I've had a number of questions about the February 22 WSJ Op Ed about Medicare and CareDx, and I've been putting together notes for an essay.
##
UPDATE - On February 29, 2024, see
##
For some CareDx news from the day before, Feb 28, see my blog here.
See also coverage of these events at Genomeweb:
I've had a number of questions about the February 22 WSJ Op Ed about Medicare and CareDx, and I've been putting together notes for an essay.
##
UPDATE - On February 29, see
updated press release from CMS
and updated billing article A58019 from MolDx.
##
But meanwhile, on February 28, CareDx held its 4Q-2023 investor call, and issued its updated SEC 10-K form.
Hint: The 10-K report uses the term "Medicare" 215 times. ("Coverage" appears 166 times, MolDx appears 82 times, Palmetto 16).
Coding in AMA CPT may include optional language, such as "Sequencing, including duplication-deletion analysis if performed."
One area of healthcare where separate coding, add-on coding, and bundled coding may fly together is imaging plus procedures. The term of art is "image bundling" and it is an area of advanced policy at AMA CPT.
See their entertaining flow chart and instructions:
https://www.ama-assn.org/system/files/2021-01/image-bundling-decision-tree.pdf
A JPEG is not as good as the PDF link above, but I include a JPEG also:
 |
| click to enlarge |
Header: Natera, which provides the bespoke (patient-tailored) Signtera test for minimal residual disease, wins MolDx coverage for breast and ovarian cancer.
##
Natera's Signatera test, which screens for minimal residual disease with a bespoke test that is custom-tuned to each patient's prior tumor exome or large panel, adds more Medicare coverage from MolDx.
Coverage is for use in neoadjuvant breast cancer therapy (chemotherapy given prior to the initial lumpectomy), the first coverage of this category for MolDx. In another first, Natera also announced coverage for MRD in ovarian cancer.
See the press release here:
The Natera Press Release - Structure and Function
In January, I wrote a blog article about how the Natera CEO presentation at JP Morgan was richly infused with facts and capabilities about their reimbursement expertise and tactics (here).
Natera's new press release, just cited, is worth studying for its use of carefully footnoted facts, call-outs to guidelines, and links to key supporting publications (#4, #7). The press release even includes selected citations to the size of population studied, number of unique biosamples, and some statistics. The study cites pivotal publications in 2022 and 2023, which is related to MolDx reliance on published trials, and MolDx timeline (counted in quarters) for review of new indications not covered before.
Both key publications (Hou 2022 in ovarian and Magbanua 2023 in breast) are open access. Example of the data power are shown in Hou 2022, Fig 3, where ctDNA+ relapse rate was 13%, vs 75% in ctDNA+. Although the "N" gets smaller +20 months, relapse rate for ctDNA- remains low.
 |
| Hou 2022; Ovarian; Click to enlarge |
 |
| Magbanua 2023; open access patient level data in Excel |
See open access coverage at Genomeweb here;
Header: John Peabody founded the medical consultancy QURE. In 2021, they published a paper on diagnostic startups, successes and failures, in "BMJ Innovations."
##
John Peabody MD founded the consultancy QURE (later acquired, still active).
I stumbled across an interesting 2021 paper of his - find the article online here. (Firewall). For the BMJ Innovations journal home page - here.
I clip the title and abstract below. One of the coauthors, Mickey Urdea, revisited in 2023. See a 45 minute vlog.
##
Postmortems on diagnostic testing start-ups:
Reports of commercial successes and failures and the case of the Zombie life science company.
Abstract
Background From 2014 to 2017, more than 1000 diagnostic companies were launched, securing more than US$10 billion in investment.
Methods We performed an in-depth exploration of 28 diagnostic companies to differentiate successful and failed startups, plus a third ‘Zombie’ state where companies have achieved financial solvency but without long-term viability.
