home email us! sindicaci;ón

Archive for Regulators



Notes from the AHIP National Policy Conference

by Fred Fortin

I’m attending the AHIP health policy conference in Washington, DC this week and getting an earful about the elections and healthcare reform. Some impressions:

First up on the podium was Chris Matthews, TV commentator of Hardball fame. Matthews is a good speaker and captures the audience right away. He believes anyone of the three presidential candidates could take the election. Yes, there is still a path for Hillary to get the nomination but a lot depends on what happens today at the polls in Texas, Ohio, Rhode Island and Vermont.

To Matthews, America is in a “rut”. The people want change, they want deliverance. And doing nothing is definitely “out”. Obama is different, not your typical politician and he believes that this election is really going to be “transformative”, the likes of which we have not seen for quite a while. While he did not address health care reform in a specific way, Matthews argues that real political change only comes from brilliant, dramatic, unpredictable and grand moves. So I don’t think health care incrementalism is in Matthews’ play book.

Donna Brazile, TV political commentator and Chair of the Democratic National Committee’s Voting Rights Institute, and super-delegate, also believes that voters are in a foul mood. There “will be blood in this election”, she says. The next president will inherit a divided country and healthcare will be right in the middle of it. In addition, the deterioration of the economy will make health care reform doubly difficult. Even so, Democrats will want to get something in healthcare reform on the table quickly after the election.

Michael Murphy, Republican Political Consultant, and TV Commentator, on this point, says a McCain presidency may, contrary to popular thinking, do more for healthcare reform since if it is proposed by Democrats, the Republicans will block it. Like Nixon going to China, you need a conservative to front this kind of liberal change.

Dan Crippen, former Director of the Congressional Budget Office, observes that many people think rising health care premiums are capricious acts; they go up by themselves and are unrelated to cost structure. He asks “How do we change the 30 year old question in healthcare from ‘who should pay’ to ‘what are we buying’.”

Ezekiel Emanuel, Chair of the Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, asks the question of how do we make sure that the process of healthcare reform is legitimate if we need to make sacrifices? What voices need to be heard? He also agrees with many of the other speakers that we need to better assess what we’re spending our money on in healthcare. We need a better strategy. In responding to those who say that cost should not be a consideration in delivering healthcare, he advocates, that cost is an essential ethical consideration in healthcare because cost has an impact on our ability to pay for other critical services and needs. And that fact alone makes it an ethical dimension worth weighing.

In a similar vein, Paul B. Ginsburg, President, Center for Studying Health System Change, provokes the audience on questions about the importance of equity in healthcare, and the public tolerance for administrative control of the distribution of health care services. Containing health care costs will be painful, he reminds us. There is no painless solution. Ginsburg warns that health care financing systems can fail, but that they fail slowly. This health care crisis has been with us for over a decade. However, the affordability problem is now invading the middle class, crowding out other important needs.

The final speaker of the day one was the notable Theodore R. Marmor, Professor Emeritus of Public Policy and Management, and Political Science, School of Management, Yale University. Marmor observes that the lack of consensus should not be surprising since with healthcare we have five Americas: The British model embodied in the Veterans Administration system; the German social insurance program model in Medicare; the 19th century poor laws model in Medicaid; the private health insurance system; and pure charity medicine.

His own criteria for judging health reform proposals are fairly simple: Does is include everyone as payers and recipients for care? Does it cover what ordinary people think is medical care? Does it contain fiscal restraints to prevent the raiding of either the public or personal funds? It is accountable for results? And is the protection portable?

Marmor would like to see a real national conversation about healthcare since right now he feels what Washington is saying up to this point is pure gibberish. How, he asks, can we avoid another mistake like that which was made by the Clintons without a real national dialogue and consensus? We cannot wait another decade for an answer.

US Senator Ron Wyden took the stage first thing the morning of day two of the conference. He’s a frequent speaker at this conference usually focusing on his ‘Healthy Americans Act’ as a step towards real healthcare reform. He says the first 100 days for the new president will be critical for healthcare. Democrats — if they win — will need to put something on the table quickly. Congress is getting ready to act and Wyden does not want a repeat of the now infamous Clinton failure of 1994. This time there is an opportunity to do healthcare reform right. He wants a system where everyone has a basic private portable health insurance plan.

Recent history shows states cannot fix healthcare by themselves because the big drivers are federal, such as Medicaid and Medicare. And if we don’t fix the private market, the country will go single payer. Wyden wants a new private health insurance market that breaks the dependence on employer-sponsored coverage. His plan would still offer a choice of an employer plan. But his ‘Healthy Americans Act’ now before Congress would provide for an alternative to both single payer, and an over-dependence on employer-sponsored healthcare.

