Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Routine Costs of Clinical Trials and Coverage of Investigational Devices A and B
Policy #:MA00.004a

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

ROUTINE COSTS

Coverage for routine costs associated with qualifying clinical trials for Medicare Advantage members who are enrolled in a clinical trial approved by Medicare are processed through the local Medicare Administrative Contractor (MAC). Therefore:
  • Providers must submit all claims for routine costs associated with qualifying clinical trials to the local MAC.
  • Claims received by the Company for routine costs associated with qualifying clinical trials, including FDA-approved prescription pharmaceuticals, biologics, or devices, are not eligible for reimbursement consideration by the Company.

Routine costs of a clinical trial include all items and services that are otherwise generally available to individuals, when a benefit exists, such as the following:
  • 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 non-covered chemotherapeutic agent)
  • Items and services required for the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications
  • Items or services needed for medically necessary care arising from the provision of an investigational item or service, particularly for diagnosis or treatment of complications

REQUIREMENTS OF A CLINICAL TRIAL

Any clinical trial receiving coverage of routine costs must meet the following three requirements:
  • The subject or purpose of the trial must be the evaluation of an item or service that falls within an Original Medicare benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery).
  • The trial must not be designed exclusively to test toxicity or disease pathophysiology: it must have therapeutic intent.
  • Trials of therapeutic interventions must enroll individuals with diagnosed disease rather than healthy volunteers; trials of diagnostic interventions may enroll healthy individuals in order to have a proper control group.

The three requirements above are insufficient by themselves to qualify a clinical trial for 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 coverage:
  • The principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes.
  • 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.
  • The trial does not unjustifiably duplicate existing studies.
  • The trial design is appropriate to answer the research question being asked in the trial.
  • The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully.
  • The trial is in compliance with Federal regulations relating to the protection of human subjects.
  • All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

WHAT IS NOT INCLUDED
  • The investigational item, drug, or service itself, unless otherwise covered outside of the clinical trial.
  • Items and services that are provided solely to satisfy data collection and analysis needs but not used in the direct clinical management of the individual (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.
  • For non-covered items and services:
    • If the item or service is not covered and is the focus of a qualifying clinical trial, the routine costs of the clinical trial will be covered by Original Medicare but the non-covered item or service, itself, will not.

COMPLICATIONS RELATED TO THE CLINICAL TRIALS

Original Medicare covers the treatment of complications arising from the delivery of a non-covered item or service and unrelated medically necessary care.

QUALIFICATION PROCESS

Some clinical trials are automatically qualified to receive coverage of their routine costs because they have been deemed, by the Agency for Healthcare Research and Quality (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.

Clinical trials that are considered to be automatically qualified are:
  • Trials funded by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), AHRQ, Centers for Medicare & Medicaid Services (CMS), Department of Defense (DOD), and Veterans Affairs (VA)
  • Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and (VA)
  • Trials conducted under an investigational new drug (IND) application reviewed by the U.S. Food and Drug Administration (FDA)
  • Drug trials that are exempt from having an IND application 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 Original Medicare coverage of routine costs.

If the principal investigator of a trial misrepresents that the trial meets the necessary qualifying criteria in order to gain coverage of routine costs, coverage of the routine costs will be denied.

REQUIRED DOCUMENTATION

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

Approval and reimbursement for individuals enrolled in a qualifying clinical trial are processed through the local Medicare Administrative Contractor (MAC).
  • Professional providers should submit claims for routine costs associated with a qualifying clinical trial to the local MAC.
  • Original Medicare/MAC pays for most of the cost of the covered services an individual will receive as part of the approved clinical trial. After Original Medicare has paid its share of the cost for these services, the Company will also pay for part of the costs.

CATEGORY A INVESTIGATIONAL DEVICE EXEMPTION (IDE)

BILLING ROUTINE COSTS OF CLINICAL TRIALS INVOLVING A CATEGORY A IDE
Professional providers are responsible for checking the CMS Coverage Website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage prior to billing for the routine costs of a clinical trial involving a Category A IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the MA plan will be responsible for payment of the routine costs associated with the Category A IDE study. The Category A IDE device remains not covered.

CATEGORY B INVESTIGATIONAL DEVICE EXEMPTION (IDE)

BILLING REQUIREMENTS FOR PROVIDERS BILLING ROUTINE COSTS OF CLINICAL TRIALS INVOLVING A CATEGORY B IDE
Professional providers are responsible for checking the CMS Coverage Website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage, prior to billing for the routine costs of a clinical trial and the Category B IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the MA plan will be responsible for payment of the routine costs associated with a qualifying clinical trial and the category B IDE device.

A list of IDE studies meeting CMS’ standards for coverage are listed and maintained on the CMS Coverage website at https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.html.


Policy Guidelines

This policy is consistent with Medicare’s coverage determination.

BENEFIT APPLICATION

Benefits and coverage for routine costs associated with qualifying clinical trials for individuals enrolled in Medicare Advantage are administered by Original Medicare.

After Original Medicare has paid its share of the cost for these services, the Company will also pay for part of the costs.

Description

A clinical research study (also called a “clinical trial”) is a research study designed to evaluate the safety and effectiveness of new types of medical care.

Routine costs of a clinical trial include all items and services that are otherwise generally available to an individual.

The Centers for Medicare & Medicaid Services (CMS), through the National Coverage Determination (NCD) process and 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 for routine costs of a clinical trial.
References

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Pub. 100-02: Medicare Benefit Policy. Transmittal 198. Medicare Coverage of Items and Services in Category A and B Investigational Device Exemption (IDE) Studies. [CMS Web site]. 11/06/2014. Effective 1/1/2015. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R198BP.pdf. Accessed August 4, 2016.

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 14: Medical Devices. [CMS Web site]. 11/06/2014. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c14.pdf. Accessed August 4, 2016.

Centers for Medicare & Medicaid Services (CMS). Medicare Claims Processing Manual. Chapter 32: Billing Requirements for Special Services. [CMS Web site]. 01/30/15. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c32.pdf. Accessed August 4, 2016.

Centers for Medicare & Medicaid Services (CMS). Medicare Managed Care Manual. Chapter 4: Benefits and Beneficiary Protections. [CMS Web site]. 04/22/16. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c04.pdf. Accessed August 4, 2016.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 310.1 Routine Costs of Clinical Trials. 07/09/2007. [CMS Web site]. Available at : https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&bc=BAABAAAAAAAA. Accessed August 4, 2016.



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)

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)



0256 Pharmacy Experimental drugs

0624 Medical/Surgical Supplies Extension of 027X - FDA Investigational Devices


Misc Code

MODIFIERS:

Q0 Investigational clinical service provided in a clinical research study that is in an approved clinical research study

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



Coding and Billing Requirements






Policy History

10/28/2016The intent of this policy remains unchanged, but the policy has been updated to clarify billing requirements.

The following revenue codes have been added to this policy: 0256 Pharmacy Experimental drugs and 0624 Medical/Surgical Supplies-Extension of 027X-FDA Investigational Devices.
10/02/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Routine Costs of Clinical Trials and Coverage of Investigational Devices A and B.
01/01/2015This is a new policy.




Version Effective Date: 10/28/2016
Version Issued Date: 10/28/2016
Version Reissued Date: N/A