September 8, 2015
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850
Delivered Electronically through www.regulations.gov
Re: Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services (CMS-5516-P)
The Center for Medicare Advocacy (Center) greatly appreciates the opportunity to comment on the proposed rule concerning Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services (CCJR).
The Center, founded in 1986, is a national, non-partisan education and advocacy organization that works to ensure fair access to Medicare and to quality healthcare. We draw upon our direct experience with thousands of individuals and their families to educate policymakers about how their decisions affect the lives of real people. Additionally, we provide legal representation to ensure that beneficiaries receive the health care benefits to which they are legally entitled, and to the quality health care coverage and services they need.
Medicare PAC Payment Reform Requires Serious Deliberation and Reliable Data
All Medicare post-acute care (PAC) reforms that the Centers for Medicare and Medicaid Services (CMS) considers, including the Comprehensive Care for Joint Replacement Payment (CCJR) model, should, first and foremost, preserve access to quality rehabilitation services provided at the appropriate level of intensity, in the right setting, and at the right time to meet the individual needs of Medicare beneficiaries. This is, of course, much easier said than done. Meeting this challenge, while making Medicare PAC payment policy more efficient, requires serious deliberation and should be based on reliable data that is comparable from one PAC setting to another. Uniform and current data need to be collected across a variety of PAC settings with a major emphasis on appropriate quality standards and risk adjustment to protect patients against underservice. Implementation of the IMPACT Act now serves this data collection purpose.
The Center favors payment and delivery models that are based on sound evidence with fully developed quality measures and risk-adjusters so that any savings are achieved through genuine efficiencies, not achieved by stinting on patient care. Unfortunately, a “bundled” PAC payment system that includes these critical beneficiary protections does not currently exist and, we expect, will take several years to develop, adequately test, and validate. This is why we support refraining from either regulating or legislating “site-neutral” PAC payments, or taking other PAC reform actions until data is collected and analyzed under the authorities enacted in the IMPACT Act.
This data can be used to develop a uniform quality assessment instrument to measure outcomes across PAC settings. Such a tool would be invaluable to developing and enacting PAC reforms that do not compromise patient care. This is a critical step in both adopting appropriate—and sufficiently detailed—quality metrics to ensure PAC patients under a bundled Medicare payment system achieve good patient outcomes and risk adjusters accurately capture the unique needs of individual patients.
Until these and other patient protections are in place, we do not support regulating or legislating PAC reforms that bundle episodes of care, impose financial incentives to treat patients in the least intensive setting, or otherwise limit rehabilitation benefits under the Medicare program. It is simply too risky to Medicare beneficiaries to implement PAC bundling or related reforms prematurely.
Therefore, we request that CMS take sufficient time to collect data under the IMPACT Act’s provisions, and this proposed rule and future rules, before adopting a short-term, underdeveloped, approach to PAC reform that may negatively impact the recovery and rehabilitation of some of Medicare’s most vulnerable beneficiaries.
Definition of “Episode of Care”
The Center recommends that CMS allow for flexibility in defining the length of the episode covered by the CCJR bundle. While preferring 90 days over 60 days, as CMS has alternatively proposed, we are concerned that an episode of care defined as the acute hospital stay plus 90 days post discharge is not adequate to address the entire period of care needed for certain types of patients needing post-acute care. Specifically, these patients include individuals with brain injuries, some spinal cord injury patients, those with multiple trauma, medically complex and ventilator patients currently in inpatient rehabilitation facilities (IRFs) and long-term care hospitals (LTCHs), and others.
The definition of the episode of care, particularly for post-acute care episodes, should be flexible and perhaps even condition-specific. Either way, it should be long enough to incentivize providers to provide timely care and not simply “run out the clock” until providers can bill separately for services covered under Medicare Part B.
