�鶹Ů��

Last November, when UnitedHealth Group said it expected to post big losses on its Obamacare policies in 2016, rivals such as Anthem and Aetna signaled their Affordable Care Act businesses were doing fine. The Obama administration used that as evidence to refute claims that systemic problems were brewing in its landmark insurance program. Now, there’s no denying it. The four biggest U.S. health insurers admit they’re each losing hundreds of millions of dollars on their Obamacare plans. Rather than expand coverage, many are pulling out of the exchanges that were set up by the ACA so people can shop for insurance plans, often with the help of government subsidies. (Tracer, 8/17)

Aetna’s decision to pull back from ObamaCare is fueling new questions about the long-term viability of the Affordable Care Act (ACA). When United Healthcare announced in April that it was leaving most ObamaCare marketplaces in 2017, supporters of the law argued against drawing broad conclusions, calling it one company’s decision. (Sullivan, 8/16)

Health insurer Aetna announced late Monday that it is dropping Obamacare insurance in 69% of the counties and 11 of 15 states where it currently offers plans. ... Here's what that means for patients, insurers, the ACA and the company's fight with the government over its effort to acquire Humana. (Bomey, 8/16)

The disclosure Monday that insurance giant Aetna will pull out of the Obamacare market next year in 11 of the 15 states it now serves poses a serious threat to the future of the program and raises anew the need for major reforms. ... Larry Levitt, a senior vice president of the Kaiser Family Foundation and a strong champion of the Affordable Care Act, said in a tweet today that the next Obamacare open enrollment period for 2017 will be key in determining the importance of Aetna’s stunning withdrawal from the program’s exchanges. (Pianin, 8/17)

The startling withdrawal of Aetna from many Affordable Care Act exchanges has accelerated the search for ways to preserve competition in those markets. Options being considered include establishing government-run plans and requiring insurers to offer exchange products as a condition for participating in Medicare Advantage or Medicaid managed care—or as a concession for proceeding with proposed mergers. (Meyer, 8/16)

The insurance marketplaces created under the Affordable Care Act face some similar challenges that public insurance programs have faced as they’ve gotten off the ground. Steps that were taken to stabilize Medicare Advantage and Medicare Part D could be a starting point to stabilize the ACA insurance exchanges, a policy brief released Tuesday by the Robert Wood Johnson Foundation suggests. (McIntire, 8/16)

Obamacare backers are suspicious of the timing of Aetna’s decision to back out of most of the law’s insurance markets, suggesting the nation’s third largest carrier is trying to strong-arm the Obama administration into approving its controversial merger with another insurer. Aetna CEO Mark Bertolini dealt a big blow to Obamacare on Monday night, announcing the company will pull out next year from all but four of the 15 state online markets where it sells health plans. He cited unsustainable losses of $430 million since 2014. (Demko and Pradhan, 8/16)

Aetna will abandon Affordable Care Act insurance exchanges next year in more than two-thirds of the counties where it now sells the coverage, the latest in a string of defections by big insurers that will limit customer choice in many markets. Dwindling insurer participation is becoming a concern, especially for rural markets, in part because competition is supposed to help control insurance price hikes, and many carriers have already announced plans to seek increases of around 10 percent or more for 2017. (Murphy, 8/16)

The 400,000-population county southeast of Phoenix currently doesn’t have a single health insurer offering coverage next year on the Affordable Care Act’s exchanges, where Americans can shop for the insurance they’re required to have under the law. With the impending pullout of major health insurers -- including Aetna Inc., UnitedHealth Group Inc., and Humana Inc. -- Pinal County is just one place around the country where Americans will be left with few, if any, choices for coverage. (Tracer and Darie, 8/16)

With health-insurance giant Aetna dropping Affordable Care Act coverage in Arizona and 10 other states next year, Pinal County residents could be left without a health-insurance marketplace option unless another insurer adds coverage to the fast-growing county. Aetna planned to expand in Pinal, and was poised to be the county's only marketplace option when coverage for the new year begins Jan. 1. But the insurer announced this week that it would drop ACA plans in Pinal and Maricopa counties as part of a nationwide pullback. (Alltucker, 8/16)

Aetna’s retreat from most ObamaCare marketplaces this week is rippling across rural America, starting with Pinal County in Arizona. The county, which has a population of about 400,000, no longer has any insurers planning to sell coverage through ObamaCare next year. (Ferris, 8/16)

Connecticut-based health insurance giant Aetna added to the drumbeat of woes for the nation's health insurance exchanges on Monday evening by announcing exits from most of the 778 counties where it currently competes. Aetna will continue to sell exchange policies in 242 counties across four states -- Delaware, Iowa, Nebraska and Virginia. (Snowbeck, 8/16)

