Join former White House policy expert Joe Grogan as he cuts through the complexities of healthcare legislation and its real-world implications. Each episode of DC EKG aims to demystify the policies shaping our healthcare system, uncovering how these changes impact patients, providers, and payers across the country.
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E139 | Elizabeth Chamblee Birch on The Pain Brokers
Episode 139
Monday, September 14, 2026 • Duration 46:37
Elizabeth Chamblee Birch, law professor and author of The Pain Brokers, exposes a coordinated healthcare fraud scheme targeting over 100,000 women. Stolen HIPAA-protected health records were weaponized by call centers in India and South Florida to convince women they needed emergency mesh removal surgery. Many women were left permanently incontinent after unnecessary procedures. The scheme involved call centers using stolen medical data, South Florida surgical operations, lawyers creating hidden liens, and litigation funders profiting from women's suffering. Birch introduces the villains: Vince Chabra (online pill mill founder), Blake Barber (travel concierge), and complicit doctors. She also highlights heroes: Barbara Bennis (defense attorney who uncovered the conspiracy) and J.R. Baxter (young plaintiffs lawyer who fought back). The episode reveals how electronic health record systems enabled massive data breaches, how private equity infiltrated the legal system, and what reforms are desperately needed to prevent future schemes.
Key Timestamps
0:53 Joe Grogan introduction
1:25 Joe asks Elizabeth about her background
1:37 Elizabeth's background: 21 years teaching mass torts
2:25 Elizabeth's MFA in narrative nonfiction at UGA
3:26 What is vaginal mesh used for?
5:21 Sharon gets intimate stolen medical data in phone call
6:00 Sharon didn't know she had mesh inserted
6:32 Call centers in India and South Florida
7:32 Alpha Law: Frankenstein firm through D.C. loophole
9:31 Outbound calls fueled by illegal stolen HIPAA data
13:24 Litigation funders threaten Sharon's house after settlement
15:00 Multi-district litigation vs class action
16:15 The perverse economics of the scheme
17:33 Economics: $15K vs $215K+ for removal
19:10 Women left permanently incontinent after unnecessary surgeries
21:15 Meet Vince Chabra and Blake Barber: the kingpins
26:11 Wolf of Wall Street moment: 14,000 claims for $40 million
27:45 Cold called over 100,000 women, signed 14,000 as clients
28:35 Barbara Bennis: defense attorney hero discovers conspiracy
30:37 Jerry Plummer and J.R. Baxter: young lawyer fighting back
34:36 Electronic health records enabled the data breach
36:07 Women receive $40K average settlement before fees
37:30 Data bias in medicine: gender gap in settlements
42:37 Solutions: anti-kickback statute reform
43:35 Private equity infiltrating law firms: the next frontier
Key Topics
Vaginal mesh litigation, healthcare fraud, HIPAA violations, stolen health records, call center fraud, litigation funding, private equity, women's health bias, legal reform, unnecessary surgery, settlement bias, data breach, electronic health records
Podcast: DC EKG with Joe Grogan | Episode: 139 | Host: Joe Grogan | Guest: Elizabeth Chamblee Birch, Law Professor, University of Georgia
Sponsor: Survivors for Solutions – https://survivorsforsolutions.org
Executive Producer: John "CZ" Czwartacki, DC EKG Podcast
Producer: Stay on Course Studios – https://www.stayoncourse.studio
John Bertrand on FDA Approval, CMS Reimbursement, and AI Healthcare Reality
Episode 138
Monday, September 7, 2026 • Duration 48:16
Guest: John Bertrand, former Digital Diagnostics
Episode Description
Joe Grogan sits down with John Bertrand, a veteran healthcare technology executive who scaled Digital Diagnostics to 75 health systems and achieved the first FDA approval and CMS reimbursement for an autonomous AI diagnostic device without a physician in the diagnostic loop. Bertrand reveals the harsh realities of bringing AI innovation to market: FDA and CMS regulatory frameworks are built for traditional medical devices and physician-driven care, not autonomous AI diagnostics. The conversation covers the shocking CMS reimbursement draft that came in 40-60% below cost of goods sold, the massive first-mover disadvantage in regulated medical device AI, and why reimbursement is the true gating factor for adoption—not clinical superiority. Bertrand explains how workflow integration and financial incentives matter far more than being clinically better. The episode explores the massive gap between what entrepreneurs think should happen with new innovations and the regulatory reality. He concludes with a sobering assessment: if building diagnostic AI again, he would choose supply chain automation instead because the regulatory and reimbursement headwinds are so significant they punish innovators. Where AI is actually making an impact today is patient-facing triage agents, administrative automation, and revenue cycle management—areas with far less friction.
KEY TIMESTAMPS
0:40 Joe introduces John Bertrand and his healthcare tech background
1:28 John clarifies he recently left Digital Diagnostics for supply chain work
2:40 John's career: 13 years at Epic Systems across multiple roles
6:10 What does Digital Diagnostics' AI device do? Automating retinal imaging
7:56 First FDA approval and first CMS reimbursement for autonomous AI diagnostic
REFILL | Tomas Philipson on IRA, Inflation, Real Wages, and COVID Policy Tradeoffs (Originally Aired: June 2, 2023)
Monday, August 31, 2026 • Duration 54:23
REFILL | Naomi Lopez on Healthcare AI, ACCESS, TEMPO, and the Future of Care (Originally Aired: January 23, 2026)
Monday, August 24, 2026 • Duration 46:24
This is a legacy episode recorded in January 2026. At the time of recording, Naomi Lopez was founder of Nexus Policy Consulting and a leading voice in healthcare policy, healthcare AI, and state health reform.
Joe Grogan sits down with Naomi Lopez from Nexus Policy Consulting to recap the first Healthcare AI Policy Summit held in December 2025 in Washington, DC. They discuss big themes shaping healthcare AI, HHS approaches to AI adoption, and what regulatory clarity could look like. The conversation covers new federal initiatives like ACCESS and TEMPO that may reshape chronic disease management for Medicare patients. They unpack HHS Deputy Secretary Jim O'Neill's vision for AI in government, including using large models to improve physician productivity, payment integrity, and care coordination. They dig into ACCESS Medicare payment model and FDA TEMPO initiative, explaining how these pilots test AI tools in real-world chronic disease management for hypertension, diabetes, musculoskeletal pain, and depression. The discussion widens to physician burnout, interoperability, rural care, states and federal preemption, and what tech companies becoming Medicare Part B providers could mean for healthcare innovation.
Key Timestamps
0:00 Intro and why the Healthcare AI Policy Summit matters
2:00 Summit recap: big themes and regulatory pressure points
6:00 Jim O'Neill at HHS: regulatory clarity and adoption inside government
12:00 ACCESS explained: Medicare chronic disease management payment model
18:00 TEMPO explained: FDA's risk-based approach for chronic care tools
24:00 Wearables, remote patient monitoring, and virtual ICU models
30:00 Privacy, de-identification, and re-identification risk
REFILL | Jackson Hammond on NHE, CMS Reform, and Making Insurance Almost Obsolete (Originally Aired: January 22, 2026)
Monday, August 17, 2026 • Duration 50:50
In this "REFILL" episode, Joe Grogan sits down with Jackson Hammond from Paragon Health Institute to unpack what the latest CMS National Health Expenditure data says about where U.S. healthcare is headed. They break down spending trends from $5.2 trillion to projections of $8.6 trillion, explaining what changed, what didn't, and what it means for affordability, Medicare, Medicaid, and long-run fiscal pressure. The conversation connects spending outlook to Jackson's work on CMS Innovation Center reform and debates whether CMMI is bending the cost curve or adding bureaucracy without accountability. Jackson argues we should aim for healthcare so affordable you barely need insurance, exploring how choice and competition could reshape the system.
