Use Case and Functional Requirements Development for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 Appendix G: Oxygen Concentrators and Portable Oxygen (OCPO) User Story Note: This user story is based on Medicare National Coverage Determination (NCD), Local Coverage Determination (LCD) and CMS Medicare regulations and guidelines. While other payers have participated in the workgroup effort, we have not received specific coverage or workflow requirements from any payer group other than CMS Medicare Fee-For-Service (FFS). If a payer’s coverage requirements necessitate a change in this user story, then a new version of the user story should be created, explicitly identifying the changes and provisions for additional, alternative, requirement-based workflows. G.1 In Scope This appendix focuses on defining the user story for oxygen concentrators and portable oxygen, based on the electronic Determination of Coverage (eDoC) General Use Case. Special attention is paid to additional constraints and identification of gaps on and in the general Use Case, as required by the user story. It reuses existing S&I Initiative efforts where possible in the process of selecting standards for structured data documentation requirements, exchange templates, interactive information capture templates, decision support rules and exchange standards. For the immediate effort to determine documentation requirements, the user story will: A. Define required and supporting documentation consistent with clinical best practice and payer policy for oxygen concentrators and portable oxygen (OCPO) B. Define providers required/allowed to complete the documentation C. Define required and supporting documentation for OCPO D. Specify requirements for OCPO documentation E. Define order(s) for OCPO F. Define certification documentation for OCPO G. Define Re-certification documentation for OCPO equipment H. Define requirements for information exchange between and among participating entities (Including workflow required for the ACA-specified OCPO equipment and an optional workflow for non-ACA-specified OCPO equipment) I. Define order validation transaction G.2 Out of Scope The user story will not address: A. Deployment of an electronic service or form that interacts directly with the participating entities B. Patient interaction with Payer for OCPO G.3 User Story Assumptions A. This user story addresses the data set requirements for determination of coverage for OCPO durable medical equipment (DME) 1 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 B. Multiple valid diagnostic, documentation, and order workflows currently exist and include the beneficiary, physician, DME Supplier and potentially other licensed providers and service suppliers. G.4 Pre-Conditions The pre-conditions section describes the state of the system, from a technical perspective, that will need to be in place prior to execution of the operation, process activity or task. No additional pre-conditions for OCPO user story G.5 Post Conditions The Post Conditions section describes the state of the system, from a technical perspective, that will result after the execution of the operation, process activity or task. Payer Contractor information system processes the submitted documentation for order validation, prior authorization, prepayment review or post payment audit for determination of coverage The ordering provider and DME supplier systems must retain the validated order, as well as all required documentation (such as the CMN) as part of the record of the provider’s order for the service, as per payer policy or relevant record retention requirements, whichever is longer. 53 G.6 OCPO Scenario Background (Medicare FFS) 54 55 56 57 58 59 60 The dispensing and use of Oxygen Concentrators and Portable Oxygen (OCPO) is a covered service under Medicare Part B benefits. Coverage for OCPO is determined reasonable and necessary for beneficiaries with significant hypoxemia who also meet the medical documentation, laboratory evidence, and health conditions as specified by policy. A 2006 Office of the Inspector General (OIG) report titled, “Medicare Home Oxygen Equipment: Cost and Servicing” reported that in 2004, home oxygen equipment accounted for 24% ($2.7 billion of $11.1 billion) of all Medicare spending for DME, prosthetics, orthotics and supplies. 