21st Century Cures Act progresses through US Congress

image 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]

Officials Weigh Options To Hold Down Medicare Costs For Hospice

By Susan Jaffe  | April 23, 2015 |  Kaiser Health News and also published in

Medicare officials are considering changes in the hospice benefit to stop the federal government from paying twice for care given to dying patients. But patient advocates and hospice providers fear a new policy could make the often difficult decision to move into hospice care even tougher.hospicecare
Patients are eligible for hospice care when doctors determine they have no more than six months to live. They agree to forgo curative treatment for their terminal illness and instead receive palliative or comfort care. However, they are also still allowed Medicare coverage for health problems not related to their terminal illness, including chronic health conditions or for accidental injuries.
Medicare pays a set amount to the hospice provider for all treatment and services related to the terminal illness, including doctor’s visits, nursing home stays, hospitalization, medical equipment and drugs. If a patient needs treatment that hospice doesn’t provide because it is not related to the terminal illness — or the patient seeks care outside of hospice — Medicare pays the non-hospice providers. The problem is that sometimes Medicare pays for care outside the hospice benefit that it already paid hospice to cover.
To reduce the chances of these duplicative payments, Medicare officials have announced that they are examining whether to assume “virtually all” the care hospice patients receive should be covered under the hospice benefit….
Seniors’ advocates are worried that putting all coverage under the hospice benefit will create obstacles for patients. Instead, Medicare should go after hospice providers who are shifting costs to other providers that Medicare expects hospice to cover, said Terry Berthelot, a senior attorney at the Center for Medicare Advocacy, who urged the government to protect hospice patients’ access to non-hospice care….”If your blood sugar gets out of control, that could hasten your death,” she said. “But people shouldn’t be rushed off to die because they’ve elected the hospice benefit.”  [More from KHN] [More in USA Today]

Obama steps up US campaign on climate change

lancet cover 2Volume 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.

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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

 

The Lancet Diabetes logo24 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

lancet cover 2Volume 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

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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

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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]

 

NIH budget shrinks despite Ebola emergency funds

image 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.

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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 ]

Aging In Rural America

For older Americans, accessing high-quality care can be a challenge. For those in rural communities, it’s even harder.

By SUSAN JAFFE  Health Affairs January 2015 Volume 34, Number 1

Care in rural America: Dr. Robert Wergin goes over medications with Sharon Stutzman at the Milford Family Medical Center in rural Nebraska.

In the southeastern Nebraska town of Milford, population 2,100, Dr. Robert Wergin understands it’s not easy for some of his older patients to get to his office. Some may live on isolated farmsteads several miles out of town, and if they don’t drive, their son or daughter—if nearby—may have to take time off from work to bring them to their appointments because there’s no public transportation. Massive snowstorms are nothing special but still cause a wave of cancellations.

 

In addition to these challenges, rural America’s elderly tend to be poorer, have higher levels of chronic disease, and have a dwindling supply of health care providers, compared to their peers in urban communities, explains Brad Gibbens, deputy director of the University of North Dakota’s Center for Rural Health, in Grand Forks. And their support system is shrinking, as more young adults seeking job opportunities head out to urban areas. “The elderly [rural] population tends to stay put because that’s where they’ve lived all their lives, and there isn’t really an economic beacon that’s pulling them to another area,” he says. [Continued in Health Affairsand PDF here]

Medicare May Help Seniors If Advantage Plans Drop Doctors

By Susan Jaffe | December 23, 2014 Connecticut Health Investigative Team and The Hartford Courant

Next year, seniors with private Medicare Advantage insurance policies whose doctors leave their plan may be able to leave, too, under a new Medicare rule.

The Centers for Medicare & Medicaid Services (CMS), which oversee Medicare Advantage programs, will create a special three-month enrollment period in any state where insurers make network changes “considered significant based on the affect or potential to affect, current plan enrollees,” according to an update to Medicare’s Managed Care Manual.

The special enrollment period – if granted by CMS – would allow Medicare Advantage members to switch out of their plans and join traditional Medicare or another Medicare Advantage plan whose provider network includes their doctors.

…U.S. Sen. Richard Blumenthal criticized the new rule because it’s not clear what “significant” network changes would trigger a special enrollment period. Instead, he spearheaded a letter sent last Friday to Medicare chief Marilyn Tavenner, asking her to prohibit mid-year provider network changes. The letter was also signed by U.S. Sens. Sherrod Brown of Ohio and Rand Paul of Kentucky, along with U.S. Reps. Rosa DeLauro, Joe Courtney, Jim Himes, Elizabeth Esty and 13 other members of Congress.
“This blatant bait and switch should not be allowed,” they wrote. [CONTINUED in Connecticut Health Investigative Team and in The Courant ]

Seniors’ Wait For A Medicare Appeal Is Cut In Half

By Susan Jaffe   KAISER HEALTH NEWS  | December 23, 2014

This KHN story also ran in wapo

The federal office responsible for appeals for Medicare coverage has cut in half the waiting time for beneficiaries who are requesting a hearing before a judge.

The progress follows an announcement last January that officials were going to work through a crushing backlog by moving beneficiaries to the front of the line and suspending hearings on cases from hospitals, doctors and other providers for at least two years.

