quickly, and consider cutting out critical steps, we may not have a full assessment of the safety of that vaccine,” Bright said. “So, it’s still going to take some time.”
Some Republicans on the subcommittee said that the hearing shouldn’t have been held at all.
Rep. Michael Burgess of Texas, the top Republican on the panel, said “every whistleblower needs to be heard,” but added the hearing was “premature” and a “disservice” to the Special Counsel’s investigation since Bright’s complaint was filed only a week ago.
And Republican Rep. Richard Hudson of North Carolina claimed that the hearing was not about the whistleblower complaint but “undermining the Administration during a national and global crisis.”
Thursday’s subcommittee meeting comes two days after a blockbuster hearing in the Senate that featured Dr. Anthony Fauci, who leads the National Institute of Allergy and Infectious Diseases. Fauci said that access to a vaccine in time for the fall school year would be “a bit of a bridge too far” and warning against some schools opening too soon, which Trump later called “not an acceptable answer.”
Fauci testified from his modified quarantine at home since he had made contact with a White House staffer who tested positive. But Bright appeared masked and in-person for his hearing on Capitol Hill, as did the lawmakers who questioned him. Many members of the House have steered clear of Capitol Hill since the onset of the outbreak, although they are expected to return on Friday to vote on a multi-trillion dollar Democratic bill responding to the crisis.

 

 

Window of Opportunity is Closing for Coronavirus Response

Posted on by • Posted in 2020 Election Issues, ACA, Biomedical Advanced Research and Development Authority (BARDA), Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Economic Crisis, Economic Stimulus, Economy, Economy Reopening, Emergency Preparedness, Employee Benefits, Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Employee Protections, Employer-Based Health Insurance, Essential Health Benefits, Health Insurance Coverage Adequacy, Health Policy, Hydroxychloroquine, Infection Control, Infectious Virus, Job, Job Market, Job Search, Job Security, Leadership Decentralized, Medicaid, Medicaid Expansion, Mortality, Out of Pocket Expenses, Pandemic, Personal Protective Equipment (PPE), Preexisting Conditions, Public Health, Public Safety, Quarantine, Social Distancing, Strategy National, Underinsured, Unemployment, Unemployment Insurance, Uninsured, Ventilators • Leave a comment

https://www.axios.com/rick-bright-testimony-opening-statement-6817ae7a-5196-4357-b83c-d3ff96990efd.html?stream=health-care&utm_source=alert&utm_medium=email&utm_campaign=alerts_healthcare

Window of opportunity – definition and meaning – Market Business News

A top vaccine doctor who was ousted from his position in April is expected to testify Thursday that the Trump administration was unprepared for the coronavirus, and that the U.S. could face the “darkest winter in modern history” if it doesn’t develop a national coordinated response, according to prepared testimony first obtained by CNN.

The big picture: Rick Bright, the former head of the Biomedical Advanced Research and Development Authority (BARDA), will tell Congress that leadership at the Department of Health and Human Services ignored his warnings in January, February and March about a potential shortage of medical supplies.

  • He will testify that HHS “missed early warning signals” and “forgot important pages from our pandemic playbook” early on — but that “for now, we need to focus on getting things right going forward.”
  • Bright’s testimony also reiterates claims from a whistleblower report he filed last week that alleges he was ousted over his attempts to limit the use of hydroxychloroquine — an unproven drug touted by President Trump — to treat the coronavirus.

What he’s saying: Bright will testify he urged HHS to ramp up production of
masks, respirators and medical supplies as far back as January. Those warnings were dismissed, Bright says, and he was “cut out of key high-level meetings to combat COVID-19.”

  • “I continue to believe that we must act urgently to effectively combat this deadly disease. Our window of opportunity is closing. If we fail to develop a national coordinated response, based in science, I fear the pandemic will get far worse and be prolonged, causing unprecedented illness and fatalities.”

Bright will call for a national strategy to combat the virus, including “tests that are accurate, rapid, easy to use, low cost, and available to everyone who needs them.”

