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Consumers know that their primary care doctors don’t talk to their specialists, who don’t talk to their pharmacists, who don’t talk to their insurance providers. The rise of consumerism in healthcare may be in its infancy, but according to research recently released by Xerox, a full 64% of consumers wish their pharmacist, healthcare provider, and insurance company were more connected regarding their health.
Consider your most recent travel experience. You probably used a website like Expedia.com to look up flights, hotels, and even rental cars. With all the relevant information displayed conveniently (and often beautifully) side-by-side, you were probably able to make an informed decision and instantly book the exact travel package that suited your needs.
Now imagine your most recent healthcare experience. Scheduling the appointment was probably a painful logistical balancing act, accompanied by terrible hold music. You likely had to find and present an insurance card, possibly even filling out another set of insurance forms and a health history for the thousandth time.
After the appointment, you doubtless received an excessive number of mailings that were maybe bills or maybe not. At this point, you might even still be unsure how much you owe, why you owe that amount, and what you can expect for your next appointment.
And you’re not the only one suffering. While all this is happening, an equally painful parallel process is taking place behind the scenes, completely unbeknownst to the consumer. It starts with the care provider, who must electronically or sometimes even still manually bill the insurance company. The claim then passes from the provider to a clearinghouse, where it is checked for errors and compatibility with payer software. When the claim finally does get to the payer, the majority of them are still faxed back to providers for more information: was the procedure medically necessary? Is a referral required? The physician’s office corrects the claims and sends it back through the same pipeline towards approval.
This process is a massive headache for everyone involved. Providers find themselves with huge amounts of extra administrative work, while consumers are completely shrouded from the billing process. It’s almost like walking into Nordstrom’s and shopping blindfolded, while trying to stay on a budget. It’s just not possible.
Thankfully, there’s a better way. Healthcare can look more like booking your next vacation — a more personalized, consumer-friendly experience, at a better price too. The first step in getting there is Application Programming Interfaces, or APIs. At a high level, APIs let data to break free of their silos, allowing it to move freely, and enabling the interconnected experience we all enjoy when booking travel. If properly used and widely adopted in healthcare, APIs will be transformative.
What’s the API model?
APIs and their use in healthcare are on the rise for a number of reasons, including the consumerization of healthcare, the explosion of smart devices, and the arrival of a generation of tech-savvy consumers who want access to healthcare resources and information in the same way they have access to everything else in their lives—anytime, anywhere, and from any internet-connected device.
In order to better serve these tech-savvy consumers, who are increasingly charged with managing their health spending via high-deductible, HSA plans, payers and providers need to be able to exchange information in real time. Take the previous simple scenario of a fairly standard visit to your healthcare provider. In an API Economy, consumers won’t need a health insurance card or to fill out any paperwork. All the relevant information can be accessed by the appropriate stakeholder on demand. Providers will be able to check eligibility and co-pay by accessing a patient profile, for example. Once the visit is complete, the EMR can trigger the claims process, sending all necessary medical information directly to payers. Claims will be immediately adjudicated in one fell swoop. What’s more, consumers will know at the point of care how much they are paying and why, and what any additional prescriptions, referrals, or follow up care will cost.
With the right APIs in place in healthcare, the need for administrative questions is essentially eliminated because every stakeholder would have access to all the relevant data. The type of data exchange described in this example is fairly basic, but the API infrastructure that will allow us to eliminate countless administrative headaches – incorrect patient information, incorrect codes, duplicate claims – is the same infrastructure that will allow us to create advanced analytics and innovative service models. Furthermore, the advanced security implicit in an API model also means that even as consumers’ valuable protected health information moves freely about, so to speak, it remains encrypted and secure.
The fact that we haven’t moved even further in this direction is especially confusing given the fact that transitioning to an API model is not necessarily an intimidating or complex process, technically speaking. Old and new technology investments can be gradually bridged, and companies like PokitDok, with its API platform, mean organizations are spared the need to build from scratch. The pieces are in place for this transformation to happen, it’s only a matter of time.
What would the API Model mean to the industry?
A shift to an API model would have at least two major impacts on healthcare:
Free the data for value-added, consumer-centric innovation and applications. With an API infrastructure, everyone will have equal access to data, meaning companies will be forced to innovate on the value of the services or analytics that can be built on top of that data. For example, we’ve already seen some companies like Castlight Health, Amino, and Grand Rounds take disparate, accessible (albeit in a difficult, not always API-enabled manner) data sources and create new dashboards with new metrics that consumers are actually interested in using. Moving forward, APIs can deliver these types of innovations in spades.
Improve customer service relationships with healthcare payers. Imagine a typical call to a customer service department, but the agent on the phone has a new set of information at their fingertips, like the caller’s type of insurance, deductible and copay, and a list of physicians within the appropriate proximity. An API model can deliver this type of informed call center and lead to highly personalized client engagement.
Adopting an API model in healthcare gives an outdated system the versatility and flexibility it needs to tackle some of our most entrenched problems. APIs can transform insurance companies from passively paying claims to actively helping its members lead healthier lives. APIs can also transform customer care in healthcare, making it more reflective of the experience we all enjoy in retail, for example. But perhaps most importantly, APIs can support more connected, more informed consumers and providers, resulting in the higher quality care that we all deserve.
Tamara St. Claire is Chief Innovation Officer for XEROX.
Categories: OIG Advisory Opinions
Dear Mrs. Clinton –
It’s probably good politics to suggest making Medicare available to some under 65s , just when Congressional Republicans are proposing to increase the Medicare eligibility age. Sometimes, though, good politics doesn’t produce good policy.
Medicare may be well-regarded by most Americans, but the program has four huge weaknesses that need to be fixed before considering any expansion.
Here’s what’s wrong.
Medicare is absurdly, insanely overcomplicated. When Medicare was created in 1965, it consisted of just two components, Part A hospital care and Part B physician and other care, with the split made only to gain AMA support for the legislation. Fast forward to 2016: we now also have Part C (Medicare Advantage), Part D (prescription drug), and seven versions of dual Medicare-Medicaid eligibility (in turn dependent on 50-plus states’ and territories’ own Medicaid regulations). And that’s all before the thousands of pages regulating payments to providers. The complexity provides a lot of jobs for bureaucrats and consultants, but does little for beneficiaries.
Medicare payments are unfair to many (including taxpayers). For beneficiaries in the fee-for-service program, Medicare currently pays all allowed provider charges (after copays and deductibles). For those choosing Medicare Advantage, the program typically pays the full premium bid by the private plan. The effect of this misplaced generosity is that one senior’s care may be subsidized by up to $5,000 a year more than another’s with the same health status in the same city—with taxpayers paying the difference.
Medicare is regressive. Traditional Medicare imposes the same deductibles and coinsurance regardless of income and charges the same Part B premiums for the vast majority of beneficiaries. Similarly, Medicare Advantage plans impose the same cost-sharing for all incomes. Congress’s answer has been to allow Medicaid to pay premiums or cost-sharing for lower-income seniors, but many of those potentially eligible are not enrolled, while Medicaid’s rules can mean that a difference of a dollar of income make the difference between eligibility and otherwise.
Medicare is enormously (and unnecessarily) costly—and getting rapidly more so. According to the latest Medicare Trustees report, Medicare expenditures will rise from $683 billion in 2016 to $1.3 trillion in 2025. Even though Medicare per capita costs are rising slightly less rapidly than overall health care costs, the Trustees project that—unless changes to the program are made—these will increase from $12,925 in 2016 to $19,400 in 2025, far, far more than we can afford!
What’s the answer? Three fixes.
One: Streamline the program structure. Consolidating the four program parts into a single whole, with all current Part B and D services available to all beneficiaries, will reduce administrative costs and enhance access. Eliminating the need for dual eligibility as described below will do even more.
This is consistent with past consolidation proposals from MedPac, the Bowles-Simpson Commission, the Commonwealth Fund, the Bipartisan Policy Center, and individual members of Congress, but more sweeping and more effective. It means a single premium and, potentially, a single deductible and out-of-pocket limit to protect beneficiaries against unexpectedly high medical expenses—something current Medicare fails to do. It also means that all Medicare beneficiaries will have a full range of medical coverage, including prescription drugs, guaranteed—again, something Medicare now fails to provide.
Two: Tie premiums, deductibles, and out-of-pocket limits to income. Medicare has to be made affordable for all seniors without imposing the humiliation of applying for Medicaid on the less well-heeled. This can be done either directly by making all beneficiary costs income-dependent, or indirectly by offering a “gold” coverage option with lower deductibles and out-of-pocket limits for a higher premium that is subsidized for low-income seniors.
Either option could eliminate the need for expensive and inefficient Medigap insurance, as well as protecting lower-income seniors from having to choose between applying for Medicaid and risking financial disaster.
Three: Move to an equitable “guaranteed contribution” approach. Various forms of premium support have been recommended by bipartisan commissions over the past twenty years as the fairest answer to controlling Medicare costs. The guaranteed contribution approach would differ significantly from that proposed by Congressional Republicans in that beneficiaries choosing coverage options below the benchmark cost would share in the program savings.
All beneficiaries would be guaranteed a choice of traditional fee-for-service and private plan options, and all beneficiaries would be assured that an option would be available for no more than their basic premium cost (with shared savings for lower-cost options). The Congressional Budget Office has estimated that such an approach could cut Medicare spending by up to $45 billion a year, not counting possible additional savings from more effective competition. Although critics have complained that such an approach would mean some beneficiaries would pay more than their basic premium unless they were willing to choose a less expensive plan, this is a far better option for controlling Medicare spending than cutting coverage, increasing all premiums, or slashing provider payments.)
So, imagine if these changes were made.
The result would be a fairer program with less administrative burden, less likely to bankrupt either the government or individual seniors, and one more in line with modern insurance than with the ideas of fifty years ago.
It would be one that could accept enrollees below the age of 65, as you have suggested, Mrs. Clinton, on a pay-as-you go basis (since under-65s would not be entitled to the same level of subsidies as over-65s). In fact, it could replace Obamacare for over-55s—a politically popular move that would give enrollees more choices, potentially lower costs, and reduce taxpayer spending.
