Wednesday, September 11, 2013

FDA changes painkiller labels to warn expectant mothers, after 2,500% growth in number of Ky. babies born addicted to drugs

The U.S. Food and Drug Administration (FDA) announced Tuesday drug-safety labeling changes and new post-market study requirements for all extended-release and long-acting opioids, and Kentucky political leaders applauded these measures to curb prescription drug abuse.

Long-acting opioids are intended to treat pain but may also lead to drug abuse, dependence or other complications if taken during pregnancy or misused. Now, as part of new FDA safety measures, the boxed warning labels on these drugs will warn expectant mothers that “the use of the products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS),” says the FDA release.

NOWS is among a group of problems called Neonatal Abstinence Syndrome (NAS) that occur in a newborn exposed to addictive drugs while in the mother’s womb. The baby's addiction can lead to birth defects, low birth weight, sudden infant death syndrome and other health conditions.

Attorney General Jack Conway and his counterparts in other states asked the FDA to act after several states reported an increase in the number of babies born addicted to prescription drugs. In Kentucky, "Instances of NAS have risen 2,500 percent over the past decade – from 29 incidents in 2001 to 730 in 2011," says a Conway release.

“I applaud the FDA for making this change that will better alert physicians and patients about the dangerous consequences of using these powerful prescription painkillers during pregnancy,” Conway said. Also as part of these safety labeling changes, certain educational materials for patients and health care professionals will be modified to reflect the new labeling.

U.S. Senate Republican Leader Mitch McConnell also praised the FDA's decision, saying it is a positive step forward in the fight against the state's prescription drug abuse problem.

Because little is known about the risks of long-term use of long-acting opioids, the FDA is also requiring the drug companies that make these products to conduct further studies and clinical trials to assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose and death, says the FDA.

"Altogether, the actions we're now announcing are part of FDA's efforts to make opioids as safe as possible for those who need them," said Dr. Douglas Throckmorton, deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research. "This is not the first or last initiative, and we will continue supporting broader efforts to solve the serious public health problems associated with the misuse and abuse of opioids."

Tuesday, September 10, 2013

Beshear announces rates in health-insurance exchange, says Kentuckians will like them, especially the federal 'discounts'

By Al Cross
Kentucky Health News

Tossing out the first examples of what Kentuckians will pay for required health coverage through the state health insurance exchange that opens Oct. 1, Gov. Steve Beshear predicted yesterday, "The vast majority of people are going to be very excited about what they find. . . . When they check it out, they’re gonna sign up."

Beshear said there has been much speculation about premiums, but little talk about the federal subsidies (he called them "discounts") that the exchange will offer to individuals and households with incomes up to 400 percent of the federal poverty level. He said subsidies will be available to individuals earning as much as $45,960 a year, and to families of four with income as high as $94,200 a year.
Beshear notes that 15 percent of Kentuckians are uninsured (light green in pie chart); at left is
Kynect Director Carrie Banahan; at right is Health and Family Services Secretary Audrey Haynes.
Tea Party activist David Adams, who recently lost the first round of his court battle to stop the exchange and Medicaid expansion, has said some consumers will have to pay almost double for their current coverage, and he told The Courier-Journal that the subsidies won't make up for that.

About 15 percent of Kentuckians, more than 640,000, have no health coverage. About 308,000 will become eligible for the Medicaid program, which is being expanded under federal health reform to include people with incomes up to 138 percent of the poverty level. Among the other 332,000, 85 percent of those people will qualify for subsidies, Beshear said, and in some cases the subsidy will be 100 percent.

The subsidies are available only through the insurance exchange, which the state has branded Kynect. The exchange will offer five plans, with premiums based only on age, income, geography, number of people on the plan and how many of them use tobacco.

State's example of bronze plan for a smoker earning $30,000
The ceiling for the tobacco surcharge is 40 percent, which has drawn criticism, but the state Department of Insurance said that is the most common surcharge in the state's health-insurance industry. Beshear said a 50-year-old man who smokes and earns $30,000 a year would still pay only $160 a month for coverage under the "bronze" plan, the one with the lowest premiums and highest deductibles and other out-of-pocket costs. Under the plan with the lowest deductibles, he would pay $279.

The bronze plan has a very large $6,300 deductible. The other standard plans are silver, gold and platinum; their deductibles are 20 percent (called "co-insurance") plus $4,600, $2,500 and $1,000, respectively. The exchange will also offer people under 30 a plan that provides only catastrophic coverage with a "very high deductible" and no subsidy, Beshear said.

Among other examples in the bronze plan, which has a $6,300 annual deductible: A nonsmoking farmer in his mid-50s earning $34,000 a year would pay $47; a family of four with no smokers and $70,000 annual income would pay $403; a 32-year-old single mother with two children and $40,000 income would pay $133.

