September 24, 2014

1. electronic Submission of Medical Documentation (esMD)electronic Determination of Coverage (eDoC) WorkgroupOxygen Concentrators and Portable Oxygen (OCPO) User Story Launch September 24, 2014

2. Sponsors & Support Pamela durbin, RN, BSN,CDS, ISSO Health Insurance Specialist, COR IICMS / OFM / Provider Compliance Group Dan Kalwa Health Insurance Specialist,CMS / OESS Michael Handrigan, MD Medical OfficerCMS / OFM / Provider Compliance Group Robert Dieterle, Initiative Coordinator Mark D Pilley, MD AAFP, AADEP, ABQAURP Medical Director Strategic Health Solutions, LLC Viet Nguyen, MD Chief Medical Information Officer Systems Made Simple, Inc. Sweta Ladwa, MPHProject Manager / Epidemiology ESAC, Inc. 2

3. Agenda / Presenter Robert dieterle Mark Pilley, MD SWETA LADWA, MPH Robert dieterle 3

4. Standards & Interoperability (S&I) Framework “…a collaborative community of participants from the public and private sectors who are focused on providing the tools, services and guidance to facilitate the functional exchange of health information.” Why use the S&I Framework? It is a robust, repeatable process that will help improve interoperability and adoption of standards and health information technology. http://siframework.org/whatis.html

5. Solution Development Lifecycle eDoC Phase Details • Challenge statement • Timelines and milestones • Goals and outcomes Charter Use Case • Create Use Case and User Stories • Actors and roles • Activity and Sequence diagrams • Dataset Requirements • Risks, Issues and obstacles • Sub-workgroup effort • Structured data requirements • Templates for data capture • Decision support Standards Harmonization • Identify candidate standards • Create data model(s) • Map data model(s) to candidate standard(s) • Identify gaps, barriers and obstacles • Work with SDOs to address gaps • Create implementation guide(s) • Identify pilot participants • Develop pilot / demonstration plan • Evaluate success • Modify Implementation guide(s) as required ImplementationGuidance & Piloting 5

6. Related S&I Framework Initiatives 6

7. eDoC Workgroup Structure 7

8. esMD Background Healthcare payers frequently request that providers submit additional medical documentation to support a specific claim(s). Until recently, this has been an entirely paper process and has proven to be burdensome due to the time, resources, and cost to support a paper system. Before esMD: Review Contractor Request Letter Phase I of esMD was implemented in September of 2011. It enabled Providers to send Medical Documentation electronically Phase 1: Doc’n Request Letter electronic Phase 2: electronic Paper Medical Record The ONC S&I Framework Electronic Submission of Medical Documentation (esMD) initiative is developing solutions to support an entirely electronic documentation request. Provider electronic 8

9. esMD Process Flow The overall esMD process can be divided into three steps: esMD Phase 1 esMD Phase 2 9

10. Electronic Determination of Coverage (eDoC) 10

11. eDoC General Workflow Patient LCMP / IDTF Physician Specialist / Service Provider Templates and Rules Payer 11

12. Oxygen Concentrator / Portable Oxygen (OCPO) 12

13. Improper Payment - OCPO • Highest Medicare Improper Payment for Service Types Billed to DME – Oxygen Supplies/Equipment • $1.2 Billion – 75.2% (CERT Improper Payments, 2013) • No Documentation – 0.3% • Insufficient Documentation Errors – 73.2% • Oxygen Concentrators (E1390) - $1 Billion – 75.6% Overpayment Rate • Claims Containing Errors – 68.1% (Medicare FFS 2013 Improper Payment Rate Report – Supplementary Appendices ) • 2006 Office of Inspector General (OIG) Report • “Medicare Home Oxygen Equipment: Cost and Servicing” • 2004 – Home Oxygen Equipment • 24% of all Medicare DME, Prosthetics, Orthotics and Supplies (DMEPOS) Costs • $2.7 Billion of $11.1 Billion total payments for DMEPOS

