Demystifying spirometry at the point of care

Cost-effective, easy-to-use tools, like spirometers need to be implemented as the standard similar to a blood pressure test in doctor’s offices and other locations where people receive their care.

A look at the evolution of the user interface in healthcare

What are the advantages of a conversational user interface over the interfaces we’ve used for decades?

Here’s how telehealth tools help hearing health professionals improve patient care

New technology is constantly being developed to improve our ability to diagnose, treat, and care for a variety of medical conditions. One up-and-coming technology trend is telehealth. Some of the telehealth tools that we have already seen include services that enable video conferencing between doctors and patients, and apps that assist in patient care. In the field of hearing care, such tools also improve healthcare delivery for both patients and service providers.

TeleHealth tools save time for professionals and patients

It is common practice in hearing care to bundle the cost of consultations and service provision into the price of the hearing aid.  As such, follow-up and fine-tuning appointments after hearing aid sales are often free of charge. Dedicated telehealth tools like texting apps offer a secure platform for patients and hearing care professionals (HCPs) to easily communicate and problem-solve in a few minutes without an office visit.  Hearing telehealth apps can even allow HCPs to remotely adjust the hearing aids’ settings.  This is convenient for the patient, but also saves the HCP valuable appointment time.

Telehealth apps can also contain simple instructional videos, FAQs, and troubleshooting guides so that patients have the information readily available to them on their smartphone. This way, they can often easily solve their problems before contacting the HCP and feel empowered with greater confidence in their new hearing experience.

Telehealth apps help hearing care professionals widen their reach

Telehealth apps can bring patients and HCPs closer than ever before.  With a reduced number of necessary in-office appointments eliminated by in-app messaging and calls, and remote hearing aid tuning features, HCPs can attract patients who live physically farther away, and are therefore less inclined to make repeated trips to the office. Similarly, they can provide services to less mobile patients who may be house-bound or live in care facilities.

Telehealth enables patient satisfaction monitoring

Patients buying new hearing aids typically have a two- to four-week home trial period before making the final purchase decision. Patient satisfaction during this time is crucial to the ultimate adoption of hearing aids. Unfortunately, this is also typically a “blind spot” for HCPs, because with the patient out of their office, they are not physically present to answer question and provide guidance when problems arise.

Telehealth apps for hearing aids allow wearers to rate their daily satisfaction. Apps can assign various listening activities for the patient to complete, such as “have dinner at a noisy restaurant” or “listen to music”, and then ask the patient to rate their satisfaction with the hearing aids in those situations.  Satisfaction ratings are sent to HCP via the app, so that the latter can actively intervene to address patient concerns in a timely manner without waiting until the next follow-up appointment.

Telehealth apps serve as a practice differentiator

The hearing care industry is a competitive field. Patients can choose from independent hearing care practices, those affiliated with physicians, hearing aid dispensing chains, “big box” wholesale stores, or even bypass the HCP altogether and choosing an amplification product online or “off the shelf.”

One of the ways a hearing care professional can stand out from the crowd is by offering exceptional service. With in-app text and call features, telehealth apps promise potential patients access to the hearing care professional’s expertise and guidance even outside of regular office hours, the convenience of fewer in-office visits, and in-app usage and troubleshooting information.  These advantages can be promoted as a part of the “white glove service” that HCPs can leverage to promote their practice.

Telehealth tools are good for business

Telehealth tools can help HCPs generate revenue in more than one way.  First of all, time is money. By reducing the number of follow-up visits, telehealth apps help free up more time for professionals to attend to revenue-generating tasks, such as diagnostics or new patient fittings. And the increasing number of younger, tech-savvy, and smartphone-dependent patients with hearing loss will be attracted to HCPs who offer conveniences like telehealth apps.

Ultimately, patient satisfaction leads to business success. By being able to monitor patient satisfaction with their new hearing aids during their home trial period, and intervene quickly when problems and doubts arise, professionals can use telehealth apps to minimize barriers that otherwise result in hearing aid returns.

Although there are smartphone apps now that help us with almost every aspect of our lives, telehealth tools that use such technology are still relatively new to the hearing care profession. As they become increasingly powerful and popular, we can expect them to bring even more benefits to patients and hearing care professionals in the future.

Photo: IAN HOOTON, Getty Images

Anti-aging tech trends you need to know about

As technology continues to evolve, humans have more and more tools at their disposal to hold off the hands of time. Anyone wanting to look — or feel — more youthful has any number of resources available to explore.

But anti-aging isn’t just about looking younger and more attractive: It’s about returning a higher quality of life to people who suffer from age-related chronic health conditions.

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Unsurprisingly, the costs of treating these conditions continue to skyrocket. For instance, private nursing homes can cost close to $100,000 every year. And because Medicare doesn’t cover long-term visits, so many people across the nation have to spend down their assets to qualify for Medicaid.

With that in mind, the most important aspect of anti-aging research is helping to lower exorbitant healthcare costs for age-related health issues. As it stands, technology may be the best way to achieve that goal.

