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Thursday, December 20, 2018

Hep C, drug abuse often go hand in hand but screening for infection lags


Not testing these patients for hepatitis C is an enormous missed opportunity, public health experts agree.


When people seek help at a drug treatment center for an opioid addiction, concerns about having contracted hepatitis C are generally low on their list.
They’ve often reached a crisis point in their lives, said Marie Sutton, the CEO of Imagine Hope, a consulting group that provides staff training and technical assistance to facilitate testing for the liver-damaging virus at more than 30 drug treatment centers in Georgia.
“They just want to handle [their drug problem],” she said. “Sometimes they don’t have the bandwidth to take on too many other things.”

Even though health care facilities that serve people who use drugs are well-positioned to initiate screening, too often that is not happening, recent studies have shown. Not testing these patients for hepatitis C is an enormous missed opportunity, public health experts agree.
“It’s a disease that can be cured the moment we identify somebody,” said Tom Nealon, president and CEO of the American Liver Foundation. “Not testing is incomprehensible when you look at what hepatitis C does to their bodies and their livers.”
As the number of people who inject drugs has soared, the rate of hepatitis C infection, frequently tied to sharing needles, has climbed steeply, too.
People who are infected with hepatitis C can go for years without symptoms, so they may not have any inkling that they’re sick. That delayed onset makes screening important, advocates say, since people may unwittingly infect others.
Screening people who misuse drugs for the deadly virus is a commonsense strategy to get people cured and break the cycle of transmission. But there are obstacles — sometimes a lack of money, staff or other resources.
“Reimbursement rates for hepatitis C testing often don’t match the cost,” said Andrew Reynolds, hepatitis C and harm reduction manager at Project Inform, an advocacy group. If patients test positive, they need to be linked to treatment, and financial support for staffing to do that is often limited, he said.
Only 27.5 percent of 12,166 substance abuse facilities reported offering testing for hepatitis C in 2017, according to research published on the blog for the journal Health Affairs in October. It is one of the first studies to look at this issue since the federal government began reporting on testing for HIV and hepatitis C in its national survey of substance abuse and treatment services in 2016.
When researchers narrowed their analysis to the much smaller number of opioid treatment programs that are federally certified to use methadone and other drugs in treatment, a higher, but still not overwhelming, proportion — just over 63 percent — said they offered screening for hepatitis C.
“We certainly thought the numbers would be higher,” said Asal Sayas, a co-author of the analysis and director of government affairs at amfAR, the Foundation for AIDS Research. “Testing is one of the most fundamental forms of prevention.”
In primary care settings, the situation sometimes isn’t much better, even when patients have a diagnosed “opioid-use disorder.”
An analysis by Boston Medical Center researchers of nearly 270,000 medical records of people aged 13 to 21 who visited federally qualified health centers from 2012 to 2017 found that 36 percent of the 875 patients with that diagnosis were tested for hepatitis C.
“Even in a setting with an identified risk factor in opioid-use disorder, too few youths are being screened for hepatitis C,” said Dr. Rachel Epstein, a postdoctoral research fellow in infectious diseases at Boston Medical Center and a co-author of the study, which was presented at the annual meeting of the Infectious Diseases Society of America in early October.
Hepatitis C is a virus that causes inflammation to the liver, in some cases leading to scarring, liver cancer and death. It is transmitted through blood, including contaminated needles that people share when they inject drugs.
The initial test for hepatitis C is an inexpensive blood test to check for antibodies in the blood that indicate exposure to the virus. If that antibody test is positive, a second test is necessary to find out if the virus is circulating in the bloodstream, which would mean someone is infected with the virus. The secondtest can cost several hundred dollars, experts say.
To be sure, some federally qualified health centers have made testing for hepatitis C a priority. Clinicians at two community health centers run by Philadelphia FIGHT — which was established as an AIDS service organization — test many of their patients who are at high risk because of injection drug use or unsafe sexual practices, such as having sex with an infected partner. The screenings are often done on an annual basis, with a reminder to the medical personnel in the patient’s electronic medical record.
“That’s something pretty basic that we’ve done in our community health centers to make sure we’re testing people and providing a cure,” said Dr. Stacey Trooskin, director of viral hepatitis programs at the FIGHT centers and clinical assistant professor at the University of Pennsylvania Perelman School of Medicine.
Among at least 3.5 million people who have the disease, most are baby boomers who were infected before routine screening of donated blood began in the early 1990s. In recent years, as the drug epidemic has taken hold, new infections have been concentrated among young people who inject drugs, in particular those between ages 18 and 29, according to the federal Centers for Disease Control and Prevention.
Complicating the effort to get people screened is the fact that many of the people who enroll in drug treatment programs are uninsured, said Imagine Hope’s Sutton. In states that have expanded Medicaid under the Affordable Care Act, the program generally picks up the tab for hepatitis C testing and treatment, though often with restrictions. But 14 states, including Georgia, haven’t expanded that coverage for adults with incomes up to 138 percent of the federal poverty level ($16,753 for one person).
Insurance coverage isn’t the only challenge. If people have to come back to a clinic for the second test, chances are they may fall through the cracks and not get that follow-up.
When a patient tests positive, a nurse or counselor at the drug treatment center, who is likely overbooked working with patients to address their addiction, must carve out time to explain this new diagnosis and talk through treatment options.
“There’s a whole system of care that needs to be built for these people and, unlike HIV, it doesn’t exist for hepatitis C at this time,” Sutton said.
Like many other clinics around the country, hepatitis C testing at Georgia drug treatment centers is supported with funding from the Focus program, sponsored by drugmaker Gilead — the first company to offer a new class of highly effective drugs that generally cure hepatitis C in three months or less with few side effects.