Senator Sanders’ supporters would love it as a possible step towards Medicare-for-All (but without costing a hundred thousand insurance jobs), President Obama would be pleased to see his liking for an Obamacare public option being implemented, Republicans would hate it, and you’d be back in charge of healthcare innovation. Why wait?
Roger Collier is the founder of the Campaign for a Rational Healthcare System (www.rational-healthcare.com). He was formerly CEO of a national healthcare consulting firm.
Categories: OIG Advisory Opinions
What if I told you that tobacco use, poor diet, lack of activity and toxic agents are not the main causes of death in the United States, as conventionally accepted?
With ever-rising healthcare costs combining with often ineffective strategies to combat suffering from preventable diseases, researchers have increasingly dedicated a particular focus on identifying ways to optimize our ephemeral resources. They are finding that the true or underlying causes of death can be linked to the economic and social circumstances of the individual, such as her or his income, education and social connectedness.
The historically accepted morbidity and mortality factors are often actions and behaviors that are driven by socio-economic factors. Identifying and addressing the root causes of these tangled health webs is recognized as the most advanced methodology to create the highest impact at the lowest cost.
These critical factors are often the most difficult to address, as depicted by the well-renowned Health Impact Pyramid recognized by the National Institutes of Health.
Recent advancements in the health information technology space have enabled some dedicated healthcare organizations to advance the understanding of social determinants of health by directing their resource flow from a primary focus on the treatment of diseases to a more holistic focus on modifying the predisposing factors that inescapably propagate these health complications. Increasingly, health care organizations are asking vendors to incorporate social determinants of health risk data into patient records.
Identifying Social Determinants
Social determinants of health are considered the complex, integrated and overlapping social structures and economic systems that are responsible for health inequities, according to the Centers for Disease Control and Prevention. The six principal socio-economic factors include economic stability, neighborhood and physical environment, education, food, community and social context, and health care systems. As depicted in the accompanying chart, constructed by the Kaiser Family Foundation, each factor encompasses a variety of contributing factors, which play significant roles in determining the health of an individual.
Economic Stability: Higher economic stability precedes higher quality options for the other social determinants of health and generally lower amounts of chronic stress.
Neighborhood and Physical Environment: Contaminants in the air, water, food and soil can cause a variety of adverse health effects. In addition, the design of communities and transportation systems can significantly influence the physical and psychological health of an individual.
Education: Closely tied with an individual’s economic status, effective education for children and lifelong learning for adults are proven key contributors to optimal health.
Food: The access to and proper education around healthy food plays a large role in determining the health of an individual, as many preventable diseases are linked to their diet options.
Community and Social Context: Social support networks are important in helping solve problems, deal with adversity, and maintaining a sense of control over life circumstances. There are many studies that show the direct link between strong social relationships and the overall satisfaction and well being of an individual.
Healthcare System: The access to quality health services facilitates more options for preventive approach to care before health conditions excel to an unmanageable state.
Sourcing the data and care management
By combining these socio-economic factors with medical and pharmacy claims, labs and health risk assessments in predictive modeling, healthcare organizations can acquire more expansive views of consumers at risk for avoidable healthcare costs. There are billions of records from nearly 10,000 public information sources, from which socio-economic data can be extracted and incorporated into a health information technology system. Vendors and healthcare organizations have found that LexisNexis is a credible source for data mining.
Some of the overall types of data available from multiple sources include:
Unique name and address records
Active U.S. business entities
Business contact records
Unique cell phone numbers
Motor vehicle records
Applications for high interest loans
Access to and proper harness of this array of information enables boundless possibilities, four of which are of particular mention: risk stratification, motivational engagement prediction, stress severity projection and geo-spatial mapping systems.
Risk stratification information is used to allocate resources at a population-wide level, identify high-risk patients, alert providers and care managers about those patients, and design interventions to prevent other individuals from becoming high-risk. This also plays particular importance in readmission prevention by identifying the patients most likely to be readmitted and intervening to provide the support they need in order to avoid readmission.
In addition, an individual’s motivation – or willingness to engage in maintaining or improving their health – is just as important as the data used to determine what puts that person at risk. Understanding which individuals in the population are motivated allows health plans to wisely allocate expensive resources, like nurse care managers. A high-risk patient who is highly motivated may get as much benefit from a low-touch wellness program as she or he would from a high-touch program.
The capture and tracking of socio-economic trends among individuals enables better projection of severe stress levels. For example, increased rates of crime in a neighborhood, a house downsize, bankruptcy, or even a woman’s last name change (signaling pregnancy or divorce) are all likely indicators of increased stress severity. Stress can spur a myriad of health consequences, including high blood pressure, circulatory complications, accelerated aging, cardiovascular disease and immune defense damage, among others.
The richness of this information could furthermore spur the generation of geo-spatial mapping systems, enabling the ability to identify community trends, such as lack of access to public parks, sidewalks or close-proximity grocery stores. Even identifying trends such as high poverty rates, large quantity of amount of fast food restaurants, or high crime locations would create a more comprehensive view of the determining factors of a patient’s overall health state.
Credit bureaus, law enforcement and pay-per-click advertisers have capitalized on personally identifiable information for many years. Per their model, by harnessing this information with predictive analytics for healthcare purposes, it holds a solid promise to significantly improve healthcare administration system and save more than $300 billion in healthcare, according to McKinsey & Company, largely through reductions in expenditures.
The incorporation of social determinants of health can contribute significantly to this by improving risk prediction accuracy and revealing inconspicuous trends. Revered as the most advanced methodology, this would enable HCOs to address the true origins of health complications by identifying the economic stability, physical environment, education level, food access, social context, and health care system via a wealth of available information sources. Recognizing the obvious benefits and acknowledging the challenges, we must maintain the notion that anything worthwhile takes time and complete devotion.
Caitlin Breanne Smith is a program consultant at Wellcentive.
Categories: OIG Advisory Opinions
Earlier this week , physicians in small private practices and rural areas breathed a collective sigh of relief. There is a possibility the implementation of changes to physician reimbursement (known as MACRA) could be delayed. Thank you, Mr. Slavitt, for listening. I am grateful to Orrin Hatch (R-UT) and Ron Wyden (D-OR) for keeping our rural needs in mind. We have a window of opportunity for rural health care to survive but we must communicate our needs as physicians and patients’ loud and clear.
Whether in reference to health care or public education, trying to increase quality while simultaneously decrease costs is an unrealistic proposition. Physicians in rural areas simply have fewer resources at their disposal. Adding insult to injury, Medicare payments to rural physicians are dramatically less than those of their urban counterparts for equivalent services, a point driven home by the fact 470 rural hospitals have closed in the past 25 years. Does it cost less to stitch up a laceration in a remote Alaskan village than in New York City? I doubt it. The expenses incurred obtaining supplies may be even greater for remote locations.
In order to set primary care physicians up for success, it is imperative those in charge understand our challenges. Rural physicians are alone, save for our spouses running our medical practices while we see patients. For physicians to be successful, additional revenue would be necessary to meet the expensive health IT burdens placed on us by this new payment model. Creating “virtual” groups to consolidate reporting will still require provision of a “virtual” assistant because it is more administrative burden than we can handle. Our profit margin is too narrow to accommodate additional employees.
I am not convinced time and money spent implementing new technology does anything to improve patient care; I am fairly certain, however, conversations with my patients provide considerable value. Can you not extract the information from claims, like private insurance companies already do? If we have to hire an additional employee, who is going to pay them? The solution is relatively simple; shift the burden of data collection from small practices to elsewhere or increase reimbursement so meeting your demands becomes feasible.
Preserve what we have in rural America until you have more clarity where we are heading in the future. According to a report on Rural Participation in the Medicare Shared Savings Program, rural providers already deliver value and quality within our existing infrastructure. Adjusted for lower volumes, Medicare spending per beneficiary is 3.5% less. Physician spending is 18.4% lower overall compared to our urban peers. We have strong personal relationships with our patients, operate at the top of our capabilities, and keep care local whenever possible. I fail to see the problem with our old-fashioned style of practice. In fact, maybe you should use us as models of efficiency or cost-containment for larger conglomerates.
Being in a small or rural practice is extremely challenging. In rural America, 75% of exchange consumers had incomes less than 250% of the federal poverty level. Every family in my practice who obtained insurance through exchanges met criteria for Medicaid, known in Washington State as Apple Health. 24% of rural children live in poverty. We are surrounded by Health Professional Shortage Areas (HPSA’s) and Mental Health Professional Shortage Areas because primary care physicians are spread entirely too thin. The elderly and poor in rural areas deserve access to quality health care. What happens to those people if small practices cannot keep their doors open as a result of overreaching government mandates?
According to the National Rural Health Association, 10% of physicians practice in underserved areas despite the fact 25% of the population lives there. One-third of automobile accidents occur in rural areas, however two-thirds of the deaths from these accidents occur on rural roads. Rural residents are more likely to die from injury due to delays in care. I have direct experience, recently providing road side care after an accident while awaiting EMS arrival for 15 minutes. Delays are related to increased travel distance and personnel limitations.
Extrapolate for a moment what could happen if numerous small practices closed in rural areas. Can you imagine if one third of strokes occurred in rural areas, but two-thirds of stroke deaths were rural due to significant delays in receiving timely treatment? It makes no sense to cripple our livelihood when we provide lifelines to underserved and disadvantaged populations.
Rural residents have fewer resources, significant geographic obstacles, and the acuity level of their medical problems is far greater. These detrimental conditions drive tremendous health disparity. We need to spend our time healing, comforting, and having conversations with patients, instead of reporting their medical problems and immunization status to non-physician statisticians.
For physicians in small or rural practices with scarce resources and deteriorating infrastructure, it will require significant investment for us to undergo meaningful transformation. Either learn more about the challenges small or rural practices face, provide waivers (like No Child Left Behind did) for exemptions, invest in our infrastructure, or leave solo physicians and our practices alone. Do not try to fix what I am not convinced is broken.
Categories: OIG Advisory Opinions
The path to consistent, quality patient care progression sounds simple enough:
1. Set and meet accurate length of stay targets based on appropriate DRGs—begin with an end in mind and proactively manage toward that end.