The Center also recommends that PAC episodes be based on standardized assessment data across PAC settings as well as discharge diagnostic and clinical information, which is not the case at this time. The Improving Post-Acute Care Transformation (IMPACT) Act of 2014 (Pub. L. 113-185) would provide at least some of the standardized data necessary to help develop clear episode recognition and definition. Until such time as patients with brain injuries, spinal cord injuries, multiple amputations and similarly serious conditions can be assured appropriate care post injury or illness, CMS should exempt these subpopulations of patients from bundled payment systems. The Center supports CMS’ exclusion of those with acute disease diagnoses, namely those with severe head injury, from the bundle.
Qualifications of the Bundle Holder
The Center also has significant reservations about the proposal to permit acute care hospitals to serve as the holder of the bundle for not only hospital care associated with lower extremity joint replacements, but all related post-acute and sub-acute care for 90 days following discharge. Regardless of their ability to assume the risk, there are strong incentives in the CCJR model for entities with little direct knowledge of rehabilitation to divert patients to the least costly PAC setting, as long as these patients are not readmitted to the acute care hospital, which comes with financial penalties. In fact, one stated goal of the CCJR model is to increase utilization of home health services and outpatient therapy, and reduced utilization of IRFs and skilled nursing facilities (SNFs) post-joint replacement. The CCJR model also encourages hospitals to recommend PAC settings that are “clinically appropriate” and “of the lowest acuity.” Current law requires CMS to pilot test a concept known as the Continuing Care Hospital (CCH), where the PAC bundle is held by a combination of post-acute care providers (i.e., LTACH, IRF and hospital-based SNF). This would, at least, place the bundle in the hands of providers who better understand rehabilitation and these patients’ needs.
The Center recommends that the bundle holder have the appropriate knowledge of the clinical needs of Medicare beneficiaries who require rehabilitation and PAC services, as this is a heterogeneous population, particularly with regard to PAC services. Bundle holders should also have an adequate understanding of the differences among settings of care, particularly the differences between inpatient hospital rehabilitation and skilled nursing. Without proper quality metrics to ensure beneficiaries are protected and criteria to ensure the bundle holder is capable of administering the bundle and its associated services, access to services for beneficiaries could be jeopardized.
Concerns of “Soft-Steering” and “Hard Steering”
The Center supports the post-acute care beneficiary protections against improper referrals as proposed in the CCJR model. CCJR hospitals must provide beneficiaries with a complete list of all available PAC options in the service area. PAC providers listed must be consistent with medical need and include cost-sharing and quality information, where applicable. Lastly, the CCJR model does not restrict the beneficiary’s freedom to choose providers, including surgeons, hospitals, PAC providers, or any other providers or suppliers. The Center stresses that such patient choice provisions must be strictly enforced, regardless of the bundle holders’ financial priorities.
While “steering” of Medicare patients to certain providers may improve efficiency, this practice still often occurs at the expense of one of the paragons of Medicare policy: patient choice. “Soft steering” is a term often used to describe ways that hospitals and other providers can arrange systems of care that attempt to preserve patient choice to the maximum extent possible. Since there can be negative consequences from this practice, the Center recommends that CMS exercise great caution if it permits “soft steering” by providers in bundled programs.
In its April 2015 meeting, the Medicare Payment Advisory Commission (MedPAC) discussed the use of “soft steering” that would allow hospitals, under specified guidelines, to encourage the use of certain providers, such as high quality, efficient providers. One concern is that the bundle holder may not have an adequate understanding of the difference between providers or provider types (such as the difference between IRFs and SNFs). Additionally, the bundle holder may drive patients to “low cost” providers in order to retain a greater share of the savings, but putting beneficiaries at clinical risk in the process and potentially stinting on care.
