PREP Course #9: Research Billing For Investigational Devices Presented by Sumathy Sundarababu, PhD Clinical Research Service

CME Disclosure Statement •

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The North Shore LIJ Health System adheres to the ACCME’s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director and Course Planner, Kevin Tracey, MD and Tina Chuck, MPH have nothing to disclose. Sumathy Sundarababu the speakers and has nothing to disclose.

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OBJECTIVES •Identify the types of investigational devices. •Perform device procurement and charge code set-up. •Integrate the process for research billing of investigational devices.

WHO REGULATES THE MEDICAL DEVICES? FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. MEDICAL DEVICE Definition: A medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized.

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FDA DEVICE CLASSIFICATON FDA classifies medical devices into 3 classes: • a) class I –general controls such as GMP regulations (bed pans, elastic bandages, handheld surgical instruments etc) • b) Class II require general and special controls such as performance standards or post market surveillance, to assure safety and effectiveness (non invasive devices such as infusion pumps, surgical needle/ drapes, powered wheelchairs etc). • c) Class III-cannot be classified under class I or II because insufficient information exists to determine that either special or general controls, would provide reasonable assurance of safety and effectiveness. Class III devices require pre-market approval (heart valves, pacemakers, ablation catheters, orthopedic implants etc) 5

Investigational Device Exemption (IDE) ISSUED BY FDA • FDA assigns a special identifier # that corresponds to each device granted an investigational device exemption (IDE). IDE devices identified by G#123456 • For significant risk unapproved devices OR approved devices tested for new indication • Allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. • An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of FD&C Act that would apply to devices in commercial distribution. 6

FDA & CMS •For purposes of assisting CMS in determining Medicare coverage, the FDA places all approved IDEs in one of two categories (category A or category B) •FDA is all about safety & effectiveness •CMS is about reasonable & necessary

CATEGORY A&B IDE DEVICES Category B (class II, III)

Category A (Class III) •

Experimental device (initial questions of safety & effectiveness not resolved)

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Non-Experimental device( underlying questions of safety & effectiveness of device have been resolved)

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Device is intended for use in diagnosis, monitoring, or treatment of immediately life-threatening disease or condition

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Device may be covered by Medicare

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Routine care costs may be covered by Medicare

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Approval from Medicare Contractor required for device and routine cost coverage

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Payment for a category B IDE device and related services may not exceed what Medicare would have paid for a comparable approved device and related services

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Device never covered by Medicare

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Routine care costs may be covered by Medicare

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Approval from Medicare Contractor required for routine cost coverage

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Categories of Devices Possibly Covered Under Medicare

FDA Approved Through the PreMarket Approval (PMA) Process

Devices Cleared by the FDA Through the 510(k) Process

FDAApproved IDE Category B Devices

Humanitarian Device Exemption (HDE)

Institutional Review Board (IRB)-Approved Devices

Post market carotid artery stenting studies (as part of IDE study/postmarket FDA approved protocol )

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Medicare Coverage for Medical Devices The NCD clinical trials policy does not address device studies. Institutions/sites/sponsor should work with their Medicare Contractor to determine coverage of all device studies.

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Medicare IDE Regulations The Medicare process for coverage of category B IDEs is outline in Medicare Benefit Policy Manual Chapter 14.

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CONTRACTUAL LANGUAGE IN DEVICE STUDIES • Subject injury & Medicare secondary payer rule • Do not cap subject injury costs • Do not ask sponsor to pay for insurance denials (MLN Matters Number: SE0822 Revised Jan 2009) • Who is paying for the device? Is it provided free of cost? • Discuss about explants/re do surgery costs • For category A: Devices must be provided free of cost and the procedure covered by sponsor. • Co-pays are patients responsibility. If a research sponsor offers to pay costsharing amounts owed by the beneficiary, this could be a fraud and abuse problem. Hospital allowed to waive collection of such charges to uninsured patients of limited means (MLN Matters Number: SE0822 Revised Jan 2009) 12

CHARGE CODE SETUP Clinical Research Service Department Procurement Material Support services Health Information management PeopleSoft Patient financial services

ESTABLISING CHARGECODES FOR IDE DEVICES/IMPLANTS (INTERNAL PROCESS) NGS approval obtained

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CRS completes implant validation form (device description, category, vendor, manufacturer, product#, IDE#, pricing) notifies procurement

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Procurement contacts device manufacturer, reviews accuracy, checks price with vendor, checks duplicates in peoplesoft, places “item add’ request” for item file “on behalf of “ Dept-sends to MSS.