Finding resources to pay for treatment is also difficult. The high costs of the new drugs when they were introduced led some public and private insurers to strictly limit access. But, in recent years, drug prices have come down as more drugs hit the market and many states have loosened Medicaid restrictions.
For example, New Mexico’s Medicaid program doesn’t require that people be sick or abstain from using illicit drugs or alcohol for a time before starting treatment. Still, “hepatitis C testing remains out of reach for many because their providers aren’t aware that their patients can get treated,” said Kimberly Page, an epidemiologist and professor of internal medicine at the University of New Mexico who focuses on hepatitis C.

Taking surprise medical bills to court


Some legal experts say contract law could provide consumers another avenue to challenge unexpected hospital bills.


Joaquin Lopez had emergency gallbladder surgery after rushing to an ER last year. He has been haggling with Baptist Memorial Hospital in Memphis over what he owes ever since.
The 37-year-old college professor was hit with a nearly $8,000 bill from the out-of-network hospital — that was after the $11,000 he and his insurer had already paid.
Consumers are increasingly vulnerable to such so-called balance bills, which represent the difference between what insurers pay and hospitals’ list prices. List prices can be several times higher than what they accept from Medicare or in-network insurers.

Congress is considering bipartisan legislation to limit balance billing. But some legal scholars say that patients should already be protected against some of the highest, surprise charges under long-standing conventions of contract law.
That’s because contract law rests on the centuries-old concept of “mutual assent,” in which both sides agree to a price before services are rendered, said Barak Richman, a law professor at Duke University.
Thus, many states require, and consumers expect, written estimates for a range of services before the work is done — whether by mechanics and plumbers or lawyers and financial planners.
But patients rarely know upfront how much their medical care will cost, and hospitals generally provide little or no information.
While consumers are obligated to pay something, the question is how much? Hospitals generally bill out-of-network care at list prices, their highest charges.
Without an explicit price upfront, contract law would require medical providers to charge only “average or market prices,” Richman said.
In several recent cases, for example in New York and Colorado, courts have stepped in to mediate cases where a patient received a big balance bill from an out-of-network provider. They ordered hospitals to accept amounts far closer to what they agree to from in-network private insurers or Medicare.
“This is the amount they are legally entitled to collect,” said Richman.
Lopez’s bill came after he sought help at the emergency room following excruciating abdominal pain. Sent home with pain medication, he awoke hours later to a phone call from the hospital: Come back! A review of his tests showed he needed surgery. He didn’t stop to ask if the hospital was in his network, or for a cost estimate.
So, in an example like that, is there mutual assent?
Hospitals say yes, that signed admission forms, which include a promise to pay, constitute mutual assent, even if there was no price disclosed.
No, counters Richman. If a tax preparer provided no upfront estimate, he could not suddenly bill a client for $10,000 if the going rate for the service was $1,000 or less. The higher fee would never hold up in court of law, since there was no “mutual assent” about price.
But what, if anything, should Lopez offer to pay? What is reasonable or average in a system where the price of a hip replacement can range from $15,000 to $150,000, or a blood test can be $5 to $500?