61 62 63 64 65 66 67 68 69 70 An oxygen concentrator is a device which concentrates the oxygen from a gas supply (typically ambient air) to deliver an oxygen enriched gas mixture. Oxygen concentrators typically use pressure swing adsorption technology and are used very widely for oxygen provision in healthcare applications, especially where liquid or pressurized oxygen is too dangerous or inconvenient, such as in homes or in portable clinics. Oxygen concentrators can also be found in a portable form. Portable oxygen concentrators (or POC) are a portable device used to provide oxygen therapy to patients at substantially higher oxygen concentrations than the levels of ambient air. It is very similar to a home oxygen concentrator, but is smaller in size and more mobile. The portable oxygen concentrator makes it easy for patients to travel freely, as they are small enough to fit in a car and many concentrators are now FAAapproved. 71 72 Certain conditions warrant the use and coverage of oxygen therapy including severe lung diseases such as chronic obstructive pulmonary disease, diffuse interstitial lung disease, cystic fibrosis, bronchiectasis, 2/8/2016 2 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story 73 74 75 76 and widespread pulmonary neoplasm. Other conditions requiring the use of oxygen therapy may include hypoxia-related symptoms or findings expected to improve with oxygen therapy such as pulmonary hypertension, recurring congestive heart failure due to chronic cor pulmonale, erythrocytosis, impairment of the cognitive processes, nocturnal restlessness, and morning headache. 77 78 79 80 81 82 83 84 85 86 87 The results of an arterial blood gas or pulse oximetry test provide required supporting evidence for the initial and ongoing need for OCPO. When oxygen is covered based on an oximetry study obtained during exercise, there must be documentation of 3 oximetry studies in the beneficiary’s medical record: 1) testing at rest without oxygen, 2) testing during exercise without oxygen, and 3) testing during exercise with oxygen applied (to demonstrate the improvement of the hypoxemia) are required. All 3 tests must be performed within the same testing session. A Certification of Medical Need (CMN) for oxygen equipment must include results of specific testing before coverage can be determined. Suppliers that bill electronically may transmit initial, revised, and recertification CMNs by electronic media using CMSestablished standard formats. Information transmitted from a revised or recertification form CMS-484 must accompany the first claim for monthly benefits submitted after the supplier has received the hard copy form CMS-484 from the certifying physician. 88 89 90 91 In order to establish the necessity of oxygen therapy, a certification from a certifying physician must be provided. An initial, recertification, or revised certification of medical necessity (CMN) must be obtained and submitted by the DME supplier providing the oxygen device to the beneficiary. The certifying physician must document testing and visit requirements for the CMN as outlined by policy. 92 A CMN is required: 93 94 95 96 97 98 99 100 101 102 103 104 1. With the first claim for home oxygen, (even if the beneficiary was on oxygen prior to Medicare eligibility or oxygen was initially covered by a Medicare HMO). 2. During the first 36 months of the rental period, when there has been a change in the beneficiary’s condition that has caused a break in medical necessity of at least 60 days plus whatever days remain in the rental month during which the need for oxygen ended.1 3. When the equipment is replaced because the reasonable useful lifetime of prior equipment has been reached. 4. When the equipment is replaced because of irreparable damage, theft, or loss of the originally dispensed equipment. a. Irreparable damage refers to a specific accident or to a natural disaster [e.g., fire, flood] b. Irreparable damage does not refer to wear and tear over time Recertification CMN is required: 105 106 1. 12 months after Initial Certification, (i.e., with the thirteenth month’s claim) for Group I (see definition for Group I below) 1 Refer to the Policy Article NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES for additional information 2/8/2016 3 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story 107 108 2. 3 months after Initial Certification, (i.e., with the fourth month’s claim) for Group II (see definition for Group II below) 109 2/8/2016 4 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story 110 Group I and II Criteria are outlined in the tables below: 111 Table 1: Group I Criteria Patient on Room Air at Rest While awake: Arterial oxygen saturation at or below 88%; or Arterial Partial Pressure of Oxygen (PO2) at or below 55 mm Hg. Patient Tested During Exercise Test 1: Room air at rest arterial saturation results above 56 mm Hg or an arterial oxygen saturation at or above 89%; and Test 2: Arterial desaturation during ambulation, without oxygen, falls to or below 55 mm Hg or an arterial oxygen desaturation at or below 88%; and Test 3: Documented improvement of hypoxemia during ambulation with oxygen. 