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
On September 9, 2021, a panel of experts convened to discuss the use of immunoglobulin (Ig) therapies, detail the therapeutic benefits of Ig therapies for various disease states, offer practitioner insights on the impact of...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
On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
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
In a late-night announcement on Friday, 1 November, the Center for Medicare and Medicaid Innovation (CMMI) gave cancer providers the first look at a possible sequel to the Oncology Care Model (OCM).
...more
11/8/2019
/ Bundled Services ,
Cancer ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Healthcare Reform ,
Life Sciences ,
Payment Methods ,
Regulatory Agenda ,
Regulatory Requirements ,
Request For Information ,
Rulemaking Process
Last week, the Centers for Medicare & Medicaid Services (CMS) announced new details of a proposed bundled payment model for radiation oncology services (RO Model), which would make fundamental (but temporary) changes to the...more
On 23 April 2019 the Centers for Medicare & Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system proposed rule for fiscal year (FY) 2020...more
4/29/2019
/ Add-ons ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Inpatient Prospective Payment System (IPPS) ,
Life Sciences ,
Long Term Care Facilities ,
Medical Devices ,
Payment Systems ,
Regulatory Agenda ,
Request For Information ,
Rulemaking Process
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
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
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
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum