Submitted Electronically RE: CMS-1609-P: ISSUE # 1: Solicitation of Comments on Definitions of Terminal Illness and Related Conditions :

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1 June 20, 2014 Submitted Electronically Ms. Marilyn B. Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services 200 Independence Avenue, SW Washington, DC RE: CMS-1609-P: Medicare Program; FY 2015 Hospice Wage index and Payment Rate Update; Hospice Quality Reporting Requirements and process and Appeals for Part D Payments of Drugs for Beneficiaries Enrolled in Hospice Dear Ms. Tavenner: LeadingAge appreciates the opportunity to comment on this proposed regulation. The members of LeadingAge and affiliates touch the lives of 4 million individuals, families, employees and volunteers every day. The LeadingAge community ( includes 6,000 notfor-profit organizations in the United States, 39 state partners, hundreds of businesses, research partners, consumer organizations, foundations and a broad global network of aging services organizations that reach over 30 countries. The work of LeadingAge is focused on advocacy, education, and applied research. We promote home health, hospice, community-based services, adult day service, PACE, senior housing, assisted living residences, continuing care communities, nursing homes as well as technology solutions and person-centered practices that support the overall health and wellbeing of seniors, children, and those with special needs. We provide comments below on the following sections of the proposed rule: Definitions of Related Conditions; Process and appeals for Part D payment for drugs while beneficiaries are under a hospice election; Future development of the Hospice Quality Reporting Process; Public Availability of Data Submitted; Proposed Adoption of the CAHPS Hospice Survey for the FY 2017 Payment Determination; Adoption of Electronic Health Records by hospice agencies; Timeframes for filing the Notice of Election and Notice of Termination/Revocation; and the proposed changes to the Hospice Election form. ISSUE # 1: Solicitation of Comments on Definitions of Terminal Illness and Related Conditions : We agree there is a need to improve the definition of related conditions in order

2 Page 2 to strengthen and clarify the current concepts of hospice care under the Medicare hospice benefit. CMS clinical collaborative effort solicits comments on the following definitions: TERMINAL ILLNESS: Abnormal and advancing physical, emotional, social and/or intellectual processes which diminish and/or impair the individual s condition such that there is an unfavorable prognosis and no reasonable expectation of a cure; not limited to any one diagnosis or multiple diagnoses, but rather it can be the collective state of diseases and/or injuries affecting multiple facets of the whole person, are causing progressive impairment of body systems, and there is a prognosis of a life expectancy of six months or less. RELATED CONDITIONS: Those conditions that result directly from terminal illness; and/or result from the treatment or medication management of terminal illness; and/or which interact or potentially interact with terminal illness; and/or which are contributory to the symptom burden of the terminally ill individual; and/or are conditions which are contributory to the prognosis that the individual has a life expectancy of 6 months or less. COMMENT: LeadingAge believes that longstanding, pre-existing conditions; and comorbidities and the maintenance of comorbidities should not be considered related conditions. We have no recommendations for revisions to the current definition of terminal illness. RECOMMENDATION: We request that CMS include in the definition of related conditions : Clarification that longstanding and / or pre-existing condition are excluded Exclusion of comorbidities that do not have a direct causal connection to the illness that contributed to the prognosis that the individual has a life expectancy of 6 months or less. ISSUE #2: Process and appeals for Part D payment for drugs while beneficiaries are under a hospice election: In section III.I, CMS is soliciting comments on the process that Part D plan sponsors could use to coordinate with Medicare hospices in determining coverage of drugs for hospice beneficiaries and resolving disagreements between the parties. COMMENTS: According to the Part D Payment for Drugs for Beneficiaries Enrolled in Hospice Final 2014 Guidance released on March 10, 2014, the beneficiary s appointed representative, or the prescriber has a number of ways to contact the Part D sponsor to request a coverage determination. The prescriber may provide a verbal explanation to the Part D sponsor regarding why the drug is unrelated to the terminal illness or related conditions or complete the Prior Approval form and submit it to the Part D sponsor via fax or mail. At times, the hospice provider may have to contact either the prescriber or the Part D sponsor in order to explain why the drug is unrelated to the terminal illness or related conditions. The guidance also states that the applicable adjudication time frame is 24 hours (for expedited requests) or 72 hours (for standard requests) from the time the explanation of un-relatedness to the terminal illness or related conditions is received from the hospice provider or prescriber.

