Coverage Analysis
The Yale Center for Clinical Investigation (YCCI) prepares Medicare Coverage Analyses (MCA) for all clinical research protocols at the Yale School of Medicine and Yale affiliates.
A Coverage Analysis (CA) is required for all clinical trials in which tests, procedures, and interventions associated with a clinical trial are invoiced to third party payers. Preparing a CA involves determining the underlying eligibility of the study for Medicare coverage and reviewing clinical events specified in the protocol to determine which can be reimbursed by Medicare. YCCI provides investigators the completed CA for review and approval.
Medicare Qualifying Clinical Trial (QCT) Determination
Coverage Analysis
A Coverage Analysis (aka: MCA, CA, PCA, routine costs allocation) is a document which determines if a study qualifies for coverage of routine costs under Medicare and outlines where charges should be routed based on whether or not the study qualifies for coverage under NCD 310.1 and other Medicare guidelines. The Coverage Analysis will mirror the schedule of events for the study and should outline all billable and potentially billable services. Our office is required to conduct the initial qualifying analysis and determine if a full Coverage Analysis will be required to define any “standard of care” procedures from those that may be covered by sponsor funding.
Medicare will not cover costs that are:
- paid for by the sponsor
- promised free in the informed consent document
- not ordinarily covered by Medicare, or
- solely to determine trial eligibility or for data collection or analysis
Why is a CA needed?
- Coverage analyses are important to facilitate billing compliance, mitigate risks of false billing and violations under the secondary payor act, ensure patients are treated equitably, and avoid billing errors.
- Yale must treat all research participants fairly and equitably. If a sponsor has offered to pay for an item or procedure, if it is not covered by the participant’s insurance, then the sponsor must pay for that procedure, in full, for ALL participants. Acceptance of a sponsor’s willingness to pay for the procedure for ONE patient and not ALL patients is a clear violation of the secondary payor act and should be avoided at all cost.
Which studies need a Coverage Analysis?
- Yale requires that all research studies involving the provision of billable clinical procedures and services must undergo a Medicare Coverage Analysis. Yale School of Medicine's Policy, Research Studies with Billable Clinical Services, dated April 1, 2019, is requiring The Yale Center for Clinical Investigation’s Central Medicare Coverage Analysis Unit to complete a coverage analysis on all qualifying trials.
What is the result of the Coverage Analysis?
- When the analysis is complete, the investigator receives a study-specific billing summary that lists all items and services to be provided as part of the clinical trial with notations of what should be billed to the research sponsor and what can be billed to Medicare. These billing grids are a valuable tool to ensure appropriate billing compliance – for additional information on Billing Compliance, click here.
Investigational Device Exemption Requests
Providers that participate in an Investigational Device Exemption (IDE) clinical study and anticipate filing Medicare claims must notify their Medicare contractor. This applies to all IDEs assigned an identifying number beginning with a ‘G’ and a Centers for Medicare & Medicaid Services (CMS) category B (B1, B2, B3, or B4) by the Food and Drug Administration (FDA); a category A IDE device clinical study before billing routine costs of clinical studies involving a Category A device; post-market approval studies or registries of carotid stents; and studies for proximal embolic protection devices (EPDs) in carotid artery stenting (CAS) procedures. Notice is not required for humanitarian use devices, post-market approval studies or registries of devices other than carotid stents, or clinical studies other than those described above. See the NGS website here.
All new or renewal IDE clinical study requests should be directed to National Government Services by one of the following methods:
- E-mail: NGS-IDE-Request@wellpoint.com
- Fax: (717) 565-3432
- Mail: National Government Services IDE Request 2400 Thea Dr., Ste. 3B Harrisburg, PA 17110
Submission by fax or e-mail is preferred.
Medicare Coverage Analysis Questions
Frequently Asked Questions
- A participant’s insurance is not covering a research procedure, but the sponsor is offering to pay – is that acceptable?
- If a sponsor is offering to pay for all procedures, but some of the procedures could be considered standard of care, how do we handle this?
- Are routine care costs associated with a clinical trial covered by private insurance coverage?
- Is pre-authorization required from private insurers for costs associated with a clinical trial?
- What does routine patient costs include?
- What is the next step once the MCA is completed?
- What is the purpose for a MCA?
- Who is responsible for performing a Medicare Coverage Analysis (MCA)?
- What needs to be submitted for a coverage analysis to be completed?
- Is additional information available to provide my patients on clinical research financial considerations?
- A participant’s insurance is not covering a research procedure, but the sponsor is offering to pay – is that acceptable?
No. Yale must treat all research participants fairly and equitably. If a sponsor has offered to pay for an item or procedure, if it is not covered by the participant’s insurance, then the sponsor must pay for that procedure, in full, for ALL participants. Acceptance of a sponsor’s willingness to pay for the procedure for ONE patient and not ALL patients is a clear violation of the secondary payor act and should be avoided at all cost.
- If a sponsor is offering to pay for all procedures, but some of the procedures could be considered standard of care, how do we handle this?
If a sponsor is offering to pay for a procedure for ALL participants, we should accept the sponsor’s payment to reduce unnecessary financial burden on our research participants and to remain compliant with CMS guidelines.
- Are routine care costs associated with a clinical trial covered by private insurance coverage?
Yes. The routine patient care costs associated with clinical trials covered by Medicare’s Clinical Trial policy will qualify for private insurance coverage.
- Is pre-authorization required from private insurers for costs associated with a clinical trial?
Yes. Pre-authorization is required from private insurers for coverage of the standard of care (routine care) costs associated with the clinical trial.
- What does routine patient costs include?
Routine patient costs include all items and services consistent with the coverage provided in the plan (or coverage) that is typically covered for a qualified individual who is not enrolled in a clinical trial.
- What is the next step once the MCA is completed?
Once the MCA is completed, a study-specific billing summary listing all items and services is available to the PI and study team. The billing summary must identify what services should be billed to the research study sponsor and what can be billed to Medicare or third-party payers.
- What is the purpose for a MCA?
Performing an MCA facilitates the following:
- Budget development and negotiation
- Billing compliance;
- Mitigating risk and avoiding billing errors which can result in civil and criminal penalties; and
- Who is responsible for performing a Medicare Coverage Analysis (MCA)?
Per YSM policy, the Yale Center for Clinical Investigation (YCCI) Medicare Coverage Analysis Unit is responsible for performing an MCA for all clinical trials.
- What needs to be submitted for a coverage analysis to be completed?
Industry funded studies will need the Final protocol, sponsor budget, and submission to OnCore/ HIC number for a QCT to be completed. Additional documents such as the informed consent form (ICF) and contract may be required depending on determinations. We recommend providing all documents (including any lab and imaging manuals) as soon as possible in order to prevent delays from occurring
Federally funded or Investigator initiated studies will require the final protocol, informed consent and submission to OnCore/HIC number for a QCT to be completed. Additional documents such as the Budget or funding sheet and contract may be required depending on determinations. Whenever possible we recommend providing all documents (including any lab and imaging manuals) as soon as possible in order to prevent delays from occurring.
For IIT studies we strongly recommend holding off on final budget negotiations with the sponsor until after a final protocol can be utilized for the coverage analysis determination as the coverage analysis may change what can or cannot be considered “SOC” under current guidelines. In many cases these determinations do not match what is considered clinical best practice and could result in unnecessary financial burden upon the patient if the coverage analysis and budget or sponsor funding do not align. Aligning the budget with the coverage analysis will also help prevent determination and billing errors from occurring
- Is additional information available to provide my patients on clinical research financial considerations?