Very Brief Blog: AMA Publishes July 1 New PLA Codes

AMA publishes new Proprietary Laboratory Analysis (PLA) codes quarterly, and here's the batch submitted circa April 1 and ratified at the May 2024 AMA CPT editorial meeting.  The new list appears July 1.   

The list also includes PLA codes from recent quarters that are too recent to be in teh CY2024 AMA code book.

https://www.ama-assn.org/system/files/cpt-pla-codes-long.pdf

The codes run from 0476U (OneOme mental health / pharmacogenomic genes) to 0520U (Sync View drug monitoring from Phenomics).  That suggests there are nearly 50 new PLA codes in the July 1 batch.   I assume all of these were covered in the June 25, 2024 CMS public meeting for new code pricing (here).

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AI Corner

One of the problems with PLA codes is that they have no organizing structure, and there are now over 500 of them.

I exported the PDF into Excel, and then copied the resulting 7 Excel sheets into 1 sheet.   I asked CHAT GPT to make some categories and list the relevant tests.  I cut and paste these below, but I have NOT manually checked them for accuracy.   Initially, it happily put the Transplantation tests into its Oncology category, and I asked it to fix that.

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ONCOLOGY:

Code	Test and Company	Test Description
0478U	Lung HDPCRTM, Protean BioDiagnostics	Oncology (non-small cell lung cancer), DNA methylation...
0485U	Caris AssureTM, Caris MPI, Inc d/b/a	Oncology (solid tumor), cell-free DNA and RNA...
0486U	Northstar ResponseTM, BillionToOne Labs	Oncology (pan-solid tumor), next-generation sequencing...
0487U	Northstar SelectTM, BillionToOne Labs	Oncology (solid tumor), cell-free circulating tumor DNA...
0490U	CELLSEARCH® Circulating Melanoma Cell	Oncology (cutaneous or uveal melanoma), circulating melanoma cells...
0491U	CELLSEARCH® ER Circulating Tumor Cell (CTC)	Oncology (solid tumor), circulating tumor cells, estrogen receptor...
0492U	CELLSEARCH® PD-L1 Circulating Tumor Cell	Oncology (solid tumor), circulating tumor cells, PD-L1 expression...
0495U	Stockholm3, BioAgilytix Diagnostics	Oncology (prostate), analysis of circulating tumor DNA...
0496U	ColoScapeTM PLUS, DiaCarta, Inc	Oncology (colorectal), cell-free DNA, 8 gene mutations...
0497U	OncoAssureTM Prostate, DiaCarta, Inc	Oncology (prostate), mRNA gene-expression profiling...
0498U	OptiSeqTM Colorectal Cancer NGS Panel, DiaCarta, Inc	Oncology (colorectal), next-generation sequencing...
0499U	OptiSeqTM Dual Cancer Panel Kit, DiaCarta, Inc	Oncology (colorectal and lung), DNA from formalin-fixed tissue...
0501U	QuantiDNATM Colorectal Cancer Triage Test, DiaCarta, Inc	Oncology (colorectal), blood, quantitative cell-free DNA...
0507U	Avantect Ovarian Cancer Test, ClearNote® Health	Oncology (ovarian), DNA, whole-genome sequencing...
0510U	PurISTSM, Tempus AI, Inc	Oncology (pancreatic cancer), augmentative data integration...
0511U	PARIS, Tempus AI, Inc	Oncology (solid tumor), tumor cell culture and response profiling...
0512U	Tempus p-MSI, Tempus AI, Inc	Oncology (prostate), augmentative algorithm for microsatellite instability...
0513U	Tempus p-Prostate, Tempus AI, Inc	Oncology (prostate), augmentative algorithm for prognostic profiling...

 

Transplantation:

• 0493U: ProsperaTM, NateraTM

  • Transplantation medicine, quantification of donor-derived cell-free DNA (cfDNA) using next-generation sequencing, plasma, reported as percentage of donor-derived cell-free DNA.

• 0508U: VitaGraftTM Kidney Baseline + 1st Plasma Test, Oncocyte Corporation

  • Transplantation medicine, quantification of donor-derived cell-free DNA using 40 single-nucleotide polymorphisms (SNPs), plasma, and urine, initial evaluation reported as percentage of donor-derived cell-free DNA with risk for active rejection.

