stack/docs/comments/2026-09-cms-2026-2377-palliative-rfi-draft.md

Comment on the Community-Based Palliative Care Request for Information

Docket: CMS-2026-2377 Rule: Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies (CMS-1848-P), 91 FR 43842 (July 16, 2026) Section commented on: Request for Information — Community-Based Palliative Care, 91 FR 43949–43950 Comment period closes: September 14, 2026

Citation conventions. References in the form "91 FR 43950 (¶957)" identify the paragraph by its Federal Register HTML paragraph anchor (#p-957) in document 2026-14327, so that each quoted question can be located exactly. References to section II.E in the form "91 FR 43938 ¶5" follow the printed-page paragraph ordinal used in our section II.E cross-read. Peer-reviewed sources are cited as Author (Year), PMID n; full records appear in Appendix A. Appendix B records the systematic-review counts and protocol.

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Introduction

We write in response to the Request for Information on Community-Based Palliative Care at 91 FR 43949–43950. CMS asks that commenters "support your statements with peer-reviewed evidence or evidence from your institution with sufficient detail for review" (91 FR 43949 (¶942); repeated at 91 FR 43950 (¶944)). We took that literally. Rather than an opinion letter, we conducted a systematic evidence review to a written protocol, scoped to the five questions CMS asks, and report its results here — including where the evidence does not support an answer.

The review identified 4,999 records — eight uncapped, relevance-sorted PubMed E-utilities searches (one per RFI part, plus three standards-anchored searches supporting the code family proposed in part (d)), forward citation-chasing from five anchor publications including CMS's own two serious-illness-identification citations, and the gray-literature standards and RFI-cited sources themselves. 4,997 were screened at title and abstract, 2,642 excluded there, 2,355 assessed for full-text eligibility, 401 excluded on full text, 1,429 unresolved because no full text was retrievable, and 525 studies included. Each included study carries a structured extraction record — design, population, setting, eligibility basis, instrument and measured performance, service elements, outcomes, effect size, risk-of-bias notes — and every citation below is drawn from it. Two limitations we state up front: screening was performed by a single reviewer using a locally hosted language model against written criteria, with uncertain decisions adjudicated in an independent second pass, rather than by two human reviewers; and the 1,429 unresolved full texts are 61 percent of records reaching full-text assessment. We note below where that second limitation bites. Counts per part, exclusion reasons and the protocol pointer are in Appendix B.

We answer the five questions in CMS's order. We do not comment on the Medicare Hospice Benefit or on maintenance versus comfort-focused dialysis; CMS directs those elsewhere (91 FR 43949 (¶938)), and we have kept them out. Where hospice research is the nearest available evidence for a question about community-based palliative care — which is the case throughout part (a) — we say so and treat it as analogy, as CMS's own framing invites: "While hospice care is not palliative care, in related disciplines and sites of care we are very interested in how to better address fraud, waste, and abuse" (91 FR 43949 (¶941)).

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(a) Fraud, waste, and abuse

"We continue to prioritize reducing fraud, waste, and abuse throughout CMS programs, and have prioritized reducing fraud, waste, and abuse in hospice programs. While hospice care is not palliative care, in related disciplines and sites of care we are very interested in how to better address fraud, waste, and abuse." — 91 FR 43949 (¶941)

"Where should CMS focus on potential fraud, waste, and abuse in community-based palliative care? Please support your statements with peer-reviewed evidence or evidence from your institution with sufficient detail for review." — 91 FR 43949 (¶942)

Recommendation. Focus on four loci, each observable from data CMS already holds and none requiring new clinician documentation: (1) enrollment and disenrollment churn — the community analog of the hospice live-discharge signal, measured as the rate at which beneficiaries are started on and then stopped from the service without death, transfer, or documented change in goals; (2) ownership form and operating margin as risk stratifiers, prioritizing review rather than triggering it; (3) the initiating trigger and the practitioner-to-auxiliary-personnel work ratio, the guardrails CMS itself raises at 91 FR 43938 ¶8–43939 ¶1; and (4) equity monitoring of the integrity program itself. We also urge CMS to treat beneficiary protection — abuse and neglect in the home — as an integrity domain, not only billing integrity.

Evidence. Hospice operating margin is positively associated with the rate of live discharge (Dolin (2017), PMID 28679817), and the same group's qualitative work found providers describing both financial motivation and fear of CMS audit as drivers of enrollment and disenrollment (Dolin (2017), PMID 28323079). That second finding is the design constraint: a blunt integrity program produces defensive under-enrollment as well as reduced over-enrollment. Problematic live-discharge patterns are identifiable from administrative data alone across 3,028 hospice programs (P < 0.001) (Teno (2015), PMID 26004403), with a stable national baseline from 2000 to 2012 (Prsic (2016), PMID 27171543). For-profit ownership is associated with episodes exceeding one year (Sengupta (2014), PMID 23744976) — a risk-stratifier finding, not a fraud finding, and we ask CMS to use it that way.

The evidence also contains a cautionary null: a specific hypothesized abuse mechanism, that increased nursing home hospice use would substitute for nursing assistant staffing, was tested across 10,759 facilities and not found (estimate 0.79, 95% CI 0.373–1.211) (Tyler (2011), PMID 21958012). Plausible fraud mechanisms are not always real ones, and CMS should hold its own integrity hypotheses to the evidentiary standard it asks of commenters here.

On equity: among 2,629 hospice patients with dementia, live discharge was substantially more likely for African American (aOR 2.42, 95% CI 1.34–4.38) and Hispanic (aOR 2.99, 95% CI 1.81–4.94) beneficiaries (Luth (2020), PMID 31750935). A churn-based integrity signal must be risk-adjusted and monitored for disparate impact or it will penalize the programs serving the populations with the least access. Conversely, concerns about health care fraud have themselves limited appropriate use of palliative and hospice services in nursing homes (Zerzan (2000), PMID 11074779) — integrity signals have an access cost that belongs in the design. Jones (2000), PMID 11009798, remains the clearest articulation of compliance-plan risk areas in this space; LeSage (2015), PMID 24848665, documents the post-discharge re-enrollment pattern a churn measure would capture.

On beneficiary protection: nine candidate quality indicators for abuse and neglect in home-based primary and palliative care were developed, all but one rated high in validity and feasibility by a technical expert panel (Sheehan (2016), PMID 27787878). This benefit is delivered in the home, to beneficiaries with impaired function and stressed caregivers; an integrity framework addressing only billing patterns will miss the harm that matters most.

What we decline to address. We decline to propose audit thresholds, screening cut-points, or a targeted-probe design. Every included study here concerns the hospice benefit rather than community-based palliative billing, and CMS itself distinguishes the two (¶941). This is also the thinnest part of our evidence base: of 174 records identified under this arm, 11 survived to inclusion, and none studies a community-based palliative payment mechanism, because none existed to study. CMS is asking for evidence about a service it has not yet created; the honest answer is that the direct evidence does not exist, and that measurement should be built into the benefit from day one rather than retrofitted.

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(b) Life expectancy and terminal prognosis as eligibility

"Defining which beneficiaries are eligible for serious illness care is a principal challenge in palliative and supportive care. … For example, complex chronic care management services require two or more chronic conditions placing the beneficiary at high risk for hospitalization, decline, or death, and requires moderate to high complexity medical decision-making. To elect the Medicare Hospice Benefit, two or more physicians must certify a beneficiary is within 6 months to the end of their life…" — 91 FR 43949–43950 (¶943)

"For any future supportive or palliative care service for Medicare beneficiaries, should eligibility be restricted to certification of a likely life expectancy duration?" — 91 FR 43950 (¶945)

"If eligibility is restricted to those beneficiaries with a terminal prognosis, is there evidence to suggest a reasonable interval (that is, less than 1 year of life expectancy as in some States' Medicaid programs)?" — 91 FR 43950 (¶946)

Recommendation. No. Eligibility should not be restricted to certification of a likely life-expectancy duration. The evidence is consistent: neither clinician judgment nor validated instruments nor administrative data can certify an interval accurately enough to gate a Part B benefit, and the errors are not random — they fall hardest on non-cancer diagnoses and on beneficiaries from minoritized groups. If CMS nonetheless adopts a prognostic criterion, the evidence supports 12 months rather than 6, as one of several alternative qualifying pathways, attested by the billing practitioner alone rather than two physicians, and never conditioned on forgoing disease-directed treatment.

Clinician prediction is not certification-grade. Clinician predictions of survival assessed in 1,833 patients in the Prognosis in Palliative care Study II proved adequate for conversation, not for categorical certification (Stone (2022), PMID 35421168); clinician prediction and the Palliative Prognostic Score were each unreliable at the individual-patient level in advanced cancer (Hui (2016), PMID 27372208; Hui (2020), PMID 31564218); and a systematic review and meta-analysis of palliative prognostic scores reaches the same conclusion across the pooled literature (Yoong (2024), PMID 38366659).

