Inflation Reduction Act Implementation: On Dec. 1, 2022, the Centers for Medicare & Medicaid Services (CMS) distributed an invitation addressed to “All Drug Manufacturers” announcing that CMS “will host monthly one-hour calls...more
12/13/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Election Results ,
Health Care Providers ,
Imports ,
Inflation Reduction Act (IRA) ,
Legislative Agendas ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Reform ,
Section 340B
Health Reform and Midterm Results: In the wake of the midterm elections, leadership changes of key committees are underway. Commentators note that while both parties may agree on problems in the pharmaceutical and healthcare...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
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
Drug Pricing Reform: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022
...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
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
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
2022 Medicaid & Government Pricing Congress Concludes: The annual Medicaid & Government Pricing Congress took place in Philadelphia from May 23-25 and virtually from June 1-2. On May 25, Latham partner Christopher H. Schott...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
Biden Administration Releases FY 2023 Budget -
The Biden Administration’s proposed Budget of the U.S. Government for FY 2023 (see also the accompanying fact sheet) includes proposals relevant to drug manufacturers....more
4/14/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Section 340B
Drug Pricing Initiatives: Senators 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), such as imposing price caps on...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
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: President Biden has indicated that a Senate vote on H.R. 5376 (the Build Back Better Act, or BBBA) will likely not occur until 2022. This follows conversations between President Biden and Senator Joe...more
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: On Nov. 19, 2021, the House of Representatives passed 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...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
Drug Pricing Initiatives: Democrats are continuing to debate the reconciliation package that contains many of President Biden’s domestic policy initiatives, including with respect to drug pricing. The budget reconciliation...more
9/30/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Life Sciences ,
Medicaid ,
Medicare ,
Medicare Part B ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
Drug Pricing Initiatives: On Aug. 24, 2021, the House of Representatives approved a $3.5 trillion budget framework, S. Cons. Res. 14, while also voting to advance the $1 trillion infrastructure bill. The deadline for the...more
8/31/2021
/ Biden Administration ,
Congressional Committees ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
HRSA ,
Life Sciences ,
Medicaid Drug Rebate Program ,
Medicaid Reimbursements ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
$1 Trillion Infrastructure Bill Includes Two Drug Pricing Provisions: On Aug. 10, 2021, the Senate passed H.R. 3684, the Investing in a New Vision for the Environment and Surface Transportation in America Act, or the INVEST...more
8/17/2021
/ 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