News & Analysis as of

Drug Pricing Reporting Requirements Centers for Medicare & Medicaid Services (CMS)

Paul Hastings LLP

CMS Proposes Major ASP Reporting Overhaul — Implications for Fair Market Value and Bona Fide Service Fees

Paul Hastings LLP on

The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

Husch Blackwell LLP on

On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Hogan Lovells

HRSA issues notice regarding 340B Rebate Model Pilot Program, limited to drugs subject to a maximum fair price (MFP) for 2026

Hogan Lovells on

On July 31, 2025, the Health Resources and Services Administration (HRSA) published a notice in the Federal Register (Rebate Model Notice) announcing a 340B Rebate Model Pilot Program (Pilot Program). Notably, the Pilot...more

Goodwin

340B Rebate Pilot Program Proposed by HRSA

Goodwin on

On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more

Blank Rome LLP

CMS Proposes New Rules for Calculating Average Sales Price for Medicare Part B Drug Reimbursement

Blank Rome LLP on

The Centers for Medicare & Medicaid Services (“CMS”) released the Calendar Year 2026 Medicare Physician Fee Schedule (“PFS”) proposed rule on July 16, 2025. (See...more

Ropes & Gray LLP

Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

Ropes & Gray LLP on

The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

ArentFox Schiff on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

McDermott Will & Schulte

CMS CY 2026 proposed rules: 340B in PFS and OPPS

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released the CY 2026 Outpatient Prospective Payment System (OPPS) proposed rule. The proposed rule includes a provision that would increase the reduction in...more

Holland & Knight LLP

CMS Releases CY 2026 Outpatient Prospective, ASC Payment System Proposed Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on July 15, 2025, issued the Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems proposed rule, which proposes updates to the...more

Hogan Lovells

Medicare proposed rules include government pricing surprises: ASP changes and maximum fair price, new bona fide service fee and...

Hogan Lovells on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more

Mintz - Health Care Viewpoints

PBM Legislation in the Reconciliation Bill is Far From Sweeping PBM Reform

Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these...more

Lathrop GPM

Administration Issues Cross-Agency Guidance Targeting Health Care Pricing and Focusing on Hospitals and Health Plans

Lathrop GPM on

On May 22, 2025, the U.S. Department of Health and Human Services, Department of Treasury and Department of Labor (the “Agencies”) announced new steps intended to “strengthen healthcare price transparency.” ...more

Venable LLP

June 1, 2025 Prescription Drug Reporting Deadline for Group Health Plans

Venable LLP on

Employer group health plans must make an annual disclosure of the plan's prescription drug and healthcare spending to the Centers for Medicare & Medicaid Services (CMS). The disclosure, called the Prescription Drug Data...more

Mintz

Mintz IRA Update — Operationalizing the Medicare Prescription Payment Plan and Medicare Inflation Rebate Program

Mintz on

In addition to the Part D Benefit Redesign, the IRA’s Medicare Prescription Payment Plan (MPPP) went into effect beginning January 1, 2025. The MPPP requires Part D Sponsors (PDPs) to allow Part D beneficiaries to pay for...more

Mintz - Health Care Viewpoints

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

In conjunction with the surge in state legislative efforts to regulate the pharmacy benefit manager (PBM) industry, Congress and federal agencies have ramped up PBM oversight efforts as part of the ongoing battle to lower...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

CMS Updates Could Help Employers on Second Round of Drug Cost Reporting

Employers facing a June 1, 2023, deadline for 2022 prescription drug cost reporting have important new clarification on issues such as plans that cover more than one employer, average monthly premium calculations, and medical...more

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

Goodwin on

​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

Mintz - Health Care Viewpoints

Six Initiatives States May Pursue to Curb Drug Prices and the 340B Factor

For much of the past 18 months, the Trump Administration, and in particular CMS, have talked a good game regarding reducing pharmaceutical prices. On October 16, 2018, a key component of the Administration’s strategy was...more

Mintz - Health Care Viewpoints

CMS Completes Final Medicare Part D Reconciliation for 2016

CMS has completed the 2016 Final Part D Payment Reconciliation. Each Medicare Part D plan sponsor’s reconciliation reports will be available on October 12, 2017....more

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