Billing Analysis is necessary to assist health care providers in their determination of responsibility of charges. The Billing Plan identifies clinical research items or services that can or cannot be billed to third-party payers. It helps to assure that processes are in place to bill third-party payers only for items or services that research billing rules allow to be billed. The Office of the Inspector General (OIG) work plans regularly include clinical research billing in their top compliance initiatives. Medicare “double billing” has been the subject of numerous OIG/DOJ investigations/settlements. From a research and business perspective, it is important to determine conventional care vs. “research-only” items and services.

The Billing Analysis process involves identifying items and services that are required to be provided during the conduct of a clinical trial that can or cannot be billed to a third party payer such as Medicare.

The identification of those items and services that cannot be billed to Medicare assists with budget development and negotiations with the sponsors to ensure all costs are covered.

Medicare is considered the gold standard because it is the largest reimbursement program for health care in the nation. It also is a federal entity, and many commercial payers base their coverage decisions on Medicare’s rules and regulations. Several states have passed legislation requiring commercial payers to follow Medicare rules.

If the trial is a Qualifying Trial, this means that the routine costs can be billed to Medicare.

Routine costs 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).
• 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 reasonable and necessary care arising from the provision of an investigational item or service-in particular, for the diagnosis or treatment of complications.

Routine costs do not include:

• The investigational item or service (whatever is being studied) unless the investigational item or service would be covered outside a clinical trial.
• Items or services solely for research purposes (e.g., data collection).
• Items or services solely to determine trial eligibility.
• Items or services paid for by the sponsor.
• Items or services promised free in the informed consent.
• Items and services not generally available:
  • Those lacking a Medicare benefit category.
  • Those that are statutorily excluded.
  • Those that fall under a national noncoverage policy.
  • Examples include: cosmetic surgery, hearing aids.

A clinical trial must have “therapeutic intent” to be a qualifying clinical trial. There are two points made in the Clinical Trial Policy [CMS, NCD for Routine Costs in Clinical Trials (310.1)]:

• “The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent.”
• “The principle purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes.”

Unfortunately, CMS has not given further clarification to this guideline or a distinct definition of what therapeutic intent is. In June 2006, a CMS official did state that to meet the therapeutic intent standard, the "primary objective" of the particular study must be measurement of therapeutic benefit.

Local Medicare Contractors do have the authority to interpret and make the determination that an item or service is “reasonable and necessary” to diagnose or treat illness or injury if the item or service is not excluded by a statute or a Non-Covered Determination (NCD).

Generally this leaves 2 courses of action:

1) The primary objective of the study needs to measure the therapeutic benefit.

Or

2) The provider can seek the decision from the Local Medicare Contractor.

Device trials are sent to CMS for approval to assure reimbursement for standard of care services for subjects enrolled in the trial, as well as for reimbursement coverage of the device. Medicare’s coverage of device trials began in November 1995, when Medicare coverage was expanded to include certain medical devices being studied as part of a Food and Drug Administration-approved clinical trial. Under this policy, the FDA and the Center for Medicare and Medicaid Services (CMS) established a more precise mechanism for classifying devices in clinical trials, making it possible for some of them to be eligible for Medicare coverage.

The two classifications of devices are:

• Category A: These devices are truly experimental devices where no similar device already exists in the market. By regulation, CMS considers these devices experimental and excludes them and any related services from coverage.
• Category B: This category represents newer generations of proven technologies or evolutionary changes in proven technologies. CMS considers these as potentially reasonable and necessary and, therefore, potentially eligible for coverage.

Notification and approval request to the Local Medicare Contractor of the intent to participate in and submit claims for Category B device trials is required before payment can be made.

Our Local Medicare Contractor (Highmark Medicare Services) requires specific documents for review before rendering a decision regarding the approval for coverage of routine costs and/or the device involved with a Device Trial. It can take up to 45 days for a decision to be rendered after we have submitted all required documents to the Local Medicare Contractor. If the study is denied coverage by the Local Medicare Contractor, this means that the routine costs cannot be billed to Medicare/third-party payers, and therefore, the sponsor or grant will need to pay for these items and/or services.

The CCT Investigator Notification of Informed Consent Document “Costs to Participant” Section is sent as a guide to the study team to help ensure that any information regarding costs to enrolled subjects and/or subjects’ insurance along with the items being paid by the sponsor (i.e., subject reimbursement, procedures, study drug) are communicated via the consent form. The study budget and billing analysis need to be approved before sending the ICD Notification, which usually occurs after the study has obtained IRB approval. The study team does not need to respond to CCT. The IRB also receives a copy of the ICD Notification, and changes on the informed consent will be communicated by the IRB to the study team or vice versa.

Coverage for services provided to beneficiaries by physicians are determined by a process developed by CMS. There are two types of coverage to administer benefits for beneficiaries: National Coverage Determination (NCD) Policy and a Local Coverage Determination (LCD) Policy.

NCD: National Coverage Determination explains the coverage of services on a national level.

LCD: Local Coverage Determinations are confirmed to a specific geographic area. We would follow the Medicare Administrative Contractor (MAC) for Maryland, which is Highmark. LCDs cannot conflict with NCDs. If a LCD and NCD exist concurrently in regard to a particular coverage policy, the NCD takes precedence. CMS resource