Aetna says it will pull out of the insurance exchange in Georgia and 10 other states in 2017, further limiting consumers’ choice of health plans here under the Affordable Care Act. The insurance giant is following on the heels of another major insurer, UnitedHealthcare, in dropping exchange coverage for individuals in Georgia and several states. Separately, state insurance officials told GHN on Tuesday that Cigna also won’t offer exchange plans in Georgia next year. Cigna officials could not be reached for comment by late afternoon. An exit by Cigna, which currently has about 1,500 members in the exchange, would leave just six health insurers in the ACA marketplace in the state, down from nine this year. (Miller, 8/16)

Next year Aetna will stop offering health insurance on the Affordable Care Act's public exchanges in Florida and 10 other states. The move leaves Floridians with fewer choices and ever increasing rates. So far, 11 companies have requested to sell insurance in Florida on the federal exchanges in 2017. That's down from 19 insurers in 2016. (Ochoa, 8/16)

Aetna Inc.'s decision to withdraw from Affordable Care Act exchanges in Pennsylvania and 10 other states means that Independence Blue Cross will be the only major firm offering individual plans for 2017 to Southeastern Pennsylvania residents. Aetna serves about 31,000 Pennsylvanians through the marketplace, about 6 percent of the state's individual health insurance market, according to the Pennsylvania Insurance Department. Coverage for those people will not change this year. (Brubaker, 8/17)

Last year, at least 50 of the state’s counties had only one insurer to offer an individual market plan, according to data from the Texas Department of Insurance. With Aetna’s pull-out, another seven could find themselves in that situation in 2017, unless other plans are introduced to those areas. With a population of just over 116,000, Parker County just west of Fort Worth is the largest. The others counties include: Colorado, Matagorda, Palo Pinto, San Jacinto, Wharton and Wilson.  (Rice, 8/16)

Next year Aetna will not sell plans in Texas on the individual health insurance exchange marketplace established under the Affordable Care Act.  Citing more than $430 million in losses since 2014 and enrollment that skews heavily toward individuals in need of high-cost care, the company announced Monday that it will reduce its presence on the individual public exchange in 2017, from 778 U.S. counties to 242.  (Rice, 8/16)

Thousands of Texans with Aetna policies from the federal marketplace will need to find other coverage. Thousands of Aetna policyholders in Texas will have to find new health care coverage next year after Aetna, the country’s third-largest insurer, said it is leaving the federal insurance marketplace created by President Barack Obama’s Affordable Care Act. Aetna is among several large insurers losing money selling their plans in the “Obamacare” marketplaces, raising questions about the stability and future of the business. (Eaton, 8/16)

Aetna will no longer provide health insurance through the federal exchange in Texas and 10 other states next year, the latest blow to the Affordable Care Act as insurers request rate increases, narrow their networks or exit markets altogether. The carrier's departure isn't likely to seriously damage the law known as Obamacare or affect Texans drastically, but experts said Tuesday that the underlying trends could have long-term consequences. (Rumbaugh and Ackerman, 8/16)

The decision by the nation’s third-largest health insurer to pull out of the Affordable Care Act’s exchanges in nearly a dozen states is a double whammy to President Barack Obama’s signature health law, increasing financial strains on the program while dragging the debate over its merits into the presidential campaign. Republicans opposed to the law immediately pointed to  Aetna Inc.’s decision, which followed similar moves by other major insurers, as evidence that the law isn’t working as intended and sought to rally voters. Donald Trump’s presidential campaign labeled the Aetna move a sign that “this broken law…is slowly imploding under its regulatory red tape.” (Armour and Wilde Mathews, 8/16)

Sen. Bernie Sanders, who mounted a strong challenge for the Democratic presidential nomination, said Tuesday that news that a major health insurer was pulling back its participation in the Affordable Care Act exchanges affirms the need for his single-payer, government-run program. He promised to introduce legislation creating “Medicare for all” again next year. This week, Aetna Inc. said it will withdraw from 11 of the 15 states where it currently offers plans, the latest major national insurer to sharply pull back its participation. (Meckler, 8/16)

For years, insurance provider Health Net Inc. used illegal severance agreements to try to keep departing employees from talking to state and federal officials about company violations, the U.S. Securities and Exchange Commission said Tuesday. The Woodland Hills company agreed to pay a $340,000 penalty to settle the SEC’s allegations. It also agreed to contact former employees who had signed the severance agreements between Aug.12, 2011, and Oct. 22, 2015, and inform them that they were not prohibited from blowing the whistle about potential securities violations. (Petersen, 8/16)

