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Lab and diagnostics: Where will you fit in? T:r U O K and Thei C E H C Warriors Podcast

Roadld Stories ertoire’s Unto ed by Rep tt Adams s host isher, Sco dcast o p s publ iTune n i d n Fou


ease of choice for you, ease of use for your customer (this is what we call a win-win proposition)

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SEKISUI DIAGNOSTICS IS YOUR PARTNER IN HEALTHCARE / 800-332-1042 / WWW.SEKISUIDIAGNOSTICS.COM © 2019 Sekisui Diagnostics, LLC. All rights reserved. OSOM® and Silaris® are registered trademarks of Sekisui Diagnostics, LLC. Acucy™ and Because every result matters™ are trademarks of Sekisui Diagnostics, LLC. FastPack® is a registered trademark of Qualigen Inc.


OCTOBER 2019 • VOLUME 27 • ISSUE 10

Lab and diagnostics: Where will you fit in?

14 PUBLISHER’S LETTER Nothing to Lose.................................. 2

PHYSICIAN OFFICE LAB Specialty Clinics Retail, urgent care and other specialty clinics are expanding their service offerings.......... 4

IDN OPPORTUNITIES

POST-ACUTE CARE

WINDSHIELD TIME

The Heat is On

Automotive-related news.........62

Post-acute providers must reduce readmissions. They could use some help........28

IMDA/HIRA ANNUAL CONFERENCE

PDPM: A resident-centered plan New reimbursement method will compensate SNFs for caring for medically complex residents.....................34

SNFs at Short End of the Stick? Savings for joint-replacement care often come at the expense of post-acute providers............................40

TRENDS You and AI Medical devices are getting smarter. Time to get caught up..............................42

Wearables: Are they anything like the ‘real thing?’.......................50

HIDA U.S. Preps for Rough Flu Season Contracting Executive Profile Kate Polczynski, Associate vice president, procurement, Geisinger, Danville, Pennsylvania.............10

POST-ACUTE CARE The Rules Keep Changing There’s a lot to keep your post-acute-care customers awake at night. Much of it is coming from Washington..................27

HIDA research on influenza vaccines offers information on patient and physician vaccination trends.....................56

HEALTHY REPS Health news and notes................58

QUICK BYTES Technology news.............................60

Speaking the Language of Value Specialty dealers discuss trends at the IMDA/HIRA Annual Conference...........64

LEADERSHIP Setting Them Up For Success A bad system will beat a good person every time...........................68

INDUSTRY NEWS News .........................................................72

repertoire magazine (ISSN 1520-7587) is published monthly by Share Moving Media, 1735 N. Brown Rd. Ste. 140, Lawrenceville, GA 30043-8153. Copyright 2019 by Share Moving Media. All rights reserved. Subscriptions: $49.00 per year for individuals; issues are sent free of charge to dealer representatives. If you would like to subscribe or notify us of address changes, please contact us at the above numbers or address. POSTMASTER: Send address changes to Repertoire, 1735 N. Brown Rd. Ste. 140, Lawrenceville, GA 30043-8153. Please note: The acceptance of advertising or products mentioned by contributing authors does not constitute endorsement by the publisher. Publisher cannot accept responsibility for the correctness of an opinion expressed by contributing authors. Periodicals Postage Paid at Lawrenceville, GA and at additional mailing offices.

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PUBLISHER’S NOTE

Nothing to Lose I’m writing this Publisher’s Letter from Southern California while attending the Fisher

Supplier summit, where I’m speaking about content. As I listened to today’s presenters discuss the importance of timely, compelling content to gain and retain customers, it hit me that I haven’t written to you about it in a while. Here at Repertoire, we constantly talk about how best-in-class brands use content to grow an audience with the goal of becoming a trusted adviser. Whether you’re a national brand or a professional salesperson, your goal should be the same when it comes to your customers. As a trusted adviser, your current clients become more committed to you, and your potential clients are drawn to you when you deliver content that’s more important to them than it is to you. I encourage you to read Repertoire each month for stories that have relevance to you – and your clients. Visit Repertoiremag.com and print out articles to show your current and potential clients. Add in a note with your insights on the content, and let these clients know you’d love the opportunity to talk with them more about the subject. What if you’ve never done anything like this, nor do you see any of your competitors doing this? That’s the exact reason you should be using content to build your personal brand. Think about your last big purchase. Chances are, you read, watched, or listened to some kind of content related to it. What about your passion in life? I’d bet big dollars you seek out content around it on a daily basis. The fact that you’re reading this magazine proves you look for content that helps you become the best rep possible. Your buyers do the same thing. Last month’s issue dealt with flu. This month has content on lab equipment. Now is a great time to try out my challenge of using content to gain and keep customers. What do you have to lose?

Scott Adams

Have a Happy Halloween! R. Scott Adams

repertoire is published monthly by Share Moving Media 1735 N. Brown Rd., Suite 140, Lawrenceville, GA 30043 Phone: (800) 536-5312, FAX: (770) 709-5432; e-mail: info@sharemovingmedia; www.sharemovingmedia.com

editorial staff editor

Mark Thill

vice president of sales

Katie Educate

keducate@sharemovingmedia.com (800) 536.5312 x5271

lthill@sharemovingmedia.com managing editor

Graham Garrison ggarrison@sharemovingmedia.com editor-in-chief, Dail-eNews

Alan Cherry acherry@sharemovingmedia.com

Lizette Anthonijs

Lizette@sharemovingmedia.com (800) 536.5312 x5266

sadams@ sharemovingmedia.com (800) 536.5312 x5256 founder

Brian Taylor

Subscriptions

www.repertoiremag.com/ subscribe.asp or (800) 536-5312 x5259

2019 editorial board Richard Bigham: IMCO Eddie Dienes: McKesson Medical-Surgical

btaylor@ sharemovingmedia.com

Joan Eliasek: McKesson Medical-Surgical

circulation

Doug Harper: NDC Homecare

Ty Ford: Henry Schein

art director

Laura Gantert

Mark Kline: NDC

Brent Cashman

lgantert@ sharemovingmedia.com

Bob Ortiz: Medline

bcashman@sharemovingmedia.com

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sales executive - East

publisher

Scott Adams

October 2019

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Keith Boivin: IMCO Home Care


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PHYSICIAN OFFICE LAB

Specialty Clinics By Jim Poggi

Retail, urgent care and other specialty clinics are expanding their service offerings

With the need for improved access to care, lower costs

and to provide more transparent pricing to healthcare customers, several types of specialty clinics have come to market in the last 20 years or so. We’re all familiar with retail convenience clinics, urgent care clinics and stand alone emergency medicine clinics. But what’s changing and what’s new? I will share my observations on the established patient care settings and some emerging types

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of clinics, and offer some thoughts on where the future of specialty clinics is leading and why.

Legacy specialty clinics The listing of privately held legacy clinics in the sidebar is organized by increasing breadth of health care services typically offered by each clinic type. Community health clinics and governmentally funded clinics are not included in this listing.


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PHYSICIAN OFFICE LAB

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Tests and services performed

How they position their customer benefits

Minor injuries, sudden minor symptoms, respiratory conditions, SOME chronic disease management and immunizations.

Flu, strep, urinalysis, hCG, glucose, BMP/ CMP. SOME A1C and lipids. Mostly CLIA waived labs.

Convenience: Over 2,800 locations in U.S. in drug stores and other large retail outlets serving over 6 million patients. Long hours (typically early morning to late evening). Transparent pricing and little to no wait to be seen. While they began by treating “skinned knees and runny noses,” many now offer immunizations, wellness and chronic care services. They’re often associated with retail pharmacies. Trending: coordinating immunizations and pharmacy services to promote wellness and health screening services.

Urgent care

Minor injuries and most typical respiratory conditions. Sudden onset of pain, bleeding or other relatively minor symptoms.

Flu, strep, urinalysis, hCG, CBC (some), mono, glucose, BMP/CMP. A higher proportion of CLIA moderate labs than retail convenience clinics. Many have X-ray and prescription services

Availability: research indicates there are over 7,000 urgent care clinics in the U.S., with over 160 million visits annually. They offer extended hours compared to primary care practices, and a broader range of services and clinical expertise compared to retail clinics and equivalent short wait times. Eight of the top 10 urgent care chains are privately owned. Larger physical footprint than retail convenience clinics. Trending: service expansion includes occupational health and drug screening.

Stand-alone emergency rooms

Their service range claims mirror hospital-based emergency rooms. Coverage hours are 24/7 in most cases. This includes acute care, imaging and lab services.

Research indicates their lab service level focuses on acute respiratory, cardiac and injury related (CBC) tests. They tend to be CLIA moderate rather than waived.

Proliferation of stand alone emergency rooms began in the Texas area and has spread quickly. Their claim is hospital service levels with locations more convenient to their patients. Trending: wait and see whether these clinics continue to acquire patient visits and how far they spread geographically. What will hospitals do?

Clinic Type

Conditions treated

Retail convenience clinics

October 2019

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PHYSICIAN OFFICE LAB Men’s health and women’s health clinics As I started looking into the changing face of patient care options, I began to realize that “men’s health” and “women’s health” clinics appeared to be experiencing the most dramatic changes to their service offerings, positioning in the healthcare system and their overall appeal to patients. Unlike the legacy clinic types, these clinics tend not to treat acute health care conditions or even a wide range of clinical conditions. In the early going, they focused on “sexual health”: diagnosis and treatment of fertility, erectile conditions and sexually transmitted diseases. Their patient demographic tended to be patients in their middle years with private health insurance coverage who wanted to understand, maintain and/or improve their sexual vitality. Geographically, they have tended to be located in suburban areas close to their target patient population. Their service offering historically did not compete with hospital or primary care practices.

possible without medical treatment. Cornerstone treatment options include bio-identical hormone replacement therapy to increase estrogen, testosterone, and other hormone levels to levels more likely to be found in younger adults (20-40 years). Their assessment program involves testing hormone levels (usually send out testing), attitude and well being patient surveys, and customization of programs to help the patient improve vitality and appearance in their desired areas. Weight loss, sexual vitality treatments and counseling along with personal appearance services are all part of their growing portfolio of services. The median age in America today is 38, and increasing annually, which creates a potential market for these clinics and services. What does their expanding service level, public awareness and appeal mean to primary care and hospital based clinical practices? From an overall health maintenance perspective, while these clinics tend to be more focused on overall vitality than in previous years, they don’t tend to treat the chronic health conditions (cardiac, cancer, stroke and diabetes) that are encountered daily in primary care and end up in hospital emergency rooms. So from a chronic care and acute intervention viewpoint, they’re not competing with our established clinical customers. They are supplementing vitality offerings and competing for health care spending, particularly discretionary cash spending of the more affluent health care customers. Additionally, the number of wearable devices available to monitor pulse rate, exercise and other vitality metrics has gone mainstream in recent years, creating substantial awareness of vitality assessment and monitoring. As a result, some forward thinking hospitals and larger primary care practices are beginning to add some of these vitality services to their options. I expect this trend to continue and, unless hormone replacement therapy is found to create unhealthy side effects, it appears there is an emerging “vitality” market. What remains to be seen is whether the vitality market will continue to grow, and which clinical settings will lead the way.

The median age in America today is 38, and increasing annually, which creates a potential market for these clinics and services. What does their expanding service level, public awareness and appeal mean to primary care and hospital based clinical practices? So, what has changed in these clinics? Their service offerings have continued to expand and their current customer value proposition has migrated from sexual health to overall health, youthfulness and vitality. With the recognition that overall vitality improves athletic, sexual and even intellectual performance, many of these clinics now offer a broad range of vitality services and options. These services tend to include appearance and aesthetic treatments. In many ways, their story is about extending physical vitality and youthful appearance later in life than previously

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IDN OPPORTUNITIES

Kate Polczynski

Contracting Executive Profile Kate Polczynski, Associate vice president, procurement, Geisinger, Danville, Pennsylvania Editor’s note: Kate Polczynski was named one of “Ten People to Watch in Healthcare Contracting” in 2018 by the Journal of Healthcare Contracting, a sister publication to Repertoire.

