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First Edition: September 22, 2016

Kaiser Health News - Thu, 09/22/2016 - 6:37am
Categories: Health Care

Reporter’s Notebook: Pregnant And Caught In Zika Test Limbo

Kaiser Health News - Thu, 09/22/2016 - 5:00am

I’m the health reporter covering the Zika story here at WLRN in Miami, and I’m a pregnant woman.

When Florida Gov. Rick Scott made free Zika testing available to all pregnant Floridians through the Florida Department of Health, I was one of the more than 2,200 women who took him up on the offer.

My station’s main studios are five blocks south of the Wynwood Zika zone, an area that authorities are recommending pregnant women avoid (though the advisory was updated to a less dire warning on Monday). As it turned out, I had been inside the suspected transmission zone before we knew the risks.

So on the morning of Aug. 12, I went to my obstetrician’s office, gave blood and urine samples and was told that it would take about seven to 10 business days to get my results.

Four and a half weeks later, I was still waiting. I had plenty of company.

My colleague Kate Stein has been helping me cover the story, whenever it veers into an area where the Centers for Disease Control and Prevention has advised pregnant women to avoid. Stein covered a Miami Beach town hall I didn’t attend. There, she met Joseph Magazine, who pleaded with officials to help his wife get her Zika test results back. She was more than five months pregnant, had experienced Zika-like symptoms a month earlier, and was waiting to hear if she had been infected.

Press releases and other communications from the Florida health department officials have repeatedly insisted it takes one to two weeks to get results.

But at another town hall, after some pushing, Dr. Lillian Rivera, head of the Miami-Dade County Department of Health, said women may wait longer. “It could be four weeks, it could be five weeks,” Rivera said. “We are preparing them for that.”

This story is part of a partnership that includes WLRN, NPR and Kaiser Health News. It can be republished for free. (details)

Rivera was quick to point out complete testing can take a long time, depending on the first round of results. That’s because the Zika test for a pregnant woman can actually be a couple of different tests. The first test is to see if she has an active infection. If that’s negative, there’s a test to see if she’s had the virus in the past 12 weeks. If that’s negative, case closed.

But if the second test is positive, or inconclusive somehow, then the woman’s samples are sent to the CDC for an even more specialized test to confirm it’s Zika and not dengue or another virus that can cause false positives.

As of last week, Florida had sent 174 tests to the CDC for clarification, including the tests of people who aren’t pregnant. That total doesn’t explain the backlog that snared me.

Obstetrician Christine Curry, with the University of Miami and Jackson Health System, said it’s helpful that all pregnant women in Florida can be tested. But getting timely test results is important, too.

“If someone’s early first trimester or second trimester and we delay disclosure because we don’t have a result by two weeks, four weeks, six weeks, eight weeks — that may be long enough for them to be out of the window of being able to terminate that pregnancy,” she said.

Florida law restricts abortion access after 24 weeks. Later-term abortions are also more complicated procedures and more emotionally fraught for parents.

Delays in testing results can change the way doctors screen the newborns of women who are still waiting on their Zika test results, Curry said. “Do we do more invasive, more aggressive testing? Do we do blood tests and urine tests and a spinal tap on the child?”

I spoke to Curry after I had been waiting more than a month for my results and that image jars me: a spinal tap on my newborn because of a bureaucratic backlog on test results?

This is when I started to get nervous and angry.

Zonnia Knight, a fellow pregnant South Floridian, compares the waiting period for the test results to being told there are spiders in the room.

“You find yourself scratching, or looking around, swatting off ghosts and stuff,” she said. “To me, there was a mosquito everywhere.”

Knight waited three weeks with those ghosts before her Zika results came back. She was negative.

The bottleneck appears to be getting us back the reports.

Dr. David Andrews

Another pregnant woman, Tracy Towle Humphrey, went to a private lab for her test and bypassed the health department. Without insurance, those tests can range from about $150 to almost $800.

Humphrey’s insurance covered it, though. Within one week, she got her negative results back.

