The European Parliament has issued an urgent resolution calling for the revision of MDR. It's a blistering diatribe, calling out the complexity of the certification process, the timelines extensions for both MDR and IVDR (which have accomplished next to nothing), the lack of harmonized processes across notified bodies, EUDAMED delays, the lack of transparency in NB fee structures, unnecessary re-certification of some devices and more.
This resolution calls for the European Commission to propose "πππππππ‘ππ πππ πππππππππ‘πππ πππ‘π π‘π π‘βπ ππ·π πππ π‘βπ πΌππ·π π‘π ππππππ π π‘βπ πππ π‘ ππππ π πππ πβππππππππ πππ πππ‘π‘πππππππ ππ π‘βπ πππππππππ‘ππ‘πππ ππ π‘βπ πππππ πππ‘ππ£π ππππππ€ππππ πππ π‘π ππππππ π π‘βπ π π¦π π‘ππππ‘ππ πππ£ππ πππ ππ πππ πππππ£πππ‘ πππ‘πππππ ππ π‘βππ π ππππ’πππ‘ππππ , πππππππππππ ππ¦ ππ ππππππ‘ ππ π ππ π ππππ‘, π‘π ππ πππππ’ππ‘ππ ππ π πππ ππ πππ π ππππ" by the end of Q1 2025.
Lott links to the underlying 5-page document from the European Parliament:
The recent European Parliament resolution emphasizes a critical and chaotic situation surrounding medical device regulations (MDR) and in vitro diagnostic regulations (IVDR) in the EU. The resolution, acknowledging ongoing delays and certification bottlenecks, urgently calls for regulatory overhaul to avoid significant disruptions in device availability. Small and medium-sized enterprises (SMEs), which form a large portion of the sector, face insurmountable regulatory and financial hurdles, limiting their ability to bring essential devices to market and impacting patient access across the EU. The Parliament highlights the need for streamlined procedures, standardized timelines, and support mechanisms, particularly for innovative and pediatric medical devices.
Key recommendations include implementing fast-track pathways, transparent and fair fee structures, and a harmonized approach to ensure access to life-saving devices. The lack of consistent certification processes and harmonized policies across member states is creating unpredictability, increasing costs, and placing patient safety and access at risk. The European Parliament urges the European Commission to act swiftly, ideally by Q1 2025, to provide a comprehensive revision, transparent timelines, and support measures for SMEs. These steps aim to prevent device shortages, protect patient safety, and improve transparency and efficiency, addressing what many see as a crisis-level disruption in EU healthcare delivery.
Don't miss a new workshop from Decibio. This one is on "Emerging Applications and Platforms in Liquid Biopsy," and airs live on November 6, 2024. 9 pacific, 12 eastern.
They write, Join us for an in-depth exploration of the emerging applications and platforms in liquid biopsy. This session will highlight the most recent advancements in early cancer detection and targeted therapies, while also addressing critical challenges in patient access and reimbursement. Featuring thought leaders from across the industry, this webinar will provide valuable insights into the innovations shaping the future of liquid biopsy and its clinical impact.
These are concise - for example, the lab reimbursement summary doesn't cover a lot of its details. However, if you need an intro to a CMS payment system you don't already work in, these 20 entry points can be a good place to start. Plus, it's a testament to the fact that there ARE twenty separate, largely unlinked payment systems (DME, physicians, ESRD, and so on).
On October 29, 2024, the National Academies (of Science, Engingeering, Medicine), NASEM, will hold an all-day workshop on the topic:
Examining Clinical Guidelines for the Adoption of Genomic Testing:
A Workshop
The workshop will be live-streamed (registration available). It may be web archived afterward, but even if not, these workshops usually result in a publication about six months later.
The meeting is Tuesday, October 29, from 830-500 Eastern (530-200 Pacific).
See the webpage here, and scroll down for meeting materials and agenda.
A planning committee of the National Academies of Sciences, Engineering, and Medicine will organize and conduct a public workshop to examine how clinical practice guidelines can impact adoption of genomics into routine medical care. The workshop will examine how guidelines for genomic testing are developed by various organizations and implemented within clinical practice, with a focus on exploring inconsistencies across guidelines.
The workshop’s presentations and discussions may focus on:
• Exploring the processes and methodologies used by different professional societies, organizations, and collaborations to gather evidence and develop clinical guidelines for appropriate genomic testing.
• Understanding how clinicians, payers, test developers, laboratory partners, and others decide which guideline(s) to follow and how they use these guidelines in practice.
