A proposed Medicare condition of participation would bring a slew of new requirements for OB care

Note: HFMA’s coverage of the payment update in the outpatient payment proposed rule can be found here.

Hospitals intending to participate in Medicare must meet new standards for obstetric (OB) care, according to CMS’s proposed outpatient rule for 2025.

The rule proposes to establish a new Medicare condition of participation (CoP), whereby hospitals and critical access hospitals (CAHs) would have to meet maternal health standards in the areas of:

• Organization, staffing and delivery of care in OB units
• Staff training
• Quality assessment and performance improvement
• Emergency readiness
• Transfer protocols

CMS requested comments on whether rural emergency hospitals also should have to meet the requirements.

In its estimate of the cost impact, CMS projected that implementing the new standards would increase costs by more than $70,600 per hospital per year. Benefits would include improved health and lower costs for patients and healthcare purchasers.

Key aspects of the CoP

Among numerous requirements in the proposed CoP is for the organization of OB services to reflect the scope of services offered by the hospital and for OB services to be appropriately integrated with other departments (e.g., lab, surgery, anesthesia).

Labor and delivery rooms or suites must be supervised by an experienced physician, nurse or physician assistant. Available equipment in the room would need to include a call-in-system, cardiac monitor and fetal doppler or monitor.

Hospitals and CAHs would need to document completion of required training in staff personnel records and be able to demonstrate staff knowledge of the training topics. CMS suggests that hospitals consider training staff on established best practices, including maternal safety bundles, from CDC’s perinatal quality collaboratives. Trauma-informed care, cultural competency and person-centered care also could be part of evidence-based training.

Facilities would be required to have adequate provisions and protocols to meet the OB emergency needs of patients, even if they do not have a dedicated OB unit. Mandatory provisions would include drugs, blood products and biologicals, equipment and supplies commonly used in lifesaving procedures, and a call-in system for each patient.

The requirements regarding provisions do not apply to CAHs, which already have mandatory supply standards for emergency services.

Hospitals and CAHs also must incorporate written policies and procedures and provide staff training for transferring patients either within the hospital or to another hospital, as needed.

Finally, a quality assessment and performance improvement program would need to be implemented for OB care, and facilities would have to conduct at least one performance improvement project per year. Leadership would be required to have involvement in the program.

Legal challenges may be forthcoming

The proposed rule was drafted before the Supreme Court’s Chevron decision reduced the assumed power and authority of federal agencies and potentially paved the way for increased reliance on litigation by affected entities. Despite the timing, language in the rule seems intended to serve as an initial line of defense against possible legal challenges, should the new CoP be finalized with few changes.

“CMS has broad statutory authority to establish health and safety regulations, which includes the authority to establish requirements that protect the health and safety of pregnant, postpartum and birthing women,” the agency wrote.

Provider groups worry that imposing a new CoP is a step too far.

The American Hospital Association said it shares the goal of improving outcomes and reducing inequity in maternal healthcare but is “deeply concerned by CMS’s continued and excessive use of conditions of participation to drive its policy agenda,” according to a written statement by Ashley Thompson, senior vice president for public policy analysis and development.

“We believe a less punitive and more collaborative and flexible approach is far superior,” Thompson said. “We will carefully review CMS’s proposals to determine whether they are feasible, sufficiently flexible for the wide variety of hospitals to which they would apply and do not inadvertently exacerbate maternal care access challenges.”

Likewise, Premier’s comments reflected concern about the impact on access.

“An obstetric services CoP that results in the loss of Medicare certification for compliance failure is far too harsh a penalty, resulting in further limits to obstetrical care and potentially higher rates of morbidity and mortality,” Soumi Saha, senior vice president for government affairs with Premier, said in a written statement.

An ongoing effort

The new CoP follows other federal initiatives to improve maternal health, including the launch of the voluntary Birthing Friendly certification program for hospitals in 2023 and a Medicaid payment model coordinated by the Center for Medicare & Medicaid Innovation.

CMS referred to the stakeholder feedback it has considered in formulating the new CoP, including through formal requests for information, along with literature reviews and industry listening sessions. The feedback appears to have been mixed.

Stakeholders voicing support said the new CoP would improve the quality and safety of maternal care and allow for services to be standardized across healthcare settings. They also said requirements about organization and staffing would promote multidisciplinary, team-based care.

Concerns voiced by stakeholders included conflicts with state requirements, increased regulatory burden and insufficient clinical evidence, in addition to the potential impact on access.

“After analyzing the issue of high rates of maternal mortality and morbidity in the U.S., receiving feedback from various stakeholders on improving maternal healthcare, and reviewing available resources and current requirements, we believe that it is necessary to establish new requirements for the provision of obstetrical services to protect the health and safety of pregnant, birthing and postpartum patients,” CMS concluded.

The rule refers to a maternal health “crisis” in the United States, where the maternal mortality rate is one of the highest among high-income countries and disproportionately affects racial and ethnic minorities. A core driver of those issues is a lack of baseline requirements for maternal health, the agency argues.

An opportunity to provide additional feedback on the CoP is available during the proposed rule’s 60-day comment period, which ends Sept. 9.