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August 27, 2021Chiquita Brooks-LaSureAdministratorCenters for Medicare and Medicaid ServicesUS Department of Health and Human Services200 Independence Avenue, SWWashington, DC 20101RE:CMS-1747-P, Medicare and Medicaid Programs; CY 2022 Home HealthProspective Payment System Rate Update; Home Health Value-Based PurchasingModel Requirements and Proposed Model Expansion; Home Health QualityReporting Requirements; Home Infusion Therapy Services Requirements; Surveyand Enforcement Requirements for Hospice Programs; Medicare ProviderEnrollment Requirements; Inpatient Rehabilitation Facility Quality ReportingProgram Requirements; and Long-term Care Hospital Quality Reporting ProgramRequirementsOn behalf of the National Coalition for Hospice and Palliative Care, we welcome theopportunity to provide comments and recommendations from our Coalition Membersto the Centers for Medicare & Medicaid Services (CMS) on the above proposed rule. Toinform our comments, we drew on the hospice expertise represented within theprofessional organizations that comprise our Coalition. We are pleased to offer thefeedback below on behalf of our Coalition.Our Coalition is dedicated to advancing the equitable access, delivery and quality ofhospice and palliative care to all those who need it. The national organizations that formthe Coalition represent more than 5,500 hospice programs and their related personnel,5,200 physicians, 1,000 physician assistants, 10,000 nurses, 5,000 chaplains, 8,000 socialworkers, researchers, and pharmacists, along with over 1,800 palliative care programscaring for millions of patients and families each year across the United States. We bringa broad, multidisciplinary perspective on hospice care and the changes this proposedrule will have on the vulnerable population we serve – patients and families nearing theend of life. These changes have the potential to dramatically impact the delivery of vitalhospice services across the nation and ensure an improved understanding of CMS’1
expectations for hospice compliance with important health and safety standards for patients, familymembers, hospice agencies and surveyors.1. Accreditation Organizations and Submission of CMS Form 2567A. AOs to Submit Statement of Deficiencies Using the CMS-2567CMS is proposing that Accreditation Organizations (AOs) will include a statement of deficiencies(that is, the Form CMS-2567 or a successor form) to document findings of the hospice programMedicare Hospice Conditions of Participation (CoPs). The CMS-2567 form will now be requiredand will need to be incorporated into the AO’s proprietary software so that the surveydeficiencies can be reported publicly.Coalition Comments: The Coalition is very supportive of the standardization of theAccreditation Organization (AO) and State Agency (SA) survey process, where both AOs and SAssubmit a CMS-2567 (or its successor) form to report hospice survey deficiencies. Coalitionmembers believe that this will promote consistency for the survey process and assure thathospices have the benefit of a standard survey process, no matter who the survey agency is.We support the requirement that the Form CMS-2567 or its successor be used by all surveyentities to document a hospice program’s compliance with Medicare Conditions ofParticipation.B. Release and Use of Accreditation Survey Results (§ 488.7)Coalition Comments: The Coalition believes that making survey findings public, no matter whothe surveying entity is, assures transparency and consistency of the survey process andprovides consumers with the opportunity to see survey results from all hospices. However, therelease of the CMS-2567 in its current form is unintelligible to the average consumer.Coalition Recommendations: Technical Expert Panel: The Coalition strongly encourages CMS to appoint a TechnicalExpert Panel (TEP) that would include national stakeholders, hospice providers, andconsumers, to carefully address the data elements needed for a form that is “prominent,easily accessible, readily understandable, and searchable for the general public.” [CY 2022Home Health xxx Proposed Rule, Hospice Survey Reform and Enforcement Remediessections, June 28, 2021] The form that is developed should undergo testing with families, other consumers andmembers of the general public to ensure that the information is understandable. National2
