First Edition: April 10, 2018
Today's early morning highlights from the major news organizations.
Kaiser Health News:
How A Drugmaker Turned The Abortion Pill Into A Rare-Disease Profit Machine
Even though the $550 yellow pills sold as Korlym have a controversial origin as the abortion pill, Leslie Edwin says they “gave me life.” The 40-year-old Georgia resident lives with Cushing’s syndrome, a potentially deadly condition that causes high levels of the hormone cortisol to wreak havoc on a body. When first diagnosed, she said, she gained about 100 pounds, her blood sugars were “out of control,” and she suffered acne, the inability to sleep and constant anxiety.“I wouldn’t leave the house,” Edwin said of her first bout with the condition. “I quit my job after a certain point. I just couldn’t keep being in front of people.” (Tribble, 4/10)
Kaiser Health News:
Can You Hear Me Now? Senate Bill On Hearing Aids May Make The Answer ‘Yes’
Last December, Deb Wiese bought hearing aids for her parents, one for each of them. She ordered them online from a big-box retailer and paid $719 for the pair. But her parents, in their 80s and retired from farming in central Minnesota, couldn’t figure out how to adjust the volume or change the batteries. They soon set them aside. “Technology is not only unfamiliar but unwelcome” to her parents, Wiese said. “I don’t know what the answer is for people like that.” (Andrews, 4/10)
California Healthline:
California Aims To Tackle Health Care Prices In Novel Rate-Setting Proposal
Supporters of the legislation, called the Health Care Price Relief Act, say California has made major strides in expanding health insurance coverage, but recent changes haven’t addressed the cost increases squeezing too many families. To remedy this, Assembly Bill 3087 calls for an independent, nine-member state commission to set health care reimbursements for hospitals, doctors and other providers in the private-insurance market serving employers and individuals. The bill faces formidable opposition from physician groups and hospitals. (Terhune, 4/10)
Kaiser Health News:
C-SPAN: FDA Commissioner Scott Gottlieb Talks To KHN
Kaiser Health News reporter Sarah Jane Tribble sat down with Dr. Scott Gottlieb, commissioner of the Food and Drug Administration, on C-SPAN’s “Newsmakers” program, which aired Sunday. Tribble was joined by Bloomberg correspondent Anna Edney. The conversation ranged from how the nation should combat the opioid epidemic to reining in drug prices. Gottlieb said competition in the drug market remains key to lowering prices. (4/9)
Reuters:
Trump Administration Issues Rule Further Watering Down Obamacare
The Trump administration took additional steps to weaken Obamacare on Monday, allowing U.S. states to relax the rules on what insurers must cover and giving states more power to regulate their individual insurance markets. The Centers for Medicare and Medicaid Services issued a final rule that allows states to select essential health benefits that must be covered by individual insurance plans sold under former President Barack Obama's healthcare law. The 2010 Affordable Care Act requires coverage of 10 benefits, including maternity and newborn care and prescription drugs. Under the new rule, states can select from a much larger list which benefits insurers must cover. (Abutaleb, 4/9)
The Washington Post:
Trump Administration Rewrites ACA Insurance Rules To Give More Power To States
The rules add two broad exemptions from the ACA’s requirement that most consumers be insured. The change offers escape hatches that will be retroactive two years, even before a recent tax law ends the penalties completely starting in 2019. People living in areas where only one insurer is selling plans in the marketplace now can qualify for a “hardship exemption.” So can people who oppose abortion and live in places where the only available plan covers abortion services. Federal health officials and private researchers have shown that about half of U.S. counties have only one ACA insurer this year. (Goldstein, 4/9)
The Hill:
Trump Officials Create New Exemptions To ObamaCare Mandate
The administration is also stepping up eligibility checks to make sure people are supposed to receive financial assistance under the law. Officials said they worried some low-income people in states that have not expanded Medicaid were overestimating their income, so that it becomes over the poverty level, thereby qualifying them for tax credits to help afford premiums on the law’s private marketplaces. (Sullivan, 4/9)
The Associated Press:
Abortion Objectors May Get A Pass On Health Law Penalty
Object to abortion? You may be able to get an exemption from the Affordable Care Act tax penalty for people who don't get health insurance. The Centers for Medicare and Medicaid Services announced final rules Monday for the ACA's health insurance marketplaces, and expanded exemptions were part of the package. Last year's GOP tax bill repealed the health law's unpopular requirement to carry health insurance or risk fines from the IRS — but that doesn't happen until next year. (Alonso-Zaldivar, 4/9)
The Wall Street Journal:
Trump Administration Allows States To Narrow ACA Coverage
