Thursday, December 8, 2016

Huge new health law has provisions for research, opioids, mental health, faster approval of drugs and medical devices, and more

By Melissa Patrick
Kentucky Health News

Congress passed legislation Wednesday, Dec. 7 that will, among other things, increase funding for medical research and speed up the federal approval of new drugs and medical devices. It now heads to President Barack Obama's desk for his signature.

Sen. Mitch McConnell
“Sending this bipartisan legislation to the president’s desk is an important step in helping foster solutions when it comes to heartbreaking illnesses like Alzheimer’s, opioid addiction, mental-health disorders and cancer," U.S. Senate Majority Leader Mitch McConnell said in a news release.

The Kentucky Republican was a leading advocate of the $6.3 billion 21st Century Cures bill, which the Senate passed 94-5 after the House passed it 392-96 the previous week. Dissenters called it a giveaway to the pharmaceutical industry.

Obama said in a statement, "We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need. . . . This bill will make a big difference."

Vice President Joe Biden
The legislation provides $1 billion for the heroin and opioid epidemic, $1.8 billion for Vice President Joe Biden's "moonshot" initiative to cure cancer and nearly $3 billion for the BRAIN and Precision Medicine Initiatives, which targets diseases like Alzheimer's. It also has measures to improve mental-health treatment and to speed up the federal approval process for drugs and medical devices.

The $1 billion for opioid prevention efforts and expanded access to treatment for substance use disorders is to be spent over the next two years in $500 million allotments. The money will be allocated through need-based grants.

Agriculture Secretary Tom Vilsack
"These additional resources are particularly critical in rural areas, where rates of opioid misuse and overdose are high, access to treatment is limited, and patients who seek treatment are often met with waitlists that can mean the difference between life and death," Agriculture Secretary Tom Vilsack said in a statement.

NPR reports that the bill is "the most significant piece of mental health legislation since the 2008 law requiring equal insurance coverage for mental and physical health," called parity.

Among other things, the measure strengthens the enforcement of requirements to treat behavioral disorders like other diseases, includes grants to increase the number of mental-health providers, works to promote early intervention for psychosis and creates a new position to oversee the Substance Abuse and Mental Health Services Administration. It also eliminates the Medicaid "same day" exclusion, which prohibits separate payment for mental health and primary care services to a Medicaid enrollee on the same day.

“On behalf of the Kentucky Hospital Association and our 127 member hospitals, I would like to commend and thank Senator McConnell and Congress for the passage of the 21st Century Cures Act," Mike Rust, KHA president, said in a statement through McConnell's office. "The legislation overhauls drug development, accelerates new cures and treatments and includes a number of provisions important to Kentucky hospitals and their work to improve patient care."

But not everyone loves the bill.

Public Citizen, a consumer watchdog group that fought the legislation, called the Cures Act a holiday gift to drug makers. "It is sorely disappointing that Congress gave Big Pharma and the medical device industry an early Christmas present by passing the 21st Century Cures Act," Dr. Michael Carome, director of Public Citizen's Health Research Group, said in a statement. "This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices."

Sen. Elizabeth Warren, D-Mass.
Sens. Elizabeth Warren, D-Mass., Bernie Sanders, I-Vt., and Jeff Merkley, D-Ore., warned that the bill will weaken regulatory standards on drugs, doesn't provide enough money for medical research and does nothing to address the rising cost of medications, Fortune. Other senators voting against the bill were Ron Wyden, D-Ore. and Mike Lee, R-Utah.

Most Democrats were pleased about the funding for medical research they wanted in the bill, many still have concerns that the amount isn't adequate and that it will have to be approved in future legislation and re-authorized every year.

“While the bill authorizes $4.8 billion to the N.I.H. over the next 10 years — on average, a mere $480 million a year — this is barely a quarter per year of what the House passed last year,” Representative Rosa DeLauro, D-Conn., told The New York Times. “There is also no guarantee that the appropriators will follow through and provide funding each year.” DeLauro voted against the measure.

And others weren't pleased with how it's being paid for.

Rich Hamburg, interim president and CEO of Trust for America's Health, the preventive-medicine advocacy group,said in a statement that his organization was "deeply disappointed" that Congress used the Prevention and Public Health Fund to offset the bill's cost. Kaiser Health News in a reported, in listing the winners and the losers from the bill, that it cuts $3.5 billion, or about 30 percent, from the fund.

Hamburg said the fund "is the nation's first and only substantial investment in moving from our current 'sick care' system to a true preventive health system. Cutting the Prevention Fund will limit the nation's ability to improve health and quality of life and prevent disease."