Results From these data, we created a five-phase, 13-item framework indicating the corporate health of a diagnostic company as it progresses from conception to commercialisation. We found 6 successful companies, 14 failures and 8 Zombies. On a scale of 0–26 points (two points per item), successful companies averaged 24.5 points (range 22–26), failures averaged 4.5 (range 0–16) and Zombies averaged 12.3 (range 3–23) (p<0.001).
To determine if there was any predictivity to this framework, we looked at only the first two phases (concept and feasibility/planning) of progress and found a distinct gradient in success potential based solely on these first two phases.
Conclusion Our five-phase framework generated a score that could predict diagnostic companies more likely to successfully and sustainably enter the market from those more likely to fail.
###
Take-home lesson, reading the business features left to right across the five columns, successes had mostly "green lights" as seen in the top rows. Failures had lots of "red lights" (bottom rows).
Not too surprisingly, QURE, which focused on helping startups with early commercial planning, found that higher quality early commercial planning was important. (I focus on some of the same in a 2024 white paper on valuation and due diligence for genomics, here).
I also looked up the QURE paper at Semantic Scholar, a free resource.. This provides an interesting feature for every article - TLDR - which means "Too Long Didn't Read," essentially a 1-sentence summary of every paper it hits. The webpage at Semantic Scholar for the paper should be here. And this is the automatic TLDR:
Semantic Scholar lets you save the hit in a private library, get code to input into reference managers, etc.
###
AI CORNER
I ran the PDF through Perplexity.ai. (More on Perplexity).
Summary?
The paper titled "Postmortems on diagnostic testing start-ups: reports of commercial successes and failures and the case of the Zombie life science company" by Peabody et al. (2021) explores the outcomes of 28 diagnostic companies, categorizing them as successful, failed, or in a 'Zombie' state. The study presents a five-phase framework to assess the corporate health of diagnostic companies from conception to commercialization. Successful companies scored high across all phases, while failures lacked in meeting key criteria. Notably, failures often stemmed from issues like inadequate market understanding, technical barriers, or lack of clinical utility evidence. The study emphasizes the importance of thorough planning, market understanding, and meeting clinical requirements for successful diagnostic startups
Main Argument?
The main argument of the paper "Postmortems on diagnostic testing start-ups: reports of commercial successes and failures and the case of the Zombie life science company" by Peabody et al. (2021) is to present a comprehensive framework consisting of five phases and 13 items to evaluate the corporate health of diagnostic companies from inception to commercialization. The study aims to differentiate successful companies, failed startups, and those in a 'Zombie' state, where companies achieve financial solvency but lack long-term viability. By analyzing 28 diagnostic companies, the paper demonstrates that successful companies scored significantly higher across all phases compared to failures and Zombies. The framework developed in the study can predict which diagnostic companies are more likely to enter the market successfully and sustainably, highlighting the importance of strategic planning, market understanding, and meeting clinical requirements for the success of diagnostic startups
Key Findings?
The key findings of the paper "Postmortems on diagnostic testing start-ups: reports of commercial successes and failures and the case of the Zombie life science company" by Peabody et al. (2021) are as follows:
The framework created in the study could predict which diagnostic companies are more likely to enter the market successfully and sustainably, emphasizing the importance of strategic planning, market understanding, and meeting clinical requirements for the success of diagnostic startups
Weaknesses? Next steps?
The weaknesses of the paper "Postmortems on diagnostic testing start-ups: reports of commercial successes and failures and the case of the Zombie life science company" by Peabody et al. (2021) include:
Good next steps for this research could involve:
These steps could further enhance the insights provided by the study and offer a more comprehensive understanding of the factors influencing the success or failure of diagnostic startups
As a Haiku?
Diagnostic startups,
Success, failure, Zombie states,
Framework predicts fate.
Header: Months ahead of each CPT meeting, AMA publishes for comment the lab test agenda.
##
Months ahead of each CPT meeting, and before other codes, AMA publishes for comment the lab test agenda. Find it here:
https://www.ama-assn.org/about/events/cpt-editorial-panel-meeting#agenda
https://www.ama-assn.org/system/files/may-2024-lab-mopath-agenda.pdf
If you want to comment:
Read the PDF. You must request a code of interest by February 29, and submit your comment by March 4.
