Technology’s changing. Economics are changing. Attitudes are changing. Are you?
Lab testing is important to physicians, patients, manufacturers, sales reps, payers and others. But the technology is changing. So are providers’ attitudes. Accuracy remains most important, but cost-effectiveness is not far behind. Repertoire asked Jim Poggi about how sale reps can navigate lab sales today and in the near future.
Repertoire: Over the past, say, 10 years, how have distributor reps improved the way they sell lab equipment, accessories, etc., to the physician office?
Jim Poggi: Distributor reps are doing a much better job today of “quarterbacking the sale,” i.e., being the coordinating force while still using the full range of supplier and their own company’s personnel and assets to close the deal and provide the best comprehensive solution. Examples include offering company-sponsored or COLA-based lab consulting, and working on large instrument and new lab set-ups with broad teams in the field, including sales, service and even the shipping companies.
Repertoire: In what respect – if any – may reps still be “missing the point” about lab sales?
Poggi: A couple of ways: 1) Some folks are still “going it alone,” which is fine for simple transactional sales but not for answering complex customer questions or addressing large system sales effectively; and 2) there are still some “high fear/low activity” product lines, like LIS and proficiency testing. Reps need to focus on the best available opportunities, but I believe there is more opportunity here than the average rep takes advantage of.
Repertoire: About 40 percent of patient encounters in primary care offices are said to involve some form of medical test. Meanwhile, the American Society for Clinical Pathology has made 25 recommendations for reducing lab tests, as part of the ABIM Foundation’s “Choosing Wisely” program. Do you think initiatives such as Choosing Wisely, as well as general cost pressures, are having an impact on point-of-care testing in the physician office? If yes, how so? If not, why not?
Poggi: As I see the recommendations of Choosing Wisely and others, the intent is to avoid testing that is either of low diagnostic value OR a needless duplication of testing. Many of their recommendations have been developed in collaboration with medical societies. Ultimately, I believe it is in the best interests of both patients and clinicians to provide “the right test at the right time for the right reason.” While I may disagree with a specific recommendation or two, I believe the dialogue they are creating is important and needed. I do NOT expect their recommendations to detract from appropriate and useful testing. My professional belief is that tests need to be performed “to initiate or modify a patient treatment program.” I believe Choosing Wisely shares this objective.
Repertoire: In January, PTS Diagnostics and Kroger Health – Kroger Co.’s arm of health and wellness facilities, services and programs – announced the full rollout of CardioChek Plus analyzers for point-of-care blood testing to help identify individuals at risk of heart attack, stroke and diabetes. Should physician office labs be worried about the impact of increased POC testing in retail clinics? If so, how should they respond? And how can distributors help them do so?
Poggi: As I see it, physician offices should be more concerned about the level of overall patient services and lab testing they offer their patients than what others, including Kroger, may be doing. With MACRA institutionalizing the need for better patient outcomes and better patient satisfaction, physician practices need to assess how effectively they are meeting customer needs and adjust their services and practices accordingly. Distributors can help by reminding the practices they call on that they need to be at the top of their game, and offer to be part of the assessment process. The exceptional distributor sales rep should approach this situation as an opportunity to learn their customer’s situation, objectives and needs, and be prepared with some “best practice” consulting ideas to help the customer improve and be competitive in their market.
Repertoire: The Protecting Access to Medicare Act of 2014 (PAMA) required CMS to develop a national fee schedule for laboratory tests based on private-payer data. CMS reported that its implementation of the new payment rates could lead Medicare to pay billions of dollars more than is necessary. Yet in a 2018 COLA survey, over 56 percent of participants reported that further cuts in the CLFS will likely cause them to stop providing laboratory services.Who’s right?
Poggi: Neither is right, and their opinions are entirely too polar and dramatic to be taken seriously. CMS’ comments centered around clinicians billing automated panel tests at the individual test level to increase reimbursement by over $10 billion – which is an absurd overstatement. I doubt this will become typical, since the jeopardy associated with this practice could be pretty severe. At the same time, cutting testing back by 56 percent would assume clinicians also decrease their dependence on testing by this amount. That choice is equally absurd. I do not consider that decrease to be credible. Important, high-value tests will continue to be used as appropriate. In my opinion, a balance between these two polar views is the most likely outcome.
Repertoire: In November 2018, researchers proposed a framework for evaluating electronic trigger tools to detect diagnostic errors. Do you foresee more integration of the EMR and lab tests? And if so, how do you think that might affect in vitro testing?
Poggi: Determining whether a lab test result is logical based on prior tests, patient demographics and other factors makes sense and represents a good cross-check to me. In my opinion, it is equally important to search the database for recent tests to avoid or minimize the amount of redundant or conflicting lab tests being requested and performed. Ultimately the test of value will be the extent to which these methods will be implemented. At the IDN or large-scale clinical practice level, they would be impactful. But without substantial numbers of clinicians enrolled and patient data being collected, analyzed and utilized, this tool is unlikely to be more than an interesting intellectual exercise.