Born and raised in Danville, Pennsylvania, Kate Polczynski received a bach-

elor’s degree from the University of Pittsburgh at Johnstown and a master’s of business administration from Shippensburg University. She also has a Certificate of Achievement in Lean Six Sigma Black Belt from Villanova University, and is a Certified Materials and Resource Professional as administered

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by the American Hospital Association. Additionally, she has served as an adjunct professor at Bloomsburg University of Pennsylvania, Zeigler College of Business. “While in college, the ‘Supply Chain’ classes focused on logistics, and ‘Contracting’ classes were for those moving toward a legal profession,” she says. “But once I was exposed by my mentors to the strategy, data and negotiation elements of healthcare contracting, I was hooked. I have always had a passion to contribute to the healthcare industry, and found that while working in Procurement I could utilize my business skills, while having the ability to impact a patient’s journey.” She joined the Geisinger procurement team directly out of college, as an assistant buyer. Looking to use her Lean toolbox and broaden her knowledge about patient outcomes and data, she move to the system’s Quality and Safety department, and explored pay-for-performance contracting. She rejoined the procurement team in July 2017. Polczynski and her husband, Eric, have two children. “They remind me to cherish each day as a new opportunity to positively impact others, continue learning and challenge the norm for a better tomorrow.” About Geisinger Danville, Pennsylvania-based Geisinger serves more than 1.5 million patients in Pennsylvania and New Jersey. The physician-led system is comprised of approximately 32,000 employees, including 1,800 employed physicians, and comprises 13 hospital campuses, a nearly 600,000-member health plan, two research centers and the Geisinger Commonwealth School of Medicine.


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IDN OPPORTUNITIES Repertoire: Can you describe the most challenging and/or rewarding supply-chain-related project in which you have been involved in the past 12-18 months? Kate Polczynski: Our team has had many large contracting engagements that have resulted in savings for our organization. But for me, the more rewarding projects have been specific to overcoming challenges, as a team, to more directly impact the patient. As an example, the healthcare industry faced significant challenges this past year specific to product availability. From a contracting perspective, traditional tactics utilized to secure favorable pricing by limiting suppliers has left many organizations vulnerable when natural disasters, or other factors, create shortages. So too have inventory-reduction initiatives by providers and suppliers. Our team has worked tirelessly to ensure that our patients have the supplies that they need, and we have used new contracting strategies to accomplish these goals. We make sure our contracts address failure-to-supply. And as we look to future contracting cycles, we will take into consideration factors such as, Where is the product manufactured? How many companies can supply it?

regional. In the service space, the potential exists for different types of outcomes or performance standards for the same service. It takes effort to ensure you are getting the service you expected. As we look toward an increasingly challenging landscape within healthcare, driving a focus towards total cost of ownership, I am excited to partner with our clinical and operations leaders to explore projects that engage beyond “price at the pump” contracting, keeping quality and patient outcome top of mind, using data or evidence to drive decision-making. Repertoire: How have you improved the way you approach your profession in the last five to 10 years? Did you have any help doing so, or was there any particular incident that was particularly significant? Polczynski: I continuously seem to evolve and adjust my approach as life experiences take me down different paths to expand my learning. During my career, I have always tried to utilize data and strategic planning in all stages of the sourcing and contracting process, with the attitude to never stop learning. This skill set now drives my home and work lives, so that all necessary tasks are completed. Coupling these skills with a lean toolbox has been critical to optimizing success at work. I have been very fortunate to have an amazing family, group of peers and mentors to assist me in personal growth and development during my professional journey. Recognizing that I am still early in my career, I couldn’t be more excited to tackle the next chapter to come.

There are usually many suppliers for a given service, and they often are regional. In the service space, the potential exists for different types of outcomes or performance standards for the same service. It takes effort to ensure you are getting the service you expected. Repertoire: Please describe a project you look forward to working on in the next year. Polczynski: Our team is expanding its work in outside purchased services. This has been a very interesting exploration phase and I have learned so much already. The contracting in this space is a bit different and presents a new element of opportunity. There are usually many suppliers for a given service, and they often are

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Repertoire: In your opinion, what will be some of the challenges or opportunities facing the next generation of supply chain professionals? What should they be doing now to prepare to successfully meet those challenges and opportunities? Polczynski: The next generation of supply chain professionals will have the challenge of being masters of many skills, not limited to data analytics, lean thinking, project management skills, savvy negotiation, and a personality to drive change with many varieties of stakeholders.


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Lab and diagnostics: Where will you fit in? Laboratory equipment and prod-

ucts remain a crucial component of the sales rep’s offering. But, like everything in healthcare, the market is changing. Molecular point-of-care tests are getting faster and less expensive. Liquid biopsy will probably transform cancer detection. And providers will most likely find that their diagnostic skills are enhanced by artificial intelligence. Repertoire covers some of the highlights of 2019 – and beyond!

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The Greatest Hits of 2019 The year’s news about lab and diagnostics The year 2019 has been full of lab- and diagnostics-

Diagnostic errors

related news. Some developments point to a future far away – others right at hand. In either case, they offer points of conversation to share with customers.

A study published in the journal Diagnosis in March found that diagnostic errors remain the most common, most catastrophic, and most costly of serious medical errors in closed malpractice claims. Researchers examined over 55,000 closed claims and 11,600 diagnostic error cases, and found that the Big Three diseases – vascular events, infections and cancers – accounted for 74.1 percent of high-severity cases (22.8 percent vascular events, 13.5 percent infections and 37.8 percent cancers). The most frequent disease in each category, respectively, was stroke, sepsis and lung cancer.

Artificial intelligence and the lab AI was one of the biggest stories of the year. For example, in July, Paige, a New York-based pathology company, announced that a study had found that its computational decision-support systems can help clinicians diagnose and treat cancer. That same month, Geisinger and its Steele Institute for Health Innovation announced it would collaborate with Medial EarlySign (Tel Aviv, Israel) to implement machine learning technology to identify individuals at risk for a range of chronic and high-burden diseases, such as significant lower gastrointestinal disorders. Meanwhile, researchers in a study funded by the National Institutes of Health said they demonstrated the effectiveness of using algorithms that analyze electronic health records to help physicians identify patients at risk for HIV who may benefit from preexposure prophylaxis. But will AI ever make it to the physician’s office? “My impression is that it COULD help in identifying ‘best practice’ treatment for complicated diseases, such as most cancers and also the expanding array of lipid markers,” says lab expert and Repertoire contributor Jim Poggi. “I imagine a day where, as a first step, the physician enters a presumptive diagnosis or set of symptoms and the expert AI system suggests a more refined diagnosis and offers a suite of tests to confirm it. Then, either the outside lab or the POL performs these tests and inputs the results, and the output confirms the diagnosis and suggests best practice course of treatment, assuming one exists.”

“Providers have begun relying on the electronic health record to help with clinical decision support, to track test results, and to flag issues. However, the EHR is only part of the solution.” Meanwhile, ECRI Institute identified “diagnostic stewardship and test result management using EHRs” as one of its Top Ten Patient Safety Concerns of 2019. “When diagnoses and test results are not properly communicated or followed up, the potential exists to cause serious patient harm or death,” writes ECRI in its annual report. “Providers have begun relying on the electronic health record to help with clinical decision support, to track test results, and to flag issues. However, the EHR is only part of the solution. “To help ‘close the loop,’ providers must not only fully utilize an EHR designed to meet their practices’ unique needs, but also recognize the importance of clear communication, both among caregivers and between caregivers and patients.”

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When it comes to testing for Influenza,

one size does NOT fit all At Quidel, we know flu. We know there’s no one-size-fits-all solution, especially for flu. Whether your customer needs a quick and easy test with the simplicity of “swab, dip and read”, accurate and objective, high-throughput automated results in as few as 3 minutes, or the next-level sensitivity of a molecular assay — don’t worry, we’ve got the right flu test for each of your call points. Another great fit for flu testing is Virena.® Coupled with Sofia® 2 or Solana,® Virena provides your customers with valuable data, enabling them to observe, track, report and respond at the earliest sign of an emerging influenza trend — ultimately keeping them ahead of demand and leading to a healthier community.

For the right fitting flu test for each of your call points, contact Quidel Account Manager at 800.874.1517, or visit us online.

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Lab and diagnostics Sexually transmitted infections The U.S. Food and Drug Administration in May cleared for marketing two new tests to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause, respectively, chlamydia and gonorrhea, through diagnostic testing of extragenital specimens. The Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for extragenital diagnostic testing of these infections via the throat and rectum. These tests were previously only cleared for testing urine, vaginal and endocervical samples.

Meanwhile, in June, SpeeDx Pty. Ltd. (Sydney, Australia) announced that the FDA granted Breakthrough Device designation for ResistancePlus GC, expediting the path towards FDA clearance. The test is said to be the first commercially available molecular test providing information on ciprofloxacin susceptibility and resistance in the treatment of N. gonorrhea. Results from the test can be used to guide treatment decisions for gonorrhea infections, giving doctors and patients the option of using ciprofloxacin instead of ceftriaxone, one of the last remaining antibiotics available for multi-drug resistant infections. The rate of sexually transmitted infections is steadily increasing, with an estimated 1.7 million cases of chlamydia and more than 500,000 cases of gonorrhea in the U.S. in 2017 alone, according to the Centers for Disease Control and Prevention.

The rate of sexually transmitted infections is steadily increasing, with an estimated 1.7 million cases of chlamydia and more than 500,000 cases of gonorrhea in the U.S. in 2017 alone, according to the Centers for Disease Control and Prevention.

Patient’s breath to detect cancer? Mayo Clinic Laboratories reported in March that it would team up with Breath Diagnostics (Tustin, California) to develop clinical diagnostic tests that use patient breath samples to identify individual biomarkers that can predict a spectrum of diseases. (Biomarkers are measurable substances that help in predicting the severity of a disease or infection, according to Mayo.) The first collaboration will focus on a test that detects lung cancer using patients’ exhaled breath. The test will be used to characterize indeterminate pulmonary nodules and monitor for potential cancer recurrence after surgery. “A CT scan can only identify the presence of suspicious pulmonary nodules, and many patients require repeated follow-up CT and PET scans or other invasive follow-up procedures like needle biopsies,” said Brian Ennis, president and CEO of

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Lab and diagnostics

Breath Diagnostics. “Our technology is noninvasive and will be a lower cost alternative.”

HIV testing The vast majority (about 80 percent) of new HIV infections in the U.S. in 2016 were transmitted from the nearly 40 percent of people with HIV who either did not know they had HIV, or who received a diagnosis but were not receiving HIV care, the CDC reported in March. The findings of the CDC report include: •T  he nearly 15 percent of people with HIV whose infections are undiagnosed account for almost 40 percent of all HIV transmissions. •T  he roughly 23 percent of people with HIV whose infections are diagnosed, but who are not receiving HIV care, account for 43 percent of all HIV transmissions. • The 11 percent of people with HIV who are receiving care, but are not virally suppressed, account for 20 percent of all HIV transmissions. When taken as directed, antiretroviral therapy reduces the amount of HIV in the body to a very low level – also known as viral suppression, says CDC. Studies indicate that people who are virally suppressed can protect their own health and have effectively no risk of transmitting HIV to others through sex, as long as they stay virally suppressed.

