Notification

Routine Costs Associated with Qualifying Clinical Trials


Notification Issue Date: 10/03/2013

This version of the policy will become effective 01/01/2014.

The policy was amended to conform to the “Coverage for Individuals Participating in Approved Clinical Trials” requirements of the Patient Protection and the Affordable Care Act (ACA).

In addition to the ACA changes, the requirement related to the completion of the Physician's Certificate of Attestation has been deleted from the policy.

The following text has been deleted from the Noncovered Services section of the policy:
· Routine costs associated with clinical trials that do not have a therapeutic intent are not considered routine and are not covered or eligible for reimbursement consideration by the Company.

Time and Event schedule or approved study budget were added to the Required Documentation section as examples of specific routine items and services provided to the individual.

A copy of the signed and dated study-specific Informed Consent Form was also added to the list of Required Documentation.

ICD-10-CM codes were added based on GEMS mapping converting current ICD-9-CM codes to applicable ICD-10-CM codes, and clinically reviewed considering the scope and intent of the policy document and the appropriateness of the codes for the policy. ICD-10-CM codes will be in effect on the determined ICD-10 compliance date. However, they are being added to policy for informational purposes only.

For the current version of this policy, click the following link: 07.00.20d Routine Costs Associated with Qualifying Clinical Trials



Claim Payment Policy


Title:Routine Costs Associated with Qualifying Clinical Trials

Policy #:07.00.20f


Application of Claim Payment Policy is determined by benefits and contracts. Benefits may vary based on product line, group or contract. Medical necessity determination applies only if the benefit exists and no contract exclusions are applicable. Individual member benefits must be verified.

In products where members are able to self-refer to providers for care and services, members are advised to use participating providers in order to receive the highest level of benefits.When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

For more information on how Claim Payment Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.

Routine costs associated with qualifying clinical trials, as defined above, are covered and eligible for reimbursement consideration for individuals enrolled in Company products that provide benefits for such costs.

US Food and Drug Administration (FDA)--approved prescription pharmaceuticals and biologics that are being used for FDA approved indications and/or are recognized as covered for an indication in medical policy in combination with a clinical study drug and are not otherwise funded are eligible for coverage and reimbursement consideration.

Any FDA-approved prescription pharmaceuticals and biologics funded by the clinical trial are not eligible for coverage and reimbursement consideration.

NONCOVERED SERVICES

The following services associated with a qualifying clinical trial are not covered and, therefore, not eligible for reimbursement by the Company:
  • Any services that the individual's plan does not routinely cover, such as, but not limited to services that:
    • Are a specified benefit exclusion
    • Have met or exceeded a benefit limitation described in the member contract
    • Are deemed not medically necessary

The following items, services, and supplies associated with a qualifying clinical trial are not considered routine and are, therefore, not covered or eligible for reimbursement by the Company:
  • The biological product, device, drug, medical treatment, procedure, or therapy under investigation
  • The services and supplies provided solely to satisfy data collection and analysis needs, which are not used in the direct clinical management of the individual enrolled in the qualifying clinical trial
  • The services and supplies customarily provided free of charge by the research sponsors for any individual enrolled in the qualifying clinical trial
  • A service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

Additional documentation that may be requested to confirm that the trial meets policy requirements include:
  • The trial name, trial sponsor, ClinicalTrials.gov identifier number, and sponsor-assigned protocol number
  • The specific routine items and services provided to the individual (Time and Event schedule or approved study budget)
  • Copy of the signed and dated study-specific Informed Consent Form
  • The specific FDA-approved prescription pharmaceutical(s) or biologic(s)being used in combination with a clinical trial that are and are not supplied or paid for by the clinical trial sponsor

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

BILLING REQUIREMENTS

Providers must report both of the following with each procedure code that represents a routine cost associated with a qualifying clinical trial or an FDA-approved prescription pharmaceutical or biologic:
  • Modifier Q1 (routine clinical service provided in a clinical research study that is in an approved clinical research study)
    Note: Facility providers that do not report Current Procedural Terminology (CPT®) or Healthcare Common Procedure Coding System (HCPCS) code(s) are not required to report this modifier.
  • The International Classification of Diseases, 10th Revision (ICD 10) code Z00.6 (Encounter for examination for normal comparison and control in clinical research program)

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, routine costs associated with qualifying clinical trials are covered under the medical benefits of the Company's commercial products.

