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Physician Payment Sunshine Act Proposed Regulations Out

CMS has published proposed rules for its implementation of the Physician Payment Sunshine Act (SUNSHINE ACT or Act), which was enacted by Congress as part of the 2010 Patient Protection and Affordable Care Act.  In short, the SUNSHINE ACT requires life science companies to report annually to CMS their conferral of anything of value, whether it be payment for services or a dinner, in connection with a particular product of the paying company.  By requiring CMS to post the information on its website, the Act seeks to ensure that interested patients become aware of physicians’ conflicts of interest that could affect their prescription of a branded drug or choice of a specific medical device.

The SUNSHINE ACT represents another example of the transparency movement, which has had varying degrees of success in either changing the behavior of the parties subject to disclosure, and/or enabling consumers to make better decisions based upon their access to the disclosed information.  It is likely that the SUNSHINE ACT will impact physicians and manufacturers’ behavior more than it will enlighten consumers about conflicts of interest.  Some physicians will simply conclude that accepting certain gifts or benefits from pharmaceutical or medical device companies isn’t worth having their names on the CMS website.  Some companies have already discovered that they haven’t necessarily reaped the value of the costs of gifting many physicians, or that the cost of recording certain activities simply isn’t worth the return on investment.  Unquestionably, certain transactions will continue to be valuable to both physician and company, and will continue.

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Me too! It’s not fair! The Tragedy of the Commons in the Health Care Marketplace

There are at least two conversations going on in the health care marketplace today, each focused on one of two key questions. One is: How can we achieve the Triple Aim? The other is: Why do they get to do that?  (It’s not fair! I want more!)

Until we stop asking the second question, we can’t answer the first question. Why? Because all too often the answer to the second question is the equivalent of: It’s OK, Timmy, I’ll buy you TWO lollipops; pick whichever ones you want.

It’s the tragedy of the commons, transposed to the health care marketplace.

Recent cases in point:

  • Avastin
  • Tufts Medical Center – Blue Cross Blue Shield of Massachusetts grudge match
  • Mammography and PSA guidelines

1.    Avastin.  Late last year, the FDA yanked its breast cancer treatment approval for Avastin, based on a finding that it does not meet the “safe and effective” standard. CMS says it will still pay for the drug anyway, as will many commercial payors, based on physician judgment.

2.    Tufts Medical Center – Blue Cross Blue Shield of Massachusetts. The contract negotiation (out in public view) focused, in part, on Tufts’ complaint that BCBSMA pays way more for health care services provided by another network, Partners Health Care, and that it should be compensated on the same scale.  (Others have noticed this disparity too, and have found that higher payments were not accompanied by higher quality — see reports by Massachusetts state agencies.)  In the context of the present discussion, we may wish to consider whether Partners should be paid less, rather than whether Tufts Medical Center should be paid more.  This episode, according to some, will pave the way for more regulations.

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No Savings from Raising Medicare Age

The Congressional Budget Office released an issue brief Tuesday that suggested lifting Medicare’s eligibility age from 65 to 67 would save the federal government 5 percent on projected outlays over the next decade, and only “a small share of those people would end up without health insurance.” The idea has been touted by numerous deficit reduction proposals, including those from Republican Paul Ryan and Democrat Alice Rivlin, the former CBO director.

It’s a bad idea, says Aaron Carroll, a professor at the Indiana University School of Medicine and director of its Center for Health Policy and Professionalism Research. “No one should be under the illusion that the federal government will save money by raising the Medicare eligibility age,” he said in an interview after attacking the report on The Incidental Economist website, which is widely read by health policy researchers and analysts.

First, it’s a cost-shifting plan, not a cost-cutting plan, he pointed out. “Someone has to pay for the health care of those older workers.”

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What do Patients Really Want?

I recently wrote about an innovator’s dilemma of sorts – or call it a paradox – in healthcare.  The paradox is that as we look to innovate in healthcare, the very authority figures we must turn to for fact-checking our innovative ideas are conflicted and highly motivated to support the status quo.  I’m talking about physicians of course.