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Unnecessary blood tests Hospitals can decrease the frequency of unnecessary blood tests by educating resident physicians – that is, making them cost-conscious and aware of the indications for ordering routine labs, researchers reported in January in the Postgraduate Medical Journal. But frequent reminders are needed to sustain the educational benefit. The researchers were testing guidelines of “Choosing Wisely” (www. choosingwisely.org), an initiative of the ABIM Foundation that seeks to identify and advance a national dialogue on unnecessary medical tests, treatments and procedures. An eight-week initiative aimed at reducing unnecessary blood tests was implemented in three internal medicine resident inpatient services. The initiative included a 30-minute educational session, reminders prior to rotation and midrotation, and posters in work areas that displayed lab pricing. Residents were encouraged to justify the purpose of ordering tests in their daily progress notes. Attending physicians were made aware of the initiative. There were 293 patient records reviewed in the preintervention period and 419 in the postintervention period. The two groups were similar in terms of age and gender. Median blood test count (complete blood count/ basic metabolic profile/comprehensive metabolic profile) decreased from four to two tests per patient per day after the intervention. The median length of hospital stay decreased from 4.9 to 3.9 days. A decreased percentage of people requiring transfusions was also noted – 6.1% in 2016, 2.9% in 2017).


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Lab and diagnostics

Liquid biopsy is coming to a provider near you The ability to detect cancer from a blood sample may not be far off Judging from developments in 2019, liquid biopsy is

set take off in clinical diagnostics, though it’s unlikely to find a place in the physician office anytime soon. The National Cancer Institutes defines liquid biopsy as a test done on a sample of blood to look for cancer cells from a tumor that are circulating in the blood or for pieces of DNA from tumor cells that are in the blood. It may also be used to help plan treatment or to find out how well treatment is working, or if cancer has returned. Here are a few blood-biopsy developments in 2019.

Lung cancer Biodesix, Inc., a Boulder, Colorado-based lung cancer diagnostic company, announced in July it had entered into an agreement with Thermo Fisher Scientific to bring a blood-based next-generation sequencing (NGS) assay to

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market with premarket approval classification from the U.S. Food and Drug Administration. The program will focus on an NGS-based solution for patients with advanced non-small-cell lung cancer. The assay is said to enable reproducible detection and analysis of tumor DNA and RNA across all major classes of somatic mutations from a single vial of blood within two days.

Early cancer detection GRAIL (Menlo Park, California) announced data from the Circulating Cell-free Genome Atlas (CCGA) study that it says demonstrates the ability of its investigational multi-cancer blood test to detect a strong signal for 12 cancer types at early stages with a specificity of at least 99 percent (or a false positive rate of one percent or less). In addition, the test identified where the cancer originated in the body (the tissue of origin) with high accuracy.


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Detection rates (sensitivity) for the 12 deadly cancer types ranged from 59 to 86 percent at early stages (stages IIII). A combined analysis of this group of cancers showed robust detection at early stages (34 percent, 77 percent, and 84 percent at stages I, II, and III, respectively). In addition, a tissue-of-origin result was provided for 94 percent of all cancers detected and, of these, the test correctly identified the tissue of origin in 90 percent of cases. The 12 pre-specified cancer types were anorectal, colorectal, esophageal, gastric, head and neck, hormone receptor negative breast, liver, lung, ovarian, and pancreatic cancers, as well as multiple myeloma and lymphoid neoplasms. Together, these cancer types account for approximately 63 percent of all cancer deaths in the United States, according to the company.

Blood biopsy beats tissue testing In February, Guardant Health (Redwood City, California) announced positive results from a lung-evaluation study that compared the Guardant 360® assay to tissue testing for the identification of guideline-recommended biomarkers in first-line advanced non-small-cell lung cancer patients. The company reported that investigators found that the assay identified guideline-recommended biomarkers in 77 patients, while tissue testing identified them in 60. For each patient in whom Guardant360

identified a target of an FDA-approved drug, tissue also detected the same alteration. Additionally, Guardant360 results were reported in an average of nine days, versus 15 days for tissue.

Alzheimer’s detection Blood biopsy may also yield information about non-cancer conditions. A report at the Alzheimer’s Association International Conference in Los Angeles in July described methods for measuring abnormal versions of amyloid protein – the building block of one of the hallmark brain lesions of Alzheimer’s disease – in blood, and correlating it with established Alzheimer’s markers. Two additional reports described new blood-based methods for assessing alpha synuclein, which contributes to the brain changes of Parkinson’s disease and Dementia with Lewy Bodies; and neurofilament light, which may turn out to be the most reliable indicator of general brain cell damage. Currently, the brain changes that occur before Alzheimer’s dementia symptoms appear can only be reliably assessed by positron-emission tomography (PET) scans, and from measuring amyloid and tau proteins in spinal fluid, according to the association. These methods are expensive and, in the case of a spinal tap, invasive. And, too often, they are unavailable, not covered by insurance or difficult to access.

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Lab and diagnostics

Point-of-care testing set for change Point-of-care testing – like healthcare itself – never

stands still. Repertoire quizzed Jonathan Overbey, director of corporate accounts for Sekisui Diagnostics, about the near-term (five-year) future of point-of-care testing in the physician office, post-acute care setting, hospital/health system, and retail clinics/urgent care/community care clinics. He responded via email. Repertoire: In the next five years, what do you think will be the most important technological development in point-of-care testing? Jonathan Overbey: 1. Faster and less expensive molecular tests for “one and done” results; 2. decentralized care for near-patient testing; and 3. smaller amount of blood needed for more CLIA-waived tests.

Bills will be passed to allow more at-home testing and more CLIA-waived tests for more disease states. In addition, more CLIA-waived tests will be available for clinics or pharmacists. Repertoire: How about regulatory/legislative developments? Overbey: Bills will be passed to allow more at-home testing and more CLIA-waived tests for more disease states.

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In addition, more CLIA-waived tests will be available for clinics or pharmacists. Repertoire: And patient-related developments, such as changing demographics, preponderant disease states, consumerism? Overbey: 1. More testing and treatments done at home or away from the hospital or doctor’s office; 2. consumers taking charge of their healthcare needs at home or at their pharmacy; and 3. more self-diagnosis and treatments by healthcare providers other than doctors – e.g., physician assistants, nurses, etc. Repertoire: In the next five years, what do you think will be the most important provider-related development (e.g., provider consolidation, staffing issues, telemedicine, etc.) affecting point-of-care testing? Overbey: Suppliers such as Amazon, eBay, etc., will ship directly to physician office labs and end users. More retail clinics/ pharmacies will be seeing and treating patients. Hospitals will be used for trauma or surgeries. All others will be treated through less expensive locations or at home. Channels will be blended; no longer one cost for a system and another for a physician office lab. One price for all channels. Hospitals and IDNs will demand one price for all locations. Repertoire: In order to be successful in the future, what’s the most important thing a distributor rep should do? Overbey: Sell and consult directly to the patient through social media. Build your brand as you do your company. Call on non-traditional sites like retail clinics/ pharmacies. Adopt “prime” customer shipping/delivery to patient homes. Train/consult on office efficiencies and productivity.


POST ACUTE CARE

The Rules Keep Changing There’s a lot to keep your post-acute-care customers awake at night. Much of it is coming from Washington.

Post-acute care providers and the gov-

ernment are, for better or worse, an inseparable pair. This month, Repertoire looks at how three regulatory developments are affecting your customers: • Readmissions penalties/incentives. • Bundled payment programs. • The newly implemented PatientDriven Payment Model, or PDPM.

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POST ACUTE CARE

The Heat is On Post-acute providers must reduce readmissions. They could use some help. About 20% – or one in five – Medicare beneficiaries

who are sent to a skilled nursing facility from a hospital are readmitted to the hospital within 30 days, points out Dr. David Gifford, senior vice president of quality and regulatory affairs and chief medical officer for the American Health Care Association. That’s too many, according to Medicare and, no doubt, to SNFs and their residents as well. Sales reps can help their post-acute-care customers by trying to understand the causes of excessive readmissions and the ways in which SNFs are trying to address the problem.

Value-Based Purchasing Medicare’s SNF Value-Based Purchasing (VBP) Program rewards – or penalizes – skilled nursing facilities based on the quality of care they provide to Medicare beneficiaries as measured by a hospital readmissions measure. “In today’s healthcare market, rehospitalizations from nursing centers is one of the most common metrics that hospitals, managed care organizations, and nursing centers themselves focus on,” says Gifford. “The measure is used by hospitals for referral decisions, managed care

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for network selection, and CMS for SNF Part A payments and its Five-Star rating system. Families and residents want to avoid rehospitalizations as well.” The CMS SNF VBP program adjusts a center’s Part A payment based on its 30-day rehospitalization rate, he explains. The adjustment can range from a cut of 2% to an increase of about 1%, which is applied for all claims submitted during a fiscal year, he says. Each year, the facility is assigned a new adjustment factor for the next fiscal year. The 30-day rehospitalization rates are converted into a score based on the facility’s ranking on their riskadjusted rate or the amount of improvement over the prior two years. Centers are then ranked on their score, and their ranking is converted into a payment adjustment factor as described above. Payment adjustments were first applied to post-acutecare providers for FY19, which started Oct. 1, 2018. The program is expected to last 10 years.

Cause and effect “Reasons for rehospitalizations are complex,” says Gifford. Many residents who are sent to skilled nursing facilities have very complex conditions, with most taking over


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POST ACUTE CARE 10 medications and having over 10 different diagnoses, he points out. A lack of information during transfers exacerbates the problem. “[P]roviding better information at the time of transfers, better access to nurse practitioners and physicians to avoid sending residents to the emergency room, and any way to more effectively monitor a resident’s condition will be important to help lower the risk of rehospitalization.” Skilled nursing facilities are doing what they can to improve the way they receive incoming residents’ information – including equipment and medications – before they arrive from the hospital, says Gifford. “Facilities are also looking at how they monitor residents’ conditions, and they are contacting physicians if there are any early changes in their conditions. Many are also using nurse practitioners to see residents more frequently, rather than sending them to the hospital.”

‘Providing better information at the time of transfers, better access to nurse practitioners and physicians to avoid sending residents to the emergency room, and any way to more effectively monitor a resident’s condition will be important to help lower the risk of rehospitalization.’ Says Shawn Scott, vice president of strategic business development for Medline, “Our skilled nursing customers as a whole have always delivered good care and will continue to do so under VBP and [the patient-driven payment model, or] PDPM. The difference we are seeing is more attention being placed on better monitoring of their residents to catch acute changes of conditions before they need to be readmitted to a hospital. They are investing in IT and training so they can handle higher acuity residents. This added attention, along with better communication

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with the hospital, has helped reduce readmissions over the last couple of years.”

Future The Value-Based Program will last at least 10 years, but will probably be tweaked between now and then. Already, the Centers for Medicare & Medicaid Services is preparing to change the rehospitalization incentives and penalties from an “all-cause” measure to “potentially preventable” ones, says Gifford. “They have not yet specified when that migration will occur, but they have specified how the potentially preventable rehospitalization measure will be calculated,” he says. “They will use the diagnosis on the hospital claim from the readmission to determine if a readmission was potentially preventable. The list of diagnoses and ICD codes captures about two-thirds of all hospital admissions, and includes diagnoses such as hypertension, diabetes, asthma and congestive heart failure.” Says Scott, “Readmissions is one of many things long-term care providers are concerned about. Although it’s an indicator of quality care, and is something referral sources are looking at, they must also look closely at their length of stay, discharge to community, staffing ratios, turnover, five star, and many other indicators that are driving quality results at their building. At the end of the day, to be successful in the skilled nursing arena, you have to be able to measure all quality metrics and to be able to move quickly to correct areas where you might be deficient, because the reimbursement dollars depend on it.” A closer relationship between acute-care providers and post-acute providers will help. Bob Miller, vice president of Gericare Medical Supply, points to data showing that increased cooperation between acute-care providers and post-acute providers not only can maximize reimbursement, but cut down on readmissions. “The challenge is to get more hospitals and postacute facilities working more closely together to make a difference in readmissions,” he says. The new PDPM payment program could also have an effect. “The record-keeping and the attitude of accountability when it comes to measuring success should all help in the readmission challenge – especially the initial assessment of a resident when they are taken in by the post-acute facility. “This will be a crucial part of the process.”


