Category: Federal agencies

The next steps for US vaccine mandates

Volume 399, Issue 10323
28 January 2022 

 

WORLD REPORT   As the Supreme Court blocks one of the Biden Administration’s plans to raise COVID-19 vaccination rates but approves another, Susan Jaffe looks at the next steps.

President Joe Biden’s efforts to encourage the most reluctant Americans to get fully vaccinated against COVID-19 have hit one legal roadblock after another. About one in four adults have still not received either the two-dose or single regimen of the vaccine, according to the Centers for Disease Control and Prevention. However, the path to greater vaccination uptake is shrinking as federal courts muddy his Administration’s pro-vaccine message, cases of infection driven by the Omicron variant continue to rise in many parts of the country, and the president’s popularity ratings fall. …In the first of two rulings on Jan 13, the Supreme Court decided 6–3 to block the Biden Administration’s mandate for private companies with more than 100 employees to require weekly COVID-19 tests for employees who have not been fully vaccinated. ,,,Yet in a pair of lawsuits the court heard along with the employer mandate cases, the court came to the opposite conclusion. In a 5–4 decision, they upheld the Biden Administration’s requirement of vaccination for 10·4 million workers at 76 000 health-care facilities that treat patients covered by the government’s Medicare or Medicaid health insurance.[Continued here.] 

 

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Holmes verdicts prompt questions over justice for patients

Volume 399, Issue 10321
15 January 2022

 

WORLD REPORT   The founder of Theranos was found guilty of defrauding some investors, but cleared of charges that she misled patients. Susan Jaffe reports.

On Jan 3, a federal jury in California found Elizabeth Holmes, creator of the blood-testing startup Theranos, guilty of lying to some of her investors about a portable blood analyser that she claimed would transform health care. It could run dozens of tests from a fingerprick of blood, she said, and deliver dependable results quickly. However, government prosecutors’ account of Holmes’s empty promises and hype failed to convince the jury that she also deceived patients and their doctors who depended on her device’s inaccurate readings. [Continued here.]  
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Theranos founder counters fraud charges in federal trial

Volume 398, Issue 10315
27 November 2021

 

WORLD REPORT   Federal prosecutors charged Theranos’ founder Elizabeth Holmes and former Theranos president Ramesh Balwani with wire fraud and conspiracy to commit wire fraud, alleging that they deceived investors and patients and their doctors by claiming that Theranos’s machine could produce accurate test results from blood collected in its tiny “nanotainer” device instead of several vials. But witnesses for the prosecution testified that the devices did not operate as promised…. “When something is brought forward as the next new thing regardless of whether it’s a drug or device, it needs to go through the process of rigorous scientific and clinical testing, then presented to the scientific community for peer review and ultimately publication”, said Roy Silverstein a haematologist and chair of medicine at the Medical College of Wisconsin. “And I’m not aware of any single publication that ever came out of this Theranos technology.” [Full story here.]  

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Legal challenges threaten Biden’s COVID-19 vaccine rule

Volume 398, Issue 10314
20 November 2021

 

WORLD REPORT  Almost a year after the first COVID-19 vaccine was approved for emergency use in the USA, roughly a third of adults have still not received it. After urging Americans to get vaccinated, US President Joe Biden has taken a tougher approach: under his administration’s new workplace safety standard, people must get vaccinated or undergo weekly tests for the virus if they work for companies with at least 100 employees. “The rule will protect more than 84 million workers from the spread of the coronavirus on the job”, said Jim Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health. …A day after OSHA’s announcement on Nov 4, 2021, multiple lawsuits to block the rule started rolling in to federal courts across the country.[Continued here.]  

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Medicare’s Open Enrollment Is Open Season for Scammers

By Susan Jaffe  | Kaiser Health News | November 11, 2021 | This KHN story also ran in The Washington Post.

