Category: Federal agencies

Feds To Waive Penalties For Some Who Signed Up Late For Medicare

By Susan Jaffe  | Kaiser Health News | June 6, 2017 | This KHN story also ran on     

[UPDATE: Since this article was published, Medicare officials extended the deadline for applying for an exemption to the Part B late enrollment penalty to Sept. 30, 2018. The announcement came in a fact sheet posted on Oct. 12, 2017.]

Each year, thousands of Americans miss their deadline to enroll in Medicare, and federal officials and consumer advocates worry that many of them mistakenly think they don’t need to sign up because they have purchased insurance on the health law’s marketplaces. That decision can leave them facing a lifetime of enrollment penalties.

Now Medicare has temporarily changed its rules to offer a reprieve from penalties for people who kept Affordable Care Act policies after becoming eligible for Medicare.

“Many of these individuals did not receive the information necessary [when they became eligible for Medicare or when they initially enrolled] in coverage through the marketplace to make an informed decision regarding” Medicare enrollment, said a Medicare spokesman, explaining the policy change.

Those who qualify include people 65 and older who have a marketplace plan or had one they lost or canceled, as well as people who have qualified for Medicare due to a disability but chose to use marketplace plans. They have until Sept. 30 to request a waiver of the usual penalty Medicare assesses when people delay signing up for Medicare’s Part B, which covers visits to the doctor and other outpatient care…

“This has been a problem from the beginning of the Affordable Care Act, because the government didn’t understand that people would not know when they needed to sign up for Medicare,” said Bonnie Burns, a consultant for California Health Advocates, a consumer group. “Once they had insurance, that relieved all the stress of not having coverage and then when they became eligible for Medicare, nobody told them to make that change.”[Continued at Kaiser Health News and NPR]…

Scott Gottlieb sworn in to head the FDA

lancet cover 2Volume 389, Number  10084 

27 May 2017 

WORLD REPORT    Scott Gottlieb becomes commissioner of the FDA, as the agency’s role is threatened by an administration adverse to regulation.  Susan Jaffe, The Lancet’s Washington correspondent, reports.

Only 6 months ago, Scott Gottlieb was still a resident fellow at the American Enterprise Institute, a conservative thinktank, when he presented testimony to a US Senate committee investigating prescription drug prices. Before he began, he volunteered that he was “a reformed government bureaucrat, having worked at FDA [US Food and Drug Administration] for a number of years”. He blamed astonishing price hikes—500% in the case of Mylan’s EpiPen—on “regulatory failures stemming from FDA policy, and I think that policy can be fixed”.

Gottlieb was sworn in as the 23rd commissioner of the FDA after being approved earlier this month by the US Senate, over the strong objections of most Democrats. Now Gottlieb will have a chance to fix a daunting array of policies. [Continued here] …

Marching for science as budget cuts threaten US research

lancet cover 2Volume 389, Number  10080 

29 April 2017 

WORLD REPORT   Americans push back against President Trump’s proposed budget cuts… Susan Jaffe, The Lancet’s Washington correspondent, reports. 

President Donald Trump is famous for his early morning Tweets and off-the-cuff remarks that can sometimes be puzzling. But what he thinks about biomedical research and basic science is quite clear in his first proposed budget for running the federal government.

March for Science, Washington, D.C. / Susan Jaffe

Trump’s America First: A Budget Blueprint to Make America Great Again outlines a $1·1 trillion spending plan that would take effect when the new fiscal year begins in October. The president wants to move $54 billion from domestic agencies to fortify the US military. To help pay for the transfer, he is proposing funding cuts for the US Environmental Protection Agency (EPA; 31%) and the National Institutes of Health (NIH; 18%) [and other domestic agencies]….

To squeeze $5·8 billion out of the agency’s $30·3 billion budget, the Trump administration would reorganise NIH’s 27 institutes and centres and “rebalance federal contributions to research funding” according to the budget blueprint. …Health and Human Services Secretary Tom Price told a congressional committee last month that the NIH could operate on a tighter budget by cutting the roughly 30% of grant money that pays for indirect research costs. These expenses can include rent, utilities, administrative staff, and equipment. “That money goes for something other than the research that’s being done”, Price said.

