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​So Long, Farewell, Auf Wiedersehen, Goodbye: CMS Proposed Regulations Say Good Night to HAIs and MDROs

Health Law Alert Alyce C. Katayama

The Centers for Medicare & Medicaid Services (CMS) has issued a proposed update to the conditions of participation (CoPs) that hospitals and critical access hospitals (CAHs) must meet to participate in Medicare and Medicaid. The proposed update requires infection prevention and control and antibiotic stewardship programs, expands patient rights, and clarifies existing regulations.

Infection Prevention and Control and Antibiotic Stewardship Programs

Hospital-acquired infections (HAIs) and multi-drug resistant organisms (MDROs) are two deadly visitors that all patients would like to avoid when they visit health care facilities. Consequently, CMS has proposed that hospitals and CAHs develop and maintain Infection Prevention and Control and Antibiotic Stewardship Programs to keep these unwanted visitors out. The programs are designed to “be active and hospital-wide for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship.” While that description won’t necessarily strike fear in to the hearts (nuclei?) of HAIs and MDROs, CMS has intentionally avoided establishing specific requirements so that health care facilities have some flexibility to choose which guidelines they want to follow. That said, the guidelines must be “nationally recognized,” meaning they cannot come from your average Joe. Rather, they must come from a source such as the Centers for Disease Control and Prevention (CDC), the Infectious Diseases Society of America (IDSA), or the Society for Healthcare Epidemiology of America (SHEA). Ultimately, CMS envisions that these programs will be designed to reflect “the scope and complexity of the hospital services provided.”

Not to be totally upstaged by the CDC, IDSA, or SHEA, CMS proposes that hospitals select leaders for the programs and suggests requirements relating to the qualifications and selection of those leaders. For the Infection Prevention and Control Program, CMS would require that the leader be trained or experienced in infection control and have the approval of “high-level hospital clinical leadership.” More importantly, this leader would get a snappy new title with “infection control professional” replacing the outdated title of “infection control officer.” For the Antibiotic Stewardship Program, CMS would require that the medical staff leadership and pharmacy leadership select a leader trained or experienced in infectious diseases or antibiotic stewardship. CMS has not proposed a title for this leader, however, leaving it up to the creativity of health care facilities. CMS would require these leaders to work together to develop and implement hospital-wide Infection Prevention and Control and Antibiotic Stewardship programs as well as accompanying policies and procedures that, as mentioned above, adhere to nationally recognized guidelines. These leaders would also be responsible for training all relevant hospital personnel and staff and documenting all program activities.

Patient Rights Expansion

Freedom from Discrimination

Presumably all health care providers know that they are not allowed to discriminate against patients based on race, color, national origin, sex (including gender identity), age, or disability. Section 1557 of the Affordable Care Act clearly prohibits discrimination on all of these bases in health programs, and the Hospital and CAH CoPs require health care facilities to be in compliance with all federal laws related to the health and safety of patients. However, the present CoP requirement is not explicit. To remove any doubt, CMS proposes adding an explicit provision requiring that hospitals not discriminate on the basis of any of the characteristics mentioned above, though it would also add religion and sexual orientation to the list. In addition, CMS would require that a hospital inform patients of their right to be free from discrimination and of how they can seek assistance if they feel their rights have been violated.

Medical Record Access

Patients have the right to access information contained in their medical record within a reasonable time frame (the Office for Civil Rights says that timeframe is 30 days). However, it is not clear whether patients have a right to request that information in an electronic format despite the prevalence of electronic medical records. CMS would require health care facilities to allow patients to access their medical records in the “form and format” they request, assuming it can be produced in that format. If it can’t be produced in that format, then the medical record would have to be supplied in a hard copy form within a reasonable time frame.

Clarification of Existing Regulations

Licensed Independent Practitioners

CMS CoPs regarding the seclusion and/or restraint of patients currently require that such measures be ordered by “a physician or other licensed independent practitioner.” When comments were received on this rule back in 2012, one commentator noted that this language would be interpreted to exclude physician assistants (PAs) from ordering restraint and/or seclusion. Rather than change the language, CMS mentioned in an appendix that the rule did not exclude PAs. Lo and behold this clairvoyant commentator turned out to be right—the licensed independent practitioner requirement has restricted the “ability of hospitals to utilize PAs to the extent of their educational preparation.” So, CMS is proposing to remove the word independent from all references to licensed independent practitioners in the context of seclusion and/or restraint orders.

Nursing Services

CMS CoPs for nursing services require, at this time, that each department be sufficiently staffed “to ensure, when needed, the immediate availability of a registered nurse for bedside care of any patient.” Some providers have interpreted “bedside” to mean inpatient services only (an unnecessary distinction) and “immediate availability” to mean physically present in the department (an unnecessary requirement for some outpatient services). Rather than waiting for another clairvoyant commentator to come along, CMS has proposed to fix these problems proactively by deleting the term “bedside” and allowing hospitals to establish policies that would specify when “outpatient departments would not be required to have an RN physically present.” These policies would have to be approved and reviewed by the medical staff at least once every three years. CMS also proposes clarifying the requirement that each patient have a nursing plan to make clear that the plan must only reflect the patient’s specific medical needs. Finally, CMS proposes that all licensed nurses must follow hospital policies and procedures and all nursing personnel must be supervised by the director of nursing services, thereby eliminating the previous distinction the regulations had made between employee and non-employee nurses and nursing personnel.

Quick Hits

Quality Assessment and Performance Improvement Program (QAPI): CMS suggests that QAPI programs be required to incorporate “data related to hospital readmissions and hospital-acquired conditions.”

Medical Record Services: CMS proposes an update to medical record requirements that would better reflect the specific information needed to document discharges as opposed to transfers and inpatient stays as opposed to outpatient visits.

Critical Access Hospitals: CMS would require that CAHs allow a “qualified dietician or qualified nutrition professional” to order nutritional care in addition to “the practitioner responsible for the care of the patients.” CMS also would require that CAHs institute QAPI programs similar to those required in hospitals.


CMS would like to hear what you think about these proposed regulations and is soliciting comments until 5 p.m. on August 15, 2016. You are allowed to submit comments in one of four ways: electronically, by regular mail, by express or overnight mail, or by hand or courier.

For questions, contact Alyce Katayama at (414) 277-5823/, or your Quarles & Brady attorney.