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News Article | February 24, 2017
Site: www.npr.org

Indiana's Claims About Its Medicaid Experiment Don't All Check Out Indiana expanded Medicaid under the Affordable Care Act in 2015, with a few extra conditions that were designed to appeal to the conservative leadership in the state. The Federal government approved the experiment, called the Healthy Indiana Plan, or HIP 2.0, and it is now is up for another three-year renewal. But a close reading of the state's renewal application shows misleading and inaccurate information is being used to justify extending HIP 2.0. This is important because the initial application and expansion happened on the watch of then-Governor, now-Vice President Mike Pence. And Seema Verma, who is now President Trump's pick to lead the Centers for Medicare and Medicaid Services, helped design it. (Among other functions, CMS oversees all Medicaid programs.) So states are watching to see if the approval of Indiana's application is a bellwether for Medicaid's future. To get the program extended again, the Indiana Family and Social Services Administration has to prove to CMS that the experiment is working and that low-income people in the state are indeed getting access to care and using health care efficiently. The key part of Indiana's experiment requires low-income participants to make monthly payments. Advocates say this promotes recipients' taking personal responsibility for their health care. But some health policy experts say the information provided by the state shows that the provision isn't working as well as it should. Here are some examples: The Claim: Most Members Are Making Regular Payments To Maintain Coverage The Fact: A Lot Of People Are Missing The First Payment The state's application says that "over 92 percent of members continue to contribute [to their POWER accounts] throughout their enrollment." This claim is missing a lot of context. To understand why it's important, here's a primer on how HIP 2.0 works: Members can get HIP 2.0's more complete coverage, the HIP Plus plan, by making monthly payments into a "Personal Wellness and Responsibility Account," or POWER account. If they don't make the payments, there are penalties. If a recipient makes less than the federal poverty level — about $12,000 a year — they're bumped to HIP Basic, a lower-value plan that requires copays and doesn't include vision or dental insurance. If a recipient is above the poverty line and misses a payment, they're locked out of coverage completely for six months. The state's claim that 92 percent of members make consistent payments is based on data in a report by the Lewin Group, a health policy research firm in Virginia that evaluated HIP 2.0's first year. But the Lewin report also says that when people are signing up for HIP 2.0, they can be declared "conditionally enrolled," which means they're eligible but have not yet made their first payment. According to the Lewin report, in HIP 2.0's first year, about a third of people who were conditionally enrolled never fully joined. "I don't see those numbers being captured," says Dr. David Machledt, senior policy analyst with the National Health Law Program, which advocates for low-income individuals. Machledt says the state should recalculate the figure to include those people, because it's potentially an indicator that people are confused about how the program works, or that they can't afford the payments. He adds that the figure cited is also based on the first year of HIP 2.0, and that the rate of losing coverage for missing payments has increased substantially since then. The Fact: More Than Half of People Don't Even Know They Have One The state says the POWER account is promoting personal responsibility in health care; meaning, if someone is aware of how much they are spending, they'll choose their medical care wisely. As evidence, the state writes in its application that 40 percent of HIP Plus members "check their [POWER Account] balance at least once a month." Again, the state leaves out important context. According to the Lewin report, most people in HIP Plus didn't know they had a POWER account. Of those who did, 40 percent of them checked their account once a month, but that's much smaller than 40 percent of all HIP Plus members. In fact, an analysis of the numbers shows only about 19 percent of HIP Plus members reported checking the balance of their POWER account monthly. Rather than evidence of personal responsibility, Judy Solomon, Vice President for Health Policy at Center on Budget and Policy Priorities, sees evidence of confusion. "I think that's another really significant finding [in the Lewin report] that so far I have never seen the state come to terms with," says Solomon. A spokesperson for the state wrote in an e-mail that the phrase, "of the members surveyed" was unintentionally omitted from the application. The message did not address the overall concern that the statement was misleading. The Claim: People On HIP Plus Are More