Summary. Page 1 of 10

Page 1 of 10

Final ACO rule adopts ANA recommendations on patient-centered care and

nursing leadership

Other nursing recommendations acknowledged & integrated to improve ACO success

Summary

ANA is pleased that the Centers for Medicare and Medicaid Services (CMS) leadership clearly heard the voice of nursing in revising its final rules on the design and implementation of Medicare Accountable Care Organizations (ACOs) that were made available to the public on October 20, 2011 (Federal Register

publication slated for November 2nd).

Several of the recommendations that ANA and partner nursing organizations submitted in their comment letters on the proposed ACO rule were adopted in whole or in part. Of special note are changes that reflect the value of nursing to the ACO, patients’ freedom of choice of primary care provider, and nursing leadership the areas of quality and process improvements. Key areas needing improvement continue to be the common understanding and assessment of care coordination, its value, and the necessity of qualified healthcare professionals – especially RNs -- to provide it.

ANA’s goals in influencing the final ACO rule have been for CMS to:

1. Acknowledge registered nurses’ (RNs) leadership in care coordination and patient-centered care, based on their core competencies of practice and demonstrated through countless innovations in care delivery that improve patient outcomes, and savings;

2. Recognize and deploy NPs, CNSs and certified nurse midwives (CNMs)as essential primary care providers; and

3. Create financial and systemic incentives for the design and implementation of care coordination systems that recognize and measure RNs’ integral contribution to quality care improvement. Highlights of a few of the important wins are described below in a little more detail. This is followed by a summary list of ANA’s recommendations on the proposed rule (with page references to ANA’s May 31st comment letter on the proposed rule) compared to CMS’s response in the final rule. More exhaustive evaluation of the final rule and its implications for nursing is still underway by ANA’s policy experts. Links to these resources are as follows:

ANA letter (5/13/2011) – comments on proposed rule

http://www.nursingworld.org/ACOcomments

CMS Fact Sheets for final ACO rule (10/20/2011)

https://www.cms.gov/apps/media/fact_sheets.asp

Final ACO rule (10/20/2011):

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Highlights

While nursing’s input improved multiple provisions appearing in the final ACO rule, a few standout issues will particularly affect the profession’s direct contribution to the success of patient-centered care within ACOs.

Issue in the proposed rule: Patient choice of providers - Assignment of Beneficiaries

CMS ADOPTS ANA RECOMMENDATION – Under the final rule, Medicare beneficiaries who get most of their primary care services from a nurse practitioner (NP) or clinical nurse specialist (CNS), will be able to continue that relationship within the ACO (presuming, of course, that the NP or CNS is in the ACO). The changed rule still requires a threshold physician visit for primary care, but avoids the problem of assigning/aligning a Medicare beneficiary to an ACO based on just a few primary care ACO physician visits when that beneficiary has received most of his or her primary care from an NP, PA or CNS or even a specialist physician within the ACO. In finding a way to recognize a beneficiary’s true primary care provider, this change achieves the goal of continuity of care and honors patients’ free choice of providers.

In its comments, CMS specifically quoted ANA’s rationale at length to support this change. CMS noted, in a paraphrase of ANA’s argument, that: “NPs, PAs and clinical nurse specialists (CNSs) have a well-established record of providing high quality and cost-effective care. We also agree that these practitioners can be significant assets to the ACO in the areas of quality and cost savings, and indeed that the appropriate use of NPs, PAs and CNSs could be an important element in the success of an ACO….” Although ANA argued that all APRNs should benefit from this changed methodology, based on each group’s Medicare Part B billing for primary care services, this change represents a significant victory for nursing. (more below)

Issue in the proposed rule: Physician-centric governance and leadership

CMS ADOPTS ANA RECOMMENDATION - The Final Rule says that an ACO must have a qualified health professional responsible for the ACO’s quality assurance and improvement program. Earlier proposed language permitted only a physician to lead such efforts, precluding other appropriately qualified healthcare professionals, including RNs, from assuming these roles. This change, urged by ANA, is a further step toward meeting the recent Institute of Medicine’s Future of Nursing report recommendation that “nurses should be full partners, with physicians and other health care professionals, in redesigning health care in the United States.” (more below)

Issue in the proposed rule: Patient-centeredness principles required internal processes to measure only physicians’ clinical or service performance.