UK Sanders-Brown Center on Aging gets grant of nearly $1 million to test new Alzheimer's 'drug candidate' on humans

The University of Kentucky Sanders-Brown Center on Aging has been awarded a grant to develop new prevention treatments for Alzheimers.

The Alzheimer's Association awarded a "Part of the Cloud Translational Research for Alzheimer's Disease" grant to Dr. Linda Van Eldick of the UK Sanders-Brown Center on Aging, whose research focuses on brain inflammation.

“The Part the Cloud initiative is an essential part of Alzheimer’s Association research funding because new, more-effective Alzheimer’s therapies are desperately needed," Executive Director DeeAnna Esslinger said in a news release. "In the United States alone, more than 5 million people live with this disease. That number is projected to more than triple to over 13 million by 2050 unless ways to stop, slow, or prevent it are found.”

The release notes that Alzheimer’s is the sixth-leading cause of death in the U.S., killing more Americans than diabetes and more than breast cancer and prostate cancer combined. Kentucky has almost 70,000 people living with Alzheimer’s.

Van Eldick's team is researching why people who have progressive loss of neurological function, called neurodegenerative disease, also have overactive and chronic inflammation that can lead to the brain cells not being able to communicate with each other and cause nerve cell damage.

Van Eldick's team has developed a new "drug candidate" that slowed the disease's progression in animals, and this $997,738, two-year grant will allow them to test for its safety in humans.

“Brain inflammation is now recognized as being an important driver of neurodegenerative disease progression, and we desperately need new brain-penetrant, selective anti-inflammatory drugs to be tested in humans," Van Eldik said in the release. "This new Part the Cloud funding will help us determine safe and potentially optimal doses of this drug candidate.”

The latest round of Part the Cloud awards supports four scientific investigations totaling more than $3 million. It is funded by proceeds generated through an annual benefit event, which has raised more than $17 million for Alzheimer’s research in the U.S. Internationally, the project has awarded more than $375 million to more than 2,400 projects.

For more information, visit the Alzheimer’s Association at alz.org or call 800-272-3900.


Wednesday, December 7, 2016

Study finds a genetic marker determines a love for salty foods; says they should be considered a treat, like dessert

Heart-disease death rate for Kentuckians over 35 in 2012-14 (CDC map)
A person's desire for salty foods may be determined by their genes, and that could spell trouble for their heart, according to a recent study at the University of Kentucky.

The College of Nursing study found that individuals with a certain "taste perception genotype" were more likely to eat more than the recommended amount of daily sodium than people without the genotype, says a UK news release.

This matters because too much salt in your bloodstream can cause high blood pressure, or hypertension, one of the major risk factors for heart disease. And heart disease is the leading cause of death in the United States, killing about 610,000 Americans a year, or one in every four deaths, according to the federal Centers for Disease Control and Prevention.

Kentucky leads the nation in both heart disease and hypertension rates. Its death rate from heart disease is 394 per 100,000 people; the national rate is 328. Kentucky ranks sixth in the number of people diagnosed with hypertension, at 39 percent, according to the State of Obesity report. The report also projects that about 1.3 million Kentuckians will be diagnosed with heart disease by 2030.

Sources of salt you may not have thought about
The release notes that the study paves the way toward future prevention opportunities, and that future research will help develop targeted approaches to reduce salt intake by people who are genetically predisposed to salty foods.

The American Heart Association recommends that most people eat no more than 2,300 milligrams of sodium per day (that's one teaspoon of salt) and ideally no more than 1,500 mg. The AHA says about 77 percent of a person's salt intake comes from prepared, packaged and restaurant foods.

An AHA graphic of "The Salty Six" shows six popular foods to pay attention to if you are watching your salt intake because they can add high levels of salt to your diet, including cold cuts and cured meats, pizza, soup, breads and rolls, chicken and burritos and tacos.

The UK release also offers some tips on how to reduce your sodium intake:
  • Keep a journal of your salt intake (1/4 teaspoon salt = 575 mg sodium; 1/2 teaspoon salt = 1,150 mg sodium)
  • Cook with minimal amounts of added salt, using herbs and spices instead. 
  • Read food labels.
  • Opt for home-cooked meals so that you can control salt amounts
  • Consider salty foods a treat, much like you would consider sugary treats
The AHA adds: "One estimate suggested that if the U.S. population moved to an average intake of 1,500 mg/day sodium from its current level, it could result in a 25.6 percent overall decrease in blood pressure and an estimated $26.2 billion in health care savings. Another estimate projected that achieving this goal would reduce deaths from cardiovascular disease by anywhere from 500,000 to nearly 1.2 million over the next 10 years."