2. Focus unit care teams on clear, appropriate care progression plans for all patients.
But admissions processes often do not capture and disseminate an appropriate target length of stay and DRG in a way that informs expectations for treatment and documentation. Thus caregivers face challenges choosing appropriate goals for managing patient progression so that everyone is working toward that goal. The resulting delays in care prolong length of stay, increase costs, frustrate patients and caregivers, and increase the possibility of preventable harm. Inconsistent care progression can also increase readmissions, as divergence from appropriate and timely care plans increases the risk that the need for treatment will reoccur.
There several key tools and disciplines unit care teams can adopt that dramatically improve consistent delivery of quality care, with resulting benefits in efficiency and patient satisfaction:
Standardize Your Patient Progression Plans: Create and track progression against standardized, patient-appropriate care plans with continuously visible goals and progress. Over time, this helps collaboration for quality care become easier and more reliable and predictable.
Assess and assign appropriate DRGs and length-of-stay targets. The refrain is so common we often forget how important it is: Effective discharge begins at admissions. That means having everyone on the care team know, understand and agree as to when each patient should leave the hospital with appropriate treatment. Hospital leaders must commit to the discipline of setting accurate and appropriate length-of-stay targets.
Have care teams consistently work toward those length-of-stay targets. The progression of quality patient care on the unit depends on care teams always seeing and working toward accurate targets for length of stay. Length-of-stay based care progression should become the focus and culture of care teams.
Make DRG and length-of-stay targets specific to your hospital. Admissions staff often look up DRGs and set care targets based on national averages that may vary considerably from the observed and expected targets for a specific hospital. Invest the time to adopt DRG guidelines that match the observed and desired case mix and associated length-of-stay targets specific to your hospital.
Adopt daily care progression huddles on every unit. It might be time to rethink your daily unit safety or shift meetings. Effective patient progression huddles gather the full unit care team for each shift to clearly understand patient progression and care goals, as well as escalate any issues outside their control to executive leaders for resolution.
Make O/E ratios a critical performance measure. Once you’re setting accurate and appropriate targets, make sure you’re continuously measuring observed (actual) versus expected length of stay. When your O/E ratios are below 1, your hospital is optimizing care progression and maximizing reimbursements and margins.
These recommendations aren’t exhaustive, but we’ve seen many hospitals adopt more precise length-of-stay targeting as the foundation for improving care efficiency, outcomes and experience. Progressing the patient’s care by focusing the care team on the immediate patient needs while anticipating and preparing for the next steps is the key to delivering the right care, reliably, in a predictably appropriate amount of time.
Solutions to Help Improve Care Progression, Quality and Experience
There are solutions focused specifically on establishing consistent, reliable progress of quality patient care on your units an across your hospital. Sustain top performance in all areas of care delivery with a range of options, from targeted solutions for unit patient progression to comprehensive solutions for clinical transformation.
Care Progression: Gives hospital unit care teams the ability to quickly and reliably assign correct DRGs and length-of-stay targets, ensuring appropriate care and reimbursements. This package combines training, technical services and software.
Care Progression Optimized: Overcomes the common barriers to unit care progression, empowering coordinators to deliver the best care consistently and efficiently. It combines optimized care progression processes with powerful software that, in a single place, informs and prompts them to take all the right next actions in their patients’ care plans.
Hospital Operating System – The Complete Transformation
Solution: Establishes a hub-and-spoke “production model” for care that dramatically improves patient care, throughput and experience. This complete transformation solution comprises a program for positive culture change, a new centralized care coordination model, and software built to ensure reliable and predictable quality care for every patient.
(A final note. We’re excited to have launched a new podcast called Who Cares? Hospital Talk. It showcases the positive, passionate healthcare heroes who work hard to improve patient care and experience in hospitals. Check it out here.
Karl Straub is President and CEO at Carelogistics.
Categories: OIG Advisory Opinions
How would you react if you sent your sputtering car to the auto mechanic, and they stopped trying to diagnose the problem after 15 minutes? You would probably revolt if they told you that your time was up and gave back the keys.
Yet in medicine, it’s common for practices to schedule patient visits in 15-minute increments — often for established patients with less complex needs. Physicians face pressure to mind the clock while they examine you.
That’s not to say that your physician “clocks out” as soon as your 1 p.m. appointment hits 1:15, or that all appointments last that long. What it does mean is that patients and doctors may be deprived of the opportunity for more meaningful discussions about the underlying causes of their problems and plans to improve them. A woman in her 50s who presents with high blood pressure and obesity might need medicine. But a longer conversation about the stresses of being the primary caregiver to her father, who has Alzheimer’s, could help provide strategies to help her look after herself.
When you see a new patient every quarter hour, there is often scant time to get to these root causes, to make accurate diagnoses, and develop the best treatment plans. And there is the danger that you miss a major diagnosis altogether.
The 15-minute appointment arose not out of evidence that it improves patient outcomes but out of production pressures — both the need to meet patient demand and to see enough patients to stay profitable.
Unpopular among patients, these production pressures have few fans among physicians either. A Mayo Clinic report stated that 54 percent of physicians meet the criteria for burnout in 2014 — up nearly 10 percent from three years earlier. Running on a treadmill all day in 15-minute sprints likely contributes to this phenomenon. Onerous documentation requirements and other pressures don’t help, either.
Some patient problems could be solved in 5, 10 or 15 minutes, but others cannot. What if health care trusted its physicians enough to take the time they need with patients and no more — and then monitored and paid for results? Could we realize better care while reducing costs, because patients are getting the right diagnosis sooner, and not coming back after their problem has been missed and their condition has worsened?
It’s not clear whether alternative payment models will achieve this. Concierge practices, in which patients pay a hefty annual fee in exchange for greater access to their physicians, may work well for those who can afford it. While this model is beyond the financial reach of many, a related model called direct primary care — or “concierge care for the masses” — is more accessible. Patients pay a monthly fee of anywhere from $25 to $85 to cover their primary care services, according to a Health Affairs report in December, and are encouraged to have insurance to cover more serious health issues. Patients and physicians might have 45 minutes to spend in an appointment. Because direct primary care usually does not bill insurance, it results in less checking boxes and more conversation.
A criticism of these models is that they may exacerbate the larger physician shortage, because physicians are responsible for significantly fewer patients than in a typical practice. Yet we need to evaluate their impact and see if their lessons might help us reclaim the patient-physician encounter.
This post first appeared in The Wall Street Journal’s blog, The Experts. Peter Pronovost, MD leads the Armstrong Patient Safety Institute at Johns Hopkins.
Categories: OIG Advisory Opinions
On July 11, 2016, the Journal of the American Medical Association published an article written by Barack Obama, JD. The JD (juris doctor) part reflects the fact that the author graduated from law school. Listed among the article’s purposes is to “recommend actions that could improve the health care system.” One of those recommended actions is “introducing a public plan option in areas lacking individual market competition.” While the President devoted only a small portion of his article to the public option, this is what he wrote:
“Some parts of the country have struggled with limited insurance market competition for many years, which is one reason that, in the original debate over health reform, Congress considered and I supported including a Medicare-like public plan. Public programs like Medicare often deliver care more cost-effectively by curtailing administrative overhead and securing better prices from providers. The public plan did not make it into the final legislation. Now, based on experience with the ACA, I think Congress should revisit a public plan to compete alongside private insurers in areas of the country where competition is limited. Adding a public plan in such areas would strengthen the Marketplace approach, giving consumers more affordable options while also creating savings for the federal government. ” (Emphasis added)
Note that the recommended action quote proposes a public option “in areas lacking individual market competition (emphasis added).” The individual market means non-group, non-employer coverage contracted for and paid for individually, still a relatively small part of the entire insurance market, albeit growing. Yet the larger quoted paragraph is not so limited, nor is Hillary Clinton’s ambiguous (intentionally so I suspect) adoption of Bernie Sanders’ position on the subject. Ms. Clinton always has favored a public option. But when you add it to her additional announcements about allowing the over 55’s into a Medicare-type coverage, we are well down the slippery slope toward single payor federally run health insurance.
Let’s look at the public option a little closer.
The most oft-stated justification for the public option is the lack of insurer competition in some areas of the United States. Commentators who favor the public option suggest that more competition is needed in those regions to “keep the insurers honest,” reflecting an understandable belief that more competition will lower prices. As I’ve written before, in healthcare, at least as presently constituted, additional insurer competition usually does not significantly reduce the price of insurance.
If the public option becomes law and is implemented, we already have a pretty good idea of what it will be like. Medicare. What do we know about Medicare?
While hugely expensive, the only way it keeps any control over its costs is by dictating (not negotiating) very, very low fees. Commercial insurers (Blue Crosses, United Healthcare, Aetna, Cigna, etc.) regularly pay hospitals and physicians 20-30% more than the federal government under Medicare. Why? Is it because the commercial insurers are insufficiently aggressive in negotiations? No. The commercial insurers for years have been the difference between survival and bankruptcy for many community hospitals and other providers.
Even so, a 2009 survey reported that more than 60% of physicians supported a public option. Really now. If implemented, an even greater portion of their revenue will be paid by the federal government at those way lower rates.
The other way that Medicare puts a dent in its costs is by a lower per insured operating expense. To put it bluntly, of course Medicare has a lower per insured operating expense rate. Its scale is enormous, and it does almost nothing other than process claims and take in money. Medicare does not manage care or do the myriad other things that private insurers do. To put it in context, Blue Cross & Blue Shield of RI covers about 500,000 lives. An expenditure by the RI plan (say a significant technology upgrade) of $50 Million would add $100 to rates. At last look, the Medicare program had almost 54 Million insureds, so a similar spend by Medicare would add 93 cents to its rates.
And even with all that, Medicare is not as “efficient” as it seems. Forbes published an article exposing the myth of Medicare’s low administrative expenses that puts all of this in better for us.
As I’ve written time and time again, operating expense accounts for a small portion of premiums, less than 10%. The CBO in a 2015 Report on p. 34 stated that in 2012, 88% of insurers’ revenues covered healthcare costs (actual claims paid for services to their insureds) while 12% went to operating expense and profits (or for nonprofits contributions to reserves). Those margins ranged from 2-3%. Compare that with virtually any other industry.