CMS ADOPTS AND EXPANDS ANA RECOMMENDATION – ANA argued against the proposed rule’s measurement of only physicians’ clinical or service performance in the ACO, a limitation that effectively hobbled any efforts for ACOs to improve overall care and service for patients over time.

Page 3 of 10 ACO recommended that at least RNs be included in such measurement. The final rule expands ANA’s recommendation to include all care providers and suppliers in the ACO to be subject to quality and cost measures. This allows for a more accurate evaluation of the quality, contributions and value of interdisciplinary patient care, providing feedback for future improvements. (more below)

Improvements in the care coordination provisions of the final rule – an essential foundation for ACO success – still do not address, however, the importance of the cognitive evaluation and decision-making by qualified health professionals for care to be truly team-delivered and patient-centered. Health information technology and electronic health records are tools to help such processes; they are not a substitute for the seasoned judgment of those whose core professional competencies include care coordination: RNs.

Nurses are deeply committed to help innovative systems succeed. ANA believes that CMS’s improved rules governing ACOs are a step in the right direction. However, we believe there is considerable room for improvement. ACOs will have a much better chance of success by recognizing and rewarding nurse’s role in improving both quality outcomes for patients and efficient resource allocation within an ACO. This blind spot regarding the contribution of RNs continues to obscure what could otherwise be an essential part of a progressive transformation of healthcare.

ANA complete recommendations on proposed ACO rule and CMS’s response

Note: parenthetical references page numbers in ANA’s comment letter to CMS on the proposed rule: http://www.nursingworld.org/ACOcomments.

Parenthetical reference to page numbers in ACO final rule:

http://www.ofr.gov/(X(1)S(5l3hjavftfdrk0r44qg4iozt))/OFRUpload/OFRData/2011-27461_PI.pdf

Promoting and Supporting Coordination of Care and Patient-Centerdness

Generally

ANA Comment: ANA critiqued several of CMS’s required “patient-centeredness criteria” in the

proposed rule as being too vague for ACOs to demonstrate specific processes and standards to support patient-centeredness and care coordination.

CMS Response: Adds specificity to ACOs’ requirements for demonstrating patient centeredness, although it has not included may of ANA’s recommendations regarding identification and payment of qualified care coordinators. In the proposed rule, an ACO was required to “provide CMS with

documentation of its plans” to address various patient-centeredness criteria under four large categories (same as in final rule):

Page 4 of 10 “promote evidence-based medicine,”

“promote beneficiary engagement,”

“internally report quality and cost metrics,” and “coordinate care.”

In the Final Rule, CMS continues largely to argue for the need for flexibility in contrast to creating more prescribed elements to establish satisfaction of criteria. Overall, though, CMS creates a new overarching requirement in the final rule, so that the ACO’s formerly vague “plan” now must specifically “define, establish, implement, evaluate, and periodically update processes to accomplish” the four basic elements of patient-centered care and associated criteria.

Issue: Qualifications and Skills of Successful Care Coordinators (p. 3; ANA letter)

ANA Comment: Adopt definition of care coordination, identifying importance of qualified individual to lead.

CMS Response: There is no discussion or definition of care coordination. Issue: Transitions in Care requirement should provide more specific guidelines

ANA Comment: ANA recommended that CMS expand the guidance for transitions by requiring the same basic elements as in the closely-related “Community Based Transitional Program” section of the ACA. (pp 5-6; ANA letter)

CMS Response: ANA recommendation for a list of specific elements was rejected as too prescriptive, but CMS does add requirement for ACO to demonstrate greater specificity about accomplishing

transitions in its ACO plan. The previous proposal only required the ACO to have “processes in place (or clear path to develop such processes)”for transition of care in place, but minimal guidance. The Final Rule says that the ACO application must define the ACO’s methods to manage care throughout an episode of care and during its transitions. (p.106)

Issue: CMS should Adopt and Build on Successful Nursing-focused Models of Care Coordination (p. 6; ANA letter)

ANA Comment: Use nurse-led models of care delivery, such as the American Academy of Nursing’s “EdgeRunners” program, as a resource or guidance for ACOs

CMS Response: This was not addressed in the final rule.