The Securities and Exchange Commission continued its boosting of whistleblowers on Tuesday, penalizing another company for restricting the rights of outgoing employees. Insurance provider Health Net Inc., the SEC said, violated securities law by taking away the ability to file applications for whistleblower awards from departing employees who wanted to receive severance payments. Without admitting or denying the SEC’s findings, Health Net agreed to pay a $340,000 penalty, the SEC said. Representatives for the company didn’t immediately respond to requests for comment. (Rubenfeld, 8/16)

A federal appeals court on Tuesday banned the Justice Department from prosecuting medical marijuana cases if no state laws were broken. A three-judge panel of the 9th U.S. Circuit Court of Appeals in San Francisco ordered the federal agency to show that 10 pending cases in California and Washington state violated medical marijuana laws in those states before continuing with prosecutions. (Elias and Johnson, 8/16)

In a potential legal breakthrough for medical marijuana, a federal appeals court ruled Tuesday that the Justice Department cannot prosecute anyone who grows, supplies or uses the drug for medical purposes under state law because Congress has barred federal intervention. The decision by the Ninth U.S. Circuit Court of Appeals in San Francisco was written by one of its most conservative judges, Diarmuid O’Scannlain, and was the first by any appeals court to prohibit federal prosecutions under spending restrictions enacted by Congress. First passed in 2014 and renewed through September, the budget amendment forbids the Justice Department to spend any money to prevent California and other states from “implementing their own state laws” that authorize the medical use of marijuana. (Egelko, 8/16)

The Arizona Department of Health Services, which oversees the medical-marijuana program, has received about 750 applications for the 31 licenses that will be awarded in October. The intense competition for the permits has set off a land rush of sorts, with applicants scrambling to lock down properties in metro Phoenix, Tucson and elsewhere that regulators might deem best suited for new dispensaries. Proposition 205, which would legalize marijuana for recreational use, would also give medical-marijuana dispensaries in good standing the first shot at the recreational licenses. (Sanchez, 8/16)

On the morning of one of the most important days in her career, Cecile Richards waited anxiously in her office at Planned Parenthood headquarters in Manhattan, texting furiously with friends across the country. A few minutes past 10 a.m., a message from her daughter flashed across the screen. A single word: Yay! “That was when I knew we’d won,” Richards says, recalling the moment when she learned of the decision in the biggest abortion-related case to come before the Supreme Court in more than two decades. In a 5-to-3 vote, the justices had ruled that Texas’s restrictions on abortion clinics placed an “undue burden” on women seeking to end their pregnancies. (Gibson, 8/16)

Texas officials have wasted little time advancing new anti-abortion policies after the U.S. Supreme Court overturned state law for building what it deemed to be unconstitutional barriers to abortion. (Zelinksi, 8/16)

Michael Bromberg, a leading health-care lobbyist who battled the Clinton White House over health-care reform and for more than four decades played an influential if rarely acknowledged role behind the scenes of Washington policymaking, died Aug. 12 at his home in Manhattan. He was 78. The cause was leukemia, said a daughter, Melissa Fass. Mr. Bromberg, whom The Washington Post once called the “dean of Washington health lobbyists,” was known for being tough but resolutely pragmatic. He cultivated friends in both major political parties over dinners at his then home in the city’s Kalorama neighborhood. (Smith, 8/16)

Longtime head of the Federation of American Hospitals Mike Bromberg, known for his knowledge of healthcare policy and the workings of Congress, died Friday, according to the FAH. He was the first Washington-based leader of the organization that represents private, for-profit hospitals and which is now celebrating its 50th year. He was CEO from 1969 to 1994 and continued to serve on the board until his death. He was also chairman of the consulting company Capitol Health Group. (Muchmore, 8/15)

Eight in 10 Americans have heard or read at least something about Zika -- a virus spread mainly by mosquitoes that has recently reached the U.S. and which can cause birth defects and other illnesses -- and most are at least somewhat concerned about a possible outbreak. Sixty-four percent of Americans are at least somewhat concerned that there will be a large outbreak of the Zika virus inside the United States within the next twelve months, including 1 in 4 who are very concerned. ... Sixty-four percent of Americans do not think the federal government is adequately prepared to deal with a widespread outbreak of Zika inside the U.S. (8/16)