Factors contributing to the anti-aging revolution

To nobody’s shock, technological advances play a prominent role in the ever-evolving capabilities possessed by anti-aging. But where is the bulk of that support being seen?

Scientific innovation has the potential to provide two key components for advancing anti-aging research. The first is the simulation model system, which allows you to precast and adjust different scenarios to save time. It also enables you to input different factors in your research to forecast for different outcomes.

The second key is the cloud system and how we computerize all the data that we collect. The system’s design is currently insufficient for data collection for the aging population.

But once we standardize the system more, the technology could provide large, reliable data sources to help us make the best choices in anti-aging research and treatment options. Reliable data and prognostications can establish more widely accepted treatments that benefit a wider net of patients.

Technological advances have already changed much of the world, and anti-aging research is no exception. As the science’s capabilities continue to grow, medical professionals are finding more chances to drill down to specific symptoms, ailments, and concerns not traditionally addressed by anti-aging.

Here is a pair of important technological trends that can specifically boost anti-aging research:

Rejuvenation of organ capacity

Organs like the heart, lungs, and kidneys carry a reserve of energy that allows them to function beyond their typical demands. As we age, however, our organs lose their vitality and must work harder. For instance, a 20-year-old’s heart moves 10 times the amount of blood a body needs, though 1 percent of that amount is lost each year after a person turns 30. Many chronic illnesses are influenced by this dysfunctional or decreasing organ capacity, and one of the biggest trends relates to the physical rejuvenation of aging-related organ degeneration.

By focusing on rejuvenation, the anti-aging industry can provide more solutions to eliminate these chronic illnesses, rather than just reducing symptoms. It will truly revolutionize the way we look at chronic illnesses, as well as alleviate the economic burden placed on the government and the healthcare industry.

Pathology of neurodegeneration

Every year, the National Institutes of Health spend nearly $480 million researching Alzheimer’s disease. The most significant challenge to comprehending such aging-related neurodegenerative diseases is their causes, so a pathological map would be valuable in understanding those causes and designing solutions.

Technology related to this area could open a new field of market focus, appeasing society and allowing it to live without concerns about dementia. It would also conclude the work of thousands of scientists and researchers who have been studying neurodegenerative disorders for decades.

Rejuvenating organ tissues and gaining a better understanding of neurodegeneration are only two of the upcoming trends poised to change healthcare in 2017 and beyond. But they’re among the most important trends to monitor, especially for patients dealing with age-related conditions.

Those cases — along with their families and the healthcare system — are increasingly feeling the burden of chronic aging-related diseases. Let technology lighten that load.

Photo: Pr3t3nd3r, Getty Images

Healthcare urgently needs a Copernican Revolution

The year 1543 A.D. will forever be celebrated as a sentinel time in the annals of science.  In that year, Nicolaus Copernicus, a Polish mathematician and astronomer, published his model of the universe and theorized that it was the sun, not the earth that was at its center—a remarkable, if not heretical, revelation for the time.  To his contemporaries, this represented an unconditional inversion of common perception; but one that which offered a new and simplified framework and sparked the scientific revolution.  In our view, the health care industry is now currently embarking on a similarly a radical “Copernican Revolution.”   Fueled by advances in digital technology and associated cultural changes, we are in the midst of experiencing a paradigm shift from a predominantly provider-centered to a customer-centered model. Yet, despite the strong evidence of this shift and technology’s power to transform business models in other industries, many healthcare leaders are having difficulty coping with this change.  Some in fact are doing all they can to hold onto the past.   But little can be done, after all, to halt this on-coming tsunami.  Today’s digital platforms and networks will indisputably herald the success of this much-needed revolution.

In January 2016, Community Catalyst, a national consumer health advocacy organization, launched the Center for Consumer Engagement in Health Innovation.   At the conclusion of the program, Amy Berman, senior program officer for The John A. Hartford Foundation, summarized the Center’s policy priorities with these incisive comments:

We live in a pre-Copernican model where all of the planets float around the healthcare system; the patient is just one of them. What we need is a shift…an entirely new frame, and this will shift everything when we do it…we need the patient at the center. We need to put the sun where it belongs.

However, we have a very long road to travel before we truly achieve patient-centered healthcare, where individuals become the authorized keepers of their health using digital platforms and networks, just as customers are empowered in other industries using Uber, Airbnb, Amazon, Facebook and LinkedIn.

