The Annual Physical: Maligned and Misunderstood

In The New York Times' Sunday Review, Elisabeth Rosenthal mounted an attack on the cost-effectiveness of the annual physical, a ritual whose net value has actually been covertly questioned for decades by many health professionals, but whose sanctity has now become safe to challenge in very public view. What we’re seeing today is a seismic collision between two forces: our historic belief that deluxe healthcare, with no test or procedure spared, is an inalienable right, and our urgent need to rethink the value of every entitlement -- including the rituals of care we hold most sacred.

Forget the tricky pharmacoeconomic calculus around PSA tests and mammograms. There’s a larger picture to look at. Problems that require immediate intervention tend to be more acute and symptomatic -- and those emergent problems don’t necessarily present in accordance with the arbitrary timetable by which we set our medical appointments. Annual cycles have astronomical and cultural meaning for us, but the body doesn’t pay them much heed. Even civilians can understand that. And, in fact, the so-called annual physical is a bit of a misnomer anyway. Relatively healthy people and those who are healthcare-averse have check-ups far less often.

Rosenthal’s general perspective is sound but she conflates a few issues to make periodic “well check-ups” seem even less productive, or cost-effective, than they are. Executive physicals are surely capitalism at work, but ironically, the people who seek them out tend to be a very small minority of relatively healthy individuals. And CT scans for headaches or MRIs for lower back pain don’t tend to come about as a result of annual check-ups; they’re usually precipitated by symptoms and sick visits. We may spend way too much on medical tests for symptoms that, on average, are transitory and unimportant, but that problem can be solved by smarter protocols and more disciplined, effective MD-patient interactions. We don’t need to bash the physical to reduce unnecessary testing.

Actually, most of the testing done for annual physicals is relatively inexpensive and non-invasive blood work, and there are useful things to be learned from it, even in patients who feel quite well. The PSA, which can produce false-positives, should be accompanied by a DRE to palpate the prostate so net costs need not be unduly high. And as someone who has helped bring bisphosphonates to market (but doesn’t choose to treat her mild osteopenia with any of them), I count on a DEXA scan every few years to track the success of exercise, provide a platform for discussion about supplements, and give me greater clarity on my risk profile.

Here are some other things the annual physical does:

• It creates a more coherent picture of each patient for his or her primary care physician. If properly spent, time in the annual physical fosters the sort of MD-patient relationship that’s bound to produce more cost-effective healthcare -- for instance, by preventing very expensive ER visits, or by promoting lifestyle change and modifying risk profiles at earlier points.
• It is probably the most reliable way to diagnose and act on hypertension in patients who are otherwise healthy, in a medical culture that has clearly documented the long-term mortality benefits of increasingly tighter BP control.
• It gives physicians and patients a regular forum for discussing trends in BP, cholesterol, and blood glucose -- and for finding trigger points that persuade recalcitrant patients to embrace more aggressive pharmacologic strategies once diet and wishful thinking have truly failed.
• It allows physicians to monitor the side effects associated with all those life-extending therapies they prescribe -- drugs that we all have come to see as involving complex risk-benefit trade-offs requiring more vigilant post-market surveillance.

There are lots of ways to cut medical costs but it’s not clear that the annual physical is necessarily the greatest source of leverage -- or the right sacred cow to slaughter. We need to decide how to use those precious 45 minutes in better ways, perhaps. But we ought to work harder on figuring out how to keep insured patients out of the ER for non-emergencies than keeping them out of the PCP’s office for regular check-ups. Developing improved lines of communication (at the annual physical, perhaps?) will go a long way towards producing healthier patient behaviors, less impetuous use of testing, and more effective patient-clinician collaboration in the realm of both prevention and treatment.

FDA DTC and ROI: The simmering alphabet soup of pharmaceutical consumer outreach

The New FDA: champion of DTC and of survey-guided policy input

Just a few weeks ago, the FDA closed its public comments period on a questionnaire for a survey it intends to conduct later this year among health care professionals. The goal of the survey is to gather insight on how consumer-targeted promotion ultimately impacts the quality of interactions and decisions in provider offices around the country. The instrument itself is still a work in progress, and no one will be surprised to hear that our firm made a number of friendly, civic-minded suggestions. It’s clear that FDA has become a patron of survey research for many purposes -- policy development as well as risk surveillance.