Beshear offered no average cost, saying “There are too many factors to create an average that would be useful. . .. The bottom line is that families must do some research,” which the Kynect website and call center can help them with starting Oct. 1. He said the plans shouldn't be compared to individual plans offered in commercial market, because “the coverages are so much different.”

One big difference is that under the federal health reform law, all plans must cover prescription drugs, hospital care, maternity and newborn services, mental health and substance abuse services, emergency care, rehabilitative services and devices, laboratory services, preventive and wellness services, chronic disease management and pediatric services. Also, they are not allowed to have any dollar limits on coverage.

The law also bans insurance companies from denying or dropping coverage because of someone's health condition, meaning that "For the first time we’re gonna be able to provide affordable health insurance of every single Kentuckian. . . . This is a historic event in the commonwealth." The federal law requires practically every American to have health insurance.

The plans' geography is based on the state's eight Medicaid regions. Beshear said at least two insurance companies will be offering plans in each region, unlike some states. He said four companies have proposed to offer dental insurance, but those plans are still under review by Kynect and the Department of Insurance, which evaluates them for actuarial soundness.

Humana Inc., Anthem Blue Cross and the new Kentucky Health Cooperative will offer policies for individuals, while Anthem, the co-op, Bluegrass Family Health and United Healthcare will provide employee coverage for businesses. Employers with fewer than 50 workers are not required to insure them, and those with fewer than 25 employees can get tax credits for doing so.

The rates are for 2014. Beshear said companies were “understandably cautious” in setting premiums without any experience on which to base them, so he expects rates to decrease in 2015.

Beshear said companies are “understandably cautious” in setting rates during the first year when they have little experience or data on which to base rates, setting them high enough to ensure a profit. But, he said, with experience and especially if they have to make rebate payments, “I foresee, quite honestly, rates moving in a favorable (lower) direction.” - See more at: http://richmondregister.com/localnews/x789526347/Beshear-Most-uninsured-Kentuckians-get-discounts#sthash.Wlrm9Ty0.dpuf
Beshear said companies are “understandably cautious” in setting rates during the first year when they have little experience or data on which to base rates, setting them high enough to ensure a profit. But, he said, with experience and especially if they have to make rebate payments, “I foresee, quite honestly, rates moving in a favorable (lower) direction.” - See more at: http://richmondregister.com/localnews/x789526347/Beshear-Most-uninsured-Kentuckians-get-discounts#sthash.Wlrm9Ty0.dpuf
Kentucky Health News is an independent news service of the Institute for Rural Journalism and Community Issues, based in the School of Journalism and Telecommunications at the University of Kentucky, with support from the Foundation for a Healthy Kentucky.

Caregivers of Alzheimer's patients suffer, sometimes to death

Jim Crabtree


It's common to hear about diseases like Alzheimer's drastically affecting the lives of those who have it, often causing severe struggles and hardships. What you may not hear much about is how caregivers of people with Alzheimer's can also suffer deeply and greatly.

Jim Crabtree was actually relieved to find out that his wife and mother had been shot and killed by his father who then shot and killed himself, Linda Carroll of NBC News reports. (Today show photo: Crabtree with his wife, Rita)

"Crabtree had been struggling" to care for his 62-year old wife, who had been diagnosed with Alzheimer's six years before, and his elderly parents: a father with dementia and a mother with crippling arthritis.

Crabtree said he felt stretched thin with the responsibility of caring for his family and that by killing them, his father actually got rid of the burdens they caused him all at once, Carroll reports.

"Although rare, there are other murder-suicide cases involving caregivers and their charges. It’s a sign of how stressful the job is," Linda Ercoli, director of geriatric psychology at the Semel Institute at the University of California, Los Angeles said in the story.

The Alzheimer's Association has created a test for caregivers to check their stress levels. 

Carroll describes how caregivers' emotions can range from helplessness to anger when they don't understand that certain annoying behaviors by their ill patients could be symptoms of the disease. Because of high emotions that can arise in a home with Alzheimer's patients, Ercoli explains that violence isn't uncommon. Studies have found that 5 percent of caregivers have been violent with their patients and 16 percent of patients have been violent with their caregivers.

Caregivers at first get a certain satisfaction from taking care of others, but as the disease progresses, they tend to suffer from deep depression, anxiety or other disorders, Ercoli explains. Also, Carroll adds, caregivers sometimes face the risk of becoming physically sick themselves. 

Experts say that caregivers should reach out more to each other for support. “People don’t say, ‘I survived Alzheimer’s’,” Crabtree said. “We are the survivors. I survived caregiving.”