3 Page 3 LeadingAge believes the problem with determining coverage responsibility may be due to the lack of understanding and consistency of the terms, Terminal Illness and Related Conditions. Additionally, the guidance CMS has given on who is responsible for paying for specific medications assumes that Medicare hospice beneficiaries will be appropriately educated at the pharmacy counter about how to secure a coverage determination from their Part D plan when prior authorization is required. Finally, LeadingAge is concerned that many Medicare beneficiaries who are denied a medication at the pharmacy counter will not receive this education and may be unaware of their appeal rights, especially since the existing standardized pharmacy notice is not tailored to situations involving hospice. This means that hospice patients, with a limited life expectancy, will lack clear, concise and targeted information about how to secure a medication when refused at the pharmacy counter. RECOMMENDATION: LeadingAge recommends the following: CMS should suspend the current policy directing Part D plans to place prior authorization requirements on all prescriptions for hospice beneficiaries. CMS needs to develop and disseminate a pharmacy notice that is tailored to situations involving hospice CMS should develop additional guidance for all Part D sponsors to follow when determining if a Medicare hospice beneficiary s medication should or should not be paid through Part D. The guidance should address the use of medications for longstanding diseases and diseases that occur due to reasons not related to the terminal illness. CMS needs to develop a dispute resolution process effective FY 2015 to address cases where the hospice provider and Part D sponsor fail to coordinate the payment for their medication benefits Hospice providers should be permitted to initiate the prior approval process before submission of a claim under Part D to avoid any issues associated with data lags or the workload associated with fulfilling prior approvals. CMS should establish and require the use of a standard Prior Approval form to facilitate the process CMS should include hospice-related complaints in the Medicare Part D sponsors star rating to identify Part D sponsors that are above the regional average for denials of payment for medications for hospice beneficiaries. ISSUE # 3: Future development of the Hospice Quality Reporting Process. CMS believes that future development of the Hospice Quality Reporting Process (HQRP) should address existing measure gaps by focusing on two primary opportunities: Expand measures already in use in other quality reporting programs that could apply to the HQRP

4 Page 4 Develop new measures if no suitable measures are ready for implementation or expansion. CMS is particularly interested in outcome measures for symptom management, particularly pain, as well as measures of patient reported outcomes. At present, it is planned to use NQF #1634 for Pain Screening and NQF #1637 Pain Assessment COMMENTS: LeadingAge is pleased the NQF 1634 Pain Screening may be completed using verbal, numeric, visual analog, rating scales designed for use with non-verbal patients, or other standardized tools. The flexibility in this screening tool will allow the hospice provider to screen for pain in verbal or non-verbal, cognitively impaired or oriented patients enrolled in hospice for 7 or more days. LeadingAge is also pleased the NQF 1637 Pain Assessment that notes the implementation of a pain assessment within 24 hours is being considered. There has been extensive research done on both of these measures. RECOMMENDATION: Although extensive research has been done on these two outcome measures, we recommend that CMS continue to ask for stakeholder input concerning the reliability and validity of the measures prior to public reporting. ISSUE # 4: Public Availability of Data Submitted. Under section 1814(i)(5)(E) of the Act, the Secretary is required to establish procedures for making any quality data submitted by hospices available to the public. The Secretary is also authorized to report quality measures that relate to services furnished by a hospice on the CMS Web site. Hospices will begin data collection in CY 2014 (Q3). The data from CY 2014 (Q3, Q4) will not be used for assessing the validity and reliability of the quality measures. Data collected by hospices during Q1 3 CY 2015 will be analyzed starting in CY Decisions about whether to report some or all of the quality measures publicly will be based on the findings of analysis of the CY 2015 data. In addition, as noted, the Affordable Care Act requires that reporting be made public on a CMS Web site and that providers have an opportunity to review their data prior to public reporting. CMS states in the proposed rule that Public reporting may occur during FY 2017, allowing ample time for data analysis, review of measures appropriateness for use for public reporting, and allowing hospices the required time to review their own data prior to public reporting. COMMENTS: LeadingAge recommends that when developing future proposals concerning public reporting of hospice quality data, CMS address the diversity in the patient characteristics of the Medicare beneficiaries being served under hospice, as well as the location of where they are being served. The diversity in Medicare hospice patient s characteristics include: Where hospice services are provided: Community hospice / Skilled Nursing Facility based hospice care Length of time in hospice: Short length of stay hospice/ long length of stay hospice Age: Pediatric/ adult and older adult

