Re: File Code CMS-4157-FC. Submitted electronically via

P a g e 1 1201 L Street, NW, Washington, DC 20005 Main Telephone: 202-842-4444 Main Fax: 202-842-3860 www.ahca.org Neil Pruitt, Jr. CHAIR UHS-Pruitt Corporation Norcross, GA Leonard Russ VICE CHAIR Bayberry Care Center New Rochelle, NY Lane Bowen SECRETARY/TREASURER Kindred Healthcare Louisville, KY Ted LeNeave EXECUTIVE COMMITTEE LIAISON American HealthCare, LLC Roanoke, VA Robert Van Dyk IMMEDIATE PAST CHAIR Van Dyk Health Care Ridgewood, NJ Orlando Bisbano, Jr. Orchard View Manor Nursing & Rehabilitation Center East Providence, RI Tom Coble Elmbrook Management Company Ardmore, OK Phil Fogg, Jr. Marquis Companies Milwaukie, OR Robin Hillier Lake Point Rehab & Nursing Center Conneaut, OH Richard Kase Cypress Health Care Management Sarasota, FL Tim Lukenda Extendicare Milwaukee, WI Frank Romano Essex Health Care Rowley, MA Gary Kelso NOT FOR PROFIT MEMBER Mission Health Services Huntsville, UT Mike Shepard NCAL MEMBER Shepard Group Mena, AR Steve Ackerson ASHCAE MEMBER Iowa Health Care Association West Des Moines, IA Shawn Scott ASSOCIATE BUSINESS MEMBER Medline Healthcare Mundelien, IL Mark Parkinson PRESIDENT & CEO June 9, 2012 Ms. Marilyn Tavenner Acting Administrator Center for Medicare & Medicaid Services Department of Health & Human Services Room 445-G, Hubert H. Humphrey Building 200 Independence Ave., SW Washington, DC 20201 Re: File Code CMS-4157-FC Submitted electronically via http://www.regulations.gov Dear Administrator Tavenner: The American Health Care Association (AHCA) appreciates the opportunity to comment on the questions posed by the Centers for Medicare & Medicaid Services (CMS) relating to the Independence of Long Term Care Consultant Pharmacists, and published in Federal Register Volume 77, Number 71, pages 22100-22107 (April 12, 2012). AHCA represents nearly 11,000 non-profit and proprietary skilled nursing and assisted living facilities dedicated to continuous improvement in the delivery of professional and compassionate care provided daily by millions of caring employees to 1.5 million of our nation's frail, elderly and disabled citizens who live in long term and post-acute care facilities. General Comments AHCA fully supports the goal of ensuring that facilities, pharmacists and physicians work collaboratively to ensure that all use of medications in nursing facilities is appropriate and in the best interest of the resident. We also support and look forward to collaborating with CMS and other stakeholders in the improvement and further development of measures designed to facilitate continuous quality improvement with regard to medication management and to contribute to ensuring the best possible care for individuals served in skilled nursing facilities. As such, we fully support the Advancing Excellence in America s Nursing Homes Campaign s new goal to ensure appropriate medication prescribing. Currently over 60% of our members have joined the Advancing Excellence campaign, which has over 50% of all nursing facilities in the country signed up and CMS as an active participant in its leadership. 1

