Exposing GPOs & PBMs
GOVERNMENT DOCUMENTS
Describing the hospital group purchasing organization (GPO) industry as "an insidious, incestuous, insider system," Connecticut Attorney General Blumenthal said that " my GPO investigation has uncovered suspect interrelationships and questionable business practices involving hospital, GPO and major medical suppliers' executives whose practices often benefit themselves, rather than patients, insurers, and government programs that pay hospital bills."
He added: "these concerns are significant and serious, requiring immediate Congressional action…Voluntary efforts offered by the GPO companies—initiated shortly after withering criticism of industry practices—are simply too little, too late."
Richard Blumenthal, Connecticut Attorney General (now U. S. senator)
Statement to the Senate Antitrust Subcommittee, March 15, 2006
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Federal Trade Commission Policy Statement Regarding Section 5 Enforcement
November 10,2022
"Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth"
(100-day report pursuant to Executive Order 14017, See pages 226-8)
White House, June 4, 2021
READ REPORT
Letter from FDA Principal Deputy Commissioner Janet Woodcock M.D. to Phillip L. Zweig, executive director PADS
November 8, 2019
READ LETTER
October 29, 2019
READ REPORT
Comments on GPOs by Justice Department Antitrust chief Makan Delrahim before the Senate Antitrust Subcommittee Oversight Hearing
C-Span, September 17, 2019
WATCH VIDEO
Food and Drug Administration: Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions
Presented by The Duke-Margolis Center for Health Policy
November 27, 2018
WATCH WEBCAST (Statement in Q&A by PADS ED Phil Zweig begin at 3:50)
Martin van Trieste, president, CivicaRx, comments to the FDA in response to request for comment on drug shortages, Oct. 31, 2018 (see reference to middleman fees on page 2).
READ LETTER
U. S House of Representatives, 115TH CONGRESS, 1ST SESSION, 2017
READ DOCUMENT
"Group Purchasing Organizations: Funding Structure Has Potential Implications for Medicare Costs"
Government Accountability Office, Nov. 24, 2014
READ DOCUMENT
"ASPE Issue Brief: Medicare Part B Reimbursement of Prescription Drugs"
Office of the Assistant Secretary for Planning and Evaluation, Dept. of Health & Human Services, June 2014
READ DOCUMENT
Government Accountability Office, Feb. 10, 2014
"Strategic Plan for Preventing and Mitigating Drug Shortages"
Food and Drug Administration, Oct. 31, 2013
"Email Correspondence with HHS OIG on Rules Concerning Independence of Federal & State Safe Harbors"
Office of the Inspector General, Dept. of Health and Human Services, Jan. 3, 2013
"Press Release on Request by Rep. Ed Markey (D-MA) et al to Acting Comptroller General of the United States Eugene Dodaro" (requesting GAO investigation in the role of GPOs in causing drug shortages and the fungal meningitis outbreak)
Nov. 15, 2012
"Food and Drug Administration Safety and Innovation Act"
Congress of the United States, July 9, 2012
"FDA's Contribution to the Drug Shortage Crisis"
House Committee on Oversight and Government Reform, June 15, 2012
"Group Purchasing Organizations: Federal Oversight and Self-Regulation"
(Study requested by Senators Herb Kohl, D-WI; Charles E. Grassley R-IA; and Tom Coburn R-OK)
Government Accountability Office, Mar. 30, 2012
READ DOCUMENT
"OIG Advisory Opinion No. 12-01
Office of the Inspector General, Dept. of Health & Human Services, Mar. 8, 2012
READ DOCUMENT
"Inspection Report, Ben Venue Laboratories"
Food and Drug Administration, Dec. 2, 2011
