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?

• Drug pricing: Price transparency requirements and value-based contracts.
• Digital health technology (specific to medical devices): Unique risks arise from SaMD (Software as a Medical Device), and the controls and oversight are much different from other areas of software development, cybersecurity, and QMS (quality management system) reviews and changes.
• Vendor-specific compliance questionnaires
• Patient reimbursement: These programs expect to broaden access for patients, but most follow regulations, including the Anti-Kickback Statute, False Claims Act, HIPAA, and FDA statutes.
• HCP (healthcare professional) engagements: With multiple HCP Engagements across the relationship, each with regulatory considerations, life science must track and monitor them to minimize the risk of noncompliance.
• End-to-end visibility, resource allocation & efficiency
• Sunshine Act reporting: Complete transparency is necessary in financial relationships with providers.

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.

CMS 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. 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:

• Ongoing risk assessments of processes: It’s critical to be your own critic. Evaluating processes regularly to ensure they meet compliance must be part of your culture. Mitigating risk is a continuous cycle that changes rapidly.
• Developing written policies: Document your compliance policies so there’s no confusion.
• Improving oversight: By designating a compliance officer and committee, you’ll have a team that dedicates much of their time to compliance issues and functions.
• Ensuring consistent communication: It sounds simple, but it’s often overlooked.
• Leveraging technology: A variety of SaaS (software as a service) platforms are available that can assist with managing HCP engagement.
• Creating a formal process and infrastructure for regulatory compliance: Your organization should proactively manage compliance by developing an end-to-end solution to which all areas of the business contribute. It can’t be a siloed approach.
• Enriching open payment data: CMS’ Open Payments database is a tool for regulators to identify noncompliance and enforce it. This data is essential for life sciences, and by enriching it with other analytics tools, it can be useful in finding compliance patterns, explaining any anomalies and enhancing your regulatory compliance practices.

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.

• Federal agency guidelines: OIG Compliance Program, CMS Regulations, FDA Guidance, FDA Office of Prescription Drug Promotion
• Industry standards: PhRMA Codes, AdvaMed Code of Ethics, ASCLS Code of Ethics, Biotechnology Innovation Organization Policies
• AdvaMed Code of Ethics - developed by the Advanced Medical Technology Association to provide guidance on ethical interactions with healthcare professionals (updated in 2020).
• Expert consulting and legal advice: Some consultancies and firms specialize in life sciences compliance. If you don’t have internal resources with this level of expertise, it may be beneficial to engage with such an organization.
• SaaS platforms: Leveraging technology is essential for modern-day compliance management. It’s too burdensome and inefficient not to use software. There are many options available to support compliance efforts

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.