by admin | March 24, 2015 1:51 pm
March 24, 2015—Members of a House health subcommittee expressed strong support for the 340B program during a hearing today, with some stating more should be done to clarify program requirements and enhance program transparency. [ms-protect-content id=”2799″]
“It looks like Congress is going to have some follow-up responsibilities,” said Chairman Joe Pitts (R-Pa.) of the House Energy & Commerce Health Subcommittee said at the end of the 90-minute session.
“This program, designed to stretch scarce federal dollars, is critically important for indigent and low-income patients who may otherwise be unable to access needed drugs or afford treatment,” Rep. Pitts said in his opening statement. But, he continued, “unclear program guidelines and inconsistent oversight is partially responsible for some of the challenges the program currently faces in being accountable to taxpayers, patients, and stakeholders.”
“Covered entities and manufacturers understandably cannot comply with rules that are unclear,” Rep. Pitts said, noting a federal district court’s ruling last year that limited the Health Resources and Services Administration’s power to regulate the 340B program. “One thing I hope we can all agree on, is that to preserve the 340B program and ensure that it is serving those who most need help, greater oversight and transparency is needed to increase the program’s accountability. Today’s hearing marks the first step in that direction.”
Rep. Fred Upton (R-Mich.), the full Energy & Commerce Committee chairman, said “through the years, the [340B] program has allowed covered entities to stretch scarce resources to better serve millions of patients in Michigan and across the country who are uninsured, underinsured, or dependent on programs like Medicaid and Medicare.”
“I’ve seen firsthand the great work this program does in my district,” he said. “It is in the interest of good government to see program integrity strengthened, the program’s operating parameters clarified, and the program’s rules consistently enforced. I believe that the biggest supporters of the program should be the biggest champions of ensuring the 340B program is well-run in a manner that is transparent and accountable to all stakeholders.”
Rep. Gene Green (D-Texas,) the subcommittee’s ranking Democrat, noted that the 340B statute “does not specify how savings must be used by covered entities, a point that has been brought up by both proponents and opponents of the program.” But he continued, the Government Accountability Office has reported that covered entities use their 340B savings “to provide more care to more patients, including medication, that would otherwise be unaffordable to those they serve.”
“I cannot underscore how important the 340B program continues to be for hospitals and other entities that provide care to underserved patients,” Rep. Green said. “With that said, the program has grown significantly and oversight is appropriate to ensure it is working properly.” While HRSA has implemented GAO oversight improvement recommendations, including conducting hundreds of covered entity audits, “additional administration action and, potentially, additional authorities may be needed for HRSA to conduct proper oversight,” he said. Congress should let HRSA release its forthcoming omnibus 340B program guidance and analyze its impact before making changes to 340B, he said.
“The 340B program has made the difference between patients getting access to lifesaving health care services and drugs or going without,” said Rep. Frank Pallone (D-N.J.), the full committee’s ranking Democrat. “Of course, for this program to continue to function as Congress intended, proper oversight is of paramount importance. I think we can all agree here today that the mission is sound, and a continued emphasis on program integrity can make the 340B program stronger now and in coming years.”
The subcommittee heard testimony[1] from HRSA, the GAO, and the Health and Human Services Office of Inspector General. HRSA Deputy Administrator Diana Espinosa spoke on HRSA’s behalf, accompanied by Office of Pharmacy Affairs Director Cmdr. Krista Pedley. Director of Health Care Debra Draper represented the GAO and Assistant Inspector General Ann Maxwell represented the OIG.
As previously reported based on advance copies of their written statements, the GAO confined its remarks to recapping HRSA’s implementation of the GAO’s past recommendations. HRSA described how it has implemented both the GAO and OIG’s recommendations, how it is using its additional funding from Congress, and what it will include in its planned omnibus program guidance.
The OIG said more transparency is needed in both 340B ceiling prices and Medicaid claims for 340B-purchased drugs. It said HRSA should:
During the question-and-answer portion of the hearing, some committee members appeared concerned about the effect of last year’s court ruling regarding the 340B orphan drug exclusion on HRSA’s ability to regulate the program. Rep. Pallone, for example, asked HRSA Deputy Administrator Espinosa if issuing program guidance instead of regulations would be “an adequate long-term solution.” Likewise, Rep. Morgan Griffith (R-Va.) told her, “I think we would give you [regulatory] authority to define what a patient is if you came to us for it.”
Rep. Renee Ellmers (R-N.C.) questioned all three witnesses about how hospitals enrolled in 340B use their program savings, and expressed concern when told that the 340B statute does not impose requirements on hospitals as to how those savings should be used.
Reps. Kathy Castor (D-Fla.), Gus Bilirakis (R-Fla.), and Billy Long (R-Mo.), meanwhile, asked questions about manufacturer overcharging of covered entities and HRSA’s plans to make 340B ceiling prices available to entities on a secure website later this year. [/ms-protect-content]
Source URL: https://340bemployed.org/house-subcommittee-holds-hearing-on-340b/
Copyright ©2024 340bemployed.org unless otherwise noted.