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April 2019 | Vol.15 No.2

Under Control

Contracting is a good place to shore up defenses against cyber criminals

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CONTENTS »» APRIL 2019 The Journal of Healthcare Contracting is published bi-monthly by Share Moving Media 1735 N. Brown Rd. Ste. 140 Lawrenceville, GA 30043-8153 Phone: 770/263-5262 FAX: 770/236-8023 e-mail: info@jhconline.com www.jhconline.com

Editorial Staff Editor Mark Thill mthill@sharemovingmedia.com Managing Editor Graham Garrison ggarrison@sharemovingmedia.com Art Director Brent Cashman bcashman@sharemovingmedia.com Publisher John Pritchard jpritchard@sharemovingmedia.com Director of Business Development Alicia O’Donnell aodonnell@sharemovingmedia.com Sales Executive Lizette Anthonijs Lizette@sharemovingmedia.com

Circulation Wai Bun Cheung wcheung@sharemovingmedia.com

The Journal of Healthcare Contracting (ISSN 1548-4165) 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: $48 per year. 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 Share Moving Media, 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.

4 Editor’s Note

36 What Can Supply Chain Be?

6 Capturing Real-World Evidence

40 The Short List

Data: The gateway arch Rachael Fleurence wants to harness digital data to evaluate the effectiveness of medical equipment and supplies

10 Captis: The Second Generation

‘The price at the pump is just the start,’ says VP Brenda Peterson

14 Under Control

Contracting is a good place to shore up defenses against cyber criminals

20 The Sepsis Puzzle

Sepsis disguises itself too well

Laurel Junk sees all kinds of possibilities Productive practices of successful supply chain leaders

42 HSCA

Prescription drug shortages: Some solutions

44 Calendar of Events 45 Elevate 2019 46 Breakthroughs 2019 48 Why Nice People Start Turf Wars 50 Industry News

30 Nothing but the Truth

The Journal of Healthcare Contracting | April 2019

Mercy believes that data is the only way to tie medical technologies with outcomes. Its trading partners agree.

EDITOR’S LETTER

Data: The gateway arch

Mark Thill

I feel most comfortable writing about things I can touch, feel and see. Stuff. Data is not one of those things. And yet that’s where many of our articles took us this issue. And I’m glad for it. For example, Rachael Fleurence, executive director of NESTcc (National Evaluation System for health Technology Coordinating Center), describes how she is tackling one of our industry’s – and our profession’s – most vexing problems: How to harness the wealth of digital data from electronic health records, insurance claims, registries, etc., to reliably evaluate the effectiveness and value of medical equipment and supplies. Doing so would be the Holy Grail of healthcare contracting. It won’t be easy, but Fleurence and NESTcc are working on it. Then we became aware of Mercy’s agreement with BD in January, which calls for the two to use Mercy’s clinical data platform to help evaluate and improve the effectiveness of medical devices and procedures, beginning with integrated vascular therapy and vascular access management. It wasn’t the first such agreement for Mercy and its vendors (or “collaborators, as Mercy President of Business Integration Vance Moore, prefers to call them). Said Moore, “I believe that traditionally, marketing has beaten science. Now we’re trying to make science beat marketing.” High-quality vendors – collaborators – are happy to join in. And our cover story on cybersecurity takes us into the darkest corners of the information age. The very strength of the Internet of Things – such as the connection between medical devices and electronic medical records – is its greatest vulnerability. Guarding our institutions from cybercriminals is now part of your job description. “There are no shortcuts [to achieving cybersecurity],” says Kevin McDonald, director of clinical information security for Mayo Clinic, and co-chair of the Joint Cybersecurity Working Group. “This is really one of those people, processes and technology things.” After wrapping up this month’s issue, I realized I had learned something important: Even though data may be vaporous, it can be a most reliable gateway to things that aren’t – like better medical devices and better outcomes.

The very strength of the Internet of Things – such as the connection between medical devices and electronic medical records – is its greatest vulnerability.

April 2019 | The Journal of Healthcare Contracting

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EXECUTIVE INTERVIEW

Rachael Fleurence

Capturing RealWorld Evidence Rachael Fleurence wants to harness digital data to evaluate the effectiveness of medical equipment and supplies Using real-world evidence – not just manufacturer-sponsored studies – to make decisions about the safety, efficacy and value of medical equipment and devices sounds simple and sensible. It does make sense. But simple? Not so much. But that isn’t stopping a group of researchers, health systems and manufacturers from exploring ways to collect and analyze real-world evidence about medical devices. Their work will very likely affect decision-makers at the U.S. Food and Drug Administration, vendors, and supply chain and contracting professionals. Clinical trials have always been – and remain – the gold standard for evidencegathering, because data is carefully collected, controlled and monitored. The problem is, such trials can be narrow in scope due to practical challenges (particularly, time and money). What’s more, they cannot always help regulators or providers predict how a medical device or piece of equipment will perform over time, after day-to-day usage. “Devices are often used in routine clinical practice for uses that are not within their cleared or approved indications for use,” pointed out the FDA in

August 2017, in its non-binding recommendations concerning the use of real-world evidence. “However, the knowledge gained from all uses of a device in medical practice is often not realized because the data collected are not systematically characterized, aggregated, and analyzed in a way that can be relied upon to inform regulatory decision-making.” The question is, how can regulatory agencies and healthcare providers harness the wealth of digital data from electronic health records, insurance claims, registries, etc., to reliably evaluate the effectiveness and value of medical equipment and supplies? That’s what the National Evaluation System for health Technology Coordinating Center (NESTcc) is working on. A Planning Board convened by the Duke-Margolis Center for Health Policy in late 2015 envisioned NEST as a voluntary network of data partners who could consolidate real-world evidence to inform medical device evaluation. In September 2016, the FDA awarded a grant for the NEST Coordinating Center to the Medical Device Innovation Consortium (MDIC), a non-profit, public-private partnership that works to promote patient access to innovative medical technologies. In April 2017, health economist Rachael Fleurence, PhD, was named executive director of NESTcc. She came to NESTcc with 15 years of research experience regarding health outcomes and cost-effectiveness, including seven years in the life sciences consulting industry. Just prior to joining NESTcc, she was a program director at the Patient-Centered Outcomes Research Institute, or PCORI.

April 2019 | The Journal of Healthcare Contracting

EXECUTIVE INTERVIEW

Demonstration projects The NESTcc demonstration projects are intended to address the following disease areas and corresponding products. Application

Project title

Disease area

Pre-market submission

Comparative effectiveness of alternative approaches for wound closure

Dermatology

Label expansion

Testing the use of real-world data from three unique sources to expand indications

Vascular

Label Expansion

The feasibility of using real-world data in the evaluation of cardiac ablation catheters

Cardiology

Label expansion

Real-world clinical outcomes in patients with mechanical heart valve replacement and anticoagulation variability

Cardiology

Label from general to specific indication

Feasibility of using real-world data to evaluate thermal ablation of liver tumors

Surgery

Postmarket surveillance

Testing the feasibility of registry and claims data linkages

Orthopedics

Postmarket surveillance

Developing capacity to conduct proactive post-marketing safety surveillance of craniomaxillofacial distractors using electronic health record data

Orthopedics

Capacity to Conduct Proactive Post Marketing Safety Surveillance of Craniomaxillofacial Distractors Using Electronic Health Record Data

Postmarket surveillance

Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Intervertebral Body Fusion Devices Using Electronic Health Record Data

Orthopedics

For a description of each test case, visit: https://nestcc.org/test-cases/

Not just any data set Health systems collect real-world patient data every day, many for internal purposes, such as quality control, says Fleurence. In some cases, they may share that information with a specific device or equipment manufacturer. But NEST is interested in using real-world data for research purposes, she says In that case, the data collected must be of a higher quality. “You can’t just use any data set; it needs special attention.” NESTcc is collaborating with 12 providers and payers, representing almost 200 hospitals and 4,000 outpatient clinics, all of whom are capable of generating high-quality data. In February 2018, Fleurence and NESTcc announced eight demonstration projects, or test cases, involving those collaborators and industry partners. Participants are exploring how they can share real-world

data efficiently and cost-effectively, and how they can overcome the many challenges in doing so, including the lack of Unique Device Identifiers (UDIs) and the inconsistency in patient-reported outcomes. The projects are being executed through collaborations with industry partners Abbott, Adhesys Medical, Johnson & Johnson Medical Devices Companies, and W.L. Gore & Associates, Inc. In addition to the manufacturers, the American Academy of Orthopaedic Surgeons (AAOS) is serving as a neutral convener, bringing together DJO Global, DePuy Synthes, Smith &

April 2019 | The Journal of Healthcare Contracting

NESTcc collaborators NESTcc is growing its relationship with network collaborators to advance the use of Real-World Evidence (RWE) generation and foster collaboration with stakeholders across the medical device field. To date, memoranda of understanding (MOUs) have been signed with 12 network collaborators. Together, they represent more than 195 hospitals and 3,942 outpatient clinics. Network collaborators have access to over 494 million patient records, and available data sources include electronic health records (EHRs), pharmacies, public and private claims, registries, and patient-generated data.