And the 88% of the premium bill, claims expense, is driven by fees and rate of use of medical services (i.e., insurance premiums not only cover increases in fees paid, but also increases (or decreases) in the rate of use of services and products by insureds). In that regard, it is very different from inflation or CPI which reflects price (the equivalent of fees) increases or decreases.
IF the federal government is suggesting that private insurers “be kept honest” and reduce their costs, the only way they can do that with a significant impact on rates is by reducing the fees paid to providers or reducing the per member use of services. There are no other ways. In regions where there is just one private insurer, usually the lack of alternatives for providers gives such insurers leverage to negotiate very low fees. Which makes for bad press and public outcry, but that’s for another time to discuss. My plan in RI which had a very large market share was accused of doing just that.
I’ll say it again. An insurer, and particularly a smaller regional insurer, even one without competition, can do only so much to reduce its operating expenses. Their regulators demand that they do much more than Medicare does. Customer service, managing care, wellness, employer group servicing, and the list goes on. And a reduction of operating expense means fewer employees who (we’d hope) do helpful things like customer service and care management. Just sayin’.
Those proposing a public option might suggest that the federal government, might agree to implement fees that are somehow “comparable” to the private insurers’ fees. That really won’t work. And reread what Mr. Obama wrote about “…securing better prices from providers,” a central basis for his suggesting a public option.
Moreover, even if the government agreed to use fee parity with private insurer, what would happen? Given that it doesn’t manage care, its claims costs would be in excess of the private insurers because the use by its insureds would be more and its fees are the same. It would be uncompetitively expensive.
Given the political environment, there may even be some claims this Fall that the public option would stand on its own and be self-supporting. That was said of the Medicare program in 1967, and look at where we are now. At least 50% of the cost of Medicare is funded by the general Treasury and not by direct employer/employee contributions (FICA) and beneficiaries’ premiums.
I lived through the fear mongering of the “Domino Effect” of the 60’s in Southeast Asia, eventually serving there for a while in courtesy of Uncle Sam. I appreciate that slippery slope arguments are too often overstated. Here, however, it is not. A public option where the federal government, which is not just a payor but also a user of services and the regulator, steps in as a “competitor” would be devastating to private insurance. It has the power of the Treasury behind it. A formidable “competitor” indeed.
Together with Medicare for over 55’s, it would gut the market and get us within shouting distance of Bernie’s single payor governmentally run health insurance dream. And we (and our children and their children) will somehow have to pay for it, because it’s not “free stuff.”
Categories: OIG Advisory Opinions
Would you buy an iPhone if the only apps that ran on it were written by Apple? Maybe, but the functionality would not be very diverse.
The same can be said of EHRs. Athena, Cerner, Epic, Meditech, and self developed EHRs such as BIDMC’s webOMR are purpose-built transaction engines for capturing data. However, it is impossible for any single vendor to provide all the innovation required by the marketplace to support new models of care I’m a strong believer in the concept of third party modules that layer on top of traditional EHRs in the same way that apps run in the iPhone ecosystem.
There are 3 such companies doing important care coordination work in Massachusetts and we’re expecting a wide rollout of their cloud hosted modules that tightly couple with EHRs, but are not authored by EHR companies.
The Right Place, is an electronic referral and bed management platform that expedites the placement of hospitalized patients to post-acute facilities that can deliver needed services. Unlike tools which push patient information downstream to providers, The Right Place functions more like OpenTable and Match.com. It supports discharge planners, patient/families and post-acute care facilities by providing a “front end” solution for case managers to search/match and a “back end” bed and referral management solution for the post acute care facility. Together, these tools provide real time data to providers on both ends that can improve outcomes, reduce unnecessary costs, and enable hospitals to track what happens to their patients after they leave the hospitals.
PatientPing enables caregivers to track and coordinate care as a patient “travels” throughout the healthcare system regardless of provider type, EHR or geography. The concept is simple. Every time a patient visits a facility, the admit/discharge/transfer data about that encounter is sent to PatientPing servers (with appropriate privacy protection) and all appropriate caregivers/care managers are notified of the encounter in real-time. Although use cases have expanded, PatientPing’s early focus was Accountable Care Organization patients appearing at skilled nursing facilities and hospitals. This community-based approach puts the patient at the center of care and breaks down institutional silos to facilitate higher quality care at lower cost.
Collective Medical Technologies creates products (EDIE/PreManage) that are like “Facebook” for providers, including Emergency Departments. Imagine that a complex patient with a formalized care plan seeks emergency care in multiple locations. Even with health information exchange, it’s hard to coordinate all the moving parts of the healthcare system. Collective Medical creates a “wall” for each patient and ensures that licensed caregivers are “friends” on that wall. When the patient presents at the hospital, the tool pushes real-time alerts, including patient-specific risk factors, visit history, and care guidelines. Thus, communication among caregivers can be better aggregated and visualized. One use case that has been effective in other states is the management of opioid-seeking patients visiting multiple facilities. Given the opioid crisis in Massachusetts, we’re hopeful that new tools like Collective Medical’s PreManage ED will help us better manage patient “treatment contracts”, executing care plans consistently at every emergency department in the state as part of a statewide rollout of the tool.
BIDMC has chosen to implement modular, cloud hosted services such as these in a unique way. We’ve created a single hub for patient admit/discharge/transfer transactions hosted at the Massachusetts eHealth Collaborative. Trusted vendors with business associate agreements can subscribe to these feeds, which are sent via HL7 version 2 messages over an encrypted transport channel. No IT department development or resources are required to add a new trading partner. It’s a very scalable model.
As FHIR matures, I imagine that every hospital and clinician practice will have a curated app store of approved modules that just plug into their EHR and health information exchange infrastructure. Some of these apps will be provider facing and some will be patient facing. My colleagues in government understand the concept of third party innovations plugging into EHRs. Hopefully as MACRA is refined, we’ll have empowering regulation to encourage this ecosystem and move beyond Meaningful Use concepts.
John Halmaka is CEO at Beth Israel Medical Center.
Categories: OIG Advisory Opinions
Vatsal Thakkar, a psychiatrist, recently wrote of the perks doctors are afforded in everyone’s favorite instrument of social justice – the New York Times. Dr. Thakkar speaks effectively and correctly about a broken health care system navigated best by pulling the ‘doctor’ card. Some on the progressive left have seized on this blatant disregard for egalitarianism as yet another example of a broken healthcare system, despite the fact that a two tiered system is exactly what they have been building over the last eight years.
To be clear, there has always been special treatment accorded fellow doctors and nurses – it has just become more obvious as the gulf between the haves and the have nots in health care has grown. Make no mistake – this is absolutely a function of multiple strategies that have created winners and losers in the healthcare space. The problem, of course, is that patients and physicians have ended up on the losing side of this equation.
In an effort to reign in costs, the federal government decided long ago that it was easiest go after the neighborhood private practice physicians that were practicing in that dastardly fee for service construct. Being a small practice neighborhood physician has never been easy – it requires a special commitment to be available for your patients on a constant basis day, and night. The financial rewards were considerable, though I would argue on a per hour basis these physicians were paid at a level more consistent with electricians than hedge fund managers. As regulatory burdens increased, the amount of time spent performing non-revenue generating tasks like prior authorization reviews began to cut into physician incomes. It started to make less and less sense to be on call for patients for 360 days of the year, and doctors began to turn to lower paying, but safer and more convenient hospital paying jobs. While this made physicians unhappy, the real burden was borne by patients. Instead of having a direct line to a doctor who knew you well, who would see you the same day or next day for an emergency, and then follow you into the hospital to direct your care – now you had to speak to a covering physician who didn’t know you, wasn’t invested in you, and was quick to direct you to the emergency room and hospital where yet another team of uninvested emergency medicine and hospitalist shift workers lay in wait.
Not content with the Comcast level consumer service that had now been implemented, bureaucrats next decided to curtail costs by shifting costs to consumers in the form of high deductibles and premiums in the the hope that the patient would exert downward pressure on health care costs. That has not happened. As Propublica reporter Charles Ornstein found out when he needed antibiotics for his son, or as journalist Steven Brill discovered when he needed emergent cardiac surgery, patients are in a poor position to negotiate prices for health care when they need it most.
In this world where risks and cost are now more than ever the patient’s to bear, is it any surprise that those with money, or influence would exert whatever levers under their control to navigate this system?
The solution from some is to no doubt provide ever more, ever better regulations, or work harder to deliver us universal health care. The inconvenient truth the control oriented free-lunch-for-all universal healthcare proponents won’t tell you is that cost controls in this system come via rationing. One of the indignities Dr. Thakkar speaks about in his piece is having to endure 6 weeks of back pain before insurance would approve a back MRI. In 2010, the average wait time for an MRI in that health system beyond compare, Canada, was up to ~12 months. There is even a helpful website you can visit that will let you know how long you can expect to wait for cancer surgery, cardiac surgery or other imaging studies.
A better solution to the current system plagued by physicians who answer first to hospital systems, insurance companies, pharmaceutical companies and regulators would be to restore the primacy of the individual beholden only to the patient: the independent physician.
<em>Anish Koka is an independent physician in Philadelphia who writes about the growing barriers between patients and physicians. Follow him on Twitter @anish_koka
Categories: OIG Advisory Opinions
On July 16, 2016, Pokemon Go had been in release for 10 days and it was already more popular than Twitter and Tinder on mobile devices. Those with the app spent more time on it than on Facebook. It became the most downloaded mobile game in U.S. history. So what does this have to do with health? Pokemon Go is a game, but it is also a health and wellness app. And it’s making people move, a lot. Because unlike the thousands of “gamified” health and wellness apps created over the last decade, Pokemon Go is a healthified game. The game comes first. That turns out to be the smarter path to actually engage large numbers of people to be active, and it is showing a world of possibility. Self-reports and early data from tracking devices reveal a massive jump in walking, almost certainly tens of billions of additional steps in just one week. Over the course of the game, trillions of steps could be walked that would not have been otherwise. What can we learn from this?
