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

DC EKG with Joe Grogan

Episode 137: Tax Expenditures, 340 B Drug Pricing, and Kidney Donation Reform

Air Date: June 15, 2026

Episode Description

In this episode, Joe Grogan sits down with Dr. Ike Brannon, President of Capital Policy Analytics and Senior Fellow at the Jack Kemp Foundation, to discuss hidden tax expenditures, the 340 B drug pricing program, and innovative solutions to the kidney shortage crisis.

Dr. Brannon brings decades of Capitol Hill experience, including roles as chief economist of the House Energy and Commerce Committee and senior advisor to Senator Orrin Hatch. He and co-author Tony LoSasso recently published groundbreaking research in Health Affairs Forefront arguing that the 340 B drug pricing program should be classified as a hidden tax expenditure costing the federal government 15 to 20 billion dollars annually.

The conversation covers how the 340 B program evolved from providing discounted drugs to uninsured patients into a massive subsidy for nonprofit institutions with little benefit to poor patients. Dr. Brannon explains how the same drug acquired at a 340 B discount often results in full commercial copays for patients.

Joe and Dr. Brannon explore other problematic tax expenditures including the mortgage interest deduction, employer health insurance exclusion, and credit union tax breaks. The episode pivots to Dr. Branons passionate work on kidney donation reform. Forty-five thousand Americans die annually from end stage renal failure due to kidney shortage, disproportionately affecting African Americans. Dr. Brannon advocates for fully reimbursing kidney donors for all expenses.

Key Topics

340 B drug pricing program, tax expenditures, pharmaceutical discounts, nonprofit hospitals, mortgage interest deduction, kidney donation, end stage renal failure, organ shortage, entitlement reform, social security, Medicare, federal deficit, health economics

Key Timestamps

0:00 Opening: What should be in a reconciliation bill?

4:38 The 340 B drug pricing program explained

13:54 How the 340 B discount does not reach patients

20:13 Mortgage interest deduction: the most irritating tax break

31:00 Prospects for reconciliation under Trump administration

34:57 The kidney donation crisis: 45,000 deaths per year

39:02 How kidney donation reimbursement would work

40:00 Would you allow kidney sales? The ethical debate

45:13 Final thoughts

About the Guest

Dr. Ike Brannon is President of Capital Policy Analytics and Senior Fellow at the Jack Kemp Foundation. He holds a PhD in Economics from Indiana University. Dr. Brannon served as chief economist of the House Energy and Commerce Committee, senior advisor to Senator Orrin Hatch on tax and trade policy, and has worked at the Congressional Joint Economic Committee, Treasury Department, and for the McCain presidential campaign. He is founder of the Prosperity Caucus and focuses on growth-oriented economic policy and healthcare innovation.

Featured Research

The 340 B Drug Pricing Program is a Hidden Tax Expenditure

Health Affairs Forefront, April 24, 2026

Co-authored by Ike Brannon and Tony LoSasso

https://www.healthaffairs.org/content/forefront/340b-drug-pricing-program-hidden-tax-expenditure

Podcast: DC EKG with Joe Grogan

Episode: 137

Guest: Dr. Ike Brannon

Sponsor: Survivors for Solutions

Producer: Stay on Course Studios

Executive Producer: John CZ Czwartacki, DC EKG Podcast

DC EKG with Joe Grogan

The Economics of Ozempic and Other Weight Loss Drugs

Episode 136.5 (“Prescription Refill” – A replay from the archives)

Original Air Date: May 2024

In this episode, Joe Grogan welcomes Ben Ippolito, Senior Fellow in Economic Policy Studies at the American Enterprise Institute, to discuss the rapidly evolving economics of GLP-1 weight loss drugs like Ozempic and Wegovy.

Ben explains the two main competitors in this market—Novo Nordisk's Ozempic and Wegovy versus Eli Lilly's Mounjaro and Zepbound. Revealing how insurance coverage decisions drive pharmaceutical marketing strategy.

The conversation reveals a critical irrationality in Medicare policy: the statutory prohibition on covering weight loss drugs despite their profound clinical and quality-of-life benefits. Yet these same drugs are covered for diabetes and cardiovascular risk reduction.

Ben explores the surprising economics of drug pricing through gross-to-net pricing—the massive gap between list prices and what insurers actually pay through rebates and discounts.

The episode examines critical implications of the Inflation Reduction Act's price negotiation provisions. Once Medicare negotiates Ozempic's price, that same price applies to all products using the same active ingredient. This creates cascading market effects: competitors must match those prices to remain on formularies, new entrants face lower pricing power even if clinically superior, and pharmaceutical companies may abandon promising programs due to regulatory uncertainty.

Ben argues Congress doesn't need to act immediately to expand Medicare coverage, but likely will within a few years.

Joe and Ben discuss unintended consequences of government price regulation, including effects on innovation and drug development pipelines. They explore how price controls announced before elections affect pharmaceutical strategy and development timelines.

Concluding with Ben's research on Medicare Advantage and why both Democrats and Republicans scrutinize this private alternative to traditional Medicare. With over 50 percent of seniors enrolled in Medicare Advantage plans, bipartisan interest in reform is reshaping healthcare policy conversations on Capitol Hill.

