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July 25, 2024 – In case you need a reminder given everything going on in Washington, DC, the Calendar Year (CY) 2025 Physician Fee Schedule (PFS) and CY 2025 Outpatient Prospective Payment System (OPPS) proposed regs were released a couple of weeks ago. Regs & Eggs will be taking bites out of these regs for the next several weeks. Last week, we explored the paradox of the positive budget neutrality adjustment in the CY 2025 PFS proposed reg. This week, we’re switching gears and focusing on a major proposal in the CY 2025 OPPS proposed reg: a proposed condition of participation (CoP) for obstetrical (OB) care. To help me describe the significance of this proposal, I’m bringing in my colleagues Leigh Feldman and Kayla Holgash.
The Centers for Medicare & Medicaid Services (CMS) has the authority to require that, in order to participate in the Medicare program, certain types of providers and suppliers meet health and safety standards specified by the Secretary. CMS has exercised this authority by establishing health and safety standards, known as CoPs, for many different Medicare providers and suppliers, including hospitals, critical access hospitals (CAHs), and rural emergency hospitals (REHs).
Physicians and other healthcare professionals are not this list. These practitioners must meet certain requirements to be licensed in a state and credentialed to work at a facility, but there are no national CoP standards for them as there are for the other providers and suppliers.
CMS’s proposal to impose new CoPs is significant because the consequence of failing to comply with a CoP is loss of participation in the Medicare program. One could argue that CoPs are one of the largest “sticks” that CMS has at its disposal to require providers and suppliers to change their protocols or take on additional responsibilities. Put another way, with great power comes great responsibility, and CMS’s proposal in the CY 2025 OPPS proposed reg to impose new CoPs on Medicare-participating hospitals for OB services, emergency services readiness and transfers isn’t something the agency or stakeholders take lightly.
To ground its proposals for new CoPs, CMS outlines the problem it’s trying to solve: the maternal health crisis in the United States.
Not only has the maternal health crisis led to one of the highest maternal mortality rates among high-income countries, it also disproportionately affects racial and ethnic minorities. The CY 2025 OPPS proposed rule notes that in 2022, the most recent year for which there is data, there were 22 maternal deaths for every 100,000 live births in the United States (more than double the rate for most other high-income countries). Native Hawaiian and Pacific Islander women, Black women, and American Indian/Alaska Native women are two to four times more likely to suffer a pregnancy-related death than non-Hispanic white women. And more than 80% of pregnancy-related deaths are considered preventable.
CMS and the rest of the Biden administration have made it clear that promoting health equity is one of their highest priorities, highlighting maternal health care and addressing the crisis throughout Biden’s term. Major actions include:
Which brings us to CMS’s CoP proposals. Currently, there are no federal baseline care requirements specific to maternal-child services for hospitals, CAHs and REHs participating in Medicare. Given concerns regarding maternal morbidity, mortality and access to care in the United States, CMS believes that new CoPs are absolutely necessary.
In the CY 2025 OPPS proposed reg, CMS outlines proposed baseline standards for the organization, staffing and delivery of care within OB units, and for staff training on evidence-based best practices on an annual basis. CMS also proposes requirements for maternal quality assessment and performance improvement (QAPI) and maternal health data reporting.
Baseline Standards for the Organization, Staffing and Delivery of Care Within OB Units
Rather than specifying its own national standard, CMS proposes to allow hospitals to adhere to existing standards established by accrediting bodies and professional medical specialty societies. If a hospital or CAH offers OB services, CMS would require the services to be “well organized and provided in accordance with nationally recognized acceptable standards of practice for physical and behavioral (inclusive of both mental health and substance use disorders) health care of pregnant, birthing, and postpartum patients.” CMS would not require adherence to any specific accrediting organization or medical professional society’s standards. Under CMS’s proposal, it seems that a hospital could stitch together elements of various organizations’ standards, as long as the hospital is “able to articulate their standards and the source(s) and to demonstrate that their standards are based on evidence and nationally recognized sources.”
CMS proposes that the organization of OB services be appropriate to the scope of services offered by the facility and integrated with other departments of the facility. As an example, CMS notes that a labor and delivery unit needs to ensure good communication and collaboration with services such as laboratory, surgical services and anesthesia services.
CMS proposes that OB privileges must be specifically spelled out for all practitioners providing OB care in accordance with the competencies of each practitioner. The OB service must maintain a roster of practitioners specifying the privileges of each practitioner.
With respect to the delivery of services, CMS proposes that labor and delivery room suites have certain basic resuscitation equipment readily available, including a call-in-system, cardiac monitor, and fetal doppler or monitor. The OB service at each hospital also must have protocols consistent with evidence-based, nationally recognized guidelines, as well as readily available supplies and equipment for OB emergencies, complications, immediate post-delivery care, and other patient health and safety events as identified as part of the facility’s QAPI program.
Training for OB Staff in Hospitals and CAHs
CMS proposes a core set of training requirements for hospitals and CAHs offering OB services. Hospitals would be required to develop policies and procedures to ensure that relevant OB services staff are trained on select topics for improving the delivery of maternal care, including facility-identified evidence-based best practices and protocols to improve the delivery of maternal care. Here too CMS is not prescriptive on the source or content of the training. Rather, CMS says the training should be on “evidence-based best practices and protocols.” CMS mentions as potential sources for such training:
Hospitals and CAHs that provide OB services would need to use findings from their QAPI programs to inform OB staff training needs and any additions, revisions or updates to training topics on an ongoing basis. Hospitals’ governing bodies would be required to identify and document which staff must complete annual training.