stakeholders and hospice providers should have input into the form’s design, dataelements, and accurate representation of survey deficiencies.The form that is developed should also focus on true, actual patient-level deficiencies thatcould impact quality of care, rather than technical deficiencies. The Coalition supports theemphasis on deficiencies related to the 4 core conditions of participation:o (§418.52) - Patient rightso (§418.54) - Initial and comprehensive assessmento (§418.56) - Care planningo (§418.58) - Quality assessment and performance improvementWe are concerned that the survey information that is publicly available shows the viewerwhen a hospice has addressed deficiencies and can show that those deficiencies areresolved. In addition, there should be careful attention to those deficiencies cited under the“see one cite one” directive, which will not represent a trend in survey deficiencies thatwould be more helpful to the consumer.C. Identifying Standard Framework to Identify Salient Survey FindingsCMS recognizes the need to develop some type of a standard framework that would identifysalient survey findings in addition to other relevant data about the hospices’ performance. CMSalso recognizes the importance of releasing survey data nationally and that collaboration withindustry stakeholders will be essential.Coalition Recommendation: The Coalition endorses the development of a standard frameworkto identify survey findings that will impact the quality and safety of patient care. Coalitionmembers and hospice providers pledge to work with CMS to develop such a framework to beused to assure survey consistency across states and across survey entities.2. Survey and Certification of Hospice ProgramsA. Surveys and Toll-free HotlineCMS is proposing a hotline, as required by CAA 2021, to collect, maintain and updateinformation on home health agencies and hospice programs, to receive complaints and answerquestions.Coalition Comment: The Coalition supports the development of a hotline for HHAs andhospices.Coalition Recommendation: The Coalition is supportive of this formal requirement for ahotline for hospice questions and complaints. The Coalition requests that CMS clarify that there3
will be a single hotline per state and that complaints or questions will be answered by the Statein a timely manner if follow up is required.B. Surveyor Qualifications and Prohibition of Conflicts of Interest (§ 488.1115)CAA 2021 requires the Secretary of HHS to establish a training and testing program for allsurveyors – State, Federal and AO – no later than October 1, 2021, and prohibits a surveyorfrom surveying a hospice program on or after October 1, 2021, until they have completed thetraining and testing program. The legislation also prohibits an individual from surveying ahospice program if the individual serves (or has served within the previous 2 years) as amember of the staff of, or as a consultant to, the program being surveyed or who has apersonal or familial financial interest in the program being surveyed.1. Surveyor Qualifications: Relative to surveyor training, CMS is proposing that all SA and AOsurveyors be required to take CMS-provided surveyor basic training currently available, andadditional training as specified by CMS. CMS proposes that until the rule is finalized, thatCMS will accept AO surveyor training that is currently in place as part of CMS’ agreementwith each AO, and that SA surveyors should already be in compliance as they must currentlycomplete a CMS-developed training and testing program.As part of the rule, CMS has provided additional information regarding the makeup ofexisting surveyor training modules, underscored that all current training modules areaccessible by the public at large, and outlined changes to the training modules that arecurrently in process and that will place increased emphasis on assessment of hospice qualityof care. CMS indicates that the revised training is expected to be implemented soon.Coalition Comments: The Coalition strongly supports uniform surveyor testing and trainingto ensure that all surveyors have an identical knowledge base and to help support greateraccuracy and consistency of survey findings. We applaud CMS’ movement toward greatertransparency over recent years by making surveyor training modules publicly available andare gratified that CMS is well on its way to releasing updated surveyor training modules.We are particularly supportive of CMS’ plans, as part of its revisions to the State OperationsManual and training module updates, to place increased focus on quality of care byemphasizing the four “core” hospice program CoPs related to Patient’s Rights; Initial andComprehensive Assessment of the Patient; Interdisciplinary Group, Care Planning andCoordination of Care; and Quality Assessment and Performance Improvement.Coalition Recommendations: Given that CMS appears to be very close to completion of its updates to hospicesurveyor training modules, we believe it would be optimal for all surveyors to undergotraining and testing using the updated modules as soon as they are available. Rather4