112 Patient Tested During Sleep If arterial PO2 at or above 56 mm Hg or an arterial oxygen saturation at or above 89% while awake, additional testing during sleep must show: a. Arterial PO2 at or below 55 mm Hg, or an arterial oxygen saturation at or below 88%, for at least 5 minutes taken during sleep; or b. Decrease in arterial PO2 of more than 10 mm Hg, or a decrease in arterial oxygen saturation more than 5%, for at least 5 minutes, taken during sleep associated with symptoms or signs reasonably attributable to hypoxemia. Table 2: Group II Criteria Patient on Room Air at Rest While awake: Arterial oxygen saturation of 89%; or Arterial PO2 of 56-59 mm Hg; and a. Dependent edema suggesting congestive heart failure; b. Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated blood pool scan, 2/8/2016 Patient Tested During Exercise Arterial oxygen saturation of 89%; or Arterial PO2 of 56-59 mm Hg; and a. Dependent edema suggesting congestive heart failure; b. Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated Patient Tested During Sleep Arterial oxygen saturation of 89%; or Arterial PO2 of 56-59 mm Hg; and a. Dependent edema suggesting congestive heart failure; b. Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated 5 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story echocardiogram, or “P” pulmonale on electrocardiography (EKG) (P wave greater than 3 mm in standard leads II, III, or AVF); or c. Erythrocythemia with a hematocrit above 56%. blood pool scan, echocardiogram, or “P” pulmonale on EKG (P wave greater than 3 mm in standard leads II, III, or AVF); or c. Erythrocythemia with a hematocrit above 56% blood pool scan, echocardiogram, or “P” pulmonale on EKG (P wave greater than 3 mm in standard leads II, III, or AVF ); or c. Erythrocythemia with a hematocrit above 56% 113 114 There are additional specific requirements based on the initial CMN for Group I and II criteria which include: 115 116 117 118 119 1. The blood gas study must be the most recent study obtained within 30 days prior to the initial date. For Group I criteria, there is an exception to the 30-day test requirement for beneficiaries who were started on Oxygen while enrolled in a Medicare HMO and transition to fee-for-service Medicare. For those beneficiaries, the blood gas supply does not have to be obtained 30 days prior to the initial date, but must be the most recent qualifying test obtained while in the HMO. 120 121 2. The beneficiary must be seen and evaluated by the treating physician within 30 days prior to the date of initial certification. 122 123 3. Medicare policy may define exceptions to the above timing requirements based on transitions from specific care settings to the home environment (See appropriate policy for specifics). 124 125 126 127 128 129 130 In reviewing a claim and the supporting data, payers compare certain items, especially pertinent dates of treatment. For example, the start date of home oxygen coverage cannot precede the date of prescription or the date of the test(s) whose results establish that the special coverage criteria are met. Medicare will only cover items when it is in use by a patient. For Medicare to continue coverage for OCPO DME, patients should need and use the equipment, and a physician must regularly document the patients continued medical need for, and use of, oxygen equipment through the patient’s medical records, as per payer policy. 131 132 133 134 135 This user story envisions an electronic order validation method that allows the ordering provider or the supplier to confirm essential elements of an order for specific services/devices prior to either the delivery of the service or submission of a claim for payment for the services/devices. The goal is to reduce the errors related to insufficient information with regard to the provider, beneficiary, supplier, service/device, and medical necessity. 136 137 138 139 140 G.6.1 Oxygen Concentrator and Portable Oxygen User Story The provider has a visit with the beneficiary who may have a severe lung disease or hypoxia-related symptoms to evaluate and assess their need for an oxygen concentrator or portable oxygen (e.g. HCPCS codes E0433 and E1390). The provider evaluates and assesses the beneficiary, making use of all available beneficiary/provider interaction documentation. Relevant information may include the history, 2/8/2016 6 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story 141 142 143 144 145 146 147 148 149 150 151 physical examination, hospital admission and discharge records, diagnostic tests, summary of findings, diagnoses, and treatment plans, as well as office records, hospital records, nursing home records, home health agency records, and records from other healthcare professionals. The provider documents their findings regarding the beneficiary’s visit within the EHR system, including findings regarding the blood gas study (either a pulse oximetry test or arterial blood gas (ABG) test). The provider, if not conducting the blood gas study in-person themselves, sends the signed order/referral requesting the blood gas study be conducted by another qualified provider or supplier of laboratory services. The qualified provider or laboratory service supplier performs the blood gas study and documents the test results within their EHR/LIS (Laboratory Information System) system, and signs and dates the entry. The qualified provider or laboratory service then sends the result of the blood gas study back to the requesting provider. 