Issue: Requirement to Develop Individualized Care Plans for High-risk Individuals (p.7; ANA letter) ANA Comment: Submitted specific elements that would serve as a minimum in CMS guidance, including technical support, for requirements of the care plan; noted nursing’s established record as high-quality care providers for high-risk and frail populations.

CMS Response: After reviewing various organizations’ recommendations for greater detail, CMS decided a more prescriptive approach would be premature and potentially impede innovation and the goals of this program. The final rule retains CMS’s viewpoint that ACOs should have the flexibility to establish processes that are best suited to their practice and patient population. The final rule does require an ACO to provide documentation in its application describing its plans to coordinate care. (pg 95; Final Rule) The ACO must submit a description of its individualized care program as part of its application along with a sample care plan and explain how this program is used to promote improved outcomes for, at a minimum, their high-risk and multiple chronic condition patients. The ACO should

Page 5 of 10 also describe additional target populations that would benefit from individualized care plans. (pg 106; Final Rule)

Issue: Use of HIT/Technology is a tool for coordinating care and not, in itself, care coordination ANA Comment: ANA criticized the coordination of care provisions as being overly reliant on HIT and technology as the end, rather than the means, for achieving coordination of care. (p.8; ANA letter) CMS Response: ANA CHANGE ACCEPTED. The proposed rule seemed to overlook the importance of qualified health professionals providing the cognitive evaluation and decision-making of care

coordination. Rather, it implied that the technology itself was synonymous with care coordination. The Final Rule language dispenses with the example of HIT as “care coordination” and speaks in terms of the actual integration of providers’ knowledge and decision-making.

Issue: Freedom for Patients to Seek Care from Providers/Suppliers Outside the ACO (p.9; ANA letter) ANA Comment: Supported the CMS proposed rule to prohibit an ACO from developing policies restricting beneficiary freedom of choice

CMS Response: The final rule specifically prohibit an ACO from requiring that beneficiaries be referred only to ACO participants or ACO providers/suppliers within the ACO or to any other provider or supplier, except that the prohibition does not apply to referrals made by employees or contractors who are operating within the scope of their employment or contractual arrangement to the employer or contracting entity, provided that the employees and contractors remain free to make referrals without restriction or limitation if the beneficiary expresses a preference for a different provider, practitioner, or supplier; the beneficiary's insurer determines the provider, practitioner, or supplier; or the referral is not in the beneficiary's best medical interests in the judgment of the referring party.(pg 656; Final rule) Issue: Documentation for ACOs may become burdensome and divert healthcare professionals from delivering care (p.10; ANA letter)

ANA Comment: Balance the need for documentation with the need to assure healthcare professionals are able not diverted from the delivery of care

CMS Response: CMS acknowledged concerns from many organizations and individuals that additional administrative burden could divert health professionals from the delivery of care. CMS noted that where possible it has tried to reduce or eliminate prescriptive or burdensome requirements that could discourage participation in the Shared Savings Program. (pg 11; Final rule)

Issue: Physician-centric governance and leadership

ANA Comment: Leadership pertaining to governance and quality issues within the ACO is exclusive to physicians and does not permit appropriately qualified health professionals, includingRNs, to assume such roles. (p. 10-12; ANA letter)

CMS Response Part 1: ANA CHANGE #1 ACCEPTED– The Final Rule says that an ACO must have a

qualified health professional responsible for the ACO’s quality assurance and improvement program. This is a change from earlier language requiring a “medical director” who is a “board-certified

physician.” (p.637; Final Rule)

CMS Response Part 2: ANA CHANGE #2 REJECTED – The proposed rule required that the clinical management and oversight of the ACO be by a “full-time senior-level medical director… who is a board certified physician and licensed in the State in which the ACO operates.” ANA argued that the ACA does not require a physician, therefore any “qualified healthcare professional” could lead the clinical

Page 6 of 10 management and oversight. This argument was rejected, despite the fact that there is no statutory requirement that the manager be a physician. (p.636) As in the proposed rule, the Final Rule retains the ability of an ACO to seek an exception (“an alternative leadership and management structure”) to this physician-director requirement

Issue: Patient-centeredness principles require internal processes to measure only physicians’ clinical or service performance.

