VIA ELCTRONIC SUBMISSION @ www.regulations.gov March 15, 2010
Ms. Charlene Frizzera Acting Administrator
Centers for Medicare and Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building
200 Independence Avenue, S.W., Room 445-G Washington, DC 20201
Attention: CMS-0033-P Dear Ms. Frizzera:
The Association of American Medical Colleges (AAMC) welcomes this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS or the Agency) proposed rule entitled
Medicare and Medicaid Programs; Electronic Health Record Incentive Program. 75 Fed. Reg.
1844 (Jan. 13, 2010). The AAMC is a not-for-profit association representing all 131 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 68 Department of Veterans Affairs medical centers; and nearly 90 academic and scientific societies. Through these institutions and organizations, the AAMC represents nearly 110,000 clinical faculty members, 75,000 medical students, and 110,000 resident physicians.
The AAMC supports and applauds CMS’s efforts to promote the widespread adoption of health information technology (HIT) through this rulemaking. We appreciate that the Agency is moving quickly to accomplish the ultimate goal of the American Recovery and Reinvestment Act (ARRA) – to provide needed funds that will stimulate the American economy – and our members are committed to adopting technology that will improve patient care and the efficiency of our nation’s healthcare delivery system. We share the Agency’s vision of ultimate
interoperability and look forward to continuing to work with CMS to create an incentive program that helps all providers reach these laudable goals.
The AAMC appreciates the difficult task CMS faced in trying to propose a very complex rule within a very short time. We also applaud the Agency’s efforts to meet with many stakeholders during that process. However, the CMS proposal presents a very aggressive time line that is not mandated by ARRA; adopts an approach that provides no flexibility to eligible professionals (EPs) or hospitals; and seems to have lost sight of the goal of providing incentives to increase the meaningful use of HIT in order to improve the quality of patient care.
While many of our hospital and group practice members have been working on achieving interoperable electronic health records (EHRs) for years, others are quite new to this venture.
Under CMS’s proposed vision for meaningful use, both those providers just beginning to adopt
and those who are quite far along in adoption would struggle and would be unlikely to meet all
of the proposed ―Stage 1‖ meaningful use requirements. Additionally, CMS’s proposal fails to recognize that HIT adoption is an incremental journey for all providers. We encourage CMS to adopt a more flexible approach to meaningful use and to permit providers who first adopt EHRs in any year to move through adoption stages at a reasonable pace and receive corresponding incentive payments. Such a process will help to ensure the program’s ultimate goal of universal EHR adoption.
While our letter addresses a number of issues, the AAMC believes the following are most critical:
The definition of hospital-based eligible professional must be redefined so as not to exclude inappropriately large numbers of eligible professionals from eligibility for HIT payments;
Individual hospitals within a hospital system should be eligible for HIT incentive payments, even if they share a single Medicare provider number;
Providers must be permitted more flexibility in achieving meaningful use;
All providers should not be required to attain Stage 3 of meaningful use by 2015; Quality reporting programs should be aligned with existing reporting programs, and
quality reporting should not be required for meaningful use in 2011; Functionality measures need to be simplified and better specified;
CMS should adopt an annual evaluation process to assess providers’ ability to achieve meaningful use and revise the definition for meaningful use accordingly;
The Medicare and Medicaid HIT incentive programs should be better aligned; and CMS should establish a mechanism for physician groups to achieve meaningful use. HOSPITAL-BASED ELIGIBLE PROFESSIONALS (PAGES 1904 – 1907)
An appropriate definition of a hospital-based eligible professional (HBEP) is crucial, as any EP who qualifies as hospital-based is not eligible for ARRA HIT incentives, even if he/she has otherwise achieved meaningful use. CMS should be mindful of the purpose of ARRA HIT incentives—to encourage the adoption and meaningful use of electronic health records—and the reason for the hospital-based eligible professional exemption—to avoid duplicate payment for EHR adoption. Consequently, it is critical that the ARRA statutory requirements be
implemented in such a way that makes appropriate incentive payments as widely available as possible.