152 153 154 155 The provider receives and reviews the test results and determines that OCPO DME is reasonable and necessary based on test results. The provider evaluation and management services are documented in the medical record, which provides the information necessary to complete a Certification of Medical Necessity (CMN) (CMS Form 484). 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 ACA 6407 requires the supplier to receive a written order (DWO/CMN) and face-to-face documentation prior to delivery of OCPO equipment for the HCPCS codes specified in the table contained in the Policy Specific Documentation Requirements Section within the LCD. The LCD states, “A DWO is required prior to delivery of OCPO Systems. The CMN may serve as a DWO, in which case the CMN needs to be received by the supplier prior to the delivery of the OCPO Systems (as listed in the ACA). A CMN is required prior to billing but the DWO/CMN can act as the order or the dispensing order. If the CMN is not being completed as a DWO, then the CMN simply needs to be completed and on file prior to submission of the claim.” If the provider creates or generates the CMN/DWO, they must complete Sections ‘A’ and ‘B’ of the CMN/DWO before sending it to the DME Supplier. The Supplier receives the documentation, and completes Section ‘C’ of the DWO/CMN before sending it back to the Provider/NPP, who completes Section ‘B’ and signs and dates Section ‘D’ of the DWO/CMN (the above mentioned workflow is required for the exchange of a CMN but optional for the exchange of a DWO). Alternately, the Supplier can also create/generate the CMN/DWO, but they must complete Sections ‘A’ and ‘C’ of the DWO/CMN before returning the documentation to the Provider/NPP. The Provider/NPP then completes Section ‘B’ and signs and dates Section ‘D’ of the DWO/CMN before sending it to the DME Supplier. Prior to signing, the order information may optionally be sent for order validation by the Provider/NPP. The Order Validation Number should be included with the DWO/CMN when it is sent to the supplier. The DME supplier receives, reviews, and processes the documentation, and upon receipt, the order information may optionally be sent by the supplier for order validation. The DME supplier provides the device to the beneficiary, and the beneficiary signs off on receiving the device within the Proof of Delivery (POD) documentation. Proof of Delivery documentation must contain: 177 178 a) Beneficiary’s name b) Delivery address 2/8/2016 7 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 c) Package identification number (linking supplier’s delivery documentation with delivery service records) d) Quantity Delivered e) Detailed descriptions of item(s) f) Manufacturer (where required) g) Serial Number/Lot Number (where required) h) Delivery Date i) Signature of person accepting delivery j) Relationship to beneficiary k) Signature date In the alternative user story flow for OCPO orders, which do not contain items specified in the ACA, the Provider evaluates and assesses the beneficiary, and determines if the patient is eligible for OCPO. After updating the beneficiary record, the Provider creates/generates a dispensing order, as per payer policy. The Dispensing Order must contain the following items: a) b) c) d) e) f) g) Description of the item Beneficiary’s name Prescribing physician’s name Date of the order (for verbal orders, use the date the supplier is contacted by the physician) Start date (if the start date is different than the date of the order) Physician signature (if written order) Supplier Signature (if verbal order) The Provider sends the dispensing order for OCPO DME (including optional order validation number if applicable) to the DME Supplier. The DME Supplier receives and reviews the dispensing order. The Provider/NPP then creates/generates the DWO/CMN documentation and follows the same document exchange sequence as outlined in the workflow required for ACA OCPO equipment. The DWO must contain: a) b) c) d) e) f) g) h) i) j) Beneficiary’s name Physician’s name Date of the order Start date (if different than date of order) Detailed description