: How to Use This Guide
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SPA Research Billing Guidance
It is important to understand the type of research trial being conducted and the associated billing rules. This Guide uses several algorithms to help determine the type of trial your site is conducting with supporting regulatory information for each type of trial. To save time, we have designed this guide to direct the researcher to only the guidance that pertains to the study that
will be submitted to SPA. Begin with the first algorithm: Determining the Applicable Research
Billing Guidance on Page 3.
Section I of this guide provides information about the Medicare’s Clinical Trial Policy (CTP)
~ National Coverage Decision (NCD) on billing for items and services related to a patient’s participation in a clinical trial. The NCD, a national coverage policy, was originally issued
September 2000 and subsequently updated in July 2007. Its purpose was to clarify and extend coverage to Medicare Beneficiaries for the cost of qualifying research. The NCD identifies which trials and services related to the trial are eligible for reimbursement from Medicare.
Section II of this guide provides information about Medicare coverage of Investigational
Devices including Investigational Device Exemptions (IDE’s) (Category A and Category B) and
Non-Significant risk devices.
Section III of this guide is on Humantarian Device Exemptions (HDE) or Humanitarian Use
Devices (HUD) (the term HDE and HUD are used interchangeably). HDE’s are not research, but are subject to Medicare coverage rules similar to IDE’s and require a financial review by
Allina.
Section IV provides information on Medicare coverage for services related to and required as a result of services which are non-covered . Use Section IV guidance to determine what is billable and what is non-billable for visits within these types of studies.
Finally, Section V contains important Miscellaneous Research Billing Compliance scenarios for review.
Researchers are expected to understand the guidance that is relevant to their clinical trial.
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SPA Research Billing Guidance
Determining the type of research study being conducted will direct you to the appropriate section in this guide. Answer the set of questions below according to each study that requires submission to SPA.
Question 1: Does the research study involve one of the following:

Investigational Device (includes IDE, post-market approval carotid stents trials, and non-significant risk devices);

If YES, proceed to Section II ;
or

Humanitarian Use Device (HUD/HDE)?

If YES, proceed to Section III ;
or

IF NO, answer Question 2
Question 2: Does the research study require Allina to bill for any items or services to a third party payer (Medicare, Medicaid, or other insurance)?

If YES, answer Question 3

If NO, you may skip Part I SPA Research Billing Guidance and proceed to Part II
Sponsored Projects Review Process and eProtocol SPA Form Guide to complete your submission to SPA.
Question 3: Does the research study involve a Non-Billable Item or Service (a specific noncoverage decision applies)?

If YES, proceed to Section IV to review guidance for billing of non-covered
items or services.

If NO, proceed to Section I to determine if your trial qualifies under Medicare’s
Clinical Trial Policy (CTP).
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SPA Research Billing Guidance
The Medicare Clinical Trial Policy (CTP) National Coverage Decision (NCD) is referred to through this guide as CTP or NCD interchangeably.
If the research study involves billing of routine care services (routine costs) to patient insurance, it is essential that the research site become familiar with the CTP before beginning the Sponsored
Projects Review Process and eProtocol submission. In order to complete the eProtocol SPA
Form and the required Schedule of Events correctly, the investigator must determine if the trial meets the qualifying criteria listed in the CTP and understand which services are allowable for billing.
Please Note: The Clinical Trial Policy National Coverage Decision (NCD) was issued by the
Center for Medicare and Medicaid services (CMS). Non-governmental payers (i.e. Blue Cross,
Medica, etc.) may have their own coverage of services policies related to clinical trials. For non-governmental payers, it is the responsibility of the research site or the research participant to determine if a service provided within a trial is covered.
After reading the NCD and related materials the research site should be able to:

Determine if the study meets the Medicare National Coverage Decision (NCD);

