IVD manufacturers who adapt to the new patient role by making consumer-friendly devices or simplifying sample collection will remain competitive.
When Jennifer went to her endocrinologist after almost three years of living with a mysterious nexus of symptoms and a large differential diagnosis, her doctor put an iPad in her hands. For years, she was accustomed to going months between tests and receiving single, typewritten, numeric results. This system was replaced by high-frequency diagnostics combined with data that she was acquiring and managing herself. Since her last visit, Jennifer had been mailing dried capillary blood spots to a lab on a regular basis to establish a trend of TSH levels. She had also been recording daily temperature, weight, and levothyroxine doses with her smartphone. For the first time in her medically complex life, Jennifer felt she was invited to share in the clinical decision-making process.
Diagnostics is undergoing a transformation from identifying specific values at specific points in time for a specific sample (a product) to generating data and decision analysis for patients and their physicians (a service). We are now seeing three complementary models for more sophisticated acquisition and management of patient data: mail-in tests on patient-collected samples (PCS), physician-office laboratory (POL) tests on small systems, and the consumerization of diagnostics through patient self-testing (PST). These models will make Jennifer’s experience a reality for more people.
One development is to have patients send samples through the mail or in person to high-complexity labs. Patient-collected samples can be generated with high frequency, and results can be used to determine baselines and trends for multiple analytes. One company, Siscapa Assay Technologies (Rockville, MD), is developing a proprietary method to accept capillary blood spots from finger-pricks on treated filter paper that contains a bar code with a patient identifier. The patient sends these samples to a central lab, where high-rate mass spectrometry can be used to determine results for up to 50 proteins. This new delivery model offers several advantages:
• Patients are more likely to complete these tests, baselines can be established, and intra-exam trending values can provide better diagnosis than a one-time measurement.
• Capital costs are concentrated on very few facilities.
• Sample collection is cost-effective because the patient can perform it without an office visit.
Another trend is toward low-throughput, small, inexpensive systems that can be distributed where they are needed. In the 1990s, troponin tests made it into the emergency department on the backs of small instruments such as Roche’s Cardiac Reader. These systems require no sample preparation or calibration, performing just one urgent assay on a microliter sample
|Figure 1. Cost versus distribution and frequency versus time to result.|
size. Generally, they can send results right into the electronic medical record, although such electronic connectivity is not yet ubiquitous. Roche, Alere Biosite, and Hemocue (Quest) have pioneered this model with designs suitable for a coat pocket or for the closet-sized “lab” or exam room at many practices. They offer ambulatory platforms for infectious disease tests, and tests for hemoglobin, cholesterol, albumin, HbA1C, and prothrombin time/international normalized ratio (PT/INR). These tests and their results have moved to where they can perform a service.
When Sir Thomas Albutt invented the clinical thermometer in 1866, he did not imagine that every household would consider it an essential medicine cabinet accessory and common diagnostic tool that would be used by patients themselves. Today, from pregnancy to cholesterol tests, consumers are not only able to purchase dozens of diagnostic tests at their pharmacies, they can also pay for them from their employer-offered flexible spending accounts. Sales from 2009 to 2011 have increased 35% in this segment.1
The most noticeable shift, however, has happened outside the pharmacy. Apple online sells glucose monitors from Sanofi and blood pressure cuffs from Withings. AT&T stores sell a device that tracks your physical activity and sleep while Nike puts health sensors in shoes.
|Table 1. Models for patient-centric diagnostics.|
This consumerization of medicine is not just a health phenomenon among the “worried well,” but also an important component in chronic-disease or intensive therapeutic management. Self-management of blood glucose (SMBG) is a standard of care because it may lead to improved glycemic control, and consequently a reduction of HbA1C.2 After 2009, when Medicare approved home PT/INR use, new consumer-friendly models of PT/INR meters were designed to transmit data wirelessly to computers and, ultimately, physicians, who could optimize therapy. In several studies, the number of complications under this regimen declined.3 Reimbursable home diagnostics include pulse oximetry, peak flow meters, blood pressure cuffs, glucose meters, ketone urinalysis, microalbumin, as well as pregnancy and ovulation tests. The original designs of these devices and tests were clinical in appearance and not user friendly. Newer devices are “smart” and have designs that take their cues from Apple and Herman Miller; some examples include Alere INRatio2, Zio Patch, Bayer Contour, Tandem TD, Animas Ping, and Ferraris Piko.
Why would patients want access to digital diagnostic devices at home? Patients cannot diagnose themselves, cannot prescribe themselves medication, and often cannot control the course of their diseases. What they can do is regain a feeling of control by having the data.
Nicholas Genes, MD, PhD, an emergency physician in New York and editor of the online medical blog MedGadget, has noted a rise in patients showing up in the emergency department with self-reported elevated blood pressure readings. He notes that unlike a patient who has received diabetes education and can understand trends, these consumers are focused on individual results. To properly diagnose and manage this type of patient, the clinician would need to page through multiple results, mentally build a trend, and have the patient supply context. Genes suggests that patients who buy an over-the-counter cholesterol test will need significantly more counseling in how to interpret results, a service pharmacies may perhaps step in to provide. “Moreover,” he says, “as devices proliferate, data displays also will need to be simplified and standardized, so patients and clinicians can grasp the significance of the data at a glance.”