• 0509U: VitaGraftTM Kidney Subsequent, Oncocyte Corporation

  • Transplantation medicine, quantification of donor-derived cell-free DNA using up to 12 single-nucleotide polymorphisms (SNPs) previously identified, plasma, reported as percentage of donor-derived cell-free DNA with risk for active rejection. ​

Infectious Diseases:

• 0480U: Bacteria, Viruses, Fungus, and Parasite Metagenomic Sequencing, Spinal Fluid (MSCSF), Mayo Clinic
  • Infectious disease (bacteria, viruses, fungi, and parasites), cerebrospinal fluid (CSF), metagenomic next-generation sequencing (DNA and RNA), bioinformatic analysis, with positive pathogen identification.
• 0483U: Ciprofloxacin Susceptibility of Neisseria gonorrhoeae, MedArbor Diagnostics, SpeeDx, Inc
  • Infectious disease (Neisseria gonorrhoeae), sensitivity, ciprofloxacin resistance (gyrA S91F point mutation), oral, rectal, or vaginal swab, algorithm reported as probability of fluoroquinolone resistance.
• 0484U: Macrolide Resistance of Mycoplasma genitalium, MedArbor Diagnostics, SpeeDx, Inc
  • Infectious disease (Mycoplasma genitalium), macrolide sensitivity (23S rRNA point mutation), oral, rectal, or vaginal swab, algorithm reported as probability of macrolide resistance.
• 0502U: QuantiVirusTM HPV E6/E7 mRNA Test for Cervical Cancer, DiaCarta, Inc
  • Human papillomavirus (HPV), E6/E7 markers for high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), cervical cells, branched-chain capture hybridization, reported as negative or positive for high risk for HPV.
• 0504U: Urinary Tract Infection Testing, NxGen MDx LLC
  • Infectious disease (urinary tract infection), identification of 17 pathologic organisms, urine, real-time PCR, reported as positive or negative for each organism.
• 0505U: Vaginal Infection Testing, NxGen MDx LLC
  • Infectious disease (vaginal infection), identification of 32 pathogenic organisms, swab, real-time PCR, reported as positive or negative for each organism.

New in JAMA! Lee Fleisher, Robert Califf, Others, on "Payers and Evidence Generation"

 Have you wondered when CMS will finalize 2023's proposed rule on new technologies, the TCET rule (here)?  

Here's a joint article in JAMA, July 1, authored by the head of FDA (Califf) and the prior Chief Medical Officer of CMS (Fleisher).   

Not Much of a Link to TCET

I was interested from a TCET perspective, because a publication like this might suggest that the final version of TCET is about to appear.  But on further review, it's not so clear.  The article is primarily by FDA authors, taking an FDA perspective (albeit on medical insurance).     

The TCET proposal is mentioned but only tangentially.  Had TCET been carefully summarized and praised in this essay, I would have tagged that, as a sign that TCET's finalization was imminent.  See also an earlier, 8/2023 article in JAMA Health Forum by Fleisher and colleagues on TCET, here.

FDA Authors Take on Payers

So take the FDA-and-payers article on its own.   FDA reports several ways in which private payers are, or could be, pivotal to post-FDA-approval evidence generation, including the simple fact that they hold all the claims data.   See the FDA's detailed website about its collaborations with payors here.

CMS CMMI and the "ACE"

The FDA article mentions TCET, coverage with evidence development (CED), and a proposal from the CMMI innovation center called "ACE, Accelerating Clinical Evidence," which would be related to different payments for drugs that have and have not completed post-approval trials.  New to me; see also here, page 3.

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Nerd note - the FDA article says that CMS first got the authority to cover routine costs of devices in clinical trials in 2003, in the Medicare Modernization Act, but it actually goes back to the Clinton-era NCD (2000) on clinical trials.  And the even earlier 1995 joint CMS-FDA regulation on Medicare coverage of IDE Category B trials (60 FR 48417) which itself developed at least in part from a legal case dating to 1994 (2nd Circuit, Yale New Haven Hosp v Leavitt, 11/16/2006). 

https://jamanetwork.com/journals/jama/fullarticle/2820534

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Unlike many policy articles, this one DOES have an abstract, which I clip below.

