Reimbursement Policy and Drug Shortages

References

• Abutaleb Y (2019) Trump administration proposes first rule on health-care cost transparency. Washington Post (July 29), https://www.washingtonpost.com/health/trump-administration-proposes-first-health-care-cost-transparency-rule/2019/07/29/7a6c3334-b23c-11e9-951e-de024209545d_story.html.Google Scholar
• AHA (2011) AHA survey on drug shortages. Technical report, American Hospital Association, Chicago.Google Scholar
• AHA (2019) Survey: Drug shortages cost hospitals $360m annually (June 27), https://www.aha.org/news/headline/2019-06-27-survey-drug-shortages-cost-hospitals-360m-annually.Google Scholar
• Alpert A, Hsi H, Jacobson M (2017) Evaluating the role of payment policy in driving vertical integration in the oncology market. Health Affairs (Millwood) 36(4):680–688.Crossref, Google Scholar
• ASA (2012) 2012 ASA drug shortage survey results. Technical report, American Society of Anesthesiologists, Schaumburg, IL.Google Scholar
• ASHP (2023) ASHP 2023 drug shortages survey report. Accessed August 30, 2024, https://www.ashp.org/-/media/assets/drug-shortages/docs/ASHP-2023-Drug-Shortages-Survey-Report.pdf.Google Scholar
• ASHP (2024) National drug shortages: January 2001 to June 2024. Accessed August 30, 2024, https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics.Google Scholar
• ASPE (2011) Economic analysis of causes of drug shortages. Technical report, U.S. Department of Health and Human Services, Washington, DC.Google Scholar
• Avenue N (2019) Will President Trump’s hospital price transparency plan lower costs? Forbes.Google Scholar
• Beauchamp TL, Childress JF (2001) Principles of Biomedical Ethics (Oxford University Press, Oxford, UK), 227–339.Google Scholar
• Berndt ER, Conti RM, Murphy SJ (2017) The landscape of US generic prescription drug markets, 2004-2016. Technical report, National Bureau of Economic Research, Cambridge, MA.Google Scholar
• Bodenreider O, Rodriguez LM (2014) Analyzing us prescription lists with Rxnorm and the ATC/DDD index. Proc. AMIA Annual Sympos., vol. 2014 (American Medical Informatics Association, Washington, DC), 297–306.Google Scholar
• Burns LR (2002) The Health Care Value Chain: Producers, Purchasers, and Providers, 1st ed. (Jossey-Bass, San Francisco, CA).Google Scholar
• Cachon GP (2003) Supply chain coordination with contracts. Henderson SG, Nelson BL, eds. Handbooks in Operations Research and Management Science, vol. 11 (North Holland, Amsterdam), 227–339.Crossref, Google Scholar
• Cherici C, Frazier J, Feldman M, Gordon B, Petrykiw CA, Russell WL (2011) Navigating drug shortages in American healthcare: A premier healthcare alliance analysis. Premier Inc. (March), https://nebula.wsimg.com/2045d9849bde3c9bf21b42ff5fbdeb7e?AccessKeyId=62BC662C928C06F7384C&disposition=0&alloworigin=1.Google Scholar
• Cho S-H, Zhao H (2018) Healthcare supply chain. Tayur S, Dai T, eds. Handbook of Healthcare Analytics: Theoretical Minimum for Conducting 21st Century Research on Healthcare Operations (John Wiley & Sons, Hoboken, NJ), 159–185.Crossref, Google Scholar
• Danzon PM, Wilensky GR, Means KE (2005) Alternative strategies for Medicare payment of outpatient prescription drugs—Part B and beyond. Amer. J. Managed Care 11(3):9.Google Scholar
• Emanuel EJ (2011) Shortchanging cancer patients. New York Times (August 6), https://www.nytimes.com/2011/08/07/opinion/sunday/ezekiel-emanuel-cancer-patients.html.Google Scholar
• FDA (2011) A review of FDA’s approach to medical product shortages. Technical report, U.S. Food and Drug Administration, Washington, DC.Google Scholar
• FDA (2013) Strategic plan for preventing and mitigating drug shortages. Technical report, U.S. Department of Health and Human Services, Washington, DC.Google Scholar
• FDA (2018) FDA drug shortage task force listening session. Technical report, U.S. Department of Health and Human Services, Washington, DC.Google Scholar
• FDA (2019) Correspondence with the authors. Technical report, Food and Drug Administration, Washington, DC.Google Scholar
• FDA (2020) Drug shortages: Root causes and potential solutions. Technical report, U.S. Department of Health and Human Services, Washington, DC.Google Scholar
• FDA (2022) Quality management maturity: Essential for stable U.S. supply chains of quality pharmaceuticals. Accessed August 30, 2024, https://www.fda.gov/media/157432/download.Google Scholar