than having AO surveyors undergo currently available surveyor basic training that maybe out of date, we recommend that CMS publish, as part of its final rule on the SurveyReform and Enforcement Requirements for Hospice Programs, information regardingwhen the updated training modules will be released along with a schedule for when allsurveyors must complete the revised training (and undergo competency testing). Theschedule should allow sufficient time so that survey entities will not be required toremove a significant number of surveyors from the field at the same time so that theimpact on survey backlogs will be minimal.We recognize that online training and testing is the most efficient and (in the currentenvironment) safest means for ensuring that all surveyors have successfully completedthe required course of study. We also believe that online pretesting, training, andtesting have the potential to somewhat degrade the training function. We encourageCMS to consider, when appropriate, offering in-person training opportunities tosurveyors to strengthen the impact of the training process and allow for communicationand dialogue during the survey process.Many surveyors have field experience that helps to guide their determinations, but thisexperience can, at times, lead to inflexibility and bias. Training and educationalmaterials should emphasize that there may be a variety of ways that a hospice can meetthe requirements of the CoPs, and that compliance with the intent of the CoPs shouldalways be at the core of any determination. Various examples of permissible provideractions to meet specific requirements could help to support this concept as part of thetraining. Further, training should emphasize that survey citations should be based onevidence of trends rather than a single violation.All training and educational materials should adequately address psychosocial,emotional, and spiritual components of hospice care. Such materials and training wouldoptimally be developed and performed by hospice-trained social workers, chaplains andcounselors.Given the new requirement to utilize additional hospice disciplines in cases where morethan one surveyor will be used, training and educational materials should be developedwith a variety of disciplines in mind.We strongly recommend that education and training materials be updated whenevernew or revised CoPs or interpretations are released. Hospice surveyors should berequired to undergo additional training/testing within a specified time period whenevernew or revised training is released.We encourage CMS to consider development of surveyor competency requirementsthat include routine training and/or testing and that ensure a surveyor maintains surveyexperience specific to the provider type being surveyed. This could include an annualrequirement to conduct a minimum number of hospice surveys to retain certification as5
a hospice surveyor. Consideration should also be given to a requirement that a surveyorhave field experience with a particular provider type to be certified to conduct surveysof that provider type.2. Prohibition of Conflicts of Interest: While CAA 2021 specifically prohibits conflicts ofinterest on the part of SA surveyors, CMS has indicated that it intends to apply theprohibitions against conflicts of interest to AO surveyors, as well. CMS is proposing tocodify existing policy in Section 4008 of the State Operations Manual to address potentialconflicts of interest between an organization and the individual conducting a survey, and toutilize the definition of “immediate family member” currently applicable to similarprovisions in existing home health regulations.Coalition Comments: While we understand that some of the AOs currently have policiesthat address surveyor conflicts of interest, we appreciate CMS’ application of the CAA 2021provisions to all surveyors, both SA and AO. We believe that this will ensure a uniformstandard related to potential conflicts.There are some potential conflicts of interest that have not been addressed as part of thisSection, including circumstances under which a surveyor may have applied for a position ata hospice it may now be surveying. We have also heard of situations where a surveyor mayhave worked for or has a financial interest in an entity that is a competitor of a hospiceunder survey, which could impact the surveyor’s view.Coalition Recommendations: Given the breadth of potential situations where conflicts ofinterest could arise, we recommend the following: CMS should develop materials to guide a surveyor in identifying situations in whichhe/she may have a conflict of interest and guidance for survey entities regardingcircumstances under which surveyors should be permitted to disqualify themselvesfrom a survey.CMS should add surveyor conflict of interest to the CMS Hospice Surveyor TrainingModules to ensure that the subject is addressed during training.CMS should develop a surveyor “Code of Ethics” or “Attestation” relative to conflicts ofinterest to convey that surveyors are responsible for maintaining objectivity throughoutthe survey process. An attestation or agreement to a Code of Ethics should beaddressed in the CMS Surveyor Hospice Training Modules and could be signed by thesurveyor during the training process.3. Multidisciplinary Survey Teams (§ 488.1120): The CAA 2021 calls for the use ofmultidisciplinary survey teams when the hospice survey team comprises more than one6