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POST ACUTE CARE

Can primary care providers help reduce readmissions? The 30-day period immediately following hospital discharge is a particularly vulnerable time for patients. According to the Agency for Healthcare Research and Quality, each year in the United States more than 35 million patients are discharged from the hospital. Among the Medicare fee-for-service population, approximately 18 percent of discharged patients are readmitted to a hospital facility within 30 days, and among the adult Medicaid population, the rate is even higher. To date, most efforts to reduce readmissions have focused on hospital-based interventions. Yet hospital providers have only a limited ability to affect what occurs once the patient has left the hospital. In fact, despite concerted national efforts from such programs as the Hospital Readmissions Reduction Program, an estimated 27 percent of hospital readmissions may still be avoidable. Less attention and study has been paid to the role of primary care providers in reducing readmissions, despite the fact that primary care is increasingly being called on to play a key role in integrating care across the continuum. To address this gap, AHRQ funded research on what is currently known about reducing readmissions from the primary care perspective. Challenges and opportunities According to AHRQ, the literature suggests that primary care providers face several challenges to caring appropriately for their patients at the time of, and immediately after, hospital discharge. They include: • A lack of compensation for peri-discharge care coordination. • Organizational challenges, including poor communication between the hospital and ambulatory environments.

•A  lack of time and support to communicate with inpatient providers and understand medication and other changes that occurred during hospitalization. • Patients’ difficulty in financing postdischarge care, inadequate physical and emotional support to comply with the post-discharge care plan, and lack of social support to address nonmedical needs, such as housing and transportation. Independent community primary-care practices face particular challenges coordinating care for patients following hospitalization because they are not affiliated with hospitals or other networks that can assist with coordination efforts during care transitions. Further, many of the primary care-based interventions reviewed by AHRQ were funded by grants or other temporary funding mechanisms. Many staff members used in these interventions – nurses, pharmacists, and care managers – did not provide directly reimbursable services. Thus, additional clinics could not initiate similar programs without external support, raising concerns about the sustainability of these programs. AHRQ found that coordinated, or bundled, interventions by hospitals, primary care providers and post-acute providers offer the best shot at reducing readmissions. They include coordinated medication management, postdischarge telephonic outreach, and patient education. In addition, transition efforts can be facilitated by clinical and financial integration of clinics and hospitals. Primary care clinics that lack the scale to hire their own dedicated care coordination staff may attempt to leverage community resources, such as those available through third-party payers or hospitals, to support their patients.

Source: Environmental Scan of Primary Care-Based Efforts to Reduce Readmissions, Agency for Healthcare Research and Quality, March 2019,

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POST ACUTE CARE

PDPM: A resident-centered plan New reimbursement method will compensate SNFs for caring for medically complex residents Editor’s note: Effective Oct. 1, 2019, your SNF customers began receiving Medicare reimbursement based on a new model of payment, called the Patient Driven Payment Model, or PDPM. This article, edited and reprinted from December 2018 Repertoire, discusses how PDPM may affect SNFs’ approach to patient care and their supply chain partners. The Patient Driven Payment Model, or PDPM, is

designed to be budget-neutral and, in a global sense, it very well might be. But there will be winners and losers. The winners? Skilled nursing facilities that accurately assess the needs of the resident upon admission, and tailor their care accordingly. The losers? Facilities that cling to the old reimbursement method, which rewards SNFs that maximize the number of hours they spend providing physical therapy, occupational therapy or speech/language pathology therapy. In the new system, more therapy hours won’t add up to more reimbursement dollars. (That said, the level of therapy anticipated for each resident will continue to be one factor in the new reimbursement scheme.) SNFs that admit medically complex residents, that is, those who need higher levels of potentially expensive

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care (e.g., expensive drugs, ventilator care, care for residents with HIV/AIDS, etc.) will receive reimbursement that more closely reflects those higher costs. “It’s good for residents,” says Robin Hillier, RLH Consulting, Westerville, Ohio, and director of reimbursement and quality metrics for Welcome Nursing Home in Oberlin, Ohio. She spoke about PDPM at the 2018 Convention and Expo of the American Health Care Association and National Center for Assisted Living in San Diego. “The current Prospective Payment System (PPS) used by CMS to pay for Medicare stays in skilled nursing facilities had the unintended consequence of leading to a ‘one size fits all’ approach to providing skilled care. The new Patient Driven Payment Model focuses more on the unique characteristics of each individual beneficiary,


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POST ACUTE CARE rewarding SNFs for focusing on the holistic, individualized plan of care that will help the person meet their specific post-acute goals.” “PDPM is a resident-centered model,” says Nate Ovenden, senior Medicare and managed care consultant, Good Samaritan Society, Sioux Falls, South Dakota, who also spoke at the recent AHCA/NCAL convention. “It will help us focus on the resident as an individual, instead of our current system, which relies on the amount of therapy minutes delivered.”

Existing method to fade out Until October 2019, Medicare paid SNFs a prospectively determined rate for each day of care. That daily rate had three components: nursing, therapy, and room and board. The nursing and therapy portions of the payment for each patient were adjusted for differences in case-mix using a classification system called resource utilization groups, or RUGs. The most recent iteration – RUG-IV – classified patients into one of 66 possible resource utilization groups, depending on the resident’s nursing care needs; amount of therapy provided; other services furnished, such as respiratory therapy and specialized feeding; the patient’s ability to perform activities of daily living; and certain medical conditions, such as pneumonia and depression. The RUG-IV system included payment for staff time spent on nontherapy ancillary (NTA) services, but not the cost, which can be high for SNF residents who require expensive drugs, a ventilator, tracheostomy care, wound care, IV medication, etc. (“Nontherapy ancillary services” refers to any ancillaries a provider uses other than therapy services, such as drugs, supplies and equipment.)

The patient-driven approach Under PDPM, residents are classified into one group for each of the five case-mix-adjusted components: • Physical therapy • Occupational therapy • Speech/language pathology • Nontherapy ancillary services • Nursing And, whereas under RUG-IV, therapy minutes delivered was the primary determinant for reimbursement, under PDPM, therapy minutes have no impact on reimbursement.

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SNF administrators and staff will enjoy another benefit from PDPM – less time spent completing assessments of their residents. RUG-IV called for SNFs to perform five scheduled assessments of the resident, at Day 5 of the stay, Day 14, Day 30, Day 60 and Day 90. In addition, SNFs were expected to perform unscheduled assessments throughout the stay, depending on the needs of the resident. Under PDPM, however, SNFs need only perform one scheduled assessment – at Day 5 – and unscheduled assessments as needed. While PDPM will save SNFs time spent on assessments, it also will demand a higher degree of accuracy at that Day 5 assessment. “For many – if not most – Part A beneficiaries, reimbursement will be based solely on the information captured on the initial (5-day) assessment,” says Hillier. “Under certain circumstances, facilities will have the ability to complete an ‘Interim Payment Assessment’ to adjust the reimbursement rate if new conditions arise during the stay that would increase the payment rate. But accurate and complete coding on the initial assessment will be critical to a facility’s success. “In order to achieve complete and accurate initial assessments, facilities will need to evaluate their admissions processes to ensure they are considering all relevant clinical information.”

Simplicity CMS hopes that PDPM will simplify the payment system, says Ovenden. “We currently spend so much time meeting regulations and doing assessments that our nurses don’t have as much time to see residents face to face. With PDPM, we will get to know our residents on a more personal basis, and our MDS [Minimum Data Set] assessments will be more accurate. We will have the resources to focus on our clinical competency skills, and make sure we’re providing great care for our residents with comorbidities.” In addition, by recognizing 50 nontherapy ancillary services for which SNFs can be reimbursed, the PDPM model will more accurately reflect the time, effort and cost of caring for clinically complex residents, rather than emphasizing therapy minutes, says Ovenden. That said, it would be a mistake to believe that PDPM will lead to a flood of new clinically complex residents in SNFs, he says. Those residents are already being cared for. But PDPM will reduce the incentive for some SNFs to


pick and choose residents who may require many therapy minutes, but who do not present clinical complexities.

Making adjustments “Under PPS, providers are paid based on the amount of therapy they provide,” says Hillier. “If two beneficiaries receive the same level of therapy, the rate is the same – regardless of their overall medical complexity. Under PDPM, providers who treat people with greater clinical complexity will finally be compensated for that care.”

All facilities have the ability to be successful under PDPM if they take the appropriate steps to prepare for it, says Hillier. Some will develop clinical programs that attract more medically complex patients, since reimbursement will be available to properly care for them, she says. The first step for SNFs is to evaluate the need in their specific market for such programs, she says. They could start by identifying patients whom hospitals are having difficulty placing, given their medical complexity. Then they should focus on what they need to do to accommodate such residents.

Nontherapy ancillary services Under the Patient-Driven Payment Model, SNFs will be reimbursed for their Medicare residents based – in part – on the nontherapy ancillary services needed. Medicare has assigned a certain number of “points” for 50 conditions. More points mean more reimbursement. The following 15 conditions receive the highest number of points. Nontherapy ancillary service HIV/AIDS Parenteral IV feeding: level high Special treatments/programs: Intravenous medication post-admit code Special treatments/programs: Ventilator or respirator post-admit code Parenteral IV feeding: level low Lung transplant status Special treatments/programs: transfusion post-admit code Major organ transplant status, except lung Active diagnoses: multiple sclerosis code Opportunistic infections Active diagnoses: asthma, COPD, chronic lung disease code Bone/joint/muscle infections/necrosis- except aseptic necrosis of bone Chronic myeloid leukemia Wound infection code Active diagnoses: diabetes mellitus (DM) code

Points 8 7 5 4 3 3 2 2 2 2 2 2 2 2 2

In addition, SNFs can use automated tools such as McKesson Quality One to focus on continuous performance improvement to quality care, performance outcomes and resident satisfaction, she says. “SNFs that adopt technology, drive training competencies on the new PDPM model and provide improved patient outcomes will be successful,” she says. “Those facilities that do not have some type of adoption will struggle with the new PDPM change.”

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POST ACUTE CARE In some cases, that may mean making physical changes to the facility, or acquiring additional capital equipment, she says. Just as important, it may call for upgrading the clinical skills of the nursing staff. “You have to make your clinical team comfortable and confident that they have the ability to provide that type of care.

“Providers and their suppliers should educate themselves about the new payment system and understand the new incentives contained within. I encourage strategic planning to identify opportunities to provide skilled care in a way that is more patient-centered and will achieve better outcomes with higher customer satisfaction.”

The distributor’s role in PDPM Repertoire readers might be especially interested in the variable rate adjustment (or “tapering”) that applies to the nontherapy ancillary services (NTA) component of Medicare reimbursement under PDPM, says Robin Hillier, RLH Consulting, Westerville, Ohio, and director of reimbursement and quality metrics for Welcome Nursing Home in Oberlin, Ohio. “Nontherapy ancillary services” refers to any ancillaries a provider uses other than therapy services, such as drugs, supplies and equipment – but not labor. For the first three days of the stay, providers will receive 300 percent of the calculated NTA payment component. Starting on Day 4, this will drop to 100 percent. CMS has created a list of conditions or diagnoses that call for higher-cost supplies or equipment. Each is assigned a certain number of points (with more complex conditions earning more points). The more points, the greater the reimbursement. “[Repertoire] readers can play an important role in helping providers identify clinical conditions and needs that contribute to the NTAS scoring early in the stay, so they can be captured on that initial assessment,” she says. “This will give providers more money at the beginning of the stay, which can be used to pay for additional supplies and equipment needed as a result of those conditions. “It’s important that whatever is applicable to the resident gets captured right away.”

