Healthcare Laws: An Overview for Radiologic Technologists

Given the risks of exposure to ionizing radiation, a number of laws, government regulatory authorities, and advisory agencies work to ensure the safe use of X-rays in medical imaging. Read about some healthcare laws that may be of interest to radiologic technologists.

HITECH Act and Meaningful Use

The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 was signed into law as part of the American Recovery and Reinvestment Act (ARRA) of 2009 as a means to promote the adoption and meaningful use of electronic health records (EHR), secure health information exchange, and other supporting technology in health care. The Act gives the Department of Health and Human Services (HHS) the authority to improve the quality, safety, and efficiency of health care through the use of information technology. The Act also gives the Office of the National Coordinator (ONC), a department within the HHS, the authority to set standards, manage stimulus programs, and establish grants for the training of personnel to implement a nationwide health information technology infrastructure.17

The HITECH Act stipulated that health care organizations would be given financial incentives for the “meaningful use” of EHRs between 2011 and 2015, following which they will become liable to penalties for failing to demonstrate the use of EHRs. This staged rollout of meaningful use required providers to demonstrate two years in one stage before graduating to the next one. The slow rate of adoption of stage 2 forced the Centers for Medicare and Medicaid Services (CMS) to delay stage 3 until 2017. To be eligible for reimbursement of incentives, health care organizations must submit compliance and governance paperwork for meaningful use attestation for each completed stage, with the failure to do so inviting penalties. To be eligible for incentives, organizations must use certified EHR technology such as medical records software that has been developed by vendors according to ONC certification rules.

Affordable Care

The Patient Protection and Affordable Care Act (PPACA) of 2010, colloquially referred to as Obamacare, is one of the healthcare laws that has garnered much media attention in recent times. This Act was signed into law in March 2010 as an effort to achieve comprehensive reform of health care insurance, expand coverage for low-income individuals, improve access to quality health care, lower health care costs, and provide consumers with more choice and increased protection. In 2012, the Supreme Court ruled 5 to 4 that individual states could opt out of the ACA’s Medicaid expansion, although the law as a whole was upheld. The government website created for Americans to compare prices on health insurance plans, HealthCare.gov, proved to be a technical failure in the beginning, but the initial issues were eventually resolved.

In 2017, the majority Republican government attempted unsuccessfully to pass several repeals of the ACA. However, the law gained majority support by late 2017. Two separate legislations within the Act have attempted to fill in the gaps and expanded Medicaid coverage to millions of the poorest Americans.

Affordable Care Part I

The first part of the Act addresses Medicare and Medicaid. The Centers for Medicare and Medicaid Services (CMS) was tasked with identifying priorities and guiding the implementation of significant changes in Medicaid and the Children’s Health Insurance Program (CHIP) with the aim to achieve more coverage for low-income Americans with a minimum income eligibility for Medicaid nationwide.

Affordable Care Part II

The second part of the Act focuses on coverage of newly eligible adults and is funded by the Federal Government for three years beginning in 2014, with the intent of phasing it down to 90% by 2020. This part of the Act also includes tools for states to design and invest in the IT systems they need to implement this proposed Medicaid coverage. The Act enables coordination and information exchange by allowing families and individuals to apply for all affordability programs through a single process. Newly eligible Americans receive minimum essential benefits in the form of a benchmark benefits pack.

The Act includes policy guidelines to improve the quality of care, to promote wellness and preventive public health, and to enhance the availability of long-term care. The care of dual Medicare-Medicaid eligible individuals will be coordinated by a new office within the CMS. The Act also includes provisions that promote transparency and integrity of the Medicaid program.

The main impact of the PPACA healthcare law on radiology in the long term is in reimbursement. It pushes the industry, in general, away from fee for service where each procedure is billed individually and toward an environment more like managed care where the reimbursement is focused on the visit as a whole. This also affects RIS and PACS tangentially in that it stresses increasing importance on correct reporting, billing, and record keeping.