surveyor, with at least one person being a RN. CMS is proposing that both SAs and AOsinclude diverse professional backgrounds among their surveyors to reflect the professionaldisciplines responsible for providing care to persons who have elected hospice care. Suchmultidisciplinary teams should include professions included in hospice core services, and“may include physicians, nurses, medical social workers, pastoral or other counselors –bereavement, nutritional, and spiritual.” When the survey team comprises more than onesurveyor, CMS proposes that the additional slots be filled by professionals from among theinterdisciplinary team (IDT). CMS also indicates that it would consider the potential use bysurvey entities of specialty surveyors (such as a pharmacist or registered dietitian) toaddress portions of the survey.Coalition Comments: We understand that a change of this magnitude requires that CMSconsider a range of issues, including the current makeup of survey teams utilized by varioussurvey entities and adjustments to the surveyor training to address the review process forall disciplines that could be involved in the survey process. Time may be needed for thoseentities to come into compliance with the new requirement for survey teams. Ourrecommendations follow.Coalition Recommendations: We provide the following comments and requests forclarification regarding this provision: Regarding the disciplines that should be drawn from when a hospice survey isconducted by more than one individual, CMS has referenced language from the hospiceCoPs related to the hospice IDT being comprised of “ .pastoral or other counselors –bereavement, nutritional, and spiritual.” While we understand that changes to the CoPsare not under consideration as part of this rule, we suggest that as part of any futureefforts related to the CoPs that CMS consider updating its terminology related to the IDTto reflect the specific functions ascribed to the team, which include the provision ofspiritual counseling, and ensure that the terminology is reflective of current practice inhospice care, which generally utilizes the term “chaplain” under such circumstances. it is not entirely clear from the discussion of this provision in the proposed rule whetherCMS will require use of other disciplines from the IDT when multiple surveyors areutilized. CMS’ language indicating that survey entities “should” leaves some lack ofclarity and promotes confusion about CMS intent. We seek additional guidance aroundthis issue. We strongly support use of multidisciplinary teams when more than onesurveyor is utilized for a hospice survey. It would also be helpful for CMS to clarify the application of the requirement. It appearsfrom the language that when more than one surveyor is used, the second surveyorcould also be a RN (given that nurses are part of the IDT and listed among the disciplines7
from which additional surveyors on a team can be drawn). Clarification of this pointwould be appreciated.The use of multiple disciplines as part of the survey process when more than onesurveyor is being utilized underscores the need for hospice surveyor training to bedesigned with various members of the IDT in mind. The training should be constructedusing language and concepts that are understandable to all disciplines on the IDT.Regardless of discipline, hospice surveyors must meet training and testing requirementsand be knowledgeable about end-of-life issues, including cases where “specialtysurveyors” may be utilized. When a hospice provides pediatric hospice and palliativecare, consideration should be given to identifying surveyors with pediatric serious illnessexpertise.4. Consistency of Survey Results (§ 488.1125): CAA of 2021 requires each state and HHS toimplement programs to measures and reduce inconsistency in the application of hospiceprogram survey results among surveyors. To achieve this end, CMS intends to conduct arandom sample (minimum of 5%) of validation surveys of SAs and AOs relative to hospiceprograms to determine the extent to which SA and AO surveyor findings align with federalrequirements. CMS also plans to calculate SAs’ “disparity rates” (currently calculated forAOs and published as part of an annual report to Congress) to identify the percentage ofvalidation surveys that have conditions identified by the SA reviewer that were missed bythe AO survey team. Disparity rates would be reported back to each survey entity and,under certain circumstances, require a formal corrective action plan to address disparitiesas part of the survey entity’s quality assurance program. CMS also plans to developobjective measures of survey accuracy for use as part of its efforts to improve surveyconsistency.Coalition Comments: Lack of consistency of survey results has been a long-standingconcern of the hospice community, and we strongly support efforts that will create moreconsistent understanding of survey requirements and more uniform application of thehospice CoPs. A great many factors play a role in ensuring consistency of survey results,including the training and testing the surveyor has undergone, the amount of fieldexperience the surveyor may have had working for a particular provider type, the amountof experience the surveyor has conducting provider-specific surveys, the surveyor’sprofessional health training, and the degree to which a surveyor has access to variousguidance and policy interpretations, to name a few. The degree to which disparities insurveyor experience can be addressed through other changes that CMS may initiate as partof survey process reforms (including surveyor qualifications) will contribute substantially toimprovements in survey consistency.8