Part of the HBEP statutory definition relates to the requirement that ―substantially all‖ of the EP’s services be performed in a hospital setting (inpatient or outpatient). The AAMC supports the proposal to define ―substantially all‖ as 90 percent of services. Another part of the HBEP definition requires a determination of which services should be counted in the 90 percent. For that requirement, CMS has chosen a proposal that will impose substantial barriers to encouraging widespread meaningful use among eligible professionals. The Agency estimates that under its proposal 27 percent of Medicare EPs will be hospital-based; however, AAMC data shows that among our members—many of which are leaders in EHR adoption—the number of
hospital-based EPs is likely to be closer to 63 percent. The AAMC’s data regarding primary care
specialties, such as family medicine and geriatrics also differs greatly from CMS’s estimates for primary care physicians. AAMC data indicates that the rate of HBEPs among these physicians is 38 percent. Rather than deny incentives to large numbers of EPs, which would run counter to the goal of expanding meaningful use by physicians, the AAMC urges CMS to revise the final rule substantially so that there will be fewer HBEPs. As discussed below, this can be accomplished while complying with both the spirit and the letter of the law.
Place of Service Codes Should Not Be the Sole Determinant of HBEP: Medicare
The central aspect of CMS’s proposal is to use place of service (POS) codes 21, 22, and 23 to implement the statutory requirement that the hospital-based determination be made by site of service. CMS has chosen those POS codes because the law describes the hospital-based EP’s services as those that are furnished in ―a hospital setting (whether inpatient or outpatient).‖ The Agency explains its proposal by stating that ―it is CMS’s longstanding policy to consider as outpatient hospital settings those settings that are owned by and integrated both operationally and financially into the entity, or main provider, that owns and operates the inpatient setting.‖ 75 FR 1905. This has led CMS to propose to include ―all types of outpatient care setting in the main provider, on-campus and off-campus provider-based departments (PBDs) of the hospital, and entities having provider-based status, as these entities are defined in §413.65.‖ 75 Fed. Reg. 1905. As a result, many physicians who provide care primarily in provider-based entities will be considered hospital-based.
It is worth bearing in mind that when CMS first proposed the establishment of criteria for provider-based clinics, the Agency noted the advantages of that structure:
Integrated delivery systems offer a wide variety of health care services and can assume responsibility for entire episodes of a patient’s illness. These systems are attractive to patients, who seek continuity of care, and to businesses seeking a single source of health services for their employees. 63 Fed. Reg. 47552, 47587 (Sept. 8, 1998).
The CMS meaningful use proposal turns an institutional decision that was intended to provide better patient care into one that will render many EPs ineligible for EHR incentives.
CMS staff have spoken publicly about the Agency’s desire to harmonize meaningful use criteria across CMS programs. The AAMC encourages CMS to strive toward such harmonization in this area as well. One option for doing this is for the Agency to look to the definition of a ―hospital setting‖ in the physician e-prescribing policy. Enacted by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), this policy measures whether a physician has adopted and uses a qualified e-prescribing system in the ambulatory setting. The e-prescribing policy provides a path for CMS to identify and exclude from its definition of a ―hospital setting‖ those services that are provided in outpatient centers and clinics, even if these services are
provided in a facility owned by the hospital. Specifically, the policy identifies services furnished in the ambulatory setting for which a specific group of non-emergency department procedural codes are used. As CMS described the e-prescribing denominator codes, ―they are typically
billed for services in the office or outpatient setting furnished by physicians or other eligible professionals.‖ 73 Fed. Reg. 69726, 69849 (Nov. 19, 2008). In other words, for the e-prescribing program the codes represent outpatient services, regardless of the particular outpatient setting. Therefore, rather than defining all services with POS of 21, 22, or 23 as hospital-based, CMS should reclassify the CPT codes that are used for the e-prescribing
denominator as not counting for the hospital-based determination. According to an AAMC data analysis, the result of doing this would be to increase the percentage of physicians who might qualify for incentives from 37 percent to 63 percent, including over 90 percent of family
medicine physicians. This is a significant increase and is consistent with the intent of ARRA to encourage the adoption and use of electronic health records in all settings. The AAMC strongly urges CMS to revise the proposal so that those services listed in the e-prescribing
denominator, even if they have a POS of 22, are excluded from the hospital-based determination.
This revision is consistent with the intent of ARRA to encourage the adoption and use of
electronic health records among eligible professionals. It also would avoid finalizing a rule that will penalize physicians because of decisions made by their institutions for reasons that were at one time recognized by CMS as being desirable for achieving better patient care.