Virologists cleaning up after the Ebola epidemic in West Africa say they've discovered something surprising and promising: People who had malaria when they caught Ebola were more likely to survive the deadly infection. People infected with malaria when they caught Ebola were, on average, 20 percent less likely to die from their Ebola infections, the National Institutes of Health team reported. Researchers are not sure why, but they're now following up with more studies to see how the malaria parasite affects the immune system, to see if it somehow boosts the body's ability to fight infection. (Fox, 8/16)

Concerned about rising rates of discarded kidneys, the nation’s most influential renal health organization is undertaking an effort to put more organs to use and increase access to lifesaving transplants. The National Kidney Foundation said it has convened a panel of experts who will develop recommendations for reforming practices that caused hospitals to throw away more than 3,100 donated donated kidneys in 2015. (Ross, 8/16)

The longer a woman is overweight or obese, the more her risk of cancer may increase along with the time. A new longitudinal study on postmenopausal women, published in the journal PLOS Medicine on Tuesday, reveals that the duration of having a high body mass index is linked to a higher risk of developing several types of cancer, from breast to endometrial. (Howard, 8/16)

Firefighters experience post-traumatic stress disorder at rates similar to what's seen among combat veterans, according to a new report released Tuesday by the International Association of Fire Fighters. While firefighters aren't exposed to the same type of trauma soldiers see in a theater of war, elements of their daily job can be traumatic with the sheer volume of calls, the nature of the job and the possibility of losing a colleague in the line of duty. (Rahman, 8/16)

When doctors tailor treatments based on the genetics, environment and lifestyle of individual patients, they are attempting  what is now known as “precision medicine.” The concept grows out of a longstanding frustration in tackling disease: Some patients just do not respond to a treatment that normally works. Not only does this failure necessitate a different remedy, it also puts someone who is ill through a costly and often painful process for no benefit. So being able to choose the right treatment from the start would be an enormous advance. (Venton, 8/16)

Pets might be a source of drug-resistant superbugs, Chinese researchers reported Tuesday. They found a pet shop worker infected with a much-feared antibiotic resistant strain of E. coli may have been infected by dogs at his store that carried the same strain. The 50-year-old man with a kidney inflammation had an infection with E. coli bacteria carrying the dreaded mcr-1 gene — a little cassette of DNA that provides resistance to an important group of antibiotics, which other bacteria can pass around like a tray of snacks. (Fox, 8/16)

This year, high-end virtual reality headsets such as HTC Vive and Oculus Rift have finally hit the market, putting immersive multimedia in the hands of consumers. While the industry has focused primarily on gaming and entertainment, a handful of start-ups are choosing a different route: fitness and medical applications of VR. This month, the Virtual Reality LA Summer Expo 2016 boasted more than 6,000 attendees who crowded the halls of the downtown Los Angeles Convention Center throughout the two-day convention. (Kim, 8/16)

Every hour, two children 5 or younger are treated in emergency rooms for injuries related to strollers or car carriers, according to researchers. Nearly 361,000 toddlers were treated in hospitals for injuries caused by falls or tip-overs during the 21-year period ending in 2010, according to a new study published Wednesday in the journal Academic Pediatrics. Most often, children suffered head injuries (nearly 62% of the total incidents) and face injuries (nearly 25%). (Scutti, 8/17)

The Kentucky Attorney General announced Tuesday that he’s seeking thousands of dollars in damages for each patient in the state who got a vaginal mesh implant made by Johnson and Johnson and its medical device unit, accusing the companies of conducting a deceptive marketing campaign. Attorney General Andy Beshear is accusing the company of concealing and mispresenting to doctors and patients many of the associated risks. The plastic mesh is used to treat pelvic organ prolapse, a condition involving the shifting of organs such as the bladder, bowel and uterus, often after childbirth, a hysterectomy or menopause. (8/16)

Kentucky has become the latest state to file a lawsuit accusing Johnson & Johnson of concealing severe risks and falsely marketing its vaginal mesh products. Earlier this year, California and Washington filed identical claims against the health care giant. As in the earlier lawsuits, Kentucky claims Johnson & Johnson failed to disclose various problems caused by its devices, which were marketed to combat stress urinary incontinence and pelvic organ prolapse. Among the side effects cited were permanent pain with intercourse; a loss of sexual function; chronic inflammation; and permanent urinary or defecation dysfunction. (Silverman, 8/16)

Kentucky's attorney general is suing health-care giant Johnson & Johnson for millions of dollars, saying the company "concealed and misrepresented" the risk of its transvaginal mesh products to doctors and patients. Johnson & Johnson called the lawsuit unjustified. Attorney General Andy Beshear said more than 15,000 women in Kentucky had transvaginal mesh implanted but Johnson & Johnson, through its medical device company, Ethicon, didn't provide enough information about adverse effects. (Almasy, 8/16)