3 PFS reviews request, validates each item, item description & IDE, creates new charge codes. Once charges are completed by IT, PFS will notify appropriate departments & CRS

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Material support services MSS checks category, adds item to file, enter in Peoplesoft. Sends to HIM /PFS

5 Department receives completed validation form and inputs the items into respective systems (Q sight/ Centricity material file) for use

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Coverage approval (Medicare) & pre-authorization (Non medicare)

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Insurance Coverage for Investigational Device Studies • Obtain prior coverage approval from Medicare contractor. • Commercial payers may or may not cover IDE. Some payers follow Medicare policies • Obtain pre-authorization from commercial payers prior to billing.

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Obtaining National Government Service Approval (In order to bill Medicare in an IDE Trial) Site/Sponsor must submit the protocol and other associated documents to NGS, your local Medicare contractor to determine coverage for the following device studies until this function is centralized at CMS per 2014 Final Rule: IDE Category B Devices assigned by the FDA with a number beginning with a “G” IDE Category A Devices PMA studies (P#___) Registries of carotid stents.Studies for proximal Embolic Protection Device (EPD) in Carotid Artery Stenting (CAS) procedures Documents may include, but are not limited, to the following: Name and Narrative Description of Device Study Protocol IRB Approved Informed Consent Form Un-redacted copy of FDA Approval Letter IRB Approval Letter Executed contract/budget NPIs of participating MDs/RNs NPI of facility 17

BILLING COMMERCIAL PAYERS IN AN IDE STUDY

Preauthorization Process Flow-Chart (Non-Medicare)

Pre-Authorization Process (Non-Medicare)

Patient consented and qualifies for enrollment in the trial

Authorization Authorization received received? No

Call payer to verify benefits and confirm contact person for preauthorization

*Determine why request denied.

Yes

Record preauthorization number, scope of the service (s) authorized, code(s) recommended, the date and time and name of person authorizing the services in the patient’s file

Appeal Process Appeal process * Preauthorization request submitted to payer

* Letter should include: - Statement oftheir Medical necessity payer preference Follow up on with payer within a day to - Details on why this of procedure inquire about status request is preferred over other treatments. - CPT codes - FDA status

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Medical record Requirements for IDE studies

Medical record must contain: • Trial name • Sponsor • Sponsor assigned protocol name

• Investigators conducting clinical trials at the NSLIJ health system must document in their operative notes if the procedure in question was part of a clinical trial and if the implant utilized was an investigational device. This documentation is required as part of Good Clinical Practice and also facilitates proper coding and capture of appropriate codes in order to submit the claims correctly to Medicare/insurance companies. This practice will also help improve the clarity of medical records and enhance compliance with Medicare regulations. 20

DEVICE ACCOUNTABILITY • Keep detailed records of medical devices used in research (receipt, use by subject, returns) •Record number of devices, lot #s used •Appropriate segregation from clinically used devices •Follow instructions on storage of investigational devices & • adequate security • Refer NSLIJHS policy GR092 handling Investigational devices

BILLING TOOLS & CLAIM FORMS

Routing charges in clinical trials MEDICARE COVERAGE ANALYSIS • A MCA is a review of clinical research items, services, procedures and Medicare billing rules to determine the appropriate payer for each item or service. • Use of MCA and billing rules mitigates the primary compliance risk and provides most defined standards for research billing. • Properly performed MCA can be used for budget development, to support contract negotiations, and for billing compliance. 23

CLAIM FORMS USED FOR HOSPITAL AND PROFESSIONAL BILLING UB-04 (Form CMS-1450) - Standard paper claim form used by institutional providers, such as hospitals, to bill Medicare and various other third party payers. (The electronic version is referred to as the 837I.) http://www.cms.gov/Regulations-andGuidance/Guidance/Transmittals/Downloads/R1104CP.pdf CMS 1500 - Standard paper claim form used by healthcare professionals (e.g. physicians) and suppliers (e.g. reference laboratories) to bill Medicare and various other third party payers. (The electronic version is referred to as the 837P.) http://www.cms.gov/Medicare/CMS-Forms/CMSForms/Downloads/CMS1500805.pdf

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CHARGEMASTER Charge Description Master (CDM) - a comprehensive listing of items billable to a hospital patient or a patient's health insurance provider CDM includes, but is not limited to, the following items: • CPT Codes • Price • Chargecodes

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CODES & MODIFIERS ON INSURANCE CLAIMS

CODING ICD-9-CM Diagnosis Code - The International Classification of Diseases, Ninth Revision, Clinical Modification that is currently used to report diagnostic information on claims. ICD-10-CM (tenth version) will replace ICD-9-CM in the future. Primary diagnosis is the actual diagnosis V70.7 in secondary diagnosis field (examination of clinical trial participant) CPT/HCPCS Code - Codes that represent procedures, products, or services that may be provided to Medicare beneficiaries and to individuals enrolled in private health insurance programs.