Hospitals warn of big hit if Obamacare repeal send them lots more uninsured patients; rural hospitals at more risk

The two big lobbies for hospitals are telling Congress and President-elect Donald Trump, who are planning to repeal and replace President Obama's health-reform law, that "the government should help hospitals avoid massive financial losses if the law is rescinded in a way that causes a surge of uninsured patients," Amy Goldstein reports for The Washington Post.

Warning of "an unprecedented public health crisis," the Federation of American Hospitals, representing investor-owned facilities, and the American Hospital Association called a press conference to go with their letter, Goldstein reports. "Joann Anderson, president of Southeastern Health, "a financially fragile rural hospital in Lumberton, N.C., one of that state’s most economically depressed areas, said the prospect of repealing the health law without a replacement to keep people insured is 'gut-wrenching . . . We cannot take additional cuts.'" Dozens of rural hospitals have closed in the last six years.

Hospitals are "the first sector of the health-care industry to speak out publicly to try to protect itself from a sharp reversal in health policy that Trump is promising and congressional Republicans have long favored," Goldstein notes. "When it was enacted in 2010, the health-care law was a product of a delicate balancing act among various parts of the health-care industry. Each essentially agreed to sacrifices in exchange for the prospect of millions of Americans gaining insurance to help cover their medical expenses."

The balancing act includes rural hospitals, which have special provisions in the law and other federal statutes. For example, the law expanded special funding for hospitals with relatively few patients, but that provision is scheduled to expire in October 2017. That would have a significant negative impact on rural hospitals, says a study just published by the Journal of Rural Health.

The exact nature of the repeal-and-replace strategy is unclear because Republicans will be in a position to make laws on their own after Trump replaces Obama Jan. 20. Until now, they have passed repeal bills with no replacement, knowing Obama would veto them. House Speaker Paul Ryan and Senate Majority Leader Mitch McConnell have said they favor phasing out Obamacare and phasing in a replacement, but the time frame for that is uncertain.

Tuesday, December 6, 2016

Study finds there is no safe amount of smoking; one cigarette per day increases risk of earlier death 64 percent

By Melissa Patrick
Kentucky Health News

Smoking a few cigarettes a day or even a week increases the risk of an earlier death compared to people who don't smoke, according to a new study.

“There is no safe level of exposure to tobacco smoke,” Maki Inoue-Choi, National Cancer Institute researcher and lead author of the study, said in the news release.

Smoking is the leading cause of preventable disease and death in the United States, accounting for more than 480,000 deaths every year, according to the federal Centers for Disease Control and Prevention. Kentucky has one of the highest smoking rates in the nation, at 26 percent. The national average is 15 percent.

The NCI study, published in JAMA Internal Medicine, found that people who consistently smoked an average of less than one cigarette per day over their lifetime had a 64 percent higher risk of earlier death than nonsmokers, and those who smoked between one and 10 cigarettes per day had an 87 percent higher risk.

In addition, the study found a strong association to lung cancer. The group that smoked less than one cigarette a day over their lifetimes had nine times the risk of dying from lung cancer when compared to nonsmokers; and those who smoked one to 10 cigarettes a day had a 12 times higher risk.

The study also found that people who smoked between one and 10 cigarettes a day had over six times the risk of dying from respiratory diseases than nonsmokers and about one and half times the risk of dying of cardiovascular disease than nonsmokers.

However, health risks were lower for those who had quit, especially for those who quit at an earlier age.

The researchers note that while many studies have documented the harmful effects of smoking on health, the health effects of "low-intensity smoking" have not been well studied and that "many smokers believe that low-intensity smoking does not affect their health."

“Together, these findings indicate that smoking even a small number of cigarettes per day has substantial negative health effects and provide further evidence that smoking cessation benefits all smokers, regardless of how few cigarettes they smoke," Inoue-Choi said.

The study analyzed data for almost 300,000 adults in the NIH-AARP Diet and Health Study. Participants were between 59 and 82 and self-reported their smoking histories over their lifetime.

The study acknowledged its limitations: self-reported data relies on memory, most participants were older and white, and despite the large number of people surveyed, there was a low number of consistent low-intensity smokers.

Monday, December 5, 2016

Foundation for a Healthy Ky. to have new direction and focus, new CEO Ben Chandler says in announcing new board members

The Foundation for a Healthy Kentucky will take a new direction under Ben Chandler, its new president and CEO, Chandler said in announcing new leaders and members for the foundation's board.

Ben Chandler
"As we look ahead to 2017 and beyond, the foundation will be developing a new strategic direction and focus and we welcome the guidance of our newest board members and officers." Chandler, who became president and CEO Sept. 1, said in a news release. Chandler, a former U.S. congressman, helped start the foundation as state attorney general.

