Informed Consent – Ensuring Compliance with CMS, TJC, and DNV
Informed consent and the applicable standards and guidelines can be confusing. The
Centers for Medicare & Medicaid Services (CMS) and other accrediting organizations
require certain elements to be included. This program will discuss the current CMS
hospital Conditions of Participation (CoPs), including the critical access hospital, The
Joint Commission (TJC) and DNV Healthcare standards on informed consent
The CMS manual on CoPs h three sections regarding consent. All hospitals that
receive Medicare and Medicaid reimbursement must comply with these regulations
and the interpretive guidelines. Additionally, the CMS requirements for hospitals and
critical access hospitals are very different and hospitals within a larger system should
be familiar with the differences. This program will explain the differences in the
Finally, health care providers must be aware of their specific state law on informed
consent. Many professional organizations such as the American College of Surgeons,
American Society of Anesthesiologists, and the American Association of Nurse
Anesthetists also have guidelines or position statements on informed consent.
At the conclusion of this session, participants should be able to:
• Recall that the CMS hospital CoPs interpretive guidelines have three
separate sections on informed consent.
• Describe the six minimum requirements that are now mandatory to be on the
informed consent form for surgery done at a hospital that receives Medicare
• Discuss the CMS and accreditation organization standards applicable to your
facility that should be reflected in the hospital’s policies and procedures.
• Identify that the medical staff must have a list of procedures and tests that
will require an informed consent under federal regulations.