Volume 386, Issue 9996, 29 August 2015
WORLD REPORT Bills providing extra funding for the National Institutes of Health while cutting other programmes could a face presidential veto. Susan Jaffe, The Lancet’s Washington correspondent, reports.
Category: Federal agencies
Clean Power Plan
Susan Jaffe | Washington Correspondent for The Lancet 25th August 2015
Before President Barack Obama’s Clean Power Plan can inspire other nations to control greenhouse gases by following the USA’s lead in dramatically reducing carbon emissions, the Administration has to convince West Virginia—and at least 15 other skeptical states. [Continued here]
…21st Century Cures
12 August 2015
A dispatch from our Washington correspondent on the sluggish progress of the 21st Century Cures Act.
Republicans and Democrats in the U.S. House of Representatives last month overwhelmingly passed the 21st Century Cures Act aimed at speeding up drug development. But the Senate is not expected to vote on its version until next year.
More than 80 percent of the House backed the legislation after it was unanimously — a word rarely heard on Capitol Hill — approved by the House Committee on Energy and Commerce. In the process, the bill was revised to address concerns that drug approvals would happen a little too quickly, circumventing safety and efficacy standards. [Continued here]
…Planning for US Precision Medicine Initiative underway
Volume 385, Issue 9986, 20 June 2015
WORLD REPORT Officials expect to launch the US President’s new health project later this year. But Congress has yet to decide whether to fully fund it. The Lancet’s Washington correspondent, Susan Jaffe, reports.
While continuing to defend his besieged health-care reform law against lawsuits and repeal threats, US President Barack Obama is championing a new health initiative. This one also has a bold goal: to radically change the medical treatment patients receive in the USA. “I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time”, the President said when he unveiled his Precision Medicine Initiative (PMI) in his annual State of the Union address to the nation in January. …Central to the PMI will be the creation of a research cohort of 1 million US volunteers who agree to provide researchers with biological, environmental, lifestyle, and other information as well as tissue samples….The effort to vastly expand the scope and practice of individually designed treatments based on genetic information could revolutionise medicine, supporters say. But the success of the PMI depends on whether Congress agrees to fund it. [Continued in full text or PDF ] …
21st Century Cures Act progresses through US Congress
Volume 385, Issue 9983, 30 May 2015
WORLD REPORT A bill to speed up the translation of biomedical discoveries is getting wide support, but some argue that it is not adequately funded. Susan Jaffe, The Lancet’s Washington correspondent, reports.
An ambitious bipartisan plan to accelerate medical innovation in the USA is moving ahead in a Congress famous for political gridlock.
The proposed 21st Century Cures Act was approved unanimously on May 21 by the US House of Representatives’ Committee on Energy and Commerce. The massive bill would promote discovery of new medicines and get them to patients more quickly. But the bill’s bipartisan support nearly collapsed when Democrats insisted on additional funds for the two federal agencies intricately involved in carrying out the bill’s far-reaching provisions.
Behind-the-scenes discussions finally yielded an infusion of US$10 billion over 5 years for the National Institutes of Health (NIH). Shortly before the committee vote, $550 million over 5 years was added for the Food and Drug Administration (FDA), which is responsible for ensuring new treatments are safe and effective. …But funding for both agencies did not come easy, is still uncertain, and might fall far short of what is needed. [Continued full text or PDF]…
Obama steps up US campaign on climate change
Volume 385, No. 9978 25 April 2015
WORLD REPORT In recent weeks, the Obama Administration has unveiled several new initiatives to tackle climate change. The Lancet’s Washington correspondent, Susan Jaffe reports.
Surgeon General Dr. Vivek Murthy and President Barack Obama
With less than half of his final term in the White House remaining, US President Barack Obama is no longer confining his efforts to slow climate change to Congress or the courts, where opponents are trying to block new, tougher environmental rules at every turn.
In the past 3 weeks, his Administration has announced a multifaceted public appeal, including plans to expand public access to tracking the impact of climate change with help from such private sector giants as Google and Microsoft, create a coalition of 30 medical, nursing, and public schools to train health-care providers to respond to the health effects of climate change, and host a climate change and health summit at the White House in the spring….
Last month, the Obama Administration submitted a US climate plan to the UN Framework Convention on Climate Change in preparation for December’s global conference in Paris. But the US pledge to reduce greenhouse gases depends in a large part on power plants reducing their carbon dioxide pollution; the US Environmental Protection Agency (EPA) is expected to finalise limits for power plants this summer. Even before they take effect, 14 states and two coal companies have taken the unusual step of challenging the agency’s still uncompleted rules in federal court.