Understand what items and services may be billed to Medicare; and

Understand which items and services are non-billable and must be paid for by the study.
Billable – classification of items or services provided to research participant as allowable under
Medicare policy for submission of a claim for reimbursement (i.e. billable to insurance)
Non-billable – classification of items or services provided to research participant that do not meet allowable (routine cost) criteria and cannot be submitted on a claim for reimbursement (i.e. non-billable to insurance)
If after reviewing the following materials the research site has questions about any of the above items, please contact the SPA Manager at 612-262-4926.
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SPA Research Billing Guidance
1.
Does the trial evaluate an item or service that falls within a Medicare benefit category and is not statutorily excluded?
2.
Does the trial have therapeutic intent and not designed exclusively to test toxicity or disease pathophysiology?
3.
If the trial evaluates a therapeutic intervention, does it enroll patients with diagnosed disease rather than healthy volunteers? (Trials of diagnostic intervention may enroll healthy patients as control group).
Definition: Medicare benefit category – a category of covered benefits under Part A or Part
B of the Medicare Program (for example, inpatient hospital services, post-hospital extended care services, and physicians services) (CMS CFR 421.404).
If YES to all three criteria, proceed to Question 4
If NO to any of the three, the study does not qualify under the CTP for coverage.
Answer Yes if the trial is:

Funded by NIH, CDC, AHRQ, CMS (HFCA), DOD, VA; or

Supported by centers or cooperatives funded by NIH, CDC, AHRQ, CMS (HFCA), DOD or VA; or

Conducted under an investigational new drug application (IND) reviewed by the FDA; or

Exempt from having an IND under 21 C.F.R. 312.2(b)(1) (until qualifying criteria are developed and certification is in place).
IF YES to any part of Question 4, the study qualifies under the Medicare CTP for coverage. The study is a ‘Qualifying Trial’ under the CTP.
If NO to all the deemed criteria in Question 4, the study does not qualify under the CTP for coverage.
For non-qualifying studies, return to either Determining Type of Research Study algorithm to
determine if your study is of another type or proceed to Section IV: Billing for Services Related to and Required as a Result of Services Non-Covered .
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SPA Research Billing Guidance
If the study is a qualifying clinical trial under the Medicare Clinical Trial Policy (CTP), it is the researcher’s responsibility to determine what is billable and non-billable and to submit the itemization of these items and services to SPA. The following information provides CTP definition of what is billable and non-billable.
when involved items and services are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial.
Routine costs in clinical trials include items or services:

Typically provided absent a clinical trial (e.g., conventional care)

Required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and

Needed for reasonable and necessary care arising from the provision of an investigational item or service--in particular, for the diagnosis or treatment of complications.

The investigational item or service itself, unless otherwise covered outside of the clinical trial;

Items and services provided solely to satisfy data collection and analysis needs and that are not used in direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan);

Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial;

Items and services for which sponsor has specifically paid provider;

Items and services for which there is no Medicare benefit category;

Items and services that are non-covered because they are statuatorily excluded or fall under a national non-coverage policy.
The information above is taken from July 2007 Medicare Clinical Trial Policy National
Coverage Decision. This guidance should be used to determine what is paid for by the study and what is billable to patient or patient’s insurance. SPA requires this information be provided in the form of a study Schedule of Events (SOE) in table format. Please see the Sponsored Projects
Review Process Schedule of Events Instructions for more information.
In addition, services that will be paid for by study (non-billable) must be added in the eProtocol
Service & Pricing Information section. See SPA eProtocol User Guide for more information .
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[Also available in text p. 6-8]
Question 1-3: Does the study meet the first three CTP qualifying criteria?
1.
Does the trial evaluate an item or service that falls within a Medicare benefit category and is not statutorily excluded?
2.
Does the trial have therapeutic intent and not designed exclusively to test toxicity or disease pathophysiology?
3.
If the trial evaluates a therapeutic intervention, does it enroll patients with diagnosed disease rather than healthy volunteers?
(Trials of diagnostic intervention may enroll healthy patients as control group).
YES
Question 4: Is the study “deemed to be automatically qualified”? Answer Yes if the trial is:

Funded by NIH, CDC, AHRQ, CMS (HFCA), DOD, VA; or

Supported by centers or cooperatives funded by NIH, CDC, AHRQ, CMS (HFCA), DOD or VA; or

Conducted under an investigational new drug application (IND) reviewed by the FDA; or

