Change is coming for life sciences organizations, and in such a regulated world, there are constantly evolving compliance regulations. One of your organization's biggest compliance burdens is likely those regarding the Physician Payments Sunshine Act. Compliance with open payments reporting is a heavy administrative burden with lots of data involved in reporting requirements. In detailing your transfers of value (ToV), you can expect new requirements, which stem from the SUPPORT Act of 2018 and become effective in 2022.
In this post, we’ll update you on the fundamental changes, penalties for noncompliance, and how to prepare. We’ll also provide tips for streamlining and simplifying the process with technology tools.
The SUPPORT Act's objective was to provide transparency and adjust how life sciences report to the Centers for Medicare & Medicaid Services (CMS). Here are the changes.
Capturing and reporting ToV for healthcare providers (HCPs) is already complex, as you know. Now, you must broaden your processes to include five new HCPs. Previously, an entity included all medical physicians, dentists, podiatrists, optometrists, osteopaths, and chiropractors. “Covered recipients” has since expanded to five additional clinician types: physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse-midwives.
Why the change? The number of licensed physicians in the U.S. is decreasing, according to the Association of American Medical Colleges (AAMC). Conversely, the number of non-physician practitioners (NPPs) is rising.
The common theme, of course, is that all these clinicians can write prescriptions. The SUPPORT Act also considered the opioid crisis and financial links between pharmaceutical companies and medical doctors and NPPs. Life science companies have already been engaging with these groups, as they do physicians, but now they’ll have to report it.
Payment categories will be different now. The regulations added three new ones—debt forgiveness, long-term medical supply or device loan, and acquisitions. It also combines accredited/certified and unaccredited/non-certified continuing education (CE) programs into one category: medical education programs.
First, CMS has the authority to audit life sciences companies at any time. They expect that the reporting you submit will be on time, accurate, and complete. It must be all three. You must also keep these records for at least five years from the date of payment or ToV.
Should CMS find your organization in noncompliance with existing or new requirements under the law, they can issue fines of up to $1 million. CMS works with the Department of Justice (DOJ) to enforce Sunshine Act.
In October of 2020, the DOJ announced its first settlement regarding violations of open reporting. A medical device maker agreed to pay over $9 million to resolve allegations of improper payments around kickbacks. While the DOJ has pursued many cases related to the False Claims Act (FCA), this was the first to include open reporting violations.
With less than a year to go, it’s time to get strategic in how you’ll handle open payments reporting. Here are some fundamental strategies to use to ensure that you’ll be ready for 2022.
The biggest overhaul deals directly with the addition of NPPs. However, since you are making updates to your open payments reporting process, it’s a good time to look critically at all opportunities to improve compliance and decrease risk.
These changes will impact many areas of your business. Key stakeholders should collaborate to develop a plan and make any decisions about new processes or technology. You’ll want people from legal, compliance, operations, and others involved in Sunshine Act reporting.
Your team should start with an assessment of your current open payments reporting processes. How are you collecting, verifying, and auditing HCP data? If there are existing obstacles in this process keeping you from streamlining, now is the time to address those challenges. It’s time to dissect every part of your processes, get feedback from stakeholders, and define the areas where you’re excelling and need support. This analysis can become the foundation for how you’ll redefine processes, choose technology, and allocate resources.
When reporting ToVs, you need the receipts and supporting documentation. If you have a lax protocol on this, then those could easily get lost or forgotten. That can cause issues down the road. To eliminate this issue, leverage technology that allows for an easy way to upload these on the go, as they happen. Having this in place can reduce inaccuracies.
If you already have some information on NPPs, then it’s a good time to update that and format just as you do the current HCPs you report to CMS. You’ll want to integrate the NPPs into your HCP validation databases so that you can verify license information for each profile. One concern is that not all NPPs have a National Provider Identifier (NPI), as each state treats them differently.
Without accurate data validation, your process could run into many issues. Sometimes those aren’t visible for some time, especially if some aspects of your procedures are manual. Using a technology platform with data validation algorithms alerts you quickly so you can fix it immediately.
The changes to payment categories will require you to reconfigure this in your system. Be sure to understand the definition of these new categories and to combine those regarding CEs.
The types of reports you can create will depend on the technology you use. There are many options for open payment reporting, but they aren’t all the same. Sometimes these platforms can fulfill some of the reporting needs but not all. Having a system such as this could expose you to risk. Accessing various reports that provide different information and analysis can be a huge plus for your organization.
Your organization's greatest advantage to ensure compliance and simplify your process is the right technology platform. That’s what MedCompli delivers with a turnkey solution that’s easy, comprehensive, and compliant. Learn more today by requesting a demo.
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