The President is also making the fight personal, recalling, during an interview on national television, that when his eldest daughter was 4 years old, she had such a severe asthma attack that her parents had to take her to the hospital for emergency treatment. “The fright you feel is terrible”, he said.
Obama warned of increased asthma cases and “a whole host of public health impacts that are going to hit home”, speaking after meeting with the medical and nursing schools coalition. [Continued: full text or PDF ]…
US initiative for prediabetes
24 April 2015
IN FOCUS Health officials in the USA want physicians to help to reduce diabetes by asking at-risk patients to join diabetes prevention programmes. Susan Jaffe reports from Washington, DC.
“…Clinicians may be talking to patients about their elevated blood sugar, but if it isn’t diabetes, some do not take it very seriously”, Ann Albright, director of the CDC’s Division of Diabetes Translation, told The Lancet Diabetes & Endocrinology. “But the evidence is clear that the earlier you intervene, the greater the likelihood is of either preventing or delaying diabetes or, if someone already has diabetes, preventing or delaying the complications.” [Continued: PDF ]…
Republicans’ bills target science at US environment agency
Volume 385, Issue 9974, 28 March 2015
WORLD REPORT Proposed legislation would change how the US Environmental Protection Agency uses science to determine pollution limits. The Lancet‘s Washington correspondent Susan Jaffe reports.
Approval of two controversial environmental bills in the US House of Representatives last week was the latest assault in the Republicans’ “war on science”, according to Democrats. Republicans, however, considered it a big step towards assuring that federal environmental regulations are based on solid scientific research. Despite the sharp difference of opinion along political lines, both sides claim to pursue similar goals—to keep the agency responsible for protecting the nation’s health and environment impartial and closely guided by the best science.
…The Secret Science Reform Act of 2015 would prohibit the US Environmental Protection Agency (EPA) from proposing or finalising any policy “unless all scientific and technical information” officials relied on is “the best available science” and is “publicly available online in a manner that is sufficient for independent analysis and substantial reproduction of research results”.
“The days of ‘trust me’ science are over”, the bill’s lead sponsor, Texas Republican Lamar Smith, told The Lancet. “The American people deserve to see the data.” [Continued: full text or PDF ]…
Robert Califf: leading cardiologist is new FDA Deputy
Volume 385, Issue 9970
28 February 2015
As the new Deputy Commissioner for Medical Products and Tobacco at the US Food and Drug Administration (FDA), world-renowned cardiologist Robert Califf arrives at a time when the FDA’s overall responsibilities have grown exponentially. The Lancet‘s Washington correspondent, Susan Jaffe, reports. [article continued as full text or PDF] [Podcast with Dr. Califf here.]
US FDA: the Margaret Hamburg years
Volume 385, Issue 9970, 28 February 2015
WORLD REPORT US Food and Drug Administration commissioner Margaret Hamburg is stepping down after nearly 6 years in office. The Lancet‘s Washington correspondent, Susan Jaffe, reports on her achievements.
Margaret Hamburg
At the end of March, Margaret Hamburg is leaving what has got to be one of the toughest unelected US Government jobs outside of the Pentagon—commissioner of the US Food and Drug Administration (FDA).
A champion of science-based regulation and streamlined approvals for breakthrough drugs, the Harvard-trained physician is one of the two longest-serving FDA commissioners in five decades.
The FDA is responsible for the safety of 20% of the products Americans buy, including more than US$1 trillion dollars worth of goods that might seem to have little in common, such as artificial hips, dietary supplements, gene therapy, surgical lasers, prescription drugs for human beings and animals, nanotechnology products, cosmetics, blood and biologics products, tobacco, and—last but not least—most of the food we eat (excluding meat and poultry, which are the domain of the agriculture department). The agency has 16 000 employees. [article continued in full text or PDF]
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NIH budget shrinks despite Ebola emergency funds
Volume 385, Issue 9966, 31 January 2015
WORLD REPORT Even with a boost in funding for Ebola research, the US National Institutes of Health’s fiscal year 2015 budget is the lowest in years. Susan Jaffe, The Lancet’s Washington correspondent, reports.
During last year’s contentious congressional hearings investigating the US response to Ebola, the Obama Administration’s top health officials fended off criticism hurled by both Democrats and Republicans. But in another show of bipartisanship only a few weeks later, Congress granted nearly all of President Barack Obama’s request for emergency funding to combat the disease here and abroad.
