PDF(Pubmed)
Abstract：
UNASSIGNED: To reduce Medicare prescription drug expenditures, the 2022 Inflation Reduction Act (IRA) allows the Centers for Medicare & Medicaid Services (CMS) to directly negotiate with drug manufacturers on Medicare prices of high-expenditure drugs (≥$200m annual spending) which meet certain eligibility criteria. However, it is unclear what proportion of high-expenditure drugs covered by Medicare, and attributable annual drug spending, would typically be eligible for CMS negotiations in a given year.
UNASSIGNED: We used historical Medicare drug spending data to determine how many high-expenditure drugs, and attributable drug spending, would have been eligible for CMS negotiations had the IRA been in effect from 2016-2019, while also determining which of the IRA\'s eligibility criteria is most restrictive.
UNASSIGNED: From 2016-2019, approximately one third (33.3% for Part B, 32.4% for Part D) of high-expenditure Medicare drugs would have been eligible for negotiation, with ineligible drugs accounting for 75.2% and 63.8% of spending on high-expenditure drugs in Medicare Part B and D, respectively. Most ineligible high-expenditure drugs were ineligible because they launched too recently. From 2016-2019, between 59 and 74 high-expenditure drugs were eligible per year, indicating that in some years there may not be enough eligible drugs for CMS to negotiate on the maximum number of drugs allowable by law.
UNASSIGNED: The IRA\'s current eligibility criteria may restrict CMS from being able to negotiate drug prices on approximately two-thirds of the high-expenditure drugs covered by Medicare and may not allow CMS to negotiate on the maximum number of drugs allowable by law. Congress could consider relaxing eligibility requirements for price negotiation, such as those pertaining to launch date recency, to ensure there are a sufficient number of high-expenditure drugs eligible for negotiation or make certain ineligible drugs contributing to significant annual Medicare spending eligible for negotiation on a case-by-case basis.
UNASSIGNED: We used historical Medicare drug spending data to determine how many high-expenditure drugs, and attributable drug spending, would have been eligible for CMS negotiations had the IRA been in effect from 2016-2019, while also determining which of the IRA\'s eligibility criteria is most restrictive.
UNASSIGNED: From 2016-2019, approximately one third (33.3% for Part B, 32.4% for Part D) of high-expenditure Medicare drugs would have been eligible for negotiation, with ineligible drugs accounting for 75.2% and 63.8% of spending on high-expenditure drugs in Medicare Part B and D, respectively. Most ineligible high-expenditure drugs were ineligible because they launched too recently. From 2016-2019, between 59 and 74 high-expenditure drugs were eligible per year, indicating that in some years there may not be enough eligible drugs for CMS to negotiate on the maximum number of drugs allowable by law.
UNASSIGNED: The IRA\'s current eligibility criteria may restrict CMS from being able to negotiate drug prices on approximately two-thirds of the high-expenditure drugs covered by Medicare and may not allow CMS to negotiate on the maximum number of drugs allowable by law. Congress could consider relaxing eligibility requirements for price negotiation, such as those pertaining to launch date recency, to ensure there are a sufficient number of high-expenditure drugs eligible for negotiation or make certain ineligible drugs contributing to significant annual Medicare spending eligible for negotiation on a case-by-case basis.
摘要：
■为了减少医疗保险处方药支出，2022年《降低通货膨胀法案》(IRA)允许医疗保险和医疗补助服务中心(CMS)直接与药品制造商就符合某些资格标准的高支出药品(每年支出≥2亿美元)的医疗保险价格进行谈判.然而,目前尚不清楚Medicare涵盖的高支出药物比例，和可归属的年度药品支出，通常有资格在给定年份进行CMS谈判。
■我们使用历史医疗保险药物支出数据来确定有多少高支出药物，和可归属的药品支出，如果IRA从2016年至2019年生效，则将有资格参加CMS谈判，同时还确定IRA的资格标准中哪一个限制性最强。
■从2016年到2019年，大约三分之一（B部分为33.3％，D部分)高支出医疗保险药物的32.4%将有资格进行谈判，不合格药物占医疗保险B部分和D部分高支出药物支出的75.2%和63.8%，分别。大多数不合格的高支出药物都不合格，因为它们推出得太早了。从2016年至2019年，每年有59至74个高支出药物符合条件，表明在某些年份，CMS可能没有足够的合格药物来协商法律允许的最大药物数量。
IRA的当前资格标准可能会限制CMS无法就Medicare所涵盖的大约三分之二的高支出药物的药物价格进行谈判，并且可能不允许CMS就法律允许的最大药物数量进行谈判。国会可以考虑放宽价格谈判的资格要求，例如与发射日期最近有关的，确保有足够数量的高支出药物符合谈判条件，或使某些不符合资格的药物符合年度Medicare重大支出的条件。
■我们使用历史医疗保险药物支出数据来确定有多少高支出药物，和可归属的药品支出，如果IRA从2016年至2019年生效，则将有资格参加CMS谈判，同时还确定IRA的资格标准中哪一个限制性最强。
■从2016年到2019年，大约三分之一（B部分为33.3％，D部分)高支出医疗保险药物的32.4%将有资格进行谈判，不合格药物占医疗保险B部分和D部分高支出药物支出的75.2%和63.8%，分别。大多数不合格的高支出药物都不合格，因为它们推出得太早了。从2016年至2019年，每年有59至74个高支出药物符合条件，表明在某些年份，CMS可能没有足够的合格药物来协商法律允许的最大药物数量。
IRA的当前资格标准可能会限制CMS无法就Medicare所涵盖的大约三分之二的高支出药物的药物价格进行谈判，并且可能不允许CMS就法律允许的最大药物数量进行谈判。国会可以考虑放宽价格谈判的资格要求，例如与发射日期最近有关的，确保有足够数量的高支出药物符合谈判条件，或使某些不符合资格的药物符合年度Medicare重大支出的条件。