14. OCPO Definition 14

15. OCPO Reviews OCPO Reviews require Suppliers to submit: • Evidence of qualifying test results • Performed within 30 days before initial date of service (DOS) • Evidence of in-person visit with a treating physician • Performed within 30 days before initial date of service (DOS) • Detailed written order • NCD – Home Use of Oxygen (240.2) • Coverage requires patient testing when in the “Chronic Stable State” • All Co-Existing “Diseases or Conditions that can cause hypoxia must be treated sufficiently.” • Patient “Must have a severe lung disease”:e.g.; • “COPD, diffuse interstitial lung disease, cystic fibrosis, bronchiectasis, widespread pulmonary neoplasm, or hypoxia-related symptoms or findings anticipated to be improved with Oxygen Therapy.” 15

16. OCPO Reviews OCPO Reviews require Suppliers to submit: • Certificate of Medical Necessity (CMN) • Completed, signed, and dated by the treating physician • May act as a substitute for detailed written order • CMS Form 484 (DME form 484.03) • Proof of Delivery • Any other medical documentation to support the LCD requirements 16

17. OCPO – Order Requirements OCPO – Detailed Written Order (DWO) • Detailed Written Order • The detailed written order must include: • Patient name; • Detailed description of the items being provided, including: a. The means of oxygen delivery, b. The specifics of varying oxygen flow rates and/or non-continuous use of oxygen, and c. The length of need; • Treating physician’s signature and date order signed; and • Start date of the order (only required if the start date is different from the signature date) • . 17

18. OCPO Definition 18

19. OCPO Submission Methods OCPO Documentation submission methods • Mail – USPS, FedEx, UPS • Fax – to secured site • CD/DVD - Password Protected • esMD – via HIH 19

20. Types of Review • Order Validation – New • Prepay Review - Ongoing • Post-pay Review - Ongoing 20

21. Request Process for OCPO Visits Physician/ Practitioner – Opt Office / ED Hospitalized for Respiratory Failure / Exacerbation of COPD / Pneumonia, etc. – Medical Documentation substantiates Requires &/or Benefits from Supplemental O2 Beneficiary IDTF/Hosp/Home Orders ABGs, Oximetry, 6-minute walk, PFTs, VO2 Max, etc. Refers for Sleep Study • Documents the in person visit or F2F visit in Medical Documentation, (progress note, medical record, Hospital H&P/Dismissal Summary/Transfer Sheet ) • Must include: • Diagnosis supporting need for OCPO, Exam findings, Required Testing Ordering Physician/Practitioner Writes, signs, and dates DWO and Completes the CMN • Submits Documentation Package including: • In person visit or F2F visit • DWO • CMN • POD • Other Supporting Documentation Receives/Files F2F visit progress note, DWO, and CMN Completes OCPO Delivery Obtains Proof of Delivery (POD) Supplier 21

22. Request Process for OCPO - Order Validation Visits Physician/ Practitioner – Opt Office / ED Hospitalized for Respiratory Failure / Exacerbation of COPD / Pneumonia, etc. – Medical Documentation substantiates Requires &/or Benefits from Supplemental O2 Beneficiary IDTF/Hosp/Home Orders ABGs, Oximetry, 6-minute walk, PFTs, VO2 Max, etc. Refers for Sleep Study • Documents the in person visit or F2F visit in Medical Documentation, (progress note, medical record, Hospital H&P/Dismissal Summary/Transfer Sheet ) • Must include: • Diagnosis supporting need for OCPO, Exam findings, Required Testing Ordering Physician/Practitioner DWO – Order Validation Writes, signs, and dates DWO and Completes the CMN • Submits Documentation Package including: • In person visit or F2F visit • DWO • CMN POD • Other Supporting Documentation Receives/Files F2F visit progress note, DWO, and CMN Completes OCPO Delivery Obtains Proof of Delivery (POD) Supplier 22

23. eDoC General Workflow Patient IDTF / Hosp / Opt Lab Physician DME Supplier Templates and Rules Payer 23

24. OCPO Documentation & Coverage Requirements • Common Oxygen and Oxygen Equipment Errors MLN ICN 904883 December 2011 • 1. Missing documentation showing that the patient was seen by a physician within the appropriate timeframes for certification or recertification of the need for oxygen supplies. • 2. Missing documentation of original blood gas or saturation test results. • 3. Missing documentation indicating that the patient needs or is using oxygen and supplies. • 4. Missing documentation to show that the patient is mobile within the home (for portable oxygen). • 5. Missing physician order for oxygen supplies. • 6. Missing the most recent Certificate of Medical Necessity (CMN).

