The House and Senate convened this week to kick off the 118th Congress. Republicans control the House after four years of a Democratic majority. House Republicans have a very slim majority, with only 222 seats to the...more
1/12/2023
/ Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Congressional Budget Resolution ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Legislative Agendas ,
Medicare ,
Medicare Part B ,
Regulatory Agenda
Key Points -
The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data.
New price setting provisions built into the IRA...more
The Inflation Reduction Act (IRA), P.L. 117-169, which became law on August 16th, included some of the most consequential prescription drug pricing reforms ever passed by Congress. This week marked a pivotal milestone in the...more
Washington, D.C. is currently focused on a September continuing resolution (CR) to keep the federal government funded, but it is worth looking ahead to the broader health care horizon and the key Medicare issues that await...more
9/19/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Lame Duck Session ,
Legislative Agendas ,
Medicare ,
Mental Health ,
Substance Abuse ,
Telehealth ,
Telemedicine
Background on Cures 2.0 -
The COVID-19 pandemic response demonstrated the tremendous impact innovation can have on a global scale. The unprecedented experiences of the past year and a half have spurred renewed interest in...more
- The proposed rule seeks to “demolish the existing bureaucratic barriers that have created a ‘valley of death’ for innovative products.”
- A new Medicare Coverage of Innovative Technology (MCIT) pathway would allow...more
• On July 18, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare & Medicaid Innovation (CMMI) published a proposal to implement a new mandatory Medicare payment model in select geographic...more
8/12/2019
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Fee-for-Service ,
Health Care Providers ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
PAMA ,
Physician Fee Schedule ,
Quality Payment Program (QPP) ,
Secretary of HHS ,
Social Security Act
• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted.
• Many of the more dramatic proposals would require federal rulemaking or...more
5/17/2018
/ Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Request For Information ,
Section 340B ,
Trade Agreements ,
Trump Administration ,
WTO
• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more
4/3/2018
/ American Medical Association ,
Cancer ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coding ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Laboratories ,
Marketing Authorization Application ,
Medicare ,
Medicare Part B ,
PAMA ,
Payment Rates ,
Personalized Medicine ,
Physician Medicare Reimbursements