Key Timestamps
0:55 Jackson's background and how he got into health policy
3:39 Focus areas: Medicare, hospitals, drug pricing, PBMs, and 340B
5:14 What the NHE report is showing
6:14 Healthcare spending trajectory: $5.2T to $8.6T and why it matters
8:00 Why health spending is not really optional
10:11 Where the money goes: payer mix and per-enrollee costs
12:23 Medicaid costs, provider taxes, and state financing tactics
15:58 Medicare spending pressure and fiscal risk
21:06 Misconception: coverage equals care
26:18 Why provider payments keep rising after COVID demand and consolidation
33:01 Rural care, consolidation, and rural emergency hospital models
40:08 Drug pricing: retrospective versus prospective MFN approaches
REFILL | Michael Cannon on STLDI and ACA Coverage: Costs, Choice, and Tradeoffs (Originally Aired: January 27, 2026)
Monday, August 10, 2026 • Duration 42:12
This is a legacy episode recorded in January 2026. At the time of recording, Michael Cannon was Director of Health Policy Studies at the Cato Institute, a leading voice on healthcare reform, the Affordable Care Act, and market-based health policy solutions.
Episode Description
Joe Grogan sits down with Michael Cannon from the Cato Institute to discuss short-term, limited-duration insurance (STLDI), also known as "Obamacare-exempt" plans, and why they can be significantly cheaper than ACA exchange coverage. Cannon explains how renewal guarantees work and why allowing more consumer choice can reduce pressure on exchange risk pools. The conversation covers the politics of pre-existing conditions, how ACA rules change insurers' incentives, and why coverage debates often miss the real drivers of cost, access, and quality. They also discuss public trust in healthcare following the Brian Thompson murder and explore how policy choices shape what insurers can and cannot do.
Key Timestamps
0:23 Michael Cannon joins and what STLDI is
2:27 STLDI explained: Obamacare-exempt plans, renewal guarantees, and lower premiums
6:00 ACA history: why STLDI was restricted
7:46 International comparisons and pre-existing conditions incentives
12:10 Why healthcare stays broken: regulation, lobbying, and government-designed systems
16:59 Subsidies and the politics of pre-existing conditions
22:22 Renewal guarantees, employer tax exclusion, and Medicare history
30:37 Public trust after Brian Thompson's murder and Cannon's letter
41:56 Wrap-up and key takeaways
REFILL | Ryan Long on 340B Drug Pricing, Enhanced ACA Tax Credits, and Medicare Part D (Originally Aired: September 24, 2025)
Monday, August 3, 2026 • Duration 47:43
Joe Grogan sits down with Ryan Long, healthcare policy expert and senior research fellow at Paragon, to discuss three critical healthcare policy issues facing Congress. First, the Congressional Budget Office's landmark analysis of the 340B drug pricing program, which revealed the program increases federal spending, drives up premiums, and channels most benefits to wealthy hospitals rather than those serving low-income patients. Second, the enhanced premium tax credits set to expire at the end of 2025, which have been plagued by fraud and fraudulent enrollment. Long explains how unscrupulous brokers have exploited the system, enrolling people without their knowledge, with billions in improper payments going to insurance companies. Third, the Inflation Reduction Act's devastating impact on Medicare Part D, including premium increases from thirty to sixty dollars monthly, coinsurance replacing copays, and seniors paying higher out-of-pocket costs despite the legislation's promise to lower drug costs.
Key Timestamps
1:20 Welcome to DC EKG and introduction of Ryan Long
2:15 Congressional Budget Office analysis of 340B program
4:06 Why CBO conducted the 340B study
4:25 How 340B increases federal spending and premiums
4:58 Studies showing 340B drives higher-cost drug utilization
5:30 Will CBO analysis lead to legislative reform efforts
6:15 Program expansion from 90 to 2,600 participating hospitals
8:06 Timeline for 340B reform legislation
10:43 340B program growth from two billion to sixty-six billion annually
11:52 Why insurance companies support limiting 340B
12:20 Enhanced premium tax credits and ACA credits expiring
14:22 Difference between baseline and enhanced ACA credits
"REFILL" | Dutch Rojas on Healthcare Economics, Direct Contracting, and Tax-Exempt Health Systems (Originally Aired: September 15, 2025)
Monday, July 27, 2026 • Duration 52:30
This is a "REFILL" episode recorded in September 2025. At the time of recording, Dutch Rojas was a healthcare entrepreneur, founder of multiple direct contracting companies, and board member of Physician Led Healthcare for America, with a growing following on social media advocating for market-based healthcare solutions.
