The Biden administration, via the Health Resources and Services Administration (HRSA) and the Department of Health and Human Services (HHS), released a proposed rule which seeks to rescind a previous final rule related to 340B discounts for insulin and injectable epinephrine that was adopted in the final months of the Trump administration. Comments on the [...] Read More
On May 28, 2021, the White House released the President’s fiscal year (FY) 2022 budget.[1] This full version of the budget follows the Administration’s “top-line” budget released in early April. For the Department of Health and Human Services (HHS), the administration is requesting $131.8 billion in discretionary.[2] In a statement about the budget request HHS [...] Read More
On the afternoon of November 20, 2020, the Trump Administration released an interim final rule with comment period (IFC) from the Centers for Medicare and Medicaid Services (CMS) to implement a mandatory, seven-year payment model called the Most Favored Nation (MFN) Model. This model will initially include a group of 50 single source drugs and [...] Read More
On September 24, 2020, the Health Resources and Services Administration (HRSA) released a proposed rule, Implementation of Executive Order 13937, “Executive Order on Access to Affordable Life-saving Medication.” This Executive Order (EO) directed HHS to take action to ensure that future grants under the Public Health Service Act are conditioned upon a Federally Qualified Health [...] Read More
President Trump has signed four executive orders (EOs) designed to lower prescription drug prices. This administration has repeatedly touted lowering drug prices as a priority and these orders touch on areas the administration has previously looked at including setting Medicare Part B payment based on international prices (referred to as “most favored nation”), prescription drug [...] Read More
This evening, the Centers for Medicare and Medicaid Services (CMS) released the final calendar year (CY) 2020 payment rule for hospital outpatient departments. The rule also includes the annual payment update for Ambulatory Surgical Centers as well as policies for 340B, wage index, and laboratory date of service. Provisions of the final rule go into [...] Read More
Here are some reimbursement related reasons why access to biosimilars has been slower than hoped, even though patient out-of-pocket costs are lower. Current System Is an Improvement Over Earlier System, But Could Be Better Part B Is For Biologics (and Some Drugs) When I was working at the Senate Legislative Counsel’s office drafting the Average [...] Read More
On July 25, 2018, CMS released its CY 2019 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment system proposed rule. The rule contains payment updates for hospital outpatient departments and ASCs as well as proposals related to pass-through payments and the 340B program. Three requests for information (RFIs), including two […]
Read MoreIn what is likely the first major Medicare policy change of the Trump Administration, Medicare payment for 340B drugs administered in the hospital outpatient department will be cut from 106% of average sales price (ASP, or ASP+6%) to average sales price less 22% (ASP-22%). Those who have been following President Trump’s statements on health care […]
Read MoreOn January 4, 2017, the Department of Health and Human Services (HHS) released the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties final rule. This rule implements a provision of the Affordable Care Act (ACA) that required HHS to publish the methods for calculating 340B ceiling prices and also imposes civil monetary […]
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