We only have to look inward to see that this is true.  As busy Orthopedic Surgeons specializing in Total Joint Replacement surgery, two of the authors frequently evaluate 40 – 50 patients in a day.  Here is the typical experience of these valued customers with our healthcare system today.  They phone our office and navigate our multilayered phone system for an appointment “on premise”, a physical space remote from their home. They wait weeks or even months for the visit and are obliged to take time away from their work or other important activities to be conveniently fit into our 8 a.m. – 5 p.m. schedules.  If a last minute surgical emergency or other scheduling conflict arises, it is not unusual for the long awaited appointment to be pushed out another few weeks. Once the customer arrives at the office, they wait until being called up to the window by a receptionist with the dreaded, “can I have your insurance card and can you please fill out these forms.”  The forms request pedantic information such as “what is your chief complaint” and redundant data that the office already has at hand—name, date of birth, primary care physician and so on. The patients then wait in the waiting room, wait in the examination room, wait for x-rays, and wait for the doctor, often multiple times.  If they have had previous imaging studies, but they are not available or accessible, the same studies are usually repeated.  If prior medical records are not available or accessible the patient is asked to pick them up at another physicians office and deliver them to ours.  And after all this hassle, the preponderance of these patients present with common orthopedic conditions and eventually receive routine treatment such as physical therapy and non-steroidal medications.  A much smaller number actually will require our surgical expertise.  This tells the all too common story of the “current state” of healthcare delivery.

Now we humbly ask: is this patient-centered health care?  Is it the patient or the healthcare provider that is the sun?  Is there any other service industry on the planet that would offer their customers such a dreadful experience and have any chance of survival?  If so, we can be assured that they are just as ripe for disruption as healthcare.

But there’s more.  For decades, the modus operandi and predominant payment methodology in healthcare has been fee-for-service, a system in which providers receive compensation for offering services regardless of their outcomes.  So, the more you do—tests, visits, labs, scans—the more you earn, even if the additional activity adds no value.  This is widely recognized as the root cause for today’s highly fragmented, inefficient, wasteful, and siloed healthcare system and it is the patients who suffer the consequences.

Here’s just one example of how this commonly plays out for patients.  In our Joint Replacement practice, two of the authors have patients, complaining of hip pain, who arrived in our offices having already gone through a gauntlet of medical interventions.  They have had major lower spine surgical procedures to no avail, followed by a series of spinal injections without improvement, followed by an inguinal hernia repair and yet still had severe unremitting activity-related pain.  Only then was it determined that their primary condition, all along, was a severely arthritic hip and replacement was indicated.

Most of us have stories like this in our health history—where we bounced around through various unrelated practitioners and treatments, at great cost, effort, and stress—before finally determining the true cause of our ailment. In 2009 one of the authors developed severe burning pain and dysesthesias in both feet.  After seeing his primary care physician, he was referred to a neurosurgeon. Testing was performed and it was concluded that he had “stenosis or a ruptured disc”.  Surgery was performed but the pain persisted so a second spinal procedure was undertaken three weeks later, once again without improvement in the severe pain.  For the next 18 months, more testing was performed and the author received extensive physical therapy, various medications, and steroid injections.  The pain continued.  Finally, a neurologist confided that the diagnosis had been incorrect and recommended a consultation with a hematologist/oncologist.  More testing including a bone marrow biopsy was carried out and the diagnosis of a variant of multiple myeloma was made.  That too proved to be incorrect.  Further blood and immunological analysis finally concluded that the diagnosis was Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), an acquired immune-mediated inflammatory disorder of the peripheral nervous system.  Two and one half years after the onset of symptoms, weekly chemotherapy treatments with Rituxan and IVIG have produced remarkable clinical palliation and remission of the disease.

The toll on these patients?  Unnecessary pain and suffering and an incredible amount of lost time trying to navigate the system to find the right doctors, obtain and share their health information, and achieve the right diagnoses.  The toll on the system for patients such as these?  Millions of dollars of wasted resources.  But this inevitably happens when the healthcare universe is physician-centered.  Each provider is doing his or her best, but is limited by knowledge, connections, and perspective.  Collaboration between multiple systems and providers, often essential, is difficult and ineffective.

The system must change.  Achieving the goal of patient-centered healthcare requires two major shifts.  First, healthcare must re-design its core processes from provider-centric to customer-centric.  Second, and related, healthcare must utilize the myriad technologies that are available today in order to provide that patient-centered care without dramatically scaling up the resources required.

Utilizing technology for patient care doesn’t only mean providing care via teleconference, but embracing the wide variety of technologies that can improve a patient’s healthcare experience—including making appointments, tracking expenses, managing records, finding support, and receiving treatments.  Access, cost, convenience, and outcome can all be improved via technology.

The Institute of Medicine defines patient-centered care as: “Providing care that is respectful of, and responsive to, individual patient preferences, needs and values, and ensuring that patient values guide all clinical decisions.”  Considering this definition and the current experience of most patients, it is clear we have a long way to go.

However, patient-centered care has become a broadly and over-used term at risk of becoming cliché.  We posit that when, not if, the health care industry truly shifts its mindset (and hence their actions!) to a bona fide customer-oriented approach using digital platforms, dramatic improvements in health care value will ensue—and costs will come down.  In his keynote remarks at the Center for Consumer Engagement in Health Innovation’s commencement, Dr. Donald Berwick said “we have enormous evidence, overwhelming scientific evidence, that when people can control their own care, the care gets better, and generally—by the way—the costs fall dramatically.”