Abstract

Importance  The US leads the world in bringing new medical products to market, but the ability to generate evidence to inform clinical practice in postmarket settings needs improvement. Although a diverse group of stakeholders is working to improve postmarket evidence generation, the role of private payers has been underappreciated.

Observations  Payers are crucial allies in improving evidence generation because better data would better inform coverage decisions, their policies and practices influence the conduct of care and research, and their claims data are a source of real-world evidence used in medical product evaluation. In addition, payers have a stake in improving evidence generation because the kinds of evidence needed to inform health care and coverage decisions are often not available when a product enters the market and may not be generated without their involvement. Here, we describe several key steps payers could take to improve evidence generation, including participating in efforts to reduce administrative and financial barriers to the conduct of clinical trials, directly incentivizing evidence generation on high-priority questions by funding potential cost-saving trials, increasing engagement with the medical products industry on evidentiary needs for coverage decisions, and improving usability of claims data by reducing data lags and routinely recording unique device identifiers. Broad payer engagement with US Food and Drug Administration recommendations regarding evidence generation will ensure that the opportunities to participate in clinical research are extended to all communities and that evidence needed to inform care is generated in trials and surveillance systems that reflect the clinical reality across the US.

Conclusions and Relevance  Increasing payer involvement in evidence generation can benefit all participants in the medical innovation ecosystem. The importance of payers in these efforts will continue to grow in response to imperatives to increase integration of care and research, engage a diverse set of communities in clinical research, and move toward alternative payment models.

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FDAs Arguments, Payers, Data, and MolDx

Just like a famous criminal said he robbed banks, "Because that's where the money is," FDA looks to payers for real world evidence, because that's where the claims are.  CMS has tons of Medicare data, from claims forms, some free, some available on payment for data runs.   But in diagnostics, more and more claims fall under the MolDx unlisted code 81479, plus a Z code.   (81479 is virtually unused outside of MolDx MACs).   But if you buy that data, you won't know the Z codes, and can't do public health research.  Even if CMS is able to sell you the claim field containing the Z code, the Z code is confidential, so you won't know what test, or category of test, was used for large proportions of molecular test claims.

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AI Corner

I also pulled an AI-generated summary (Chat GPT 4).

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Summary of the Article: "Why Evidence Generation Should Matter to Payers and How They Can Help"

Authors: Ali B. Abbasi, MD; Lesley H. Curtis, PhD; Lee A. Fleisher, MD; Robert M. Califf, MD

Main Points:

1. Current State of Evidence Generation:

   • The US excels in bringing new medical products to market but lags in generating postmarket evidence that informs clinical practice and policy.
   • Postmarket evidence is crucial for understanding comparative effectiveness, cost-effectiveness, and optimal sequencing of treatments.

2. Role of the FDA:

   • The FDA is working on enhancing real-world evidence (RWE) in regulatory decisions, promoting pragmatic clinical trials, improving trial diversity, and integrating care with research.
   • The agency collaborates with federal and external partners but sees an underappreciated role for private payers in supporting evidence generation.

3. Importance of Payers:

   • Private payers are critical for generating evidence to improve health outcomes and guide coverage decisions.
   • They influence care and research through their policies and practices, and their claims data is a valuable source of RWE.

4. Proposed Steps for Payers:

   • Reduce Barriers: Streamline administrative and financial barriers to conducting clinical trials.
   • Incentivize Evidence Generation: Fund trials addressing high-priority questions and cost-saving interventions.
   • Engage with Industry: Collaborate with medical product developers on evidentiary needs for coverage decisions.
   • Improve Claims Data: Enhance usability of claims data by reducing lags and recording unique device identifiers.

5. Benefits of Payer Involvement:

   • Increased payer involvement can lead to better evidence generation, ultimately benefiting all stakeholders in the medical innovation ecosystem.
   • This involvement aligns with broader goals of integrating care and research, engaging diverse communities in clinical trials, and transitioning to alternative payment models.