On Monday, the foundation board named Delta Dental of Kentucky President and CEO Clifford T. Maesaka Jr. and Berea College professor Janie Brudette Blythe as members, and elected its 2017 officers: Charles Ross, retired director of the Purchase District Health Department in Paducah, as its new chair; Mark Carter, CEO of Passport Health Plan, new vice chair; Allen Montgomery, a Norton Healthcare executive, secretary; and Dr. Brent Wright, a Glasgow family physician, treasurer.

The 15-member board establishes and oversees the financial, program and policy affairs activities of the foundation, which works to improve Kentuckians' health and address unmet health care needs in the the state.

Janice B. Blythe
Blythe, who returns to the board following an interim appointment that expired in November 2015, has been a nutrition and dietetics health professional for more than four decades. She is the Julia Parmly Billings Chair in Child and Family Studies and an academic division chair at Berea.

Clifford Maesaka Jr.
Maesaka has led Delta Dental and its subsidiaries since 1995. He holds a dental degree from Indiana University and an MBA from the University of St. Thomas in St. Paul, Minn. Click here for more information on the foundation's newest board members.

Outgoing board members are Christopher Roszman, chief financial officer of Centerstone Kentucky (formerly Seven Counties Services) in Louisville, and Rosalie Albright, a registered nurse from Bullitt County who works in the Danville-based Ephraim McDowell Health Community Services Department.

"We will miss the endless hours of dedicated leadership both Chris and Rosie have contributed and are deeply grateful for their years of service to the Foundation and to Kentuckians," Chandler said.

Sunday, December 4, 2016

Annual study of Ky. kids' well-being looks at role of race, income and location; includes lots of county-level data, graphics maker

By Melissa Patrick
Kentucky Health News

The annual Kentucky Kids Count report has measured the overall well-being of Kentucky's children for 26 years, but this year's report digs deeper and looks at influences of family income, race and location on these measures, and finds that they matter.

“We need to continue to implement policies and practices that help all children, and in order to do that, we must face some uncomfortable truths," Terry Brooks, executive director of Kentucky Youth Advocates, said in a news release. "One of those truths is that the ZIP code in which children live, the amount of money their family earns, and the color of their skin are pervasive and powerful influences on the childhood they will have and the future they can embrace."

The report paints a vivid picture of what Brooks refers to: "We know that a toddler growing up in a rural southeastern Kentucky county will have different opportunities than a toddler growing up in the suburbs of Northern Kentucky, just like a young girl whose family is in deep poverty will have different life experiences than a young girl whose family is financially stable. And a black teenager will experience high school differently than his or her white peer."
Overall child well-being: Counties grouped from high to low

The Kentucky counties with the highest overall child well-being are Oldham, Boone, Spencer, Woodford, and Ballard. Wolfe, Clay, Martin, Owsley and Lee counties scored worst.

The report, released Sunday by KYA, is part of the 26th annual release of the County Data Book, which ranks every Kentucky county on overall child well-being through 16 measures in four areas: economic security, education, health and family, and community strengths. 

The report notes that the 2016 report can only be compared to the 2015 report because of changes made last year. Click here to see the full report. Click here for the Kids Count Data Center for access to national, state and county data.

Most of the 16 indicators didn't change much from last year, but the report found that income, race and location influenced every area of child well-being measured in the study. The report gives a detailed overview of these findings and offers solutions to address them.

Economic security

More than one in four Kentucky children live in poverty: 26 percent. In several counties, the figure is more than 50 percent.

The report found that the state's young children, those in Eastern Kentucky, and black and Hispanic children have a higher chance of living in poverty.

"There are several reasons why these groups face additional challenges in financial stability such as the high cost of child care for families with young children, job losses due to declining industries, and historical discrimination that prevented black and Hispanic families from building wealth and assets," the report says. The study noted that race is a strong indicator of childhood poverty, with black and Hispanic children more likely to experience deep poverty, and to live in a neighborhood with concentrated poverty.

The report calls for "enhanced income and earning potential, building assets and rewarding personal responsibility through work supports" to help families find their way out of poverty. But it also lists specific legislation to decrease poverty, including paid family leave, a refundable earned-income tax credit, expanding access to child-care subsidies and limiting jail time for parents who have committed minor offenses to allow them to keep their jobs and support their families.

Education: rural-urban disparities

For more than 20 years, Kentucky has made gradual, steady progress on the percentage of fourth graders who are proficient in reading, which is important because studies show that a child who struggles to read proficiently in fourth grade is less likely to graduate. That trend continues, as the number of fourth graders not proficient in reading dropped to 44 percent in 2015-16 from 48 percent in 2014-15.

The rates varied greatly across school districts. The study also found that low-income children were half as likely as their higher-income peers to be proficient in reading by the fourth grade and that black and Hispanic students face greater barriers to reading proficiency.