• Examining elements that are consistent and those that differ across clinical guidelines for genomics and how these areas impact patients (e.g., access, coverage, and equity in care), clinicians, payers, test developers, laboratories, and others.
• Discussing opportunities for a possible path forward for more compatible clinical guidelines for genomics to improve patient care.
The planning committee will organize the workshop, develop the agenda, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A proceedings-in brief of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.
You can't follow lab industry, or other healthcare, news without hitting a qui tam case every week. These are cases where a relator - or "whistleblower" - brings fraud evidence to the governments and the courts, and, within certain rules, gets a chair of the fraud recoupment (such as 15%).
In a September 30, 2024, ruling, Florida judge Kathryn Kimball Mizelle has ruled in her federal court that qui tam violates the constitution. While this idea has surfaced occasionally, it's never been used to win a case. (Justice Clarence Thomas has raised the issue, but only as a dissent).
News reports seem to treat the decision as a local outlier that may be overruled on appeal. But it's still news.
On October 14, 2024, the College of American Pathologists released a 16-page report on the problems and burdens for pathologists caused by difficulties with private payer reimbursement.
(Just 47 views as of October 24, so be sure to like and subscribe.)
See also a collection of Google NotebookLM resources, like a 13 minute auto-podcast and briefing guide, study notes, and FAQ - here. You can also access the auto-podcast via YouTubehere.
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AI CORNER
Chat GPT 4o reads the CAP report.
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Review of CAP Report on Private Payer Challenges
In its October 2024 report, the College of American Pathologists (CAP) tackles critical concerns regarding the role of private payers in healthcare and their impact on pathology services. With the increasing consolidation of insurance companies and the implementation of regulations like the No Surprises Act, many physicians, especially pathologists, are grappling with burdensome administrative requirements, diminished reimbursement, and restrictions on care delivery. The report highlights how these private payer policies interfere with the doctor-patient relationship and limit access to essential diagnostic services.
Key Findings from the CAP Report
The report emphasizes that pathologists play a pivotal role in patient care, from diagnosing complex diseases like cancer to guiding chronic disease management. However, private payers are employing a range of tactics—network manipulation, reimbursement cuts, and prior authorization measures—that make it harder for these specialists to deliver timely and accurate diagnoses.
1. Network Manipulation and Consolidation
CAP identifies insurance consolidation as a significant issue, noting that many health insurance markets are dominated by a few large players, giving insurers immense bargaining power over healthcare providers. This concentration enables insurers to reduce in-network providers or push patients towards lower-cost providers, often at the expense of quality. Pathologists are frequently excluded from networks or subjected to reduced participation, particularly in rural areas, which exacerbates the access gap for patients requiring specialized care.
2. Reduced Reimbursement
One of the report’s central grievances is the steady decline in reimbursement rates. Insurers are cutting payments below the cost of service provision, which CAP warns could threaten the financial viability of smaller, independent pathology practices. Many pathologists have reported being forced into “take it or leave it” contracts, which offer inadequate compensation for their services. According to the report, this approach benefits insurers while jeopardizing timely care, especially in settings where pathologists are integral to the diagnostic process.
3. Prior Authorization and Utilization Management
The report also sheds light on how prior authorization requirements delay care. CAP argues that these practices impede patient access to necessary laboratory testing, leading to delayed diagnoses and treatment, particularly for those with chronic conditions or rare diseases. Prior authorization can create significant bottlenecks, adding unnecessary administrative burdens on pathology practices already stretched thin.
4. Non-Standard Coding
Another concern is the imposition of non-standard coding requirements. For example, some insurers mandate the use of proprietary codes like DEX Z-codes instead of universally recognized CPT codes for certain molecular pathology tests. CAP argues that such non-standard codes introduce administrative complexity, raising costs and delaying claims processing.
Recommendations
To address these challenges, the report outlines several recommendations. These include requiring health plans to maintain adequate networks that include hospital-based physicians like pathologists, prohibiting network manipulation based solely on economic factors, and enhancing antitrust scrutiny to combat the effects of insurance consolidation. CAP also urges policymakers to ensure meaningful enforcement of network adequacy standards and to preserve the physician-led, team-based model of care.
Impact on Pathology Practices
For pathologists, these payer policies mean a struggle to maintain financial viability while adhering to increasingly complex administrative processes. The survey data cited in the report paints a grim picture: 72% of pathology practice leaders reported being negatively impacted by declining reimbursement rates over the past five years, with many forced to reduce staffing or increase turnaround times for critical diagnostic tests.