Democrats and some consumer groups denounced the rule as another effort by the administration to undermine the ACA. They have said that weakening the scope of the benefits offered in ACA plans will hurt consumers by reducing coverage. The new rule will “undermine protections for people with pre-existing conditions with a race-to-the-bottom approach that fundamentally undermines the Affordable Care Act’s essential health-benefit coverage guarantee,” said Brad Woodhouse, campaign director of Protect Our Care, a group that is an advocate for the ACA. (Armour, 4/9)
The Associated Press:
Democratic Attorneys General Fight Texas Health Care Lawsuit
Sixteen Democratic attorneys general pushed back Monday against a Texas lawsuit aimed at striking down former President Barack Obama's health care overhaul. California Attorney General Xavier Becerra led 14 other states and the District of Columbia in filing a motion to intervene in the Texas case and defend the law, suggesting the Trump administration wouldn't take such action. (Ronanye, 4/9)
Los Angeles Times:
California Seeks To Intervene To Defend Obamacare In Court
“It is an irresponsible action,” Becerra said of the Texas lawsuit. “It is a legally unsound action, and it is a dangerous action for millions of Americans who left the bad days of pre-existing conditions and the inability to get care for their children. ”The lawsuit by Texas challenges Obamacare as unconstitutional, arguing that because Congress has set the penalty for going without insurance at zero, it does not count as a tax. A 2012 Supreme Court decision had upheld the law as a tax. The motion to intervene by California, New York and other states argues that Texas’ lawsuit is legally insufficient and would cause chaos in the healthcare market. (McGreevy, 4/10)
The New York Times:
F.D.A. Restricts Sales Of Bayer’s Essure Contraceptive Implant
The Food and Drug Administration on Monday said it would require Bayer to restrict sales of its Essure birth control implant to medical practices like doctors’ offices that agree to fully inform women about the device’s risks. Since the implant became available 16 years ago, thousands of women have sued Bayer, Essure’s manufacturer, with many claiming they suffered severe injuries, including perforation of the uterus and the fallopian tubes from the metal implant. (Kaplan, 4/9)
The Associated Press:
FDA Puts Restrictions On Birth Control Implant But No Recall
The Food and Drug Administration said only women who read and have the opportunity to sign a brochure about the risks of the device will be able to receive the implant made by Bayer. The checklist of risks must also be signed by the woman's doctor. The new requirement comes almost two years after the FDA added its strongest warning to Essure, citing problems reported with the nickel-titanium implant. The agency also ordered Bayer to conduct a study of the device's safety. (Perrone, 4/9)
The Washington Post:
FDA Restricts Sale Of Essure Contraceptive Device, Requires That Women Be Informed Of Risks
FDA Commissioner Scott Gottlieb said in a statement that the agency was making the checklist mandatory because some women were not being adequately informed of Essure's risks “despite previous efforts to alert women to the potential complications ... That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.” (McGinley, 4/9)
The Hill:
FDA Restricts Sale Of Essure Birth Control After Thousands Of Complaints
“We take the concerns of all women affected by Essure very seriously," FDA Commissioner Scott Gottlieb said in a statement Monday. "I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.” Patient advocacy groups and lawmakers have called for the FDA to remove the device from the market. (Hellmann, 4/9)
The Wall Street Journal:
FDA Adds Restrictions On Sale Of Bayer’s Essure
Women who had testified before a panel of independent medical advisers described fatigue, hair loss and depression, as well as persistent pelvic or abdominal pain after taking Essure. There were also reports of rash, hives, nausea, swelling and increased symptoms of asthma and arthritis that women attributed to the implant. Since adding the warnings in 2016, the FDA said sales of Essure have declined roughly 70% in the U.S. Essure gained FDA approval for sale in 2002. (Moise, 4/9)
Stat:
Here’s What’s In The FDA Plan To Include Pregnant Women In Clinical Trials
The FDA has taken a big step in encouraging drug companies to include pregnant women in clinical trials, issuing a draft guidance outlining how to do so safely and ethically. Nearly 4 million women in the U.S. give birth each year, but few drugs have been approved as safe and effective to use during pregnancy. The new guidance aims to help drug companies address those information gaps “through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk.” (Thielking, 4/10)
Stat:
Aetna Auditor Says CVS Improperly Reported Generic Prices To Medicare
The CVS Caremark pharmacy benefit manager improperly reported generic drug prices to the federal government, causing Medicare and its beneficiaries to overpay for medicines, while pocketing a difference in pricing, according to a lawsuit filed by an actuary at the Aetna health insurer. The lawsuit revolves around complicated, behind-the-scenes contracts between pharmacy benefit managers and Medicare Part D plans, and the pricing that must be reported to the Centers for Medicare and Medicaid Services. (Silverman, 4/9)