Responsible The Fact: Experts Say HIP Plus Is Just Better Insurance The application also says "HIP members who contribute [to their POWER accounts] are twice as likely to obtain primary care (31 percent to 16 percent), have better prescription drug adherence (84 percent to 67 percent), and rely less on the emergency room for routine treatment." Machledt says simply showing that HIP Plus members use the emergency room less frequently than HIP Basic members doesn't tell the whole story. "They don't talk about the risk profile of those different groups," Machledt says. He says people who are above the poverty line are generally less likely to frequent the ER in the first place. "There's no evidence to me that they've risk adjusted... to show that they're comparing apples to apples," he says. Indiana argues that the higher levels of primary care use and drug adherence for those making POWER account payments, "confirms the principle of personal responsibility." But Solomon says the differences in behaviors actually just confirm something else: Those who pay their POWER account have better insurance. HIP Plus makes it easier for people to access primary care and to adhere to their prescription drug regimens, Solomon says. "The policy for people in HIP Plus is that they get a three-month supply of drugs, and can even use mail order, without any copays," she says. Meanwhile, people in HIP Basic have to pay copays and are limited to a one-month supply of drugs. Solomon says getting less primary care and relying on the ER for health crises is worse for patients and could also mean higher costs. "You have large numbers of people that are not getting care in the right place at the right time, and not maintaining adherence to prescription drug regimens." The Claim: HIP 2.0 Is Meeting Its Enrollment Projections The Fact: No, It Isn't The state's application reads "HIP has continued to meet its enrollment goals with over 394,000 individuals fully enrolled in HIP as of December 1, 2016." But the state isn't meeting its enrollment goals. According to a chart published in 2014 in Indiana's original proposal for HIP 2.0, its enrollment goal for December of 2016 was higher — 424,339. (The chart to the right is off by a month, because the state started HIP 2.0 a month later than planned, so the actual projection for December 2016 appears on the line for November 2016.) The most recent enrollment report shows 403,142 HIP members in January 2017, short of the state's projection of 427,702. The Fact: The Survey Data Is Not Reliable There's reason to doubt the survey results that underlie much of the Lewin report, according to Dr. Leighton Ku, director of the Center for Health Policy Research at the Milken Institute School of Public Health at George Washington University. "They were not using what would generally be considered best practices in their survey methodology," Ku says. Ku says the methodology available to the public is vague. From the information provided, he says there are multiple ways that bias could have been introduced into the survey results used in the Lewin report. For one thing, the sample sizes of the survey were too small to draw accurate conclusions, Ku says, and the data was analyzed using "not an optimal method." Ku says the results are not displayed in a scientific manner, and that it appears the survey and analysis were done in a hurry. "You would not, as a survey researcher, have great confidence in the results that they show," he says. As Indiana looks to extend HIP 2.0, health policy experts say it's important to get an accurate picture of how well the program is working. Requiring POWER account payments was key to making the program a reality in Indiana, but they say a more traditional Medicaid expansion — one that does not require monthly payments and 6-month lockouts — is a better option. Dr. Jennifer Walthall heads the Indiana Family and Social Services Administration, the government agency that runs HIP 2.0. She said that in order to comment on discrepancies between the state's extension application and the Lewin report, "I would have to go back and look at the way that these data were reported." She continued, "I'm happy to look into that and get that for you." In a separate prepared statement, the agency noted that the state "has made significant achievements" on HIP 2.0's stated goals and that it looks forward "to continuing to build on these successes with future versions of HIP ... The analysis of this program is constant and ongoing and includes continuous conversation with our federal partners to discuss all aspects of the proposed waiver as well as program outcomes." If the application does not go forward, the state could choose to expand Medicaid under the Affordable Care Act without any special provisions, or not accept the expansion at all. The federal government is welcoming public comment on Indiana's application until March 17. This story is part of a reporting partnership with NPR, WFYI, Side Effects Public Media and Kaiser Health News.