Do Not Use Place of Service Codes As the Sole Determinant of Hospital-Based: Medicaid
CMS has proposed using a similar approach to determining HBEPs for the Medicaid incentive program, with the major difference being that the ―substantially all‖ analysis of the place of service of the EP’s claims will be based on an EP’s Medicaid claims data, or, for EPs who deliver care via Medicaid managed care programs, by analyzing either encounter data or other equivalent data, at the state’s option.
In some states, Medicaid programs do not distinguish between services in provider-based clinics versus office-based clinics, and instruct providers to bill POS 11 (office) rather than POS 22 (outpatient hospital). In those states that do not recognize POS 22 for services in provider-based clinics, more Medicaid EPs will be eligible for incentives, even though for Medicare purposes the same services delivered in the same setting by the same eligible provider would be counted for the hospital-based determination. This underscores the fact that using place of service as the sole determinant of hospital-based status is arbitrary and will result in inconsistencies that will stymie the goals of encouraging meaningful use.
We further ask CMS to provide a definition of "covered professional services" for purposes of the Medicaid incentive payments, to clarify that the evaluation of whether a provider is hospital-based for Medicaid purposes will use Medicaid claims data or, for Medicaid managed care programs, either encounter data or other equivalent data sources. The Medicaid regulatory definition of "hospital-based professional" cross-references 42 C.F.R. § 495.4 (see 42 C.F.R. § 495.304(c)), which relies on the phrase "covered professional services." Although this phrase is defined in the Medicare section of the regulations as meaning professional services paid under the Medicare physician fee schedule, there is no definition for Medicaid purposes, which could cause confusion. The preamble clarifies that CMS contemplates a Medicaid-specific analysis.
75 Fed. Reg. at 1906-07 (―For Medicaid purposes, we are proposing that State Medicaid agencies make the determination about whether or not an EP is hospital-based by analyzing an EP’s Medicaid claims data, or in the case of EPs who deliver care via Medicaid managed care programs, by analyzing either encounter data or other equivalent sources.‖). To make this clear, CMS should provide an appropriate definition of ―covered professional services‖ in proposed 42 C.F.R. § 495.302 clarifying that for Medicaid purposes, ―covered professional services‖ means professional services paid by the Medicaid program.
EHR Payment as One Criteria for NOT Being Hospital-Based
The CMS proposal also fails to implement the part of the statute which talks about hospital-based eligible professionals using the ―facilities and equipment of the hospital.‖ Many faculty practice plans and other physician groups contribute to the cost of the acquisition, maintenance, and upgrade of the electronic health record in the ambulatory setting, even if the setting is a provider-based clinic. An AAMC survey of our members indicates that physician practices often participate in the funding of all phases of EHR adoption in provider-based clinics (hardware, software, implementation and maintenance).
Clinical Services Commonly Fund All
Phases of EHR Adoption
0% 25% 50% 75% 100%
Hospital Clinical Services Other
% Res po nd e nts
EHR Funding Sources
Hardware Software Implementation Maintenance
Who funds the costs of an EHR?
Clinical services defined as funding from the faculty practice, medical school, or department. Totals for each phase may exceed 100% because multiple funding sources could be selected. Source: Summer 2009 AAMC Survey of EHR implementation at Academic Clinics, N=38 Data restricted to institutions with provider-based clinics that reported EHR funding sources.
The AAMC’s data shows that on average, the survey respondents’ practices paid for over half of the total costs of EHR adoption.
By making this contribution, the physicians should not be considered to be using ―the equipment of the hospital.‖ The AAMC strongly urges CMS to exclude from the definition of hospital-based all physicians who contribute to outpatient EHRs. The AAMC recognizes that it is reasonable to require a minimum contribution.
Again, seeking consistency with already existing programs, the AAMC suggests that CMS look to the EHR exception to the physician self-referral regulation (42 C.F.R. § 411.357(w)) as a model. This exception allows for ―nonmonetary remuneration (consisting of items and services in the form of software or information technology and training services) necessary to create, maintain, transmit, or receive electronic health records‖ if a list of conditions is met, including that the physician ―pays 15 percent of the cost for the items and services.‖ Additionally, under the self-referral exception, the donor of the items and services cannot finance or provide a loan to the physician for them. Using this exception as precedent, we recommend that qualified hospital EHRs be defined as EHRs for which the hospital funded more than 85 percent of the cost of acquisition, implementation, maintenance and/or upgrades. In other words, if physicians—or the physician group practice to which the EP assigns his/her HIT incentive payments—funds at least 15 percent of the cost of the EHR, they should not be considered to be using the hospital’s equipment and therefore should not be considered hospital-based.