The United States Occupational Safety and Health Administration (OSHA)

The United States Occupational Safety and Health Administration (OSHA) regulates occupational exposure to radiation and is responsible for regulations concerning the “right to know” of employees with regard to hazards that may be present in the workplace. OSHA is one of the agencies of the United States Department of Labor. The US Congress had established this agency under the Occupational Safety and Health Act. It serves as a monitoring agency in areas of employment, primarily in industry. OSHA is responsible for the regulation of occupational exposure to radiation, as well as the regulations concerning the employee’s “Right to Know” about the hazards that could be present in the working environment.

The agency has published standards, Federal Registers (including the rules, notices, and proposed rules), directives (including instructions for the officers of compliance), standard interpretations (such as official letters of interpretation of the standards), and many other federal standards associated with ionizing radiation. Twenty-five states, along with Puerto Rico and the Virgin Islands, have state plans approved by OSHA and they have all adopted their own standards and enforcement policies. The majority of these states have adopted the standards that are identical to Federal OSHA. However, some states have adopted different standards that are pertinent to this topic or may have different enforcement policies.

Occupational Safety and Health Act: A Federal Law

Health and Safety in the private sector and the federal government of the United States are governed by the Occupational Safety and Health Act, which is a primary federal law. It was enacted by the US Congress in 1970 and was approved by President Richard Nixon on the 29th of December, 1970. The primary goal of this healthcare law is to make sure that the employers provide the workers an environment that is safe and free from known hazards like ionizing radiation.

The Act can be seen in Title 29, Chapter 15 of the United States Code. Occupational exposure is regulated by OSHA through 29 CFR 1910. It is accountable for the regulation of the employee’s “Right to Know”. The term “Right to Know” is a legal principle, which is used in the context of the United States workplace and the community environmental law. It states that an individual has the right to know all the chemicals to which he could be exposed to in his work routine and daily activities. Not only is it embodied in federal law in the United States, but also in the local laws implemented in several states of America. The “Right to Know” law has two major forms: (1) Community “Right to Know” and (2) Workplace “Right to Know”. Each form provides certain rights to such groups. Any possible exposure to ionizing radiation in the working environment must be revealed to the employees and occupants as stated by the law regulated by OSHA. The agency also manages different training programs in the workplace as part of the Act.

The U.S. Food and Drug Administration (FDA)

The Food and Drug Administration is currently conducting a product radiation control program to regulate the design and manufacture of electronic products, such as diagnostic x-ray machines. To determine an accurate level of compliance among all manufacturers and x-ray facilities to the given standards, the FDA performs an onsite inspection of the equipment, especially the mammography units. Compliance to FDA standards ensures the protection of those persons who may or may not be exposed occupationally from faulty manufacturing.

The US Congress has passed a law known as the Radiation Control for Health and Safety Act (Public Law 90-602) of 1968. This Act protects the general public from the potential danger of unwanted and unnecessary radiation exposure from electronic products like microwave ovens, color televisions, and diagnostic x-ray equipment. It allowed the establishment of the Center for Devices and Radiological Health (CDRH).

The CDRH belongs under the jurisdiction of the Food and Drug Administration. Basically, it is in charge of conducting an ongoing electronic product radiation control program. It includes organizing and setting up standards for the installation, manufacturing, assembly, and maintenance of radiograph machines for diagnostic or radiologic procedures. Its other responsibilities are to assess the biologic effects of ionizing radiation, evaluate emissions of radiation from general electronic products, and conduct research to lessen the exposure to radiation. In 1974, the code of standards for diagnostic x-ray equipment was implemented. The code applies to major components and complete systems that are manufactured from that year onward. However, the law does not regulate the user or administrator of a diagnostic x-ray. It is only an equipment performance standard.