The Center believes that the CCJR model may even go as far as promoting “hard steering” that more severely undermines freedom of choice and care in the Medicare program. The Center opposes such hard steering. In fact, one stated goal of the CCJR model is to increase utilization of home health services and outpatient therapy, and reduced utilization of IRFs and SNFs post-joint replacement. The CCJR model also encourages hospitals to recommend PAC settings that are “clinically appropriate” and “of the lowest acuity.” The Center also is concerned that the CCJR model may function like accountable care organization (ACO) networks, where while it will be mandatory to tell beneficiaries what providers are in network, it will not be mandatory to disclose out-of-network options. In this way, the Center believes that the model will deny patients information about the availability of, and ultimately access to, IRFs where clinically appropriate.
Alternatively, the bundle holder could “steer” patients to providers with which it has a financial relationship regardless of clinical need. In any event, the bundle holder should be required to continue to inform the beneficiary of his or her freedom of choice rights.
Therefore, CMS should carefully consider how CCJR providers can be given the flexibility to develop innovative relationships and require beneficiary protections, such as quality metrics, that ensure patients receive clinically appropriate care.
All Prosthetics, Orthotics and Custom DME Should Be Exempt from the Bundle
The Center recommends the exclusion from the CCJR bundle of all prosthetic limbs and orthopedic braces. The Center would also support a further exclusion of customized durable medical equipment (currently included in the bundle), particularly mobility devices known as “complex rehabilitative technology” (CRT) as well as Speech Generating Devices (SGDs). The Center believes that certain devices and related services should be exempt from the bundled payment system as they are critical to an individual in returning to full function and would likely be delayed or denied under a bundled payment system. All customized devices (such as prosthetics, orthotics, CRT and SGDs) that are relatively expensive and intended to be used by only one person should be separately billable to Medicare Part B during the 90-day bundled period. These devices and related services are critical to the health and full function of people with limb loss and other disabling conditions. Not all Medicare beneficiaries require prosthetics, orthotics, CRT and/or SGDs, but these devices are critical to the health and function of some patients. Under a bundled payment system, there are strong financial incentives to delay or deny entirely access to these devices and related services until the bundle period lapses. Once this occurs, Medicare Part B would be available to cover the cost of these devices, but this delay is very detrimental to patient outcomes, and opportunities are lost for rehabilitation and training on the use of the device or technology during their stay.
This phenomenon was witnessed when Congress implemented prospective payment for skilled nursing facilities (“SNFs”) in 1997 and initially included orthotics and prosthetics in the SNF bundle or prospective payment system (“PPS”). As a result, most SNFs began to delay and deny access to prosthetic and orthotic care until the beneficiary was discharged from the SNF and then Medicare Part B assumed the cost of O&P treatment. During this period, Medicare patients experienced inappropriate and unreasonable delays in access to orthotic and prosthetic care that often make the difference between independent function and life in a nursing home. In 1999, Congress recognized this problem and exempted a large number of prosthetic limb codes from the SNF PPS consolidated billing requirement, thereby permitting these charges to be passed through to Medicare Part B during the SNF stay. As a result, SNF patients once again had access to prosthetic care during the course of their SNF stay. This experience should not be repeated under new bundled payment systems and, therefore, we recommend that CMS exempt all prosthetics, custom orthotics, CRT and SGDs from any bundling regulation.
Exemption of Certain Vulnerable Patients from Bundling
Bundling that includes PAC services is a concept that is clearly untested at this time, and we strongly favor fully developed quality measures and risk-adjusted payment systems so that savings are not achieved by stinting on patient care to protect vulnerable Medicare beneficiaries. Among these Medicare patients are people with brain injuries, spinal cord injuries, moderate to severe strokes, multiple-limb trauma, amputations, and severe neuromuscular and musculoskeletal conditions. While this is clearly a minority of Medicare beneficiaries, it is a very important subgroup that, we believe, should be exempt from any bundled payment system. As stated above, the Center supports CMS’ proposal that those with acute disease diagnoses, namely those with severe head injury, will be excluded from the bundle. We believe the most vulnerable patients should only be included in bundling on a mandatory basis when the bundled payment systems can demonstrate sufficient quality outcomes, risk adjusters, and patient safeguards to ensure quality care.