Pay increases for many top Massachusetts hospital executives outpaced the growth of state health spending in 2014, according to new filings with the Internal Revenue Service. Leading the pack was Elizabeth G. Nabel, president of Brigham and Women’s Hospital in Boston, who drew total compensation of $5.4 million that year, up 119 percent from her $2.5 million pay package in 2013. Most of the increase was attributed to a jump in deferred compensation in 2014, the year she vested in a retirement plan managed by Brigham and Women’s corporate parent, Partners HealthCare. The compensation data from the Brigham and other hospitals are contained in IRS filings by nonprofit organizations that are made with a nearly two-year lag. (Weisman, 8/16)

Banner Health faces several lawsuits after revealing on Aug. 2 that 3.7 million customers’ medical records were exposed during a sophisticated hack this summer. “The health care industry has been known to have some of the worst cyber security systems of any industry that holds this kind of sensitive information,” said James Bilsborrow, an attorney with Weitz and Luxenberg in New York City, which this week launched an investigation into the breach. (8/16)

Gov. Dannel P. Malloy’s administration unveiled plans Tuesday that would privatize 40 state-run group homes and a host of services for the intellectually disabled and eliminate the need for 605 state jobs, saving Connecticut almost $70 million annually by next fiscal year. The changes at the Department of Developmental Services are planned to comply with a major reorganization and savings initiative the governor and the General Assembly ordered in May when they adopted the latest state budget. The administration, which already has laid off 113 DDS employees, would eliminate another 492 workers in two stages, most happening after Jan. 1. (Thomas and Phaneuf, 8/16)

Parents who receive addiction treatment are much more likely to get their kids back, but four in five parents fail to complete their treatment regimen. The Early Intervention Family Drug Court in Sacramento aims to change that by helping parents complete treatment before their children enter the foster care system. If they fail, they’ll be sent next door to a formal family drug court, where their children are taken away and given attorneys of their own. But before that, the parents get this opportunity to enter recovery, through a mix of support, medication-assisted treatment and tough love. (Gold, 8/17)

One day after starting what was expected to be a three-week trial, Health First reached a settlement with the doctors who were suing the health system and its former executives for  more than $100 million in damages. Executives for OMNI Healthcare, which was the lead plaintiff in the case, said in a statement on Tuesday afternoon that the financial claims against all the defendants have been settled.  (Miller, 8/16)

Sheriff’s deputies normally guard the jail in Fairfax County, but when a call crackled over the radio Monday night about a man wielding a weapon at an INOVA Fairfax Hospital bus stop, a veteran deputy nearby hurried to the scene, police said. The 29-year-old man had struck a security guard with a metal sign post and appeared to be in the throes of a mental health episode, so the deputy tried to calm him, police said. (Jouvenal and Hedgpeth, 8/16)

The married owners of two mobile diagnostic testing companies who knowingly produced thousands of fraudulent medical test reports have received lengthy prison terms. Federal prosecutors say Nita Patel received a 6 ½-year sentence Tuesday, while Kirtish Patel was sentenced to more than eight years. They must pay more than $4.8 million in restitution.The Rockaway couple pleaded guilty in November to health care fraud related to their Parsippany, New Jersey-based companies, Biosound Medical Services and Heart Solution PC. (8/16)

If you count those contributions, Clinton has raised much more money from the industry than Obama had by mid-2012.All told, Clinton and the independent super PACs supporting her have already collected $3.9 million from the health care field, surpassing Obama, according to an analysis conducted for STAT by the Center for Responsive Politics. Trump, by comparison, has brought in only $82,000. (Kaplan, 8/16)

Promising new cholesterol-lowering drugs, priced at $14,000 a year per person, could add $120 billion annually to the USA's health care costs if taken by all eligible patients, according to an economic analysis published Tuesday in JAMA. Authors of the analysis said they hope the estimate will spur a national conversation about drug prices, the value of new medications and how much Americans are willing to pay to improve health. (Szabo, 8/16)

Amgen Inc., Sanofi and Regeneron Pharmaceuticals Inc. would need to cut prices on their new cholesterol-lowering drugs by more than two-thirds to make them cost-effective to use in the U.S., a study found. The high list prices of the injectable medicines Praluent and Repatha -- which on average cost more than $14,000 per patient each year in the U.S. -- is “uniquely challenging” because they are meant to be lifelong treatments for a growing number of people, according to the study, published Tuesday in the Journal of the American Medical Association. (Paton, 8/16)

