On June 13, 2016, CMS published a proposed rule intended to revise the conditions of participation (CoPs) required for hospitals and critical access hospitals (CAHs) to participate in the Medicare and Medicaid programs, with a focus on quality of care.

Highlights from the proposed rule are outlined in further detail below.

Infection-prevention and antibiotic stewardship

In response to growing concern over the rise of healthcare-associated infections (HAIs) and potentially life-threatening anti-microbial resistant infections, CMS proposes requiring that hospitals and CAHs develop and maintain infection control and prevention and antibiotic stewardship programs. CMS will provide hospitals the flexibility to develop programs that reflect the scope and complexity of the services provided.

In establishing these programs, CMS would require that hospitals and CAHs document their surveillance activities (i.e., infection detection, data collection and analysis, monitoring, and evaluating preventive interventions).  CMS envisions that a single infection control professional and designated antibiotic stewardship leader would be responsible for implementing the hospital-wide programs, including responsibility for training hospital personnel and staff and documenting surveillance and prevention activities.  CMS would hold the hospital governing body accountable to ensure that systems are in place and active for tracking infection surveillance activities, prevention, control, and antibiotic use activities.

Lastly, CMS proposes requiring that hospitals and CAHs adhere to nationally recognized infection prevention and control guidelines for reducing the transmission of infections, including best practices for improving antibiotic use.

Quality indicator data

The Quality Assessment and Performance Improvement (QAPI) program requires that each hospital participating in Medicare periodically examine and report on the quality of its services. CMS requires that hospitals incorporate patient care data into their QAPI programs.  Hospitals now collect and analyze data for several quality reporting and performance programs (e.g., Hospital Inpatient Quality Reporting Program, Hospital-Acquired Condition Reduction Program, etc.).  CMS proposes requiring that hospital QAPI programs incorporate the quality indicator data received from these sources, including data related to hospital readmissions and hospital-acquired conditions.  The proposed rule, if finalized, would also require that CAHs develop their own QAPI program.

Nursing services and medical record requirements

CMS proposes to revise the CoP requirements for nursing services to require that nursing staff be available to meet patient needs regardless of whether the patient is an inpatient or an outpatient. CMS proposes that hospitals prepare a written policy clarifying which hospital outpatient departments would not require the physical presence of a registered nurse and plans for alternative staffing.  CMS would require that such policies take into account recognized standards of practice, the types of services provided, and the patient population served by the facility.  The policy would require initial medical staff approval and subsequent review at least once every three years.

CMS proposes requiring that patient medical records contain information necessary not only to justify inpatient admission and continued hospitalization, but also to document patient progress, services provided, and any inpatient or outpatient stays. All patient medical records must also document discharge and transfer summaries, including plans for transitional and follow-up care.

Finally, CMS proposes clarifying that patients have the right to request access to their clinical records in any format, including in electronic format when the records are maintained electronically.

Patient non-discrimination rights

CMS proposes establishing a specific requirement that hospitals and CAHs not discriminate on the basis of race, color, national origin, sex (including gender identity), age, disability, religion or sexual orientation, and that hospitals and CAHs establish written policies prohibiting discrimination on any of these bases. CMS would also require that hospitals and CAHs inform patients and/or their representatives of their right to be free from discrimination.

Patient nutritional needs in the CAH setting

To ensure that patients have timely access to nutritional care, particularly in remote or rural areas, CMS proposes requiring that CAHs ensure individual patient nutritional needs are met in accordance with recognized dietary practices. CMS currently permits only practitioners responsible for care of the patient to prescribe a therapeutic diet for a patient.  CMS explains that a team-based approach to ensuring that patient nutritional needs are met is necessary.  In addition to the prescribing or ordering physician, CMS proposes granting registered dietitians or qualified nutrition professionals medical staff or specific nutritional ordering privileges.

The proposed rule is expected to publish in the Federal Register on June 16, 2016. CMS must receive comments on the proposed rule by 5 p.m. EST no later than 60 days after the date of publication in the Federal Register.


*Blake Walsh is admitted only in Tennessee. Her practice is supervised by principals of the firm admitted in the District of Columbia.