HHS

rfk-jr.‘s-bloodbath-at-hhs:-blowback-grows-as-losses-become-clearer

RFK Jr.‘s bloodbath at HHS: Blowback grows as losses become clearer

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Last week, Health Secretary and anti-vaccine advocate Robert F. Kennedy Jr. announced the Trump administration would hack off nearly a quarter of employees at the Department of Health and Human Services, which oversees critical agencies including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services (CMS).

The downsizing includes pushing out about 10,000 full-time employees through early retirements, deferred resignations, and other efforts. Another 10,000 will be laid off in a brutal restructuring, bringing the total HHS workforce from 82,000 to 62,000.

“This will be a painful period,” Kennedy said in a video announcement last week. Early yesterday morning, the pain began.

It begins

At the FDA—which will lose 3,500 employees, about 19 percent of staff—some employees learned they were being laid off from security guards after their badges no longer worked when they showed up to their offices, according to Stat. At CMS—which will lose 300 employees, about 4 percent—laid-off employees were instructed to file any discrimination complaints they may have with Anita Pinder, identified as the director of CMS’s Office of Equal Opportunity and Civil Rights. However, Pinder died last year, The Washington Post noted.

At the NIH—which is set to lose 1,200 employees, about 6 percent—new director Jay Bhattacharya sent an email to staff saying he would implement new policies “humanely,” while calling the layoffs a “significant reduction.” Five NIH institute directors and at least two other senior leaders have been ousted, in addition to hundreds of lower-level employees. Bhattacharya wrote that the remaining staff will have to find new ways to carry out “key NIH administrative functions, including communications, legislative affairs, procurement, and human resources.”

At CDC—which will lose 2,400 employees, about 18 percent—the cuts slashed employees working in chronic disease prevention, sexually transmitted diseases, HIV, tuberculosis, global health, environmental health, occupational safety and health, maternal and child health, birth defects, violence prevention, health equity, communications, and science policy.

Some leaders and workers at the CDC and NIH were reportedly reassigned or offered transfers to work at the Indian Health Services (IHS), an HHS division that provides medical and health services to Native American tribes. The transfers, which could require employees to move to a remote branch, are seen as another way to force workers out.

RFK Jr.‘s bloodbath at HHS: Blowback grows as losses become clearer Read More »

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RFK Jr. claws back $11.4B in CDC funding amid wave of top-level departures

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Those departures follow Kevin Griffis, head of the CDC’s office of communications, who left last week; Robin Bailey, the agency’s chief operating officer, left late last month; and Nirav Shah, a former CDC principal deputy director.

Pulled funding

Meanwhile, NBC News reported this afternoon that the Department of Health and Human Services (HHS) is pulling back $11.4 billion in funding from the agency, which it allocated to state and local health departments as well as partners.

NBC reported that the funds were largely used for COVID-19 testing and vaccination, and to support community health workers and initiatives that address pandemic health disparities among high-risk and underserved populations, such as rural communities and minority populations. The funds also supported global COVID-19 projects.

“The COVID-19 pandemic is over, and HHS will no longer waste billions of taxpayer dollars responding to a non-existent pandemic that Americans moved on from years ago,” HHS Director of Communications Andrew Nixon said in a statement. “HHS is prioritizing funding projects that will deliver on President Trump’s mandate to address our chronic disease epidemic and Make America Healthy Again.”

State health departments told NBC News that they’re still evaluating the impact of the withdrawn funding. On Monday, some grantees received notices that read: “Now that the pandemic is over, the grants and cooperative agreements are no longer necessary as their limited purpose has run out.”

Since the public health emergency for COVID-19 was declared over in the US on May 11, 2023, over 92,000 Americans died from the pandemic virus, according to CDC data. In total, the pandemic killed over 1.2 million in the US.

RFK Jr. claws back $11.4B in CDC funding amid wave of top-level departures Read More »

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Report: mRNA vaccines are in RFK Jr’s crosshairs; funding in question

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Ars Technica has reached out to the NIH and HHS for comment and will update this story with any new information provided. The agencies did not respond to comment requests from KFF.

Kennedy’s misinformation

Before becoming the top health official in America, Kennedy had long railed against vaccines, becoming one of the world’s most prominent anti-vaccine advocates and most prolific spreaders of misinformation and disinformation about vaccines. A 2019 study found Kennedy was the single leading source of anti-vaccine ads on Facebook. Kennedy subsequently faced bans from YouTube, Facebook, and Instagram for spreading misinformation.