News Article | February 15, 2017
Site: www.npr.org

Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, has opened an inquiry into potential abuses of the Orphan Drug Act that may have contributed to high prices on commonly used drugs. In a statement, Grassley said the inquiry is "based on reporting from Kaiser Health News" and strong consumer concern about high drug prices. "My staff is meeting with interested groups and other Senate staff to get their views on the extent of the problem and how we might fix it," Grassley wrote. A six-month Kaiser Health News investigation published in January found that the orphan drug program intended to help desperate patients is being manipulated by drugmakers. While the companies aren't breaking the law, they are using the Orphan Drug Act to secure lucrative incentives and gain monopoly control of rare disease markets where drugs often command astronomical price tags. KHN's investigation, which was published and aired by NPR, found that many drugs that now have orphan status aren't entirely new. More than 70 were drugs first approved by the Food and Drug Administration for mass market use. Those include cholesterol blockbuster Crestor, Abilify for psychiatric disorders and rheumatoid arthritis drug Humira, the best-selling drug in the world. Others are drugs that have received multiple exclusivity periods for two or more rare conditions. About 80 drugs fall into this latter category, including cancer drug Gleevec and wrinkle-fighting drug Botox. Before the Orphan Drug Act passed, drugs for rare diseases were often abandoned during development, hence the name orphan. The patient populations were simply too small for the drugs to be financially viable for companies, they said. Grassley, the senior senator from Iowa, is well positioned to call for changes in the law's incentives. The Judiciary Committee he oversees has jurisdiction over anticompetitive and patent-related issues. Grassley made headlines late last year calling for hearings to demand that drugmaker Mylan justify its price hikes for the lifesaving EpiPen. Grassley's office has reached out to staff members of the Senate Health, Education, Labor and Pensions committee, which has jurisdiction over the FDA. When asked this week about a possible update to the law, the committee lauded the Orphan Drug Act for helping millions of families and said it "will continue oversight of the law to ensure it is working as intended." But there are questions over whether the law is working as intended. Dr. Robert Califf, who left his post last month as commissioner of the FDA, said it's time to review the orphan drug program and the incentives offered to corporations. While the law has been very successful in bringing effective treatments to patients with rare disease, Califf said, it's also the case that when a program "reaches a mature phase it's important to reassess it." Califf went on to say, "It's understandable that whenever you put a financial incentive in place in the United States, people will try to figure out how to take advantage of it — almost all of them within the law. So, I'm not talking about illegal activity but ... there is a game of cat and mouse that goes on." Government incentives for orphan drug development are needed because the research involved is costly, risky and uncertain, Anne Pritchett, vice president of policy and research at PhRMA, the drug industry's lobbying group, said in an interview in late 2016. This week, a PhRMA spokeswoman said the group hadn't heard of any movement on changing or updating the Orphan Drug Act. Dr. Martin Makary, a professor at Johns Hopkins University School of Medicine and a vocal critic of the high prices of orphan drugs, has suggested that drugmakers should repay some of the federal incentive money once a drug reaches a $1 billion in annual sales. Former U.S. Rep. Henry Waxman, D-Calif., who pioneered the Orphan Drug Act in the 1980s, thinks Congress should tackle prescription drug pricing on a variety of fronts, and that an update to the Orphan Drug Act should be part of the solution. But Peter Saltonstall, president of the National Organization for Rare Disorders, said his group has heard "no energy" for changing the law now. "I think the Orphan Drug Act, at least from our perspective, has been successful," Saltonstall said, adding that there are other drug pricing concerns that could be addressed by Congress. Today, more than 450 orphan drugs have been approved. Obtaining orphan designation for a product is a popular business strategy for manufacturers. Drugs approved to treat rare diseases made up 40 percent of new drugs approved by the FDA in 2016 and nearly 50 percent of new drugs approved in 2015. The drugs are also expensive, at $111,820 for a year's treatment with an orphan drug, on average, in 2014 compared with $23,331 for a mass market drug. Kaiser Health News is an editorially independent newsroom that is part of the nonpartisan Henry J. Kaiser Family Foundation. KHN's coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.