Key Topics

GLP-1 drugs, Ozempic, Wegovy, Mounjaro, Zepbound, weight loss medications, obesity treatment, Medicare coverage, drug pricing, Inflation Reduction Act, pharmaceutical competition, rebates, gross-to-net pricing, health economics, cardiovascular benefits, diabetes treatment, Medicare Advantage, healthcare policy, innovation incentives

Key Timestamps

00:00 Cold Open: "Turned Up to 11"

00:24 Welcome to DC EKG

00:46 Meet Ben Ippolito (AEI)

03:48 The GLP-1 Landscape: Ozempic, Wegovy, and the Field

05:04 One Drug, Two Names

06:45 Medicare's Weight-Loss Coverage Ban

07:21 Blockbusters and Big Effect Sizes

09:32 Why Isn't Congress Acting?

10:17 Why It Costs Less Than You Think

12:34 The Coverage Irrationality

14:05 Quality of Life as a Real Benefit

15:17 Beyond Weight: Cravings and Addiction

18:21 Devil's Advocate: Why Cover It At All?

19:48 Gross-to-Net and the Rebate Problem

22:41 Why Can't You Just Pay Cash?

25:43 The IRA and the Ozempic Price Cut

27:32 One Ingredient, One Price

30:10 Unintended Consequences in Part D

34:01 New Competitors and Killed Programs

38:03 What's Next: Medicare Advantage

42:04 Wrap-Up and Credits

About the Guest

(As of May 2024) Ben Ippolito is a Senior Fellow in Economic Policy Studies at the American Enterprise Institute. He holds a PhD and Master's degree in Economics from the University of Wisconsin-Madison and a Bachelor's degree in Mathematics and Economics from Emory University. Ben examines drug pricing policy, Medicare Advantage, and healthcare innovation economics with regular engagement with Congress.

Podcast: DC EKG with Joe Grogan

Guest: Ben Ippolito

Sponsor: Survivors for Solutions

Producer: Stay on Course Studios

Executive Producer: John CZ Czwartacki, DC EKG Podcast

In Episode 136 of DC EKG, Joe Grogan hosts Tom Barker, a top drug-pricing attorney at Foley Hoag and former acting general counsel of Health and Human Services (HHS) under the Bush administration. Tom helped implement Medicare Part D and now advises drugmakers and policymakers on complex pricing issues. The episode traces 20 years of policy: what went right with Part D, what the Inflation Reduction Act (IRA) did, and what effective policy should look like.

Tom explains that Part D's success rested on three pillars: private plans only, limited government control over benefit design, and a non-interference clause barring the government from intervening in negotiations among plans, pharmacies, and manufacturers. Competition worked and premiums stayed low, until the government asserted more control and weakened those pillars. The IRA, he argues, was a 16-year Democratic effort to repeal non-interference, creating price controls disguised as negotiations.

The Trump administration has taken a different tack, focusing not on the IRA but on MFN and Globe Guard models pegged to other developed countries. Tom also breaks down the 340B program, now the country's second-largest expenditure program, and the fight between manufacturers and covered entities over contract pharmacies.

His prescription is simple: let competition work. Speed FDA approval of generics and biosimilars, and trust the marketplace over price controls. He points to hepatitis C, where prices fell sharply once competition entered.

In This Conversation

The three pillars that made Part D successful for 20 years

How non-interference kept government from setting drug prices

The IRA as a 16-year Democratic push to repeal non-interference

Why Tom calls the IRA price controls disguised as negotiations

The Trump administration's focus on MFN and Globe Guard pricing

340B and the battle between manufacturers and covered entities

The Chevron repeal's impact on drug pricing law

HRSA's proposed rebate model and ongoing 340B litigation

Why effective policy means competition, not controls

Tom's work helping North Korean defectors and refugees

Key Timestamps

1:51 Tom's background at HHS and CMS

2:30 The three pillars of Part D's success

5:10 Why Democrats wanted to repeal non-interference

5:55 Ted Kennedy's compromise and bipartisan votes

11:38 The IRA as a 16-year repeal attempt

12:03 What the IRA changed in Part D

15:02 IRA negotiations vs. real negotiations

16:25 How the excise tax makes it no real negotiation

21:32 Trump's focus on MFN and Globe Guard

25:37 340B's history back to 1991

28:45 340B as the second-biggest expenditure program

29:30 Manufacturer vs. covered-entity acrimony

33:18 The Chevron repeal's impact on pricing

34:54 HRSA's rebate model, the next step on 340B

35:40 The lawsuit over "patient" in 340B

38:18 Tom's advice: let competition work

39:30 Hepatitis C: competition drives prices down

40:34 Competition for gene therapies and CRISPR

41:36 Tom's work for North Korean defectors

44:49 Sponsoring Free North Korea Radio

Medicare Part D, drug pricing policy, Inflation Reduction Act, non-interference clause, 340B program, MFN pricing, Globe Guard pricing, pharmacy benefit managers, covered entities, contract pharmacies, biosimilars, generics, federal drug pricing, government price controls, Tom Barker

About the Guest

Tom Barker is a partner at Foley Hoag in Washington, DC, and one of the country's top drug pricing attorneys. He served as acting general counsel of HHS and chief legal officer at CMS under the Bush administration, where he helped implement Part D from its inception. He is now a go-to expert on drug pricing, and helps North Korean defectors navigate US immigration law.

Podcast: DC EKG with Joe Grogan

Episode: 136 Guest: Tom Barker

Sponsor: Survivors for Solutions - https://survivorsforsolutions.org

Executive Producer: John "CZ" Czwartacki,

DC EKG Podcast Producer: Stay on Course Studios - https://www.stayoncourse.studio