Researchers directly blame Kennedy and the Trump administration for the attack on vaccine research.

“Kennedy’s war on vaccines has started,” the mRNA vaccine researcher in Philadelphia told KFF.

“There will not be any research funded by NIH on mRNA vaccines,” the scientist in New York similarly told the outlet. “MAGA people are convinced that these vaccines have killed and maimed tens of thousands of people. It’s not true, but they believe that.”

Kennedy has made various statements against vaccines generally, as well as mRNA vaccines specifically. He falsely claimed the vaccine causes severe harms, including causing neurodegenerative diseases, such as Parkinson’s. In 2021, during the height of the pandemic, Kennedy petitioned the Food and Drug Administration to revoke the authorization of COVID-19 vaccines and refrain from approving any future COVID-19 vaccines. A study in 2022, meanwhile, estimated that the vaccines had saved more than 3 million lives and prevented more than 18 million hospitalizations.

The NIH’s recent moves aren’t the first sign that Kennedy will use his powerful position to attack mRNA vaccines. Late last month, Bloomberg reported that HHS was considering canceling a $590 million grant to vaccine-maker Moderna to develop mRNA vaccines against potential pandemic influenza viruses. That includes the H5N1 virus that is currently devastating US poultry and spreading wildly in dairy cows.

An HHS spokesperson told media at the time that “while it is crucial that the US Department and Health and Human Services support pandemic preparedness, four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production.”

It remains unclear what is happening with that grant review. Moderna declined to comment when Ars reached out for any potential updates Monday.

Report: mRNA vaccines are in RFK Jr’s crosshairs; funding in question Read More »

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RFK Jr. promptly cancels vaccine advisory meeting, pulls flu shot campaign

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Indefinite changes

Stat asked the HHS specifically about the Wild to Mild campaign as well as promotional campaigns for other vaccines, but an HHS spokesperson puzzlingly responded with a statement saying: “No, the CDC was not told to take down the flu vaccination campaign webpage,” which wasn’t what the outlet had asked about.

The statement went on to say: “Unfortunately, officials inside the CDC who are averse to Secretary Kennedy and President Trump’s agenda seem to be intentionally falsifying and misrepresenting guidance they receive.” NPR received the same statement.

Meanwhile on Thursday, The Washington Post reported that the HHS told the CDC to indefinitely postpone a meeting of its vaccine advisory committee (the Advisory Committee on Immunization Practices, or ACIP), which Kennedy has criticized. ACIP, comprised of independent experts, meets regularly to review and discuss vaccine safety and efficacy data and vote on recommendations.

ACIP was previously scheduled to meet February 26 to 28 to discuss a large number of vaccines, including those against meningitis, influenza, RSV, chikungunya, HPV, mpox, pneumococcal infections, Lyme disease, COVID-19, and CMV. An HHS spokesperson told the Post that the meeting was “postponed to accommodate public comment in advance of the meeting,” but there is no rescheduled date.

Leading medical experts and organizations, such as the American Medical Association, quickly sent a joint letter urging Kennedy to preserve the meeting. “Each ACIP meeting holds tremendous weight and relevance,” the letter states. ‘Infectious diseases are constantly evolving opponents; vaccines are among the best tools for constantly adapting and responding to the latest public health threats. … Making America healthy requires healthy discussion and timely, evidence-based decisions. This meeting should be no different.”

But, also on Thursday, Politico reported that Kennedy is preparing to remove ACIP members. And, the AP noted earlier that during a speech to HHS employees on Tuesday, Kennedy vowed to investigate the CDC’s childhood vaccine schedule, despite assuring senators prior to his confirmation that he would not make changes to it.

RFK Jr. promptly cancels vaccine advisory meeting, pulls flu shot campaign Read More »

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22 states sue to block new NIH funding policy—court puts it on hold

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Regardless of what else they might be doing, the indirect costs pay for various critical campus services, including at research hospitals. Suddenly having that amount slashed would create a major budgetary shortfall that will be hard to cover without shutting programs down.

The resulting damage to research campuses in their states was one of the harms cited by the states that joined the suit as part of their effort to establish standing. The other was the harm caused by the general slowdown in biomedical research that the policy will trigger, which the states argue will delay the availability of treatments for their citizens.