Conclusion
While CAP’s report clearly lays out the challenges private payers pose to pathology services, the concerns resonate across the healthcare industry. For lab professionals, the report provides a strong call to action, emphasizing the need for reform in insurance practices that prioritize patient care over profit. Although private payers argue that these measures are necessary to control costs, CAP insists that this cost-cutting approach undermines both the quality of care and the financial stability of pathology practices. It is clear that greater regulatory oversight and policy change will be required to address the growing tensions between healthcare providers and insurers.
Thanks to Jason Shafrin for pointing to USC's recent 3-hour symposium on Coverage with Evidence Development. Find the home page here, with links to a YouTube video of the whole summit:
The program was co-supported by the Tufts Center for Evaluation of Value and Risk in Health and the Stanford Mussallem Center for Biodesign
Here's the program summary online:
Medicare is considering changes to an important program meant to provide beneficiaries with access to newly approved drugs and devices while collecting data on how they work in the real world. The nearly 20-year-old program, known as Coverage with Evidence Development (CED), has recently faced questions about whether it’s working as intended.
The USC Schaeffer Center, in partnership with the Tufts Center for Evaluation of Value and Risk in Health and the Stanford Mussallem Center for Biodesign, hosted a conversation on the future of CED at USC’s Capital Campus in Washington, D.C. Attendees heard from the Centers for Medicare and Medicaid Services (CMS) official overseeing updated guidance, learned about the latest research and shared ideas on how CED could be improved.
Below, I include a news article generated by Chat GPT from an autotranscript. I also include, further below, a similar news article generated by (free) Google Notebook LM.
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AI CORNER
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Note. The first Chat GPT draft was concise with a couple quotes. I asked for a longer, more detailed version. I also asked for quote from Dr Makower, since Stanford was a co-sponsor. It made a better, longer article, and, surprised me with insertion of 4 Makower quotes (!). I've left the text as generated.
CHAT GPT 4o:
Improving Medicare’s Coverage with Evidence Development (CED):
A Policy at the Crossroads
The recent symposium at USC's Schaeffer Center, held on October 22, 2024, brought together experts from government agencies, academia, and industry to address the challenges and opportunities surrounding Medicare’s Coverage with Evidence Development (CED) policy. The event illuminated the evolving role of CED in bridging the gap between emerging medical technologies and the evidence needed to justify their coverage under Medicare.
The Legacy of CED: A Policy Born Out of Necessity
CED has been a tool in Medicare’s arsenal for over 20 years, designed to provide conditional coverage for innovative technologies while collecting additional data to confirm their effectiveness. As Tamara Syrek Jensen, Director of the Coverage and Analysis Group at CMS, explained during the event, CED allows Medicare to avoid saying "no" when the evidence supporting a technology is incomplete, but its potential clinical benefit is promising. It provides a pathway for patients to access new therapies while data collection continues, reducing the risk that a potentially life-saving or life-enhancing treatment is denied coverage prematurely.
However, Jensen also acknowledged that CED has not always worked smoothly. The process, while valuable, often encounters delays, and there are persistent challenges in aligning evidence development timelines with regulatory and reimbursement requirements.
Challenges in CED Implementation
One of the key challenges discussed was the complexity of coordinating parallel review processes between the FDA and CMS. FDA approval is based on safety and efficacy, while CMS coverage decisions hinge on whether a technology is "reasonable and necessary" for the Medicare population. This statutory difference in focus creates inherent friction in how quickly technologies can move from approval to coverage.
Jensen highlighted that the small size of CMS's Coverage and Analysis Group, which includes only about 38 staff members, is a bottleneck for processing National Coverage Determinations (NCDs) and managing CED programs. In addition, while CED allows for coverage during the evidence development phase, the burden of generating high-quality evidence—without the resources for randomized controlled trials (RCTs) in every case—poses a significant obstacle for sponsors.
The Role of Sub-Populations and Representation in Evidence Development
A pivotal issue raised at the symposium was the need for better representation of Medicare beneficiaries in clinical studies. Medicare patients tend to be older and have multiple comorbidities, which distinguishes them from the general population often used in FDA trials. Jensen stressed the importance of ensuring that studies reflect the diversity of the Medicare population, not just in terms of age and health conditions but also race and gender. This represents a shift towards requiring more robust, real-world evidence that can capture the outcomes relevant to the complex, multimorbid Medicare population.