In brief, lab codes are:
Header: SCITE is a subscription tool that supercharges your ability to instantly see and evaluate citations to an index paper. In a few seconds, you get "the buzz" of what a dozen later papers think of your index paper.
##
There are coming to be hundreds of special AI tools, and a whole YouTube genre of reviewing them. One that I've found useful a number of times is SCITE. You give it an index paper, and it shows you all the papers that cite it. But that's not what's new.
SCITE also shows you the context in which each paper cites your index paper. And that is truly a new capability. Instead of finding and downloading a dozen PDFs known to cite your index paper, on one screen in a few seconds you can see the context of their remarks on your index paper.
##
Take an example. You figured out that the go-to paper on the fizzle of the CMS Oncology Care Model is JAMA, 2021, Keating. Here it is highlighed as a key paper in SCITE.
One of the articles that cites KEATING, is BROOKS 2022. OK, now in Brooks 2022, Keating is reference #13. And SCITE will show you all 6 places where Brooks refers to Keating 2021, and the context, like a half paragraph.
Header: The Lab Industry remembers PAMA 2014 for lab pricing law, but it also created Appropriate Use Criteria (AUC) for Imaging. It's fallen down, as did a Radiation Oncology payment model.
##
PAMA #1 - Lab Price
PAMA, the Protecting Access to Medicare Act, in the lab industry is shorthand for a major new lab test repricing law, based on median community pricing of lab tests. PAMA has been on hold and in limbo from 2020 to at least 2025.
PAMA #2, #3 - RVU Rules and AUC Project
Two other initiatives from PAMA were a section that gave CMS much more authority to set and revise RVU values, and a section that created mandatory "Appropriate Use Criteria" for advanced imaging (e.g. MRI).
The Advanced Imaging AUC Project
The AUC proceded in fits and starts and has finally been put on hold indefinitely, as per a recent notice to contractors from CMS. More details could be found by perusing 8 years of Federal Register annual rulemakings on the topic.
Tie In to Genomics
I thought the AUC was worth watching becaise" if you could apply required AUC to orders for $600 MRI tests why not also apply required AUC rules to $3000 genomic tests.
##
BTW - RO Model Also Deep Six'ed
Speaking of radiology, another issue was radiotherapy, where CMS proposed an unpopular Radiation Oncology bundled price model that was "modality agnostic." This was extremely unpopular in the clinical community and was even delayed sometimes by an act of Congress. See an extensive, 6-page letter on perceived severe problems with RO MODEL, written by numerous stakeholders to CMS in 2021.
See a 2021 article on RO MODEL by Milliman here.
In 2022, the RO MODEL was delayed or suspended to cancel a prior go live date in 2023, and stop or delay out to a future date "to be determined."
See ASTRO, https://www.astro.org/Daily-Practice/QPP/Alternative-Payment-for-RO
See also Fierce Healthcare on the same topic, https://www.fiercehealthcare.com/providers/cms-indefinitely-delays-controversial-radiation-oncology-model
AI Corner
Perplexity discusses the 7-page ASTRO and multi stakeholder complaint to CMS, here.
Header: In a few seconds, an alternative, open-access AI (Perplexity) generates several short essays about the outlook for value-based oncology.
##
A few weeks ago, this blog highlighted a new article by two oncologists, Klein & Kolodziej, here. Their new article is a look-back and look-forward relative to their ten-year-old forecast for value based care and value based payment in oncology.
##
Fast forward. This week, I've had several sessions playing with the free level of Perplexity.ai. In the example below, I asked it three questions about value based care in oncology. 1) What's a general overview; 2) What's the main barriers, and 3) What's the five year outlook?
In each case, Perplexity combines very rapid internet research and a strong general knowledge database (as in "regular" AI like Chat GPT).
Perplexity also extensively footnotes its reports. One of the big concerns of 2023, that AI's would not give sources and would make things up, is largely left in the rear view mirror, when you use Perplexity.
