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 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
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
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: 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: 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
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: 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
Biden Releases Federal Budget Proposal for 2022: On May 28, 2021, President Biden released the proposed budget for fiscal year 2022, which would increase health spending by 23%. The proposal urges Congress to enact drug...more
6/7/2021
/ Audits ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
Life Sciences ,
Medicaid ,
Medicare Part B ,
New Regulations ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Premiums ,
Section 340B
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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