Supporters of a California ballot measure, which is designed to lower drug prices, lost a state court bid on Monday to alter the wording of a key analysis that may affect the outcome of the closely watched battle. And the decision comes amid intensifying jockeying over a measure that is seen as a litmus test for public discontent over prescription drug costs. At issue is a report by a California state office that assessed the California Drug Price Relief Act, which would require the state Medicaid program and other state programs to pay no more for medicines than the prices negotiated by the US Department of Veterans Affairs. Currently, the VA gets a 24 percent discount off average manufacturer prices. The vote is scheduled for Nov. 8. (Silverman, 8/16)

A state board recommended Tuesday night that more needy Coloradans receive potentially curative treatments for hepatitis C. But the board stopped short of recommending that the treatments — new drugs that have been shown to have a 90 percent cure rate — be extended to all Coloradans on Medicaid. And that means the American Civil Liberties Union may file a federal lawsuit against the state to force it to provide treatment to everyone. (Ingold, 8/17)

The Ohio Supreme Court has ruled that a proposal aimed at controlling prescription drug prices lacks enough valid signatures to meet the state’s requirements, and backers must collect more for it to move ahead. The court said Monday that roughly 10,000 signatures submitted by supporters of the Drug Price Relief Act were erroneously validated, and more than 5,000 signatures are now needed for the initiated statute. (8/16)

A ballot campaign to reduce prescription drug prices will be back in Ohio next year. Michael Weinstein, president of the AIDS Healthcare Foundation, said his group was stymied this year, but will collect supplemental signatures, as permitted by Monday's Ohio Supreme Court decision. He conceded the issue is dead for the Nov. 8 election. A drug price ballot issue almost identical to Ohio's is a hot ticket in California, where opponents, primarily major pharmaceutical companies, have spent nearly $70 million opposing the proposal. The Los Angles-based foundation put up about $9.4 million through early July, according to figures from the California Secretary of State. (Johnson, 8/17)

Almost half of a special group of drugs, defined as those developed to treat rare diseases, were used for other purposes, according to a new report by America’s Health Insurance Plans. The greatest price increases among this group of drugs — called orphan drugs — were for those used for purposes other than treating the rare diseases they were developed to target. (Owens, 8/15)

What’s in a name? An awful lot when it comes to biosimilars. A newly released survey suggests variations in how biosimilars are named may affect the willingness of pharmacists to substitute a so-called interchangeable biosimilar for a more expensive biologic. While a biosimilar is supposed to be highly similar to a biologic, interchangeability confers a higher threshold — it’s a distinct regulatory description for a biosimilar producing the very same clinical result as a biologic. (Silverman, 8/15)

The Washington lobbying group representing big pharmaceutical manufacturers is shedding high-level officials even as it prepares for what is shaping up to be an intense battle over rising prescription drug prices. Several top employees have left or are preparing to leave the Pharmaceutical Research and Manufacturers of America, or PhRMA. That includes Charles Clapton and Pam Smith, considered the group's top Republican and Democratic representatives, industry lobbyists and other sources said. Jennifer Romans, the vice president of federal advocacy, also left recently, and several sources said they expect more departures. (Mershon, 8/11)

In the face of growing criticism over its efforts to place a value on new medicines, the Institute for Clinical and Economic Review is trying to strike back. Recently, the nonprofit took a conciliatory approach by soliciting suggestions for improving its methods, but this week it became more aggressive by trying to dispel what it calls the “myths” about its operations and motives. The controversial organization released a manifesto on Tuesday that attempts to rebut its many critics, who have chastised ICER for purportedly having cozy relationships with insurers; failing to sufficiently take into account the views of patients; and not providing enough time for drug makers to respond to assessments, among other things. (Silverman, 8/11)

Concordia International Corp. tumbled to the lowest level in more than two years after the drug company slashed its 2016 forecast, suspended its dividend and announced the departure of a key executive amid disappointing second-quarter results. Concordia sank 24 percent to C$16.20 at 10 a.m. in Toronto, the biggest drop in 10 months and the lowest since April 2014. The stock has plummeted 71 percent this year after a more than seven-fold increase since 2012. The drugmaker lowered its outlook for 2016 revenue to a range of $859 million to $888 million, compared with the average estimate of about $939 million based on a Bloomberg survey. Concordia’s revised forecast for 2016 adjusted earnings before interest, taxes, depreciation and amortization of $510 million to $540 million also falls short of analysts’ estimates for about $575 million. (Lam, 8/12)