of the item(s) (adhering to requirements as per LCD) The prescribing practitioner's National Provider Identifier (NPI) Physician signature and signature date The means of oxygen delivery (cannula, mask, etc.) The flow rate Frequency of use 2/8/2016 8 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story 215 216 217 218 219 220 The provider processes, signs, and dates all documentation received by the DME Supplier, including the DWO/CMN, and dispensing order, without which payment will be denied by the Payer. The Provider then proceeds to send all of the completed documentation to the DME supplier within the time-period specified by the payer. The DME supplier receives, reviews, and processes the documentation. The DME supplier provides the device to the beneficiary, and the beneficiary signs off on receiving the device within the Proof of Delivery (POD) documentation. 221 222 223 224 225 226 227 228 229 The DME supplier prepares and submits the signed documentation, including the CMN, DWO, and POD, for payment for the OCPO DME to the payer, including the Order Validation Number if one exists. If prepayment review is required, the DME Supplier submits supporting documentation prior to payment. The payer receives the signed documentation and pays the DME supplier. The payer conducts a postpayment audit and requests documentation from the DME Supplier. The DME Supplier prepares, signs, dates, and submits all required documentation to the Payer for review. The payer receives and processes the signed documentation and responds to the DME supplier. (Best clinical practice indicates the DME supplier should notify the provider(s) on delivery and acceptance of the OCPO DME. Transactions involved with this best practice are out of scope.) 230 231 232 233 234 235 236 237 238 To facilitate the creation of a valid order for OCPO this user story introduces the concept of an optional order validation method that involves communication of specific order elements between the Provider or DME Supplier and the responsible Payer. It is the expectation that this validation process will enable the Payer to verify order elements that are transmitted as part of the validation process. The Payer will respond to the order validation request by identifying errors if they exist, or, if the order elements are successfully verified, provide a unique “order validation number” for the order that may be included in the claim submission. Based on this concept, the Provider and/or DME Supplier may send elements of the dispensing order and/or the DWO to the Payer for order validation. Order validation may occur at any of four points in the OCPO workflow: 239 240 241 242 243 244 245 246 1. Prior to the Provider issuing the dispensing order for OCPO DME to the Supplier (Alternate Workflow for non-ACA specified OCPO equipment) 2. After the DME Supplier receives the dispensing order for OCPO DME from the Provider and before they dispense the OCPO DME (Alternate Workflow for non-ACA specified OCPO equipment) 3. After the Provider/NPP completes and signs the DWO/CMN (ACA Specified OCPO equipment) 4. After the Supplier receives the signed and dated DWO/CMN/Progress Note (if required by Supplier) from the Provider (ACA Specified OCPO equipment) 247 248 249 250 251 The Payer receives and validates the elements of the dispensing order and/or the DWO. The Payer responds to the order validation request, and if successful, returns an order validation number to the Provider or DME Supplier. The Provider or DME Supplier receives the “order validation number” if validation is successful. For a successful response the DME supplier will include the order validation number in the claim submission. 2/8/2016 9 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story 252 Order Validation Error Response 253 254 255 256 If order validation fails, then the payer will return an error response indicating the order elements that failed validation. The Provider may make the appropriate corrections to the order and either the Provider or DME Supplier may resubmit the elements of the dispensing order and/or the DWO for order validation. 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 Additional Scenarios That May Require a New Order for OCPO (see Payer policy)Break in medical necessity of over 60 days Beneficiary moving to another region out of the suppliers’ service area Prescription for flow rate changes based on ABG or pulse oximetry tests Change from stationary O2 to portable O2 (and vice versa) New treating physicians Recertification for continued medical need past 36 months Length of need expiration Change in supplier for OCPO Equipment replacement Equipment replacement post reasonable useful lifetime G.6.2 Medicare FFS - Specific OCPO Requirements The corresponding LCD policy for Oxygen Concentrators and Portable Oxygen (OCPO) is included in the attached document below: 272 273 274 275 276 277 G.6.3 Sequence Diagram A Sequence Diagram is primarily used to show the interactions between objects in the sequential order that they occur. This representation can make it easy to communicate how the exchange works by displaying how the different components interact. The primary use of the diagram is in the transition from requirements expressed as use cases to the next and more formal level of refinement. 