Repertoire: Researchers at Dartmouth-Hitchcock Medical Center recently reported they created a deep learning model that classified lung cancer slides similarly to how three pathologists did. Meanwhile, in January, NIH researchers reported they are pairing artificial intelligence analysis with smartphone cameras to help detect pre-cancerous changes that could lead to cervical cancer. What impact will these kinds of activities have on in vitro tests?
Poggi: There is a lot of interest in reducing variables and human error and interpretation, particularly in anatomical pathology. I do expect a lot of challenges from the clinical pathology community as this trend gathers momentum. Ultimately, the obvious determining factor will involve whether “deep learning” and artificial intelligence models have more predictive power and better diagnostic utility. I expect it to take a number of years for our understanding of those issues to be entirely clear. At the same time, I would expect certain pathology procedures (PAP smears, lung cancer aspirates and others) to be evaluated individually, so the adoption curve for this sort of technology is likely to be dependent on evaluation of individual pathology procedures.
Repertoire: Wearables are big. We read about connected smartwatches, which can connect to medical devices, such as glucometers or scales, and collect and transmit information. A smartband is being developed (by Empatica) that will detect patterns associated with epileptic seizures. HHS hopes that one day, wearables will be able to detect when someone is coming down with the flu or other illness. What impact will wearables have on in vitro testing?
Poggi: In my opinion, wearables are the latest fashion trend for the worried well and avid fitness advocates. I see that as positive and useful. For wearables to take hold to a greater extent, however, I believe they would need to be targeted to either patients with specific risk conditions requiring real-time monitoring (e.g., diabetes, epilepsy or narcolepsy) or deployment as sentinels for either seasonal illness (respiratory diagnosis) or to signal a threat condition (e.g., chemical or biological weapons). Development of the right applications for needed monitoring is the most critical need, as I see it.
Repertoire: Liquid biopsies are said to detect and identify cancer (e.g., colorectal cancer), to reveal whether a replacement heart is failing in the body of a transplant recipient, to predict premature births, even to detect Alzheimer’s. How far in the future is this? Will it ever occur in the physician office?
Poggi: The current technology is not suitable for the physician office, but liquid biopsy is here and gathering momentum quickly. I am impressed by it and believe it is becoming a potent diagnostic tool in tertiary care sites. Trickle down to the physician office? At some point, I would expect the technology to become sufficiently easy to use and interpret results to fit into larger oncology or mixed specialty practices. I doubt it would penetrate further than that.
Repertoire: Diagnostics is said to be the key to precision medicine, because it can tell us if costly therapies and interventions would be useful on specific patients. The FDA appears to be approving more targeted medicines for specific disease subtypes. Will this change in-office testing? If so, how?
Poggi: In the near term, the number of tests designed to determine the utility of targeted medicines and therapies will continue, especially in tertiary care centers. Probably the biggest issue I see is less the availability of appropriate testing methods, since a range of methods – including next-generation sequencing – have emerged, and more a concern that targeted therapeutic choices are becoming more complex than ever before and that clinicians need to overcome the learning curve. My impression is that the growth of targeted therapies will be somewhat dependent on “expert guidance” software and development of complex algorithms to guide treatment (and even testing) choices. I do not see a trickle-down into the testing choices of the average physician practice.
Repertoire: Do you foresee any changes in the way FDA clears diagnostic tests for marketing – or the way in which CMS and commercial payers decide to reimburse? If so, can you describe?
Poggi: There is already activity by the FDA to more closely regulate “laboratory-developed tests” – that is, in vitro diagnostic tests designed, manufactured and used in a single laboratory – to assure they are developed and implemented appropriately. FDA issued requests for comment as recently as 2014 and issued a “discussion paper” in 2017. They have not yet decided to create regulatory surveillance, but they have identified what they consider to be potentially serious issues, including inadequate evidence that claims have been proven and inadequate control systems for some assays. It is only a matter of time before they begin to actively regulate this area of lab medicine, assuming they can fund this practice. Cutting edge tests will always be subject to intense scrutiny by the payer community, and I do not expect this pressure to decrease. Rather, I believe it will increase as pressure on the cost of healthcare continues to rise. New tests will be under more scrutiny than ever before to demonstrate that utilizing them will avoid or reduce downstream costs of patient care.
Repertoire: Are antibiotic stewardship programs having an impact on how physician offices conduct lab testing?
Poggi: The most evident changes involve respiratory testing, where the range of high quality assays has increased well beyond influenza and group A strep. As test choices continue to become available to differentiate between viral and bacterial causes, the ability to decide whether antibiotic use is appropriate or not will become more based on testing rather than signs and symptoms. It is my impression that antibiotic stewardship has had a more direct impact on lab test manufacturers than physicians directly. Lab test manufacturers are creating tests that enable physician practices to align their decision-making on antibiotic usage with clear evidence needed to make the right choice – prescribe an antibiotic or not.