Now the healthcare world might argue that it is different, and somehow uniquely immune to the havoc wreaked by digital connectivity and network disruption in other industries.  We disagree.   Consider the following examples where once powerful industries believed that their legacy business models were immune from digital disruption:

  • Airbnb is among the most valuable hoteliers, but owns no hotels
  • Uber is more valuable than Ford and GM, yet has no cars
  • Facebook is the world’s largest publisher with 1.7 billion editors
  • Amazon’s market cap has grown beyond Walmart’s

The good news is that some leaders already understand what a healthcare revolution will look like.  Dr. John Noseworthy, President and CEO of the Mayo Clinic, recently said, “It took Mayo Clinic 136 years to serve 20m patients per year… We will innovate to serve 200m patients per year by 2020, without building new hospitals”.   How is this possible?  Only by accessing digital technologies—including everything from teleconferencing, virtual healthcare to machine learning—can the Mayo Clinic scale its patient care at this rate.

With the writing on the wall, it’s time for those in the health care industry to follow the Mayo Clinic’s lead and ask:  What is our digital transformation strategy?  Healthcare is the largest private-sector industry—accounting for 13% of the total United States workforce and 18% of the Gross Domestic Product, and if it doesn’t transform itself soon, Silicon Valley is waiting to enter the market and bring a new, more customer-friendly experience.

In fact, there is evidence that the transformation has already begun and that digital platforms are starting to re-engineer healthcare delivery.  New online networks, such as Patientslikeme, allow communities of patients to learn from each other about their conditions and potential treatments.  New platforms, such as MotherKnows, allow patients to better access, manage, and even share their personal health records.  New systems, such as Heal, Pager, and Talkspace, allow patients to access a network of doctors over phone and video chat for remote diagnosis and care.  New technologies, such as machine learning, are changing the way diagnoses are made—IBM’s Watson now can provide evidence-based treatment recommendations for oncologists!  Slowly, healthcare is changing—from end to end.

Consequently, It is now essential that leaders in the health care universe step forward and invert their thinking and their actions to put patients at the center.  Doing this will require investing in digital platforms rather than physical platforms in order to serve patients as the center of the system.

Those of us in the healthcare industry who want to be a part of this transformation will need to do three things:

  1. Change our thoughts:  what we currently believe about health care determines the system we create;
  2. Recruit new digitally savvy leaders and board members: an essential step in all transforming industries; and
  3. Change our actions: put customers at the center and given them the information they need;

Our future is in our hands.  We must come to grips with the notion that we in healthcare are not uniquely disruption-proof and that we must invert our traditional views of the provider-customer relationship.  Other industries that have held out hope that they were immune to innovation are now losing value at an alarming rate to Silicon Valley start-ups.   We still have time to put patients where they belong—at the center, but our time is running out.  Apple, Google and Microsoft have already entered the health care industry, collectively funneling billions of venture capital dollars into this space.  We are, therefore, proverbial sitting prey.  Nigel Fenwick, principal analyst at Forrester, has said “by 2020, businesses that learn to master digital will become the predator, while those that make minor changes or don’t do anything at all will become digital prey.” For decades, we’ve been insulated from forces that have unmistakably and formidably re-shaped other business sectors. Not this time. The power of the digital network is like a tsunami. Prevailing obstacles will be overcome by this wave of network power. It’s time to move, or be pushed aside.

The future of healthcare is cognitive

We are on the cusp of better harnessing information to find optimal treatments for individual patients, but the smart systems that will make this possible are still being developed. These systems will collect data (e.g. medical images, genetics, and other test results) from many patients around the globe, allowing physicians to use real-life evidence to identify treatments that have worked for similar patients.

Medical imaging is the area of medicine that is rich in standardized, structured data, yet much of the value of this data is lost because it is not easy to accurately measure. The measurement process is manual, time-consuming, and labor-intensive, and the tools available to radiologists have limited computing power and are often difficult to use. Because of the time required to quantify images, and the volume of images radiologists need to read each day, accurate measurement of all the regions of interest is often skipped. Clinically, this translates into diagnostic decisions that are mostly based on visual assessments, with techniques that vary from physician to physician. This qualitative analysis results in unacceptably high variability and great difficulty in accurately tracking disease from scan to scan.

If we can’t track disease accurately, then patients may continue to receive ineffective treatments for far longer than needed. This incurs unnecessary costs and can have a negative impact on the patient’s prognosis. Also, without accurate tracking, we cannot identify early enough whether a stable condition has worsened or changed, making it much harder to catch issues early.

This is why we need much faster, yet accurate and consistent solutions to quantify medical images and track changes between scans. In the near future, we believe that consistent, automated measurement of disease will enable more precise diagnoses and better treatment decisions. Automated analysis will also allow physicians to focus more of their time on patients rather than performing tedious tasks and building reports manually.

Not only will patients benefit, but it will also help advance medical knowledge as a whole. Once automated and consistent image quantification is established, then big data analytics tools can be built from these quantified images, outcomes and other relevant clinical data. Aggregating the data of many patients with the same condition can lead to a better understanding of how their disease progressed under different treatments, and then we can begin to predict which treatments are more likely to result in positive outcomes for individual patients.