News Article | February 15, 2017
Site: www.npr.org

The confirmation of Tom Price, the orthopedic surgeon-turned-Georgia congressman, as secretary of Health and Human Services on Friday represents the latest victory in the ascendancy of a little-known but powerful group of conservative physicians in Congress — the GOP Doctors Caucus. During the Obama administration, the caucus regularly sought to overturn the Affordable Care Act, and it's now expected to play a major role determining the Trump administration's plans for replacement. Robert Doherty, a lobbyist for the American College of Physicians, the professional organization for internal medicine doctors, says the GOP Doctors Caucus has gained importance with Republicans' rise to power. "As political circumstances have changed, they have grown more essential," Doherty says. "They will have considerable influence over the discussion on repeal and replace legislation," he says. Price's supporters have touted his medical degree as an important credential for his new position, but Price and the caucus members are hardly representative of America's physicians in 2017. The "trust us, we're doctors" refrain of the caucus obscures its conservative agenda, critics say. "Their views are driven more by political affiliation," says Mona Mangat, an allergist-immunologist and chair of Doctors for America, a 16,000-member organization that favors the current health law. "It doesn't make me feel great. Doctors outside of Congress do not support their views." For example, while the American College of Obstetrics and Gynecology has worked to protect access to abortion, the three obstetrician-gynecologists in the 16-member House caucus are anti-abortion and oppose the ACA provision that provides prescription contraception without copays. While a third of the U.S. medical profession is now female, 15 of the 16 members of the GOP caucus are male, and only eight of them are doctors. The other eight members are from other health professions, including a registered nurse, a pharmacist and a dentist. The nurse, Rep. Diane Black of Tennessee, is the only woman. On the Senate side, there are three physicians, all of them Republican and male: Sen. John Barrasso, an orthopedic surgeon from Wyoming; Sen. Bill Cassidy, a gastroenterologist from Louisiana; and Sen. Rand Paul, an ophthalmologist from Kentucky. While 52 percent of American physicians today identify as Democrats, just two out of the 14 doctors in Congress are Democrats, Reps. Ami Bera and Raul Ruiz, both of California. About 55 percent of physicians say they voted for Hillary Clinton and only 26 percent voted for Donald Trump, according to a survey by Medscape in December. Meanwhile, national surveys show doctors are almost evenly split on support for the health law, mirroring the general public. And a survey published in the New England Journal of Medicine in January found almost half of primary care doctors liked the law, while only 15 percent wanted it repealed. Rep. Michael Burgess, R-Texas, a caucus member first elected in 2003, is one of the longest serving doctors in Congress. He says the anti-Obamacare Republican physicians do represent the views of the profession. "Doctors tend to be fairly conservative and are fairly tight with their dollars, and that the vast proportion of doctors in Congress [are] Republican is not an accident," he says. Price's ascendency is in some ways also a triumph for the American Medical Association, which has long sought to beef up its influence over national health policy. Less than 25 percent of practicing physicians are in the AMA, the organization says. Price is an alumnus of a boot camp the AMA runs in Washington each winter for physicians contemplating a run for office. Price is one of four members of the caucus who went through the candidate school. In December, the AMA immediately endorsed the Price nomination, a move that led thousands of doctors who feared Price would overturn the health law to sign protest petitions. Even without Price, Congress will have several GOP physicians in leadership spots in both the House and Senate. Those include Rep. Phil Roe of Tennessee, the caucus co-chair, who also chairs the House Veterans Affairs Committee, and Burgess, who chairs the House Energy and Commerce subcommittee on health. Sen. Cassidy sits on both the Finance and the Health, Education, Labor and Pension Committees. Sen. Barrasso chairs the Senate Republican Policy Committee. Roe acknowledges that his caucus will have newfound influence. Among his goals in molding an ACA replacement are to kill the requirement that most people buy health insurance (called the individual mandate) as well as to kill the requirement that 10 essential benefits, such as maternity and mental health care, must be in each health plan. He says the caucus will probably not introduce its own bill, but rather evaluate and support other bills. The caucus could be a kingmaker in that role. "If we came out publicly and said we cannot support this bill, it fails," Roe says. The GOP Doctors Caucus has played a prominent role in health matters before. For example, in 2015, when former House Speaker John Boehner needed help to permanently repeal a Medicare payment formula that threatened physicians with double-digit annual fee cuts, he turned to the GOP Doctors Caucus. It got behind a system to pay doctors based on performance — the so-called "doc fix." "When the speaker had a unified doctors' agreement in his coat pocket, he could go to Minority Leader Nancy Pelosi and show that, and that had a lot to do with how we got this passed," Roe says. But not all doctors are unified behind the caucus. Ruiz, one of the two physicians in the House who are Democrats, says he worries because few doctors in Congress are minorities or primary care doctors. Ruiz, an emergency room physician who was elected in 2012, says he is wary about Price leading HHS because he is concerned Price's policies would increase the number of Americans without insurance. Indeed, many doctors feel the caucus' proposals will not reflect their views — or medical wisdom. "My general feeling whenever I see any of their names, is that of contempt," says Don McCanne, a family medicine physician in California who is past president of the Physicians for a National Health Program. "The fact that they all signed on to repeal of ACA while supporting policies that would leave so many worse off demonstrated to me that they did not represent the traditional Hippocratic traditions which place the patient first." This story was produced through a collaboration between NPR and Kaiser Health News, an editorially independent program of the Henry J. Kaiser Family Foundation. Follow Phil Galewitz on Twitter: @philgalewitz.


