Articles
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June 2, 2011Submitted Electronically
Donald Berwick, M.D.
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mail Stop C4-26-05Attention: CMS–1345–P
7500 Security Boulevard
Baltimore, MD 21244-1850
Dear Dr. Berwick:
On behalf of Focus On Therapeutic Outcomes, Inc., (FOTO) I am pleased to submit comments on the proposed rule for the Medicare Shared Savings Program also known as Accountable Care Organizations (ACOs) [CMS–1345–P].
As the leading developer of quality and outcomes measurement systems for outpatient rehabilitation therapies, FOTO serves providers and facilities nationwide. For over eighteen years, FOTO has been developing, improving, perfecting and providing valid and reliable methods for the assessment of function in patients receiving outpatient physical and occupational therapy services.Using data gathered from over 3.900 clinical practice locations, FOTO has developed a robust database of over 3.1 million episodes of therapy and has advanced user-friendly, economical methods for collecting, analyzing and utilizing functional status measures in clinical decision-making. Moreover, FOTO is an approved registry for the Physician Quality Reporting System (PQRS).
Sec. 3022 of the Affordable Care Act (ACA) requires the Centers for Medicare & Medicaid Services (CMS) to establish a voluntary, three-year program “by Jan. 1, 2012 that promotes accountability for a patient population, coordinates items and services under Medicare Parts A and B, and encourages investment in infrastructure and redesigned care processes for high quality and efficient service delivery.” Participating entities, referred to as Medicare Accountable Care Organizations (ACOs), that meet quality and performance standards are eligible to receive payments for shared savings.
The Centers for Medicare and Medicaid Services (CMS) has published the proposed rule which would implement this provision of the ACA which mandates coordination of care for Medicare beneficiaries through Accountable Care Organizations (ACOs).ACOs are intended to serve a “triple aim” of better care, lower cost, and better health outcomes and to do so by creating incentives for physicians, hospitals and other health care providers to coordinate care and meet defined performance standards. The ACO providers will share in any savings derived from the coordinated care. Patient and provider participation in the ACO is voluntary.
Eligible Professionals
The statute and the proposed rule make it clear that an ACO must have physicians, especially primary care physicians, and may or may not include hospitals. There are two types of health care providers/suppliers who can participate in the ACO:
·ACO professionals (hospitals and physicians) as defined in the ACA.
·And “ACO Participants” who are Medicare-enrolled entities such as physical therapists who practice in nonhospital settings such as private practice, physical therapy groups, rehabilitation agencies, skilled nursing facilities and home health agencies.
FOTO Comment
FOTO applauds CMS for creating the category of “ACO participant” which will enable non-physician providers such as physical and occupational therapists to collaborate in this effort to deliver more efficient and more cost-effective care.
Definition
An ACO is defined as a group of health care providers accountable for the quality, cost, and overall care of the Medicare fee-for-service beneficiaries assigned to the organization. It must meet specified quality performance standards to receive a share of any savings if the actual per capita expenditures of their assigned Medicare beneficiaries are a sufficient percentage below benchmark amounts set by CMS. The ACO law is to be operational by January 2012.
The proposed rule would require an ACO to have a formal and legal structure that allows the ACO to receive and distribute payments for shared savings.
FOTO Comment
FOTO believes that in the final rule CMS should explicitly state that the ACO is required to demonstrates that “ACO participants” will be able to share in savings and how those savings will be distributed.
Leadership and Management
FOTO wishes to raise several concerns and questions with respect to this section. In the NPRM, CMS specifically proposes that ACOs have an infrastructure, such as health information technology, that enables the ACO to collect and evaluate data and provide feedback to the ACO providers/suppliers across the entire organization.
FOTO Comment
This provision, while well-intentioned, raises some concern for FOTO and its clients. First, as you know, rehabilitation therapists were not included in programs that resulted in government subsidies for health information technology and such professionals are not eligible for incentives even if they have an electronic health record. The lack of resources/support for therapists to adopt electronic health records (EHRs) puts these professionals at a significant disadvantage. We believe that having a sophisticated EHR could be a de facto requirement to participate in an ACO. Not including these community-based providers disadvantages not only these professionals but also the ACO and ultimately the beneficiary because of the cost-effectiveness routinely achieved in these environments.
FOTO also wonders what steps CMS will take to ensure interoperability of EHRs. Because efficiencies will be very difficult to achieve without comprehensive interconnectedness.