Based on the hospital’s list prices, Lopez’s bill came to nearly $21,000. Insurer Cigna, using a formula it said is similar to what Medicare uses, said the maximum it would cover was $11,160. It paid 80 percent of that lower amount, and Lopez paid the remainder. Baptist hospital is billing Lopez for nearly $8,000 more, saying it wants the full charges.
“I’m an economist,” said Lopez, who teaches at the University of Memphis. “I understand how abusive these practices are. There is not a single market price.”
Indeed. Healthcare Bluebook, a consumer website that uses claims data to estimate costs , shows gall bladder surgery in Memphis costs as little as $14,000, but could be tens of thousands more, with a “fair price” of about $18,000 — which is generally less than full billed charges, but more than in-network insurers would pay.
That complexity — and the cost of hiring an attorney — have made legal challenges to medical bills on the basis of contract law relatively scarce.
Also, “it’s not a well-settled area of the law,” said Hall.
Even though hospitals have lost some cases, their arguments have also found traction.
The Virginia Supreme Court last year ruled in favor of a hospital, saying admission paperwork patient Glenn Dennis signed in the emergency room was a valid contract. The hospital had sued him over an $84,000 bill for his out-of-network care.
Still, the court left open the key question of just how much of that Dennis owed, sending that back to a lower court. That court previously ruled that Dennis owed only about $500 on top of the $27,255 his health insurer had paid. That reflected a discount the hospital commonly gave uninsured patients, the circuit court judge wrote. The two sides are still working on a settlement.
For those caught up in the disputes, determining a fair price is hard.
“That’s where courts struggle, creating health care prices,” said Mark Hall, director of the Health Law and Policy Program at Wake Forest Forest University, who backs the contract law protection theory.
One way is to look at what hospitals accept for in-network care from private insurers. But hospitals generally object to releasing that, saying it’s a trade secret.
A 2017 Texas Supreme Court ruling has, at least for now, broken through this position. It said that hospitals in some legal disputes must disclose those in-network rates they allow in-network insurers to pay.
“Hospitals are really trying to prevent this sort of thing because they are uncomfortable having someone ask them to justify [their charges],” said George Nation, a law professor at Lehigh University in Pennsylvania, who filed a court brief in the Texas case on behalf of the patient’s argument.
In June, the hospital involved in the dispute asked for a rehearing, saying such disclosure would weaken its bargaining power. Several other hospitals are backing its request, illustrating the broad concern.
Lopez has hired a lawyer to fight his bill.
Consumers in some states might have legal backup under balance-billing laws. But rules vary, often don’t apply to all types of insurance and may cover only emergency medical treatment costs.
Tennessee’s law, which went into effect in July, requires hospitals to notify patients of estimated costs and that they could receive balance bills.
After getting a balance bill, consumers should attempt to negotiate a reduced amount, said Wendy Netter Epstein, a health law professor at DePaul University College of Law. Online lookup tools like Healthcare Bluebook or Fair Healthcan provide estimates of average costs for procedures.
Lopez said he offered to pay 20 percent of the disputed amount, but it has not — so far — been accepted.
Baptist Memorial Hospital encourages patients to file appeals and, if a better offer is made by the insurer, “we accept it and dismiss the patient’s balance,” said David Elliott, vice president of managed care and CEO of Baptist Health Services Group, in an emailed statement.
Lopez has appealed twice to insurer Cigna to cover more of the bill —without success.
For now, his lawyer has written to the hospital, disputing that Lopez owes more than was already paid by the insurer. The letter said Lopez planned to avail himself of any protection under state or federal law.

