Marrying Reimbursement with Technology - A Multi-function Ventilator that Measures Outcomes

Miriam Lieber: President, Lieber Consulting

Nick Macmillan: Director, Market Access and Strategy, Ventec Life Systems Please Complete Your Evaluation Everyone should have received an evaluation form upon entering the session. Please complete evaluation form and turn in to room monitor as you exit the session. Or, you can complete your evaluation in the mobile app. Locate the session in the app and tap on the clipboard icon to begin the survey. Please help us keep the Medtrade Education sessions the best in the industry by completing an evaluation for every session you attend! Your feedback is very valuable to us and will be used in planning future Medtrade events!

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#Medtrade19 Marrying Reimbursement with Technology - A Multi-function Ventilator that Measures Outcomes

Objectives: 1. Learn what a multi-purpose ventilator is and how to utilize a comprehensive E0467 billing checklist to ensure proper payment. 2. Receive detailed instructions for multi-purpose ventilator (E0467) documentation. 3. Track utilization trends and patterns for value-based care and strong communication with stakeholders. Presenters Miriam Lieber • Miriam Lieber is an independent consultant and trainer specializing in homecare reimbursement and operations management. Ms. Lieber’s clientele includes, home health care companies, managed care organizations, hospitals, wholesalers, pharmacists and manufacturers. She is known to have practical approaches to complex reimbursement matters and assists her clients with the nuts and bolts of running a profitable business. Nick Macmillan • Healthcare executive with extensive clinical, managerial, and executive experience in multiple business environments, from start-ups to multi- national organizations. Proficient in hospital and home care services, business operations, product development and management, sales and marketing, and education. Agenda

• Multi-Function Ventilator (VOCSN) • PDAC Review • Reimbursement: – Medicaid, Medicare and Commercial Payers • Detailed Documentation and Billing Instructions • FAQs • Value-Based Care and Data Trending • Value Proposition • Summary VOCSN is the first device to integrate five machines into a single unified respiratory system

6 © 2019 Ventec Life Systems Confidential and Proprietary Typical Respiratory Equipment Ventilator patients usually require numerous medical devices

7 Benefits of Integrated Care

SIMPLE MOBILE CARE CHANGING • Intuitive touchscreen • Five therapies in one device • Switch between therapies operation • 70% lighter and smaller than with the touch of a button • Single integrated Ventec- five devices • Uninterrupted ventilation One circuit • Up to 9 hours of on-board between therapies • Software enabled updates battery • Designed to reduce the risk of and data capture • 100G impact protection with infection • Quick and easy setup case • Up to 3x quieter

device to learn device to transport circuit for all therapies device to clean device to charge touch to operate 1 alarm to silence 1 power supply to carry 1device to monitor VOCSN is Simple, Mobile, and Care Changing

8 © 2019 Ventec Life Systems Confidential and Proprietary Clinical Advantages of E0467 Compliance with prescribed therapies • The seemingly simple act of disconnecting from one device and connecting to another device, as occurs with suctioning or separate cough assist devices, can often be neglected by patients and caregivers due to the time required by the caregiver, anxiety of the patient, and concerns about safety for both. The VOCSN Multi-Function Ventilator permits multiple therapies through the same circuit, mitigating these concerns, and improving compliance with therapies that are critical to my patients’ outcomes. Decreased risk of mistakes • These susceptible patients experience multiple dynamic care needs. This device is designed to reduce a patient’s and/or caregiver’s equipment anxiety, confusion or errors with a single, easy to use operating system. It’s not uncommon for mistakes to lead to unplanned healthcare encounters, adding increased demands on an already burdened healthcare system. Increased patient mobility • Patients and caregivers are often challenged with the challenge of packing and moving multiple medical devices when traveling outside the home, including work, school, and regular healthcare visits. The VOCSN Multi-Function Ventilator with a single battery and power cord greatly facilitates the ability of patients to travel with all physician ordered therapies. Improved patient monitoring and trending data • The VOCSN Multi-Function Ventilator is the first system to trend data for all five therapies providing a more complete and holistic view of the patient. This data can improve my ability to proactively address exacerbations, reduce complications, prevent hospital readmissions and other unplanned healthcare encounters, and decrease overall costs. Less regulatory and administrative burden • A significant amount of time is exhausted through documenting and substantiating the therapies provided by multiple respiratory devices, each with differing criteria and forms. By combining devices, the Multi-Function Ventilator not only decreases front-line administrative burdens on physicians but may also result in cost savings for payers by decreasing the number of prescribed devices, duplicative claim submissions and the costs of processing those claims.

