Blogs

Steven R. Peskin, MD, MBA, FACP
Is Executive Vice President and Chief Medical Officer
of MediMedia, USA, which publishes Managed Care

Steven Peskin MD"You Can't Outrun Your Past"........ The title of a slide in a grand rounds presentation by Dr. David Kountz, senior VP for medical and academic affairs at Jersey Shore Medical Center and professor of medicine, UMDNJ-Robert Wood Johnson Medical School. The subtext is that the impact of being black in our society confers incremental risk across a range of cardiovascular and cardiometabolic conditions irrespective of socioeconomic status.

A 1997 journal article by Thomas, et al. reported the results of a 23–25 year longitudinal surveillance study of a cohort of all black physicians who graduated from Meharry Medical College from 1958 to 1965 compared to an all-white cohort that graduated from Johns Hopkins from 1957 to 1964. The black physicians had much higher risk of cardiovascular disease (RR= 1.65), incidence rates of diabetes and hypertension twice that of whites, a rate of coronary artery disease 1.4 times as high, and much higher case fatality rates (52 percent versus 9 percent). Most surprising to me from this study: Black physicians in this cohort had incidence of cardiovascular disease comparable to low socioeconomic status (SES) blacks. Higher SES in this well-educated, health-literate cohort did not improve health CV health outcomes.

In the study of Women's Health Across the Nation (SWAN), everyday discrimination was positively related to subclinical carotid artery disease for black but not for white women, and chronic exposure to discrimination over five years was positively related to coronary artery disease in black women.

A final study without a health care endpoint but one that drives home the impact of discrimination:

Pairs of young, well-groomed, well-spoken college men with identical resumes apply for 350 entry-level jobs in Milwaukee. Two teams of applicants are white and two teams are black. In each team, one applicant says that he had served an 18-month prison sentence for cocaine possession. The study found that it was easier for a white male with a felony conviction to get a job than a black whose record was clean.

Genetics, diet, physical activity, other factors certainly contribute. Nonetheless, these are sobering studies that strongly point to the adverse health consequences of allostatic load on the health of black Americans in the United States.

Robert M. Goldberg is a co-founder and vice president of the Center for Medicine in the Public Interest (CMPI).

Robert M. Goldberg, PhDThere has been a lot of discussion of the Food and Drug Administration’s decision to revoke approval for the use of Avastin in metastatic breast cancer. Most of it takes at face value FDA Commissioner Margaret A. Hamburg’s 69- page decision in which she claims that the “objective” evidence of benefit did not exist to support approval relative to the serious side effects of the drug.

In fact, the decision is less about Avastin and more about the deep resistance at the Office of Cancer Drugs (OCD) to accelerated approval.

Dr. Hamburg’s sympathy and support clearly lies with patients and the accelerated approval process. However, her explanation of the reason for the withdrawal of the approval reflects a combination of evasiveness and duplicity on the part of FDA staff in the Office of Cancer Drugs that has dogged the accelerated approval of Avastin from the start.

Dr. Hamburg seeks to refute the claim that the FDA never switched the outcome measure of additional studies Genentech conducted to support ongoing approval of Avastin for metastatic breast cancer (MBC). She claims (and I will guess this was written for her) that progression-free survival (PFS— how long people lived without tumors growing) was always the standard and that the OCD did not demand to see an increase in overall survival (how long people with and without Avastin treated before they died of any cause), which is a harder goal to meet.

In fact, her decision memo shows that the FDA never came straight out to say PFS of any given length would be the basis for approval. Rather, the FDA used the words “probably” or “might” and talked about the “potential” of using PFS for approval as long as the “magnitude” of the benefit was significant, given the risks of the drug. Did FDA ever define what “magnitude” was sufficient? Never. Rather, Dr. Richard Pazdur, who runs OCD, told Genentech he would determine what the right “magnitude” would be when he saw the results.

Additionally, Dr. Hamburg claims that the magnitude of clinical benefit has nothing to do with achieving a statistically significant benefit. (Those words might and should be used by companies as they design clinical trials.) All well and good. Yet the FDA ultimately revoked approval because Avastin did not show a statistically significant increase in overall median survival. So does statistical significance matter or not? Apparently it does when you want to undercut approval for use of a product you opposed at the outset.

Similarly, when Dr. Hamburg claims that Genentech could never identify a subset of patients that might be more likely to benefit from Avastin in MBC, she fails to point out that the FDA never asked for such data, nor did it state that it would extend approval based on response in a small group of patients. In any event, the FDA decided that post-hoc analysis to identify super-response of a statistically significant amount is not evidence of magnitude.

