Month: November 2011

Off-label Drug Promotion and the First Amendment

Nov 3, 2011• 1

By David E. Williams

Doctors can and often do prescribe medications for different purposes than what the FDA has approved them for. But drug companies face tight restrictions on communicating with physicians about these so-called “off-label” uses. If the pharmaceutical industry has its way, those restrictions may soon ease. Such a change would be healthy overall.

Drugs undergo clinical trials for specific indications, such as Avastin for colorectal cancer. The label received from the FDA upon approval allows the manufacturer to promote the drug to physicians for those specific indications only. But a drug that works for one disease may work for a related disorder (e.g., another form of cancer) or something that seems totally different, like macular degeneration. Often the drug company will follow its initial clinical trials with trials for other indications in order to broaden the label and expand sales, but salespeople can’t bring up these uses until they’re officially on-label.

Drug companies get in trouble all the time for off-label promotion. According to the Wall Street Journal (The Free Speech Pill), 15 off-label cases were settled between 1996 and 2010 for a total of $8.7B.

Herman Cain’s (Mostly) Conventional Plan for Health Care Reform

Nov 3, 2011• 8

By Avik Roy

It’s easy to forget, but Herman Cain first became famous in political circles for his wonky takedown of President Bill Clinton at a town hall meeting where the President was touting his universal health-care plan. (Herman Cain walked President Clinton through the math of why Clinton’s plan would drive Godfather’s Pizza out of business.) Today, Republican Presidential candidate Herman Cain spent half an hour with the GOP Congressional Health Care Caucus, where he outlined his proposals for health reform.

As Newsweek put it at the time, Cain was “the real saboteur” of the Clinton plan:

An articulate black entrepreneur, Cain transformed the debate when he challenged Clinton at a town meeting in Kansas City, Mo., last April. Cain asked the president what he was supposed to say to the workers he would have to lay off because of the cost of the “employer mandate.” Clinton responded that there would be plenty of subsidies for small businessmen, but Cain persisted. “Quite honestly, your calculation is inaccurate,” he told the president. “In the competitive marketplace it simply doesn’t work that way.”

The switchboard at Godfather’s was lit up with supportive calls. It was as if the small business community — a very large and politically powerful group — had been told to march on Washington. Cain, said Larry Neal, an aide to Sen. Phil Gramm, “was the lightning rod.”

For better or worse, Cain’s platform effectively represents consensus Republican thinking on health care. This is good, insofar as Cain endorsed repealing Obamacare, Medicaid block grants, etc. But it’s unclear if he proposed anything that would move beyond the meat-and-potatoes of Republican consensus. And there’s a lot more to do with health-care reform than simply repealing Obamacare.

Jason Millman of Politico was at today’s GOP confab for Cain’s address. “Cain said if he had the right numbers in Congress, he would sign legislation repealing health care reform on March 23, 2013 — three years after it was signed into law. A bill by Rep. Tom Price (R-Ga.), H.R. 3400, would be the starting point for replacement legislation, he said.”

Is Incentive-Driven Healthcare the Holy Grail of Engagement?

Nov 2, 2011• 16

By Michael Dermer

Industry studies confirm the strong connection between healthcare costs and the ingrained behavior of consumers and providers. Ironically, consumers and providers have access to more health information, tools, programs and support than ever before; yet healthcare costs continue to increase and chronic diseases continue to affect a larger portion of the population.

The healthcare industry is at an inflection point where payers, employers, providers and consumers must all be directly involved in the effort to manage the cost of care and to improve health outcomes. A critical aspect of this effort involves the motivation and behavior of all healthcare market participants, but primarily applies to the healthcare consumer and provider at the point of care delivery.

To drive engagement in programs designed to improve health, organizations have applied both incentives and disincentives, with varying degrees of success, as part of an overall engagement strategy. Generally, the presence of an incentive leads to improved results, but most incentive designs have fallen short of their potential. But some valuable lessons have been learned.

The healthcare industry has learned, for example, that incentives can drive behavior change, and can help establish a new baseline for consumer expectations, consumption patterns and health awareness. In turn, this newfound awareness has the potential to address the root causes of the nation’s healthcare crisis, leading to a more rational care model and slower rate of health cost increases.

More importantly, the well-intentioned but haphazard evolution of the application of incentives to various healthcare initiatives has yielded a robust volume of actual performance and cost-related information that can finally provide reliable links between program participation, behavior change, health outcomes and cost savings; and all of the necessary data to determine return on investment.

Is Fee-for-Service Really the Problem?

Nov 2, 2011• 21

By Larry Weed, MD and Lincoln Weed

The authors’ recent book, Medicine in Denial, briefly mentions the subject matter of this post — the effects of fee-for-service payment. This post examines the issue in more detail, because of its importance to health care reform.

The medical practice reforms contemplated by Medicine in Denial have large implications for a host of policy issues. As an example, consider the issue of fee-for-service payment of providers. The health policy community has arrived at a virtual consensus that fee-for-service is a root cause of excessive cost growth in health care. Payment for each medical service rendered seems to involve an unavoidable conflict of interest in physicians: their expertise gives them authority to increase their own payment by deciding on the need for their own services. This conflict of interest has driven countless attempts at health care regulation. These attempts usually involve some combination of price controls, manipulation of incentives, and third party micromanagement of medical decision making. For decades these attempts have proven to be hopelessly complex, illegitimate in the eyes of patients and providers, often medically harmful, and economically ineffective.