What is needed is a system that can automatically create accurate measurements in images, track these measurements across several scans for each patient, and aggregate this data from around the world. This type of solution is now feasible, as cloud infrastructure and Artificial Intelligence (AI) have both matured. With the cloud, we can aggregate data and can also access far more computing power than what is available at the hospital. With AI, we can accurately automate the identification of regions of interest in scans and their measurement. Furthermore, the combination of cloud capacity and AI also enables several new acquisition techniques that only used for research today because the file sizes they generate are too big for current systems. A powerful GPU cloud backbone is an enabler on both the visualization and AI quantification for these enormous, information-rich files.

The advent of secure, cloud-based imaging analytics has already begun to transform medical practice by providing timely, valuable information that was very difficult to access before. This new technology is being used in clinical settings today to better inform care decisions and improve outcomes, while enabling more efficient workflows across teams of healthcare providers.

Photo: nambitomo, Getty Images 

Clinical checklists blended with patient education and engagement can drive better outcomes

When you’re sick or require medical attention, you need your wits about you. But emotions and physical limitations can impede the ability of a patient or their family to understand and retain important details, such as instructions for surgical prep or aftercare, which can have a significant impact on a patient’s health outcomes. In fact, it’s estimated that 50 percent of patients don’t experience optimal clinical outcomes because they don’t correctly follow their physician’s instructions.

Not only does lack of adherence affect individual patients and their families, but it can drive up health care costs for families, employers and the country. In fact, in the United States alone, avoidable costs from non-adherence range from $68 to $146 billion annually, with the largest contributor being unnecessary hospitalizations.

Patient education and clinical checklists go digital
Fortunately, an emergence of new technology coupled with clinical expertise and best practices in patient education and engagement is delivering promising results in this area. The result is interactive technology that blends clinical checklists with patient education and engagement content in a digital format.

Checklists are a best practice in clinical settings and have been used to reduce surgical infections and medical errors for some time. For example, a clinical trial known as the Keystone ICU Project, which was launched in Michigan in October 2003, demonstrated that the use of checklists contributed to a 66 percent reduction in catheter-related bloodstream infections in 18 months.

What’s new
Advancements in personal technology and the growth and availability of mobile devices have created new opportunities for hospitals to blend their checklist strategy with patient education and outreach in ways that engage patients and families in care delivery and condition management.

These cutting-edge technology platforms are being delivered in an open, interactive content framework that reflects patient preferences, with a focus on patient-centered care and shared decision making. Data sharing and reporting are essential features that give clinical staff real-time access to patient-reported outcomes and measures while enabling system-wide reporting.

The ability to integrate a patient engagement platform into a hospital’s existing electronic health record (EHR) is essential, because it gives physicians the ability to prescribe educational content and care instructions with a great degree of personalization. For example, rather than sending home a printed sheet of instructions with a patient before or after a surgical procedure, health care providers can prescribe instructions that are delivered via telephone, text or email to patients at the time they need to take a particular action; whether it’s prepping for a surgical procedure or managing a long-term condition.

A win-win for patients and providers
Interactive patient engagement platforms are proving to be a win-win for patients and health care providers alike. Not only do they support hospital quality and safety initiatives related to things like infection rates, but they also align with value-based payment systems and reporting requirements, such as MACRA and MIPS, that focus on clinical outcomes and patient-centered care. At a system-level, this technology can help health systems reduce costs associated with last-minute surgical cancellations and readmissions, while improving patient satisfaction scores on surveys such as HCAPS.

For patients and their families and caregivers, new technologies are giving them anytime access to their health care information and opening the lines of communication with clinical staff like never before. This increases the likelihood that patients will receive the right information at the right time, and they will have the knowledge to follow care instructions. At the end of the day, that can translate to a faster recovery time, decreased chance of readmission or complications after surgery, and reduced out-of-pocket expenses.

As we make our way through 2017, there is sure to be change in the health care system. But the focus on quality, safety, outcomes and cost will remain. And the innovative use of technology solutions that engage patients and improve care delivery will continue to be just what the doctor ordered.

Photo:  Hero Images, Getty Images

Lawmakers wrestle with the promise and risk of drug importation

On December 8, 2003, President George W. Bush signed into law the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”).

The MMA sought to ensure access to medically necessary prescription drugs. This involved mandating the passage of regulations to allow importation of prescription drugs from Canada into the U.S. upon certification of the drugs’ safety and the prospect of significant cost savings. Since the MMA’s enactment, however, that certification has fallen short.  

Since the Clinton administration, legislative efforts to produce a single, comprehensive approach to legalizing imputation have stalled, often due to disagreement about the safety requirements and degree of government oversight necessary to ensure the safety and quality of drugs produced overseas.

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Now, in the wake of Congressional investigations into the affordability of Epi-Pen, naloxone, and other drug therapies, two proposals have emerged for accelerating drug imports. We explore both here. 