Nephew, Stryker, and Zimmer Biomet for a test case that will bring together NESTcc Network Collaborators with the American Joint Replacement Registry (AJRR) which is housed at AAOS. “It definitely is possible” to overcome the challenges of compiling and analyzing real-world data, says Fleurence. “We’re in a transition phase, from the old world to the new world. We will reach a point where this will be done seamlessly, and we will have data to analyze how patients are doing with specific implants, for example. “Will every institution be at the same level at the same time? No. But we are seeing bright spots – examples of studies that were not possible before. And that will keep scaling up. It’s definitely happening. “We are building NEST to answer questions for a number of different parties – first, the FDA, industry and payers, but also patient groups and health systems, so they can determine the value and effectiveness of the medical devices they are using,” she continues. “We haven’t prioritized the question, ‘How can supply chain use real-world data when selecting medical devices and equipment?’” she says. “But we are building NESTcc so that, ultimately, providers will be able to answer that question directly.”

The Journal of Healthcare Contracting | April 2019

• Duke University Health System • HealthCore • Lahey Hospital & Medical Center • Mayo Clinic • MDEpiNet • Mercy Health • STAR • University of Florida Health System • PEDSnet • Vanderbilt University Medical Center • Weill-Cornell Medicine • Yale New Haven Health System

A definition of terms Real-world data (RWD) are data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources. Examples include data derived from electronic health records (EHRs), claims and billing data, data from product and disease registries, patientgenerated data including in-home-use settings, and data gathered from other sources that can inform on health status, such as mobile devices. Real-world evidence (RWE) is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD. Under the right conditions, data derived from real-world sources can be used to support regulatory decisions. RWD and associated RWE may constitute valid scientific evidence depending on the characteristics of the data, though it doesn’t replace FDA’s regulatory-decisionmaking evidentiary standards Source: “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” U.S. Food and Drug Administration, Aug. 31, 2017

RPC PROFILE

Captis: The Second Generation ‘The price at the pump is just the start,’ says VP Brenda Peterson

In September 2017, the Upper Midwest Consolidated Services Center, a regional purchasing coalition, with headquarters in Minnesota, changed its name to Captis, which comes from the Latin word meaning “to influence,” “to hold the attention of,” “to captivate.” Given the RPC’s growth from its founding in 2008, the name makes sense. That’s because in 2008, Captis comprised just 10 health systems; by 2011, it had grown to 34; and today, 85 members generate an annual purchasing volume exceeding $9 billion. And it no longer is just an Upper Midwest affair. Captis has members in 26 states, from California to New York to Florida. And things continue to change. In fact, Captis has given a name to its change initiative – Captis 2.0. That said, a couple of things have remained constant. For example, the RPC is managed – as it has been since 2008 – by Vizient. And, just as it did in 2008, Mayo Clinic, a founding member of Captis, provides sourcing and contracting services.

Contracting is key Vice President and General Manager Brenda Peterson began her healthcare career in nursing, and managed the startup of a home infusion therapy service line for a national DME company in the Twin Cities. She received an MBA with a specialization in healthcare from the University of St. Thomas in 1995. For nine years she served on the board of a local community hospital, which she regards as an important career experience. She joined VHA (now part of Vizient) in 1998, and stepped into the company’s Upper Midwest region in the

mid 2000s. In 2007, she found herself working with a team on the creation of an RPC. “We worked on it for nine months – at least,” she recalls. Contracting remains a core part of Captis’ mission. Captis members are involved throughout the sourcing and contracting cycle and ultimately approve every contract contained in the Captis portfolio, explains Peterson. Six functional bodies are in place for decision-making, including the Board of Managers, Business Development Committee, Clinical Committee, Finance Committee, Operations Committee and Pharmacy Council. Each plays a crucial role in the Captis structure and governance. Captis manages 300 contracts, which cover about 95 percent of its members’ needs in commodities, and clinician- and physician-preference items. The RPC pursues primarily suppliers who have been awarded a national contract with Vizient. “We have gotten creative in the past few years addressing supply chain issues unique to regional pockets of our members,” says Peterson. “So far, we haven’t met a challenge we haven’t been able to overcome. “Our mature processes include information-gathering and analysis by a team of analysts dedicated to Captis,” she continues. “In addition, we enlist the Mayo Clinic Clinical Quality Value Analysis team for the clinical review of products, and also assemble physicians and subject matter experts to serve as champions or advisory panelists/council members. Providers across our 26 states also provide clinical feedback to our sourcing and contracting team. All of the information

April 2019 | The Journal of Healthcare Contracting

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RPC PROFILE

gathered from our stakeholders is collated and defines the contracting strategy we ultimately bring to market.”

Captis 2.0 In 2014 Captis’ board of managers approved Captis 2.0, a program designed to deliver value beyond sourcing and contracting. “Captis members know that the price at the pump is just the start,” says Peterson. “Ultimately, it’s about utilization.” The mission of Captis 2.0 includes: • Achieving improvements collaboratively that are improbable when systems act alone. • Evaluating product and service consumption. •O perating activities previously performed by suppliers and members. • Pursuing value of all kinds (cost savings, utilization savings, clinical enhancements, growth enablement, capital allocation and funding, revenue enhancement, etc.) “These programs include clinical leading practices, utilization, standardization, supply chain efficiency enhancement and innovation as well as pharmacy cost reduction,” she says. “Program ideas receive rigorous evaluation by the Captis Business Development Committee, other committees and the program management office.” In 2018 alone, Captis 2.0 programs generated $53.7 million in savings and more than $5.4 million in program revenue. A blood management program, for example, was created to align Captis members’ clinical behavior with protocols supported by evidence-based national blood standards. The goal is to reduce usage and complication rates. In 2017, the Captis Custom Procedure Tray program embarked on a mission to reduce the number of components used, and to increase consistency across the Captis membership. With the support of the Mayo Clinic Quality Value Analysis (CQVA) Team, 281 components were reviewed on behalf of the membership and formulary products identified. Over the course of the year, Captis, its members and its CPT supplier reduced by 34 percent the number of unique components used, and garnered an associated $500,000 in member savings. In another project, the Pharmacy Council and Finance Committee revised the billing methodology and reduced pharmacy program fees for 88 percent of Captis members. Two cost-avoidance initiatives were identified, formulary products were instituted and utilization was managed, and helped Captis members avoid more than $10 million in drug costs.

Virtual item master Captis reveal™ is a data-sharing resource developed with aptitude LLC, which allows contracted suppliers to see their market share in a monthly updated, web-based app, at the SKU level, and by each member. In addition, suppliers can see their competitors’ market shares. In other words, the data-sharing “reveals” the total product market, by item, by each individual member, and by respective share. It includes each facility’s consumption patterns by the same criteria. Members can use the same information to identify opportunities for additional savings through contract optimization. In February 2019, Captis members chose Vizient to create a centralized and automated item master tool for a supply chain innovation program. The virtual item master will contain item description data and the associated information for all items in inventory. This creates a common dictionary and data repository for all members, allowing translation from the Captis item master to their local systems. After the item master is intact, additional capabilities, such as inventory management, will be vetted. This could include visibility into inventory levels among network members. Captis has several strategic initiatives underway: • Continue to grow membership with a focus on cultural fit while allowing flexibility and choice of membership type. • Increased participation in the Captis portfolio. • Identification of new programs, alternative membership options and new revenue models. Says Peterson, “We will continue to deliver value across the membership through the expansion of our portfolio, cost/savings improvement, and reduction of waste through utilization, standardization, increased clinical effectiveness and operational efficiency.”

