DC EKG

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
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

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
32:02 MAHA moment and removing red food dyes from food supply
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

Podcast TitleDC EKG with Joe Grogan: A Healthcare Policy Podcast

This is a REFILL of Episode124 - (Original air date: January 27, 2026)

Episode Title - Ryan Long on the ACA Subsidy Fight, Phantom Enrollees, and Reforming 340B

Episode Description - Joe Grogan is joined by Ryan Long of Paragon Health Institute and the University of Southern California to break down two fights shaping health policy right now: a California wealth tax pitch framed as a health care fix, and the battle over extending enhanced Affordable Care Act subsidies.

They unpack how enhanced subsidies changed who qualifies, why zero-premium plans opened the door to broker-driven enrollment and fraud, and why the medical loss ratio creates perverse incentives that can push premiums higher. They also explain how silver loading and cost-sharing reduction policy distort the exchange market, and what reforms could lower costs without writing a blank check.

The episode closes with Ryan's latest work on the 340B program, including why drug arbitrage rewards hospitals with a stronger commercial mix and can fuel consolidation, and why direct, targeted assistance could better support hospitals that truly serve low-income and rural patients.

Chapters and Timestamps
00:01 Intro
00:23 Welcome, and what is on the agenda
01:25 California wealth tax and structural deficits
11:20 Enhanced ACA subsidies and the shutdown fight
16:54 Income caps, zero premium plans, and phantom enrollees
21:50 Fraud, Medicaid exposure, and public trust
30:39 Medical loss ratio incentives and ACA market fixes
38:41 340B: how arbitrage works and why it drives consolidation
44:51 What reform could look like
47:20 Closing

SEO Keywords | Affordable Care Act, ACA subsidies, enhanced subsidies, premium tax credits, exchange plans, zero premium plans, phantom enrollees, medical loss ratio, cost sharing reduction, silver loading, Medicaid fraud, Minnesota fraud, California wealth tax, 340B program, drug arbitrage, hospital consolidation, site neutral payments, commercial mix, Medicare Trust Fund

About Our Guest | Ryan Long is a health policy expert with experience on Capitol Hill, including years in the Speaker's office and on the House Energy and Commerce Committee. He is affiliated with Paragon Health Institute and the University of Southern California.

CreditsSponsor: Survivors for SolutionsExecutive Producer: John “CZ” Czwartacki, DC EKG PodcastProducer: Julie Riga, Stay on Course Studios, https://www.stayoncourse.studio

An episode pulled from the archives, Joe Grogan and Eric Ueland welcome Dr. Tevi Troy, former Deputy Secretary of Health and Human Services, presidential historian, and best selling author of Fight House: Rivalries in the White House from Truman to Trump. First aired in February 2023 at the midpoint of the Biden administration, this conversation diagnoses how White House infighting actually works, why the Biden team leaked so much less than its predecessors, and what discipline does and does not buy a president.
From there the conversation turns to the machinery of the State of the Union, why the speech always collapses into a laundry list, and how Ronald Reagan invented the pageantry that every president has copied since. Troy then makes the bipartisan case for reforming the Centers for Disease Control, arguing for a congressional charter and a sharper pandemic mission separate from behavioral health. Along the way Joe, Eric, and Tevi cover Lyndon Johnson and Vietnam, Ed Koch and the art of criticizing opponents without alienating voters, the real origin of the Bull Connor line in Biden speeches, and why Troy believes the Republican party has a brighter future after Trump than the Democrats have after Biden.

TIMESTAMPS
0:00 Tevi Troy on a brighter Republican future after Trump
0:47 DC EKG intro
1:10 Joe and Eric welcome Tevi Troy, refill context from February 2023
3:00 Why the Biden White House leaks far less than Trump's did
6:15 Neera Tanden, Afghanistan, and where the grumbling did surface
9:30 Is the press softer on Democratic administrations
12:10 Lessons from the hyper disciplined Bush 43 operation
15:00 Friction as a feature: Johnson, Ford, and creative tension
18:20 Johnson, Vietnam, and the limits of dominating Congress
21:00 Biden faces a Republican House and a debt ceiling fight
24:15 How a State of the Union actually gets built
27:30 Why every State of the Union becomes a laundry list
30:45 Reagan, Lenny Skutnik, and the birth of pageantry
33:50 The case for reforming the CDC with a congressional charter
36:20 Behavioral health versus the pandemic mission
39:10 Ed Koch, Carter, and criticizing without alienating voters
41:40 Where Meacham's Bull Connor line came from
44:30 Troy's path to DC: AEI, Ben Wattenberg, and the PhD
47:15 The conservative movement in flux and the future of the parties
48:33 Wrap up

ABOUT OUR GUEST
Dr. Tevi Troy is a presidential historian, best selling author, and former Deputy Secretary of the Department of Health and Human Services. An insider's insider in Washington, he warned of US vulnerability to coronavirus in 2016 and has since written widely on the failures at the CDC. He began his career at the American Enterprise Institute working for Ben Wattenberg, earned a PhD from the University of Texas at Austin, and served in a range of roles in the George W. Bush administration, including at the Domestic Policy Council. He is the author of Fight House: Rivalries in the White House from Truman to Trump, What Jefferson Read, Ike Watched, and Obama Tweeted, and Intellectuals and the American Presidency, along with more than four hundred articles.