Finding the best private Medicare drug or medical insurance plan among dozens of choices is tough enough without throwing misleading sales tactics into the mix.  Yet federal officials say complaints are rising from seniors tricked into buying policies — without their consent or lured based on questionable information — that may not cover their drugs or include their doctors.

In response, the Centers for Medicare and Medicaid Services has threatened to penalize private insurance companies selling Medicare Advantage and drug plans if they or agents working on their behalf mislead consumers.  The agency has also revised rules making it easier for beneficiaries to escape plans they didn’t sign up for or enrolled in only to discover promised benefits didn’t exist or they couldn’t see their providers.

The problems are especially prevalent during Medicare’s open-enrollment period, which began Oct. 15 and runs through Dec. 7. A common trap begins with a phone call like the one Linda Heimer, an Iowa resident, received in October. [Full story in The Washington Post and Kaiser Health News.] 

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3 States Limit Nursing Home Profits in Bid to Improve Care

“If they choose to rely on public dollars to deliver care, they take on a greater responsibility,” says New York Assemblyman Ron Kim. “It’s not like running a hotel.” 
By Susan Jaffe | KAISER HEALTH NEWS | October 25, 2021 |  This story also ran on

Nursing homes receive billions of taxpayers’ dollars every year to care for chronically ill frail elders, but until now, there was no guarantee that’s how the money would be spent.

Massachusetts, New Jersey and New York are taking unprecedented steps to ensure they get what they pay for, after the devastating impact of covid-19 exposed problems with staffing and infection control in nursing homes. The states have set requirements for how much nursing homes must spend on residents’ direct care and imposed limits on what they can spend elsewhere, including administrative expenses, executive salaries and advertising and even how much they can pocket as profit. …With this strategy, advocates believe, residents won’t be shortchanged on care, and violations of federal quality standards should decrease because money will be required to be spent on residents’ needs. At least that’s the theory. [Continued on Kaiser Health News, Fortune, NBC News, Yahoo Finance, and Chicago Sun-Times]…

The Push For Nursing Home Reform In The Middle Of A Pandemic

Sept. 20, 2021 | Today on NPR‘s news program “1A,”  reporter Susan Jaffe discusses her Kaiser Health News story about new state laws protecting nursing home residents in response to the COVID-19 pandemic. Changes affect staffing, visitation rights, virtual communications, “essential support persons,” and more. A  resident of a Connecticut nursing home quoted in this KHN article is also a guest. …

New 9/11 casualties strain health-care programme

Volume 398, Issue 10304
11 September 2021

 

On this 20th anniversary of the September 11th attacks, first-responder Terence Opiola won’t be attending any memorial events. “I’ll go to church and pray that people remember and understand that it’s not over,” he said. “We’re losing people every week.”

Now a funding shortfall threatens the World Trade Center Health Program, which provides free medical monitoring and treatment for Opiola and increasing numbers of other 9/11 survivors and first responders.  [Full story here.]…

After pandemic ravaged nursing homes, new state laws protect residents

So far, 23 states have passed more than 70 new pandemic-related provisions affecting nursing home operations. 

By Susan Jaffe | KAISER  HEALTH  NEWS | August 17, 2021 |  This story also ran in

When the coronavirus hit Martha Leland’s Connecticut nursing home last year, she and dozens of other residents contracted the disease while the facility was on lockdown. Twenty-eight residents died, including her roommate.

“The impact of not having friends and family come in and see us for a year was totally devastating,” she said. “And then, the staff all bound up with the masks and the shields on, that too was very difficult to accept.” She summed up the experience in one word: “scary.”

But under a law Connecticut enacted in June, nursing home residents will be able to designate an “essential support person” who can help

take care of a loved one even during a public health emergency. Connecticut legislators also approved laws this year giving nursing home residents free internet access and digital devices for virtual visits and allowing video cameras in their rooms so family or friends can monitor their care.