April 2019 | The Journal of Healthcare Contracting

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MC14605

Under Control

Contracting is a good place to shore up defenses against cyber criminals

Had you been at the big healthcare technology expo – HIMSS 2019 – this winter, you would have noticed a few things. For example, about 400 people attended the all-day Cybersecurity Forum on Monday, Feb. 11. You would have seen that the Cybersecurity Command Center – where vendors of technologies designed to protect your organization against cyber adversaries – was much bigger than last year’s. And you would have had your pick of about 70 sessions on cybersecurity, some with unsettling titles, including: • “Dealing with the tsunami of unmanaged devices.” • “Levers of human deception.” • “Buried under an avalanche of medical device special snow flakes.” • “I will hack your laptop in 30 seconds.” “We’re seeing more awareness and resources going to the Internet of Things,” says Kevin McDonald, director of clinical

information security for Mayo Clinic (and presenter of the “avalanche” session at HIMSS 2019). Medical devices are at the center of it, which means supply chain executives are too. In addition to his work at Mayo, McDonald is co-chair of the Joint Cybersecurity Working Group, a standing group of the Healthcare and Public Health Sector Coordinating Council. In January 2019, the group published its “Medical Device and Health IT Joint Security Plan.”

No silver bullets Technology no longer exists in a silo, says McDonald. Rather, it interacts intimately with clinical processes – often multiple processes. Think of infusion pumps, ventilators or ICU telemetry. That’s a lot of technology, and a lot of devices and equipment. “There are no shortcuts [to achieving cybersecurity],” he says. “This is really one of those people, processes and technology things,” which demands ongoing cooperation

April 2019 | The Journal of Healthcare Contracting

among those in contracting, IT, biomed and the clinical staff, not to mention vendors. “Integrating cybersecurity into an organization necessitates organizational and process changes that come with considerable time and monetary investments,” the Working Group concluded. Its Joint Security Plan is intended to provide a framework for making necessary organizational and process-related changes. It’s true that some software firms have developed tools to help providers identify the devices and equipment that present risks. But these tools aren’t silver bullets, says McDonald. “The main thing that the software does is to listen to the communications on your network and, from the messages the devices send, infer what the device is. Some of the more mature companies that are doing this can have a pretty high identification rate based upon what they have ‘profiled’ in the past, but specialized devices may come back with no or limited information. “These are good tools and serve a purpose, but they are limited by what is in the network messages sent and the communication patterns,” he continues. “The rest of the value comes from how the company can augment it with additional data from other sources.”

Your priorities Nor will such software prioritize devices based upon risk, he adds. “Risk needs to be based upon the inherent risk of the device, what additional compensating controls you can

put in place, the threats the hospital may have, and what the patient impact of a vulnerability would be.” No facility has the resources to thoroughly assess and monitor the cybersecurity risk associated with every piece of equipment and every device in its possession. Only by developing a robust prioritization program can inroads be made. And common sense can help, says McDonald. For example, a piece of equipment that produces ionizing radiation, which has the potential to harm patients, would be a higher priority than, say, an automated blood pressure cuff. Resources are available to help with prioritizing a facility’s cybersecurity activity. One example is the Australian Cyber Security Centre, which is the Australian government’s lead on national cybersecurity. It has identified what it calls the “Essential Eight,” that is, eight activities which, if implemented, can eliminate a large portion of a facility’s cybersecurity risk. These “Essential Eight” can be implemented even by smaller facilities: 1. Application whitelisting, to control the execution of unauthorized software. 2. Patching applications, to remediate known security vulnerabilities. 3. Configuring Microsoft Office macro settings, to block untrusted macros. 4. Application hardening, to protect against vulnerable functionality. 5. Restricting administrative privileges, to limit powerful access to systems.

How about that legacy equipment? Addressing the cybersecurity of medical devices and equipment at the time of acquisition is one thing. But monitoring and minimizing the risks over the life of that equipment is another. In its “Medical Device and Health IT Joint Security Plan,” published in January 2019, the Joint Cybersecurity Working Group summed up the dilemma: The relatively short lifespan for operating systems and other relevant platforms such as commercial off-the-shelf software is inherently misaligned in health care, as medical devices and EHRs may be utilized for 10, 15, 20, or more years. This misalign-

The Journal of Healthcare Contracting | April 2019

ment may occur for a variety of reasons. Hospitals operate on thin budgets and cannot replace capital equipment like MRIs as quickly as new operating systems are released. Product vendors have a product development lifecycle that may take several years, and they may start development using one operating system and by the time the product comes to market, newer operating systems may be available. Creative ways of addressing the aforementioned challenge areas may be found by engaging key clinical and cybersecurity stakeholders, including software vendors.

CYBERSECURITY 6. Patching operating systems, to remediate known security vulnerabilities. 7. Multifactor authentication, to protect against risky activities. 8. Daily backups, to maintain the availability of critical data. Other examples include the work done by the Center for Internet Security (https://www.cisecurity.org) and the Healthcare Sector Coordinating Council (https://healthsectorcouncil.org).

Contracting A strong, well-thought-out contract with medical device and equipment vendors can be an important, early line of defense against cyber criminals. Monitoring cybersecurity “should be built into your purchasing process,” says McDonald. It needs to be another bullet point in the process, just as an RFP. “Make sure the tollgates or controls are in place. That’s the only way I’ve seen it work well.

Ask your vendor Vendors of medical devices and equipment should provide customers with security documentation to enable risk assessments, to identify security controls, and to better protect their systems. The following are examples of the types of information that may be included in documentation of security for medical devices or health IT: •P roduct description. (Basic description of function.) • Hardware specifications. (List of hardware components and specs.) • Operating systems. (List of hardware operating systems and versions.) • Third-party software. (Also referred to as a “bill of materials,” includes a list of third-party software and version numbers. Should be provided upon purchase and after significant software or hardware upgrades.) • Network ports and services. • Sensitive information and data transmitted (including personally identifiable information and protected health information.) • Sensitive information and data stored (including personally identifiable information and protected health information.) • Network and data flow diagram (showing system components, types of connectivity, types of data in transit and rest, and how these are secured). • Malware protection. (Anti-malware measures available.)

•P atch management. (Describes and recommends method by which vendor maintains, provides and deploys patch updates.) •A uthentication and authorization. (Describes and recommends the controls that customers have with user’s authenticating and granting permissions to features and functionality, including the ability to disable user accounts.) •N etwork Controls. (Firewall rules, browser Internet access restrictions, etc.) • E ncryption. (Describes and recommends where and how encryption is applied on the system.) •A udit logging. (Describes audit logging process, who has access to audit logs, etc.) • Remote connectivity (e.g., ports, protocols, URLs). • Service handling. (Describes routine maintenance performed by service personnel, including security policies and procedures they follow.) • End-of-life and end-of-support. (Describes when product will no longer be sold, updated and supported.) • Secure coding standards. • System hardening standards. • Risk summary. (Summary of risks found within a penetration test, remediation report, or other topics and compensating controls that correspond to additional risks outlined in the product security white paper.)

Source: Medical Device and Health IT Joint Security Plan, Healthcare & Public Health Sector Coordinating Councils, January 2019 (https://healthsectorcouncil.org/wp-content/uploads/2019/01/HSCC-MEDTECH-JSP-v1.pdf)

April 2019 | The Journal of Healthcare Contracting

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CYBERSECURITY “It doesn’t work with individual heroics.” The Joint Security Plan urges vendors of devices and equipment to create and distribute to customers what it refers to as “customer security documentation,” which describes all pertinent security information related to their products, including a software “bill of materials,” data flow diagrams and patch management plans. “Customers … are responsible for processing vendor-provided customer security documentation to complete questionnaires, agreements, and/or risk assessments during product procurement phases, and incorporating results into a risk management platform as well as an asset management platform for ongoing management,” according to the authors of the Plan. When researching device and equipment purchases, providers can narrow down their cybersecurity-related questions using various standards that are available, including that from the ISO, says McDonald.