• Fox ER, Sweet BV, Jensen V (2014) Drug shortages: A complex health care crisis. Mayo Clinic Proc. 89(3):361–373.Crossref, Google Scholar
• Fox ER, Birt A, James KB, Kokko H, Salverson S, Soflin DL (2009) ASHP guidelines on managing drug product shortages in hospitals and health systems. Amer. J. Health-System Pharmacy 66(15):1399–1406.Crossref, Google Scholar
• GAO (2011) Drug shortages: FDA’s ability to respond should be strengthened. Technical report, U.S. Government Accountability Office, Washington, DC.Google Scholar
• GAO (2014) Drug shortages: Public health threat continues, despite efforts to help ensure product availability. Technical report, U.S. Government Accountability Office, Washington, DC.Google Scholar
• GAO (2016) Drug shortages: Certain factors are strongly associated with this persistent public health challenge. Technical report, U.S. Government Accountability Office, Washington, DC.Google Scholar
• Gottlieb S (2018) FDA is advancing new efforts to address drug shortages. Accessed July 2023, https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-formation-new-drug-shortages-task-force-and-fdas.Google Scholar
• Gray J, Tomlin B (2016) Contract manufacturing and quality risk: Theory and empirical evidence. Working paper, Tuck School of Business, Hanover, NH.Google Scholar
• Gray JV, Siemsen E, Vasudeva G (2015) Colocation still matters: Conformance quality and the interdependence of R&D and manufacturing in the pharmaceutical industry. Management Sci. 61(11):2760–2781.Link, Google Scholar
• Hemphill TA (2016) U.S. pharmaceutical gray markets: Why do they persist—And what to do about them? Bus. Soc. Rev. 121(4):529–547.Crossref, Google Scholar
• HSCA (2011) Group purchasing organizations (GPOs) work to maintain access to product supply for America’s health care providers. Technical report, Healthcare Supply Chain Association, Washington, DC.Google Scholar
• HSGAC (2023) Short supply: The health and national security risks of drug shortages. Accessed August 30, 2024, https://www.hsgac.senate.gov/wp-content/uploads/2023-06-06-HSGAC-Majority-Draft-Drug-Shortages-Report.-FINAL-CORRECTED.pdf.Google Scholar
• Iacocca K, Zhao Y, Fein A (2013) Resell versus direct models in brand drug distribution. Internat. J. Pharmaceutical Healthcare Marketing 7(4):324–340.Crossref, Google Scholar
• ISMP (2018) Drug shortages continue to compromise patient care. Technical report, Institute for Safe Medication Practice, Plymouth, PA.Google Scholar
• Jacobson M, Alpert A, Duarte F (2012) Prescription drug shortages: Reconsidering the role of Medicare payment policies. Technical report, Health Affairs, Washington, DC.Google Scholar
• Jacobson M, Earle CC, Price M, Newhouse JP (2010) How Medicare’s payment cuts for cancer chemotherapy drugs changed patterns of treatment. Health Affairs (Millwood) 29(7):1391–1399.Crossref, Google Scholar
• Jia J, Zhao H (2017) Mitigating the U.S. drug shortages through Pareto-improving contracts. Production Oper. Management 26(8):1463–1480.Crossref, Google Scholar
• Jia J, Zhao H (2019) Reflection on mitigating the U.S. drug shortages through Pareto-improving contracts. Production Oper. Management 28(11):2716–2718.Crossref, Google Scholar
• Känzig DR (2021) The macroeconomic effects of oil supply news: Evidence from OPEC announcements. Amer. Econom. Rev. 111(4):1092–1125.Crossref, Google Scholar
• Keith K (2019) Unpacking the executive order on health care price transparency and quality. Health Affairs Forefront (June 25), https://www.healthaffairs.org/content/forefront/unpacking-executive-order-health-care-price-transparency-and-quality.Google Scholar
• Lee J, Lee HS, Shin H, Krishnan V (2021) Alleviating drug shortages: The role of mandated reporting induced operational transparency. Management Sci. 67(4):2326–2339.Link, Google Scholar
• Levinson DR (2005) Medicaid Drug Price Comparison: Average Sales Price to Average Wholesale Price (Office of the Inspector General, Washington, DC).Google Scholar
• Markowski ME (2012) Drug shortages: The problem of inadequate profits. Accessed July 18, 2023, https://dash.harvard.edu/handle/1/11940215.Google Scholar
• Mullen P (2007) The arrival of average sale price. Biotech. Healthcare 4(3):48.Google Scholar
• Muoio D (2024) HHS, FTC want to know if GPOs, drug wholesalers are fueling generic drug shortages. Accessed August 29, 2024, https://www.fiercehealthcare.com/regulatory/hhs-ftc-want-know-if-gpos-drug-wholesalers-are-fueling-generic-drug-shortages.Google Scholar