Quality and Monitoring
The NPRM would require the ACO to have a physician-directed quality assurance and process improvement committee that would oversee an ongoing quality assurance and improvement program that would be accountable for meeting performance and compliance standards.CMS will conduct site visits and will require patient surveys, and quarterly and annual reports focused on five domains:
·Patient/caregiver care experiences;
·Care coordination;
·Patient safety;
·Preventive health; and
·At-risk population/frail elderly health
The proposed rule identifies 65 measures for use in the calculation of the ACO Quality Performance Standard. The quality standard is based on a measure scale with a minimum attainment level established.
For the first year of the three-year period, the quality performance standards are at the reporting level and are aligned with PQRS, EHR Incentive Program, and Hospital Inpatient Quality Reporting Program. ACO providers/suppliers and participants who are also eligible professionals under PQRS may earn PQRS incentives as a group practice under the Shared Savings Program. To do so, the measures must be reported by the ACO using the Group Practice Reporting Option (GPRO).
CMS proposes to make available a CMS-specified data collection tool and a survey tool for proposed measures listed in the rule where the proposed method of data submission is listed as “GPRO”. The GPRO tool would allow ACOs a mechanism through which beneficiary lab results and other measures requiring clinical information can be reported to CMS. CMS also proposes that for some measures ACOs collect data via survey instruments.
CMS proposes for establishing quality standard rewards through a performance score approach, which rewards ACOs for better quality with larger percentages of shared savings. CMS would use quality performance standards to arrive at a total performance score for an ACO. The measures would be organized by domains as identified above and the performance on each measure would be scored. The scores of the measures will be rolled up into a score by each domain and ACOs will receive performance feedback at both the individual measure and domain level.
FOTO Comment
First and foremost, a sixth domain should be created that includes the patient’s functional status. This is fundamentally and critically important since one of the three primary purposes (Triple Aim) of the Shared Savings Program is to achieve better health, which is essentially ignored in this proposal.
Specifically, FOTO is concerned that:
·the quality measures to be used in years 2 and 3 have not yet been identified;
·the quality measures proposed for year 1 do not include health status or functional outcomes;
·There is no requirement for procedures involving risk adjustment to quantify the impact of demographic factors that contribute to measuring change in health status or functional health.
·a considerable amount of confusion could result if an ACO is reporting PQRS measures for a participant but that eligible professional is also reporting as an individual (or through a registry) for the measures used on Medicare patients not assigned to the ACO.
·Considerable confusion surrounds the provisions of the NPRM pertaining to quality. Having quality measurement based on some (but not all) of the PQRS measures and including some hospital-specific measures when hospitals are not necessary for an ACO to exist, are problematic and burdensome for the clinical professionals. Moreover, a practice or provider who is participating in an ACO and is also striving to achieve the PQRS bonus, will be challenged by having to report some measures to the ACO (so it can report to PQRS via the GPRO mechanism) and others directly to CMS via a claims-based reporting system or to a registry if that is their vehicle of choice.
Additionally, basing the quality measures on PQRS omits certain providers and sites of service including rehabilitation agencies and hospital outpatient departments. While it may be permissible to use the PQRS measures, especially those that measure the functional status of the patient, the agency must permit providers heretofore not allowed to participate in PQRS, to be eligible to use said measures. Moreover, PQRS measures are largely process measures which are not inherently and completely consistent with the Triple Aim. Outcomes measures should be not only included but emphasized in the Medicare Shared Savings Program.
Through the quality and monitoring provisions, CMS is promoting quality measurement and therefore it should make the systems and the goals consistent.
FOTO knows from experience that in order to manage individual patient outcomes, real-time data is necessary. If CMS is not able to provide such feedback in this manner, the agency must empower entities such as registries to provide timely data upon which ACOs can make adjustments to care and conditions rapidly. Without exception, the most reliable method for obtaining these data that enable data-driven clinical decision-making is through the use of registries that measure functional health status (outcomes) of the beneficiary.
Processes to Promote Evidence-Based Medicine, Patient Engagement, and Coordination of Care
CMS proposes that in order to be eligible to participate in the Shared Savings Program, the ACO provide documentation in the application describing its plans to: 1) promote evidence-based medicine; 2) promote beneficiary engagement; 3) report internally on quality and cost metrics; 4) coordinate care. CMS states that this option was favored so that ACOs can have the flexibility to choose tools that are most appropriate for their specific practitioners and patient populations.