Price’s suggestion was especially disturbing coming from the person who is responsible for overseeing the NIH, said Harold Varmus, who directed the NIH in the 1990s and headed the National Cancer Institute at NIH for 5 years until 2015. “You can’t do research in the dark”, he said. “You can’t do research—at least my kind of research—without a building and without electricity and water and administrative expenses”. [Continued  here]

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US health and science advocates gear up for battle over EPA

lancet cover 2Volume 389, Number  10075 

25  March 2017 

WORLD REPORT    The Trump administration’s proposed budget makes large cuts to the US Environmental Protection Agency.  Susan Jaffe, The Lancet’s Washington correspondent, reports. 

As Oklahoma Attorney General, Scott Pruitt represented his state in more than a dozen lawsuits challenging the US Environmental Protection Agency’s (EPA) efforts to limit air and water pollution. Several cases sought to block President Barack Obama’s Clean Power Plan aimed at reducing the greenhouse gas emissions from coal plants linked to climate change.

…Less than a year later, Pruitt and his opponents have switched sides. President Donald Trump appointed Pruitt to lead the EPA and now those opponents accuse the Trump administration of federal overreach by seeking to undermine key environmental laws.

The administration has already taken steps to begin rolling back some environmental rules issued by the EPA under President Barack Obama (panel). And last week, Trump unveiled his proposed federal budget, which reduces federal non-defence spending by US$54 billion, including a 31% ($2·6 billion) cut in EPA funding—more than any other domestic agency.  [Continued here] …

Experts confident of congressional funding for US Cures Act

lancet cover 2
Volume 389,  Number 10065
14  January 2017

How future funding for the landmark 21st Century Cures Act and repeal of the Affordable Care Act may affect its success.  [Interviews with lead sponsors Representatives Fred Upton, Diana DeGette, NIH Director Francis Collins, and patient advocates.  Full article here] …

COBRA, Retiree Plans, VA Benefits Don’t Alleviate Need To Sign Up For Medicare

By Susan Jaffe  | Kaiser Health News | December 14, 2016 | This KHN story also ran on     

When Cindy Hunter received her Medicare card in the mail last spring, she said she “didn’t know a lot about Medicare.” She and her husband, retired teachers who live in a Philadelphia suburb, decided she didn’t need it because she shared his retiree health insurance, which covered her treatment for ovarian cancer.

Cindy Hunter, who is battling ovarian cancer, says she mistakenly thought she didn’t need to enroll in Medicare because her husband’s retiree insurance would cover her. (Steph Brecht/Courtesy of Cindy Hunter)

“We were so thankful we had good insurance,” she said. So she sent back the card, telling officials she would keep Medicare Part A, which is free for most older or disabled Americans and covers hospitalization, some nursing home stays and home health care. But she turned down Part B, which covers doctor visits and other outpatient care and comes with a monthly premium charge. A new Medicare card arrived that says she only has Part A.

Her story isn’t unique.

When Stan Withers left a job at a medical device company to become vice president of a small start-up near Sacramento, Calif., he took his health insurance with him. Under a federal law known as COBRA, he paid the full cost to continue his coverage from his previous employer. A few years earlier, when he turned 65, he signed up for

This KHN article also ran in The Philadelphia Inquirer.

Medicare’s Part A. With the addition of a COBRA plan, he thought he didn’t need Medicare Part B.

Hunter and Withers now know they were wrong and are stuck with medical bills their insurance won’t cover. …Advocates for seniors and some members of Congress want to fix the problem, backed by a broad, unlikely group of unions, health insurers, patient organizations, health care providers and even eight former Medicare administrators.  [Continued on Kaiser Health News or NPR or The Philadelphia Inquirer]…

Biomedical research bill becomes law, but critics raise concerns over long-term implementation

Susan Jaffe | Washington Correspondent for The Lancet | 14 December 2016

The 21st Century Cures Act that President Barack Obama signed into law this week dedicates – but doesnthe-lancet-usa-blog-logo1‘t guarantee – billions of dollars to accelerating the discovery of new drugs and medical devices and getting them to patents more quickly, as well as supporting opioid addiction treatment and reforms in mental health care.