The surprise question does not export across diseases. Meta-analysis across 25,718 patients found overall accuracy of 74.8 percent (95% CI 68.6–80.5) with poor positive predictive value (White (2017), PMID 28764757), which a more recent systematic review and meta-analysis combining the surprise question with clinician-predicted prognosis confirms (Gupta (2024), PMID 38925876). Disease-specific validations show the spread: 93.4 percent sensitivity against 37.5 percent specificity for 12-month mortality in 378 patients with end-stage liver disease (Homann (2025), PMID 39952927); poor accuracy for 90-day mortality in 100 patients with decompensated cirrhosis (Selesky (2025), PMID 40658791); sensitivity 0.95 against specificity 0.35 for an end-of-life state determination in 315 patients (Arahata (2023), PMID 36636714); and AUC 0.68, sensitivity 55 percent, specificity 74 percent on external validation of the ProPal-COPD tool in 523 patients (Broese (2022), PMID 36579356).

The administrative operationalization is worse. The most directly Medicare-relevant study in our part (b) set examined the "less than six-month prognosis" item in the Minimum Data Set for 20,397 U.S. nursing home residents with cancer and found 94.2 percent specificity but 13.7 percent sensitivity against actual survival (Vu (2024), PMID 38560743). The existing administrative six-month prognosis field correctly identifies fewer than one in seven of the people it is meant to identify. CMS should not build eligibility on a data element with that operating characteristic.

Statistical models do better, but still not well enough to gate. AUROC 0.861 (95% CI 0.856–0.867) for an explainable EHR model in 5,926 patients with stage 3–4 solid cancer (Zhuang (2024), PMID 38769564); AUC 0.82 for a 1-year mortality index externally validated in 215,731 community-dwelling adults aged 65 and over (Frechman (2025), PMID 40298901); AUC 0.79, adjusted hazard ratio 31.02 (95% CI 27.44–35.08), for language-model prediction of hospice eligibility in 9,872 patients with dementia (McCoy (2025), PMID 41216867); AUC 0.751 for 1-year mortality in 591 patients with multisystem chronic illness (Bretos-Azcona (2022), PMID 32581004); and the RESPECT tool derived and validated for home care users (Hsu (2021), PMID 34226263). These are respectable population-targeting statistics. None is certification-grade for an individual, and no included study claims otherwise.

Gating on prognosis produces churn and inequity. Re-enrollment after live discharge is documented (LeSage (2015), PMID 24848665); the disenrollment burden falls disproportionately on Black and Hispanic beneficiaries with dementia (Luth (2020), PMID 31750935); and a policy analysis concludes the hospice eligibility and election structure does not prepare the system to meet the need it serves (Wallace (2015), PMID 26161945). A prognosis-gated palliative benefit would import these failure modes wholesale.

If CMS gates anyway: the interval. Twelve months, not six. Nearly every instrument in the included set validated for community identification is calibrated to a one-year horizon: SPICT (Piers (2021), PMID 34059507), ProPal-COPD (Broese (2022)), the multisystem chronic illness model (Bretos-Azcona (2022)), RESPECT (Hsu (2021)), the Epic End of Life Care Index (Frechman (2025)), and the population-based functional screen of Ankuda (2021), PMID 33506111. A randomized trial successfully enrolled 381 participants using "estimated life expectancy of between 1 month and 1 year," showing the interval is operationally workable (Kutner (2015), PMID 25798575). A 12-month framing also places the service upstream of hospice rather than in competition with it — which is the population CMS says it wants to reach.

What we decline to address. We decline to endorse any particular State Medicaid interval as evidence-based. No study in our included set compares alternative interval thresholds head to head in a Medicaid or Medicare population, and we will not manufacture support for a number the literature has not tested.

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(c) Daily function, ADLs, and caregiver strain

"Defining eligibility for palliative services beyond the potential criterion of a terminal prognosis is likely necessary to better understand who is eligible for serious illness care. While for complex care management services we restrict eligibility to beneficiaries requiring moderate to complex medical decision making as well as a count of chronic conditions, common definitions of serious illness include not just chronic condition counts but also indicators of the impact on a person's daily function or excessive caregiver strain." — 91 FR 43950 (¶947)

"For any future supportive or palliative care service for Medicare beneficiaries, how could we consider impact on the daily functions of life or activities of daily living as part of who is eligible for the service?" — 91 FR 43950 (¶951)

"Would eligibility best be based on impact on daily function, on caregiver strain, or both?" — 91 FR 43950 (¶952)

"How can we avoid overly burdensome requirements for defining eligibility for services?" — 91 FR 43950 (¶953)

Recommendation. Both — as alternative qualifying pathways, not cumulative requirements. Eligibility should be met by satisfying any one of: (i) a documented deficit in two or more activities of daily living, or documented instrumental-ADL decline; (ii) a positive screen on a brief validated caregiver-strain instrument; (iii) a qualifying serious-illness diagnosis with any functional impairment; or (iv) the 12-month prognostic pathway from part (b). Burden is avoided not by lowering the evidentiary bar but by reusing assessments already collected, accepting attestation of a single met criterion, and paying for the assessment inside the service.

Function is measurable and predictive at population scale. ADL-based functional disability, screened across 30,885 adults aged 65 and over in the National Health and Aging Trends Study, predicted both mortality and hospitalization — the two outcomes this service is meant to change (Ankuda (2021), PMID 33506111). Barthel and Lawton–Brody measurement in 201 patients with advanced respiratory disease identified predictors of increasing ADL disability (OR 1.41, 95% CI 1.14–1.74, p = 0.002) (Fettes (2024), PMID 38073190). Simpler measures work too: usual gait speed predicted one-year mortality in 142 hospitalized patients aged 75 and over (AUC 0.748, p = 0.006; HR 7.456, 95% CI 1.58–35.19) (Van de Vyver (2020), PMID 33234124), and in COPD is accurate, simple, reliable and inexpensive (Karpman (2014), PMID 25473277). The Minimum Data Set 3.0 — already mandated by CMS — supports identification of functional decline in long-term care (Anderson (2012), PMID 22784699), and the Barthel Index has estimated palliative need across 2,028 community residents (Chandra (2022), PMID 36447509).

Caregiver strain is measurable with short validated instruments. The eight-item CAREPAL-8 was validated in 232 caregivers (Ullrich (2024), PMID 39095830) and is under multicenter longitudinal validation in 510 more (Haufschild (2026), PMID 42536973); the Modified Caregiver Strain Index has adequate psychometric properties in 200 palliative caregivers (Ramadasa (2023), PMID 37924086) and reached Cronbach's α of 0.91 in its traditional Chinese form in 125 family carers (Cheng (2021), PMID 34627225); the Zarit Burden Interview has good properties in this population (Quadir (2025), PMID 39510815) and serves as a primary endpoint in outpatient palliative trials (Kluger (2019), PMID 30779960). These are instruments of eight to twenty-two items. They are not burdensome.

The combination outperforms either alone. The most directly applicable study we found validated criteria for identifying populations who may benefit from home-based primary care using the National Health and Aging Trends Study linked to Medicare claims (n = 21,727); those criteria combine serious illness, functional impairment, and social isolation — precisely the construct CMS describes at ¶947 — and are computable from data CMS already holds (Salinger (2025), PMID 39404637). Functional impairment and caregiver capacity are entangled and should be assessed together (Reckrey (2023), PMID 37349637, n = 2,521). Multi-domain complexity scales perform well: PALCOM, validated in 283 advanced cancer patients (Viladot (2023), PMID 37627210) and, pooled across 607, discriminating clinical instability at OR 4.3 (95% CI 1.86–9.73, p < 0.001) (Tuca (2024), PMID 38730696). Descriptions of advanced multimorbidity converge on combined rather than single-domain definitions (Bowers (2025), PMID 40110541).

Diagnosis codes alone are not sufficient. EHR phenotypes for late-stage disease in 463 decedents achieved positive predictive value of 68.6 percent for stage 4 cancer but only 46.4 percent for stage 4–5 chronic kidney disease (Ernecoff (2019), PMID 31396813); natural language processing over 7,000 records was needed to find serious illness that ICD coding missed (Udelsman (2019), PMID 30251922). Care in the last year of life is substantially fragmented, worse in dementia (p = 0.002) (Nothelle (2022), PMID 35488709) — which is why a documentation requirement spanning several sources would be most burdensome in exactly the population CMS wants to reach. Conjoint patterns of symptom distress and functional impairment, rather than either alone, predict survival (Wen (2018), PMID 29545065).

On CMS's own citations. CMS cites Kelley (2017) at footnote 113 and the Kelley and Bollens-Lund denominator paper at footnote 114 (91 FR 43950 (¶948), (¶949)). Both are in our evidence base (Kelley (2017), PMID 26990009; Kelley and Bollens-Lund (2018), PMID 29125784) and both resolved as uncertain / unavailable-fulltext because we could not retrieve full text through an open-access route. We therefore rely on them as CMS does — for the framing of the denominator problem — rather than asserting extracted findings we did not verify.

Avoiding burden (¶953) — three mechanisms. First, reuse existing instruments: ADL items are already collected in the MDS 3.0, OASIS, and the Annual Wellness Visit health risk assessment, and any should satisfy the functional criterion without re-administration. Second, accept attestation of a single met criterion on the claim rather than a scored instrument or narrative justification — any one of the criteria above identifies a population with elevated mortality and utilization, so requiring all of them buys precision CMS does not need. Third, pay for the assessment inside the service: the PCM-1 assessment below is the eligibility determination, and making it a billable first service rather than an unpaid gate removes the incentive to under-identify and produces an auditable record as a by-product of care.

