Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies

As a condition for payment, section 6407(a) of the Affordable Care Act (Pub. L. 111-148, March 23, 2010) requires that prior to certifying a patient's eligibility for the home health benefit, the physician must document that the physician himself or herself or a non-physician practitioner (NPP) has had a face-to-face encounter with the patient. In the Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices final rule (75 FR 70427) (hereinafter referred to as the CY 2011 HH PPS final rule), we established that the certifying physician must document the face-to-face encounter regardless of whether the physician himself or herself or one of the permitted NPPs performed the face-to-face encounter. Sections 6407(a)(1)(B) and 6407(a)(2)(B) of the Affordable Care Act further describe NPPs who may perform this face-to-face patient encounter.

In the Medicare Program, Home Health Prospective Payment System Rate Update for Calendar Year 2012 final rule (hereinafter referred to as the CY 2012 HH PPS final rule), we stated that the Medicare home health benefit relies on the patient's physician to determine eligibility for home health services (76 FR 68596), noting that this type of physician involvement is critical from both a quality of care and program integrity perspective. Prior to enactment of section 6407(a) of the Affordable Care Act regarding the home health face-to- face encounter provision, the patient's physician often relied on information provided by an HHA when making decisions about patient care. In the CY 2012 HH PPS final rule (76 FR 68597), we stated that, in addition to the certifying physician and allowed NPPs, the physician who cared for the patient in an acute or post-acute care facility, and who had privileges in such facility, could also perform the face-to- face encounter and inform the certifying physician, who would document the encounter as part of the certification of eligibility, and that encounter supported the patient's homebound status and need for skilled services. During the CY 2012 HH PPS rulemaking comment period, stakeholders requested that CMS allow any physician to complete the face-to-face encounter, rather than limiting it to the certifying physician or allowed NPP; however, CMS referred commenters to the CY 2011 HH PPS final rule where we stated we did not believe that we had the statutory authority to allow for this additional flexibility (76 FR 68596). The Affordable Care Act established the requirement for a physician face-to-face encounter prior to certifying a patient's eligibility for home health services, along with other program integrity provisions, to address concerns surrounding ineligible patients receiving home health services and concerns that physicians who had no firsthand knowledge of the patient's clinical condition were certifying the patient's eligibility for home health. In the CY 2011 HH PPS final rule, we described research that showed fewer re- hospitalizations when the home health patient had a recent encounter with the physician responsible for the home health care plan. As such, 42 CFR 424.22(a)(1)(v)(A) requires that a face-to-face encounter be performed by the certifying physician; the certifying allowed practitioner (nurse practitioner, clinical nurse specialist, physician assistant); or a certified nurse midwife. Additionally, 42 CFR 424.22(a)(1)(v)(C) requires that a face-to-face encounter be performed by the certifying physician or allowed practitioner unless the encounter is performed by a certified nurse midwife or a physician, physician assistant, nurse practitioner, or clinical nurse specialist with privileges who cared for the patient in an acute or post-acute care facility from which the patient was directly admitted to home health and who is different from the certifying practitioner.

Section 3708 of the Coronavirus Aid, Relief, and Economic Security Act, 2020 (CARES Act) (Pub. L. 116-136, March 27, 2020) amended sections 1814(a) and 1835(a) of the Act to allow nurse practitioners (NPs), clinical nurse specialists (CNSs), and physician assistants (PAs) (as those terms are defined in section 1861(aa) of the Act), to order and certify patients for eligibility under the Medicare home health benefit and establish a plan of care. Since its implementation in the March 31, 2020 COVID-19 interim final rule with comment period (85 FR 27550), CMS has received requests from

stakeholders to change the current face-to-face encounter policy to allow any practitioner to perform the face-to-face encounter and not limit this regulation to the certifying practitioner, a permitted NPP, or a physician or allowed practitioner with privileges who cared for the patient in an acute or post-acute care facility from which the patient was directly admitted to home health, as set out at Sec. 424.22(a)(1)(v)(C). Commenters have stated that the CARES Act language allows this additional flexibility. Additionally, commenters have stated, and CMS agrees, that the current regulation text at Sec. 424.22(a)(1)(v)(A)(1) through (4) can be read to allow NPs, CNSs, and PAs to perform the face-to-face encounter regardless of whether they certify the patient for home health services, but limits the provision of the face-to-face encounter to the certifying physician or a physician, with privileges, who cared for the patient in an acute or post-acute care facility from which the patient was directly admitted to home health. Therefore, stakeholders have requested that any physician, in addition to NPs, CNSs, and PAs, be allowed to perform the face-to-face encounter regardless of whether they are the certifying practitioner or whether they cared for the patient in the acute or post-acute facility from which the patient was directly admitted to home health and who is different from the certifying practitioner. Some commenters have referenced situations in which a patient sees a physician in the same practice as the patient's primary care physician (PCP), but where the patient's PCP was unavailable to see the patient on a particular date.

As stated in the CY 2026 proposed rule, we agree that it would be reasonable for the patient's PCP to certify eligibility under the Medicare home health benefit and establish the plan of care even though a different physician or allowed practitioner in the same practice conducted the face-to-face encounter. However, we note that it would not be appropriate for a practitioner who specializes in optometry to certify a patient for home health services that are needed due to orthopedic reasons. These are only a couple of examples of circumstances that could occur, and we do not enumerate in this rulemaking all situations in which the certifying provider may be different than the provider who conducted the face-to-face encounter.

Regarding our original concern in limiting the face-to-face encounter to the certifying provider (or the provider who cared for the patient in the inpatient facility), we still believe physician or allowed practitioner involvement is critical from both a quality of care and program integrity perspective. However, we note that additional program integrity protections exist currently in the certification policies. To be eligible for Medicare home health services, in accordance with Sec. 424.22(a)(1)(iv) a patient must be under the care of a physician or an allowed practitioner. Additionally, in accordance with Sec. 424.22(a)(1)(v), the face-to-face encounter documentation must be related to the primary reason the patient requires home health services, occur in the required time frame by an allowed provider type, and the certifying practitioner must include a signature and the date of the encounter as part of the certification. Furthermore, our subregulatory guidance in the Medicare General Information, Eligibility and Entitlement Manual (Pub. 100-01, chapter 4, section 30.1) provides that physicians and allowed practitioners should complete the certification when the plan of care is established, or as soon as possible thereafter, and that it is not acceptable to wait until the end of the required time frame to complete the requirements. As such, the certification also cannot be completed after a patient is discharged from home health services.

Additionally, our subregulatory guidance in the Medicare General Information, Eligibility and Entitlement Manual (Pub. 100-01, chapter 4, section 30.1), the Medicare Benefit Policy Manual (Pub. 100-02, chapter 7, section 30.5), and the Medicare Program Integrity Manual (Pub. 100-08, chapter 6, section 6.2.1 and 6.2.3) also supports our program integrity and quality goals. Specifically, the subregulatory guidance provides additional details on requirements that include the following: specific signature and date requirements; a requirement for an actual clinical note from the certifying practitioners for the face- to-face encounter visit; specific information that must be present in face-to-face encounter documentation; a requirement that a new face-to- face encounter is required if the patient's condition has changed; a requirement that home health eligibility must be supported by other medical entries in the certifying provider's medical record for the patient and this documentation must be available for medical reviews as needed; and a requirement that documentation of the face-to-face encounter can only be from physicians or allowed NPPs who do not have a financial relationship with the HHA.

We also stated in the CY 2026 proposed rule that we believe the regulations at 42 CFR 424.22(a)(1), in conjunction with the Medicare home health eligibility requirements at 42 CFR 424.22(c), finalized in the CY 2019 final rule (83 FR 56627), provide sufficient preservation of our original intent of ensuring that the home health benefit relies on the patient's physician (or subsequently, the allowed practitioner) to determine eligibility for home health services, and that the physician or NPP performing the face-to-face encounter should be a practitioner who is most knowledgeable and has firsthand information of the patient's current clinical condition when certifying the patient's eligibility for home health services and establishing a patient's plan of care.

As such, we proposed to revise Sec. 424.22(a)(1)(v)(A) to state that the face-to-face encounter must be performed by one of the following: a physician, a nurse practitioner, a clinical nurse specialist, or a physician assistant as defined at 42 CFR 484.2; or a certified nurse-midwife as defined in section 1861(gg) of the Act as authorized by State law. We also proposed to remove Sec. 424.22(a)(1)(v)(C), which limits the face-to-face encounter to the certifying physician or allowed practitioner unless the encounter is performed by either of the following:

A certified nurse midwife as described in paragraph (a)(1)(v)(A)(4) of this section.

A physician, physician assistant, nurse practitioner, or clinical nurse specialist with privileges who cared for the patient in the acute or post-acute facility from which the patient was directly admitted to home health and who is different from the certifying practitioner.

We stated that this additional flexibility should decrease ambiguity regarding which providers are able to complete the face-to- face encounter and potentially improve access to home health services by increasing the number of providers allowed to perform the face-to- face encounter. We noted that these revisions would also address concerns that the current regulations do not align with the CARES Act language.

We solicited comments on these proposed revisions to 42 CFR 424.22(a)(1)(v) and the proposed removal of Sec. 424.22(a)(1)(v)(C).

Comment: All commenters expressed strong support for the proposed changes that would expand who can conduct face-to-face encounters. Some commenters specifically expressed appreciation that CMS proposed these changes after they were suggested by

stakeholders in past comments and letters to CMS. Commenters consistently praised CMS for aligning regulations with the CARES Act provisions and simplifying the process, which addresses timely care initiation while maintaining program integrity. Additionally, commenters stated that the proposed changes would improve access to care and administrative efficiency due to operational flexibility, streamlined processes, and reduce administrative complexity. They also stated that the proposed changes would improve workforce optimization allowing for team-based care and resource utilization, especially in complex care settings, rural areas, HHAs with staffing challenges, and when managing referrals from various settings.

Response: We thank commenters for their support.

Comment: A few commenters requested that CMS provide additional clarification and guidance related to implementation details, documentation requirements, and acceptable formats to ensure consistent application across contractors, specifically as they relate to facility and community referrals, MACs, and auditors. Another commenter requested clarification regarding the requirement that face-to-face encounters need to be related to the primary reason for home health services, mentioning that this requirement has been interpreted by HHAs to mean that the primary diagnosis needs to be in perfect alignment with the face-to-face encounter. Additionally, a few commenters asked clarifying questions related to the proposed face-to-face encounter changes as follows: Will HHAs be required to delay sending the certification statement until the completed face-to-face encounter documentation is received, or can a handoff be documented in other ways? If documentation of collaboration is required, will it suffice for the HHA to record the process, or must a formal order be signed by both the certifying provider and the face-to-face encounter provider? If a specialist performs the face-to-face encounter, will HHAs be required to demonstrate how that specialist is involved in the patient's plan of care? And will CMS mandate that Medicare Advantage (MA) plans align their requirements with CMS policy, or should HHAs prepare for distinct processes across MA plans? A few commenters requested guidance on whether CMS intends to issue parameters to guide how HHAs and practitioners demonstrate that the face-to-face encounter is conducted by the most knowledgeable practitioner, especially in situations where care is shared among providers. These commenters also requested that CMS maintain flexibility for HHAs and practitioners to determine, based on clinical judgment and care team structure, which practitioner is best positioned to perform the face-to-face encounter while still meeting eligibility and certification requirements. One commenter also recommended that educational materials related to regulatory changes be made available in Spanish to avoid errors in the interpretation of documentation requirements.

Response: We thank the commenters for their recommendations. We will take all these suggestions into consideration when updating subregulatory guidance with additional clarifying information and examples if needed. Additionally, we have issued instructions in the past to the contractors who perform medical reviews to ensure compliance with this regulation, and we will continue to educate MACs and auditors to further support consistent application of existing regulations and this added flexibility. We would like to remind readers that these changes only add flexibility to the face-to-face encounter and do not otherwise change the intent, documentation requirements, or acceptable formats of the face-to-face encounter. We refer readers back to our subregulatory guidance in the Medicare General Information, Eligibility and Entitlement Manual (Pub. 100-01, chapter 4, section 30.1), the Medicare Benefit Policy Manual (Pub. 100-02, chapter 7, section 30.5), and the Medicare Program Integrity Manual (Pub. 100-08, chapter 6, sections 6.2.1 and 6.2.3) for additional details on our program integrity, quality goals, and requirements for the face-to-face encounters.