Start with the experience. Gamified health and wellness apps or tools have been around for years. And they have been largely ineffectual, because nobody really enjoyed them. Yes, some of us do get briefly pulled in to one app or another; even things as simple as step trackers can get some people to make behavior changes for a time, but nothing has really been able to move the needle at a population health level. In contrast, the developers of Pokemon Go (Nintendo partnered with a Google spinoff called Niantic) had learned from millions of hours of playing time on other games what people actually enjoy, and asked themselves a simple question: how can we immerse them in an augmented version of the real world and make them get out and explore it while they play?
One of the tricks Pokemon Go uses is intermittent reinforcement. One of the oldest and strongest findings in experimental psychology is that intermittent reinforcement elicits a more persistent response than highly predictable reinforcement. A mouse presented with the prize of cheese from hitting a lever will hit the lever more times when it can’t predict which hit will bring the cheese, and it might come at any time. If I know I will get a prize with a small effort, like one press, I do the small effort and get sated. If I know it will be a huge effort, like 1,000 presses, I only make that effort when necessary (like if I need to avoid starvation). But if I don’t know how many presses it will take, suddenly the act of pressing the lever becomes more interesting because of the uncertainty and anticipation, and reward centers of the brain are engaged much longer. Las Vegas was built on intermittent reinforcement, along with some other quirks of human psychology, like our propensity to misjudge the likelihood of highly unlikely events. But unlike gambling, finding pocket monsters is not a zero sum game.
Another trick Pokemon Go uses is that the goals are open-ended (there is always more to do: another new challenge to accept, a Pokemon to find, a level to gain) and they are framed as in-game objectives rather than health objectives, by and large. While there is a badge for walking 10 kilometers, you aren’t aiming for a specific step goal and then stopping when you reach it. People, especially adults, are exercising more than they have in months or years without even realizing it, until they can no longer ignore the pain in their feet or legs.
One of the remarkable things about Pokemon Go is that it is able to inspire such high levels of participation without any monetary incentive. No one is getting paid to lose weight, or walk 10,000 steps a day, or keep their cholesterol low. If the engagement level in Pokemon Go can be replicated by other games (and surely it will be) this could have big implications for corporate wellness programs, which have tended to myopically focus on financial incentives to change behavior. This may turn out to be unnecessary. As developers create more engaging wellness games that don’t require financial payouts, it could substantially reduce the cost of such programs, or eliminate a reason to create them entirely (though the latter is unlikely).
The world is the playground. This is not the first iteration of healthy gaming for Nintendo. For the Wii console, Nintendo made what was, at the time, the best integration of motion sensitive controls and game play. Millions of people were flailing their arms to hit virtual tennis balls (and sometimes throwing their controllers into their TV screens), and shifting their legs on the “balance board” to move around in ways that made their onscreen avatars mimic them. But with the Wii you had to stay in your living room, and if you were using the board for a real workout, you had to stay on a very small platform. The same limitation applies to Microsoft XboX’s Kinect sensor that allows you to move and interact with the video game…as long as you stay right in front of the sensor’s view. As promising as Oculus Rift and immersive virtual reality gaming is, it has a similar limitation to the Wii, Xbox and other traditional gaming devices. You had better not walk out into a real street with it, but stay in the safety of your room (or even better, a room in which objects you might bump into are carefully removed).
The room, let alone couch, is a limitation that Pokemon Go just doesn’t have. The world is opening up to gaming. Pokemon Go and its ilk are not virtual reality, but augmented reality. Game destinations are added to a real map of the real world. Once you arrive at the right place, you use your Android or iOS device to “see” and “catch” the creatures around you, with their images superimposed on images your camera takes.
The pleasure of the game has another dimension that has only begun to be tapped: it’s social. Real people, of all ages, races and walks of life, are congregating in the same places pursuing the same goals in a way that isn’t zero-sum. And they’re smiling, amused at being thrown together doing something silly, casual and serious all at the same time. Right now the game hasn’t given these people a very deep experience at interacting, cooperating or battling, and so mostly they are just co-existing and feeling the comraderie of fellow-travelers.
After the fad. Is Pokemon Go a fad? Of course it is. But it’s a fad that opens a door to unimaginably many other fads and enduring games that will change the face of both gaming and health and wellness tools generally.
Take social engagement. Crowds of people are mingling around the world at hot spots for the little pocket monsters, and smiling in recognition of their fellow human who made it to the same spot on the same quest. But deeper social engagement already exists in another app from Niantic, on which Pokemon Go was partly based, Ingress. In that game, players must form teams and conduct elaborate strategies at real world sites of significance (like museums and monuments) to advance. That’s right, games now are giving people history lessons and showing them parts of town they had never visited before. How long will it be before some spawn of Pokemon Go and OK Cupid gets people to walk around town on quests, imaginatively participate in the history of their locale, and hook up with a potential partner?
On the other end of the spectrum, augmented reality could also be used in shooter games. I have two young children, and recently played laser tag for the first time in almost 30 years. As primitive as it was, with cumbersome gear needed to register a “hit,” I had a blast. It was perhaps the best cardio workout I’ve had all year (pathetic, I know, but we lazy people are legion, and we are the ones who need these kinds of games). Augmented reality could create an engaging backstory, and use special goggles to take a real world obstacle course or city park and add to it virtual monsters and robots, or alter how other players look, to take first-person shooter games like Call of Duty or Halo and make people actually run, duck and dive for victory. The question at this point isn’t whether such games will be created, but how long before the first killer app that is good enough to have millions scrambling for cover.
And soon some clever game designers will figure out how to make socially-interactive apps that not only encourage movement, but other healthy behaviors like good nutrition, in an immersive and fun experience. If the effects on childhood nutrition are large enough, we may even want to rethink the use of games in school settings. For some of the good behaviors learned will likely stick long after kids have stopped playing a particular game, and the public health benefits may be worth giving in a little on how we think kids, especially younger ones, should be spending their time in school. But first there has to be a game, a fun one, and not just a wellness tracking tool with a game-like veneer on top.
Jonathan Halvorson is new economy editor for THCB.
Categories: OIG Advisory Opinions
When diagnosed with abdominal mesothelioma, a rare cancer with a blighted future, evolutionary biologist and writer, Stephen Jay Gould, turned his attention to the statistics; specifically, the central tendency of survival with the tumor. The central tendency – mean (average), median and mode – project like skyscrapers in a populated city and are the summary statements of a statistical distribution.
The “average” is both meaningful and meaningless. The average utility of average is zero. Consider a gamble – fair coin toss where you get $50 if it lands heads and lose $50 if it lands tails. The average (net) gains of this coin toss, if the coin is thrown hundreds of time, is zero. But no one gets nothing – you either get $50 or lose $50. The average is twice wrong – it over estimates for some and under estimates for others. But the average of this gamble has important information. It helps you decide if you could profit from making people play this gamble – you wouldn’t profit unless you charged a small fee to play the gamble.
The median is the mid-point of a distribution. Gould’s cancer had a median survival of eight months. This meant that half (unlucky half) lived fewer than eight months and half (lucky half) lived more than eight months with the cancer. The mean is affected by outliers but the median is not. For example, consider Mumbai’s billionaires. They raise the average income of the city, not the median income. Skewness of a distribution affects the mean, not the median. Put another way, the median (Mumbai’s slums) conceals the skewness (Bollywood).
Gould, describing in his classic essay “The median is not the message,” ignored the median survival but looked at the skewness of the distribution. The distribution was right-sided – some patients with mesothelioma who lucked out with survival lucked out big. Gould was initially despondent when he saw that the median survival of his cancer was so short. Gould was an optimist. He was dealt a rough hand but was not going down without a fight. His optimism, and fight, increased as he unraveled the distribution – first with the hope that he could be in the lucky half of the distribution, then with the hope that he could be one of the outliers in that skewed distribution, then with the hope that the treatment that he was being given, an experimental cocktail, could make him a lucky outlier.
Gould lived twenty years after his diagnosis, perhaps, in part, because of his optimism, although we don’t know for sure that optimism helped. Gould didn’t know for sure that he would be an outlier. He did not choose to be in the long positive tail – he hoped he was. He could, quite easily, have settled his affairs, written his will, and traveled the world believing he had only 8 months to live. For every optimistic Gould who lives twenty years with mesothelioma there may be ten optimistic Goulds who live only two months.
Gould’s story is at the heart of tension in evidence-based medicine (EBM). This is not a tension, strictly speaking, but an uprising. EBM is driven by central tendency – averages – amongst others. But averages are built by individuals who vary. Variation is a fact of life. All theory is gray, said Goethe. And gray, not black and white, is the only truth in medicine. Actually, variation is only half-truth – half remains concealed because whilst we know that we’re part of a variation we don’t know where exactly we’re placed, we don’t know which shade of gray we belong to.
Cancers vary in prognosis. Cancers vary in their response to treatment. This begs the question: in the absence of perfect information, what should the oncologist tell the patient? Should the oncologist reveal the median survival only? If so, why? What normative ethics say only the central tendencies of a distribution be disclosed? Should the oncologist give a whiff of hope that the patient could be an outlier? Should the oncologist mention the short left and not long right tail and stress the imminence of death so that the patient can die gracefully? What is the truth – is it the median, the long tail of optimism or the short tail of pessimism? If all three are truths which truth should be mentioned first and which truth should be mentioned last?
The simplistic answer is that it depends on the patient. My friend, an interventional oncologist, tells me that patients seek him for hope. He gives them hope and is unapologetic about doing so. Some might say that he gives his patients false hope – but that accusation assumes a numerical probability of death, a threshold or a range, which neatly separates false from true hope, hype from reality. There is no such number and even if it existed it’d be near impossible to give every person their unique threshold of true vs. false hope, as the question will once again arise – what if I’m the lucky outlier?
When I pressed my friend further about false hope, he retorted. “I’m an oncologist, not a fucking undertaker.” Fair point. Many of his patients, with livers riddled with metastases and a hopeless prognosis, see the undertaker shortly after his interventions. Because hope is most in demand when reality is most hopeless. His patients see him for possibilities, not limitations. Like Gould, his patients wonder if there are outliers (there often are) in the survival distribution of their advanced cancer, a few extra months or even weeks, and if they could be that outlier.
