What goes into a CBO score?

By David Lim and Katherine Ellen Foley

Rep. Michael Burgess met with the Congressional Budget Office to better understand how it estimates the long-term effects of health care policy. | Anna Moneymaker/Getty Images

HOUSE BUDGET GOP CHATS IRA WITH CBO — Republicans on the House Budget Committee’s health care task force met with the Congressional Budget Office, an economist and an investor Thursday to discuss the office’s estimates of the impact the Inflation Reduction Act will have on future drug development.

The takeaway? Republicans acknowledge there is no short-term legislative path to claw back or tweak the parameters of Medicare price negotiations, but they want a better understanding of how the nonpartisan office estimates the long-term effects of health care policy.

Rep. Michael Burgess (R-Texas) told reporters that the roundtable with CBO Director Phillip Swagel, former CBO Director Doug Holtz-Eakin, venture capital investor Peter Kolchinsky and health care economic firm Vital Transformation’s Duane Schulthess was not intended to be a forum to bash the nonpartisan CBO but rather an opportunity to understand its methodology.

“We as members of Congress need to be better at discerning when we get a CBO report,” Burgess said. “What is nice to know, and what is the real impact?”

In July 2022, CBO estimated the law would prevent 15 in 1,300 drugs from coming to market over the next 30 years.

Republicans question why private investors and drugmakers estimate the law will have a far greater adverse effect on innovation in the pharmaceutical industry than the CBO. They also want additional information about the type of drugs that might not come to market.

“We had a member on the other side of the dais say, ‘I’ll give up some innovation if I can have cheaper drugs,’” Burgess said. “OK, fair enough, that’s a fair statement, but maybe we ought to know ... what are we giving up?”

Larry Levitt, KFF executive vice president for health policy, told POLITICO that projecting the long-term impact of any law is a difficult exercise.

“CBO often focuses on the first-order implications of health policy changes, particularly the effects on spending and revenues,” Levitt said. “Over the long term, the effects on people's health become important but are really hard to project.”

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Best of luck to all the Marine Corps Marathon runners this weekend!

Send news, tips and cool weather vibes to Lauren Gardner (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, host Evan Peng talks with POLITICO health care reporter Daniel Payne, who sorts through the debate in Congress over health workforce issues, including the Biden administration's proposed rules to set minimum staffing requirements for nursing homes.

A message from CVS Health:

Learn how we’re delivering the future of health care. More here.

The FDA is expected to ban menthol cigarettes and flavored cigars by year's end. | Jeff Chiu/AP

AN END-OF-YEAR MENTHOL BAN? Brian King, the nation’s top tobacco regulator, said Thursday that the FDA plans to finalize rules banning menthol cigarettes and flavored cigars by the end of the year.

“The big picture is that it is on the unified agenda,” he said at the Food and Drug Law Institute’s two-day conference on nicotine and tobacco policy, acknowledging that the agency previously had targeted August for the rules’ completion on the Office of Management and Budget calendar. He said that some of the delay came from responding completely to each public comment the agency received on the proposed rules, which were sent to the White House for final review two weeks ago.

King added that the agency plans to propose a rule limiting the amount of nicotine in cigarettes after the rules banning menthol cigarettes and flavored cigars are finalized. A long road lies ahead: Experts predict tobacco giants will sue to prevent implementation of all the proposed rules.

E-cigarettes as a way to reduce tobacco-related harm for adult smokers remained a hot topic at the FDLI affair. So far, the FDA has ordered all but 23 tobacco-flavored e-cigarette products off the market. Its latest rejections earlier this month were for menthol and berry-flavored vapes from tobacco giant R.J. Reynolds.

Attendees asked King if the agency would authorize a nontobacco-flavored vape if manufacturers could demonstrate that adults prefer them to cigarettes and use them to stop or reduce smoking.

“The onus is on the entities submitting to see if they meet the necessary bar,” King said, referring to the standard that authorized vapes must show they benefit adults more than they pose a risk to minors initiating e-cigarette use. “The bottom line is we need to ramp up the quality of the science, folks.”

Many attendees said more authorized e-cigarettes could lead to more smokers quitting. “Currently in the United States, the No. 1 technique to try quitting, whether we like or not, is e-cigarettes over any FDA-approved product,” said Dr. Jasjit Ahluwalia, a professor of medicine at Brown University Alpert School of Medicine. “We’re not doing the things that are probably going to be the most effective [to get smokers to quit], which is getting authorized, regulated e-cigarettes out there to help people who can’t quit.”

GO INSIDE THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO is proud to partner with the Milken Institute to feature a special edition of our Future Pulse newsletter at the 2023 Milken Institute Future of Health Summit from November 6-8. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators solving the biggest public health issues to ensure a healthier, more resilient future for all. SUBSCRIBE TODAY TO RECEIVE EXCLUSIVE COVERAGE.

SENATE INCHES TOWARD MINIBUS — The upper chamber is working through a number of amendments to a trio of spending bills that includes the Agriculture-FDA, Military Construction-VA and Transportation-HUD — a package Senate Majority Leader Chuck Schumer said he hopes to achieve final passage “as soon as next week.”

THE DEVICE IDENTIFIER DRUMBEAT — Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) want FDA Commissioner Robert Califf to again throw his agency’s support behind their push to include device identifier data on Medicare claims forms after the National Committee on Vital and Health Statistics recommended the FDA review feedback it received on the proposal.

“The inclusion of DIs on claims transactions would greatly improve our health care system’s ability to identify risks and reach patients who may be affected by device failures, which contribute to serious health problems and impose significant financial costs,” Warren and Grassley wrote of the policy priority they have pushed for years.

A message from CVS Health:

MANUFACTURERS EYE COMBINATION VACCINES — Pfizer and BioNTech said Thursday that early clinical trials showed its combination flu and Covid-19 mRNA vaccines generated an ample immune response for both respiratory viruses.

The companies said they plan to begin a Phase III trial in the coming months. This comes on the heels of competitor Moderna’s announcement earlier this week that it had begun a late-stage trial on its combination Covid and flu vaccine.

A NEW POLITICO PODCAST: POLITICO Tech is an authoritative insider briefing on the politics and policy of technology. From crypto and the metaverse to cybersecurity and AI, we explore the who, what and how of policy shaping future industries. We’re kicking off with a series exploring darknet marketplaces, the virtual platforms that enable actors from all corners of the online world to traffic illicit goods. As malware and cybercrime attacks become increasingly frequent, regulators and law enforcement agencies work different angles to shut these platforms down, but new, often more unassailable marketplaces pop up. SUBSCRIBE AND START LISTENING TODAY.

The state of Florida recently submitted a revised drug importation plan proposal to the FDA, intended to address questions raised by the agency, Jim Saunders reports for the South Florida Sun Sentinel. The FDA said the development means it likely will not render a decision by the end of October, as initially planned.

Steven Leslie has been promoted to director of educational programs at the Food and Drug Law Institute. Previously, he served as acting and deputy director of educational programs.

The FDA issued draft guidance on remote interactive evaluations of drug manufacturing facilities.

A message from CVS Health:

Whether in the community, at home or virtually, consumers want health care that is convenient, personalized and affordable. And we’re delivering. By connecting each step of your care – from a medical appointment to a trip to the pharmacy to ongoing check-ins with your care team – we’re making healthier happen together.

Learn more.

Follow us on Twitter

David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley

Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings

This email was sent to by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA

Please click here and follow the steps to .