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Prevalence of Benzodiazepine Use 12.6 Percent in the United States


Overall, 12.6 percent of U.S. adults report past-year benzodiazepine use, with misuse accounting for 17.2 percent of overall use, according to a study published online Dec. 17 in Psychiatric Services.
Donovan T. Maust, M.D., from the University of Michigan in Ann Arbor, and colleagues conducted a cross-sectional analysis of data from the 2015 and 2016 National Survey on Drug Use and Health limited to adults aged ≥18 years (86,186 participants) and respondents reporting benzodiazepine use (10,290 participants). The authors examined the prevalence of benzodiazepine use, including variation by age.
The researchers found that 30.6 million adults (12.6 percent) reported past-year benzodiazepine use: 10.4 and 2.2 percent as prescribed and misuse, respectively. Overall, misuse accounted for 17.2 percent of use. The highest prescribed use was seen for adults ages 50 to 64 years (12.9 percent). Misuse was highest for those ages 18 to 25 years (5.2 percent) and lowest for those aged ≥65 years (0.6 percent). There was a strong correlation for misuse and abuse of or dependence on prescription opioids or stimulants with benzodiazepine misuse. The most common type of misuse was misuse without a prescription, with the most common source being a friend or relative.
“Although clinicians should be mindful of the potential for benzodiazepine misuse among patients with any level of substance use, findings indicated that prescription opioid and stimulant use disorders were most strongly associated with benzodiazepine misuse,” the authors write.

1 in 4 People Over 25 Will Be Hit by Stroke


A quarter of the world’s people over the age of 25 will experience a debilitating stroke during their lifetime, a new study estimates.
Rates vary country to country, but in the United States 23 percent to 29 percent of people can expect a stroke sometime in their lives, concluded a team led by Dr. Gregory Roth.
He’s professor of health metrics sciences at the University of Washington, in Seattle.
“These findings suggest that adults need to think about their long-term health risks, including stroke, at a much younger age,” Roth said.
For the new report, Roth and his colleagues used data from the Global Burden of Disease study to estimate the lifetime risk for having a stroke for those over the age of 25.
The investigators looked at the two major forms of stroke: ischemic strokes, caused by clots, which make up about 85 percent of strokes; and strokes caused by bleeding in the brain, called hemorrhagic strokes, which make up about 15 percent. The data came from 195 countries and spanned the years 1990 to 2016.
Looking at 2016 data, Roth’s team found that the risk of stroke for people over the age of 25 ranged from 8 percent to 39 percent, depending on where in the world they lived. The Chinese had the highest risk (with more than a 39 percent lifetime risk), followed by people in Central and Eastern Europe. The lowest risk was among those living in sub-Saharan Africa.
Gender didn’t seem to matter, with no significant differences in stroke risk seen between men and women, according to the report.
A person’s odds for a stroke rise with certain risk factors, including obesity, smoking and lack of exercise. So the new findings could help public health agencies around the world boost their public education efforts, Roth suggested.
For example, programs that encourage young adults to exercise and eat healthier diets (more fruits, vegetables and whole grains) are needed, Roth said. So are efforts that help young adults avoid smoking or excessive drinking.
“Physicians should warn their patients at a much earlier age about actions they can take to prevent stroke and other vascular diseases later in life,” Roth said.
Governments can also work to lower prices on blood pressure and cholesterol-lowering medicines, the researchers noted.
Dr. Richard Libman is vice chair of neurology at Long Island Jewish Medical Center in New Hyde Park, N.Y. He said, “Stroke remains a leading cause of disability and death worldwide. On a large scale, prevention of stroke before it ever occurs may be even more crucial in certain geographic areas, although no region is exempt from this debilitating condition.”
The report was published Dec. 20 in the New England Journal of Medicine.
More information
The American Stroke Association has more about stroke prevention.
SOURCES: Gregory Roth, M.D., assistant professor, health metrics sciences, Institute for Health Metrics and Evaluation, University of Washington, Seattle; Richard Libman, M.D., vice chair, neurology, Long Island Jewish Medical Center, New Hyde Park, N.Y.; Dec. 20, 2018, New England Journal of Medicine