The report also found that half of kindergarten students still don't meet the standards that define "readiness to learn." This measure is also influenced by income; 60 percent of low-income three- and four-year-olds in Kentucky are not in pre-school.

Young children in rural areas are less likely to attend an early-childhood learning program than those in urban areas, and "Research shows that children living in rural areas who start kindergarten with lower levels of reading achievement are more likely to fall behind their suburban and urban counterparts by third grade, even when controlling for household income," the report says.

The report calls for communities to recognize and support parents as children's first teachers, prevent summer learning loss and keep children healthy, which aids learning. It also suggests improved teacher training, more help for students and limiting discipline practices that remove children from the classroom. In addition, it calls for policymakers to increase investments in high-quality early learning programs, with a focus on reaching children who need it the most.

Fewer teen births, but smokers are a problem

The good news is that Kentucky's teen birth rates continue to drop, to 37.9 teen births per 1,000 in this year's report, compared to 40.6 per 1,000 last year.

But the report also points out that 8.7 percent of Kentucky's babies are born with a low birthweight (less than 5.5 pounds) and that Kentucky has the second highest rate of births to mothers who smoked during pregnancy (21.5 percent), a known cause of low birthweight. Kentucky has the nation's second highest smoking rate, 26.5 percent.

The report calls for tobacco-prevention programs for youth, smoking-cessation programs for pregnant women, and strong smoke-free workplace ordinances to reduce the rates of low-birthweight babies.

"Infants born at a low birthweight are more likely to face short- and long-term health complications and are 25 times more likely to die within their first year of life than those born at a normal weight," says the report, adding that it is "also associated with impaired cognitive development, which impacts educational success, regardless of socioeconomic status."

In Kentucky, the percentage of low-weight babies ranges from a low of 5 percent in Carlisle County, on the Mississippi River, to a high of 14 percent in Lee County, with the highest rates found in Eastern Kentucky. Babies born to low-income mothers are also more likely to have low weight.

The Kids Count Data Center can display comparative historical data for up to seven counties. Here's a multi-line graph of births to smoking mothers in the Lake Cumberland region since 2004-06.

The graph shows that all seven have all exceeded the state average of births to smoking mothers, that Russell County has always led the group of seven, and that its rate has gradually declined since a jump a decade ago.

Family and community: crime and dropouts hurt

The report found that more than one in 10 Kentucky children have lived with a parent who has served time in jail or prison, the highest rate in the nation.

It also found that over the past 10 years, the share of Kentucky children whose head of household has at least completed high school has steadily increased. However, in 17 counties, at least one in four births was to a mother who did not complete high school.

"The more education parents have, the more likely their children are to be prepared for school, to succeed academically and complete high school by age 20, and the less likely they are to be born at a low birthweight, engage in unhealthy behaviors, and become a teenage parent," the report says.

The report noted that adults in rural areas have consistently had lower educational levels and are more likely to be poor, regardless of education level, than those in urban areas; low educational levels are strongly linked to low incomes; and black and Hispanic children in Kentucky are more likely to live in a family where the head of household lacks a high school diploma.

The report calls for Kentucky to utilize a two-generation approaches that address both the needs of parents and children to help them attain needed educational levels and increased economic stability. It also called on workforce development efforts to provide benefits that help parents improve their skills and education.

Brooks said: “For kids in Kentucky, there are reasons why place, income, and race matter. Those reasons have been imbedded in us for years, and it is going to take time to change policies and attitudes to give every child a chance to thrive. We must learn, grow, and move forward together. It’s going to take all of us. Kids Count brings us the facts. Let’s face the facts and grow together to make Kentucky the best place in America to be young for all children. Our kids deserve no less."

McConnell says Obamacare will have to be replaced gradually

The Patient Protection and Affordable Care Act will be replaced "in a phased-in way over a period of time," not right away, Senate Majority Leader Mitch McConnell said Saturday.

"You can't just snap your fingers and go from where we are today to where we're headed," McConnell told the Kentucky Farm Bureau Federation at its annual meeting in Louisville. "This has to be done carefully."
Sen. Mitch McConnell spoke at the annual Farm Bureau meeting Saturday. (Photo by Ry Barton, WFPL)
"This emerging 'repeal and delay' strategy, which [House] Speaker Paul D. Ryan discussed this week with Vice President-elect Mike Pence, underscores a growing recognition that replacing the health care law will be technically complicated and could be politically explosive," report Robert Pear, Jennifer Steinhauer and Robert Kaplan of The New York Times.

Bruce Schreiner of The Associated Press paraphrases McConnell as saying: "Congress will begin work immediately next year toward repealing President Barack Obama's health-care law but delay the changes as Republicans try to come up with an alternative," something they didn't have to do when they passed repeal bills because they knew Obama would veto them.

