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PhRMA Lays Down Markers for 340B Mega-Reg

Calls for program to be limited to "uninsured individuals" 

May 29, 2014—The nation's major drug companies gave White House officials a 16-page document last week detailing changes they want to see made to the 340B drug discount program in the forthcoming comprehensive 340B regulation. … [Read more...]

Federal Judge Invalidates 340B Orphan Drug Regulation

Rules that Congress did not grant HHS the requisite rulemaking authority 

May 23, 2014—A federal district judge ruled today that the Department of Health and Human Services has no authority under the 340B statute to promulgate regulations implementing the Affordable Care Act's 340B orphan drug exclusion, which applies to hospitals registered in 340B as critical access hospitals, sole community hospitals, rural referral centers, and free-standing … [Read more...]

340B Comes Up During House Hearing on Medicare Payments

Lawmakers' questions echo drugmakers' and private oncologists' complaints 

May 22, 2014—Reps. Renee Ellmers (R-N.C.), Tim Murphy (R-Pa.), and Bill Cassidy (R-La.) voiced concerns about the 340B program during a House Energy and Commerce Health Subcommittee hearing yesterday on Medicare payment reform.  … [Read more...]

HRSA on Track to Accept Bids to Run 340B Prime Vendor in June

Proposal that "offers the best value" to providers will be chosen, it says 

May 21, 2014—The Health Resources and Services Administration has taken the first step toward soliciting proposals to operate the 340B Prime Vendor Program. … [Read more...]

Study: Hospitals Pay for 60 Percent of Uncompensated Care

Second study finds cost of cancer drugs is skyrocketing 

May 14, 2014—Hospitals shoulder roughly 60 percent of the cost of uncompensated health care in America, more than four times the share borne by private office-based practices, Urban Institute researchers report in the latest edition of Health Affairs. … [Read more...]

HRSA Releases 340B Audit Statistics

Analysis covers the 51 audits conducted in fiscal 2012 

May 9, 2014—The Health Resources and Services Administration has published a brief statistical analysis of findings from its first round of 340B covered entity audits.   … [Read more...]

OIG Confirms 340B Guidance Is Silent on Medicaid MCO Duplicate Discounts

Groups said report implied that entities were ignoring a duty that, in fact, doesn't exist 

April 30, 2014—Federal 340B contract pharmacy guidance "does not specify" whether covered entities are responsible for ensuring that states do not collect manufacturer rebates for 340B-purchased drugs reimbursed by Medicaid managed care organizations, the Department of Health and Human Services Office of Inspector General says in a letter to two 340B provider groups. … [Read more...]

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