Thursday, July 2, 2026

The 2027 OPPS Proposed Rule: CMS Wrestles Actively with Software as a Medical Service (SaMS)

 Header:  The OPPS proposed rule for 2027 is released.  After a couple years of patchwork solutions, CMS adopts broad interim measues for software-dominant services.  CMS also promised a more worked-out plan for next year.

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Find the proposed rule here:

https://www.federalregister.gov/public-inspection/2026-13656/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment

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CMS Takes the Next Step on Paying for Medical Software:

From RFI to Rulemaking

In July 2025, CMS asked the public how Medicare should think about reimbursement for software-based medical services. It did so in both major Medicare payment worlds: the Physician Fee Schedule, where the issue is practice expense and Part B professional services, and OPPS, where the issue is hospital outpatient payment. In the PFS proposal, CMS specifically asked for comment on “Software as a Service,” noting that software algorithms and AI do not fit comfortably into older practice-expense categories built around clinical labor, supplies, and equipment.

December widened the aperture. In December 2025, HHS issued a broader RFI on accelerating the adoption and use of AI in clinical care. One of its sections focused directly on reimbursement, noting that government fee-for-service payment can be slow in recognizing high-value interventions. (HHS.gov) (Federal Register)

That December HHS RFI was not limited to Medicare coding minutiae. It asked a larger policy question: if AI-enabled tools can improve care, reduce friction, or avoid downstream costs, how should federal health programs avoid becoming the bottleneck?


ACCESS as the Parallel Universe

CMMI is already testing a different answer. The ACCESS model — Advancing Chronic Care with Effective, Scalable Solutions — tests outcome-aligned payments in Original Medicare for technology-supported chronic care. CMS describes ACCESS as a model that uses predictable payments, with full payment tied to measurable health goals rather than simply paying for enumerated activities. (CMS) (CMS)

That matters because ACCESS is, in effect, one policy laboratory for paying software-enabled care. Vendors and care organizations can receive recurring payments for chronic disease interventions, but they must meet defined outcome measures to avoid reduced payments. This is very different from the OPPS problem, where CMS is still trying to decide whether a software output should sit in a clinical APC, a new technology APC, a packaged status indicator, or something else entirely.

SaaS Becomes SaMS

In the new OPPS proposal, CMS says it has been evaluating a comprehensive SaMS payment approach for several years, has sought input through several comment solicitations, and wants a payment strategy aligned with quality, health improvement, cost reduction, and system strengthening.

A new name for a Medicare problem. CMS now proposes to retire “SaaS” and use “Software as a Medical Service,” or SaMS. The reason is partly linguistic and partly policy-driven. “SaaS” already means ordinary cloud-based software in the technology world. CMS wants a Medicare term for software-based technologies that support clinical decision-making through algorithmic analysis, including diagnostic or clinical functionality.

The distinction is important. CMS is not talking here about ordinary hospital IT, billing software, EHR modules, or cloud subscriptions. It is talking about clinical software that produces medical information — for example, algorithmic analysis of images, risk models, computer-aided detection, and other outputs that assist diagnosis or treatment planning.

Why OPPS Has Trouble With Software

The old system prices tangible inputs. CMS candidly states the core problem. Medicare Part B payment systems, including OPPS, were built mainly to pay for services with material resources: staff time, equipment, supplies, rooms, and procedural overhead. SaMS is different. Its value may lie in a proprietary algorithm, a trained model, scalable non-material infrastructure, licensing terms, and clinical performance.

That creates two awkward questions. First, how should Medicare value a service when the “cost” is not a scanner, a catheter, or a technician’s minutes, but a licensed algorithm? Second, how should Medicare handle hospital acquisition models that may involve subscriptions, enterprise licenses, per-use charges, or “per-click” fees?

CMS also flags program integrity. A per-click software fee can look like a cost input, a royalty, a utilization incentive, or all three, depending on how the business arrangement is structured.

The 2027 Interim Policy: A Holding Pen

New technology APCs for now. For CY 2027, CMS proposes an interim policy. It would designate 36 HCPCS codes as SaMS services. For 21 separately paid SaMS codes currently assigned to clinical APCs, CMS would move them into new technology APCs that approximate their CY 2026 payment rates.

This is not yet a full value-based methodology. It is more like a structured holding pen. CMS is saying that the clinical APC architecture does not adequately accommodate SaMS, but CMS is not yet ready to announce a final long-term payment model.


  • SIDEBAR:  Table 61 shows 36 HCPCS codes that will be reclassifed as SaMS.

The New O1 Status Indicator

A label with payment consequences. CMS also proposes a new OPPS status indicator: “O1,” defined as Software as a Medical Service, paid under OPPS with separate APC payment. Functionally, O1 would behave like status indicator S, meaning separate payment and no multiple-procedure discounting.

