U.S. Sen. Mike Braun (R-Ind.) did not seek to amend a PBM oversight bill that is being marked up today to require 340B hospitals and possibly other covered entities to be more transparent about how they use money saved or earned through the 340B program.
The Senate Health, Education, Labor, and Pensions Committee began meeting this morning to markup four bills addressing access to generic drugs and oversight of pharmacy benefit managers.
It is the resumption of a May 2 hearing that was recessed amid Republican procedural complaints. News organization STAT reported at that time that Braun would offer an amendment to the PBM bill, which he is a co-sponsor of, to “make hospitals that serve uninsured and underinsured patients disclose how they use discounts that drug companies are required to provide.”
Committee chair Bernie Sanders (I-Vt.) said about 90 minutes into today’s hearing that all amendments that were going to be offered to all bills under consideration had been offered. Braun offered one amendment to the PBM bill during the hearing, but it was not related to 340B.
What exactly Braun was going to offer about 340B transparency was never clear. He has reintroduced a bill, S. 1133, he sponsored in the last session of Congress to require all 340B covered entities to let the Department of Health and Human audit, at HHS’s expense, “the records of the entity to determine how net income from purchases under this section are used by the covered entity.” S. 1113 also would require entities to “retain such records and provide such records and reports” as HHS determines necessary.
The American Society of Health-System Pharmacists sent members a “call to action” email yesterday asking them to urge their senators to oppose S. 1113.
Maneuvering in the House
Meanwhile, pressure is building for U.S. House Energy & Commerce health subcommittee chair Brett Guthrie (R) to allow a vote next week on the Republican vice chair’s draft 340B legislation that reportedly would split the subcommittee along party lines.
Rep. Larry Bucshon’s (R-Ind.) draft bill would impose new 340B reporting requirements on disproportionate share hospitals and potentially other covered entities as well. The subcommittee reportedly will hold a hearing Wednesday, May 17, to markup up to 17 bills to foster transparency and competition in health care. It had not yet been announced as of early this morning.
Lobbyists say Guthrie does not want his subcommittee to markup any bills that lack bipartisan support. One said all subcommittee Democrats would vote against Bucshon’s bill. Hospital groups are telling their members to tell their elected officials to reject significant new reporting requirements for hospitals, and that any measures to increase reporting requirements for 340B providers should include new transparency requirements for drug manufacturers.
Lobbyists said early last weekend that the subcommittee would not move any 340B legislation in May. Pressure for a vote on Bucshon’s bill apparently grew during the weekend and Monday. Lobbyists said late Tuesday and mid-day yesterday that Republican and Democratic subcommittee staffers now were saying that Bucshon’s bill would be brought up for a vote on the 17th.
One lobbyist said that if all subcommittee Democrats in fact will oppose Bucshon’s bill, Bucshon might symbolically offer then withdraw it.
ASAP 340B One-Pagers
ASAP 340B, the group Pharmaceutical Research and Manufacturers of America and the National Association of Community Health Centers co-founded to promote 10 joint principles to guide federal 340B legislation, has released targeted one-page explainers for health centers, HIV and STD care providers, and rural hospitals.
The documents for health centers and HIV and STD clinics are mostly the same and emphasize ASAP 340B’s positions on the intent of 340B, contract pharmacy, PBMs, creating a neutral claims data clearinghouse, patient definition, and transparency. The document for rural hospitals leaves out the claims data clearinghouse and includes that ASAP 340B backs letting critical access hospitals that convert into rural emergency hospitals keep their 340B eligibility if they meet the same 340B standards as CAHs.
All three documents end with an invitation “to work with ASAP 340B to realign the 340B program in the interest of true safety-net providers and the communities they serve.”
NACHC Director, Policy & Regulatory Affairs Vacheria Keys said yesterday that her group “had productive conversations” at last week’s second annual 340B Grantees Conference in New Orleans.
“It’s clear that there is broad support for strengthening the program through legislation as we work to find alignment on 340B policy,” Keys said. “We welcome input and feedback from all stakeholders and will continue to work with 340B covered entities through ASAP 340B to further develop these ideas into legislation.”