Often-used standards are ISO 80001(Application of risk management for IT-networks incorporating medical devices, https://www.iso.org/standard/44863.html) and AAMI TIR 57 from the American National Standards Institute (https://www.aami.org/productspublications/ProductDetail. aspx?ItemNumber=3729). The latter standard was developed

“ Monitoring cybersecurity should be built into your purchasing process.” by the Association for the Advancement of Medical Instrumentation and is called Principles for Medical Device Security. “It’s doable, but it can’t be fit it in over someone’s lunchtime,” says McDonald. “The way to make it work is to make someone responsible for the outcomes.” At Mayo Clinic, these are the people working in McDonald’s areas of information security and specialized areas in clinical equipment. “You really need to fit this into your institution’s processes.”

Via an online survey in February, the Journal of Healthcare Contracting readers responded to questions about cybersecurity.

Question

Weighted Avg

In your opinion, how much of a threat (from a cybersecurity point of view) do medical devices and equipment present to your organization, your patients, your staff? (1 is none, 4 is very much).

2.81

When you are considering acquiring a new piece of equipment or a new device, how important is cybersecurity to you? (1 is not at all, 4 is very much).

3.16

To what extent do you rely on someone within supply chain to assess the cybersecurity-related risks of a medical device or piece of equipment? (1 is not at all, 4 is very much)

1.81

To what extent do you rely on someone in another department (e.g., IT) to assess those risks? (1 is not at all, 4 is very much)

3.71

How much do you rely on your GPO to assess the cybersecurity-related risks of devices/ equipment? (1 is not at all, 4 is very much)

1.93

How much do you rely on the vendor to inform you of the safety (from a cybersecurity perspective) of its device or equipment? (1 is not at all, 4 is very much)

3.0

In your opinion, how effective are the steps you and your organization have taken to ensure the safety (i.e., cybersecurity) of new devices/equipment? (1 is not effective, 4 is very effective)

2.71

In your opinion, how effective are the steps you and your organization have taken to ensure the safety (i.e., cybersecurity) of legacy devices/equipment? (1 is not effective, 4 is very effective)

2.50

April 2019 | The Journal of Healthcare Contracting

TRENDS

The Sepsis Puzzle Sepsis disguises itself too well

But oftentimes, early identification and treatment fail to occur. “The signs of both infection and organ dysfunction may be subtle and difficult to recognize in older adults with multiple comorbidities,” says Roberts. “Fever may be absent. There is a lower incidence of tachycardia and hypoxemia. Confusion, delirium, weakness, falls, anorexia, and incontinence may be symptoms of sepsis, but they can be non-specific in older adults.” What’s more, in long-term-care facilities, it’s often a certified nursing assistant (CNA) – not a professional nurse – who is at the bedside with the resident, and the CNA may not recognize these subtle changes in a resident’s medical condition as an early sign of sepsis, she adds.

What it isn’t … and what it is

Sepsis: It’s subtle, and deadly. It offers some clues of its existence, but you have to be watching for them. Early diagnosis is essential to stop it in its tracks. Sepsis impacts between 900,000 and 3 million people in the United States each year, according to Terri Lee Roberts, BSN, RN, CIC, FAPIC, senior infection preventionist for the Pennsylvania Patient Safety Authority, who has written and spoken extensively about the subject. Over a two-year period (April 2014 – March 2016), 486 potential occurrences of sepsis with 17 potential sepsis-related fatalities were recorded for residents in long-term care in Pennsylvania, she says. With a mortality rate of 15 percent to 30 percent, it is a leading cause of death in the United States. Adults age 65 years or older are five-fold more likely to have sepsis than younger adults (6.5 percent vs. 1.3 percent), and nursing home residents are seven-fold more likely to have sepsis, compared with sepsis rates in adults not residing in a nursing home (14 percent vs. 1.9 percent). Eighty percent of sepsis cases occur outside of the hospital. “Over 70 percent of patients who present with sepsis will recover if treatment is initiated on a timely basis and pursued aggressively,” says lab expert Jim Poggi, principal, Tested Insights, Providence Forge, Virginia. “The key is early diagnosis and initiation of treatment, typically with broad spectrum antibiotics and fluid replacement therapy.”

“First of all, a couple of things sepsis is NOT,” says Poggi. “It is NOT a disease and it is not contagious. While its onset is a complication of an infection, sepsis is the body’s overwhelming and life-threatening response to the infection.” While any infection can lead to that life-threatening response, some have a higher association with sepsis, says Poggi: • Respiratory infections including pneumonia, group A streptococcus and influenza. • Urinary tract infections. • Enteric (GI) diseases, including C. difficile. • Skin infections, including MRSA. • Blood stream infections (bacteremia).

April 2019 | The Journal of Healthcare Contracting

In 2016, the Third International Consensus Definitions for Sepsis and Septic Shock defined sepsis as the development of systemic inflammatory response syndrome (SIRS) in addition to a documented or presumed infection, continues Poggi. SIRS symptoms include: • Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F). • Heart rate of more than 90 beats per minute. • Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2 ) of less than 32 mm Hg. • Abnormal white blood cell count (>12,000/µL or < 4,000/µL or >10% immature [band] forms).

• Complete blood count with differential. • Serum lactate. • Procalcitonin. • Metabolic and organ panels, including Basic Metabolic panel, AST, ALT, creatinine and urea nitrogen. “Recent advances in molecular assays that can diagnose a variety of pathogens within hours have substantially improved speed of result for bacterial identification,” says Poggi.

“ It’s the team members who spend the most time with the resident – not just licensed professionals – who can best recognize subtle changes in a resident’s condition.” –Terri Lee Roberts

The Sepsis Alliance – a nonprofit organization dedicated to raising awareness of sepsis – uses an acronym to define typical patient conditions that can lead to a presumptive diagnosis of sepsis: • S: Shivering, fever or very cold. • E: Extreme pain or discomfort. • P: Pale or discolored skin. • S: Sleepy, difficult to rouse, confused. • I: “I feel like I might die.” • S: Shortness of breath.

Procalcitonin is a newer assay that is highly correlated to sepsis as well as its progression, he continues. Procalcitonin concentration is < 0.15 ng/ml in normal patients, but quickly rises in concentration with severity of the disease process (0.15-2.0 ng/ml for mild bacterial infections and > 2.0 ng./ml for sepsis). In addition, the procalcitonin test can be performed within hours rather than days.

Diagnosis

In the public eye

On the laboratory front, sensitivity, specificity and speed of available tests have presented challenges, says Poggi. CBC tests, including elevated WBC and decreased platelets, are sensitive but non-specific. The same is true of lactate and C-reactive protein. While microbiological cultures can identify specific organisms, routine plated media methods have lacked the speed needed to support a rapid diagnosis.

Awareness of sepsis among the public is higher than ever, but there is more work to be done, says Roberts. A 2012 incident involving a 12-year-old boy in New York drew national attention to sepsis. On March 28, 2012, the boy, Rory Staunton, scraped his arm diving for a ball in gym class. No one recognized the early signs of sepsis and he was misdiagnosed with dehydration. By the time he was diagnosed with sepsis, it was too late, and Rory died on April 1. His death was a springboard for a discussion about the seriousness of sepsis. The Centers for Disease Control and Prevention (CDC) launched a comprehensive campaign targeting clinicians and the public on how to prevent sepsis, how to identify risk factors, how to recognize warning signs, and why medical attention should be sought immediately, as sepsis

Lab diagnostic tools include: • Blood, wound or urine culture. • Molecular testing for specific pathogens.