DEFINITION OF ELIGIBLE HOSPITAL (PAGE 1911)
The payment incentives contained in ARRA are available to each hospital that becomes a ―meaningful user‖ of a certified EHR. ARRA defines an ―eligible hospital‖ as a Medicare subsection (d) hospital, which is a general, acute care, short-term hospital. The AAMC is extremely concerned about CMS’s proposal to rely exclusively on CMS Certification Numbers (CCNs, also known as Medicare provider numbers) to identify those hospitals that are eligible for HIT incentive payments and urges the Agency to modify this proposal in the final rule to recognize all hospitals within those hospital systems that utilize a single provider number.
Defining hospitals solely by CCN will, contrary to the intent of ARRA, create a barrier to widespread EHR adoption and use for many hospitals across the country. There is no standard policy that defines the specific types of hospital facilities to which a Medicare provider number applies. For example, a single provider number may encompass multiple hospitals within a hospital system. Because the Medicare and Medicaid payment incentives in ARRA are calculated using a per-hospital base amount, plus a capped per-discharge amount per hospital, using only a provider number to define a hospital would result in ARRA incentives being distributed in a manner that does not foster widespread EHR adoption and use. Specifically, a health care system with multiple hospitals but a single Medicare provider number would be disadvantaged, because the system would be eligible for only one base amount and would be much more likely to reach the discharge cap. In addition, such a health care system could be subject to HIT penalties at the system level, even if, for example, only one of the system’s multiple hospitals was found not to be a meaningful user.
Linking HIT incentive payments only to the single Medicare provider number would not
accurately reflect the deployment costs of all EHR systems across all hospitals in a system. The total cost of EHR implementation far exceeds the purchase cost of the actual application or software. Even hospitals that are part of the same system often require significant variations in their EHRs, as local policies and processes must be incorporated into EHR utilization. For example, installations must accommodate the differing network infrastructures of legacy
software, physician preferences, clinical protocols, expert rules protocols, workflows and
ancillary system integration. Differences in clinical services offered at the sites may also require additional unique system variations among facilities, requiring different system interfaces and clinical systems. Further, hospital systems incur additional administrative costs for necessities such as workstation installation, servers, staff training, and differences in clinical services among each of the hospitals, resulting in additional variation among facilities.
There is established precedent for CMS to identify individual hospitals within hospital systems and to make payments based on characteristics of those individual hospitals. CMS has already defined these separate inpatient facilities as ―remote location[s] of a hospital‖ in the provider-based regulations:
Remote location of a hospital means a facility or an organization
that is either created by, or acquired by, a hospital that is a main provider for the purpose of furnishing inpatient hospital services under the name, ownership, and financial and administrative control of the main provider, in accordance with the provisions of this section. A remote location of a hospital comprises both the specific physical facility that serves as the site of services for which separate payment could be claimed under the Medicare or Medicaid program, and the personnel and equipment needed to deliver the services at that facility. The Medicare conditions of participation do not apply to a remote location of a hospital as an independent entity. For purposes of this part, the term ―remote location of a hospital‖ does not include a satellite facility as defined in § 412.22(h)(1) and § 412.25(e)(1) of this chapter.
42 C.F.R. § 413.65(a)(2). The AAMC encourages CMS to use this already-established definition to identify hospitals for purposes of the HIT incentive payment program.
Identifying distinct hospitals that are part of a system for HIT incentive purposes also would be entirely consistent with CMS’s approach to payment for remote locations of subsection (d) hospitals that are located in different Core Based Statistical Areas (CBSAs) than the main
provider. CMS currently permits these individual hospital campuses to establish a wage index at the rate appropriate to the individual hospital’s location:
For hospitals that consist of two or more separately located inpatient hospital facilities, the national adjusted prospective payment rate is based on the geographic location of the hospital facility at which the discharge occurred.
42 C.F.R. § 412.64(b)(5). (See also, 42 C.F.R. § 412.230(d)(2)(v), permitting a ―campus of a multicampus hospital that is located in a geographic area different from the area associated with the provider number of the entire multicampus hospital‖ to seek reclassification to another CBSA.) Thus, CMS already distinguishes for payment purposes among various hospitals within
a hospital system and provides additional payment for an individual hospital’s higher costs. As discussed above, hospital systems incur higher HIT implementation costs for their remote hospital locations and should be paid accordingly.
