Corporate Overview
Introduction
Mission
Issues
Jeffrey J. Kimbell & Associates provides legislative solutions to clients in the healthcare community facing issues related to product approval, coverage and reimbursement, marketing practices, and more. Founded in 1998, Kimbell & Associates has since grown to include five full-time lobbyists and/or policy experts in the life sciences field, including medical devices, pharmaceuticals biotechnology, provider services, and biodefense. Currently, the firm represents 17 selected clients, all of which reside in the life sciences area.
The firm ’s expertise focuses on the executive and legislative branches of the U.S. federal government and specializes in providing strategic solutions to a select group of healthcare sector clients seeking creation, modification, or proper implementation of public law. Through active lobbying on Capitol Hill, as well as working with the relevant federal healthcare agencies, Kimbell & Associates can dismantle the roadblocks that obstruct an organization’s ability to deliver technologies and services to their patients. The firm currently lobbies on behalf of clients with issues before the U.S. Department of Health & Human Services, the U.S. Department of Commerce, the U.S. Department of Homeland Security, and the U.S. Department of Defense. The firm maintains strong relationships with political appointees and policy teams in cabinet-level departments, agencies, and sub-agencies. The firm’s principals have more than 30 years of experience working with the Congressional committees with oversight and budget authority over the various federal departments including the House and Senate Appropriations Committees, the House Ways & Means Committee, the House Energy & Commerce Committee, the Senate Finance Committee and the Senate Health, Education, Labor & Pensions Committee.
With backgrounds in both the private and public sectors, the firm’s principals leverage institutional knowledge and valued relationships as former staff to Congressional Members and Governors, Administration appointees, and private sector analysts on behalf of our clients. Each principal has played a pivotal role in developing policy and affecting the legislative agendas on some of the most critical domestic policy issues, including those related to Medicare, Medicaid, private sector healthcare, medical liability reform, and the Food and Drug Administration. Our principals’ experience enables the firm to advocate for and protect our clients’ interests by identifying, accessing, and educating key officials in the healthcare sector.
As a leader in the life sciences area, our firm is privy to key insider legislative and regulatory information. This includes knowledge of proposed healthcare-related legislation in both the U.S. Senate and House of Representatives; FDA and CMS regulatory initiatives; staff reaction and anticipated Member response to any legislative or regulatory proposals; expected legislative hearings and mark-ups; and, health-related media events and public policy forums, among other things. We apply this knowledge as we engage in the following activities on behalf of our clients:
Establishing & Bolstering a Washington Presence for Life Sciences Corporations & Organizations
Corporations and organizations often encounter issues that negatively impact their technology or services and possess no established relationships within the federal government to counter such problems. We help our clients build lasting, trusting relationships with federal officials in Washington to ensure that policy makers have a clear understanding of their technology and/or service and its value. We have built strong regulatory and political relationships with key individuals at the FDA, CMS, HHS and with members of the Senate Finance Committee, the Senate Health, Education, and Labor (HELP) Committee, the House Ways and Means Committee and the House Energy and Commerce Committee, as well as with Leadership offices in both bodies. These relationships are critical to ensuring that our clients’ interests are taken into consideration as both legislative and regulatory polices are developed, which directly impact their products and services.
Shaping Legislation, Regulatory & Government Policy through Direct Lobbying & Coordination with Members of Congress, Administration Officials & Key Staff
Kimbell & Associates coordinates with our clients to create the most effective and representative messages regarding their products and services. We then work directly with Members of Congress, their staff, and agency officials to ensure that our clients’ interests are considered as these policymakers implement new federal rulings.
Monitoring, Analyzing & Reporting on Legislation & Regulation
Our firm is immediately cognizant of any legislative or regulatory developments and utilizing our own industry knowledge and intelligence, our firm will impact our clients’ businesses or service. For example, some of this work involves implementation of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, which created a new Medicare drug benefit beginning in 2006. It also included several provisions that changed the payment methodology for Part B drugs and certain aspects of the physician fee schedule. Many of our clients’ products are covered and reimbursed by Medicare under these systems. Several of those provisions took effect in January 2004 and continuous regulatory activity surrounds these issues. The new Medicare payment methodologies should maximize beneficiaries’ access to innovative and clinically appropriate therapies in accessible settings, while preserving the independence of providers’ clinical decisions and minimizing inappropriate payment barriers to choice of medicines. We help ensure that any legislative or regulatory changes meet these principles.