The Journal of Healthcare Contracting | April 2019

TRENDS

is a medical emergency. The CDC wanted people to ask the question, “Could this be sepsis?” says Roberts. “Sepsis Alliance has done a great job of raising awareness that people who were otherwise healthy have succumbed to this syndrome,” says Roberts, who has had personal experience with sepsis. About 10 years ago, her

10-year-old nephew almost died from sepsis after developing an infection from a splinter of mulch under his fingernail. Several days passed before the infection – and resulting sepsis – was finally identified, and he is healthy today.

Rory Staunton’s story The parents of 12-year-old Rory Staunton have done much to raise the public’s awareness of sepsis. They tell his story on the website of the Rory Staunton Foundation for Sepsis Prevention. “In March 2012, our son Rory was a strong, 5-foot-9-inch, 169-pound, 12-year-old boy, living a life full of laughter and love. … On Wednesday March 28, 2012, Rory dived for a ball during gym class at the Garden School in Jackson Heights, NY, and cut his arm. The gym teacher did not send him to the nurse, who was on duty in her office, but instead applied two band-aids. He did not clean Rory’s wound. After midnight Rory woke up moaning with a pain in his leg. We coaxed him back to sleep and the following morning he had a fever of 104.” The pediatrician diagnosed a stomach virus that had been making its way around New York. “She advised us to take him to the hospital for re-hydration and fluids, she said he would have diarrhea the next day and the virus would run its course. Dr. Levitsky assured us there was ‘nothing to worry about.’ “We made our way to the ER department at a major New York medical institution, where the doctors said Rory’s discomfort was caused by a sick stomach and dehydration. They gave him two bags of intravenous fluids. Three vials of blood were drawn and he was given a prescription for an anti-nausea drug called Zofran. “The pediatrician at the hospital who examined Rory wrote ‘pt improved’ on his chart before discharge. She said it was a stomach virus and that Rory could take up to a week to recover. “We brought Rory home on that Thursday night; he fell into a deep sleep but the following morn-

ing Friday, he continued to complain of pain. We repeatedly called his pediatrician … and told her Rory wasn’t eating and we couldn’t control his temperature with Tylenol or Motrin. We brought Rory back to hospital on Friday evening and this time they admitted him to the ICU. He was gravely ill. “Rory was fighting a serious infection. This infection had been in his blood when we brought him to his pediatrician and to the hospital on Thursday. Bacteria had entered his blood, through the cut on his arm. Rory was in septic shock. “When we brought Rory to his pediatrician and the emergency room on Thursday night, he was in fact fighting for his life. Critical information gathered by his pediatrician and at the hospital that night had not been viewed as important. In fact, Rory’s vital signs had worsened before he left the emergency room on Thursday night. “The blood values that the doctor ordered stat (immediate) were not viewed by the hospital doctor who ordered them. The laboratory in the hospital had flagged Rory’s blood as showing an abnormality within an hour of Rory’s arrival there, but there was no system in place and no one took the time to alert the emergency room with this information. When the critical value tests returned showing Rory was extremely ill, we had already left the hospital. “The hospital made no attempt to follow up with us, his family, to inform us that he was seriously ill. Our pediatrician did not follow up with the hospital on Friday when we called her with our concerns that he was not improving. “Rory fought valiantly to survive throughout Friday and Saturday but it was too late. On Sunday evening, Rory died.”

April 2019 | The Journal of Healthcare Contracting

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ENVIRONMENT OF CARE

INTERVENTIONAL CARE

TRENDS

Sepsis: After the hospital stay Sepsis is the leading cause of death of hospital patients, and half of survivors do not completely recover, with a third of those dying in the following year and a sixth experiencing severe, persistent physical disabilities or cognitive impairment. In one study, only 43 percent of previously employed patients returned to work within a year of contracting septic shock and only 33 percent of patients living at home prior to contracting sepsis returned to living independently by six months following their discharge. University of Pittsburgh and University of Michigan medical scientists studied the issue and developed recommendations for post-hospital recovery care. “We need to focus not only on saving the patient’s life, but on ensuring the patient will have the best possible quality of life after leaving the hospital,” said Derek Angus, M.D., M.P.H., chair of University of Pittsburgh’s Department of Critical Care Medicine, and an author of a recent article about sepsis in the Journal of the American Medical Association.

Angus and lead author Hallie Prescott, M.D., M.Sc., assistant professor of pulmonary and critical care medicine in University of Michigan’s Institute for Healthcare Policy & Innovation, recommend three strategies to prevent long-term disabilities: • High-quality early sepsis care that includes rapidly following protocols to help the patient fight infection, managing pain through light sedation that allows for the patient to be awakened and reoriented daily, and encouraging early mobility while the patient is still hospitalized. • Post-discharge assessment and treatment that gets patients into rehabilitation with physical, occupational and speech therapy shortly after discharge, and quick referral to therapists if new impairments develop. • Screening of patients for conditions that may have been present prior to hospitalization, such as high blood pressure, and tailoring post-discharge medications to account for individual patients’ increased susceptibility to new complications.

Screening for sepsis Although anyone can get an infection, and any infection can lead to sepsis, some people are at higher risk of infection and sepsis, says Roberts. They include: • Adults 65 or older and children less than 1. • People with chronic medical conditions such as diabetes, lung disease, cancer, and kidney disease. • People with weakened immune systems, such as those who have had a solid organ transplant, people who are on long-term steroid therapy or taking chemotherapy. Additionally, immune function decreases with age. Because of the difficulty in identifying sepsis, a long-term-care-specific sepsis screening tool may help to optimize safety in this population, she says. INTERACT’s “Stop and Watch Early Warning Tool” or the Minnesota Hospital Association’s LTC-specific “Seeing Sepsis Tool Kit” to facilitate early detection of sepsis are available for healthcare providers to use. “I am

“While its onset is a complication of an infection, sepsis is the body’s overwhelming and life-threatening response to the infection.” – Jim Poggi

often called upon to provide education regarding the early detection of sepsis in all healthcare facility types, whether it be through professional conferences, statewide/multistatewide webinars, or in-person presentations,” she adds. Judicious use of an electronic health record can help. “The EHR has the strong potential to improve the detection of sepsis early by

April 2019 | The Journal of Healthcare Contracting

collecting and organizing the clinical data required to make the diagnosis,” says Roberts. More specifically, a facility’s EHR system could collect vital signs and laboratory test information on patients, triggering a “sepsis alert” for those with the facility’s defined parameters, such as ≥2 SIRS (systemic inflammatory response syndrome) criteria (fever, tachycardia, tachypnea, leukocytosis) plus ≥1 major organ dysfunction (SBP ≤ 90 mm Hg, lactic acid ≥2.0 mg/dL). “A facility could incorporate their chosen sepsis screening tool into their EHR system, and a positive screening could trigger a ‘sepsis alert,’” she adds.

Reprinted with permission of the Minnesota Hospital Association

Communication Screening and early detection are just the beginning. Without good communication among the long-term-care team, little action may result. “Because the sepsis syndrome is comprised of a constellation of signs and symptoms, and because no one test can identify sepsis, the healthcare team must communicate effectively and timely to recognize the signs of early sepsis and implement evidence-based therapies to improve outcomes and decrease mortality,” says Roberts. “Healthcare providers – not just LTC team members – may have different communication styles. Differences in training, cultural differences, culture barriers, etc., may lead to lack of communication, miscommunication, or ineffective communication.” Exacerbating the situation are high turnover rates among CNAs, decreased continuity of care, and the fact that many clinicians are not onsite to be able to communicate with the rest of the healthcare team directly. “It’s the team members who spend the most time with the resident – not just licensed professionals – who can best recognize subtle changes in a resident’s condition,” she says. “When I worked in a facility as an infection preventionist, I made everyone my front-line ‘infection prevention eyes.’ “I would tell them, ‘If you see something you don’t think is right, tell someone.” She recalls a situation where an environmental services staff member recognized that one patient – a 16-year-old boy – was acting differently. Over about 12 hours, the patient had lost his interest in video games and didn’t want to talk, as he had before. It turns out the boy had indeed developed sepsis. But he was treated in time to save his life. “Everyone plays a role.”

