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Shining a Light on Conflict of Interest in Biomedical Research

Last week Francis Collins, the director of the National Institutes of Health proposed important new rule changes for federally-funded investigators that are designed to increase transparency and remove many of the conflicts of interest that abound in biomedical research.

The proposed NIH rules, which are open for comment and expected to go into effect before the end of the year, represent the first time financial reporting requirements have been overhauled since 1995. The rules require investigators to disclose to their institutions all payments they receive from industry above $5,000, as well as any equity position they hold in a company. Research funding, speaking fees, paid authorship and travel expenses all must be part of this accounting. The previous limit was $10,000. The new regulations, which are aimed at reducing or removing industry bias from academic research, also require the academic medical centers to come up with a plan to manage investigator’s conflicts of interest—for example, university officials might insist that an investigator sell stock he owns in a company that helps pay for his research. Institutions will also be required to post all relevant payments (along with names of individual investigators) on a public website.

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10 Rules for Good Medicine

The recent discussion of the appropriateness of bringing patients back to the office has really gotten me thinking about my overall philosophy of practice.  What are the rules that govern my time in the office with patients?  What determines when I see people, what I order, and what I prescribe?  What constitutes “good care” in my practice?

So I decided to make some rules that guide what I think a doctor should be doing in the exam room with the patient.  They are as much for my patients as they are for me, but I think thinking this out will give clarity in the process.

Rule 1:  It’s the Patient’s Visit

The visit is for the patient’s health, not the doctor’s income or ego.  This means three things:

  1. All medical decisions should be made for what is in their interest, including: when they should come in, what medications they are given, what tests are ordered, and what consults are made.
  2. Patients who request things that are harmful to themselves should be denied.  People who ask for addictive drugs or unnecessary tests should not get them.  Patients who are doing harmful things to themselves should be warned, but only in a way that is helpful, not judgmental.
  3. All tests done on the patient should be reported to them in a way that they can understand.

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An Open Letter to Senator Scott Brown

Paul Levy Star

Dear Scott,

I understand the Senate confirmation process in Washington, DC, and how the appointment of individuals
gets hung up for a variety of political reasons. I don’t particularly like it, but I understand it.

But I don’t understand how with regard to the appointment of Don Berwick as head of CMS, the Medicare agency, this can be the case, as reported recently in the Boston Globe:

Senator Scott Brown, a Massachusetts Republican, has not decided how he will vote, a spokesman said.

That Don Berwick is an internationally renowned expert in health care delivery is not in doubt. That he is an honest, hard-working, and thoughtful person is also clear to the thousands of people in the health care professions with whom he has worked. That his primary focus has always been on reducing harm and medical errors is likewise the case. He is also interested in reducing costs in the health care delivery system when such costs represent waste and inefficiency.

Scott, the issue here is not whether the recently passed health care bill was right or wrong for the country. I respect your opinion on that matter. But that vote has been taken.

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In Defense of Paul Levy

Picture 7

Paul Levy, the blogging CEO of Boston’s Beth Israel Deaconess Medical Center, found himself in hot water last

month over an inappropriate relationship with a female subordinate. While some of the details of the transgression remain sketchy, I think I now know enough to opine on it. To my mind, Paul has been an extraordinary healthcare leader, and – while the episode represents a lapse in judgment that deserves censure – he should not lose his job.

Let’s start with some background. Paul took the helm of BIDMC 8 years ago. At the time, the hospital – which operates in the shadow of its more storied Harvard cousins, Brigham and Mass General – was in crisis: its staff was dispirited, it was losing a million dollar a week, and it was still reeling from the challenges of blending the cultures of its two recently merged progenitor hospitals, Beth Israel and Deaconess. (Hint: the religious mismatch was only the start of the tsuris.)

Paul was an unusual choice for the position of CEO. BIDMC CEOs have historically been physician-leaders, whereas Paul’s major prior roles had been to teach Environmental Policy at MIT and to lead the Massachusetts Water Resources Board, where he spearheaded the cleanup of Boston Harbor. Some folks wondered whether he was up to the task of being CEO.

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Is HITECH Working? #7: Where’s Plan B? Congress and ONC need to address major flaws in HITECH

By VINCE KURAITIS JD, MBA and DAVID C. KIBBE MD, MBAVince Kuraitis

Pop quiz: Among early-stage companies that are successful, what percentage are successful with the initial business model with which they started (Plan A) vs. a secondary business model (Plan B)?