MANDATES

This policy is consistent with applicable Federal and state mandates.

Description

A clinical trial, which is also referred to as clinical research or a clinical study, is a research study with human volunteers to test new methods of screening, prevention, diagnosis, or treatment of disease. These studies are conducted by physicians and other health professionals in a controlled environment to help determine the safety and efficacy of biological products, devices, drugs, medical treatments, procedures, or therapies to improve health.

Clinical trials involving drugs or biological products are classified by the US Food and Drug Administration (FDA) and are designated by the following terms:
  • Phase 0 (zero): Preliminary exploration of an investigational new drug (IND) clinical study that involves limited human exposure and no therapeutic or diagnostic intent (e.g., screening studies, microdose studies)
  • Phase I: Initial clinical studies to determine the metabolism and pharmacologic actions of drugs in individuals, the side effects associated with increasing doses, and the early evidence of effectiveness; may include healthy participants and/or individuals with the disease or condition under study
  • Phase II: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication(s) in individuals with the disease or condition under study and to determine the common short-term side effects and risks of the drug
  • Phase III: Expanded controlled and uncontrolled clinical trials conducted after preliminary evidence has been obtained to suggest the effectiveness of the drug; also intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for labeling
  • Phase IV: Post-marketing clinical studies to delineate additional information, including the drug's risks, benefits, and optimal use

A qualifying clinical trial, as defined by the Company, is the systematic, intensive investigation or evaluation of a biological product, device, drug, medical treatment, procedure, or therapy that meets all of the following requirements:
  • It investigates a service that falls within a benefit category of a Company benefit contract.
  • It is not a benefit contract exclusion.
  • It does not unjustifiably duplicate existing studies.
  • It is designed to collect and disseminate reliable evidence and answer specific questions being researched in the trial.
  • It is designed and conducted according to appropriate standards of scientific integrity.
  • It complies with federal regulations relating to the protection of human subjects.
  • It is conducted by a participating provider in a participating facility, unless otherwise pre-approved by the Company.
  • It is based on available clinical and scientific rationale.
  • It is being studied in a Phase I, II, III, or IV clinical trial in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition.

In addition, the qualifying clinical trial must meet one of the following requirements:
  • It is funded by, or supported by, centers or cooperative groups that are funded by one of the following:
    • National Institutes of Health (NIH)
    • Centers for Disease Control and Prevention (CDC)
    • Agency for Healthcare Research and Quality (AHRQ)
    • Centers for Medicare and Medicaid Services (CMS)
    • Department of Defense (DOD), Department of Veterans Affairs (VA) or Department of Energy
  • It is being conducted under an IND application reviewed by the FDA or is an IND exemption as defined by the FDA.
  • It is being conducted under an Investigational Device Exemption (IDE).

An Institutional Review Board (IRB) is a specially constituted review body established or designated by an entity (e.g., hospital) to protect the welfare of human subjects selected to participate in biomedical or behavioral research.

Reliable evidence is classified as any of the following:
  • Reports and articles published in the authoritative medical and scientific literature
  • Written protocol(s) used by the treating facility or the protocol(s) of another facility studying substantially the same biological product, device, drug, medical treatment, procedure, or therapy
  • Written informed consent used by the treating facility or by another facility studying the same biological product, device, drug, medical treatment, procedure, or therapy

The term experimental/investigational (E/I) is defined by the individual's product or plan.