QAPI Programs
CMS proposes to revise the existing QAPI standards to require hospitals and CAHs that offer OB services to use their programs to assess and improve health outcomes and disparities among OB patients on an ongoing basis. CMS outlines minimum requirements for these assessments. CMS reminds stakeholders of the August 2022 adoption of two maternal health quality measures in the Hospital Inpatient Quality Reporting Program (a measure of severe OB complications and a measure of low-risk cesarean section rates) and says that hospitals may use these maternal health quality metrics to inform their QAPI activities.
Regarding data reporting, CMS notes that under many states’ laws, hospitals are already required to report to Maternal Mortality Review Committees (MMRCs) – multidisciplinary teams that work at the state or local level to engage stakeholders, comprehensively review deaths that occur during or within a year of pregnancy (pregnancy-related deaths), and develop recommendations aimed at preventing future pregnancy-related deaths. CMS proposes that if an MMRC is available in the state or local jurisdiction in which the hospital is located, a hospital that offers OB services must have a process for incorporating MMRC data and recommendations into its QAPI program.
In the CY 2025 OPPS proposed reg, CMS proposes revisions to existing emergency services and discharge planning CoPs to address hospitals’ emergency services readiness and transfer policies. While these proposed CoPs seem designed to address core concerns around OB care, they would apply much more broadly.
Emergency Services Readiness
The Emergency Medical Treatment and Active Labor Act (EMTALA) requires Medicare-participating hospitals with emergency departments to always be ready to provide individuals with an appropriate medical screening exam and stabilizing treatment if an emergency medical condition is found or, under certain circumstances, appropriately transfer such individuals to receive stabilizing care at another facility with higher treatment capabilities not available at the originating hospital. Citing concerns it has heard that emergency department “readiness can be suboptimal, especially for OB, geriatric and pediatric populations, among others,” CMS proposes to refine its existing emergency services CoP. CMS proposes a new standard entitled “emergency services readiness” within the existing emergency services CoP for hospitals and CAHs (§ 485.618) to “set clear expectations as well as improve facility readiness in caring for emergency services patients, including pregnant, birthing, and postpartum patients.” These requirements would apply to all hospitals and CAHs offering emergency services, regardless of whether a hospital/CAH offers additional specialty service lines (such as OB services).
CMS proposes that facilities would be required to:
Transfer Protocols
CMS notes that existing CoPs for CAHs and REHs include requirements related to the transfer of patients in the event that the facility is unable to deliver needed services for a patient or the patient requires a higher level of care. However, CMS believes that a comprehensive discharge planning CoP for hospitals, including documented requirements for transfer protocols, will enhance the existing requirements and “better protect the health and safety needs of all patients, including pregnant, birthing, and postpartum women.” CMS therefore proposes to require that hospitals have written policies and procedures for transferring patients under their care. CMS believes this would ensure patients are transferred to the appropriate level of care “promptly and without undue delay,” although CMS seeks comment on what definitions or criteria exist to determine if a transfer is carried out pursuant to that standard. CMS also proposes to require hospitals to provide training to the relevant staff (as determined by the facility) regarding the hospital’s policies and procedures for transferring patients under its care. CMS encourages all hospitals receiving transfers to have policies and procedures in place regarding the acceptance of transfers, and reminds hospitals of their obligations to comply with EMTALA and federal civil rights laws.
CMS seeks comments on all aspects of the newly proposed CoPs. Stakeholders will likely consider several key questions as they craft their responses.
One question stakeholders will likely grapple with is whether the CoPs, as proposed, strike the right balance between providing a national “floor” and allowing hospitals discretion to formulate policies that will work best for their organization. In cases where CMS is not entirely prescriptive on how hospitals must meet the requirements (for example, CMS proposes to allow hospitals to determine which staff would be required to receive OB training), some stakeholders may ponder whether the agency is running the risk of codifying hospitals’ patchworks of policies rather instituting a single evidence-based standard.
The estimated cost for hospitals to implement the requirements laid out in the CoP is significant (one could say, with great power, comes great cost). CMS estimates that adopting the requirements would cost hospitals approximately $4.27 billion and would take 28.3 million hours to complete over 10 years. Hospitals likely will be running internal analyses to see whether they can actually cover these costs. On a more global scale, another question that stakeholders may consider is whether that level of investment is enough to move the needle on the maternal health crisis in the United States.
Stakeholders have until September 9, 2024, to respond to the proposed CoPs and all other aspects of the OPPS proposed reg. After considering the comments, CMS will ultimately decide whether to finalize the new CoP as proposed, modify it, delay its implementation date of January 1, 2025, or not finalize it at all. We may find out CMS’s plan as soon as the release of the CY 2025 OPPS final reg, which is expected on or around November 1, 2024.
Until next week, this is Jeffrey (and Leigh and Kayla) saying, enjoy reading regs with your eggs.
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