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�� {Question#Protocol Related Items and ServicesResponseBilling Grid"Qualifying Clinical Trial AnalysisWDoes the study enroll subjects with a diagnosed disease, (not healthy volunteers only)?Medicare Benefit CategoriesScreening / EnrollmentYes, Diagnostic ImagingYes, Durable Medical Equipment'Yes, Laboratory and Diagnostic Services$Yes, Medical Devices and Prosthetics$Yes, Medical and Surgical Procedures-Yes, Other: [Please type category here XXXXX]$YES, it is stated this way: XXXXXX�The purpose of this Tab is to make initial assessments of payment responsibility for all items and services provided in the clinical study. A version of this grid can be used for budgeting.pThe purpose of this tab is to identify key protocol information and the documents used to complete the analysis.Post Treatment PeriodLocation in ProtocolD1Visit 1D2Visit 2D3D4D5Visit 3Visit 4Visit 5Visit 6D6D7D8D9Device Trial AnalysisFollow-up Items�YES, this is a Qualifying Clinical Trial and reimbursement for routine costs may be sought from Medicare. The remaining questions on this tab may be skipped.HNO, this is not applicable to my trial. Please go to the next question./The Grant Agreement is dated: [Month Day, Year]BThe Grant / Sponsor Agreement was not available for this analysis.-This study does not have a financial sponsor.,The ICF was not available for this analysis.Please list the protocol name:3Please list the Principal Investigator's (PI) Name:7Please list the Sponsor's protocol version and/or date:6Please list the Institutional Review Board (IRB) ID #:RWhat is the version and/or date of the executed Clinical Trial Agreement or Grant?PWhat is the version and/or date of the IRB approved Informed Consent Form (ICF)?+Is this a drug, device, or procedure study?%What is the FDA Status of the Device?)YES, the disease under study is: XXXXXXX�It is provided under an IDE exemption as determined by [the FDA / the IRB]. This is a Qualifying Clinical Trial and reimbursement for routine costs may be sought from Medicare. The remaining questions on this tab may be skipped.rNot available for this analysis. Please determine the FDA status of the device before this analysis is finalized.zNO, the documentation is being prepared for submission. This analysis cannot be finalized until the results are obtained.�NO, the analysis is complete. This is not a qualifying clinical trial. Please review for possible submission to the Medicare / Medicaid Contractor. �No, this analysis is complete. This is not a qualifying clinical trial. Please review for possible submission to the Medicare / Medicaid Contractor. The remaining questions on this tab may be skipped.:The [Internal/External] Budget is dated: [Month Day, Year]CThe [Internal/External] Budget was not available for this analysis.6This study does not have a [Internal/External] Budget.�NO, the study sponsor is preparing documentation for submission. This analysis cannot be finalized until the results are obtained.6Is this drug or procedure typically covered by Medicare / Medicaid
(it is in a benefit category)?
Note: The subject or purpose of the trial must be the evaluation of an item or service that falls within a benefit category and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids). d�If the study was approved by the FDA on or after 1/1/15, has CMS approved billing for the medical device and the related services?/It is a HUD, PMA, or 510K device that is being used for the indication listed on the product label and does not required pre-approval before billing. This is a Qualifying Clinical Trial and reimbursement for routine costs may be sought from Medicare. The remaining questions on this tab may be skipped.�YES, the CMS Approval Letter is attached to this analysis. This is a Qualifying Clinical Trial and reimbursement for routine costs may be sought from Medicare. The remaining questions on this tab may be skipped.'YES, the CMS Approval is indicated on http://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.html with an approval date of MM/DD/YYYY. This is a Qualifying Clinical Trial and reimbursement for routine costs may be sought from Medicare. The remaining questions on this tab may be skipped.Q0 / Q1 Modifiers
(as needed)�What is the name of the investigational item, procedure or service:
Please list the generic/trade name of the drug(s) or the name of the procedure. If this is unclear, or if this is a combination drug/device study, please clarify with the Study Sponsor.CD
E:Visit Schedule (Cycle Length = XXXX [enter if applicable])�The executed Clinical Trial Agreement (or related document) with the most recent documentation of payment for patient care costs is dated: [Month Day, Year]Other document(s) referenced:JPlease list the National Clinical Trial (NCT) #:
(use format NCTXXXXXXXX) 1Study Information and DocumentsGeneral Comments:CPT / HCPCS Codes�Please list the names of the Financial Sponsor(s):
If there are multiple sponsors, please list them. If a financial sponsor has not been identified, please state "Investigator-Initiated".53Is this an Outpatient (OP) or Inpatient (IP) visit?[Should Dx Code Z00.6 / V70.7 (and Condition Code 30, where applicable) appear on the claim?Yes, Drugs and BiologicalsdYES, the statement is too long to include here, however it can be found on page XXX of the protocol.�NO, it is not stated in the Primary or Secondary Objectives. This is not a Qualifying Clinical Trial. Please review for possible submission to the Medicare / Medicaid Contractor. The remaining questions on this tab may be skipped.`Does the study have therapeutic intent stated in the protocol's primary or secondary objectives?)The Draft ICF is dated: [Month Day, Year]7The IRB Approved ICF was approved on: [Month Day, Year]'This is not a billable item or service.[to be used for NB-only lines])Please refer to 'General Comments' above.2[to be used only for the research related comment]mThis item will be analyzed at a central lab (Protocol, p. XX). It is therefore considered to be non-billable.\[to be used only for centrally submitted labs. Please ensure reference document is updated.]�X = Additional information is required to complete this analysis. Please refer to item specific comments and/or follow-up items on Tab 1.sQ1 = Routine clinical service provided in a clinical research study that is in an approved clinical research study.{Q0 = Investigational clinical service provided in a clinical research study that is in an approved clinical research study.Billing Grid Key:Billing Grid Definitions:5Please list the short study title or Protocol number:�R = Research: Identified as research-only service in consent, protocol, other communication. (i.e.: free, extra, optional, not essential)�If the study was approved by the FDA prior to 1/1/15, has the CMS Medicare Administrative Contractor approved billing for the medical device and the related services?Communications:Huron Comments/QuestionsCA Date:CA Version:Date�* The CMS website listed in question 12 was accessed on 8/12/16. Please check the website on a regular basis for periodic CMS updates. VIs this study required by Medicare as a part of the "Coverage with Evidence Development" process?