FDA Standards for X-ray Equipment

Here are some of the provisions included in this healthcare law (standards for diagnostic X-Ray equipment): Automatic limitation of the radiographic beam to the image receptor regardless of image receptor size; a condition known as positive beam limitation.

• Appropriate minimal permanent filtration of the x-ray beam to ensure an acceptable level of beam quality. Filtration provides a significant reduction in the intensity of very “soft” X-Rays that contribute only to added patient absorbed dose.
• The ability of x-ray units to duplicate certain radiation exposures for any given combination of kilovolts at peak value (kVp), milliamperes (mA), and time to ensure both exposure reproducibility and linearity. Reproducibility is defined as consistency in output in radiation intensity for identical generator settings from one individual exposure to other subsequent exposures. *A variance of 5% or less is acceptable. Exposure linearity is defined as consistency in output radiation intensity at a selected kVp setting when changing from one mllliamperage and time combination (mAs = mAx exposure time) to another. Linearity, which is defined as the ratio of the difference in mR/mAs values between two successive generator stations to the sum of those mR/mAs values, must be less than 0.1.
• Inclusion of beam limitation devices for spot films taken during fluoroscopy. Such devices should be located between the x-ray source and the patient.
• The presence of “beam on” indicators to give visible warnings when x-ray exposures are in progress and both visual and audible signals when exposure has terminated.
• Inclusion of manual backup timers for automatic (photo-timed) exposure control to ensure the termination of the exposure if the automatic timer fails.

Consumer-Patient Radiation Health and Safety Act

The Consumer-Patient Radiation Health and Safety Act of 1981 is a healthcare law that was enforced by federal legislation. It requires the establishment of minimal standards for the accreditation of education programs for those who manage radiologic procedures and certification of professional technologists. The Act is under the directorship of the secretary of Health and Human Services. The rationale of this federal act is to make sure that standard dental and medical radiologic procedures are strictly in compliance with safety precautions and standards. It recommends the individual states to ratify similar statutes and administer certification and accreditation programs based on the established standards. Because there is no legal penalty imposed for non-compliance, many states have not responded yet with proper legislation. The full legislation is included under 42 CFR 10001.

FDASIA

The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 is a regulatory framework which aims to promote innovation in health technology including mobile applications. The Act was signed into law in July 2012 to expand the authority of the U.S. Food and Drug Administration (FDA) to safeguard and advance public health. The Commissioner of the FDA, the Secretary of Health and Human Services (HHS), the Office of the National Coordinator (ONC) and the Chairman of the Federal Communications Commission worked in conjunction to develop strategies and recommendations to protect patient information safety. Although the main focus of this legislation is on generic and prescription drugs, it also covers imaging products and medical devices. To fund innovation in new products, the Act gives authority to collect user fees from industry stakeholders. The Act also aims to promote quicker patient access to innovative, safe, and effective products. The Act hopes to advance public health with increased stakeholder engagement and enhanced safety of the global drug supply chain.

The American College of Radiology (ACR)

The American College of Radiology was founded in 1923 and publishes The Journal of the American College of Radiology (JACR) and The ACR Bulletin. It is a non-profitable, professional medical association comprised of medical physicists, diagnostic radiologists, interventional radiologists, radiation oncologists, and nuclear medicine physicians.

Its mission is to serve patients as well as society through maximizing the value of different fields of radiology, such as radiation oncology, interventional radiology, medical physicists, and nuclear medicine by advancing the science of radiology, improving the quality of patient care, positively influencing the socio-economics of the practice of radiology, providing education for radiology and allied health professions, and conducting research for the future of radiology. The college accredits facilities so that they can execute diagnostic imaging procedures.

Nationwide Evaluation of X-Ray Trends (NEXT)

In a unique collaboration, the FDA’s Center for Devices and Radiological Health (CDRH) partners with the Conference of Radiation Control Program Directors (CRCPD) to conduct a survey that evaluates patient radiation doses and quality assurance in the practice of diagnostic radiology. One radiological modality is selected and radiation data is compiled from a nationwide sample of U.S. facilities and presented as the Nationwide Evaluation of X-Ray Trends or NEXT.