President Barack Obama signs the 21st Century Cures Act, Tuesday, Dec. 13, 2016. (Photo by Susan Jaffe)

The overwhelming support for the law marks a stark contrast from the Affordable Care Act, another landmark health reform bill Obama signed in the second year of his presidency.  Republicans promise to repeal it as soon as the new Congress convenes next month and Donald Trump is sworn in as president. But before the promised elimination of the ACA, Congress took nearly $5 billion from its Prevention and Public Health Fund to pay for most of the law.[Continued here.]

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US global health leadership hangs on election result

lancet cover 2Volume 388, Number  10055 

22  October 2016 

WORLD REPORT   On most issues, the US presidential candidates have polar opposite views; engagement in global health is no different.  Susan Jaffe, The Lancet’s Washington correspondent, reports.

Americans will choose their next president in less than 3 weeks and yet some global health experts still wonder what would happen to the international health programmes that the USA has championed in recent decades if the Republican contender, Donald Trump, is elected. The uncertainty comes despite the Ebola virus and Zika virus threats that made global health front-page news.  [Continued here] …

EpiPen’s price-gouging response “sickens” Congressional panel

Susan Jaffe | Washington Correspondent for The Lancet | 28th September 2016

The latest drug company chief to appear before Congress did not dodge questions by taking refuge in the Fifth Amendment’s protection against self-incrimination, as did Martin Shkreli, the former CEO of Turing Pharmaceuticalthe-lancet-usa-blog-logo1s.  But after a nearly four-hour congressional hearing last week investigating spikes in Mylan’s EpiPen prices, Maryland Democrat Elijah Cummings told Mylan CEO Heather Bresch, “You might as well have taken the Fifth, too, with the kind of information that we’ve gotten here today.” [Continued here]  
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US presidential candidates’ proposals to reduce drug prices

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Volume 388,  Number 10047
27 August 2016
 WORLD REPORT   US presidential candidates’ proposals to reduce drug prices Clinton and Trump seem to agree on at least some ways to bring down the cost of prescription drugs, but Clinton offers more details.   Susan Jaffe, The Lancet’s Washington correspondent, reports. [Continued here] 
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US presidential candidates urged to support health research

lancet cover 2Volume 387, Number  10037 
18 June  2016 

WORLD REPORT   Advocates for medical research are eager to hear how the presidential candidates would advance the search for new treatments.  Susan Jaffe, The Lancet’s Washington correspondent, reports.

As the most tumultuous presidential primary season in recent times comes to an end, biomedical researchers, physicians, and advocacy groups want the candidates campaigning for the White House to address some of the substantive matters they worry about: National Institutes of Health (NIH) funding, advancing Alzheimer’s disease research, speeding up drug development, and a host of research related issues.

… In New Hampshire last year, the campaigns provided a preview of the kind of discussion between candidates and voters that research and patients’ advocacy groups would like. It revealed a stark difference between Clinton and Trump on funding for Alzheimer’s research and support for those caring for the 5·4 million Americans stricken with the disease. [Continued here]

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Biden Pleads for Open Data for Cancer Moonshot

Susan Jaffe | Washington Correspondent for The Lancet | 10th May 2016

Three months after Vice President Joe Biden convened the first meeting of the Cancer Moonshot Task Force—aimed at accelerating the-lancet-usa-blog-logo1cancer prevention, treatment and cures—he pleaded for help from people who know how to marshal massive amounts of health data to create successful businesses, or apps that can guide consumers to the best hospitals. [continued here]…

US responds to increase in Zika cases

 lancet cover 2Volume 387, Number  10030
30 April  2016 
WORLD REPORT    Health officials pursue Zika research and prepare to combat a formidable foe—the mosquito— despite uncertain funding.   Susan Jaffe, The Lancet’s Washington correspondent, reports.

Anthony Fauci

As the number of confirmed cases of people who have contracted the Zika virus increases across the globe, the growing knowledge  about this once rare infection is not reassuring. “The more we learn, the more we get concerned”, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases…. 

Representative Tom Cole, the Oklahoma Republican who is chairman of the House appropriations health subcommittee, said its questions about [President Barack Obama’s $1.9 billion Zika emergency funding] request are not unreasonable….“Let us do our job to make sure we do this as prudently as possible and we will get there”, he said. “Nobody thinks this is not a serious challenge”….

While clinical research and the funding debate continues, protection from the Zika virus will depend largely on avoiding the mosquitoes that carry it….