At this time, these studies involve: Allogeneic Hematopoietic Stem Cell Transplant for Myelodysplastic Syndromes (MDS), Allogeneic Hematopoietic Stem Cell Transplant for Multiple Myeloma, Allogeneic Hematopoietic Stem Cell Transplant for Myelofibrosis, Allogeneic Hematopoietic Stem Cell Transplant for Sickle Cell Disease, Amyloid PET, Artificial Hearts, Autologous Platelet-rich Plasma, Cochlear Implantation, CPAP For Obstructive Sleep Apnea, Extracorporeal Photopheresis for Bronchiolitis Obliterans Syndrome Following Lung Transplant, FDG PET and Other Neuroimaging Devices for Dementia, Home Oxygen for Chronic Obstructive Pulmonary Disease <��(COPD), Home Oxygen for Cluster Headache, Magnetic Resonance Angiography and Magnetic Resonance Imaging, NaF-18 PET for Bone Metastasis, Off-label use of Colorectal Cancer Drugs, Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis, Percutaneous Left Atrial Appendage Closure (LAAC), Pharmacogenomic Testing for Warfarin Response, Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral Valve Repair.
http://cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/index.html last accessed on 10/12/16.evS = Standard of Care: Item is routine care based on Medicare guidelines. This item can be billed to the payer/patient.�NO, it is not stated in the Primary or Secondary Objectives. This is a not a Qualifying Clinical Trial and has been determined to be for data collection only. Therefore a coverage analysis was not performed.8Drug or Biologic Study, please go to question number 12..Device Study, please go to question number 19.1Procedure Study, please go to question number 12.USA Comments/Questions�Is this study automatically deemed?
In order for a study to be "deemed", it must meet one of the following criteria:
1. This trial is conducted under and Investigational New Drug (IND) application reviewed by the FDA
2. This trial is exempt from IND application under 21 CFR 312.2 (b)(1)
3. This trial is funded by the NIH, CDC, AHRQ, CMS, DOD, or the VA
4. This trial is supported by a center or cooperative group that is funded by the NIH, CDC, AHRQ, CMS, DOD, or the VA�The study drug is approved under an Expanded Access IND # [ ]. It has been determined that this is not a clinical trial and therefore does not required a coverage analysis.�The study drug is approved under an Expanded Access IND # [ ]. It has been determined that this is a clinical trial and therefore does required a coverage analysis.�YES, this study is funded by the [NIH, CDC, AHRQ, CMS, DOD, VA]. This is a Qualifying Clinical Trial and reimbursement for routine costs may be sought from Medicare. �YES, the study drug is provided under an IND exemption as determined by [the FDA / the IRB]. This is a Qualifying Clinical Trial and reimbursement for routine costs may be sought from Medicare.�YES, the study drug is provided under [BLA / BB IND / IND] # XXX,XXX. This is a Qualifying Clinical Trial and reimbursement for routine costs may be sought from Medicare.mNO, as this is not a drug or biologic study and is not funded by the NIH, CDC, AHRQ, CMS, DOD, VA or a group funded by these organizations it is therefore not a Qualifying Clinical Trial. Consider submission to the Medicare / Medicaid Contractor for review. This analysis has been completed under the assumption that this study is not a Qualifying Clinical Trial.IND information for the study drug was not available for this analysis and the study is not funded by the NIH, CDC, AHRQ, CMS, DOD, VA or a group funded by these organizations. Please determine the FDA status of the drug before this analysis is finalized.6It is provided under IDE # XXXXX. Go to Question #18.UN/A, the device trial was approved by the FDA on or after 1/1/15. Go to question #19.�YES, this study is supported by a center or cooperative group that is funded by the [NIH, CDC, AHRQ, CMS, DOD, VA]. This is a Qualifying Clinical Trial and reimbursement for routine costs may be sought from Medicare. �Each item indicated with an "S" designation below is considered billable per either the 2017 Physician's Fee Schedule, Laboratory Fee Schedule, or Medicare OPPS (as appropriate) when a routine care timepoint is described.
or
Each item indicated with an "R" below is considered research-related per the approved [ICF / executed CTA / other relevant document] (Document, title, p. XXXX). Unless otherwise indicated, these items, procedures, or services will be paid for by the sponsor.
or
This study is considered to be a non-qualifying clinical trial. Items, procedures, or services that might be considered conventional care regardless of the patient's participation in the clinical trial have been reviewed as such. General appropriateness of billing was established as if the corresponding item was not related to the non-qualifying protocol.aNB = Non-Billable: Item is non-billable and included as part of sponsor-paid research staff time.��VPWQ
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