The Centers for Medicare & Medicaid Services (CMS) recently published a Federal Register notice detailing opportunities for public comment on several agency information collection activities. This notice, appearing in Volume 91, Number 126, on Thursday, July 2, 2026, signals CMS's intent to gather information crucial for its operations, particularly regarding a significant shift in hospital care delivery and the continued integrity of clinical laboratory oversight. The most notable development is the formalization of the Acute Hospital Care at Home (AHCAH) program, alongside extensions for information collections under the Clinical Laboratory Improvement Amendments (CLIA).
Acute Hospital Care at Home: From Waiver to Permanent Program
At the forefront of CMS's announcements is a new information collection request (CMS-10950) specifically for the Acute Hospital Care at Home program. This initiative, initially established by CMS on November 23, 2020, was a direct response to the immense strain placed on hospital capacity during the severe national surge of coronavirus disease 2019 (COVID-19). It offered a crucial flexibility to healthcare systems, allowing them to provide acute-level care to patients in their homes rather than in traditional hospital settings. The program waived specific provisions of the Hospital Conditions of Participation (CoPs), namely Sections 482.23(b) and (b)(1), which mandate 24/7 on-premises nursing services and immediate availability of a registered nurse.
Critically, the AHCAH initiative has now been codified into legislation through the Consolidate Appropriations Act, 2025. This legislative action means the program is no longer operating under the temporary 1135 waiver authority. Instead, its framework and any subsequent changes will be based on this new legislative authority. This transition marks a substantial policy shift, integrating a previously emergency-driven measure into the permanent healthcare landscape.
Evidence supporting the efficacy and safety of at-home hospital care has been a cornerstone of this program. Leading academic journals, including reports from a major study funded by a Healthcare Innovation Award from the Center for Medicare and Medicaid Innovation (CMMI), have consistently shown that the quality and safety of care provided through AHCAH are at least comparable to that received by similar patients in traditional brick-and-mortar hospitals. This research has been vital in demonstrating the viability of such care models.
The AHCAH program is distinct from traditional home health services. It targets beneficiaries who require acute inpatient admission and necessitates daily rounding by a physician, continuous monitoring by a medical team, and a minimum of two daily in-person visits by registered nurses or mobile integrated health paramedics. Patients can be admitted to the program either from an Emergency Department or by transfer from an inpatient hospital bed. Importantly, there is no change in payment structures, and hospitals are prohibited from billing Medicare or beneficiaries for costs beyond those of a typical inpatient admission.
CMS reports a significant uptake of the program, with 433 individual hospitals or CMS Certification Numbers (CCNs) having submitted waiver requests, and 396 of these receiving approval. Hospitals with prior experience in this care model (treating at least 25 patients) can submit an expedited request through a series of attestations. All approved hospitals are also asked to submit voluntary monthly or weekly data on patient admissions, discharges, escalations back to the hospital, and unexpected mortalities via an online portal. While this data submission is voluntary for ongoing participation, it is crucial for program evaluation and policy refinement. The current waiver submission process is slated to conclude on September 30, 2030.
Sustaining Quality: Updates to CLIA Regulations
In addition to the AHCAH program, CMS is seeking public comment on the extension of two existing information collections related to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA establishes certification requirements for entities performing testing on human beings, ensuring performance standards based on test complexity and the risk of erroneous results.
The first extension (CMS-R-26) concerns the Clinical Laboratory Improvement Amendments Regulations themselves. This collection reflects a series of records laboratories must maintain to participate in the CLIA program. Revisions outlined in the notice are based on a final quality assessment rule published in 2003 and a more recent final rule from December 28, 2023 (88 FR 89976). These updates primarily amended histocompatibility and personnel regulations, addressing obsolete provisions and incorporating technological advancements. The revisions also drew from recommendations by the Centers for Disease Control and Prevention's (CDC) Clinical Laboratory Improvement Advisory Committee (CLIAC), aiming to streamline requirements by removing specific regulations already covered by broader general provisions.
The second extension (CMS-R-185) pertains to the granting and withdrawal of deeming authority to private nonprofit accreditation organizations and CLIA exemption under State Laboratory Programs. This critical aspect of CLIA allows CMS to recognize private accreditation bodies and state licensure programs whose standards meet or exceed federal requirements. Initial regulations were established in 1992, with revisions in 1998 aimed at consolidating and clarifying requirements for accreditation organizations and state programs seeking approval. The latest iteration requires these organizations and programs to update their policies and procedures in accordance with the aforementioned final rule, CMS-3326-F, published in December 2023.
Implications and Future Outlook
These announcements by CMS collectively point to a continued federal commitment to adapting healthcare delivery while maintaining rigorous quality and oversight standards. The codification of the Acute Hospital Care at Home program is a landmark development, signifying a permanent shift towards patient-centric models that leverage technology and evidence-based practices to bring acute care into the home. This move has profound implications for hospital capacity, patient experience, and the overall structure of healthcare services, necessitating ongoing data collection and evaluation to ensure its sustained success and safety.
Simultaneously, the extensions for CLIA-related information collections underscore the enduring importance of robust regulatory frameworks for clinical laboratories. As medical technology advances and diagnostic testing becomes increasingly sophisticated, maintaining stringent quality controls through CLIA is essential for patient safety and public health. The ongoing refinement of these regulations, incorporating modern practices and addressing outdated provisions, reflects an adaptive regulatory environment. The public comment period provides a crucial opportunity for stakeholders, including healthcare providers, patients, and industry representatives, to contribute to the shaping of these vital federal healthcare policies.
