Defense and National Security
CRD Associates has played a pivotal role for organizations concerned with defense, military health and homeland security. Our work has run the gamut of security-related activities, including digitizing classified records; creating marketing opportunities for new biodefense-related products; and securing funds to improve treatment for war-related injuries.
- Founded in 1862, the Armed Forces Institute of Pathology (AFIP) was an internationally recognized source for diagnostic consultation, education, and research in the medical specialty of pathology. When this rich repository of tissue samples was threatened by a Base Realignment and Closure (BRAC) proposal, CRD Associates organized a coalition to preserve this valuable scientific resource. Working with key lawmakers, industry and defense officials, our firm helped convince Congress to establish a Joint Pathology Center, which will assume AFIP's responsibilities in consultation, education, research and the modernization of its unique tissue repository.
- In the face of a mounting number of military personnel who suffer extremity war injuries, the American Academy of Orthopaedic Surgeons sought CRD Associates’ help with building a Defense Department-funded program dedicated to these types of injuries. Based on our knowledge of operations at the Department of Defense and the Service branches, our team developed a strategic plan of action to raise the visibility of this issue and build support in the military hierarchy and in Congress. As a result, a new, dedicated peer-review research program was created and, thus far, $182 million has been appropriated by Congress.
Education and Employment
CRD Associates has a track record of success helping institutions of higher learning achieve their priority goals, from major university centers to small private colleges and the associations that represent them. We have crafted federal policies creating networks of academic centers of excellence; secured direct funding for capital projects; and helped colleges forge partnerships with local communities and surrounding businesses. In the elementary and secondary field, CRD Associates worked with nonprofit organizations to buttress local school districts with additional support for reading programs, teacher development and health and wellness activities.
- On behalf of Rutgers University, CRD Associates worked with congressional lawmakers to secure more than $16 million for institutional development projects, including $10 million for the creation of a state-of-the-art internal communications system that opened up classes to high achieving students in urban high schools, a biological science research facility and an environmental laboratory. CRD Associates also secured $6.5 million in annual authorizations for the University’s National Transit Institute and the Center for Advanced Infrastructure and Transportation.
- CRD Associates created and managed the University Laboratory Consortium for Biodefense and Pandemic Preparedness, a coalition of 11 universities operating Regional Biocontainment Laboratories. The Consortium’s primary mission is to ensure the integration of the labs into a national response strategy to acts of bioterrorism or pandemics.
- Since 2009, CRD Associates has represented the interests of the State University System (SUS) of Florida, its chancellor and the Board of Governors. With its 11 public universities and 312,000 students, SUS of Florida is the fourth largest higher education system in the nation. In addition to advising the system’s leadership on long-term strategic and policy matters, CRD Associates closely monitors federal agencies for grant opportunities available to Florida’s universities as well education policy and regulatory issues affecting the system and its students. Much of our work is supports the New Florida Initiative, a multi-year endeavor to ensure that Florida’s knowledge and innovation economy is sustained by high-technology, high-wage jobs in the fields of science, technology, engineering and mathematics.
- The University of Pittsburgh is world renowned for its research on the neurobiology of pain. Its Center for Pain Research houses basic and clinical scientists from a variety of disciplines who employ a range of techniques including genetics, molecular biology, anatomy, electrophysiology and computational modeling. The University retained CRD Associates to organize and manage a coalition of academic research institutions, out of which came a $40 million federal investment into pain research supported by the National Institutes of Health (NIH).
- On behalf of the Collegiate Consortium for Workforce and Economic Development, CRD Associates secured $2.3 million through the Department of Defense appropriations for a worker retraining initiative for veterans, National Guard members and reservists returning from Iraq and Afghanistan.
- Shortly after enactment of welfare-to-work legislation, states found themselves overwhelmed by the law’s new tracking and processing requirements. CRD Associates linked key federal officials at the Department of Health and Human Services (HHS) Administration for Children and Families and the Office of Child Support Enforcement with our client, the State Information Technology Consortium, to launch a program to pilot test innovative approaches for meeting federal reporting requirements. Over an eight-year period, SITC received $31 million to help identify and implement best practices across all states.
Public health, research and patient advocacy
The federal government continues to play a dominant role in setting the tone and direction of public health policy. Decisions made in Congress and at federal agencies guide medical and health services research priorities at public and private research institutions; determine funding for disease prevention, treatment and health promotion; and provide direct support for needed patient and family services. CRD Associates has helped patient groups, medical societies and pharmaceutical companies draw attention and resources to the issues that matter most to them.