Exempt from having an IND under 21 C.F.R. 312.2(b)(1) (until qualifying criteria are developed and certification is in place)?
NO
NO
YES The study qualifies under the Medicare CTP for coverage. The study is a ‘Qualifying Trial’ under the CTP
The study does not qualify under the
Medicare CTP for coverage.
Proceed to either
Determining Type of Research Study
algorithm to determine if your study is of another type or proceed to
Section IV: Non-
Covered study.
May not bill Medicare for:

The investigational item or service itself, unless otherwise covered outside of the clinical trial;

Items and services provided solely to satisfy data collection and analysis needs and that are not used in direct clinical management of the patient
(e.g., monthly CT scans for a condition usually requiring only a single scan);

Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial;

Items and services for which sponsor has specifically paid provider;

Items and services for which there is no Medicare benefit category;

Items and services that are non-covered because they are statutorily excluded or fall under a national non-coverage policy.
© 2001-2011 Allina Health System, Sponsored Projects Administration
May bill Medicare for routine costs of trial when involved items and services are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial.
Routine costs in clinical trials include items or services:
 typically provided absent a clinical trial (e.g., conventional care)
 required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
 needed for reasonable and necessary care arising from the provision of an investigational item or service--in particular, for the diagnosis or treatment of complications.
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SPA Research Billing Guidance
Indications and Limitations of Coverage
Effective for items and services furnished on or after July 9, 2007, Medicare covers the routine costs of qualifying clinical trials, as such costs are defined below, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply.
Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial except:
 The investigational item or service, itself unless otherwise covered outside of the clinical trial;
 Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan); and
 Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.
Routine costs in clinical trials include:
 Items or services that are typically provided absent a clinical trial (e.g., conventional care);
 Items or services required solely for the provision of the investigational item or service
(e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate
 monitoring of the effects of the item or service, or the prevention of complications; and
Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service--in particular, for the diagnosis or treatment of complications.
This policy does not withdraw Medicare coverage for items and services that may be covered according to local medical review policies (LMRPs) or the regulations on category B investigational device exemptions (IDE) found in 42 CFR 405.201-405.215, 411.15, and
411.406. For information about LMRPs, refer to www.lmrp.net, a searchable database of
Medicare contractors' local policies.
For noncovered items and services, including items and services for which Medicare payment is statutorily prohibited, Medicare only covers the treatment of complications arising from the delivery of the noncovered item or service and unrelated reasonable and necessary care.
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SPA Research Billing Guidance
However, if the item or service is not covered by virtue of a national noncoverage policy in Pub.
100-03, NCD Manual and is the focus of a qualifying clinical trial, the routine costs of the clinical trial (as defined above) will be covered by Medicare but the noncovered item or service, itself, will not.
A. Requirements for Medicare Coverage of Routine Costs
Any clinical trial receiving Medicare coverage of routine costs must meet the following three requirements:
1.
The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
2.
The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent.
3.
Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.
The three requirements above are insufficient by themselves to qualify a clinical trial for
Medicare coverage of routine costs. Clinical trials also should have the following desirable characteristics; however, some trials, as described below, are presumed to meet these characteristics and are automatically qualified to receive Medicare coverage:
1.
The principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes;
2.
The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use;
3.
The trial does not unjustifiably duplicate existing studies;
4.
The trial design is appropriate to answer the research question being asked in the trial;
5.
The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully;
6.
The trial is in compliance with Federal regulations relating to the protection of human subjects; and
7.
All aspects of the trial are conducted according to the appropriate standards of scientific integrity.
B. Qualification Process for Clinical Trials
Using the authority found in §1142 of the Act (cross-referenced in §1862(a)(1)(E) of the Act), the Agency for Healthcare Research and Quality (AHRQ) will convene a multi-agency Federal panel (the "panel") composed of representatives of the Department of Health and Human