From an operational perspective, implementing a program that allows for HIT incentive
payments for individual hospitals within a hospital system would not be difficult. Given CMS’s expertise, the Agency may envision a number of ways to implement this policy in a way that is the least administratively burdensome. Below, we provide some perspective on how CMS might consider approaching the operational issues.
CMS first would need to determine a means to identify each remote hospital location of the hospital system. Two options for identifying these locations include requiring Fiscal Intermediaries (FIs) and Medicare Administrative Contractors (MACs) to obtain such
information or collecting the information through the Medicare hospital cost report. For wage index purposes, CMS currently obtains information about multicampus hospitals directly from that hospital’s FI or MAC. In Agency guidance, CMS instructed FIs/MACs to identify separate hospital campuses by means of a unique identifier:
Under our current policy, a multicampus hospital with campuses located in the same labor market area receives a single wage index. However, if the campuses are located in more than one labor market area, payment for each discharge is determined using the wage index value for the CBSA (or metropolitan division, where applicable) in which the campus of the hospital is located. When the satellite campus is located in a different labor market area, the fiscal intermediary should assign a unique identifier (usually a 2 digit suffix), which is added after the provider’s Online Survey Certification and Reporting (OSCAR) number. This provider-specific ―suffix‖ will ensure the campus-provider-specific payment is based on the wage index for the labor market area where the campus is geographically located.
Pub. 100-04 Medicare Claims Processing, Transmittal 1067, Change Request 5276, September 26, 2006 (page 8). Similarly, CMS could require FIs/MACs to use a unique identifier to recognize remote locations of hospitals for HIT incentive payment purposes. However, we believe a potentially better alternative may be that the Agency could revise the Medicare cost report to require providers to identify their remote hospital locations. Because this option would take longer to implement, CMS could consider using the suffix method described above in the interim.
After identifying each location, CMS would then need to decide how to calculate incentive payments that take into account each of the hospitals within a system. Having considered this issue, we offer CMS two possible approaches.
The HIT Medicare incentive payment formula for hospitals takes into account a hospital’s total discharges (up to a statutory maximum) as well as its Medicare share. Under the first option, CMS could calculate a separate Medicare share and total number of discharges for each remote hospital location within a hospital system. CMS could revise the Medicare hospital cost report to require each of these remote hospitals to report separate discharge data and other information required to calculate the Medicare share. CMS also could revise the Medicare cost report to collect Medicaid data, which states could then use to calculate each remote hospital location’s Medicaid discharges and Medicaid share. CMS updated the Medicare cost report in May 2008 to provide for the reporting of FTE data by campus for wage index purposes (see Worksheet S-3, Part 1, Lines 61 and 62), and nothing would preclude the Agency from making similar revisions to the cost report to reflect the needs of the HIT incentive program.
If CMS adopts this approach of calculating data by remote location, the AAMC encourages the Agency to consider adopting an interim data collection mechanism to account for the time before any new cost report lines would go into effect. Even if a revised version of the cost report that incorporates such new lines were released in the next several months, hospital data would not be available until late 2011, at the earliest. CMS could consider, for example, surveying the
affected hospitals to collect this data or establishing a mechanism for calculating interim payments for these remote hospital locations.
Alternatively, CMS could adopt an approach that requires less additional data collection by basing payments to individual hospitals within a system on average numbers of discharges and on the average Medicare share within the system. CMS could use the number of total Medicare discharges for all campuses, as reported by the main provider on the Medicare cost report, and divide that number by the total number of hospital campuses within the system (i.e. the main provider plus all remote hospital locations that share the single provider number). In a similar manner, CMS could use aggregate data to calculate an average Medicare share that would be applied to each campus. Medicaid incentive payments could also be calculated in the same manner. This approach would still require CMS to add a line to the cost report for providers to identify their multi-campus locations, but it would avoid the need for additional lines for discharge and Medicare or Medicaid share data.
CMS’s proposed rule grants states the flexibility to use a variety of auditable data sources to determine a hospital’s eligibility, including the applicable patient volume thresholds, for
Medicaid HIT incentive payments. If CMS chooses this second option for making payments for remote hospital locations of hospital systems, the Agency should also extend discretion to state Medicaid programs to collect additional data required to make eligibility determinations for Medicaid payments.
