The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more
7/29/2025
/ Ambulatory Surgery Centers ,
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Outpatient Prospective Payment System (OPPS) ,
Pending Litigation ,
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Physician Fee Schedule ,
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Vouchers
On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more
7/15/2025
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Medicare ,
Orphan Drugs ,
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Pharmacies ,
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Trump Administration
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
7/1/2025
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Medicare Part D ,
Most-Favored Nations ,
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Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Section 340B
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
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Department of Health and Human Services (HHS) ,
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Most-Favored Nations ,
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Pharmacies ,
Prescription Drugs ,
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Supply Chain
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
5/6/2025
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Section 340B ,
Trump Administration
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
The pharmaceutical industry faced pressure and uncertainty in 2023 and that will likely continue in 2024, partially because of the implementation and evolution of the Inflation Reduction Act. Meanwhile, states are expected to...more
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 ,
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Prescription Drugs ,
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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
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 ,
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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) ,
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FOIA ,
Food and Drug Administration (FDA) ,
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Life Sciences ,
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Medicare ,
Medicare Part B ,
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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
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: Congress and stakeholders continue to discuss drug pricing reform measures, including those that were originally part of H.R. 5376 (the Build Back Better Act, or BBBA).
In a related development,...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 ,
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Life Sciences ,
Medicaid ,
Medicare ,
Medicare Part B ,
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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
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