Harvard Business School Professor Clay Christensen studied this issue.  He found that among successful companies, only 7% succeeded with their initial business model, while 93% evolved into a different business model.

So let’s take this finding and reexamine our human nature. In light of these statistics, what makes more sense:

  • Defending Plan A to your dying breath?
  • Assuming Plan A is probably flawed, and anticipating the need for Plan B without getting defensive?

We question many of the assumptions underlying HITECH Plan A. We also want to talk about the need and content for Plan B in a constructive way.

In this essay we’ll discuss:

1) The Need for HITECH Plan B

2) Questioning Assumptions — Issues to Reconsider in Plan B

a) Rewarding Incremental Progress
b) Addressing Root Causes for Non-adoption of EHR Technology
c) Questioning Health Information Exchanges (HIEs) as Building Blocks for the Nationwide Health Information Network (NHIN)
d) Catalyzing Movement Toward Modular EHR Technology
e) Focusing Incentives on High Leverage Physicians
f) Recalibrating Expectations for EHR Technology Adoption
g) Getting Bang-for-the-Buck in Achieving Meaningful Use Objectives
h) Comprehensively Revamping Privacy/Security Laws vs. Tweaking HIPAA
i) Maximizing Sync Between HITECH and PPACA
j) Leveraging Potential for Patient-Driven Disruptive Innovation
k) Promoting EHR Adoption Beyond Hospitals and Physicians, e.g., long-term care, home health, behavioral health, etc.
l) Dumping CertificationContinue reading…

Commentology: Is This the Future of Insurance Negotiations?

Names withheld to protect the innocent.

Dear Patient:

You may have read
recent media
coverage concerning contract negotiations between XXXX Insurance
Company and XXXX Healthcare Group. First, on behalf
of XXXX
Healthcare Group, our hospitals and our physicians, I would like
to
apologize that you heard this information via the media and not from us.
We
were very surprised XXXX Insurance
Company contacted the press about the negotiations because when XXXX
released its media communications,
we hadn’t even had a face to face discussion about the contract
proposals. Most
contract negotiations include actual “negotiating” to arrive at
reasonable
terms, but it appears XXXX Insurance
Company preferred to start things off by pressuring patients to end
their
existing relationships with family physicians and local hospitals.

We believe XXXX Insurance
Company’s approach of distorting the facts and
misleading the public instead of negotiating a reasonable contract is an
attempt to deflect attention from XXXX Insurance
Company’s overall plan to increase their profits. It’s a negotiating
tactic we
feel is designed more to frighten patients than resolve differences.

We want to give our
patients as
much information as we can to help them navigate this situation. First,
you
should be aware that XXXX Insurance
Company is required by law to notify you by June 1, 2010 that the
contract may
terminate on July 1, 2010 and XXXX Insurance
Company may even advise you to select a new in-network physician. Your
letter
should arrive any day but your coverage with XXXX Insurance
Company remains unchanged today.

However, that
letter does
not mean you must change your physician. We understand how important it is for you to maintain a relationship
with a
physician you trust and knows about your health. That is why our
existing contract
allows patients and employers to request XXXX
Insurance Company to keep the doctors and facilities in-network for one
year or
until the employee’s subscriber contract anniversary date, whichever
date is
earlier should we not have a new contract in place by July 1.

We encourage patients
and their
employers to write to XXXX Insurance
Company today and request they keep XXXX Healthcare
Group doctors and facilities
in-network and to continue to negotiate a fair contract.

XXXX Insurance Company has
alleged XXXX Healthcare Group’s costs are higher
than
state and national averages. We disagree with this statement and
challenge
their data. We monitor the cost of care very closely through independent
actuaries used by many of the largest payors in the country and know
that our
commercial reimbursement is comparable to other healthcare providers
across the
state. We asked XXXX Insurance
Company to substantiate its data, which is based on its own company
information, but they have ignored our request.

In the last two years XXXX
Insurance Company earned $2.6
billion in profits. In contrast, XXXX Healthcare
Group has made $10 million in net
income in the last two years while also providing $222 million in
charity care
for patients who were uninsured. While XXXX
Insurance Company wants to argue they are fighting for their members,
it’s
clear they are looking for ways to prepare for healthcare insurance
reform
while still maintaining their profits for shareholders. One of those
ways is to
squeeze hospitals and physician clinics that are already operating on
very slim
margins.