Except for the text in red, everything below was written in a few seconds by Perplexity. Some of it is sharp; some of it is harmless general prose. It would certainly jump-start someone who had to think about this topic and didn't have a starting place.
###
Unfortunately, I couldn't get the Perplexity report to word-wrap correctly on this blog, so to read the report with the important web links, I'll need to send you either to Plexplexity (in open access mode) or to Google Doc, below.
ESSAY WITH LIVE LINKS:
https://www.perplexity.ai/search/I-have-to-.90d.BX3T72_Fa9Ua_MfGA?s=c
https://docs.google.com/document/d/1z3wME1QtHNv-JdMn-C9QiA--F2SgIZDikBaaE2F1vK0/edit?usp=sharing
###
ESSAY WITHOUT LIVE LINKS:
All the text below, except that in red, were generated in a few seconds by Perplexity. To click on links, use the cloud based document resources above, not the passage below.
###
Part 1 -
Overview of a Report on Value-Based Oncology
To write a comprehensive report on value-based oncology care, focusing on patient outcomes, cost-effectiveness, provider incentives, and challenges, it's essential to integrate findings from recent studies and analyses. Here's a structured approach to crafting your report:
Introduction
Begin with an overview of value-based care in oncology, emphasizing the shift from volume-based to value-based models. Highlight the global need for affordable, accessible cancer care that produces optimal patient outcomes1.
Patient Outcomes
Discuss how value-based care aims to improve patient outcomes by focusing on the quality rather than the quantity of care. Mention the lack of standardization in measuring long-term patient outcomes and the need for universal clinical and patient-reported outcome measures (PROMs)1. Also, address the challenges in implementing these measures, especially in less developed countries1.
Cost-Effectiveness
Examine the financial aspects of value-based care, including the rising cost of cancer care and the financial toxicity associated with it2. Discuss strategies to improve cost-effectiveness, such as using composite tools to assess the value of drugs and increasing cost communication between patients and oncologists2. Highlight the importance of frameworks like the ASCO Value Framework and the ESMO Magnitude of Clinical Benefit Scale in assessing the value of clinical interventions2.
Provider Incentives
Explore how reimbursement incentives influence physician practice in oncology. Mention that value-based reimbursement policies may align physician incentives with patient needs more effectively3. However, also note the skepticism among physicians regarding the impact of financial incentives on their practice3.
Challenges
Identify the primary challenges in implementing value-based care models, such as navigating the payer landscape, identifying cost-reduction opportunities4, and accounting for patient and disease complexity5. Highlight specific examples where value-based models like the Oncology Care Model failed to account for these complexities, leading to financial losses5.
Conclusion
Conclude by emphasizing the potential of value-based care in oncology to align healthcare delivery with patient needs, improve outcomes, and manage costs. However, also acknowledge the significant challenges that need to be addressed, including standardizing outcome measures, ensuring cost-effectiveness, aligning provider incentives, and overcoming implementation barriers.
Throughout the report, use examples from the provided studies to illustrate both successful implementations and areas where value-based care models have fallen short. This balanced approach will provide a comprehensive view of the current state of value-based oncology care, its potential benefits, and the obstacles that must be overcome.
Part 2 -
What are the key challenges to implementing value-based care in oncology?
The main challenges and hurdles that have impeded the development of value-based oncology payments include:
These challenges have contributed to the complexity and slow progress of implementing effective value-based oncology payment models. Overcoming these hurdles will be essential for the successful development and implementation of value-based care in oncology.
Part 3 -
What is the 5 year outlook?
You are chief commercial officer, for biotech, precision oncology, and genomics.
The five-year outlook for value-based care in oncology presents a landscape of both potential growth and persistent challenges. Specialists are expected to accelerate the adoption of value-based care models, leading to increased effectiveness and scalability, particularly in fields like nephrology and oncology2. However, the transition to value-based care in oncology is not without its hurdles.