Off-label use of antipsychotic medications in nursing facilities AHCA recognizes the growing nationwide concern regarding the potential risks of offlabel use of antipsychotic drugs for elderly individuals with dementia. In recognition of current clinical practice standards and in response to this concern, AHCA has implemented a quality initiative among its members that incorporates four specific clinical and operational goals, one of which is to safely reduce off-label use of antipsychotics by 15% by the end of this year. AHCA members are embracing this initiative and implementing strategies to ensure that antipsychotic use in this setting is appropriately minimized. AHCA is also working actively with CMS and a broad array of stakeholder groups to support facilities in implementing best practices around personcentered care for persons living with dementia to improve quality of life while minimizing the use of antipsychotics whenever possible. Current regulations and Guidance to Surveyors AHCA notes that nursing facilities currently operate under an extensive set of regulations, which we believe provide CMS with sufficient authority to address the issues identified in this rule without the need for additional rulemaking. New regulatory requirements will only serve to increase regulatory burden on this sector of providers and seems contrary to the expressed desire to ensure that regulations are not unnecessarily burdensome beyond what is required to meet essential objectives. If CMS perceives that these current requirements are not achieving their intended objectives, we recommend beginning with a thorough root cause analysis, consistent with the Quality Assurance Performance Improvement (QAPI) framework that CMS has articulated for nursing facilities and other healthcare providers to determine why this is and what actions are required to address the root causes. Adding to the already lengthy list of regulatory requirements addressing the issues of medication management, pharmacy and physician/medical Director services, quality of care and quality of life without first assessing why the current regulations are not achieving the intended effect is unlikely to result in significant changes in processes or outcomes. This approach is the equivalent of creating a second checklist to check to see if the first check list is being completed rather than understanding why the first checklist is not being used correctly. We discuss a number of these existing regulatory provisions below. 483.60(b), Pharmacy Services (F425) and 483.60(c), Drug Regimen Review (F428) and the associated Guidance to Surveyors, respectively, specify the intent of these requirements as, the licensed pharmacist helps the facility identify, evaluate, and address/resolve pharmaceutical concerns and issues that affect resident care, medical care, or quality of life and to assure, the facility maintains the resident s highest practicable level of functioning and prevents or minimizes adverse consequences related to medication therapy to the extent possible The pharmacist serves a critical role in assisting the facility, which is working to deliver such assurance. AHCA believes that the regulation and the associated Guidance to Surveyors, which delineates CMS expectations of the pharmacist in the Review process, provide adequate support for CMS 2

to deal with potential conflicts of interest on the part of the consultant pharmacist that may exist in some facilities. In addition to the regulations that govern the work of the consultant pharmacist, the role of the attending physician is also clearly delineated in existing regulations, in 483.40(b), Physician Visits (F386), which states that the physician must, review the resident s total program of care, including medications and treatments, at each required visit Guidance to Surveyors for this section identifies its intent as, to have the physician take an active role in supervising the care of residents. This should not be a superficial visit, but should include an evaluation of the resident s condition and a review and decision about the continued appropriateness of the resident s current medical regime. Further, 483.75(i), Medical Director (F501), requires the nursing facility to designate a physician to serve as medical director. The medical director is responsible for, (i) implementation of resident care policies; and (ii) the coordination of medical care in the facility. Guidance to Surveyors for this section states that, The medical director is responsible for coordination of medical care in the facility. The medical director helps coordinate and evaluate the medical care within the facility by reviewing and evaluating aspects of physician care and practitioner services, and helping the facility identify, evaluate, and address health care issues related to the quality of care and quality of life for the residents. A medical director should establish a framework for physician participation, and physicians should believe that they are accountable for their actions and their care. The Guidance further specifies that areas for medical director input to the facility may include, facilitating feedback to physicians and other health care professionals about their performance and practices; reviewing consultant recommendations; discussing and intervening (as appropriate) with a health care practitioner about medical care that is inconsistent with applicable current standards of care. In addition to the above-referenced requirements related to the professional services of pharmacists and physicians, existing nursing facility regulations also stipulate that: (1) each resident s drug regimen must be free from unnecessary drugs ( 483.25(l), Unnecessary Drugs); (2) the resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident s medical symptoms ( 483.135(a) Restraints); and (3) that each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care ( 483.25, Quality of Care). Finally, under 483.75(o), Quality Assessment and Assurance, the nursing facility is required to maintain a quality assessment and assurance committee. Per the Guidance to Surveyors for this section, the committee s responsibilities include, continuous evaluation of facility systems with the objectives of: keeping systems functioning satisfactorily and consistently including maintaining current practice standards; preventing deviation from care processes from arising, to the extent possible; discerning issues and concerns, if any, with facility systems and determining if issues/concerns are identified; and correcting inappropriate care processes. Prior to contemplating the imposition of additional regulatory requirements to address the perceived problems CMS identifies, we recommend careful consideration of ways in 3

