If your organization has products listed in the Medicare Part D Formulary, you may have received a notification from the Centers for Medicare & Medicaid Services (CMS) about additional reporting requirements under the Open Payments Program. These Open Payments Program letters may leave you wondering: Are we meeting all the necessary obligations? Is there anything we’re missing? Are we at risk of penalties?
If these questions are on your mind, you’re not alone. The Open Payments Program is an essential part of promoting transparency in healthcare, but staying compliant can sometimes feel overwhelming.
If you’ve gotten a notification from CMS, it is crucial to review the details carefully and ensure that your organization is tracking and submitting the required data to CMS. Non-compliance with Open Payments requirements can lead to substantial penalties, both financially and reputationally.
So about those questions… let’s break down the essentials of Open Payments reporting, explain the recent CMS letters, and help ensure your organization is ready to respond.
What is the Open Payments Program?
At its core, the Open Payments Program is about transparency. It’s designed to disclose financial relationships between healthcare providers (like physicians, teaching hospitals, and advanced practice providers) and life sciences companies (like pharmaceutical, medical device, and biotech manufacturers). The goal is to help prevent possible conflicts of interest and give patients the information they need to make informed decisions about their care.
Under this program, companies are required to report any payments or transfers of value to healthcare providers. These payments can cover a wide range of categories, including meals, travel, consulting fees, or even research grants. If your company has prescription products that are covered under the CMS healthcare programs, you need to submit data on these interactions to CMS annually.
Why Are Companies Getting CMS Notifications Now?
The recent letters from CMS are a reminder that companies with products listed under Medicare Part D might need to expand their reporting efforts to comply with the requirements of the Open Payments Program. CMS is signaling that reporting obligations may be broader than some organizations initially realized.
If your company received one of these notifications, it’s a cue for you to take a closer look at your reporting practices. CMS wants to ensure that every manufacturer is aware of the full extent of its reporting requirements — and this is an opportunity for manufacturers to address any gaps before it’s too late.
Common Questions About Open Payments Reporting
So what does that mean, specifically, for your organization? Let’s dive into some of the most frequently asked questions about Open Payments Reporting:
1. Who Needs to Report?
If your company manufactures drugs, devices, biological products, or medical supplies covered by Medicare, Medicaid, or CHIP, you’re required to report. This reporting requirement applies to applicable manufacturers and applicable group purchasing organizations (GPOs), alike.
Reports should cover payments made to:
- Physicians (including MDs, dentists, chiropractors, and more.)
- Teaching hospitals
- Advanced practice providers, such as nurse practitioners and physician assistants, clinical nurse specialists, certified registered nurse anesthetists & anesthesiologist assistants, and certified nurse-midwives (CNMs).
2. What Kinds of Payments Must Be Reported?
The payments or transfers of value you need to report can range widely, but here are the basics:
- General payments: This includes things like meals, travel, consulting fees, and speaker honoraria.
- Research payments: Money provided to support clinical research or product development.
- Ownership or investment interests: If a physician or their family members have a financial interest in your company, that also needs to be disclosed.
Along with payment details, you’ll need to provide the healthcare recipient’s information, such as their NPI (National Provider Identifier) and state license number for individuals or TIN (tax identifier number) for organizations, and the date and dollar amount of the payment.
3. When Do We Need to Report?
Reports are due annually and cover payments made in the previous calendar year. Once you submit your data to CMS, there’s a review and dispute period where covered recipients can review the data and issue disputes before it’s made public.
4. What Happens If We Don’t Report Correctly?
CMS takes non-compliance seriously, and the penalties can be steep. Depending on the quantity and type of errors or omissions, civil monetary penalties can reach approximately $1.4 million. And beyond the financial hit, failing to accurately report can damage your company’s reputation with healthcare providers and patients.
5. How Can We Ensure Compliance?
One of the most important steps is to establish reliable processes and systems for tracking payments and transfers of value to covered recipients. Make sure you’re gathering all the necessary information upfront and keeping it organized for annual submission.
With the recent CMS notifications in mind, it’s a good idea to audit your current processes to ensure you’re not missing any newly required reporting categories. And if possible, get ahead of disputes by regularly verifying the accuracy of your data with the healthcare providers you work with.
Time to Review Your Reporting Practices
If you’ve received a letter from CMS, it’s a great opportunity to take a fresh look at your reporting practices. Even if you haven’t been flagged, it’s worth auditing your processes to make sure you’re fully compliant with the Open Payments program. Here’s where to start:
- Review your tracking systems: Are you capturing all of the applicable payments and transfers of value?
- Check your data for accuracy: Ensure that your records include all relevant details, from payment amounts to covered recipient identifiers.
- Get ahead of disputes: Take the time to verify that your reporting data is correct before it’s submitted to CMS.
Proactively reviewing your reporting practices will help you avoid the headaches of disputes, penalties, or compliance issues down the line.
Need Help with Open Payments Reporting?
Navigating the Open Payments program and staying on top of CMS reporting requirements can be complex, but you don’t have to do it alone. At RLDatix Life Sciences, our Professional Services team is here to help you understand these requirements, respond to CMS notifications, and meet critical reporting deadlines.
We offer tailored advice to ensure that your organization remains compliant, including:
- Guidance on reporting requirements: We’ll help you determine which payments need to be reported.
- Support in responding to CMS notifications: Our team can assist you in reviewing any letters you’ve received and what they mean for your company.
- Help in preparing for submission: We’ll work with you to make sure your data is complete, accurate, and ready for submission to CMS.
Contact us today for more information on how we can help your organization stay compliant with Open Payments reporting.
We’re here to help you stay ahead of the reporting curve and maintain transparency in your relationships with healthcare providers. Reach out to our Professional Services team today for more information!