The very fact that this particular survey is on the docket speaks volumes about what many FDA-watchers have already concluded: that the agency has morphed from wary and grudging to comfortable and upbeat about the benefit of allowing pharma to converse with patients. After several decades of experience, the FDA seems ready to conclude that direct-to-consumer advertising (DTC) can do more than bring relevant therapies to broader awareness. It can also, through “fair balance,” arm patients with many of the pros and cons to promote more informed conversation with caregivers. Actually, my husband (an attorney, not a citizen of our pharma community) has often expressed astonishment that any of my clients pay to run ads on TV because he is utterly convinced that they make patients run fast in the other direction. As it happens, he is mistaken.

Oncologists Answer the Question: What is an Added Month of Life Worth?

We recently surveyed U.S. oncologists in order to gain their perspectives on the emerging changes and challenges in the cancer landscape. The survey results spotlight an increasing tension between oncologists’ overwhelming optimism about the state of advancing science and their deep pessimism about the affordability of care.

One particular line of survey questioning addressed oncologists’ views of the value of incremental survival in the context of advanced cancer. We asked a series of questions designed to assess whether oncologists believe a new therapy that improves survival would be “worth it” under a variety of different contextual scenarios. Holding as a constant the assumption that the baseline price of the next best alternative care would total $15,000, we systematically varied: (1) expected survival time with the next best alternative care (either two months or nine months); (2) incremental survival with the new therapy (from one month to 12 months); and (3) the total cost of the new therapy (from $40,000 to $120,000 -- in other words, an increase in $25,000 to $105,000 over the cost of the next best alternative).

There are two key findings from those questions. First, in order for a majority of oncologists to declare the new therapy “worth it” even at the lowest of the prices we tested, the therapy must deliver a median of three additional months of life. Second, for the majority to judge those three additional months of survival an acceptable value, the cost of each additional month must be no more than roughly $9,000 to $10,000, regardless of whether baseline survival is two months or nine months.

A Survey of Battlefields in the War on Cancer: Oncologists Reporting from the Front Lines

In 2008, we launched an oncology market surveillance program, “Oncologists Look at Oncology: Prognosis for U.S. Cancer Care.” We were moved to do this by what we were hearing from oncologists as we conducted in-depth interviews with them on behalf of our clients. Our clients in the field, who range from small startups to leading “Big Pharma” companies, shepherd innovative molecules from the bench to the clinic and, if successful, to the commercial marketplace. But over 35 years after the “War on Cancer” was famously declared by President Nixon in 1971, what we were hearing from oncologists on the front lines of cancer care was a sense of frustration, even despair.

A significant part of oncologists’ frustration at the time was financial. In 2006, Medicare and Medicaid reimbursement to physicians for in-office intravenous cancer medications was cut dramatically. Private practice oncologists had been earning 50 percent or more of their total personal income from profits on IV medication -- profits earned directly from reimbursement paid by public and private payers. The industry published fictional “average wholesale prices” (AWP) that set the reimbursement physicians would receive, but physicians were able to purchase drugs at prices substantially below AWP. Centers for Medicare and Medicaid Services’ updated reimbursement policy based on actual average selling prices rationalized reimbursement but changed the game for oncologists.

But loss of personal income wasn’t the only thing that seemed to have disheartened oncologists. They told us that they were sending more patients to hospitals for drug administration when coverage was uncertain -- even though patients generally feel more comfortable receiving treatment in familiar, less institutional treatment settings -- because private practices could no longer absorb unreimbursed drug costs. They told us that they were unable to treat patients with the best available care because of patients’ inability to afford requisite out-of-pocket co-payments. They told us that they did not see how providers or patients or payers could keep pace with the escalating costs of new cancer therapies. They told us that their colleagues were retiring and their children were pursuing specialties other than oncology because both financial compensation and lifestyle were better in procedure-oriented fields.