ANA Comment: ANA recommended including nursing measures – process and outcomes. (p. 12; ANA letter)

CMS Response: ANA CHANGE ACCEPTED IN CONCEPT – Expanded recommendation to include all care providers and suppliers in the ACO to be subject to quality and cost measures. The Final rule requires that the ACO “develop an infrastructure for its ACO participants and ACO providers/suppliers to internally report on quality and cost metrics that enable the ACO to monitor, provide feedback, and evaluate its ACO participants and ACO providers/suppliers performance and to use these results to improve care over time.

Quality of Care Issues

Issue: Measures to Assess the Quality of Care Furnished by and ACO (pp. 13-16; ANA letter) ANA Comment: The number of measures (65) are burdensome and should be reduced

CMS Response: Based on many commenters' recommendations, CMS determined there will be 33 final, required quality measures, which will be scored as 23 measures. CMS was sensitive to the concerns raised by commenters regarding the administrative burden of the proposed measures, and modified the proposal by reducing the number of required measures by removing measures perceived as redundant, operationally complex, or burdensome it retains those that would still demand a high standard of ACO quality, focus on priority areas and are areas of high prevalence and high cost in the Medicare

population. These domains have been modified and care coordination and patient safety are combined into one domain resulting in 4 rather than 5 domains. [Note: Table 1 starting on page 324 of Final Rule provides a list of the final measures.]

ANA Comment: Proposed rule vague about patients making improvements but still not meeting a measure’s optimal requirements. (pp. 13-14; ANA letter)

CMS Response: CMS noted a comment made by ANA that factors outside the control of an ACO may affect an ACO's quality measure performance, such as the patient's right to decide whether he or she will follow recommendations of health care professionals. CMS agreed that the personal preferences of beneficiaries play an important role in their health behaviors. However, it also commented that the lack of patient adherence may also represent a legitimate dimension of care, as it could be indicative of poor communication between ACO providers/suppliers and their patients. (pg 266; Final Rule). Ultimately, no revision has been made to address this issue.

ANA Comment: Recommended changing the quality scoring methodology to give more weight to measures categories “Domain 1 (Patient/Caregiver Experience)” and “Domain 2 (Care Coordination)” to reflect that they are the foundation for the success of the other domains that address process and outcomes. Also suggested that CMS include NQF Measure Application Partnership (MAP) – of which ANA is a member -- as guide for prioritizing measures. (p. 14; ANA letter)

Page 7 of 10 CMS Response: CMS did not address.

ANA Comment: CMS should evaluate if a potential measure relates to care across the continuum. (pp.14-15; ANA letter)

CMS Response: CMS agrees that the quality measures should be tested, evidence-based, target

conditions of high cost and high prevalence in the Medicare population, reflect priorities of the National Quality Strategy, address the continuum of care to reflect the accountability that ACOs accept for their patient populations, and align with existing quality programs and value-based purchasing initiatives. At this time, CMS concludes that it is most appropriate to focus on quality measures that directly assess the overall quality of care furnished to beneficiaries. It is adopting a measurement set that includes patient experience, outcomes, and evidence-based care processes. (pg 260; Final Rule)

ANA Comment: Recommended that quality measures reflect the interprofessional composition of the ACO, particularly the contribution of RNs. Consolidate/augment measures of patient/caregiver experience by using the CAPHS ® Hospital and Home Health Care Survey and supplement the Clinician/Group CAPHS® Survey to evaluate the care of nurse practitioners. (pp.15-16; ANA letter) CMS Response: Noting ANA’s comment, CMS stated that CAHPS does not adequately capture the team care experience of an ACO and suggested adding specific supplemental questions to CG-CAHPS. (pg 268) CMS commented it does not believe the hospital CAHPS is appropriate as a Shared Savings Program tool at this time, since not all ACOs will include a hospital. (p. 270; Final rule). Use of the Home Health Care survey is not addressed.

