2022年和解法案药物条款的影响：到目前为止我们学到了什么，还有什么问题？（英）

Presentation to CBO’s Panel of Health Advisers AustinBarselau, Budget Analysis DivisionScott Laughery, Health Analysis Division Major Drug Provisions of the 2022 Reconciliation Act ▪Drug Price Negotiation.The secretary of Health and Human Services negotiates pricesfor certain prescription drugs covered under Medicare Part B and Part D. ▪Inflation Rebate.Manufacturers of drugs covered under Medicare Part B and Part D mustpay rebates to Medicare if the prices of brand-name drugs without generic or biosimilarcompetition exceed an inflation-adjusted benchmark. ▪Part D Benefit Redesign.Enrollees’ annual out-of-pocket costs are capped and premiumincreases are temporarily limited; Part D plans’ share of costs beyond the out-of-pocketcap is increased; manufacturers are required to provide new mandatory price discounts. Developments Since CBO’s Original Estimate andTheir Expected Effects on Budgetary Savings CBO originally estimated that together, the three drug provisions of the 2022 reconciliation act wouldreduce the deficit by$129 billionthrough 2031. CBO has learned new information about the effects of the provisions. That information suggests thatthe agency probably overestimated the amount of savings from the act’s drug provisions, and theagency has subsequently changed its projections of the effects of those provisions. ▪Drug Price Negotiation:Price reductions for the first cohort of selected drugs were smaller thanexpected. CBO now projects smaller budgetary savings. ▪Inflation Rebate:General consumer price inflation was higher than expected after thecoronavirus pandemic; that reduced the policy’s effect on drug prices and inflation rebatecollections. CBO now projects smaller budgetary savings. ▪Part D Redesign:Plan bids for 2025 were higher than expected, in part because of changes indrug spending in 2023. CBO now projects greater outlays. Plan bids for 2026 were also higherthan expected. The 2022 Reconciliation Act and Drug Innovation CBO continues to study the effect of the 2022 reconciliation act on drug innovation. In December 2023, CBO issued blog post calling for research on new drug development.The same month, CBO also released additional information about its simulation model ofdrug development in a letter to Chairman Arrington and Representative Burgess. CBO analysts are tracking data on venture capital funding and drug development, trackingdrug development literature as it emerges, and engaging with stakeholders. CBO is currently updating its drug development model to address feedback from theCongress, responses to its call for research, and other input. The agency continues to seek input to enhance its analysis of factors that affect new drugdevelopment and will provide updates when it has more information to share. Drug Price Negotiation Drug Price Negotiation: Introduction Eligibility:In Part D, drugs must be among the 50 top-selling products. When Part B drugsbecome eligible in 2026, those selected must be among the top 50 top-selling products in Part B.In both Part B and Part D, drugs must meet other criteria as well, such as they cannot havegeneric or biosimilar competition at the time of selection. Negotiated Price:The MFP determined through negotiations cannot exceed the lower of twovalues: –The drug’s previous average price in Medicare or–A specified percentage of the drug’s previous nonfederal average manufacturer price. Penalties:Manufacturers that do not comply with the negotiation process face penalties, namelythe following: –Mandatory withdrawal of all drug products from the Medicare and Medicaid programs or–An excise tax on a product’s sales in the United States. MFP = maximum fair price. Budgetary Effects of Drug Price Negotiation CBO originally estimated that negotiation would reduce the deficit by$99 billionthrough 2031. CBO expected that drug manufacturers would comply with the negotiation process because thecosts of not doing so would be greater than the revenue lost from negotiated lower prices. On the basis of the predictions of its bargaining model, CBO expected that in some cases, thesecretary’s leverage in negotiations would be sufficient to attain prices below the upper limitestablished in the law. CBO estimated that net prices for selected drugs would decrease byroughly 50 percent, on average, as a result of negotiation. Because those drugs were projected to account for less than one-fifth of total spending net ofdiscounts and rebates in 2031, CBO estimated that the overall reduction in net prices inMedicare would be much smaller than 50 percent. Drug Price Negotiation: What Have We Learned? Smaller price reductions for negotiated products have led to lower projected savings. ▪CBO’s original estimate included an average netprice reduction of 50 percent for drugs facingprice negotiation. $9 billion CBO’s original estimate of federal savings from negotiation ofdrugs in the 2026 cohort $4 billionFederal savings implied from negotiation of