The Push for Transitional Coverage of Emerging Technologies (T-CET)
In response to these challenges, CMS is piloting a new initiative known as Transitional Coverage of Emerging Technologies (T-CET). T-CET aims to engage with manufacturers earlier in the development process, ideally a year before FDA approval, to align evidence generation requirements and facilitate faster coverage decisions. The goal, as Jensen described, is to avoid unnecessary delays by ensuring that the evidence needed for CMS decisions is already being collected during the FDA trial phase, potentially bypassing the need for CED altogether in some cases.
Balancing Speed with Quality
While the aspirations behind CED and T-CET are clear, the execution remains a balancing act. There is a desire to move faster—both in terms of approving coverage for promising technologies and in expediting the evidence collection process. But as Jensen pointed out, the statutory requirements around public comment periods and the need for thorough data review create a natural tension between speed and thoroughness.
The introduction of T-CET marks an attempt to address some of these concerns, especially the resource constraints at CMS. By encouraging early collaboration between CMS, FDA, and manufacturers, the hope is that evidence generation can be better streamlined, reducing the time to market for innovative therapies.
Looking Forward: A Call for Greater Resources and Streamlined Processes
Despite the clear benefits that CED offers—particularly in avoiding outright denials for new technologies—the backlog of NCDs waiting for review and the limited resources available for processing them pose significant barriers. Jensen was candid about the need for more resources, not only to clear this backlog but to proactively engage in CED and T-CET initiatives. The wish list, according to Jensen, includes expanding CMS's capacity to handle both the increasing volume of NCD requests and the burgeoning complexity of evidence requirements.
The event underscored that while CED remains a critical tool in ensuring Medicare patients have access to cutting-edge treatments, it is a policy in need of refinement. Greater efficiency in evidence development, more robust representation of Medicare populations in trials, and early engagement through programs like T-SET are seen as essential to the future of Medicare coverage policy.
As the healthcare landscape evolves with new technologies and treatments, so too must the policies that govern their coverage. CED has helped to navigate the uncertainty surrounding new technologies, but it will require continued innovation and support from policymakers to fully realize its potential.
The challenge moving forward will be to maintain the integrity of Medicare’s coverage determinations while accelerating access to new therapies—striking the right balance between speed and evidence quality.
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Google Notebook LM
Coverage with Evidence Development: A Policy in Need of an Overhaul?
Coverage with Evidence Development (CED) is a Medicare policy intended to provide beneficiaries access to promising new technologies while simultaneously generating evidence to assess their value. However, as the policy enters its third decade, experts are raising concerns about its effectiveness and calling for significant reforms.
One of the primary criticisms of CED is that it has a mixed record of success. While there have been instances where the policy has successfully facilitated early patient access and generated valuable data, these successes are often overshadowed by concerns about the program's complexity, cost, and limited impact on coverage decisions.
Dr. Darius Lakdawalla, Chief Scientific Officer of the Schaeffer Center for Health Policy and Economics at USC, notes that CED is often successful in expediting patient access to therapies that might not otherwise be covered. However, he also highlights cases where CED can inadvertently restrict access for certain patient populations, potentially exacerbating existing healthcare disparities.
A key challenge identified by experts is the lack of clarity surrounding the criteria for requiring CED. The concept of “reasonable and necessary,” which underpins Medicare coverage decisions, is subject to interpretation and can be difficult to define in a transparent and consistent manner, particularly when economic considerations are excluded. This ambiguity creates uncertainty for innovators, particularly small startups, who may be reluctant to pursue CED due to the risk of a non-coverage decision, which could be fatal to their technology.
Another concern is the burden placed on providers and patients involved in CED evidence generation activities. Registries and trials associated with CED often involve extensive data collection requirements, which can be time-consuming and complex. For example, the TVT registry for transcatheter valves has over 276 fields and can take clinicians up to four hours to complete. This burden can lead to attrition from studies and potentially compromise data quality. Additionally, the Centers of Excellence model, which often requires patients to travel to specialized facilities for treatment, can impose significant travel burdens, particularly on those in rural areas.
Dr. Lakdawalla's research indicates that the Centers of Excellence model can unintentionally exacerbate access issues for rural and socioeconomically disadvantaged populations. His analysis of discharge statistics reveals that hospitals eligible for CED participation tend to serve a significantly smaller proportion of rural patients and patients from socioeconomically disadvantaged areas compared to other hospitals.
The unclear process for reconsidering or ending CED requirements is another area ripe for improvement. The absence of fixed timelines or clear guidance on what constitutes sufficient evidence to lift CED requirements can prolong the evidence development process and delay final coverage decisions.