Even though the
negotiations
have started rather unpleasantly, we will work in good faith to come to
terms
with XXXX Insurance Company so you
can continue to have XXXX Healthcare Group
physicians and hospitals as
an option for your care.

If you have any
questions
concerning this situation you can call us at xxx-xxx-xxxx.

Sincerely,

Introducing San Francisco Health Innovation Week

Hiw logo

Health 2.0, LLC and Health Care Conference Administrators, LLC (HCCA) are excited to bring you Health Innovation Week, October 3 – 10, 2010 in San Francisco.

Together with the REC/HIE, EHR and HIPAA Summits, the popular HealthCampSFBay and the 4th Annual Health 2.0 conference, Health Innovation Week will be a fantastic opportunity to get immersed in the world of health and technology innovation in the beautiful city by the Bay.

To find out more about the events of Health Innovation Week, or to add your own to the calendar, check out:  http://healthinnovationweek.com/.

ReachMD: 2.0 Tools and Healthcare

Matthewholt Web 2.0 tools have made the Web more
interactive for everybody. But what is Health 2.0?

Find out, with Matthew Holt, healthcare futurist, co-founder of the
Health 2.0 conference and founder of The Health Care
Blog,
tells you why you should.

Listen to the ReachMD
broadcast or podcast
— Then it’s your turn. Vote in the ReachMD Poll.

You can also:

  • Add your comments at Tweet us
  • Post on Facebook
  • Or call the ReachMD Listener Line at 888-639-6157
    to record your comments (portions of which may air).

Hospital Bills, Insurers and Pricing

A few weeks ago I wrote here about my
unhappy experience of inadvertently mixing two different types of drain
cleaners together
. I learned then, and thought it useful to relate,
a painful in-home science lesson: the combination of hydrochloric acid
and hypochlorite (bleach) apparently forms chlorine gas, which was used
as an agent of chemical warfare early in World War I. Serious lung
damage and death are real possibilities. After a trip to the emergency
room, a follow-up visit to my doctor and the passage of time– I’m ok.

But the other day I got the bill, or thankfully, as I am insured
through my employer, the explanation of benefits. My present insurance
company, CIGNA, detailed the claim in an easy to read and understandable
manner. It is telling.

med-bill-breakdown2

I was in the
Emergency Room for about 4 hours (they had wanted to keep me overnight
for observation but released me under the condition (and my pleading)
that I return immediately if any number of things happened). I received
oxygen and breathing treatments, x-rays, lab work, an electrocardiogram,
and the care of a physician.  The total billed was $2,270. But perhaps
more importantly, the amount “discounted,” or the amount my insurance
company did not pay through its negotiated pricing contract with the
hospital, was $2007. Which is to say that my insurance company  paid a
total of only $263 of this bill. Thankfully, I owe nothing except a
small co-pay.

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It Slices, It Dices, It Fleeces

Infomercials annoy me.  They are social polyps that have grown to outlandish proportions on the intestines
of a bloated and sick American media.  The portmanteau term “ infomercial” is clearly an oxymoron describing the contradiction of programs that are both hosted and devoured by morons.  The fact that infomercials are even allowed by the FCC is a sign of the advanced dry rot in our American entertainment, economic and regulatory systems.

The FCC, according to one gadfly, now stands for “Forget Catching Criminals.”  It appears that after decades of exporting our innovation, manufacturing and customer service, the dregs of commerce have reached new lows where 30 minute advertisements fill vacant morning programming time –  feeding bread crumb promises to an inactive and unemployed America gulping down like boat marina carp visions of cleaner colons, miraculous weight loss without exercise and abs as chiseled as parking lot speed bumps.

I can recall the first time I was ripped off by a false advertisement via a DC Marvel comic book. The “Live Sea Horses” actually turned out to be ionized pieces of tire rubber.  As they floated and swirled in my “seahorse garden”, I felt my first sensations of buyer’s remorse. I had been had.  Weeks later, I was tempted to send away for X-Ray glasses.  The idea of being able to watch the older eighth grade girls PE class run laps with my three dimensional goggles was intoxicating.  Yet, the cynical memory of pathetic black floating bits of rubber had already eroded the tint from my rose colored glasses.  My father, the advertising man, later explained to me the simple Latin maxim that would echo in my brain for decades:  “Caveat Emptor – Buyer Beware.”

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