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Deborah Haywood, vice president of sales and strategic development for McKesson Medical-Surgical, says the industry is “very early into understanding the full financial impact that PDPM will have for our SNF providers. The NTA case mix provides additional resources to facilities for treating potentially vulnerable populations, such as ventilator, infection isolation, end-stage renal disease (ESRD), diabetes, wound infections, IV medication, bleeding disorders, behavioral issues, chronic neurological conditions, and bariatric care. The initial admission assessment will set the case-mix reimbursement level and will be important for manufacturers and distributors to support their SNFs in driving the best outcomes for the residents’ care.” Haywood notes that SNFs can gain a better understanding of the financial impact of PDPM from their RUG data from CMS. “McKesson’s partner Pathway Health offers providers tools, such as the PDPM Financial Impact Analysis Tool, which can help them understand their current data, potential impact and clinical impact to their organization.” In addition, SNFs can use automated tools such as McKesson Quality One to focus on continuous performance improvement to quality care, performance outcomes and resident satisfaction, she says. “SNFs that adopt technology, drive training competencies on the new PDPM model and provide improved patient outcomes will be successful,” she says. “Those facilities that do not have some type of adoption will struggle with the new PDPM change.”


POST ACUTE CARE

SNFs at Short End of the Stick? Savings for joint-replacement care often come at the expense of post-acute providers. The three-year-old bundled payment program for joint

replacement has resulted in a reduction in average episode payments for Medicare. But the reductions have come largely at the expense of institutional post-acute-care settings, particularly skilled nursing facilities, not only in reduced lengthsof-stay, but in greater complexity of patients. During the first two years, the Comprehensive Care for Joint Replacement (CJR) program resulted in decreases in average payments for lower-extremity joint replacements (LEJR) of $997, according to the Lewin Group’s “Performance Year 2 Evaluation Report.” The reduction in average episode payments was due to decreases in inpatient rehabilitation facility and skilled nursing facility payments, PY1-2 Inpatient rehabilitation facilities

-$357

Skilled nursing facilities

-$508 $62

Part B

-$39

Readmissions

-$107

-$600

-$500

-$400

-$300

-$200

-$100

Home health agencies

$0

$100

Relative change in average payments

Source: Lewin analysis of Medicare claims and enrollment data for episodes initiated in 2012 through 2014 that ended between April 2012 and March 2015 (baseline) and episodes initiated during or after April 2016 that ended by December 2017 (intervention).

“Decreases in payments were due to shifts from more to less intensive post-acute care,” according to the authors of the report, which was commissioned by the Centers for Medicare & Medicaid Services. “CJR participant hospitals discharged a relatively smaller proportion of patients to an inpatient rehabilitation facility and a relatively larger proportion of patients to a home health agency than control group hospitals. “Furthermore, CJR patients with a skilled nursing facility stay spent relatively fewer days in a SNF than control group patients. These shifts in utilization resulted in statistically significant decreases in inpatient rehabilitation

facility and SNF payments, which drove the decrease in average episode payments.” Average SNF payments for CJR episodes decreased by $508 more than for control group episodes, or 9.3% from the CJR baseline. The average number of SNF days decreased by 2.3 days more for CJR episodes than for control group episodes from the baseline (pre-CJR) to the intervention period. Despite the decrease in overall payments, quality of care – as measured by the unplanned readmission rate, emergency department visits, and mortality – was maintained under the CJR model, according to the researchers. “Further, by the end of the 90-day episode, CJR and comparison patient survey respondents reported similar functional status gains and pain levels from before their hospitalization to after the end of the episode.” More disheartening news for post-acute-care providers: The report found that among CJR patients discharged to post acute care, the proportion who improved their functional status during their post-acute stay decreased relative to control patients (that is, patients that were not part of the CJR program). “Orthopedic surgeons and other clinicians we interviewed and consulted were consistent in their view that home was the best place for most patients to recover,” the researchers reported. That said, the researchers point out that the reduction in length of SNF stays might indicate that CJR patients in these settings likely had less time for improvements in functional status and pain while receiving post-acute care. Implemented in April 2016, the Comprehensive Care for Joint Replacement model tests whether episode-based bundled payments and quality measurement for lower extremity joint replacements can lower payments and improve quality. Under the model, an LEJR episode of care begins with the hospitalization for the surgery and extends through the 90 days after hospital discharge. All Medicare-covered items and services provided during this period, with some exclusions, are included in the episode bundle. All providers and suppliers involved in the episode continue to be paid under Medicare’s fee-for-service payment systems.

For more information visit: CMS Comprehensive Care for Joint Replacement Model: Performance Year 2 Evaluation Report, https://innovation.cms.gov/Files/reports/cjr-secondannrpt.pdf

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TRENDS

You and AI Medical devices are getting smarter. Time to get caught up. In May the FDA granted marketing clearance to a de-

vice called eMurmur ID, by Ottawa, Canada-based eMurmur®. The device is mobile- and web-based, and it operates in conjunction with an electronic stethoscope. It uses advanced machine learning to identify and classify pathologic and innocent heart murmurs, the absence of a heart murmur, and S1, S2 heart sounds, according to the developer. Bottom line: It uses its algorithm – which was developed based on real-world observations – to help providers identify innocent and pathological heart murmurs, or the absence of a heart murmur, in seconds.

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That’s the kind of technology which healthcare providers will be contracting for in the future. Medical devices are getting smarter. In other words, devices and equipment that incorporate artificial intelligence, or AI, can actually “learn” over time. And as they do so, they can help clinicians make better diagnoses and therapeutic plans. That fact raises all kinds of issues for all those in the healthcare supply chain. For example, how does one know the AI-based technology is “smart,” a “good learner?” How does the buyer contract for such a technology? How much will it cost?


The U.S. Food and Drug Administration is grappling with some AI-related issues as well. For example, as an AI-based device takes in more information and offers new insights to clinicians, should it be considered a “new” device? Should it go through FDA’s marketing clearance procedures every time it learns something new? And how can the healthcare community trust that the device will make better choices or recommendations a year from now, or five years from now, than it does at its introduction?

Continuous learning The old rules of the road for medical device regulation – which have been around since the 1970s – don’t apply anymore, says Zach Rothstein, vice president, technology and regulatory affairs, AdvaMed. “In terms of regulation, the most unique aspect of AI, or machine learning, is that it can continuously learn,” he points out. “The inputs it receives in the field inform future outputs. The question is, ‘How do you truly allow for that continuous learning aspect of the device to occur?’” Thus far, the FDA has handled the question by granting marketing clearance for AI-based products that are essentially “locked,” says Rothstein. Their algorithms are typically based on thousands of data points – which make them very smart indeed. But they haven’t been FDAcleared to get any “smarter” in the field. In other words, they are prevented from continuously learning. FDA is trying to re-imagine its approach to AIbased devices by adopting a “change management protocol,” which would establish parameters that would allow devices to continuously learn in the field. “Without that, things have to be locked,” says Rothstein. “If a developer wants to update the software of an AI device based on input received from the real world, the developer has to go back to the FDA for marketing clearance.”

FDA trying to catch up To catch up to AI technology, FDA is simultaneously exploring two paths: 1. Precertifying developers of AI-based devices. 2. D  eveloping a framework for AI-based medical devices In July 2017, the agency launched its “Pre-cert pilot program” as part of its “Digital Health Innovation Action

Plan.” The gist is to look at the software developer or digital health technology developer, rather than primarily at the product. After reviewing systems for software design, validation and maintenance, FDA would determine whether the company meets quality standards and if so, would precertify the company. The agency compares it to the Transportation Security Administration’s Precheck program, which screens travelers and awards them with a “Known Traveler Number,” speeding up their airport security checks.

FDA is trying to re-imagine its approach to AI-based devices by adopting a ‘change management protocol,’ which would establish parameters that would allow devices to continuously learn in the field. With the information gleaned through the pilot program, the agency hopes to determine the key metrics and performance indicators for precertification and identify ways that precertified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool. The FDA is also considering – as part of the pilot program – whether and how precertified companies may not have to submit a product for premarket review in some cases. In September 2017, the agency announced the names of the companies selected to participate in the pilot program The agency’s intention was to include a wide range of companies and technology in the digital health sector, including small startups and large companies, high- and low-risk medical device software products, medical product manufacturers and software developers. Participants selected include:

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TRENDS • Apple, Cupertino, California. • Fitbit, San Francisco, California. • Johnson & Johnson, New Brunswick, New Jersey. • Pear Therapeutics, Boston, Massachusetts. • Phosphorus, New York, New York. • Roche, Basel, Switzerland. • Samsung, Seoul, South Korea. • Tidepool, Palo Alto, California. • Verily, Mountain View, California. As part of the Pre-cert pilot program, participants have agreed to provide access to measures they currently use to develop, test and maintain their software products,

including ways they collect post-market data. Participants also agreed to be available for site visits from FDA staff, and provide information about their quality management system. This sharing will help the FDA continue to build its expertise in these areas, while giving the agency the information it needs to provide proper oversight of these products and firms.

A broader framework for AI devices In April 2019, then-FDA Commissioner Scott Gottlieb announced that FDA was exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation.

Get to know these terms Artificial Intelligence. The science and engineering of making intelligent machines, especially intelligent computer programs. Artificial intelligence can use different techniques, including models based on statistical analysis of data, expert systems that primarily rely on if-then statements, and machine learning.

“Locked” algorithms. Algorithms that don’t continually adapt or learn every time they are used.

Algorithm Change Protocol, or “Predetermined Change Control Plan.” Proposed plan by FDA that would include the types of anticipated modifications – referred to as the “Software as a Medical Device Pre-Specifications” – being used to implement changes in a controlled manner that manages risks to patients. In this approach, the FDA would expect a commitment from manufacturers on transparency and real-world performance monitoring for artificial intelligence and machine learning-based software as a medical device, as well as periodic updates to the FDA on what changes were implemented as part of the approved pre-specifications and the algorithm change protocol.

“Adaptive” or “continuously learning” algorithms. Machine-learning algorithms that can learn from new user data presented through real-world use. They don’t need manual modification to incorporate learning or updates. For example, an algorithm that detects breast cancer lesions on mammograms could learn to improve the confidence with which it identifies lesions as cancerous or may learn to identify specific subtypes of breast cancer by continually learning from real-world use and feedback.

Software as a Medical Device. Software intended to be used for one or more medical purposes that are not part of a hardware medical device. It can be used across a broad range of technology platforms, including medical device platforms, commercial “off-the-shelf” platforms, and virtual networks, to name a few. Such software was previously referred to by industry, international regulators, and health care providers as “standalone software,” “medical device software,” and/or “health software.”

Machine Learning. An artificial intelligence technique that can be used to design and train software algorithms to learn from and act on data.

Source: U.S. Food and Drug Administration

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TRENDS “For traditional software as a medical device, when modifications are made that could significantly affect the safety or effectiveness of the device, a sponsor must make a submission demonstrating the safety and effectiveness of the modifications,” Gottlieb wrote at the time. “With artificial intelligence, because the device evolves based on what it learns while it’s in real world use, we’re working to develop an appropriate framework that allows the software to evolve in ways to improve its performance while ensuring that changes meet our gold standard for

may learn to identify specific subtypes of breast cancer by continually learning from real-world use and feedback, Gottlieb pointed out. “Our ideas are the foundational first step to developing a total product lifecycle approach to regulating these algorithms that use real-world data to adapt and improve.”

What’s ahead?