After years of cuts in federal and local funding for mosquito control, Zika is “a pretty major wake up call to rebuild those capacities”, said Lyle Petersen, director of CDC’s division of vector-borne infectious diseases. The virus is the latest “major pathogen that has come into the Americas” in recent years—after chikungunya, dengue fever, and West Nile virus—“and it won’t be the last.” [continued here]  [listen to podcast here] …

Paris Climate Change agreement to be signed in New York

Susan Jaffe | Washington Correspondent for The Lancet | 19th April  2016

Secretary of State John Kerry will join world leaders at the United Nations headquarters in New York on April 22 to sign the landmark Paris Climate Change agreement, aimed at controlling greenhouse gasThe Lancet USA blog logoes and preventing what many scientists believe would be the harmful effects of global warming.

Representatives of some 155 countries  are expected at the signing ceremony, including President François Hollande of France, Canadian Prime Minister Justin Trudeau and other heads of state. …UN Secretary-General Ban Ki-moon has urged all countries to ratify the agreement as soon as possible.  “It is in their national interest to implement the agreement and reap the benefits of sustainable global climate action,” he said in an email to The Lancet.

…When 55 countries responsible for at least 55 percent of global emissions do so, the agreement takes effect.  That could happen this year said UN spokeswoman Devi Palanivelu, noting that several countries are coming to New York with ratification documents they will submit after signing the agreement.  But things are not moving as swiftly in the U.S.  [Continued here]  …

Zika response threatened by funding shortage

Susan Jaffe | Washington Correspondent for The Lancet | 14 March 2016The Lancet USA blog logo

Congress hasn’t budged in the five weeks since President Barack Obama asked Congress for more than $1.8 billion in emergency funding to deal with the Zika virus. But Zika isn’t waiting.

In the weeks since the president’s request, the number of cases of the mosquito-borne virus among people who traveled to countries where transmission has been confirmed has almost quadrupled to 193, as of March 9. It is in nearly twice as many states — 32 and the District of Columbia — with Florida, New York and Texas topping the list. In Puerto Rico, the U. S. Virgin Islands, and American Samoa, the number of cases is 174, or 19 times higher, reports the US Centers for Disease Control and Prevention.  [continued here]  …

NIH hopes funding increases will continue

 lancet cover 2Volume 387, Number  10019
13 February 2016
WORLD REPORT   The US National Institutes of Health welcomed a record budget boost that might be the start of more sustained support. The Lancet’s Washington correspondent, Susan Jaffe, reports.

The US Congress recently approved the largest single increase in funding for the National Institutes of Health (NIH) in 12 years—a US$2 billion raise that was twice as much as President Barack Obama requested. But almost as soon as NIH supporters stopped cheering, they began to worry about next year’s budget, and the challenge of a new public health threat, Zika virus.

NIH Director Francis Collins told The Lancet that the funding boost “was enormously gratifying”. But if it is “a one-hit wonder”, he said “it won’t be sufficient to take full advantage of the remarkable scientific opportunities and talent that is out there”.   [Continued here] [podcast here]

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Congress Wrangles Over Funding for Zika Research

Susan Jaffe | Washington Correspondent for The Lancet | 12th February 2016

President Barack Obama asked Congress this week for more than $1.8 billion in emergency funding The Lancet USA blog logoto respond to Zika virus and administration officials wasted no time in explaining why at four congressional hearings less than two days later.

While such Capitol Hill visits are part of the budget process, the looming virus adds a new urgency to the proceedings–though not necessarily enough to deter controversy. [Continued here]…

Shkreli pleads the Fifth on drug price hikes

Susan Jaffe | Washington Correspondent for The Lancet | 10th February 2016

Like many Americans, members of Congress are frustrated and angry about the huge spikes in prescription drug prices. While a congressional hearing held last week to investigate the practice united Democrats and Republicans in outrage, it did not reveal potential solutions.

