Over the last several days I have seen numerous articles and had numerous conversations about treatment and prevention approaches meant specifically to replace FDA-approved pills and surgical interventions. Mostly these alternatives come in the form of health services now thought to be more effective or equally effective as compared to their more “medical” counterparts. These alternate approaches often include three components: cognitive behavioral therapy, focused exercise, and targeted nutrition. Sometimes they also include other types of services or programs, such as mindfulness or breathing exercises. What they don’t include is traditional medical products. No drugs, no devices, and thus few to no negative side effects.
Perhaps this resurgence in services interest is a response to the ever-increasing price of drugs and surgical interventions taking them out of reach for many; perhaps it’s a response to the fact that the medical interventions often fail to provide the panacea promised to promote relief. Perhaps the trend is a function of an emerging body of evidence showing that non-invasive forms of therapy produce equal or better outcomes. Whatever it is, the search for ways to replace drugs and surgery with services is definitely on the upswing. The problem, of course, is that our existing system of benefits and payments is somewhat allergic to paying for these alternative approaches. Our system is relatively rigged to prefer “things” over services. For some reason, services are often considered less scientific in a world that favors white coats over perceived tree-hugging.
And yet, when you look at such challenges as lower back pain, you have to be open to new ideas. This category has long been controversial and has driven an extreme level of cost (some estimate as much as $200 Billion, with a “B” per year) and overuse of dangerous medications as well as tons of useless (and radiation-plagued) imaging. In the U.S. lower back pain is the 2nd highest cause of physician visits, after things like the common cold and flu. Too often people subject themselves to interventions that fail to bring relief or worse. Unfortunately, our typical benefit designs and medical system’s payment incentives have driven people to these solutions when others might do equally well or far better. As a result, many employers, payers and others are finally starting to see the light and thinking about ways of providing and paying for lower cost, higher value ways of solving this epidemic of a problem.
As an example, PCORI (the Patient Centered Outcomes Research Institute) has just announced $22 million in new funding for patient-centered comparative clinical effectiveness projects on low back pain. PCORI is specifically seeking studies that compare optimal clinical strategies that both do and don’t include spinal fusion surgery. It will be interesting to see what they use to compare, as there is much evidence that targeted physical therapy is as good or better for managing back pain in many cases. One would hope that this would drive CMS and others to reimburse for alternative treatment approaches at a rate that would drive down what we are willing to pay for surgical interventions. In a world of bundled payments, payers should be paying for “relief from back pain” not spinal fusion. Call me cynical (because you would be accurate), but until the DRG for “relief from back pain” equals the DRG for spinal fusion, spinal fusion it is. People who work within health systems are as coin-operated as everyone else on earth.
In fact, a recent study published in JAMA, the Journal of the American Medical Association, assessed the value of mindfulness-based stress reduction, a program developed at the University of Massachusetts Medical Center in the 1970s, and cognitive behavioral therapy, “a form of psychotherapy that helps reframe negative thoughts and is considered an evidence-based treatment for chronic pain.“ The results in pain reduction were pretty striking particularly considering that use of opioids is the usual alternative. And unless you have been hiding in a barrel to escape the election coverage, you know that opioid overuse hasn’t led us to very good outcomes and has led us back to the super-fun days of 1970’s-style heroin addiction – what we gain in lower back pain relief we are losing in drug overdoses. You know you are in trouble when the FDA has to issue black box warnings on drugs and quarrel with pharma companies about the cost of addiction treatments. Perhaps the FDA’s new plan to label opioids with warnings that opioids are “associated with lower sex hormone levels and reduced interest in sex” might finally get some people to stop thinking opioids are a good idea. The only thing people like more than drugs is sex, I figure.
We are seeing similar examples where coaching and related services succeed as effective alternatives to drug intervention when it comes to our other favorite U.S. disease: Type II diabetes. The federal government announced this week that it will pay for diabetes prevention coaching programs, such as those provided by Omada Health, because the results of such programs are significant with respect to improved clinical outcome and cost reduction. CMS noted that Medicare saved $2,650 for each person enrolled in cognitive behavioral therapy based coaching and prevention programs over 15 months, as compared with similar beneficiaries not in the program. This approach is key to success because just treating people with drugs like Metformin don’t change their behavior. If you change behavior, you can potentially reduce the number of Type II cases altogether, rather than just postpone 100% of them, but guarantee their ultimate arrival.
