Health policy is our largest practice at CRD Associates. We help clients create new initiatives to combat public health threats; ensure fair and equitable reimbursement for medical services, drugs, and devices; and open new opportunities for precision genomic medicine. Voluntary health organizations have turned to us for help convincing Congress of the merits of channeling more federal resources to medical and health services research. Hospitals and medical societies have relied on us to help modify payment levels and structures. Businesses have tapped into our understanding of complex federal structures to open new marketing opportunities or block disruptive regulatory proposals.
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.
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).
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.
PERSONALIZED MEDICINE, ADVANCED DIAGNOSTICS
Research that can predict which medical treatments are safe and effective for each patient—and which are not—has ushered in a new era in health care: personalized medicine. 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. CRD Associates 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.
HEALTH INFORMATION TECHNOLOGY
Since the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, CRD Associates has helped a variety of organizations capitalize on new opportunities to acquire electronic health records for their practices; navigate the complex and evolving regulations defining meaningful use of HIT; and avoid penalties for noncompliance. As these issues evolve, CRD Associates will continue to advise clients on regulatory policy that may affect their business decisions as well as how HIT privacy standards will affect research, disease diagnosis and patient access.
MEDICAL EDUCATION, 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.
INSURANCE COVERAGE and mandates
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 now and in the future will continue depending on the detailed rules and regulations developed by federal agencies. CRD Associates has worked with insurers, patient advocates and consumer groups to secure adoption of special provisions in the Affordable Care Act, and we are working now to ensure that proposed regulations reflect both the letter and the spirit of the law.