25. OCPO Documentation & Coverage Requirements • Overlooked Policy Requirements MLN ICN 904883 December 2011 • 1. Medicare requires home oxygen to be ordered by a physician after evaluating a patient’s medical need. This visit must occur either prior to, but no earlier than, 2 days prior to the inpatient hospital discharge date, or while the patient is in a chronic stable state. The physician notes must establish the need for oxygen based upon Local Coverage Determination (LCD) requirements and show that the visit (and test) does not exceed 30 days from the Initial Date on the CMN. • 2. For Medicare to pay for oxygen equipment, a patient must have both a continued need for oxygen in the home and must also be using the equipment. • 3. For patients to qualify for portable oxygen, they must be mobile within the home and be tested under specific conditions (during exercise or at rest). • 4. Medicare requires all patients who use home oxygen to first be tested either by arterial blood gas (ABG) or oximetry test (SAT). There must be a record of the test results in the physician’s notes to verify that the test occurred.

26. OCPO Documentation & Coverage Requirements • Oxygen Documentation Checklist • Medicare requires the following documentation for Medicare oxygen therapy: MLN ICN 904883 December 2011 • Detailed Written Order • The detailed written order must include: • Patient name; • Detailed description of the items being provided, including: • a. The means of oxygen delivery, • b. The specifics of varying oxygen flow rates and/or non-continuous use of oxygen, and • c. The length of need; • Treating physician’s signature and date order signed; and • Start date of the order (only required if the start date is different from the signature date)

27. OCPO Documentation & Coverage Requirements • Oxygen Documentation Checklist • Medicare requires the following documentation for Medicare oxygen therapy: MLN ICN 904883 December 2011 • Coverage • Home oxygen therapy is covered only if all of the following conditions are met: • The treating physician has determined that the patient has a severe lung disease or hypoxia-related symptoms that might be expected to improve with oxygen therapy. • The patient’s blood gas study meets the criteria stated below. • The qualifying blood gas study was performed by a physician or by a qualified provider or supplier of laboratory services. • The qualifying blood gas study was obtained under the following conditions (a or b): • a. If the qualifying blood gas study is performed during an inpatient hospital stay, the reported test must be the one obtained closest to, but no earlier than, 2 days prior to the hospital discharge date; or • b. If the qualifying blood gas study is not performed during an inpatient hospital stay, the reported test must be performed while the patient is in a chronic stable state (that is, not during a period of acute illness or an exacerbation of his or her underlying disease). • Alternative treatment measures have been tried or considered and deemed clinically ineffective.

28. OCPO Documentation & Coverage Requirements • Oxygen Documentation Checklist • Medicare requires the following documentation for Medicare oxygen therapy: MLN ICN 904883 December 2011 • Medicare Qualifying Saturation Test Results • Medicare covers home oxygen therapy only if the patient’s arterial saturation test results meet the following criteria: • The patient’s test results must be within 48 hours of the date of delivery, unless the arterial saturation tests were taken during an outpatient encounter or during the patient’s sleep. If tests were taken during an outpatient encounter or during the patient’s sleep, the patient’s arterial saturation test results must be within 30 days of the date of delivery. • Arterial saturation test results that qualify for coverage are classified into Group I or Group II. The group determines specific CMN requirements. The criteria for each group are listed in Table 1 and Table 2 below. (Following Slides)

29. Structured Information for OCPO • Supports • Data collection by providers during in person visit or face-to-face visit • Reporting of clinical information for coverage determination • Clinical decision support and automated determination of coverage 29

30. Evaluation Process for OCPO Structured Documentation • Examination of individual clinical elements for each section of the template • Determine if a clinical element is codifiable (e.g. Diagnosis), requires a narrative (e.g. History of Present Illness), or is mixed (e.g. Review of Systems) • Compare coded elements to existing standard coding systems (e.g. SNOMED-CT, ICD) and CDA components • Map to CDP1 Template Sections and Entries based on User Story Requirements 30

