Overview of the 340B Drug Pricing Program

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Health Resources and Services Administration, Department of Health and Human Services. 2014c. Audit results: Office of Pharmacy Affairs update. http://www.hrsa.gov/opa/ updates/140509auditresults.html. Health Resources and Services Administration, Department of Health and Human Services. 2014d. FAQs: 340B Drug Pricing Program. http://www.hrsa.gov/opa/faqs/index.html. Health Resources and Services Administration, Department of Health and Human Services. 2014e. Interpretive rule: Implementation of the exclusion of orphan drugs for certain covered entities under the 340B program. Rockville, MD: HRSA. Health Resources and Services Administration, Department of Health and Human Services. 2014f. Medicaid exclusion/Duplicate discount prohibition. http://www.hrsa.gov/opa/ programrequirements/medicaidexclusion/index.html. Health Resources and Services Administration, Department of Health and Human Services. 2014g. Orphan drugs exclusion. http://www.hrsa.gov/opa/programrequirements/ orphandrugexclusion/index.html. Health Resources and Services Administration, Department of Health and Human Services. 2014h. Program integrity: Audit results. http://www.hrsa.gov/opa/programintegrity/auditresults/ results.html. Health Resources and Services Administration, Department of Health and Human Services. 2013. 340B Drug Pricing Program notice. Release no. 2013–3. Clarification of eligibility for hospitals that are not publicly owned or operated. March 7. http://www.hrsa.gov/opa/ programrequirements/policyreleases/nondiscrimination05232012.pdf. Health Resources and Services Administration, Department of Health and Human Services. 2012. 340B Drug Pricing Program notice. Release no. 2011–1.1. Clarification of nondiscrimination policy. May 23. http://www.hrsa.gov/opa/programrequirements/policyreleases/ nondiscrimination05232012.pdf. Health Resources and Services Administration, Department of Health and Human Services. 2010. Notice regarding 340B Drug Pricing Program—Contract pharmacy services. Final notice. Federal Register 75, no. 43 (March 5): 10272–10279. Health Resources and Services Administration, Department of Health and Human Services. 1996. Notice regarding Section 602 of the Veterans Health Care Act of 1992 patient and entity eligibility. Final notice. Federal Register 61, no. 207 (October 24): 55156–55158. Hirsch, B. R., S. Balu, and K. A. Schulman. 2014. The impact of specialty pharmaceuticals as drivers of health care costs. Health Affairs 33, no. 10 (October 1): 1714–1720. IMS Institute for Healthcare Informatics. 2014. IMS health study: Spending growth returns for U.S. medicines. News release. April 15. Overview of the 340B Drug Pricing Program | May 2015 23
IMS Institute for Healthcare Informatics. 2012. The use of medicines in the United States: Review of 2011. Parsippany, NJ: IMS Institute for Healthcare Informatics. Medicare Payment Advisory Commission. 2013. Report to the Congress: Medicare and the health care delivery system. Washington, DC: MedPAC. Medicare Payment Advisory Commission. 2007. Report to the Congress: Medicare payment policy. Washington, DC: MedPAC. Office of Inspector General. 2015. Examining the 340B Drug Pricing Program. Testimony of Ann Maxwell, Assistant Inspector General, Office of Evaluation and Inspections, Office of Inspector General, Department of Health and Human Services, before the Subcommittee on Health, Committee on Energy and Commerce, U. S. House of Representatives. March 5. Office of Inspector General, Department of Health and Human Services. 2014. Memorandum report from Stuart Wright, Deputy Inspector General, to Mary K. Wakefield, Administrator, Health Resources and Services Administration. Contract pharmacy arrangements in the 340B Program, OEI–05–13–00431. February 4. Office of Inspector General, Department of Health and Human Services. 2011. State Medicaid policies and oversight activities related to 340B-purchased drugs. Washington, DC: OIG. Office of Inspector General, Department of Health and Human Services. 2006. Review of 340B prices. OEI–05–02–00073. Washington, DC: OIG. Safety Net Hospitals for Pharmaceutical Access. 2015. Analysis: 340B DSH hospitals have high low-income patient loads and provide significant uncompensated care. http://www.snhpa. org/340b-resources/why-340b-matters/340b-dsh-hospital-safety-net-role. U.S. House of Representatives. 1992. The Medicaid drug rebate amendments of 1992. Report 102–384, part 2. 102nd Cong., 2nd sess. Wallack, M. C., and S. B. Herzog. 2011. Demonstrating the value of the 340B Program to safety net hospitals and the vulnerable patients they serve. Perspectives from SNHPA members. Washington, DC: Safety Net Hospitals for Pharmaceutical Access. 24 Overview of the 340B Drug Pricing Program | May 2015
Page 1 and 2: M a y 2 0 1 5 Report to the Congres
Page 4: Acknowledgments The Commission bene
Page 8 and 9: Executive summary The 340B Drug Pri
Page 10: Overview of the 340B Drug Pricing P
Page 13 and 14: Several types of providers are elig
Page 15 and 16: Formula for calculating 340B ceilin
Page 17 and 18: HRSA’s current guidance, released
Page 19 and 20: Figure 1 FIGURE X Title here The nu
Page 21 and 22: Figure 3 FIGURE X Medicare spending
Page 23 and 24: Medicare spending for outpatient ch
Page 25 and 26: (Health Resources and Services Admi
Page 27 and 28: Endnotes 1 Although there are no re
Page 29 and 30: 19 This study excluded physician-ad
Page 31: References Apexus. 2014. 340B Unive
Page 36 and 37: The 340B ceiling prices represent t
Page 38 and 39: Endnotes 1 According to the Health
Page 40 and 41: About MedPAC
Page 42 and 43: Commission members Glenn M. Hackbar
Page 44: 425 I Street, NW • Suite 701 •

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