CMS Revises Guidance on Hospital Grievance Policies Effective September 19, 2005

The Centers for Medicare and Medicaid Services ("CMS") charges State health agencies with determining whether or not hospitals are complying with applicable Medicare health and safety regulations, or Conditions of Participation ("COP").  To assist the State health agencies in performing this regulatory function, CMS publishes a State Operations Manual (CMS-Pub. 100-07) (the "SOP") which guides State surveyors on how to interpret the various COP regulations.  Appendix A of the SOP contains both the survey guidelines derived from the COP regulations, and the applicable interpretive guidance.

On August 18, 2005, CMS issued a series of revisions to Appendix A (the "August Revisions").  The changes, which will take effect September 19, 2005, revise the interpretive guidance applicable to the following COPs:

• COPs for Governing Body (42 CFR §482.12) - Clarifies that in a state that permits midwives to admit patients (and in accordance with hospital policy and practitioner privileges), CMS requires only that Medicare patients of a midwife be under the care of a doctor of medicine or osteopathy.  CMS does not require that Medicaid or other non-Medicare patients admitted by a midwife be under the care of a doctor of medicine or osteopathy.
• COPs for Patient Rights (42 CFR §482.13) - Provides further guidance on the definition of a patient grievance.  The changes to the grievance policy interpretive guidelines are discussed in more detail below.
• COPs for Laboratory Services (42 CFR §482.27) - Clarifies the extent to which hospitals must make emergency lab services available to patients.
• COPs for Food and Dietetic Services (42 CFR §482.28) - Clarifies that therapeutic diets must be ordered by the person responsible for the care of the patient.

Notably absent from the August Revisions is a series of changes to the COPs for obtaining patients' informed consent.  According to CMS, revisions to the interpretive guidance on the informed consent COP will be issued later this Fall.

The remainder of this article will outline the patient rights/grievance policy requirements in the August Revisions and will discuss the current status of and anticipated changes to the patient rights/informed consent requirements.

Patient Rights/Grievance Policy

In May of 2004, the Centers for Medicare and Medicaid Services ("CMS") issued a revision to the interpretive guidelines applicable to the Hospital COPs related to patient grievances and informed consent (the "2004 Guidelines").  Most notably, the new interpretive guidelines accomplished the following:

• Broadened and attempted to clarify the definition of "patient grievance".  Specifically, under the revised standards, the definition of a "patient grievance" was broadened to include formal and informal grievances, whether written or verbal.¹
• Specified that in responding to a grievance, a timeframe of seven days for the written response would be considered appropriate, though the hospital's resolution need not be complete within the seven-day limit.
• Clarified that a hospital must provide a written response, conforming with applicable CMS requirements, to the patient in all grievance cases, regardless of how the grievance was resolved.

While the 2004 Guidelines were meant to provide additional clarity about the definition and scope of "grievance", the broadened definition of grievance prompted more questions than it answered.  In response to provider concerns about the 2004 Guidelines, CMS further revised the grievance requirements in the August Revisions. 

As revised, a "patient grievance" is defined as "a written or verbal complaint (when the verbal complaint is not resolved at the time of the complaint by staff present) by a patient or the patient's representative regarding the patient's care, abuse or neglect, issues related to the hospital's compliance with the CMS Hospital COPs, or a Medicare beneficiary billing complaint related to rights and limitations provided by 42 CFR §489."²  "Staff present" which was not defined in the 2004 Guidelines, is now defined to refer to "any hospital staff present at the time of the complaint or who can quickly be at the patient's location (i.e. nursing, administration, nursing supervisors, patient advocates, etc.) to resolve the patient's complaint."  Additionally, the August Revisions clarify that a patient complaint or grievance is deemed "resolved" when the patient or his or her representative is satisfied with the actions taken by the hospital on their behalf.

In addition to the new definitions of "patient grievance" and "staff present", the August Revisions provide the following clarifications about what constitutes a grievance:

• A verbal complaint is a patient grievance if:
  • It cannot be resolved at the time of the complaint by staff present;
  • Is postponed for later resolution;
  • Is referred to other staff for later resolution; or
  • Requires investigation and/or requires further actions for resolution
• Billing issues are not usually considered a patient grievance.  However, a billing complaint related to rights and limitations contained in 42 CFR §489 is considered a grievance.
• A written complaint is always considered a grievance, whether from an inpatient, outpatient, released or discharged patient or their representative as long as the concern expressed in the grievance concerns one of the three areas constituting a grievance (i.e., the care provided to the patient, abuse or neglect, or the Hospital's compliance with the COPs). 
• Information obtained from a patient satisfaction survey does not usually meet the definition of a grievance.  However, if a patient attaches a written complaint to a survey and requests resolution, then the written complaint is a grievance.
• A grievance may include a situation where the patient or his or her representative phones the hospital with a concern that constitutes a grievance (i.e., the care provided to the patient, abuse or neglect, or the Hospital's compliance with the COPs).  Post-hospital verbal communications that would routinely have been handled by staff present if the communication had occurred during the hospital stay do not constitute grievances. 
• All verbal or written complaints regarding abuse, neglect, patient harm or hospital compliance with COPs are grievances.
• All instances in which a patient or his or her representative requests that their complaint be handled as a formal complaint or grievance or where the patient requests a response constitute grievances.

In addition to clarifying what constitutes a grievance, the August Revisions accomplish the following:

• Clarify that a grievance committee is comprised of more than one person and must include adequate numbers of qualified people to comply with CMS grievance process requirements;
• Specifies that grievances should on average be resolved within seven days and acknowledges that staff fluctuations and the complexity of a particular grievance may affect the amount of time required for resolution. The 2004 Guidance included a more rigid time frame of seven days absent extenuating circumstances;
• Includes information about when a Hospital-Issued Notice of Non-coverage ("HINN") or Notice of Discharge and Medicare Appeal Rights ("NODMAR") should be issued;
• Explicitly permits resolution of grievances via e-mail, and provides some additional clarification about what a hospital must include in its formal written response to grievances;
• Acknowledges that there may be times when the patient or his or her representative continue to be dissatisfied with the hospital's actions even when the hospital has taken reasonable actions to address the applicable concerns.   In these circumstances, the August Revisions permit the hospital to deem the complaint or grievance resolved even though the patient or his or her representative is not satisfied with the outcome.

Patient Rights/Informed Consent

42 C.F.R. Section 482.51(b)(2) requires hospitals to insure that a properly executed informed consent form is obtained from the patient before an operation is performed, except under emergency circumstances.  The 2004 Guidelines include a controversial revision involving the process of obtaining informed consent from the patient: 

"the name of the practitioner(s) performing the procedure(s) or important aspects of the procedure(s), as well as the name(s) and specific significant tasks that will be conducted by practitioners other than the primary surgeon/practitioner.  Significant surgical tasks include: opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues".

For purposes of the interpretive guidelines, "practitioners" include medical doctors, doctors of osteopathy, dentists, oral surgeons, podiatrists, registered nurse first assistants, nurse practitioners, surgical physician assistants, surgical technicians, etc.  The 2004 Guidelines further provide that the patient must be informed when practitioners other than the primary surgeon will perform important parts of the surgical procedures, even when performed under the primary surgeon's supervision, and the informed consent form must identify these other practitioners.  Accordingly, in non-emergency situations, whenever an assistant at surgery is performing a "specific significant surgical task," the assistant's name must be provided to the patient in the informed consent form.  As it currently stands, if the hospital will not know who will assist the surgeon until the day of the surgery, then the hospital must update the informed consent on the day of the surgery.  Not surprisingly, complying with this standard has proven somewhat burdensome.

At the behest of the provider community, it appears that CMS will soon be revising its interpretive guidelines regarding informed consent.  Although there is no definitive word yet on precisely how the 2004 Guidelines on informed consent will be revised, continued correspondence with certain CMS officials indicates that under the revised guidance, the actual names of the practitioners may not be required so long as some indication of their education/experience level is given.  CMS officials have indicated that until the revised interpretive guidelines are issued, state surveyors have been instructed not to cite providers for failing to provide the names of the individual practitioners that will assist the primary surgeon on the informed consent form.  Notwithstanding such instructions to state surveyors, until CMS formally revises the 2004 Guidelines, providers might consider including on their informed consent forms the generic official title and/or experience level of any practitioners that would be expected to perform "specific significant tasks" during the operation.  For example, if a hospital anticipates that a registered first assistant will harvest a graft during a particular operation, the hospital should note that on the informed consent form.

If you have any questions or would like more information on the interpretive guidelines described in this article, please contact David Stephan.

¹ Prior to 2004,  "patient grievance" was defined as a "formal, written or verbal grievance that is filed by a patient when a patient issue cannot be resolved promptly by staff present."

² This section of the CFR sets forth the requirements for provider agreements and supplier approval and includes patient rights relative to discharge.