Coalition Recommendations: Following are some specific recommendations related toCMS’ plans to address hospice survey consistency: While we understand the importance as part of the survey review process of identifyingsurvey deficiencies that a surveyor may have missed (calculation of a surveyor’s“disparity rate”), we believe that as part of the disparity rate, CMS should also assesswhether citations that have been imposed are actually warranted based on availableevidence. Ensuring that imposed citations are justified along with identification ofmissed deficiencies will contribute to greater survey accuracy overall.CMS should study the prevalence of errors in identification of survey deficiencies todetermine whether additional surveyor guidance or enhanced educational modules arewarranted relative to particular CoPs.Given that validation surveys are generally conducted weeks or months after a surveyhas been conducted, there is significant concern in the hospice community regardingthe ability of validation surveys to accurately identify surveyors’ errors relative toidentification of deficiencies. For this reason, we strongly recommend that CMSsupport performance of validation surveys concurrent with, or shortly after, the SA orAO survey. Where concurrent surveys are not possible, performing the validationsurvey in close succession (within a week or two) or the Sa or OA survey should beencouraged.Comprehensive, consistent, and accurate guidance for surveyors is essential toconsistency of survey findings. For this reason, we recommend that CMS developprotocols to assist surveyors in identifying deficiencies. Such protocols should indicatethat the manner and degree of an offense must be considered when assessing theappropriateness of imposition of a citation. Additionally, such protocols should conveythat a certain level of compliance is needed to demonstrate that a hospice has met thegoals of the CoPs and that a single instance of non-compliance, such as the practice of“see one, cite one”, may not be indicative of a systemic problem. Such protocols mustallow some flexibility to allow for surveyor judgment.5. Special Focus Program (SFP) (§ 488.1130): CMS proposes to establish a Special FocusProgram (SFP) for poor-performing hospicesCoalition Comments: The Coalition very much supports additional oversight andtechnical assistance to the poorest performing hospices to improve the quality ofhospice care delivered to the terminally ill. Development and implementation of aspecial focus program is complex as was identified with the implementation of suchprogram with nursing homes.9
The Coalition appreciates that CMS has proposed an SFP that does not include the statequotas and is not exactly the same as the nursing home program. Having an SFPselection system that is not centralized at the federal level leaves open the possibilitythat a poor performing hospice that should be in the program is not and likewise, that ahospice that may be a poor performer at the state level but not at the lowestperformance level nationally will be unnecessarily filling a spot in the SFP.Coalition Recommendations: The Coalition recommends a centralized selection system at the federal level. CMSshould ensure that the selection process identifies poor performing hospices are inthe program and are selected with the same criteria no matter what state theymight be in. The Coalition requests that CMS reconsider the SFP selection processbased on State priorities and consider a “level playing field” for selection for the SFPregardless of the hospice’s locationThe Coalition strongly recommends the creation of a TEP charged with informing thedetails of the SFP. CMS has asked for feedback on the possibility of utilizing a TEP toenhance the SFP in terms of selection, enforcement, and technical assistancecriteria. Due to the complexity of the SFP and potential long-term impacts, thisprogram should not be implemented until the TEP has completed its work in thisarea.The Coalition recommends that the TEP consider the following details in theirdeliberations:o SFP Eligibility: The Coalition recommends consideration be given to whethercurrent condition/standard level designations are the most helpful indetermining a hospice’s eligibility for the SFP or if a scope and severity grid forhospice deficiencies, where penalties are based on how widespread the problemis and the seriousness of the level of harm may be more appropriate. Notimeframe for the substantiated unique complaint survey or the severity of thecomplaints for the proposed eligibility criteria was identified. This should be astrong consideration in determining a hospice’s eligibility as the nature ofcomplaints can vary widely and the time between substantiated complaintsurveys could be considerable, i.e., years.o Use of Other Data for SFP Eligibility: The eligibility criteria for the SFP could bemodified in the future to incorporate the Consumer Assessment of HealthcareProviders and Systems (CAHPS) Hospice Survey star rating. Careful considerationneeds to be given to this or any other possible eligibility criteria and shouldinclude an opportunity for stakeholder input. In addition, the Coalition10