2/8/2016 10 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story Provider/NPP EHR System Qualifying Provider/Laboratory EHR System DME Supplier Information System Payer/Payer Contractor Information System Beneficiary 1. Evaluate & Assess Beneficiary 2A. Perform O2 Saturation Study, Document, and Sign Result Alt: 2B1. Send Signed Order Requesting ABG Test 2B2. Receive Signed Order 2B3. Document, and Sign ABG Test Results 2B4. Send Signed, Documented Results 2B5. Receive Signed ABG Test Results 2B6. Review & Co-Sign ABG Test Results 3. Update Beneficiary Record, Including evaluation and management services 4B. Alt: Creates/Generates DWO/CMN and completes Sections ‘A’ and ‘C 4A. Creates/Generates DWO/CMN (can be used as DWO) 4A1. Sends DWO/CMN prior to delivery of OCPO With Section ‘A’ and ‘B’ Completed 4A2. Receives DWO/CMN with Sections A and B Completed 4A3. Completes Section C of DWO/CMN 4A4. Returns DWO/CMN Documentation to Provider/NPP with section ‘A’ , ‘B’, ‘C’ 4B1. Returns DWO/CMN Documentation to Provider/NPP with sections ‘A’ and ‘C’ completed 4A5. Receives DWO/CMN 4B2. Completes Section ‘B’ of DWO/CMN 5. Signs Section ‘D’ of DWO/CMN Alt: 6. Send Order Information for Order Validation 6A. Receive Order Validation Request 6B. Review DWO 6C. Generate response to Order Validation Request Alt: 6D1. Payer Response Includes Order Validation Number Alt: 6D1a. Receives Order Validation Including Order Validation number Alt: 6D2. Payer Response Includes Error Notification 6D. Payer Response Alt: 6D2a. Receives Order Validation Response Including Error notification 7. Signs and Dates Section ‘D’ of DWO/CMN 8. Send DWO/CMN for OCPO DME (Including Optional Order Validation Number) Send Progress Note (if Required by Supplier Prior to Delivery) 9. Receives and Reviews DWO/CMN Alt: 10. Send Order Information for Order Validation 10A. Receive Order Validation Request 10B. Review DWO 10C. Generate response to Order Validation Request Alt: 10D1. Payer Response Includes Order Validation Number 10D. Payer Response Alt: 10D1a. Receives Order Validation Including Order Validation number Alt: 10D2. Payer Response Includes Error Notification Alt: 10D2a. Receives Order Validation Response Including Error notification 10E. Send Error Notification Response for Order Modification 10F. Receive Error Notification Response from Supplier 11. Send F2F Encounter Documentation or Progress Note to Supplier (May also be sent earlier with DWO/CMN, as it may be required prior to dispensing) 12. Receives F2F Encounter Documentation or Progress Note 13. Dispense OCPO DME to Beneficiary 14. Beneficiary Receives OCPO DME 15. Beneficiary Signs POD 16. Beneficiary Returns POD to Supplier 17. Receives POD 18. Prepares Documentation for Payment 19. Maintains all documentation regarding OCPO DME for Respective Beneficiary 20. Send claim, CMN, and optional order validation number for payment (and other supporting documents if pre-payment review is required) 21. Receives and Reviews Supplier Documentation for Payment 22. Payer Submits Payment to Supplier 23. Conducts Post-Payment Audit 24. Sends Request for Documentation Regarding Post-Payment Audit 25. Receives and Reviews Request for Documentation 26. Send All Signed and Supported Documentation 27. Receive & Process Signed Documentation 28. Send Response 29. Receive & Process Response Provider/NPP EHR System 278 279 Qualifying Provider/Laboratory EHR System DME Supplier Information System Payer/Payer Contractor Information System Beneficiary Figure 1- Workflow for ACA Specified OCPO Equipment (Sequence Diagram) 2/8/2016 11 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story Provider/NPP EHR System Qualifying Provider/Laboratory EHR System DME Supplier Information System Payer/Payer Contractor Information System Beneficiary 1. Evaluate & Assess Beneficiary 2A. Perform O2 Saturation Study, Document, and Sign Result Alt: 2B1. Send Signed Order Requesting ABG Test 2B4. Send Signed, Documented Results 2B2. Receive Signed Order 2B3. Document, and Sign ABG Test Results 2B5. Receive Signed ABG Test Results 2B6. Review & Co-Sign ABG Test Results 3. Update Beneficiary Record, Including evaluation and management services 4. Create/Generate Dispensing Order Alt: 5. Send Order