Several experts suggest that the time is ripe for a comprehensive overhaul of the CED program. Dr. Peter Neuman, Director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, argues that CED “debuted in a period of blackberries and DVDs” and is in dire need of modernization to leverage advancements in analytics and data collection. He advocates for a more robust investment in data infrastructure and a shift away from the current one-off approach to evidence generation, proposing a “national evidence generation ecosystem” that transcends CED but incorporates it as a key component.
There is also a growing consensus that CMS needs significantly more resources to effectively manage and improve the CED program. While the $10 million allocated in the proposed HR 1691 bill is a step in the right direction, experts argue that a more substantial investment is necessary to address the program's backlog, expand staffing, and enhance data collection infrastructure. Some experts have even suggested exploring user fees, similar to the model employed by the FDA, as a potential funding mechanism, although this idea has faced resistance from industry groups.
The debate over whether different types of technologies, such as drugs and devices, require distinct CED pathways is another point of contention. Greg Daniel, Vice President of Global Public Policy at Eli Lilly and Company, argues that the different regulatory frameworks, evidentiary requirements, and practice settings for drugs and devices necessitate tailored approaches to CED. He points to the experience with Alzheimer's disease drugs, where the application of CED designed for medical devices has resulted in unintended consequences, such as limited patient access despite traditional FDA approvals based on robust clinical endpoints.
Commercial payers have also expressed interest in expanding CED into the private sector. Bob McDonough, Executive Director for Clinical Policy and Research at Aetna, highlights the potential for private payers to play a more active role in evidence development. However, he acknowledges that there are open questions regarding the feasibility and benefits of private payer participation, as well as the willingness of plan sponsors to support such initiatives.
Ultimately, the future of CED hinges on the ability of policymakers, CMS officials, and stakeholders to address these challenges and forge a path toward a more efficient, effective, and equitable system for evaluating and covering new medical technologies.
The report also documents the concentration of Medicare Advantage providers, despite the existence of "hundreds of MA plans" - with three master plans covering 60% of MA patients.
The report includes a focus on high denial rates for post-acute-care claims (e.g. hospital discharge to Part A nursing home stay (rehab).) An AHRQ report to Congress last month highlighting post-discharge care as a cause of high variance in the cost of sepsis patients. Note, however, that in many cases post-acute care may be critically valuable for the care of such patients. See an October 21 news item about Blue Shield automating prior auth.
AI Corner
Here's an auto-generated Chat GPT 4o article from the Senate report. (Since the Senate PDF is 140mb, I converted it to a text file (.txt) before uploading to Chat GPT).
Senate Report Sheds Light on
Medicare Advantage Claims Denials and Automation Concerns
A recent Senate investigation has revealed alarming findings regarding the use of prior authorization and artificial intelligence (AI) technologies in Medicare Advantage (MA) plans. The report highlights that major insurers—UnitedHealthcare, Humana, and CVS—have used prior authorization to significantly limit access to post-acute care, a critical component of recovery for many seniors. These denials have raised serious concerns about the impact of automation on patient care and access to medically necessary services.
The Senate's Permanent Subcommittee on Investigations (PSI) examined over 280,000 documents from the three largest Medicare Advantage providers, which together cover nearly 60% of all MA enrollees. The investigation found that these companies denied prior authorization requests for post-acute care at rates far higher than for other types of care. For example, in 2022, UnitedHealthcare and CVS denied post-acute care requests at rates three times higher than their overall denial rates, while Humana’s denial rate was a staggering 16 times higher.
Automation and AI: Faster Decisions, More Denials
One of the most troubling findings is the role that automation and predictive technologies play in these denials. The investigation revealed that UnitedHealthcare's implementation of a machine-assisted prior authorization system led to a sharp increase in denial rates. Testing of the technology showed faster processing times but also more adverse decisions—indicating that AI systems flagged more cases for denial, often based on cost-saving measures rather than medical necessity.
The automation of prior authorizations has been framed as a tool to reduce clinician workload and speed up the decision-making process. [*] However, internal documents show that UnitedHealthcare was aware that the use of automation would lead to more denials, and the company approved the use of these technologies despite these concerns. For instance, UnitedHealthcare’s denial rate for skilled nursing facility care increased by nine times between 2019 and 2022.
[*] Press release about Safeforce.com and Blue Shield ramping up automation - here.
