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No Slowdown in Sight When It Comes to Focus on Drug Pricing Policy

Congress may be in recess, but that has not slowed down drug pricing policy developments. In recent days, the Centers for Medicare & Medicaid Services (CMS) and the Congressional Budget Office (CBO) have rolled out a series...more

Happy Birthday Two You, IRA: Drug Pricing Dynamics to Watch as Maximum Fair Price Announcements Loom

This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more

The Health Over Wealth Act Takes Aim at Private Equity Investment in Health Care

Key Points - Congress is increasing oversight and legislative activity related to the role of private equity in health care. Sen. Markey and Rep. Jayapal jointly introduced the Health Over Wealth Act on July 25, which aims to...more

The Corporate Crimes Against Health Care Act: Washington Continues Efforts to Chill Private Equity Investment in Health Care

Senators Ed Markey (D-MA.) and Elizabeth Warren (D-MA.) unveiled “The Corporate Crimes Against Health Care Act of 2024” on June 11, 2024, which seeks to create new civil and criminal penalties for health care investors who...more

Anti-Obesity Medications: Noteworthy Developments as Policymakers Weigh Coverage Considerations

Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more

FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In over Four Years

On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more

Analysis: CY 2025 Revisions to Medicare Advantage and Part D Rules Governing Agent, Broker and Third Party Compensation

On April 4, the Centers for Medicare & Medicaid Services (CMS) released the Contract Year (CY) 2025 Medicare Advantage (MA) and Medicare Part D Policy and Technical Changes final rule (“Final Rule”), which included revisions...more

The Road Ahead for Private Equity: Health Care & Life Sciences

Despite strong private equity interest in drug and device targets, policy changes in the healthcare industry have made the M&A market tricky to navigate. Healthcare has been one of the most active policy focus areas in 2023...more

The Road Ahead for Private Equity: Reflections and Predictions

The year 2023 will be remembered as a challenging one for private equity (PE), with complexities to navigate on many fronts. Traditional debt financing was expensive and scarce, expectations on valuations were tricky to...more

Congress and White House Press Ahead on AI in Health Care & Life Sciences

Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

FDA Serves Up More Food for Thought: 2024 Will Be a Pivotal Year for the Agency’s Reorganization Efforts

In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

Fall Congressional Outlook

Introduction - Congress returns from the August recess with a robust agenda and limited time to pursue it. The calendar is further constrained by the September 30 deadline to pass appropriations packages or a continuing...more

10 Health Issues to Watch as Congress Returns from August Recess

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

From Private Equity Ownership to PBMs and Drug Pricing: Congress Scrutinizes the Health Care Industry

Congress is taking a closer look at business practices in the health care sector and considering bipartisan reforms in light of increasing consolidation and its perceived affects on patient access and affordability. Various...more

Software and Digital Health Policies Issued by FDA

Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more

FDA Gets Digital, Agency Issues Digital Health Policies on PCCP, Cybersecurity and Drug Development

In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more

Drug Pricing Déjà Vu: The Biden-Harris Administration’s Fiscal Year 2024 Budget Doubles Down on Inflation Reduction Act Reforms;...

Are Accelerated Approval Drugs a New Target for Cost Reductions? As outlined in our prior analysis, the Inflation Reduction Act (IRA) included sweeping drug pricing reforms for the Medicare program and the Biden-Harris...more

Food for Thought: FDA Proposes New Vision for the Human Foods Program

On January 31, 2023, the U.S. Food and Drug Administration (FDA) announced a proposal to restructure the agency’s human foods program. FDA regulates almost 80 percent of the nation’s food supply and this work is a cornerstone...more

The Drug Pricing Drumbeat Continues: IRA Update and Key Areas to Watch in 2023

The Biden-Harris administration and Congress appear poised to continue focusing on drug pricing issues this year, most notably with the Centers for Medicare & Medicaid Services moving forward with implementation of the drug...more

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