recommends that the addition of the CAHPS hospice survey star rating system gothrough the rulemaking process.o SFP Graduation: When a hospice has had two consecutive surveys under theSFP without a condition level deficiency, the hospice would graduate from theSFP. A hospice that does not improve and does not come into substantialcompliance after two consecutive surveys would be put on the terminationtrack. The Coalition recommends that the CMS request should consider TEPinput on the length of time between being put on the termination track andactual termination and what steps should be part of this process.o Promising Progress: The Coalition requests that CMS consider TEP inputregarding whether ‘promising progress’ (i.e., sale of the hospice to a companywith a strong compliance and quality of care track record) should impact thetermination decision, including steps in the process and timeframes.Services Provided under Special Focus ProgramThe purpose of the SFP is to offer technical assistance and more frequent surveys tohospice providers.Coalition Recommendation: The Coalition strongly encourages CMS to take a technicalassistance approach first — that is, an approach that is not punitive in nature but ratherprovides necessary technical assistance for providers to learn hospice best practices andconsistent compliance with Medicare regulations. Added survey frequency andsupervision will assess the hospice’s progress in this program. If improvement is notseen by reviewers in the special focus program, additional intermediate remediesshould be sought.Publicly Reported InformationFor the hospice that has entered the SFP, consideration should be given to theinformation listed on Care Compare about the hospice.Coalition Recommendation: Any graphics and details about the special focus programshould be carefully developed and discussed with stakeholders to convey informationaccurately and without undue alarm. The Coalition recommends that this issue be onthe agenda for the TEP to get stakeholder feedback and concurrence. CMS needs toalso commit to keeping this information as current as possible; if a hospice is no longerin the special focus program, the information needs to be updated accordingly in atimely fashion.11
It is not clear if the list of hospices eligible for the SFP will be displayed publicly as itcurrently is for nursing homes. If there is going to be a public list, CMS should commit toensuring that it is updated timely.3. Proposed New Subpart N – Enforcement Remedies for Hospice Programs with DeficienciesA. Proposed Additions to Enforcement Remedies: Beyond the enforcement remedies required inthe CAA 2021, CMS is proposing the addition of a directed plan of correction and directed inservice training. The Coalition appreciates and supports these proposed additions as they maybe some of the most effective remedies for long term improvement and it aligns the remedieswith those available in home health.Unlike home health, there is currently no dispute resolution process available to hospices forcondition-level deficiencies. Clear guidance for surveyors is also missing on when to cite ahospice at the condition level.Coalition Recommendation:Considering the seriousness of the proposed consequences of condition level deficiencies andthe history of deficiencies for hospices, the Coalition recommends a dispute resolution processbe available to hospices for all deficiencies.B. Disparities in Application of Payment SuspensionCoalition Comments: As proposed, there is some disparity between provider types regardingpayment suspensions. Specifically, CMS is proposing at § 488.1240 that it may suspend all orpart of the payments to which a hospice program would otherwise be entitled with respect toitems and services furnished by a hospice program on or after the date on which the Secretarydetermines that remedies should be imposed. While this language is consistent with the CAA, itis not consistent with the remedies that are in effect for home health agencies and nursing
Aug 27, 2021 · CMS will accept AO surveyor training that is currently in place as part of CMS agreement with each AO, and that SA surveyors should already be in compliance as they must currently complete a CMS-developed training and testing program. As part of the rule, CMS has pr