CVS and Humana: Similar Strategies, Growing Denial Rates
CVS, which saw a 57.5% increase in prior authorization requests for post-acute care between 2019 and 2022, also developed algorithms that focused on predicting which requests had a high probability of being denied. The company’s internal data showed that the financial savings from denials vastly outweighed savings from approvals, suggesting a strategic emphasis on denying care to protect profits. In one year, CVS saved over $660 million by denying inpatient facility requests.
Humana, on the other hand, saw a 54% rise in denials for long-term acute care hospital requests after instituting training sessions that focused on how to deny care and successfully uphold those denials during appeals. Although the extent of AI’s role in these decisions remains unclear, the company’s internal policies indicated that third-party contractors could use AI systems to assist in the denial process.
Recommendations for Reform
The Senate subcommittee’s report calls for stricter oversight and more transparency in how MA insurers use prior authorization and automation. Among the key recommendations are:
Enhanced Data Collection: The Centers for Medicare & Medicaid Services (CMS) should require insurers to break down prior authorization data by service category, allowing for targeted audits where denial rates are unusually high.
Audits of Denials: CMS should conduct targeted audits if data shows increases in adverse determination rates, particularly for post-acute care.
Regulating AI and Automation: CMS should expand regulations to ensure that predictive technologies do not unduly influence human reviewers, who may face pressure to follow algorithmic recommendations without fully considering the medical needs of the patient.
The Human Cost
While automation is intended to streamline healthcare processes, this report underscores the risks of relying too heavily on AI-driven decisions, particularly when the stakes involve access to vital post-acute care services. The findings of the Senate investigation suggest that these practices may prioritize cost-saving measures over patient care, leaving vulnerable seniors at risk of being denied the treatments they need during critical recovery periods.
The report serves as a wake-up call for policymakers, highlighting the need for regulatory updates that safeguard patient care from the overreach of automation in healthcare.
This story reflects the growing tension between efficiency and ethics in the administration of healthcare services, particularly as AI technologies play an increasingly central role in decision-making processes.
Here's one of a wide number of genomics companies that had a Covid Bubble in valuation (even thought these genomics companies had no connection to infectious disease).
While MarketCap can only show public companies, private valuations were also stronger during CY2021.
According to Diaceutics, "This paper outlines the 5 critical recommendations developed by The Health and Economic Forum to provide industry and policy makers with valuable and clear economic guidance and recommendations to overcome the challenges obstructing the advancement of precision medicine."
It's open access at the above link (email registration). See subscription coverage at Genomeweb here.
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Separately, see Diaceutics Highlights from ESMO - here.
See also a new paper, August 2024, from Hofman, Liquid and Tissue Biopsies in Lung Cancer: Algorithms and Perspectives, open access at Cancers, here. He writes that appropriate genomics and biopsies (or LBx) are not well-integrated and this could be improved by standard practices and algorithms.
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AI CORNER
Here's a mini summary by AI of Hofman:
Liquid biopsies, especially for non-small cell lung cancer (NSCLC), offer a valuable complement to tissue biopsies by detecting actionable mutations through circulating tumor DNA (ct-DNA) analysis. Next-generation sequencing (NGS) enhances this, enabling complex genomic profiling for targeted therapies.
While tissue biopsies remain the gold standard, liquid biopsies are faster, less invasive, and crucial when tissue samples are insufficient. However, cost and infrastructure issues, particularly in Europe, limit routine use.
The author concludes that standardized practices and algorithms would improve the availability of genomic information, benefiting both clinicians and patients
Header: Someone mentioned at a conference that the 2017-2021 Trump administration had proposed setting US Part B drug prices to European levels. I had (mis)remembered that as starting in the Obama admininstration. The legal history starts in the Trump Administration and stops in the Biden administration, but an unfavorable federal court ruling was a big part of the end-game.
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I suspect that some policy work on setting Part B (injectible) drug prices to European levels did start under Obama (2012-2016) (here, here, here). But the major landmark came in the middle of the Trump administration, October 2018, when CMS released a Federal Register "advance notice of proposed rule-making." See webpage for "IPI International Price Indexing" Modelhere and Fed Reg here.
Under the updated title, "MFN Most Favored Nation" Model, CMS released a "interim final rule" on MFN on November 27, 2020 (here). This was later rescinded by a Biden-era final rule, December 27, 2021 (ibid).
In between, on December 28, 2020, one month after the interim final rule for MFN, the US District Court for Northen California issued an injunction (part of BIO v Azar, 3:20-cv-08603).