If CMS implements the HIT incentive program in a way that identifies each remote hospital location of a hospital system, we wish to emphasize that it would also be necessary to make a determination of whether a hospital meets the required meaningful use criteria at the individual hospital level, rather than at the system level. Likewise, the Association believes that penalties for failure to become a meaningful user should be assessed at the hospital level and not at the level of the entire hospital system. The calculation of penalties that will be imposed under the
Medicare HIT incentive program on hospitals that fail to become meaningful users by 2015 will be the subject of future CMS rulemaking, and the AAMC reserves the right to comment on such penalty calculations at that time.
Regardless of the approach the Agency adopts, the AAMC believes that requiring each hospital to meet meaningful use criteria and providing a separate HIT incentive payment for each hospital campus is the best way to encourage all hospitals to adopt EHRs. Providing payments for both the main provider and each remote location of a hospital recognizes that each location legitimately incurs costs in adopting EHRs and provides incentives for achieving meaningful use.
DEFINITION OF MEANINGFUL USE (PAGES 1850-1854)
Contemplating that ―meaningful use‖ will occur over a number of years, ARRA calls for increasingly stringent measures to be imposed over time. To implement this provision, CMS proposes to define meaningful use in three stages. The Agency sets forth its vision for Stage 1 in this proposed rule and states that it will propose criteria for Stages 2 and 3 in later rulemaking. The AAMC supports defining the functionality in phases, but as is discussed below, we urge CMS to adopt a more measured approach to achieving meaningful use, both in the definitions for each stage and in the timeline that the stages must be achieved.
Concerns Regarding the Progression of Stages
CMS has proposed a chronological progression through the stages of EHR adoption, such that all meaningful users of EHRs will be at the same level of meaningful use (Stage 3) by 2015. The AAMC appreciates CMS’s desire to have all providers at the same level of meaningful use by a specific date, but given that it takes many years to fully adopt EHRs, this proposal would impose double penalties for ―late adopters,‖ i.e., those who do not qualify for meaningful use by 2011 or 2012. The first penalty is imposed by law—late adopters will be eligible for less incentive money or they will incur penalties if they are not meaningful users by 2015. The second penalty is created by the CMS proposal—EPs and hospitals will have much less time to achieve the Stage 3 meaningful use threshold and may be unable to do so at all because of the truncated time frame that is imposed by the ―Stage 3 by 2015‖ approach. Providers entering the Medicare incentive program in 2014, for example, are required to progress directly from Stage 1 to Stage 3 in 2015, without being permitted to master Stage 2 first. Providers entering the Medicare
incentive program in 2015 are required to immediately meet Stage 3 requirements.
The legislation does not require that EPs and hospitals achieve Stage 3 of meaningful use by a specific date; ARRA only stipulates penalties ―if the eligible professional [or eligible hospital] is not a meaningful EHR user.‖ Even for late adopters, CMS should recognize incremental
achievements attained over a number of years. The AAMC urges the Agency to change its proposal, so that providers who are later adopters will be considered ―meaningful users‖ as long they meet Stage 1 meaningful use criteria for their first payment year. The Association also requests that CMS define a reasonable time period for providers to progress through each of the stages.
Concerns Regarding the Definition of Future Stages
The AAMC agrees with the need for providers to move along a continuum and to increase electronic information exchange gradually. For our members—many of which are tertiary referral centers—quick and accurate communication with the providers with whom they interact is highly beneficial for improved patient care. Therefore, we urge CMS to adopt requirements in Stages 2 and 3 that do not pose insurmountable barriers to hospitals that are not as far along the interoperability spectrum. Many of our members have deep expertise in implementing
interoperable EHRs, and we encourage CMS to draw on this expertise as the Agency develops Stages 2 and 3. Additionally, we encourage CMS to provide insight as early as possible into what the Agency believes will be the Stage 2 and 3 requirements, so that all providers and vendors have sufficient time to strive toward the new goals.
Need for an Evaluation Mechanism
Although CMS states that it will elaborate on requirements for Stages 2 and 3 in future rulemakings, the Agency does not discuss how it will evaluate the level of participation in the program during and after Stage 1. The AAMC appreciates the iterative nature of the
development of this program and encourages CMS to design a robust evaluation mechanism that will be used annually to assess whether the goals the Agency sets were ultimately reasonable and attainable. CMS should then use the data it collects from such an evaluation to inform the Agency’s future rulemaking and make adjustments to the program that will encourage the broadest possible level of provider participation.