Services research agencies (National Institutes of Health (NIH), Centers for Disease Control and
Prevention (CDC), the Food and Drug Administration (FDA), AHRQ, and the Office of Human
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SPA Research Billing Guidance
Research Protection), and the research arms of the Department of Defense (DOD) and the
Department of Veterans Affairs (VA) to develop qualifying criteria that will indicate a strong probability that a trial exhibits the desirable characteristics listed above. These criteria will be easily verifiable, and where possible, dichotomous. Trials that meet these qualifying criteria will receive Medicare coverage of their associated routine costs. This panel is not reviewing or approving individual trials. The multi-agency panel will meet periodically to review and evaluate the program and recommend any necessary refinements to CMS.
Clinical trials that meet the qualifying criteria will receive Medicare coverage of routine costs after the trial's lead principal investigator certifies that the trial meets the criteria. This process will require the principal investigator to enroll the trial in a Medicare clinical trials registry, currently under development.
Some clinical trials are automatically qualified to receive Medicare coverage of their routine costs because they have been deemed by AHRQ, in consultation with the other agencies represented on the multi-agency panel to be highly likely to have the above-listed seven desirable characteristics of clinical trials. The principal investigators of these automatically qualified trials do not need to certify that the trials meet the qualifying criteria, but must enroll the trials in the
Medicare clinical trials registry for administrative purposes, once the registry is established.
Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are:
1.
Trials funded by NIH, CDC, AHRQ, CMS (HCFA), DOD, and VA;
2.
Trials supported by centers or cooperative groups that are funded by the NIH, CDC,
AHRQ, CMS (HCFA), DOD and VA;
3.
Trials conducted under an investigational new drug application (IND) reviewed by the
FDA; and
4.
Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status.
CMS, through the national coverage determination (NCD) process, through an individualized assessment of benefits, risks, and research potential, may determine that certain items and services for which there is some evidence of significant medical benefit, but for which there is insufficient evidence to support a “reasonable and necessary” determination, are only reasonable and necessary when provided in a clinical trial that meets the requirements defined in that NCD.
Medicare will cover the routine costs of qualifying trials that either have been deemed to be automatically qualified, have certified that they meet the qualifying criteria, or are required through the NCD process, unless CMS's Chief Clinical Officer subsequently finds that a clinical trial does not meet the qualifying criteria or jeopardizes the safety or welfare of Medicare beneficiaries.
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SPA Research Billing Guidance
Should CMS find that a trial's principal investigator misrepresented that the trial met the necessary qualifying criteria in order to gain Medicare coverage of routine costs, Medicare coverage of the routine costs would be denied under §1862(a)(1)(E) of the Act. In the case of such a denial, the Medicare beneficiaries enrolled in the trial would not be held liable (i.e., would be held harmless from collection) for the costs consistent with the provisions of §§1879, 1842(l), or 1834(j)(4) of the Act, as applicable. Where appropriate, the billing providers would be held liable for the costs and fraud investigations of the billing providers and the trial's principal investigator may be pursued.
Medicare regulations require Medicare+Choice (M+C) organizations to follow CMS's national coverage decisions. This NCD raises special issues that require some modification of most M+C organizations' rules governing provision of items and services in and out of network. The items and services covered under this NCD are inextricably linked to the clinical trials with which they are associated and cannot be covered outside of the context of those clinical trials. M+C organizations therefore must cover these services regardless of whether they are available through in-network providers. M+C organizations may have reporting requirements when enrollees participate in clinical trials, in order to track and coordinate their members' care, but cannot require prior authorization or approval.
Note:
The documents provided in Section I are selected portions of the Medicare Clinical Trials ~
National Coverage Decision (NCD), Provider Bulletin, and Questions and Answers.
Research sites are responsible for making sure they have the most current information. The information can be found on the Centers for Medicare and Medicaid Services web site: https://www.cms.gov/ClinicalTrialPolicies/
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SPA Research Billing Guidance
Medicare covers most medical devices used as part of a clinical trial. Often this requires preapproval by a Medicare contractor. Medicare’s coverage of medical devices can be found in the
Medicare Benefit Policy Manual Chapter 14: Medical Devices
( http://www.cms.gov/manuals/Downloads/bp102c14.pdf
).
Investigational Devices that may be covered by Medicare include the following categories:

FDA Investigational Device Exemption (IDE) special Category A

FDA IDE Category B devices; and

Hospital Institutional Review Board (IRB) approved Non-Significant Risk devices.
If the study involves one of the covered devices listed above, proceed to Determining Applicable
Guidance for Type of Device .
If the FDA changes the status of the device (e.g., change the IDE device from Category B to
Category A or removes the IDE entirely), Allina can no longer bill for the device as currently approved and will need to take steps to ensure the device is billed correctly. It is the responsibility of the research site to notify SPA immediately upon learning of the change in device category status. Send an email with the information of the status change and effective date of the change to spa@allina.com
. In addition, submit a Project Amendment Form in eProtocol detailing the change. SPA will evaluate the submission and determine next steps, including the billing impact and if Allina will continue with the project.
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SPA Research Billing Guidance
The study involves a FDA Category A Device Exemption (IDE) and the study may bill routine care services included in the study to patients or patient insurance.
If true, proceed to Category A Device Trial: Billing Items or Services to Medicare
The study involves a FDA Category B Investigational Device Exemption (IDE) and the study may bill routine care services included in the study to patients or patient insurance.
If true, proceed to Category B Device Trial: Billing Items or Services to Medicare
The study involves a Post Market Approved (PMA) carotid stent study and/or is a Post-Market
Extension Study.
If true, contact SPA Manager.
The study involves a non-significant risk device (non-IDE) and the study may bill routine care services to Medicare patients enrolled in the study.
If true, proceed to Non-Significant Risk Device
The study will not be billing any items or services to Medicare, Medicaid, other third party payors or insurances. All items and services related to the study are paid for by the sponsor.
If true, billing guidance does not apply. Proceed to the guide for the Sponsored Projects
Review Process and eProtocol SPA Form Guide to complete your submission to SPA.
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SPA Research Billing Guidance
A Category A IDE is an experimental device, which absolute risk of the device type has not been established (i.e., initial questions of safety and effectiveness have not been resolved and the FDA is unsure whether the device type is safe and effective). Medicare Benefit Policy Manual
Chapter 14 Section 20.1
Effective for routine costs incurred on or after January 1, 2005, Medicare will cover the routine costs of clinical trials involving Investigational Device Exemption (IDE) Category A devices used in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. The Category A device itself remains non-covered.
Policy: Section 731 (b) of the MMA authorizes Medicare to cover the routine costs of clinical trials involving IDE Category A devices effective for routine costs incurred on or after January 1, 2005. Category A (experimental/investigational) devices are innovative medical devices believed to be in Class III, for which “absolute risk” of the device has not been established (that is, initial questions of safety and effectiveness have not been resolved and the Food and Drug Administration (FDA) is unsure whether the device can be safe and effective). For a trial to qualify for payment of routine costs, it must meet certain criteria established by the Secretary to ensure that the trial conforms to appropriate scientific and ethical standards. [..]As guidance in evaluating the immediately life-threatening requirement, contractors should use the following definition: “a stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.”
Excerpted from CMS Pub 100-20, CR 3548.
Per Medicare requirements, Allina SPA must submit the investigational device and clinical trial information to each Medicare contractor (Part A & Part B) for approval prior to the study taking place at an Allina facility.
See Category B definition of billable and non-billable charges if Medicare billing is approved (p.
18).
Follow the instructions for submission requirements in the Sponsored Projects Review Process and SPA eProtocol User Guide to submit to SPA for review and subsequent submission to the
Medicare Contractor(s).
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SPA Research Billing Guidance
Category B IDE devices are nonexperimental and/or investigational devices believed to be in classes I or II or devices believed to be in Class III where the incremental risk is the primary risk in question (i.e., underlying questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA approval for that device type. Medicare Benefit Policy
Manual Chapter 14 Section 20.2.
If the study will bill routine care items or services to Medicare, Medicare may cover Category B devices if they are considered reasonable and necessary and if all other applicable Medicare coverage requirements are met. Medicare has assigned the determination of coverage for FDA
Approved Category B devices to the Medicare contractors.
Allina SPA will submit the investigational device and clinical trial information to each of its
Medicare contractors (Part A & Part B) prior to the study taking place at an Allina facility.
The following information provides Medicare’s Clinical Trial Policy (CTP) definition of what is billable and non-billable once the trial is approved for coverage. Since there is no specific guidance on the billable and non-billable items and services for device trials, researchers should apply the CTP criteria.
when involved items and services are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial.
Routine costs in clinical trials include items or services:
 typically provided absent a clinical trial (e.g., conventional care);
 required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
 needed for reasonable and necessary care arising from the provision of an investigational item or service--in particular, for the diagnosis or treatment of complications.
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SPA Research Billing Guidance

