The Changing Landscape of Medicare's Clinical Trial Coverage Policies for Medical Devices. Michael Sanchez, M.A., CCA Reimbursement Advisor

Transcription

1 The Changing Landscape of Medicare's Clinical Trial Coverage Policies for Medical Devices Michael Sanchez, M.A., CCA Reimbursement Advisor

2 Disclaimer The reimbursement information provided in this presentation is gathered from third-party sources and is presented for illustrative purposes only. This information does not constitute reimbursement or legal advice. The presenter makes no representation or warranty regarding this information or its completeness, accuracy, timeliness, or applicability with a particular patient. Further, the presenter disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information in this presentation. CPT Copyright 2007 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

3 Agenda Topics Key Terms and Milestones Recent National Coverage Revisions Seeking Category-B IDE Coverage Identifying Category-B IDE Claims Private Payers Summary Q&A

4 Key Terms Centers for Medicare & Medicaid Services (CMS): Federal agency responsible for the national Medicare program Carrier (Medicare Part-B): Local CMS contractor responsible for physician claims and payments Fiscal Intermediary (Medicare Part-A): Local CMS contractor responsible for hospital claims and payments

5 Milestones Medicare program begins FDA implements IDEs FDA/HCFA Interagency Agreement National Clinical Trial Policy (CTP) Category-A Coverage per 2003 MMA National CTP modified

6 : Anything investigational/experimental by definition not considered Reasonable & Necessary All devices must have final FDA market-approval 1995: FDA/HCFA Interagency Agreement 1 FDA designates IDEs as a CMS Reimbursement: Category-A (Experimental) Originally meant no coverage Category-B (Non-Experimental/Investigational) Coverage available at discretion of each local contractor (not automatic)

7 2000: National Clinical Trial Policy (CTP) 2 Federal Agency funded & INDs/IND-exempt trials Deemed Medicare covers routine costs only Does not withdraw 1995 Interagency Agreement 2005: Category-A IDEs Coverage per MMA 3 Effective 01/01/05, contractors may consider coverage of Category-A IDEs Must be for...an immediately life-threatening disease or condition.

8 2007: CTP Reconsiderations 4 7/9/07-1 st reconsideration final decision Adds CED and clarifies coverage of investigational items/services if otherwise covered outside the trial 10/17/07-2 nd reconsideration final decision Maintains existing CTP as modified on 7/9/07 Separate CMS Q&A clarifies no change rationale and local coverage of other trials: 210qa.pdf

9 1995 Interagency Agreement 1 Applies only to IDE (device) studies Prior approval of the local CMS contractor Medicare claims identified (IDE# & 624 or Q0 modifier) Includes the device payment 2000 Clinical Trial Policy 2 Applies to Deemed Trials (E.g., IND, Agency funded, CED) No prior approval of the local CMS contractor (National Policy) Medicare claims identified (Cond. Code 30, Q1, & V70.7) May include device payment if otherwise covered outside trial Separate & Distinct Coverage Regulations

10 Category-B IDE Fundamentals

11 Category-B IDE Fundamentals Seek coverage & identify claims 1. Submit a written request to your local Medicare Part- A and -B contractors before submitting IDE claims 5 2. Identify Medicare claims with the IDE # and a Q0 (Q zero ) physician modifier or a hospital revenue code 624 6,7 3. Obtain payments limited to what Medicare would have paid for a comparably approved device and service (E.g., MS-DRG, APC, Fee Schedule) 5

12 Seeking Category-B IDE Coverage: Items needed for a local coverage decision

13 Submit a written request to your local Medicare Part-A and -B contractors before submitting IDE claims 5 1. A copy of the FDA approval letter provided to the sponsor or manufacturer of the device Enclose the IDE letter with Category-B designation 2. The name of the device (Both trade, common or usual) Provide trade name with familiar description 3. Any action taken to conform to any applicable IDE special controls FDA Class III device, requires IRB approvals 4. A narrative description of the device sufficient to make a payment determination Provide device use statement from IDE protocol

14 5. A statement indicating how the device is similar to and/or different from other comparable products Describe how IDE device is comparable to predicate device(s) 6. Indication of whether the device will be billed on an inpatient or outpatient claim Could be both or either depending on the therapy 7. A brief summary of the study design or a copy of the actual trial protocol Enclose copy of IDE protocol 8. The provider s protocol for obtaining informed consent Enclose consent example and description of process

15 Identifying Category-B IDE Claims

16 Identify Medicare claims with the study s IDE # and a hospital revenue code Hospital Billing Requirements (UB-04/CMS-1450) Revenue Code (Field 42) Revenue code 624 is used for billing of IDE device charges in place of your standard revenue codes (E.g., Instead of 275 for Pacemaker ) Description (Field 43) Must reflect the IDE number, along with the description of the investigational device (E.g., FDA IDE # G )

17 Identify Medicare claims with the study s IDE # and a Q0 physician modifier 9 Physician Billing Requirements (CMS-1500)...Identify claims for investigational devices and/or services incident to the use of such devices with a [Q0] modifier*...enter the investigational device exemption number (IDE#) assigned to the device Use item (field) 23 of the HCFA-1500 *Note: Q0 (Q zero ) replaced the QA modifier on IDE claims for services dates on or after 1/1/08 7

18 Private Payers

19 Private Payers Private insurers are not bound by local or national Medicare coverage determinations Clinical trial providers should consider: Contacting major local payers to determine Investigational coverage policies E.g., Focus on top 80% of private payer mix Continuing to follow pre-authorization and other contract requirements Disclosing use of investigational device consistent with contracts

20 Summary Medicare s coverage regulations for IDE trials differs from its coverage policy for IND trials IDE providers must obtain local pre-approval and identify their claim submissions For now, Medicare coverage for device trials remains largely unchanged but future policy landscape remains uncertain

21 Questions?

22 References 1. U.S. Food and Drug Administration: IDE Memorandum #D95-2 (09/15/95) 2. Centers for Medicare and Medicaid Services: 2000 Clinical Trials NCD (p. 2) 3. CMS MedLearn Matters Article: MM3548 (12/17/04) 4. Medicare Clinical Trial Policies - Overview 5. Medicare Benefit Policy Manual: Chapter 14, Medical Devices (10/01/03) 6. Medicare Claims Processing Manual: Chapter 32, Billing Requirements for Special Services (11/06/06) 7. CMS MedLearn Matters Article: MM5805 (01/18/08) 8. Medicare Claims Processing Manual: Chapter 25, Completing and Processing the Form CMS-1450 Data Set (Pp. 95, 113) (01/01/08) 9. Medicare Carriers Manual: Part 3, Chapter IV, Claims Review 4122 (P. 22), (05/25/01)