which to better ensure effective evaluation of compliance with existing rules through the current survey process. Current Practice and Constraints The nursing facility and long-term care pharmacy industries have taken a number of voluntary steps to address potential conflicts of interest in order to ensure that actions taken are in the best interests nursing facility residents. Over the last 10 or more years, the majority of LTC pharmacies have transitioned to service agreement models for LTC facility clients that include separate contracts for consulting pharmacist services and pharmacy dispensing services. Still more are working toward implementing separate service agreements with LTC facilities. A major hurdle in moving toward this service agreement model is the insufficient number of independent consultant pharmacist providers and the financial investment required by the industry to establish a national service capability. As Medicare and Medicaid reimbursement to nursing facilities continues to decline, the ability to pay for consultant pharmacist services at higher market-based rates becomes increasingly difficult. As AHCA noted in our December 12, 2011 comments on the proposed rule, if CMS were to build Pharmacy consultant fees at market-based rates into skilled LTC facility reimbursement rates, we expect that residents/patients would experience increased medication safety and improved quality. For example, if LTC reimbursement rates were increased by $25 - $40/per patient/per month, CMS could impose a meaningful admission review requirement of each resident s/patient s medications resulting in improved medication safety and quality. A consultant pharmacist could thoroughly review the medications and the resident s/patient s condition and diagnoses, then make informed recommendations regarding the prescribed medications and discussing these recommendations in person with the attending physician. The end result, according to many providers, could save money for all payors (e.g., by using fewer medications and/or less expensive medications that are equally effective), improve resident/patient care, and improve patient outcomes. The American Society of Consultant Pharmacists (ASCP) has developed and promoted tools for assisting consultant pharmacists and LTC pharmacies with improving transparency, including sample service agreements for consultant pharmacist services and LTC pharmacy services, a sample disclosure statement and a sample integrity agreement that can be used with LTC facility clients. AHCA supports the use of these tools. Following are AHCA s specific responses to the questions posed by CMS in the request for comments contained in the material published in the FR. 1. What actions/steps should be taken to strengthen attending physician (and other prescribers) medication management and prescribing practices to ensure the best quality of care for the nursing home resident? AHCA recognizes the critical role that attending physicians and Medical Directors play in ensuring that patients/residents in nursing facilities receive all necessary and appropriate medical care to support their ability to attain and maintain their highest practicable level of well-being. Given the increasing acuity and medical complexity of 4

individuals receiving services in skilled nursing facilities, the role of physicians in these settings continues to be increasingly important in providing the best possible care and services. There are numerous studies that demonstrate the need for improvement in medication management in all health care settings: hospitals, home health, physician offices. This issue is not unique to nursing facilities. For example, over half of all antipsychotic medication prescriptions in the nursing facility were present at admission. Also, there are numerous studies that show antipsychotic medication prescribing for persons with dementia is prevalent in the community and hospital setting. If CMS believes that physician medication management needs to be improved in order to improve the health of Medicare beneficiaries, we strongly encourage CMS to look at multidisciplinary strategies to address antipsychotic utilization in all settings, not just nursing facilities. This work has already been started by the Pharmacy Quality Alliance (PQA). That said, AHCA recommends several steps that could be taken to further strengthen practice specific to medication management and prescribing for this setting: Develop approved continuing education programs specific to the clinical and regulatory issues related to long-term care residents and to the elderly in general. For example, an education program targeting enhanced understanding by prescribers of the risks of antipsychotic use in the absence of a psychiatric diagnosis. It is important to note that such programs must extend to all practice settings, including those seeing elderly patients in the hospital, home care, and other settings. With the growth of the hospitalist movement, nursing facilities note that they are seeing increasing numbers of admissions of individuals who have been prescribed antipsychotics in the hospital by physicians often unfamiliar with these individuals baseline condition and with limited practice experience with geriatric patients, who at times are using antipsychotic prescriptions for their sedating effects as sleep aids as well as frequent prescribing of PRN antipsychotics, including injectables. Encourage hospitals to send information with patients at the time of transfer to a skilled nursing facility that will help the SNF physician understand why antipsychotics were ordered in the hospital, and if short term use and discontinuation might be appropriate. This would help in the SNF admission decision process and in supporting the provision of the most appropriate care for individuals upon admission to nursing facilities. Support the key elements of effective collaboration between prescribing physicians and consulting pharmacists described in a joint policy statement of The American Medical Directors Association and the American Society of Consultant Pharmacists on Physician-Consultant Pharmacist Roles and Collaboration in The Nursing Home. Encourage widespread use of existing medication management education, tools, and resources for all prescribers, direct care staff and members of the interdisciplinary team treating patients in nursing facilities. Support collaborative efforts to revise existing tools, resources and guidelines and to develop new ones as necessary for all prescribers and consultant pharmacists serving this population, in nursing facilities as well as in hospitals and community 5