The investigational item or service itself, unless otherwise covered outside of the clinical trial;
For Example:

Category B devices approved by FI are billable

Investigational procedure, if not otherwise covered outside of the clinical trial, is not billable

Items and services provided solely to satisfy data collection and analysis needs and [that are] not used in direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan);

Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial;

Items and services for which sponsor has specifically paid provider;

Items and services for which there is no Medicare benefit category;

Items and services that are non-covered because they are statuatorily excluded or fall under a national non-coverage policy.
SPA will submit the device information to the Medicare Contractors for claims billed by Allina.
Follow the instructions for device study submission requirements in Part II: Sponsored Projects
Review Process and the SPA eProtocol User Guide to submit to SPA for review and subsequent submission to the Medicare contractor(s).
For any services not billed by Allina, but involving the use of the device, the research site should submit to the Medicare contractor for billing approval. For example, if a non-employed cardiologist will insert an IDE stent into an Allina patient, Allina will seek approval for billing the technical services performed at Allina’s hospital, but the cardiologist’s group must obtain approval from the Medicare contractor for the billing of professional services.
Every payer has different rules for coverage of investigational devices. It is the responsibility of the research site or research participant to determine if the investigational device and related procedures will be covered by the non-governmental payer(s).
If there is no billing of items or services to Medicare, Medicaid, other third party payers or insurances, then billing guidance does not apply. Proceed to Part II: Sponsored Projects Review
Process and eProtocol SPA Form Guide to complete the study submission to SPA.
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SPA Research Billing Guidance
If the study will bill routine care items or services to Medicare, Medicare may cover nonsignificant risk (FDA IDE not required) devices if they are considered reasonable and necessary and if all other applicable Medicare coverage requirements are met. Medicare has assigned the determination of coverage for non-significant risk devices to the Medicare contractor(s).
Allina SPA will submit the investigational device and clinical trial information to each of its
Medicare contractors (Part A & Part B) prior to the study taking place at an Allina facility.
See Category B definition of billable and non-billable charges if Medicare billing is approved (p.
18).
SPA will submit the device information to the Medicare Contractors for claims billed by Allina.
Follow the instructions for Device Study Submission requirements in Part II: Sponsored Projects
Review Process and the SPA eProtocol User Guide to submit to SPA for review and subsequent submission to the Medicare Contractor(s).
For any services not billed by Allina, but involving the use of the device, the research site should submit to the Medicare contractor for billing approval. For example, if a non-employed cardiologist will insert non-significant risk device into an Allina patient, Allina will seek approval for billing the technical services performed at Allina’s hospital, but the cardiologist’s group must obtain approval from the Medicare contractor for the billing of professional services.
Every payer has different rules for coverage of study devices. It is the responsibility of the research site or research participant to determine if the non-significant risk device and related procedures will be covered by the non-governmental payer(s).
If there is no billing of items or services to Medicare, Medicaid, other third party payors or insurances, then billing guidance does not apply. Proceed to the guide for the Sponsored
Projects Review Process and eProtocol SPA Form Guide to complete your submission to SPA.
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SPA Research Billing Guidance
A Humanitarian Device Exemption (HDE)/Humanitarian Use Device (HUD) is a device that is intended to benefit fewer than 4,000 patients in the United States per year. Humanitarian devices are not research, but an exception from approved PMA devices. HUD billing requires approval by the Medicare Fiscal Intermediary and Allina.
If a HDE and related services will be billed to Medicare, Allina will need to apply for coverage to the Medicare fiscal intermediary (Part A contractor). The Medicare carrier (Part B contractor) does not require an application for billing approval.
Allina SPA will submit the device information to its Medicare Part A contractor prior to its approval for use at an Allina facility.
SPA will submit the device information to the Medicare Part A contractor for claims billed by
Allina. Follow the instructions in the SPA eProtocol User Guide to submit the appropriate information to SPA for review and subsequent submission to the Medicare contractor.
For other, non-governmental, payers it is the responsibility of the research site or humanitarian use device recipient to determine if the device and related procedures will be covered by nongovernmental payer(s).
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SPA Research Billing Guidance
When categories of services, items, or devices are excluded from coverage, the Medicare Non-
Covered Billing Algorithm