As part of its application, the ACO shall describe:
•The evidence-based guidelines and patient engagement processes it intends to establish, implement and periodically update.
•Its process to report internally on quality and cost measures, and how it intends to use that process to respond to the needs of its Medicare population and to make modifications in its care delivery.
FOTO Comment
In pursuit of the Triple Aim, especially the goal of “better health” CMS should include a requirement that ACOs adopt a survey that not only includes patient and caregiver satisfaction (report of experience) but requires the ACO (or its participants) to assess the risk adjusted functional status (or health status) of the beneficiary.
This would be an effective way by which quality measures can be shared internally and how an emphasis can be placed on improving care, achieving better health and not just achieving savings. In other words, this involves doing the right thing for all the right reasons, not just with an eye on the bottom line. This takes on more significance and pragmatism as FOTO is not confident CMS will be able to provide quality measure feedback on a timely basis. For example, in April 2011, the Agency released a report of quality measures for 2009. This is not helpful to an ACO or its participants who need real-time data that helps drive clinical decision-making.
CMS also proposes to require ACOs to use the Clinician and Group CAHPS survey and to adopt a survey that assesses the functional status of the patient. FOTO suggests that CMS require that the latter be done using any valid, reliable, and responsive functional health status tool that includes the gathering of data necessary for valid risk adjustment..
Public Reporting
CMS identifies the information regarding the ACO that shall be publicly reported including organizational information, shared savings or loss information, and the quality performance standard scores of each ACO.
FOTO Comment
In implementing the public reporting provisions, FOTO urges CMS report the risk adjusted functional status (in an aggregate or composite manner to protect privacy) of the beneficiaries assigned to the ACO. The program should require measurement and reporting on all aspects of each category of the Triple Aim. “What gets measured, gets done.” In order to serve the triple aim comprehensively risk adjusted functional status measurement is imperative.
Additional FOTO Comment
CMS estimates that 75-150 entities will be approved as ACOs and will generate savings in the range of $5 billion. The agency also estimates that startup capital requirements for an ACO to be in the range of $1.5 million. The beneficiary assignment to an ACO will not take place until after the ACO receives approval. Thus, it would appear difficult to develop a viable business plan for this entity.
CMS should exercise its authority to waive certain regulations that are rendered unnecessary due to the existence of the overarching shared savings incentives. Such regulations include the therapy cap or the requirement for a physician plan of care. Since the purpose of the shared savings program is to incentivize providers to render the most effective care in the most efficient manner, micro regulations whose purpose is (also) to restrain utilization are unnecessary and perhaps even counter-productive. Other examples include the three-day hospital stay requirement before admission to a skilled nursing facility and the face-to-face visit with a physician before a beneficiary can receive home care.
However, CMS should recognize that waiving the anti-kickback law and self-referral restrictions can have the unintended consequence of fostering overutilization since such behavior would be more rewarding to individual physicians in self-referral situations than the amount they stand to lose when the shared savings or losses are tallied. The savings realized by the selection of less costly rehabilitations services could be masked or understated by the potential overutilization inherent in such relationships.
FOTO recognizes that there have been many public statements made urging CMS to significantly revise, simplify or scale down the rule for implementing the Medicare Shared Savings Program. If the Agency decides on such a course and wishes to move incrementally toward development of accountable care organizations, we would encourage CMS to consider pilot projects in the rehabilitation therapy field where functional outcomes can be readily and accurately measured and episodes of care succinctly defined.Further, we would urge the Agency to rely, at least in part, on the work that has already been completed in this regard for CMS. Specifically, we refer the Agency to the study conducted by FOTO which implemented a pay-for-performance (P4P) simulation, aligning financial incentives with the achievement of better clinical outcomes. The study demonstrated a value-based purchasing method that aligns financial incentives with achievement of better patient outcomes in an efficient manner can be designed and implemented. [Hart D, Connolly J. Pay-for-performance for physical therapy and occupational therapy: Medicare Part B Services. Grant #:18-P-93066/9-01]
On behalf of Focus On Therapeutic Outcomes and the clients we serve, thank you for the opportunity to provide these comments on the proposed rule to operationalize the Medicare Shared Savings Program. FOTO recognizes the challenge facing CMS in this regard and stands ready to continue to cooperate and collaborate with CMS as needed. We look forward to more opportunities to partner with CMS in pursuit of meaningful effective change of the Medicare program.
Sincerely,
Ben E. Johnston, Jr., PT
General Manager
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