Joe Grogan sits down with Dutch Rojas, healthcare entrepreneur and social media advocate, to discuss his journey from accounting to building direct contracting companies that revolutionize employer healthcare. Rojas explains how direct contracting allows employers to negotiate directly with physicians, bypassing insurance middlemen. The conversation covers his experience building ambulatory surgery centers, certificate of need laws, self-funded employer plans, and his critique of not-for-profit health systems. Rojas argues that academic medical centers masquerade as not-for-profit organizations while receiving seventy-four subsidies annually from taxpayers, acquiring massive real estate holdings, and avoiding property and federal taxes. He advocates for policy changes on not-for-profit tax status and site-neutral payments, arguing these represent unfair advantages that harm independent physicians and patients.
Key Timestamps
0:18 Joe introduces Dutch Rojas and asks who is Dutch Rojas
1:32 Dutch's background, career path, and journey to social media
2:22 Physician-led Healthcare for America and PHA board
4:32 Starting in accounting, real estate investment trust, and ambulatory surgery centers
5:14 150 ambulatory surgery center deals and certificate of need experience
7:34 Building a practice in Scottsdale and expanding to 16 states
9:30 First direct contracting company in 2009 and how direct contracting works
Self-funded employer plans and 106 million Americans not covered by insurance
"REFILL" | Dr. Brian Miller on FDA Regulatory Reform and the Valley of Death in Medical Innovation (Originally Aired: March 21, 2025)
Monday, July 20, 2026 • Duration 44:40
In this "Refill" episode, Joe Grogan sits down with Dr. Brian Miller to discuss the "Valley of Death" - the gap between FDA approval and CMS coverage - and how regulatory reform can accelerate medical innovation. Miller explains how FDA product review can be made more efficient through automation and algorithmic analysis of routine tasks, allowing highly trained reviewers to focus on clinical interpretation rather than data processing. The conversation covers clinical trial reform, device review modernization, third-party review programs, and CMS coverage decision processes. Miller argues that these are operational challenges that can be fixed with executive leadership, and that transforming FDA and CMS procedures is critical to bringing new medicines and devices to patients faster.
Key Timestamps
1:23 Brian Miller background and AEI role
2:47 The Valley of Death - gap between FDA approval and CMS coverage
5:06 Making FDA and CMS review processes more synergistic
7:43 Example of hypertension drug review and routine tasks
8:26 Data overload in FDA review process
10:40 Supplemental applications and unnecessary information
12:01 FDA reviewer burnout and middle management proliferation
15:30 Automating routine tasks at FDA
17:33 Clinical trial reform discussion and regulatory risk
20:03 Practical approach for new FDA commissioner and DOGE
21:22 Operational changes needed at FDA
22:48 Tobacco regulation at FDA and resource allocation
"REFILL" | Peter Pitt on FDA Advisory Committees, Make America Healthy Again, and Drug Pricing (Originally Aired: May 23, 2025)
Monday, July 13, 2026 • Duration 45:14
Joe Grogan sits down with Peter Pitt, FDA veteran and expert on healthcare regulation, to discuss FDA advisory committees, the Make America Healthy Again initiative, and critical gaps in pharmaceutical labeling. Pitt addresses why obesity-related drug dosing information is missing from labels, the importance of vaccine safety, food regulation reform, and strategies for lowering drug prices through generic drug reviews and supply chain diversification. He also discusses the need for FDA and CMS to work together and warns against mission creep at CMS.
