“A research network funded with millions by the Affordable Care Act will begin conducting vast studies next year to compare standard medical treatments. But what about the 100 million patients in the network — do they have a choice in the matter?
Will researchers get permission from each of those patients? And if patients are told about the studies, what, exactly, will they be told? These questions have bioethicists, scientists and health care officials debating how to bring the question of patient informed consent into the 21st century.
Obamacare is best known for extending health coverage to more Americans. But the health care law has many provisions aimed at improving health care outcomes and safety while lowering costs. One element is “comparative effectiveness” research: not just finding out whether a drug or treatment is safe and effective but comparing drugs head to head to find out which is better, for everyone or certain populations.
And with electronic medical records and vast pools of data, some of these studies have the potential to make lightning-fast, dramatic discoveries. But informed consent issues have the potential to slow such studies and make them too expensive.”

“Over the past few weeks, the American Medical Association has complained publicly and privately to the Centers for Medicare and Medicaid Services over its so-called Open Payments database, which will display what drug and device makers pay physicians. The system was created in response to concerns that medical practice and research may be unduly influenced by industry. But the database has been plagued by delays and technical glitches. The AMA is concerned that physicians lack the needed time to ensure correct data is displayed and that the public will understood what they see. The database is expected to go live on Sept. 30, but the AMA wants a six-month postponement to compensate for the problems. So far, CMS says no. We spoke with AMA president Robert Wah about the frustrations. This is an edited version.”

“The District of Columbia U.S. Circuit Court of Appeals in Washington on Thursday said the full 11-member court will rehear (PDF) the controversial case that ruled Americans could not receive subsidies to help pay for plans on federally run health insurance exchanges. Oral arguments will begin Dec. 17.
The court’s decision to rehear the case en banc, which experts said is rare for the D.C. appellate court, vacates the judgment issued earlier this summer. On July 22, a three-judge panel ruled 2-1 in Halbig v. Burwell that the Patient Protection and Affordable Care Act forbade people with lower incomes from receiving tax subsidies from insurance marketplaces run by the federal government, effectively making those subsidies illegal in 36 states.
Opponents of the Affordable Care Act greeted the D.C. court’s initial ruling with praise, saying the judges upheld the text of the law. The law’s supporters, however, argued the court read the text too narrowly and applied an unreasonable and inaccurate interpretation of exchange subsidies.
The July ruling dealt a fresh blow to President Barack Obama’s healthcare law, which relies on the insurance subsidies to make coverage more affordable for millions of people. However, the Obama administration vowed at the time to petition for a full court review of the decision.”

“Unlike the financial services industry, health care companies lack measures to adequately prevent identity theft, even as they continue to digitize medical records and other sensitive information.
Twelve years ago, when Nikki Burton was 17, she tried to donate blood for the first time. She was denied without explanation. Perplexed, the Portland, Ore. resident called Red Cross headquarters to inquire, only to learn that her Social Security number had been used to receive treatment at a free AIDS clinic in California, rendering her ineligible to donate blood.
Years later, she wondered if, when asked whether she had any preexisting conditions, that instance of fraud might show up. So she called the Red Cross again. The organization told her that it no longer asked for Social Security numbers and she could donate blood without it. “I said, that’s fine for you guys to receive the donation, but that doesn’t solve the problem of that information existing in your system,” Burton says. “What if it got out?”
In 2013, the health care industry experienced more data breaches than it ever had before, accounting for 44% of all breaches, according to the Identity Theft Resource Center. It was the first time that the medical industry surpassed all others, and stood in stark contrast to the financial services industry, which represented just 3.7% of the total.
Identity theft is so pervasive in health care that, according to a 2013 ID Experts data security survey of 91 healthcare organizations, 90% of respondents had experienced a data breach in the previous two years and 38% had had more than five incidents.”

“Republicans vying to wrest the Kentucky House from Democratic control for the first time in nearly a century promised Tuesday to try to repeal the state’s Medicaid expansion and rein in other parts of the federal health care overhaul.
House Republican leaders made stops in western Kentucky as part of a multi-day tour to promote their legislative agenda, called the “Handshake with Kentucky.” They said they would push for legislation prohibiting mandatory participation in a workplace union and for a revamped state tax code and creation of medical expert panels to review proposed medical malpractice claims before they could be pursued in court.
“If the people of Kentucky entrust us with the majority, we are committing to immediately begin debate with the intention of passing each of these pieces of legislation,” House GOP Floor Leader Jeff Hoover said.
State Democratic Party Chairman Dan Logsdon called them “warmed over” ideas repackaged to get Republicans to the polls.
“It’s not leadership,” he said. “It’s pandering to their base.”
Republicans have not had a majority in the Kentucky House since 1920. Democrats have been whittled to a 54-46 majority, putting the GOP within striking distance of consolidating power in the Kentucky General Assembly. Republicans have solid control of the state Senate.”