But how will health insurers respond to these proposed new changes? Cajoling his audience of health plan representatives, he argues that his approach would be one way to stop playing the healthcare blame game, replete with its usual designated healthcare villain of the day being held responsible for all that is wrong in healthcare. Health plans have all too often shared this distinction.

Andy Stern, President of Service Employees International Union, started his talk with an all-too-familiar tragic story of a healthcare disaster that end bankrupting an American family. He then switched gears to share the changes his own union has had to undergo to confront the new global economy. Healthcare, he believes, has also not reacted well to this new global economy. What we have now is a healthcare sector; what we need to build is a healthcare system. “Change is inevitable but progress is optional,” he lamented.

If there is one truth about healthcare reform, Stern believes, it is that the longer you wait, the worse it gets. And the US employer-based healthcare system is not sustainable for the economy of the future. It is dead and it’s time for hard choices. We need to move on to a more competitive approach. But he doesn’t think the country is ready, willing or able to go for a single payer system. We have to build a broader coalition on healthcare and negotiate a new blend in order to move on.

Stern warned that there is a big target painted on health insurers and the bullets are getting closer. Health insurers will have to walk in a new direction. People are ready for change. But where is the solution? “Be the agents of change”, he charged, “not the assassins of change”.

Gail Wilensky, Senior Fellow, Project Hope and a former Medicare chief, observed that even when we have expanded access to healthcare — such as the recent addition of drug benefits to Medicare, we still have problems with cost and quality. Medicare’s cost is unsustainable and its population is becoming more politically forceful. The program’s provider financial incentives are perverse and its spending constraints are ineffective when it comes to value and quality. It will be an immense challenge to moderate the Medicare’s cost growth.

Bruce Vladeck, Senior Health Policy Advisor, Ernst & Young, and also a former Medicare chief noted that the healthcare reform proposals put forth by the presidential candidates rarely mention Medicare or Medicaid. Problems with Medicare are the problems with the healthcare system generally speaking. He argues that Medicare costs — even with new efficiencies — cannot be sustained without new money. Politicians need to be more open and explicit about this hard fact. And he adds, that we must stop confounding the problems having to do with improving the quality of healthcare, with the problems of moderating the cost of care. It is a fantasy, he says, that improved quality will save serious money in healthcare.




Health Care Privacy and the Surveillance State: The Struggle for Balance

by Fred Fortin

Health care privacy is part of the bigger picture of a society’s respect for human rights and individual persons. Balancing privacy, security as well as transparency and openness is a cultural and political challenge for any nation. Surveillance is the modern compromise for living in a dangerous world. But how much, who, where and when are choices and decision-points by authorities that affect us all. And consequently, the way we manage the tensions between privacy and legitimate surveillance generally, will impact the way we think about the privacy of medical information.

Privacy International has come out with their international privacy rankings and determinations of the world’ leading surveillance societies. The 2007 rankings indicate “an overall worsening of privacy protection across the world, reflecting an increase in surveillance and a declining performance of privacy safeguards.” One category the report is the surveillance of “medical and financial movement” in which countries like the U.S. and the U.K. (and others) are deemed countries with the worst records providing “weak protections of financial and medical privacy.”

A few weeks ago I attended the World Healthcare Innovation and Technology Conference (WHIT 3.0) where a different perspective was being advocated, namely that health care privacy laws were too strict and impeding progress in the implementation of information technologies and new media that’s needed to improve quality, access and constrain cost. Figures such as Adam Bosworth were unequivocal: Government is “trading off the deaths of hundreds of thousands of people to prevent the exposure of very few” with these laws against “possible and rare risks to privacy.” In that conference, no one contested his position. I could imagine a very different conference, say of privacy or health care activists, who would find Bosworth’s position an extreme one indeed.

I once visited a thriving hospital in Beijing where patients were lined up outside just to get services. Once inside the hospital physician’s office, they sat across the desk from the doctor along with the next few patients in the waiting line, who watched and even participated in an open door, open seating and open discussion of the patient’s problems. Certainly a surprise to westerners, but it is a normal practice at many of China’s public hospitals.

The point is, the struggle to find balance in this area is going to run up against a strong phalanx of opinion and cultural differences no matter where one sits. And it is by no means clear or self-evident, despite all manner of strong assertions to the contrary, where that balance point resides.




Health Vault: Software Freedom Folks Want Dialogue with Medical Community

by Fred Fortin

Fred Trotter wants to talk to you about Microsoft’s new Health Vault (MHV).