We also remind commenters that diagnosis codes are not required to be on the face-to-face documentation and do not exactly have to match the primary diagnosis for which the patient is receiving home health services. Rather, the face-to-face documentation has to sufficiently demonstrate that the encounter was related to the primary reason that home health services were needed (42 CFR 424.22(a)(1)(v)). With respect to the specific questions on timing of the face-to-face encounter and certification statement, the HHA's method of recording collaboration between providers including specialists, and how HHAs and practitioners can demonstrate the most knowledgeable practitioner, we remind readers again that these changes allow for additional flexibility with respect to the practitioners who can complete the face-to-face encounter; the intent and guidelines of the face-to-face encounter and other payment policies are otherwise unchanged. Additionally, a condition of participation for HHAs includes care coordination, such as assuring communication with all physicians or allowed practitioners involved in the plan of care and integrating orders from all physicians or allowed practitioners involved in the patient's plan of care to assure the coordination of all services and interventions. We agree with the commenter that HHAs should use clinical judgment to determine what practitioner is the most appropriate to perform the face-to-face encounter, and we intend to maintain this flexibility for HHAs; however, the documentation needs to support that the physician completing the face-to-face encounter has firsthand information of the patent's primary reason for needing home health services and also is the most appropriate (that is, the most knowledgeable) provider to complete the face-to-face encounter. Lastly, regarding Medicare Advantage plan requirements, this is outside the scope of our proposed policy, as this policy only applies to Medicare FFS home health payment requirements.

Comment: A commenter requested that the face-to-face encounter requirement be eliminated, noting their belief that it creates an administrative burden due to diverting limited resources from patient care to paperwork navigation and creating unnecessary obstacles for patients and providers, causes access to care concerns due to delays and disruptions to care, and is ineffective in achieving the original intent of the requirement, which was to reduce fraud, waste, and abuse. This commenter suggested that CMS focus its program integrity efforts on targeting “bad providers” instead of implementing broad requirements that burden “good providers” and prioritize outcomes over administrative processes.

Response: We appreciate the commenter's feedback; however, the face-to-face encounter requirement is set forth in section 1814(a)(2)(C) of the Act, and, because this is a statutory requirement, we must require this encounter as a condition for payment and have no regulatory discretion to eliminate it. As such, we refer readers back to the CY 2011 HH PPS final rule, where we cited research that supports that recent physician involvement results in significantly better patient outcomes and decreased hospitalizations compared to patients who did not receive a face-to-face physician visit during their episode of

care (Wolff et al., 2009, p. 11511). Additionally, the CY 2011 HH PPS final rule addressed concerns about feasibility by providing increased flexibility to the time frames in which face-to-face encounters are completed in order to address access to care risks, especially those faced in rural areas, and accounted for administrative burden. Care coordination, including assuring communication with all physicians or allowed practitioners involved in the plan of care, is a condition of participation and the responsibility of the HHA. Additionally, we note that these changes provide additional flexibility by allowing more providers to conduct the face-to-face encounter.

Comment: A few commenters requested that telehealth face-to-face encounters be permitted to reduce burden on beneficiaries and improve access to care. One commenter requested that Puerto Rico be given this flexibility to utilize telehealth face-to-face encounters due to the recurring natural disasters that they face.

Response: We thank commenters for their suggestions. Telehealth face-to-face encounters can be performed at an approved originating site as specified in the Medicare Benefit Policy Manual (Pub. 100-02, chapter 7, section 30.5.1.1).

Final Decision: We are finalizing the changes to the face-to-face encounter regulations as proposed.

The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act. Section 1895(b)(3)(B)(v)(II) of the Act requires that, for 2007 and subsequent years, each home health agency (HHA) submit to the Secretary in a form and manner, and at a time, specified by the Secretary, such data that the Secretary determines are appropriate for the measurement of health care quality. To the extent that an HHA does not submit data in accordance with this clause, the Secretary shall reduce the home health market basket percentage increase applicable to the HHA for such year by 2 percentage points pursuant to section 1895(b)(3)(B)(v)(I) of the Act. As provided at section 1895(b)(3)(B)(vi) of the Act, depending on the market basket percentage increase applicable for a particular year, as further reduced by the productivity adjustment (except in 2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of the Act, the reduction of that increase by 2 percentage points for failure to comply with the requirements of the HH QRP may result in the home health market basket percentage increase being less than 0.0 percent for a year, and may result in payment rates under the HH PPS for a year being less than payment rates for the preceding year. Section 1890A of the Act requires that the Secretary establish and follow a pre-rulemaking process, in coordination with the consensus-based entity (CBE) with a contract under section 1890 of the Act, to solicit input from certain groups regarding the selection of quality and efficiency measures for the HH QRP. The HH QRP regulations can be found at 42 CFR 484.245 and 484.250.

In accordance with the statutory authority at section 1895(b)(3)(B)(v) of the Act, we proposed the following policies in the proposed rule: We proposed to remove the “COVID-19 Vaccine: Percent of Patients Who Are Up to Date” measure and the item related to the measure and corresponding data element. CMS proposed the removal of four assessment items: one Living Situation item, two Food items, and one Utilities item. We also proposed to revise the policy to allow providers that fail to provide complete, timely data to CMS to submit a request for reconsideration if they can demonstrate full compliance. We noted in the proposed rule that in very limited circumstances, we would permit the HHA to request an extension to file a reconsideration request if the HHA was affected by an extraordinary circumstance beyond the control of the HHA (that is, a natural disaster such as a hurricane, tornado, or earthquake) during the 30-day reconsideration period. We also proposed to implement a revised HHCAHPS Survey beginning with the April 2026 sample month. The proposed rule also included a proposal to update regulatory text to account for all-payer data submission of OASIS data. As part of the request for information (RFI) contained in the proposed rule, we sought feedback on a potential change to the final data submission deadline from 4.5 months to 45 days after the close of the period. We also sought feedback on the digital quality measurement (DQM) transition for HHAs. We solicited feedback from the public on the current adoption of health IT and standards, including Fast Healthcare Interoperability Resources (FHIR), and what related challenges or barriers HHAs are facing. Finally, we sought input on future HH QRP quality measure (QM) concepts of interoperability, cognitive function, nutrition, and patient well- being.

For a detailed discussion of the considerations we historically use for measure selection for the HH QRP quality, resource use, and other measures, we refer readers to the CY 2016 HH PPS final rule (80 FR 68695 through 68696). In the CY 2019 HH PPS final rule with comment period (83 FR 56548 through 56550), we finalized the factors we consider for removing previously adopted HH QRP measures.

The HH QRP currently includes 19 measures for the CY 2026 program year, as described in table C-19. BILLING CODE 4120-01-P

[GRAPHIC] [TIFF OMITTED] TR02DE25.043

BILLING CODE 4120-01-C

D. Removal of the “COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date” (Patient/Resident COVID-19 Vaccine Measure) Beginning With the CY 2026 HH QRP

In the CY 2026 HH PPS proposed rule, we proposed to remove the COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date” measure (“Patient/Resident COVID-19 Vaccine” measure) beginning with the CY 2026 HH QRP under removal Factor 8, the costs associated with a measure outweigh the benefit of its continued use in the program (Sec. 484.245(b)(3)(viii)). We noted that the estimated burden of collecting this information annually across all 11,904 active HHAs is 47,168 hours at a cost of $4,326,249 and referred readers to section VII of the proposed rule for more details on the estimated burden reduction related to the proposal.

When we adopted the Patient/Resident COVID-19 Vaccine measure, COVID-19 continued to be a major challenge for HHAs, with older adults at a significantly higher risk of mortality, severe disease, and death following infection (88 FR 77762). We refer readers to the CY 2024 HH PPS final rule, where we adopted Patient/Resident COVID-19 Vaccine measure into the HH QRP for further background on the adoption of this measure (88 FR 77762 through 77764). Since that time, HHAs have expressed concerns about data collection challenges and increased provider burden in collecting patient immunization data.\15\ Providers were required to integrate the required Patient/Resident COVID-19 Vaccine OASIS item into their assessment instrument and ensure accurate assessment for all their patients. While preventing the spread of COVID-19 remains a public health goal, the number of COVID-19 cases and deaths \16\ is declining, and as noted in the proposed rule, we believe the continued costs and burden to providers of reporting this measure outweigh the benefit of continued information collection on COVID-19 vaccination coverage among patients in HHAs. For the COVID-19 items collected at transfer of care, death at home, and discharge, we estimate a decrease in clinician cost of $4,326,249 or $363 ($4,326,249/11,904) for each of the 11,904 active HHAs. We refer readers to section VII.A.3. of the proposed rule for more details on this estimated burden reduction.

\15\ Standing Technical Expert Panel for the Development, Evaluation, and Maintenance of Post-Acute Care (PAC) and Hospice Quality Reporting Program (QRP) Measurement Sets Summary Report December 15, 2023. https://www.cms.gov/files/document/december-2023-pac-and-hospice-cross-setting-tep-summary-report.pdf-1.

\16\ Provisional COVID-19 Deaths, by Week, in The United States, Reported to CDC. Accessed on March 18, 2025, via https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_select_00.

We proposed that, effective with assessments completed on or after the date of publication of this CY 2026 HH PPS final rule, the data from the “Patient/Resident COVID-19 Vaccination is Up to Date” OASIS item (O0350) would no longer be used in the calculation of the Patient/ Resident COVID-19 Vaccine measure, and the measure itself would be withdrawn pursuant to measure removal factor eight (set out at 42 CFR 484.245(b)(3)(viii)). We proposed to remove the Patient/Resident COVID- 19 Vaccination is Up to Date item (O0350) from the OASIS effective April 1, 2026, since it is not technically feasible to remove the item earlier. However, under our proposal, until this item can be removed from the OASIS, HHAs would be permitted to submit any valid response (0--No, 1--Yes, or dash) on a Transfer, Death at home, or Discharge OASIS assessment, without any future quality measure implications. Note that the item must be completed with one of these three valid responses (must not be left blank) in order for the submitted assessment not to be rejected by the iQIES under existing submission specification edits.

We invited public comments on our proposal to remove the COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date measure from the HH QRP beginning with the CY 2026 HH QRP. The following is a summary of the comments received and our responses:

Comment: A majority of commenters supported CMS's proposal to remove the Patient/Resident COVID-19 Vaccine measure from the HH QRP, with most citing the collection burden associated with the measure as support for its removal. Many commenters highlighted that there are many other sources that provide national COVID-19 vaccination rates. Some cited the end of the public health emergency and the reduced need to track COVID-19 vaccination rates through a standalone process. Some commenters also recommended that, given the expected timeframe for removal of this measure, CMS should clearly explain how providers could reduce their burden associated with the proposal to make the Patient/ Resident COVID-19 Vaccination is Up to Date OASIS item (O0350) voluntary.

Response: We thank commenters for their support. We agree that the burden associated with this measure, including the resources spent by HHA staff in trying to ascertain patients' vaccination status, outweighs the benefit of its continued inclusion in the program, particularly given the end of the COVID-19 PHE,\17\ the decrease in COVID-19 cases, as well as the availability of treatments for COVID-19. We will ensure that HHAs understand that submission of the Patient/ Resident COVID-19 Vaccination OASIS item (O0350) is voluntary with the final posting of this final rule through a range of CMS communication methods. This will allow for providers to immediately reduce efforts in collecting the O0350 item by providing any valid response until the item is removed with the implementation of OASIS E2 on April 1, 2026.