…Still, about 900,000 appeals are awaiting decisions, with most filed by hospitals, nursing homes, medical device suppliers and other health care providers, said Jason Green, OMHA’s program and policy director. The wait times for health providers’ cases have doubled since last year, and are nearly four times longer than the processing time for beneficiary appeals. [Continued in KHN] [Continued in Washington Post]

Medicare To Offer Help To Some Seniors When Advantage Plans Drop Doctors

By Susan Jaffe  | December 22, 2014 |  Kaiser Health News and also published in

Starting next year, the government will offer some seniors enrolled in private Medicare Advantage insurance an opportunity to leave those plans if they lose their doctors or other health care providers.

Last year, thousands of seniors in at least 10 states were left stranded or assigned new doctors when insurers discontinued contracts with the physicians. Medicare Advantage policies cover 16 million seniors and are an alternative to the government-run Medicare program. Medicare Advantage members can only get care from a network of providers under contract to participate in their plan. They must remain in their plans for the calendar year, with some rare exceptions, but losing their doctor has not been among the permitted reasons. [More from KHN] [More in USA Today]

 

Second round of enrolment begins under Affordable Care Act

image Volume 384, Issue 9956, 15 November 2014 

WORLD REPORT Ahead of the next phase of enrolment for insurance plans, Republicans vowed to target the health law following their election win. Susan Jaffe, Washington correspondent, reports.

Federal health officials promise that last year’s embarrassing enrolment problems will not be repeated when the sign-up season begins on Nov 15 for 2015 health insurance policies offered under the Affordable Care Act (ACA). But even as more insurance companies and millions more Americans enter the second year of the health insurance programme, the opportunity for critics to chip away at it will never be better when Republicans regain control of Congress in January.

…Under the law, all adults are required to have health insurance and, with some exceptions, those without it are penalised. People who don’t get health coverage through their jobs can buy policies through the online state or federal insurance exchanges from Nov 15 to Feb 15. To minimise the delays many experienced last year, federal officials who run the exchanges in 37 states have shortened the application and no longer require shoppers to spend time setting up accounts before they can review the plans.

Although this month marks the second enrolment period, US Department of Health and Human Services (HHS) Secretary Sylvia Matthews Burwell has been eager to stress that it won’t be a rerun of last year. “It’s not year two”, she told reporters recently, because this is the first time the exchanges will be renewing current policies while also handling first-time applications. [MORE full text or PDF ]

Disabled Vt. Senior Wins Medicare Coverage After 2nd Lawsuit

By Susan Jaffe | Kaiser Health News in collaboration with National Public Radio | October 30, 2014

A disabled senior with serious health problems who successfully challenged Medicare for denying her home health care coverage has racked up another win against the government.

In her latest federal lawsuit filed in June, Glenda Jimmo, 78, argued Medicare should have paid for the nursing care and other skilled services she received at her home during 2007. On Wednesday, Medicare officials agreed, invalidating an April ruling that she was not entitled to coverage because her condition had stabilized and she was not improving. “I won,” said Jimmo, who is receiving rehab therapy at a Vermont nursing home and hopes to return home soon. “I’m very pleased. It makes me feel America is still in good shape.”

The settlement doesn’t mention that Jimmo was the lead plaintiff in a 2011 class-action lawsuit seeking to eliminate the so-called “improvement standard” as a criteria for Medicare coverage. In the 2012 settlement that bears her name, the government agreed that improvement was not required and allowed many Medicare beneficiaries with chronic conditions and disabilities to appeal claims that had been denied because they were unlikely to get better. [MORE from Kaiser Health News and NPR]

Disabled Vt. Senior Who Led Class Action Suit Sues Medicare — Again

By Susan Jaffe | Kaiser Health News in collaboration with National Public Radio | October 27, 2014

A 78-year-old Vermont mother of four who helped change Medicare coverage for millions of other seniors is still fighting to persuade the government to pay for her own care.

Glenda Jimmo, who is legally blind and has a partially amputated leg due to complications from diabetes, was the lead plaintiff in a 2011 class-action lawsuit seeking to broaden Medicare’s criteria for covering physical therapy and other care delivered by skilled professionals. In 2012, the government agreed to settle the case, saying that people cannot be denied coverage solely because they have reached a plateau and are not getting better.

The landmark settlement was a victory for Medicare beneficiaries with chronic conditions and disabilities who had been frequently denied coverage under what is known as “the improvement standard” —a judgment about whether they are likely to improve if they get additional treatment. It also gave seniors a second chance to appeal for coverage if their claims had been denied because they were not improving.

Jimmo was one of the first seniors to appeal her original claim for home health care under the settlement that bears her name. But in April, the Medicare Appeals Council, the highest appeals level, upheld the denial. The judges said they agreed with the original ruling that her condition was not improving — criteria the settlement was supposed to eliminate.

After running out of options appealing to Medicare, her lawyers filed a second federal lawsuit in June to compel the government to keep its promise not to use the improvement standard as a criterion for coverage.The council’s decision makes no sense to Judith Stein, executive director of the Center for Medicare Advocacy, which filed the original class action lawsuit with Vermont Legal Aid and helped negotiate the Jimmo settlement. “People shouldn’t have to decline in order to get the care they need,” Stein said. [MORE from Kaiser Health News and NPR]