CMS also asks whether a status indicator behaving more like T — subject to multiple-procedure discounting — would be more appropriate. That is a small technical question with large implications. If SaMS tools are frequently used alongside imaging, procedures, or other diagnostic services, multiple-procedure discounting could materially change the business model.

Packaging Is Not Forgotten

CMS avoids sudden disruption. Some SaMS codes are currently conditionally packaged under Q1. CMS considered more aggressive packaging, including unconditional packaging under status indicator N, but concluded that such a move could interrupt patient access. For 2027, CMS proposes to maintain current clinical APC and status-indicator assignments for SaMS codes that are already conditionally packaged.

That is classic CMS incrementalism. The agency is not declaring that every algorithm deserves separate payment. But it is also not forcing all software into packaging before it has a durable framework.

The Table Is the Policy

Table 61 is the map. The proposal includes a detailed Table 61 listing the HCPCS codes CMS proposes to treat as SaMS. The list includes automated retinal imaging analysis, coronary FFR derived from CT angiography, fracture-risk software, concussion eye-movement analysis, ECG algorithmic risk assessment, brain MRI quantitative analysis, cardiac arrhythmia simulation, prostate cancer estimation mapping, perivascular fat cardiac risk assessment, 3D anatomical segmentation, and other software-derived clinical analyses.

The diversity of the list is the point. SaMS is not one clinical specialty. It is a payment category cutting across ophthalmology, cardiology, radiology, neurology, orthopedics, oncology, and procedural planning.

The Laboratory Pivot

The next problem is lab algorithms. CMS proposes that primarily software-driven or algorithmic lab tests are no longer classed as lab tests, but as non-CLFS software medical services.  This will certainly be controversial.  CMS proposed to remove about a dozen codes from the CLFS and plant them instead on the OPPS code list.  For now, prices would be crosswalked from the most recent CLFS price.

Why This Matters

CMS is separating the specimen from the software. This is the conceptual move. The original lab work may be regulated, coded, and paid as a laboratory test. But subsequent algorithmic interpretation of already-generated data may be a different thing. It may be proprietary. It may be scalable. It may not map cleanly onto CLFS, PFS, or OPPS conventions.

For laboratories, hospitals, AI companies, and genomics firms, this is a major signal. CMS is beginning to build vocabulary and payment architecture for software-derived medical information, even when that information is downstream from a conventional diagnostic input.

The Policy Direction

Not value-based yet, but not business-as-usual. The 2027 OPPS proposal does not create a grand unified theory of medical software payment. It does something more modest and more practical. It renames the category, creates a SaMS-specific status indicator, moves many separately paid services into new technology APCs, preserves some packaging arrangements, and asks for further comment.

Seen alongside the July 2025 RFIs, the December HHS AI RFI, and the ACCESS model, the direction is clear. Federal policy is no longer treating medical software as a novelty at the edge of the payment system. CMS is now trying to decide whether SaMS should be paid like a diagnostic test, a procedure, a hospital resource, a software license, or an outcome-linked intervention.

For 2027, the answer is still transitional. But the transition itself is the story.


Run, Don’t Walk: AMA CPT Big Changes for Software-Dependent Services

Run, Don’t Walk: AMA CPT Big Changes for Software-Dependent Services

I wrote a long blog on Appendix S a few days ago, here's the concise version I used as a mini-post on Linked In.
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AMA has published the 2027 version of “Appendix S,” its greatly-revised policies for software-intensive services. 
  • But there’s more! AMA is also rolling out BIG changes and never-before-seen requirements in the CPT new code process.
  • Apply quickly to understand and track these changes before the 9/2026 CPT meeting in Minneapolis.

See the AMA CPT AI press release:
https://lnkd.in/gufqGaNj

See the new 2027 Appendix S for AI:
https://lnkd.in/gZ-55ggj

Go to AMA CPT “Smart App”, being sure you click at top for “interested Party Portal.” (May require email registration.)
https://lnkd.in/gx-YVr8P

Now, click on Tab 94 for IP (Interested party) access.

This is the lab version of the CPT application, but I believe the general-code version opens for comment by July 13.

See "green" text: There are A LOT of changes proposed for evaluating and documenting AI or other software during the CPT application process – including a lot of new applicant work and new committee review responsibilities.

I expect by mid-July CMS will release the same changes for the "general purpose" code change process.  AMA CPT may also soon release information on the new CMAA algorithmic services code category - that will be either now July-August or this winter December-January.

CMS Drops a Bomb on top of AI Lab Policy (OPPS Rule)

HEADER: CMS Proposes Big Shift for Software-intensive Lab Services

 See pages 457-462 of the new Hospital Outpatient rulemaking for CY2027:

https://www.federalregister.gov/public-inspection/2026-13656/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment


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What was Wet Lab and Dry Lab is now... Wet Lab and Not-A-Lab?  ?!?

