March 6, 2014—While attention has focused on the forthcoming comprehensive regulation for the 340B program, aka the "mega-reg," the Health Resources and Services Administration is moving ahead with three other significant program regulations. [ms-protect-content id="2799"] One would create a mandatory administrative dispute resolution process for 340B, another would impose … [Read more...]
HRSA Sketches out Its Priorities for 340B Funding
Verification of ceiling prices emerges as an area of focusMarch 5, 2014—Details about the Health Resources and Services Administration's (HRSA) policy priorities for the 340B program this fiscal year and next have emerged in a drug industry newsletter and in a supplement to President Obama's budget request to Congress.[ms-protect-content id="2799"] The Obama administration yesterday asked Congress to provide $17 million for the … [Read more...]
White House Seeks $17 Million for 340B Program
$7 million would come from user fee on purchasesMarch 4, 2014—The Obama administration is seeking $17 million for the 340B drug discount program in fiscal 2015, consisting of $10 million in appropriated funds and $7 million from a 0.1 percent user fee on 340B drug purchases. [ms-protect-content id="2799"] The request came today in the President's proposed budget for the coming fiscal year. The administration's Budget in … [Read more...]
CMS OK’s California’s 340B Medicaid Carve-Out Ban and AAC Billing Requirement
Lawsuit over the policy is now before a federal appeals courtFebruary 28, 2014—The federal Centers for Medicare and Medicaid Services (CMS) has approved California Medicaid's 2009 policy requiring 340B covered entities to "carve in" their Medicaid purchases and to pass their 340B discounts on to Medicaid by billing such drugs at no more than actual acquisition cost (AAC) plus a dispensing fee. [ms-protect-content id="2799"] The state … [Read more...]
That Takes Chutzpah
We’ve noticed that Eli Lilly and Co. has been taking pot shots at the 340B program calling for more oversight and transparency. This from a company that agreed to plead guilty and pay $1.4 billion for promoting its antipsychotic drug Zyprexa for uses not approved by the Food and Drug Administration including marketing it to elderly patients with dementia. Health care providers … [Read more...]
Bayer Limiting Distribution of Multiple Sclerosis Drug Betaseron
Customer's 340B status will not affect allotment, company says in letterFebruary 20, 2014—Bayer HealthCare Pharmaceuticals has limited sales of its widely used, genetically engineered multiple sclerosis (MS) drug Betaseron due to inability to meet demand, effective with orders received on or after Jan. 1, the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) announced on its website today.[ms-protect-content … [Read more...]
340B Provider Groups Urge HHS to Address Manufacturer Compliance
Coalition wants OPA funding boost used to police drugmakers more closelyFebruary 20, 2014—Health care providers in the 340B program are urging Health and Human Services (HHS) Secretary Kathleen Sebelius to use the program's $6 million funding boost to make sure that drug manufacturers aren't overcharging for covered outpatient drugs. [ms-protect-content id="2799"] The 340B Coalition, which consists of 11 national organizations representing 340B … [Read more...]