But she said for that week, she had trouble sleeping. She would wake up in the middle of the night “thinking, ‘Oh my gosh, what if it’s positive? What are we going to do?'”

After four and a half weeks, I called the Florida Department of Health.

I didn’t identify myself as a reporter. I was afraid that might affect my ability to get information on my own records. I was repeatedly told the health department doesn’t give out results over the phone and they’ll be sent to my doctor.

But after explaining a couple of times that I just wanted to know where my test was, I ended up talking to someone in the local epidemiology department who said she might be able to look up my test. She did, and I learned my test results were completed in the state lab in Jacksonville on Aug. 19 and Aug. 26.

So my completed tests were sitting there, I learned, for more than two weeks, and neither I nor my doctor had been informed of the results.

“Your story is completely consistent with my understanding,” said Dr. David Andrews, who runs the pathology laboratories at Jackson Health System and is on faculty at the University of Miami’s med school.

He told me he’s had upward of 900 pregnant women waiting on their Zika test results. The backlog is so large, he can’t even make a good calculation on the average turnaround time. “It is my sense that most of these specimens have been tested and are being tested in a reasonable amount of time, but the bottleneck appears to be getting us back the reports,” Andrews said.

Mara Gambineri, a spokesperson for Florida’s health department, sent an email that didn’t specifically respond to my question about why it takes so long to release results once the tests are completed:

“The department has been working with area hospitals and providers, particularly in Miami-Dade County, to ensure doctors are receiving test results quickly and communicating the information with their patients. We continue to work to improve and streamline the process.”

Another spokesperson named Sarah Revell said in the same exchange of emails:

“The department continues to dedicate significant resources to our public health labs and we have contracted with a private lab to assist with processing Zika tests quickly and accurately. Florida is the first and only state to offer such extensive resources to pregnant women and we are constantly working to improve our process.”

On Wednesday, Sept. 14, Gov. Scott announced the CDC is sending seven more people to help out with labs and testing “in order to ensure pregnant women get results back faster.”

On Friday, Sept. 16, a few hours after WLRN aired a story about the testing backlog and my wait, I got a call from the county health department asking for my doctor’s contact information. They released my test results to my obstetrician, who shared them with me: They are negative.

Kate Stein contributed to this report. This story is part of a partnership that includes WLRN, NPR and Kaiser Health News.

Categories: Health Care

The EpiPen Outrage Continues

Medicare -- New York Times - Wed, 09/21/2016 - 9:52pm
It’s time for Congress to stop letting pharmaceutical companies get away with price gouging on lifesaving drugs.
Categories: Elder, Medicare

It’s Not Just For Kids: Medicare EpiPen Spending Up 1,100 Percent

Kaiser Health News - Wed, 09/21/2016 - 5:50pm

Even as the cost of EpiPens dramatically rose, so too did the number of prescriptions written for patients in Medicare, sending spending by the program skyrocketing nearly 1,100 percent from 2007 to 2014, a report out today shows.

During the same period, the total number of Medicare beneficiaries using EpiPens climbed 164 percent, from nearly 80,000 users in 2007 to more than 211,000 in 2014, according to the analysis by the Kaiser Family Foundation. While the report does not delve into what’s behind the increase, factors could include increased awareness among people with allergies, marketing efforts and access to insurance coverage.

The abrupt rise is notable because many people think that life-threatening allergies are less common among the elderly. In addition, epinephrine — the active ingredient in EpiPens — can pose greater risks to older adults. Food and Drug Administration labeling urges caution when prescribing to this age group.

Use Our Content This KHN story can be republished for free (details).

“That level of increase gives me pause,” said Martha Twaddle, senior medical officer for Illinois at Aspire Health, which provides home-based supportive care for people with serious illness.  She did not work on the study. Epinephrine — the active ingredient in EpiPens — can cause side effects including chest pain, rapid increase in blood pressure or irregular heart rhythms, which could be fatal, for people with certain medical conditions, including heart disease.