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News in Brief

[ChatGPT]

CMS has proposed a major CY2027 OPPS policy shift for “software as a medical service” analyses performed on prior laboratory test data. In recent years, lab AI and lab-plus-algorithm services have often been channeled through MAAA, PLA, and CLFS coding/payment pathways. The new OPPS proposal partially reverses that direction. 

CMS argues that once the original laboratory work is complete, downstream algorithmic analysis of stored data—such as genomic, transcriptomic, or digital pathology data—may no longer be a clinical diagnostic laboratory test at all.

CMS proposes to move 10 such HCPCS codes out of the CLFS and into OPPS New Technology APCs, with a new status indicator “O1” for separately paid software-as-a-medical-service items. The agency emphasizes that these analyses may be performed by non-CLIA software entities, creating a new Medicare boundary between the laboratory test and later AI/software interpretation.

[I'm not sure that they can be performed by non-CLIA entities, but I'll leave that to CLIA law experts.]


Deeper Dive

CMS’s CY2027 OPPS proposed rule includes a compact but potentially far-reaching section on what it calls “SaMS analyses performed on laboratory tests.” SaMS stands for software as a medical service. The target is not ordinary hospital software, and not simply AI used inside a lab workflow. Rather, CMS is focused on algorithmic analyses performed downstream of a prior laboratory test, especially where the raw or processed data already exist and the later service is essentially computational.

CMS gives the example of genomic sequencing. The sequencing itself may be performed once by a CLIA-certified laboratory. But after that, the same underlying sequence data can be reanalyzed many times by different algorithms to produce diagnostic, prognostic, risk, or treatment-related information. CMS’s key point is that this later algorithmic step may not require a CLIA laboratory at all. A non-CLIA software entity with the relevant program could perform the computation. That distinction drives the policy proposal.

This is why the proposal feels like a flip-flop from the recent coding and payment trajectory for lab AI. Over the past several years, the ecosystem has treated many lab-plus-algorithm products as laboratory services. AMA created MAAA codes for multi-analyte assays with algorithmic analysis. PLA codes have also been used for proprietary lab and algorithmic services. CMS has then often placed these items on the Clinical Laboratory Fee Schedule, using crosswalk or gapfill logic. In practical terms, the system has been willing to treat “lab data plus algorithm” as a lab test.

Now CMS is drawing a sharper line. The agency says it does not believe these secondary algorithmic analyses should be considered clinical diagnostic laboratory tests or priced under the CLFS when they do not require CLIA-regulated laboratory performance. CMS instead characterizes them as “other diagnostic tests” under Medicare law, not “diagnostic laboratory tests.” That is a significant conceptual move.

CMS also flags payment-policy concerns

  • The CLFS generally lacks beneficiary cost-sharing and is not budget-neutral in the same way OPPS is. 
  • CMS also says it often receives limited transparent cost information for algorithmic components because companies consider the details proprietary. 
  • Historically, CMS may have relied on visible lab methods in code descriptors—NGS, RT-PCR, methylation, and so on—but CMS now says that comparison is not appropriate when the service at issue is entirely computer-based.

For CY2027, CMS proposes to assign 10 existing HCPCS codes to OPPS New Technology APCs, choosing APC bands that approximate current CY2026 CLFS payment levels. These include oncology and digital pathology AI services, transcriptomic or genomic algorithmic analyses, tumor-response prediction, recurrence scoring, MSI/HRD assessment, and comparator exome analysis. The proposal also creates a new status indicator, “O1,” meaning software as a medical service, paid separately under OPPS.

The larger issue is not just these 10 codes. CMS also proposes that future SaMS analyses performed on lab-test data should go to New Technology APCs under OPPS rather than the CLFS. If finalized, this could reshape the business model for lab-adjacent AI, blur the old PLA/MAAA assumptions, and force companies to think much harder about whether their product is a laboratory test, a software diagnostic, or both.

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SIDEBAR: The Road to Today...

The CMS OPPS announcement was inevitable once AMA CPT last winter began issuing lab-AI codes as Category III codes. CMS handles every Category III code in its OPPS rulemaking, so the AMA CPT maneuver back in February,  loaded the gun for this OPPS proposal now in July.

SIDEBAR: Odd Code List Table

CMS lists 9 PLA codes plus CPT code 81416 (comparator exome).  I would think they'd leave off wet lab exome 81416, but could have included 81417 (exome re-analysis dry lab) and 81427 (genome re-analysis dry lab.)

SIDEBAR: Typo  493.21, 493.2

CMS refers erroneously to "CFR 493.21," which does not exist.  What CMS is saying there - in awful syntax - is that it thinks there are things that are performed on lab tests, which are software rather than CLIA lab services (as define at CLIA 493.2).  These "things" will be called, by CMS, SaMS or Software as a Medical Service.

 There's no claim by CMS that SaMS is a CLIA term, at 493.2, 493.21 (sic), or anywhere else.


What was Wet Lab and Dry Lab is now... Wet Lab and Not-A-Lab?

Changing Codes Table 62. Two parts.  Click to enlarge.