ANA Comment: Consider important measures that identify the quality of care contributions by interdisciplinary teams and registered nurses at the individual and population level. (p. 16; ANA letter) CMS Response: CMS did not respond to ANA’s comment regarding the need for a measure of the contributions of interdisciplinary teams. (p. 279; Final Rule)

ANA Comment: Over time specific measures should be added to the “core” set of measures to evaluate care that contributes to reducing avoidable readmissions and promote patient engagement. (pp. 16-18; ANA letter)

CMS Response: The ANA comment was not specifically addressed; however, CMS notes it expects to expand the measures to include other highly prevalent conditions and areas of interest, such as frailty, mental health, substance abuse, including alcohol screening, as well as measures of caregiver

experience. (pg 264) CMS also reiterated from the proposed rule that new measures would be considered in the future. (p. 316; Final rule)

Maximizing Registered Nurses’ Ability to Assist in Reducing Readmissions (p. 18; ANA letter) ANA Comment: ANA endorses the emphasis on readmissions.

CMS Response: Quality measure 8 on readmissions was retained as one of the 33 measures (p. 324; Final Rule).

ANA Comment: Public reporting should be accessible to beneficiaries to take into account health literacy and numeracy. Reports should be available in the languages commonly used by the ACO beneficiaries. An ombudsperson who can discuss the reports objectively should be available.

Page 8 of 10 CMS Response: This was not included in the comments. Health literacy was mentioned only in the context of risk-adjustment for the ACOs.

Patient Choice of Providers

Issue: Patient choice of providers - Assignment of Medicare Beneficiaries to ACOs

ANA Comment: The controversial provision in question is about how to determine the proportion of primary care services that a beneficiary must receive from an ACO in order to be assigned/aligned the ACO; the purpose is so that the ACO can be properly and fairly held accountable for the quality, cost and overall care of that beneficiary. (Clarification: It is not about whether non-physician providers can

participate in the ACO.) ANA asserted that the proposed methodology for assigning Medicare

beneficiaries unnecessarily negated primary care services provided by ACO providers other than certain primary care physicians, distorting the complete assessment of who provides a beneficiary’s care. Further, ANA argued that the Secretary of HHS had discretion to revise the assignment methodology to accommodate beneficiaries who get most of their primary care services from an NP, PA, CNS or

specialist physician. (pp. 19-21; ANA letter)

CMS Response: ANA APPROACH MODIFIED AND ACCEPTED –The Final Rule removes the proposed requirement that only a plurality of primary care services provided by an ACO primary care physician can be used to decide a beneficiary’s assignment to an ACO. CMS accepted ANA’s rationale that any primary care services provided by an ACO physician could trigger a beneficiary’s ACO assignment -- even if it was just one visit, as long as some other ACO participant provided the plurality of primary care services to that beneficiary.

This approach conforms to the statutory constraint that requires utilization of an ACO’s primary care physician services to assign a beneficiary to an ACO, but also permit the HHS Secretary to use her discretion to decide how to implement this requirement. ANA successfully argued that assignment can be made without requiring a plurality of services from the ACO primary care physician, while still preserving the ACO goal of “patient-centerdness.” This change in the assignment methodology accommodates beneficiaries who get most of their primary care services from an NP, PA, CNS or specialist physician who is in the ACO. The change avoids the problem of assigning/aligning a Medicare beneficiary to an ACO based on just a few primary care ACO physician visits when that beneficiary has received the plurality of his or her primary care from an NP, PA or CNS or even a specialist physician within the ACO. In finding a way to recognize a beneficiary’s true primary care provider, this change achieves the goal of continuity of care and honors patients’ free choice of providers.