McConnell "insisted that some 20 million Americans who have health care through the six-year-old law will not lose coverage, though the likely upheaval in the insurance industry suggests many could," Schreiner reports.

"President-elect Donald Trump says he would like to keep major elements of the law — allowing children to remain on their parents' plans until age 26 and ensuring companies don't deny coverage for pre-existing conditions. But it's unclear how a new version of the law could force insurance companies to provide the latter coverage."

One way to do that would be to keep the law's requirement that all Americans buy health insurance, an idea that many Republicans favored before Obama was elected but opposed when he pushed the law through Congress with only Democratic votes. A possible alternative would be to keep the requirement but allow younger people to buy cheaper policies with thinner coverage.

The details of that will wait, as Republicans push a repeal bill through the House and the Senate, in the latter under budget-reconciliation rules that will prevent Democrats from blocking it with a filibuster. "The health law includes insurance market standards and other policies that do not directly affect the budget, and Senate Republicans would, in many cases, need 60 votes to change such provisions," the Times notes.

The "repeal and delay" approach "is meant to give Mr. Trump’s supporters the repeal of the health law that he repeatedly promised at rallies," the Times reports. "It would also give Republicans time to try to assure consumers and the health industry that they will not instantly upend the health insurance market, and to pressure some Democrats to support a Republican alternative."

Unwinding the law "could be as difficult for Republicans as it was for Democrats to pass it in the first place and could lead Republicans into a dangerous cul-de-sac, where the existing law is in shambles but no replacement can pass the narrowly divided Senate. Democrats would face political pressure in that case as well," the Times reporters write. "It is not sheer coincidence that at least one idea envisions putting the effective date well beyond the midterm congressional elections in 2018."

Tennessee Sen. Lamar Alexander, chair of the Senate health committee, told the Times, “I imagine this will take several years to completely make that sort of transition — to make sure we do no harm, create a good health care system that everyone has access to, and that we repeal the parts of Obamacare that need to be repealed.”

However, the Times reporters write: "Health policy experts suggest 'repeal and delay' would be extremely damaging to a health care system already on edge. “The idea that you can repeal the Affordable Care Act with a two- or three-year transition period and not create market chaos is a total fantasy,” Sabrina Corlette, a professor at the Health Policy Institute of Georgetown University, told the Times. “Insurers need to know the rules of the road in order to develop plans and set premiums.”

The Times reports, "Any legislation is likely to include elements on which Republicans generally agree: tax credits for health insurance; new incentives for health savings accounts; subsidies for state high-risk pools, to help people who could not otherwise obtain insurance; authority for sales of insurance across state lines; and some protection for people with pre-existing conditions who have maintained continuous coverage.

"Republicans said they hoped that the certainty of repeal would increase pressure on Democrats to sign on to some of these ideas. Democratic leaders, for now, feel no such pressure. Republicans 'are going to have an awfully hard time' if they try to repeal the health law without proposing a replacement, said Sen. Chuck Schumer of New York, the next Democratic leader. 'There would be consequences for so many millions of people.'"

Saturday, December 3, 2016

New guidelines say sleep aids should only be used short-term; physicians recommends "cognitive behavioral therapy"

Photo illustration: medicalnewstoday.com
Sleep aids are readily available to the one-third of adults who suffer from insomnia, but health-care providers are beginning to steer patients away from them because of the risks the drugs pose, Laura Landro reports for The Wall Street Journal.

“Drugs don’t provide a natural sleep, and the side effects are significant,” Nitin Damle, an internist and president of the American College of Physicians, told Landro.“It’s true in all age groups, but even more problematic for older adults."

After reviewing more than 15 years of evidence, the physicians' group issued new guidelines in May for the management of chronic insomnia, recommending cognitive behavioral therapy as the first-line of treatment for adults. Cognitive behavioral therapy determines patient's actions that may be prohibiting sleep, and then develops a customized list of "do"s and "don’t"s for optimal sleeping.

The guidelines also say that drugs should only be used if therapy is unsuccessful, should only be used short-term, defined as four to five weeks, and only after the benefits and risks have been discussed with the patient. “The intent is for them to be on a short course, and then get off of it,” David Maness, a professor of family medicine at the University of Tennessee Health Science Center in Memphis, told Landro.

“But then the problem is perpetuated, and before you know it, it’s 10 years later, and it keeps getting refilled and no one has reviewed it.” In addition to their addictive properties, prescription sleep aids can cause fuzzy thinking, short-term memory loss, and diminished liver and kidney function, which can cause fatigue, weakness and impaired balance, in older patients. Longer term, sleep drugs may contribute to more serious mental-function issues, Landro reports.

