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