- Working with the Cooley’s Anemia Foundation, CRD Associates helped to devise a strategy enabling this group of patient advocates to play an integral role in support of a new drug application for a treatment that is critically important to their patients’ survival. The plan involved multiple meetings with Food and Drug Administration (FDA) officials reviewing the applications, and presenting expert witnesses at an FDA advisory committee hearing. The drug was recommended for approval by the advisory committee and subsequently approved by the FDA.
- Noting the mounting number of military personnel who suffer extremity war injuries, the American Academy of Orthopaedic Surgeons sought CRD Associates’ help with building a Department of Defense-funded program dedicated to these types of injuries. Based on our knowledge of operations at the Department of Defense and the service branches, our team developed a strategic plan of action to raise the visibility of this issue and build support in the military hierarchy and in Congress. As a result, a new, dedicated peer-review research program was created and, thus far, $182 million has been appropriated by Congress.
- The American Association for the Study of Liver Diseases partnered with CRD Associates to devise a plan to mobilize government agencies to stem the rapid increase in new cases of viral hepatitis and related diseases. CRD Associates conceived a strategy that helped convince officials at the HHS and the CDC to develop a Viral Hepatitis Action Plan. Released in May 2011, the plan, combined with newly-approved drug treatments, will move viral hepatitis into a new level of public attention, treatment and cures. The plan leverages opportunities to improve coordination of viral hepatitis activities across the U.S. Public Health Service; sets priorities for achieving public health and primary care infrastructure needs; and provides a framework for government-wide coordination in viral hepatitis prevention and treatment.
- On behalf of AcademyHealth, the preeminent professional society for health services researchers and health policy analysts, CRD Associates represents the Friends of AHRQ and the Friends of NCHS—voluntary alliances of over 200 organizations that advocate for increased funding for the Agency for Healthcare Research and Quality (AHRQ) and the National Center for Health Statistics (NCHS). Over the past seven years, CRD Associates employed a variety of strategies and tactics—including congressional briefings, national grassroots campaigns and agency outreach activities—that have led to a 30 percent increase in both agencies’ operating budgets. As demand grew from all sectors of the health care system for more comparative clinical research, CRD Associates played a role in crafting the comparative effectiveness research program first launched in the 2009 economic stimulus bill. The firm is currently working with AcademyHealth on implementation of the Patient-Centered Outcomes Research Institute (PCORI).
- While in its formative years, the Alzheimer’s Association sought to draw attention and resources to growing epidemic of Alzheimer’s in an aging society. Through a combination of careful strategic planning, direct lobbying and well-coordinated grassroots campaigns, CRD Associates helped the Alzheimer’s Association build and sustain an infrastructure of federal programs that support research, patient services and caregiver assistance. NIH now allocates more than $450 million each year for Alzheimer research; the Administration on Aging annually awards grants to states that provide innovative health and long-term care services to families caring for Alzheimer patients; and the CDC supports community-based prevention and surveillance activities related to Alzheimer’s disease.
Reimbursement, coverage and coding
CRD Associates has deep expertise in the economics of medicine, ranging from hospital and physician reimbursement to coverage policies for medical services, devices and diagnostic tests. We work with medical specialty societies to establish and value CPT codes under the Medicare physician fee schedule. We partner with organizations seeking federal and regional coverage for services by Medicare and private insurers. And we have experts experienced at working with the quality stakeholders, including the American Medical Association (AMA) Physician Consortium for Performance Improvement, the National Quality Forum and the Centers for Medicare and Medicaid Services (CMS).
- We have assisted the leadership of numerous medical and scientific societies in establishing new and revising existing ICD-9-CM diagnosis and procedure codes, which are recognized by both private and public insurers. CRD Associates has worked with physician leaders in various specialties to develop and present coding proposals to the CMS and the National Center for Health Statistics (NCHS), which oversee the ICD-9 and the soon to be implemented ICD-10 coding systems. CRD Associates also has assisted several medical societies with the transition from ICD-9-CM to ICD-10-CM to assure that all revisions are reflective of current practice and conform to international coding systems.
- CRD Associates advises drug, device and equipment manufacturers and medical societies on the American Medical Association’s (AMA) CPT coding and Relative Value Update Committee (RUC) valuation processes, and has served as staff to both of these panels for medical society clients. We have extensive experience with preparing and presenting CPT code applications and have assisted numerous medical societies with the survey and consensus process used to make recommendations to the RUC. In addition, we assist in preparing estimates of practice expense costs for services, including an evaluation of staff time, supplies and equipment.
- CRD Associates has years of experience working with medical societies and drug, device and equipment manufacturers seeking to influence Medicare national coverage determinations and Medicare administrative contractors’ local coverage policies. We have helped clients with evaluating data required by Medicare’s coverage process and with presenting that information before the Centers for Medicare and Medicaid Services (CMS). We have worked with clients to draft model coverage policies to proactively seek coverage for services on the local level.