The foundation study comes amid ongoing scrutiny — including congressional testimony Wednesday by Mylan CEO Heather Bresch — over EpiPen price increases. (Kaiser Health News is an editorially independent program of the Foundation.)

Average total Part D spending per EpiPen prescription increased nearly five-fold, a 383 percent increase. (Kaiser Family Foundation)

EpiPens are used in cases of severe allergic reactions. Costs for a two-pack of the pens has gone from about $94 in January 2007 to $609 in May of this year. In response to criticism of its price increase, Mylan announced in late August that it would make a generic version and price it at half of its current brand name price.

The new numbers from Medicare could add fuel to the debate over these price increases and voters’ demands that Congress take action to roll back the cost of the popular medication.

The health insurance program for senior citizens and disabled people spent about $6.4 million on the devices in 2007, but spent $75.3 million in 2014, with sharp price hikes by the manufacturer driving much of the increase. Those figures reduce the amount spent based on estimates of how much Medicare saved in rebates from manufacturers, although the agency would not disclose the exact amounts.

Still, when patients show up in emergency rooms with life-threatening allergic reactions, epinephrine is a first line of defense, said Robert Glatter, emergency room physician at Lenox Hill Hospital in Manhattan. Those whose allergic reaction isn’t immediately life threatening would more likely get a mix of steroids and antihistamines, he said.

All patients with suspected severe allergic reactions — even the elderly — are given either a prescription or an actual epinephrine auto injector upon discharge, he said.

“We tell them to have it and use it if they have a lip or tongue swelling, shortness of breath, a skin rash [or other symptoms] of a problem,” said Glatter, adding that adults tend to become more susceptible to food allergies as they age.

Increased awareness among doctors and patients about the importance of epinephrine could account for some of the increase seen in the study, said Richard Lockey, a past president of both the World Allergy Organization and the American Academy of Allergy, Asthma & Immunology.

“Most people survive an allergic reaction … the people who don’t survive are those who don’t get epinephrine or don’t get it soon enough,” said Lockey, who says it is necessary to balance this idea with the possible risks epinephrine poses for older patients. “It’s a matter of clinical judgment.”

The study did not break down the number of Medicare EpiPen users by age, so it is not known how many of the more than 211,000 patients getting EpiPens in 2014 are older than 65. That population has certainly grown in the past few years as Baby Boomers age into the program. But, although Medicare is generally thought of as the government health program for older people, about 16 percent — or 9.1 million beneficiaries — are younger than 65. They are generally disabled or have kidney problems requiring dialysis.

“You can come up with a ton of reasons why the under-65 population might see an increase in EpiPen use,” said James Goodwin, an expert in geriatric medicine at the University of Texas Medical Branch in Galveston. He did not work on the study.

As for the overall increase, Goodwin said there are likely many factors and it isn’t necessarily evidence of overutilization. Still, Goodwin says he specializes in patients older than age 80 and has never prescribed an EpiPen, nor had three of his colleagues, who work with slightly younger elderly patients.

One geriatrician said he has patients who are on it with prescriptions from their allergists, who weigh the pros and cons of having the drug. Those physicians “are the ones to say your allergy is serious enough to potentially become life threatening.”

At the American Geriatrics Society, epinephrine is not included on the organization’s list of potentially inappropriate medicines, said Nicole Brandt, a professor at the School of Pharmacy at the University of Maryland.

“When you look at in context of someone having a severe anaphylactic reaction, which is life threatening, you want access to treatment,” said Brandt. She said doctors should caution patients about the appropriate use of the devices and encourage them to seek additional medical attention if they experience side effects.

She suggested the increase in Medicare prescriptions seen in the study reflects access to insurance more than overuse.

Since Medicare drug plans cover part of enrollees’ total drug costs, beneficiaries in prescription drug plans pay less that the full retail price. But beneficiaries still paid significantly more of their own money for EpiPens during the seven-year period studied in the report. Average out-of-pocket spending for beneficiaries with Medicare drug coverage nearly doubled for each EpiPen, from $30 to $56. The report does not include price increases beyond 2014.

