Congress and the 340B Program: What the Past Says About 2015 · 3/3/2015 · Maureen Testoni Senior Vice President and General Counsel SNHPA [email protected] . Author: Valerie

© 2014 Safety Net Hospitals for Pharmaceutical Access 1 © 2014 Safety Net Hospitals for Pharmaceutical Access

Congress and the 340B Program: What the Past Says About 2015

Maureen Testoni Senior Vice President and General Counsel Safety Net Hospitals for Pharmaceutical Access February 13, 2015

© 2014 Safety Net Hospitals for Pharmaceutical Access 2

Timeline of Congressional Activity

Sept. 2011

•  GAO publishes report on 340B program •  Chairman Upton and Sens. Hatch and Grassley write to

HRSA demanding more oversight

Dec. 2012 •  HRSA begins audits of covered entities

Spring & Summer 2012

•  Members of Congress write to 340B stakeholder organizations and to hospitals inquiring about use of 340B

•  HRSA begins recertification of covered entities



Jan 2013

•  6 Members of Congress write to HRSA requesting audit and recertification results

July 2013

• Senate Appropriations bill reaffirms 340B’s purpose

July 2013

• Sen. Grassley questions Walgreens about contract pharmacy arrangements



Aug 2013

• Members of Congress express bipartisan support for 340B

Sept. 2013

•  Sen. Grassley sends letters to two drug companies

2013 • Committees request briefings from

HRSA


Congress in 2014 •  Questions raised at various Congressional

hearings:   Can 340B save money for Medicare Part B?   Should purpose of 340B be reevaluated?   Too much contract pharmacy growth?   Impact on oncology market?   How are 340B entities using their savings?

•  Members of Congress express bipartisan support for 340B (again)

•  FY15 Appropriations 340B Language


FY15 Appropriations 340B Language December 2015 compromise language between House and Senate appropriators

"HRSA is required to make 340B ceiling prices available to covered entities through a secure Web site," the report's passage about 340B reads. "Funding was provided in fiscal year 2014 to implement such requirements, including the creation of a Web site. HRSA is directed to provide a briefing to update the House and Senate Appropriations Committees on implementation by March 3, 2015."

"There are concerns that HRSA has been unable to demonstrate that the 340B program benefits the most vulnerable patients...In order to best serve the public need, the program should examine its ability to ensure patients' access to 340B savings for outpatient drugs. HRSA is directed to work with covered entities to better understand the way these entities support direct patient benefits from 340B discounted sales."


Medicare Part B Payments:

•  Will determine how much Medicare Part B spending could be reduced if Medicare were able to share in the savings for 340B-purchased drugs.

Medicare Part D Audits

Duplicate discounts for 340B purchased drugs:

•  Will assess the risk of manufacturer discounts and rebates both being paid on 340B-purchased drugs dispensed to Medicaid managed care beneficiaries.

•  Will describe states’ efforts to prevent such rebate requests

OIG Reports Expected in 2015


•  Second GAO study on the 340B program

Topics may include:

-  comparisons between 340B and non-340B hospitals and their use of outpatient clinics, and involvement in oncology

-  the level of charity care and uncompensated care provided by 340B and non 340B hospitals

-  how changes made by the ACA might impact 340B, especially in areas such as Medicaid enrollment and disproportionate share payments

GAO Report Expected in 2015


Statistics for 340B Disproportionate Share (DSH) Hospitals

•  340B DSH hospitals provide:   Twice as much care to Medicaid and low-income

Medicare patients (41.9% vs. 18.1%)   Almost twice as much uncompensated care

($24.6 billion vs. $12.9 billion)   Compared to non-340B hospitals, more 340B

hospitals provide services that are viewed as “unprofitable,” but have tremendous value for the community, such as:

•  Children’s wellness programs •  Psychiatric child/adolescent services •  Crisis prevention

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Thank you!

Maureen Testoni Senior Vice President and General Counsel

SNHPA [email protected]

Documents

Congress and the 340B Program: What the Past Says About 2015 · 3/3/2015 · Maureen Testoni Senior Vice President and General Counsel SNHPA [email protected] . Author: Valerie