  • “Without clear planning and implementation of the steps that I and other experts have outlined, 2020 will be darkest winter in modern history.”

Read Bright’s prepared statement.

 

 

 

 

Trump will urge Supreme Court to strike down Obamacare

Posted on by • Posted in 2020 Election Issues, ACA, Dept of Health and Human Services (HHS), Dept of Justice (DOJ), Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Employee Protections, Employer-Based Health Insurance, Essential Health Benefits, Health Insurance Coverage Adequacy, Health Insurance Industry, Health Policy, Health System, High Deductible Health Plans, High Drug Prices, High Premiums, High Prices, Hospital, Hospital Industry, Medicaid, Medicaid Expansion, Out of Pocket Expenses, Preexisting Conditions, Rural Health, Rural Hospital, Safety Net Hospitals, Safety-Net Providers, Supreme Court, Surprise Bills, Underinsured, Unemployment, Unemployment Insurance, Uninsured • Leave a comment

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Trump will urge Supreme Court to strike down Obamacare - YouTube

Attorney General Bill Barr had urged the White House to soften its attack on the law during the pandemic.

President Donald Trump on Wednesday said his administration will urge the Supreme Court to overturn Obamacare, maintaining its all-out legal assault on the health care law amid a pandemic that will drive millions of more Americans to depend on its coverage.

The administration appears to be doubling down on its legal strategy, even after Attorney General William Barr this week warned top Trump officials about the political ramifications of undermining the health care safety net during the coronavirus emergency.

Democrats two years ago took back the House of Representatives and statehouses across the country by promising to defend Obamacare, in particular its insurance protections that prevent sick people from being denied coverage or charged more because of a health condition. The issue may prove to be even more salient in November amid the Covid-19 outbreak that health experts believe will persist through the fall.

The Justice Department had a Wednesday deadline to change its position in a case brought by Republican-led states, but Trump told reporters Wednesday afternoon his administration would stand firm. DOJ declined to comment.

“Obamacare is a disaster, but we’ve made it barely acceptable,” Trump said.

The Supreme Court later this fall will hear a lawsuit from the GOP-led states that argue the Affordable Care Act was rendered invalid after Congress eliminated its tax penalty for not having health insurance. A coalition of Democratic state attorneys general and the Democratic-led House of Representatives are defending the law in court.

The Trump administration had previously shifted its legal position in this case, but appears to have decided against doing so again. DOJ originally argued the courts should throw out just Obamacare’s preexisting condition protections, before last year urging that the entire law be struck down.

The Supreme Court is expected to hear the case during its next term starting in October, but it hasn’t scheduled arguments yet. A decision is unlikely before the Nov. 3 election. The court has previously upheld Obamacare in two major challenges that threatened the law’s survival.

About 20 million people have been covered by Obamacare, and the law is expected to provide a major safety net during the economic freefall brought on by the coronavirus. Millions more are expected to join the Medicaid rolls, especially in states that joined Obamacare’s expansion to poor adults. Others who lost workplace health insurance can sign up on the law’s health insurance marketplaces, though the Trump administration isn’t doing much to advertise coverage options.

House Democrats in a filing to the Supreme Court on Wednesday said the pandemic showcased why justices should preserve the law.

“Although Congress may not have enacted the ACA with the specific purpose of combatting a pandemic, the nation’s current public-health emergency has made it impossible to deny that broad access to affordable health care is not just a life-or death matter for millions of Americans, but an indispensable precondition to the social intercourse on which our security, welfare, and liberty ultimately depend,” their brief read.

Obamacare has grown more popular since the GOP’s failed repeal bid during Trump’s first year in office, though the law is still broadly disliked by Republicans. Many Democrats are eager to again run on their defense of Obamacare this fall. That includes presumptive presidential nominee Joe Biden, who has advocated for building on the health care law rather than pursuing a comprehensive progressive overhaul like “Medicare for All.”