Dr. Hamburg offers some hints about how to show clinical benefit going forward: patient outcome data will count, and trials should be designed to show which people might gain the most from medications. Her brief discussion about how groups that support continued use of Avastin in MBC could appear to biased because they receive unrestricted support from Genentech is a very low blow and hypocritical because the FDA is seeking to loosen its own conflict of interest rules to get more qualified experts on it’s advisory committees.

All this suggests that allowing the FDA to retain discretion over what is enough benefit will generate more uncertainty and discourage pursuit of accelerated approval. The Avastin decision says less about the science of the FDA and more about how uncertainty, as a result of bias or lack of knowledge, can undermine innovation.

Steven Peskin MD
A recent conversation reminded me of the forgotten population in health care — the non-utilizers. I was speaking with a physician leader in Lancaster, Pa., about his program that emulates the good work of Dr. Jeff Brenner and his team in Camden, N.J., that has targeted the 1 percent of patients responsible for 30 percent of the cost. In similar fashion, the program in Lancaster targets 10 percent of the population that account for 50 percent of the cost.

Dr. Atul Gawande's New Yorker article this past January drew attention to this important work and to several other super-utilizer programs.

http://www.newyorker.com/online/blogs/newsdesk/2011/01/atul-gawande-supe...

The physician from Lancaster then commented, But what about the 50 percent of our population that uses only three percent of health care resources? In that cohort there will likely be a few of next year's super-utilizers. I am not advocating medicalization of healthy people. However, surveillance, risk identification and stratification, early warning systems, and investment in continued health and well-being of today's non-utilizers may defuse a few ticking time bombs and advance a culture of health versus a system of sickness care and super-utilizers.

Steven R. Peskin, MD, MBA, FACP
Executive Vice President and Chief Medical Officer
of MediMedia, USA, which publishes Managed Care

I was amused and somewhat unsettled when I heard of Kaggle, a company with a novel approach to data analysis. As I understand it, Kaggle is a middleman between companies that have large amounts of data and are looking for certain kinds of analysis and the people or companies that can provide that analysis. But with a twist.

The companies with the data can be any kind of company. And the analysts? They could be anybody, too, and some of them might even be nobodies. Here's a quotation from the website, (http://www.kaggle.com/): "Kaggle is a platform for data prediction competitions that allows organizations to post their data and have it scrutinized by the world's best data scientists. In exchange for a prize, winning competitors provide the algorithms that beat all other methods of solving a data crunching problem. Most data problems can be framed as a competition." You don't have to be a big-time scientist to engage in the competition. You just need a big idea.

One competition, sponsored by California’s Heritage Provider Network, is to "identify patients who will be admitted to a hospital within the next year, using historical claims data." Practically the holy grail of managed care. There are over 1,000 contestants, and Heritage will hand out $3 million to the winner.

This is a pretty ingenious way to get people to work on a project that you might otherwise spend $3 million contracting with a single company and not get what you had hoped to get. Using a Kaggle competition, you could get exceptional value for your money. But if lots of jobs were done this way, there would be an awful lot of work done without being paid for, which is bad in itself, and which might shred the business of many kinds of consultants.

In managed care, I am thinking of the predictive modeling (PM) consultants who emerged 10 or 15 years ago and have been more and more accepted by health plans. Will operations like Kaggle mean the end of these vendors? Will competitions make PM consulting less lucrative and reduce the number of players? Or will it result in improved modeling with no downside for the sponsors of the competition?

This sounds like a disruptive innovation that bears watching.

John Marcille is editor of Managed Care.

Steven Peskin MD

Three times during the past month a friend has asked for advice regarding his/her personal health care or that of a family member out of frustration and concern stemming from not receiving clear communication/information about the health problem(s).

This scenario is all too common. Despite the ostensible focus on patient experience/satisfaction, the informed patient, and shared decision-making, health care professionals, health plans, and plan sponsors too frequently are not providing the explanation/information that patients and/or their caregivers seek. Sometimes language incompatibility, gaps in health literacy, or cultural differences lead to the disconnects. In all three of these instances, the individuals are well-educated and work within health care with good foundational knowledge of medicine, though are not clinically trained.

Those of us involved in the delivery, coordination, and management of health care are accountable to improve our performance to our patients, members, or their caregivers/loved ones. We must provide clear and understandable information.

Steven R. Peskin, MD, MBA, FACP
Executive Vice President and Chief Medical Officer
of MediMedia, USA, which publishes Managed Care

Paul Terry PhD
The Affordable Care Act codified the worksite wellness exemption to the federal medical underwriting provisions in the group health plan market. This means companies are allowed to use an “outcomes-based” incentive model that provides financial rewards for those who satisfy a prescribed health standard such as a BMI of less than 30 or who meet a “reasonable alternative standard” or obtain a waiver from their physician. What some see as “rewards” others view as penalties or surcharges and, given the absence of evidence to confirm the role of such incentives in actually improving population health, the new provisions have unleashed a debate about the ethics and putative effectiveness of the new provisions.