     The unwilling star witness was Martin Shkreli, the former head of Turing Pharmaceuticals who was responsible for the company’s decision to raise the price of Daraprim, used to treat toxoplasmosis, a parasitic infection that affects HIV patients, from $13.50 to $750 a pill. [Continued here]  …

Budget boon for biomedical research

Susan Jaffe | Washington Correspondent for The Lancet | 31st December 2015

budget 123115The US Congress has become famous for political gridlock  but sThe Lancet USA blog logohortly before going home for the holidays, members approved a 2,009-page budget for fiscal year 2016 with generous increases for some key health and science agencies, most notably the ailing National Institutes of Health. [Continued here.]…

Paris climate change agreement faces hurdles in the USA

Susan Jaffe | Washington Correspondent for The Lancet | 31st December 2015
Only a few hours after thousands of representatives from 195 countries approved the landmark Paris cliThe Lancet USA blog logomate change agreement, President Barack Obama stepped before the TV cameras at the White House to congratulate them. It Paris 2offers the best chance we have to save the one planet we have,” Obama said. “We’ve shown that the world has both the will and the ability to take on this challenge.”
But the international consensus to reduce global warming failed to move the Republican candidates competing for Obama’s job.  {Continued here.]
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As drug prices go up, some point consumers up north

Susan Jaffe | Washington Correspondent for The Lancet | 8th December 2015
Pharmaceutical sticker shock has renewed American interest in drugs sold in other countries, particularly our northern neighbor.
Many Americans and even government health programs are feeling squeezed by rising drug costs, with federal officials reporting last week that US The Lancet USA blog logohealth care spending in 2014 rose at the fastest rate since 2002 “in part due to the introduction of new drug treatments for hepatitis C as well as of those used to treat cancer and multiple sclerosis.”120815
Treatments for hepatitis C, which affects around 3 million people in the USA, can cost more than $100,000, Health and Human Services Secretary Sylvia Matthews Burwell said at an unprecedented day-long conference on drug pricing HHS hosted last month.
“And that’s an issue for both patients and the organizations and governments that serve them. Since more than three out of four infected adults are baby boomers, this disease has become one of the main cost drivers for Medicare’s prescription program.  Impacts have also been significant in state Medicaid programs.”
…Prompted by the HHS conference and recent price hikes, two leading Senate Republicans, Charles Grassley of Iowa and John McCain of Arizona want Burwell to use a provision of a 2003 law to certify that drug importation is safe and would significantly reduce drug prices.  [Continued here.]
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USA grapples with high drugs costs

 lancet cover 2Volume 386, Number  10009 
28 November 2015
WORLD REPORT   More Americans are getting health insurance, including coverage for prescription drugs, but high prices may make them inaccessible. Susan Jaffe, The Lancet’s Washington correspondent, reports.
 Patients in the USA pay more for prescription drugs than almost anywhere else in the world, forcing as many as one in four who can’t afford the high prices to go without their medicine last year, according to a Kaiser Family Foundation survey. So even though more Americans have health insurance, the new therapies and cures that can prevent more expensive health complications might be out of reach.
After several well-publicised, huge spikes in drug prices—including Turing Pharmaceutical’s increase for pyrimethamine (marketed as Daraprim) from US$13·50 to $750 a pill—the problem is drawing unprecedented attention from nearly every quarter: the Obama Administration, Congress, state officials, health insurance companies, drug makers, as well as the physicians and their patients who have clamoured for help for years. It also surfaced during this month’s Democratic presidential debate.
Heather Block, a patient advocate from Delaware who spoke at a day-long pharmaceutical forum hosted by the US Department of Health and Human Services (HHS) earlier this month, pays $9800 a month for the drugs she takes to treat breast cancer that has spread to her liver and lungs. Although she has Medicare coverage, she is still responsible for a share of her medical expenses. “Innovation is meaningless if nobody can afford it”, she said. “I still face financial insecurity and eventually bankruptcy—if I live that long.”     [Continued here ]
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End in sight for revision of US medical research rules

lancet cover 2Volume 386, Number  10000 
26 September 2015
WORLD REPORT   End in sight for revision of US medical research rules US health officials expect to update 25-year-old regulations on human participation in research by the end of next year.  Susan Jaffe, The Lancet’s Washington correspondent, reports.Lancet photo 092615
After proposing massive changes 4 years ago to rules first issued in 1991 protecting people participating  in research studies, federal health officials produced yet another revision earlier this month and say the effort to update the rules is on a fast track.
The revolution in science, technology, medicine, and public involvement that has transformed biomedical research over the past 25 years might be sufficient reason for the latest update, a daunting task that began in 2009, shortly after Barack Obama became president. But now there’s another factor driving the effort. [Continued  here]
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