July 11, 2014—The Senate Finance Committee's Democratic chairman and a senior Republican member want Gilead Sciences to justify the $1,000-a-day price of its hepatitis C virus drug Sovaldi.[ms-protect-content id="2799"] In a July 11 joint letter, Sens. Ron Wyden (D-Ore.) and Charles Grassley (R-Iowa) said that, "given the impact Sovaldi's cost will have on Medicare, Medicaid … [Read more...]
Some Hospitals Report Glitch in 340B Registration
HRSA believes it has fixed the Issue, which is limited to certain web browsersJuly 8, 2014—The Health Resources and Services Administration says it believes it has resolved technical issues that prevented hospitals using older versions of the Internet Explorer web browser from registering parent and child sites in 340B due to their browser's incompatibility with HRSA's revamped hospital registration interface.[ms-protect-content id="2799"] HRSA is … [Read more...]
HRSA Limits 340B Entities’ Ability to Dispute Adverse Audits
Will no longer issue preliminary reports to audited providersJuly 7, 2014—The Health Resources and Services Administration has truncated the 340B audit dispute process, ending one of two opportunities health care providers had to challenge adverse findings.[ms-protect-content id="2799"] HRSA announced the change in audit procedures in a July 3 posting on the Office of Pharmacy Affairs website. Under the old process, if an audit … [Read more...]
Feds Seek Extension for Filing in 340B Orphan Drug Lawsuit
Talks with PhRMA cited in request for a delay until July 14July 3, 2014—Federal government and drug industry lawyers have discussed but been unable to agree on the terms of a cooperative resolution to the drugmakers' latest motion in their suit over the 340B orphan drug exclusion regulation, the government said in a July 2 filing in the case.[ms-protect-content id="2799"] The government currently has a July 7 deadline to respond to … [Read more...]
340B Hospital Recertification Due to Begin Aug. 6
Hospitals will have five weeks to certify they are eligible and obey all requirementsJune 26, 2014—Hospitals will have from Aug. 6 through Sept. 10 to recertify their eligibility for the 340B drug discount program, the Health Resources and Services Administration announced during a webinar today.[ms-protect-content id="2799"] HRSA said the hospital executive who legally authorizes his or her institution to participate in the drug discount program—typically, … [Read more...]
HRSA Posts Six More 340B Provider Audit Summaries for FY 2013
No adverse findings in five of the auditsJune 26, 2014—The Health Resources and Services Administration yesterday posted six more brief summaries of results from the 340B covered entity audits it conducted during fiscal year 2013.[ms-protect-content id="2799"] The audits were of four disproportionate share hospitals, one children's hospital, and one critical access hospital. HRSA made no adverse findings in five of … [Read more...]
WSJ Scrutinizes Florida Oncology Practice
The Community Oncology Alliance has been slinging mud at 340B hospitals for months. Now, a Wall Street Journal investigation has found that a Florida oncology practice with close ties to COA racks up big dollars billing Medicare for the anemia drug Procrit, which "can speed tumor growth and hasten death in cancer patients." In fact, one-sixth of the $128 million that Medicare … [Read more...]