In its comments, CMS specifically quoted ANA’s rationale at length to support this change. CMS noted, in a paraphrase of ANA’s argument, that: “NPs, PAs and clinical nurse specialists (CNSs) have a well-established record of providing high quality and cost-effective care. We also agree that these practitioners can be significant assets to the ACO in the areas of quality and cost savings, and indeed that the appropriate use of NPs, PAs and CNSs could be an important element in the success of an ACO….” Although ANA argued that all APRNs should benefit from this changed methodology, based on each group’s Medicare Part B billing for primary care services, this change represents a significant victory for nursing.

Page 9 of 10 Thus, while there is still a requirement for a threshold ACO physician visit for primary care services, NPs, CNSs and PAs who are in the ACO can continue to be their patient’s primary care provider. The rule continues to retain the overarching provision that beneficiaries are still free to seek care from any Medicare provider they want. CMS notes that “nothing in the statute *ACA+ precludes an ACO from sharing savings with NPs and other practitioners, whether or not their services are included in the assignment process.” (p. 206; Final Rule)

Issue: Use of approved charges to identify the “plurality of primary care” can disadvantage patients of APRNs (due to 15% discount from Medicare Physician Fee Schedule). (pp. 22-23; ANA letter)

CMS Response: ANA’s recommendation was discussed at length and two entire paragraphs were quoted verbatim, including a recommendation that payment should be based on the service—not on the provider. ANA recommended using RVUs to determine the plurality source of primary care rather than approved charges because NP approved charges suffer from the discount. CMS considered ANA’s recommendation to use RVUs rather than charges because use of those RVUs would retain many of the benefits of employing charges while correcting for the effects of some factors such as geographic payment adjustments to approved charges that arguably should not affect assignment. CMS decided against this recommendation since that method might not work with FQHCs/RHCs, but they will continue to consider the alternative of using RVUs as they gain experience under the Shared Savings Program.

Issue: Innovative models of community based care, for which ACOs should receive incentives, should be expanded.(pp.23-24; ANA letter)

ANA Comment: The rule should include innovative models of care led by health professionals other than physicians. The proposed rule’s financial incentives for including FQHCs and RHCs in ACOs should be expanded to include nurse managed health centers and school-based health centers. (pp.23-24; ANA letter)

CMS Response: The final rule allows both FQHCs and RHCs to independently become ACOs. This is in addition to the earlier proposal which provided ACOs financial incentives for including FQHCs and RHCs. CMS did not address nurse managed health centers or school based health centers.

Payment Reform and Goals of the ACO

Issue: Assuring adequate funding and staffing for ACO’s care coordination function and care coordinators (p. 24; ANA letter)

CMS Response: CMS did not directly respond to this recommendation. CMS indicated they have aligned their proposed documentation requests regarding clinical and administrative systems with the statutory processes of the ACA. They indicated that this streamlining of document requests addresses the commenters’ suggestions for additional detail regarding certain clinical and administrative

processes. Notwithstanding this alignment, they continue to believe that ACOs should submit certain documentation regarding their clinical and administrative systems to ensure that the ACO meets the eligibility requirements, has the requisite clinical leadership, and has a reasonable chance of achieving the three-part aim. In addition, they will use the documents to assess whether ACO participants and ACO provider/supplier(s) have the requisite meaningful commitment to the mission of the ACO. Issue: Using savings to benefit patient care

Page 10 of 10 ANA Comment: ANA supports CMS’s requirement in the proposed rule that an ACO should describe in detail its plan to meet the “triple aim” of better care for individuals, better care for populations, and lower growth in expenditures through improvements in care. CMS should tie savings back to benefiting direct patient care. (p. 25; ANA letter)

CMS Response: CMS did not directly respond to the recommendation that savings be tied to benefiting direct patient care. It did, however, reiterate and further specify that any organization that applies for ACO status must include a description of how it plans to use any shared savings payments and include how the proposed plan will achieve the general aims of better care for individuals, better health for populations, and lower growth in expenditures. ACOs, ACO participants, ACO providers/suppliers, and other individuals or entities performing functions or services related to ACO activities are prohibited from providing gifts or other remuneration to beneficiaries (as inducements for receiving items or services from or remaining in, an ACO or with ACO providers/suppliers in a particular ACO or receiving items or services from ACO participants or ACO providers/suppliers).