The states taking part include most of those that were won by Kamala Harris in 2024, as well as states that voted for Trump but currently have Democratic governors and attorneys general: Arizona, Michigan, Nevada, North Carolina, and Wisconsin. Notably, the suit only seeks relief from the altered NIH policy for institutions located in those states; they’re essentially leaving states controlled by Republicans to suffer the damages caused by the new policy.

Allegations and backup allegations

The states allege that the new NIH policy, by applying to all grants in progress, is equivalent to rewriting a contract. It cites an earlier legal decision that determined that “Once the [Notice of Award] is signed or money is drawn, the [Notice of Award] and the grant terms are binding on the grantee and the government.” Beyond that, the states argue the policy violates two separate pieces of legislation.

The first is the Administrative Procedures Act, which describes the processes that agencies need to follow when they formulate formal rules to translate legislation into implementations. Among other things, this prevents agencies from formulating rules that are “arbitrary and capricious.” It argues that, by including audits and negotiations in the process of setting them, the current individualized indirect rates are anything but.

By contrast, the states argue, there’s no significant foundation for the 15 percent indirect rate. “The Rate Change Notice is arbitrary and capricious in, among other ways, its failure to articulate the bases for the categorical rate cap of 15 percent,” the suit alleges, “its failure to consider the grant recipients’ reliance on their negotiated rates, and its disregard for the factual findings that formed the bases for the currently operative negotiated indirect cost rates.”

22 states sue to block new NIH funding policy—court puts it on hold Read More »

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Public health emergency declared amid LA’s devastating wildfires

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The US health department on Friday declared a public health emergency for California in response to devastating wildfires in the Los Angeles area that have so far killed 10 people and destroyed more than 10,000 structures.

As of Friday morning, 153,000 residents are under evacuation orders, and an additional 166,800 are under evacuation warnings, according to local reports.

Wildfires pose numerous health risks, including exposure to extreme heat, burns, harmful air pollution, and emotional distress.

“We will do all we can to assist California officials with responding to the health impacts of the devastating wildfires going on in Los Angeles County,” US Department of Health and Human Services (HHS) Secretary Xavier Becerra said in a statement. “We are working closely with state and local health authorities, as well as our partners across the federal government, and stand ready to provide public health and medical support.”

The Administration for Strategic Preparedness and Response (ASPR), an agency within HHS, is monitoring hospitals and shelters in the LA area and is prepared to deploy responders, medical equipment, and supplies upon the state’s request.

Public health emergency declared amid LA’s devastating wildfires Read More »

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Over 86% of surveyed health care providers are short on IV fluids

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Trucks and Gatorade

Federal officials, meanwhile, are working with Baxter to help support increasing supplies, setting up temporary imports, and expediting consideration of any shelf-life extension requests.

In a letter earlier this week, Department of Health and Human Services Secretary Xavier Becerra told health care leaders that the department is “working tirelessly to mitigate the sterile solutions supply chain disruptions” and, beyond the current crisis, is also working to diversify the supply chain so it is less reliant on a single plant.

For now, though, “HHS is encouraging all providers and health systems, regardless of whether they have experienced a disruption in their supply, to take measures to conserve these critical products,” the letter read. Some hospitals have already reported giving patients Gatorade and Pedialyte to conserve IV fluid supplies.

In one bright spot in the current disruptions, fears that Hurricane Milton would disrupt another IV fluid manufacturing plant in Florida were not realized this week. B. Braun Medical’s manufacturing site in Daytona Beach was not seriously impacted by the storm, the company announced, and production resumed normally Friday. Prior to the storm, with the help of the federal government, B. Braun reportedly moved more than 60 truckloads of IV fluid inventory north of Florida for safekeeping. That inventory will be returned to the Daytona facility, according to reporting by the Associated Press.

Over 86% of surveyed health care providers are short on IV fluids Read More »

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COVID shot now or later? Just getting it at all is great, officials respond.

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Viral defences —

As the summer wave peaks, officials are prepping for the coming winter wave.

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A 13-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021.

Enlarge / A 13-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021.

With the impending arrival of the 2024–2025 COVID-19 vaccines approved yesterday, some Americans are now gaming out when to get their dose—right away while the summer wave is peaking, a bit later in the fall to maximize protection for the coming winter wave, or maybe a few weeks before a big family event at the end of the year? Of course, the group pondering such a question is just a small portion of the US.

