Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies...more
In this podcast, explore how health insurance companies are adapting to the Inflation Reduction Act's new requirements, including the Part D redesign.
The US healthcare landscape is undergoing significant changes as the...more
Inflation Reduction Act and Health Reform: The Centers for Medicare & Medicaid Services (CMS) is continuing its efforts to staff the new Medicare Drug Rebate and Negotiations group and has posted various related job openings....more
11/8/2022
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more
10/26/2022
/ Biden Administration ,
Biosimilars ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Drug Pricing Reform: President Biden, in remarks delivered on Sept. 27, 2022, touted insulin pricing provisions in H.R. 5376, the Inflation Reduction Act of 2022 (IRA), which became law on Aug. 16, 2022. He referred to...more
Inflation Reduction Act: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022.
Republican leaders on the House Energy & Commerce and...more
9/13/2022
/ Biden Administration ,
Canada ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
FOIA ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Imports ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicaid ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Section 340B
Latham's Government Price Reporting Team covers general developments, the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, Medicare Part B, and state law developments.
...more
Congress Passes Inflation Reduction Act: On Aug. 7, 2022, the Senate approved H.R. 5376, the Inflation Reduction Act of 2022 (the Act), along party lines, with support from 50 Democratic and independent senators and Vice...more
Historic statute introduces mandatory Medicare price negotiations, Medicare Part B and D inflation rebates, and Medicare Part D benefit redesign.
H.R. 5376, the Inflation Reduction Act of 2022 (the Act), marks Congress’s...more
Drug Pricing Initiatives: The Senate is expected to vote on a revised version of H.R. 5376 (the Build Back Better Act, or BBBA), now styled as the Inflation Reduction Act of 2022 (IRA). The House originally passed H.R. 5376...more
Drug Pricing Initiatives: Democrats renewed their efforts to pass drug pricing reform measures in the form of a revised H.R. 5376 (the Build Back Better Act, or BBBA). Democrats intend to adopt the BBBA as part of the budget...more
7/20/2022
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Medicaid ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
Latham’s Government Price Reporting Team covers general developments, the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, Medicare Part B, and state law developments.
Drug Pricing Initiatives: Congress and...more
Drug Pricing Initiatives: Discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the Build Back Better Act, or BBBA).
...more
5/24/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Co-payments ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Section 340B
Drug Pricing Initiatives: In advance of the midterm elections in November, discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the...more
5/12/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicare ,
Medicare Part B ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Secretary of HHS ,
Section 340B
Drug Pricing Initiatives: Senators, Representatives, and stakeholders continue to discuss some of the drug price reform measures that were originally part of H.R. 5376 (the Build Back Better Act, or BBBA).
...more
Drug Pricing Initiatives: President Biden referred to some of the drug price reform measures originally part of H.R. 5376 (the Build Back Better Act, or BBBA) in his State of the Union address on March 1, 2022. Senator...more
Drug Pricing Initiatives: With no clear pathway to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA), Democrats are considering whether to separately adopt individual BBBA drug price reform measures. One such...more
Drug Pricing Initiatives: Discussion continues regarding pathways to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA). Potential approaches include a reduced or modified version of the BBBA, although details...more
2/15/2022
/ Drug Pricing ,
Health Care Providers ,
Hospitals ,
Life Sciences ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
Drug Pricing Initiatives: The pathway to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA) remains unclear. President Biden has suggested splitting up the BBBA and individually passing those provisions that...more
340B PROGRAM -
Further State Legislation Seeks to Regulate PBMs in Relation to 340B: Florida, Kentucky, Missouri, Nebraska, and New Hampshire recently introduced legislation aiming to regulate pharmacy benefit managers...more
1/20/2022
/ Antitrust Litigation ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Supply Chain
Drug Pricing Initiatives: The pathway to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA) is unclear, following Senator Joe Manchin’s withdrawal of his support for the measure. The BBBA is an approximately...more
1/5/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
Drug Pricing Initiatives: Discussion continues of H.R. 5376 (the Build Back Better Act, or BBBA), the approximately $2.2 trillion social safety net, climate, and tax bill that includes measures related to drug pricing and...more
Drug Pricing Initiatives: Late on Nov. 5, 2021, the House of Representatives passed H.R. 3684 (the Infrastructure Investment and Jobs Act). This $1 trillion infrastructure bill, which was passed earlier by the Senate, is part...more
11/9/2021
/ Budget Reconciliation ,
Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
Drug Pricing ,
Final Rules ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Section 340B
2021 Medicaid Drug Rebate Program Conference Concludes: The conference took place in New Brunswick, N.J., Oct. 11-13 and virtually Oct. 18-20. Christopher H. Schott spoke in person as part of the “Fireside Chat: External...more
10/26/2021
/ Biden Administration ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
Drug Pricing Initiatives: The fate of the reconciliation package that contains many of President Biden’s domestic policy initiatives, including with respect to drug pricing, remains in limbo as Democrats continue to debate...more
10/12/2021
/ Biden Administration ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B