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(d) Differentiating care management for the seriously ill, and the essential service elements

"In section II.E. of this proposed rule, we are explicitly reconsidering the future of the care management services that form the basis for payment adequacy for important between visit care (in addition to E/M services for outpatient or home visits). Care for the seriously ill involves interdisciplinary care teams and involves even greater coordination and between visit care than primary care services." — 91 FR 43950 (¶954)

"How should we differentiate the care management requirements for seriously ill beneficiaries from other Medicare beneficiaries?" — 91 FR 43950 (¶957)

"What are the essential service elements that must be included? For example(s), continuity with a designated team member, access to timely clinical support, comprehensive symptom and caregiver assessment, electronic care plans, coordination with treating physicians, patient/caregiver education, timely follow up after ED/discharge. What other service elements should be included? Should any not be included?" — 91 FR 43950 (¶958)

A note on the cross-reference. CMS's question directs commenters to section II.E. We read it closely. Nothing in section II.E is proposed — every policy idea there is "seeking comment," "considering," or something CMS "may consider in future rulemaking"; the only operative care-management-adjacent text in the rule is the G2211 change proposed in section II.D, cross-referenced at 91 FR 43937 ¶3 with proposed modifiers at ¶6. We therefore answer II.E's questions rather than support proposals that do not exist, and we rest on CMS's own concessions: that "uptake of the care management codes has been limited," with CMS seeking "feedback on whether a different payment structure might be more appropriate" (91 FR 43938 ¶5); that APCM "retains the fundamental structure of FFS billing and may not provide sufficient incentives for practices to focus on proactive, population-based non-visit care management activities" (91 FR 43941 ¶11); and that APCM billing runs higher among Shared Savings Program-assigned beneficiaries, which CMS reads as evidence that ACO "accountability and care management infrastructure" drives adoption (91 FR 43942 ¶1). Those three concessions are the agency-record predicate for a care-management track aimed at the population CMS's own data show the existing family fails to reach.

On CMS's Innovation Center synthesis (¶939–940). CMS grounds this RFI in the Innovation Center white paper Palliative Care Projects: Synthesis of Evaluation Results 2012–2021, stating that its results "indicate that a comprehensive approach to palliative care services, including access to interdisciplinary teams, home visits, and shared-decision-making may improve care for Medicare beneficiaries" (91 FR 43949 (¶939), footnote 112 at (¶940)). We could not retrieve that document through our full-text pipeline and so do not represent its contents. We note instead that our independent peer-reviewed review converges on the same three elements, and that one of the model families the synthesis covers is evaluated in literature we did retrieve (Ruiz (2017), PMID 30480116, on Health Care Innovation Award models including Advanced Illness Management). The three requirements CMS's own synthesis names are the three we recommend making mandatory service elements: a named interdisciplinary core team, an expected home-visit cadence, and documented shared decision-making recorded in the PCM-2 care plan.

Recommendation. Differentiate on five axes, and establish a distinct three-code palliative care management family rather than adding conditions to APCM. The differentiators are: (1) a named interdisciplinary core team — physician or advanced practice clinician, registered nurse or advanced practice nurse, social worker, and chaplain or spiritual care professional — rather than undifferentiated "clinical staff"; (2) the home as an expected site of service, with a stated home-visit expectation; (3) 24-hour access to a clinician with access to the care plan, not merely a triage line; (4) the caregiver as a unit of assessment and service, not as an informant; and (5) a reassessment cadence measured in weeks to months, driven by symptom change rather than an annual cycle.

The element set, and home visits. A synthesis of scalable principles of community-based high-value care for seriously ill individuals identifies interdisciplinary team-based care, 24/7 access and responsiveness, concurrent palliative care alongside disease-directed treatment, targeting to high-risk patients, integrated medical and social supports, and caregiver support (Parikh (2017), PMID 27687915). CMS's ¶958 list is close to this; the literature supports adding concurrent care and integrated social supports, and making caregiver assessment a service element rather than a documentation item. Hughes (2023), PMID 37740895, reviews community palliative program components specifically — the unit of analysis CMS's question needs. On the home: in a population-based cohort of 231,047 people, a physician home visit versus none carried an odds ratio of 1.95 (95% CI 1.91–2.00) on the utilization outcomes studied, the largest delivery-model effect in our part (d) set (Brown (2021), PMID 33884934); and a claims-derived taxonomy of Medicare-funded home-based clinical care gives CMS a ready mechanism to distinguish home- from clinic-delivered care management in its own data (Ankuda (2023), PMID 36747175).

Programme effect on utilization and cost. Cost reductions: roughly $12,000 per patient across 651 patients in an ACO-embedded home program, p = 0.0002 (Lustbader (2017), PMID 27574868); $619 per patient per month, 95% CI −1,124 to −114, p = 0.0404, across 746 (Yosick (2019), PMID 30950679); $5,669 (95% CI 4,736–6,602) and $4,606 (95% CI 3,221–5,990) for Advanced Illness Management and $2,122 (95% CI 575–3,670) for a second Innovation Award model, all p < 0.001 (Ruiz (2017), PMID 30480116); $24,643 per member, a 16.7 percent reduction (Gordon (2022), PMID 34637346); and further plan-level results across 24,882 members (Bower (2024), PMID 38271576) and 1,453 Medicare Advantage beneficiaries (Cassel (2016), PMID 27590922). Utilisation: against hospice-only comparators in 7,177 patients, relative risks of 0.80 (95% CI 0.77–0.83) for hospitalization and 0.68 (95% CI 0.62–0.74) for skilled nursing facility stays (Wang (2019), PMID 30830695). We flag the counterweight honestly: a systematic review restricted to randomized trials in adult non-cancer patients found the approach cost-saving or cost-neutral, observational studies reporting larger savings than trials do (Janke (2024), PMID 39098890). CMS should expect this benefit to pay for itself, not to generate net savings.

Timely follow-up after ED visit or discharge. A transitional model of weekly home visits or calls for four weeks then monthly follow-up produced a readmission relative risk of 0.55 (95% CI 0.35–0.88) in 84 randomized patients with end-stage heart failure (Wong (2016), PMID 26969631); meta-analyzed randomized transitional-care trials in serious illness show a standardized mean difference of 0.20 (95% CI 0.08–0.33) at moderate-to-very-low certainty (Di Nitto (2025), PMID 40389925). Saunders (2019), PMID 31201875, reviews acute-to-community transitions but found most constituent studies at high risk of bias, so we do not rest weight on its pooled direction. On the ED link: the EMPallA randomized trial of 500 older adults reported a 9.6-point quality-of-life difference (95% CI 5.9–13.3) (Schmucker (2021), PMID 34247588), and Stoltenberg (2022), PMID 36518882, describes an integrated geriatric palliative consultation service built into the ED. This element is well supported and should be required.

24-hour access and out-of-hours response. Goodrich (2024), PMID 38381768, synthesises systematic-review evidence on out-of-hours utilization of community palliative services; a program combining coordination centers, an out-of-hours telephone line and discharge in-reach nurses across 3,594 patients produced odds ratios of 0.20 (95% CI 0.17–0.27) and 0.33 (95% CI 0.21–0.50) for hospital death in its two areas (p ≤ 0.001) (Purdy (2015), PMID 24838731), and a transmural care pathway raised death at the preferred place (adjusted OR 3.14, 95% CI 1.49–6.62, p = 0.003) among 711 older adults (Van Doorne (2023), PMID 37533107).

Team composition beyond the physician. Across 574,567 high-intensity home-based primary care users in national Medicare claims, nurse practitioner-delivered care performed comparably on twelve quality measures in three domains — direct evidence that supervision should not be physician-only (Perloff (2024), PMID 39291622). Core competencies for palliative social workers support the social worker as a defined team member rather than optional auxiliary personnel (Yao (2025), PMID 40490802); community health workers delivering monthly home visits were evaluated across 903 patients (Britt (2019), PMID 30541333) and economically across four cancer centers (Monton (2025), PMID 41193212); nurse-led rural COPD models are reviewed in Poston (2025), PMID 40724712.

Electronic care plans and coordination. This is the thinnest element and we say so. Voruganti (2017), PMID 28720558, piloted a web-based collaborative-care tool in 48 patients with advanced cancer; Fathi (2016), PMID 27217093, developed an interdisciplinary team communication framework and quality metrics for home-based medical care practices, a record that resolved as uncertain / unavailable-fulltext and which we cite for scope only. CMS should require an electronic care plan available at transitions of care because it is a prerequisite for the coordination elements that are well evidenced, not because the artefact itself has been shown to change outcomes.

Initiating trigger, and telehealth. Early palliative identification across 2,370 patients produced a hazard ratio of 1.69 (95% CI 1.56–1.82) for subsequent palliative service use (Mittmann (2020), PMID 32005036); with Salinger (2025) in part (c), this supports registry- or risk-based identification as a legitimate initiating trigger, and we recommend against a face-to-face initiating visit within a fixed window as the only permitted trigger — the question CMS raises at 91 FR 43938 ¶8–43939 ¶1. On modality: a review of telehealth integration into community-based palliative care across seven studies reports functional status, hospitalization, psychological distress and quality-of-life outcomes but notes most constituent trials carried some concerns of bias and two were at high risk from attrition (Haroen (2025), PMID 41230403). Telehealth should be explicitly permitted for the follow-up code and explicitly insufficient on its own to satisfy the home-visit expectation.

