Medicare Compliance & Reimbursement

Pocket This Primer On Informed Consent Forms

Critical: CMS revises interpretive guidance on informed consent.

An increase in state statutes focused on improving informed consent protocols caused CMS to get involved and update federal guidance.

Details: On April 1, the Centers for Medicare & Medicaid Services (CMS) issued a memorandum to state survey directors. The CMS memo reminds providers about their requirements under the Medicare Conditions of Participation (CoPs), updates “hospital interpretive guidance in the State Operations Manual,” and advises state surveyors to be vigilant when reviewing hospitals’ policies.

“Hospitals must utilize an informed consent process that ensures patients, or their representatives, are given the information and disclosures needed to make an informed decision about whether to consent to a procedure, intervention, or type of care that requires consent,” CMS cautions.

Additionally, the medical record must show that the patient or the patient’s representative were fully informed and consented to the treatment or procedure. The medical record should also include the required documentation and form as well as “which procedures and treatments require written informed consent” according to medical staff, the memo indicates.

Forms: With the exception of emergencies, “all inpatient and outpatient medical records must contain a properly executed informed consent form prior to conducting any procedure or other type of treatment that requires informed consent,” CMS says. According to the memo, a well-executed consent form must include specific items, and the state where the procedure occurs may also require additional information to be included in the form. Here is a list of what CMS requires be on your facility’s consent forms and what your state might also mandate:

• Name of the facility or hospital
• Name of the procedure or treatment
• Name of the provider administering treatment/ performing the procedure
• Documentation or statement that the patient was offered a comprehensive explanation about the procedure/treatment
• List of the “anticipated benefits, material risks, and alternative therapies” of the procedure
• If applicable, a statement outlining what other physicians or residents assisting will be doing and how they’ll be supervised by the responsible operating physician
• If applicable, a statement outlining what other qualified medical staff assisting will be doing, the tasks they will perform, and how that aligns with state law, regulations, and hospital policy
• Signature(s) of the patient, patient’s representative, and person witnessing the signatures
• Date and time consent was signed by all parties

Here’s What CMS Added to the Manual

The lack of informed consent in lieu of more non-physician practitioners, advanced practice providers, and students “perform[ing] training- and education-related examinations outside the medically necessary procedure” has spurred changes to the State Operations Manual’s interpretive guidance for hospitals, the memo notes.

Due to these concerns and other state-related provisions, CMS opted to add the following new guidance in bold to the manual:

“Whether physicians other than the operating practitioner, including, but not limited to, residents, medical, advanced practice provider (such as nurse practitioners and physician assistants), and other applicable students, will be performing important tasks related to the surgery, or examinations or invasive procedures for educational and training purposes, in accordance with the hospital’s policies. Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices, and placing invasive lines. Examinations or invasive procedures conducted for educational and training purposes include, but are not limited to, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law.”

Resource: Review the CMS memo to state surveyors, which was effective as of April 1.