FDA is probably a few years away from figuring all this out, says Rothstein. Congressional legislation may be required for some of the changes being considered. “From most people’s perspective, these proposals are “Our ideas are the foundational first step to outside the bounds of the Federal developing a total product lifecycle approach Food, Drug, and Cosmetic Act,” says to regulating these algorithms that use realRothstein. For that reason, Congressional legislation may be required. world data to adapt and improve.” – Scott Gottlieb Still, next year may be a pivotal one, as FDA prepares to present concrete proposals for Congress to consider. “This will certainly delay the deployment of certain safety and effectiveness throughout the product’s lifecycle technologies,” says Rothstein. “But FDA is doing its best – from premarket design throughout the device’s use on to expedite the process. Long-term, I don’t think it will the market.” significantly impact the advancement of AI technology. For example, an algorithm that detects breast cancer Any developer that’s serious about getting into this space lesions on mammograms could learn to improve the conwill do so.” fidence with which it identifies lesions as cancerous or

What if AI makes a mistake? The premise behind artificialintelligence-based devices is that they can “learn” over time. In other words, based on realworld inputs and experience, they can make better diagnoses and better care recommendations as time goes by. But what if those recommendations result in harm to a patient? What if the diagnosis is wrong? Who’s to blame? Not physicians, says the American Medical Association.

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In their recent annual meeting in June, delegates to the AMA endorsed some policy recommendations regarding AI. Among those recommendations is the following: “Liability and incentives aligned so the individual or entity best positioned to know the AI system risks and best positioned to avert or mitigate harm do so through design, development, validation, and implementation. When a mandate exists to use AI, the individual or entity issuing the mandate must be assigned all applicable liability. Developers of autonomous AI systems with clinical applications (screening, diagnosis, treatment) are in the best position to manage issues of liability arising directly from system failure or misdiagnosis and must accept this liability.”


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TRENDS

AI-based technologies on the market. Examples of AI-based devices that have received FDA marketing clearance.

Heart murmur detection In May 2019, eMurmur®, Ottawa, Ontario, announced that its eMurmur ID received FDA clearance. The company says eMurmur ID is a mobile and cloud solution which operates in conjunction with an electronic stethoscope. It uses machine learning to identify and classify pathologic and innocent heart murmurs, the absence of a heart murmur, and S1, S2 heart sounds. The solution is comprised of AI-based analytics, a mobile app, and a web portal (all HIPAA compliant). Evidence for the device is based on five studies involving more than 1,000 patients, according to the company. Chest X-ray triage product In May 2019, Zebra Medical Vision, Tel Aviv, Israel, received marketing clearance from the U.S. Food and Drug Administration for its artificial intelligence-based chest X-ray triage product. The FDA approval focuses on an alert for urgent findings of pneumothorax, an accumulation of gas within the space between the lung and the chest wall that can lead to total lung collapse. It is usually diagnosed by chest X-ray scan but is difficult to interpret. Detection of left ventricular EF In June 2018, San Francisco-based Bay Labs announced its EchoMD AutoEF software had received 510(k) clearance from the U.S. Food and Drug Administration for the fully automated clip selection and calculation of left ventricular ejection fraction (EF). EF is said to be the single most widely used metric of cardiac function and used as the basis for many clinical decisions. The EchoMD AutoEF algorithms are intended to eliminate the need to manually select views, choose the best clips, and manipulate them for quantification, said to be a time-consuming and highly variable process. The company says that its software algorithm “learned” clip selection and EF calculation after

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being trained on a curated dataset of over 4 million images, representing 9,000 patients.

Detection of diabetic retinopathy In April 2018, the FDA permitted marketing of the IDx-DR, from IDx LLC, Coralville, Iowa, said to be the first device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. The IDx-DR is a software program that uses an artificial intelligence algorithm to analyze images of the eye taken with a retinal camera. A doctor uploads the digital images of the patient’s retinas to a cloud server on which IDx-DR software is installed. If the images are of sufficient quality, the software provides the doctor with one of two results: (1) “more than mild diabetic retinopathy detected: refer to an eye care professional,” or (2) “negative for more than mild diabetic retinopathy; rescreen in 12 months.” The FDA evaluated data from a clinical study of retinal images obtained from 900 patients with diabetes at 10 primary care sites. Potential stroke warning In February 2018, the FDA permitted marketing of the Viz.AI Stroke Platform from San Franciscobased Viz.ai, Inc. A stroke occurs if the flow of oxygen-rich blood to a portion of the brain is blocked. When this happens 2 million brain cells die every minute. The Viz.AI Contact application (part of the Stroke Platform) is designed to analyze CT images of the brain and send a text notification to the mobile device of a neurovascular specialist if a suspected large vessel blockage, or occlusion, has been identified. The device could benefit patients by notifying a specialist earlier, thereby decreasing the time to treatment.


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TRENDS

Wearables: Are they anything like the ‘real thing?’ Editor’s note: This is part of a continuing series on wearables and mobile medical applications, and their potential impact on providers, patients and Repertoire readers. Future articles will address such questions as: How are physicians incorporating these devices into their everyday practice? How are Medicare and other payers reimbursing physicians for remote monitoring of patients? What do sales reps need to know?

New mobile medical applications – often

in the form of watches, patches or apparel – keep on coming. Consumers have little to lose – except cash – by buying (or subscribing to) them. But for doctors, nurse practitioners and others, the stakes are higher. They need to know, “Are these things accurate?” “Can I trust them enough to base treatment plans on the information they give me?” “Do they really work?” To gain clarity, Repertoire asked Bakul Patel, director of the U.S. Food and Drug Administration’s digital health division, to respond to some questions.

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TRENDS Repertoire: In April 2016, the Federal Trade Commission created a web-based tool for developers of health-related mobile apps in conjunction with FDA, the Office of the National Coordinator for Health Information Technology (ONC) and the Office for Civil Rights. The purpose was to give app developers clear information about the laws that apply to their health-related products. Three and a half years later, how would you characterize mobile app developers’ understanding and compliance with those laws? Bakul Patel: The FDA often engages with digital health developers through a variety of channels to ensure that developers are aware of FDA regulations. Through guidances, webinars, external conferences and our email address (DigitalHealth@fda.hhs.gov), developers have multiple ways to engage with the FDA. Some of the bright spots include our engagement with companies and organizations as we design and develop the software precertification pilot program for software as a medical device. While nine companies are formally involved in the program, the FDA has engaged with many companies and stakeholders to hear critical feedback as we look at ways to find efficiencies in our regulation of digital health products. Repertoire: It has been reported that the industry is seeing a rise in FDA-cleared digital therapeutics. Do these things really Bakul Patel work? Can a doctor trust the EKG readings that a patient’s watch is recording? Can he or she feel confident making a diagnosis or treatment plan based on it? Patel: [Makers of] medical devices – including software as a medical device (SaMD) – that require premarket review by the FDA demonstrate to the agency in their application that the product is both safe and effective for the intended use. It is important to note, though, that many medical products, including SaMD, may have limitations in their use. These limitations, contraindications and other

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important information about the use of the product are included in the FDA-required labeling for a product. Doctors, patients and their caregivers can understand the specific FDA-reviewed use of the product. In the case of SaMD product, it could include information about additional confirmatory tests being required. For example, the Apple ECG application provides users very specific guidelines in its labeling: “The ECG App is a mobile app that is used with the Apple Watch to create, record, store, transfer and display a single channel electrocardiogram (ECG). The ECG App is also intended to detect the presence of AF and regular (sinus) rhythm. The app displays the heart rhythm as one of the following: sinus rhythm, AF, inconclusive due to other rhythms, or inconclusive due to poor signal quality. The ECG data displayed is intended for informational use only and does not replace traditional methods of diagnosis or treatment. If AF is detected, a health care provider should be consulted for additional testing and monitoring. The ECG App is not recommended for patients with other known arrhythmias.” Repertoire: Who decides if a developer of a mobile medical application or device should seek FDA clearance? Is it the developer of the application or device? The FDA? Somebody else? Patel: Medical device manufacturers or developers are responsible for ensuring they fulfill all applicable FDA regulatory requirements. FDA has several resources and has published several guidances to help developers decide when a clearance is required. We encourage all developers to review these resources and make that determination. Repertoire: Who decides whether a mobile medical application or “wearable” can be administered only through a prescription? Patel: Manufacturers submit product applications (premarket approval, a de novo or premarket clearance) with information about the intended use of the product, including whether the product will be for prescription use only or over the counter.


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TRENDS Repertoire: The FDA defines a device as something “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” If that’s the case, shouldn’t all mobile medical applications be subject to FDA approval?

Repertoire: In April 2019, then-FDA Commissioner Scott Gottlieb announced that the agency was building a Digital Health Center of Excellence “to develop more efficient ways to ensure the safety and effectiveness of technologies like smart watches with medical apps.” Can you talk about the two or three most important initiatives in which the Center of Excellence is engaged? Patel: The Center is not yet formally launched. We plan to create a Center of Excellence on Digital Health to establish the regulatory paradigm, build new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices. Implementing these regulatory innovations and information technology improvements are essential for advancing software-based technologies that improve the health and quality of life of patients while assuring critical safeguards, as the current regulatory framework is not well-suited for driving the development of safer, more effective software-based devices, including the use of machine learning and artificial intelligence.

Implementing regulatory innovations and information technology improvements are essential for advancing softwarebased technologies that improve the health and quality of life of patients. Patel: No, not all mobile medical applications are making a claim to treat, cure, mitigate or prevent a disease or condition. For example, sleep tracking applications may help users track their sleep patterns, which is informational only and not meant to diagnose or treat a disease or condition.

To view a sampling of pre-market submissions that include mobile medical applications cleared or approved by the FDA, go to https://www.fda.gov/medical-devices/mobile-medical-applications/examples-pre-market-submissions-include-mmas-cleared-or-approved-fda. Readers should also note that the FDA launched its “Pre-cert pilot program” as part of its “Digital Health Innovation Action Plan” in July 2017. The gist is to scrutinize the software developer or digital health technology developer, rather than primarily at the product. After reviewing systems for software design, validation and maintenance, FDA would determine whether the company meets quality standards and if so, would precertify the company. The agency compares it to the Transportation Security Administration’s Precheck program, which screens travelers and awards them with a “Known Traveler Number,” speeding up their airport security checks. With the information gleaned through the pilot program, the agency hopes to determine the key metrics and performance indicators for precertification and identify ways that precertified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool. The FDA is also considering – as part of the pilot program – whether and how precertified companies may not have to submit a product for premarket review in some cases.

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U.S. Preps for Rough Flu Season HIDA research on influenza vaccines offers information on patient and physician vaccination trends

The flu season in the United States last season ran a

little longer than normal, but overall the Centers for Disease Control and Prevention (CDC) classified it as “moderate,” according to the latest data out from the government’s flu tracking experts. The Health Industry Distributor Association’s new 2019 Influenza Vaccine Production & Distribution Market Brief provides insights into the flu products supply chain and key information regarding the influenza vaccine, including vaccine makeup, effectiveness, and reimbursement costs. The report also provides resources to help distributors prepare for the upcoming 2019-2020 flu season. The U.S. has been keeping a close eye on Australia, which in 2019 experienced one of its worst flu seasons since it began tracking flu data. A recent report by World Health Organization Influenza Center said the number of cases were about “five times what we’d normally see in that inter-seasonal period.” Australia is often a harbinger of what to expect in an upcoming flu season in the U.S. The 2018-2019 influenza season in the U.S. occurred from October 1, 2018, to May 4, 2019, and the CDC estimates that influenza virus infection caused up to 43 million symptomatic illnesses; a bit more than 20

2019 HIDA Influenza Vaccine Production & Distribution report provides key information on:

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million medical visits; up to 647,000 hospitalizations; and as many as 61,200 deaths in the U.S.

Meaningful Measures The Centers for Medicare & Medicaid Services (CMS) has made efforts to streamline reporting requirements under its Meaningful Measures program, with a number of flu-related measures removed or will be removed in the future. Influenza immunization has been included as a measure for several providers’ quality reporting programs per the annual Medicare reimbursement regulation from CMS. CMS finalizes measures for providers to receive their full annual Medicare payment update. If providers fail to report on these measures, they will receive a cut in their Medicare payment. As part of their quality reporting requirements, some types of providers are required to report on the percentage of their patients who were assessed and appropriately given the seasonal influenza vaccine. CMS is also requiring a number of quality reporting programs to send healthcare personnel vaccination rates to the CDC’s National Healthcare Safety Network. Immunization of both patients and staff continues to be a trend in the CMS Quality Reporting Program.