5 Page 5 Clinical condition: Neurological disorders, Cancer, etc. Availability of family support It is important that the public have a valid assessment of the Medicare beneficiaries being served by the specific hospice providers as they review the data in each quality measure. RECOMMENDATION: We encourage CMS to continue to ask for stakeholder input concerning the reliability and validity of the measures prior to public reporting in order to demonstrate the ability of the measures to distinguish between the quality of services provided. The public should have access to information on where hospice services are provided, the length of time in hospice, the age of the hospice patient, the clinical condition of the hospice patient and the availability of family support. This information should be included with the quality measures on the CMS website used to report individual hospice quality. ISSUE # 5: Proposed Adoption of the CAHPS Hospice Survey for the FY 2017 Payment Determination. In the Hospice FY 2015 Proposed rule, the process of adopting the CAHPS Hospice survey is described. The monthly surveys would begin on April 1, COMMENTS: LeadingAge believes this timeframe may not be sufficient to adequately finalize the survey questions, approve, train and hire vendors, complete the dry run and correct any concerns that may arise from the dry run. Our conclusion is based on the history of the implementation of the CAHPS Home Health Survey, as well as the special and complex needs of individuals served by hospice, including the terminally ill patient and the family and friends. Also, we know that primary caregivers of patients who died within 48 hours of admission to hospice care are excluded from completing the CAHPS Hospice Survey. According to the March 2014 MedPAC Commission Report to Congress, over a quarter of Medicare hospice decedents enter hospice in the last week of life, a length of stay that is thought to be less benefit to patients. 1 Growth in long-stays has slowed in recent years. LeadingAge is concerned that the data from the CAHPS Hospice Survey may vary based on how long an individual on hospice is utilizing the service. Not for profit hospices tend to have significantly lower average lengths of stay compared to for profit hospices. In 2012, the average length of stay for a for-profit hospice was 105 days compared to 69 days for not for profit hospice providers. 2 It is important that the CAHPS Hospice survey document the length of stay in order to provide an accurate picture of the caregiver s perception of the quality of care the hospice provided to meet the special and complex needs of terminally ill patients and their family and friends. RECOMMENDATION: We encourage CMS to: 1 Medicare Payment Advisory Commission, Report to the Congress: Variation and Innovation in Medicare (Washington: MedPAC, March 2014), chap ibid

6 Page 6 Determine in the dry run if the amount of time the individual receives hospice services impacts the results of the CAHPS Home Health Survey Report the results of the CAHPS Home Health Survey based on time frames, such as 7 days or less, 8 days to a month and more than a month. Consider beginning the monthly surveys in January ISSUE #6: Electronic Health Records. CMS is soliciting feedback and input from providers on topics such as decision support, whether hospices have adopted an EHR and if so, what functional aspects of the EHR do hospices find most important (for example, the ability to send or receive transfer of care information, ability to support medication orders /medication reconciliation); does the EHR used in the hospice setting support interoperable document exchange with other healthcare providers (for example, acute care hospitals, physician practices, and skilled nursing facilities? In addition to seeking public input on the feasibility and desirability of electronic health record adoption and use of HIE in hospices, CMS is also interested in public comment on the need to develop and the benefits and limitations of implementing electronic clinical quality measures for hospice providers. COMMENTS: LeadingAge finds that its hospice members that are part of a continuum of care that may include a hospital system, physician practice, home health agency, PACE, skilled nursing facility, assisted living facility and continuing care retirement community have adopted electronic health records. These not for profit hospices state that the electronic health records help them improve and maintain the continuity in communication among the various disciplines caring for the hospice patient. The plan of care and each professional s notes are easily accessible by everyone involved in the care of the hospice patient. The electronic health record is especially useful in maintaining the accuracy of medication orders and ensuring respect of patient s desires when up to date Advance Directives are maintained and exchanged. Our hospice members that are part of a continuum of care state they try to use the same EHR software vendor as the other providers in their organization, such as home health. The major barrier is that the hospice electronic health record is frequently not interoperable with the electronic health records used in the hospital or physician s office. Also, small hospices and /or hospices in rural/frontier areas tend to have lower financial margins and less access to capital in order to implement an electronic health record system. RECOMMENDATION 3 : Low-interest loan programs could be established to fund initial investment in the health IT infrastructure and accelerate EHR adoption. 3 LeadingAge CAST 2013 HER for Long-Term and Post-Acute Care: A Primer on Planning and vendor selection mer_on_planning_and_vendor_selection.pdf (June 2013)

