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HRSA Replaces 340B Orphan Drug List for Second Quarter of 2014

Update removes drugs no longer having orphan designations 

March 31, 2014—The Health Resources and Services Administration alerted 340B stakeholders by email this morning that on March 27 it posted a new version of its orphan drug designation list governing the second quarter of 2014 in order to address a problem in the version it posted on March 3. … [Read more...]

Most 340B Hospitals Should Be Ousted From Program, Drug Industry-Led Group Suggests

Says study shows only about 20 percent "are doing it the right way" 

March 25, 2014—A drug-industry led coalition seeking major changes to the 340B drug discount program claimed today that relatively few 340B hospitals account for most of the charity care that all such hospitals provide. … [Read more...]

HRSA Posts First 340B Provider Audit Summaries for FY13

No adverse findings in 10 out of 13 audits 

March 21, 2014—The Health Resources and Services Administration today posted its first brief summary of results from 340B covered entity audits it conducted during fiscal year 2013.   … [Read more...]

Bill Would Recognize Pharmacists as Providers Under Medicare

Aim is to expand care in medically underserved communities 

March 20, 2014─A bipartisan group in the U.S. House has introduced a bill to expand access to pharmacist-provided health services in communities with few physicians and other health professionals.   … [Read more...]

CMS Wants to Ramp up Medicaid Rebate Oversight

Closer monitoring of manufacturer compliance could have 340B implications 

March 18, 2014—The Obama administration proposes to audit and survey drugmakers more often to ensure they are fulfilling their Medicaid drug rebate obligations and to increase penalties for those that knowingly report false information for the calculation of rebates. … [Read more...]

340B Savings Critical for Ore. Health Centers, Study Concludes

Says mandated pass-through to MCOs could reduce access to medicines, services 

March 12, 2014—Requiring Oregon health centers to give the state all of their 340B savings on drugs for Medicaid beneficiaries, whose care is mainly managed and paid for by the state's new Medicaid coordinated care organizations, "may not actually be effective and could adversely impact patient care," a new study concludes. … [Read more...]

HRSA to Issue Three More 340B Regulations

Rules will create dispute resolution system and establish sanctions for manufacturers and providers 

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. … [Read more...]

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