31. References/Contact Information • Links • esMD Initiative: http://wiki.siframework.org/esMD+Initiative • esMD Program: http://www.cms.gov/esmd • esMD eDoC Initiative: http://wiki.siframework.org/esMD+- +Electronic+Determination+of+Coverage • Contact Information • Robert Dieterle – esMD Initiative Coordinator (rdieterle@enablecare.us) • Sweta Ladwa – ESAC (sweta.ladwa@esacinc.com ) • Dan Kalwa – CMS (Daniel.Kalwa@cms.hhs.gov) • Pamela Durbin – CMS (Pamela.Durbin@cms.hhs.gov) • Dr Mark Pilley – Co Lead (m.pilley@strategichs.com) • Dr. Viet Nguyen – Co Lead (viet.nguyen@systemsmadesimple.com 31

32. References for Coverage and Documentation Requirements • Complete coverage and documentation requirements are outlined in the following policy and CMS Publication: • National Coverage Determination (NCD) for OCPO • http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=169&ncdver=1&DocID=240.2&SearchType=Advanced&bc=IAAAABAAAAAA& • CMS MLN Matters - https://www.cms.gov/Outreach-and Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM4389.pdf • Provides further guidance and clarification about documentation for physicians and treating practitioners when ordering OCPO 32

33. References for Coverage and Documentation Requirements • Additional Guidance regarding coverage and documentation requirements are outlined in the following CMS Transmittals: • The NCD can be found in transmittal 57, CR4389, at • http://www.cms.gov.Regulations-and-Guidance/Guidance/Transmittals/downloads/R57NCD.pdf on the CMS website • Claims processing instructions are available in Transmittal 961, CR4389, which is available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads?R961CP.pdf on the CMS website 33

34. References for Coverage and Documentation Requirements • Additional Guidance regarding coverage and documentation requirements for Home Oxygen Use for Cluster Headache (CH) are outlined in the following CMS Transmittals: • Assigned Codes for Home Oxygen Use for Cluster Headache (CH) in a Clinical Trial (ICD-10) – MM7820 – Transmittal #: R2465CP • http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM7820.pdf • The official instruction, CR7820, is located at http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2465CP.pdf on the CMS website 34

35. References for Coverage and Documentation Requirements • DME MAC policy regarding coverage and documentation requirements are outlined in the following policies: • LCDs and LCD Articles for OCPO • Jurisdiction A LCD • Jurisdiction B LCD • Jurisdiction C LCD • Jurisdiction D LCD • http://www.cms.gov/medicare-coverage-database/search/search- results.aspx?SearchType=Advanced&CoverageSelection=Local&ArticleType=SAD%7cEd&PolicyType=Both&s=All&CntrctrType=10&KeyWord=Oxygen+and+Oxygen+Equipment&KeyWordLookUp=Title&KeyWordSearchType=Exact&kq=true&bc=IAAAAAAAAAAAAA%3d%3d& 35

36. References for Coverage and Documentation Requirements • DME MAC policy regarding coverage and documentation requirements are outlined in the following policies: • LCDs Oxygen and Oxygen Equipment (OCPO) • Jurisdiction A LCD • http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=11468&ContrId=137&ver=69&ContrVer=1&SearchType=Advanced&CoverageSelection=Local&ArticleType=SAD%7cEd&PolicyType=Both&s=All&CntrctrType=10&KeyWord=Oxygen+and+Oxygen+Equipment&KeyWordLookUp=Title&KeyWordSearchType=Exact&kq=true&bc=IAAAABAAAAAAAA%3d%3d& • Jurisdiction B LCD • http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=27221&ContrId=138&ver=44&ContrVer=1&SearchType=Advanced&CoverageSelection=Local&ArticleType=SAD%7cEd&PolicyType=Both&s=All&CntrctrType=10&KeyWord=Oxygen+and+Oxygen+Equipment&KeyWordLookUp=Title&KeyWordSearchType=Exact&kq=true&bc=IAAAABAAAAAAAA%3d%3d& • Jurisdiction C LCD • http://www.cms.gov/medicare-coverage-database/shared/handlers/highwire.ashx?url=http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx@@@LCDId$$$11446***ContrId$$$140***ver$$$75***ContrVer$$$2***SearchType$$$Advanced***CoverageSelection$$$Local***ArticleType$$$SAD|Ed***PolicyType$$$Both***s$$$All***CntrctrType$$$10***KeyWord$$$Oxygen+and+Oxygen+Equipment***KeyWordLookUp$$$Title***KeyWordSearchType$$$Exact***kq$$$true***bc$$$IAAAABAAAAAAAA$$$$$$***&session=phelks45atn2ebmyr5z3ot55&kq=876734436 • Jurisdiction D LCD • http://www.cms.gov/medicare-coverage-database/shared/handlers/highwire.ashx?url=http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx@@@LCDId$$$11457***ContrId$$$139***ver$$$72***ContrVer$$$2***SearchType$$$Advanced***CoverageSelection$$$Local***ArticleType$$$SAD|Ed***PolicyType$$$Both***s$$$All***CntrctrType$$$10***KeyWord$$$Oxygen+and+Oxygen+Equipment***KeyWordLookUp$$$Title***KeyWordSearchType$$$Exact***kq$$$true***bc$$$IAAAABAAAAAAAA$$$$$$***&session=phelks45atn2ebmyr5z3ot55&kq=1789128138 36