6. Case Studies and Examples:

   • Historical precedents and current initiatives illustrate the potential for payer-supported trials to provide valuable evidence and cost savings.
   • Examples include CMS’s coverage with evidence development policy and the Enhancing Oncology Model, which emphasize the importance of payer engagement in research.

7. Operational Considerations:

   • Improving claims data quality can enhance postmarket surveillance and support the efficient conduct of clinical trials.
   • Initiatives like the FDA’s Sentinel Initiative and the Biologics Effectiveness and Safety System demonstrate the utility of high-quality claims data in regulatory decisions.

8. Conclusion:

   • Increasing payer engagement in evidence generation is essential for the future of medical innovation and healthcare delivery.
   • Collaboration among stakeholders, including payers, is necessary to ensure that evidence generation is integrated with clinical practice and addresses public health priorities.

Author Information:

• Ali B. Abbasi, MD: Affiliated with the US Food and Drug Administration (FDA).
• Lesley H. Curtis, PhD: Affiliated with the US Food and Drug Administration (FDA).
• Lee A. Fleisher, MD: Affiliated with the University of Pennsylvania, Philadelphia.
• Robert M. Califf, MD: Commissioner of the US Food and Drug Administration (FDA), based at the White Oak Campus in Silver Spring, Maryland.

Article Citation:

• JAMA. doi:10.1001/jama.2024.7616
• Published online July 1, 2024.

This article emphasizes the pivotal role of private payers in generating postmarket evidence to improve healthcare outcomes and support effective medical innovation. The authors argue for a collaborative approach involving payers, the FDA, and other stakeholders to address gaps in evidence and enhance the quality and applicability of clinical research.

Brief Blog: ONC Issues Grants Program for Innovation and Quality in Healthcare AI

 The Office of the National Coordinator for Health Information Technology (ONC) has issued a call for grants applications, issued May 13, letter of intent by May 28, final application due July 12, 2024.  The 13-page memo has the title,

• The Office of the National Coordinator for Health Information Technology (ONC) Announces Special Emphasis Notice (SEN) Interest in Projects to Develop Innovative Ways to Evaluate and Improve the Quality of Healthcare Data Used by Artificial Intelligence (AI) tools in Healthcare and Accelerate Adoption of Health Information Technology in Behavioral Health.

$2M is available, with single grants eligible for up to $1M.

Find it here:

https://www.healthit.gov/sites/default/files/page/2024-05/LEAP%20FY2024%20SEN_508.pdf

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AI Corner (Chat GPT 4)

The Office of the National Coordinator for Health Information Technology (ONC) has announced a Special Emphasis Notice (SEN) for projects focused on two main areas of interest:

1. Developing Innovative Ways to Evaluate and Improve the Quality of Healthcare Data Used by AI Tools in Healthcare
2. Accelerating the Adoption of Health Information Technology in Behavioral Health

Purpose

The initiative aims to fund projects under the Leading Edge Acceleration Projects (LEAP) in Health IT funding opportunity for fiscal year 2024. The goal is to address challenges that inhibit the development, use, or advancement of health IT, particularly focusing on AI and behavioral health.

Key Areas of Interest

1. Develop Innovative Ways to Evaluate and Improve Healthcare Data for AI Tools

   Goal: Develop scalable solutions to evaluate and improve the quality of healthcare data in electronic health records (EHRs) used by AI tools, in alignment with Executive Order 14110 and ONC’s HTI-1 Final Rule. (my notes here.)

   Key Objectives:

   • Develop solutions to evaluate and improve data quality in EHRs.
   • Ensure solutions adhere to the transparency requirements of the HTI-1 final rule.
   • Promote standards-based tools for evaluating and improving AI tools.

   Background:

   • AI can significantly impact healthcare by optimizing real-time solutions.
   • EHR data is critical for predictive modeling in clinical decision support (CDS).
   • Ensuring data quality in EHRs is crucial for the safe, effective, and trustworthy use of AI tools.

2. Accelerate Adoption of Health Information Technology in Behavioral Health

   Goal: Support the development of lightweight health IT solutions using open standards to enhance capabilities in behavioral health settings and improve care coordination.

