Medical Policies - the secret starting point for assessing new opportunities

You're starting to assess a clinical innovation for the US market. Where do you begin? There are so many different aspects to explore: Prevalence of disease or procedure, available treatments, reimbursement, relevant studies, outcomes, health-economics, billing codes, etc.

Use medical policies as a starting point

Medical Policies as your starting point

Medical Policies are published by Health Plans to inform providers about coverage and eligibility criteria for various medical services or drugs. Providers have to be aware of these policies ahead of providing care to avoid potential denials.

Since the decisions regarding coverage include many factors, they are a succinct summary of many different data points about the disease/condition and treatment in question.

Medical Policies are developed by expert committees

Typically, a committee of experts is pulled together to develop such policies. In the process, they review a lot of information to make their coverage determination.

Because experts put these documents together and have to justify their decisions, they are very high quality documents and contain the most salient information to make these determinations in a single resource.

Policies are updated periodically as new information keeps flowing: new clinical evidence, guidelines, coverage determination by other health plans, etc.

A treasure trove of information

Policy documents are densely packed with curated information. One such document can give you a phenomenal starting point of information to dive deeper into.

So much info in one document

A single medical policy document could include all of the following sections:

• Introduction - often includes an overview of the condition/treatment.

• Coverage Decision - The coverage decision section would include the decision itself, any applicable eligibility criteria, and very importantly the decision rationale & justification.

• Billing Codes - This section would include applicable billing codes related to the treatment, including variations and certain guidance.

• Clinical Evidence - This section includes a form of literature review and assessment of available clinical evidence for the treatment in question.

• Clinical Guidelines - If there are clinical guidelines by professional societies and associations they will be referenced. Global guidelines are often included as well and can be an indication of trends on the horizon.

• Clinical Trials - A listing of relevant completed clinical trials, along with their characteristics. Many times ongoing and unpublished trials are also listed.

• FDA regulatory standing - a summary of regulatory clearances and approvals related to the topic in question are sometimes included. Specific attention is given to indications for which these clearances or approvals apply.

All references are cited and linked

A single medical policy could include references and links to dozens of publications, approvals, guidelines, trials, etc. This serves as a fantastic curated list to dig into for further insights.

Where can you find medical policies?

Medicare policies and coverage determination

Coverage determination from Medicare often serves as a starting point for private health plans to follow. The key documents you want to look for are National Coverage Determination (NCD) or Local Coverage Determination documents.

Visit the MCD search page on CMS

In addition to Coverage Determinations, CMS publishes a number of other interesting documents (you can filter and search for these on their database):

• Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) Proceedings

• Billing & Coding

• Technology Assessments

• Drafts and proposed guidance

• Articles

Private insurers and Health Plans

These will be available on the provider facing website area of the insurer. You can also search "medical policy" or "coverage policy" along with the insurer's name and the treatment area of interest on google to directly locate some of these policies.

Here are a few examples of pages for leading health plans:

• Cigna's policies

• United Health Policies

• Anthem provider links by state

• Aetna policies

⚠️ Note that private insurers might have several policies for the same treatments/services depending on plans. They will typically indicate which plans the policy applies to on the document itself.

Sometimes you won't find a relevant policy

Not all services, treatments and drugs will have a policy. There could be a number of reasons for that:

• Coverage is mandatory by law - Coverage might be required based on regulatory obligations, such as preventive care services mandated by law. In such cases a coverage policy might not exist. You might be able to find clinical guidelines or preventive care policies that cover your area.

• The insurer prefers to address coverage on case by case basis - A policy is a way to address coverage determination at scale and once established becomes a rule. Insurers can choose to address requests on an individual basis without establishing a policy.

• The area is too new to develop a policy - certain treatments or drugs may be too new to have sufficient data that supports a policy. The default for new and not clinically established treatments would be a denial.

In Summary

When you are just beginning your assessment, looking at Medical Policies can be a great starting point:

1. They contain highly condensed insights

2. Include many pointers to highly relevant resources

3. Provide an overview of evidence, trends and trials

4. Address economic aspects and reimbursement