What should not be included. We recommend against three requirements: a minimum monthly staff-time threshold as the sole basis for payment (no included evaluation identifies a time threshold as the active ingredient, and such thresholds are part of the complexity CMS says it wants to simplify, 91 FR 43938 ¶5); a requirement that the beneficiary forgo disease-directed treatment (concurrent care is one of Parikh's scalable principles, and part (a) shows what happens when a benefit forces that trade-off); and physician-only supervision, for the reasons in Perloff (2024). Singer (2016), PMID 27533892, surveying populations and interventions across the field, supports breadth of population rather than narrowing by intervention type.

The concrete structure: a three-code palliative care management family

These are draft descriptors offered for comment, not valued codes: nothing here models RUC valuation, RVU inputs, or budget neutrality. Each is crosswalked to three professional standards — the Center to Advance Palliative Care (CAPC) program standards, the National Association of Social Workers (NASW) Practice Standards for Serious Illness Care: Hospice and Palliative Social Work, and The Joint Commission (TJC) Palliative Care (PAL) performance measure set — so that every required element is an existing professional-standards requirement rather than an invention of this comment.

PCM-1 — Palliative care screening and initial assessment.

Palliative care screening and comprehensive initial assessment of a patient with serious illness, by a member of the palliative care core interdisciplinary team; including validated symptom screening (pain, dyspnea), assessment of functional status and caregiver strain, psychosocial and spiritual screening, and documentation of screening results in the medical record; first 60 minutes

Standards: CAPC screening-criteria consensus (Weissman and Meier (2011), PMID 21133809) and daily symptom-assessment metric domain (Weissman, Morrison and Meier (2010), PMID 19922199); NASW Standard 3 (Assessment); TJC PAL-01, PAL-02, PAL-03, and the core-team face-to-face population definition. PFS analogs: 99497; 99495. Answers parts (b), (c), (d).

PCM-2 — Palliative care planning.

Development and documentation of a patient-centered palliative care plan by the interdisciplinary team with patient and caregiver participation; including goals of care, treatment preferences, advance directive reconciliation, and shared decision-making; recorded as an electronic care plan available at transitions of care, including discharge

Standards: CAPC patient-centered goals-of-care metric domain (2010 consensus, PMID 19922199); NASW Standards 4 (Intervention/Treatment Planning) and 7 (Documentation); TJC PAL-04 and PAL-05. PFS analogs: 99497/99498; the care-plan element of 99490. Answers part (d).

PCM-3 — Palliative care follow-up.

Palliative care follow-up management, per calendar month: symptom reassessment and care-plan revision; continuity with a designated team member; access to timely clinical support; coordination with treating physicians; patient and caregiver education and support; and timely follow-up after emergency department visit or facility discharge

Standards: CAPC transitions-across-care-sites and caregiver-support metric domains (2010 consensus, PMID 19922199); NASW Standards 8 (Interdisciplinary Teamwork) and 6 (Empowerment and Advocacy); TJC core-team continuity underlying the PAL population. PFS analogs: G0556–G0558; 99490/99487. Answers parts (d) and (e).

The service elements in PCM-3 deliberately track CMS's own list at ¶958 — continuity with a designated team member, access to timely clinical support, comprehensive symptom and caregiver assessment, electronic care plans, coordination with treating physicians, patient and caregiver education, and timely follow-up after ED visit or discharge — and the crosswalk shows each is also a professional-standards requirement. The elements we would add are concurrent care with disease-directed treatment, integrated medical and social supports, and an expected home-visit cadence, each supported above.

Three design points. First, make this a distinct track, not an APCM modifier: CMS's concession about APCM's incentives (91 FR 43941 ¶11) applies with more force to a population whose care is almost entirely non-visit-based. Second, these codes would be valued into a declining conversion factor — the non-qualifying-APM factor falls from $33.4009 in the CY2026 final rule (90 FR 49266) to $32.8409 as proposed for CY2027 (91 FR 43842), a 1.7 percent reduction — while the between-visit infrastructure the family requires does not shrink with it. Third, CMS should decide deliberately whether the family is a designated primary care service for Shared Savings Program attribution under 42 CFR 425.400(c); that designation moves clinician revenue and ACO attribution denominators at once, and CMS's own ACO finding (91 FR 43942 ¶1) suggests the two questions are not separable.

Finally, the record. Commenters have been telling CMS this for a decade. A lexical sweep of the last ten Physician Fee Schedule dockets — covering 196,698 of 196,739 docketed comments with locally retrievable text — identifies 418 comments discussing palliative care in every cycle from CY2018 through CY2027, peaking at 127 in the CY2019 cycle (the E/M office-visit code collapse) and 69 in CY2026. Their recurring themes map onto this RFI: payment adequacy for long, complex visits; recognition of interdisciplinary and non-physician team members; quality measurement anchored on "feeling heard and understood" and the National Consensus Project guidelines; and access framing beyond fee-for-service.

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(e) Quality safeguards

"Currently, for Advanced Primary Care Management (APCM) services (HCPCS codes G0556 through G0558), we require physicians to report to the MIPS Value Pathway for primary care as part of our safeguards for high quality primary care. If we elect to develop additional care management services for seriously ill beneficiaries, however we may define serious illness in the future, determining how best to report quality of care safeguards will be essential to ensure high quality care delivery." — 91 FR 43950 (¶959)

"Should care management services for seriously ill beneficiaries also require reporting to a MIPS Value Pathway? Which quality measures should be reasonably included?" — 91 FR 43950 (¶961)

"If no viable MIPS Value Pathway reporting mechanism is found, what are the essential quality elements required for palliative care management? Is sole reporting of ambulatory palliative care patients feeling heard and understood (CBE 3665) sufficient? Should other measures be considered?" — 91 FR 43950 (¶962)

Recommendation. Yes to a reporting requirement; no to the primary-care MIPS Value Pathway; and no, CBE 3665 alone is not sufficient. CMS should require quality reporting as a condition of billing the family but develop a serious-illness MVP rather than extending the primary-care MVP to this population. In the interim, CMS should require a five-element minimum set: one care-experience measure (CBE 3665), one patient-reported symptom measure, one documented-process measure, one claims-computable utilization outcome, and one caregiver measure.

Why not the primary-care MVP. Its measure concepts — blood pressure control, hemoglobin A1c control, cancer screening completion — are the wrong targets for a population in the last year or two of life, and requiring them would penalize good care. In 381 adults randomized with an estimated life expectancy of one month to one year, discontinuing statin therapy produced no excess mortality (23.8 versus 20.3 percent; 90% CI −3.5 to 10.5 percent; p = 0.36), with improved quality of life and cost savings (Kutner (2015), PMID 25798575). Deprescribing is the evidence-based act; a primary-care MVP would score it as a care gap.

On CBE 3665. We support including the measure and oppose relying on it alone, for three reasons. First, its measurement properties support use as one measure, not the measure: the Feeling Heard and Understood scale validated in 608 outpatients showed excellent internal consistency (Cronbach's α = 0.93) but a test–retest intraclass correlation of 0.54, only moderate stability (Takahashi (2025), PMID 40547401). Second, we could not verify the measure's own development and testing literature: the inpatient development study (Gramling (2016), PMID 26596879), the before-and-after benchmarking study (Ingersoll (2018), PMID 29729348), and the RAND MACRA testing summary report (Ahluwalia (2022), PMID 35837526) all reached full-text assessment and all resolved as uncertain / unavailable-fulltext. A safeguard whose validation literature is not readily obtainable by the clinicians subject to it is a poor candidate for sole reliance. Third, an experience measure is only collectable from beneficiaries who can respond; the nursing-home cancer cohort of Vu (2024), PMID 38560743, and the dementia cohorts of Luth (2020), PMID 31750935, and Nothelle (2022), PMID 35488709, show the scale of that exclusion. A set resting entirely on patient self-report will systematically not measure the sickest beneficiaries.

Candidate measures. Patient-reported symptom burden. The Integrated Palliative care Outcome Scale (IPOS) is the best-evidenced community candidate: validated in 376 adults across home, outpatient and community settings (α = 0.77, acceptable-to-good test–retest reliability) (Murtagh (2019), PMID 31185804); implemented as measurement-based palliative care across 1,507 community patients (α = 0.78), where staff valued it and perceived improved service quality (Sandham (2022), PMID 35805407); and, in 557 patients, surfacing information physicians had not otherwise known in 69.3 percent of questionnaires (Müller (2023), PMID 36641450) — it changes what clinicians know, not just what regulators see. Across 458 specialized institutions, 92 percent of PROM users considered them useful for symptom management (p = 0.002) (Ito (2023), PMID 36894802). The Edmonton Symptom Assessment System is a reasonable alternative. One caution: professionals need training and implementation support to use PROMs well (Bausewein (2011), PMID 21507232, n = 663), so CMS should phase this requirement in.

Documented process. Piloting the PEACE measures in 593 patients found two both usable and feasible — screening for physical symptoms on admission and documentation of treatment preferences (Schenck (2014), PMID 24921162) — exactly the elements PCM-1 and PCM-2 require, so they can be computed from care already paid for. The gap is large: among 562 seriously ill hospitalized patients, a comprehensive palliative assessment was completed for 10 percent, against 56 percent of those receiving specialist palliative care (p < 0.001) (Hanson (2012), PMID 22687268). De Roo (2013), PMID 23809769, provides the systematic-review basis for indicator selection.