37. References on OCPOs from the DME MACs • Jurisdiction A: NHIC, Corp. • http://www.medicarenhic.com/dme • Jurisdiction B: National Government Services (NGS) • http://www.ngsmedicare.com/wps/portal/ngsmedicare/home • Juridiction C: CGS • http://www.cgsmedicare.com/jc • Jurisdiction D:Noridian Administrative Services, LLC (NAS) • https://www.noridianmedicare.com/dme 37

38. eDoC OCPO Timeline Feb ‘15 Oct ‘14 Dec ‘ 14 Mar‘15 Jan ‘15 Sept ‘14 Nov ‘14 Apr ‘15 Kick-Off OCPO – User Story Development Standards/Data Model/Harmonization OCPOPilots Sub Workgroup LLP Structured Data OCPO Implementation Guide 38

39. eDoC Timeline We are here December ‘14 October ‘14 August ‘14 June ‘14 October ‘13 February ‘14 April ‘14 February ‘15 December ‘13 Electronic Determination of Coverage WG PMD and LLP e-Clinical Template Pilots Home Health User Story Oxygen Concentrators and Portable Oxygen User Story LLP User Story eDoC Harmonization and Structured Data eDoC Administrative Documents Templates IG for HL7 Ballot eDoC HL7 Clinical Documents for Payers Set 1 Ballot Reconciliation

40. Call for Public Participation • As an S&I Initiative, esMD is requesting public participation and input to identify and assess existing standards and define requirements for the eDoC OCPO User Story • Targeted Participants: • Medicare, Medicaid, and Commercial Payers • Providers, Provider Organizations • Service suppliers (e.g. DMEs) • Health Information Handlers (HIHs) • HIT/EHR Vendors and Vendor Associations • State HIEs, HIE Vendors • SDOs • Others with Expertise/Interest in Coverage Determination, Structured Documentation, Decision Support, and Pre-authorization, 40

41. Summary eDoC workgroup identifies Best Practice for: • Payer interaction with providers for determination of coverage • Developing, delivering and using structured information to support coverage determination • Addressing Author of Record requirements • Establishing secure electronic communication between payers, provider, suppliers and beneficiaries • Creating implementation guides for payers and providers for all required eDoC processes and transactions • The focus for next user story is on Oxygen Concentrators and Portable Oxygen (OCPO) 41

42. Next Steps • The electronic Determination of Coverage Workgroup is open for anyone to join. This community will meet weekly by webinar and teleconference from 1:00 to 2:00 pm ET on Wednesday see S&I Framework calendar for webinar information: http://wiki.siframework.org/Calendar • Information on how to join the esMD Community can be found on the electronic submission of Medical Documentation (esMD) page: http://wiki.siframework.org/esMD+Initiative • In order to ensure the success of the eDoC efforts, we encourage broad and diverse participation from the community. Wide community participation will ensure that the standards reflect technology that is useable across the industry and meets the needs of all stakeholders. • This is your chance to have an impact on the evaluation and selection of standards, in addition to the creation of business requirements and implementation guides for the electronic Determination of Coverage OCPO User Story 42

43. Thank You

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