Health Highlights: Aug. 17, 2017
EpiPen Maker Settles Government Lawsuit for $465 Million Big Pharmacy Manager to Limit Opioid Prescriptions Researchers Developing Early Detection Test for Lyme Disease Obamacare Payments Will Be Made for August, White House Says
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
EpiPen Maker Settles Government Lawsuit for $465 Million
The maker of EpiPen has agreed to pay the federal government $465 million to settle claims that it overbilled Medicaid for a decade.
This is not the first settlement that Mylan Inc. has made with the federal government: In 2009, the company did the same in a suit that said Mylan had allegedly overcharged the government for its severe allergy attack rescue device, the Associated Press reported Thursday.
The new case claimed Mylan paid rebates that were too low to Medicaid, by classifying its brand name product as a generic, which requires lower rebates, the newspaper said.
The practice came to the attention of the U.S. Justice Department after Sanofi Inc., which makes a rival product to the EpiPen, alerted government officials, the AP reported.
In 2015, Sanofi recalled nearly 500,000 of its devices from the market, because some did not administer the correct dose to reverse a severe allergic attack, the newspaper said.
Big Pharmacy Manager to Limit Opioid Prescriptions
Joining the campaign to combat the nation's opioid epidemic, Express Scripts, the largest pharmacy benefit manager in the United States, will start limiting the number and strength of opioid painkillers to first-time users of the drugs.
According to the Associated Press, the campaign is based on what the company called a successful 2016 pilot program to control use of the highly addictive drugs.
Express Scripts launched a yearlong pilot program last year in an effort to reduce patients' dependency on opioids and the risk of addiction, said Snezana Mahon, the company's vice president of clinical product development.
An analysis of 106,000 patients in the pilot program showed a 38 percent reduction in hospitalizations and a 40 percent reduction in emergency room visits, compared to a control group, the AP said.
The nationwide program is set to launch Sept. 1 for Express Scripts members whose employer or health insurer has enrolled to participate, the news service reported.
The American Medical Association is critical of the program, the AP said, because it believes treatment plans should be the responsibility of doctors in tandem with their patients.
Under the program, first-time opioid users will be limited to seven-day prescriptions, even if a doctor's prescription calls for longer use of the drugs. Mahon said the average prescription is for 22 days, the news service said.
The program will not affect patients in hospice or palliative care, or those with cancer, the AP said.
An Express Scripts competitor, CVS Caremark, has a similar program.
An estimated 12.5 million Americans misused prescription opioids -- such as oxycodone (OxyContin and Percocet) and hydrocodone (Vicoprofen) -- in 2015, according to federal health officials. More than 33,000 deaths were blamed on opioid overdoses that year.
Researchers Developing Early Detection Test for Lyme Disease
Although the research is in its infancy, scientists say they're on the hunt for an early detection blood test for tick-borne Lyme disease infection.
The test uses a "signature" of molecular patterns in blood to help ID infection with the Lyme bacteria, and differentiate it from another tick-borne illness called Southern Tick-Associated Rash Illness (STARI), the Associated Press reported.
According to the AP, Lyme disease currently infects about 300,000 Americans annually. It's spread by bites from the black-legged tick (deer ticks) that are found primarily in the Northeast and Midwest. Heralded by the onset of fever, fatigue and flu-like symptoms, Lyme can often be stopped with the quick use of antibiotics.
But Lyme disease is often tough to diagnose -- while the hallmark "bull's-eye" rash is one indicator that you may have the illness, the rash isn't always present with Lyme disease. And if it goes undiagnosed and untreated, Lyme disease can have much more serious, debilitating long-term symptoms.
According to the AP, today's best test for Lyme disease is only 40 percent accurate, so a better diagnostic tool is needed.
"We are trying our best to come up with something to help the diagnosis in the very early stages of this infection," researcher and microbiologist Claudia Molins of the U.S. Centers for Disease Control and Prevention, told the AP. "Our goal really is to try to fill that gap."
She worked with Colorado State University microbiologist John Belisle, and others, to come up with a much more specific screening.
The newly developed test looks for what Belisle called a biological "fingerprint" that shows that the body is moving to fight off the Lyme bacteria -- even before the immune system develops telltale antibodies.
The test focuses on cellular byproducts called metabolites that would show up in the blood of Lyme-infected people but not uninfected people.
In their research, the team discovered just such a "signature" that not only pointed to Lyme infection, but also was able to distinguish Lyme from STARI.
STARI's symptoms appear very much like Lyme disease, but it's spread by another species of tick and is caused by an as-yet-unknown bacterium. As the AP explained, STARI is also very hard to diagnose, because other illnesses must first be ruled out to come to a diagnosis.
Overall, the new blood test was 82 percent accurate in diagnosing Lyme disease, the researchers reported Aug. 16 in Science Translational Medicine.
Still, many more years of research are needed to translate the findings to something that could be routinely used in laboratories, Molins said.
Reviewing the findings, Lyme disease expert Dr. John Aucott told the AP that -- if successful -- the test might also someday be able to tell if a particular treatment is helpful to patients infected with Lyme disease.
"If you can show the host metabolic signature goes back to normal, that could be a great test of cure," said Aucott, who runs Johns Hopkins University's Lyme Disease Clinical Research Center in Baltimore.
Obamacare Payments Will Be Made for August, White House Says
Despite recent calls by President Donald Trump that he would stop payments to cover the Affordable Care Act ("Obamacare"), those funds will go through for August, the White House said Wednesday.
The payments -- totaling $7 billion for this fiscal year -- are given to health care insurers to help pay for benefits for poorer Americans, CBS News said.
In a statement, Sen. Lamar Alexander (R-Tenn), chair of the Senate Health, Education, Labor and Pensions Committee, said that Trump's move to authorize the August payments helps "18 million Americans who buy health insurance on the individual market. State insurance commissioners have warned that abrupt cancellation of cost-sharing subsidies would cause premiums, copays and deductibles to increase, and more insurance companies to leave the markets in 2018."
The move comes a day after the nonpartisan Congressional Budget Office warned that cutting off payments would lead to premiums rising by 20 percent next year, and add an additional $194 billion to the federal deficit over a decade.