• Flu vaccine production, supply, and allocation • Patient and physician vaccination trends • Managing influenza with diagnostic resources • Manufacturing and distribution processes • Medicare reimbursement quality reporting measures


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HEALTHY REPS

Health news and notes HPV vaccination recommendation expanded The Centers for Disease Control and Prevention in August recommended that females and males through the age of 26 who failed to get vaccinated against human papillomavirus (HPV) by age 11 or 12 receive a “catchup” vaccination. It’s a change: Catch-up vaccination has been recommended since 2006 for females through age 26 years, and since 2011 for males through age 21 years and certain special populations through age 26 years. (For adults aged 27 through 45 years, CDC regards the public health benefit of HPV vaccination to be minimal; shared clinical decision-making is recommended because some persons who are not adequately vaccinated might benefit.).

of a questionnaire submitted by 43,722 women suggest that cutting off lights at bedtime could reduce women’s chances of becoming obese. The results varied with the level of artificial light at night exposure. For example, using a small nightlight was not associated with weight gain, whereas women who slept with a light or television on were 17% more likely to have gained 5 kilograms, approximately 11 pounds, or more over the follow-up period. The association with having light coming from outside the room was more modest. Scientists cautioned that this is a basic research finding, and wondered if not getting enough rest factored into the findings.

Emergency hypoglycemia treatment OK’d Lights out Sleeping with a TV or light on in the room may be a risk factor for gaining weight or developing obesity, according to scientists at the National Institutes of Health. The research, which was published online June 10 in JAMA Internal Medicine, is the first to find an association between any exposure to artificial light at night while sleeping and weight gain in women. The results

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The U.S. Food and Drug Administration in July approved Baqsimi nasal powder, the first glucagon (hormone) therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. Severe hypoglycemia occurs when a patient’s blood sugar levels fall to a point where he or she becomes confused or unconscious or suffers from other symptoms that require assistance from another person to treat. Typically,


severe hypoglycemia occurs in people with diabetes who are using insulin treatment. Baqsimi is approved to treat severe hypoglycemia in patients with diabetes ages four and older.

Pregnant women and group B strep Most babies born to women who test positive for group B strep (GBS) bacteria do not need treatment if their mother received antibiotics during labor. The American College of Obstetricians and Gynecologists and American College of Nurse-Midwives (ACNM) recommend women get tested for GBS bacteria when they are 36 through 37 weeks pregnant. To administer the test, clinicians use a sterile swab to collect a sample from the vagina and the rectum. Women who test positive for GBS are not sick. However, they are at increased risk for passing the bacteria to their babies during birth. Babies born to women with GBS who receive antibiotics have about a one-in-4,000 chance of developing GBS disease; but babies born to women who fail to get antibiotics have a one-in-200 chance of doing so.

for hepatitis B virus infection in pregnant women. The Task Force recommended that all pregnant women be screened for hepatitis B infection at their first prenatal visit to prevent infection in newborns. (Hepatitis B is a viral infection of the liver that can cause chronic conditions such as liver disease or liver cancer. When babies become infected with hepatitis B from their mothers, they have a 90 percent chance of developing these lifelong chronic infections.) Although babies are now routinely vaccinated for hepatitis B virus shortly after birth, rates of maternal hepatitis B virus infection have increased by more than 5 percent each year since 1998, the Task Force noted. This is why it is important to screen all pregnant people.

Sleeping with a TV or light on in the room may be a risk factor for gaining weight or developing obesity, according to scientists at the National Institutes of Health.

Blood pressure control may be good for the brain Intensive blood-pressure control may slow age-related brain damage, report researchers in a National Institutes of Health study. Researchers using magnetic resonance imaging to scan the brains of hundreds of participants in the National Institutes of Health’s Systolic Blood Pressure Intervention Trial (SPRINT) found that intensively controlling a person’s blood pressure was more effective at slowing the accumulation of white matter lesions than standard treatment of high blood pressure. The results complement a previous study published by the same research group that showed that intensive treatment of BP significantly lowered the chances that participants developed mild cognitive impairment. Several studies have suggested that people who have hypertension have a greater chance of accumulating white matter lesions and also of experiencing cognitive disorders and dementia later in life.

Pregnancy and hepatitis B screening The U.S. Preventive Services Task Force in July published a final recommendation statement on screening

Pivot point for low-dose aspirin Medical consensus once supported daily use of lowdose aspirin to prevent heart attack and stroke in people at increased risk for cardiovascular disease. But in 2018, three major clinical trials cast doubt on that conventional wisdom, finding few benefits and consistent bleeding risks associated with daily aspirin use, according to Harvard Medical School. Taken together, the findings led the American Heart Association and American College of Cardiology to change clinical practice guidelines earlier this year, recommending against the routine use of aspirin in people older than 70 years or people with increased bleeding risk who do not have existing cardiovascular disease. “Our findings show a tremendous need for health care practitioners to ask their patients about ongoing aspirin use and to advise them about the importance of balancing the benefits and harms, especially among older adults and those with prior peptic ulcer disease,” said lead author Colin O’Brien, Harvard Medical School clinical fellow in medicine at Beth Israel Deaconess.

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QUICK BYTES Editor’s note: Technology is playing an increasing role in the day-to-day business of sales reps. In this department, Repertoire will profile the latest developments in software and gadgets that reps can use for work and play.

Technology news E-commerce chase scene Microsoft continues its competitive race against Amazon in the retail space, reports Modern Retail. In early August, Microsoft announced that it purchased marketing technology platform PromoteIQ for an undisclosed amount of money. The acquisition, though small, is the latest in Microsoft’s attempts to level the playing field with Amazon, according to the magazine. Over the last few years Microsoft has garnered individual partnerships with retailers, which has laid the groundwork for marketers to see it as a potential alternative to Amazon. Still, the company has a ways to go: Amazon has a solid leg up on both advertising (which brought in $3 billion in the second quarter) and cloud storage (which hit $8.38 billion in Q2 of this year). Adding PromoteIQ – whose clients include Overstock.com, Office Depot and Kohl’s – indicates that Microsoft is strategizing about how to expand and undercut the competition.

A friendly reminder Google was preparing to unveil a new feature for its Assistant software that lets people send reminders to friends and family on their phones or Google Home devices, according to CNET. Here’s how the update (called “assignable reminders”) works: You trigger the Google Assistant (Google’s rival to Amazon’s Alexa and Apple’s Siri) by saying “Hey Google.” Then you add a command. For example, tell the software to remind your spouse to take out the trash at 6 p.m. That person will get a reminder on their phone, Google Home smart speaker or a smart display that works with the Assistant. You can send reminders only to people who are listed as family in your Google account or are linked and voice-matched to the same Google Home device. You can also set a reminder based on someone’s

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location. For example, if you want a friend to pick up something at the grocery store, you can set a reminder to pop up when they get to the building.

Super annoying Google eradicated 85 Android apps from the Google Play Store this summer after researchers found they were adware posing as legitimate software, reports ZDNet. The apps reportedly masqueraded as photography utilities and games to lure Android handset users to download them. But once installed, they would push advertisement after advertisement. Most annoying was the fact that each advertisement was displayed in full-screen mode, forcing the user to watch the entire thing before being able to exit the screen or return to the app. The adware-laden applications included Magic Camera: Make Magical Photos, Blur Photo Editor, Background Replacement, Find the difference: smart detective, and Color House2019.

Keep intruders out! What if you could plug in a box and instantly protect yourself and your family from online advertisers, big tech companies, ISPs and criminals? That’s exactly what the Winston Privacy Filter is designed to do, according to Digital Trends. The device encrypts your entire Internet activity, according to Winston CEO Richard Stokes, adding, “It scrambles it up with all the other Winstons out there, and then it’s putting into play various technology solutions, both at the network and application layer, to disable things like cookie tracking and browser fingerprinting.” The idea is that you plug your Internet connection into this unobtrusive box, plug your router into the other end, and every device on your home network is protected.


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WINDSHIELD TIME Chances are you spend a lot of time in your car. Here’s something that might help you appreciate your home-away-from-home a little more.

Automotive-related news Scooters, bikes and pedestrians We’ve all seen the increase in bicycle traffic – and now motorized scooters – on busy streets. It’s no surprise, then, that U.S. pedestrian and bicyclist deaths rose in 2018 while overall traffic deaths fell 1% in 2018, to 36,750, reports the National Highway Traffic Safety Administration (NHTSA). The auto safety agency said it did not know the cause of the overall decline but has said a dramatic increase in traffic deaths in 2016 was the result of more people killed on foot, bicycle or motorcycle. Pedestrian deaths accounted for 16% of all U.S traffic deaths in 2017, up from 12% in 2009. The agency has been investigating the role of distracted drivers in overall U.S. traffic death figures but has found challenges in getting an accurate picture of all distracted crashes because of the unwillingness of individuals to acknowledge they were distracted.

Protected bike lanes: Do they really protect? Bike lanes separated from the roadway by physical barriers make cyclists feel safer and encourage more people to ride. But a study by the Insurance Institute for Highway Safety shows that protected bike lanes vary in terms of injury risk. Factors such as the number of driveways or alleys intersecting the lanes and whether the lanes are one- or two-direction affect the likelihood of a crash or fall. Compared with a major road with no bike infrastructure, the risk of a crash or fall was much lower on two-way protected bike lanes on bridges or raised from the roadway – for example, within greenways. In contrast, the risk of a crash or fall on a two-way protected bike lane at street level was much higher than that of a major road. One-way protected bike lanes differed little from major roads in terms of injury risk. That said, the types of bicyclist crashes seen in street-level protected lanes weren’t the type that are typically most severe. Most fatal bicyclist crashes involving motor vehicles occur midblock, while cyclists in protected bike lanes in the

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study collided with vehicles most often at intersections or junctions with driveways and alleys. In such cases, vehicles are usually turning and traveling slowly.

Knee airbags Airbags save lives. More airbags, one might assume, would provide even greater protection. But a recent study by the Insurance Institute for Highway Safety shows that one increasingly common type of airbag – the knee airbag – has a negligible effect on injury risk. Knee airbags usually deploy from the lower dashboard and are intended to distribute impact forces to reduce leg injuries. They may also help reduce forces on an occupant’s chest and abdomen by controlling lower body movement. In an analysis of real-world crashes, knee airbags reduced overall injury risk by half a percentage point, from 7.9 percent to 7.4 percent, but this result wasn’t statistically significant. That said, it is possible that knee airbags would help unbelted occupants in realworld crashes. But the hope is, there aren’t many unbelted occupants on today’s roads.

Is flood damage insured? Floods are the most common natural disasters in the U.S. Does your car insurance cover flood damage? Yes, but you will need comprehensive auto coverage if you want your insurance company to pay you for damage to your flooded vehicle, according to an article in Motor Trend. Insure.com reports that the average rate for comprehensive coverage is $189 per year, which you’ll pay in addition to collision, which averages $523. If you don’t have comprehensive coverage and your car gets flooded, you’re likely out of luck. Home insurance doesn’t cover flood damage, and even if you have a flood insurance policy tacked on, it will only cover damage to personal belongings in your car. There is one recourse, though. In the event of a natural disaster, you may be eligible for assistance from the Federal Emergency Management Agency (FEMA) in the form of a low-cost loan.


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IMDA/HIRA ANNUAL CONFERENCE

Speaking the Language of Value Specialty dealers discuss trends at the IMDA/HIRA Annual Conference

Selling medical devices has changed over the years. A

big reason is, your customers have changed. Providers are increasingly reimbursed – or penalized – on the basis of patient outcomes. They’re concerned about patient satisfaction. All of their payers – public and private – are stingier with reimbursement. Doctors are no longer the sole decision-makers on new technologies.