settings, including clinical pathways for medication use in the elderly, focusing on the primary medications identified in Section N of MDS 3.0. 2. What is and should be the role of the nursing home medical director in overseeing the attending physician (or other prescribers) medication management activities? In his or her capacity and in accord with the responsibilities outlined in the existing regulation and Guidance to Surveyors discussed above, the Medical Director should coordinate all aspects of medical care in the facility, including medication management. The Medical Director s active role in ensuring the quality of medical care and services is critical to the overall quality of care and quality of life of patients/residents. With regard to medication management in particular, the Medical Director s role should include: Setting appropriate expectations for effective medication management through development of policies and procedures; Providing education to attending physicians; Ongoing review of the quality of medical care in the facility, including appropriateness of prescribing practices and responses to consultant pharmacist recommendations by attending physicians; Involvement in the QAA/QAPI process to understand root causes and rationale for greater than normal variances in use of medications not generally recommended; Serving as a resource for education of all clinicians responsible for care and services in the facility with regard to appropriate medication use. As stated earlier, CMS should look at why this existing regulation is insufficient rather than creating new regulations or requirements. 3. What actions, if any, should the medical director take when attending physicians (or other prescribers) fail to engage in appropriate/adequate medication management activities? The existing regulations and Guidance to Surveyors discussed previously, which outline the accountability of the Medical Director for coordination of medical care in the facility, should guide the actions of Medical Directors in these circumstances. Facility policies and procedures, rather than more prescriptive regulatory requirements, should outline detailed action steps as well as roles and responsibilities of the Medical Director and others (Administrators, Directors of Nursing, etc.) when the prescribing/medication management activities of attending physicians do not comply with established standards of practice or evidence-based prescribing practices. Also, most state Medical Boards and state physician licensure laws require physicians to report to the Medical Board when they are aware of other physicians not meeting clinical standards. We encourage CMS to work with the Federation of Boards of Medical Licensure on developing educational material and policies to address this concern. 4. What actions/steps could be undertaken to establish and ensure the independence and effectiveness of a consulting pharmacist in conducting their medication reviews on behalf of nursing home residents? 6