Appropriate PAC Quality and Outcome Measures
The Center recommends that quality measures be particularly strong in the CCJR model, especially with regard to patient experience and pain measures. Patient experience measures should be administered frequently to counterbalance the economic interests of the hospitals. Pain measures should be conducted every day, and long-term measures should be conducted in intervals of three months, six months, nine months, and one year following the procedure to guarantee the best care.
Quality measures must be mandated in any bundling regulation to assess whether patients have proper access to necessary care. This is one of the most important methods of determining whether savings are being achieved through better coordination and efficiency, or through denials and delays in services. Uniform quality and outcome measures that cross the various PAC settings do not currently exist. The existing LTACH CARE instrument for LTACHs, the IRF-PAI for rehabilitation hospitals, the MDS 3.0 for SNFs, and the OASIS instrument for home health agencies, are all appropriate measurement tools for each of these settings. But they measure different factors, are not compatible across settings, and do not take into consideration to a sufficient extent a whole series of factors that truly assess the relative success of a post-acute care episode of care.
Create Financial Disincentives Preventing Clinically Inappropriate Diversion of Patients to Less Intensive Settings
The Center believes that, while CMS intends to evaluate the CCJR model, on, among other things, “unintended consequences” including “evidence of stinting on appropriate care” and “evidence of inappropriate referrals practices,” inappropriate stinting of care remains a major concern of the CCJR model. As mentioned above, one stated goal of the CCJR model is to increase utilization of home health services and outpatient therapy, and reduce utilization of IRFs and SNFs post-joint replacement. The CCJR model also encourages hospitals to recommend PAC settings that are “clinically appropriate” and “of the lowest acuity.”
In order to protect against diversion of patients to less intensive, inappropriate PAC settings, we recommend that any bundling legislation include instructions to the HHS Secretary that payment penalties should be established to dissuade bundle holders from underserving patients.
Reduction in Scope
Due to the concerns expressed above, the Center asserts that instead of a mandatory bundling model incorporating 75 Metropolitan Statistical Areas (MSAs), CMS should implement the CCJR model in a voluntary bundling model incorporating no more than 5-10 MSAs.
The Center greatly appreciates the opportunity to provide feedback on the proposed rule concerning the CCJR model. For further information please contact Center Senior Policy Attorney David Lipschutz, firstname.lastname@example.org.
Center for Medicare Advocacy
 Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services; Proposed Rule, 80 Fed. Reg. 41,198 (July 14, 2015) at 41,219.
 Id. at 41,215, 41,308.
 Id. at 41,254.
 Id. at 41,268.
 CMS has not yet pursued the mandated CCH pilot program.
 Comprehensive Care for Joint Replacement Payment Model, 41,250.
 Id., at 41,297.
 Id., at 41,296, 41,313.
 Id. at 41,254.
 Id. at 41,268.
 Id. at 41,308.
 Bipartisan legislation has been introduced in both houses of Congress to create a separate designation under the Medicare program for CRT entitled, “Ensuring Access to Quality Complex Rehabilitation Technology Act of 2013,” H.R. 942 and S. 948.
 Balanced Budget Act of 1997, Pub. L. No. 105˗33, § 4432, 111 Stat. 251, 414 –22 (1997) (codified at 42 U.S.C § 1395yy).
 Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, Pub. L. No. 106˗113, § 103, 113 Stat. 1501A-321, 1501A-325–26 (1999) (codified at 42 U.S.C § 1395yy(e)).
 Unfortunately, Congress did not similarly exempt custom orthotics from the SNF consolidated billing requirements which has led to a serious lack of access to appropriate custom orthotic care in the SNF setting.
 Comprehensive Care for Joint Replacement Payment Model, 41,215, 41,308.
 Comprehensive Care for Joint Replacement Payment Model, 41,299.
 Id. at 41,254.
 Id. at 41,268.