9 © 2019 Ventec Life Systems Confidential and Proprietary Provider Advantages of E0467 Streamlined Payer and DME Billing • By combining devices the payer and DME communities may recognize cost savings by decreasing payer processing load and costs by decreasing the number of claim submissions and claim submission errors

Greater access to all five therapies • One of the key challenges to National Competitive Bidding (NCB) is that multiple DME suppliers could win varying bids, i.e. one supplier wins oxygen while another receives suction and nebulizers. This creates an enormous coordination of care burden. • Because the multi-function ventilator in not competitively bid AND it combines the most common therapies required for the ventilate patient, access and care coordination challenges are mitigated.

Higher reimbursement rate, uncapped • The fee schedule amounts for code E0467 are established using the Medicare fee schedule amounts for ventilators and the average cost of the additional functions performed by multi-function ventilators. • Consequently, reimbursement is higher for E0467 in all Medicare jurisdictions and in many Medicaid jurisdictions when compared to ventilation alone.

Single ownership schedule • VOCSN integrates five separate devices including a ventilator, oxygen concentrator, cough assist, suction, and nebulizer into one unified respiratory system. • That takes inventory management, service contracts, and warranty management burdens from five to one. • And once one rental episode is complete, the DME can furnish the equipment to other beneficiaries for separate rental periods.

Not part of competitive bidding • E0467 is not part of the competitive bidding process nor does Ventec support any ventilator being included in the competitive bidding program.

10 © 2019 Ventec Life Systems Confidential and Proprietary Prior to 2019 No reimbursement mechanism for integrated devices

• Centers for Medicare & Medicaid Services (CMS) has not provided a mechanism for devices that integrate multiple types of Durable Medical Equipment (DME) into one device, to receive reimbursement using a single Healthcare Common Procedure Coding System (HCPCS) reimbursement code. Consequently, that would mean that under traditional rules, VOCSN would only be allowed to be billed according to the ventilator. VOCSN would not be eligible for additional reimbursement for the oxygen, cough, suction or nebulizer therapies without a new rule from CMS.

[Ventec participated in numerous meetings to educate CMS policy makers on the need for a single code and the benefits of integrated care]

Jan 1, 2019 New billing code (E0467) established to pay for VOCSN under Medicare

• CMS released the final 2019 payment rule announcing a new Medicare Part B reimbursement policy for multi- function ventilators, while at the same time the PDAC established a new billing code, HCPCS code E0467, effective January 1, 2019.

Present Medicaid and Commercial Payers are adopting E0467

• Several states and commercial payers are in varying states of adoption, including full adoption and payment, product review and scheduled face to face meetings with Ventec • Dialogue is ongoing with CMS to clarify E0467 “same and similar” guidelines

11 © 2019 Ventec Life Systems Confidential and Proprietary Reimbursement • Medicare – November 2018: CMS finalized and approved official coverage of multi-function ventilators: Effective January 1, 2019 – Medicare reimbursement for the E0467 is based on an average of all five functions, regardless of how many functions are utilized – Check reimbursement for your state here. • Medicaid – Thirty states covering, 5 more pending • Commercial Payers Current Medicare Coverage

Alaska Alabama Arizona Arkansas Colorado Connecticut Delaware Georgia

E0465/66 $899.78 $934.17 $1,099.02 $934.17 $934.17 $934.17 $1,099.02 $1,099.02 $1,099.02 $1,099.02

E0467 $1,156.50 $1,105.15 $1,267.29 $1,260.15 $1,116.35 $1,106.78 $1,287.06 $1,277.35 $1,275.43 $1,278.09

Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Maine Maryland

E0465/66 $962.16 $1,043.56 $942.52 $1,099.02 $934.17 $1,058.15 $1,099.02 $963.81 $1,022.06 $934.17

E0467 $1,209.84 $1,215.73 $1,115.14 $1,285.28 $1,105.48 $1,230.32 $1,270.87 $1,134.93 $1,203.85 $1,111.13

New Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Hampshire New Jersey

E0465/66 $1,099.02 $1,099.02 $1,099.02 $934.17 $1,024.49 $960.00 $1,062.13 $1,099.02 $1,099.02 $1,099.02

E0467 $1,284.07 $1,283.47 $1,271.19 $1,101.72 $1,198.01 $1,137.79 $1,234.30 $1,267.60 $1,278.34 $1,282.81

North South New Mexico New York North Carolina Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina Dakota

E0465/66 $1,059.43 $1,099.02 $1,099.02 $1,099.02 $1,099.02 $1,099.02 $1,077.07 $1,099.02 $934.17 $1,099.02

E0467 $1,225.88 $1,275.05 $1,270.87 $1,267.08 $1,283.18 $1,278.10 $1,247.69 $1,279.12 $1,104.48 $1,270.39

South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming

E0465/66 $1,099.02 $1,099.02 $1,099.02 $1,009.27 $964.37 $1,097.84 $934.17 $1,099.02 $940.60 $1,099.02

E0467 $1,270.39 $1,268.29 $1,270.26 $1,181.89 $1,143.69 $1,275.84 $1,106.66 $1,284.62 $1,126.86 $1,270.71

13 © 2019 Ventec Life Systems Confidential and Proprietary Currently 30 States: • Alaska Current Medicaid State Coverage • Arizona** • California* • Colorado* • Delaware*** • District of Columbia • Florida* • Idaho • Illinois • Indiana • Kansas • Kentucky • Maryland • Michigan* • Montana • Nebraska* • Nevada • New Jersey • New Mexico • North Carolina* • Oregon* • Pennsylvania* • Rhode Island • South Carolina • South Dakota • Texas Full Medicaid State Adoption in Blue • Utah Gray State Designations: • Virginia *Will consider via Prior Authorization (PA) or after first claim • West Virginia* **Will cover By Report (BR) • Wyoming* ***Manually Priced

14 © 2019 Ventec Life Systems Confidential and Proprietary Reimbursement

• Commercial Payers – Tell the story of cost savings, improved outcomes, and breadth of clinical, industry, and patient support – Proactive outreach and real time reactive response to billing issues Commercial Payer Targets

Successfully Billed E0467 Top Targets

16 © 2019 Ventec Life Systems Confidential and Proprietary Documentation and Billing Instructions

• Ventilators (including multi-function ventilators) are categorized by CMS under the frequent and substantially serviced category – Never caps - no purchase option – Rental includes all functional components, accessories, supplies, maintenance/servicing, and repairs – Requires documentation of continued medical need and continued medical use Documentation and Billing Instructions • Bill one code: HCPCS E0467 – The Multi-Function Ventilator performs at least one or more additional function: • I.e.: oxygen, cough assist, suction, and nebulizer – The beneficiary must also meet coverage criteria for those additional functions • Primary Medicare Guidance Documents that govern multi-function ventilator billing: – Two related bulletins document CMS expectations for claim processing. • MLN Matters Article • Change Request Related Medical Conditions Multi-function ventilator improves care for four major patient populations The multi-function ventilator provides invasive and non-invasive ventilation for patients weighing 5 kg and above. The multi-function ventilator includes additional DME therapies that ventilator patients will need as their conditions progress.

Patient Populations Requiring Additional DME Therapies When Representative Medical Conditions Home Ventilator Support Medically Necessary

ALS, Dystrophies (Myotonic, Duchenne, • Cough stimulator, suction, and nebulizer Neuromuscular Disease Becker, Limb-girdle), and Post-Polio • Some patients may require oxygen

• Suction and nebulizer Complete and incomplete spinal cord Spinal Cord Injury • Oxygen, cough stimulator if high injuries cervical or complete injury

Lung Cancer, COPD, Emphysema, Cystic • Oxygen, nebulizer, and suction Impaired Pulmonary Function Fibrosis, and Acute Respiratory Distress • Some patients may require a cough Syndrome (ARDS) stimulator

Complications of prematurity, • Oxygen, suction, and nebulizer Bronchopulmonary Dysplasia (BPD), Chronic Pediatric Conditions • Some patients may require a cough Lung Disease (CLD), Tracheal malacia, stimulator Cystic Fibrosis

19 © 2019 Ventec Life Systems Confidential and Proprietary Documentation and Billing Instructions

