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September 26, 2024 – As I mentioned last week, comments are in on major calendar year (CY) Medicare payment regulations. Besides the CY 2025 physician fee schedule, another big reg is the CY 2025 Outpatient Prospective Payment System (OPPS) proposed reg, which would revise payment and establish policies for outpatient hospital services. More than 2,000 stakeholders commented on this reg. One of the major proposals was a condition of participation (CoP) for obstetrical (OB) care. The CoP itself received almost 300 comments.
While a previous Regs & Eggs blog post provided background on the OB CoP proposal, let’s start with a quick refresher. The Centers for Medicare & Medicaid Services (CMS) has the authority to require certain types of providers and suppliers to meet health and safety standards specified by the Secretary in order to participate in the Medicare program. CMS has exercised this authority by establishing CoPs for many different Medicare providers and suppliers, including hospitals, critical access hospitals (CAHs), and rural emergency hospitals (REHs).
In the OPPS proposed reg, CMS discussed the maternal health crisis in the United States and noted the absence of federal baseline care requirements specific to maternal-child services for hospitals, CAHs, and REHs participating in Medicare. To address concerns regarding maternal morbidity, mortality, and access to care in the United States, CMS believes that new CoPs are necessary. CMS outlined 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 proposed requirements for maternal quality assessment and performance improvement and maternal health data reporting. In addition to the obstetric care CoP, CMS proposed 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 also would apply more broadly. If finalized, these polices would become effective for hospitals and CAHs starting January 1, 2025 (CMS did not propose to require REHs to comply with the CoPs). CMS estimated that adopting the requirements would cost hospitals approximately $4.27 billion and would take 28.3 million hours to complete over 10 years.
The comments CMS received on these proposals overwhelmingly had the following basic message (with some exceptions): CMS was right to identify the maternal health crisis as a significant issue that must be addressed, but going forward with the CoPs as proposed could backfire and exacerbate the crisis, not ameliorate it. Hospital associations and many physician groups were almost unanimous in their concern that hospitals, especially smaller hospitals and those located in rural areas, would not be able to meet these new requirements. Some said that hospitals are barely able to keep providing OB care in their communities now, and if they had to bear the additional cost of adhering to the CoPs, they could be forced to close their labor and delivery units. Others said that the proposed CoPs were redundant with existing regulations, lacked clarity, and would impose potentially unworkable one-size-fits-all requirements.
Some stakeholders recommended that instead of going forward with CoPs, CMS should promote more evidence-based approaches to help address underlying causes of maternal mortality. These stakeholders said that if CMS does not accept their recommendation to halt the implementation of the CoPs, the agency should, at a minimum, postpone implementation and slowly phase in the CoPs over time. They also requested that CMS seek additional input from key interested parties before finalizing the CoPs in any form, noting that CMS did not provide adequate time for feedback before proposing the CoPs. While CMS did seek comment on potential CoPs in the Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed reg, CMS issued the OPPS reg with the OB CoP proposal just one month after comments were due on the IPPS reg. In these commenters’ view, one month was not enough time for CMS to read through all the comments, digest them, and then propose CoPs that incorporated that feedback.
In the OPPS proposed reg, CMS also solicited comments on whether the proposed CoPs should apply to REHs going forward. Stakeholders responded that it would be premature to apply the CoPs, if finalized, to these facilities. They stated that not only are REHs’ resources limited, but coming into compliance with these requirements may not be possible because several elements of the proposed CoPs do not apply to REHs. Stakeholders therefore urged CMS to allow for a meaningful open public comment period before even considering applying the CoPs to REHs.
While most commenters expressed some level of opposition to the CoPs, others did support the CoPs, appreciating that CMS was taking such a strong stand in trying to tackle the maternal health crisis. Some even stated that CMS should go above and beyond the CoPs to help ensure equitable treatment of all patients seeking reproductive care. For example, one commenter requested that CMS include specific practices designed to end routine drug testing of pregnant people, outline how informed consent is achieved, and narrow reporting to prevent criminalization or family separation that is detrimental to the pregnant person’s health during and after pregnancy.
The CoP proposals also garnered comments regarding the appropriate scope of practice of non-physician practitioners. CMS proposed that “OB patient care units (that is, labor rooms, delivery rooms, including rooms for operative delivery, and post-partum/recovery rooms whether combined or separate) be supervised by an individual with the necessary education and training, and specify that that person should be an experienced registered nurse, certified nurse midwife, nurse practitioner, physician assistant, or a doctor of medicine or osteopathy.” While nursing groups and others supported CMS’s acknowledgement that non-physician practitioners can provide OB services, and appreciated that the CoPs would not prevent these practitioners from practicing to the full extent of their education and clinical training, physician groups opposed CMS’s proposal to allow some non-physician practitioners to provide care unsupervised in certain cases. Physician groups stated that OB patient care units should operate as part of a physician-led team, with the physician providing the necessary supervision.
Finally, some emergency medicine groups and other societies requested that CMS expand the proposed emergency readiness CoP to address emergency department (ED) boarding. ED boarding occurs when ED patients who have been admitted to the hospital are in a holding pattern as they wait for inpatient beds to open up. Patients can remain boarded in the ED for days, weeks, or even months, leading to increased ambulance diversions, increased adverse events, preventable medical errors, lower patient satisfaction, clinical staff burnout, violent episodes in the ED, and higher overall healthcare costs. In these stakeholders’ view, boarding has become its own public health emergency, as EDs across the country are gridlocked and overwhelmed. The groups specifically recommended in their comments that CMS include a requirement that hospitals have in place an actionable protocol to move emergency patients deemed to need inpatient admission or observation out of the ED when their capacity for handling these patients has been exceeded. The protocol would be triggered when the number of patients requiring inpatient hospitalization or observation exceeds 25% of the emergency service’s dedicated treatment areas at any given time. Under commenters’ proposal, hospitals would be required to report their performance and adherence to the protocol using a standardized method and use findings from these performance reports to help inform any additions, revisions, or updates to the protocol on an ongoing basis.
CMS is now in reading mode, going through the comments on the CoPs and other OPPS proposals. Based on the feedback received, CMS could decide to:
We will likely find out CMS’s plan with the release of the CY 2025 OPPS final reg, which is expected on or around November 1, 2024.
Until next week, this is Jeffrey saying, enjoy reading regs with your eggs.
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