Claims-computable utilization outcomes. These impose no reporting burden because CMS computes them. Place of death and hospice enrollment were validated as end-of-life quality measures across 1.5 million nursing home residents (Mukamel (2012), PMID 22500481). Potentially-inappropriate-end-of-life-care indicators — chemotherapy near death, two or more emergency department visits, two or more admissions, hospitalizations over 14 days, intensive care admission, hospital death — applied across 43,067 patients distinguished specialist from generalist palliative models at an adjusted odds ratio of 0.20 (95% CI 0.15–0.26, p < 0.001) (Boddaert (2022), PMID 33355176). Days alive and out of hospital, and quality-of-life-adjusted days at home, were used in 272 patients with heart failure (Campbell (2018), PMID 29952090); days at home most closely tracks what beneficiaries say they want. Indicators derived for 14,312 seriously ill home care clients from the Resident Assessment Instrument for Home Care reached an odds ratio of 2.77 (95% CI 2.66–2.89) against negative health outcomes (Harman (2019), PMID 30626374) — an existing instrument can carry the set.

Caregiver measures. Caregiver-reported quality measures were characterized in 391 home hospice patients using the Burden Scale for Family Caregivers, FAMCARE-2 and CEQUEL (Phongtankuel (2020), PMID 32856023); CEQUEL itself was validated in 275 caregivers of advanced cancer patients (Higgins (2013), PMID 23762467). Since caregiver strain is one of the eligibility constructs CMS raises at ¶947 and ¶952, measuring the caregiver outcome closes the loop.

Equity monitoring. End-of-life quality metrics among 126,434 Medicare decedents with poor-prognosis cancers differed at minority-serving cancer centers on all four metrics examined (10.3 versus 7.4 percent, p < .01; 32.9 versus 30.4 percent, p = .03; 39.5 versus 37.0 percent, p = .03; 19.4 versus 16.2 percent, p < .01) (Wasp (2020), PMID 31925998), and hospice CAHPS scores across 217,596 patients ranged from 74.9 to 89.5 (Parast (2021), PMID 33469741). Whatever set CMS adopts should be stratified and reported by race, ethnicity, dual-eligibility status and rurality from the first performance year. On selection principles and what is coming, see Kamal (2015), PMID 25827852, on "measuring what matters," and Schlang (2026), PMID 42157151, on patient-reported serious-illness quality measures now in development — the most promising near-term source of measures purpose-built for this population.

What we decline to address. We decline to nominate a specific, ready-to-implement MVP composition with weights and benchmarks. No study in our included set evaluates MVP-level reporting for a palliative population; the measures above are validated individually, not as a scored composite, and we will not represent an untested composite as evidence-based. We likewise decline to recommend a performance threshold or payment-adjustment magnitude.

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Summary of recommendations

1. Do not restrict eligibility to a certified life-expectancy duration. Clinician prediction, validated instruments and administrative data all fail the accuracy standard a categorical gate requires; the Minimum Data Set six-month prognosis field achieves 13.7 percent sensitivity (Vu (2024), PMID 38560743).
2. If a prognostic criterion is adopted, use 12 months, not 6, as one of several alternative qualifying pathways, attested by the billing practitioner alone, with no second certification and no requirement to forgo disease-directed treatment.
3. Make functional impairment and caregiver strain independent qualifying pathways, satisfied by any one of: two or more ADL deficits or documented IADL decline; a positive screen on a brief validated caregiver-strain instrument; a qualifying serious-illness diagnosis with any functional impairment; or the 12-month prognostic pathway.
4. Avoid documentation burden by reusing instruments CMS already collects (MDS 3.0, OASIS, the Annual Wellness Visit health risk assessment), by accepting attestation of a single met criterion, and by paying for the comprehensive assessment as a service rather than requiring it as an unpaid precondition.
5. Establish a distinct three-code palliative care management family (PCM-1, PCM-2, PCM-3) rather than layering conditions onto APCM, with the descriptors set out above.
6. Differentiate care management for the seriously ill on five axes: a named interdisciplinary core team; the home as an expected site of service; 24-hour access to a clinician with access to the care plan; the caregiver as a unit of assessment and service; and a symptom-driven reassessment cadence.
7. Require, as essential service elements, all seven of CMS's ¶958 examples, plus concurrent care with disease-directed treatment, integrated medical and social supports, and an expected home-visit cadence.
8. Do not require a minimum monthly staff-time threshold as the sole basis for payment, a face-to-face initiating visit as the only permitted trigger, or physician-only supervision.
9. Permit registry- and risk-based identification as an initiating trigger (Mittmann (2020), PMID 32005036; Salinger (2025), PMID 39404637).
10. Permit telehealth for follow-up but do not allow it to satisfy the home-visit expectation.
11. Require quality reporting, but develop a serious-illness MVP rather than extending the primary-care MVP, whose measure concepts would penalize evidence-based deprescribing (Kutner (2015), PMID 25798575).
12. Do not rely on CBE 3665 alone. Require a five-element minimum set: CBE 3665; a patient-reported symptom measure (IPOS or ESAS); two PEACE-derived process measures (symptom screening at initiation; documented treatment preferences); one claims-computable utilization outcome (days at home, or potentially-inappropriate-end-of-life-care indicators); and one caregiver measure (CEQUEL or equivalent).
13. Stratify and publicly report all quality results by race, ethnicity, dual-eligibility status and rurality from the first performance year.
14. Focus program-integrity attention on enrollment and disenrollment churn, ownership and margin as risk stratifiers, the initiating trigger and practitioner-to-auxiliary work ratio, and equity monitoring of the integrity program itself — and treat abuse and neglect in the home as an integrity domain, using the indicator set of Sheehan (2016), PMID 27787878.
15. Build measurement into the benefit from day one. The clearest finding of this review is that the direct evidence CMS asks for does not yet exist for a service Medicare has not yet created. The remedy is a designed evaluation, not a longer wait.

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Respectfully submitted,

[Name] [Title] [Organization]

Date: [date] Docket: CMS-2026-2377 Re: CY 2027 Physician Fee Schedule Proposed Rule (CMS-1848-P), Request for Information — Community-Based Palliative Care, 91 FR 43949–43950

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Appendix A — Studies cited

Records are drawn from the project evidence base. Unless otherwise noted, each was included at the full-text eligibility stage (stage:4-included). Records marked [full text not retrievable] reached the full-text stage but resolved as uncertain / unavailable-fulltext; they are cited for their stated scope, as CMS itself cites two of them, and not for extracted results.

Part (a) — fraud, waste, and abuse

1. Jones DH, Woods K. The new hospice compliance plan: defining and addressing risk areas. Caring. 2000. PMID 11009798. (Cited from the indexed abstract; the full text of this trade-journal article is not available in any online archive.)
2. Zerzan J, Stearns S, Hanson L. Access to palliative care and hospice in nursing homes. JAMA. 2000. PMID 11074779.
3. Tyler DA, Leland N, Lepore M, et al. Effect of increased nursing home hospice use on nursing assistant staffing. Journal of Palliative Medicine. 2011. PMID 21958012.
4. Sengupta M, Park-Lee E, Valverde R, et al. Trends in length of hospice care from 1996 to 2007 and the factors associated with length of hospice care in 2007: findings from the National Home and Hospice Care Surveys. American Journal of Hospice & Palliative Care. 2014. PMID 23744976.
5. LeSage K, Borgert AJ, Rhee LS. Time to death and reenrollment after live discharge from hospice: a retrospective look. American Journal of Hospice & Palliative Care. 2015. PMID 24848665.
6. Teno JM, Bowman J, Plotzke M, et al. Characteristics of hospice programs with problematic live discharges. Journal of Pain and Symptom Management. 2015. PMID 26004403.
7. Prsic E, Plotzke M, Christian TJ, et al. A national study of live hospice discharges between 2000 and 2012. Journal of Palliative Medicine. 2016. PMID 27171543.
8. Sheehan OC, Ritchie CS, Fathi R, et al. Development of quality indicators to address abuse and neglect in home-based primary care and palliative care. Journal of the American Geriatrics Society. 2016. PMID 27787878.
9. Dolin R, Hanson LC, Rosenblum SF, et al. Factors driving live discharge from hospice: provider perspectives. Journal of Pain and Symptom Management. 2017. PMID 28323079.
10. Dolin R, Holmes GM, Stearns SC, et al. A positive association between hospice profit margin and the rate at which patients are discharged before death. Health Affairs. 2017. PMID 28679817.
11. Luth EA, Russell DJ, Brody AA, et al. Race, ethnicity, and other risks for live discharge among hospice patients with dementia. Journal of the American Geriatrics Society. 2020. PMID 31750935.