Key Timestamps
0:44 Background: East Coast native, McGill University, from New York City
1:07 How he got a professorship at University of Paris School of Medicine
2:35 Mark McClellan connection and FDA career start
5:19 Conflicts of interest versus interests in FDA advisory committees
7:07 Why people need to be dismissed from advisory committees
9:13 Three basic reasons FDA holds advisory committee meetings
11:08 Why Canada keeps advisory committees secret versus FDA transparency
14:08 Advisory committees for CYA, new science, and lack of consensus
19:44 Op-ed on vaccines and nutrition under Make America Healthy Again
22:44 Cancer drug dosing for obese patients and missing label information
27:15 Learning about drug dosing outside of clinical trials
30:42 Food regulation and FDA's second-class treatment of food safety
MAHA moment and removing red food dyes from food supply
9:02 Joe's threshold question: shouldn't better innovation be easily adopted?
9:50 Reality: workflow integration and reimbursement matter more than clinical quality
11:50 The adoption curve: all successful FDA-approved AI devices have CMS reimbursement
14:10 FDA experience: desire to help but frameworks built for old technology
15:40 FDA scrutiny on AI exceeds scrutiny on human clinicians
18:05 FDA guidance changes every 6-12 months, creating constant pivoting and delays
20:08 Shifting to CMS: the shocking draft reimbursement story
20:45 Draft came in at $10 per test, needed $30+ to be viable
22:42 Four months of negotiations with CMS to shift value argument
24:40 Process not codified: each company follows unique regulatory path
28:04 Six years at Digital Diagnostics: was it worth it?
28:44 John would not recommend diagnostic AI to new founders
33:02 Turning down multiple diagnostic AI opportunities post-Digital Diagnostics
34:19 AI hype vs reality: where are patients actually seeing life improvements?
34:19 Patient-facing triage agents are the second inning of real AI opportunity
36:25 Reimbursement for chat-based triage: who gets paid?
38:23 Autonomous vs assistive AI: the regulatory gap that exists
40:31 Could Digital Diagnostics have done physician-in-loop from the start?
41:33 Real opportunity: clinical practices deploying their own AI
42:20 State licensing nightmare: deploying AI across 50 states
44:55 The real concern: RCM automation becoming a zero-sum AI bot battle
45:20 Dead Internet Theory applied to healthcare revenue cycle
47:38 Closing: a tour de force on AI healthcare reality
Key Topics
AI in healthcare, FDA approval process, CMS reimbursement, autonomous AI diagnostics, Digital Diagnostics, diabetic retinopathy, regulatory frameworks, first-mover disadvantage, workflow integration, reimbursement strategy, patient-facing AI, healthcare innovation, regulatory friction, adoption barriers, state licensing, RCM automation, healthcare AI reality
About the Guest
John Bertrand is a veteran healthcare technology executive with over 20 years of experience. He spent 13 years at Epic Systems in analyst, product manage
35:00 AI inside HHS and FDA: productivity, payment integrity, care coordination
41:00 Reducing admin burden and physician burnout
47:00 Rural healthcare: scaling diagnostics and access with AI
52:00 Interoperability and data sharing: APIs, friction, and incentives
58:00 State AI laws versus federal preemption
1:04:00 2026 outlook: tech companies as Medicare Part B providers
1:09:00 Wrap-up and what to watch next
Key Topics
Healthcare AI, ACCESS payment model, TEMPO initiative, FDA regulation, Medicare reimbursement, chronic disease management, AI in government, physician productivity, care coordination, wearables, remote patient monitoring, privacy and de-identification, rural healthcare, interoperability, state AI regulation, federal preemption, healthcare innovation, payment integrity
About the Guest (at time of recording, January 2026)
Naomi Lopez is the founder of Nexus Policy Consulting and a leading voice in healthcare policy, healthcare AI, and state health reform. She co-founded a healthcare AI working group and co-hosted the inaugural Healthcare AI Policy Summit in December 2025 in Washington, DC. Her work focuses on how regulation, Medicare and Medicaid policy, and state law shape healthcare innovation, access, and affordability.