NIH Director Francis Collins
In his State of the Union address earlier this month, the President expressed his appreciation: “In west Africa, our troops, our scientists, our doctors, our nurses, and health-care workers are rolling back Ebola—saving countless lives, and stopping the spread of disease”, he said, drawing applause from both sides of the aisle. “I couldn’t be prouder of them, and I thank this Congress for your bipartisan support of their efforts.”
Congress narrowly approved the US$5·4 billion emergency Ebola funding contained in the $1·1 trillion spending bill that kept the US Government running. But so far, it has done little to loosen the budget constraints on the National Institutes of Health (NIH)—even as a global health crisis such as Ebola reminded many lawmakers of its value. [MORE full text or PDF ] …
US federal health agencies questioned over Ebola response
Volume 384, Issue 9953, 25 October 2014
WORLD REPORT A congressional inquiry into the handling of Ebola in the USA has sparked new guidance to protect health-care workers. Susan Jaffe, The Lancet’s Washington correspondent, reports.
As US President Barack Obama ramped up the country’s response to the Ebola crisis domestically and abroad (panel), his top health officials attempted, during a tense congressional hearing last week, to address potential solutions to the epidemic ravaging west Africa, which has now reached the USA, confronting emergency medical providers at a well regarded hospital in Dallas, Texas.
But the Republican-controlled House of Representatives’ Committee on Energy and Commerce, which undertook the inquiry, did not seem particularly interested in discussing additional long-term investments in medical research—there is currently no cure for the disease—or the need to shore up, if not create, health-care infrastructure in the west African countries where more than 4500 people have died of the disease.
“To protect the USA, we have to stop it at the source”, said Tom Frieden, director of the US Centers for Disease Control and Prevention (CDC), at the hearing. “There is a lot of fear of Ebola, and…one of the things I fear about Ebola is that it could spread more widely in Africa. If this were to happen, it could become a threat to our health system and the health care we give for a long time to come.” [MORE full text or PDF ] …
US President’s science panel advises on antibiotic resistance
Volume 384, Issue 9948, 20 September 2014
WORLD REPORT The US President’s science council will soon publish its long-awaited report on antibiotic resistance. But will it affect the debate? Washington Correspondent Susan Jaffe reports.
Since its reformation 5 years ago, the President’s Council of Advisors on Science and Technology (PCAST) has grappled with some of the most difficult scientific controversies, including climate change and cybersecurity. In the next few weeks, the council will issue recommendations for controlling antibiotic resistance. “Antibiotic-resistant infections are associated with an additional 23 000 deaths in the USA each year”, Eric Lander, the report’s cochair, told The Lancet. The US Centers for Disease Control and Prevention (CDC) has estimated that the economic effect of antibiotic-resistant infections is at least US$50 billion annually in direct health-care costs and lost productivity. [MORE] [PDF]
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Congress stalls on BRAIN Initiative funding
16 August 2014
WORLD REPORT US Congress is yet to decide next year’s funds for the BRAIN Initiative. Meanwhile, researchers move ahead with initial grants and a scientific plan. Washington correspondent Susan Jaffe reports.
The US National Institutes of Health is expected to announce next month the recipients of the first US$40 million in research grants to be awarded under President Barack Obama’s ambitious brain research project he says will give scientists the tools to discover “how we think and how we learn and how we remember.”
Despite uncertain future funding, Obama’s Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is moving ahead. At the White House a year ago, the president compared it to the Apollo space mission that landed a man on the moon, GPS technology, and even the creation of the internet. “All these things grew out of government investments in basic research”, he said. [MORE]…
PCORI, NIH Announce Plans For $30 Million Study On Falls
By Susan Jaffe June 5,2014 KAISER HEALTH NEWS in collaboration with 
The nation’s largest and most intensive study of how to best prevent seniors’ injuries from falling will begin next year under a $30 million grant announced Wednesday by the Patient-Centered Outcomes Research Institute and the National Institutes of Health. A diverse group of 6,000 adults over age 75 or their caregivers will be recruited around the country to participate in the study.
More than 18,000 seniors died as the result of falls in 2010, and thousands more are injured every year, according to the federal Centers for Disease Control and Prevention.
“A serious fall that leads to a bone fracture or hospitalization has been demonstrated to be one of the most devastating events in the life of an older person, comparable to a serious stroke,” said Dr. Thomas Gill, a geriatrician and professor at Yale School of Medicine and one of the study’s three principal investigators. [More from KHN] [More from Washington Post]…
As HHS Moves To End Overload Of Medicare Claims Appeals, Beneficiaries Will Get Top Priority
By Susan Jaffe Jan. 21, 2014 KAISER HEALTH NEWS in collaboration with
Medicare beneficiaries who have been waiting months and even years for a hearing on their appeals for coverage may soon get a break as their cases take top priority in an effort to remedy a massive backlog.