Proposal #1: Expediting importation in certain instances  

On February 14, a bipartisan group of U.S. Senators wrote to HHS Secretary Tom Price urging him to permit the importation of drugs from Canada under four circumstances:

  1. The drug is off patent or no longer marketed in the U.S. by the innovator company that initially developed the drug;
  2. Significant and unexplained increases in price;
  3. No direct competitor drug is currently in the market and introduction of a competitor drug will benefit the prices paid by taxpayers and consumers;
  4. The drug is produced in another country by the name brand manufacturer that initially developed the drug or by a well-known generic manufacturer that commonly sells pharmaceutical products in the U.S.;

“Where these conditions are met,” the Senators wrote, “the Secretary should permit importation from Canada with a fast track approval process for the competitor.”  

The letter to Secretary Price omitted some notable details, however. For example, it did not define “price” or when “increases” are “unexplained” or “significant” enough to justify accelerated importation. Also unspecified are the “prices paid by taxpayers and consumers” (presumably including public health insurance programs) and how such prices will benefit from the introduction of a competitor drug.

Proposal #2: Overhauling the current regulatory framework

On February 28, Senate Democrats unveiled S. 469, the Affordable and Safe Prescription Drug Importation Act. House Democrats introduced a companion bill, H.R. 1245, the same day.  

The law, if passed, would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to require the HHS Secretary to promulgate regulations that allow wholesale distributors, U.S. pharmacies, and individuals to import “qualifying prescription drugs” manufactured at FDA-inspected facilities from licensed Canadian sellers.

The bill excludes controlled substances and compounded drugs. It imposes supply chain security requirements and mandates a review of drug safety, cost savings, and expenses within 18 months of the law’s implementation. After two years, the bill would permit drug imports from all OECD member countries that have implemented statutory or regulatory standards for the approval and sale of prescription drugs that are comparable to those in the U.S.

The Senate and House bills drew praise and criticism from politicians, drug industry stakeholders, and health care provider and patient advocacy organizations.

Importation’s twin goals and drawbacks: savings and safety

While the debate over drug importation presents a myriad of political, economic, and health policy issues, most distil down to drug quality and safety and lower costs for patients.

Proponents of drug importation argue that easing restrictions on imports would promote broader access to more affordable prescription drugs and drive competition to lower the cost of drugs produced and sold in the U.S. They argue the safety of American consumers can be maintained by “strengthening and expanding the current regulatory system, including inspections of foreign production plants” and by limiting importation to Canada, initially at least, citing the security of the Canadian regulatory system. These arguments enjoy obvious appeal, but should be viewed with some skepticism.  

In 2004, the Congressional Budget Office examined how much private consumers and governments would save if drug importation was permitted. It concluded that permitting importation from Canada alone would produce a “negligible reduction in drug spending.” On the other hand, “importation from a broad set of industrialized countries was estimated to reduce total drug spending by $40 billion over 10 years, or by about 1 percent.”  

That same year, the HHS Report on Prescription Drug Importation acknowledged that “under any safe, legalized commercial importation program, when the scope is limited, intermediaries would likely capture a large part of the price differences. (This is based on evidence from European countries where some form of importation is legal.)”

More pressing, of course, are public health concerns raised by the sale of drugs produced outside the current safety system established by Congress under the FDCA.

HHS concluded in 2004 that “it would be extraordinarily difficult to ensure that drugs personally imported by individual consumers could meet the necessary standards for a certification of safety to be made,” and that “a commercial importation program could be feasible but would require new legal authorities, substantial additional resources, and significant restrictions on the type of drugs that could be imported, which could increase the costs of imported drugs.”

These problems are exacerbated by the fact that Canada and other would-be drug exporters could possibly obtain pharmaceuticals and pharmaceutical ingredients from countries with less rigorous regulatory oversight.

Indeed, concerns regarding the quality, safety, and authenticity of drugs produced abroad are borne out by the prevalence of substandard, adulterated, and counterfeit drugs. The World Health Organization has cautioned that “no countries remain untouched by this issue,” estimating in 2013 that “up to 1 percent of medicines available in the developed world are likely to be fraudulent,” ranging from “ordinary painkillers and antihistamines to ‘lifestyle’ medicines… to life-saving medicines including those for the treatment of cancer and heart disease.” Use of these medicines carries potentially life-threatening consequences. 

What now?

As policymakers wrestle with drug access and affordability, brand and generic drugs are arriving in the U.S. from all corners of the developed and developing world. FDA has taken enforcement action against poorly-regulated and bogus foreign and internet operations, but the significantly increasing volume of imported drugs makes it difficult to quantify, monitor, control, and ensure safety. In 2003, for instance, Americans imported 12 million prescription drug products with a value of approximately $700 million from Canada alone.  

A national drug importation policy is critical to managing the influx of drugs into the U.S. and ensuring Americans continue to enjoy “the benefit of one of the safest drug supplies in the world.” As HHS observed, “safety and protection of the public health are paramount; safety should not be sacrificed for affordability.” 