He hopes that by publishing his concerns that he might be able to draw some attention from the medical community to what the free software community is saying about MHV. “Its something of a blind date,” he says “but I strongly believe the two of them should definitely meet!”

Specifically, Trotter wants to examine the implications of a proprietary software personal health record (PHR) on software freedom and his concerns about the ownership, privacy and security of the medical information put in it. He writes,

“The ideals of software freedom are that users should have control of software, rather than companies controlling users through software. It may seem like a trivial point to my geek readers, but without control of software it is not possible to have control of data.”

His arguments span a number of issues:

  • MHV fails in its commitment to maintaining the longevity of medical information across future generations (the seven generations test, he calls it), a commitment that is vitally necessary to understanding of DNA and its relevance to medical conditions over time, for example;
  • A private, for-profit, corporation is an inappropriate storehouse for records that future generations will need;
  • Microsoft has a long history of standards abuse and “famous” for incorrectly implementing standards and creating new incompatible “dialects”;
  • Portions of medical records operate under different disclosure rules based on whether they reveal a persons HIV status, for example. How can this kind of complexity be managed he asks?

“Medical records belong to the patient, except when they don’t. They should be accessible to the patient except when they shouldn’t. The records of minors are always open to their guardians except when they are closed. Segmenting data in order to protect portions of health information is currently an intractable problem of free-text analysis. Tagging patient records with critical information is difficult. Trust is far more complex than is first seems. Finally, patients should be allowed to “control” their own record, except when that control would allow them to do something that would invalidate the record.”

And finally, he argues that the publicized attestations as to the privacy and security of health information in MVH have not been really validated. “What matters” according to Trotter, is not what Microsoft, or anyone says, but “what the software actually does and the only way to determine this, one way or another is to read the source code.”

The mistake he argues, is that we, the medical community, are assuming the issues with MHV and PHRs are legal/medical and ethical ones rather than legal/medical/ethical and technical problems.

We may want to take a listen to what he has to say.




McCain’s Health Plan — “Feeding Health Care to the Big Dogs” Part Two

by Fred Fortin

John McCain is now the third candidate to announce that, if he were president, he would allow people to buy health insurance nationwide — Giuliani and Duncan Hunter (R-CA) being the other two — rather than “limiting them to in-state companies” and also permit people to buy insurance “through any organization or association they choose as well as through their employers or directly from an insurance company.” This approach would leapfrog individual state jurisdiction over health care when it comes to health insurance.

Well that makes the Wall Street Journal happy at least. The same-day editorial made that perfectly clear:

“One major difference among these front runners concerns insurance regulation, and here Mr. McCain comes out on top. Part of the reason coverage costs differ so sharply among states is because some have chosen to impose multiple rules and mandates. Mr. McCain would allow people to purchase policies across state lines, which is currently prohibited.”

I’ve argued before that nationalizing the private health insurance market place would be a big mistake. Such a policy would end up feeding health care to the big dogs — large national and multi-national corporations as well as deposit de facto control of health care into the hands of Washington. The impact would be to continue to distance and marginalize states and local communities from important decisions (and any levers of control they now have) that impact the quality of their everyday lives.

One point I did not mention in my previous post, however, is that the mandates and rules at the state level, that would be essentially trashed under such a scheme, are incredibly important. They level the competitive playing field, ensure financial responsibility and mandate (for the most part) that critical benefits — such as mental health, well child care and prenatal care, for example — are included in all policies. You may be able to buy all the cheap health insurance you want from some national company but what will you get? Not much I think. The simple and hard truth is that the health care we all want is inherently expensive. That is the nut we have to crack.

What’s interesting is how little public attention or controversy this fairly radical idea generates. Maybe we are so used to another big box coming into town and gutting the local countryside that we’re resigned to health care following the same dispiriting course.




Podcast interview with Mike Totterman, Chairman and CEO of iCardiac Technologies

by David Williams

Drug safety is a major issue these days. FDA has been criticized for allowing drugs with safety problems to reach the market, Merck is embroiled in thousands of lawsuits over heart problems allegedly caused by Vioxx, and not a month goes by without the cardiac safety profile of a marketed drug being questioned. Recently, the Senate passed a bill granting the FDA greater authority to restrict the use of drugs when safety problems are discovered after launch.I recently joined the board of iCardiac Technologies, a start-up company that is developing new tests that use ECGs to find cardiac safety problem with drugs early in development. iCardiac has already signed a research alliance with Pfizer and attracted investment from venture capitalists.

I visited the company recently and spoke with its Chairman and CEO, Mike Totterman. Listen in and hear what he has to say.

icon for podpress  Standard Podcast: Play Now | Play in Popup | Download