CREDITS
Podcast: DC EKG with Joe Grogan
Episode: 137b
Guest: Dr. Tevi Troy, former Deputy Secretary of Health and Human Services
Sponsor: Survivors for Solutions, https://survivorsforsolutions.org
Executive Producer: John “CZ” Czwartacki, DC EKG Podcast
Producer: Stay on Course Studios, https://www.stayoncourse.studio

Dr. Jay Bhattacharya on COVID-19 Seroprevalence, Natural Immunity, and the Great Barrington Declaration (Originally Aired July 20, 2023)

This episode originally aired on July 20, 2023, the same day Stanford University President Tessier-Levine was forced to resign. Dr. Jay offers detailed commentary on the hostile work environment at Stanford and how government, big tech, and academia conspired to suppress scientific voices.

Episode Description
In this wide-ranging conversation, Joe Grogan and Eric Ueland sit down with Dr. Jay Bhattacharya to discuss his groundbreaking work on COVID-19 seroprevalence studies, the suppression of natural immunity data, and the origins of the Great Barrington Declaration.

Dr. Bhattacharya shares his immigrant family story and early recognition that COVID-19 was far more widespread than official counts indicated. He conducted one of the first seroprevalence studies in April 2020 in Santa Clara and Los Angeles Counties, using antibody test kits provided by Major League Baseball, and found that the disease was 40 to 50 times more common than reported cases.

The episode covers the intense backlash Dr. Bhattacharya faced for publishing these findings, including death threats, racist attacks, and institutional pressure from Stanford to suppress the research. He discusses how public health authorities suppressed evidence of natural immunity, the unethical decision-making by officials like Tony Fauci and Debbie Birx, and the formation of the Great Barrington Declaration.

Dr. Bhattacharya details the coordinated campaign against him, censorship on social media, including Twitter blacklisting, federal government threats to ensure censorship, and the terrible price paid that will echo through generations. He reflects on the failures of scientific institutions and the reforms needed to restore public trust in science.

Key Timestamps

4:27 Background: born in India, immigrant family, father was a rocket scientist
14:07 COVID enters consciousness: late December 2019, early January 2020
16:47 Wall Street Journal op-ed calling for seroprevalence studies
19:06 Major League Baseball provides 10,000 antibody test kits
20:30 Study results: 3 percent of Santa Clara had COVID by April 2020
26:12 Death threats, racist attacks, and pressure from Stanford
34:51 Evidence of natural immunity being suppressed by Fauci and Birx
39:52 Genesis of Great Barrington Declaration, October 2020
50:10 Hostile work environment at Stanford and Tessier-Levine impact
56:44 FOIA requests revealing government targeting
1:00:16 Twitter blocklist discovery and Elon Musk's Twitter Files
1:05:00 Reform is needed in the scientific community to restore public trust

About the Guest (at time of recording, July 2023)
Dr. Jayanta Jay Bhattacharya is a Professor of Health Policy at Stanford University's School of Medicine and a Senior Fellow at the Hoover Institution. He holds an MD and a PhD in Economics from Stanford. Born in Kolkata, India, he immigrated to the US at age four. His research focuses on the health and well-being of vulnerable populations. He has published over 160 peer-reviewed articles and is the author of a leading textbook on health economics. Dr. Bhattacharya co-authored the Great Barrington Declaration and is a co-founder of the Academy of Science and Freedom.

Dr. Jay's Current Role (June 2026)
Since this episode was recorded in July 2023, Dr. Bhattacharya has assumed significant leadership roles in the federal government. He is the 18th Director of the National Institutes of Health (NIH), confirmed March 25, 2025, and took office April 1, 2025. As of February 18, 2026, he also serves as Acting Director of the Centers for Disease Control and Prevention (CDC), bringing his emphasis on scientific integrity and evidence-based policy to these critical positions.

Podcast: DC EKG with Joe Grogan
Guest: Dr. Jay Bhattacharya
Host: Joe Grogan and Eric Ueland

Sponsor: Survivors for Solutions
Executive Producer: John CZ