Arguing that cancer patients in the United Kingdom are missing out on new treatments, two leading charities are calling for the government to conduct direct price negotiations with drug makers and push for flexible pricing based on patient outcomes. In making their case, Breast Cancer Now and Prostate Cancer UK funded a report that found cancer patients in some countries of comparable wealth — such as Germany, France, Australia, Canada, and Sweden — generally have quicker access to cancer medicines. As a result, the charities maintain the approach taken in the UK to measure clinical effectiveness and cost effectiveness should change. (Silverman, 8/16)

The pharmaceutical industry has become a major health hazard to the American people. Our nation pays -- by far -- the highest prices in the world for prescription drugs. As a result, nearly one in five Americans cannot afford to fill their prescriptions. That is unacceptable. A lifesaving product does no good if patients cannot afford it .A new report from Americans for Tax Fairness explains how a pharmaceutical company, Gilead Sciences, games the system to charge high prices and then shifts the profits offshore to avoid billions in U.S. taxes. (Sen. Bernie Sanders, I-Vt., 8/15)

Flush from its triumphant gutting of a bill to impose even a modicum of transparency on drugmakers in California, the pharmaceutical industry last week cranked up the volume against a ballot initiative aimed at lowering the price of prescription drugs. “Proposition 61 is opposed by a broad coalition of more than 130 organizations,” read the dispatch, citing “bureaucratic hurdles” and other problems with the measure that would prohibit the state from paying more for drugs than the federal Department of Veterans Affairs does. For good measure, they added that one of the initiative’s backers is “controversial.” (8/12)

From coast to coast, state lawmakers are pushing legislation in hopes of putting a lid on rising drug prices. More than a dozen bills have been proposed that require companies to either fork over information about their costs or explain recent price hikes for some medicines. ... Admirable as it is, this transparency movement is unlikely to make much, if any, difference. (Ed Silverman, 8/16)

More than 100 state and national medical societies are trying to water down the Physician Payments Sunshine Act, a law that protects doctors and their patients from undue influence by pharmaceutical and medical device companies. ... But they can’t rewrite history in the process. Senator John Barrasso (R-Wyo.) recently introduced the Protect Continuing Physician Education and Patient Care Act. It would roll back the Sunshine Act requirement that drug and device companies report payments they’ve made to fund continuing medical education for doctors or to send them copies of research studies. (Paul D. Thacker, 8/10)

Disappointing earnings. Substantially lower guidance for 2016. A CFO departure. A suspended dividend. A drug-pricing controversy. Oh, and a libel suit against a chicken farmer. All were features of Concordia International's unusually calamitous earnings report on Friday. For a day, at least, the Ontario-based specialty pharma firm one-upped its better-known progenitor Valeant, which has had a mixed week of its own. Concordia's most troubling resemblance to Valeant is that it, too, has become a poster child for major trends in pharma. First, the FDA is approving generics at a much faster rate than it has in the past, as it works through a backlog of applications, increasing competition for the older drugs on which Concordia relies. Secondly, U.S. payers are aggressively clamping down on pricey drugs, including some of Concordia's. (Max Nisen, 8/12)

Precision medicine aims to be a transformative paradigm that moves away from the “one-size-fits-all” approach in which treatments work for some people but not others. To the average American, especially one who has cancer, precision medicine sets a high expectation of a more targeted, and so more effective, treatment. But all too often the science underpinning these targeted therapies has not been up to snuff and the result has been greater uncertainty about optimal treatment — just the opposite of what precision medicine intends to do. (Spencer Phillips Hey and Aaron S. Kesselheim, 8/11)

What happens when the volume of an industry's unit sales remains essentially flat for five years?In most cases that would create stagnant revenue and falling net profits as costs rise. Not so in pharma, an industry that relies on lobbyists to exempt it from the usual processes of economics such as market competition. Between 2010 and 2014, the number of prescriptions written for the 30 top-selling drugs rose by 20 percent, but the prices on those same products increased by an average 76 percent, the Wall Street Journal reported. That resulted in a revenue increase from those brands of 61 percent. The price increases amounted to more than eight times the rate of inflation. (Daniel R. Hoffman, 8/16)

Die-hard opponents of the 2010 health reform law, the Affordable Care Act, have often used its real and imagined problems to argue that it is fatally flawed. Now they are seizing on an announcement by Aetna that it will reduce its participation in the health insurance marketplaces set up by the law. Donald Trump’s campaign called Aetna’s move “the latest blow to this broken law that is slowly imploding under its regulatory red tape.” This is hyperbole. The law has survived many setbacks, and it will overcome Aetna’s decision, too. (8/16)