Benzodiazepines, like Halcion, and non-benzodiazapenes, like Ambien, Lunesta and Sonata, are the most commonly prescribed sleeping pills. These drugs, called sedative hypnotics, slow activity in the brain to bring on sleep.

"The American Geriatrics Society recommends against using benzodiazepines or other sedative hypnotics in older adults as first choice for insomnia because large-scale studies consistently show that the risk or motor-vehicle accidents, falls and hip fractures leading to hospitalization and death can more than double in older adults taking the drugs," Landro writes.

There is a new class of sleeping pills that act differently than sedative hypnotics, but are not physically addictive and don't have withdrawal symptoms after stopping the drug. However, they do have some side-effects like drowsiness the next day, sleepwalking and performing activities while sleeping.

Landro reports that over-the-counter drugs can also be risky because many of them use the antihistamine diphenhydramine, which is a type of drugs known as anticholinergics. "A study last year in JAMA Internal Medicine suggested higher cumulative use of anticholinergics, which can impair memory and attention, is associated with an increased risk for dementia," she writes.

Patients who are dependent on sleeping pills should not stop them abruptly, but should taper off of them, Sean Jeffrey, director of clinical pharmacy services at Hartford Healthcare and a clinical professor at the University of Connecticut School of Pharmacy, told Landro.

The hospital ER you visit may be in your insurance network, but your ER doctor may not be, and that could cost you big money

You go to the emergency room of a hospital, choosing it because it's in the network of your health insurer. But then you get a big bill because the ER doctor who treated you isn't in the network.

"Such 'surprises' have surfaced as a major patient problem, but because of entrenched healthcare interests, a solution is not likely anytime soon," Trudy Lieberman writes in her "Thinking About Health" column for Rural Health News Service.

"Because ER docs are usually assured a steady stream of patients, many believe they don’t need to accept potentially lower fees from insurers in exchange for any new patients they might attract by belonging to a network," Lieberman writes. "That’s not the case for other specialists who may rely on insurer networks for more business. Whatever the reason, emergency-room patients may be stuck with huge bills their insurance company may not cover, or it will pay less than if patients had used in-network doctors."

A Yale University study published in the New England Journal of Medicine "found that out-of-network doctors treated 22 percent of the patients who visited emergency departments," Lieberman reports. "The average bill patients incurred was $623. The highest bill was more than $19,000. . . . Not surprisingly, researchers found out-of-network ER doctors ended up getting paid a lot more than those who were part of a network."

Chuck Bell, programs director for Consumers Union, told Lieberman, “Consumers would be astonished to see how poor the odds are of getting an in-network doctor in the emergency room. . . . The fact this type of price gouging has become routine operating procedure in so many emergency departments is shameful and appalling.”

A Texas study by the liberal Center for Public Policy Priorities found that 45 percent of in-network hospitals in the state used by United Healthcare, and 56 percent of Humana Inc.'s hospitals, had no in-network ER doctors.

"The odds of getting redress are also low," Lieberman reports. "Too many consumers don’t contest their bills. Only about 25 percent of those getting surprise bills do, Bell told me. Of those who do protest to their insurer, only half get their bill forgiven or reduced." Medicare patients "can protect themselves from these excess charges should they use a doctor who doesn’t accept Medicare’s fee schedule by buying Medigap policies Plan F and Plan G. For those with Medicare Advantage plans, there’s no protection until the beneficiary reaches the plan’s out-of-pocket spending limit."

"The standard advice, to ask if your doctor is in the network, is silly when it comes to care in the ER. What patient having a heart attack is going to look up and say, 'Hey, Doc, are you with Aetna?' . . . Bell says it will take an act of Congress to solve this problem. Public outrage will have to get much louder if that’s to happen."

Meanwhile, "Think twice before you choose to go to the ER for a problem that can wait until you see your regular doctor," Lieberman advises. "Although Obamacare was supposed to cut down on emergency-room use ... people are still going to ERs for less serious conditions, many being enticed by hospitals themselves that advertise their ER wait times on billboards."

Been faced with surprise billing? Tell Trudy at trudy.lieberman@gmail.com.

Friday, December 2, 2016

UK researchers develop video game to teach agricultural safety to college and high-school students

Screen shot of "Hazard Ridge" video game
Researchers at the University of Kentucky are using a video game to educate young people about the dangers of agriculture, a line of work that has one of the highest rates of workplace fatalities in the U.S., Olivia McCoy reports for UKnow.

Since 2013 researchers at the UK College of Education and the Southeast Center for Agricultural Health and Injury Prevention, in UK's College of Public Health, have been teaching agriculture students and high-school students ag safety using a 3-D game called Hazard Ridge, which "simulates an injury that has occurred in a small rural town where teens are disappearing and the town is going bankrupt," McCoy writes.