Only 22.5 percent of adults and 14 percent of children in the country are estimated to have gotten the 2023–2024 vaccine. In contrast, 48.5 percent of adults and 54 percent of children were estimated to have gotten a flu shot. The stark difference is despite the fact that COVID-19 is deadlier than the flu, and the SARS-CoV-2 virus is evolving faster than seasonal influenza viruses.

In a press briefing Friday, federal health officials were quick to redirect focus when reporters raised questions about the timing of COVID-19 vaccination in the coming months and the possibility of updating the vaccines twice a year, instead of just once, to keep up with an evolving virus that has been producing both summer and winter waves.

“The current problem is not that the virus is evolving so much, at least in terms of my estimation,” Peter Marks, the top vaccine regulator at the Food and Drug Administration, told journalists. “It’s that we don’t have the benefits of the vaccine, which is [to say] that it’s not vaccines that prevent disease, it’s vaccination. It’s getting vaccines in arms.” When exactly to get the vaccine is a matter of personal choice, Marks went on, but the most important choice is to get vaccinated.

Estimates for this winter

The press briefing, which featured several federal health officials, was intended to highlight the government’s preparations and hopes for the upcoming respiratory virus season. The FDA, the Centers for Disease Control and Prevention, and the Department of Health and Human Services (HHS) are urging all Americans to get their respiratory virus vaccines—flu, COVID-19, and RSV.

CDC Director Mandy Cohen introduced an updated data site that provides snapshots of local respiratory virus activity, national trends, data visualizations, and the latest guidance in one place. HHS, meanwhile, highlighted a new outreach campaign titled “Risk Less. Do More.” to raise awareness of COVID-19 and encourage vaccination, particularly among high-risk populations. For those not at high risk, health officials still emphasize the importance of vaccination to lower transmission and prevent serious outcomes, including long COVID. “There is no group without risk,” Cohen said, noting that the group with the highest rates of emergency department visits for COVID-19 were children under the age of 5, who are not typically considered high risk.

So far, CDC models are estimating that this year’s winter wave of COVID-19 will be similar, if not slightly weaker on some metrics, than last year’s winter wave, Cohen said. But she emphasized that many assumptions go into the modeling, including how the virus will evolve in the near future and the amount of vaccine uptake. The modeling assumes the current omicron variants stay on their evolutionary path and that US vaccination coverage is about the same as last year. Of course, beating last year’s vaccine coverage could blunt transmission.

COVID shot now or later? Just getting it at all is great, officials respond. Read More »

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US prepares for bird flu pandemic with $176M Moderna vaccine deal

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Pandemic fears —

Phase 3 trial is expected to begin next year.

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US prepares for bird flu pandemic with $176M Moderna vaccine deal

The US government will pay Moderna $176 million to develop an mRNA vaccine against a pandemic influenza—an award given as the highly pathogenic bird flu virus H5N1 continues to spread widely among US dairy cattle.

The funding flows through BARDA, the Biomedical Advanced Research and Development Authority, as part of a new Rapid Response Partnership Vehicle (RRPV) Consortium. The program is intended to set up partnerships with industry to help the country better prepare for pandemic threats and develop medical countermeasures, the Department of Health and Human Services said in a press announcement Tuesday.

In an announcement of its own Tuesday, Moderna noted that it began a Phase 1/2 trial of a pandemic influenza virus vaccine last year, which included versions targeting H5 and H7 varieties of bird flu viruses. The company said it expects to release the results of that trial this year and that those results will direct the design of a Phase 3 trial, anticipated to begin in 2025.

The funding deal will support late-stage development of a “pre-pandemic vaccine against H5 influenza virus,” Moderna said. But, the deal also includes options for additional vaccine development in case other public health threats arise.

“mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic,” Moderna CEO Stéphane Bancel said in the announcement. “We are pleased to continue our collaboration with BARDA to expedite our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparedness against potential outbreaks.”

US health officials have said previously that they were in talks with Moderna and Pfizer about the development of a pandemic bird flu vaccine. The future vaccine will be in addition to standard protein-based bird flu vaccines that are already developed. In recent weeks, the health department has said it is working to manufacture 4.8 million vials of H5 influenza vaccine in the coming months. The plans come three months into the H5N1 dairy outbreak, which is very far from the initial hopes of containment.

Botched response

The US is badly fumbling its response to the unprecedented outbreak, drawing criticism from US-based and international experts alike. Genetic analyses suggest that the virus has been spreading among the country’s dairy cattle since late last year. But, it wasn’t until months later, on March 25, that the US Department of Agriculture confirmed the first four infected herds in two states (Texas and Kansas). Since then, the outbreak has spread to around 140 herds in 12 states—at least.

