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