On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness to adopt stakeholder suggestions...more
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction Act (IRA) on August 16, 2022. The Drug...more
On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant drug pricing-related provisions. The bill generally revives many of the drug pricing provisions...more
This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more
The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more
4/26/2021
/ Biden Administration ,
Critical Infrastructure Sectors ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part D ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda
As we begin the new year, we wanted to highlight two final developments from December 2020:
First, on Dec. 27, 2020, the stimulus legislation H.R. 133, the Consolidated Appropriations Act of 2021 (link), Pub. L. 116‑260...more
1/8/2021
/ Civil Monetary Penalty ,
Consolidated Appropriations Act (CAA) ,
Drug Pricing ,
Financial Stimulus ,
MACPAC ,
MDRP ,
MedPAC ,
New Legislation ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B
On December 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that materially modifies current Medicaid Drug Rebate Program (MDRP) regulations, largely finalizing the proposed rule dated June...more
On November 19, leaders of our Life Sciences and Health Care team met for a panel discussion of the impacts on the industry of the 2020 U.S. election. This was the first event in a series of conversations, with other webinars...more
12/1/2020
/ Affordable Care Act ,
Biden Administration ,
Biotechnology ,
China ,
Coronavirus/COVID-19 ,
Drug Pricing ,
FDA Approval ,
Healthcare Reform ,
Infectious Diseases ,
Life Sciences ,
Operation Warp Speed ,
Presidential Elections ,
Trans-Pacific Partnership ,
US Trade Policies ,
Vaccinations
Tuesday, 24 November 2020 -
U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more
11/24/2020
/ Affordable Care Act ,
Biden Administration ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Pricing ,
FDA Approval ,
Healthcare Reform ,
Infectious Diseases ,
Interim Final Rules (IFR) ,
Life Sciences ,
Medical Reimbursement ,
Medicare ,
Medicare Part B ,
Most-Favored Nations ,
Pfizer ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Vaccinations
On November 20, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (IFR) with comment period implementing a mandatory “Most Favored Nation” demonstration model (MFN Model) to test...more
11/24/2020
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Health Insurance ,
Healthcare Reform ,
Interim Final Rules (IFR) ,
Medicare Part B ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Prescription Drug Coverage ,
Reimbursements
Life Sciences and Health Care Horizons virtual event series -
The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more
11/9/2020
/ Affordable Care Act ,
Business Disruption ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Emergency Use Authorization (EUA) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Imports ,
Life Sciences ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Presidential Elections ,
Public Health ,
Supply Chain ,
Trade Relations ,
Webinars
In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more
2/11/2019
/ Anti-Kickback Statute ,
Comment Period ,
Drug Pricing ,
Health Insurance ,
Incentives ,
Life Sciences ,
Managed Care Contracts ,
Medicaid ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Rebates ,
Regulatory Agenda ,
Safe Harbors ,
Trump Administration
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
11/30/2018
/ Digital Health ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Investment Funds ,
Investment Opportunities ,
Life Sciences ,
Medicaid ,
Medical Reimbursement ,
Medicare ,
Pharmaceutical Industry ,
Private Equity ,
Regulatory Agenda ,
Section 340B
On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more
10/30/2018
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
President Trump yesterday touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing options to test Medicare reimbursement based on...more
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more
10/24/2018
/ Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Compelled Speech ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Price Transparency ,
Proposed Rules ,
Registration Requirement ,
Regulatory Oversight ,
Television Commercials ,
Trump Administration
On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices.
...more
5/15/2018
/ Biosimilars ,
Comment Period ,
Competition ,
Drug Pricing ,
Life Sciences ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Section 340B ,
Trump Administration
On February 12, 2018, the White House Office of Management and Budget released an overview of the president's Fiscal Year (FY) 2019 Budget (the Budget), which makes, among many others, several proposals regarding drug pricing...more
2/16/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
MDRP ,
Medicaid Reimbursements ,
Medical Reimbursement ,
Medicare Part B ,
Medicare Part D ,
Section 340B ,
Trump Administration