\17\ https://archive.cdc.gov/www_cdc_gov/coronavirus/2019-ncov/your-health/end-of-phe.html.

Comment: A few commenters opposed the proposed removal of the Patient/Resident COVID-19 Vaccine measure from the HH QRP. These commenters cited the continued recommendation by the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) in 2025 for adults and especially adults 65 or older to receive the COVID-19 vaccine due to higher rates of hospitalization and deaths amongst this population associated with COVID-19. Another commenter noted that this measure offers valuable information to clinicians entering a patient's home and helps providers to better understand a patient's risk of contracting or transmitting COVID-19.

Response: We appreciate the commenters' concerns for providers and patients in home health. We note that since the end of the COVID-19 PHE, there has been an increase in the availability of treatments, including antiviral medications used to treat mild to moderate COVID-19 in vulnerable populations.\18\ The CDC has also recently updated its adult and child immunization schedules to apply individual-based decision-making to COVID-19 vaccination.\19\ As we stated in the proposed rule, because the number of COVID-19 cases and deaths[thinsp]is declining and the availability of treatments has increased, we believe the threat to vulnerable populations,

such as HH patients, is also reduced. There has also been a reduction in risk to HH providers treating patients in homes. On these bases, we believe the continued costs and burden to providers of reporting this measure outweigh the benefit of continued information collection on COVID-19 vaccination coverage among patients in HHAs.

\18\ COVID-19 Treatment Options, https://www.cdc.gov/covid/treatment/index.html.

\19\ https://www.cdc.gov/media/releases/2025/cdc-immunization- schedule-adopts-individual-based- decision.html#:~:text=Unlike%20the%20COVID%2D19%20primary,physicians% 2C%20nurses%2C%20and%20pharmacists.

Final Decision: After consideration of the public comments, we are finalizing our proposal to remove the COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date measure from the HH QRP beginning with the CY 2026 HH QRP. Beginning with patients discharged on or after April 1, 2026, HHAs would not be required to collect and submit the Patient/Resident COVID-19 Vaccine measure data to CMS. Until that time and with the posting of this final rule, HHAs may submit any valid response (0--No, 1--Yes or dash) on a Transfer, Death at home, or Discharge OASIS assessment, without any future quality measure implications.

In the CY 2025 HH PPS final rule (88 FR 88433 through 88439), we finalized the adoption of four items as standardized patient assessment data elements under the social determinants of health (SDOH) category: one item for Living Situation (R0310); two items for Food (R0320A and R0320B); and one item for Utilities (R0330). As finalized in the CY 2025 HH PPS final rule, HHAs would be required to report these data elements using the OASIS beginning with patients discharged in the CY 2027 HH QRP and each program year after (89 FR 88433 through 88439).

In the proposed rule, we proposed to remove the four standardized patient assessment data elements under the SDOH category, as we acknowledged the burden associated with these items. We noted that we continuously look for ways to balance the need for data collection regarding quality care and the burden of data collection on health care providers. CMS has a goal to facilitate improved health care delivery by requiring different systems and software applications to communicate and exchange data. Therefore, we noted we will work towards the workflow for these specific data elements being part of a low burden interoperable electronic system. The focus will turn towards how these data and associated recommendations exchanged can improve care coordination, efficiency, reduction in errors and patient experience.

As health IT advances and interoperability of data becomes more standardized, the burden to collect and share clinical data on these and other relevant patient information will become less burdensome, allowing for better outcomes for HH patients and their families. The objectives of the HH QRP continue to be the improvement of care, quality and health outcomes for all patients through transparency and quality measurement, while not imposing undue burden on essential health providers. HHAs and providers across the ndustry play a vital role in improving the health of all patients, including those who may be experiencing unstable housing, food insecurity or challenges paying utilities. At the same time, we recognized the burden that the collection of the additional data will impose on already overextended staff. We also acknowledged the additional cost and resources HHAs will bear for training HH staff and altering their workflows if they are required to collect and submit these items. The objectives of the HH QRP continue to be the improvement of care, quality and health outcomes for all patients through transparency and quality measurement. The estimated savings from not collecting this information annually across all 11,904 HHAs is 158,835 hours, with total savings of $13,484,033 (or $1,133 per HHA). We referred readers to section VII.A.3. of the proposed rule for more details on this estimated burden reduction.

We proposed that HHAs would no longer be required to collect and submit Living Situation (R0310), Food (R0320A and R0320B), and Utilities (R0330) beginning with patients discharged on or after April 1, 2026. We noted that these items would not be required to meet HH QRP requirements beginning with the CY 2026 HH QRP.

We invited public comments on our proposal to remove four standardized patient assessment data elements collected under the SDOH category from the HH QRP beginning with the CY 2026 HH QRP. The following is a summary of the comments received and our responses:

Comment: A slight majority of commenters expressed their support for the proposal to remove the four standardized patient assessment data elements focused on collecting information related to SDOH. These commenters often acknowledged the importance of better understanding of SDOH in addressing healthcare challenges and noted that there may be less burdensome methods for obtaining SDOH data.

Response: We thank commenters for their support of our proposal to remove these four SDOH items from the standardized patient assessment data elements collected and submitted using the OASIS. We continue to monitor the HH QRP data collection requirements to look for ways to reduce the administrative burden, where appropriate, while maintaining a high standard of quality care. We agree that removing these items at this time will alleviate some of the burden on HH providers associated with HH QRP data collection and submission requirements. We intend to align the HH QRP more closely with our overarching goal for improved health care delivery through health IT advances and low-burden interoperable electronic systems. As we stated in the CY 2026 HH PPS proposed rule (90 FR 2908), we plan to refocus efforts on how data elements can improve care coordination, efficiency, reduction in errors, and patient experience.

Comment: Many commenters opposed CMS' proposal to remove the four SDOH items from the HH QRP. Many commenters who opposed the SDOH items' proposed removal shared that collecting these data allows HHAs to identify barriers to care access and adherence to care plans. Some commenters further stated that they are already collecting SDOH data on their patients to support efforts of nurses, social workers, and care managers. A commenter stated that these items are particularly useful in rural HHAs to address deficits in rural patients' living situations. A few commenters stated these SDOH items were particularly important in caring for patients with complex or chronic conditions and geriatric patients. These commenters noted that integration of SDOH into care planning can result in cost savings by reducing readmissions and emergency department visits while improving patients' post-care outcomes.

Response: We appreciate the commenters' concerns and feedback regarding the importance of collecting these SDOH items from HH patients and acknowledge the value that commenters ascribe to the collection of this information for discharge planning and care coordination. We recognize commenters' experiences using SDOH data to improve outcomes and facilitate high quality care through improved coordination between HH providers. We also acknowledge feedback from commenters that healthcare outcomes may be different for those patients experiencing unstable housing, food insecurity, or challenges paying utilities.

However, in reviewing the data collection and reporting requirements for the CY 2027 HH QRP, we determined that these SDOH items should be removed from the OASIS prior to the start of data collection and submission. We have re-evaluated the value of adding these SDOH items to the OASIS for the purposes of the HH QRP against their need at this time. We considered that HHA have not yet begun to report these data, we do not currently have a specific use for these items in the HH QRP, these SDOH items are not clinical items related to direct patient care, and we have refocused efforts on modernization of health care and health care systems which may support less burdensome ways of collecting SDOH data in the future. We continuously review and reassess the balance of data collection and HH provider burden for the HH QRP, and at this time, determined these SDOH items should be removed prior to implementation.

The objectives of the HH QRP continue to be the improvement of care, quality, and health outcomes for all patients through transparency and quality measurement, while balancing burden for HHAs and their staff. As outlined in our RFI in the CY 2026 HH PPS proposed rule (90 FR 29108), we are refocusing our efforts to advance the digital quality measurement transition to include ways for data elements, such as those related to SDOH, to be collected as part of a low-burden interoperable electronic system. Given these administrative goals and efforts to reduce burden for HHAs, we do not believe that the collection of SDOH items via the OASIS assessment outweighs the cost and burden of collecting them at this time.

Comment: Some commenters noted that SDOH screening has already been integrated into many HHAs care coordination workflows and that removing the SDOH items without a plan would disrupt current care processes.

Response: The purpose of the HH QRP data is to meet CMS quality reporting requirements. Even though we will no longer require HHAs to collect and submit these four items to CMS using the OASIS, HHAs can still collect and use SDOH information and share it with local agencies, in compliance with applicable laws governing confidentiality and privacy of patient information, if they believe this would be beneficial.

We understand implementation efforts to collect and submit any data elements for the purposes of meeting HH QRP requirements are inherently burdensome for HHAs and their staff, particularly adopting and implementing new data elements since they involve adjustments to health IT systems and electronic health record (EHRs), workflows, and staff training. We are always reviewing and reassessing this balance of data collection and HH provider burden for the HH QRP. For the four SDOH items, we reconsidered the value of their collection and submission to us for the purposes of the HH QRP against their need at this time. We specifically considered that these items are not clinical in nature. While they reflect certain aspects of a resident's health that may inform clinical decisions, they are not factors within the scope of care that an HHA and its staff provide.

Comment: A few commenters who opposed our proposal to remove the four SDOH items noted that these items are critical for risk adjustment and evaluating HHA performance across demographic groups.

Response: We wish to clarify that these four SDOH items are not currently being used for risk adjustment for any HH QRP measures, and we do not currently utilize them for evaluating HH performance across demographic groups. Furthermore, there are no current plans for utilizing the four SDOH items in risk adjustment models or to report HH performance stratified by these elements, either publicly or in confidential feedback reports. While we finalized the adoption of the four SDOH items in the CY 2025 HH PPS final rule (88 FR 88433 through 88439), these items were not yet available on the OASIS. Because data collection has not begun and we do not have an active use for these items, we have re-evaluated the value of adding them to the OASIS at this time.

Final Decision: After consideration of the public comments, we are finalizing our proposal to remove four standardized patient assessment data elements (one item for Living Situation (R0310); two items for Food (R0320A and R0320B); and one item for Utilities (R0330)) collected under the SDOH category from the HH QRP beginning with the CY 2026 HH QRP without modification.

The HH QRP reconsiderations and appeals process was finalized in the CY 2013 HH PPS final rule (77 FR 67096). At the conclusion of the required quality data reporting and submission period, we review the data received from each HHA during that reporting period to determine if the HHA met the HH QRP reporting requirements. HHAs that are found to be non-compliant with the HH QRP reporting requirements for the applicable calendar year will receive a 2-percent point reduction to its market basket percentage update for that calendar year. In the CY 2018 HH PPS final rule (82 FR 52738 through 51740), CMS finalized a process for HHAs to request and for us to grant exceptions and extensions for the reporting requirements of the HH QRP for one or more quarters beginning with the CY 2019 HH QRP when there are certain extraordinary circumstances outside the control of the HHA. When an exception or extension is granted, we finalized that we would not reduce the HHA's PPS payment for failure to comply with the requirements of the HH QRP.

In that rule, we finalized a policy that, in very limited circumstances, CMS could grant a request by an HHA to extend the proposed deadline for their reconsideration requests (82 FR 52738 through 51740). We stated that, to extend the deadline, HHAs would have to request an extension and demonstrate that “extenuating circumstances” existed which prevented the filing of the reconsideration request by the proposed 30-day deadline (82 FR 52738 through 51740).

In the CY 2018 HH PPS final rule (82 FR 51752), we codified the reconsideration policy and process for HHAs at Sec. [thinsp]484.250. As codified, our regulation at Sec. [thinsp]484.250 addressed how we send our written notification of non-compliance to an HHA, the process for an HHA to request reconsideration, what information an HHA must include with its reconsideration request (for example, documentation that demonstrates the HHA's compliance HH QRP requirements), and how we would notify the HHA of our final decision regarding its reconsideration request. In 2019, we moved the regulatory text to Sec. [thinsp]484.245 and updated and clarified the regulatory text in the CY 2020 HH PPS final rule (84 FR 60645).