AHCA recommends a number of possible actions to ensure the independence and effectiveness of consulting pharmacists: Implementation of a conflict of interest disclosure statement within contracts between the pharmacist and the nursing facility provider. Consultant pharmacists should provide nursing facility clients with disclosure statements identifying any financial relationships that may give the appearance of conflicts of interest and affirmation that all recommendations are free from bias. The ASCP approved a Code of Ethics for consultant pharmacists in February 2010. This Code may also provide language or concepts that could be incorporated into disclosure statements. Upon request or as part of direct dialogue between a consultant pharmacist and prescriber, consultant pharmacists may provide independent documentation which supports a recommendation for changes to an LTC resident s medication regimen, especially in cases where the change may be to a more expensive drug that may or may not result in a higher profit for the pharmacy. 5. What training and best practice models would assist all nursing home staff to better understand behavior signs and symptoms and respond appropriately and effectively in assisting and caring for nursing home residents? AHCA member facilities have been and continue implementing numerous best practices to improve care for persons with dementia and reduce negative behavioral expressions while minimizing use of antipsychotic drugs. These include but are not limited to: AHCA has made a number of resources available to our membership in connection with our Quality Initiative to foster best practices with regard to appropriate use of antipsychotic drugs, gradual dose reduction and discontinuation, and processes to ensure that non-pharmacological alternatives have been implemented prior to initiating antipsychotic drug use. These include nursing processes and nurse-physician communication tools to support gradual dose reduction, staff training programs, and a suite of tools developed by the University of Iowa with support from the Agency for Healthcare Research and Quality, designed to help clinicians, providers, and consumers better understand, assess and address challenging behaviors in people with dementia using evidencebased approaches. The Advancing Excellence in Nursing Homes Campaign has also compiled an extensive set of resources available to all nursing facilities nationwide to support quality improvement efforts designed to reduce the off-label use of antipsychotic drugs. CMS could and should provide more financial support to Advancing Excellence. Implementing proactive multidisciplinary reviews (Social Services/nursing/Director of Nursing/Administrator) of any new order for an antipsychotic or a newly admitted resident with an antipsychotic order in place to determine whether all possible alternative approaches have been exhausted and to promptly assess the appropriateness of drug treatment. Education for all care-related staff related to the risks and benefits of antipsychotic medication for persons with dementia demonstrating challenging behaviors. 7

Educational interventions to help staff better interpret and respond to behavioral expressions as communication of unmet needs. For example, improving understanding of best practices in pain management and ways to recognize that a change in behavior can be indicative of pain. Staff training in recognizing and responding to physical needs of pain, hunger, thirst, boredom, and loneliness in addition to responding to emotional, mental, and spiritual needs are core components of many person-centered care initiatives striving to change the culture of nursing home care being implemented across the nation. Improved access to mental health professionals to provide education/training to staff and assist in developing individualized care plans. Training in best practices for care planning to document the effectiveness of responses to challenging behaviors, both with and without the use of medications. 6. What data are needed to enable and support the Medicare and Medicaid programs and others in monitoring the appropriateness and adequacy of medication management activities, including the use of antipsychotic drugs? Existing regulatory requirements and Guidance to Surveyors provide surveyors with the tools necessary to review consultant pharmacist reports in order to evaluate the appropriateness of medication therapies. Measures that could be used to examine outcomes potentially associated with adequacy of medication therapy management as indicators of effectiveness may include: o MDS-based measures currently in development by CMS targeting offlabel use of antipsychotic drugs o Potential measures that could be developed cross-referencing antipsychotic use to other outcomes such as falls with major injury, ADL decline, urinary incontinence, weight loss, and presence of pressure ulcers to identify and monitor trends. Making Part D data that is linked with data on beneficiary setting of care (e.g nursing facility, home health, etc) available for feedback reports to physicians as well as health care facilities could also provide valuable information to help affect physician prescribing. 7. What data are needed to enable CMS to study the effectiveness of consultant pharmacist medication reviews? The Pharmacy Quality Alliance is currently working with an expert panel and industry stakeholders to evaluate and recommend appropriate data and metrics for studying the effectiveness of pharmacist medication reviews. AHCA recommends that CMS consider the outcomes of this process prior to making any independent determinations about data and measures needed for this purpose. 8. What data are needed to create public performance metrics regarding the independence of consultant pharmacists and prescribers from pharmacies and drug manufacturers/distributors? 8