The Oncology Care Model (OCM), a major attempt to introduce value-based care into oncology, faced difficulties, with the successor model, Oncology Care First, now in doubt5. The OCM demonstrated challenges in managing the cost of new and expensive cancer therapies, impacting the ability to achieve cost savings5. Despite these obstacles, the potential for growth in value-based care remains significant, with the landscape evolving to address issues of quality, outcomes, and cost management2.
In the next five years, the value-based care market could reach a valuation of $1 trillion, driven by increased adoption and enhanced capabilities across providers, employers, and other healthcare stakeholders2. The continued traction in the value-based care market is expected to lead to improved quality of care and outcomes while providing benefits for patients, clinicians, and investors2. However, it's crucial to address the challenges related to cost management, equity issues, and the development of effective payment models to ensure the success of value-based care in oncology5.
In summary, the five-year outlook for value-based care in oncology presents a landscape of potential growth and continued challenges. While the adoption of value-based care models is expected to accelerate, addressing issues related to cost management and equity will be crucial for its long-term success. The evolving landscape of value-based care in oncology holds significant potential for improving patient outcomes and delivering benefits across the healthcare ecosystem.
 |
| click to enlarge |
Header: Some groups are quite upset at CMS proposals to close or tighten access to research data.
##
CMS has very extensive public data resources https://data.cms.gov/ as well as massive data resources available through agreements and contracting.
According to several recent news sources, CMS plans to make the data access harder, to say the least. See an article at Forbes here:
At Medriva here:
##
See a CMS announcement that the news articles are building on:
See recent articles about how $2B in Medicare fraud was picked up by outside parties (like ACO's) through their access to relevant CMS data - here.
I don't believe this affects currently open access data such as, "Medicare Physician & Other Practitioners by Provider and Service." What does that mean? Physician by Provider - doctor by doctor name. By Service - by CPT code. Each doctor and each paid CPT code he got, by year. Here.
Header: Decibio has released a 15-page white paper that assumes the FDA LDT regulation will go forward, more or less just as proposed, and then taking a wide view of the strategic implications.
##
The FDA's proposal to regulate LDTs, rolling out reviews or test withdrawals within a few years, has triggered many responses. Some organizations are strongly supportive, others are strongly opposed (for the downsides, see exhibits like the ACLA comment letter and the Hyman Phelps comment letter). For the FDA's plans (full steam ahead) see links and quotes from FDA, here.
The Decibio White Paper on FDA LDT
The consultancy Decibio has released an important 15-page white paper that takes a distinctive posture. The white paper assumes the FDA LDT regulation will proceed, more or less as proposed, and then takes an elaborate and wide-ranging view of what that means for stakeholder strategies.
Find it here:
https://data.decibio.com/regulatory-reckoning-ldt-white-paper
Worthwhile reading.
##
I've mostly had a different entry point - that the costs and man-years of labor both at FDA and outside it make the plan unfeasable at anything like its current form/ Nobody has $50B to spend on a couple years on regulatory labor, nor does the labor even exist, if the money appeared.
Plus, tie-ups in court could last several years (see ACLA and Hyman Phelps earlier). Under the resulting mess, alternatives like VALID could resurface, not now, but in 4-5 years... By which time the US would also incorporate what would be several years of European experience with the LDT lessons from the imminent IVDR.
 |
| clilck to enlarge |
You haven't seen much about Theranos or WeWork or Bird or other venture capital "unicorns" (valued over $1B) a few years ago.
Here's how Fortune magazine captures the shift in venture funding from left to right:
i can't do justice to the complexity of this rule, but the Mintz law firm can. Here is a go-to detailed article on the requirements:
VERY worth while reading. By attorney Pat Oullette. The actual 247 page rule is very dense, and in some parts, scary. Regarding overlap with FDA regulations for software and SAMD, they remark helpfully that if you've made it through FDA, you likely have much of the data required by THIS separate complex rule. But no guarantees.
##
AI Corner.