In a fee-for-service world, physicians are both the fountain of relevant knowledge and the source of all revenue.  So we have built our workflows, systems and processes around their comfort and success.  As physicians succeed, so does the rest of the healthcare juggernaut.  I know other industries fall victim to these kind of MC Escher-like business models, but it seems particularly acute in healthcare.

My belief is that this paradox makes our industry highly susceptible to under-imagining what real innovation could look like.  We have some pretty deep blinders on, it seems.  One of my favorite Steve Jobs legends is that when asked about the consumer research that led to the development of the iPad, he quipped, “We don’t expect consumers to be able to tell us what they don’t realize they need.” [I am paraphrasing, but this is reasonably accurate.]

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Super Bowl Sanitation: “Washed Up” Giants Outpoint Docs

Is the New York Giants bathroom more sanitary than your hospital room? Could be. And that player cleanliness may even have helped send the team to the Super Bowl.

Freakonomics co-author and self-confessed germophobe Stephen Dubner, working on a Football Freakonomics segment for the National Football League, noticed that every urinal in the football Giants’ bathroom had a plastic pump bottle of hand sanitizer perched on top – a phenomenon he promptly documented photographically.

Health care-associated infections cause more than 98,000 patient deaths every year. Yet as I’ve noted previously, the guy who just used the toilet at the train station is way more likely to have clean hands than the guy walking up to your bed – or into the operating room – at the local hospital. That’s based on my comparing hospital sanitation with the results of a surreptitious survey by researchers from Harris Interactive of more than 6,000 adults using restrooms at six high-volume sites across the country.

At New York City’s Grand Central Station and Penn Station, only 80 percent of men and women washed up. However, even Atlanta’s Turner Field, where just 65 percent of men washed their hands, looked positively sterile compared to hospitals. The Centers for Disease Control and Prevention found that baseline compliance for hand hygiene was just 26 percent in intensive care units and 36 percent in non-ICUs.

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EHR and Practical, Tactical Outcomes

I hope people are watching the news around the Meaningful Use attestation data released by CMS recently, because it is so instructive as to the difference between where we are in health care and where the deliverers of keynotes THINK we are. Since last September, we’ve been publishing our Meaningful Use (MU) dashboard data and as of this week for example, we know that 83% of our Medicare MU doctors have attested to the measures.

But our constraints as a marketplace are at the practical, tactical level. According to our analysis, some 48% of what doctors order does NOT turn into a documented update to the chart within 60 days of that order. And we all know the average EHR makes docs go slower—causing employment by hospitals in large numbers—at large losses to the hospital. And NOW, based on the CMS data, it looks like a large percentage of docs are on track to miss a bloody lay-up of a bonus from the federal government! Do you guys really think we are going to build integrated ACOs that drive down hospitalization?

Pass it on—we are further behind than we think we are, and we need to hold ourselves accountable for PRACTICAL, TACTICAL outcomes before we even talk about grand outcomes like “total quality.” So what do we do? So glad you asked. I hazard three guesses, and you guys can throw in more… or challenge mine.

1. Make a market for health information exchange. Today, HIE is universally used as a NOUN. It’s a thing you buy from Aetna or Lockheed Martin or IBM. In every other information supply chain I know of, people who WANT info PAY others to give that info to them. They pay only when the info is delivered in usable form. This is, of course, not allowed in health care, but it can be. We should get behind legislation that allows for the most rudimentary mechanism for exchange in the history of man.

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Feed the Beast: Renewing the Prescription Drug User Fee Act

The entire biopharmaceutical industry is suffering a crisis of poor productivity in research and development, some of which is due to overregulation. It’s not suprising that an increasing number of observers conclude that the Food and Drug Administration is broken and needs radical redesign.

The pages of august publications such as the Wall Street Journal are peppered with op-eds condemning the FDA’s sluggish proceedings and bloated bureaucracy. Proposed solutions include stripping the FDA’s power to judge the “efficacy” of new medicines, and limiting it to determining “safety”; increasing patients’ freedom to use investigational new medicines before being finally approved by the FDA; and (my own long-standing recommendation) allowing American patients to use medicines approved in Europe or other developed jurisdictions, if the FDA is too slow.

