Policy & Compliance

Expert Analysis

• Previewing FDA Preapproval Access In Psychedelics EO

  

  The second of two pathways for psychedelic drug access outlined in President Donald Trump's recent executive order constitutes an unprecedented expansion of the Right to Try Act, which could fundamentally alter the psychedelic access landscape while presenting significant regulatory, operational and legal challenges, say attorneys at Husch Blackwell.

• Previewing FDA National Priority Vouchers In Psychedelics EO

  

  President Donald Trump's recent executive order on psychedelic drug access represents a watershed moment in federal drug policy, but its significance lies in two distinct regulatory pathways, the first being the Commissioner's National Priority Vouchers, which offer a significant opportunity to compress U.S. Food and Drug Administration review, say Kimberly Chew at Husch Blackwell and Odette Hauke at Odette Alina.

• AG Watch: Texas Charts A Course On Investigative Authority

  

  The Texas Supreme Court's recent decision in Texas v. PFLAG affirmed, and arguably expanded, the Texas attorney general's civil investigative demand authority, providing a road map that other courts evaluating state attorney general CIDs may find instructive, amid a lack of precedent, say attorneys at Kelley Drye.

• Initial Virginia AG Actions Signal Focus On Multistate Efforts

  

  Now that Virginia Attorney General Jay Jones has reached the 100-day mark in office, his first set of actions reveals a clear preference for coalition with regional and national counterparts, which means the primary risk for businesses is no longer just the fact of enforcement, but the speed at which investigations can escalate, says Lauren Cooper at Hogan Lovells.

• How CMS Fraud Priorities Complicate Provider Acquisitions

  

  As the Centers for Medicare & Medicaid Services steps up usage of its affiliates authority and post-transaction audits, parties contemplating the acquisition or sale of home health and hospice providers should take steps to avoid the potential suspension of Medicare billing privileges, say attorneys at Alston & Bird.

• Mapping Philly US Atty's White Collar Enforcement Push

  

  Attorneys at Blank Rome discuss the U.S. Attorney for the Eastern District of Pennsylvania David Metcalf’s commitments and priorities, survey early results from his first year, and suggest practical action items for companies operating under the office's jurisdiction.

• How The Coming Months Will Shape State Drug Price Boards

  

  The future of state prescription drug affordability boards may be determined in the next few months, between an upcoming court decision in a challenge against state authority to set drug prices, and pending state decisions about whether to use federal Medicare maximum fair prices as reference, say Michael Kolber, Steven Chen and Kelechi Ezealaji at Manatt.

• Steps To Consider As DOJ Launches Fraud Division

  

  The establishment this month of the National Fraud Enforcement Division within the U.S. Department of Justice is a significant reorganization that suggests an increase in enforcement activity involving federally funded programs but leaves a number of important questions unanswered, say attorneys at Crowell & Moring.

• Court's HRSA Policy Reversal Leaves 340B Rules Murky

  

  A D.C. federal court's recent decision in Premier v. U.S. Department of Health limits the Health Resources and Services Administration's ability to enforce long-standing Section 340B interpretations through subregulatory guidance, leaving open core statutory questions about purchasing models, inventory classification and program oversight, says Martha Cramer at Hooper Lundy.

• Fresenius Ruling May Shift Anti-Kickback Enforcement

  

  The Ninth Circuit's recent decision in Fresenius v. Bonta suggests that businesses have a First Amendment right to donate to certain charities, even if those donations are motivated by economic self-interest, potentially calling into question years of Anti-Kickback Statute proceedings against pharmaceutical manufacturers for making similar donations, says Jonah Knobler at Patterson Belknap.

• The Challenge Of Stabilizing Rural Hospitals On The Brink

  

  The outlook for rural hospitals has grown more concerning, as recent policy and regulatory developments are decreasing hospital revenues and increasing the cost of uncompensated care, which may result in additional hospital closures, service reductions, or mergers and acquisitions, say Omur Celmanbet, Kristy Piccinini and Sabiha Quddus at FTI Consulting.

• Fraud Enforcement, Sentencing Face Unusual Convergence

  

  The Trump administration’s newly created task force to eliminate fraud and the U.S. Sentencing Commission’s recent proposals to scale back certain elements of the federal sentencing framework seem to point in opposite directions, creating a collision of policy priorities that may reshape how fraud cases are charged, negotiated and sentenced for years to come, says David Tarras at Tarras Defense.

• Peptide Policy Is Shifting Toward Sanctioned Compounding

  

  The policy landscape for peptides is undergoing a significant shift under the Trump administration, moving toward a complex system of verified compounding and complementary enforcement that will likely bring peptides firmly back into the sphere of legitimate consumer products, say attorneys at Sheppard.