While I can't recommend the Mintz article highly enough, and it's quite detailed, as an experiment I asked the AI resource Perplexity to summarize the rule, too.
https://brucedocumentblog.blogspot.com/2024/02/perplexity-and-hhs-onc-rule-on-ai.html
On February 14, 2024, LA TIMES published a lengthy and mostly negative article about in-process new guidelines for Alzheimer biomarker testing.
This was a cover stody at LATimes on Sunday, February 18. See a coincidental Op Ed on prodromal diagnostics, at JAMA NEUROL by Erickson here.
##
I asked Chat GPT for a review and "critique" ... to see what would happen.
##
Since the whole point of the experiment is to see what Chat GPT would make of this, pro and con, I've put the Chat-generated article over here.
It's about Chat GPT. It's done as an experiment in what AI could write, not claiming to be the "correct" assessment of the LAT article as it lays out pro's and con's.
https://bqwebpage.blogspot.com/2024/02/ai-corner-chat-gpt4-la-times-negative.html
In December 2023, the Bipartisan Policy Center released an 85-page report on the future of Medicare. See the press release and the PDF here:
https://bipartisanpolicy.org/report/sustaining-and-improving-medicare/
https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2023/12/BPC_Medicare-Report_R04.pdf
The BPC's comprehensive report outlines urgent reforms needed to sustain Medicare, focusing on immediate restructuring to ensure affordability and the program's long-term viability. It proposes consolidated deductibles, an out-of-pocket spending cap, and adjustments in Medicare Advantage payments, emphasizing the need for bipartisan support to enact these critical changes.
##
##
AI Corner
Executive Summary
More than 65 million older Americans and those with disabilities rely on Medicare for health care, but as the population rapidly ages, the program faces increasingly urgent financial challenges. Indeed, expenditures in recent years have consistently outpaced dedicated revenue streams. With Medicare’s Hospital Insurance (HI) Trust Fund facing insolvency by 2031, and with beneficiaries and taxpayers frustrated by the lack of progress in ensuring greater affordability, policymakers must overcome their political fears of addressing the problems and focus on reforms that will sustain and improve Medicare in the coming years.
Central to ensuring Medicare’s long-term survival is for Congress to address the program’s core financial issue—the gap between rising spending and lagging revenue. Medicare now covers nearly 20% of the U.S. population, and total expenditures for benefits are projected to exceed $1 trillion this year, up from $580 billion only 10 years ago. The number of workers who help finance the program through payroll taxes relative to the number of beneficiaries is declining. There were about four workers for every beneficiary from 1980-2008; by 2022, the number had dropped to about 2.9, and by 2030 it is expected to be 2.5.
Congress also needs to examine a second significant problem: how Medicare can better meet the needs of enrollees. Beneficiaries, many of whom are retirees on fixed incomes, are struggling to pay their share of expenses and navigate a complex Medicare system to find the right coverage and benefits. Health care advocates question the program’s fairness, too, as some enrollees get benefits that others do not, depending on which coverage options they select.
In this report, the Bipartisan Policy Center issues recommendations for Congress to improve the program—both its financing and the benefits it provides. BPC’s 2021 report, The Cost of Waiting to Act on Medicare’s Hospital Insurance Trust Fund, points to recurring examples of policymakers’ hesitancy to address reform, analyzes various reform proposals, and demonstrates that waiting only increases the price of action.
Congress has been reluctant to address Medicare’s long-term solvency, due largely to the scale of the financial adjustments required and aversion to the political risks involved. Reforming Medicare undoubtedly will invite political opposition: Older Americans turn out for key elections in disproportionately high numbers. Earlier in 2023, when some in Congress suggested restraining Medicare spending as part of a deal to raise the debt ceiling limit, others strongly opposed the move. In his State of the Union address in February 2023, President Biden urged both parties to commit to keeping Medicare benefits unchanged. In a rare demonstration of unity, both Democrats and Republicans stood and applauded. Without a politically viable path toward bipartisan compromise, Congress took Medicare changes off the table and raised the debt ceiling in May without addressing the challenges facing the program when it passed the Fiscal Responsibility Act of 2023.
