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Bipartisan Reform of 340B Drug Discount Program?

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

An Updated Look at the Federal Health Care Policy Legislative Landscape: Opportunity for Action or ‘Groundhog Day’?

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

Federal Health Care Legislative Agenda: Fall Updates

As Congress returns and summer turns to fall, the federal health care legislative agenda remains crowded. While much near-term energy is focused on September 30 and averting a shutdown of the federal government before the...more

Debt Ceiling Deal: How Will it Impact the Health and Energy Sectors?

As congressional leaders focus on passing an agreement negotiated over the weekend by the Biden administration and House Speaker Kevin McCarthy that would increase the debt limit through early 2025 and prevent a potential...more

Three New Prescription Drug Innovation Models Latest Action on Drug Pricing

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

Congressional Balance of Power & Implications for the 118th Congress

Republicans are in line to regain control of the House of Representatives, although with a narrower margin than predicted. As of Wednesday (Nov. 9) evening, Republicans are just over 200 votes in the House, needing 218 to...more

Fall 2022 Federal Healthcare Legislative Landscape

With President Biden signing the Inflation Reduction Act (IRA) into law on August 16, the next big question is what the last third of 2022 will bring. Enacting the IRA takes the “will it or won’t it happen” issue of...more

Key Senate Panel Releases Youth Mental Health Measure

The Senate Finance Committee’s release of a draft bill focused on addressing youth and adolescent mental and behavioral health challenges marks the latest positive indicator of bipartisan interest in enacting legislation to...more

Outlook for the 2022 Federal Health Legislative Landscape

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

Lawmakers Introduce Cures 2.0 Legislation

Nearly five months after releasing their initial 21st Century Cures 2.0 draft, Congressman Fred Upton (R-MI) and Congresswoman Diana DeGette (D-CO) introduced the long-anticipated bill on November 15. The bill includes...more

FDA Advances Patient Engagement via PDUFA VII Performance Goals

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

Long-Awaited 21st Century Cures Act 2.0 Draft Released

Following months of anticipation by stakeholders including patient organizations, research institutions and medical product developers, Representatives Fred Upton (R-MI) and Diana DeGette (D-DO) released a 21st Century Cures...more

ICER Turns Attention to Health Insurers — New Report Will Examine Whether Plans Provide ‘Fair Access’ to Drugs

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

Take Two! House Democrats Announce Earmark Revival with New Guardrails

After much discussion, House Democrats have announced they will allow members to request funding for specific projects as part of the process for assembling the spending bills that must be completed by September 30 to fund...more

Senate Republicans Offer Details on COVID-19 Relief

As Democrats in Congress move toward using budget reconciliation to advance a nearly $2 trillion COVID-19 response bill, a group of 10 Republican senators are pushing a more targeted and limited proposal that weighs in at...more

Budget Reconciliation use in Recent Years

The looming 50-50 Senate, in which ties will be broken by Vice President-elect Kamala Harris, has triggered much interest in the budget reconciliation process. Budget reconciliation has many complexities, but at its core it...more

Bipartisan Lawmakers Put Forth $908 Billion COVID-19 Relief Package

In an attempt to break the logjam on a COVID-19 relief package before Congress adjourns, a group of bipartisan lawmakers put forth a $908 billion relief package that seems to be a middle-ground between the Democrats’ $2...more

Post-Election Health Policy Outlook & Analysis

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

Senate Republicans Introduce COVID-19 Relief Proposals: How Does It Compare to Democrats’ Priorities?

On Monday, July 27, Senate Republicans released a series of bills to embody the latest COVID-19 relief package. Proposing several separate bills at once gives the Senate the option of passing provisions that enjoy broader...more

The HEROES Act: Policy Overview and Political Prospects for the Latest COVID-19 Relief Bill

On May 12, U.S. House Democrats introduced a massive, $3 trillion COVID-19 relief bill, the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, and are expected to pass it as soon as this week. This...more

Congress Closer to Expanding Popular CARES Act Programs

On Tuesday the United States Senate passed by unanimous consent a $484 billion expansion of the Coronavirus Aid, Relief and Economic Security (CARES) Act, including $310 billion for the popular Paycheck Protection Program and...more

Congress Nears Passage of $2 Trillion COVID-19 Relief Package

Following days of protracted negotiations, Congress is heading toward enacting a $2 trillion measure to respond to the coronavirus pandemic. Anticipated to clear the House of Representatives on Friday and be promptly signed...more

On To Phase Three: A Third Supplemental Package Is Aimed at Curbing the Economic Downturn From COVID-19

One day after H.R. 6201, the Families First Coronavirus Response Act, a relief package, was signed into law, Senate Republicans threw down their marker for an even more significant phase three relief package that includes...more

The Election’s Impact on Health Care Interests

The results of the midterm elections will bring about a significant change to the federal health care policy landscape in 2019. Democratic control of the House of Representatives will effectively end any legislative...more

Trick or Treat? Expected and Surprising Provisions in the New Medicare Advantage Regulation

On October 26, the Centers for Medicare and Medicaid Services (CMS) released a 362-page proposed regulation that makes changes to three expected areas: - New telehealth flexibilities for Medicare Advantage (MA) plans....more

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