Podcast: DC EKG with Joe Grogan
Host: Joe Grogan
Guest: Naomi Lopez
Sponsor: Survivors for Solutions
Executive Producer: John CZ Czwartacki, DC EKG Podcast
49:20 2026 outlook and closing thoughts
Key Topics
National Health Expenditure, healthcare spending, CMS reform, CMS Innovation Center, Medicare spending, Medicaid costs, hospital consolidation, rural healthcare, drug pricing, PBMs, 340B program, provider payments, patient-centered care, healthcare affordability, choice and competition, fiscal policy
About the Guest (at time of recording, January 2026)
Jackson Hammond is a Senior Policy Analyst at the Paragon Health Institute focused on health spending, CMS policy, and reforms centered on choice, competition, and patient-centered care. He authors Paragon's Paragon Prognosis analyses and has written extensively on CMS Innovation Center reform and strategies for making healthcare more affordable through competitive market approaches.
Podcast: DC EKG with Joe Grogan
Host: Joe Grogan
Guest: Jackson Hammond
Sponsor: Survivors for Solutions
Executive Producer: John CZ Czwartacki, DC EKG Podcast
About the Guest (at time of recording, January 2026)
Michael Cannon is the Director of Health Policy Studies at the Cato Institute and a leading voice on healthcare reform, the Affordable Care Act, health insurance regulation, and market-based health policy solutions. He is a policy expert focused on expanding consumer choice and reducing the regulatory barriers that limit access to affordable coverage options.
Podcast: DC EKG with Joe Grogan
Host: Joe Grogan
Guest: Michael Cannon
Sponsor: Survivors for Solutions
Executive Producer: John CZ Czwartacki, DC EKG Podcast
16:34 Zero-dollar plans and fraud mechanisms
18:19 Broker fraud and fraudulent enrollment schemes
21:09 How fraudulent brokers exploit free plans and commission structure
22:53 Paragon study showing four times over-enrollment in Florida
25:30 Misleading polling about ACA credits expiring
28:18 Groups pushing misleading messaging on enhanced credits
29:31 Political dynamics and Republican position on credits
33:17 Government shutdown politics and Democrat strategy
36:09 Elevance exiting standalone Medicare Part D plans
38:03 Migration from Part D to Medicare Advantage due to IRA
39:15 How IRA's out-of-pocket cap restructuring increased premiums
40:34 Coinsurance replacing copays and cost shift to seniors
42:20 IRA using fictitious list price to calculate negotiated savings
44:47 Multiple factors causing Medicare Part D premium increases
Key Topics
340B program, Congressional Budget Office, drug pricing, hospital consolidation, enhanced premium tax credits, ACA fraud, fraudulent enrollment, broker fraud, government subsidies, Medicare Part D, out-of-pocket costs, coinsurance, Inflation Reduction Act, pharmaceutical pricing, program integrity
About the Guest (at time of recording, September 2025)
Ryan Long is a Senior Research Fellow at the Paragon Health Institute and affiliated with the USC Schaefer Center for Health Policy and Economics. He is a healthcare policy expert with extensive experience on Capitol Hill, including service as a staffer on the House Energy and Commerce Committee and chief health policy advisor to Speaker Kevin McCarthy. Long specializes in healthcare reform, pharmaceutical pricing policy, Medicare and Medicaid issues, and legislative strategy.
Podcast: DC EKG with Joe Grogan
Host: Joe Grogan
Guest: Ryan Long
Sponsor: Survivors for Solutions
Executive Producer: John CZ Czwartacki, DC EKG Podcast
12:45
15:22 Deals with banks and large employers in New York City
18:09 The difference between clinical medicine and business in medicine
22:15 Building insurance products on top of physician-led care
28:30 How direct contracting saves employers money
32:18 The three companies Dutch has started and sold
38:45 Healthcare as a percentage of GDP and rising costs
42:10 Regulatory hurdles and state-level barriers
46:54 Not-for-profit tax status and academic health systems
48:07 How health systems receive subsidies but claim non-profit status
48:22 Academic medical centers owning four to five percent of city real estate
49:21 Site-neutral payments and payment disparities between settings
50:28 Dutch's social media reach and audience impact
Key Topics
Direct contracting, healthcare economics, physician-led care, ambulatory surgery centers, certificate of need, self-funded employer plans, not-for-profit health systems, tax exemptions, site-neutral payments, healthcare regulation, real estate holdings, academic medical centers, employer negotiations, insurance reform, market-based healthcare
About the Guest (at time of recording, September 2025)
Dutch Rojas is a healthcare entrepreneur with over 25 years of experience in healthcare economics and business. He started in accounting and real estate investment, then moved into healthcare, developing over 150 ambulatory surgery centers. Rojas founded multiple direct contracting companies that help employers negotiate directly with physicians, bypassing traditional insurance intermediaries. He serves on the board of Physician Led Healthcare for America. He has built a significant social media following on X (formerly Twitter), sharing his analysis of healthcare policy and economics. Rojas is the author of the Rojas Report and hosts a YouTube channel and Substack focused on healthcare reform and market-based solutions.
Podcast: DC EKG with Joe Grogan
Host: Joe Grogan
Guest: Dutch Rojas
Sponsor: Survivors for Solutions
Executive Producer: John CZ Czwartacki, DC EKG Podcast
25:10 Device world getting short shrift in FDA priorities
27:33 Third-party 510k review program and third-party organizations
29:09 COVID diagnostic tests and pandemic review process
30:51 Reforming CDRH through third-party reviews
31:36 70-year comparison of heart attack treatment advances
32:46 CMS coverage decisions and Coverage with Evidence Development
36:02 Medicare Administrative Contractors (MACs) and local coverage decisions
38:12 Practical market-based approach to MAC appeals
39:54 National vs local coverage decisions and reasonable and necessary standard
42:28 Defining reasonable and necessary through algorithms and guidance
Key Topics
FDA regulatory reform, Valley of Death, clinical trial reform, FDA product review automation, CMS coverage decisions, Medicare Administrative Contractors, third-party device review, drug development costs, medical innovation, device regulation, regulatory science, operational efficiency
About the Guest (at time of recording, March 2025)
Dr. Brian Miller is a physician and non-resident fellow at the American Enterprise Institute (AEI) focusing on FDA regulatory policy and Medicare payment policy. He practices medicine at Johns Hopkins Hospital and serves as an associate professor of medicine and business at Johns Hopkins University. His research and policy work emphasize making regulatory systems more efficient to accelerate the development and approval of innovative medicines and medical devices.
Podcast: DC EKG with Joe Grogan
Host: Joe Grogan
Guest: Dr. Brian Miller
Sponsor: Survivors for Solutions
Executive Producer: John CZ Czwartacki, DC EKG Podcast
32:02
34:00 Dietary supplements regulation under DSHEA
35:21 Nutrition labeling updates and soda bottle serving sizes
38:21 PDUFA reauthorization and user fees
40:32 User fees about predictability not speed
42:54 CMS mission creep and encroaching on FDA authority
Key Topics
FDA advisory committees, transparency, vaccine safety, Make America Healthy Again, pharmaceutical labeling, obesity and drug dosing, food regulation, dietary supplements, generic drug review, PDUFA reauthorization, user fees, CMS mission creep, drug pricing
About the Guest (at time of recording, May 2025)
Peter Pitt is President and Co-Founder of the Center for Medicine in the Public Interest and a visiting professor at the University of Paris School of Medicine. He is a former associate commissioner at the FDA where he oversaw advisory committees and served as a senior policy and communications advisor. Pitt is a native of New York City, a McGill University graduate, and speaks fluent French.
Podcast: DC EKG with Joe Grogan
Host: Joe Grogan
Guest: Peter Pitt
Sponsor: Survivors for Solutions
Executive Producer: John CZ Czwartacki, DC EKG Podcast