Drafting Letters, Testimony & Agency Comments
As part of our work to monitor and analyze legislative and regulatory activities, our firm provides clients with political strategy options to ensure an effective response plan and future action. In addition to information-sharing, our firm offers clients proactive legislative and regulatory strategy options, which may include drafting letters, testimony or agency comments. Wherever possible, efforts are made to arrange client testimony or to be part of a panel discussion. For example, if a scheduled Congressional hearing is expected to impact a client, our firm will advise a client on the potential for participation and will work with Congressional staff to ensure our client is represented. Similarly, our firm alerts clients to expected legislation or regulations and potential opportunities that move our clients’ agenda. This includes assisting clients with written comments to appropriate regulations. We also assist clients when they need to move a particular issue through the regulatory and/or legislative process.
Coordinating Congressional Member & Staff Educational Trips to Tour Client Facilities & Learn More About our Clients’ Products & Services
In order for Members of Congress and their staff advisors to understand the critical role that life sciences companies and healthcare providers play in the safe and efficient delivery of healthcare in the U.S., we routinely organize educational tours of our clients’ manufacturing and R&D facilities, as well as visits to hospitals or other clinical settings to witness procedures that utilize our clients’ technologies or demonstrate our provider clients’ services. These educational trips may range from a 4-hour tour and procedure-viewing at a local hospital to a more comprehensive, 4- to 5-day trip outside of the Washington area that will include manufacturing tours, physician presentations, patient testimonies, hospital tours, and procedure viewings.
Securing Funding for Life Sciences Grants & Appropriations
Our firm identifies potential funding opportunities within the federal budget and/or annual appropriations process for advanced research practices. We also collaborate with disease-specific patient organizations to discover additional funding opportunities for these research practices. These activities include identifying procurement opportunities within the U.S. Department of Defense and the U.S. Department of Homeland Security, when appropriate.
Provide Trade Association Management & Involvement
Our firm fully advises and manages our clients’ relationship(s) with the most relevant and appropriate trade associations in Washington, D.C. Many of our clients are members of the Medical Device Manufacturers Association (MDMA); the Advanced Medical Technology Association (AdvaMed); the Pharmaceutical Research and Manufacturers of America (PhRMA); the Biotechnology Industry Organization (BIO); and/or the Council on Radionuclides and Radiopharmaceuticals (CORAR), among others. We work closely with the Board and key committees at these associations and monitor all activity on the relevant committees that are important to our clients. Often, our principals serve as the client’s primary representative responsible for this activity.
Collaborate with patient groups, disease-specific organizations, and specialty societies
Few companies consider or properly collaborate with any of the major patient groups, disease organizations or specialty societies which have a Washington presence. Our firm has long established working relationships with many of these organizations and work with them to expand availability of our clients’ products to patient populations.
Secure Appointments on Key Agency Panels
Many federal agencies (including HHS, FDA, CMS, among others) have created advisory panels or advisory committees through which recommendations are made related to product approvals, reimbursement policy and other regulatory changes. As a firm, we work to place employees of our clients or key persons with close relationships to our clients (i.e., physicians, clinical investigators) onto the relevant agency panels as an industry representative. Although most panels require the industry rep to recuse him/herself from voting on issues directly related to the client, it is very helpful for these individuals to build relationships with the agency officials, scientific advisors, physician representatives and other stakeholders who serve on the same committee or panel.
The following are representative issues in which Kimbell & Associates has been engaged:
- Appropriations
- New Medicare prescription drug benefit
- Medicare and Medicaid reimbursement, coverage and coding in all payment settings
- Centers for Medicare and Medicaid Services Broad Initiatives
- Medicare Pay-for-Performance
- Medicaid policy issues
- Comparative Effectiveness
- Health Information Technology
- NIH Reauthorization
- Stem Cell Research
- Drug and Device Safety Issues
- Drug Reimportation
- Medical Device User Fees
- Prescription Drug User Fees
- Patent and Trademark Office User Fees
- Patent Reform
- Biodefense/Project BioShield
- Government Procurement of Medical Technologies