Similar benefits are not required by the Centers for Medicare & Medicaid Services, the federal agency that oversees nursing homes and pays for most of the care they provide. But states can impose additional requirements when those federal rules are insufficient or don’t exist.  And that’s exactly what many are doing, spurred by the virus that hit the frail elderly hardest. [Continued at Kaiser Health News and USA Today] 

 

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Chiquita Brooks-LaSure: innovative US federal health director

Volume 398, Issue 10300
14 August 2021

 

PROFILE  
Chiquita Brooks-LaSure, President Joe Biden’s choice to lead the Centers for Medicare and Medicaid Services, presides over an agency with a US$1 trillion budget that provides health insurance to more than 154 million people. Tackling health-care inequities is one of her top priorities. “These disparities have long existed, but COVID-19 has illuminated them in a way that is really unprecedented”, she said. [Full story here.]

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US FDA defends approval of Alzheimer’s disease drug

Volume 398, Issue 10294
3 July 2021

 

WORLD REPORT An avalanche of criticism has forced the US Food and Drug Administration to defend its decision to grant accelerated approval for aducanumab, the first new Alzheimer’s disease treatment in two decades. “It will be a very long time before we ever figure out whether or not this drug really works”, said Aaron Kesselheim, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School who resigned in protest from an FDA advisory panel that recommended against approval.[Continued here.]

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Zooming Into the Statehouse: Nursing Home Residents Use New Digital Skills to Push for Changes

By Susan Jaffe  | Kaiser Health News | June 9, 2021 | This KHN story also ran onand

Patty Bausch isn’t a Medicaid expert, lawyer or medical professional. But she still thinks Connecticut legislators need her input when they consider bills affecting people like her — the roughly 18,000 residents who live in the state’s nursing homes.

With help and encouragement from Connecticut’s Long Term Care Ombudsman Program, Bausch signed up and testified remotely before a legislative hearing this year. Nursing home residents who have been using digital technology to reach out to family and friends — after the covid pandemic led officials to end visitation last year — could also use it to connect with elected officials once the legislature moved to remote hearings. Speaking into an iPad provided by the ombudsman’s office, Bausch testified without ever leaving her room at the Newtown Rehabilitation & Health Care Center, where she has lived since having a stroke three years ago. The combination of a virtual legislature and nursing home residents equipped with internet access has created an opportunity most nursing home residents rarely have — to participate in their government up close and in real time.  [Continued on Kaiser Health News, Next Avenue and Connecticut Public Radio.]…

US drug importation plan hits snag

Volume 397, Issue 10291
12 June 2021

WORLD REPORT The Biden administration says it has “no timeline” for deciding if states can import cheap drugs from Canada. 

President Joe Biden’s administration said last week that it won’t decide whether to allow states to import drugs from Canada anytime soon, if ever. Biden supported drug importation during the presidential campaign, as did his opponent, Donald Trump, to mitigate sky-rocketing drug costs in the USA. Americans pay more per capita for prescription drugs than any other country…. [Continued here.]

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$6·5 billion proposed for new US health research agency

Volume 397, Issue 10288
22 May 2021

WORLD REPORT The Advanced Research Projects Agency for Health would fund high-risk, high-reward medical research, but its short-term planning could stymie basic research. Susan Jaffe reports.

During his first address to a joint session of Congress last month, US President Joe Biden drew little applause from Republicans in the physically distanced, masked audience. A rare exception to their steadfast silence came when he unveiled an ambitious plan to eradicate cancer.

To help reach this goal, Biden would establish a new biomedical research agency within the National Institutes of Health (NIH) called the Advanced Research Projects Agency for Health (ARPA-H). The agency would provide a fast track for transforming basic science into real-world applications. [Continued here.]