As we noted in the proposed rule, we became aware that there were inconsistencies in our preamble and regulation text regarding HHA requests for reconsideration. On this basis, in the proposed rule, we sought to address those inconsistencies.

2. HH QRP Reconsideration Policy: Amending and Codifying Requirements Related to Requests for Extension To File Reconsideration Request Beginning With the CY 2027 HH QRP

As noted previously, in the CY 2018 HH PPS final rule (82 FR 51738 through 51740), we provided that, in very limited circumstances, we may grant a request by an HHA to extend the deadline to submit its reconsideration request, so long as the HHA requested the extension and demonstrated that extenuating circumstances existed that prevented it from filing a reconsideration request by the 30-day deadline (82 FR 51738 through 51740). However, we did not codify this policy-- permitting HHAs to request an extension to file their reconsideration request--in our regulation text at Sec. 484.245(d).

In implementing this finalized policy, we have noted an area where further clarity would be beneficial to HHAs. Specifically, we have noted that HHAs may benefit from clearly demarcated deadlines. Although we believe an HHA would have an interest in asking for an extension to file a reconsideration request prior to the deadline, our policy currently does not specify a deadline for an HHA to submit its request for such an extension (82 FR 51738 through 51740). in order to support such a request, the HHA must demonstrate that extenuating circumstances existed that prevented filing the reconsideration request by the 30-day deadline (82 FR 51738 through 51740). However, we have not specified a deadline from when the extenuating circumstances occurred. We believe HHAs may benefit from further specificity by setting a deadline for submitting a request to extend the deadline to file a reconsideration request.

On this basis, we proposed to amend our reconsideration policy as codified at Sec. 484.245(d) to permit a HHA to request, and CMS to grant, an extension to file a request for reconsideration of a non- compliance determination if, during the period to request a reconsideration as set forth in Sec. 484.245(d), the HHA was affected by an extraordinary circumstance beyond the control of the HHA (for example, a natural or man-made disaster such as a cyber-attack, hurricane, tornado, or earthquake). We proposed that the HHA submit its request for an extension to file a reconsideration request to CMS via email no later than 30 calendar days from the date of the written notification of non-compliance. We proposed that the HHA's extension request, submitted to CMS, must contain all of the following information: (1) the CCN for the HHA; (2) the business name of the HHA; (3) the business address of the HHA; (4) certain contact information for the HHA's chief executive officer or designated personnel; (5) a statement of the reason for the request for the extension; and (6) evidence of the impact of the extraordinary circumstances, including, for example, photographs, newspaper articles, and other media. We proposed to codify this process at Sec. 484.245(d)(5).

We further proposed that we would notify the HHA in writing of our final decision regarding its request for an extension to file a reconsideration of the non-compliance request via an email from CMS. We proposed to notify the HHA via email because this would allow for more expedient correspondence with the HHA, given the 30-day reconsideration timeframe. We proposed to codify this process at Sec. 484.245(d)(6).

We noted that we considered proposing similar modifications across all post-acute care setting quality reporting programs to more closely align the reconsideration processes.

We invited comments on these proposals to amend the HH QRP reconsideration policy to permit HHAs to request an extension to file a reconsideration request beginning with the CY 2027 HH QRP and to codify this proposed policy and process at Sec. 412.634(d)(5) and (d)(6). The following is a summary of the comments received and our responses:

Comments: All commenters supported the proposal to amend the current reconsideration policy to permit HHAs to request an extension to file a reconsideration request, citing the increasing number of natural and man-made emergencies that could require HHAs to submit such a request.

Response: CMS thanks commenters for their support of the proposed updates to the current reconsideration policy that would permit HHAs to request an extension to file a reconsideration request.

Final Decision: After consideration of the public comments received, we are finalizing these proposals to amend the HH QRP Reconsideration policy to permit HHAs to request an extension to file a reconsideration request beginning with the CY 2027 HH QRP and to codify this proposed policy at Sec. 484.245(d)(5) and (d)(6). 3. Codifying the Bases on Which CMS Can Grant a Reconsideration Request

As discussed previously, in the CY 2013 HH PPS final rule, we stated that, after we reviewed an HHA request for reconsideration, we may reverse our initial finding of non-compliance if: (1) the HHA provides proof of compliance with all requirements during the reporting period; or (2) the HHA provides adequate proof of a valid or justifiable excuse for non-compliance if the HHA was not able to comply with requirements during the reporting period (77 FR 67096). We also stated that we will uphold an initial finding of non-compliance if the HHA cannot show any justification for non-compliance (77 FR 67096).

As previously discussed, we codified our reconsideration policy at Sec. 484.245(d) in the CY 2013 HH PPS final rule (77 FR 67096). Our regulation at Sec. 484.245(d)(3) requires that an HHA's request for reconsideration includes accompanying documentation that demonstrates the HHA's compliance with the HH QRP requirements. Then, we will notify the HHA in writing regarding our final decision on its reconsideration request (Sec. 412.634(d)(4)).

We noted in the proposed rule that we believe it would be beneficial for HHAs if we codify our specific bases for granting a reconsideration request in our regulation at Sec. 484.245(d). These have not been previously outlined in regulatory text and CMS has outlined these details for clarity for any HHA seeking an extension in the reconsideration process.

On these bases, we proposed to modify our reconsideration policy to provide that we will grant a timely request for reconsideration and reverse an initial finding of non-compliance, only if CMS determines that the HHA was in full compliance with the HH QRP requirements for the applicable program year. We would consider full compliance with the HH QRP requirements to include CMS granting an exception or extension to HH QRP reporting requirements under our extraordinary circumstance exception and extension (ECE) policy at Sec. 484.245(c). However, to demonstrate full compliance with our ECE policy, the HHA would need to comply with our ECE policy's requirements, including the specific scope of the exception or extension as granted by CMS.

We proposed to amend Sec. 484.245(d)(4) to codify this modified policy. We noted that we considered proposing similar modifications across all post-acute care setting quality reporting programs to more closely align the reconsideration processes.

We invited comments on these proposals to amend the bases by which we grant a reconsideration request

under the HH QRP reconsideration policy and to codify this proposed policy at Sec. 484.245(d)(5). The following is a summary of the comments received and our responses:

Comment: All commenters supported CMS's proposal to clarify the current data non-compliance reconsideration policy. Some commenters noted that this update was needed, with HHAs facing a range of disasters more frequently. Many commenters also expressed that the consistency of the policy across care settings was also welcomed. One commenter requested that CMS further provide technical assistance and practical examples of acceptable supporting documentation, especially for smaller agencies that may lack compliance resources. Another commenter sought to determine CMS's plans to update guidance to surveyors in light of this policy update.

Response: CMS thanks commenters for their support of the updates to the data non-compliance reconsideration request policy and process. CMS will seek to ensure the requirements of acceptable supporting documentation as part of the reconsideration process are available to stakeholders. CMS will also ensure all stakeholders engaged in the reconsiderations process have clear guidance on how this update affects current processes that evaluate HHA compliance.

Final Decision: After consideration of the public comments received, we are finalizing our proposals to amend the bases by which we grant a reconsideration request under the HH QRP reconsideration policy and to codify this proposed policy at Sec. 484.245(d)(5).

Section 1891(d) of the Act, cross-referencing section 1891(c)(2)(C)(i)(I) of the Act (section 4021(b) of Pub. L. 100-203 (December 22, 1987)) requires the Secretary to develop a comprehensive assessment for Medicare-participating HHAs. In 1993, CMS (then known as HCFA) developed an assessment instrument that identified each patient's need for home care and the patient's medical, nursing, rehabilitative, social and discharge planning needs. As part of this assessment, Medicare-certified HHAs were required to use a standard core assessment data set, the Outcome and Assessment Information Set (OASIS). As part of the home health assessment, the statute requires a survey of the quality of care and services furnished by the agency as measured by indicators of medical, nursing, and rehabilitative care provided by the HHA. OASIS is the designated assessment instrument for use by an HHA in complying with the requirement and HHAs must submit the data collected by the OASIS assessment to CMS as an HHA condition of participation (42 CFR part 484.45).

Section 704 of the Medicare Prescription Drug Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, December 12, 2003) “suspended” the legal authority of the Secretary to require HHAs to report non-Medicare and non-Medicaid patient data to CMS until at least 2 months after the Secretary published final regulations on CMS's collection and use of OASIS data following the submission of a report to Congress on the study required under section 704(c) of the MMA. Subsequently, CMS conducted the study from 2004 to 2005 and submitted a report \20\ to Congress in 2006 titled “The OASIS Study: The Costs and Benefits Associated with the Collection of Outcome and Assessment Information Set (OASIS) Data on Private Pay Home Health Patients-- Report to Congress.” While the 2006 report recommended that the suspension continue, the passage of the Improving Medicare Post-Act Care Transformation (IMPACT) Act (Pub. L. 113-115) in 2014 required CMS to create a uniform quality measurement system that allows CMS to compare outcomes across post-acute care (PAC) providers.

\20\ https://www.cms.gov/files/document/cms-oasis-study-all-payer-data-submission-2006.pdf.

The final rule titled, “Medicare Program; Calendar Year (CY) 2023 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Program Requirements; Home Health Value-Based Purchasing Expanded Model Requirements; and Home Infusion Therapy Services Requirements” \21\ finalized the requirement for HHAs to report OASIS data on all patients, regardless of payer, for the applicable 12-month performance period (example July 1, 2025-June 30, 2026) (87 FR 66862). With the CY 2025 HH PPS final rule, CMS established that start of care (SOC) is the first assessment that can be submitted for a non-Medicare/ non-Medicaid patient, either on or after January 1, 2025, for the phase-in (voluntary) period or on or after July 1, 2025, for the mandatory period. CMS would use the M0090 “Date Assessment Completed” date of the SOC assessment to identify non-Medicare/non-Medicaid patient assessments in the phase-in and mandatory periods (89 FR 88439 through 88441). This ended the suspension of the OASIS data collection on non-Medicare and non-Medicaid HHA patients. As discussed in the final rule, the most accurate representation of the quality of care furnished by HHAs is best captured by calculating the assessment-based measures rates using OASIS data submitted on all HHA patients receiving skilled care, regardless of payer.

\21\ https://www.federalregister.gov/documents/2022/11/04/2022-23722/medicare-program-calendar-year-cy-2023-home-health-prospective-payment-system-rate-update-home.

2. Updates to the Home Health Agency CoPs To Align With the OASIS All- Payer Submission Requirements (Sec. Sec. 484.45(a) and 484.55(d)(1)(i))

Section 484.45(a) of the HHA CoPs currently requires an HHA to encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary, with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. To align with the transition to OASIS all-payer submission requirements as outlined in the CY 2023 Home Health PPS final rule, we proposed at Sec. 484.45(a) to remove the term “beneficiary” and replace it with the term “patient.”

Patients must receive, and an HHA must provide, a comprehensive assessment no later than 5 calendar days after the start of care. The comprehensive assessment not only examines patients' current health, psychosocial, functional, and cognitive status, but also must incorporate the most current version of the OASIS data items. This includes clinical record items, patient history, supportive assistance, etc. Currently, the comprehensive assessment, including administration of OASIS, must be updated and revised as frequently as the patient's condition warrants, but not less frequently than the last five days of every 60 days beginning with the start-date of care. Language at Sec. 484.55(d)(1)(i) references a “beneficiary elected transfer” in reference to one scenario in which an OASIS assessment would be updated. To support the transition to OASIS all-payer submission requirements, we also proposed to remove the term “beneficiary” at Sec. 484.55(d)(1)(i).

We noted that these technical changes to update terminology would further clarify that the requirement for reporting OASIS information applies to all HHA patients receiving skilled services and align the language in the CoPs with the requirements finalized in the CY 2023

and CY 2025 Home Health PPS final rules. We noted that this policy would not change current patient exemptions for OASIS, which are as follows: patients under the age of 18; patients receiving maternity services; and patients receiving only personal care, housekeeping, or chore services.