Summary
So whatever the earliest history of IPI/MFN ideas, there was major activity in the mid-Trump period (2018), and the interim final rule came out at the very end of the Trump administratoin (November 2020), and collided with courts by December 2020.
Using different concepts (negotiation), the IRA nflationi Reduction Act signed in August 2022 has been going into effect rapidly, lowering certain Medicare drug prices. It involves both Part B and Part D.
There's been an unusual zone of activity in CMS policy, in their area of ACO and "Shared Savings" calculations when the patient billing records contain large dollar amounts of abuse and fraud. CMS is better at "holding harmless" themselves and others, than "holding responsible."
Recall that ACO's generally have Part B fee for service members, and the ACO is held "responsible" for all Part B spending (not just when the bene visits the ACO's own health system.) Abuse and fraud in "regular" Part B adds to the costs "attributed" to the ACO's overall patient management. In a special rule September 24, 2024, CMS created a "hold harmless" escape valve for ACO's whose patients racked up mysterious large bills for catheteres (A4352, A4353). The latter code rose by 5000X as the payments continued to pour out. (89FR79156; All references at bottom).
They turned the rule around quickly (draft, July 3, final, September 24, less than 90 days). Public awareness of the problem dates back to at least 2/15/2024 (here).
CMS awareness dates, at least, to the beginning of the year in question, CY2023 (CMS writes in the press release, "In early 2023, CMS identified a concerning rise in urinary catheter billings, which was attributed to a small group of durable medical equipment supply companies. CMS determined that the beneficiaries did not receive catheters and were not billed directly, physicians did not order these supplies, and supplies were not needed." CMS calls this SAHS billing, "Significant, Anomalous, and Highly Suspect" billing.
Billing vs Payments
CMS cleverly attributes the problem to a small group of companies with erroneous billing. Does anyone see the problem yet? It's not erroneous billing, it's erroneous payments.
It doesn't require "AI" or super software to detect this. The massive increase in ludicrous amounts of catheters, coming in as "bills," should never (after a month or two) continue to result in payments. It's exactly the same as the completely insane, nonsensical, billion dollars of payments for obscure full sequencing gene codes, often a dozen per each patient, arriving at MACs in 2018-2022. Some MAC systems were able to completely thwart such crazy payments (NGS MAC, the various MolDx MACs) while others paid out patently ludicrous claims patterns and volumes for years on end.
While it's OK to hold harmless the ACO's, who are unaware of fraudulent billing to Part B MACs in real time, the CMS announcements say far too little about firing the idiots in charge of the payments trigggered by the billing.
CMS's weak reply to the payment problem seems to be *(89FR79156), "The proposed changes do not impose new rules or requirements related to provider billing and payment. The proposed changes are specific to ACOs" [and their profit calculations].
Here's the final rule at 89 FR 79152 (9-27-24, 21pp): "Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023
Header: AMA publishes new proposed PLA codes. Public comment is possible. Final results will be released 12/31/2024.
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Every quarter, AMA CPT takes applications for new PLA codes, publishes them for possible public comment, and quickly finalizes them. Results are published at the end of the quarter, and codes become effective one quarter later.
In the current round, applications were submitted in September. AMA releases them for comment in mid-October. The CPT Editorial Panel will vote on them in November (usually a quick online roll call), and codes will be released around January 1 2025 and effective for use April 1 2025. CMS will consider them for national pricing in Summer 2025.
There are about 35 action items, but about 5 of them are minor revisions.
HEADER: On October 10, 2024, several MACS - NGS MAC, Palmetto, CGS, Noridian, and WPS MACs - all finalized a new complex LCD for AI-assisted coronary angiography. Several take-home lessons.
Chat GPT could have made the convoluted coverage rules far more clear.
Note the billing and coding for these AI CCTA codes 0623T-0626T, only make sense in light of separate LCDs for CCT and CCTA (L33947) and computer-assisted fractional flow reserve FFR (L38771).
Get all the documents PLUS the redline in a zip file.
Some take home lessons.
REQUEST TO DRAFT
The time from request letter to draft LCD was 15 months (Feb 2023, May 2024).
LONG
The LCD is long, 14000 words and 80 citations in the final version.
REDLINES
There were extensive comments and extensive redlining of the final LCD
(I made a redline in Word, but I didn't attempt to decipher all the changes.)
DRAFT TO FINAL: FIVE MONTHS
The multiple MACs (some inside and some outside of "MolDx") were able to issue the LCD, take complex comments, add numerous citations, and finalize it from May to October.
