State Medicaid Agencies Clarify 340B Drug Billing Requirements
Updates circulated in Minnesota, Oregon, and HawaiiJune 12, 2013—Medicaid officials in three states have recently issued provider bulletins clarifying the procedures for billing 340B drugs used for fee for service (FFS) and managed care beneficiaries.
HRSA Approves Condition on 340B-Priced Neulasta
Says specialty distribution requirement won't affect discounted pricingJune 12, 2013—The Health Resources and Services Administration (HRSA) says Amgen’s decision to sell its biologic drug Neulasta at 340B pricing exclusively through specialty distributors “will not violate the 340B statute,” the agency has told both the association representing 340B hospitals and the 340B prime vendor. Neulasta is an expensive, man-made human protein used to [...]
Bayer Limits Sales of New Contraceptive in Short Supply
Notice says 340B customers will be treated equitablyJune 7, 2013—Bayer HealthCare Pharmaceuticals is limiting distribution of its new intrauterine device (IUD) Skyla due to high demand and productions delays, the Office of Pharmacy Affairs (OPA) has announced. Under OPA policy, drug manufacturers can develop a limited allocation plan for 340B covered outpatient drugs when supply is inadequate to meet demand, so long [...]
340B Hospitals Ask Amgen to Withdraw Purchasing Restriction on Drug
All Neulasta at 340B pricing must now be handled through specialty distributorsMay 31, 2013—The group that represents hospitals in the 340B drug discount program has asked the pharmaceutical manufacturer Amgen to withdraw its new requirement that all 340B purchases of the company’s drug Neulasta be made exclusively through specialty distribution channels. In a May 30 statement, Safety Net Hospitals for Pharmaceutical Access (SNHPA) said the policy [...]
Study Suggests VA and DOD Could Negotiate Lower Drug Prices
DOD pays more per unit for generics while VA pays more for brandsMay 31, 2013—The Department of Veteran Affairs (VA) and the Department of Defense (DOD) are paying different prices for the same prescription drugs, the Government Accountability Office (GAO) has found. However, the findings may not be that surprising considering the purchasing patterns of the two agencies, GAO researchers found.
Purchases of Orphan Drug to Treat Hormone Deficiency Limited
OPA posts notice of allocation procedures for IncrelexMay 23, 2013—The manufacturer of the only FDA-approved orphan drug for children with a rare hormone deficiency that causes short stature is limiting purchases due to an imminent halt in production. The Office of Pharmacy Affairs (OPA) posted the notice by Ipsen Biopharmaceuticals, the maker of the drug Increlex, on its website’s home page on [...]
Over 30 Million Expected to Remain Uninsured in 2023
Projection in CBO's latest federal budget outlook could have 340B implicationsMay 17, 2013—About 25 million Americans will gain health coverage by 2023 under the Affordable Care Act (ACA) but about 31 million will remain without insurance, according to new projections from the nonpartisan Congressional Budget Office (CBO). The health coverage figures were included in CBO’s latest federal budget projections for the coming decade.
340B Orphan Drug Rule Is Back on Hold
Duration of delay is unclearMay 16, 2013—The long-awaited regulation to implement health care reform’s partial limit on 340B discounts for orphan drugs is back on hold. On May 8, the White House Office of Management and Budget (OMB) reported online that its review of the Health Resources and Services Administration’s (HRSA) proposed 340B orphan drug exclusion final rule had [...]
Mylan Mails Checks for 340B Overcharges
Refunds are certain products sold from 1994 through 2006May 15, 2013—Drug manufacturer Mylan has mailed refunds to 340B providers for overcharges on all products sold by its Mylan Specialty subsidiary (formerly known as Dey Pharma) from late 1994 through late 2006. Last November, the Office of Pharmacy Affairs (OPA) posted a message from Mylan on its home page explaining that the company needed [...]
Judge Invalidates Calif. 340B Medicaid Carve-in Mandate
Says state ignored statutory and regulatory procedural requirementsMay 7, 2013—A federal district judge has ordered California to stop requiring 340B health care providers to “carve in” all Medicaid patients and to bill the state for 340B drugs given to such patients at actual acquisition cost (AAC). Acting in a case brought by the AIDS Healthcare Foundation (AHF), U.S. District Judge Manuel L. [...]