News Article | February 22, 2017
Site: www.npr.org

Heart Screening For Teens May Cause More Problems Than It Solves Dozens of not-for-profit organizations have formed in the past decade to promote free or low-cost heart screenings for teens. The groups often claim such tests save lives by finding abnormalities that might pose a risk of sudden cardiac death. But the efforts are raising concerns. There's no evidence that screening adolescents with electrocardiograms prevents deaths. Sudden cardiac death is rare in young people, and some physicians worry screening kids with no symptoms or family history of disease could do more harm than good. The tests can set off false alarms that can lead to follow-up tests and risky interventions or force some kids to quit sports unnecessarily. "There are harms that I don't think a lot of people realize," said Dr. Kristin Burns, who oversees a two-year-old registry at the National Institutes of Health of sudden deaths in people under 20. It's one of several efforts aimed at gathering better data about cardiac abnormalities in kids. Studies using limited data have found that between 1 and 4 sudden cardiac deaths occur annually per 100,000 kids between ages 1 and 18. By comparison, 22 in 100,000 U.S. teens are killed each year in accidents, including those involving motor vehicles; 9 in 100,000 commit suicide, according to the Centers for Disease Control and Prevention. Some screening advocates believe sudden cardiac deaths are underreported and that not enough is being done to spare families from the fate of losing a child. "We have to acknowledge that every kid who drops dead, they've been failed by the current system," said Darren Sudman, who founded Simon's Fund, a screening effort in greater Philadelphia in memory of his infant son, who died of an arrhythmia. Screening programs say they're educating parents about the risks. "What we want to emphasize is, make sure your kid is heart-safe," said Dr. Jonathan Drezner, a sports and family medicine specialist at UW Medicine and medical director of the Seattle-area Nick of Time Foundation. Enthusiasm for EKGs, which measure the electrical activity in the heart to detect abnormalities, grew after a 2006 study showed they lowered death rates among athletes in Italy. But research in other countries hasn't yielded similar results, and the Italian researchers recently were accused of refusing to share their data so they could be evaluated independently. Some 60,000 to 70,000 U.S. teens were screened with EKGs in 2016, most by foundations created by families who lost a child to sudden cardiac death, said Sudman, who runs the online directory Screen Across America. It's unclear whether high school athletes face higher risk than nonathletes, so screening programs usually invite everybody. Screenings typically are held in high schools and overseen by volunteer cardiologists, with funding from individuals and businesses including hospitals. A handful of hospitals and for-profit companies also run screenings. It may be presumptuous to claim EKGs save lives, but parents often believe they do, said Sudman. "If I find a heart condition, I promise you there are parents who are thanking me for savings their kid's life," he said. That perception is stoked by tragic stories in the media of children who died suddenly after never reporting a symptom. Meanwhile, the drawbacks of EKGs are seldom depicted. As many as 1 in 10 EKGs detects a potential abnormality, and the emotional and financial toll of such a finding can be significant — especially when it turns out to be wrong. Following a screening EKG and echocardiogram last fall, Daniel Garza, 16, a talented sophomore basketball player in San Antonio, was told he had hypertrophic cardiomyopathy, a thickening of the heart muscle and the most common cause of sudden cardiac death in young people. He was advised to quit all exercise, at least temporarily. "We were shocked, just shocked," said his mother, Denise. She said her son became depressed when he couldn't play the sport he enjoyed and excelled at. "He came home and cried himself to sleep. He said, 'Mom, why did God give me this gift to take it away?' " The Garzas traveled to the Mayo Clinic in Rochester, Minn., where further tests indicated his enlarged heart was a benign condition known as athletic heart, a result of intense training. His mother estimates that correcting the misdiagnosis cost more than $20,000, including medical costs, travel and lost work. Daniel has returned to the basketball court. Still, Denise Garza said the emotional toll was rough: "It was one of the hardest things my family has ever endured." Several cardiologists said they often see cases like this — or worse. Even after follow-up testing, it can be unclear which cases are life-threatening, so kids with low risk could be restricted from exercise or given life-altering interventions such as implantable defibrillators, surgery or anti-arrhythmic medications. Medical groups have wrestled with the issue. The American Heart Association and the American College of Cardiology recommended in 2014 against mass EKG screening, noting that sudden cardiac death is rare in teens and false positives generate "excessive and costly second-tier testing." EKGs also miss at least 1 in 10 cases of hypertrophic cardiomyopathy and more than 9 in 10 cases of congenital anomalies, the second-most-common cause. But the medical panel accepted voluntary screening "in relatively small cohorts," if there's physician involvement, quality control and a recognition of unreliable results and ancillary costs. Efforts are underway to improve the accuracy of the screening programs. Some are adding echocardiograms, which use ultrasound to produce images of the heart, to assess potential abnormalities. Advocates say false positives have dropped as a result of better interpretation guidelines, known as the Seattle Criteria, which are expected to soon be endorsed by cardiology societies in revised form. But the criteria aren't perfect, and there's a "giant gap" in training cardiologists to use them, said Drezner, one of the developers. He's also a medical adviser for Parent Heart Watch, a consortium of foundations. "If I was a parent, I'd want to know about the experience of the [cardiologists] and what they're going to do to help my kid if they have a positive screen." One problem with EKGs is a lack of good data. "There's no evidence we have that [EKG] screening saves lives," said Dr. Jonathan Kaltman of the National Heart, Lung, and Blood Institute. "There's never been a controlled clinical trial, which is the only way to answer that question." At the urging of screening advocates, the NIH partnered with the CDC to rigorously track cardiac deaths as part of a Sudden Death in the Young Case Registry. So far a handful of states and counties have joined the effort, which helps local health departments collect better data. The goal is to standardize death investigations and get a firm handle on how often kids die from heart abnormalities as well as the role of factors such as genetics. Initial findings are expected to be available in about two years. The NIH is also funding three university-based research groups to answer key questions about sudden cardiac death in the young. Some screening organizations are getting behind a nascent initiative with the Cardiac Safety Research Consortium to harness their own screening data for research. It would require standardizing their practices and tracking outcomes, which organizations aren't now equipped to do. "Screening is happening. We can't avoid that," said Dr. Salim Idriss, director of pediatric electrophysiology at Duke University and co-chair of the initiative. "We have a really good opportunity to get the data we need to make it better." Separately, the UT Southwestern Medical Center in Dallas recently began a four-year pilot study involving athletes and band members at eight high schools to determine the feasibility of a full-scale randomized controlled trial. A valid finding on the overarching question of whether EKG screening saves lives could require at least 800,000 participants and a cost of $15 million, said Dr. Benjamin Levine, a cardiologist and the lead researcher. The pilot is partly a response to legislation that would mandate EKGs for student athletes in Texas. A similar bill was also introduced in South Carolina. Both bills failed, but it's expected there will be more attempts to mandate EKGs, leaving state legislators looking for better guidance. "We're not going to solve this by having more debates, but by having more data," Levine said. Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Mary Chris Jaklevic is a freelance health and environment writer based in Chicago. She's on Twitter: @mcjaklevic


