by Adele Merenstein

On June 16, 2016, the U.S. Department of Health and Human Services Centers (DHHS) Centers for Medicare and Medicaid Services (CMS) published in the Federal Register a proposed rule (Proposed Rule) that would update the requirements that hospitals and critical access hospitals (CAH) must meet to participate in the Medicare and Medicaid programs (Conditions of Participation or CoPs).

Hospitals and CAHs must meet the minimum health and safety standards established in the CoPs to be eligible for certification and reimbursement from these programs. Since most hospitals participate in the Medicare and Medicaid programs and a sizeable portion of their revenues derive from these programs, it is important for hospitals and CAHs to stay abreast of changes in the CoPs and to prepare for new standards introduced in proposed rules.

Highlights of the Proposed Rule

Non-Discrimination: There are a number of federal laws prohibiting discrimination including a new DHHS Office of Civil Rights final rule, effective July 18, 2016, that prohibits discrimination based on sex, gender identity and sex stereotyping in the provision of healthcare. Notwithstanding, the current hospital CoPs do not explicitly prohibit discrimination. Because discriminatory behavior by healthcare providers can negatively impact access to and effectiveness of healthcare delivery, CMS proposes to amend the CoPs to establish requirements that hospitals (including CAHs) not discriminate on the basis of race, color, national origin, sex (including gender identity), sexual orientation, age, disability or religion.

Further, hospitals must establish and implement written policies prohibiting such discrimination. The Proposed Rule would require hospitals to inform a patient (including the patient’s representative and/or support person, as applicable) of the patient’s right to be free from discrimination and the process for filing a complaint if the patient encounters discrimination.

Terminology Changes to Promote Access to Care: In the “Patient’s Rights” CoPs that govern the use of restraint and seclusion in the hospital setting, CMS proposes to eliminate the use of the term “licensed independent practitioner” (LIP) and substitute “licensed practitioner” to clarify that physician assistants (PA) may order and monitor the use of restraint or seclusion if permitted to do so by hospital policy in accordance with State law, notwithstanding PAs do not practice independently. The change was prompted by a recognition that independent practice is “not a measure of a healthcare professional’s educational preparation, competency or ability to provide quality medical care,” and that the LIP terminology is inconsistent with the movement toward team-based healthcare delivery.” Unnecessary limitation of the PA’s scope of practice also burdens hospitals, particularly small hospitals and rural hospitals.

Medical Records Access in Electronic Format: CMS proposes to clarify that a patient has the right to access their medical records, upon an oral or written request, in the form and format requested if it is readily producible in such form or format including an electronic format when medical records are maintained electronically. Currently, the CoPs guarantee access but do not specify the format for production and do not specifically provide for access with a verbal request only.

Quality Assessment and Performance Improvement (QAPI) Program: Per the current CoPs, hospitals must maintain hospital-wide data-driven quality assessment and performance improvement programs. If amended, the CoPs will require hospitals to incorporate quality indicator patient care and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs including data related to hospital readmissions and hospital-acquired conditions.

By adding the highlighted language, CMS hopes to encourage hospitals to draw from the readily available and rich source of quality data produced by the Medicare quality data reporting programs (e.g., Hospital Inpatient Quality Reporting program, Hospital Value-Based Purchasing Program) when developing their QAPI programs. In turn, use of this data can help drive continued improvement in care.

New Antibiotic Stewardship Requirements and Focus on Infection Prevention: CMS proposes to require hospitals and CAHs to develop an “antibiotic stewardship program” as a means to improve hospital antibiotic-prescribing practices and reduce patient risk for potentially life-threatening antibiotic resistant infections. In addition, the CoPs would be modified to emphasize the role of prevention in infection control including the surveillance, prevention and control of healthcare associated infections (HAI).  The program would have to demonstrate adherence to nationally recognized prevention and control guidelines for reducing transmission of HAIs, and best practices for improving antibiotic use.

For example, CMS proposes to eliminate the reference to “infection control officer” and substitute the more current “infection preventionist/infection control professional.”  And instead of focusing on transmission of infections between “patients and personnel,” the Proposed Rule focuses on “transmission of infection” in a broader sense which encompasses, prevention and control of infections between individuals across the entire hospital setting, for example, among patients, personnel and visitors, and even between the hospital and other healthcare institutions and settings. The Proposed Rule would require hospitals to designate leaders of the infection prevention and control program and the antibiotic stewardship program respectively, who are qualified through education, training, experience, or certification. Finally, the infection prevention and control program must reflect the scope and complexity of the services offered by the hospital.

CMS is accepting comments until 5 p.m. on August 15, 2016. The Proposed Rule can be found here: https://www.gpo.gov/fdsys/pkg/FR-2016-06-16/pdf/2016-13925.pdf.

-Adele Merenstein is with Hall Render Killian Heath & Lyman in Indianapolis, Indiana.