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ReimbursementHospital Buyer & Reimbursement
ASC Site-of-Service Shift
Migration of procedures from hospitals to ambulatory surgery centers.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Many procedures historically performed inpatient have shifted to ambulatory surgery centers (ASCs) as CMS expanded the ASC-payable procedure list and as physician-owned ASC economics drove adoption - most visibly in orthopedics (total joints) and cardiology. CMS adds procedures to the ASC covered list through the annual OPPS and ASC rule, and removed total knee and hip replacement from the inpatient-only list in 2018 and 2020. The shift changes who buys devices, puts more pressure on price and inventory, and makes outpatient data and site-of-service economics more important in sales planning. What the regulation says
While regulations primarily focus on the safety and effectiveness of medical devices and procedures, the shift to ASCs is influenced by reimbursement policies set by entities such as the Centers for Medicare & Medicaid Services (CMS). These policies, which determine payment rates for procedures performed in different settings, indirectly impact device manufacturers by driving where procedures are performed. Manufacturers must ensure their devices meet all applicable regulatory requirements regardless of the clinical setting, according to regulations like 21 CFR Part 820 for quality systems, even as the site of service changes.What this means in practice
Site-of-service shift compresses device pricing power: ASC payments are typically 60% of HOPD rates. Capital, capital-equipment, and disposables strategies must adapt to ASC budgets.Examples
- A medical device manufacturer designs a new surgical robot for orthopedic procedures, ensuring its footprint and operational requirements are compatible with the typically smaller operating rooms found in ASCs.
- A company developing an ocular implant for cataract surgery provides training and technical support tailored to the specific needs and workflows of ASC staff, acknowledging the high volume of these procedures performed in an outpatient setting.
- A device manufacturer conducts post-market surveillance specifically tracking adverse events and device performance in ASC settings to identify any unique challenges or use errors associated with that environment, fulfilling requirements under 21 CFR Part 803 for medical device reporting.
Common pitfalls
- •Assuming that regulatory requirements for devices change based on the site of service, rather than remaining consistent across all approved clinical settings.
- •Failing to consider the impact of reimbursement policies on product development and market access strategies.
- •Overlooking the need for a quality management system that supports devices used in various healthcare settings, including ASCs.
Frequently asked questions
The site-of-service shift itself does not directly alter the regulatory approval process for medical devices. Device approvals are based on safety and effectiveness data, independent of where the procedure is performed. However, manufacturers may need to provide data relevant to ASCs if the device has specific operational considerations in that setting.
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Cited by
Where this term appears across MedTech Terms.
Ecosystems (1)
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 2Regulator guidance and consensus· 1Tier 4Trade press and expert commentary· 2
Link health: 3 verified· last checked 2026-06-20
CMS·1AMA·1AdvaMed·1
- 1CMS ASC paymentTier 2 VerifiedCMScms.gov
- 2AMA CPT ResourcesTier 4 VerifiedAMAama-assn.org
- 3AdvaMed - Payment & CoverageTier 4 VerifiedAdvaMedadvamed.org
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