News Article | February 23, 2017
Site: www.npr.org

To Test Zika Vaccines, Scientists Need A New Outbreak Researchers are eager to test promising vaccines against Zika, the virus that sparked a global health emergency last year. But uncertainty over whether the Zika epidemic will continue affects researchers' ability to finish testing vaccines. They need locations with an active viral outbreak to conduct large-scale human trials and make sure the vaccine actually protects against disease. "On one hand, you don't want to see outbreaks of infection," says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "But on the other hand, [without that testing] you might have to wait a long time to make sure that the vaccine works." All the vaccines being tested are in Phase I clinical trials, which means they are being tested for safety in a small number of people. According to a review paper published Tuesday in the journal Immunity, the vaccines represent a variety of scientific techniques to thwart the disease, ranging from inactivating the virus to manipulating its DNA. The NIAID announced Tuesday it is launching yet another Phase I trial for a vaccine made out of proteins found in mosquito saliva. The product is intended to trigger a human immune system response to the mosquito's saliva and any viruses mixed with it. If successful, the product could protect humans against a number of mosquito-transmitted diseases, including Zika virus, dengue and chikungunya. All three have infected people in the United States. Col. Nelson Michael, director of the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research and co-author of the paper, says he expects preliminary reports on the safety of some of the older vaccines in April. As of now, he says, it is impossible to guess which vaccine will prove most effective in providing immunity. "Sometimes it's difficult to predict which horse will win the race," Michael says. Zika, which is spread from infected people to others by mosquito bites or sexual contact, often infects people without showing symptoms. In some cases it causes flu-like symptoms, such as fever, muscle aches and joint pain in adults ― and, in rare cases, Guillain-Barré syndrome, which can cause temporary paralysis. But it is most notorious for causing some children to be born with microcephaly, a devastating a birth defect in which a child's head and brain is smaller average size ― if their mothers were exposed to Zika. The virus garnered international attention after hundreds of cases of disabled babies surfaced in Brazil. It quickly swept through South America and the Caribbean before stopping on the southern coast of the U.S. The World Health Organization declared the outbreak a "public health emergency of international concern" on Feb. 1, 2016, then ended the alert on Nov. 18. Vaccines that meet the safety standard in Phase I clinical trials undergo subsequent rounds of testing to gauge effectiveness. To measure this, researchers rely on the gold standard of administering the vaccine to large number of people at risk to see if the vaccine is effective. However, Zika's recent arrival to the Western Hemisphere means researchers don't know whether the virus will become a perennial threat, or was a one-time explosion. The uncertainty poses challenges for Zika vaccine development. A lull in the outbreak could cause significant delays in testing, pushing back the timetable for a commercially available product, Fauci says. While researchers can use alternative methods to measure efficacy without large-scale testing, a decline in the circulation of the Zika virus could set progress back by years because the vaccine testing would be less reliable. "If we don't get a lot of infections this season in South America and Puerto Rico, it may take years to make sure the vaccine works," Fauci says. Fauci expects to launch the next round of human trials for a DNA vaccine developed by the NIAID next month. Michael also worries that a lag in the number of Zika cases could lead the private sector to pull funds from vaccine development. It takes millions of dollars to develop a drug or vaccine, and pharmaceutical companies play a critical role in making and manufacturing them, he said. But those companies have many competing interests, he notes, and if it is hard to test a vaccine this year, federal agencies and private companies may turn their Zika prevention efforts elsewhere. "This is a constant issue, where you put your resources," Michael says. So far, signs suggest that the climate could be ripe for Zika again this year. Warmer-than-usual temperatures are affecting areas across the Western Hemisphere, including hotbeds of the Zika outbreak in Brazil. The National Oceanic and Atmospheric Administration found that South America experienced the second hottest January in recorded history. The balmy temperatures rev up the Aedes aegypti's behavior in multiple ways, says Grayson Brown, professor of entomology at the University of Kentucky. They tend to move faster, lay more eggs per day and feed more frequently. However, the heat is not necessarily correlated to higher numbers of the mosquito, Brown says, as they tend to live among humans, not in the wild. "This mosquito breeds almost exclusively in human created containers," he says. "You don't really find it out in the woods." In the United States, areas with populations of the Aedes aegypti are closely monitoring their numbers. Last year, Texas and Florida dealt with locally acquired cases of Zika infection. In Texas, public health officials have monitored mosquito populations throughout the winter to track their numbers and any presence of the virus. Despite unseasonably warm weather, Chris Van Deusen, spokesman for the Texas Department of State Health Services, says they have seen lower numbers of the Aedes aegypti and no cases of Zika. Van Deusen says the state is also monitoring the outbreak in Mexico, since heavy traffic across the border increases the possibility of transmission in Texas. Officials are expecting another outbreak of locally transmitted cases of disease, Van Deusen says. But when and where? That's a mystery. "There's so many factors that go into it, it's really impossible to make an ironclad prediction," he says. This story was published as part of a partnership between NPR and Kaiser Health News (KHN), which is an editorially independent program of the Henry J. Kaiser Family Foundation.