"Letter from Senators Herb Kohl (D-WI), Barbara Boxer (D-CA), Charles E. Grassley (R-IA), Richard J. Durbin (D-IL), and Tom Harkin (D-IA) to Federal Trade Commission chairman Jonathan Leibowitz" (requesting investigation on GPO contracting practices)
Nov. 9, 2011
READ DOCUMENT
"Executive Order 13588: Reducing Prescription Drug Shortages"
White House, Oct. 31, 2011
READ DOCUMENT"A Review of FDA's Approach to Medical Product Shortages"
Food and Drug Administration, Oct. 31, 2011
READ DOCUMENT
"Economic Analysis of the Causes of the Drug Shortages"
Department of Health & Human Services (HHS), Oct. 28, 2011
"Drug Shortage Workshop"
Food & Drug Administration, Sept. 26, 2011
"Empirical Data Lacking to Support Claims of Savings With Group Purchasing Organizations" (Study requested by Sen. Charles E. Grassley, R-IA)
Senate Finance Committee, Minority Staff Report, Sept. 24, 2010
"Group Purchasing Organizations: Services Provided to Customers and Initiatives Regarding Their Business Practices"
Government Accountability Office, Aug. 2010
"Statement by Connecticut Attorney General Richard Blumenthal to the Senate Antitrust Subcommittee"
Hearing of Mar. 15, 2006
(See also the "Congressional Hearings" page)
"Review of Revenue from Vendors at Three Group Purchasing Organizations and their Members"
Office of the Inspector General, Department of Health and Human Services (HHS), Jan. 2005
"Discussion Draft: A Bill to amend Title XI of the Social Security Act to repeal a safe harbor with respect to vendors in order to ensure full and free competition in the medical device and hospital supply industries"
U. S. Senate, 109th Congress, 1st Session, 2005
"Medical Device Competition Act of 2004 (S. 2880)"
U. S. Senate, 108th Congress, 2nd Session, 2004
"Improving Health Care: A Dose of Competition: A Report by the Federal Trade Commission and the Department of Justice"
[Based on joint FTC/DOJ hearings on health care and competition law and policy held on Sept. 26, 2003]
July 2004
"Group Purchasing Organizations: Use of Contracting Processes and Strategies to Award Contracts for Medical-Surgical Products"
Government Accountability Office. July 16, 2003
"Letter from Senator Herb Kohl (D-WI) and Mike DeWine (R-OH) to Secretary of Defense Donald Rumsfeld"
May 2, 2003
"Compliance Program Guidance for Pharmaceutical Manufacturers"
Dept. of Health & Human Services, Office of the Inspector General, Apr. 2003
READ DOCUMENT
"Group Purchasing Organizations: Pilot Study Suggests Large Buying Groups Do Not Always Offer Hospitals Lower Prices"
General Accounting Office. Apr. 30, 2002
Letter from Senator Patrick Leahy (D-VT) to Inspector General Janet Rehnquist, Department of Health and Human Services (HHS)
Sept. 21, 2001
"Letter from Senator Patrick Leahy (D-VT) to Attorney General John Ashcroft, Department of Justice"
Mar. 5, 2001
"Up front Rebates," "Prebates" and "Signing Bonus" Payments"
Office of the Inspector General, Dept. of Health and Human Services
Opinion letter, July 17, 2000
"FACT SHEET: Federal Anti-kickback Law and Regulatory Safe Harbors"
Office of the Inspector General, Dept. of Health and Human Services
Nov. 1999
"Letter from Assistant Attorney General Joel Klein, Antitrust Division, Department of Justice, to Senator Paul Sarbanes (D-MD)"
Aug. 28, 1998
"Letter from Senator John McCain (R-AZ) to Assistant Attorney General Andrew Fois, Department of Justice"
Aug. 17, 1998
"Statements of Antitrust Enforcement Policy in Health Care"
Federal Trade Commission and Department of Justice
Aug. 1996
Anti-kickback safe harbor final rules
Office of the Inspector General, Dept. of Health & Human Services
July 29,1991
Anti-kickback Safe Harbor provision
Medicare and Medicaid Patient and Program Protection Act of 1987