The Hill:
Dem Questions Hiring Of Former CVS Executive To Lead Drug Pricing Reform
Rep. Keith Ellison (D-Minn.) is questioning the hiring of a former CVS executive to oversee drug pricing efforts at the Department of Health and Human Services (HHS). Ellison, who is often outspoken on the issue of rising drug costs, said Dan Best's hiring poses a "potential conflict of interest" because he has worked in both the pharmaceutical and pharmacy industry. (Hellmann, 4/9)
Stat:
How To Reduce Health Care Costs? Experts Say Lots Of Ideas, Few Successes
Most countries have systems in place to evaluate drugs and their value, unlike the U.S. [Steven] Pearson, whose nonprofit group conducts similar analyses, argues that studies of whether one drug is demonstrably better than another will push progress. “If we do a better job discriminating, it will make companies go for the home run. The business model will reward those that try to innovate.” His organization concluded that a $475,000 drug for pediatric leukemia was worth its price. But a $75,000 drug for tardive dyskinesia, piggybacking on another rare-disease drug, was not. (Cooney, 4/9)
Bloomberg:
30,000 Strong And Counting, UnitedHealth Gathers A Doctor Army
Disruptors are circling the health-care industry. UnitedHealth Group Inc., the biggest U.S. health insurer, has built an army of tens of thousands of physicians to fend off invaders. Health care in the U.S. has been plunged into a high-speed reconfiguration that could redraw longstanding relationships between patients, doctors, drugmakers and insurers. Outsiders such as Amazon.com Inc. and Walmart Inc. are looking for ways to shake up the business. (Tracer, 4/9)
Bloomberg:
Hedge Fund Adage Reaps Big Initial Gain On Health-Care Takeover
Adage Capital Management, a $30 billion hedge fund founded by two former money mangers from Harvard University’s endowment, reaped an initial gain of more than $100 million Monday after Swiss drugmaker Novartis AG agreed to acquire AveXis Inc. AveXis, which has a promising drug to treat a rare disease that afflicts infants, rose 80 percent to $208.05 a share at 9:32 am in New York trading. Novartis’ $8.7 billion offer represented an 88 percent premium to AveXis’ Friday closing price. (Stein, 4/9)
Stat:
Companies, Academics Search For Better Overdose-Reversal Drugs
Naloxone is the only widely available drug to reverse opioid overdoses. But anecdotal reports of its limitations against synthetic opioids are on the rise. Spurred by that public health threat — as well as a booming commercial market for the antidote — drug companies, researchers, and health officials are eagerly eyeing the development of new treatments to augment the use of naloxone or, in some cases, potentially replace it. (Blau, 4/10)
CQ:
Congress Prepares For Week Of Opioid Hearings
Four different hearings on combating aspects of the opioid crisis are set for Wednesday, as the House and Senate ramp up efforts to pass legislative packages this spring. Legislative action is scheduled in both chambers. The Senate Health, Education, Labor, and Pensions Committee plans to discuss a bipartisan legislative package revealed last week and the House Energy and Commerce Health Subcommittee will consider 34 bills. (Raman, 4/9)
The Associated Press:
Court To Decide If Drug Use While Pregnant Is Child Abuse
Pennsylvania's highest court will decide whether a woman's use of illegal drugs while pregnant qualifies as child abuse under state law. The Supreme Court recently took up the case of a woman who tested positive for suboxone and marijuana at the time she gave birth early last year at Williamsport Hospital. (Scolforo, 4/9)
The Associated Press:
New Way Of Defining Alzheimer's Aims To Find Disease Sooner
Government and other scientists are proposing a new way to define Alzheimer's disease — basing it on biological signs, such as brain changes, rather than memory loss and other symptoms of dementia that are used today. The move is aimed at improving research, by using more objective criteria like brain scans to pick patients for studies and enroll them sooner in the course of their illness, when treatments may have more chance to help. (Marchione, 4/10)
NPR:
Some Scientists Want Brain Changes, Not Symptoms, To Define Alzheimer's
Instead of defining the disease through symptoms like memory problems or fuzzy thinking, the scientists want to focus on biological changes in the brain associated with Alzheimer's. These include the plaques and tangles that build up in the brains of people with the disease. But they say the new approach is intended only for research studies, and isn't yet ready for use by most doctors who treat Alzheimer's patients.If the new approach is widely adopted, it would help researchers study patients whose brain function is still normal, but are likely to develop dementia caused by Alzheimer's. (Hamilton, 4/10)
The Washington Post:
With $2 Million, Kaiser Permanente Wants To Help Revive Underfunded Gun-Violence Research
Kaiser Permanente announced Monday that it will begin studying gun violence — a long-ignored issue because of the political pressures surrounding firearms in this country — by investing $2 million in research that will involve doctors and other professionals across its hospitals and centers nationwide. Officials at the giant health system said they hope the move will encourage other systems to wade into this field of research, which has had lack of funding and data in the more than two decades since the federal government virtually abandoned such studies. (Wan, 4/9)