UK researcher calls for change in state law to allow syringe exchange program to curb hepatitis C epidemic in Eastern Ky.

Despite the benefits associated with syringe- or needle-exchange programs in preventing the spread of hepatitis C, Kentucky law still prohibits them, and a researcher from the University of Kentucky is calling upon policymakers to help curb this public health threat in Eastern Kentucky.

Syringe exchange programs were first created 30 years ago in response to the AIDS epidemic, and they are an important component of a comprehensive disease prevention strategy, says the Center for Disease Control and Prevention. Yet, Kentucky law prohibits them even though federally funded programs have successfully reduced disease transmission.

A recent study of 500 Appalachian drug users found that nearly two-thirds of them were infected with hepatitis C, reports Stu Johnson of WEKU News. Transmission of the disease in rural Appalachian communities is predominantly due to injection drug use, but community opposition and legal restrictions are barriers to establishing exchange programs.

UK epidemiologist Jennifer Havens would like to see a change in the state law to establish syringe exchange programs in Kentucky. She says these programs don't encourage drug use, which has in the past been an incorrect perception that can inhibit exchange adoption, says the CDC. The programs can instead reduce disease transmission.

“I don’t think anyone walking by the program, the syringe service program, is going to say, `I’m going to start doing drugs today because there’s a syringe service program.’ All it does is allow folks who are already injecting a safer way, a safer source of syringes and potentially program that they wouldn’t otherwise be able to access,” Havens told Johnson.

Haven's previous research, which examined individual and network factors among Appalachian drug users, found an association between injection of prescription opioids and hepatitis C. The study concluded that efforts preventing drug users' transition to injection, especially among prescription opioid users, may curb transmission of the disease. 

One public health tool that has successfully reduced disease transmission in other states is the creation of a syringe exchange program, says the CDC. In addition to asking for a policy change, Havens is calling for federal funding to establish syringe exchange programs in an area of Kentucky particularly impacted by the disease: the eastern region.

“In talking to a lot of the leaders in Eastern Kentucky, I haven’t necessarily approached this issue in particular, but they are at their breaking point with regard to what do we do about this epidemic, so I think, actually at the end of the day, a syringe service program would probably be fairly welcome,” Havens told Johnson.

Beyond reducing the spread of hepatitis C, syringe exchanges can also bring abusers into drug treatment programs, says Havens. The programs are reported to effectively link hard to reach drug users with prevention services, such as screening and drug abuse/ recovery programs, says the CDC. 

Monday, September 9, 2013

Beshear to speak on insurance exchange implementation, perhaps rates, at 1 p.m. ET Tuesday; can be viewed on YouTube

Gov. Steve Beshear will hold a press briefing at 1 p.m. Tuesday in the Capitol to discuss implementation of the state’s health insurance exchange, which is scheduled to start selling policies, offering subsidies and referring the poor to Medicaid on Oct. 1.

"Administration officials would not provide additional details, and it remained unclear if Beshear would release any figures on the cost to purchase insurance policies through the exchange," which the state has branded as Kynect, reports Mike Wynn of The Courier-Journal.

"Anthem, Humana and the new Kentucky Health Cooperative will all offer plans for individuals, while Anthem, Kentucky Health Cooperative, Bluegrass Family Health and United Healthcare will offer plans for small businesses," Wynn reports.

Courier-Journal runs comprehensive list of questions and answers about health insurance exchange set to open Oct. 1

Webinar Tuesday from 12:30 to 1:30 p.m. Eastern Time will look at rates and plan offerings in state health-insurance exchanges

The second in a series of webinars for journalists covering the Patient Protection and Affordable Care Act will be held Tuesday from 12:30 to 1:30 p.m. ET. This one will look at insurance rates and plan offerings in the new state-based marketplaces known as health benefits exchanges.

The co-directors of the Kaiser Family Foundation's program for the study of health reform and private insurance, Senior Vice President Larry Levitt and Vice President Gary Claxton, will give a brief presentation on the early reports of rates, how and why they vary, and what consumers would pay after taking tax credits into account. They will also answer journalists' questions about the new insurance market rules taking effect in 2014, and how to interpret insurance rates.

Journalists who want to register for the webinar can RSVP by clicking here. Shortly after registering, each participant will receive a confirmation email that contains information about how to join the webinar. If you are unable to attend the second webinar, but would like to receive all future updates on the series, please email your name and media affiliation to acawebinars@kff.org.

During the webinar series, participants are welcome to continue the conversation on Twitter with the hashtag #ACA101KFF. Archived video from the first webinar, "What Do Consumers Need to Know About Health Reform's Changes," is available on the foundation website. For more information, contact Victoria Chao at 650-854-9400 or the email address above.