should be used to determine if any items or services may be billed to
Medicare.
If the study does not meet the Medicare Clinical Trial Policy (CTP) and does not involve an investigational or humanitarian use device discussed previously, the services provided may be covered according to Medicare billing guidance for non-covered services.
For billing of services related to and required as a result of non-covered items or services under
Medicare (e.g., investigator-initiated, non-device study, Category B or HDE device denied by
Medicare contractor), the following is guidance excerpted from the Medicare Benefit Policy
Manual, CMS Pub. 100-02, Ch. 16, Part 180:
Medical and hospital services are sometimes required to treat a condition that arises as a result of services that are not covered because they are determined to be not reasonable and necessary or because they are excluded from coverage for other reasons. Services “related to” noncovered services (e.g., cosmetic surgery, noncovered organ transplants, noncovered artificial organ implants, etc.), including services related to follow-up care and complications of noncovered services which require treatment during a hospital stay in which the noncovered service was performed, are not covered services under Medicare. Services “not related to” noncovered services are covered under Medicare.
Following are examples of services “related to” and “not related to” noncovered services while the beneficiary is an inpatient:
A beneficiary was hospitalized for a noncovered service and broke a leg while in the hospital.
Services related to care of the broken leg during this stay is a clear example of “not related to” services and are covered under Medicare.
A beneficiary was admitted to the hospital for covered services, but during the course of hospitalization became a candidate for a noncovered transplant or implant and actually received the transplant or implant during that hospital stay. When the original admission was entirely unrelated to the diagnosis that led to a recommendation for a noncovered transplant or implant, the services related to the admitting condition would be covered.
A beneficiary was admitted to the hospital for covered services related to a condition which ultimately led to identification of a need for transplant and receipt of a transplant during the same hospital stay. If, on the basis of the nature of the services and a comparison of the date they are received with the date on which the beneficiary is identified as a transplant candidate, the services could reasonably be attributed to preparation for the noncovered transplant, the services would be “related to” noncovered services and would also be noncovered.
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SPA Research Billing Guidance
Following is an example of services received subsequent to a noncovered inpatient stay:
After a beneficiary has been discharged from the hospital stay in which the beneficiary received noncovered services, medical and hospital services required to treat a condition or complication that arises as a result of the prior noncovered services may be covered when they are reasonable and necessary in all other respects. Thus, coverage could be provided for subsequent inpatient stays or outpatient treatment ordinarily covered by Medicare, even if the need for treatment arose because of a previous noncovered procedure. Some examples of services that may be found to be covered under this policy are the reversal of intestinal bypass surgery for obesity, repair of complications from transsexual surgery or from cosmetic surgery, removal of a noncovered bladder stimulator, or treatment of any infection at the surgical site of a noncovered transplant that occurred following discharge from the hospital.
However, any subsequent services that could be expected to have been incorporated into a global fee are considered to have been paid in the global fee, and may not be paid again.
Thus, where a patient undergoes cosmetic surgery and the treatment regimen calls for a series of postoperative visits to the surgeon for evaluating the patient’s progress, these visits are not paid.
For services related to a non-covered device, excerpt from Center for Medicare and Medicaid
Services Publication 42 CFR Sec 405.207:
(a) When payment is not made . Medicare payment is not made for medical and hospital services that are related to the use of a device that is not covered because CMS determines the device is not “reasonable and necessary” under section 1862(a)(1)(A) of the Act or because it is excluded from coverage for other reasons.
These services include all services furnished in preparation for the use of a non-covered device, services furnished contemporaneously with and necessary to the use of a non-covered device, and services furnished as necessary after care that are incident to recovery from the use of the device or from receiving related non-covered services;
(b) When payment is made . Medicare payment may be made for services, ordinarily covered by Medicare, to treat a condition or complication that arises because of the use of a noncovered device or from the furnishing of related non-covered services.
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SPA Research Billing Guidance
Is the visit for a medically necessary service as defined by Medicare?
If No , none of the care for the initial visit is billable to Medicare.
If Yes , may bill Medicare for services “not related to” the preparation, provision, or after care that is incident to recovery from the noncovered service.