Part (b) — prognosis and eligibility interval

12. Wallace CL. Hospice eligibility and election: does policy prepare us to meet the need? Journal of Aging & Social Policy. 2015. PMID 26161945.
13. Kutner JS, Blatchford PJ, Taylor DH, et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Internal Medicine. 2015. PMID 25798575.
14. Hui D, Park M, Liu D, et al. Clinician prediction of survival versus the Palliative Prognostic Score: which approach is more accurate? European Journal of Cancer. 2016. PMID 27372208.
15. White N, Kupeli N, Vickerstaff V, et al. How accurate is the "Surprise Question" at identifying patients at the end of life? A systematic review and meta-analysis. BMC Medicine. 2017. PMID 28764757.
16. Hui D, Ross J, Park M, et al. Predicting survival in patients with advanced cancer in the last weeks of life: how accurate are prognostic models compared to clinicians' estimates? Palliative Medicine. 2020. PMID 31564218.
17. Piers R, De Brauwer I, Baeyens H, et al. Supportive and Palliative Care Indicators Tool prognostic value in older hospitalised patients: a prospective multicentre study. BMJ Supportive & Palliative Care. 2021. PMID 34059507.
18. Hsu AT, Manuel DG, Spruin S, et al. Predicting death in home care users: derivation and validation of the Risk Evaluation for Support: Predictions for Elder-Life in the Community Tool (RESPECT). CMAJ. 2021. PMID 34226263.
19. Bretos-Azcona PE, Ibarrola GC, Sánchez-Iriso E, et al. Multisystem chronic illness prognostication in non-oncologic integrated care. BMJ Supportive & Palliative Care. 2022. PMID 32581004.
20. Broese JMC, van der Kleij RMJJ, Verschuur EML, et al. External validation and user experiences of the ProPal-COPD tool to identify the palliative phase in COPD. International Journal of COPD. 2022. PMID 36579356.
21. Stone PC, Chu C, Todd C, et al. The accuracy of clinician predictions of survival in the Prognosis in Palliative care Study II (PiPS2): a prospective observational study. PLoS One. 2022. PMID 35421168.
22. Arahata M, Asakura H, Morishita E, et al. Identification and prognostication of end-of-life state using a Japanese guideline-based diagnostic method: a diagnostic accuracy study. International Journal of General Medicine. 2023. PMID 36636714.
23. Yoong SQ, Bhowmik P, Kapparath S, et al. Palliative prognostic scores for survival prediction of cancer patients: a systematic review and meta-analysis. Journal of the National Cancer Institute. 2024. PMID 38366659.
24. Vu L, Koroukian SM, Douglas SL, et al. Understanding the utility of less than six-month prognosis using administrative data among U.S. nursing home residents with cancer. Palliative Medicine Reports. 2024. PMID 38560743.
25. Zhuang Q, Zhang AY, Cong RSTY, et al. Towards proactive palliative care in oncology: developing an explainable EHR-based machine learning model for mortality risk prediction. BMC Palliative Care. 2024. PMID 38769564.
26. Gupta A, Burgess R, Drozd M, et al. The Surprise Question and clinician-predicted prognosis: systematic review and meta-analysis. BMJ Supportive & Palliative Care. 2024. PMID 38925876.
27. Homann S, Pfaff J, Stovicek E, et al. Evaluating performance of the Surprise Question to predict 12-month mortality in patients with end-stage liver disease. American Journal of Hospice & Palliative Care. 2025. PMID 39952927.
28. Selesky M, Li L, Zeng C, et al. Accuracy of the "Surprise Question" in predicting 90-day mortality among hospitalized patients with decompensated cirrhosis. Hepatology Communications. 2025. PMID 40658791.
29. Frechman E, Jaeger BC, Kowalkowski M, et al. External validation of a proprietary risk model for 1-year mortality in community-dwelling adults aged 65 years or older. Journal of the American Medical Informatics Association. 2025. PMID 40298901.
30. McCoy TH, Perlis RH. Predicting hospice eligibility among dementia patients using language models. Alzheimer's & Dementia. 2025. PMID 41216867.

Part (c) — function, ADLs, and caregiver strain

31. Anderson K, Baraldi C, Supiano M. Identifying failure to thrive in the long term care setting. Journal of the American Medical Directors Association. 2012. PMID 22784699.
32. Karpman C, Benzo R. Gait speed as a measure of functional status in COPD patients. International Journal of COPD. 2014. PMID 25473277.
33. Kelley AS, Covinsky KE, Gorges RJ, et al. Identifying older adults with serious illness: a critical step toward improving the value of health care. Health Services Research. 2017. PMID 26990009. [full text not retrievable; cited by CMS at 91 FR 43950 (¶948)]
34. Wen FH, Chen JS, Chou WC, et al. Distinct patterns of conjoint symptom distress and functional impairment in the last year of life predict terminally ill cancer patients' survival. Journal of Pain and Symptom Management. 2018. PMID 29545065.
35. Kelley AS, Bollens-Lund E. Identifying the population with serious illness: the "denominator" challenge. Journal of Palliative Medicine. 2018. PMID 29125784. [full text not retrievable; cited by CMS at 91 FR 43950 (¶949)]
36. Udelsman B, Chien I, Ouchi K, et al. Needle in a haystack: natural language processing to identify serious illness. Journal of Palliative Medicine. 2019. PMID 30251922.
37. Ernecoff NC, Wessell KL, Hanson LC, et al. Electronic health record phenotypes for identifying patients with late-stage disease: a method for research and clinical application. Journal of General Internal Medicine. 2019. PMID 31396813.
38. Kluger BM, Katz M, Galifianakis N, et al. Does outpatient palliative care improve patient-centered outcomes in Parkinson's disease: rationale, design, and implementation of a pragmatic comparative effectiveness trial. Contemporary Clinical Trials. 2019. PMID 30779960.
39. Van de Vyver C, Velghe A, Baeyens H, et al. Can usual gait speed be used as a prognostic factor for early palliative care identification in hospitalized older patients? BMC Geriatrics. 2020. PMID 33234124.
40. Ankuda CK, Freedman VA, Covinsky KE, et al. Population-based screening for functional disability in older adults. Innovation in Aging. 2021. PMID 33506111.
41. Cheng HL, Leung DYP, Ko PS, et al. Reliability, validity and acceptability of the traditional Chinese version of the carer support needs assessment tool in Hong Kong palliative care settings. BMC Palliative Care. 2021. PMID 34627225.
42. Nothelle S, Kelley AS, Zhang T, et al. Fragmentation of care in the last year of life: does dementia status matter? Journal of the American Geriatrics Society. 2022. PMID 35488709.
43. Chandra A, Bhatnagar S, Kumar R, et al. Estimating the need for palliative care in an urban resettlement colony of New Delhi, North India. Indian Journal of Palliative Care. 2022. PMID 36447509.
44. Reckrey JM, Kleijwegt H, Morrison RS, et al. Paid care for people with functional impairment and serious illness: results from the Health and Retirement Study. Journal of General Internal Medicine. 2023. PMID 37349637.
45. Viladot M, Gallardo-Martínez JL, Hernandez-Rodríguez F, et al. Validation study of the PALCOM scale of complexity of palliative care needs: a cohort study in advanced cancer patients. Cancers. 2023. PMID 37627210.
46. Ramadasa U, Silva S, Udumulla U, et al. Caregiver strain among patients of palliative care in Sri Lanka: validation of modified caregiver strain index — Sinhala version. BMC Palliative Care. 2023. PMID 37924086.
47. Fettes L, Bayly J, Chukwusa E, et al. Predictors of increasing disability in activities of daily living among people with advanced respiratory disease: a multi-site prospective cohort study, England UK. Disability and Rehabilitation. 2024. PMID 38073190.
48. Tuca A, Viladot M, Carrera G, et al. Evolution of complexity of palliative care needs and patient profiles according to the PALCOM scale (part two). Cancers. 2024. PMID 38730696.
49. Ullrich A, Bergelt C, Marx G, et al. The CAREPAL-8: a short screening tool for multidimensional family caregiver burden in palliative care. BMC Palliative Care. 2024. PMID 39095830.
50. Salinger MR, Ornstein KA, Kleijwegt H, et al. Defining and validating criteria to identify populations who may benefit from home-based primary care. Medical Care. 2025. PMID 39404637.
51. Quadir SS, Alam A, Bhuiyan AKMMR, et al. Caregiver burden in advanced cancer in tertiary care palliative medicine. BMJ Supportive & Palliative Care. 2025. PMID 39510815.
52. Bowers SP, Black P, McCheyne L, et al. Descriptions of advanced multimorbidity: a scoping review with content analysis. Journal of Multimorbidity and Comorbidity. 2025. PMID 40110541.
53. Haufschild C, Oechsle K, Zapf A, et al. Psychosocial burden and supportive care needs of informal caregivers in specialist palliative care. JMIR Research Protocols. 2026. PMID 42536973.