Photo: arunchristensen, Getty Images

Getting past the pilot: Tips for entrepreneurs partnering with health plans

Health systems and insurers are actively seeking out technologies and innovations that drive change in the healthcare system, many focusing on solutions that make healthcare a more seamless experience for people to access and navigate. Given that healthcare represents 17.8 percent of the U.S. economy, health plan investment in innovative startups that create efficiencies and enable better patient outcomes should continue for the foreseeable future.

However, while investments are being made, many health plans are challenged to launch and scale commercial partnerships with these innovators after the closing dinner.  Some are stuck in a health plan’s procurement spin cycle, or unable to grow beyond an initial pilot, all of which can be a life-or-death challenge for a startup company, only adding to the underlying investment risks.

For health plans’ strategic investment programs to mature, they must resolve the challenge of bringing innovations to scale for the benefit of broader membership.
Ultimately, the burden falls to entrepreneurs to decide where to invest their time and limited resources. I have observed decades worth of partnerships, many of which have not lived up to expectations. Entrepreneurs should consider the following when evaluating potential strategic partners and investors to increase their chances of success:

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Do they have a long-term vision?

Every company has their mission on their website, but is their business structured to support their vision? Not all health plans are aligned with their often transformative-sounding mission statements, and their annual business objectives are not always driving toward marketplace disruption. Entrepreneurs should really examine whether the plan and its leaders are incentivized to implement innovations – or just keep doing what they do.

Right room, wrong people

Time and time again entrepreneurs make agreements with health plans to fund a pilot, the teams get to work, and as the pilot wraps up, no long-term agreements are made. At times technology and time spent are wasted, and entrepreneurs are left scratching their heads.

To ensure a long-term partnership, entrepreneurs must ensure they’ve established direct relationships with a cross-functional team inside the health plan — including an executive sponsor (with real budget and decision-making authority) and leaders from other business units touched by the startup’s technology. Ensuring these key players are making decisions, and offering input from the start will lead to successful partnerships.

Adapt. And then adapt again.

Every health plan has their own processes and systems. Some require procurement approvals in advance, others after some work has been accomplished. Some parties may require roundtables and constant check-ins, while there are organizations that want progress reports at the end of each quarter. In every aspect of health care, no size fits all. Entrepreneurs must be nimble and adapt to each plans’ internal processes and requirements.

Are they tire kickers?

Not every health plan has deep experience in partnering with startups – and it is clear that few of us get it right the first few times.  There are many lessons for organizations to learn about aligning incentives, driving project budgets, making systems integrate and data sharing easier. Entrepreneurs must examine the plan’s track records: Do they stick it out for the long term, or are they tire kickers? Can they execute on the partnership once they make the investment? If entrepreneurs find stage-agnostic portfolios with a track record of long-term investment commitments, chances are the plan is in it for the long term, and not looking to kick the small guys to the curb.

Healthcare is a mess, and the industry has many problems and needs. Smart entrepreneurs have no shortage of opportunities to create billion dollar companies.  However, if companies choose to use partnerships to speed their growth and development, entrepreneurs must always keep in mind that the wrong partner can smother them with attention, bury them in the process, and ultimately freeze them in pilot mode. Many strategic investors are looking for ways to facilitate these partnerships to run more efficiently and allow for better functioning. Startups and entrepreneurs, let us know what you are experiencing, what’s working well, and what’s not, in the market.

Miss the SXSW festival? Here were the healthcare highlights from Biden to health innovation hubs

Disruption has been the theme for healthcare at South by Southwest with everyone looking to disrupt the status quo. Other than the cold and rain, the Health track may have been the real disruptor of SXSW 2017, which was exciting for those passionate about the healthcare disruption movement.  The health track sessions moved from the JW Marriott to the Austin Convention Center, and saw significant wait times at sessions.

It was great to be reunited with the supportive and collaborative SXSW community not viewing innovation as a transactional, zero-sum game, but inspired by a group of people working on the same problems and supporting the success of each other.  Shawna Butler of Singularity University, an Austinite,  referenced the city in a way I loved saying, “Austin is full of pathologically helpful people”.  I could not agree more about Austin or the SXSW community.

The SXSW health track attendees covered the ecosystem of patient care, provider support, policymakers, entrepreneurs and investors seeking to improve healthcare globally.

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Rise of the health innovation hubs

TMCx, athenahealth, StartUp Health and J&J Innovation had a nice presence at SXSW.  These accelerators attract and reward top startups with capital and nurturing to rapidly commercialize concepts within healthcare ecosystems.  Look for the next wave of successful digital health companies from these channels that nurture leading concepts and top talent they select when they believe they can accelerate them.

GE Vice Chair Beth Comstock and Steve Case, chairman and CEO of investment firm Revolution LLC, discussed his “Rise of the Rest” concept on a panel.  They discussed how tech innovation first evolved regionally from within corporations. Innovation then consolidated to venture capital markets in New York City, San Francisco and Boston. Case’s boomerang theory represents today’s third wave from venture arms in corporations that fund and partner with external startups to tap into the entrepreneurial spirit and harvest innovation. Case used the healthcare hubs as an example. He also referenced GM for leading Lyft’s recent round.