Data on compliance with existing regulatory requirements discussed previously that incorporate performance expectations and responsibilities for consultant pharmacists and prescribers are currently available to the public, as are all survey findings. AHCA does not support additional public reporting of metrics regarding the independence of consultant pharmacists and prescribers. Although there is value in sharing this information with parties directly responsible for and being impacted by medication management activities, it is unclear how making this information public will improve patient/resident outcomes or the performance of consultant pharmacists, prescribers or LTC facilities. We do not know what information, if any, can be used by parties with no direct role on a patient s care plan to improve that patient s outcome or the leverage better performance. We are further concerned that such information could be taken out of context and misrepresented, misinterpreted, or misunderstood by members of the public. 9. Are data needed on the number and type of interventions recommended by consultant pharmacists and on the outcomes of those recommendations? If so, how could such data be used and by whom? Counting numbers of yesses and nos in the response of one health care provider to another s recommendations will not give us meaningful information on the quality of these recommendations nor the responses to them. The only valid measurements of effectiveness of are the outcomes in quality of care and quality of life, which are at the core of existing regulations and the nursing facility survey process. This question implies the need to strengthen compliance with a specific required process of care (consultant pharmacist review and recommendations) rather than focusing more on the actual prescribing or outcomes. We recommend focusing efforts on making sure appropriate prescribing and outcomes occur rather than on how consultant pharmacists make their recommendations. 10. What specific details regarding the financial (and other) arrangements between LTC facilities, consultant pharmacists, and LTC pharmacies providing consulting and/or dispensing services should be disclosed, and to whom should this information be available? CMS already has ample authority and ability to secure financial information under current rules. AHCA supports transparency for all providers in all settings responsible for direct patient care. There is no rationale for requirements in this setting to exceed those posed in any other health care settings. As discussed in response to question #4, we support the development and use of disclosure statements addressing any potential conflicts of interest, which should be available for CMS to review. 11. Should the public be informed of financial and other arrangements between LTC facilities, consultant pharmacists, and LTC pharmacies providing consulting and/or dispensing services? If so, what metrics could be used? 9

We do not support making publicly available information pertaining to contracts and financial arrangements between nursing facilities, consultant pharmacists and prescribers. It is unclear how making this information public will improve patient/resident outcomes or the performance of consultant pharmacists, prescribers or LTC facilities. It is unknown how this information can be used by parties with no direct role in developing a patient care plans to improve outcomes or leverage better performance. We are further concerned that such information could be taken out of context and misrepresented, misinterpreted, or misunderstood by members of the public. It is also unclear why consultant pharmacists in the long term care setting should be singled out for such an action, when this is an issue for numerous different types of providers in numerous different settings. If CMS believes this requires reporting, then it should apply in all settings, not just the long term care setting. 12. What information is needed to assess the independence and adequacy of physician (and other prescriber) medication management and oversight on behalf of nursing home patients? What metrics could be used to assess the adequacy and appropriateness of prescriber response to consultant pharmacist recommendations? The process of conducting medication regimen reviews (MRRs) adequately documents the information necessary to assess whether a prescriber is providing adequate and unbiased medication management. The MRR documents whether the medications prescribed are for an indicated condition, and should document whether the medication prescribed is for off-label use. Existing regulations and Guidance to Surveyors provide CMS with standards against which to assess adequacy and appropriateness. 13. What metrics could be used to describe the adequacy and appropriateness of a LTC facility s medication management program? First and foremost, the existing regulatory requirements and Guidance to Surveyors clearly articulate standards against which to assess the adequacy and appropriateness of the facility s medication management program. The entire survey process is structured to determine practice and compliance as it relates to quality of care and quality of life, as noted in our introductory comments. Additional metrics that may be considered for use as indicators may include: o Improved patient outcomes using MDS-based measures such as those discussed in response to question number six above. o Trends in percentages of dose reductions and discontinuation of antipsychotics and other drugs. o Reduced rates of off-label use of antipsychotics or reduced rates of offlabel use of antipsychotics without evidence of prior unsuccessful nondrug intervention. 14. Describe the incentives and other arrangements that create the conflict of interest in LTC that contributes to overutilization and inappropriate drug use in LTC 10

facilities. How can the conflict of interest stemming from these incentives and arrangements be contained or eliminated? We support increasing transparency through the disclosure of conflicts of interest to support all professionals in all health care settings acting in the best interest of their patients and clients when making their recommendations and treatment decisions. AHCA appreciates the opportunity to provide these comments and looks forward to working with CMS and other stakeholders to constructively and collaboratively address the concerns identified in the Federal Register in ways that will support and foster the best possible quality of care for the individuals served in nursing facilities while ensuring that regulatory requirements are not unduly burdensome or excessive to meet their intended purposes. Sincerely, Ruta Kadonoff, MA, MHS Vice President, Quality and Regulatory Affairs 11