Part (d) — delivery model and service elements

54. Purdy S, Lasseter G, Griffin T, et al. Impact of the Marie Curie Cancer Care Delivering Choice Programme in Somerset and North Somerset on place of death and hospital usage: a retrospective cohort study. BMJ Supportive & Palliative Care. 2015. PMID 24838731.
55. Wong FKY, Ng AYM, Lee PH, et al. Effects of a transitional palliative care model on patients with end-stage heart failure: a randomised controlled trial. Heart. 2016. PMID 26969631.
56. Cassel JB, Kerr KM, McClish DK, et al. Effect of a home-based palliative care program on healthcare use and costs. Journal of the American Geriatrics Society. 2016. PMID 27590922.
57. Singer AE, Goebel JR, Kim YS, et al. Populations and interventions for palliative and end-of-life care: a systematic review. Journal of Palliative Medicine. 2016. PMID 27533892.
58. Fathi R, Sheehan OC, Garrigues SK, et al. Development of an interdisciplinary team communication framework and quality metrics for home-based medical care practices. Journal of the American Medical Directors Association. 2016. PMID 27217093. [full text not retrievable]
59. Lustbader D, Mudra M, Romano C, et al. The impact of a home-based palliative care program in an Accountable Care Organization. Journal of Palliative Medicine. 2017. PMID 27574868.
60. Parikh RB, Bowman B, Dahlin C, et al. Scalable principles of community-based high-value care for seriously ill individuals: diamonds in the rough. Healthcare (Amsterdam). 2017. PMID 27687915.
61. Ruiz S, Snyder LP, Giuriceo K, et al. Innovative models for high-risk patients use care coordination and palliative supports to reduce end-of-life utilization and spending. Innovation in Aging. 2017. PMID 30480116.
62. Voruganti T, Grunfeld E, Jamieson T, et al. My Team of Care Study: a pilot randomized controlled trial of a web-based communication tool for collaborative care in patients with advanced cancer. Journal of Medical Internet Research. 2017. PMID 28720558.
63. Wang SE, Liu ILA, Lee JS, et al. End-of-life care in patients exposed to home-based palliative care vs hospice only. Journal of the American Geriatrics Society. 2019. PMID 30830695.
64. Yosick L, Crook RE, Gatto M, et al. Effects of a population health community-based palliative care program on cost and utilization. Journal of Palliative Medicine. 2019. PMID 30950679.
65. Saunders S, Killackey T, Kurahashi A, et al. Palliative care transitions from acute care to community-based care — a systematic review. Journal of Pain and Symptom Management. 2019. PMID 31201875.
66. Britt HR, JaKa MM, Fernstrom KM, et al. Quasi-experimental evaluation of LifeCourse on utilization and patient and caregiver quality of life and experience. American Journal of Hospice & Palliative Care. 2019. PMID 30541333.
67. Mittmann N, Liu N, MacKinnon M, et al. Does early palliative identification improve the use of palliative care services? PLoS One. 2020. PMID 32005036.
68. Brown CRL, Webber C, Seow HY, et al. Impact of physician-based palliative care delivery models on health care utilization outcomes: a population-based retrospective cohort study. Palliative Medicine. 2021. PMID 33884934.
69. Schmucker AM, Flannery M, Cho J, et al. Data from emergency medicine palliative care access (EMPallA): a randomized controlled trial. BMC Emergency Medicine. 2021. PMID 34247588.
70. Gordon MJ, Le T, Lee EW, et al. Home palliative care savings. Journal of Palliative Medicine. 2022. PMID 34637346.
71. Stoltenberg MJ, Kennedy M, Rico J, et al. Developing a novel integrated geriatric palliative care consultation program for the emergency department. JACEP Open. 2022. PMID 36518882.
72. Ankuda CK, Ornstein KA, Leff B, et al. Defining a taxonomy of Medicare-funded home-based clinical care using claims data. BMC Health Services Research. 2023. PMID 36747175.
73. van Doorne I, de Meij MA, Parlevliet JL, et al. More older adults died at their preferred place after implementation of a transmural care pathway for older adults at the end of life. BMC Palliative Care. 2023. PMID 37533107.
74. Hughes MC, Vernon E, Hainstock A. The effectiveness of community-based palliative care programme components: a systematic review. Age and Ageing. 2023. PMID 37740895.
75. Bower KA, Hallock J, Li X, et al. Cost and utilization implications of a health plan's home-based palliative care program. Journal of Palliative Medicine. 2024. PMID 38271576.
76. Goodrich J, Watson C, Gaczkowska I, et al. Understanding patient and family utilisation of community-based palliative care services out-of-hours. PLoS One. 2024. PMID 38381768.
77. Janke K, Salifu Y, Gavini S, et al. A palliative care approach for adult non-cancer patients with life-limiting illnesses is cost-saving or cost-neutral: a systematic review of RCTs. BMC Palliative Care. 2024. PMID 39098890.
78. Perloff J, Hoyt A, Srinivasan M, et al. The quality of home-based primary care delivered by nurse practitioners: a national Medicare claims analysis. Journal of the American Geriatrics Society. 2024. PMID 39291622.
79. Di Nitto M, Durante A, Caggianelli G, et al. Effectiveness of transitional care interventions in patients with serious illness and their caregivers: a systematic review and meta-analysis of randomized controlled trials. BMC Nursing. 2025. PMID 40389925.
80. Yao H, Wang J, Zhu R, et al. E-CARE as core competencies for palliative social workers: a systematic review. BMC Palliative Care. 2025. PMID 40490802.
81. Poston K, Nasti A, Cormack C, et al. Transforming palliative care for rural patients with COPD through nurse-led models. Healthcare (Basel). 2025. PMID 40724712.
82. Haroen H, Juniarti N, Sari CWM, et al. Integrating telehealth into community-based palliative care: a systematic review. Journal of Multidisciplinary Healthcare. 2025. PMID 41230403.

Part (e) — quality measurement

83. Bausewein C, Simon ST, Benalia H, et al. Implementing patient reported outcome measures (PROMs) in palliative care — users' cry for help. Health and Quality of Life Outcomes. 2011. PMID 21507232.
84. Mukamel DB, Caprio T, Ahn R, et al. End-of-life quality-of-care measures for nursing homes: place of death and hospice. Journal of Palliative Medicine. 2012. PMID 22500481.
85. Hanson LC, Rowe C, Wessell K, et al. Measuring palliative care quality for seriously ill hospitalized patients. Journal of Palliative Medicine. 2012. PMID 22687268.
86. Higgins PC, Prigerson HG. Caregiver Evaluation of the Quality of End-of-Life Care (CEQUEL) scale: the caregiver's perception of patient care near death. PLoS One. 2013. PMID 23762467.
87. De Roo ML, Leemans K, Claessen SJJ, et al. Quality indicators for palliative care: update of a systematic review. Journal of Pain and Symptom Management. 2013. PMID 23809769.
88. Schenck AP, Rokoske FS, Durham D, et al. Quality measures for hospice and palliative care: piloting the PEACE measures. Journal of Palliative Medicine. 2014. PMID 24921162.
89. Kamal AH. Signposts along the journey toward high-quality palliative care: the value of measuring what matters. Journal of Pain and Symptom Management. 2015. PMID 25827852.
90. Gramling R, Stanek S, Ladwig S, et al. Feeling heard and understood: a patient-reported quality measure for the inpatient palliative care setting. Journal of Pain and Symptom Management. 2016. PMID 26596879. [full text not retrievable]
91. Ingersoll LT, Saeed F, Ladwig S, et al. Feeling heard and understood in the hospital environment: benchmarking communication quality among patients with advanced cancer before and after palliative care consultation. Journal of Pain and Symptom Management. 2018. PMID 29729348. [full text not retrievable]
92. Campbell RT, Petrie MC, Jackson CE, et al. Which patients with heart failure should receive specialist palliative care? European Journal of Heart Failure. 2018. PMID 29952090.
93. Harman LE, Guthrie DM, Cohen J, et al. Potential quality indicators for seriously ill home care clients: a cross-sectional analysis using Resident Assessment Instrument for Home Care (RAI-HC) data for Ontario. BMC Palliative Care. 2019. PMID 30626374.
94. Murtagh FE, Ramsenthaler C, Firth A, et al. A brief, patient- and proxy-reported outcome measure in advanced illness: validity, reliability and responsiveness of the Integrated Palliative care Outcome Scale (IPOS). Palliative Medicine. 2019. PMID 31185804.
95. Wasp GT, Alam SS, Brooks GA, et al. End-of-life quality metrics among Medicare decedents at minority-serving cancer centers: a retrospective study. Cancer Medicine. 2020. PMID 31925998.
96. Phongtankuel V, Reid MC, Czaja SJ, et al. Caregiver-reported quality measures and their correlates in home hospice care. Palliative Medicine Reports. 2020. PMID 32856023.
97. Parast L, Tolpadi AA, Teno JM, et al. Hospice care experiences among cancer patients and their caregivers. Journal of General Internal Medicine. 2021. PMID 33469741.
98. Boddaert MS, Pereira C, Adema J, et al. Inappropriate end-of-life cancer care in a generalist and specialist palliative care model: a nationwide retrospective population-based observational study. BMJ Supportive & Palliative Care. 2022. PMID 33355176.
99. Sandham MH, Hedgecock E, Hocaoglu M, et al. Strengthening community end-of-life care through implementing measurement-based palliative care. International Journal of Environmental Research and Public Health. 2022. PMID 35805407.
100. Ahluwalia SC, Vegetabile BG, Edelen MO, et al. MACRA palliative care quality measure development — testing summary report: measure name: feeling heard and understood. RAND Health Quarterly. 2022. PMID 35837526. [full text not retrievable]
101. Müller E, Mayer-Steinacker R, Gencer D, et al. Feasibility, use and benefits of patient-reported outcome measures in palliative care units: a multicentre observational study. BMC Palliative Care. 2023. PMID 36641450.
102. Ito N, Ishii Y, Aoyama M, et al. Routine patient assessment and the use of patient-reported outcomes in specialized palliative care in Japan. Journal of Patient-Reported Outcomes. 2023. PMID 36894802.
103. Takahashi M, Hirayama H, Aoyama M, et al. Development of a Japanese version of the Feeling Heard and Understood scale: reliability and validity in outpatients. Journal of Patient Experience. 2025. PMID 40547401.
104. Monton O, Drabo EF, Masroor T, et al. Economic evaluation of a hybrid type 1 effectiveness-implementation trial comparing a community health worker palliative care intervention to enhanced standard of care. BMJ Open. 2025. PMID 41193212.
105. Schlang D, Anhang Price R, Wolf J, et al. Developing patient-reported measures of serious illness care quality: synthesis of input from patients, family caregivers, health care professionals, and other experts. BMC Palliative Care. 2026. PMID 42157151.

