On February 2, 2024, a bipartisan group of six U.S. senators released much-anticipated draft legislation to reform the Health Resources and Services Administration’s (HRSA) 340B drug discount program. Known as the SUSTAIN...more
With Congress again delaying full resolution of fiscal year 2024 (FY24) federal spending legislation, now until at least early March, health care stakeholders are once again left waiting to resolve several priority issues. ...more
As the Biden administration moves ahead to implement provisions of the Inflation Reduction Act (IRA), including those related to drug negotiation and inflationary rebate, the administration announced three Medicare and...more
As the 117th Congress moves into its second legislative session, there is no shortage of health care policy issues dotting the landscape. The COVID-19 pandemic, legislative gridlock and a 2021 that was largely locked down by...more
On August 23, 2021, the Food and Drug Administration released the PDUFA VII commitment letter, which contains the agency’s performance goals for the five-year window (Fiscal Year 2023 to 2027) covered by the next iteration of...more
On May 12, 2021, the Institute for Clinical and Economic Review (ICER or the Institute) released plans to begin an annual examination into health insurance drug coverage policies to assess “fair access” to prescription drugs....more
The following provides a high-level overview of how the November 3, 2020 election results will impact certain health care issues and policies. This analysis assumes that the Biden-Harris Electoral College win will be...more
11/16/2020
/ Affordable Care Act ,
Biden Administration ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Prescription Drugs ,
Presidential Elections ,
Trump Administration
The Trump Administration released a draft regulation published in the Federal Register on October 18, 2018, which proposes to require drug manufacturers to include a drug’s list price in its direct-to-consumer (DTC)...more
In its latest effort to implement the Trump administration’s plan to address concerns over the cost of drugs, the Centers for Medicare and Medicaid Services (CMS) announced that Part D drug plans can begin applying...more
On Friday, May 11, 2018, President Trump delivered a highly anticipated speech addressing high drug prices and unveiling his administration’s blueprint to lower drug prices and reduce out-of-pocket costs. American Patients...more
Earlier this month, the Food and Drug Administration (FDA) solicited public comments on the agency’s proposal to create a new Office of Patient Affairs. The agency said in its Federal Register notice that the concept was...more
Dialing up the issue of high-cost medications, Rep. Henry Waxman, the lead Democrat on the House Energy & Commerce Committee and Rep. Diana DeGette of Colorado are calling today for a hearing into the impact Sovaldi will have...more