Big private insurance companies bailing out of a government-sponsored healthcare program, complaining about financial losses. Hundreds of thousands of customers lose their health plans. Terminations are especially severe in rural counties, leaving virtually no competition. Total enrollment drops. Obamacare, 2016? No, Medicare, 1998-2002. During that time, insurers canceled nearly half of their contracts to participate in the managed care program then known as Medicare+Choice and now called Medicare Advantage. Between 300,000 and 1 million customers lost their plans. Total managed care enrollments fell to 4.6 million from 6.4 million. The future of the program was very much in doubt. And yet, enrollments in Medicare Advantage today number 17.2 million. (Michael Hiltzik, 8/16)

People joked for a while about how insurers were pulling out of Obamacare markets so fast we might end up with areas in which there were no insurers at all. It’s no joke anymore: with Aetna’s massive withdrawal yesterday from the Affordable Care Act marketplace, Pinal County, Arizona, the third most populated county in that state, currently has no insurers selling policies on the Exchange. (Seth Chandler, 8/16)

The political debate over Obamacare — boon or boondoggle? — reminds us of an old Saturday Night Live skit about New Shimmer. "It's a floor wax!" Gilda Radner marveled. "It's a dessert topping!" Dan Aykroyd insisted. Turns out they were both right. Six years after its enactment, President Obama's crowning domestic policy achievement still divides the country. Its fans focus on the 20 million people who have left the ranks of the uninsured. Its foes see only rising premiums and rigorous regulations. (8/16)

Today, millions more have access to coverage — and the number of Americans without insurance is dramatically down. We’ve made real progress, but we can and should do much more. Because when consumers have access to a stable, sustainable market, every American who needs affordable coverage can get it. That starts with fixing critical problems with the Affordable Care Act. The unexpected shortfall in a key program known as “risk corridors” left hundreds of thousands with reduced coverage options. Some game the system — such as those who wait to sign up for coverage until they get sick, or provider groups that pay patients’ premiums so they can bolster their reimbursements. (Marilyn Tavenner, 8/16)

Aetna is pulling out of 11 of the 15 states it serves on the Obamacare exchanges. Longtime readers of this column will be unsurprised at the reason: It’s losing substantial amounts of money on its exchange policies. That’s not necessarily the only reason, of course. Companies in heavily regulated industries -- and health care is now probably our most heavily regulated sector outside of nuclear power plants -- spend a lot of time engaging in n-dimensional chess games with the various government entities that have jurisdiction over their operations. (Megan McArdle, 8/16)

Policymakers, legislators and regulators have for decades labored under a similar bigger is better delusion, implementing policies that favor, or regulations designed to promote, large “integrated” systems at the expense of smaller, independent enterprises. In health care, large hospitals and hospital systems have convinced lawmakers that they are the best stewards of the public’s health, arguing that only they have the required collaborative ability to bring care to populations and in the process have attempted to become all of health care to all people. (Jan Vest, 8/16)

Drug Enforcement Administration officials must be smoking something if they actually believe that heroin and marijuana deserve to be listed in the same category as controlled substances posing extreme dangers to public health. The two aren’t even in the same drug universe. For years, the DEA has designated marijuana, along with heroin, ecstasy, LSD and peyote, as Schedule I controlled substances. “Schedule I drugs are considered the most dangerous class of drugs with a high potential for abuse and potentially severe psychological and/or physical dependence,” the DEA says. That not only ignores reality and makes almost no scientific sense, but in effect ties the hands of researchers looking for ways to expand the legitimate medicinal uses of marijuana. But last week the DEA reaffirmed marijuana’s Schedule I classification, though it made it easier for research facilities to get permission to grow and study it. (8/16)

Baby M arrived in our neonatal intensive care unit the other day. Barely 24 hours old, she was clearly in pain. Her high-pitched cry pierced the unit again and again, her tiny legs twitched uncontrollably, and she couldn’t sleep. It’s difficult to comfort her — no amount of swaddling, holding, rocking, soft humming, offering her a pacifier, or other strategies soothe her. Like the multitude of other babies in this NICU at Nationwide Children’s Hospital, Baby M was born dependent on drugs that her mother took while pregnant. (Gail Bagwell and Amy Thomas, 8/16)

After an initial healthy curiosity about electronic nicotine delivery devices around 2014, a nervous pall seems to have settled over the use of e-cigarettes and vaping. Strikingly, it is members of the public health establishment that have fanned the pessimism surrounding the battery-powered devices that deliver nicotine without the carcinogenic tar. (Sally Satel, 8/16)