Based on feedback from patients and interested parties, CMS launched an effort to update and shorten the Home Health Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) survey. CMS conducted a mode experiment with 100 HHAs in 2022. The experiment tested a web-mail mode and a revised survey instrument. The revised survey is shorter than the current survey and includes new questions on topics suggested by interested parties. Specifically, the changes proposed to the survey and the quality measures derived from testing included the following:

Addition of three new questions to assess new topics of importance to patients:

++ Whether the care provided helped the patient take care of their health.

++ Whether the patient's family/friends were given sufficient information and instructions.

++ Whether the patient felt the staff cared about them “as a person.”

Removal of questions or topics of less importance to patients (that is, six questions about medications were reduced to two questions).

The following 4 questions were removed:

++ Whether someone asked to see all the prescription and over-the- counter medicines the patient was taking.

++ Whether the patient is taking any new prescription medicines or whether the patient's medicines have changed.

++ Whether home health providers talked to the patient about the purpose for taking new or changed prescription medicines.

++ Whether home health providers talked to the patient about when to take the medicines.

Removal of questions not currently used in public reporting composites (that is, three questions on which type of staff served the patient--nurse, physical or occupational therapist, and home care aide).

Removal of one question which did not perform well in testing to stand alone or fit into one of the revised composite measures:

Whether the patient got information about what care and services they would get when they first started getting home health care.

Minor text changes to selected existing questions to help clarify the question or response options, based on feedback from patients.

The revised HHCAHPS Survey, including the revised Care of Patients and Communications between Providers and Patients measures, and the three stand-alone measures that remain from the current Specific Care Issues measure were reviewed as part of the 2025 Measures Under Consideration list (MUC2024-054, -055, -061, -062, & -063) through the Pre-Rulemaking Measure Review (PRMR) Post-Acute Care/Long-Term Care (PAC/LTC) Committee. The PRMR PAC/LTC Committee recommended four out of the five measures without any conditions and one of the measures with conditions, such as stratifying the survey data for analysis and including greater detail about the types of medications. For more information, please see https://p4qm.org/sites/default/files/2025-02/PRMR-2024-2025-MUC-Recommendations-Report-Final.pdf. Since the publication of the proposed rule, the HHCAHPS Survey and measures went through consensus-based entity re-evaluation as described here: https://p4qm.org/EM. As of August 7, 2025, the updated HHCAHPS measures were endorsed with a condition that a robust logic model illustrating the actions accountable entities can take to improve patient experience is included in the next measure evaluation in 2030. Due to the very favorable recommendations from the PRMR, we proposed to move forward with the five measures. CMS proposed to implement the revised HHCAHPS Survey beginning with the April 2026 sample month. Table C-20 provides a comparison of the current and proposed HHCAHPS Survey measures. Proposed to move forward with the five measures. CMS proposed to implement the revised HHCAHPS Survey beginning with the April 2026 sample month. Table C-20 provides a comparison of the current and revised or new HHCAHPS Survey measures. BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C b. Impact on Public Reporting and Star Ratings

HHCAHPS Survey measure scores are calculated across four rolling quarters and are published quarterly for all HHAs over the reporting period. The Summary Star Rating is currently based on the Overall Rating of Care and the three composite measures that are equally weighted. We proposed calculating the Summary Rating based on the Overall Rating of Care, the two modified composite measures (Care of Patients and Communications between Providers and Patients), and the three new stand-alone measures related to talking about home safety, reviewing prescribed and over-the-counter medicines, and talking about medicine side effects. In the calculation of the Summary Star Rating, we proposed that the Overall Rating of Care and two modified composite measures would each have a weight of 1 and each of the three new stand- alone measures would have a weight of one-third. The Summary Star Ratings will continue to be calculated using four rolling quarters and will be publicly reported for all HHAs with 40 or more completed surveys over the reporting period. Star Ratings are updated every quarter. To determine what impact the changes to the survey measures will have on public reporting, CMS considered the nature of the measure change. As Talk About Home Safety, Review Medicines, and Talk About Medicine Side Effects are new measures for the HHCAHPS Survey, since they will be reported individually, we will have to wait to introduce public reporting until we have four quarters of data. Although the revised Care of Patients measure is conceptually similar to the current Care of Patients measure, we believe the change (adding two new questions and dropping one question) is substantive and the revised measure should be treated as new for purposes of public reporting and Star Ratings. Similarly, the revised Communications Between Providers and Patients measure is also conceptually similar to the current Communications Between Providers and Patients measure; however, the change (dropping two questions and adding one new question) is substantive and the revised measure should be treated as new for purposes of public reporting and Star Ratings. As such, we proposed waiting to publicly report the new versions of Care of Patients and Communications Between Providers and Patients until we have four quarters of data. We anticipate that the first Care Compare refresh in which publicly reported measures scores will be updated to include the new measures will be October 2027, with scores calculated using data from Q2 2026 through Q1 2027. In the interim period, measure scores will be made available to HHAs confidentially via their Provider Preview reports on the HHCAHPS Survey website after two full quarters of data are submitted.

We believe the change to the Overall Rating measure (minor wording change from “provider” to “staff”) is non-

substantive (i.e., does not meaningfully change the measure) and along with the unchanged Willingness to Recommend the Agency measure, both measures can continue to be publicly reported in the transition period between the current and new surveys. During the transition period, scores and Star Ratings for the Overall Rating and Willingness to Recommend measures will be calculated by combining scores from quarters using the current and new survey and continue to be reported. c. Survey Administration Changes

No survey administration changes were proposed with the new survey. d. Case-Mix and Mode Adjustments

Prior to public reporting, HHAs' HHCAHPS Survey scores are adjusted for the effects of case mix. Case mix refers to characteristics of the patient that are not under control of the HHA that may affect reports of home health experiences. Case-mix adjustment is performed within each quarter of data after data cleaning. The current case-mix adjustment model includes the following variables: patient age, patient education, self-reported overall health, self-reported mental health, diagnosis of schizophrenia or dementia, whether the patient lives alone, whether the patient or a proxy answered the survey, and language in which the survey was completed. The model used and adjustments are updated quarterly and are available on the HHCAHPS website at this link: https://homehealthcahps.org/General-Information/Archived-Publicly-Reported-Data. Based on testing the revised survey in a 2022 Mode Experiment, CMS reviewed the variables included in the case-mix adjustment models currently in use for the HHCAHPS Survey to determine if any changes needed to be introduced along with the revised survey. We found that while no case-mix variables need to be added, and the diagnosis adjustments were no longer significant. As such, CMS proposed to drop the adjustment for diagnoses of schizophrenia or dementia with the revised survey.

Using data from the 2022 Mode Experiment, CMS also tested for whether there were impacts in how someone responds to the survey based on the mode of survey administration. Mode effects were observed with the 2022 Mode Experiment, so CMS proposed to add a mode adjustment in addition to the case-mix adjustment, with the revised survey. Case-mix adjustment will be performed within each quarter of data after data cleaning and before mode adjustment. When we make mode adjustments, it is necessary to choose one mode as a reference mode. One can then interpret all adjusted responses from all modes as if they had been surveyed in the reference mode. CMS will use mail-only as the reference mode for the HHCAHPS Survey, because it is the most used mode for HHCAHPS. The choice of mail mode as the reference mode does not indicate that mail mode is preferable to other approved modes in any way. In the 2022 HHCAHPS Survey mode experiment, telephone-only respondents were more negative in their evaluations of care relative to mail-only respondents across the HHCAHPS measures. The mode adjustments are generally small--most are around 2 percentage points.

Please see the HHCAHPS Revised Survey Mode Adjustments on https://homehealthcahps.org for the mode adjustments if these measures are finalized through rulemaking.

We invited public comment on the HHCAHPS Survey proposals. The following is a summary of the comments received and our responses:

Comment: Most commenters expressed support for revising the HHCAHPS Survey to make it shorter and simpler. Some commenters noted that these changes represent a meaningful step toward making the instrument more patient-centered and less burdensome. Some commenters expressed strong support for adding the three new HHCAHPS Survey items noting that ensuring family caregivers are better equipped to meet the needs of the individuals they care for is critical for home health care and the new items strengthen the survey's relevance to patients.

Response: We thank the commenters for their support.

Comment: A few commenters asked for a crosswalk and dry run period so agencies are not penalized during the transition to the new survey in April 2026, as well as information for vendors to prepare to administer the updated survey for their client agencies.

Response: The revised HHCAHPS Survey instrument and crosswalks between the original and proposed publicly reported measures are available on the HHCAHPS website at https://homehealthcahps.org/Survey-and-Protocols/Survey-Materials. CMS conducted a focused HHCAHPS Survey Vendor Update Training in late August 2025 to help the approved survey vendors prepare for the transition. There will also be an opportunity for survey vendors to submit test files to ensure they are properly formatted. Additionally, the updated XML data file layouts and XML file schemas used for data submission are available on the HHCAHPS website at https://homehealthcahps.org/Data-Submission/Data-Submission-Resources.

Comment: A few commenters voiced concerns about the proposed measure changes to the HHCAHPS Survey, specifically eliminating three composite measures: Care of Patients, Communication between Providers and Patients, and Specific Care Issues. A commenter supported the removal of the four medication questions that are currently included in the Specific Care Issues measure.

Response: The Specific Care Issues measure is being retired because four of the seven items that made up this measure have been removed from the updated HHCAHPS Survey with the remaining three survey items being reported as individual measures. As we were shortening the survey, we removed four of the six current HHCAHPS Survey questions related to medications patients are taking that were previously included in the Specific Care Issues measure. The Care of Patients and the Communications Between Providers and Patients measures are not being retired. However, CMS will not be able to report them publicly until there are at least 12 months of data that reflect the survey updates.

Comment: A commenter suggested freezing the HHCAHPS Star Ratings on the website during the transition period to the new measures and caveating the changes on the Care Compare website.

Response: We will take into consideration feedback on how the HHCAHPS data are reported during the transition period.

Comment: A commenter asked whether the following question was tested: In the last 2 months of care, did home health staff from this agency provide your family or friends with information or instructions about your care as much as you wanted? Another commenter noted that they found the phrase “as much as you wanted,” when referring to the amount of information sharing a patient desired from home health staff, to be a challenging for assessing quality. This commenter also noted that the phrasing “helped you take care of your health,” could be interpreted by respondents in a variety of ways. This same commenter also recommended that the following question focus on the plan of care: In the last two months of care, how often did you feel that home health staff from the agency care about you as a person?

Response: All three questions were developed based on important aspects of home health care identified during a literature review and focus groups with

home health patients. Questions were cognitively tested with home health patients and their family members through both one-on-one interviews with an experienced interviewer and as part of the 2022 mode experiment. Patients felt that home health agencies should give pamphlets and information to the family members and friends that help with the person's care, such as spouses and children, which led to the development of the question “In the last two months of care, did home health staff from this agency provide your family or friends with information or instructions about your care as much as you wanted”. When asked what the phrase “helped you take care of your health” meant in the question “In the last 2 months of care, how often have the services you received from this agency helped you take care of your health” patients explained that that they were thinking about the ways the care they received helped them to walk better, helped their wounds to heal, and helped with their diets and overall health. Patients understood the question “In the last two months of care, how often did you feel that home health staff from the agency cared about you as a person” to mean whether staff took the time to get to know them on a personal level or form a personal connection with them, for example, treating them like people and not “like a number”. Results from several rounds of interviews consistently showed that questions were well understood and supported by patients and their families.

Comment: Several commenters requested CMS to add the web mode of survey administration, stating that the HHCAHPS Survey should be offered in an electronic format delivered by email or text.

Response: A web-based mode was tested during the 2022 mode experiment with very few respondents opting to complete via web. Obtaining email addresses for sample members was challenging and not routinely available. CMS will continue to evaluate the possibility of a web-based mode for this population in the future.

Comment: A few commenters did not support the removal of the case- mix adjustment for patients with diagnoses of schizophrenia or dementia as they believed communication challenges with individuals with these diagnoses would not be accounted for without the adjustment.