Because regulating the conflict of interest has proven to be so difficult, the health policy consensus is now that the only escape from the conflict is to avoid fee-for-service payment. But this consensus misunderstands the conflict’s origin. The conflict of interest arises not from fee-for-service payment but from physicians’ monopolistic authority over two distinct services: deciding what medical procedures are needed and executing the procedures they select. The conflict does not disappear when payment switches from fee-for-service to its opposite–-capitation. Indeed, then the conflict becomes even more acute–-physicians have an incentive to withhold their expertise from costly patients who need it the most.

Inside the NHS Reform Fight

Nov 1, 2011• 2

By Richard Hoey

President Obama’s battle to get his healthcare bill through Congress was big news on this side of the Atlantic last year, not least for the way our own National Health Service (NHS) was used as a reference point in the debate. Now though, it is Britain’s (or, to be specific, England’s) turn to be consumed by arguments about healthcare reform, and if you were to listen to some critics, you’d imagine just as much was at stake. The reform in question is the British Government’s Health and Social Care Bill, which is currently the subject of some fairly furious wrangling in the House of Lords. The bill entered committee stage last week after the Government won a key Lords vote, but although it now looks almost certain to become law in some form, there’s still fierce debate about many of the details.

Depending on where you stand, the health bill will either drag Britain’s creaking NHS into the 21^st century, or it marks the first stage in the dismantling of a national institution. Actually though, some of this rhetoric is a little overblown. The bill represents a wide-ranging and pretty dramatic package of reforms, but it’s still some way short of an Obama moment. One thing it does not do is challenge the fundamental tenet on which the NHS was founded, which is that everyone in Britain has access to universal healthcare ‘free at the point of use’, funded through taxation. That tenet is rather less perfectly applied than is sometimes admitted – many people do have to pay prescription charges, and NHS coverage of dentistry is pretty patchy – but it’s nevertheless an article of faith for the British public, and no mainstream political party would dare to challenge it (overtly at least).

Still, the bill does make two very substantial changes to the way the NHS is organised across England (although it has been brought by the UK government, it does not apply to Scotland, Wales or Northern Ireland, all of which have devolved powers for their own parts of the NHS). The two key changes are both designed to make the NHS more efficient in the face of Britain’s financial crisis, both could have far-reaching implications and both have been hugely controversial. Firstly, it abolishes a whole tier of NHS management and hands its powers instead to the family doctors at the frontline – the general practitioners, or GPs, as they are known here. Secondly, it loosens the constraints on the NHS’s internal market, providing scope for private companies to compete to run many more NHS services. The two reforms are intended to work together to drive efficiency across the health service, and the efficiencies required are pretty frightening – 4% a year for the next four years.

Overestimating Consumer Demand for Health Care Technology

Nov 1, 2011• 3

By Jane Sarasohn-Kahn

More people with higher levels of concern about their health feel they are in good health, see their doctors regularly for check-ups, take prescription meds “exactly” as instructed, feel they eat right, and prefer lifestyle changes over using medicines.

And 40% of these highly-health-concerned people have also used a health technology in the past year.

At the other end of the spectrum are people with low levels of health concern: few see the doctor regularly for check-ups, less than one-half take their meds as prescribed by their doctors, only 31% feel they eat right, and only 36% feel they’re in good health.

While roughly one-fourth to one-third of U.S. adults have been early adopters of consumer technologies in general across low-moderate-and-high health concern segments, more of those with greater health concerns tended to use health tech products in the past twelve months: 40% of the highest concerned people vs. 25% of those with moderate health concerns and 14% of those at the lowest-concern level.

These insights are discussed in a report, The New Role of Technology in Consumer Health and Wellness from the Consumer Electronics Association (CEA), published in October 2011.

Apps Against Abuse–the Winners

Nov 1, 2011• 1

By Matthew Holt

The Federal government has been getting behind the Challenges craze in a big way but this one from the Vice President’s Office and HHS is a doozy. Called Apps Against Abuse it asked developers to create an application that would help young people deal with abuse and violence, primarily in the world of dating and relationships. (FD my company Health 2.0 has a contract with HHS to run challenges, and Apps Against Abuse was featured in the Health 2.0 Developer Challenge and we worked on publicizing the project).

Today two winners were announced on the White House Blog by HHS Secretary Kathleen Sebelius and in a conference call hosted by Aneesh Chopra (Federal CTO) and Todd Park (CTO, HHS) and some fellow called Joe Biden was there too!

OnWatch is a phone based app that has a series of alarms and prompts built in. For example, it can be set with a message sent to friends saying “I went to a party at XYZ dorm, if I don’t come back by midnight come find me” or it has a panic button that calls 911 or the campus police.

The other winner is called Circle of 6 and it comes from the team at ISIS. (FD I’m on the board of ISIS but I didn’t even know they’d entered the contest!). Circle of 6 puts you in touch with 6 of your closest friends and asks them to come help you if you’re in trouble. It even plugs in the coordinates for them. The ISIS team intends to build out Circle of 6 which is currently an iPhone only prototype.

There were more than 33 entries for Apps Against Abuse, even though there was no prize money at stake. It’s good to see that such commonsense use of these new technologies is finding so many spirited innovators willing to help.