Baylor Scott & White Hospitals put together a talk on Embrace Digital Disruption to Reinvent Healthcare with a panel of exciting digital health startup CEOs they’re partnering with.  Baylor realizes, like many hospital systems, they are ill-equipped to innovate and develop digital tools and seeks outside partnerships to assist their desired change towards consumerism, greater access, and improved population health outcomes. PediaQ CEO, Jon O’Sullivan, discussed their partnership and how their Q.care mobile app provides triage video access to answer questions and navigate a patient to the best point of care or old fashioned house calls on demand.

The Impact Pediatric Health competition was hosted by eight top hospitals to showcase pediatric healthcare innovations they can accelerate and commercialize.  Keriton was the digital health winner for improving breast milk for NICU babies and Luminopia won in Medtech using VR for visual and neurological care.

Runner-up CareDox created a technology hub connecting schools, families and providers to coordinate care. CareDox CEO and founder, Hesky Kutscher, framed the opportunity and importance to improve pediatric care in a new way for me, “with 50 million children enrolled in U.S. public schools, it is a patient population larger than Medicare. School nurses, teachers and coaches need to be tremendous partners with hospitals in improving children’s health outcomes and prevention.” Connecting the overall community to improve our care system, rather than talking about HIPAA, is the exciting disruption we need.

Connecting the overall community to improve our care system, rather than talking about HIPAA, is the exciting disruption we need.

The latest on health tech investing

Whether listening to investment panels, or meeting investors at the Capitol Factory Founders party, there is clearly a lot of money seeking the next disruptive startup. We have seen fewer total deals recently with more late-stage deals completed, however, there is still a lot of interest and money looking at early stage deals.  With the lower costs for bringing minimally viable products (MVP) to market today, we are seeing VCs willing to make smaller bets on earlier stage companies than their primary investment thesis, when they like the team, concept and see follow-on investment opportunities.

Troy Bannister, director of scouting and onboarding from the StartUp Health army of Health Transformers, led a panel on Real Success Stories of Hackathons.  This panel adapted the MIT Hacking Medicine concept teaching healthcare entrepreneurship to solve global healthcare problems. The group discussed what entrepreneurs need to do next to build an MVP and then a successful company. Bannister discussed the entrepreneurial mindset required to create and communicate a vision that can attract both ‘A players’ and capital as used in StartUp Health to assist their companies achieve this.

Disrupting healthcare requires strong leadership, a strong team and a vision but also the ability to remain nimble in a rapidly evolving system.  Positioning the company for where the puck might be in a few years is a foundation VCs seek more than a great product or business model.

Telemedicine Magazine publisher, Logan Plaster, and I walked the convention floor together discussing innovative presenters.  Two that stood out to us were PokitDok and Tellus as the infrastructure players that will be at the heart of the new digital systems.  PokitDok calls itself the infrastructure for digital health with an API allowing two-way interoperability between devices, apps, hospitals and payers.  Tellus has patented the technology allowing hospitals to add apps to their system.

One other consistent point I heard was that the health systems are seeking partners, products and services that lower cost or increase access.  Hospitals and systems expect to serve more underinsured patients and take on more bad debt.  These leaders seek to improve care, but all have a top-down mandate to seek solutions that lower costs.  Follow the money as investors look for cost saving platforms.

Joe Biden discusses his Cure Cancer Moonshot

The passionate former Vice President Joe Biden headlined the Connect to End Cancer sessions. Technology is playing a greater role in research to accelerate finding cancer cures but also to improve care in innovative ways. Biden spoke intimately about losing his son to the disease and the need for scientists to share data and research rather than everyone working in silos.

After Biden’s talk, an attendee spoke to him and shared how his wife was battling Leukemia.  Biden asked how she was and looked relieved to learn she was in remission. Then he demanded to get her on the phone.  Joe left her a long message telling her how much her husband cared for her and how much he admired her courage for fighting her battle. Everyone attending this session was inspired and strengthened that Biden is making Cure Cancer his personal moonshot.

Social fabric of Austin

Guerilla marketing was as popular as ever, even with the weather. Supa was one group I enjoyed running into.  Many panels discussed sports, AI, biometrics, and cognitive tracking, and the Supa Heroes infiltrated events and parties in their onesies and sweaters to promote their sports, fashion and biometrics products.

It’s shameful to not take advantage of the social fabric of Austin, as that’s part of the SXSW experience — seeking out the best parties and staying out later than planned. The rain altered the SXSW ethos around party hopping and relaxing with a drink and live music in the sun. Still, we were able to work in some of the local culinary favorites — a margarita and some tacos al pastor at Guero’s Taco Bar,  breakfast tacos at Tacodeli, and Texas brisket at Stubb’s.

One thing will never change about SXSW.  It was a great week to see old friends, make new connections, and get inspired by new technology and entrepreneurs.  Thank you, Austin, and your community of pathologically helpful people.