340B Drug Pricing Program

Federal Health Policy Update for September 10

Don’t Miss: Energy and Commerce to weigh multiple health care bills HRSA shares upcoming 340B administrative changes CMS continues distributing Rural Health Transformation Program $$$ The following is the latest health policy news from the federal government for September 4-10. Some of the language used below is taken directly from government documents. The White House The White House announced that the federal government will issue refunds of $500 a person to nearly one million Americans who it says were overcharged for Affordable Care Act exchange health plans because their premiums included user fees that were charged to cover the cost [...]

joe2026-09-10T14:54:12-04:00September 10, 2026|340b, Affordable Care Act, Center for Medicare and Medicaid Innovation, CMMI, Congress, hospitals, Medicaid, Medicare, Medicare regulations, Medicare reimbursement policy, MedPAC|

Administrative Changes Coming to 340B

The Health Resources and Services Administration has released new information about changes coming to its 340B Office of Pharmacy Affairs Information System on October 1. According to the agency, the changes “… support program integrity, transparency, and operational efficiency by enhancing several registration, recertification, and change request processes.” Among the areas that will see changes are: documentation requirements for some eligible entities hospital terminology changes requirements for additional information from family planning covered entities The October changes do not, the agency notes, “… change the underlying statutory eligibility requirements for participation in the 340B Program.” Learn more about administrative changes [...]

joe2026-09-08T14:24:28-04:00September 10, 2026|340b|

Federal Health Policy Update for September 3

Don’t Miss: 340B data reporting requirements for Medicare Part D claims data – repository opens October 1 CMS permanently permits providers to deliver telehealth from home without listing home address on Medicare enrollment application The following is the latest health policy news from the federal government for August 28-September 3. Some of the language used below is taken directly from government documents. Centers for Medicare & Medicaid Services (CMS) CMS is preparing to launch a new Medicare Part D Claims Data 340B Repository on October 1. The 340B data repository will be a centralized, federally managed information system that will [...]

joe2026-09-03T17:26:34-04:00September 3, 2026|340b, Centers for Medicare & Medicaid Services, Congress, COVID-19, hospitals, Medicaid, Medicare, Medicare regulations, MedPAC, Telehealth|

CMS Sets Soft Launch for 340B Data Repository

The Centers for Medicare & Medicaid Services will launch a new Medicare Part D Claims Data 340B Repository on October 1. The agency’s 340B data repository will be a centralized, federally managed information system that will collect, store, and process specific claim-level utilization data for prescription drugs dispensed under the Medicare Part D benefit that also are subject to discounts through the 340B Drug Pricing Program. CMS developed the repository to support implementation of the Medicare Prescription Drug Inflation Rebate Program, which was mandated by the Inflation Reduction Act of 2022. Under this program, the federal government must exclude drug [...]

joe2026-09-02T12:49:27-04:00September 3, 2026|340b, Medicare|

Disagreement Over 340B’s Future

Almost immediately after the Department of Health and Human Services announced a pilot program to test using a rebate model in the 340B Drug Pricing Program, members of Congress responded with proposed legislation that would prevent HHS from implementing that pilot. Last week, HHS’s Health Resources and Services Administration announced its 340B Rebate Model Pilot Program, a refined version of a previous pilot program that a federal court rejected earlier this year. Under this new model, qualifying drug manufacturers will be able to provide the 340B ceiling price to eligible 340B providers through rebates, an approach manufacturers have increasingly sought, [...]

joe2026-08-11T15:58:28-04:00August 12, 2026|340b, hospitals|

HRSA Tries Again With New 340B Model

Following a federal court rejection earlier this year of a previously announced pilot program to alter how the 340B Drug Pricing Program is administered, the Department of Health and Human Services’ Health Resources and Services Administration has announced that it will implement a revised 340B Rebate Model Pilot Program. Under this new model, qualifying drug manufacturers will be able to provide the 340B ceiling price to eligible 340B providers through rebates, an approach manufacturers have increasingly sought, rather than the upfront discounts that providers prefer. According to a HRSA news release, the agency believes its new model will: Improve claims-level [...]

joe2026-08-06T15:15:39-04:00August 10, 2026|340b|

More Medicaid DSH Money Coming for Some Hospitals?

Some hospitals may be in line for larger Medicaid disproportionate share hospital payments as a result of a federal court decision that calls for changes in how those Medicaid DSH payments are calculated. Last week, a U.S. District court in Texas again vacated a 2023 Centers for Medicare & Medicaid Services regulation that excludes inpatient days covered by uncompensated care pools, such as through section 1115 waivers, when quantifying Medicaid days for the purpose of calculating hospitals’ Medicaid DSH payments. This decision applies nationwide and has implications for the computation of some hospitals’ Medicaid DSH payments and for establishing hospitals’ [...]

joe2026-08-05T11:40:12-04:00August 6, 2026|340b, hospitals, Medicaid disproportionate share, Medicaid DSH|

Federal Health Policy Update for February 26

The following is the latest health policy news from the federal government for February 20-26. Some of the language used below is taken directly from government documents. Congress Both chambers of Congress are in session this week and next. The partial shutdown of the Department of Homeland Security that began on February 23 continues. The House Ways and Means Committee held a hearing titled “Advancing the Next Generation of America’s Health Care Workforce” to examine the shortage of resident physicians and explore ways to strengthen rural health care providers and Graduate Medical Education (GME). Watch the hearing and review the witness testimony here. Centers for Medicare & [...]

joe2026-02-26T15:43:01-05:00February 26, 2026|340b, Center for Medicare and Medicaid Innovation, Centers for Medicare & Medicaid Services, CMMI, COVID-19, hospitals, Medicaid, Medicaid disproportionate share, Medicaid DSH, Medicaid managed care, Medicaid regulations, Medicare, Medicare regulations, Medicare reimbursement policy, Telehealth|

Feds Taking Another Shot at 340B Changes

Only a week after a federal court rejected for a second time its attempt to introduce a new approach to administering the 340B Drug Pricing Program, the Health Resources and Services Administration is going back to the drawing board and trying again to launch the model. In its first step, HRSA has issued a Request for Information (RFI) to gather input from interested parties on whether the agency should implement a rebate model under the 340B program and how best to implement such a model. The RFI notes that in 2024, HRSA began receiving inquiries from drug companies seeking to [...]

joe2026-02-18T10:37:51-05:00February 18, 2026|340b|

Federal Health Policy Update for January 15

The following is the latest health policy news from the federal government for January 9-15. Some of the language used below is taken directly from government documents. The White House The White House has unveiled “The Great Healthcare Plan,” which it describes as “… a broad healthcare initiative that will slash prescription drug prices, reduce insurance premiums, hold big insurance companies accountable, and maximize price transparency in the American healthcare system.” The major components of the plan, and the key steps for each, are: lower drug prices slash prescription drug prices allow more over-the-counter medicines lower insurance premiums send the [...]

joe2026-01-15T16:13:09-05:00January 15, 2026|340b, Affordable Care Act, Centers for Medicare & Medicaid Services, Medicaid, Medicaid disproportionate share, Medicaid DSH, Medicaid DSH allotments, Medicare|