A project of the Galen Institute

Issue: "Medical Innovation"

FDA vs. right to try: Our view

Editorial board
USA Today
Tue, 2014-08-19
"The deadly Ebola outbreak spreading through Africa is so extreme, it is driving health officials to do something that they would instinctively resist in normal circumstances: Subject patients to unproven experimental drugs. The drugs are risky. Some have not even been tested on humans. Even so, a World Health Organization ethics committee just declared such use ethical, and its reasoning is hard to dispute, at least for patients who would otherwise die. Some chance is better than none, even with unknown side effects. Too bad American patients suffering from terminal illnesses have so much trouble getting the same chance. The process for getting experimental drugs is so daunting that fewer than 1,000 people sought and got federal approval to take such drugs last year. Food and Drug Administration rules require patients to clear a series of hurdles. First, they and their doctors must find a company to provide its drug.

States, Feds on Collision Course Over ‘Dallas Buyers Club’ Laws

Jonathan Easley, Morning Consult
Tue, 2014-08-19
"Health policy hashed out in Washington is usually discussed in terms of billions of dollars or percentage of market share. But, more often than other areas of policy, it can also lead to a focus on whether it will directly cause unnecessary suffering or even death for individuals. Pointing to the deeply personal implications of health policy is not unfamiliar. Consider Sarah Palin’s accusation that Obamacare would create “death panels,” or recent debates over FDA approval of Avastin, a cancer drug. The argument that the government shouldn’t regulate the behavior of a dying patient has sprouted up once again in 2014, and may be setting the stage for a showdown between the states on one side, and the federal government and Congress on the other. In May, Colorado Gov.

First Look At Medicare Quality Incentive Program Finds Little Benefit

Jordan Rau, Kaiser Health News
Thu, 2014-08-07
"One of Medicare’s attempts to improve medical quality –by rewarding or penalizing hospitals — did not lead to improvements in the first nine months of the program, a study has found. The quality program, known as Hospital Value-Based Purchasing, is a pillar of the federal health law’s campaign to use the government’s financial muscle to improve patient care. Since late 2012, Medicare has been giving small increases or decreases in payments to nearly 3,000 hospitals based on how patients rated their experiences and how faithfully hospitals followed a dozen basic standards of care, such as taking blood cultures of pneumonia patients before administering antibiotics. As much as 1 percent of their Medicare payments were at stake in the first year and 1.25 percent this year, though most hospitals gained or lost a fraction of that.

Feds stop public disclosure of many serious hospital errors

Jayne O'Donnell, USA Today
Wed, 2014-08-06
"The federal government this month quietly stopped publicly reporting when hospitals leave foreign objects in patients' bodies or make a host of other life-threatening mistakes. The change, which the Centers for Medicare and Medicaid Services (CMS) denied last year that it was making, means people are out of luck if they want to search which hospitals cause high rates of problems such as air embolisms — air bubbles that can kill patients when they enter veins and hearts — or giving people the wrong blood type. CMS removed data on eight of these avoidable "hospital acquired conditions" (HACs) on its hospital comparison site last summer but kept it on a public spreadsheet that could be accessed by quality researchers, patient-safety advocates and consumers savvy enough to translate it. As of this month, it's gone.

Some California Hospitals, Insurers Disappointed in ‘Bundled Payments’

Daniela Hernandez, Kaiser Health News
Tue, 2014-08-05
"Giving health-care providers a lump sum payment for certain treatments – touted as a way to save money and improve coordination of care — yielded disappointing results for some major California hospitals and insurers, a study found. The RAND Corp. study, funded by a $2.9-million federal grant, looked at “bundled payments” for care of insured orthopedic patients under 65 at a handful of large hospitals and insurers in California. Six of the state’s biggest insurers and eight hospitals started out in a pilot program in 2010, but only three insurers and two hospitals actually decided to enter contracts to adopt bundled payments.

Real World Data and its promise for medicine and research

Grace-Marie Turner, Galen Institute
Tue, 2014-07-29
"Better access to data about real world patient experience holds enormous potential to help achieve many of the goals of health reform, including improving the quality and delivery of medical care, reducing costs, and improving safety and outcomes by accelerating the knowledge base upon which the development of new treatments and cures relies. Capturing data about the actual experience of patients outside of the carefully controlled clinical trial setting – Real World Data – can help fill the knowledge gap between clinical trials and clinical practice. RWD offers a treasure-trove of information that could allow providers, innovators, health plans, researchers, and others in the scientific and medical communities to make faster, more efficient, and less costly advances in medical research and clinical treatment.

Implementing Health Reform: Appellate Decisions Split On Tax Credits In ACA Federal Exchange

Timothy Jost, Washington and Lee University
Thu, 2014-07-24
"July 22, 2014 was arguably the most important day in the history of the implementation of the Affordable Care Act since the Supreme Court issued its ruling in the National Federation of Independent Business case in June of 2012. As no doubt most readers of this blog know by now, shortly after 10 a.m. the United States Court of Appeals for the District of Columbia Circuit handed down its decision in Halbig v. Burwell. Two judges ruled over a strong dissent that an Internal Revenue Service rule allowing federally facilitated exchanges to issue premium tax credits to low and moderate income Americans is invalid. Approximately two hours later the Fourth Circuit Court of Appeals in Richmond, Virginia, unanimously upheld the IRS rule in King v. Burwell. Combined, the cases contain five judicial opinions, three in the Halbig case and two in King. Four of the six judges voted to uphold the rule, two to strike it down."

GOP seeks to kill O-Care device tax

Bernie Becker, The Hill
Tue, 2014-05-13
"Senate GOP leaders on Tuesday called for a vote to kill ObamaCare’s tax on medical devices, as part of a broader package to revive tax breaks that expired at the end of last year. But the tax package is popular with members of both parties, and it’s unclear if Republicans have the leverage to win a vote on the medical device tax. Republicans stopped short of saying they would oppose the tax package without the medical device vote."

Why Both Sides Are Losing the Health Care Debate

Robert F. Graboyes
Politico Magazine
Tue, 2014-05-06
"The Great Debate, you see, is not a debate but, rather, dueling monologues, spoken in mutually unintelligible languages that use the same words, grammar and syntax."

Get Ready for Huge Drug Cost Gap in Obamacare

The Associated Press
Mon, 2013-05-13

"Cancer patients could face high costs for medications under President Barack Obama's health care law, industry analysts and advocates warn. Where you live could make a huge difference in what you'll pay."

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