Nancy Griswold, the chief judge of the Office of Medicare Hearings and Appeals (OMHA), announced in a memo sent last month to more than 900 appellants and health care associations that her office has a backlog of nearly 357,000 claims. In response, she said the agency has suspended acting on new requests for hearings filed by hospitals, doctors, nursing homes and other health care providers, which make up nearly 90 percent of the cases. But beneficiaries’ appeals will continue to be processed.
“We have elderly or disabled Medicare clients waiting as long as two years for a hearing and nine months for a decision,” said Judith Stein, executive director of the Center for Medicare Advocacy. [More from KHN] [More from Washington Post]…
Fighting ‘Observation’ Status
By Susan Jaffe | January 10, 2014, 2:41 pm 
Every year, thousands of Medicare patients who spend time in the hospital for observation but are not officially admitted find they are not eligible for nursing home coverage after discharge. 
…Medicare officials have urged hospital patients to find out if they’ve been admitted. But suppose the answer is no. Then what do you do?
Medicare doesn’t require hospitals to tell patients if they are merely being observed, which is supposed to last no more than 48 hours to help the doctor decide if someone is sick enough to be admitted. (Starting on Jan. 19, however, New York State will require hospitals to provide oral and written notification to patients within 24 hours of putting them on observation status. Penalties range as much as $5,000 per violation.) [Continued in The New York Times.]…
UnitedHealthcare Dropping Hundreds Of Doctors From Medicare Advantage Plans
By Susan Jaffe | November 29, 2013 | Kaiser Health News produced in collaboration with 
Dorathy Senay’s doctor had some bad news after her last checkup, but it wasn’t about her serious blood disorder called amyloidosis. Her Medicare Advantage managed care plan from UnitedHealthcare/AARP is terminating the doctor’s contract Feb. 1. She is also losing her oncologist at the prestigious Yale Medical Group — the entire 1,200 physician practice was axed. Senay, 71, of Canterbury, Conn., is among thousands of UnitedHealthcare Medicare members in 10 states whose doctors will be cut from their plan network.
The company is the largest Medicare Advantage insurer in the country, with nearly 3 million members. More than 14 million older or disabled Americans are enrolled in Medicare Advantage plans, an alternative to traditional Medicare that offers medical and usually drug coverage but members have to use the plan’s network of providers.
“I have a rare incurable disease and these doctors have saved my life,” said Senay. “I am in good hands and I will not change doctors.”
…Medicare officials review the private plans every year to make sure they comply with network adequacy and other requirements, but the agency did not approve the reconfigured networks resulting from the new provider cancelations. Spokesman Raymond Thorn said the agency “is currently reviewing UHC and other plans’ provider networks and closely monitoring all areas that have experienced disruptions to ensure that beneficiaries have full, transparent and timely information and access to needed care.” [More from KHN] [More in USA Today]…
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Volume 381, Issue 9882, Pages 1975 – 1976, 8 June 2013
WORLD REPORT Health and science agencies in the USA have been operating on reduced budgets, enforced by sequestration, for just over 3 months Susan Jaffe reports from Washington, DC.
The automatic budget cuts known as sequestration that the US Congress approved in 2011 were intended to be so onerous that they would never happen. Lawmakers would surely find a more reasonable way to save at least US$1·2 trillion over the next decade before the cuts would begin in 2013. Instead, Republicans and Democrats could not agree on an alternative, and the first wave of cuts, totalling $85 billion through to September, 2013, are phasing in for most non-defence US Government operations. Everything from White House tours to the most promising cancer research have been limited by a lack of funding.
..Many services provided by the US Department of Health and Human Services (HHS) are affected, including programmes at the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), and medical research funded by the National Institutes of Health (NIH). Even the Affordable Care Act (ACA)—President Barack Obama’s landmark health reform law—will feel the impact, with supporters worried that enrolment for next year’s new health insurance coverage will have a difficult start in October. [FULL STORY AS PDF]
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By December 17, 2012 | Kaiser Health News in collaboration with 
Dan Driscoll used to be a smoker. During a regular doctor’s visit, his primary-care physician suggested that Driscoll be tested to see if he was at risk for an abdominal aortic aneurysm, a life-threatening condition that can be linked to 
smoking. The doctor said Medicare would cover the procedure. So Driscoll, 68, who lives in Silver Spring, had the test done and was surprised when he got a bill from Medicare for $214.