Response: In the most recent mode experiment, despite robust statistical testing, the potential schizophrenia and dementia adjusters were no longer statistically significant and did not show an impact on responses. Since these patients are most likely to have proxy respondents, this helps with the validity of these patients' responses.

Comment: A couple of commenters were concerned about the increased cost to agencies for retraining staff and revising their systems for the new survey.

Response: The updated HHCAHPS Survey instrument should not require any changes to existing data that HHAs provide their HHCAHPS Survey vendors. The approved survey vendors will need to update their systems and materials.

Comment: A commenter suggested fielding both the revised and original survey items concurrently during a transition period.

Response: Many agencies having very small sample sizes and given the expense of running two instruments simultaneously, CMS has elected to phase out the current survey and phase in the new survey rather than run two separate surveys concurrently.

Comment: A commenter suggested that CMS eliminate the “Overall Rating” and “Willingness to Recommend” stating that the responses to these questions do not always align with the responses to other more specific questions in the survey. Another commenter asked that these questions be at the beginning of the survey.

Response: CMS administers these two standard questions across all of its CAHPS surveys to provide a cross-provider metric. These questions also capture a combined assessment of a patient's entire home health experience, integrating all aspects of their interactions with the home health agency and staff. To keep CAHPS surveys fairly short, we are unable to ask questions that encompass all aspects of care. We agree that the home health-specific survey measures and individual items are critical and CMS will, therefore, continue to report these as well. Overall rating questions are generally at the end of all CAHPS surveys so a respondent can provide an overall assessment of their experiences after thinking about more specific aspects of their care.

Comment: A commenter recommended that CMS ensure that the Spanish HHCAHPS Survey is not simply a literal translation, but one that is culturally and linguistically validated; raised challenges in Puerto Rico related to internet connectivity, mail access, and responsiveness to phone calls; and suggested that survey vendors conducting telephone outreach in Puerto Rico be required to use a Puerto Rico area code (787) when placing calls.

Response: The Spanish translation was developed by a reliable translation service provider and thoroughly reviewed by native Spanish speakers. The translation service was asked to retain phrasing from the current HHCAHPS Survey instrument as much as possible since that translation was reviewed and cognitively tested specifically with patients in Puerto Rico to ensure that they could understand the questions. We appreciate the challenges of conducting both mail and telephone surveys in Puerto Rico and encourage agencies there to work closely with their HHCAHPS Survey vendors to implement mixed-mode surveys (i.e., mail survey with telephone follow-up of non- respondents), which give patients a choice of how to respond. We have provided vendors with your suggestion to use a Puerto Rico area code when making outbound calls. Agencies in Puerto Rico should work with their vendors to implement this and any other measures (within HHCAHPS protocols) to help maximize response rates.

Final Decision: After consideration of the public comments we received, we are finalizing our proposal to update the HHCAHPS measures beginning with the April 2026 sample month.

In the CY 2026 HH PPS proposed rule (), we sought input on the importance, relevance, appropriateness, and applicability of each of the quality measure concepts under consideration listed in Table C-21 for future years of the HH QRP. In the CY 2024 HH PPS proposed rule (88 FR 43738 through 43740), we included an RFI on a set of principles for selecting and prioritizing HH QRP measures, identifying measurement gaps, and suitable measures for filling these gaps. We refer readers to the CY 2024 HH PPS final rule (88 FR 77773 through 77774) for a summary of the public comments received in response to the RFI.

We sought input on four concepts for future measures for the HH QRP in the CY 2026 HH PPS proposed rule. 1. Interoperability

We sought input on the quality measure concept of interoperability, focusing on information technology (IT) systems' readiness and capabilities in the HH setting. Title XXX of the Public Health Service Act defines “interoperability” in part, and with respect to health IT, as health IT that enables the secure exchange of electronic health information with, and

use of electronic health information from, other health IT without requiring special efforts by the user.\22\ The definition further states that interoperability of health IT allows for complete, including by providers and patients, access, exchange, and use of electronically accessible health information for authorized uses under applicable State or Federal law.\23\ We requested input and comment on approaches to assessing interoperability in the HH setting, for instance, measures that address or evaluate the level of readiness for interoperable data exchange, or measures that evaluate the ability of data systems to securely share information across the spectrum of care.

\22\ 21st Century Cures Act, 42 U.S.C. 300jj(9) (2016).

\23\ 21st Century Cures Act, 42 U.S.C. 300jj(9) (2016).

Illnesses associated with limitations in cognitive function, which may include stroke, traumatic brain injuries, dementia, and Alzheimer's disease, affect an individual's ability to think, reason, remember, problem-solve, and make decisions. The IMPACT Act identifies cognitive function as a key quality measure domain, and an area for inclusion as a standardized assessment data element.

Two sources of information on cognitive function currently collected in HHAs are the Brief Interview for Mental Status (BIMS) and Confusion Assessment Method (CAM(copyright)).\24\ Both the BIMS and CAM have been incorporated into the OASIS. Scored by providers via direct observation, the BIMS is used to determine orientation and the ability to register and recall new information. The CAM assesses the presence of inattention, disorganized thinking, and level of consciousness.

\24\ Centers for Medicare & Medicaid Services. Long-Term Care Hospital Continuity Assessment Record and Evaluation (CARE) Data Set Version 5.0. Effective October 1, 2022. https://www.cms.gov/files/document/ltch-care-data-set-version-50-planned-discharge-final.pdf.

The BIMS and CAM include items representing different aspects of cognitive function, from which quality measures may be constructed. Although these instruments have been subjected to feasibility, reliability, and validity testing, additional development and testing would be required prior to transforming the concepts reflected in the BIMS and CAM (example temporal orientation, recall) into fully specified measures for implementation in the HH QRP.

This RFI requested input on cognitive functioning measures that may be available for immediate use, or that may be adapted or developed for use in the HH QRP, using the BIMS or the CAM. In addition to comment on specific measures and instruments, CMS sought input on the feasibility of measuring improvement in cognitive functioning during a HH stay, which typically averages 56 days; \25\ the cognitive skills (example executive functions) that are more likely to improve during an HHA stay; conditions for which measures of maintenance--rather than improvement in cognitive functioning--are more practical; and the types of intervention that have been demonstrated to assist in improving or maintaining cognitive functioning.

\25\ Based on home health episodes ending in CY2021 (the most recent year for which complete data are available).

Most commenters on the interoperability measure concept stressed the value and importance of advancing interoperability in healthcare in general and in home health specifically. Many commenters shared that national standards will be critical for any interoperability measure concept. Most commenters also shared that federal funding was needed to ensure that home health could have the same advances in health record systems seen in hospital and physician practices. Numerous commenters cited the HITECH Act (Pub. L. 111-5), that subsidized the adoption and

implementation of certified electronic health record (EHR) systems for hospitals and physician practices but that was not available to home health, behavioral health, and other post-acute care settings. They note, without this funding, HHAs have not had access to the same level of financial or technical support to build and maintain an interoperable infrastructure. Many commenters specifically noted that HH was behind in the development of health IT deployment and this would be a barrier to any measure.

Those who support the development of an interoperability measure concept outlined criteria that must be considered. Some shared that any measure must evaluate both technical readiness or capability and the processes or practices of data exchange. Others shared that a measure should address interoperability between health care providers, between providers and patients, and between providers and payers. One commenter noted that the exchange of information needs to account for clinical as well as social determinants of health information. A number of commenters highlighted the work of The Post-Acute Care Interoperability (PACIO) project \27\ that supports development of FHIR (Fast Healthcare Interoperability Resources) technical implementation guides and suggested any interoperability work builds on these ongoing efforts. One commenter shared that this measure concept should include caregiver information in electronic health records. Another advocated for building out a measure process based on the Trusted Exchange Framework Common Agreement (TEFCA) initiative.

\27\ For more information on the Post-Acute Care InterOperability (PACIO) project, see: https://pacioproject.org/.

Several commenters who stressed the importance of interoperability also noted that they didn't support an interoperability measure concept for HH due to what they described as significant financial and operational barriers to advancing standardized interoperability in HH. They argue that home health agencies currently are largely not at the appropriate level of technology adoption for interoperable data exchange or measures that evaluate the ability of data systems to securely share information across providers and with patients. 2. Cognitive Function

Commenters shared that addressing cognitive function in home health care is a critical clinical area. Many commenters shared that the OASIS tool already has several tools that evaluate aspects of cognitive function. The PHQ 2-9(copyright), Brief Interview for Mental Status (BIMS(copyright)), and Confusion Assessment Method (CAM(copyright)) were often referenced, and commenters shared that those tools would not be sufficient to address the range of issues that encompass cognitive function. One commenter highlighted that the current tools are not effective in assessing mild cognitive impairment that can affect activities of daily living or instrumental activities of daily living. Several commenters particularly note that these tools were intended to assess some areas of cognition but not intended for performance measures.

Some commenters shared that the trajectory of patients with cognitive function challenges can vary and make the use of any one tool alone insufficient to address the range of cognitive function challenges. Some patients with progressive neurological conditions will have steady decline and not likely to expect cognitive improvement. Patients with chronic conditions may complicate assessment of cognitive function and a patient's expected care path would also be progressive decline. These issues are made more challenging due to the short average length of stay that numerous commenters suggest is too short to have a meaningful impact on cognitive function.

With these considerations, many commenters stressed that CMS should not target a cognitive function measure focused on improvement but rather focus on maintenance or limiting cognitive decline. Some commenters, after considering the complexity of cognitive function, argued against developing a single measure to address this domain or to not develop this measure domain with the present challenges. One commenter shared that there would need to be additional resources for home health agencies to build expertise in addressing cognitive function needs to justify introducing a new measure related to this measure domain. 3. Well-Being

Numerous commenters provided input on the well-being measure concepts. Many commenters shared that addressing well-being could be important for home health patients. Commenters often also shared that any measure concept addressing well-being should account for what HHAs can reasonably affect with respect to well-being during a home health stay. Most commenters also shared that any measure of well-being should be an evidence-driven, validated tool.

A commenter highlighted the importance of including caregiver input on assessing patient well-being, where appropriate. Some commenters had suggestions about what kinds of tools may best address the well-being measure concept. A few commenters suggested CMS consider focusing on a patient reported outcome measure structure. Other commenters suggested specific components of the OASIS that could already be valuable as part of a wellbeing measure such as the BIMS, CAM, and PHQ 2-9 and not duplicate the value of these tools when considering a well-being concept.

Many commenters also suggested that given the timeframe of a home health stay, the focus for CMS should be on a process rather than outcome measure since the HHA would have limited ability to affect the broad concept of well-being. Others cautioned that HHAs could not address an issue as broad as well-being in the timeframe of a patient's HH care and that this measure concept should not be considered for the HH QRP. 4. Nutrition

Many commenters described the importance of nutrition in patient care and in home health specifically. Commenters share that clinicians can support patients' health by understanding their nutritional status. Commenters who supported developing a nutrition measure concept often stressed the need for using tools that were validated and reliable. Commenters suggested a range of nutrition tools such as the standardized Mini Nutritional Assessment (MNA) or Malnutrition Screening Tool (MST) that could provide reliable data. Another commenter suggested the DETERMINE nutrition risk scale as a screening tool. Another tool suggested was the hand grip strength (HGS) through purposeful activities and further referencing research that shows in older adults, a significant association between malnutrition and HGS. Yet another commenter noted that weight was collected and start of care and resumption of care and that CMS should use data already available in consideration of a new measure concept. The most commonly cited tool from commenters was the Malnutrition Care Score (MCS), an electronic clinical quality measure (eCQM) adopted into the Inpatient Quality Reporting (IQR) program for acute care hospitals.

Commenters stated they favored the MCS because it assesses a different aspects of care that are essential to addressing malnutrition in any care setting. One commenter noted that the

MCS addresses the malnutrition care workflow that are necessary to identify and manage malnutrition risk in a timely and effective manner. Commenters described the four steps of: (1) Screen for malnutrition risk; (2) Conduct nutrition assessment; (3) Document malnutrition diagnosis; and (4) Document nutrition care plan strong, clear, clinical processes underpinning the measure. A number of commenters highlighted that this tool has been successfully utilized in quality reporting and therefore is key for CMS consideration for the HH QRP.