These are all great ideas, but they are not ready for primetime in 2012. Indeed, over emphasizing them now runs the risk of making the situation significantly worse. This is because the federal law that largely determines the FDA’s funding, the Prescription Drug User Fee Act (PDUFA) must be reauthorized by this September. This would result in the fifth version of PDUFA, which was first passed in 1992.

These renewals have generally granted more money and power to the FDA, in exchange for promises of faster approval of new medicines – promises which were fulfilled initially but eventually slipped. The negative consequences of the FDA’s failure to meet its commitments have become very apparent in all segments of biopharmaceutical enterprise.

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Do You Want Your Doctor to Tell You When You’re Going to Die?

Paul Kostick’s DNA was under attack and his fate was sealed. Forces beyond his control were hacking large pieces of genetic material off the ends of his chromosomes. His telomeres (a bit of junk DNA that protects other DNA whenever his cells divide) were wearing down. In patients with this amount of telomere destruction, the average life expectancy is around five years.

Should Kostick’s doctor tell him how long he has to live? Not how long as in: “You are going to perish on February 26, 2017.” Instead, I’m asking whether this physician, when discussing the pros and cons of colon cancer screening with Kostick or when talking about the risks and benefits of major surgery, should make sure Kostick knows that there is a good chance he won’t live long enough to experience the benefits of these procedures.

At first glance the answer to my question is obvious: of course doctors should discuss life expectancy with terminally ill patients when they face important medical decisions. And yet, Kostick’s doctor never mentioned this terminal illness to him. In fact, most doctors taking care of people with Kostick’s condition are hesitant to discuss prognosis with these dying patients.

If this were the 1960s, such silence would not be so surprising. Surveys back then revealed that more than 90% of doctors routinely withheld cancer diagnoses from terminally ill patients, out of concern that such news would cause patients to suffer. Better to comfort them with evasions and out-and-out lies than to burden them with the truth of their imminent demise.

This silence largely ended in the 1970s, a decade that saw the rise of the empowered patient—the dawn of the bioethics movement. Doctors realized that they could no longer keep patients in the dark about their health and healthcare. “Informed consent” became the law of the land—as in: if you don’t inform your patients about their situations before consenting them for interventions, you will be held legally responsible!

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Public Needs Voice in Health Care Decisions

As the presidential election heats up and the Supreme Court prepares to hear arguments on the 2010 health care overhaul, it’s clear that the issue will remain a major national priority this year.

Comparative effectiveness research, the idea of doing research to find out what works for whom in health care, has been a prominent, and at times contentious, issue in health care reform.

Prominent because CER can serve a very important purpose in advancing high-quality care. Contentious because some propose that CER be used by the government to decide what medical care should and shouldn’t be available to patients.

The institute created by the law is now up and running. The Patient-Centered Outcomes Research Institute holds great potential in advancing comparative effectiveness research that supports doctors and patients and improves the quality of care.

One of the reasons that so many organizations representing patients, providers and people with disabilities supported creation of the PCORI was the opportunity that it offers for us to have a meaningful voice in decision-making.

The PCORI recently began the process of making a crucial early policy decision — that of setting national priorities for comparative effectiveness research.

Unfortunately, the PCORI’s process does not give patients and people with disabilities a real opportunity for meaningful input in this decision. That’s because the only priorities that it is seeking comment on are broad categories of health care that restate the institute’s research mandate from statute.

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Am I My Genes? The Question Of Fate, Free Will And Genetics

“I live with knowledge of my own death,” she told me. “I found out I have the Alpha mutation, and that it will eventually kill me.”

Individuals who learn they have a genetic mutation often feel this way. They may struggle to cope with this sense of fate, and frequently wonder: “Why me?”

The answers are not easy.

Genetic testing is on the rise and beginning to confront us with profound questions of who we are, and why. The human genome was first decoded only 10 years ago. But the price of sequencing the full 3 billion “letters” that make us has fallen from $10 billion per person to less than $1,000 per person, and will soon probably be only $100. Hence, many medical centers are now arranging to sequence every patients’ genome. In a few years, most, if not all of us will have our full genomes mapped, whether we like it or not. We will learn what mutations we each have, and what diseases we may get.

This knowledge can potentially help in preventing certain diseases, and determining which medications, at which doses will work best for us.

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