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Under New Cost-Cutting Medicare Rule, Same Surgery, Same Place, Different Bill

By Susan Jaffe  | Kaiser Health News | March 21, 2021 | This KHN story also ran in The Washington Post

For years, Medicare officials considered some surgeries so risky for older adults that that the insurance program would cover the procedures only for patients admitted to the hospital. Under a new Medicare policy that took effect this year, these operations can be provided to patients who are not admitted. But patients still have to go to the hospital. The change saves Medicare money while patients can pay a larger share of the bill — for the same surgery at the same hospital.  [Full story in The Washington Post and Kaiser Health News.] 

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Biden’s first legislative victory: $1·9 trillion for COVID-19

Volume 397, Issue 10279
20 March 2021

WORLD REPORT US President Joe Biden’s first legislative triumph will fund the COVID-19 response and economic recovery, and address social determinants of health. Susan Jaffe reports from Washington, DC. 

By narrowly approving a massive COVID-19 response and economic relief package last week, Democrats in Congress handed President Joe Biden his first legislative victory after only 50 days in the White House. The US$1·9 trillion, 628-page, American Rescue Plan Act is a signature achievement so monumental that it has been compared to President Lyndon B Johnson’s sweeping Great Society legislation that raised many Americans out of poverty, with a safety net of social and health services, including the Medicare and Medicaid insurance programmes.

…As the government begins to roll out these benefits, Biden promised “fastidious oversight to make sure there’s no waste or fraud, and the law does what it’s designed to do. And I mean it: we have to get this right… because we have to continue to build confidence in the American people that their government can function for them and deliver.” [Full story with “where the money goes” sidebar here.]

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What Happens to Nursing Home Workers Who Missed COVID-19 Vaccinations?

by Susan Jaffe | AARP | March 26, 2021

COVID-19 has rampaged through nursing homes and other long-term-care facilities, leaving a death toll near 180,000 and counting. So when the first coronavirus vaccines became available at the end of last year, nursing home residents and staff were first in line, given top priority along with emergency responders and health care providers.

The federal government paid CVS and Walgreens to offer three vaccination clinics for residents and staff at nearly every nursing home in the U.S. That effort, called the Pharmacy Partnership for Long-Term Care Program, wraps up this month.  So how do new nursing home residents and workers who missed the onsite clinics get vaccinated now? For residents, plans are in the works to make sure they get the shots. But so far, many of those plans don’t include the staff members who care for them. [Continued here.]…

New leadership at the US CDC

Volume 397, Issue 10270
16 January 2021

 

WORLD REPORT Rochelle Walensky, an infectious diseases expert, promises to provide transparency, accountability, and restored trust at the embattled organisation. Susan Jaffe reports from Washington, DC.  [Full story here.]

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Rochelle Walensky: New Director of the US CDC

Volume 397, Issue 10271 
14 January 2021
PROFILE  Rochelle Walensky 

A highly respected researcher, Walensky has published nearly 300 papers, many focused on the cost-effectiveness of HIV interventions and aimed at improving patients’ care. “I call the research that I do policy motivating”, Walensky says. One example is a 2006 landmark study showed that advances in HIV treatment in the USA added nearly 3 million years to patients’ lives.[Full story here.]…

Nursing Homes Fined for COVID Infection Control Lapses

By Susan Jaffe  | Contributing Writer | MedPageToday  | November 25, 2020

During the COVID-19 pandemic, the Centers for Medicare and Medicaid Services (CMS) has fined 218 nursing homes more than $17.6 million for the most serious infection control violations that put residents in “immediate jeopardy,” conditions CMS believes are likely to seriously injure or kill them.

More than 91,000 residents and staff of long-term care facilities have died after contracting COVID-19 — about 40% of the total deaths in the U.S., according to a Kaiser Family Foundation analysis. …Frustrated by repeated violations of infection control requirements during the pandemic, CMS raised the penalty amounts and announced a crackdown on egregious offenders in August. But the hard-line approach doesn’t seem to have produced the intended results. (Click here for a list of nursing homes that were fined.)  [Continued here.]

