Drugs, FDA

US FDA: the Margaret Hamburg years

lancet cover 2

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]

 

Global Health, NIH, The Lancet

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 ]

Affordable Care Act, Long term care, Medicare costs

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 Affairs, and PDF here]

Medicare Advantage

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 ]

Appeals

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 Advantage

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]

 

Affordable Care Act, The Lancet

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 ]

Appeals, Long term care, Medicare costs, Physical therapy

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]

Appeals, Long term care, Physical therapy

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]

CDC, Global Health, NIH, The Lancet

US federal health agencies questioned over Ebola response

image 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 ]

Long term care, Observation care

Hospitals Required To Tell Patients Of Observation Care Status

By Susan Jaffe   |   September 30, 2014
Connecticut Health Investigative Team and The Hartford Courant

Starting Wednesday, a new state law requires Connecticut hospitals to tell all patients when they are being kept in the hospital for observation instead of being admitted and to warn them about the financial consequences.

Anyone who goes to the hospital can be placed on observation status, so that doctors can determine what’s wrong, and decide whether the patient is sick enough to be admitted or well enough to go home. Observation patients may receive diagnostic tests, medications, some treatment, and other outpatient services. Depending on their insurance, they can be charged a share of the cost. In addition to hospital bills, Medicare observation patients whose doctors order follow-up nursing home care will have to pay the nursing home themselves. Medicare covers nursing homes only after seniors are admitted to the hospital and stay through three consecutive midnights. A month in a Connecticut nursing home can cost as much as $15,000.

Medicare does not require hospitals to tell patients when they are getting observation care and what it means. And the number of Medicare observation patients is growing rapidly — 88 percent in the past six years, to 1.8 million nationally in 2012, according to the Medicare Payment Advisory Commission, an independent government agency.

…Meanwhile, more states are trying to address the situation. Connecticut becomes at least the third state in the nation, after New York and Maryland to require notification for observation status. Massachusetts, New Jersey and Pennsylvania are considering similar laws. CONTINUED in Connecticut Health Investigative Team CONTINUED in The Courant

FDA, The Lancet

US President’s science panel advises on antibiotic resistance

image 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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Long term care, Observation care

You’re Being Observed In The Hospital? Patients With Private Insurance Better Off Than Seniors

By Susan Jaffe   KAISER HEALTH NEWS  | September 11, 2014 | This KHN story also ran in wapo

An increasing number of seniors who spend time in the hospital are surprised to learn that they were not “admitted” patients — even though they may have stayed overnight in a hospital bed and received treatment, diagnostic tests and drugs.

Because they were not considered sick enough to require admission but also were not healthy enough to go home, they were kept for observation care, a type of outpatient service. The distinction between inpatient status and outpatient status matters: Seniors must have three consecutive days as admitted patients to qualify for Medicare coverage for follow-up nursing home care, and no amount of observation time counts for that three-day tally. That leaves some observation patients with a tough choice: Pay the nursing home bill themselves — often tens of thousands of dollars – or go home without the care their doctor prescribed and recover as best they can.

But most observation patients with private health insurance don’t face such tough choices. Private insurance policies generally pay for nursing home coverage whether a patient had been admitted or not. Here’s a primer comparing how Medicare and private insurers handle observation care. [Continued in KHN] [Continued in Washington Post]

NIH, The Lancet

Congress stalls on BRAIN Initiative funding

lancet cover 2

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]

Medicare Advantage, Medicare costs, Observation care

Medicare Testing Payment Options That Could End Observation Care Penalties

By Susan Jaffe   KAISER HEALTH NEWS  | July 22, 2014 | This KHN story also ran in wapo

Medicare officials have allowed patients at dozens of hospitals participating in pilot projects across the country to be exempted from the controversial requirement that limits nursing home coverage to seniors admitted to a hospital for at least three days.

The idea behind these experiments is to find out whether new payment arrangements with the hospitals and other health care providers that drop the three-day rule can reduce costs or keep them the same while improving the quality of care. They are conducted under a provision of the Affordable Care Act that created the Center for Medicare and Medicaid Innovations to develop ways of improving Medicare.

If the experiment saves Medicare money and improves care, “we should be able to make an argument to Medicare that there is a way to do it for all our patients,” said Dr. Eric Weil, clinical affairs associate chief for the general internal medicine division at Massachusetts General Hospital in Boston. The hospital is one of five in the Partners Health System that began offering the waiver in April, after testing a limited version.

“It gets patients to the care they need much quicker and prevents them from clinically declining at home,” said Weil. If patients can spend less time in the hospital, he said that frees up valuable resources for sicker patients. And it saves money for Medicare because nursing home care or home health care is cheaper than a hospital stay. [Continued in KHN] [Continued in Washington Post]