News Article | February 23, 2017
Site: www.npr.org

A lot of people are confused about when and if Republicans can "repeal and replace" the Affordable Care Act. Kaiser Health News' Julie Rovner clears things up in the first of a series.(Image credit: Joe Raedle/Getty Images)


Some See 'Flat-Fee Primary Care' As A GOP-Friendly Way To Provide Routine Care Back in the day, people paid for routine, primary medical care on their own and used insurance only when something serious came up. Some primary care doctors are betting that model can thrive again through a monthly subscription for routine care and a high-deductible insurance policy to take care of the big stuff. But the changes raise questions about whether that approach really leads to more effective and efficient health care. It's easy to understand the appeal of direct primary care, as it's called, for doctors and patients. Doctors charge a monthly fee, generally from $50 to $150, to provide routine clinical care and consultation, sometimes including basic lab work and tests. Patients who need other care — an MRI or surgery, for example — would be covered by their insurance policy, if they have one. Freed from having to devote time and money to managing insurance claims, doctors say they can accept fewer patients and spend more time with them without focusing on the question of which services are paid for. Patients, meanwhile, may get more personalized care. They also may save money on insurance if they can pair their primary care plan with a cheaper, high-deductible policy. Although only a fraction of primary care doctors practice this way, the proportion has grown from 2 percent to 3 percent in the past year, according to data from the American Academy of Family Physicians, which supports this type of practice. Advocates of direct primary care believe their prospects are bright because the new Republican administration favors market-driven approaches to health care. The plan introduced by Health and Human Services Secretary Tom Price when he was in Congress would allow people to pay monthly fees for direct primary care with funds from health savings accounts. A bipartisan bill introduced in January for consideration by the current Congress would amend Internal Revenue Service rules to permit that. William Bayne, a commercial real estate developer in Las Vegas, joined MedLion, a direct primary care company, last October. For $300 a month, Bayne gets routine primary care for himself, his wife and their five children. "It's great for the little stuff that comes up with five kids," says Bayne, 41. They also have a comprehensive family insurance plan. When Bayne's 8-year-old son woke up with what looked like a big pimple on the side of his eye one morning, they called MedLion and made an appointment for 12:30 that afternoon. But their family physician, Dr. Samir Qamar, called before that, having seen their names on the schedule, and asked for a photo of the boy's eye. Qamar said it looked like an oil gland in an eyelid was clogged and suggested they wait a day before coming in, because it would probably clear up on its own. It did. Qamar used to have a high-end concierge practice in Pebble Beach, Calif., where he provided on-call primary care services. When the Great Recession hit in 2007, he says, he and his wife, who was a physician with a traditional primary care practice, decided to offer concierge-style primary care at a lower price point. They moved to Las Vegas and opened MedLion, which is now available in seven locations in the Las Vegas area and works with 429 affiliated physicians in 25 states. Like many direct primary care practices, MedLion has shifted its focus from individuals to the employers who offer the service as a benefit. Workers typically pick one of their company's regular insurance plans and add the direct primary care service if they wish to. The company pays the monthly fee for those who choose the option and may or may not pass that cost along to workers. In perhaps the largest effort of its kind, the state of New Jersey recently kicked off a pilot program with Philadelphia-based direct primary care provider R-Health that aims to enroll at least 60,000 state employees in the first three years. Not surprisingly, the program is particularly appealing to people with chronic conditions, says Mason Reiner, CEO of R-Health. "Those are the folks who really need and can benefit from relationship-based primary care," he says. "It can make a big difference for them and for the state, since so much of the cost of care is driven by these folks." Improving access to primary care is important, says Dr. A. Mark Fendrick, an internist who directs the Center for Value-Based Insurance Design at the University of Michigan. But he cautions that while direct primary care doctors who get a flat monthly fee aren't motivated to provide unnecessary, low-value care, patients don't have the same incentive. For patients, an "all you can eat model" may encourage them to get care they don't need. "By removing fee-for-service [payments], this model is positive on the provider side," Fendrick says. "But it isn't nuanced enough on the patient side to get the system where we need it to be." Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Follow Michelle Andrews on Twitter: @mandrews110.