Commenters who supported a nutrition measure for HH often stressed that a measure concept related to nutrition should be a process measure because of the complex range of issues that encapsulate nutrition issues. One commenter suggested that any measure concept should also align with broader efforts to improve access to nutrition supports, such as the Supplemental Nutrition Assistance Program (SNAP) and nutrition programs authorized under the Older Americans Act. Some commenters who differed in support for the development of a nutrition measure concept were unified in arguing that CMS needed to support HH by increasing funding to address nutritional challenges. Currently, HHAs incorporate dietician or nutritionist services with no expectation of reimbursement. The commenter suggested that CMS should reimburse for dietician services and empower HHAs to more comprehensively address nutritional issues in their patients.

Several commenters did not support current development of a nutrition measure concept because of a number of factors. They cited the lack of reimbursement for services that would support nutrition interventions. They also noted that the complex issues around nutrition care would not fall within the scope of HHAs to address in the limited time frame of home health care. They often cited the current margins in HH care that are being taxed in providing the essential services of the home health benefit.

Response: We thank all the commenters for responding to this RFI. While we are not responding to specific comments in response to the RFI in this final rule, we will take this feedback into consideration for our future measure development efforts for the HH QRP.

Section 1895(b)(3)(B)(v)(I) of the Act states that for 2007 and each subsequent year, the home health market basket percentage increase applicable under such clause for such year shall be reduced by 2 percentage points if a home health agency does not submit quality data to the Secretary in accordance with subclause (II) for such a year. Section 1899B(f)(1) of the Act also requires the Secretary to provide confidential feedback reports to PAC providers on the performance of such PAC providers for quality, resource use, and other measures required under sections 1899B(c)(1) and (d)(1) of the Act beginning 1 year after the applicable specified application date. Further, section 1899B(g) of the Act requires the Secretary to establish procedures for making available to the public information regarding the performance of individual PAC providers for quality, resource use, and other measures required under sections 1899B(c)(1) and (d)(1) of the Act beginning not later than 2 years after the applicable specified application date. The procedures must ensure, including through a process consistent with the process applied under section 1886(b)(3)(B)(viii)(VII) of the Act for similar purposes, that each PAC provider has the opportunity to review and submit corrections to the data and information that are to be made public for the PAC provider prior to such data being made public.

Although assessment data submission, quarterly performance reports, and public reporting are required by statute, timing of data submission under the HH QRP is not specified. Thus, in the CY 2017 HHS PPS final rule (81 FR 76784) we finalized our proposal, to comply with the requirements of section 1899B(g) of the Act, that HHAs would have approximately 4.5 months after the reporting quarter to correct any errors of their assessment-based data to calculate the measures. During the time of data submission for a given quarterly reporting period and up until the quarterly submission deadline, HHAs could review and perform corrections to errors in the assessment data used to calculate the measures.

In the process of implementing the public reporting programs, CMS has become concerned that the time between when data are collected and when the measures are reported from those data may be too long to get the desired results in a public reporting program. Public reporting programs are designed to provide patients and their families with the most current information so they can make quality-informed decisions about where to receive their care. Currently, the largest contributing factor to the 9- month lag between end of the data collection and when measures are publicly reported is the current 4.5-month timeframe for data submission. If the timeframe for data submission was reduced from 4.5 months to 45 days, the lag time between collection and reporting could be reduced by up to 3 months. This would result in more timely public reporting that would be more valuable for patients and families as they make decisions about where they can receive the best care.

An important consideration in reducing the data submission timeframe is the potential burden it may place on providers, which could lead to lower quality data. CMS conducted analysis to evaluate the potential impact of reducing the timeframe by determining how many charts are being submitted by 60 days currently. Using 2022 data, CMS found that only 1.3 percent of all OASIS assessments were submitted after the 60-day timeframe. Of those submissions, approximately seventy percent (or 0.9 percent of the total) were submitted between 60 days and 4.5 months and hence have potential to be impacted. Because assessments are tied to payment, providers are likely to submit assessments close to the date of service and to close out medical records once the patient is discharged from service. Therefore, we noted in the proposed rule that we believe by reducing this deadline from 135 days to 45 days, we could reduce the time between data collection and public reporting resulting in the improvement in timeliness with limited change in burden to providers.

We requested feedback on this potential future reduction of the HH QRP data submission deadline from 4.5 months to 45 days. Specifically, we requested comment on the following:

How this potential change could improve the timeliness and actionability of HH QRP quality measures.

How this potential change could improve public display of quality information.

How this potential change could impact HHA workflows or require updates to Systems.

Comment: Most commenters supported a reduction in the final data submission deadline from 4.5 months, with additional recommendations related to implementation. They agreed with the CMS assessment that timely

public reporting is essential for informed consumer decision-making and enhances transparency and accountability. Some commenters stressed that with any reduction in timeframe, CMS should adopt a phased approach over several fiscal years to allow for providers and other stakeholders to adjust to the transition. Many commenters suggested that CMS should pilot the reduction in submission deadlines before moving to national implementation of the policy update, stating that this would allow CMS to evaluate the impacts and determine appropriate technical guidance, stakeholder engagement, and operational flexibility needed to successfully implement this change.

Other commenters cautioned that a transition from 4.5 months to 45 days would cause harm to a range of HHAs due to additional administrative burden. They noted that this would especially be the case for small HHAs, stand-alone HHAs that operate with limited resources, HHAs that manage coding and review in-house, HHAs experience high field staff turnover, or HHAs that lack robust EMR or analytics systems. They noted this could introduce errors and comprise the quality of OASIS data submitted. One commenter expressed concerns due to the rate cuts that are currently under consideration for HHAs. Commenters who expressed concerns with the potential reduction in the submission deadline had suggestions for how to make the transition manageable for HHAs. Many suggested that the submission deadline should be 60 days to be consistent with the data CMS cited in the original RFI, which showed that only 1.3% of data was submitted after 60 days. Other commenters noted that 60 days would be a reasonable target since the 60-day time frame would align with the current HHA episode of care, and with some HHA's expectations around HH QRP conditions of participation guidelines. A few commenters suggested 90 days to account for the current administrative burdens HHAs are managing. A few commenters cited the financial pressure currently faced by HHAs and opposed the reduction in the submission deadline over concerns that HHAs would not be able to meet the new workflow and operational challenges in the current resource environment.

Along with feedback on this RFI, numerous commenters provided feedback related to OASIS submissions. Many commenters suggested that CMS should move to a four-year cycle in updating the OASIS. One commenter requested that the timeframe for updating claims-based measures be reduced to also provide more timely information related to these measures which have grown in importance. One commenter also requested that CMS align any reconsideration updates to account for the reduction in submission deadlines.

Response: We thank all the commenters for responding to this RFI. While we are not responding to specific comments in response to the RFI in this final rule, we will take this feedback into consideration for our future measure development efforts for the HH QRP.

As part of our effort to advance the digital quality measurement (dQM) transition, issued an RFI in the CY 2026HH PPS proposed rule to gather broad public input on the dQM transition in HHAs. 1. Background

As we noted in the proposed rule, we are committed to improving healthcare quality through measurement, transparency, and public reporting of quality data, and to enhancing healthcare data exchange by promoting the adoption of interoperable health IT that enables information exchange using Fast Healthcare Interoperability Resources[supreg] (FHIR[supreg]) standards. Proposing to require the use of such technology within the HH QRP in the future could potentially enable greater care coordination and information sharing, which is essential for delivering high-quality, efficient care and better outcomes at a lower cost. In the CYs 2022 and 2023 HH PPS proposed rules,\28\ we outlined several HHS initiatives aimed at promoting the adoption of interoperable health IT and facilitating nationwide health information exchange. Further, to inform our digital strategy, in the CY 2022 HH PPS proposed rule (86 FR 35980) we shared and sought feedback on the following:

\28\ “Advancing Health Information Exchange” in the CY 2022 HH PPS proposed rule (86 FR 35979) and CY 2023 HH PPS proposed rule (87 FR 37602).

Our intent to explore the use of FHIR[supreg]-based standards to exchange clinical information through application programming interfaces (APIs).

Enabling quality data submission to CMS through our internet Quality Improvement and Evaluation System (QIES).

To work with healthcare standards organizations to ensure their standards support our assessment tools.

We considered opportunities to advance FHIR[supreg]-based reporting of patient assessment data for the submission of the OASIS. Our objective was to explore how HHAs typically integrate technologies with varying complexity into existing systems and how this affects HH workflows. In this RFI, we sought to identify the challenges and/or opportunities that may arise during this integration, and determine the support needed to complete and submit quality data in ways that protect and enhance care delivery.

We also sought input on future measures under consideration including applicability of interoperability as a future measure concept in post-acute care settings. We refer readers to section III.H.1. of this proposed rule for more information.

Any updates specific to the HH QRP program requirements related to quality measurement and reporting provisions would be addressed through separate and future notice-and-comment rulemaking, as necessary. 2. Solicitation of Comment

We sought feedback on the current state of health IT use, including electronic health records (EHRs), in HHAs:

To what extent does your HHA use health IT systems to maintain and exchange patient records?

If your agency has transitioned to using electronic records, in part or in whole, what types of health IT does your HHA use to maintain patient records? Are these health IT systems certified under the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program? If your agency uses health IT products or systems that are not certified under the ONC Health IT Certification Program, please specify. Does your agency use EHRs or other health IT products or systems that are not certified under the ONC Health IT Certification Program? If no, what is the reason for not doing so? Do these other systems exchange data using standards and implementation specifications adopted by HHS? Does your agency maintain any patient records outside of these electronic systems? If so, are the data organized in a structured format, using codes and recognized standards, that can be exchanged with other systems and providers?

Does your HHA submit patient assessment data to CMS through your current health IT system? If a third-party intermediary is used to report data, what type of intermediary service is used? How does your agency currently

exchange health information with other healthcare providers or systems, specifically between HHAs and other provider types? What about health information exchange with other entities, such as public health agencies? What challenges do you face with electronic exchange of health information?

Are there any challenges with your current electronic devices (for example, tablets, smartphones, computers) that hinder your ability to achieve interoperability, such as collecting, storing, sharing, or submitting data? Please describe any specific issues you encounter. Does limited internet or lack of internet connectivity impact your ability to exchange data with other healthcare providers, including community-based care services, or your ability to submit patient assessment data to CMS? Please specify.

What steps does your HHA take with respect to the implementation of health IT systems to ensure compliance with security and patient privacy requirements such as HIPAA?

Does your HHA refer to the Safety Assurance Factors for EHR Resilience (SAFER) Guides (see newly revised versions published in January 2025 at https://www.healthit.gov/topic/safety/safer-guides) to self-assess EHR safety practices?

What challenges or barriers does your agency encounter when submitting quality measure data to CMS as part of the HH QRP? What opportunities or factors could improve your agency's successful data submission to CMS?

What types of technical support, guidance, workforce trainings, and/or other resources would be most beneficial for the implementation of FHIR[supreg]-based technology in your agency for the submission of the OASIS to CMS? What strategies can CMS, HHS, or other Federal partners take to ensure that technical assistance is both comprehensive and user-friendly? How could Quality Improvement Organizations (QIOs) or other entities enhance this support?

Is your agency using technology that utilizes APIs based on the FHIR[supreg] standard to enable electronic data sharing? If so, with whom are you sharing data using the FHIR[supreg] standard and for what purpose(s)? For example, have you used FHIR[supreg] APIs to share data with public health agencies? Does your agency use any Substitutable Medical Applications and Reusable Technologies (SMART) on FHIR[supreg] applications? If so, are the SMART on FHIR[supreg] \29\ applications integrated with your EHR or other health IT?

\29\ https://smarthealthit.org/.

