Adapting to new regulatory norms.
By Pete Mercer
In an era where healthcare regulations seem to shift almost as quickly as the technology that drives patient care, ambulatory surgery centers (ASCs) find themselves under increasing pressure to stay compliant. As new rules emerge and existing guidelines evolve, ASCs must continually adjust to ensure they’re meeting both the letter and the spirit of the law.
From changes in billing practices to heightened patient safety standards and updated infection control protocols, the landscape is anything but static. Understanding the dynamic world of ASC compliance is critical to operating in this day and age, especially as regulatory standards continue to change. Adapting to these new regulatory norms has to be the way of life for any healthcare organization in today’s market.
Navigating the regulatory landscape
ASCs are facing a growing number of regulations that affect nearly every aspect of their operations. Whether it’s compliance with Medicare standards, state health department rules, or infection control protocols, there’s no shortage of regulatory hurdles to navigate. With so many moving parts, it can be challenging to keep up.
One of the major catalysts for change regarding ASC regulations is the federal government. Organizations like Centers for Medicare & Medicaid Services (CMS) and Health and Human Services (HHS) regularly update and issue new rules that have an impact on daily processes like billing procedures and safety protocols. Jeff Kremer, the senior director of business development for Henry Schein Medical’s ASC division, said, “ASCs are highly regulated healthcare facilities that must comply with several federal, state, and accredited bodies such as the Joint Commission, the Accreditation Association for Ambulatory Health Care, the Accreditation Commission for health Care, and QUAD A. These organizations ensure that ASCs maintain a high standard of care, patient safety, and legal compliance requirements. Each accrediting body significantly influences surgery center operations, shaping policies and procedures.”
These organizations are responsible for setting the regulatory framework for the whole of healthcare, but there are also regulatory expectations on the state-level. Kara Newbury, Chief Advocacy Officer for the Ambulatory Surgery Center Association, said, “I think the challenge is that you do have to stay on top of compliance issues. Staying on top of it can be difficult, because you have to pay attention not only to what’s happening at the federal level but also the state level.”
Newbury said that ASC operators who want to better understand the regulatory expectations on a state-level should join their state associations, as well as the ASCA for the national-level association. “The ASCA typically comes into the fold as an educational source. We make sure that all of our facilities are aware of the ASC Quality Reporting Program, which ASCs have to participate in to comply with Medicare requirements.”
Kremer also recommended joining associations to keep informed about the evolving regulatory environment. “Actively participating in professional associations such as the ASCA and regularly attending industry conferences are effective ways to stay informed about regulatory changes.”
Balancing compliance with patient care
One of the challenges with maintaining regulatory standards is how to balance those measures against the quality and effectiveness of the patient care. While adhering to regulations is crucial for avoiding penalties and ensuring safety, it’s essential that these efforts don’t overshadow the core mission of providing quality care. In fact, many regulatory changes are intended to improve patient outcomes, such as updated infection control protocols or patient safety standards, which ultimately benefit both providers and patients.
Newbury said that the ASCA has raised certain concerns with the CMS about the ASC Quality Reporting Program as the 2026 rulemaking process begins. “One of them is concerned with whether the quality reporting measures that are being added to the program really speak to the quality of the facility, and it’s information that’s beneficial to the facility and the patients. We’re not seeing that with some of these measures, so we’re trying to make sure that any of these measures that our facilities have to report on are actually helping someone.”
When that balance between compliance and patient care is off, it often points to a lack of alignment across the board. Think about it like this – an orchestra is made up of a lot of different components, all working together towards a common goal. Different sections of the orchestra play different parts, but they all contribute to something greater than an individual instrument can achieve on its own. When all the pieces of an ASC – everything from billing to patient intake – are working together to meet regulatory requirements, it’s much easier to get a perfect balance between patient care and compliance.
“ASCs should strive to align technology, policies, and ongoing staff training to meet patient needs, while maintaining compliance requirements. ASCs should integrate compliance into the facility’s culture, making it a shared mission of the staff, rather than a burden,” Kremer said.
The future of ASC compliance
As regulations continue to evolve, particularly with the shift towards value-based care, ASCs will increasingly rely on advanced analytics and automation to manage compliance efficiently. Predictive tools and AI-driven software will help identify potential compliance risks before they become issues, enabling proactive action. At the same time, regulators are likely to place even more focus on outcome-based measures, pushing ASCs to not only comply with safety and billing standards but also to demonstrate measurable improvements in patient care.
Kremer said, “As procedures shift from hospitals to more convenient and cost-effective settings, such as ASCs, [CMS] regularly updates its reimbursement rules, increasing pressure on ASCs to demonstrate efficiency and high-quality outcomes.”
In order to meet the changing regulatory requirements, Kremer said that ASCs can work to develop a cross-functional team of stakeholders to understand and assess regulatory changes from clinical, financial, and operational perspectives.
As regulatory mandates continue to change, ASCs must stay agile, adjusting quickly to new policies and guidelines that emerge. The increasing complexity of these regulations, coupled with a heightened emphasis on patient outcomes, will demand innovative strategies for maintaining compliance while achieving high-quality care. In this environment, technology will play an even more significant role, with electronic health records, real-time monitoring, and data-driven decision-making becoming indispensable tools for compliance management.
Newbury said that one of the topics discussed in Congress is site neutrality, which is the idea that the patient would pay the same amount of money for a procedure, regardless of the site of service. “We want to make sure all the sites are created equal. Site neutrality is nuanced, and it’s important that each surgical site has the same regulations and complies with the same safety physical requirements, ensuring that we are directing care to the appropriate sites of service.”
With discussions around site neutrality gaining traction, ASCs will need to closely monitor how legislation unfolds and assess how any changes could impact their financial structures and operational workflows. These ongoing legislative and regulatory changes are pushing ASCs to refine their practices and ensure that they not only meet the letter of the law but also contribute to a healthcare system focused on both cost efficiency and quality outcomes.