Many view the current and more common use of participation-based incentives as too easily exploited and insufficient to break intractable health habits. Others see the emerging trend toward use of outcomes-based incentives as draconian and a subterfuge for insurance cost shifting. I think the wisdom is in the middle and, with my colleague David Anderson, have argued that we need move beyond these opposing views by proposing an alternative "progress-based" incentive model that we believe can increase employee accountability and engagement while preserving fairness and equity in the use of incentives: “Finding common ground in the use of financial incentives” (http://www.ajhpcontents.org/doi/pdf/10.4278/ajhp.26.1.c2)

In contrast to the commentaries from the American Heart Association and the American Cancer Society in the above link that argue that incentives should be confined to participation only, we believe that a “progress-based” incentive strategy will provide a participant-centered, risk-adjusted and safer approach to achieving population health goals.

In a “progress-based” model, the attainment of a reasonable individually-tailored health goal, such as losing 10 percent of body weight, offers participants who fail to satisfy the health standard with an opportunity to earn incentives regardless of how far from the recommended health standard they begin their journey. Confining rewards to only those who hit the outcome target risks alienating those at highest risk who have the furthest to go and generate the highest costs to the organization. A “progress-based” approach, on the other hand, has the potential to engage everyone in setting achievable, measurable targets that yield health improvements.

What are your thoughts on the best use of financial incentives? The new provisions of the Affordable Care Act seem to signal a conviction that employees' accountability for their health should be bolstered. Has Congress inadvertently put employers in the role of insurance cost shifting?

Paul E. Terry, Ph.D., CEO, StayWell Health Management

Al Lewis
When an employer group shifts from one health plan to another, why not allow them to take their claims data to the next health plan? That way, the new plan would gain immediate knowledge of the specific disease burden faced by its new members and be able to act accordingly vis-à-vis care management programs and other interventions. As it stands now, the new plan would have to wait many months and even then would lack the history that the earlier plan no longer needs. And when the new plan “finds out" about a member's condition, it might be due to a claim for an event that could have been prevented had the carrier had access to the earlier data.

Here’s how the system would work. When a group signs up with a carrier, it could reserve the right to have its data transferred if it changes carriers. Obviously, it wouldn’t be able to “see” its own patient-identified data any more than it does now, but the data would accompany the change of carriers.

This can certainly be done without an Act of Congress. It might need to be safe-harbored by a brief regulation or administrative ruling under the Health Insurance Portability and Accountability Act, but I think one could argue that there is no prohibition against doing this now.

My question to the group is, what am I missing? Why aren’t we already doing this? Why wouldn’t a health plan offer this to an employer, for a fee, once it is clear that the employer is leaving for another carrier anyway?

Al Lewis is Executive Director of the Disease Management Purchasing Consortium

Life is change. We here at Managed Care are breathing new life into our website by changing its look, but not only the look. Sure, it is more streamlined and easier on the eyes, but the change that excites us is in the content, which is richer and more interactive. Our home page is now a blog, and will feature short, pointed, readable articles by a varied group of contributors—people from many areas of health care, from present and former health plan medical directors to pharmacy experts, practicing physicians, consumer and employer advocates and representatives, and people active in many other sectors of health care.

We hope to promote dialog on significant issues among the many people in health care who visit our site. Our new format allows for many more authors and categories of information and argument than can be accommodated in our flagship, the monthly Managed Care magazine, which is the best-read monthly publication in its category. We will post current articles from Managed Care, as we always have.

This new blog is a blank slate. See an article that could use some support, or maybe a rebuttal? We are interactive: You are invited to post responses to any item. We also invite you to contribute in a more substantial way by sending appropriate submissions directly to BlogEditor@ManagedCareMag.com.

John Marcille, Editor of Managed Care

Steven Peskin MD

As we move Managed Care into the blogosphere, my curiosity was arosed about the number of active English language blogs. As with many internet related statistics, I found a wide range of estimates from 152 million (BlogPulse, February 2011) to 450 million — Hat Trick Associates. I unsuccessfully spent a bit of time searching for the number of healthcare specific blogs.

Suffice to say, a surfeit of blogs. Since we seek value in managed care, I pose the question, "What is the relative value of blogs?" — reading blog posts, contributing to blogs, operating blogs.

I nudged our Editor, my colleague and friend, to join the fray in this domain of the market place of ideas. My own view, blogs do have value to stimulate thinking, to allow for healthy debate, to give our readers and authors opportunities to expand upon the information and insight that appear in articles.

Please join us to make our blog a vital forum in the managed care market place of ideas.

Steven R. Peskin, MD, MBA, FACP
Executive Vice President and Chief Medical Officer
of MediMedia, USA, which publishes Managed Care