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Billing Modifiers Modifier - Provides the means by which the reporting physician or provider can indicate that a service or procedure performed has been altered or modified by a specific circumstance, but not changed in its definition or code. •Only reported on outpatient or physician claims •Proper use of modifiers is essential for submitting correct claims •Certain modifiers are used by Medicare and other third party payers for payment purposes, whereas others are used for reporting and data collection purposes only •Q0 and Q1 are examples of research modifiers used by Medicare only for data collection purposes and at this time do not result in payment decisions • Q0 Modifier – Investigational item/service, e.g. Investigational drug J9999 Q0 •Q1 Modifier – Routine item/service, e.g. Physical Exam 99215 Q1 28

OTHER CODES Revenue Code - A four digit code that is submitted by institutional providers and represents a specific location or type of service provided Payer billing requirements for revenue codes may vary Example: Medicare accepts revenue code 0624 for IDEs, but many other payers allow for this to be billed using revenue code 0278, Other Implants Condition Code - Code reported in UB-04 fields 18-28 to describe any conditions or events that apply to the billing period, e.g. Condition Code 30, Qualifying Clinical Trial Value Code - A two digit or alphanumeric code that is reported in UB-04 fields 39-41 and is used to report additional information that applies to the billing period D4 is reported when the clinical trial number assigned by the National Library of Medicine (NLM)/National Institutes of Health (NIH) is reported on the claim. Refer to other third party payer-specific policies for reporting requirements FD to report no cost/device credits

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CLINICALTRIALS.GOV # OR NCT# As of Jan 2014 NCT# mandatory on all Medicare qualified clinical trial claims. Unique ID for a protocol NCT # 12345678  Append NCT# on Medicare claims Medicare can track inconsistent billing across sites and within site using NCT# on claims Site 1 EKG tech

Medicare

Site2

EKG prof

Study

EKG tech

Study

Site 3

EKG prof

Study

EKG tech

EKG prof

Medicare

NSLIJ Internal process: Submit forms with basic info & NCT# to registrar

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BILLING

What goes on the Insurance Claims? Item

Medicare Requirement(s) •

Routine Costs (outpatient billing)

Routine Costs submitted by Institutions(outpatient) • UB-04 • CMS 1450

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ICD-9 Diagnosis code V70.7 – Examination of participant in clinical trial reported as a secondary • ICD-10-CM Diagnosis code Z00.6 – Examination for normal comparison and control in clinical research program CPT Code Modifier (outpatient claims only) • Q0 Modifier – Investigational clinical service/device/drug • Q1 Modifier – Routine clinical service

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All of the above

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Condition Code 30 – Qualifying clinical trial (only on facility claims)

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IDE # on Revenue Code 0624 line – FDA Investigational Devices • If device provided at no cost, report device credit received with value code FD. • NCT# on both Physician and Hospital claims

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Research Billing 101

Type of Study

• Medicare Claims Processing Manual, Chapter 32

Qualifying Clinical Trial

Hospital Charges (UB-04) Inpatient Claims •

Medicare Clinical Trial Policy •

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Instructions apply to conventional care, including treatment of complications Billing provider must include in the medical record the following information: trial name, trial sponsor, and sponsor-assigned protocol number

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ICD-9 diagnosis code V70.7 as the secondary diagnosis code for trial participation ICD-9 diagnosis code V70.7 as the primary diagnosis code for healthy controls only Condition Code 30 (qualifying clinical trial) reported at the claim level for both trial participants and healthy controls Include V70.7 and Condition Code 30 regardless of whether all services on the claim are related to the clinical trial or not NCT #- required as of January 1, 2014 IDE devices: report IDE# in rev code 624 with charges in covered charges field. Report “zero/ token $1.00 for devices provided free of cost.