Radiation control personnel in about 45 states collaborate with CDRH staff to capture, analyze, and declare data on patient exposure, imaging technique, image quality, and film processing. This is not a healthcare law as such, but more a survey for assessment. The survey is conducted periodically to identify trends. NEXT has conducted such surveys since 1973 on the adult chest, abdomen, upper gastrointestinal fluoroscopy, computed tomography of the head, mammography, lumbosacral spine, pediatric chest imaging, and dental radiography.

Use of Phantoms for NEXT

Between 1973 and 1983, the program focused on an annual survey of the most commonly performed diagnostic radiological examinations. Standard references were based on manually collected exposure data. The introduction of AEC (automatic exposure control) made it necessary for the CDRH to develop phantoms to simulate radiographic attenuation by real patients. These phantoms, which were economical and mobile, tested AEC systems under a range of clinical conditions and yielded results consistent with real-world situations.

The earliest phantoms developed by CDRH were of the adult abdomen/LS spine and adult chest. These phantoms were tested in the NEXT annual surveys of the adult chest in 1984 and 1986. The NEXT now has seven phantoms in its repertoire, including adult abdomen/LS spine, adult posterior anterior chest, adult fluoroscopy, pediatric chest, dental, mammography, and CT. The CT head phantom was developed in conformity with parameters outlined in section CFR 1020.33 (b) (6) for CT dosimetry phantoms. The NEXT mammography phantom was developed with an equivalent compressed breast thickness of 4.2 cm. The mammography, adult chest, fluoroscopy, and dental phantoms from NEXT are all commercially available now. NEXT mammography surveys are no longer necessary because data about this imaging modality is collected from 10,000 MQSA inspections annually.

Current NEXT Surveys

Presently, NEXT surveys are a nationally-relevant resource to acquire comprehensive data on the selected modality of radiology, examining film processing integrity, image quality, and general practice. The results of the surveys serve as guidelines in the development of exposure and dose guides that are used by state and local radiation control programs to minimize radiation exposure. The American Association of Physicists in Medicine (AAPM), at the bidding of the American College of Radiology (ACR), is depending on NEXT data to develop reference values for commonly performed radiographic studies.

NEXT survey results and phantoms are being increasingly requested by international organizations such as the International Atomic Energy Agency (IAEA) to aid their efforts in outlining recommendations for patient exposure. The challenge facing NEXT in the coming years is the increasing use of digital imaging technology where film exposure cannot be relied upon to define the relationship between image quality and patient exposure. In the future, NEXT will have to focus on newer technologies and increasingly complex studies.

The Joint Commission (TJC)

The Joint Commission was formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JHACO). It is a non-profit, tax-exempted organization based in the United States. The Joint Commission accredits more than 20,000 health care programs and organizations in the U.S. State governments have largely assembled to recognize the Joint Commission accreditation as a condition of licensure and the receipt of Medicaid reimbursement. The organization’s declared mission is “To continuously improve health care for the public in collaboration with other stakeholders by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.”

TJC does not formulate healthcare laws and it is not a complete monopoly. Although most of the states make use of their services, some do not. Some states have already built their own alternative assessment procedures. States including Pennsylvania, Wisconsin, and Oklahoma (except for patients on a hospital-based outpatient mental health service) do not recognize TJC for state licensure. In the state of California, TJC takes part in a joint survey process, together with the state authorities. However, Medicare and other private insurance companies universally require some kind of accreditation.

This organization is affecting radiologic technologists in the sense that it maintains the ambulatory and hospital care facilities where they work in order to check and keep current documentation considering the technologists and equipment licensure as well. TJC ensures that the corresponding safety standards are observed and well-implemented.