Editor’s note: INTERACT® (Interventions to Reduce Acute Care Transfers) is a quality improvement program from Pathway Health (www.pathway-interact.com) that focuses on the management of acute change in resident condition. It includes clinical and educational tools and strategies for use in every day practice in long-term care facilities.

The Journal of Healthcare Contracting | April 2019

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April 2019 | The Journal of Healthcare Contracting

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CONTRACTING PROFESSIONALS REVISITED

What Can Supply Chain Be? Laurel Junk sees all kinds of possibilities Laurel Junk is excited about what sheâ&#x20AC;&#x2122;s doing, almost 10 years after joining Kaiser Permanente and seven years after being named Contracting Professional of the Year by the Journal of Healthcare Contracting in 2012.

Laurel Junk

April 2019 | The Journal of Healthcare Contracting

She sees the potential for supply chain to play a key role in supporting affordable healthcare to all, improving outcomes, and addressing the tough issues facing some communities, such as a lack of accessible healthcare, scarcity of fresh food, lack of affordable housing, even violence. “When I arrived here in 2009, I knew the opportunities around supply chain were big,” says Junk, senior vice president of enterprise shared services, Kaiser Permanente, Oakland, California. “Reflecting back, I don’t think I appreciated how big they were. “The basics of an efficient supply chain hold for us as they do for any industry, and we have put the fundamentals in place. But today, I see that was just a drop in the bucket of what supply chain can really mean.” Prior to joining Kaiser Permanente, Junk served as vice president of supply chain and contract manufacturing at biotech firm Amgen. Previous positions include vice president, global supply chain for Johnson & Johnson’s Medical Device & Diagnostics Division, as well as leadership roles in supply chain, finance, and systems at IVAC Medical Systems and Eli Lilly & Co. In her current role, Junk has responsibility for supply chain, national facilities services, clinical technology, security and more. She identifies ways to leverage Kaiser Permanente’s size and scale. And she has plenty of material to work with. As of Jan. 1, 2019, the system had 694 medical offices and 39 hospitals. Last year it opened 12 medical offices across the country, including the LEED Gold-certified Downtown Commons Medical Office in Sacramento and the Skyport Medical Office in San Jose. Additionally, Kaiser Permanente is actively designing and constructing more than 50 new medical offices, which are scheduled to open in the next three years.

The Journal of Healthcare Contracting | April 2019

The system also added eight retail clinics in Target stores across Southern California last year, with plans to open nine more in 2019.

Affordability agenda “Central to our shared services strategy is our affordability agenda,” says Junk. “How do we make ourselves more affordable to the people who have to pay premiums?” Working alongside the clinical team, supply chain is an important part of that effort. “We can’t – and won’t – tell our physicians what products to use,” she says. “We believe that product selection starts with the right clinical product.” Supply chain and the medical staff agree on the importance of being evidence-based. “Our challenge is bringing the right information to the table to demonstrate what’s working well in one part of the organization, and what might be an improvement in another area. “As long as it’s evidence-based, doctors are hungry for information. In fact, they push us with, ‘How can we get more relevant data?’”

“ The basics of an efficient supply chain hold for us as they do for any industry, and we have put the fundamentals in place. But today, I see that was just a drop in the bucket of what supply chain can really mean.” Since 2012, Junk has accomplished many of the goals she laid out for herself, including deployment of a single-instance ERP system for purchasing and inventory management. Other accomplishments include: • Transportation centralization. In 2012, about 1,500 vehicles criss-crossed the Kaiser Permanente system, run by many different organizations, she says. “Nobody was overseeing how things moved across the system.” Bringing all that under one roof was an early win for supply chain. “Now we’re taking it beyond transportation centralization, to ‘logistics

CONTRACTING PROFESSIONALS REVISITED

optimization,’” she says. “How do we optimize all the supply chains within Kaiser Permanente?” • Med/surg distribution. In 2017, Kaiser Permanente switched its primary med/surg distributor. It was a “pretty audacious” move, says Junk, given that it involved converting 45,000 products. But it has proven to be a worthwhile one, she adds. • Healthcare Transformation Group. Kaiser Permanente was one of five healthcare systems to form HTG in 2010, the others being Geisinger Health System, Intermountain Healthcare, Mayo Clinic and Mercy. “We have helped move the needle on GS1 standards,” which assign unique numbers to trading partners as well as items at all levels of packaging. “And that sets the table for evidence-based medicine, which supports quality care for our members.”

Enterprise shared services Junk believes that her supply chain experience allows her to see tremendous opportunities in enterprise shared services. “When you look at supply chain, we can do the tactics really well, and that’s important,” she says. “But now we’re asking ourselves, ‘How can we really drive our mission?’ One thing that immediately comes to mind is our initiative for total health spend optimization. “We’re looking at our $20 billion spend and asking, ‘How can we drive more of that into our communities and build local economic engines?’” Supporting diverse suppliers is one way. And using local contractors to build clinics in underserved communities is another. “We have a beautiful medical facility in Los Angeles that will support people in the community, but that also employed local construction talent.” Kaiser Permanente CEO Bernard Tyson has challenged everyone in the system to look at how the system’s assets can be used to improve health in the communities served, she adds. That’s especially important in low-income areas, whose citizens lack access to high-quality care. In Oakland, Kaiser Permanente is working with community partners to connect local urban food producers to FoodService Partners, a company that provides meals for hospitals, schools, stores and other institutions. Fruit and vegetables are grown hydroponically (that is, in water instead of soil), while fish are stocked

“When you look at supply chain, we can do the tactics really well, and that’s important. But now we’re asking ourselves, ‘How can we really drive our mission?’”

“If you expand your mind, there are brilliant people out there, all trying to figure out, ‘How can we make lives better for everybody?’” and farmed in an aqua pond. Food is prepared daily and shipped to local healthcare facilities. “It’s sustainable, and it will have a huge community impact – at least 300 jobs,” says Junk. “And we won’t pay any more for the food than we do through our normal distribution network.” First in supply chain, now in shared services, Junk sees many opportunities to have an impact on healthcare. And she encourages young people to consider supply chain as a career. “Healthcare is undergoing dramatic change in ways that will help solve issues like food deserts, and helping people live longer by offering them support and better healthcare,” she says. “A lot of young people are looking for purpose as well as financial stability. They can do that in healthcare supply chain. If you expand your mind, there are brilliant people out there, all trying to figure out, ‘How can we make lives better for everybody?’”

April 2019 | The Journal of Healthcare Contracting

TRENDS

No. 1: Align your team to the system objective(s) and understand the decisionmaking process to achieve the departmental contributions for those objectives

The Short List Productive practices of successful supply chain leaders

The Journal of Healthcare Contracting and a group of experienced industry veterans put their heads together to create a short list of things that supply chain leaders can do to make this year their best (and most productive) yet! John Pritchard, Joe Walsh, and Kreg Kofford presented this advice in a webinar sponsored by Vantage Point Logistics (VPL).

Everyone can improve, but sometimes that’s hard to see when it seems like everything is already going right. To truly thrive, you need to avoid getting complacent because of your success. If your primary goal is to run the most efficient and optimized supply chain around, then you aren’t thinking strategically and aren’t doing anything to progress or unlock the potential of the supply chain. On the other hand, its also not good to get so focused on finding and implementing new “best practices” and innovations that you’re no longer aligned with the goals of your organization. Stay aligned with your organization’s objectives by meeting with the key leaders of the different business units to understand challenges and perspectives. Familiarize yourself with the organizational metrics that are used – including those outside your department. Once you can speak their language, you can better align all the departments to reach the collective objectives. For instance, if you’re talking with a chief medical officer, be sure to couch things in terms of clinical-value. If you’re talking to a CFO, you might want to try talking in terms of economical value.

No. 2: Know your numbers and have spend transparency Lots of small inefficiencies can lead to large decencies. That is why data consolidation a critical step to making

April 2019 | The Journal of Healthcare Contracting

insights and spend transparency easier to get to. Analyze the data to understand the breakdown of not only the spend of supply chain, but of the overall organization. This will allow you to identify the greatest areas of opportunity. If all you’re doing is trying to squeeze more value out of the same categories, you will only reap smaller and smaller benefits. Look for new areas where you can see and affect major change. Kreg Kofford While it is important to focus on current spend, it is perhaps more important to look at future spend. And remember – previous spend is not a good preJoe Walsh dictor of future spend!