USA Today:
FDA's Scott Gottlieb Pushes For More Food Safety To Improve Health
The Trump administration’s top food and drug regulator is pushing for less salt in food, more nutrition information on labels and innovative ways to communicate healthy ways of eating, all of which Scott Gottlieb says could make more of a difference than anything else his agency could do, short of curing cancer. Gottlieb, the Food and Drug Administration commissioner, has positively surprised critics of the administration’s regulatory agenda elsewhere. (O'Donnell and Parker, 4/6)
The Washington Post:
Anti-Vaccine Reviewers Target Children’s Books On Amazon
“Judah Maccabee Goes to the Doctor: A Story for Hanukkah” does not read like the product of an outraged mind. The story describes a young boy named Judah who must brave a pediatrician's needle — for his health and, he comes to realize, his little sister's. The book, published in August, is so zippy and crisp that you can hardly tell author Ann D. Koffsky wrote it from a place of anger. Koffsky is an Orthodox Jew and describes herself as religious. She said she became furious at reports of Jewish families that claimed religious exemptions from vaccinations and sent their non-vaccinated children to private schools. (Guarino, 4/9)
The New York Times:
Doctors Urge Elite Academy To Expel A Member Over Charges Of Plagiarism
Election to the elite National Academy of Medicine is one of the highest honors a doctor can achieve. Many of its members have been giants in public health: Dr. Herbert Needleman, who discovered the dangers of lead on children’s brains; Dr. Anthony S. Fauci, known for his groundbreaking work on AIDS; and Dr. Margaret Hamburg, former head of the Food and Drug Administration. And then there’s Eric K. Noji, a disaster medicine specialist who was admitted in 2005. (Kaplan, 4/9)
Reuters:
In Key Kentucky House Race, Healthcare Anxieties Loom Large
Andy Barr, a Republican lawmaker representing central Kentucky, won his last three elections promising to repeal and replace Obamacare. This year, his Democratic challengers for Congress in Kentucky's sixth district are betting that message will ring hollow. Their hopes lie with voters like Joyell Anderson, who went for President Donald Trump in 2016 and said she generally votes Republican. This year, she is not sure who to support for Congress, but she knows what her top priority is: healthcare. (4/9)
Reuters:
Mississippi's Last Abortion Clinic Expands Lawsuit On Restrictions
Mississippi's last remaining abortion provider expanded a federal challenge on Monday to laws that ban abortions in the state after 15 weeks of pregnancy and block access to the procedure in myriad ways, it said. The ban on abortions after 15 weeks, signed into law last month by Mississippi Governor Phil Bryant, put the strictest time limit on legal abortions in the United States. (Woodall, 4/9)
Reuters:
Flint School Children To Be Screened For Effects Of Lead After Agreement
School children in Flint, Michigan, will receive screening and in-depth health assessments to measure the effects of lead-tainted drinking water on their ability to learn, under a more than $4 million legal agreement reached on Monday. The agreement partially settled a federal lawsuit related to a water crisis in Flint that drew international attention and prompted dozens of other civil lawsuits and criminal charges against former government officials. (Dobuzinskis, 4/9)
The Associated Press:
California Bill Would Create Health Care Price Controls
California's government would set prices for hospital stays, doctor visits and other health care services under legislation introduced Monday, vastly remaking the industry in a bid to lower health care costs. The proposal, which drew swift opposition from the health care industry, comes amid a fierce debate in California as activists on the left push aggressively for a system that would provide government-funded insurance for everyone in the state. (4/9)
The Associated Press:
Salmonella In Chicken Salad Kills 1, Sickens 265 In 8 States
Chicken salad made by an Iowa food processing company and distributed by Fareway Stores in the Midwest sickened 265 people in eight states and caused one death in Iowa from salmonella contamination, the U.S. Centers for Disease Control and Prevention said. The outbreak which sickened people from Jan. 8 through March 20, appears to have ended, the CDC said in an update posted on Friday. Ill people ranged in age from less than 1 year to 89 years. Sixty-seven percent were female. (4/9)
Los Angeles Times:
L.A. County Unveils New Budget, Emphasizing Homeless Services And Other Safety-Net Programs
Los Angeles County officials released a proposed $30.8-billion budget for the next fiscal year Monday, emphasizing the need to combat and prevent homelessness and to provide crucial safety-net services. "Of all of the issues confronting the county none is more urgent and complex than homelessness," Sachi Hamai, the county's chief executive, said at a news conference. (Agrawal, 4/9)