Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more
6/18/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
5/20/2025
/ Comment Period ,
Department of Health and Human Services (HHS) ,
Deregulation ,
Drug Pricing ,
Executive Orders ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicaid ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B ,
Supply Chain
The bipartisan legislative push could create big hurdles for drug development, with concerns mounting over limited patent protections and increased litigation risks, hears Marisa Woutersen.
The US pharmaceutical industry...more
5/1/2025
/ Biosimilars ,
BPCIA ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Drug Pricing ,
Generic Drugs ,
Hatch-Waxman ,
Inflation Reduction Act (IRA) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Proposed Legislation
On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order includes various provisions that are relevant to the pharmaceutical industry,...more
4/22/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Reform ,
Tariffs ,
Trump Administration
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
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
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) 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: 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: 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
Drug Pricing Initiatives: US lawmakers continue to debate the drug pricing measure introduced by House Democrats, H.R. 3 (the Elijah E. Cummings Lower Drug Costs Now Act). Among other things, H.R. 3 would empower the...more
8/4/2021
/ Drug Pricing ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation
PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule -
On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more
5/24/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
HRSA ,
Medicaid ,
Medicare ,
Medicare Part B ,
OMB ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Proposed Rules ,
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