As used in this policy, routine costs include:
  • Services covered under the benefit contract that would typically be provided according to the standard of care for the diagnosed disease in the absence of the qualifying clinical trial

In addition, routine costs may include the following, unless covered by the study Sponsor:
  • Services and supplies required solely for the provision of the biological product, device, drug, medical treatment, procedure, or therapy under investigation in the clinical trial
  • The clinically appropriate monitoring of the effects of the biological product, device, drug, medical treatment, procedure, or therapy under investigation in the clinical trial that is required for the prevention of complications during the clinical trial
  • Services and supplies required for the diagnosis or treatment of medical complications arising from the provision of the biological product, device, drug, medical treatment, procedure, or therapy under investigation in the clinical trial

Examples of routine costs may include, but are not limited to, the following:
  • Office/outpatient visits
  • Routine laboratory tests
  • Imaging studies
  • Echocardiography
  • Electrocardiogram

References


American Cancer Society. Clinical trials: state laws regarding insurance coverage. Special agreements: New Jersey consensus agreement. [Cancer.org Web site]. Last Revised 04/02/2010. Available at: http://www.cancer.org/cancer/analcancer/overviewguide/4-2-test-1.
Accessed August 10, 2015.

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Pub 100-04: Medicare Claims Processing. Transmittal 1723. Insuring only clinical trial services receive fee-for-service payment on claims billed for managed care beneficiaries. [CMS Web site]. 10/01/2009. Available at:http://www.cms.gov/transmittals/downloads/R1723CP.pdf. Accessed August 10, 2015.

Centers for Medicare & Medicaid Services (CMS). Medicare National Coverage Determinations Manual. Routine costs in clinical trials: Chapter 1, Part 4, §310.1. [CMS Web site]. 07/09/2007 (Rev. 173, Issued: 09-04-14, Effective: Upon Implementation of ICD-10). Available: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ncd103c1_part4.pdf. Accessed August 10, 2015.

Company Benefit Contracts

National Cancer Institute (NCI). National Institutes of Health. Dictionary of Cancer Terms. Clinical trial. [NCI Web site]. N.D. Available at: http://www.cancer.gov/dictionary?CdrID=45961. Accessed August 10, 2015.

National Institutes of Health. Learn About Clinical Studies. [ClinicalTrials.gov Web site]. Last reviewed December 2014. Available at: https://clinicaltrials.gov/ct2/about-studies/learn. Accessed August 10, 2015.

National Cancer Institute (NCI). National Institutes of Health. Dictionary of Cancer Terms.Phases I, I/II, II, II/III, III, IV. [NCI Web site]. N.D. Available at: http://www.cancer.gov/dictionary. Accessed August 10, 2015.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Code of Federal Regulations. Title 21, Vol 5: Food and drugs. [FDA Web site]. Original: 04/01/04 (Revised: 04/01/14). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1. Accessed August 10, 2015.

US National Institutes of Health. Glossary: Phase I, Phase II, Phase III, Phase IV Trials. [ClinicalTrials.gov Web site]. Last reviewed February 2015. Available at: http://www.clinicaltrials.gov/ct2/info/glossary. Accessed August 10, 2015.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD-10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD-10 Diagnosis Code Number(s)

THE FOLLOWING DIAGNOSIS CODE MUST BE REPORTED WITH EACH SERVICE REPRESENTING A ROUTINE COST ASSOCIATED WITH A QUALIFYING CLINICAL TRIAL:

Z00.6 Encounter for examination for normal comparison and control in clinical research program



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A


Misc Code

Modifier:

THE FOLLOWING MODIFIER MUST BE REPORTED WITH EACH CPT/HCPCS THAT REPRESENTS A ROUTINE COST ASSOCIATED WITH A QUALIFYING CLINICAL TRIAL:

Q1 Routine clinical service provided in a clinical research study that is in an approved clinical research study



Coding and Billing Requirements


Cross References

Related Documents


Policy History

Effective 10/05/2017 this policy has been updated to the new policy template
format.
Version Effective Date: 10/02/2015
Version Issued Date: 10/02/2015
Version Reissued Date: N/A



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