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US election 2020: the future of the Affordable Care Act

Volume 396, Number 10260     31 October 2020 

WORLD REPORT   President Donald Trump pledges to replace the Affordable Care Act while his Democratic opponent Joe Biden offers detailed proposals to improve it. Susan Jaffe reports from Washington, DC.

Since winning the presidency in 2016 in large part by promising to eliminate Obamacare, otherwise known as the Affordable Care Act (ACA), Donald Trump has promised more than a dozen times that his replacement plan would be ready soon. The plan would be released in 2 weeks, a White House spokeswoman said 2 months ago.

“We’re going to have a health-care plan that will be second to none”, Trump said in 2017. “It’s going to be great and the people will see that.” And at last week’s final presidential debate, he vowed “to terminate Obamacare, [and] come up with a brand new beautiful health care”.

A decade after the ACA—President Barack Obama’s signature achievement—became law, repealing and replacing Obamacare is again central to Trump’s re-election. And improving and expanding the law is a crucial part of the campaign of his challenger, former Vice President Joe Biden. [Continued here.]     

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US election 2020: research and health institutions

Volume 396, Number 10259

24 October 2020

 

WORLD REPORT   How will the NIH, CDC, and FDA change if President Donald Trump wins a second term or if his Democratic challenger, Joe Biden, defeats him? Susan Jaffe reports from Washington, DC. 

Whoever wins the presidency needs to “restore the CDC and improve it by letting [scientists] know that they will have an opportunity to do the best science and make the best recommendations…” says James Curran, dean of the Rollins School of Public Health at Emory University in Atlanta. [Continued here.]…

US election 2020: public health

Volume 396, Number 10256

3 October 2020

 

WORLD REPORT   In the race for the White House, where do US President Donald Trump and his Democratic challenger, former Vice President Joe Biden, stand on public health? Susan Jaffe reports from Washington, DC. 

Analyzing the candidates’ plans to address the opioid epidemic, gun violence, women’s health, global health and COVID-19.

Unlike more conventional presidential candidates, Trump does not intend to issue formal policy proposals or position papers. With less than 5 weeks remaining before the election, his campaign says he will share “details about his plans through policy-focused speeches on the campaign trail”. …Joe Biden’s campaign has released a total of 51 policy proposals outlining how he will accomplish his goals if he wins in November. [Continued here.]…

Media reports reveal political interference at the US CDC

Volume 396, Number 10255

26 September 2020

 

WORLD REPORT  News accounts say that Trump administration officials wanted to edit and approve COVID-19 studies and publish guidance without the usual scientific review. Susan Jaffe reports.

After news stories about attempts by members of the Trump administration to manipulate COVID-19 reports published by the US Centers for Disease Control and Prevention (CDC) and over-rule its scientists, one top official is taking a sudden leave of absence for health reasons. Another’s government contract has abruptly ended. The 2-month absence of Michael Caputo, chief spokesman for the US Department of Health and Human Services (HHS), comes after he claimed that a CDC “resistance unit” seeks to undermine Trump. He and an adviser reportedly demanded the right to revise and approve COVID-19 studies published in the CDC’s highly respected Morbidity and Mortality Weekly Report journal.  [Continued here.]…

House Committee Approves Bill to Ease Medicare Part B Enrollment

Seniors would be notified about eligibility to avoid late fees, coverage gap

By Susan Jaffe  | Contributing Writer | MedPageToday  | July 15, 2020

A House committee unanimously approved legislation Wednesday that would make changes for the first time in 50 years to the complex rules for enrolling in Medicare’s Part B, which covers doctor visits and other outpatient care.

Currently, seniors who don’t get Part B when they first become eligible for Medicare pay permanent, recurring late enrollment penalties and can only sign up during the first 3 months of the year for coverage that begins July 1, unless they qualify for an exception. To make matters worse, they cannot buy other health insurance during their months-long wait. [Continued here.]

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