Stephen Forster on Centers for Medicare & Medicaid Services (CMS)

How the Health Tech Investment Act Could Reshape Medicare Reimbursement for Algorithm-Based Services

As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures. The Health Tech Investment Act, or S. 1399, introduced in...more

5/27/2025 / Algorithms , Artificial Intelligence , Centers for Medicare & Medicaid Services (CMS) , Digital Health , FDA Approval , Health Technology , Medical Devices , Medicare , Proposed Legislation , Reimbursements

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

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

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

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

CMS Updates IRA Landscape for Future Medicare Drug Price Negotiations

The Centers for Medicare & Medicaid Services on May 3, 2024, released its draft guidance on administration of the Medicare Drug Price Negotiation Program for initial price applicability year 2027. The program—established by...more

5/29/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Excise Tax , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

Temporary Relief: CMS Will Not Finalize Best Price Stacking Provision

At a time when pharmaceutical drug prices are at the height of political scrutiny, manufacturers can breathe a small sigh of relief as the Centers for Medicare and Medicaid Services (CMS) announced on May 15, 2024 that it...more

5/28/2024 / Centers for Medicare & Medicaid Services (CMS) , Manufacturers , Pharmaceutical Industry , Prescription Drugs

Delaware Court Rules Inflation Reduction Act’s Drug Price Negotiation Program to Remain Intact

The US District Court of Delaware recently ruled against AstraZeneca in its case challenging the constitutionality of Medicare’s new Drug Price Negotiation Program (the Program). The court, in granting the federal...more

3/12/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Pharmaceutical Industry , Prescription Drugs

Stephen Forster

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