No. 3: Filter out best practices As an industry, we are sometimes guilty of getting a pack-mentality when it comes to innovation – we all want to do the same thing at the same time. But every organization is unique and faces unique challenges. Just because a big and influential IDN rolls out a brilliant new initiative, that doesn’t mean your organization can or even should attempt to emulate it. (Having a central distribution center is great for a system that has the space to implement it – but a IDN in the middle of Manhattan should probably look for another idea) When you’re looking at a bunch of good ideas, you might be tempted to try them all. Instead, filter through the best practices out there to find the ones that apply to your organization and figure out how to develop and implement them in a way that works for you. Otherwise you get bogged down, sidetracked, and start wasting some very good tools on the wrong solution.

The Journal of Healthcare Contracting | April 2019

No. 4: Find some quick wins Finding an area where you can get some quick success is great – it’s even better if you can use the story of that success to elevate your supply chain. And that’s all down to using good storytelling techniques. Storytelling is so powerful because it’s a way of organizing facts and data to give someone context. Story engages emotions, which engages the brain in a different and more memorable way than just going through rows of data. (Case in point: You can probably tell anyone about the basic story

Just because a big and influential IDN rolls out a brilliant new initiative, that doesn’t mean your organization can or even should attempt to emulate it. of a movie you saw once, a decade ago. But you probably couldn’t accurately list off more than one or two numbers from your most recent budget meeting.) And just as important as it is to strategically use those quick wins to elevate your department, as a leader, you also need to make sure that you’re taking time to celebrate those wins and the people who helped bring them about.

No. 5: Remind your system that suppliers aren’t the enemy Evaluate your suppliers and take time to foster good relationships with a few of the important and exceptional ones – you’ll be able to show both your own organization the value of having good partners, as well as providing a model for other vendors to try to strive for. Work on moving away from having only transactional relationships with your vendors. Turn them into supplier partners. Take a leap in the direction of those key suppliers to leverage their expertise and let them bring additional value to your organization. Shift the conversation away from “Who gets what percentage of the pie,” to a conversation about how you can work together to collectively create value. This has nothing to do with what they can sell you, but they have resources they are more than willing to deploy against your problem statements, your opportunity statements, and your initiatives – if you let them in. You’ll find that they’re more than willing to do it, you just have to be willing to extend that trust. To listen to the recent webinar download the MP3 at https://www. vantagepointlogistics.com/what-can-supply-chain-leaders-do-to-makethis-year-their-best-and-most-productive-year-ever/

HSCA

Prescription drug shortages: Some solutions Across the country, ongoing critical prescription drug shortages continue to jeopardize patient access to medications and treatments. These shortages are multifaceted and are the result of a number of issues, including manufacturing delays or natural disasters like Hurricane Maria, creating further hardship for patients and providers alike. As the Food and Drug Administration (FDA) has repeatedly noted, drug shortages are a complex issue caused By Todd Ebert by quality problems, manufacturing delays, and capacity difficulties, and one that requires a multi-stakeholder solution. As the sourcing and purchasing partners for America’s acute and longterm healthcare providers, healthcare group purchasing organizations (GPOs) play an important role in helping healthcare stakeholders prevent and mitigate drug shortages. And in pursuit of finding a multi-stakeholder

solution, the Healthcare Supply Chain Association (HSCA) and its GPO members participated in a drug shortage working group composed of leading healthcare provider organizations – including hospitals, health-system pharmacists, physicians, GPOs, and other supply chain stakeholders – to develop policy proposals to help prevent and address drug shortages in a comprehensive manner. Together the group worked to develop key policy steps the FDA could take, including:

April 2019 | The Journal of Healthcare Contracting

FDA should encourage early drug shortage alerts and ongoing multistakeholder communications. FDA should encourage all stakeholders in the market, including providers, manufacturers, wholesalers, GPOs, and others, to communicate with the FDA as soon as a potential shortage situation is identified, and continue to share information as available. FDA and others should continue working to improve inter-agency communication and cross-agency coordination in shortage situations, such as the injectable narcotic shortage that occurred earlier this year, which required involvement of both the FDA and the Drug Enforcement Administration (DEA). Encouraging early and ongoing communication is critical for mitigating risk and reducing the likelihood of shortage situations.

FDA should enhance transparency requirements for drug shortage information. FDA should require the reporting of accurate and timely information regarding shortages, including anticipated duration, supplier information about what drugs are manufactured at which plants and where those plants are located, and other disclosures, to ensure that all stakeholders take the most effective steps toward addressing drug shortages and ensuring uninterrupted, quality care for patients. The goal for policy solutions should be to ensure that all parties operate under good, complete and timely information.

FDA should strengthen drug shortage disclosures. Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA) should be strengthened to require notifications to include disclosure of the problem

causing the interruption, the extent of the shortage, and the expected duration of the shortage. Failure to provide timely notice of a drug shortage should result in a monetary penalty for the manufacturer. Also, manufacturers should be required to report current or anticipated supply concerns, including issues pertaining to the production or acquisition of raw materials. The information provided should be collated and organized by the FDA into a source on its website and easily accessible by the public.

FDA should expand its drug shortage list. The FDA should expand its list of drug shortages to incorporate shortages included on other lists – such as the drug shortage list maintained by American Society of Health-System Pharmacists

As the sourcing and purchasing partners for America’s acute and long-term healthcare providers, healthcare group purchasing organizations (GPOs) play an important role in helping healthcare stakeholders prevent and mitigate drug shortages. (ASHP) – to ensure a comprehensive and current list of drug shortages is being used. A more complete list can be used to help determine appropriate prioritization and will include more information that is needed to mitigate shortages – e.g., information on 503B compounders. The FDA’s list fails to take into account drugs that are in shortage based on their administration form and dosage, and does not include drugs that are experiencing significant regional shortages. An expanded list would enable feedback from providers that are on the front line. HSCA, its member GPOs, and all other members of the drug shortage working group will continue to work together to find solutions and ensure consistent patient access to essential medications.

Todd Ebert, R.Ph., is president and CEO of the Healthcare Supply Chain Association.

The Journal of Healthcare Contracting | April 2019

Send all upcoming events to Graham Garrison, managing editor, at ggarrison@sharemovingmedia.com

CALENDAR

AHRMM AHRMM Conference & Exhibition July 28-31, 2019 San Diego, Calif.

Intalere Elevate 2019 May 13-16, 2019 Gaylord Rockies Denver, Colo.

GHX Supply Chain Summit April 29 – May 1, 2019 JW Marriott San Antonio Hill Country Resort & Spa

Premier Breakthroughs Conference & Exhibition June 18-21, 2019

Health Connect Partners Spring ’19 Hospital Supply Chain Conference April 29 - May 1, 2019 Miami, Fla.

Nashville, Tenn.

Share Moving Media Fall ’19 Hospital Supply Chain Conference September 23-25, 2019 Kansas City, Mo.

IDN Insights East May 16-17, 2019 Nashville, Tenn.

HealthTrust HealthTrust University Conference August 12-14, 2019 Nashville, Tenn.

IDN Summit Spring IDN Summit & Reverse Expo April 8-10, 2019 Omni Orlando Resort at ChampionsGate Orlando, Fla. Fall IDN Summit & Reverse Expo September 9-11, 2019 JW Marriott Desert Ridge Resort and Spa Phoenix, Ariz.

National Accounts Summit November 14-15, 2019 Atlanta, Ga.

