Stephen Forster at Morgan Lewis

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more

4/24/2025 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Medicaid , Medicare , National Security , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Popular , Prescription Drugs , Supply Chain

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and...more

2/21/2025 / Acquisitions , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Investors , Life Sciences , Mergers , OIG , Pharmaceutical Industry , Private Equity , Regulatory Requirements , Risk Management

Patient Assistance Programs – The Dos and Don’ts from HHS OIG

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more

2/19/2025 / Enforcement Actions , False Claims Act (FCA) , Health Insurance , Medicare , OIG , Patient Assistance Programs , Pharmaceutical Industry , Prescription Drugs

US Administration Signals Potential Changes to Inflation Reduction Act Drug Price Negotiations

In what appears to be a response to manufacturer complaints regarding “black box” Inflation Reduction Act (IRA) drug price negotiations, the US administration issued a statement on January 29, 2025, stating it planned to...more

2/12/2025 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Insurance , Inflation Reduction Act (IRA) , Medicare , Pharmaceutical Industry , Regulatory Reform

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more

2/12/2025 / Centers for Medicare & Medicaid Services (CMS) , Constitutional Challenges , Guidance Documents , Inflation Reduction Act (IRA) , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements , Statutory Interpretation

FCA Enforcement Risk Remains for Rare Disease Stakeholders

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

2/12/2025 / Anti-Kickback Statute , Department of Health and Human Services (HHS) , Enforcement Actions , False Claims Act (FCA) , Healthcare Fraud , Medicaid , Medicare , Pharmaceutical Industry , Prescription Drugs

HHS OIG Sets Out Limited Guardrails for Patient Assistance Arrangements

In honor of Rare Disease Day on February 28, 2025, Morgan Lewis is publishing a series of posts on As Prescribed and Health Law Scan throughout the month of February on issues impacting the rare disease community....more

2/5/2025 / Department of Health and Human Services (HHS) , Financial Assistance Policies , Genetic Testing , Healthcare Fraud , OIG , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

Key Takeaways from the 2025 JP Morgan Healthcare Conference

Several members of our firm’s life sciences team were on the ground at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13 to 16, 2025. It was an exciting and sunny four days, during which key...more

2/3/2025 / Acquisitions , Artificial Intelligence , Biotechnology , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Food and Drug Administration (FDA) , Investment , Life Sciences , Mergers , Pharmaceutical Industry

Trump Executive Order Signals Drug Pricing Reforms Likely on the Horizon

Through the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a...more

1/28/2025 / Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Executive Orders , Inflation Reduction Act (IRA) , Medicare , Pharmaceutical Industry , Popular , Prescription Drugs , Trump Administration

How the US Election May Affect Drug Pricing, Medicare, and Medicaid Programs – Key Areas to Watch

Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more

12/5/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Manufacturers , Medicaid , Medicare , Medicare Beneficiaries , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Section 340B , Trump Administration

Falling Stars Ratings in Medicare Advantage Lead to Meteoric Payment Losses

The enormous impact of Medicare Stars Ratings on payments received by Medicare Advantage plans cannot be overstated. And with billions of dollars in bonus payments at stake, it may come as no surprise that stringent standards...more

12/2/2024 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicare , Medicare Advantage , Medicare Advantage Organizations (MAOs)

CMS Announces Updated List of Drugs Under the Inflation Rebate Program

Bipartisan efforts to lower prescription drug costs remains a core focus for the US Congress. Effective October 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has announced the follow-on cohort for its...more

10/24/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Medicare , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

District Court Affirms Louisianas Protection of 340B Contract Pharmacy Arrangements

340B litigation remains full speed ahead. Manufacturer and covered entity (CE) disputes, not all of which are being actively litigated, include, but are not limited to, federal and state regulation of contract pharmacies,...more

10/21/2024 / Covered Entities , Department of Health and Human Services (HHS) , Drug Pricing , Medicaid , Pharmaceutical Industry , Pharmacies , Prescription Drugs , Section 340B

Are PDABs Pushing the Limit Drug Pricing Complexities Collide with Implementation

In response to rising prescription costs and overall state-level healthcare spending, numerous states, including Maryland and Oregon, have established prescription drug affordability review boards (PDABs) to review certain...more

10/7/2024 / Drug Pricing , Medicaid , Medicare , Pharmaceutical Industry , Prescription Drugs

No Surprise: 340B Audits Are on the Rise!

While audits are part of doing business in the ordinary course, businesses are generally less than eager to open the books. And the same is true when it comes to the 340B Drug Pricing Program. Audits are now making the list...more

9/10/2024 / Audits , Drug Pricing , HRSA , Pharmaceutical Industry , Prescription Drugs , Section 340B

The Ins and Outs of Medicare’s Prescription Payment Plan

Through its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government....more

8/16/2024 / Centers for Medicare & Medicaid Services (CMS) , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Prescription Drugs

Unpackaging CMS’s HOPPS Proposed Rule and Payments for Diagnostic Radiopharmaceuticals

In what can only be characterized as a necessary but significant proposed departure from current political initiatives focused on lowering pharmaceutical drug prices, the Centers for Medicare & Medicaid Services (CMS)...more

7/23/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Medicare , Medicare Part B , Pharmaceutical Industry , Prescription Drugs

Medicare Part B Enrollees Will Save on 64 Newly Selected Drugs Under Inflation Rebate Program

Medicare Part B enrollees as of July 1, 2024 will experience savings on coinsurance for 64 drugs selected by the Biden administration. Pursuant to the Inflation Reduction Act and its Medicare Prescription Drug Inflation...more

7/16/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Care Providers , Medicare , Medicare Part B , Pharmaceutical Industry , Prescription Drugs

Life Sciences Post-Chevron: Navigating the Range of Legal and Regulatory Challenges Raised by Loper Bright

The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer to administrative...more

7/9/2024 / Administrative Procedure Act , Chevron Deference , Chevron v NRDC , Government Agencies , Judicial Authority , Life Sciences , Loper Bright Enterprises v Raimondo , Regulatory Authority , Relentless Inc v US Department of Commerce , SCOTUS , Statutory Interpretation

Stephen Forster

Morgan Lewis

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