“I didn’t accept that,” he said, because based on everything he had read from Medicare, he was sure this was a covered service. So Driscoll did something that seniors rarely do: He filed an appeal. Of the 1.1 billion claims submitted to Medicare in 2010 for hospitalizations, nursing home care, doctor’s visits, tests and physical therapy, 117 million were denied. Of those, only 2 percent were appealed.
“People lose, and then they lose heart, or they are too sick, too tired or too old, and they give up,” said Margaret Murphy, associate director of the Center for Medicare Advocacy, which has offices in Washington and Connecticut. “Or their kids are handling the appeal and they are too overwhelmed caring for Mom or Dad.” [Continued at Kaiser Health News and The Washington Post.]
How To File A Medicare Appeal Here are some basic steps for challenging Medicare coverage denials…. [Continued at Kaiser Health News.]
Seniors Need To Be Tenacious In Appeals To Medicare
By December 17, 2012 | Kaiser Health News in collaboration with
Dan Driscoll used to be a smoker. During a regular doctor’s visit, his primary-care physician suggested that Driscoll be tested to see if he was at risk for an abdominal aortic aneurysm, a life-threatening condition that can be linked to smoking. The doctor said Medicare would cover the procedure. So Driscoll, 68, who lives in Silver Spring, had the test done and was surprised when he got a bill from Medicare for $214.
“I didn’t accept that,” he said, because based on everything he had read from Medicare, he was sure this was a covered service. So Driscoll did something that seniors rarely do: He filed an appeal. Of the 1.1 billion claims submitted to Medicare in 2010 for hospitalizations, nursing home care, doctor’s visits, tests and physical therapy, 117 million were denied. Of those, only 2 percent were appealed.
“People lose, and then they lose heart, or they are too sick, too tired or too old, and they give up,” said Margaret Murphy, associate director of the Center for Medicare Advocacy, which has offices in Washington and Connecticut. “Or their kids are handling the appeal and they are too overwhelmed caring for Mom or Dad.” [Continued at Kaiser Health News and The Washington Post.]
How To File A Medicare Appeal Here are some basic steps for challenging Medicare coverage denials…. [Continued at Kaiser Health News.]
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A new law passed in July to strengthen the work of the US Food and Drug Administration may hit some serious barriers to implementation. Susan Jaffe reports from Washington, DC.
WORLD REPORT Volume 380, Issue 9852, Pages 1458 – 1459, 27 October 2012
The massive drug and medical device safety bill that won extraordinary near-unanimous support in the US Congress—despite a budget crisis and a contentious political campaign—is facing major challenges less than 3 months after President Barack Obama signed it into law in July. And in the process, prospects may be fading for additional reforms. [MORE]
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Volume 380, Issue 9848, Pages 1133 – 1134, 29 September 2012
WORLD REPORT Comprehensive domestic health-care reform is one of the top defining issues in the campaign, overshadowing global health. Susan Jaffe reports from Washington, DC.
President Barack Obama and his rival Republican Mitt Romney would agree that the American health-care system is unsustainable, providing some of the world’s most expensive and yet fragmented care. But as they campaign for the presidency, the two candidates offer profoundly different solutions.
“The Affordable Care Act helps make sure you don’t have to worry about going broke just because one of your loved ones gets sick”, said Obama, describing his signature legislative achievement at a recent campaign stop in Colorado. “I don’t think a working mom in Denver should have to wait to get a mammogram just because money is tight”, he continued. “That’s why we passed this law. It was the right thing to do.” [more, as PDF]
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Volume 379, Issue 9828
The US Food and Drug Administration is calling for greater reliance on global partners to improve the safety of America’s foreign imports. Susan Jaffe reports from Washington, DC.
In its latest effort to promote a global strategy for protecting Americans against unsafe imported pharmaceutical, food, and medical products, the US Food and Drug Administration (FDA) has called for unprecedented international cooperation to cope with seemingly overwhelming challenges. FULL STORY
Medicare Combats Fraud With Billing Statements That Beneficiaries Can Understand
Susan Jaffe | March 7, 2012 | KAISER HEALTH NEWS produced in collaboration with 
In the latest effort to enlist seniors in the fight against Medicare fraud, federal officials have overhauled Medicare billing statements to make it easier to find bogus charges without a magnifying glass. ….And for those who might need an incentive to scour their bills, the new statements promise a reward of up to $1,000 for a tip that leads to uncovering fraud.[Continued here.]…