Hospital Charges (UB-04) Outpatient Claims •

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ICD-9 diagnosis code V70.7 as the secondary diagnosis code for trial participation ICD-9 diagnosis code V70.7 as the primary diagnosis code for healthy controls only Q1 Modifier- for both participants and healthy controls- apply to each service identified as conventional care only on line items related to the clinical trial Q0 Modifier- for each service identified as investigational Condition Code 30 (qualifying clinical trial) reported at the claim level for both trial participants and healthy controls Include V70.7 and Condition Code 30 regardless of whether all services on the claim are related to the clinical trial or not NCT #- required as of January 1, 2014

Professional Charges (CMS-1500) •

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ICD-9 diagnosis code V70.7 as the secondary diagnosis code for trial participation ICD-9 diagnosis code V70.7 as the primary diagnosis code for healthy controls only Q1 Modifier- for both participants and healthy controls- apply to each service identified as conventional care only on line items related to the clinical trial Q0 Modifier- for each service identified as investigational NCT # required as of January 1, 2014 Report IDE#

Note: CMS will return claims as unable to process if the V70.7 is not on claim with the Condition Code 30

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SAMPLE HOSPITAL CLAIM

Medicare Advantage Plan Billing in IDE Device Trials Medicare Managed Care Beneficiary enrolled in clinical trials(IDE Device) All services are Research. Billed to study

Bill advantage plan (MAP)as primary (Category B IDE trials have

Inpatient/ outpatient claims

Clinical Trial Standard of care services (V70.7,CC30,NCT# )

been covered, at contractor discretion (within CMS's rules and guidelines), since November 1, 1995, under 42 CFR 405.201 to 405.215. Category B IDE costs are included in the Medicare Advantage (MA) payment rates. Therefore, these claims are not paid on a fee-for-service basis by Medicare (fiscal intermediaries and carriers).

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Reporting and Charging Requirements When a Device is Furnished Without Cost to the Hospital or When the Hospital Receives a Full or Partial Credit for the Replacement Device •

Effective January 1, 2014, when a hospital furnishes a new replacement device received without cost or with a credit of 50 percent or more of the cost of a new replacement from a manufacturer, due to warranty, recall, or field action, the hospital must report the amount of the device credit in the amount portion for value code “FD” (Credit Received from the Manufacturer for a Replaced Medical Device). Also effective January 1, 2014 hospitals must report one of the following condition codes when the value code “FD” is present on the claim:

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49 Product Replacement within Product Lifecycle—Replacement of a product earlier than the anticipated lifecycle due to an indication that the product is not functioning properly.

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50 Product Replacement for Known Recall of a Product—Manufacturer or FDA has identified the product for recall and therefore replacement 36

HUMANITARIAN & COMPASSIONATE USE 

Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.

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A humanitarian device exemption (HDE) obtained from FDA.

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Medicare has no specific rules, regulations, or instructions with regard to HUDs. •

Each Medicare contractor has different requirements for submission of HUDs and has different policies around billing HUDs.

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Compassionate use: The compassionate use provision allows access for patients who do not meet the requirements for inclusion in the clinical investigation but for whom the treating physician believes the device may provide a benefit in treating and/or diagnosing their disease or condition. This provision is typically approved for individual patients but may be approved to treat a small group.

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No specific rules from Medicare on compassionate use coverage 37

Remember….. Utilize the Coverage Analysis as a guide/tool Identify study-related visits and services • Compare charges for items/services to those identified in the Coverage Analysis/Billing Grid for payer assignment • Obtain coverage approval from Medicare • Provide registration forms • Keep records of medical devices used for research (refer GR092 NSLIJHS policy on handling investigational devices; www.feinsteininstitute.org/hrpp/guidane; GCP ISO 14155) Notify CRS of any BRANY approved Device trials to setup charge codes PI/study team provide sufficient documentation for items/services in medical records Apply V70.7 on inpatient and outpatient claims. Q0/Q1 modifiers on Outpatient claims Health Information Management Patient Financial Services / Registration Apply NCT # and Condition Code 30 & Revenue codes Patient Financial Services For Medicare approved category B device trials, bill Medicare advantage plan as primary. 38

THANK YOU Sumathy Sundarababu PhD Manager, Financial Operations Clinical Research Service North Shore-Long Island Jewish Health System The Feinstein Institute for Medical Research Manhasset, NY 11030 Tel (516) 562-3642 Fax (516) 562-1006 [email protected]

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