"Players serve as the investigator of this issue and learn how agricultural injuries have negative effects on the town’s economy and citizens," McCoy writes. "The game teaches investigative skills and educates on how to conduct a financial analysis of injury."

Jennifer Watson, research coordinator for the Southeast Center for Agricultural Health and Injury Prevention, "said one of the goals for the game is to 'overcome the culture of comfort'," McCoy writes. Watson told McCoy, "Spending their entire lives around dangerous equipment lulls those working and living on farms into a false sense of safety and lessens their belief that they are at risk for injury." She said preventive measures, such as the game, reduces the risk of injury or death. (Read more)

Thursday, December 1, 2016

Republicans agree on bill to speed medical research and drug approval, increase funding; some Democrats want changes

Legislation to speed up the federal approval of new drugs and medical devices and to increase funding of medical research passed the U.S. House of Representatives 392-96 on Wednesday, Nov. 30 and is likely to get a Senate vote soon, though it faces opposition from some Democratic senators.

Senate Majority Leader Mitch McConnell
"This medical innovation bill is one that can have a substantial impact for families across the country," said Senate Majority Leader Mitch McConnell, R-Ky., a strong supporter of the legislation. He has pushed for a provision in the bill to allow the U.S. Food and Drug Administration to accelerate approval of stem cell therapies, formally called "regenerative advanced therapies," Sheila Kaplan reports for Stat, the health-and-medicine supplement to The Boston Globe.

The provision "call(s) for devices used with a stem cell product to be considered moderate risk, unless the secretary of Health and Human Services determines that the device or use requires a higher risk classification," Kaplan reports.

Opponents of the provision believe stem-cell therapies should be more closely regulated and subject to clinical trials.

Sen. Elizabeth Warren, D-Mass., in a Monday floor speech, said a big contributor to McConnell's campaign would benefit from this stem-cell therapy provision, Kaplan reports in a separate article. “This mega-donor has poured millions of dollars into Mitch McConnell’s personal campaign coffers and into his Republican super PAC, and now he wants his reward. So the Cures Act offers to sell government favors," she said.

The $6.3 billion legislation would give states $1 billion to fight the opioid crisis; provide $4.8 billion for continuing three "signature Obama administration research programs" over the next 10 years, including: Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative; a $500 million increase to the FDA and a number of programs to improve mental health care, Kaplan reports.

A "major sticking point" for the bill, Kaplan reports, is that House Democrats required it to have funding for medical research, but Republicans on the Senate Health, Education, Labor and Pensions Committee would not approve funding without determining where the money would come from.

But now that the Patient Protection and Affordable Care Act is likely to be repealed, with the election of Donald Trump, Democrats have agreed "to underwrite the Cures Act with some money from the ACA, and some to be generated by sales of part of the Strategic Petroleum Reserve," Kaplan writes. NPR adds that it will also be paid for through reduced payments to Medicare and Medicaid.

"Leaders from both parties have called passage of the Cures bill the most important thing Congress could do this year," Kaplan writes.

Opposition to the bill

Warren said she also opposed the Cures Act because she said it had been "hijacked" by the pharmaceutical industry.

The bill has been debated at length over the past three years, Kaplan notes, with "a parade of celebrities" and more than 1,300 lobbyists representing pharmaceutical companies, medical device firms and patient advocacy groups pushing for its passage.

The Society for Public Health Education opposes the bill because it takes money away from the Public Health and Prevention Fund, which pays for programs that address obesity, diabetes, smoking cessation, cancer screenings, access to vaccinations and access to healthy foods, to pay for the Cures Act.

"Taking $100 million from the Prevention & Public Health Fund will have disastrous consequences for the future of public health," the group said.

Many consumer groups continue to oppose the bill, agreeing with Warren, who has said that many Democrats are agreeing to the bill in order to get the additional funds for medical research, which isn't guaranteed and will have to be approved in future legislation.

“While there are positive aspects of this legislation, many provisions would severely weaken the FDA’s drug and medical device approval standards and seriously harm rather than help patients,” Jack Mitchell, director of government relations for the National Center for Health Research, which advocates for patient safety, told Kaplan. “Congress shouldn’t sacrifice the safety and effectiveness of medical products in order to increase research monies.”

Kaplan also reports that many public health advocates have called the bill's provisions a "weaker alternative to the current gold standard of randomized clinical trials."

Sen. Chuck Grassley, R-Iowa, has voiced his opposition to the bill because it "exempts companies from reporting payments made to doctors for receiving continuing medical education sessions, medical journals or textbooks, " Ed Silverman writes for Stat. Consumer groups have also called for the removal of this provision.