That said, a politically viable path forward is possible, and this report outlines how. It is not without precedent for Congress to act on a bipartisan basis to address Medicare’s cost and solvency issues. Examples include but are not limited to the Social Security Act Amendments of 1983, which established a new prospective payment system for inpatient hospital services, and the Balanced Budget Act of 1997, which established both a prospective payment system for outpatient services and Medicare Part C. Both examples occurred when divided government existed, which is to say different parties held the White House and at least one chamber of Congress. Indeed, the political divide is virtually a prerequisite to avoid the temptation to politicize any effort to improve Medicare. These previous accomplishments demonstrate policymakers’ ability to come together when the need arises and leaders of the two parties lead.
This report creates a road map for bipartisan action that Congress should pursue in a two-step process. The changes in the first step would secure meaningful improvements that would make Medicare more affordable for the federal government, taxpayers, and beneficiaries. It also lays the foundation for a second set of fundamental reforms that build upon the first step’s goals by ensuring further simplification for beneficiaries and promoting competition within the program.
The road map’s first step, outlined in Phase 1 below, calls on Congress to immediately address the HI Trust Fund’s impending insolvency and affordability challenges for beneficiaries by slowing spending increases and raising revenues. At the same time, policymakers would enhance Traditional Medicare (TM) by improving benefits, reducing costs, and simplifying the program for easier access.
Phase 1 also addresses enforcement of past triggers that Congress has instituted—but ignored—to force action when federal spending on Medicare dangerously exceeds revenues. To be sure, important new prescription drugs and devices are contributing to Medicare’s increased spending, and that should be a factor for policymakers to consider as they make decisions about appropriate levels of spending. Nevertheless, it will be important to fix the current general revenue trigger so that it more effectively pressures Congress and the administration to take corrective steps as appropriate to ensure the program’s financial sustainability.
The recommendations in the second step, outlined in Phase 2, would create apples-to-apples competition between Traditional Medicare and Medicare Advantage (MA), allowing beneficiaries to easily compare these coverage options based on a standard set of benefits.
It is crucial for Congress to embrace both parts of this road map; rationalizing and improving how MA plans and TM fairly compete within an improved competitive policy will not in and of itself address all solvency and affordability issues facing the program. Because of demographics, Medicare’s costs will increase regardless of how efficient the program becomes; enhanced revenues and payment reforms, as a result, will have to be part of any bipartisan compromise that thoughtfully deals with solvency.
Public Trustees: Dysfunctional Nominations
BPC also encourages the Senate to swiftly engage in full, fair, and prompt consideration of the Social Security and Medicare public trustees. The Senate Finance Committee approved two nominees on November 2, 2023, but a full Senate vote is required, and at the time of publication, the Senate had not moved forward. In addition to the four trustees who are members of the administration, the two public trustees serve as objective experts who report on the status of the trust funds to Congress and the American people; they also provide credibility for the annual reports. Since 2015, these two positions have been vacant due to Senate inaction. Congress should ensure that these positions are consistently filled moving forward
###
10 Key Takeaways from the Bipartisan Policy Center's Medicare Report
In January 2024, the Bipartisan Policy Center (BPC) issued a 34-page white paper, Strengthening Regulatory Collaboration Between FDA and CMS. Find it here:
https://bipartisanpolicy.org/report/strengthening-fda-cms-regulatory-collab/
https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2023/12/CMS-FDA-Final-Report.pdf
The recommendations aim to improve information sharing between FDA and CMS to foster collaboration, without changing their statutory roles or current processes. Most of the report (not indicated in the title) is about drug approvals and coverage.
Key proposals are for FDA to regularly share information on upcoming drug reviews and approvals with CMS, for Congress to increase CAG funding and review FDA-CMS MOUs, for AHRQ to analyze CMS real-world evidence on drugs, for CMS to engage with sponsors of accelerated approval drugs, for an NIH/CMS/FDA working group on surrogate endpoints, for FDA training of state Medicaid staff on the drug approval process, and for cross-agency training programs. The goal is to ensure CMS has timely drug information for coverage and payment decisions.
