Leveraging Clinical Data to Support Reimbursement

A look into the coverage determination pathways

Got data? Data from clinical studies, registries, and medical record review supports reimbursement pathways by demonstrating a favorable clinical benefit/safety ratio in the context of value (cost). Many skin substitute companies are finding themselves with a data deficit and unable to meet reimbursement coverage data requirements. If your company is in need of growing your pool of data to support coverage decisions for skin substitutes or other devices, please continue reading our latest blog.

What are Local Coverage Determinations?

A Medicare administrative contractor (MAC) is a regional insurer that processes Medicare claims, manages provider reimbursement, audits institutions, and establishes local coverage determinations (LCDs). An LCD provides a decision as to whether a particular product or service can be covered under the MAC’s jurisdiction when there is no national coverage determination.

An LCD may allow coverage if it meets all of the following conditions per the Social Security Act (SSA):

• The benefit category for the product or service exists and is not excluded in Title XVIII of the SSA;
• The product or service is not already covered as a specified Medicare benefit; and
• The product or service is considered “reasonable and necessary” under Section 1862 (a)(1)(A) of the SSA. This is defined in the Medicare Program Integrity Manual Section 13.5.4 (Rev 863, 02-12-19):
  • “Safe and effective;
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary); and
  • Appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
    • Furnished in a setting appropriate to the patient’s medical needs and condition;
    • Ordered and furnished by qualified personnel;
    • One that meets, but does not exceed, the patient’s medical need; and
    • At least as beneficial as an existing and available medically appropriate alternative.”

The MAC’s rationale for determination includes a summary and an analysis of clinical evidence to determine if the product or service is “reasonable and necessary”. Demonstrating “reasonable and necessary” involves an evaluation of safety and efficacy clinical data for the approved indication for use. Data can be compiled from peer-reviewed, published literature, FDA MAUDE database, clinical studies, and real-world evidence collections (e.g., medical record review). The number and type of adverse events are assessed for safety. For efficacy, validated outcomes should show clinically meaningful benefit at appropriate timepoints. These results are taken in context with the certainty of evidence.

What are Private Coverage Determinations?

Most private insurers follow national or local determinations as a precedent. In the absence of these, private insurers may develop their own policies. For example, BlueCross and BlueShield has “Clinical Coverage Criteria” (e.g., BCBS Kansas). Similarly, Anthem develops “Medical Policies” and “Clinical Utilization Management Guidelines”. In these determinations for medical necessity, specific products are listed for a particular indication along with a summary of peer-reviewed, published clinical data.

How can Skin Substitutes be Reimbursed through Insurance?

Recent changes have limited CMS coverage for skin substitutes. However, private and local coverage determinations may offer pathways forward for reimbursement. Currently, an LCD concluded  there is “insufficient evidence-based literature to support coverage” for amniotic products for non-wound indications. Similarly, an Anthem Clinical Utilization Management Guideline stated that “additional data is needed for an adequate evaluation” for a particular amnionic product’s use in ulcer treatment. Specifically, “further large-scale, blinded studies are needed to confirm these findings and better define the populations most likely to benefit from [amnionic product] treatment”.

Therefore, more robust clinical data are needed to support coverage determinations of skin substitutes. These studies need to be designed to be randomized and blinded where possible and with bias reduction methods to increase the certainty of evidence. Further, the study population should include older adults and various races/ethnicities so that the results are generalizable to the Medicare population.

Is your product in need of clinical data to reach a coverage decision? We can help!

MED Institute offers a variety of clinical trial services and is a full-service clinical research organization (CRO). We have over 40 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries. Our studies are conducted to meet the applicable requirements of Good Clinical Practices (GCP), ISO 14155, and national regulations (US CFR, HIPAA). MED partners with 3Aware, who developed a platform to collect real-world evidence from electronic health records, inventory, and accounting programs from health systems.

Contact us today to start your project discussion: 855.463.1633 | askmed@medinstitute.com | medinstitute.com