Shiffman M.L.,Health News | Benhamou Y.,Sercive dHepatologie
Liver International | Year: 2015

Chronic hepatitis C virus (HCV) causes chronic liver injury and can lead to cirrhosis and hepatocellular carcinoma (HCC). HCV can also interact with the immune system to cause several HCV related disorders including essential mixed cryoglobulinemia, vasculitis, dermatitis, glomerulonephritis and lymphoma. A strong association between HCV and diabetes mellitus also exists. These extrahepatic features may lead to increased fatigue and a reduced quality of life. It is now possible to cure most patients with chronic HCV using oral antiviral therapy. Many of these HCV-related disorders and symptoms can be cured when HCV is eradicated. However, some patients may have irreversible injury to extrahepatic sites, cirrhosis that cannot resolve, an increased risk for HCC, persistent fatigue and a reduced quality of life, despite achieving sustained virological response. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.


Shiffman M.L.,Health News
Liver International | Year: 2016

Chronic hepatitis C virus (HCV) infection affects an estimated 123 million persons worldwide and is the leading cause of cirrhosis and hepatocellular carcinoma in most countries. Approximately 75% of persons with chronic HCV were born between the years 1945-1965 and screening of patients in this birth cohort is now advocated. Unfortunately, these recommendations are not readily applied and a sizable population of infected persons who could benefit from treatment fall outside the birth cohort. Universal screening for HCV would be optimal. However, the primary limitation once patients are identified is accessing treatment which remains restricted in most countries. © 2016 John Wiley & Sons A/S.


Shiffman M.L.,Health News
Current Opinion in Gastroenterology | Year: 2014

Purpose of Review The evolution of treatment for patients with chronic hepatitis C virus (HCV) is evolving at a rapid pace. Two new oral antiviral agents, simeprevir and sofosbuvir, have already been approved and are now available for treatment of patients with chronic HCV. Other antiviral agents will be available during 2014. Recent Findings The protease inhibitor simeprevir was recently approved for use with peginterferon (PEGINF) and ribavirin (RBV) in patients with chronic genotype 1. About 80% of patients achieve a rapid virologic response and can be treated for 24 weeks the sustained virologic response (SVR) in treatment-naive patients is about 80%. Sofosbuvir, the first polymerase inhibitor, is effective in all HCV genotypes. When utilized with peginterferon and RBV for 12 weeks in treatment-naive patients with genotypes 1, 4, 5 and 6, an SVR of 90% is observed. Sofosbuvir and RBV have also been studied without interferon and represent the first interferon-free therapy for chronic HCV. Summary: It is now possible to cure chronic HCV in the vast majority of patients with chronic HCV and in many patients without interferon.

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