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Drugmakers Seek Big Changes to 340B Mega-guidance

PhRMA and BIO say HRSA needs to do more to rein program in 

November 20, 2015—Brand-name drug and biotech companies are pleased with parts of the proposed 340B program guidance that would raise the prices hospitals pay for drugs. But in their comments to the Health Resources and Services Administration, the two main trade groups for branded drug manufacturers say the guidance doesn't go far enough. … [Read more...]

AMA Calls for Ban on Consumer Drug Advertising

Part of new policy aimed at making prescription drugs more affordable 

November 20, 2015—The American Medical Association called for a ban on direct-to-consumer advertising for prescription drugs and medical devices at the group’s annual meeting in Atlanta. … [Read more...]

Orphan Drugs Approaching 20 Percent of Pharmaceutical Sales

Recent court decision foreclosed 340B discounts for rural, cancer hospitals 

November 11, 2015—The biopharmaceutical industry's affinity for orphan drugs keeps growing, with orphans projected to account for 20.2 percent of all prescription drug sales worldwide by 2020 – up from 11.2 percent in 2010 and 6.1 percent in 2000, a new study shows. … [Read more...]

Key Committee Chair Rep. Joe Pitts to Retire in 2016

Lawmaker has concerns about clarity of 340B program rules, oversight 

November 10, 2015—Rep. Joe Pitts (R-Pa.), the chairman of the House subcommittee with primary jurisdiction over the 340B program, is retiring from Congress when his current term ends in 2016. … [Read more...]

MedPAC Evaluates Options On Part B

May advise Congress to reduce Part B drug payments to 340B hospitals 

November 6, 2015 -- The Medicare Payment Advisory Commission discussed options to reduce Medicare Part B drug payments to hospitals participating in the 340B program during its November public meeting, held yesterday. MedPAC previously raised this issue in its June 2015 report to Congress but made no recommendations. … [Read more...]

OIG Plans to Issue Two Studies on 340B in FY 2016

Topics are Part B reimbursement and Medicaid managed care duplicate discounts 

November 5, 2015—The Department of Health and Human Services Inspector General plans to issue a pair of reports about the 340B program this fiscal year. … [Read more...]

OIG Clarifies Policy on Hospitals Waiving Patients’ Drug Charges

No sanctions for discounts or waivers on self-administered outpatient drugs Part B doesn't cover 

November 5, 2015—Hospitals needn't worry about getting slapped with federal anti-kickback sanctions if they waive all or part of what patients owe for self-administered drugs provided during outpatient stays and that Medicare Part B doesn't cover, the Department of Health and Human Services says. … [Read more...]

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