Plan B and Public Health: Morning-After Problems We Can’t Easily Fix

Today I signed a petition to protest Kathleen Sebelius’ decision to override the recommendations of the FDA and the American Academy of Pediatrics by banning OTC availability of Teva’s Plan B morning-after contraceptive. I say that without intent to be provocative. I simply want to acknowledge right up front that I have no moral compunction about morning-after contraception -- although I tend, dispositionally, to prefer a pound of prevention to even an ounce of cure -- and I certainly don’t believe in subjugating science to religious principles. I was surprised at the Administration’s decision because it most assuredly wasn’t in the best interest of public health -- but neither do I know how to chalk up the political wins and losses on this for Obama, who was clearly willing to ignite a controlled burn on his left in order to avoid a firestorm on his right.

The petition I signed enjoined the President “not to put politics above science” -- a credo that sounds like the right slogan for the professional (and personal) world I inhabit. Still, I can’t help but note the irony that since all regulation of public health is inherently political, this distinction is forced and artificial. The FDA came down on what I happen to think is the right side of this issue -- public health and equal protection for those young teens who have, as a practical matter, limited access to all health resources. But the FDA, like all agencies charged with health policy oversight, is an instrument of politics. Public health is just a euphemism for politics. In fact, the whole public health sphere is becoming a house built by government and merely furnished by science.

Universal Health Insurance Coverage -- Really?

"Universal" vs. "Coverage"

Yesterday, CNN’s Tim Langmaid reported that Health and Human Services estimates that the percent of insured young people aged 19 to 25 rose from 64 percent to 73 percent. Based on census figures, that percentage change represents about 2.5 million young people. The increase is attributed by some to a provision of the health care reform legislation signed into law last year that allows young adults to remain on their parents’ insurance plans through age 26.

Today, however, Sara Rosenbaum writes in The New England Journal of Medicine about the Douglas cases for which the Supreme Court heard oral arguments in October. These consolidated cases are comprised of suits against California Medicaid for cutting reimbursement rates to the degree that, plaintiffs argued, beneficiaries’ access to care was seriously threatened.

The question before the Supreme Court is all about legal standing in the shadowy ground between federal legislative authority and the role of the states. Does the U.S. Constitution give private individuals the right to go to court to halt state actions that violate federal law and threaten immediate and irreparable harm? This will be a key issue in the years ahead as the federal government and the states get set to squabble over who gets the last legislative word in the realm of public health and safety.

Healthcare cost savings from expanded access to preventive medicine could be dead on arrival

Enormous, and enormously unrealistic, hope is being placed on preventing illness and its complications as a means to improving health outcomes and containing healthcare costs.

A major criticism of the U.S. fee-for-service healthcare model is that it rewards the treatment of health problems over their prevention. Much of the effort at reform is aimed at revising incentives to motivate providers to deliver preventive medicine.

The logic is that if physicians and other providers are compensated for a focus on prevention, and patients have access to affordable primary care, then people will be motivated to use that care and do the things needed to stay healthy. The reality, however, may be quite different.

Emerging notions of 'Valued-Based Health Care' are raising the bar and extending forecasting horizons for new drug therapies

Not long ago, a New England Journal of Medicine article, "What is Value in Health Care?" by Harvard Business School professor Michael Porter, offered up an analysis of healthcare value and its measurement in health outcomes research. Porter, along with and his colleague and co-author Elizabeth Olmsted Teisberg, describe three types (tiers) of health outcomes:

• Health status achieved or retained -- survival, degree of health/recovery
• Process of recovery -- time to recovery/normal living, short-term liabilities of treatment
• Sustainability of health -- time to/nature of recurrences, longer-term liabilities of therapy

This "Outcome Measures Hierarchy" is being used by a growing number of large multi-hospital providers, small group practices, health plans, and employers in the U.S. and abroad as they work toward implementing value-based principles to guide therapy choices and outcome assessments.