My friend blasts his patients with chemotherapy and if there are new agents, he tries them out as well. There are no short cuts with hope. When he suspects a complication of cancer, such as a clot in the lungs, he goes after it with hammer and tongs. Because there’s no retreating from hope.
Most patients who wish they are lucky outliers won’t be lucky outliers. The difference between hope and reality, therefore, is overtreatment. Hope and overtreatment are a dialectic – a marriage of convenience. Hope is a state of mind, a culture of expectation, will of the people, a belief in self-determination, and a rejection of the afterlife. Hope can’t be switched off by pressing a button. The most powerful driver of medical costs at the end of life is not the incentive structure. It is not doctors’ fear of being sued. The most powerful driver is hope.
(This piece originally appeared in 3 Quarks Daily)
Categories: OIG Advisory Opinions
Etiology, pathogenesis and translational science beat drums to which modern medicine marches – with escalating cadence. Yes, there is cacophony on occasion and missteps, but we all wait for the next insight to trigger a wave of enthusiasm at the bench and beyond. “Disease” is no longer an elusive monster in the swamp of ignorance; “disease” is prey. It can be defined, parsed, deduced, and sometimes defeated.
Little of this pertains to “health.” Health does not objectify itself. Nor is it simply the absence of disease. Health has temporal and geographic dimensions. Health is inseparable from the context in which it is experienced. Health has a narrative laced with peculiar, often idiosyncratic idioms. Furthermore, there is a crucial difference between the health of a person and the health of the people.
Science has limitations when it comes to studying health. For one, the studying becomes a component of the experience of health. Nonetheless, we have accumulated a great deal of substantive information that serves to define the boundaries of healthfulness and offers options with salutary potential. Much of this reflects a century of considering the personal ramifications of gainful employment. Much of this falls under the purview of occupational medicine and should be a source of pride.
The Health of the Worker
To live a year without an episode of headache, heartache, heartburn, respiratory symptoms or back pain is abnormal. To live several years without shoulder, neck, or knee pain likewise is abnormal. Health is having the wherewithal to cope so effectively that the last episode is not long memorable. Functioning may be compromised, but usually to a degree we can tolerate and largely circumvent; “presenteeism” is a choice that need not be medicalized or penalized (even my computer is afflicted on occasion.) Myriad remedies, from poultices to pills, have always been purveyed for remittent and intermittent predicaments of life. These options cater to “common sense”, which is neither geographically or temporally common. None is “indicated” on an evidentiary basis.
Predicaments of life are a bane at work, just as they are at home. In both settings, one can turn to “community” for emotional and physical support if “community” is available. The importance of social cohesiveness and social capital in the industrial age was a seminal contribution of the social philosopher, David Émile Durkheim (The Division of Labour in Society, 1893). When, despite personal and community support, a worker is overwhelmed by any morbid challenge the morbidity qualifies as illness and the functional compromise as the illness of work incapacity.
The political climate in Durkheim’s day was partisan and contentious. An imperious establishment was ill prepared to assuage a labor force angered by disenfranchisement, poverty, insecurity, and rampant work incapacity from disease, injury and age. Labor’s plaint was bolstered by the development of the union movement and plaintiff’s bar and by the stridency of the likes of Marx and Lassalle. Violence was postponed by Prussia’s “Iron Chancellor”, Otto von Bismarck, who shepherded a “welfare monarchy” through the Reichstag. This ground breaking social legislation rewarded the citizenry with personal security based on their value to society (1). For predicaments of life and other illnesses, health care would be provided. However, recourse was not universal for the illness of work incapacity itself. If incapacity arose out of and in the course of employment and occurred by accident, there would be no loss of income. If incapacity precluded further gainful employment but was not causally related to work, a modest pension would be provided. But if this individual never had substantial earnings, the pension was meager.
The industrialized and industrializing world rapidly accepted stratification by worthiness as sensible. With some modifications (2), Prussia’s Workmen’s Accident Insurance, Public Pension Insurance, and Public Aid have left their mark on social legislation and social conscience ever since. Most tried to bend the Prussian paradigm to their preconceptions. For example, David Lloyd George and W.J. Braithwaite fashioned the British version to dull the cutting edge of the welfare monarchy (3). Meanwhile, in America Theodore Roosevelt was trying to reprise his presidency on the Progressive (Bull Moose) Party ticket. His platform called for universal health insurance and many other features of the Prussian precedent. Roosevelt lost and so did the platform. Only Workmen’s Compensation Insurance made landfall – and not easily. It was declared a breach of the commerce clause of the Constitution. Hence it reverted to the states, one at a time, each with distinctive features. Federal disability insurance waited a half century, and universal health insurance is barely out of the oven.
The Health of the Workforce
There have been great strides in assuring that illnesses, including the illness of work incapacity, are not consequent to exposures that are peculiar to a workplace. Sadly, most of these strides represent efforts after-the-fact. If a worker suffers physical, thermal or toxic injury in the modern workplace, it is considered a reproach to regulatory agencies and management. The victim will be afforded optimal care without wage loss and usually return to gainful employment if possible. As for any responsible party, a financial penalty, sometimes more, awaits.
This is not the case for the illnesses of work incapacity consequent to predicaments of life. For some predicaments, risk analysis impugns the workplace more than the home. For example, one might be more likely to be infected with influenza at work than at home given the differential intensity of exposure to respiratory droplets. But we do not consider it sensible to consider “flu” an occupational disease, let alone a compensable injury. A worker with “flu” can elect presenteeism or “sick leave” and go home without anyone questioning the presumptive diagnosis. Besides, no one would raise an eyebrow if the real reason was that their child had flu. Furthermore, if the co-worker didn’t return promptly, one is inclined to reach out to offer assistance.
Another course of events is likely if the co-worker chooses absence for regional back pain (4) and other predicaments of life that are considered “work related” despite the absence workplace-attributable risk. For the regional musculoskeletal disorders, the causal inference is a social construction, understandable but sophistical. Biomechanical forces that exacerbate regional back pain are no more likely a feature of tasks at work than similar tasks outside work, nor are they proximally causal (5). Calling a backache an “injury” is akin to calling angina “stair climber’s chest.” Furthermore, it has been clear for decades, that for many a worker the complaint of a regional “back injury” is surrogate for “My back hurts but I can’t cope with this episode.” The latter narrative could suggest a range of solutions (6). But for the past 85 years a worker’s back pain has been considered a compensable injury sending far too many into a vortex of disability determination (7).
The Disabled, the Disallowed, the Disaffected, and the Disavowed (8)
All this is entrenched in governmental policy, labor-management agreements, and the public mind. All this has generated bureaucracies, professions, indemnity schemes, and political agendas that have gained wide acceptance and a life of their own. All this has become an important cost of doing business, so important that primary prevention is a priority. Despite expending fortunes on wellness programs and ergonomic ingenuity, little has been accomplished to spare the worker the illness of work incapacity. To the contrary, workers with the illness of work incapacity abound and many have been harmed by the recourse they are offered. Too often they find themselves in a Kafkaesque gantlet: the work-relatedness of their injury is contested, they are blamed for therapeutic failures, and the magnitude of their work incapacity is discounted. This is a gantlet that converts the illness of work incapacity into a pervasive, recalcitrant morbid state in a milieu structured to blame the victim (9). The result is a life course that is colored by persistent illness, meager income and disenfranchisement and that leads to death before their time (10).
Much of 20th Century social legislation leaves a proud legacy. Recognizing the plight of the worker with the illness of work incapacity is an example. However, while the remedy foisted on society a century ago was expedient and seemed sensible at the time, it is ineffective if not iatrogenic for the 21st C. Furthermore, it is anchored by the entropy of its familiarity, political influence, and the enormous transfer of wealth it drives. As many have learned the hard way, substantive reform is not possible. It must be supplanted by an approach that takes advantage of the precedent object lessons.
That conclusion will seem counterintuitive to many, fatuous to some. After all, it is a reproach not just to one of the pillars of modern society but to minions employed to push the pillar upright. This brief, solicited editorial presents only an outline of the basis for my conclusion. For references, I chose articles that mark its evolution. However, the conclusion grows out of 45 years of my scholarship and my close review of the scholarship of many others. I have written 7 books since 2004, each considering the literature that relates to many aspects of the illness of work incapacity. These volumes are more than systematic reviews, they are exercises in hermeneutics. The Last Well Person is a treatise on medicalization written for a broad audience (McGill MQUP, 2004). The 3rd Edition of Occupational Musculoskeletal Disorders (LWW, 2005) was written with the involved professional disciplines in mind. The next 5 are published by UNC Press (11). Stabbed in the Back details the arguments in this editorial.
The most recent, By the Bedside of the Patient, includes a discussion of a rational indemnity scheme that could well supplant the Prussian precedents. It is a scheme that has been 25 years in development. It is a defined contribution scheme that covers what is now called health, compensation, disability and life insurance in a single benefits instrument. It is designed so that the premium will be less per capita than the average cost of health insurance alone for OECD members. Interventions that have been demonstrated to offer no clinically meaningful efficacy need not be covered. It is fiduciary and sufficiently cost-effective that a goodly percentage of the premium will be returned to employees to purchase ancillary health insurance policies that serve personal circumstances. And it is designed to revolve around the patient-physician dialogue.
Lewis Carroll’s Alice could believe in 6 impossible things before breakfast. I’ll settle for just one, before it’s too late.
