Key Questions to Answer When Evaluating Your Compliance Program

Key Questions to Answer When Evaluating Your Compliance Program

Life science compliance is an evolving, complex ecosystem. For each stakeholder in the environment, there are different healthcare regulatory compliance mandates. No matter what role you play in healthcare, compliance is mandatory, and failure to comply can be costly. However, it’s no secret that organizations struggle with compliance; fortunately, many solutions are available to support them.

For those in the life science realm—pharmaceutical companies, medical device manufacturers, or biotech—understanding the specifics around their healthcare compliance obligations and how to manage them is cumbersome. In this post, we’ll be focusing on healthcare compliance and best practices for this segment.

What is Life Science Healthcare Compliance?

Life science companies face a mountain of regulatory scrutiny. There are important compliance measures across all aspects of the business. Additionally, the number of regulations is steadily increasing, revolving around globalization, transparency, new technologies, and other rules.

There are several key areas of compliance for life sciences. All have their own challenges and laws, but they should be part of a holistic view.

What Are the Regulations Life Science Organizations Face?

In consideration of all these compliance burdens, what best practices should life sciences follow?

Life Sciences Compliance Best Practices: Drug Pricing, Digital Health Technology, and Patient Reimbursements

For each of the categories above, certain best practices can help mitigate risk

You must ensure that you’re meeting price transparency regulations in each state regarding drug pricing because requirements vary. Value-based contracts require data aggregation and an analytics engine to ensure patient privacy and government price reporting compliance.

The Centers for Medicare & Medicaid Services (CMS) Open Payments Program is the government agency that enforces price reporting compliance and sees to it that medical companies adhere to these best practices.

One example of a CMS price compliance violation involves the Minnesota-based medical device manufacturer, Medtronic USA, Inc. Medtonic was fined $9.2 million for various violations, including $1.11 million for failing to accurately report payments it made to a South Dakota neurosurgeon.

The CMA determined that Medtonic paid for elaborate social gatherings at the neurosurgeon’s privately-owned restaurants in exchange for favors from preferred clients and referral sources. The CMS found Medtronic in violation of the Open Payments Program for failing to accurately report these transactions.

HCP Engagement and Sunshine Reporting Best Practices

Whether your organization has a contractual or non-contractual arrangement with HCPs, expect continued scrutiny from regulators, legislators, the media, and other watchdogs. Life science companies must always be on the alert, ready to shift as regulatory guidelines do.

The best practices for compliance with HCP interactions comes from having internal frameworks and processes, including:

Noncompliance Risks

The concerns of noncompliance go much further than monetary fines, although those are serious. Further, you can face severe legal ramifications for not following the law precisely in almost any category. You could end up being sued by the federal government, which can result in financial losses and reputational harm. The most damaging effect of noncompliance would be a shutdown of your business.

What are the best resources and tools to keep you on the compliance path? Here are some options:

The concerns of noncompliance go much further than monetary fines, although those are serious. Further, you can face severe legal ramifications for not following the law precisely in almost any category. You could end up being sued by the federal government, which can result in financial losses and reputational harm. The most damaging effect of noncompliance would be a shutdown of your business.

A Turnkey HCP Engagement Compliance Software

Life science organizations can rely on one platform to manage compliance associated with HCP engagement with MedCompli. This robust SaaS offering enables risk mitigation across the interaction. It includes modules for Open Payment reporting, establishing fair market value, Sunshine Act reporting, contract management, HCP self-service functionality, and more.

With our software, you can simplify compliance and customize it to fit your needs. Contact us today to request a demo.