   Key Objectives:

   • Design and develop lightweight applications, such as SMART on FHIR apps.
   • Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources
   • Pilot these applications in behavioral health settings to ensure they are ready for adoption.
   • Facilitate interoperability and patient engagement functionalities in behavioral health IT.

   Background:

   • Behavioral health providers have lower EHR adoption rates compared to physical health providers.
   • There is a significant gap in health IT capabilities and interoperability in behavioral health settings.
   • The HHS Roadmap for Behavioral Health Integration and the President’s Strategy to Address our National Mental Health Crisis highlight the need to bridge these gaps.

Application Details

• Funding: Up to $1 million per award, with a total of $2 million available.
• Eligibility: Applicants must clearly state their area of interest and demonstrate relevant expertise.
• Deadlines:
  • Letter of Intent: May 28, 2024
  • Application Submission: July 12, 2024

Further Guidance

All requirements and application instructions are detailed in the LEAP in Health IT Notice of Funding Opportunity. An informational session will be held on May 21, 2024, providing further details and instructions for potential applicants.

Contact Information

• Program Inquiries: Alison Kemp and Anastasia Perchem, ONC-LEAP@hhs.gov
• Grant Inquiries: Carmel Halloun, oncgrants@hhs.gov

This announcement underscores the ONC's commitment to leveraging AI and health IT advancements to improve healthcare outcomes, particularly in behavioral health, and supports responsible AI development through enhanced data quality and interoperability standards​

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Bonus AI Corner:

OK, you've successfully spelled out the abbreviation "SMART on FHIR." 

What the heck does it really mean??

SMART on FHIR (Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources) is a framework that enables developers to create healthcare applications that can be integrated into any certified Electronic Health Record (EHR) system using a standard Application Programming Interface (API). Here’s what it means in more detail:

SMART on FHIR Components

1. Substitutable Medical Applications (SMART):

   • SMART is a standard that provides a consistent way to build applications that can work across different healthcare systems.
   • It focuses on making apps "substitutable," meaning they can be easily replaced or updated without significant changes to the underlying system.

2. Reusable Technologies (SMART):

   • The SMART framework promotes the use of common, reusable technology components, which reduces redundancy and improves the efficiency of app development.

3. Fast Healthcare Interoperability Resources (FHIR):

   • FHIR is a standard developed by Health Level Seven International (HL7) for exchanging healthcare information electronically.
   • It uses modern web technologies (such as RESTful APIs) to facilitate easy, secure, and scalable data exchange.
   • FHIR provides a common language and framework for exchanging health information, making it easier to integrate and access data across different systems.

How SMART on FHIR Works

• Interoperability: SMART on FHIR apps can access and interact with health data stored in different EHR systems using standardized APIs. This interoperability ensures that the apps can work in a variety of healthcare settings without needing extensive customization.

• Integration: The framework allows these apps to be embedded within the user interface of an EHR system, providing seamless access to additional functionality directly within the clinician's workflow.

• Flexibility: Because SMART on FHIR apps use standard APIs, they can be developed independently of any specific EHR vendor. This makes it possible to create a wide range of apps for different purposes, such as clinical decision support, patient engagement, or data analytics.

Example Application

• A SMART on FHIR app might provide clinicians with a "snapshot" view of a patient’s health data, pulling information from various sources to present a comprehensive and up-to-date overview. This could include lab results, medication lists, and recent clinical notes, all integrated within the clinician’s existing EHR system.

Overall, SMART on FHIR represents a significant step forward in creating an open, flexible, and interoperable ecosystem for healthcare IT, enabling innovation and improving the delivery of healthcare services. 

Congressional Support of Breakthrough Coverage: The Latest Iteration

June 27, 2024 - see a press release from Congr. DelBene that "Breakthrough Legislation" has sailed past a bipartisan House committee, on a 35-6 vote.