Professional standards relied on for the PCM-1/2/3 crosswalk

106. Weissman DE, Morrison RS, Meier DE. Center to Advance Palliative Care palliative care clinical care and customer satisfaction metrics consensus recommendations. Journal of Palliative Medicine. 2010. PMID 19922199. [full text not retrievable]
107. Weissman DE, Meier DE. Identifying patients in need of a palliative care assessment in the hospital setting: a consensus report from the Center to Advance Palliative Care. Journal of Palliative Medicine. 2011. PMID 21133809. [full text not retrievable]
108. Center to Advance Palliative Care. Quality Standards and Certifications for Palliative Care Programs (basic standards, May 2025). https://www.capc.org/quality-standards-and-certifications/
109. National Association of Social Workers. NASW Practice Standards for Serious Illness Care: Hospice and Palliative Social Work (Standards 3, 4, 6, 7, 8). https://www.socialworkers.org/Practice/NASW-Practice-Standards
110. The Joint Commission. Palliative Care (PAL) Performance Measure Set, version 2026A1 (PAL-01 through PAL-05; core-team population definition). https://manual.jointcommission.org/

Sources cited by CMS in the RFI and reviewed by us

111. Centers for Medicare & Medicaid Services, Innovation Center. Palliative Care Projects: Synthesis of Evaluation Results 2012–2021 (CMS footnote 112, 91 FR 43949 (¶940)). [full text not retrievable through our pipeline]
112. Center to Advance Palliative Care. Building and Supporting Effective Palliative Care Teams (CMS footnote 115, 91 FR 43950 (¶955)). [full text not retrievable through our pipeline]
113. Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood, CBE 3665 (measure record). https://p4qm.org/measures/3665

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Appendix B — Evidence review: counts and protocol

Protocol and provenance. The review protocol, search strategy, screening criteria, and exclusion-reason taxonomy are recorded in the project reference library and reproduced in the accompanying analysis notebook, notebooks/palliative_care_rfi.py, which regenerates every count below directly from the library on each run. Identification was executed on 2026-08-18 (dev/scripts/search_pubmed_palliative_rfi.py). Title/abstract screening (stage 2) and full-text eligibility assessment (stage 3) were executed against written criteria using a locally hosted language model, with records the first-pass model marked uncertain adjudicated in an independent second pass with the first-pass rationale withheld. Full-text retrieval followed an Unpaywall → PMC Open Access → Europe PMC → mirror cascade; records with no retrievable full text resolve as uncertain / unavailable-fulltext rather than being silently dropped. The section II.E cross-read supporting part (d) is recorded separately at docs/spec/2026-08-20-cy2027-iie-crossread-palliative-rfi.md.

PRISMA 2020 flow.

Stage	n
Records identified	4,999
Records screened (title/abstract)	4,997
Records excluded at title/abstract	2,642
Records assessed for full-text eligibility	2,355
Excluded at full text	401
Unresolved at full text (unavailable-fulltext)	1,429
Studies included	525

Identification sources (a record may carry more than one source tag): PubMed E-utilities database searches, 4,993; forward citation-chasing (NCBI elink) from five anchor publications, 328; sources cited in the RFI itself, 5; professional standards documents, 3.

Included studies by RFI part (a study relevant to more than one question is counted in each): part (a) fraud, waste and abuse, 11; part (b) prognosis, 74; part (c) function and caregiver strain, 92; part (d) delivery and service elements, 190; part (e) quality measurement, 169; code-family standards arm, 36.

Records identified by search arm: part (a), 174; part (b), 803; part (c), 805; part (d), 1,438; part (e), 1,677; code-family standards arm, 469.

Principal exclusion and non-resolution reasons (reason tags applied; a record may carry more than one, so these do not sum to the flow counts above): full text not retrievable, 1,442; no bearing on an RFI question, 1,344; off topic, 483; no usable evidence for the question, 387; wrong population, 330; symptom pharmacology only, 209; inpatient-only setting, 174; wrong outcome, 161; no comparator, 59; editorial or commentary, 55; not in English, 35; case report, 28.

Declared limitations. (i) Single-reviewer screening by a language model against written criteria, with an independent second-pass adjudication of uncertain records, rather than dual human screening. (ii) A high non-resolution rate at full text (1,429 of 2,355 records reaching that stage, 61 percent), driven by paywalled literature; this is the reason several sources central to CMS's own questions — including the CBE 3665 development and testing literature and CMS's two serious-illness-identification citations — are marked in Appendix A as not verifiable by us. (iii) No formal meta-analysis or GRADE assessment was performed; effect estimates are reported as extracted from each study. (iv) Grey literature (professional standards, CMS reports, measure records) bypassed clinical screening by design and is cited as documentary evidence, not as study findings.

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Coverage check

Every paragraph of the RFI at 91 FR 43949–43950 (¶938 through ¶962), with the section of this comment that answers it.

¶	Page	Solicited question (abbreviated)	Answered in
938	43949	Background and scoping: hospice and ESRD comments directed to their own dockets	Honoured — see "Out of scope" below and the Introduction
939	43949	Seeking comment on the specific requirements CMS should consider given prior Innovation Center model tests	Part (d), "On CMS's Innovation Center synthesis"; Recommendations 6, 7
940	43949	CMS footnote 112 (Innovation Center synthesis 2012–2021)	Part (d), "On CMS's Innovation Center synthesis"; Appendix A item 111
941	43949	Framing: CMS's interest in fraud, waste and abuse in related disciplines and sites of care	Part (a), opening and evidence
942	43949	Where should CMS focus on potential fraud, waste, and abuse in community-based palliative care?	Part (a), recommendation and evidence; Recommendation 14
943	43949–50	Framing: defining who is eligible for serious illness care; CCM and hospice comparators	Part (b), opening; part (c) recommendation
944	43950	Framing: request for feedback on eligibility and care management, supported by evidence	Introduction; each part's evidence section
945	43950	Should eligibility be restricted to certification of a likely life expectancy duration?	Part (b), recommendation ("No"); Recommendation 1
946	43950	If restricted to terminal prognosis, is there evidence for a reasonable interval (e.g. <1 year)?	Part (b), "If CMS gates anyway: the interval"; Recommendation 2. Partially declined — we decline to endorse a specific State Medicaid interval as evidence-based; no included study compares interval thresholds head to head
947	43950	Framing: serious-illness definitions include daily function and caregiver strain, not only condition counts	Part (c), opening and evidence
948	43950	CMS footnote 113 (Kelley 2017)	Part (c), "On CMS's own citations"; Appendix A item 33
949	43950	CMS footnote 114 (Kelley and Bollens-Lund 2018)	Part (c), "On CMS's own citations"; Appendix A item 35
950	43950	Framing: request for feedback on the following	Part (c)
951	43950	How could we consider impact on daily functions of life or ADLs as part of eligibility?	Part (c), recommendation and "function is measurable"; Recommendation 3
952	43950	Would eligibility best be based on daily function, caregiver strain, or both?	Part (c), recommendation ("Both, as alternative pathways") and "the combination outperforms either alone"; Recommendation 3
953	43950	How can we avoid overly burdensome requirements for defining eligibility?	Part (c), "Avoiding burden (¶953) — three mechanisms"; Recommendation 4
954	43950	Framing: section II.E cross-reference; interdisciplinary teams and between-visit care	Part (d), "A note on the cross-reference"
955	43950	CMS footnote 115 (CAPC teams toolkit)	Part (d), team-composition evidence; Appendix A item 112
956	43950	Framing: request for feedback on the following	Part (d)
957	43950	How should we differentiate care management requirements for seriously ill beneficiaries?	Part (d), recommendation (five differentiators) and PCM-1/2/3 structure; Recommendations 5, 6
958	43950	What are the essential service elements? What others should be included? Should any not be included?	Part (d), element-by-element evidence, "What should not be included", PCM descriptors; Recommendations 7, 8, 9, 10
959	43950	Framing: APCM's primary-care MVP reporting requirement as a quality safeguard	Part (e), opening and "Why not the primary-care MVP"
960	43950	Framing: request for feedback on the following	Part (e)
961	43950	Should these services require MVP reporting? Which quality measures should be included?	Part (e), recommendation and "Candidate measures"; Recommendations 11, 12, 13. Partially declined — we decline to specify an MVP composition with weights and benchmarks; no included study evaluates MVP-level reporting for a palliative population
962	43950	If no viable MVP, what are the essential quality elements? Is CBE 3665 alone sufficient? Other measures?	Part (e), "On CBE 3665" (not sufficient) and the five-element minimum set; Recommendation 12

No solicited question at ¶938–962 has been skipped. Two are answered in part and expressly declined in part, for the reasons stated in the table and in the body.

Out of scope by CMS's own direction. Paragraph 938 directs comments on the Medicare Hospice Benefit to the FY 2027 Hospice proposed rule and comments on maintenance versus comfort-focused dialysis to the CY 2027 ESRD proposed rule. This comment addresses neither.