CONTEXT:
The LCD's value only makes sense in the context of other codes. There is traditional "invasive" coronary angiography, then, computer-assisted (non invasive, CT based) coronary angiography, to which can be added FFR fractional flow reserve. The RVU valuation of that has been a hot potatoe for CMS Part B for years. Finally, there is the newest layer, AI-assisted CCTA.
The AI CCTA codes 0623T forward, are probably unpriced by CMS RVUs, so the "delta" the AI captures is not easily visible but is a key outcome.
TERMINOLOGY
The LCD has a good terms & definitions & abbreviations section.
Convoluted Coverage Rules: Can AI Help?
The coverage rules start out simple with 3 rules, but then have multiple asterisk-based complexities. I'm just cutting and pasting, note the asterisks. The bracketed numbers [1] refer to 2021 and 2022 national guidelines [3 is a correction to [2]).
AI-QCT/AI-CPA using CCTA* is considered reasonable and medically necessary as a diagnostic study when:
ONE
The patient has acute or stable chest pain with no known CAD1 and is eligible for CCTA*, AND
TWO
CCTA classifies patient as:
Intermediate risk ** ORCAD-RADs [1], CAD-RADS [2] or CAD-RADS [3] *** category on CCTA [1,2] AND
THREE
Cardiac evaluation is negative or inconclusive for acute coronary syndrome (ACS) [1]
####
ALSO NOTE ASTERISKS:
* See L33947 for criteria for CCTA. AI-QCT/AI-CPA should not be performed until after the base study (CCTA) has been completed and interpreted. Software to perform AI-QCT/AI-CPA must be FDA cleared or approved.
** Intermediate and high-risk as defined in the 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain [1]
*** CAD-RADS 1-CAD-RADS 3 category as defined by CAD-RADS™ 2.0–2022 Coronary Artery Disease Reporting and Data System (CAD-RADS): an Expert Consensus document of the Society of Cardiovascular Computed Tomography (SCCT), the American College of Cardiology (ACC), the American College of Radiology (ACR), and the North America Society of Cardiovascular Imaging (NASCI). [2 ,3]
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I asked CHAT GPT to read the whole LCD, then, to focus on the top-line coverage rules and explain them in English if possible. I do not guarantee that the Chat GPT re-writing exactly captures the Medicare rules. However, I do guarantee, that if an LCD author wrote his confusing rules, then, started again with the CHAT GPT rules, and then, did any final editing to be sure the AI English exactly matched his maze-like coverage plan in his head, the end result would be a lot more clear than the published final rules in the LCD.
Here's Chat GPT 4o:
Coverage Conditions:
Patient Eligibility:
The patient must have either acute or stable chest pain.
The patient should have no history of coronary artery disease (CAD).
The patient must be eligible for a Coronary CT Angiography (CCTA).
CCTA Results:
The CCTA should show the patient as intermediate risk (based on specific guidelines).
Alternatively, the CCTA may classify the patient under CAD-RADS 1, 2, or 3, indicating varying levels of non-obstructive to moderate stenosis.
Cardiac Evaluation Outcome:
A prior cardiac evaluation must show no signs of acute coronary syndrome (ACS) or have inconclusive results.
Additional Notes:
The CCTA must be done and interpreted before using AI-QCT/AI-CPA.
The software used for AI-QCT/AI-CPA must have FDA clearance or approval.
This summary simplifies the rules while retaining the essential coverage criteria for clarity. Let me know if any further details are needed!
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SIDEBAR
For curious readers, I include as a sidebar, a Chat GPT 4o comparison of the draft and final LCDs. I have labeled this clearly as FYI only, because I have not verified the AI comparison of the two long documents. No doubt, it's directionally correct and it shows an approach to strucutring the comparison. Sidebar HERE.
TIDBIT
Noridian sometimes publishes Cat III code local prices, which I have not looked into, for this blog. Here.
One of the interesting parts of the proposal to regulate LDTs via the FDA medical device manufacturing laws, is the degree of overlap with CLIA.
It's not just a little, it's a lot, and quickly each aspect of the overlap becomes painfully complex.
For a guide, see the curretly free 120 page guide to FDA QSR for LDTs (quality system regulations for lab developed tests) issued in September 2024 by CLSI, the Clinical Lab Standards Institute.
Learn for example what it means to track vender records, supply quality, and reagent validation under FDA vs CLIA. Dive into the FDA labeling recommendations, which are new and complex for LDTs and have an iron grip on promotional claims and remarks as well.
