Regulating the Healthcare Industry: How Standards and Quality are Assured

 Adapted from a text by: E. Dennis Tolman, Ph.D. (Founder of the BYU Idaho Healthcare Administration Program)

This document focuses on the concepts of licensure, CMS Certification, accreditation, Physician Board Certification and medical staff credentialing and privileging.

Licensure 

Each state, through its Health Department, licenses all healthcare providers, including facilities – hospitals, long-term care facilities, ambulatory surgery centers, free-standing urgent care facilities, etc. – and medical professional—including physicians, chiropractors, podiatrists, dentists, oral surgeons, orthodontists, nurses, physician assistants, CRNAs (Certified Registered Nurse Anesthetists), pharmacists, clinical psychologists, respiratory therapists, physical therapists, speech therapists, occupational therapists, nurse midwives, in short, everyone who provides clinical care to patients. Every provider must be licensed before providing care. Note that some states (e.g., Utah and Idaho) have reciprocal licensing for physicians. This means that a license to practice in one state is valid in the other. This does not apply to organizations, but only to individual physicians.

“Physicians may hold one or more licenses to practice medicine in 54 US licensing jurisdictions, including the fifty states, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands. Licenses are granted to ensure the public that the physician who presents himself/herself for licensure has successfully completed an appropriate sequence of medical education, including a specified amount of residency training in an accredited program, and has demonstrated competence through successful completion of an examination or other certification demonstrating qualification for licensure.” (Quoted from the AMA website)

CMS Certification

The Centers for Medicare and Medicaid Services (CMS) maintains oversight for compliance with the Medicare health and safety standards for laboratories, acute and continuing care providers (including hospitals, nursing homes, home health agencies), end-stage renal disease (ESRD) facilities, rehabilitation facilities, hospices, and other facilities serving Medicare and Medicaid beneficiaries), and makes available to beneficiaries, providers/suppliers, researchers and State surveyors information about these activities.

The survey (inspection) for this determination is done on behalf of CMS by the individual State Survey Agencies. The functions the States perform for CMS under the agreements in Section1864 of the Social Security Act (the Act) are referred to collectively as the certification process. This includes, but is not limited to:

  1. Identifying Potential Participants: Payment for health services furnished in or by entities that meet stipulated requirements of the Act. Identification includes those laboratories seeking to participate in the CLIA program.
  2. Conducting Investigations and Fact-Finding Surveys: Verifying how well the health care entities comply with the "conditions of participation" (CoPs) or requirements. This is referred to as the "survey process."
  3. Certifying and Recertifying: Certifications are periodically sent to the appropriate Federal or State agencies regarding whether entities, including CLIA laboratories, are qualified to participate in the programs.
  4. Explaining Requirements: Advising providers and suppliers, and potential providers and suppliers in regard to applicable Federal regulations to enable them to qualify for participation in the programs and to maintain standards of health care consistent with the CoPs and Conditions for Coverage (CfCs) requirements. * (Quoted from the CMS website)

Without a CMS certificate, as described above, no provider may bill CMS for services without violating the False Claims Act. Administrators who are prudent about their businesses take great care to ensure that their facilities are CMS certified and that they are always in compliance with the CMS Conditions of Participation.

Physician Board Certification

While medical licensure is required and sets the minimum competency requirements to diagnose and treat patients, it is not specialty specific. Board certification—and the Gold Star (awarded by the American Board of Medical Specialties) —demonstrate a physician’s exceptional expertise in a particular specialty and/or subspecialty of medical practice.

The Gold Star signals a board certified physician’s commitment and expertise in consistently achieving superior clinical outcomes in a responsive, patient-focused setting. Patients, physicians, healthcare providers, insurers and quality organizations look for the Gold Star as the best measure of a physician’s knowledge, experience and skills to provide quality healthcare within a given specialty.

Certification by an ABMS Member Board involves a rigorous process of testing and peer evaluation that is designed and administered by specialists in the specific area of medicine. There are approximately 145 different medical specialty certificates. A physician may be Board Certified in more than one, depending upon his/her training and successfully passing the ABMS member board certification exam(s). You should be aware that some physicians claim to be “Board Eligible,” which means nothing more than that they are still attempting to pass the Board Certification examination.

Note, physician certification is a voluntary process. In other words, it is not required for a physician to be certified by the ABMS. However, a physician may seek to become credentialed and privileged at a hospital where ABMS certification is required. At that point, it is up to the physician to pursue ABMS certification or forego the ability to practice medicine at that specific facility.

Medical Staff Credentialing and Privileges

There are two separate parts to this process. First, through the recommendation of a physician’s peers on the medical staff, the Governing Board verifies that his/her credentials are in order and that they meet the criteria for membership on the Medical Staff of that facility. This is what constitutes “credentialing.” Second, also upon recommendation of the physician’s peers, the Governing Board delineates the precise procedures and practices that the physician will be permitted to perform within that institution. This is what constitutes the extension of Medical Staff Privileges to the physician.

Note: In Quaternary level institutions – hospitals associated with Medical Schools with a research role – there is a unique organization that is known as the Institutional Review Board. When a research protocol or treatment is proposed, which has not yet been approved for regular medical staff privileges, the application to perform this protocol on human patients is made to the IRB. If approved, each procedure is carefully “policed” by the IRB for a specified period of time and/or a specified number of patients. It is the IRB that extends or grants Medical Staff Privileges for each approved procedure. This body is legally responsible for the quality of care provided under their watch. Once a research protocol or procedure has been proven and becomes part of usual and customary medical care, it becomes the domain of the Governing Board of community hospitals to grant privileges to their medical staff to carry it out. This is the procedure through which medicine expands from research into everyday practices.

Accreditation

The oldest and largest standards-setting and accrediting body for healthcare organizations in the United States is the Joint Commission. It was founded in 1951 as a combined effort of the American College of Surgeons and the American Hospital Association – hence the original name The Joint Commission on Accreditation of Hospitals. That name was later expanded and changed to include all “healthcare organizations.” It is now known merely as “The Joint Commission.” “The Joint Commission seeks 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 patient care of the highest quality and value. The Joint Commission evaluates and accredits more than 22,000 health care organizations and programs in the United States. To earn and maintain The Joint Commission’s Gold Seal of Approval™, an organization must undergo an on-site survey by a Joint Commission survey team at least every three years. (Laboratories must be surveyed every two years.)” (Joint Commission website, May, 11 2020)

Accreditation is a completely voluntary process. It began with the “joint” efforts of the AHA and the ACS in a desire to improve the quality of care delivered in our hospitals. It has steadily improved its procedures and its processes and, today, is considered the gold standard of accreditation in the industry. The Joint Commission accredits approximately 80% of all eligible healthcare organizations.

ISO—the International Organization for Standardization

ISO 9000 is a “family” of standards that represents an international consensus on good quality management practices. It consists of standards and guidelines relating to quality management systems and related supporting standards. ISO 9001 is the standard that provides a set of standardized requirements for a quality management system, regardless of (a) what the user organization does, (b) its size, or (c) whether it is in the private or public sector.

ISO accreditation is different in many respects from that of the Joint Commission: