With the release of the CIA changes within the General Compliance Program Guidance (GCPG), the OIG has officially moved the goal posts. This isn’t just a new set of rules for organizations under investigation.
The May 2026 update to the Corporate Integrity Agreement (CIA) framework signals a definitive shift from passive reporting to active governance. Compliance is no longer an administrative sub-function. It’s now a board-level strategic imperative.
This is the first article in a series on medical necessity — an area that many compliance programs struggle with. In this piece, we explain the medical necessity compliance risk in general, while subsequent articles highlight specific examples of enforcement actions experienced by medical providers such as hospitals and health systems.
For years healthcare leaders have been faced with demonstrating their value and answering the question, “How is compliance doing?” Getting the answers typically involves a scattered, manual process of pulling data from multiple sources, departments, and teams, then going through the process of aggregating that data to pull important, need-to-know information. By the time that step is complete, often the information is already out of date.
For healthcare compliance leaders, financial literacy is not optional. Compliance risk often hides in the fine print of financial data, making literacy a prerequisite for effective oversight.
To identify anomalies or potential regulatory “red flags,” compliance officers must move beyond a high-level view of healthcare finance and understand how clinical operations translate into financial entries.
This Q&A with compliance expert, Lisa Herota, RHIA, CHC, CHIAP, CHPS, CCS covers best practices for a data-savvy compliance leader. Learn about realistic compliance metrics and how to share them effectively. Read more about Lisa’s background and experience at the end of this blog.
It’s the nature of our mission to stay on top of what’s happening in the world of healthcare compliance. And right now, that focus couldn’t be more important.
These are unusual times, and Compliance is feeling the impact. The Medicare Fiscal Year 2026 Final Rules were expected to be late but came through on time. However, hospitals must still rush to analyze and respond with action plans in short order. CMS transmittals are also likely impacted by the government shutdown (more on that later).
That leaves many hospital compliance teams unprepared and under-resourced to cope with fast-coming changes. The price of noncompliance, even under extenuating circumstances, is reimbursement risk.
Two Areas Needing Compliance Attention: Final Rules and Transmittals
Final Rules – Legally binding federal regulations that establish new policies in particular areas of healthcare.
CMS Transmittals – Internal instructions for updating CMS operational manuals to reflect new or changed policies.
Two Important CMS Timelines: Fiscal Year and Calendar Year
The CMS guidance for healthcare comes with its own deadlines attached, and every year there are two important and separate timelines for fiscal year and calendar year Final Rules.
In healthcare, fiscal year guidance typically has an October 1 effective date, and that Final Rule usually drops in August. This year, YouCompli analysts got through the fiscal year Final Rules incredibly quickly, because CMS cut a lot of the material in the preamble, and that allowed more efficient review and analysis.
Effective Date of Calendar Year Final Rule Coming Up Fast
As every seasoned compliance professional knows all too well, CMS puts out a handful of big, omnibus rules for different areas of health care on an annual basis. This time of the year brings us the final rules affecting outpatient costs and billing. These areas usually get addressed during the calendar year, and these calendar year communications started dropping this year on November 5. That gives an effective date of January 1 of the next year.
It’s important to get these annual changes synthesized and implemented in a health care organization because they cover the entire year. Even when Rules drop at the usual time (and not during a government shutdown), the short time frame to the established effective date still puts pressure on providers to analyze and develop a compliance action plan. That’s where having a partner like YouCompli already breaking down these rules and translating them into actionable business requirements is essential.
Transmittals Could Be Delayed and Affect Claims Processing
On top of concerns about Final Rules delays, CMS transmittals ceased to come out on September 30. Transmittals are typically issued on a running basis as they come up. In a given month, you can have anywhere from 15 to 150 transmittals come out.
A CMS transmittal is not the same as a Final Rule. They are two distinct types of guidance documents from the CMS. Transmittals are official documents to communicate new or changed policies, procedures, claims and other operational guidance to Medicare administrative contractors (MAC), regional offices, and healthcare providers. The communications update specific CMS program manuals, instructions, and other documentation to ensure consistent implementation of Medicare rules.
MACs Also Risk Claims Backlog with Transmittal Delays
Another job of a transmittal is to direct the MACs on what to do in processing claims. These third-party contractors are hired by CMS to administer claims, and they can get backlogged on their instructions and claims processing when transmittals run late.
Any claims processing delays impact providers, so it’s important to keep an eye on when these transmittal communications come out, especially if it drags out for weeks. If MACs struggle with claims processing because they can’t keep up with the updates, providers lose money.
Whether it be through time-related loss, because then they have to reissue claims with fixes and things of that nature, delays directly impact revenues. That’s not good at a time when health systems are already under the gun.
Solution: Proactive Compliance to Know, Act and Verify
If you’re a YouCompli customer, you wouldn’t have to scramble to prepare for last-minute changes, because we would handle it.
If communications are ever delayed, creating a time crunch, let us act as your analysist team, grabbing communications as soon as they come out, and breaking it down for you. We capture the necessary data and deliver it, along with easily understandable business requirements.
You’ll know what you need to do to comply, so when the next Final Rule or transmittal hits your inbox, you’re ready to run with updating procedures, training and other requirements.
We suggest getting on board with us now, so when that time comes, you’re not struggling with these risks and delays.
About the Author
Nate Ward, J.D. is the Manager of Compliance and Content Development at YouCompli Software. He comes from a deep background in healthcare compliance and the legal field. Nate leads a team of experts who read regulations, analyze how they apply, and recommend action plans for healthcare compliance.
Compliance professionals sometimes feel undervalued in comparison to other functions in their organization. They think leaders and colleagues don’t really understand what they do.
These resources will help. Packed with ideas, tips and recommendations, these pieces were written by professionals with many years of compliance experience.
You can quickly skim for articles that relate to your needs and interests. Bookmark this page as a reference for future questions or projects.
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A conflict of interest (COI) in healthcare occurs when a person or organization involved in medical decision-making, such as a doctor, researcher or healthcare administrator, has a secondary interest (financial, professional or personal) that could compromise or influence their objectivity and clinical judgment.
This secondary interest has the potential to affect decisions about diagnosis, treatment, or research in a way that’s not aligned with the best interests of the patient or public health.
In this expert interview, Amy shares insight surrounding compliance management software (like YouCompli) and examples of what it takes for organizations to be successful.