Integrating the Healthcare Enterprise (IHE)

In Illinois, a non-profit organization was established, known as Integrating the Healthcare Enterprise. It supports and sponsors the initiative of the health care industry to enhance the sharing of information through computer systems. IHE was founded in 1998 by a group of radiologists and experts in information technology. The “Integration Profiles” of the IHE had helped to make an easier implementation and integration of the systems. It also helped the health care providers to effectively use the information. Delivery of optimal patient care is the ultimate goal of the IHE. Their integration profiles describe a workflow scenario or a need for clinical information and document how to utilize established standards to achieve it.

The program also describes how clinical information management uses cases, and it specifies how to use existing standards as well. There is a system which implements the same integration profile that deals with the need or scenario in a mutually compatible way. For instance, the DICOM Standards (Digital Imaging and Communications in Medicine) make use of various formats for image data. A given set of images that is in compliance with some optional parts of the standards may not be accepted by the application used by a certain radiologist. Such incompatibilities may be reduced by integration profiles. For equipment vendors and manufacturers, integration profiles are considered as the implementation guides. For health care providers on the other hand, the profiles are shorthand for integration requirements in purchasing documents. Integration Statements inform customers of the IHE profiles that are supported by the release of a specific product.

The American Registry of Radiologic Technologists^® (ARRT^®)

The American Registry of Radiologic Technologists is considered as the largest credentialing organization of radiologic technologists worldwide. Their contribution to healthcare laws is that they are responsible for testing and certifying technologists and for facilitating continuing education and ethics requirements for the annual registration. The registry promotes high quality standards for patient care through recognition of individuals who are qualified for radiation therapy, medical imaging, and other interventional procedures that make use of radiology.

In support of this mission, the ARRT^®:

• adopts and upholds standards for educational preparation for entry into the profession
• adopts and upholds standards of professional behavior consistent with the level of responsibility required by professional practice, and
• develops and administers examinations that assess the knowledge and skills underlying the intelligent performance of the tasks typically required by professional practice in the discipline

In addition to initial recognition, the registry provides a means to recognize individuals who continually demonstrate their qualifications by adherence to the standards of professional behavior and compliance with requirements for continuing education. You can read about the ARRT^® mission here.

Every state in America also has its own licensing and regulatory requirements in terms of radiation safety and technologist licensure. Most states choose to defer to the ARRT^® for licensure, however some states such as California, Texas, and Florida choose to permit limited licensed technologists under the state’s regulatory umbrella.

The American Society of Radiologic Technologists (ASRT)

The ASRT is the world’s oldest and largest membership association for radiation therapists and medical imaging technologists. The members of this association are health care personnel who administer diagnostic imaging examinations and those that deliver radiation therapy treatments. The personnel could be specialists in a certain area of radiologic technology like mammography, nuclear medicine, computed tomography, or magnetic resonance imaging.

The association provides the members with different educational opportunities, promotes radiation technology as a career, and monitors state and federal legislation that may affect the profession. It is in charge of establishing standards of practice intended for developing educational curricula and radiologic science profession. The mission of ASRT is “to give radiologic technologists the knowledge, resources, and support they need to provide quality patient care.”

The Image Gently and Image Wisely Campaigns

In 2006, the Alliance for Radiation Safety in Pediatric Imaging was established. It is also known as the Image Gently Alliance. It is composed of 44 health care organizations and serves more than 500,000 health care providers throughout the world, including the Society for Pediatric Radiology, The American Society of Radiologic Technologists, The American College of Radiology, The American Association of Physicists in Medicine, and the Society for Pediatric Radiology.

The main objective of the alliance is to increase awareness in the imaging community about the need to adjust the dose of radiation when dealing with children. Its ultimate goal is to alter or change the practice in consideration of the increased concern of the general public and the ongoing progress of best practices. It was in 2007 that the alliance launched the Image Gently Campaign. It is designed to uphold high quality imaging studies through the use of lowest doses and best practices on radiation safety that is available for pediatric patients. Their campaign has been supported and applied by an increasing number of different professional medical organizations throughout the world. It has also been supported and assisted by some radiology equipment manufacturing companies.