One cannot establish baselines or perform regression analysis without multiple points. It is true that with EMRs, data from multiple tests are stored, and it is possible to page from one record to another looking at the change in any metric. But consumer-driven tools worn or used by patients produce significantly more intra-exam information, establish trends, engage the patient, and enable personalized interventions. In a TedMED presentation, Leslie Saxon, MD, at the USC School of Medicine and Center for Body Computing, cites more than 150,000 potential therapeutic interventions from implanted devices wirelessly transmitting data.4 Saxon recounts how, while reviewing incoming ECGs from patients transmitting them remotely via their mobile phones, she was able to notify a patient in Mumbai that he was about to experience an impending heart attack.
Pharmaceutical brand managers privately admit that the area they have the least access to but want the most control over is that moment between the diagnosis and the therapeutic decision. If they were present in the exam room and on the iPad, it would make a difference not only in prescription volumes, but also in medication adherence. Diagnostics could be the vehicle for providing a patient service that educates and involves the patient in his or her care, improving adherence and outcomes as well as prescriber confidence.
Advancements in the availability of POL and PST diagnostics are the result of technical progress and changes in the larger manufacturing and software development landscape. A lag in initial adoption is caused, in part, by the uncertainty with which patients and physicians approach new devices, but also by the revenue limits of a new device. However, long-term economic motivations will drive increased adoption of POL and PST modalities. Ten such considerations are presented here.
1. PCS mailed to a laboratory have the lowest sample-collection cost. Capital equipment and maintenance cost is concentrated at just a few processing centers. While POL-based tests will remain important and cost-effective for a few urgent tests (such as acute infections and pregnancy), payers ultimately will encourage migration to the cheapest sufficiently accurate option.
2. The clinical benefit of intervening sooner or more appropriately is likely to stem complications from acute conditions or offer improved control of chronic conditions, resulting in lower costs of care.
3. Patients may comply better with routine testing if they do not need to schedule an appointment. Although higher utilization may represent more cost, the diagnostic information has the value of potentially preventing a higher-cost complication. Better compliance alone may prompt payers or disease-management companies to reimburse for PST or PCS.
4. Clinicians who receive some value-based reimbursement (pay-for-performance or P4P) will be accountable for changes in testable values (e.g., HbA1C) for the populations they manage. Access to cheap ways of generating this data may be attractive to accountable care organizations (ACOs) and other groups.
5. POL testing may offer additional revenue for physicians and may offer self-pay options for rapid diagnostics (such as strep tests, HIV tests, and diabetes checkups), allowing individual practices to compete with Minute Clinic-type care centers.
6. To control healthcare costs and improve outcomes, patients will have to become more involved in their care. Diagnostic trends have traditionally been a powerful tool for educating patients.
7. Employers, payers, and disease-management companies will opt for tele-health options that involve patients on a daily basis and provide more real-time control over disease progression, without the need for an office visit.
8. Flexible spending accounts, health clubs, and employers will opt for fitness, weight, and nutrition tracking as well as consumer diagnostics as a motivational tool. Combined with “gamification” of these tools, employers will use these strategies to improve health, work efficiency, and costs. We are already seeing employers give pedometers to employees, for example.
9. PST and POL-type services will have increased retail presence, as large stores try to build their health footprints. Stores will help patients with reimbursement or offer benefit programs themselves. Data from purchases, on-site testing, and even devices sold under subscription agreements will be used to optimize advertising and promotion of health-appropriate food, clothing, and other consumer packaged goods.
10. Pharmaceutical companies will use physician office tests and PST to reduce label risk by screening or monitoring for appropriate populations. They will use results to identify potential trial participants, or share data with physicians to help them improve aggregate health statistics in their patient panels.
To lower the costs associated with the burden of managing chronic diseases, the patient’s role is changing. IVD manufacturers that adapt to the new patient role by making consumer-friendly devices or simplifying sample collection will remain competitive. Ultimately, payers will incentivize care-delivery models to trust patients, devices, and services, while physicians will need to be convinced that PST and PCS tests deliver accurate results. As this challenge is met and these trends are realized, patients will receive optimized care at an economy of scale.
1. Hamacher Resource Group, 2011.
2. AJ Farmer, et al., “Meta-analysis of individual patient data in randomised trials of self monitoring of blood glucose in people with non-insulin treated type 2 diabetes,” BMJ 2012; 344: e486.
3. HE Bloomfield, et al., “Meta-analysis: Effect of Patient Self-Testing and Self-Management of Long-Term Anticoagulation on Major Clinical Outcomes,” Annals of Internal Medicine 154 (2011): 472-482.
4. L Saxon, TedMED 2012 talk. Retrieved from Internet at http://youtu.be/e_NZnG3ClbU.
Bryce Sady is a senior consultant with Scholz Consulting Partners LLC, an IVD consulting group. He specializes in diabetes, chronic disease, mHealth, medical communications, and software. He can be reached via e-mail at firstname.lastname@example.org.
Manfred Scholz, PhD, MBA, is president and principal consultant at Scholz Consulting Partners LLC. He can be reached via e-mail at email@example.com.