February 24, 2011—Jeff Bingaman of New Mexico, who is widely considered the U.S. Senate's leading authority on 340B issues, will retire when his current term expires following the 2012 elections. The five-term veteran made the announcement on Feb. 18 in Albuquerque. Meanwhile, GOP Sen. John Thune of South Dakota, another strong 340B supporter, has decided not to seek his … [Read more...]
OPA to Announce Cutbacks in 340B Technical Assistance
Some stakeholders will get no assistance while others will see their services reduced.February 17, 2011—The Office of Pharmacy Affairs (OPA) will formally announce in coming days that, due to a shortage of funding, it will no longer provide free technical assistance to all 340B stakeholders and will provide covered entities with differing levels of service depending on their types. OPA Director Krista Pedley disclosed the cutbacks on Feb. 10 during the 340B … [Read more...]
Focus on Health Care Fraud Likely to Continue This Year and Beyond
Request for doubling of funds, scads of pending whistleblower cases signal more scrutiny of drug makers.February 16, 2011—Last year, the federal government won or negotiated a record $2.5 billion in health care fraud judgments and settlements, with much of that amount coming from pharmaceutical manufacturers. Now, with the Obama administration seeking $581 million for health care fraud and abuse control in fiscal 2012—nearly double the current amount—and with nearly 200 active … [Read more...]
HRSA Sends Draft Orphan Drug Regulations to OMB for Review
Rules are expected to define the conditions under which the prohibition applies.February 16, 2011—The Health and Human Resources Administration (HRSA) has sent the White House Office of Management and Budget (OBM) draft proposed regulations to implement health care reform's partial prohibition on 340B discounts for orphan drugs. OMB, which reviews all federal rules prior to their publication in the Federal Register, received the draft from HRSA on Feb. … [Read more...]
Proposed 340B User Fee Would be Modeled on VA Program
Document implies that levy might become drug discount program's sole funding source.February 16, 2011—The Obama administration's proposed 0.1 percent user fee for safety-net providers enrolled in the 340B program would be patterned on the Department of Veterans Affairs' (VA) "industrial funding fee"—a 0.5 percent surcharge on pharmaceuticals and other health care products and services that federal agencies and their authorized contractors buy from the VA's … [Read more...]
Obama Calls for 340B User-Fee System
President proposes a penny charge on every $10 in drug purchases to fund OPA.February 14, 2011—The Obama administration today proposed the first-ever user fee for providers enrolled in the 340B drug discount program, a 0.1 percent levy on each purchase to pay for the program's operating expenses and improve its administration and oversight. The White House included the user fee plan in its formal budget request to Congress for the fiscal year that … [Read more...]
U.S. Senate Rejects Measure to Repeal Health care Reform
Vote comes just days after a judge declares the entire law unconstitutional.February 3, 2011—The Democratic-controlled U.S. Senate yesterday defeated a Republican-sponsored amendment to an aviation bill that would have repealed last year's health care reform law, including its expansion of the 340B drug discount program and gradual elimination of the "donut hole" in Medicare beneficiaries' Part D prescription drug benefits. The vote came two weeks … [Read more...]