Some farms are refusing to test, and experts expect that there is a significant number of undocumented herd infections, particularly given the widespread detection of inactivated H5N1 in the commercial milk supply. Further, of the 140 herds with documented infections, federal officials do not know how many are still actively infected rather than recovered. It is unclear if infected cows can become reinfected, and if so, how quickly after an infection.

While the risk to the general public is considered to be low currently, farm workers are at higher risk of contracting the infection. To date, there have been three confirmed infections among dairy farm workers—one in Texas and two in Michigan, which has had a uniquely robust response to the outbreak. Still, with hundreds to thousands of farm workers at risk of contracting the virus, only 53 people in the country to date have been tested for H5 influenza.

In a presentation in London last month, global health leader Seth Berkley said it was “shocking to watch the ineptitude” of the US response to the H5N1 outbreak. He, like other experts, questioned whether the US public health community has learned or improved from the failures of the COVID-19 pandemic.

Similar to problems during the pandemic, a key barrier to the H5N1 response is resistance from farmers and farm workers to partner with state and federal health officials. Federal agencies have limited authority within states, but they have announced an array of assistance programs for dairy farms, including compensatory funding and access to personal protective equipment for farm workers. They have also issued guidance and restrictions to tighten biosecurity measures. But there has been little voluntary participation on both fronts.

For instance, officials figured out early in the outbreak that movement of cattle, workers, and equipment between farms is the main way H5N1 is spreading among dairies. In April, the USDA required testing of a portion of cows prior to their movement across state lines. But movement within states is governed by states. In a survey last month, which captured data from 54 percent of affected farms at the time, more than 60 percent of farmers said they continued to move cattle off their infected farms after the onset of clinical signs of infection in their animals.

The more the virus expands its footprint across US dairy farms, adapts to its newfound mammalian host, and comes in contact with humans, the more and more chances it has to leap to humans and gain the ability to spread among us.

In HHS’s Tuesday announcement of the Moderna award, Dawn O’Connell, assistant secretary for Preparedness and Response, spoke to the growing concern that the H5N1 outbreak could spark another pandemic. “The award made today is part of our longstanding commitment to strengthen our preparedness for pandemic influenza,” O’Connell said. “Adding this technology to our pandemic flu toolkit enhances our ability to be nimble and quick against the circulating strains and their potential variants.”

US prepares for bird flu pandemic with $176M Moderna vaccine deal Read More »

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Amid paralyzing ransomware attack, feds probe UnitedHealth’s HIPAA compliance

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most significant and consequential incident —

UnitedHealth said it will cooperate with the probe as it works to restore services.

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Multistory glass-and-brick building with UnitedHealthcare logo on exterior.

As health systems around the US are still grappling with an unprecedented ransomware attack on the country’s largest health care payment processor, the US Department of Health and Human Services is opening an investigation into whether that processor and its parent company, UnitedHealthcare Group, complied with federal rules to protect private patient data.

The attack targeted Change Healthcare, a unit of UnitedHealthcare Group (UHG) that provides financial services to tens of thousands of health care providers around the country, including doctors, dentists, hospitals, and pharmacies. According to an antitrust lawsuit brought against UHG by the Department of Justice in 2022, 50 percent of all medical claims in the US pass through Change Healthcare’s electronic data interchange clearinghouse. (The DOJ lost its case to prevent UHG’s acquisition of Change Healthcare and last year abandoned plans for an appeal.)

As Ars reported previously, the attack was disclosed on February 21 by UHG’s subsidiary, Optum, which now runs Change Healthcare. On February 29, UHG accused the notorious Russian-speaking ransomware gang known both as AlphV and BlackCat of being responsible. According to The Washington Post, the attack involved stealing patient data, encrypting company files, and demanding money to unlock them. The result is a paralysis of claims processing and payments, causing hospitals to run out of cash for payroll and services and preventing patients from getting care and prescriptions. Additionally, the attack is believed to have exposed the health data of millions of US patients.

Earlier this month, Rick Pollack, the president and CEO of the American Hospital Association, called the ransomware attack on Change Healthcare “the most significant and consequential incident of its kind against the US health care system in history.”