Information for Order Validation 5A. Receive Order Validation Request 5B. Review Dispensing Order/DWO Alt: 5D1. Payer Response Including Order Validation Number 5D. Payer Response Alt: 5D1a. Receives Order Validation Including Order Validation number 5C. Generate response to Order Validation Request Alt: 5D2. Payer Response Includes Error Notification Alt: 5D2a. Receives Order Validation Response Including Error notification 6. Send Dispensing Order for OCPO DME (Including Optional Order Validation Number) 7. Receives and Reviews Dispensing Order Alt: 8. Send Order Information for Order Validation 8A. Receive Order Validation Request 8B. Review Dispensing Order/DWO Alt: 8D1. Payer Response Includes Order Validation Number 8C. Generate response to Order Validation Request 8D. Payer Response Alt: 8D1a. Receives Order Validation Including Order Validation number Alt: 8D2. Payer Response Includes Error Notification 8E. Send Error Notification Response for Order Modification Alt: 8D2a. Receives Order Validation Response Including Error notification 8F. Receive Error Notification Response from Supplier 9. Dispense OCPO DME to Beneficiary 10. Beneficiary Receives OCPO DME 11. Beneficiary Signs POD 12. Beneficiary Returns POD to Supplier 13. Receives POD 14B. Alt: Creates/Generates DWO/CMN and completes Sections ‘A’ and ‘C’ 14A. Creates/Generates DWO/CMN (can be used as DWO) 14A1. Sends DWO/CMN prior to delivery of OCPO With Section ‘A’ and ‘B’ Completed 14A2. Receives DWO/CMN with Sections ‘A’ and ‘B’ Completed 14A3. Completes Section C of DWO/CMN 14A4. Returns DWO/CMN Documentation to Provider/NPP with section ‘A’ , ‘B’, ‘C’ 14B1. Returns DWO/CMN Documentation to Provider/NPP with sections ‘A’ and ‘C’ completed 14A5. Receives DWO/CMN 14B2. Completes Section ‘B’ of DWO/CMN 15. Signs Section ‘D’ of DWO/CMN 16. Sends All completed documentation back to the Supplier 17. Receives all completed documentation 18. Prepares Documentation for Payment 19. Maintains all documentation regarding OCPO DME for Respective Beneficiary 20. Send claim, CMN, and optional order validation number for payment (and other supporting documents if pre-payment review is required) 22. Payer Submits Payment to Supplier 21. Receives and Reviews Supplier Documentation for Payment 23. Receive and Processes Payment 24. Conducts Post-Payment Audit 25. Sends Request for Documentation Regarding Post-Payment Audit 26. Receives and Reviews Request for Documentation 27. Send All Signed and Supported Documentation 29. Send Response 28. Receive & Process Signed Documentation 30. Receive & Process Response Provider/NPP EHR System Qualifying Provider/Laboratory EHR System DME Supplier Information System Payer/Payer Contractor Information System Beneficiary 280 281 Figure 2 - Workflow for Non-ACA Specified OCPO Equipment (Sequence Diagram) 2/8/2016 12 Use Case Development and Functional Requirements for Interoperability Electronic Determination of Coverage (eDoC) Use Case Oxygen Concentrators and Portable Oxygen User Story 282 283 284 The following document maps each of the inter-system steps in the Sequence Diagram to a particular document or document set exchanged between systems as part of this user story. The following notation is used for the artifacts: XNY • X=Source N= Document number Y= Signature, where A indicates a document without a co-signature and B indicates a document with a co-signature If a document is co-signed, the original document does not need to be included. If N changes, all versions of N should be included. An Artifact can either be one or more CDA compliant documents 285 286 287 288 289 290 291 G.7 Dataset Requirements 292 293 294 295 296 The final Dataset Requirements list has been provided in a spreadsheet format and is linked/embedded below. If you have any difficulty opening this file, you may also find a link to the same on the esMD eDoC Wiki (http://wiki.siframework.org/esMD+-+Electronic+Determination+of+Coverage). Elements within the Dataset Requirements have been mapped to the artifacts established as part of the Sequence Diagram analysis referred to within the Sequence Diagram portion of this user story. 297 This table lists the data elements and data element sets that will be available within the documentation including the Face to Face Encounter, signed and dated Certification, signed and dated Plan of Care, and documentation bundle. Historically, the optional/required nature of each data element is deferred to the discussions during the harmonization phase of the Initiative; however, some data elements do contain recommendations for optionality. Each data element listed below is necessary for some aspect of the User Story; however, the table does not specify exactly how they may be used together. esMD OCPO Data Set Requirements 2/8/2016 13