“Utah Gov. Gary Herbert isn’t backing down from insisting on a work requirement in his Healthy Utah alternative to Medicaid expansion, even though Pennsylvania’s governor dropped the same mandate to win federal approval.
“We’re always keeping an eye on what’s happening in other states that are in a similar situation. That said, we’re not always reactive,” Herbert spokesman Marty Carpenter said Tuesday. “It’s still a very important element of the deal to the governor.”
Last week, the Obama administration announced it had signed off on Pennsylvania Gov. Tom Corbett’s plan to use the money available under the Affordable Care Act to provide health care coverage to low-income uninsured residents.
Corbett’s Healthy PA plan is close to what fellow Republican Herbert has proposed, except that the Pennsylvania governor dropped a requirement that able-bodied recipients look for a job.”

“From Halbig to Sovaldi, this summer was a busy one for health policy and politics. We’ve made it easy to catch up, collecting all of the top stories you clicked on over the past few months. Together, they tell a story about the state of healthcare in the U.S., and offer clues as to where things may be headed when Congress returns in the fall.
Among them: The political battle over Obmacare has become more complicated for Republicans since the government cleaned up the Healthcare.gov mess, and with midterm elections around the corner, the focus will be on how much either party continues to attack or ignore the law. There are policy, legal and business matters to be settled as well – the employer mandate is under attack from the left and the right, the courts have been a wildcard for the health law to this point and could continue to be so, and employers and employees are finding themselves wading through the on-the-ground impacts of the law. That doesn’t even get to our top three storylines of the summer, so be sure to click through to find out what tops the list.”

“The widely accepted view among policymakers in Washington, D.C. is that even if President Obama’s health care law is currently more unpopular than ever, by the time 2016 rolls around, it will be an immovable object, impossible to wholly repeal.
In past columns for The Morning Consult, I have argued this is an incomplete picture of the politics of the issue, one which underestimates the Republican base’s dedication to repeal, and the necessity of Republican candidates to respond to that desire.
You could assume that the continued unpopularity of Obamacare would play to Republicans’ advantage within the battle over health care policy, and that’s certainly correct at the moment. The fact that a Democratic Senator touting his support for Obamacare (albeit without naming which law he voted for) is national news is an indication of that. Had the politics of the Affordable Care Act played out as most Democrats anticipated, every candidate up for re-election would be loudly trumpeting their support for it.
So in the short-term, the law plays into the hands of Republican critics, who have plenty of easy targets and little need to propose a comprehensive reform. But what about what comes after 2016, assuming a Republican presidency but lacking 60 votes in the Senate? At that point, Obamacare’s political toxicity may actually hamper efforts to achieve pro-market reforms.
Consider Avik Roy’s recent proposal, Transcending Obamacare, which is possibly the most comprehensive proposal for health reform offered by a conservative. Not content to merely focus on replacing Obamacare, Roy’s plan relies heavily on the expansion of the existing private insurance marketplace as a replacement for the Great Society, shifting individuals away from Medicare and Medicaid and the VA, and toward private insurers.”

“The Republican fight against Medicaid expansion is far from over, but there are fewer opponents than there used to be.
The expansion of the government health insurance program was originally supposed to be mandatory under the Affordable Care Act, but the Supreme Court made it optional as part of a landmark decision on the law in June of 2012.
In the wake of the decision, Republican governors flocked to announce they were declining to expand coverage.
As of 2014, 19 states — 18 of which are led by Republican governors — have declined outright to expand coverage, but some former holdouts are beginning to come to terms with expansion.
This week, Pennsylvania formally agreed to terms with federal regulators, raising the number of states that have expanded coverage for low-income residents under Obamacare to 27. Pennsylvania is the ninth state led by a Republican governor to expand Medicaid.:”

“PHOENIX — The Arizona Supreme Court has agreed to hear Gov. Jan Brewer’s appeal of an appeals-court decision that could unravel the Medicaid expansion she fought for last year.
The high court has not yet set a date, but indicated it will hear Brewer’s argument that about three dozen Republican lawmakers don’t have the legal standing to challenge the controversial vote.
The court’s decision, reached in a scheduling conference, comes on the heels of Tuesday’s primary election in which every Republican lawmaker who voted to expand the state’s Medicaid program won re-election. That means it would be highly unlikely the next Legislature would vote to reverse the 2013 decision, which was a consistent fault line in numerous GOP legislative primaries.
The case revolves around whether the Legislature’s 2013 vote to impose an assessment on hospitals to help cover the cost of expanding the Arizona Health Care Cost Containment program was a tax. If so, it would require a two-thirds vote of the Legislature.”