7 Page 7 The Centers for Medicare and Medicaid Services (CMS) should provide additional funding, including payment incentives tied to quality improvement and/ or cost savings, to accelerate EHR adoption among hospice providers, particularly smaller (stand-alone) hospice providers and those operating in rural areas. Mandate the development and use of uniform standards to govern Health Information Exchange (HIE). More work is needed to create a uniform standard for electronic health information exchange so all providers are speaking the same language when they participate in statewide or regional health information networks. These uniform standards would ensure that all Continuity of Care Documents (CCD), including the Consolidated Clinical Document Architecture (C-CDA), Advance Directives, pharmacy orders and medication reconciliation documents contain common data elements and use the same vocabulary. Government officials should review and adjust regulations that inhibit the seamless exchange of electronic information. For example, regulations in some states make it difficult to transmit pharmacy orders electronically due to regulators discomfort with electronic signatures. In addition, regulations governing how patients consent to the exchange of their health information can create barriers to health information exchange. ISSUE # 7: Proposed Timeframes for Filing the Notice of Election and Notice of Termination/Revocation (a) in section VI. The regulations at (a) would be revised to require hospices to file a NOE within 3 calendar days after the effective date of election; the regulations at and would be revised to require filing of the Notice of Termination or Revocation (NOTR) within 3 calendar days after the effective date of a beneficiary s discharge or revocation, if they have not already filed a final claim. CMS is proposing that when the NOE is filed beyond this 3 day period, the hospice providers would be liable for the services furnished during the days from the effective date of hospice election to the date of NOE filing. COMMENTS: The proposed requirement to file a Notice of Election with its Medicare claims processing contractor within 3 days after the effective date of the election statement and the requirement to file a Notice of Termination of Election within 3 days is an issue for small and/or rural/frontier hospice agencies. RECOMMENDATION: We encourage CMS to consider revising this date to 7 calendar days to allow for small, rural and frontier hospice agencies that may have limited administrative staff available to meet the proposed reporting requirement timely.

8 Page 8 ISSUE # 8: Proposed Changes to the Election Statement ( ) - Including the attending physician on the Hospice Election form. The Medicare Audit Contractors are reporting that the NPI of the attending physician was sometimes changed, and was different from the NPI reported on the Notice of Election. CMS is proposing that the election statement include the patient s choice of attending physician, if the individual wants to change the attending physician, they must file a signed statement identifying the new attending physician and the effective date. COMMENT: Over a third of hospice patients have had multiple providers submit Part B claims as the attending physician using a modifier. It is common practice that the patient s primary care physician may be the attending physician ordering hospice, but the primary care physician refers to a specialist, such as an oncologist for ongoing coverage. Having multiple physicians involved in the patient s treatment does not necessarily mean that the hospice patient did not choose the attending physician that would be writing the orders for hospice services. There is no indication that having multiple physicians reported on the Notice of Election is not in line with the Hospice Condition of Participation stating that the hospice patient chose the attending physician. RECOMMENDATION: LeadingAge recommends that CMS wait until the adoption of the CAHPS Hospice Survey and more data is available to determine the patient s and caregiver s satisfaction with hospice services, including their choices of attending physician. We also believe that legislation needs to be passed that will increase the frequency of surveys of hospice providers. Adding more information to the Election statement, as well as increasing the number of documents that need to be signed by the hospice patient is not the most efficient and accurate method of ensuring the hospice patient is choosing the physician that will order the hospice care. Feedback from patients and caregivers and oversight through the survey process is a more effective way of ensuring that the Hospice Conditions of Participation choice of physician requirement is met. Again, LeadingAge appreciates the opportunity to comment on this proposed rule. We hope our comments will be helpful to you. Please do not hesitate to contact us if you have any questions or would like further discussion. We look forward to our continued work with you on this and related issues. Sincerely, Cheryl Phillips, MD Senior VP Public Policy and Advocacy