It is pretty clear that programs that foster better nutrition, exercise, physical therapy, mindfulness and targeted cognitive behavioral therapy can have a better outcome for many costly and miserable diseases. Companies like Ceresti and Neurotrack are demonstrating this for Alzheimer’s and dementia. There is no doubt that these same types of programs reduce cardiovascular disease and improve recovery from cardiovascular interventions, as evidenced by companies like Abilto and others. Given that this is the number one killer in the U.S. and elsewhere, it would be a good idea to build a world supportive of services models, including an insurance world that pays for them meaningfully. And yet our insurance benefits are still largely built around paying for traditional drugs, surgeries and other very medical-ized models that may no longer be the best standard of care. Companies that offer services are still fighting for coverage even when they have clear evidence of equivalent or superior outcome.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
It was groundbreaking for HHS to announce coverage this week for the Diabetes Prevention Program. That’s a problem. It shouldn’t be groundbreaking, it should be “oh duh.” I spent time on the phone this week with a colleague whose non-traditional, non-invasive treatment for panic disorder, Freespira, has demonstrated markedly better cure rates than alternatives but which is having trouble figuring out how to get insurers to pay. The machinations that are required to get a new code or some new concept paid for are so arduous that it makes patients give up and just and reach for the pill bottle and entrepreneurs give up and reach for the scotch bottle.
Beyond the reimbursement issue, and that’s a big one, the other big question is this: how do you get people to want to engage and not want the perceived quick fix of a pill or surgery? If one can pop a pill and suddenly be better, stronger, faster, healthier, it’s pretty compelling. But here’s the rub: often these pills have bad side effects (e.g., drug addition), sometimes they just don’t work (e.g., back pain) and sometimes they are damned expensive. On the other hand, people are inherently lazy. Not all people perhaps, but most people and we know who we are. Committing to a life long program of nutritional eating, exercise and thoughtful self-help through mindfulness sounds like a buzzkill to many, relegating one to a life of tree-hugging in Berkeley or Mill Valley rather than Tesla driving in San Francisco or New York City. We have definitely created a society where it is considered acceptable and even advisable to choose more work hours over self-care and where advertising tells us that if we have opioid-induced constipation we should take another pill to cure it, never mind that getting off the opioids is another option.
But it is an unmitigated truth: if people are going to do more on the healthy living front to reduce healthcare costs, they are going to have to relearn how to deal with their own bad habits. You can’t foster a work environment where no one is supposed to leave their desk to eat or go home and also expect people to engage in the kinds of healthy and healthcare services that take them off their butts and into a better place. For this reason we see companies like Elysium offering what purports to be a $50/month nutraceutical (pill) for anti-aging (aka reducing dementia, improving health) getting funded in Silicon Valley. Ok, sure, maybe it works (?) but if you can achieve more through proper diet an exercise and mindfulness, and those are effectively free, what can we do to make those ingrained behaviors for people who are constantly exposed to advertising for Doritos and Beer and Pizza and those damn Cadbury Easter Eggs.
How do we equate health with fun and sex and partying? We never see commercials that show people eating healthy foods and saying “Man, it never gets better than this.” But we do see beer commercials that say that. We need commercials that show that kale consumption leads to hot sex or more friends or whatever it takes to motivate people, starting in their youth, to value healthy behaviors over the alternatives because it makes them hipper, cooler, hotter.
And our health insurance plans need to follow and fast. If we could eliminate billions of dollars in expense by substituting basic services for expensive surgeries, we would make a fast dent in the healthcare budget. But the new services products always face a reimbursement jury that assumes guilty til proven innocent from a scientific point of view. I wish our payers of all types would be a bit more creative in allowing for services alternatives as the first line of expense, rather than the last ditch effort when other expensive things have failed. Is there a way to get payers to believe that paying for mindfulness, behavioral therapy, nutrition, exercise programs makes them hipper, cooler, hotter? Now that’s the startup I want to fund.
