Journey to Claims Management
As pharmaceutical companies produce higher volumes of digital content to meet ever-growing demand, we need to stay focused on complying with regulatory requirements. Just last year, the Office of Prescription and Drug Promotion issued numerous warning letters with regard to claims, and because of this, the agency has now increased its focus on false or misleading claims.
This doesn’t mean that anyone is intentionally doing anything wrong. But it does prompt us to take a closer look at how we currently manage our claims and to work towards having the best, most effective claims review process possible.
Several considerations make this critical. The first is the significant time and expense required for an agency to reference a piece of content. This is especially true if you’ve just hired a new agency – they need to get up to speed on learning your library, your claims, and the content they’ll be working with. Bad or faulty referencing can increase the number of review cycles, which in turn leads to reviewer fatigue. A good way to prevent this is to incorporate a medical pre-review, to ensure that the medical material is fully vetted before other committee members start their review.
A second obstacle to effective claims management is high personnel turnover at agencies, which means that who you previously trained may not be the same person handling your work. It’s therefore critical to establish well-documented training for your claims management process. Claims are not easy. Input from highly skilled subject matter experts is essential: regulatory professionals, legal counsel, and medical information advisors. We rely on these well-trained experts to keep up with industry trends, assist with business strategy, provide direction, mitigate risk, and interpret medical data and regulatory requirements.
During the approval process for a claim or reference, subject matter experts should review marketing content to determine if it’s appropriate for a specific audience, such as HCPs or consumers. Your medical expert should always have the final word in ensuring that references are credible and medically accurate.
Another aspect of the claims process involves what I call my “cousins,” by which I mean the people or places I look to for guidance. I trust several organizations as authorities on referencing citations for websites, reprints, and other kinds of literature: the Modern Language Association, the American Psychological Association, and the American Medical Association. Every company I’ve worked for relies on at least one of these bodies for formatting their references. Once you’ve chosen and set up your format structure, it becomes easy to search and locate references in your library.
Claims Management Goals
Claims come from a variety of sources: for example, a label update, a new campaign tactic, or a recent publication that aligns with how your product is being used. As you develop a piece of content, you’ll want to highlight the list of supporting references. When new information arises, your first priority should be ascertaining whether you have approval to include it in your materials.
It’s important to identify the individuals within company leadership who need to sign off on new claims and references. Performing this evaluation upfront will eliminate confusion for the team during the materials review process, enabling you to focus on your desired claim and its supporting evidence. It also helps foster a well-organized reference library that sets the standard for all stakeholders. In addition, it can serve as the basis for establishing an anchor naming convention that will be helpful to others later on.
The most critical goal is gaining leadership agreement and sign-off. Once you have both, you can begin tracking your information. Bring together your list of claims, audience information, and supporting evidence to create a reference usage report that documents the citations in your materials.
This usage report will be helpful when transitioning to Veeva’s new claims management feature, Vault PromoMats Auto Claims Linking.
Automating and optimizing the claims management process with Vault Auto Claims Linking will help you gain the following:
- Less reliance on paper and spreadsheets
- A standardized workflow that helps save time
- A seamless process for providing claims information
- An established program for onboarding new personnel
Vault Auto Claims Linking has improved claims creation and management across all points of the process: agencies can more easily find and link claims, MLR teams can review and approve claims quicker, and marketing organizations can create content faster.
If you’re interested in learning more about Vault Auto Claims Linking, check out this video on Automating Claims Management.