• Bill one code: HCPCS E0467 when… – A new ventilator patient qualifies for a ventilator and at least one of the additional functions (oxygen, cough, suction, nebulizer). • This includes beneficiaries that switch to Medicare from other payers – An existing ventilator customer has used cough, suction, and nebulizer for less than 13 months and oxygen for less than 36 months Documentation and Billing Instructions

• Bill one code: HCPCS E0467 when… – E0467 will be denied for same or similar if a beneficiary is actively renting any of the items that are included in the functionality of the multi-function ventilator in the same month, or if any of these items have capped in the last five years. These components include: • Oxygen • Nebulizers • Suction • Cough assist Documentation and Reimbursement Tools

• VentecLife.com/E0467 – Eligibility – Reimbursement • 2019 DMEPOS Fee Schedule – Ownership & Billing – E0467 Checklist – Multi-Function Ventilator Educational Webinar Multi-function Ventilator (E0467) Checklist (Source: van Halem Group) • Policies • Documentation to support medical necessity of ventilator • Documentation to support medical necessity of oxygen, nebulizer, cough stimulator, or suction pump • Additional documentation required • Take a look… FAQs • What happens if one of the five components breaks down? • What if a Medicare Part B patient has been using a nebulizer that has capped and now needs a nebulizer and ventilator? • How do we show continued need and continued use for a Medicare VOCSN patient? • If a patient is using the ventilator and cough assist components, is there a need to have medical necessity documentation for oxygen on file? • What type of chart/progress note information is needed to prove medical need? • When should I expect a same/similar denial? Value-Based Care VBC Models • Private organizations, public companies, and federal and local governments are searching for ways to transform health care in America • Alternative payment models, such as Accountable Care Organizations (ACOs) and incentives for decreased readmissions are being explored as payors transition away from the traditional fee-for-service model • These transformational models share the collective triple-aim: 1. Improve the patient experience of care (including quality and satisfaction), 2. Improve the wellbeing and health outcomes of populations, 3. Reduce the per capita cost of health care. Value-Based Care

Most common models: • Additional payments that support delivery systems reform • Episode-based payments • Population-based payments Value-Based Care Data is Key • Both payers and providers require a significant amount of data when operating alternative payment models • Programs need to both have and be able to share timely and accurate data in order to effectively administer an alternative payment model, and hold providers accountable for performance measures associated with those models • Existing systems do not provide adequate information about clinical outcomes, which many new payment and delivery system initiatives aim to track as part of their accountability structure Value-Based Care Keys to Success • Providers need to be ready to enter into new payment arrangements, both financially and clinically, and to be able to know what and how to make delivery system changes that achieve the goals of payment reform • Delivery systems consists of providers that are at different points along a continuum • Some providers are well resourced and capable of taking on alternative payment models with shared risk, while others operate slim or negative margins and struggle raising the capital needed to invest in important changes necessary to operate under an alternative payment model • Some states have the resources to hire external vendors that provide technical assistance to providers • Need to provide practices with transformation support, change management, and quality improvement • Need help to develop assessment reports, work plans, and to establish a quality improvement collaborative Back to that data thing: VOCSN Therapy Tracking - Validating Use and Benefit

Report Information Trending Summary Alarm Summary Therapy Use Overview Monitoring Details Therapy Log Alarm Log Event Log

29 © 2019 Ventec Life Systems Confidential and Proprietary Value Proposition

• Based on Keys to Success… – You now have new access to new data – Therapy Tracker has developing EMR capability bridging the care continuum chasm – A new reimbursement pathway (E0467) offers new tools for offering value-based care at decreased investment risk – New opportunity to re-engage payers with an outcomes focus, either locally or broader, i.e. CareCentrix – Start the conversation Summary

• There is great promise in value-based reform: Not only for patient care but for our industry • Improved delivery models and high-quality data are essential to alternative payment models • There is value in bringing stakeholders into the early planning process for designing alternative payment models • While implementing successful alternative payment models requires resources, advancing technology makes its reality within reach • Multi-payer reform is a major opportunity to drive value, but it’s not all or nothing (start with one payer) Marrying Reimbursement with Technology - A Multi-function Ventilator that Measures Outcomes Miriam Lieber: President, Lieber Consulting [email protected]

Nick Macmillan: Director, Market Access and Strategy, Ventec Life Systems 844.698.6276 (o) | 317.525.9500 (m) [email protected]