Top Trump officials have long been split on the legal strategy in the Obamacare lawsuit. Barr and Alex Azar, the Health and Human Services secretary, both opposed a broader attack on the law, but White House officials have been more supportive, seeing it as a chance to fulfill Trump’s pledge to repeal Obamacare. Barr, in a Monday meeting with Vice President Mike Pence and other White House officials, made an eleventh-hour plea for the administration to soften its legal stance ahead of the Supreme Court’s briefing deadline.

 

 

 

The U.S. coronavirus recovery is way behind Europe

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Health Policy, Infection Control, Infectious Virus, Leadership Decentralized, Mortality, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing • Leave a comment

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Nathan Newman 🧭 (@nathansnewman) | Twitter

Other countries — even some hit hard by the coronavirus — are beating back their outbreaks more successfully than the U.S., Axios’ Dave Lawler and I report.

Why it matters: The number of new cases every day is holding steady in the U.S., but it’s not going down — a key benchmark many other countries achieved before loosening their lockdowns and social distancing measures.

In some of Europe’s hardest-hit countries, case counts seemed to skyrocket uncontrollably even amid some of the world’s strictest lockdowns.

  • Italy and Spain followed a similar pattern. New cases climbed over about a month from under 100 per day to terrifying peaks of roughly 8,000 per day in Spain and 6,000 per day in Italy.
  • The fall was nearly as sharp. Within two weeks of the peak, the rates of daily recorded cases had been halved. They’ve continued to fall since.

America’s daily rate climbed faster and higher (due in part to its larger population), but appears to have peaked at around 30,000 new cases per day in the first week of April.

  • But rather than falling, the rate stagnated. Outside of New York (which has bent its curve) the rate is actually continuing to climb.

Between the lines: The U.S. didn’t lock down as tightly as some of those countries, and made a host of mistakes early in the response.

  • Italy and Spain issued strict nationwide lockdowns that forced most people to remain inside except to shop for necessities. Spain didn’t allow children outside at all.
  • “Our economic shutdown … wasn’t as broad as some of the other countries’, so there was more opportunity for the virus to spread,” said Amesh Adalja, a senior scholar at the John Hopkins Center for Health Security.

The big picture: “It seems that this is a controllable pandemic without it having to run its natural course,” says Columbia University economist Jeffrey Sachs.

 

 

 

Whistleblower alleges Trump administration ignored coronavirus warnings

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Research Funding, Clinical Testing, Clinical Trials, Conflicts of Interest, Coronavirus, Credibility, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Food and Drug Administration (FDA), Health Policy, Hydroxychloroquine, Misinformation, Mislead, Misleading, Mistake, Mistrust, Scientists, Transparency, Trust, Truth, U.S. Biomedical Advanced Research and Development Authority (BARDA) • Leave a comment

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Whistleblower alleges Trump administration ignored coronavirus ...

Rick Bright, the former director of the U.S. Biomedical Advanced Research and Development Authority (BARDA), filed a whistleblower complaint Tuesday alleging that the Department of Health and Human Services failed to take early action to mitigate the threat of the novel coronavirus.

Flashback: Bright said last month he believes he was ousted after clashing with HHS leadership over his attempts to limit the use of hydroxychloroquine to treat the coronavirus.

What’s new: In his complaint, Bright claims he was excluded from an HHS meeting on the coronavirus in late January after he “pressed for urgent access to funding, personnel, and clinical specimens, including viruses” to develop treatments for the coronavirus should it spread outside of Asia.

  • Bright alleges it “became increasingly clear” in late January that “HHS leadership was doing nothing to prepare for the imminent mask shortage.”
  • Bright claims he “resisted efforts to fall into line with the Administration’s directive to promote the broad use of chloroquine and hydroxychloroquine and to award lucrative contracts for these and other drugs even though they lacked scientific merit and had not received prior scientific vetting.”
  • He adds that “even as HHS leadership began to acknowledge the imminent shortages in critical medical supplies, they failed to recognize the magnitude of the problem, and they failed to take the necessary urgent action.”

The White House declined to comment. HHS did not immediately respond to a request for comment.

https://www.documentcloud.org/documents/6882494-NEW-R-Bright-OSC-Complaint-Redacted.html