1. Beck H. The Origins of the Authoritarian Welfare State in Prussia. Ann Arbor: The University of Michigan Press, 1995.
2. Hadler NM. The disabling backache. An international perspective. Spine 1995; 20:640-9.
3. Grigg J. Lloyd George. The people’s champion. London: Eyre Methuen, 1978.
4. Hadler NM. Regional back pain. N Engl J Med 1986; 315:1090-2.
5. Hadler NM, Tait RC, Chibnall JT. Back pain in the workplace. JAMA 2007; 297:1594-6.
6. Hadler NM. The injured worker and the internist. Annals Intern Med 1994; 120:163-4.
7. Hadler NM. Workers with disabling back pain. N Engl J Med 1997; 337: 341-3.
8. Hadler NM. The disabled, the disallowed, the disaffected and the disavowed. J Occp Environ Med 1996; 38:247-51.
9. Hadler NM. If you have to prove you are ill, you can’t get well. Spine 1996; 21:2397-400.
10. Marmot M. The Status Syndrome. New York: Henry Holt, 2004
11. Hadler NM. http://uncpress.unc.edu/browse/author_page?title_id=3262
Categories: OIG Advisory Opinions
My wife of 47 years likes to tell of her travails after having married me. She claims she had no inkling that I would specialize in despised career choices. Right after we were married, I served as an infantry airborne officer in Viet Nam, a then despised profession. Then I became a trial lawyer. A very despised profession. And then in 2004, I became the CEO of a health insurer, the pinnacle of my career in despised professions. At one point she stopped reading the Providence Journal and listening to local talk radio. When asked if she were my wife, she’d often reply, “Why do you want to know?”
So I have some perspective on emotional reactions of people in varied contexts. Here we will discuss the hyper-emotionalism that lawsuits engender, because they indeed cause people to act in ways that are confounding. Of course, an individual plaintiff in a medical malpractice lawsuit is hyper-emotionally involved. But more to the point of this article, so is the defendant physician.
Why is that? For the plaintiff, that’s easy to understand. They believe (or were convinced) that the physician harmed them through negligent conduct, and that they should be compensated (and perhaps apologized to). Their world often starts to revolve around the lawsuit as if nothing else mattered. It consumes them, and the outcome is rarely satisfying.
The physician reacts almost equally emotionally when sued. While that is counterproductive, they typically can’t help themselves because it is a direct and personal attack going to the heart of who and what they are professionally and as human beings. Heavy stuff.
Unlike games, with lawsuits it’s about YOU, and they can inflict lasting scars and cause irrational behavior. It needn’t be that way.
So let me discuss this subject in hopes that if you or your organization are sued, you may temper your reaction in a way that allows you to continue to make rational decisions and live your life normally. And get through the experience with your sanity and perhaps your wallet intact. [I realize there is the whole thing about malpractice insurance, but let us leave that aside for now.]
To a good trial lawyer, there is nothing like a hotly contested lawsuit. Lawyers know that the participants (sometimes antithetically called “parties”) fear and hate them, and yet the smell of blood in the water is so intoxicating. If you are the lawyer doing the cross examining, watching an adverse witness on the stand slowly self destruct is nearly heaven. You can make a witness who plays fast and loose with the facts literally flinch each time you reach for his deposition transcript to contradict his testimony.
Lawyers are successful when they throw you off your game. People who are scared, angry, or just off balance make mistakes, and that is what opposing counsel wants. He or she may seem nice, but never let that fool you. You will not convince them of the justness of your side of the case, and do not ever let your guard down–they are not your friend. I had a CEO client who, during depositions, always placed a pencil between him and the opposing lawyer to remind him of just who the enemy was and where he was.
Just like being an Eagle Scout, one never says he “was” a lawyer, so I guess I am a lawyer. I tried cases in court–real trials with real judges and juries, for 25 years. And then for twelve years, I stopped practicing law and became a client as the COO and CEO of a health insurer. During that time, my feelings about lawyers changed a little. Upon reflection, that is understandable, and I gained a real appreciation for why CEOs sometimes lose their patience with lawyers. Because often with lawyers it’s all about the process, which it most definitely is not with CEOs.
I want to discuss the fear of lawsuits, but first let’s talk about lawyers. Overwhelmingly, lawyers are trustworthy professionals. I believe in the profession. There are, of course, bad apples just as there are in the medical profession. But lawyers have always, since Shakespearian times, had a bad rep and that will never change. The myriad reasons are too numerous for this article, so we’ll accept it for what it is.
Oddly enough, lawyers are typically risk-averse. Physicians can understand this since it looms large in their profession as well. They are traditionalists who see things through the lens of “what is the worst thing that could happen?”
For example, when CEOs look at a draft contract, they focus on the deal terms. When lawyers look at a draft contract, they focus on the termination clauses. Why? If the deal goes south, they want to know how their client can get out of it, or how they can keep the other party in it if it is to their advantage. And they assume the deal will go south. Otherwise, there will be no call to action.
Moreover, lawyers take notes during meetings to later review and ponder. They live in the retrospective. They are observers and recorders, at least until trial. On the other hand, CEOs do not take notes during meetings. They live in that moment, and they do not leave meetings with assignments. Their task ends with the end of the meeting. Moreover, CEOs try to observe people during meetings—facial expressions, body language. They want to get a sense of who is feeling what without saying so. This reflects different perspectives of CEOs from counsel, which in turn may account for the sometimes lack of clear connection between counsel and the CEO. They just think and approach things differently.
So let’s talk about lawsuits in the business context, because healthcare is a business. Your business (and despite suggestions to the contrary, being a physician is the conduct of a business) may be sued. It probably will be at some point. You may be sued by an individual or by another business, or by the government. If you are a physician, it is likely that you will be sued for malpractice at least once in your career. Try to keep in mind that it is a business lawsuit. The suit is a claim of negligent provision of professional services.
It can help physicians to think of suits against them in that context–it’s less personal. And you need that separation so that the claim, whether with or without merit, does not cause undue angst and distraction in your professional and personal lives. That is VERY important. You cannot put everything on hold and obsess over the suit for the next three years.
Beyond malpractice litigation, B2B lawsuits are nothing more than business tools. They are tools of your trade as a business person and should be considered as such. If you are in business, you should be familiar with them and their use. Do not let your ego or emotions get in the way. The are prosecuted or defended based on good business reasons, and remember, over 97% of lawsuits are settled, sooner or later.
You might sue or be sued to send a “message.” Not just to the defendant, but to the community of observers, that certain activity is unacceptable and will not be tolerated. As CEO, I once was asked in the context of a suit against a company that provided medical services to our subscribers whether the amount of the recovery was of most importance. I said, no…my goal is to send a message to the provider community that fraudulent billing will not be tolerated. So if that means taking the matter all the way regardless of the eventual recovery, so be it.
I believe it helped that the community knew I was a trial lawyer and was not intimidated by lawsuits or the process. Whether or not that was the reason, we weren’t sued often while I was CEO. I recall at a meeting being told by an entity’s lawyer that it was considering bringing a class action against my company regarding claims processing issues. Having investigated the matter and being convinced we’d done nothing wrong, my response was a slow smile and saying, “If you do, you’d better be prepared to go the distance, because I won’t settle. Ever.” We weren’t sued. Was it my lack of emotion? Perhaps. In any event, I lost no sleep over the threat.
When an individual sues your business, that gives rise to risks and opportunities. The “community” watches that as well, and the community often consists of other plaintiffs’ lawyers. How do you react? What is the settlement? Are you an easy mark? Is it kept confidential? When sued by an individual, IF you discover that you are in the wrong, try to settle quickly but don’t be a holdup victim. Use mediation if possible. It’s a quick and effective way to resolve claims early and fairly.
When a governmental entity, whether or not a regulator, sues you, that is the time to use a lawyer who has experience with that entity and the subject matter. That is not the time for amateurs. Get out in front of the matter, get to the bottom of it quickly, and again if you’re wrong, deal with it and resolve the matter ASAP. Your relationship with your regulator or other governmental entity is important, as is your credibility.
However, if you truly believe you are in the right, that actually can be much more difficult, because with governmental entities, you can lose by winning at times. To go to the mat with a governmental entity requires top flight legal counsel and strong nerves. Governmental reserves and resources seem, and often are, boundless. But at times, you have to take a stand. Good luck on choosing the right time.
Civil (non criminal) lawsuits, after commencement, proceed with what we call “discovery.” This is where the lawyers make their money because very few cases actually proceed to trial. Usually, the first thing that happens in discovery is that documents are exchanged, and there are always fights over that. But then come the depositions. Depositions are when witnesses are questioned in a lawyer’s office, under oath, about the facts of the case. If you are deposed, your lawyer also attends and represents you, but he or she will not do a whole lot at your deposition other than make sure it is conducted fairly.
There is nothing more important in the whole pretrial process than being properly prepared for your deposition (or that of any of your side’s witnesses). And I mean prepared. For a decent sized case, your lawyer should spend at least 6 hours preparing you so that there are no surprises for you at the deposition. You must know the rules, you must know what you should do, and you must know what you should not do. This is critically important, and I don’t care how verbally nimble you think you are. The very worst deposition witnesses are super confident sales people and, yes, lawyers. And physicians, who have this compelling need to know the answer to every question asked by the opposing attorney, whether they are sure they know it or not. They don’t want to look dumb. That usually is disastrous, because a wrong guess under oath is the same as a lie under oath.
Bottom line with lawsuits. Don’t flinch. As with karate (which teaches good life and business lessons), when the other side takes a swing at you, keep your eyes open, your wits about you, and step in rather than back. As with snakes, there are harmless lawsuits and dangerous ones. Knowing which is which and handling them accordingly makes all the difference.
If you are reading this, it is likely you are involved with healthcare. Healthcare disputes are different from other disputes in a number of ways. They often involve parties which must continue to do business with one another after the dispute is resolved. They often involve executives who have known each other for years. And they often involve confidential and competitively sensitive information. And often, once public, they can be above the fold news. You don’t want that to happen, believe me. Again, resolution through mediation makes perfect sense.
We have all heard about lawsuits that have ended with absurd results (e.g., overheated McDonald’s coffee). While there are some urban legends, there have been some wacky results, just as there are in other pursuits. Yes, the “system” is imperfect, and bad results can obtain, just as some surgeries can end in tragedy despite the lack of any negligence on the part of the surgeon.
But in cases where there are seemingly absurd results, strikingly often there is, buried within the facts of the case, a reason for that result. It is understandably easy to criticise the judicial system given some of the results when you are unfamiliar with what we lawyers call the “travel of the case.” But with almost every strange result, there is a smoking gun reason.