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But some things about selling haven’t changed. For example, honesty and sincerity still count. So does respect for the customer’s “rules of engagement,” even if those rules (e.g., vendor credentialing) rub suppliers the wrong way. Specialty dealers can reconcile the new realities of selling with the old by selling value – a key topic at the


IMDA/HIRA Annual Conference, “The Many Facets of Value,” held in suburban Chicago this summer.

Where cost, quality and outcomes intersect Mike Schiller, vice president of healthcare engagement for Matrix IT, urged conference attendees to familiarize themselves with the CQO initiative of the Association for Health Care Resource & Materials Management. (Schiller was the senior director of AHRMM prior to joining Matrix IT.) “CQO” stands for “cost,” “quality” and “outcomes,” and it examines the intersection of: •C  ost (i.e., all costs associated with caring for individuals and communities). •Q  uality (achieving the best possible health). •O  utcomes (i.e., financial results driven by exceptional patient outcomes). Dealers can – and must – help their customers connect the dots between all three, said Schiller.

Make your case Dealers know that’s not easy, especially considering that providers are approached dozens of times every month about new technologies. For that reason, they should avoid overloading potential customers with information, suggested value analysis expert Dee Donatelli, Newton, Kansas. “Too much information is a roadblock,” said Donatelli, who is the incoming president of AHRMM as well as past president of the Association of Health Care Value Analysis Professionals. “Less is more.” Boil your information down to the pertinent factors, she suggested. Provide links if necessary. And don’t fret if you lack randomized, double-blind clinical studies for your technology. They rarely exist, particularly for new technologies. If all you have is a case study or success story, go with it, she advised. “But don’t buffalo your buyer and try to pull off ‘information’ as ‘evidence,’” she said. “Don’t pass off your marketing slick as evidence.”

Reaching the C suite

Bring the right answers to providers before they ask the questions, advised Donatelli. Anticipate questions like these: • “How much will this technology increase revenues?” • “How, specifically, will it help reduce cost?”

The third speaker on quality – Richard Priore, president and CEO, Excelsior HealthCare Group – pointed out that health system administrators are swamped with competing priorities. They lack time to consider the value proposition of every new device or piece of equipment. But

• “How will it lead to improved outcomes?” • “How much savings will the provider realize through improved utilization?” • “What will be the costs associated with converting to the new technology?” • “Will this device or technology improve physician relationships or help my health system grow market share?”

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IMDA/HIRA ANNUAL CONFERENCE

A ‘gentleman’ rep Forty years after beginning his medical sales career, despite all the changes that have occurred in the industry, Tom Pruitt has clung to one essential element in sales: Always be a gentleman. It is a lesson he learned from two mentors – his older brother, Lee, and another independent rep, Lee Walters. “They gave me a selling style that was used when they started, and it has served me well all these years,” he says. “An independent rep stays in a territory for decades. A lot of customers become friends. Just always treat everybody the way you would like to be treated.” Pruitt was awarded the Lee Walters Award at the recent HIRA/IMDA Annual Conference in Chicago. (Walters was the first president of the Health Industry Representatives Association.) Pruitt was born in 1952 at Letterman Army Medical Center in San Francisco. His father, Francis, was a career Army physician. It was in Tulsa, Oklahoma, where Tom and Lee Pruitt were raised by Francis and their mother, Mae. Twenty-three years his senior, brother Lee got into medical sales with national distributor Will Ross in 1952. There, he negotiated the first GPO agreement in the country, with a group of hospitals in Denver, in the 1960s, says Tom. Lee left Will Ross in 1971 and formed EP Industries, an independent rep firm with Bob Elliott (who previously had been a partner in another firm with Lee Walters). They covered Texas, Oklahoma, Arkansas and Louisiana. Tom began working for EP Industries in 1979, covering Oklahoma and Arkansas. In 1988, he left EP to form his own firm. “I have operated as a sole proprietor until recently,” he says. “My daughter, Sarah, started working in the medical sales business approximately three years ago, and we recently formed Pruitt Medical Sales, LLC. “When Sarah joined me it meant there are

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three generations of Pruitts in the medical sales business,” he adds. “Counting our father, there has been a Pruitt in healthcare since 1928.” The hospital distribution business has changed much since he began selling in 1979, says Pruitt. “When I started there were 10 distributors with brick and mortar operations in Oklahoma. Now there is one. But the relationship has always been about trust. If a distribution rep asks you to work on a project, and another distribution rep wants to work on the same project later, you need to use the Darrell Royal rule: ‘You gotta dance with the one that brung you.’” Personal relationships with providers still matter too, despite the consolidation among hospitals and health systems. Reps who believe that the average OR nurse lacks sway in OR product decisions are missing the boat, he says. “That’s way, way wrong. They do – but you gotta know them.” Pruitt is enjoying selling and working with his daughter, and he has no plans for retirement. That said, he points out that the rep industry is crying for young people. “Most of us are 50-plus, so there’s opportunity. You can make a nice living, and more important, you get to be your own boss. You get to sell what you want, for the most part, choosing companies and products you want to associate with.” Now 90 years old, Lee Pruitt remains an important part of his brother Tom’s life. “He gave me a chance with the rep business and taught me to sell and run a rep business, and I will always be grateful. He is 90 now, and I still look to him for advice, both personal and professional.” Tom is also grateful for his wife, Nancy, a recently retired attorney and wife of 42 years; and his daughter, Sarah, “who is becoming a great salesperson.” Then there’s life in Tulsa, “the best city that no one knows about.”


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vendors that can monetize quality, that is, translate “quality” into “return on investment,” may get a hearing. (Priore has more than 25 years in the investor-owned for-profit, private not-for-profit and government healthcare sectors, with senior executive roles in integrated and academic health systems, physician-owned specialty hospitals, and large multispecialty group practices.) Dealers should have a grasp of basic financial concepts, and they should study customer-level financial data before making sales calls, advised Priore. They should be prepared to discuss things like shared-risk agreements with the health system. It’s true that the movement to value-based payment is occurring more slowly than payers and providers had anticipated, he said. “Value equals quality over cost. And you can’t talk about quality without talking about cost.”

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LEADERSHIP

Setting Them Up For Success A bad system will beat a good person every time By Lisa Earle McLeod

The waitress was late with the food.

She looked frazzled and frustrated. After she rushed off, we discovered the salad we requested with dressing on the side was doused in ranch. Clearly, she wasn’t a good server. Or was she? Edwards Deming said, “A bad system will beat a good person every time.” I’ll take it a step further; a bad system will chip away at your soul. Bad systems can turn even the most enthusiastic workers into frustrated, poor performers.

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LEADERSHIP Paying the price for systemic failures Let’s go back to our waitress. The food was late because the kitchen was short staffed that day. Our server had noted salad dressing on the side in the order system. But the salad was mixed before they got to the expo station. The food runner saw dressing on the side, so he added another container of ranch to our plate. As for being frazzled, wouldn’t you be if half your orders were late, and customers were complaining about dressing? If you’ve ever waited tables, you’ve no doubt experienced this for yourself. The front line often pays the price for systemic failures.

employees would promise to look into it, and fail to call back. Further investigation revealed that employees were making notes with the intent of getting back to customers. Yet as the day wore on, and the tasks piled up, they never circled back. After it sat for a few days, the employees either forgot about it, or were too embarrassed to call back. The leadership team assumed it was a training and accountability issue. If the top performers could do it, clearly something must be wrong with everyone else. After watching the team for an afternoon, I saw the problem. The top performers had created workarounds to ensure they never lost track of client issues. One woman put Post Its across her wall, another kept his client to do’s on a yellow pad. There was no systemic way for people to log notes, and have them pop back up until they were handled. It’s easy to say people should create their own systems, but individual systems can’t scale. One of my friends used to keep a birthday daybook. She was great about sending everyone a nice note on their special day. In terms of birthdays, she was a top performer. I always felt guilty not being that kind of friend. Now, thanks to Facebook reminders, my good intentions can scale. Mediocre me is now a top performer in the birthday category. If you want your team to excel at scale, look at your systems. Whether it’s dressing on the side, scheduling patient appointments, or how you handle inventory, ask yourself, is my system setting my team up for success? A bad system will beat a good person. A great system will help all the good people be great.

As you look at your own organization, be it your workplace or your home, ask yourself, are your systems set up to help people be their best, or do they create obstacles? As you look at your own organization, be it your workplace or your home, ask yourself, are your systems set up to help people be their best, or do they create obstacles? As a consultant, I frequently see organizations try to solve problems by training employees or trying to get better employees. In many cases the issue is the system. Recently, we were working with an organization where customer callbacks were a problem. A few employees were great at calling clients backs. But, more often than not, when customers called in with problems, the

Lisa Earle McLeod is a sought after keynote speaker who has rocked the house everywhere from Apple to Peterbilt Trucking. McLeod is known for her cutting edge ideas, practical techniques, and inspirational humor. She is the author of 4 bestselling books, in 4 genres: leadership, sales, personal development and a collection of humor essays. For more information, visit https://www.mcleodandmore.com

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NEWS

Industry news Henry Schein Medical expands SolutionsHub with GreenLight Behavioral Assessments Henry Schein Medical announced the expansion of its SolutionsHub into the behavioral health space with GreenLight Behavioral Assessments, a cloud-based digital platform featuring patient administered behavioral assessments designed to enhance efficiency, improve clinical outcomes, and expand mental health offerings in medical practices. GreenLight features over 25 validated behavioral health assessments that simplify the process of identifying and monitoring the health conditions of patients. In addition to mental health assessments, GreenLight also provides a variety of substance use and social determinants tests, enabling a much wider dimension of patient care.

U.S. reported its highest measles case count in 25 years The latest preliminary reports provided to the World Health Organization (WHO) show that there have been more measles cases in the first six months of 2019 than in any year since 2006. There have been almost three times as many cases reported to date in 2019 as there were at this same time last year. This follows successive yearly increases since 2016, indicating a concerning and continuing upsurge in the overall measles burden worldwide, WHO said. The United States has reported its highest measles case count in 25 years. The Democratic Republic of the Congo, Madagascar and Ukraine have reported the highest numbers of cases this year. Major outbreaks are ongoing in Angola, Cameroon, Chad, Kazakhstan, Nigeria, Philippines, South Sudan, Sudan and Thailand. The largest outbreaks are in countries with low measles vaccination coverage, currently or in the past, which has left large numbers of people vulnerable to the disease. At the same time, protracted outbreaks are occurring even in countries with high national

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vaccination rates. This results from inequities in vaccine coverage, and gaps and disparities between communities, geographic areas, and among age-groups. When enough people who are not immune are exposed to measles, it can very quickly spread.

Masimo announces investment in pulmonary care company TNI medical AG Masimo (Irvine, CA) recently closed on a strategic investment with TNI medical AG (Würzburg, Germany), a privately held, commercial-stage medical device company. TNI’s novel softFlow technology is designed to provide high flow, warmed and humidified respiratory gases to spontaneously breathing patients suffering from pulmonary disease. The softFlow technology provides efficient and comfortable respiratory support by generating a precisely regulated, stable high flow of room air or a mix of room air and oxygen. The system, comprised of an integrated flow generator, respiratory circuit, and patient interface, operates without the need of pneumatic systems and can be used both in the hospital and at home. Terms of the acquisition were not disclosed.

New episode of Road Warriors podcast, featuring Gary Keeler In the newest episode of the Road Warriors podcast, Repertoire Publisher Scott Adams interviews Gary Keeler of McKesson. Scott and Gary discuss today’s healthcare environment and everything from Gary’s biggest challenges, to how the industry and national meetings have changed, as well as advice for people starting a career in healthcare sales. To listen to the podcast, download it on iTunes, access it via the RepConnect app, or visit www.repertoiremag.com/road-warriors-podcast-episode10-gary-keeler.html.


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