Still, those costs are far less than what some people with private insurance might pay, particularly those with high deductibles. As a result, at least one doctor — geriatrician David Barile from Princeton, New Jersey — who did not work on the study, speculated that the rise in Medicare use of EpiPens might simply be older people getting them for their grandchildren.

Liz Szabo contributed to this report.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Categories: Health Care

How Housing Vouchers Can Better Promote Economic Mobility

Center on Budget and Policy Priorities - Wed, 09/21/2016 - 3:47pm

In House testimony today, CBPP’s Barbara Sard outlined the benefits of helping low-income families use housing vouchers to move to neighborhoods with less poverty and more opportunity and discussed reforms to advance that goal.  Here’s an excerpt from the introduction:

Categories: Benefits, Poverty

Opinion: Dear Hillary And Donald, You'd Be A Better President If You Got More Exercise

CommonHealth (WBUR) - Wed, 09/21/2016 - 2:20pm
Clearly, the two are no couch potatoes; they are frantically busy campaigning. But still, it's a fail. And not a trivial one, considering that Americans spend well over a trillion dollars a year on health care that better lifestyles could prevent.
Categories: Health Care

Behind the Scenes at the Swearing-in of the 14th Librarian of Congress

In Custodia Legis - Wed, 09/21/2016 - 1:33pm

This is a guest post by Roberta I. Shaffer, Law Librarian of Congress, whose posts include 2016 New Year’s Greetings from the Law Librarian of Congress and An Interview with Roberta Shaffer, Law Librarian of Congress.

Chief Justice of the United States John G. Roberts, Jr. swears in Carla Hayden as the 14th Librarian of Congress, along with Speaker of the U.S. House of Representatives Paul Ryan and Mrs. Colleen Hayden, September 14, 2016. Photo by Shawn Miller.

For so many people, including me, the swearing in ceremony of Carla Hayden as the 14th Librarian of Congress was an experience of a lifetime.  I had the added  thrill of having a small task behind the scenes. I was to greet the Chief Justice of the United States, John Roberts, as he entered the Library of Congress building to administer the oath of office to the new Librarian.

The route that the Chief Justice took brought him through the Main Reading Room of the Jefferson Building, which was closed to the public for the duration of the ceremony.  As he entered the room, the Chief Justice commented, “This is my second most favorite building in Washington – the Supreme Court is first, of course.”  While I have long admired this Chief, it is not the first time that our opinions have differed.  I naturally replied, “Oh really, this is my favorite! It just is so American.”  And his reply, with a huge smile on his face, was “Yes, it is.”

One other thing that happened in the course of that short walk that also struck me as “so American” was the fact that the Chief Justice of the United States made sure to have eye contact and a greeting for each of the Library staff standing at their work stations waiting for the Library patrons that would shortly be allowed to re-enter the Main Reading Room and to resume the semblance of a normal day on this really most extraordinary of days.  The Chief made himself so “real” that I believed for those few seconds he became the human representation of grace, accessibility, and openness. These American values are hallmarks of our judiciary but are also portrayed in nearly every nook and cranny of the Main Reading Room, and throughout the walls and halls of the entire Jefferson Building.  These are, indeed, the enduring values of a democracy.

For me, the “so American” theme became my real memory of the ceremony.  I had the great fortune to have an almost “front row” (6 rows back) seat from which to witness the actual event.  After a number of inspiring speeches, the Chief Justice administered the oath of office and then he shook the new Librarian’s hand. It may be more accurate to say that they took each other’s hands. I noticed they both held on for a few seconds longer and looked directly at each other. I could not help but think, with Speaker Paul Ryan behind the two and standing next to Carla Hayden’s proud mother, that the handshake was delivering a message from everyone in the Great Hall and the countless others watching remotely from around the world. “We embrace you as you embark on this noble service to our nation. You are now part of the critical leadership of our country. We are all glad that you are here.” In those few seconds, I felt so empowered to be an American and by the role that all libraries, not just the Library of Congress, play in defining what “American” means. It was a “swearing-in” for us all.

Categories: Research & Litigation

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