How do you anticipate the adoption of technology using FHIR[supreg]-based APIs to facilitate the reporting of patient assessment data could impact provider workflows? What impact, if any, do you anticipate it will have on quality of care?

Does your facility have any experience using technology that shares electronic health information using one or more versions of the United States Core Data for Interoperability (USCDI) standard? \30\

\30\ For more information about USCDI see https://www.healthit.gov/isp/united-states-core-data-interoperability-uscdi.

Would your HHA and/or vendors be interested in participating in testing to explore options for transmission of assessments, for example testing the transmission of a FHIR[supreg]- based assessment to CMS?

The Trusted Exchange Framework and Common AgreementTM (TEFCATM) framework supports nationwide health information exchange by connecting health information networks (HINs) across the country.\31\ Additionally, TEFCATM facilitates FHIR exchange by requiring Qualified HINs (QHINs) to perform patient discovery for those querying for data and providing data holders with FHIR endpoints to enable point-to-point exchange via FHIR APIs. How could the TEFCATM support CMS quality programs' adoption of FHIR[supreg]-based assessment submissions consistent with the FHIR[supreg] Roadmap (available here: https://rce.sequoiaproject.org/three-year-fhir-roadmap-for-tefca/)? How might patient assessment data hold secondary uses for treatment or other TEFCATM exchange purposes?

\31\ For more information about TEFCATM, see https://www.healthit.gov/topic/interoperability/policy/trusted-exchange-framework-and-common-agreement-tefca.

What other information should we consider that could facilitate successful adoption and integration of FHIR[supreg]-based technologies and standardized data for patient assessment instruments like the OASIS?

We invited any feedback, suggestions, best practices, or success stories related to the implementation of these technologies and noted that we would use the input to inform our future dQM transition efforts.

Comment: Many commenters expressed support for a transition to dQMs in the HH QRP, citing that using FHIR as a standard can alleviate administrative burden and improve data quality if implemented effectively. Many of these commenters supported the transition but had recommendations for CMS on successful implementation for HHAs, including a phased implementation or “glide path” approach, reporting flexibility, and adequate time to update systems after CMS finalizes a change to HH QRP requirements. Many commenters recommended funding or incentive opportunities to obtain resources and technology for improved exchange of health information. Numerous commenters also noted that implementation and updating EHRs is resource intensive, and that HHAs, along with other PAC providers, were not included in Meaningful Use funding through the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.

Several commenters expressed concerns about the differences in dQM and IT readiness across HHAs. They highlighted data that over time, the adoption of EHR technology has increased in the post-acute care; however, the interoperability of that technology remains limited. A commenter gave examples of HHAs still receiving records via fax and noted that many HHAs lack connectivity to EHRs. Commenters suggested that technical assistance would be needed for HHAs that were the least advanced in health IT capabilities, and to also provide opportunities for those farther along to meet today's certified EHR technology (CEHRT) standards. Some commenters went further to note that they could not support any implementation around dQMs without federal commitment of additional funding for these goals.

Commenters addressed other related issues related to a dQM's implementation. Some commented on the need to manually submit OASIS and other PAC assessment data. They recommend that CMS develop and implement standardized Application Programming Interfaces (APIs) that would allow for direct data exchange between certified EHRs and CMS systems (directly). Another commenter noted that CMS has regulations that limit use of technology in populating OASIS items from a patient's medical chart. With the ability of artificial intelligence and other technologies, they noted that HHAs could now incorporate some patient data more efficiently without removing clinician review of the data. They argued this could significantly reduce the time required to complete the OASIS.

Several commenters also provided detailed responses to the RFI's questions about their agency's current state of health IT use, challenges and/or opportunities that may arise during

integration of technologies with varying complexity into existing HH systems, how it affects workflow, and what support may be needed to complete and submit quality data in ways that protect and enhance care delivery.

Response: We thank commenters for their feedback. While we will not be responding to specific comments submitted in response to this RFI in this final rule, we intend to use this information to inform future dQM transition work and potential future rulemaking to further our efforts toward a patient-centric digital health ecosystem.

As authorized by section 1115A of the Act and finalized in the CY 2016 HH PPS final rule (80 FR 68624), the Center for Medicare and Medicaid Innovation (Innovation Center) implemented the Home Health Value-Based Purchasing (HHVBP) Model (“original Model”) in nine states on January 1, 2016. The design of the original Model leveraged the successes and lessons learned from other CMS value-based purchasing programs and demonstrations to shift from volume-based payments to a model designed to promote the delivery of higher quality care to Medicare beneficiaries. The specific goals of the original Model were to--

Provide higher incentives for better quality care with greater efficiency;

Study new potential quality and efficiency measures for appropriateness in the home health setting; and

Enhance the current public reporting process.

The original Model resulted in an average 4.6 percent improvement in HHAs' total performance scores (TPS) and an average annual savings of $141 million to Medicare without evidence of adverse risks.\32\ The evaluation of the original Model also found reductions in unplanned acute care hospitalizations and skilled nursing facility (SNF) stays, resulting in reductions in inpatient and SNF spending. The U.S. Secretary of Health and Human Services (the Secretary) determined that expansion of the original Model will further reduce Medicare spending and improve the quality of care. In October 2020, the CMS Chief Actuary certified that expansion of the HHVBP Model will produce Medicare savings if expanded to all states.\33\

\32\ https://innovation.cms/gov/data-and-reports/2020/hhvbp-thirdann-rpt.

\33\ https://www.cms.gov/files/document/certification-home-health-value-based-purchasing-hhvbp-model.pdf.

On January 8, 2021, CMS announced the certification of the HHVBP Model for expansion nationwide, as well as the intent to expand the Model through notice and comment rulemaking.\34\ In the CY 2022 HH PPS final rule (86 FR 62292 through 62336), we finalized the decision to expand the HHVBP Model to all Medicare certified HHAs in the 50 States, territories, and District of Columbia beginning January 1, 2022. CY 2022 was a pre-implementation year. The first payment year is CY 2025 based on the first performance year which was CY 2023. Our codified policies for the expanded HHVBP Model can be found in our regulations at 42 CFR part 484, subpart F, Sec. Sec. 484.300 through 484.375.

\34\ https://www.cms.gov/newsroom/press-releases/cms-takes-action-improved-health-care-seniors-announces-intent-expand-home-value-based.

In the CY 2024 HH PPS final rule (88 FR 77676), we finalized proposals to codify in the Code of Federal Regulations (CFR) the measure removal factors finalized in the CY 2022 HH PPS final rule; to replace the two Total Normalized Composite Measures (for Self-Care and Mobility) with the Discharge Function Score measure effective January 1, 2025; to replace the OASIS-based Discharge to Community (DTC) measure with the claims-based Discharge to Community-Post Acute Care (PAC) Measure for Home Health Agencies, effective January 1, 2025; to replace the claims-based Acute Care Hospitalization During the First 60 Days of Home Health Use and the Emergency Department Use without Hospitalization During the First 60 Days of Home Health measures with the claims-based Potentially Preventable Hospitalization measure effective January 1, 2025; to change the weights of individual measures due to the change in the total number of measures; and to update the Model baseline year to CY 2023 for all applicable measures in the finalized measure set beginning with performance year CY 2025.

We proposed removing three measures from the current applicable measure set and adding four measures starting in CY 2026. The proposed removal of the three measures was necessary due to revisions to the Home Health Consumer Assessment of Healthcare Providers and System[supreg] (HHCAHPS) Survey that were proposed beginning with the April 2026 sample. These proposed survey revisions prevent the three HHCAHPS Survey-based measures from being calculated as currently specified for the expanded HHVBP model. 1. Removal of Three HHCAHPS Survey-Based Measures From the Expanded HHVBP Model Applicable Measure Set

The HHCAHPS Survey, a nationally standardized and publicly reported survey, is designed to measure the experiences of people receiving home health care from Medicare-certified HHAs. It is conducted for HHAs by approved HHCAHPS Survey vendors. Currently, the expanded HHVBP Model includes five HHCAHPS Survey-based measures:

Care of Patients

Communications between Providers and Patients

Specific Care Issues

Overall Rating of Home Health Care

Willingness to Recommend the Agency

The Care of Patients, Communications between Providers and Patients, and Specific Care Issues measures are based on multiple items from the HHCAHPS Survey while Overall Rating of Home Health Care and Willingness to Recommend the Agency are single-item measures.

Elsewhere in the proposed rule, CMS proposed changes to the HHCAHPS Survey. These proposed changes would affect the survey questions used to calculate three measures that are used in the expanded HHVBP Model. CMS plans to make changes to the questions used for two of the multi- item measures (Care of Patients and Communication between Providers and Patients). In addition, the Specific Care Issues measure will no longer exist as four of the seven items used for that measure will be removed from the survey. These changes are described in section III.H. of the final rule, and will become effective beginning with the April 2026 sample month.

Given these proposed changes, we proposed to remove the following HHCAHPS Survey based measures from the HHVBP applicable measure set starting with CY 2026:

Care of Patients

Communications between Providers and Patients

Specific Care Issues

We proposed to remove these three HHCAHPS Survey-based measures using the proposed and finalized Removal Factor 9: It is not feasible to implement the measure specifications. This measure removal factor is described in more detail previously in section IV.B. of this final rule. The removal of these measures is necessary because the proposed changes to the HHCAHPS Survey instrument have been finalized, as the current measure specifications cannot be calculated using the finalized survey revisions. Because the proposed changes to the HHCAHPS Survey instrument are finalized, several of the survey questions used to calculate the Care of Patients and Communication Between Providers and Patients measures will be changed and will no longer match the measure specifications. Also, four of the seven survey items used to calculate the Specific Care Issues measure will be removed because the survey changes have been finalized, making it impossible to calculate the measure as currently specified.

While CMS could revise the HHCAHPS measures to use the proposed HHCAHPS Survey instrument changes, a full year of data with the revised HHCAHPS measures will not be available until CY 2027. Data from multiple quarters will be needed to establish benchmarks and achievement thresholds for the revised HHCAHPS Survey-based measures. Removing these three measures as part of this rulemaking cycle will give CMS the time needed to collect the required data and potentially develop updated benchmarks and achievement thresholds for revised or new measures.

If CMS decides to propose the addition of the new versions of the Care of Patients and Communications between Providers and Patients measures and individual item measures to replace the Specific Care Issues measure, CMS will do so through future rulemaking.

We invited public comments on this proposal. The following is a summary of the comments we received and our responses:

Comment: Several commenters provided feedback regarding the proposed removal of certain HHCAHPS Survey items. Most of the commenters supported the changes to the HHVBP applicable measure set. A commenter stated that they supported the removal of outdated composite measures, such as those removed in the revised HHCAHPS Survey. Another commenter supported changing the HHVBP applicable measure set based on HHCAHPS Survey changes but encouraged CMS to revise the HHCAHPS Survey- based measures rather than remove them entirely.

Response: CMS appreciates the support for aligning the HHVBP Model applicable measure set with the revised HHCAHPS Survey change. At this time, CMS is not introducing replacement measures for those based on removed elements of the HHCAHPS Survey. However, we will take these public comments into consideration as we continue to refine the HHVBP Model applicable measure set.

Comment: A few commenters opposed any measure set changes at this time.

Response: CMS notes that these measures cannot be retained in the expanded HHVBP Model given the finalized changes to the HHCAHPS Survey.

Comment: A commenter encouraged CMS to remove all HHCAHPS Survey- based measures from the calculation of HHA quality scores to focus on objective clinical measures.

Response: CMS declines to remove all HHCAHPS Survey-based measures from the calculation of HHA quality scores and believes that self- reported patient experience data remains valuable for holistically measuring quality of care. As such, the measures still calculable from the revised HHCAHPS Survey, Overall Rating and Willingness to Recommend, will remain in the expanded HHVBP Model's applicable measure set.

Final Decision: After consideration of the public comments received, CMS is finalizing the removal of three HHCAHPS Survey-based measures as proposed.