each institution must know exact costs so that it can bid appropriately and remain financially viable. Complicating this approach are the various regulatory requirements and the fact that each contract is somewhat different in terms of services and costs. Laboratories are continually reviewing their test menus, methodologies, etc., for the most clinically relevant, cost-effective approach to diagnostic testing.
Current problems related to health care costs include a growing federal deficit and concerns about the future viability of Medicare, the increasing inability of state budgets to fund rising Medicaid expenditures, an aging population that will generate increasing demands on health care resources, the proliferation of costly technological and pharmacological advances in the ability to diagnose and treat disease, and a health care insurance and delivery system unable to provide insurance and predictable access to care for approximately 40 million Americans (3).
Immediately prior to the 21st century, Congress began to focus on legislation and regulation in health care, perhaps the two most striking examples of which are the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The four main regulations that are relevant to pathology and laboratory medicine are CLIA, HIPAA, the Occupational Safety and Health Administration (OSHA) standards for occupational exposure to blood-borne pathogens, and the Stark regulations that prohibit self-referral by health care providers.
CLIA ’88
The Clinical Laboratory Improvement Amendments were enacted in 1988; however, the regulations were not implemented until 1992. Although changes to the regulations continue to be made, the amendments in their current form are well established and are applicable to all testing performed on humans. Specific regulations include personnel standards, patient test management, quality assurance, proficiency testing, provisions for inspection and certification, and both civil and criminal penalties for noncompliance. Inspection and accreditation options are multiple and include government and private-sector organizations such as the College of American Pathologists and the Joint Commission.
HIPAA
The Health Insurance Portability and Accountability Act was passed in 1996. The Privacy Rule standards address the use and disclosure of individuals’ health information (protected health information) by organizations subject to the Privacy Rule (covered entities) as well as standards for individuals’ privacy rights to understand and control how their health information is used. Within the U.S. Department of Health and Human Services, the Office for Civil Rights (OCR) has responsibility for implementing and enforcing the Privacy Rule with respect to voluntary compliance activities and civil money penalties (http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html; accessed 4/3/2015).
A major goal of the Privacy Rule is to assure that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public’s health. The Rule strikes a balance that permits important uses of information, while protecting the privacy of people who seek care and healing. Given that the health care marketplace is diverse, the Rule is designed to be flexible and comprehensive to cover the variety of uses and disclosures that need to be addressed.
“Individually identifiable health information” is information, including demographic data, that relates to and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual:
• the individual’s past, present, or future physical or mental health or condition,
• the provision of health care to the individual, or
• the past, present, or future payment for the provision of health care to the individual.
OSHA Standards for Occupational Exposure to Blood-Borne Pathogens
The standards for exposure to blood-borne pathogens were developed in 1991 by OSHA of the Department of Labor in response to widespread concerns by unions representing health and hospital workers concerning the inadequacy of protective practices, equipment, and other safeguards for employees with regular and predictable exposure to body fluids and substances with the potential to transmit HIV, hepatitis B virus, and hepatitis C virus. More complete information can be found at http://www.osha.gov/SLTC/bloodbornepathogens/index.html (accessed 4/3/2015).
In order to reduce or eliminate the hazards of occupational exposure to blood-borne pathogens, an employer must implement an exposure control plan for the worksite with details on employee protection measures. The plan must also describe how an employer will use a combination of engineering and work practice controls, ensure the use of personal protective clothing and equipment, and provide training, medical surveillance, hepatitis B vaccinations, and signs and labels, among other provisions. Engineering controls are the primary means of eliminating or minimizing employee exposure and include the use of safer medical devices, such as needleless devices, shielded needle devices, and plastic capillary tubes.
The Stark Laws
The Stark regulations were enacted sequentially over a period of several years and severely limit referral of a wide variety of services (including laboratory testing) to entities in which the referring provider has a financial stake. The regulations are named for Rep. Fortney “Pete” Stark (D.-CA) who was the legislative sponsor of the initial regulations enacted in 1992 (Stark I) that prohibited a physician from making Medicare referrals for clinical laboratory services if the physician or an immediate family member had any financial relationship with the laboratory. In 1993, the Stark II legislation extended the regulations to Medicaid and broadened coverage to 10 additional health services, including, among others, occupational and physical therapy, durable medical equipment, radiology, and radiation therapy. However, the regulations are very complex and difficult to interpret. Enforcement by the government, particularly the Justice Department, is closely linked to other “fraud and abuse” enforcements under a variety of federal anti-kickback and “false claims” statutes (68).
In the last few years, many inpatient procedures have been shifted to the outpatient setting in response to payer per diem cost containment initiatives. Most institutions are actively involved in developing or expanding outreach programs, including laboratory services, teaching, and consultations. Another area that will continue to expand is point-of-care testing (POCT), or testing at the site of the patient (bedside, emergency room, or clinic), or alternative-site testing (home or shopping mall). With this expansion comes new technology that is advertised as “fail-safe and foolproof,” some of which may be true and some of which may be exaggerated. Obviously, this approach is directly linked to patient and overall customer satisfaction related to a short turnaround time for test results. Since more and more patient care is being delivered on an outpatient basis as decentralized care, reductions in length of hospital stay and in cost continue to be issues for review.
In some institutions that service very specific patient groups, POCT may offer distinct advantages; however, in institutions with highly efficient specimen transport systems and rapid response capabilities within the main clinical laboratory, advantages of POCT may be minimal to none. Continued review of regulatory requirements, QC issues, proper and consistent documentation, proficiency testing, performance enhancement, and cost-effectiveness
