Client Results

Appropriations Victories
Health-Related Legislation
Halted Legislation

Every year Kimbell & Associates has been actively lobbying in Washington, the firm has assisted in either passing a new law or has stopped legislation, which would have been detrimental to its clients.

Appropriations Victories include:

• U.S. Department of Defense Appropriations Act of FY 2007 (2006- HR 4613)
  Inserted a follow-up provision for a small biotechnology-medical device company to receive an additional $1.1M (for a total of $7.58M over 4 years) for research and development related to a portable pathogen reduction system for blood for the armed forces.
• U.S. Department of Defense Appropriations Act of FY 2006 (2005- HR 4613)
  Inserted a follow-up provision for a small biotechnology-medical device company to receive an additional $2M for research and development related to a portable pathogen reduction system for blood for the armed forces.
• U.S. Department of Defense Appropriations Act of FY 2005 (2004- HR 2658)
  Inserted a provision for a small biotechnology-medical device company to receive $2M for research and development related to a portable pathogen reduction system for blood for the armed forces.
• U.S. Department of Defense Appropriations Act of FY 2004 (2003- HR 5010)
  Inserted a provision for a small biopharmaceutical company to receive $2.48M from the U.S. Department of Defense for research and development related to a hand-held anthrax and pathogen testing system.

Health-related legislative and regulatory successes including introduction, passage, or implementation of:

• The Access to Better Choice in Dialysis (ABCD) Act (H.R. 5321), which would create a demonstration project at CMS to reimburse for more-frequent hemodialysis while collecting data to analyze the clinical and economic outcomes associated with the therapy.
• New Formulary Key Drug Type under the U.S. Pharmacopeia's (USP) Medicare Model Guidelines Version 2.0.
• The Medical Device User Fee Stabilization Act of 2005 (H.R. 3423), which amends the Federal Food, Drug, and Cosmetic Act.
• Regulation of Contact Lens as Devices (S. 172 - P.L. 109-96), which amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of all contact lenses as medical devices, and for other purposes.
• The American Jobs Creation Act of 2004 - Tax repatriation
• The Medical Devices Technical Corrections Act of 2003 (H.R. 3493 - P.L. 108-214), which provides technical corrections to the amendments to the Federal Food, Drug and Cosmetic Act made by the Medical Device User Fee Modernization Act.
• The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (H.R. 1 - P.L. 108-391), which provides for an outpatient drug benefit under a new, voluntary Medicare Part D delivered through private risk-bearing entities under contract with the Department of Health and Human Services. Under this legislation, beginning in 2006, all Medicare beneficiaries will have access to a prescription drug benefit for the first time in the history of the program; and
• The Medical Device User Fee Modernization Act of 2002 (H.R. 5651 - P.L. 107-250), which establishes a user fee program for the Center for Devices and Radiological Health (CDRH) at FDA, providing much-needed resources to the center and allowing the center to hire additional device reviewers, helping to provide timely patient access to new medical technologies.
• The Medicare, Medicaid, SCHIP [State Children's Health Insurance Plans] Benefits Improvement and Protection Act of 2000 (H.R. 5543 - P.L. 106-554), which provides benefit improvements and beneficiary protection in the Medicare and Medicaid Programs and the State child health insurance program SCHIP, as revised by the Balanced Budget Act of 1997, and the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999;
• The Balanced Budget Reform Act of 1999 (H.R. 3075 - P.L.106-113), which made corrections and refinements in the Medicare Program as revised by the Balanced Budget Act of 1997;
• The FDA Reform Biomaterials Access Assurance Act of 1998 (H.R. 872 - P.L. 105-230), which governs and limits product liability actions against raw materials and bulk component suppliers to medical device manufacturers;
• The Food and Drug Administration Modernization Act of 1997 (S. 830 - P.L.105-115), which overhauled the Federal Food, Drug, and Cosmetic Act (FDCA) to improve the regulation of food, drugs, devices, and biological products;
• The Export Enhancement Act of 1995 (H.R. 3603 - P.L.105-368), which amends the FDCA to modify the circumstances in which a drug, device, or biological product (including a partially processed biological product) may be exported;

Other federal affairs victories of Kimbell & Associates include the halting of legislation, such as:

• The Drug Patent Term Restoration Review Procedure Act of 1999 (S. 1172), which would have provided a patent term extensions for certain drug products such as Claritin;
• Elimination of similar user fee provisions in the Clinton Administration's budget requests for 1995-98, attempting to levy $115 million in new taxes on entrepreneurial, high technology companies; and
• The Medical Device User Fee Act of 1994 (H.R. 4864/ S. 2276), which would have authorized the assessment and collection of fees from applicants for medical device review.