Focus of the Alliance

The alliance had chosen to concentrate primarily on CT (computed tomography) scans. This strategy of the alliance is justified by a dramatic increase in the amount of pediatric CT scans executed within the past 5 years in the United States. It was also due to the rapid evolution, change, and availability of CT equipment and technology. The Image Gently Campaign has grown to include digital radiography, parent information, nuclear medicine, fluoroscopy, and interventional radiology alongside with the CT scans. A Step Lightly Campaign was later introduced to concentrate on the field of interventional radiology.

After the success of the Image Gently Campaign, other organizations have also launched a campaign similar to it called “Image Wisely”, which caters to the issues of the adult population. Some of the organizations who have launched Image Wisely are the American College of Radiology, the American Association of Physicists in Medicine, the Radiological Society of North America, and the American Society of Radiologic Technologists. Furthermore, the International Atomic Energy Agency (IAEA) and the World Health Organization are also working in this field and they have continuing projects that are designed to minimize patient radiation dose and broaden the best practices in radiography.

The Mammography Quality Standards Act (MQSA)

The Mammography Quality Standards Act is a law proposed by the United States Congress. It is responsible for regulating the quality of care in mammography. Its primary intention is to maintain high quality mammography in the U.S. and its territories.

The MQSA was passed to ensure that every woman in the state will have access to quality mammography in order to detect breast cancer at its earliest and most treatable stage. This Act requires all the mammography facilities throughout the nation to meet uniform quality standards. An availability of treatment options may result in an increased survival rate.

According to the law, all mammography facilities must adhere to the following:

1. Accreditation by an FDA-approved body.
2. Certification by the FDA or its State equivalent as meeting the standards.
3. Undergo an annual MQSA inspection, and
4. Prominently display the certificate issued by the agency.

   

   The Food and Drug Administration was appointed by Congress to implement and develop the MQSA regulations. As a result of the enactment of the MQSA, all facilities administering mammography procedures are required to provide the patients with a written result of their test in a language that can be easily understood. This written output is also referred to as the “lay report”. Mammography facilities are also required to establish a consumer complaint mechanism, so that the patients will have access to a systematic process for addressing their concerns. When necessary, the patient has the right to obtain not only the copies, but the original mammograms as well. In case mammograms performed at the facility are found to be substandard and impose a risk to the health of the general public, facilities are required to inform the patient and their corresponding doctors and suggest a suitable and appropriate plan of action to resolve the issue.

   The Consolidated Appropriations Act

   The Consolidated Appropriations Act, passed in 2016, will allow Medicare to pay 20% less to providers who submit claims for x-rays performed on analog systems starting in 2017. Medicare payments will be similarly reduced for imaging done on CR systems by 7% between 2018 and 2022 and 10% after 2022. The act is an attempt to push healthcare providers in the United States towards adopting digital radiography (DR).

   The new law’s provision regarding analog equipment is not expected to have any major impact because the number of large sites still using traditional systems is insignificant. However, the reduction in payment for CR studies will have a more widespread effect because, as of 2016, there are still many thousands CR units in operation in the nation. The facilities using these systems will have to replace them with DR equipment or suffer reduced payments. This act will affect smaller facilities more since many smaller, low-volume facilities have replaced film-screen equipment with CR equipment as a cost-saving measure where cassettes were replaced with imaging plates that produced a digital output.

   A recent survey indicated that in 2015 more than 60% of hospitals were planning to either buy a new DR system or retrofit kit. DR provides better workflow efficiency, reduced cost per procedure due to increased throughput, and lower radiation dose, so U.S. hospitals will be forced to make the switch sooner rather than later from antiquated analog and CR technology to digital radiography.

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