• Naumov S, Noh IJ, Zhao H (2025) Evaluating quality reward and other interventions to mitigate us drug shortages. J. Oper Res. Management 71(3):335–372.Google Scholar
• Navarro R (2009) Managed Care Pharmacy Practice (Jones & Bartlett Learning, Burlington, MA).Google Scholar
• NORC (2019) Recent trends in hospital drug spending and manufacturer shortages. Technical report, NORC at the University of Chicago, Chicago.Google Scholar
• Persad G, Wertheimer A, Emanuel EJ (2009) Principles for allocation of scarce medical interventions. Lancet 373(9661):423–431.Crossref, Google Scholar
• PEW (2016) The ‘least costly alternative’ approach for payment of Medicare part B drugs. Accessed September 9, 2024, https://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2016/03/the-least-costly-alternative-approach-for-payment-of-medicare-part-b-drugs.Google Scholar
• Ridley DB, Lee CY (2020) Does Medicare reimbursement drive up drug launch prices? Rev. Econom. Statist. 102(5):980–993.Crossref, Google Scholar
• Saedi S, Kundakcioglu OE, Henry AC (2016) Mitigating the impact of drug shortages for a healthcare facility: An inventory management approach. Eur. J. Oper. Res. 251(1):107–123.Crossref, Google Scholar
• Scheunemann LP, White DB (2011) The ethics and reality of rationing in medicine. Chest 140(6):1625–1632.Crossref, Google Scholar
• Schwarz LB (2010) Healthcare-product supply chains: Medical surgical supplies, pharmaceuticals, and orthopedic devices: Flows of product, information, and dollars. Yih Y, Duffy V, Yu D, eds. Handbook of Healthcare Delivery Systems (CRC Press, Boca Raton, FL), 45–63.Google Scholar
• Schwarz LB, Zhao H (2011) The unexpected impact of information sharing on US pharmaceutical supply chains. INFORMS J. Appl. Analytics 41(4):354–364.Link, Google Scholar
• Siegel J (2006) Impact of the Medicare prescription drug improvement and Modernization Act on the management of colorectal cancer. Amer. J. Health. Systems Pharmacy 63(suppl 2):S18–S21.Crossref, Google Scholar
• Stomberg C (2016) Drug shortages, pricing, and regulatory activity. NBER Working Paper No. 22912, National Bureau of Economic Research, Cambridge, MA.Google Scholar
• Tucker EL, Daskin MS, Sweet BV, Hopp WJ (2020) Incentivizing resilient supply chain design to prevent drug shortages: Policy analysis using two- and multi-stage stochastic programs. IISE Trans. 52(4):394–412.Crossref, Google Scholar
• Tyler LS (2002) Understanding drug and managing shortages. Proc. Breakfast Sympos. 37th ASHP Midyear Clinical Meeting, 1–13.Google Scholar
• Ventola CL (2011) The drug shortage crisis in the United States. Pharmacy Therapeutics 36(11):740–757.Google Scholar
• Weidner S, Diaz M, Schaedig C, Gordan L (2021) Observations regarding the average sales price reimbursement. Evidence-Based Oncology 27(4):156–160.Google Scholar
• Wellman GS (2001) National supply-chain survey of drug manufacturer back orders. Amer. J. Health. Systems Pharmacy 58(13):1224–1228.Crossref, Google Scholar
• White DB, Katz MH, Luce JM, Lo B (2009) Who should receive life support during a public health emergency? Using ethical principles to improve allocation decisions. Ann. Internal Medicine 150(2):132–138.Crossref, Google Scholar
• Wolfram CD (1999) Measuring duopoly power in the British electricity spot market. Amer. Econom. Rev. 89(4):805–826.Crossref, Google Scholar
• Woodcock J, Wosinska M (2013) Economic and technological drivers of generic sterile injectable drug shortages. Clinical Pharmacology Therapy 93(2):170–176.Google Scholar
• Yurukoglu A, Liebman E, Ridley DB (2017) The role of government reimbursement in drug shortages. Amer. Econom. J. Econom. Policy 9(2):348–382.Crossref, Google Scholar
• Zhao H (2016) Supply chain optimization in healthcare. Terlaky T, Anjos MF, Ahmed S, eds. Advances and Trends in Optimization with Engineering Applications (SIAM, Philadelphia), 469–478.Google Scholar
• Zhao H (2023) Pharmaceutical supply chains and drug shortages. Tutorials in Operations Research: Advancing the Frontiers of or/MS: From Methodologies to Applications (INFORMS, Catonsville, MD), 228–245.Link, Google Scholar
• Zhao H, Xiong C, Gavirneni S, Fein A (2012) Fee-for-service contracts in pharmaceutical distribution supply chains: Design, analysis, and management. Manufacturing Service Oper. Management 14(4):685–699.Link, Google Scholar