Now, three weeks into the attack, many health systems are still struggling. On Tuesday, members of the Biden administration met with UHG CEO Andrew Witty and other health industry leaders at the White House to demand they do more to stabilize the situation for health care providers and services and provide financial assistance. Some improvements may be in sight; on Wednesday, UHG posted an update saying that “all major pharmacy and payment systems are up and more than 99 percent of pre-incident claim volume is flowing.”

HIPAA compliance

Still, the data breach leaves big questions about the extent of the damage to patient privacy, and the adequacy of protections moving forward. In an additional development Wednesday, the health department’s Office for Civil Rights (OCR) announced that it is opening an investigation into UHG and Change Healthcare over the incident. It noted that such an investigation was warranted “given the unprecedented magnitude of this cyberattack, and in the best interest of patients and health care providers.”

In a “Dear Colleague” letter dated Wednesday, the OCR explained that the investigation “will focus on whether a breach of protected health information occurred and Change Healthcare’s and UHG’s compliance with the HIPAA Rules.” HIPAA is the Health Insurance Portability and Accountability Act, which establishes privacy and security requirements for protected health information, as well as breach notification requirements.

In a statement to the press, UHG said it would cooperate with the investigation. “Our immediate focus is to restore our systems, protect data and support those whose data may have been impacted,” the statement read. “We are working with law enforcement to investigate the extent of impacted data.”

The Post notes that the federal government does have a history of investigating and penalizing health care organizations for failing to implement adequate safeguards to prevent data breaches. For instance, health insurance provider Anthem paid a $16 million settlement in 2020 over a 2015 data breach that exposed the private data of almost 79 million people. The exposed data included names, Social Security numbers, medical identification numbers, addresses, dates of birth, email addresses, and employment information. The OCR investigation into the breach discovered that the attack began with spear phishing emails that at least one employee of an Anthem subsidiary fell for, opening the door to further intrusions that went undetected between December 2, 2014, and January 27, 2015.

“Unfortunately, Anthem failed to implement appropriate measures for detecting hackers who had gained access to their system to harvest passwords and steal people’s private information,” OCR Director Roger Severino said at the time. “We know that large health care entities are attractive targets for hackers, which is why they are expected to have strong password policies and to monitor and respond to security incidents in a timely fashion or risk enforcement by OCR.”

Amid paralyzing ransomware attack, feds probe UnitedHealth’s HIPAA compliance Read More »

elizabeth-holmes-barred-from-federal-health-programs-for-90-years

Elizabeth Holmes barred from federal health programs for 90 years

Elizabeth Holmes, exclusion, federal health program, fraud, health, HHS, Science / /

Excluded —

The former Theranos CEO is barred from receiving payments from federal health program.

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Theranos CEO and founder Elizabeth Holmes.

Theranos CEO and founder Elizabeth Holmes.

Elizabeth Holmes—the disgraced and incarcerated founder of the infamous blood-testing startup Theranos—is barred from participating in federal health programs for nine decades, according to an announcement from the health department Friday.

The exclusion means that Holmes is barred from receiving payments from federal health programs for services or products, which significantly restricts her ability to work in the health care sector. It also prevents her from participating in Medicare, Medicaid, and other federal health care programs. With a 90-year term, the exclusion is lifelong for Holmes, who is currently 39.

The exclusion was announced by Inspector General Christi Grimm of the Department of Health and Human Services’ Office of Inspector General.

Holmes is serving an 11-year, three-month sentence for defrauding investors of her blood-testing startup, Theranos, which she founded in 2003. At the time, Holmes claimed to have developed proprietary technology that could perform hundreds of medical tests using just a small drop of blood from a finger prick. The remarkable claim helped her drive the company’s valuation to a stunning $9 billion in 2014, and set up lucrative partnerships. But, in reality, the technology never worked. The company collapsed in 2018, and she was convicted of fraud in 2022.

In today’s announcement, the health department noted that the statutory minimum on exclusions for convictions like Holmes’ is just five years. But other factors are considered when determining the term, including how long the fraud took place, the length of the prison sentence, and the amount of restitution ordered. In addition to her 11-year prison sentence, Holmes was ordered to pay approximately $452,047,200 in restitution, the HHS-OIG noted.

“Accurate and dependable diagnostic testing technology is imperative to our public health infrastructure. False statements related to the reliability of these medical products can endanger the health of patients and sow distrust in our health care system,” Grimm said. “As technology evolves, so do our efforts to safeguard the health and safety of patients, and HHS-OIG will continue to use its exclusion authority to protect the public from bad actors.”