Getting Closer to Generating Cells Lost to Diabetes


 People with diabetes often don’t have enough insulin-producing beta cells to control their blood sugar, but a combination of two novel drugs may coax the body into making more of these vital cells, an early study finds.
Together, the drugs caused beta cells to reproduce at a rate of about 5 percent to 8 percent a day, according to the researchers. Work has only been done in the lab and in rodents, and a major hurdle remains before this treatment could be tried in humans: researchers need to develop a targeted delivery system.
“We’re at a stage where we have nuclear warheads but no guided missiles. We can’t just release the treatment because we don’t want to affect other cells,” explained study senior author Dr. Andrew Stewart. He’s the director of the Mount Sinai Diabetes, Obesity and Metabolism Institute in New York City.
Stewart said researchers are now working on ways to deliver the medication only to beta cells, and he’s hopeful that they’ll make progress on that front.
“While it might not seem fast for people with diabetes, the rate of progress in beta cell regeneration has been astonishingly fast on the scientific side. Ten years or so ago, there were no drugs that could regenerate beta cells. Now we have those drugs,” he said.
Beta cells are found in the pancreas and they produce the hormone insulin. This hormone ushers the sugar from foods into the body’s cells to be used as energy.
People with type 2 diabetes are resistant to the effects of insulin, and may not make enough insulin. About 30 million people in the United States have type 2 diabetes, according to the American Diabetes Association (ADA). Type 2 diabetes is associated with obesity and a sedentary lifestyle.
Type 1 diabetes is an autoimmune disease that causes the body to mistakenly destroy beta cells. People with type 1 diabetes make little to no insulin, and must replace that lost insulin through injections or an insulin pump. Approximately 1.25 million Americans have type 1 diabetes, the ADA says.
The current research builds off previous work done by Stewart’s group. The researchers found that a drug called harmine could prompt beta cell regeneration in the lab and in mice. But harmine could only regenerate about 2 percent of beta cells a day, which isn’t sufficient, according to Stewart.
That led the researchers to look for another drug to use with harmine. They found one that boosted the beta cells’ ability to reproduce by as much as 18 percent when combined with harmine (the average was 5 to 8 percent a day).
Andrew Rakeman is assistant vice president of research for JDRF (formerly the Juvenile Diabetes Research Foundation). He said, “These findings are really exciting. If we go back 10 or 12 years ago, the idea that you could even get beta cells to regrow or regenerate was controversial. Now we know not only is it possible, but it could be impactful.”
He did add a caveat, however. “There are still some challenges ahead,” Rakeman said.
One is developing a drug delivery system. Another is the concern that in people with type 1 diabetes, it’s possible the immune system might destroy any newly made beta cells. And it isn’t clear if the drug combination would be able to reproduce the cells quickly enough to make a difference if the immune system was attacking the new cells.
There’s also a concern that a drug designed to make beta cells reproduce could induce other cells in the body to reproduce and cause unwanted side effects.
“There’s still work to do before testing in people. But this study highlights what the next steps need to be,” Rakeman said.
The findings were published Dec. 20 in the journal Cell Metabolism.
More information
Learn more about diabetes from the American Diabetes Association.
SOURCES: Andrew Stewart, M.D., director, Mount Sinai Diabetes, Obesity and Metabolism Institute, New York City; Andrew Rakeman, Ph.D., assistant vice president, research, JDRF; Dec. 20, 2018, Cell Metabolism

Celgene initiated at BTIG


Celgene resumed with a Neutral rating at BTIG
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