Influential Lawmakers Request Documents from 340B Stakeholders

by admin | March 7, 2012 1:40 pm

March 7, 2012—Four influential members of Congress have asked Safety Net Hospitals for Pharmaceutical Access (SNHPA), Apexus, Inc., which operates the 340B Prime Vendor Program (PVP), Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Industry Organization (BIO) for a wide range of documents about their involvement in the 340B program.

The March 5 letters[1] were sent by Sens. Charles Grassley of Iowa, ranking Republican on the Judiciary Committee; Michael Enzi of Wyoming, ranking Republican on the Health, Education, Labor and Pensions Committee; Orrin Hatch, ranking Republican on the Finance Committee; and Rep. Joe Pitts (R-PA), the chairman of the Energy and Commerce Subcommittee on Health.[ms-protect-content id=”2799″] They asked the organizations to respond by March 15.

“With the reliance on self-policing among participating manufacturers and covered entities and the increase in the number of new settings in which the program is offered, the risk of improper purchases or diversion of 340B drugs has significantly increased,” the lawmakers wrote. Shortcomings in the program identified by the Department of Health and Human Services Inspector General last June and the Government Accountability Office (GAO) last September “need resolution,” they said.

Questions for Hospitals

The members of Congress asked SNHPA, which represents hospitals enrolled in the drug discount program, for information “regarding your interpretation of the program’s original intent, program requirements, and thoughts on how to improve oversight of the program going forward.”

More specifically, they asked for all documents SNHPA has provided to its members regarding:

• The definition of a 340B patient
• The eligibility of hospital outpatient sites to acquire drugs at 340B discounts
• Inventory replenishment or virtual inventory programs
• Contract pharmacies
• Accountable care organizations (ACOs) and their interaction with 340B
• Hospitals on the cusp of the 340B disproportionate share hospital (DSH) eligibility threshold (i.e., those “on the bubble”)
• Program guidance documents provided in the members-only section of SNHPA’s web site
• All materials provided to covered entities in preparation for and during 340B conferences held in the past three years
• Any materials SNHPA can access through PVP’s 340B University

The lawmakers also put the following questions to the hospital group:

• Does SNHPA recommend organizational and administrative changes to members for the purposes of maximizing the 340B program benefits?
• How often does SNHPA communicate with the Office of Pharmacy Affairs (OPA) to coordinate 340B education services for covered entities?
• What conflict of interest policies are in place for SNHPA leadership, outside consultants, and legal counsel?
• Does SNHPA coordinate advocacy activities between SNHPA hospital members and other federal grantees participating in the 340B program?
• Does SNHPA track how its members use their 340B program savings?
• Does SNHPA provide guidance to members on how to best stretch scarce 340B resources?
• Does SNHPA have a protocol for identifying non-compliant 340B entities and a process under which it submits such information to [the Health Resources and Services Administration, HRSA] for additional oversight?

SNHPA issued a statement saying it “is committed to the integrity of the 340B program and looks forward to working with Congress in supplying the requested information.”

“The 340B program is vitally important to safety-net providers because it supports their ability to both improve access to care and increase much-needed health care services for their vulnerable patient populations,” the group said.

Questions for Apexus

The members of Congress asked Apexus/340B PVP for documents it has provided to covered entities about 340B patient eligibility or customer eligibility, to HRSA regarding any concerns of drug diversion or program misuse, and to 340B stakeholders as part of its 340B University.

They also asked Apexus about:

• Its nonprofit status and its contract with OPA to run PVP
• The value-added products and services it provides
• Its role in helping providers determine patient eligibility
• Its processes for determining covered entities’ 340B eligibility
• Its opinions of or involvement in the development of split billing software systems
• Whether it helps entities become 340B eligible
• Whether it knows of and has reported potential instances of covered entities improperly using group purchasing organizations
• Its 340B University program

Apexus issued a statement saying “we intend to fully cooperate with [the] request and will be providing a response in the near future.”

“Apexus believes the program is an essential federal program, and we are committed to providing value to the eligible organizations we serve,” it said. “Apexus actively supports HRSA’s current integrity initiatives to improve program oversight, and we are dedicated to promoting ethical standards to all participants.”

Questions for Manufacturers

Finally, the lawmakers asked the two pharmaceutical manufacturer associations for documents it provided to GAO for its recent study on 340B. They also asked for documents forwarded to HRSA regarding drug diversion, program misuse, or audits being conducted by their member companies and documents they can access through the 340B University offered through the prime vendor program.

The two associations were also asked to provide information regarding:

• Their policy positions on patient definition
• Examples of 340B drug diversion, in particular instances of drugs primarily used in an inpatient setting being purchased for outpatient use
• For details about any manufacturer audits of covered entities
• For examples of hoarding in the program that disrupted market supply
• For information provided to manufacturers related to verification of covered entities’ eligibility and to ensure that covered entities can access 340B discounts for eligible products
• For their members’ protocols to ensure the avoidance of duplicate discounts and/or federal overpayments of drugs purchased at 340B prices
• For information provided to members to ensure covered entities can access 340B discounts for eligible products
• For any information they provide to members related to the nondiscrimination requirement under the law to ensure covered entity access to 340B discounted products

The letter also requested:

• Documents provided by your associations to the Government Accountability Office (GAO) during their most recent investigations of the 340B program.
• Documents provided by your associations to the Health Resources Services Administration (HRSA) regarding any concerns of drug diversion or program misuse.
• Documents provided to HRSA regarding audits conducted by companies that are members of your associations.

A spokesman for BIO said the group was reviewing the letter and would respond to the lawmakers as requested. PhRMA Senior Vice President Matt Bennett likewise said “we currently are reviewing the lawmakers’ request for information and look forward to working with Congress on this important issue.”

Mr. Bennett additionally told the Bureau of National Affairs news service that “strong oversight is essential to ensuring the [340B] program adheres to its original intent, which is to benefit uninsured indigent patients who receive outpatient care in true safety net facilities.”[/ms-protect-content]

Source URL: https://340bemployed.org/influential-lawmakers-request-documents-from-340b-stakeholders/

---