HHS-OIG also excluded former Theranos President Ramesh Balwani from federal health programs for 90 years. Balwani was also convicted of fraud and is serving a nearly 13-year sentence.

Elizabeth Holmes barred from federal health programs for 90 years Read More »

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CVS, Rite Aid, Walgreens hand out medical records to cops without warrants

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prescription for privacy —

Lawmakers want HHS to revise health privacy law to require warrants.

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CVS, Rite Aid, Walgreens hand out medical records to cops without warrants

All of the big pharmacy chains in the US hand over sensitive medical records to law enforcement without a warrant—and some will do so without even running the requests by a legal professional, according to a congressional investigation.

The revelation raises grave medical privacy concerns, particularly in a post-Dobbs era in which many states are working to criminalize reproductive health care. Even if people in states with restrictive laws cross state lines for care, pharmacists in massive chains, such as CVS, can access records across borders.

Lawmakers noted the pharmacies’ policies for releasing medical records in a letter dated Tuesday to the Department of Health and Human Services (HHS) Secretary Xavier Becerra. The letter—signed by Sen. Ron Wyden (D-Ore.), Rep. Pramila Jayapal (D-Wash.), and Rep. Sara Jacobs (D-Calif.)—said their investigation pulled information from briefings with eight big prescription drug suppliers.

They include the seven largest pharmacy chains in the country: CVS Health, Walgreens Boots Alliance, Cigna, Optum Rx, Walmart Stores, Inc., The Kroger Company, and Rite Aid Corporation. The lawmakers also spoke with Amazon Pharmacy.

All eight of the pharmacies said they do not require law enforcement to have a warrant prior to sharing private and sensitive medical records, which can include the prescription drugs a person used or uses and their medical conditions. Instead, all the pharmacies hand over such information with nothing more than a subpoena, which can be issued by government agencies and does not require review or approval by a judge.

Three pharmacies—CVS Health, The Kroger Company, and Rite Aid Corporation—told lawmakers they didn’t even require their pharmacy staff to consult legal professionals before responding to law enforcement requests at pharmacy counters. According to the lawmakers, CVS, Kroger, and Rite Aid said that “their pharmacy staff face extreme pressure to immediately respond to law enforcement demands and, as such, the companies instruct their staff to process those requests in store.”

The rest of the pharmacies—Amazon, Cigna, Optum Rx, Walmart, and Walgreens Boots Alliance—at least require that law enforcement requests be reviewed by legal professionals before pharmacists respond. But, only Amazon said it had a policy of notifying customers of law enforcement demands for pharmacy records unless there were legal prohibitions to doing so, such as a gag order.

HIPAA and transparency

The lawmakers note that the pharmacies aren’t violating regulations under the Health Insurance Portability and Accountability Act (HIPAA). The pharmacies pointed to language in HIPAA regulations that allow health care providers, including pharmacists, to provide medical records if required by law, with subpoenas being a sufficient legal process for such a request. However, the lawmakers note that the HHS has discretion in determining the legal standard here—that is, it has the power to strengthen the regulation to require a warrant, which the lawmakers say it should do.

“We urge HHS to consider further strengthening its HIPAA regulations to more closely align them with Americans’ reasonable expectations of privacy and Constitutional principles,” the three lawmakers wrote.

They also pushed for pharmacies to do better, encouraging them to follow the lead of tech companies. “Pharmacies can and should insist on a warrant, and invite law enforcement agencies that insist on demanding patient medical records with solely a subpoena to go to court to enforce that demand. The requirement for a warrant is exactly the approach taken by tech companies to protect customer privacy.” The trio noted that Google, Microsoft, and Yahoo have since 2010 required law enforcement to have a warrant to obtain customers’ emails.

Also noting tech companies’ lead, the lawmakers encouraged pharmacies to publish annual transparency reports. In the course of the investigation, only CVS Health said it planned to do so.

“Americans deserve to have their private medical information protected at the pharmacy counter and a full picture of pharmacies’ privacy practices, so they can make informed choices about where to get their prescriptions filled,” the lawmakers wrote.

For now, HIPAA regulations grant patients the right to know who is accessing their health records. But, to do so, patients have to specifically request that information—and almost no one does that. “Last year, CVS Health, the largest pharmacy in the nation by total prescription revenue, only received a single-digit number of such consumer requests,” the lawmakers noted.

“The average American is likely unaware that this is even a problem,” the lawmakers said.

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