The investigational item or service itself,

Time and effort (E/M) related to study enrollment,

Items and services provided solely to satisfy data collection and analysis needs and [that are] not used in direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan);

Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial;

Items and services for which sponsor has specifically paid provider;

Items and services for which there is no Medicare benefit category;

Items and services that are non-covered because they are statuatorily excluded or fall under a national non-coverage policy;

Services during the hospital stay in which the noncovered services was performed related to follow-up care and/or complications of noncovered services

Services furnished in preparation for the use of a non-covered device

Services furnished contemporaneously with and necessary to the use of a non-covered device

Services furnished as necessary after care that are incident to recovery from the use of the device or from receiving related non-covered services
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SPA Research Billing Guidance
Routine care (inpatient or outpatient) provided as follow-up care for the initial non-covered services ordinarily covered by Medicare and “reasonable and necessary in all other respects” may be covered.
Subsequent visits that may have been expected to “have been incorporated into a global fee” such as ongoing treatment regimen for the non-covered service(s) are not billable to Medicare.
Items or services “required to treat a condition or complication that arises as a result of the prior noncovered services may be covered when they are reasonable and necessary in all other respects.”
May not bill for items or services required to treat a condition or complication that is not ordinarily covered by Medicare.
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SPA Research Billing Guidance
Double dipping is being paid for the same service twice. Double dipping constitutes fraud and is illegal. For example, a researcher is paid to conduct a qualifying clinical trial and is paid to conduct a service related to the trial (the item is specifically identified in the budget). The researcher orders a service to be performed at an Allina facility and, the research site fails to notify SPA of the research visit in a timely manner (i.e. submission of Research Registration
Form). As a result, Allina bills the service to a third party payer. Allina has just “double dipped” even though it did not receive the initial payment from the sponsor.
Fair Market Value is the reasonable value of the items or services provided by a research site in a clinical trial. Research-related items and services should approximate fair market value. For example, if a Principal Investigator is participating in a trial and is receiving $5,000 per patient to collect a history and physical and to complete three data collection worksheets, the $5,000 would seem to exceed Fair Market Value.
The Sponsored Projects Review Process (SPRP) and subsequent eProtocol submission identifies billable and non-billable items and services (see Schedule of Events Instructions ) prior to beginning a study. The process of submitting a claim to a third party “in hopes that they will pay it” is not consistent with SPRP policies or procedures and may be considered submitting a false claim to the third party payer.
A sponsor or research site are not permitted to reimburse or pay a Medicare research patient’s co-pays for routine care. This may be considered an inducement and not allowed under Medicare rules. There are times, when this may not be considered an inducement, such as, when an injury has occurred. Please consult with SPA if payment for routine care co-pay or co-insurance has been proposed.
Industry representatives and/or study sponsors sometimes provide guidance on billing and coding issues for research services. This guidance may or may not be accurate and Allina will always follow its internal coding standards.
Billing rules and regulations that apply to the primary payer apply to all third party payers. If the service is not covered under the primary insurance, it is not billable to any other third party payer
(i.e., Medigap, supplemental, etc.) on the patient’s account. For example, if the patient does not have a drug benefit in his or her plan, Allina will not submit a claim in order to subsequently bill the secondary payer so that Allina may receive payment. Allina considers this type of billing to be a false claim.
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SPA Research Billing Guidance
Per the Medicare Clinical Trial Policy (CTP), “reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials” are covered items. SPA requires notification of services provided for a complication as a result of a clinical trial through the submission of a Research Registration Form .
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