Very often it is not about the facts themselves, but rather about a document that was destroyed or altered, or a lie under oath. That was how the first cigarette cancer cases were won. Think of how this has hurt, for example, governmental officials from Nixon, to Clinton (Bill), to Clinton (Hillary). Good lawyers alway tell clients that the facts will be what they will be, but if they illegally destroy documents or lie under oath, they cannot be saved. They are dead meat. Plus it’s just plain wrong (and incidentally against the law) to lie under oath or destroy evidence. And so many, many bad results were about the destroyed document and lie under oath, rather than the facts.
So what your parents told you about telling the truth is, well, true.
And the truth is that with good lawyers on both sides, matters generally are resolved properly. But don’t abdicate your executive responsibility to the lawyers. They are advisors. Not dictators. They advise you and YOU make the decisions. Unless you want to hide behind them, which is generally a terrible way to conduct business.
Categories: OIG Advisory Opinions
Senate leaders now say they won’t consider companion legislation to the House-passed 21st Century Cures Act until September, after months of delay. Lawmakers would then have to reconcile the differing House and Senate versions, presumably by year’s end during a lame-duck Congress.
We believe the summer delay is a good thing, and that Congress should actually extend consideration of the complex legislation into 2017 when must-pass FDA funding through industry user-fees will be on the congressional calendar. That way, lawmakers can debate the implications of the proposed bills in the context of the resources FDA needs.
Why further delay? Because the legislation—which makes substantial changes to the way the Food and Drug Administration (FDA) approves drugs and devices—is flawed. As currently crafted, it lowers standards for drug and device approvals and safety, and risks adding to the rising cost of prescription drugs.
The ostensible rationale for the legislation—being pushed by drug and device companies—is that the FDA stifles innovation and advances in treatment by approving drugs and devices too slowly compared with other countries.
That premise is faulty. Nearly two-thirds of the novel drugs approved in 2015, for example—29 of 45, 64 percent — were approved in the United States before being approved in any other country. The proportion was even higher in 2012 and 2013. Moreover, the majority of those drugs (60 percent) took advantage of existing FDA expedited review programs—fast track, breakthrough, priority review, and accelerated approval—and nearly half (47 percent) were approved to treat rare or orphan diseases.
As for devices, research shows that “it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices” in the U.S. compared to Germany, France, Italy, and Britain.
The House and Senate bills ignore the above facts. They essentially seek to speed-up the approval process by relaxing FDA’s safety and effectiveness standards. And to make that more palatable, sponsors have attached the changes to increases in funding for the National Institutes of Health and the FDA.
But while the public supports increases in biomedical research funding, it is deeply skeptical about lowering the standards for drug and device approval. In the most recent poll on this issue, just under 60 percent of Americans opposed changing federal regulations to speed the development and approval of drugs, according to a STAT-Harvard poll released in May. Respondents’ main concern: faster approval would allow products on the market that don’t work or are unsafe.
The survey echoed a previous poll by Consumers Union that found 82 percent of Americans believe that preventing safety problems is more important than limiting safety testing to speed the clearance or approval of devices or promote innovation.
The House’s 21st Century Cures Act received broad bipartisan support in part because it put a significant amount of money for research on the table. The House bill pledges a $9 billion increase in mandatory funding for the National Institutes of Health over five years, gaining the support of universities and medical schools. It also promises $550 million to the FDA (which, according to the CBO’s analysis, would not fully pay for the additional workload the Act assigns the FDA).
The drug and device industries intensely lobbied House members to pass the legislation. The Pharmaceutical Research and Manufacturing Association (PhRMA) increased its lobbying from $4 million to $5.4 million in the quarter before the 21st Century Cures Act passed. The Advanced Medical Technology Association upped its spending from $550,000 to $740,000 in the same quarter. The Senate’s lobbying database listed more than 1,100 lobbyists working on the legislation.
The Senate legislation—actually, 19 separate bills—is an improvement over the House’s 21st Century Cures Act. But, on balance, the Senate bills are still weighted heavily in favor of speeding medical products to market by weakening FDA approval standards.
New drugs and devices are often an improvement over existing products, of course. And when they clearly are, FDA has established pathways to get them to market and patients as fast as possible. The agency, for example, grants more than one-third of requests from industry for “breakthrough” designation for new drugs. But the history of medicine is replete with examples of drugs and devices that caused more harm than good, some of which were approved too hastily — such as Avastin for breast cancer, Vioxx for arthritis, and metal-on-metal hip implants. Innovative drugs and devices simply must be required to actually work and not harm patients.
Below we list the Senate bills that, in our view, increase risks to patients and those we think would improve public health.
Increases risks and should be rejected or significantly modified:
The MEDTECH Act would prevent the FDA from collecting adverse events due to flawed electronic medical records, and from recalling certain types of defective medical software. Some of this software has had life-threatening flaws in the past, such as oncology electronic medical record systems that calculated and recorded incorrect drug dosages for highly toxic chemotherapy drugs.
The PATH Act would allow antibiotics to be approved with minimal evidence of safety and effectiveness through a “limited population” approval pathway. But, antibiotics approved in this way are promoted by companies so that they are more widely prescribed in order to increase sales. As they are, we won’t have information about whether they’re actually safe or effective for those groups of patients.
The Advancing Breakthrough Devices for Patients Act would encourage shorter and smaller clinical trials for medical devices. Abbreviated clinical trials will make it difficult, if not impossible, to include sufficient participation from subpopulations such as women, seniors, and racial and ethnic minorities in the analysis of the trials. In an increasingly diverse America, this is unacceptable.
The Advancing Hope Act would continue the existing pediatric priority review voucher program through 2022. The program is currently set to expire at the end of September. The program’s ability to stimulate innovation is questionable: a recent GAO review of the program concluded that the six drugs for which vouchers have been awarded so far were in development before the program existed. By allowing drug makers to buy a priority review, the bill removes FDA’s ability to set its work priorities and resource allocations based on public health needs. In a time of threats such as the Zika virus, our government agencies must be able to prioritize public health, and not be bound by vouchers that were sold to the highest corporate bidder.
Would promote innovation and protect public health, and should be passed:
The Preventing Superbugs and Protecting Patients Act will help prevent drug-resistant infections from contaminated duodenoscopes and other reusable medical devices that have caused harm and deaths. If enacted, this bill will require certain reusable medical devices to have validated cleaning, disinfection, and sterilization procedures.
The Next Generation Researchers Act invests in the brightest young researchers to ensure that the United States remains at the forefront of biomedical research.
The Promoting Biomedical Research and Public Health for Patients Act reduces unnecessary administrative burdens on researchers and encourages compliance with clinicaltrials.gov reporting requirements.
The FDA and NIH Workforce Authorities Modernization Act will make it easier for FDA to recruit and retain top scientific and technical experts by making salaries more competitive with those offered by industry. It will also lead to the development of standards for regenerative medicine — such as regenerating human cells, tissues, or organs to restore or establish normal function.
Lawmakers are also considering adding the REGROW Act to the Senate’s package of bills. The bill would allow complex regenerative medicine therapies to be conditionally approved based on preliminary evidence. Since at least half of all drugs fail in the last stage of testing, many patients could end up receiving therapies that are later found to be unsafe or ineffective.
On Saturday June 25, six former FDA commissioners from Democratic and Republican administrations suggested at the Aspen Ideas Festival that Congress make the agency independent of the Department of Health and Human Services — similar to the Securities Exchange Commission, for example. With regulatory purview over products that represent a quarter of the U.S. economy, the group said the FDA is harmed by an unstable federal budget process and persistent political meddling. The group said they would issue a white paper on their proposal for the next administration.
That’s another reason why Congress should postpone consideration of this legislation until 2017.
A version of this post was previously published on the Health Affairs blog.
Paul Brown is Government Relations Manager and Tracy Rupp is Director of Public Health Policy Initiatives at the National Center for Health Research. Steven Findlay is an independent health care journalist and consumer advocate.
Categories: OIG Advisory Opinions
In my personal time away from my role at Deloitte, I am a private pilot and passionate volunteer for a charity that facilitates free air transportation for children and adults with medical conditions who need to get to treatment far from home. In my interactions with these patients I hear how important communication is to their well-being. I also hear how outreach from life sciences companies enables improvements in their lives and puts them back at the center of the health ecosystem.
It is not controversial to say that patients must be at the center of the current and the future healthcare ecosystem; however, it may be to admit that today they are not well served by this ecosystem. The need to enable and effectively support care coordination across health care professionals (HCPs), providers, and other care team members to drive effective and appropriate use of pharmaceutical products is something I hear my clients in health care asking for on a daily basis. My clients ask for strategies that will enable them to build loyalty through extraordinary execution of their patient engagement programs, and through that loyalty drive adherence and better health outcomes. This ability to deliver consistent, high-quality, reliable service across all channels of engagement is a game changer. Recently Deloitte Consulting leaders discussed this subject on a webinar for our clients.
When these programs are well implemented they provide transparent information to build trust, while anticipating how to proactively respond to patients’ and their care team’s needs. Insight and strategic intelligence enable our clients to demonstrate measurable benefits of their treatments and to provide guidance about how cost aligns to outcomes.
So what does a great patient engagement program platform look like? It provides consistent high-touch interactions across channels (e.g., companion app, portal, phone, text, and chat). It enables the care network to collaborate with HCPs, families and other care team members. It provides a vehicle for internal and external data analysis to bring unique insights into patient treatment and interactions and demonstrate real-world evidence. All it does all of this while aggregating patient data from multiple sources and connecting both pharmaceutical and external vendor data to create a single view of patient interactions. All of these capabilities are easily empowered by a cloud-based, scalable technology platform like Salesforce Health Cloud. In fact, Deloitte Digital announced our approach to the market on March 2 of this year and will soon be making another major announcement as our platform advances.
In my personal interactions with the patients I fly, I can see the importance of a well-defined patient engagement program that feeds real-world evidence and intelligence back into the product-development lifecycle. This output data of the health care system is the key to creating a learning loop that will enable life sciences companies to continue to make quantum leaps in gaining the best possible outcomes from current products and feeding the funnel to find new treatments for these families. Hopefully this means better results for patients and fewer flights for me.
Chris Zant is a Principal in Life Sciences for Deloitte Digital.
Categories: OIG Advisory Opinions
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