Press Release

https://delbene.house.gov/news/documentsingle.aspx?DocumentID=3878

Legislative Text [23pp]

https://delbene.house.gov/uploadedfiles/breakthrough_bill_text.pdf

See coverage at MedPage Today, where I'm quoted:

https://www.medpagetoday.com/publichealthpolicy/fdageneral/110913

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AI Corner [edited], Chat GPT

Breaking Down the Ensuring Patient Access to 

Critical Breakthrough Products Act of 2023

A Promising Leap Towards Faster Medicare Coverage

After 15 years of policy work on the commercialization of novel medical technologies, I'm enthusiastic about the forward movement for the Ensuring Patient Access to Critical Breakthrough Products Act of 2023. The legislation promises to significantly enhance the Medicare coverage landscape for breakthrough medical devices.

Streamlining Access to Innovation

Currently, the path from FDA approval to Medicare coverage can be unpredictably slow, often taking up to three years. This delay impedes seniors' access to life-saving and life-enhancing medical devices. The proposed legislation addresses this by establishing a four-year transitional coverage period for FDA-designated breakthrough devices, ensuring they are deemed reasonable and necessary for Medicare coverage immediately upon approval or clearance.

Quoting Representative Suzan DelBene, "Seniors should not be forced to wait years for cutting-edge, safe, and effective treatments that could change or even save their lives." This sentiment underscores the urgent need for a more efficient process, one that this bill seeks to implement​. 

Key Provisions of the New Bill

1. Transitional Coverage:

   • Breakthrough devices will be covered by Medicare for a four-year transitional period starting from the date of FDA approval or clearance.
   • During this period, these devices will receive additional payments under various Medicare payment systems, such as the inpatient and outpatient prospective payment systems.

2. Unique Coding and Payment Adjustments:

   • The Secretary of Health and Human Services (HHS) is mandated to assign unique codes to each breakthrough device within three months of FDA approval/clearance.
   • Payment systems will be updated semiannually or quarterly to incorporate these codes, ensuring that the costs associated with breakthrough devices are adequately recognized.

3. Specified Breakthrough Devices:

   • The bill introduces the concept of "specified breakthrough devices," which covers breakthrough devices that do not have a prior benefit category under Medicare. 
   • This provision is particularly innovative as it expands coverage to include devices like digital therapeutics that were not contemplated when Medicare was first established​. 

4. Permanent Coverage Determination:

   • By the end of the transitional period, CMS must make a permanent coverage determination based on the data collected. This ensures continued access to innovative devices while fostering the generation of real-world evidence.

Impact on Bundled Payments

One of the significant challenges in Medicare reimbursement has been the integration of breakthrough devices into bundled payment systems. The proposed legislation addresses this by making these devices eligible for additional payments during the transitional period, even if they are typically included in broader service payments. This approach recognizes the unique costs associated with breakthrough devices and aims to ensure that they do not fall through the cracks of bundled payment methodologies.

A Win-Win for All Stakeholders

The Ensuring Patient Access to Critical Breakthrough Products Act is a win-win for innovative companies, healthcare providers, and, most importantly, patients. It provides a clear and predictable path for the integration of breakthrough devices into Medicare, encouraging continued investment and innovation in medical technologies. By expediting the coverage process, it ensures that seniors receive timely access to the latest advancements in medical care.

The 'specified breakthrough device' is an unusually named policy by which breakthrough devices can be covered even if they don't have a prior benefit category. This provides an excellent initial period for real-world evidence. Such devices will receive careful tracking and reports to Congress. So far, it looks like a win-win for innovative companies, providers, and patients.

 [ / end Chat GPT ]

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See a February 2024 letter from AdvaMed to CMS asking for quick action on TCET.

Brief Blog: AMA CPT, Register for Sept 19-21 Mtg in Albuquerque

 You can register now for the AMA CPT hybrid meeting (Zoom option) in Albuquerque on September 19-21, 2024.

The lab agenda, was has a rapid public-comment calendar, will be posted July 12 (CPT applications were due June 12).

https://www.ama-assn.org/member-benefits/events/cpt-editorial-panel-meeting?utm_asset_name=CPT%20Editorial%20Panel%202024&utm_channel_name=

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Meanwhile, in the quarterly PLA code world, applications were due June 10 for the summer quarter cycle, and those applications will also be posted for comment on July 12.   (Spring quarter PLA codes will be posted circa July 1 at the bottom of this webpage.)

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The next meeting will be February 6-8, 2025, in San Jose.