Medical device approval and clearance
This is a crucial time for medical device manufacturers. The Food and Drug Administration (FDA) is in the midst of a major overhaul of the medical device approval and clearance pathways. The agency also is developing its regulatory scheme for laboratory tests and mobile health products. CRD Associates represents traditional medical device manufacturers, purveyors of digital and mobile health products and commercial and academic-based hospital laboratories that develop laboratory tests. CRD Associates helps medical device manufacturers anticipate changes to regulatory pathways and modify their business strategies accordingly.
- CRD Associates has assisted several genetic testing companies with their response to Food and Drug Administration (FDA) enforcement action questioning their regulatory compliance. Part of our work included preparing company executives for congressional hearings on industry practices by drafting testimony, providing briefing materials and holding mock hearings.
Personalized medicine and advanced diagnostics
The promise of research that increases our ability to predict which medical treatments are safe and effective for each patient—and which are not—has ushered in a new era in health care, called personalized medicine. With its acquisition of HealthFutures in 2009, CRD Associates gained a strong foothold in a field where disruptive technologies are the norm. In an effort to keep pace with science, Congress and federal regulators are working to draft policies that foster innovation while simultaneously ensuring that patients have access to high quality, safe medical products. But rapid advances in co-developed drug and diagnostic products, complex laboratory testing, targeted therapeutics and other personalized medicine technologies are outpacing the current regulatory and reimbursement framework and challenging both federal regulators and the industry. Led by a board-certified genetic counselor, the CRD Associates team helps clients anticipate and navigate the regulatory and reimbursement policies for this rapidly growing sector and advises on strategies to further drive the adoption of these products into medical practice.
- A company that has developed a unique laboratory test sought CRD Associates’ help with raising awareness of the value of risk-stratification tools in the prevention of diabetes. To that end, our firm planned, coordinated and executed a half-day policy symposium on the prevention of type 2 diabetes in partnership with a local academic medical center. The symposium included keynote speakers from well-respected institutions, including the lead investigators implementing the YMCA-United Healthcare-Centers for Disease Control and Prevention (CDC) lifestyle intervention program. We solicited partners for hosting the event, completed all of the planning and day-of logistics and successfully advertised the event that led to more than 100 attendees from industry, the agencies, Congress, academia, and providers and patients.
- Members of our team recently assisted a medical society in its work with the Centers for Medicare and Medicaid Services (CMS) to develop a National Coverage Determination (NCD) on genetic diagnostic tests for certain cancers. This included preparing an analysis of the draft NCD, assisting experts in the field with drafting and presenting comments before the Medicare Coverage Advisory Committee (MedCAC).
Medical education and health professions training
So long as health care outcomes and costs hold the attention of policymakers, the supply and distribution of physicians will remain a hot topic of discussion. Academic medical centers and large hospitals have developed graduate medical education programs that focus on discovery, innovation and subspecialty care, while national health experts decry the shortage of primary care physicians to serve the general population’s needs. CRD Associates has helped organizations in their efforts to expand the pool of available graduate medical education (GME) slots, while advocating policies that channel added resources to areas of greatest need.
- With the primary care physician shortage expected to deepen, training of the next generation of health professionals is of critical importance. CRD Associates has worked with groups to help innovate within the graduate medical education (GME) program to ensure that it prepares physicians for practice in settings outside of the hospital in areas where many people currently lack access to care.
- Our team of experts understands the intricacies of the Title VII health professions training programs and successfully advocated for new initiatives authorized in 2010, including expansion of primary care training assistance, loosening of service commitments in the National Health Service Corps and creation of a National Health Care Workforce Commission.
Enactment of the Affordable Care Act (ACA) marked an historic watershed for consumers, small businesses and insurers. While the essential goals of this landmark legislation are to expand coverage, control costs and improve the health care delivery system, the practical outcome in large part will depend on the detailed regulations developed by federal agencies. We worked with insurers, patient advocates and consumer groups to secure adoption of special provisions in the ACA and are working now to ensure that proposed regulations reflect both the letter and the spirit of the law.
- Since 1990, CRD Associates has represented Delta Dental, the nation’s largest dental benefits carrier. Despite efforts by some to limit participation in the insurance exchanges created by the Affordable Care Act (ACA), the firm helped advance a provision permitting stand-alone dental plans to participate as well. During the most recent expansion of the Children’s Health Insurance Program (CHIP), CRD Associates teamed with consumer groups to secure a guaranteed children’s dental benefit.
- During deliberations over landmark health care reform legislation, members of our team managed a coalition of over 70 patient advocacy organizations and industry organizations that helped convince Congress to eliminate lifetime limits on private health insurance. The change was among the first to be implemented shortly after enactment of the ACA.