Vizient Vizient Spring Connections Summit April 2-5, 2019 Aria, Las Vegas, Nevada

Vizient Fall Connections Summit September 16-20, 2019 The Wynn, Las Vegas, Nevada

April 2019 | The Journal of Healthcare Contracting

Elevate 2019 Elevate 2019 – Intalere’s largest member and supplier event – will be held May 13-16 at the Gaylord Rockies Resort & Convention Center in Denver, Colorado. In addition to numerous education tracks, more than 300 suppliers will be on hand for efficient networking. Highlights include a keynote address from Alison Levine, polar explorer, mountaineer and best-selling author; the Intalere Healthcare Achievement Awards; and entertainment from musician, singer and songwriter Gavin DeGraw. www.intalere.com

The Journal of Healthcare Contracting | April 2019

CALENDAR

Breakthroughs 2019 Premier’s annual Breakthroughs Conference and Exhibition will be held June 18-21 at the Gaylord Opryland Resort & Convention Center in Nashville, Tennessee. At the exclusive member event, attendees can select from more than 150 sessions offered in more than 25 different educational tracks. Continuing

More than 500 suppliers will exhibit at the supplier trade show. education credits are available through several organizations, including the Association for Healthcare Resource & Materials Management. More than 500 suppliers will exhibit at the supplier trade show. And, as in years past, the Innovation Celebration will give members a chance to learn about cutting-edge companies. Premier will recognize member and supplier organizations with the following top performance awards: • QUEST® Award for High-Value Healthcare. • Supply Chain Excellence Award. • Supply Chain Innovation Award. • Supplier Legacy Award. • Supplier Horizon Award. • Supplier Diversity Award. • AEIX Risk Management Award.

April 2019 | The Journal of Healthcare Contracting

D E N W O N D I REACHING 4,400 IDN EXECUTIVES, 2,400 HOSPITAL EXECUTIVES AND 700 GPO DECISION MAKERS. CALL US FOR MORE INFORMATION:

LIZETTE ANTHONIJS

770-263-5266 e-mail: Lizette@sharemovingmedia.com

LEADERSHIP

By Lisa Earle McLeod

Why Nice People Start Turf Wars 48

Steve knew he was facing a challenge. As he walked into the budget meeting, he squared his shoulders and took a deep breath. The facts were on his side. Now it was time to convince the rest of the senior team, and, most importantly, his CEO. The challenge at hand was the marketing budget. For the last two budget cycles, Steve had been shorted. Or at least thatâ&#x20AC;&#x2122;s how he perceived it. His budget had been cut to the bone while the IT and Operations budgets grew.

April 2019 | The Journal of Healthcare Contracting

This time he was ready. Armed with data about market share and competitive spending, he wasn’t going to let his department go underfunded again. His team was counting on him. Steve was relatively new to the senior leadership team. He’d only had a few years as a manager before he’d gotten promoted. But one thing he learned early on was, good leaders fight for their people. For Steve it was all about his team.

If the leader wants to get everyone going in the same direction, the senior team’s primary alliance must be to each other, and their collective goals. The problem was, Steve was fighting for the wrong team. If you ask most leaders who their team is, they’ll tell you it’s their direct reports. Yet in more successful organizations, a leader’s first alliance is to the larger team. In Steve’s case, that was his peers and the CEO.

Danger of silos Patrick Lencioni, author of the classic book “The Five Dysfunctions of a Team,” says, when

team members put their individual needs or even the needs of their divisions above the collective goals of the team it creates inattention to results. A leadership team with 10 agendas is never as effective as a leadership team focused on one agenda. Steve is like many well-intended leaders. He cares deeply about his people, and he also cares about the organization’s success. Increasing the marketing budget may be the right thing to do. But Steve’s approach, even if he wins, will only accelerate siloed thinking amongst the team. In my experience, turf wars are silos with emotion. The original cause is almost never malice. The eventual war is the all too natural result of the three common conditions:

No. 1: The expertise trap The VP of marketing is unlikely to know much about IT. Steve is playing in the space he knows, the area he was assigned.

No. 2: Personal connections Most leaders spend more time with their direct reports than their peers. In Steve’s case, he’s relatively new to the role. When you’re in a new job one of the first things you do is connect with your team. Steve has probably been so busy leading his own team he hasn’t built strong relationships with his peers, who he likely only sees at big group meetings.

No. 3: Lack of holistic leadership Because the first two conditions (above) are almost always a given, leaders have to be relentlessly proactive in aligning their teams against the larger organizational goals. If Steve’s boss goes around the table at meetings discussing individual goals and budgets, that’s what people are going to focus on. If the leader wants to get everyone going in the same direction, the senior team’s primary alliance must be to each other, and their collective goals. Putting department agendas aside in favor of team goals requires trust. Leaders must have confidence their peers are in it for the team, not simply jockeying for themselves. The biggest challenge is, no one wants to go first. But when teams are brave enough to trust each other, and let go of their divisions, there’s nothing they can not do.

Lisa Earle McLeod is a leading authority on sales leadership and the author of four provocative books including the bestseller, Selling with Noble Purpose. Companies like Apple, Kimberly-Clark and Pfizer hire her to help them create passionate, purpose-driven sales organization. Her NSP is to help leaders drive revenue and do work that makes them proud.

The Journal of Healthcare Contracting | April 2019

NEWS

Industry News Industry leaders launch Healthcare Transparency Initiative (HTI) Several leading healthcare companies and providers – including BD Healthcare Solutions, Trinity Health, and University of Vermont Health Network, as well as Resilinc announced the launch of the Healthcare Transparency Initiative (HTI). HTI is a unique cross-industry collaboration focused exclusively on leveraging data with artificial intelligence (AI) and data science to improve supply chain transparency, lower risks and reduce disruptions in healthcare supply chains in order to improve patient outcomes. HTI will immediately drive lower costs by creating a shared ecosystem and improving visibility and transparency across the healthcare value chain, leveraging AI and data science. The initiative is powered by Resilinc’s trusted platform and healthcare supply chain data, which offers unique transparency and insights for the industry today.

Beaumont Health, Henry Ford Health System both seek new hospitals in Oxford Beaumont Health (Royal Oak, MI) and Henry Ford Health System (Detroit, MI) have both submitted plans to construct new hospitals in Oxford, MI. Beaumont wants to build a $140 million, 117-bed hospital; and Henry Ford plans a 116-bed, $160 million hospital. Only one hospital will be approved because the Michigan Certificate of Need Commission determined that Oxford is a “limited access area” that needs only an additional 117 hospital beds to meet local residents’ healthcare needs.

IL governor signs bill to add funding for critical access hospitals Illinois Governor JB Pritzker signed SB 1469 to strengthen critical access hospitals in rural communities. The bill will provide $55 million in funding for critical access hospitals throughout the state. It will allow them to hire more doctors and nurses, expand treatments and services, and

provide additional care, the governor said. “Healthcare is a right, not a privilege. Your income or your ZIP code should never dictate your access to that right,” the governor said during a visit to Ferrell Hospital (Eldorado, IL). “Critical access hospitals are on the front lines of our work to provide quality healthcare in all of our communities.”

UPMC breaks ground on new UPMC Vision and Rehabilitation Tower UPMC broke ground on the new UPMC Vision and Rehabilitation Tower at UPMC Mercy. The facility is part of UPMC’s $2 billion investment in specialty care. The 410,000 square-foot, nine-story tower is projected to open in late 2022. The state-of-the-art facility also will offer gene and cell therapies to treat diseases of the eye. Other vision services for patients will include high-resolution imaging and state-of-the-art ocular testing, laser-assisted cataract surgery, micro-invasive ocular surgery and more than 25 scientific teams developing the therapies to fight blindness. In addition, an urgent care eye clinic for eye and vision emergencies with extended hours where patients can access ophthalmologist specialists directly.

LifePoint Health appoints two division presidents LifePoint Health (Brentwood, TN) named Sandra Podley as Western Division president and Robert Wampler as Mountain Division president. As president of the Western Division, Podley will lead hospitals in Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington and Wyoming. She most recently served as SVP of hospital operations at Presbyterian Healthcare Services (Albuquerque, NM). As president of the Mountain Division, Wampler will oversee hospitals in Arkansas, Iowa, Kansas, Louisiana, Mississippi, Oklahoma, Tennessee, Texas and Wisconsin. He is the former interim Western Division president at LifePoint, a role he has held since November 2018.

April 2019 | The Journal of Healthcare Contracting

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