Healthcare laws overview

This section presents additional laws that affect healthcare. Throughout the textbook, these laws and others will be discussed in more depth. This chapter introduces the more common laws that impact ambulatory healthcare.

Patient Protection and Affordable Care Act

The Patient Protection and Affordable Care Act is commonly known as the Affordable Care Act. This federal statute was signed into law in 2010. The goal of the law was to provide Americans with affordable health insurance. It also attempted to reform the healthcare system and reduce healthcare spending. Some of the reforms were as follows:

• Insurance coverage of preventive services and immunizations.
• People with preexisting health conditions cannot be dropped or charged more for insurance.
• Dependents can stay on their parent’s insurance plan until age 26.
• Large businesses have to provide insurance to full-time workers. Small businesses are eligible for tax credits to help offer insurance coverage to their employees.
• The Physician Payments Sunshine Act (PPSA), part of the law, increases the transparency between providers, teaching hospitals, and manufacturers of medical products (e.g., drugs and medical devices). The manufacturers must report any payments and transfers of value (e.g., gifts, meals) to the Open Payments Program of the Centers for Medicare and Medicaid Services (CMS).

Clinical Laboratory Improvement Amendments

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988. CLIA establishes quality standards and regulates laboratory testing. The quality standards focus on the accuracy, reliability, and timeliness of test results. The following federal agencies are involved in administering CLIA:

• Food and Drug Administration: Oversees the medical laboratory tests. Categorizes the tests based on their complexity: waived, moderate, or high complexity. High-complexity laboratories can perform more tests than waived-complexity laboratories.
• Centers for Medicare and Medicaid Services: Inspects laboratories and issues certificates. Enforces compliance with regulations.
• Centers for Disease Control and Prevention (CDC): Develops standards and laboratory practice guidelines. Develops professional information and resources mostly related to health and disease topics (Visit the CDC website for more).

All agencies providing clinical laboratory services, including ambulatory care laboratories, must meet the CLIA requirements. The laboratories must have a CLIA certificate to operate and must be certified by the state. Smaller ambulatory care laboratories have one of the following certificates:

Certificate of Waiver: Allows the facility to perform CLIA-waived tests, which are simple and accurate with little risk for error if done correctly. A urine pregnancy test is a waived test.

Certificate for Provider-Performed Microscopy Procedures (PPMP): Allows the provider to perform only specific microscopy procedures and waived tests.

Additional certificates are obtained by larger laboratories. These laboratories perform more complex tests.

Good samaritan laws

Good Samaritan laws are state laws that provide legal protection for those assisting an injured person during an emergency. If possible, the injured person needs to agree to help. The person responding must meet the following criteria:

• Not be paid for the care given
• Act reasonably, exercising the same standard of care (for their profession) within the limitations of the emergency
• Not act negligently or recklessly; such action makes the responder liable for damages

The Good Samaritan law does not mean you cannot be sued. In some states, healthcare professionals who do not assist another person in an emergency can be held liable. It is important to be aware of your state’s Good Samaritan law and find out if medical assistants have an obligation to stop and provide first aid.

Laws for end-of-life issues

A medical assistant should be aware of laws that relate to end-of-life issues. The following is a brief summary of acts that relate to advance directives, organ donation, and determining death:

• Patient Self-Determination Act (PSDA): Requires most healthcare institutions to inform patients of their right to make decisions and the facility’s policies respecting advance directives.
• Uniform Determination of Death Act (UDDA): Served as a guide for state lawmakers to create their own laws that define death.
• Uniform Anatomical Gift Act (UAGA): Purpose of the act was to make organ donation easier for people.
• National Organ Transplant Act (NOTA): Established the Organ Procurement and Transplant Network (OPTN) and also established a national registry for organ matching.