Concerns Regarding the Stages: Medicaid
The AAMC also is concerned about the CMS proposal to use the same stages for the Medicare and Medicaid programs. While Medicare incentives are available for 5 years, Medicaid incentives are available for varying periods. Medicaid EPs can begin receiving incentive payments as late as 2016 and may receive incentives through 2021. They also do not have to be meaningful users in consecutive years. Hospitals that are eligible for Medicaid HIT incentives may receive payments over a 3 to 6 year period, depending on how the state decides to structure the program. Should CMS finalize the proposed stages for the Medicare incentives, the Agency must provide clarification and guidance about how the stages will apply to providers eligible for Medicaid incentives. Clarification also is needed about whether there are any circumstances under which a Medicaid EP who does not achieve meaningful use in a given year will be subject to Medicare penalties (assuming that the EP also treats Medicare beneficiaries).
Concerns with the “All or Nothing” Approach
To receive incentive payments in Stage 1, CMS proposes that eligible hospitals must meet 23 separate meaningful use measures, and eligible professionals must attain 25 separate meaningful use measures including quality reporting requirements. The AAMC is extremely concerned that this ―all or nothing‖ approach will severely limit the number of EPs and hospitals that will
qualify for incentives and will frustrate Congressional intent. As will be described below, while attempting to encourage health care providers and hospitals to achieve meaningful use, CMS has not taken into account such factors as the actual capabilities of electronic health records as they exist today; the state of electronic quality reporting; and the money, time, and disruptions to work flow that are required, at least initially. For example, one AAMC member faculty practice plan began the adoption of EHRs in October 2008. Even with continuous efforts, to date, the adoption covers only 40-45 percent of physicians. This member estimates that full adoption and optimization will take 3 to 5 years, or even longer.
CMS should recognize that providers’ approaches to adoption vary widely, such that different providers focus on implementing various EHR functionalities using different strategies. Providers cannot successfully incorporate all 23 or 25 measures at once, even if they are fully committed to achieving the goals of meaningful use. Further, the proposed approach
disadvantages providers who work hard to become meaningful users but ultimately come up short. For instance, an eligible hospital could meet 22 of the 23 measures (and only miss that final measure by a fraction of a percentage) and still be disqualified from receiving any HIT incentive payments. This stringent approach might deter providers from even trying to achieve meaningful use. The AAMC supports the spirit behind the recommendation the HIT Policy Committee made at its February 17, 2010, meeting, encouraging CMS to adopt a more flexible definition of "meaningful use" in the final rule.
For these reasons, the AAMC strongly encourages CMS to adopt an approach to each phase of meaningful use that permits providers the flexibility to select measures that reflect their patient populations or practices.
Concerns Regarding Potential “Realignment” of Hospital Meaningful Use Criteria (page 1907)
In the proposed rule section on hospital-based eligible professionals, CMS states that the Agency may ―consider ways to realign the meaningful use objectives and criteria to include a broader definition of hospital care to include outpatient services‖ in a future rulemaking. The AAMC requests that CMS clarify what it means by this statement. We share CMS’s concern that it is important to encourage the broadest possible implementation of EHRs. Given limitations imposed by the legislation, and, as discussed in more detail below in the section specifically addressing hospital-based eligible professionals, we believe that the best way to encourage the implementation of ambulatory EHRs in outpatient settings is through a narrow definition of hospital-based eligible professional. We are concerned by the suggestion that expanding meaningful use requirements in a way that would obligate hospitals to collect additional data – without providing them the resources to do so – would contradict the intent of ARRA and could make an already difficult-to-achieve meaningful use standard nearly impossible to meet.
Concerns Regarding Individual Meaningful Use Measures
In addition to the above concerns about CMS’s overall approach to meaningful use, the AAMC also has specific concerns about individual meaningful use measures. We have included in the Appendices to this letter a list of detailed comments regarding ways the Association believes
CMS should clarify or improve individual measures. The AAMC also has several overarching concerns about the measures themselves.
First, at least during the initial years of this program, we are extremely concerned about how the measures are defined, particularly those that use percentages to demonstrate meaningful use. The numerators and denominators are not explicitly defined, and the specifications have not been reviewed or endorsed by a multi-stakeholder consensus group. At this point, the EHR industry has not automated the generation of these data; therefore, EPs and hospitals need to spend additional time and resources to extract data in this format. This difficulty is compounded when the measure denominator cannot be derived from information in the EHR. Denominators that are not embedded in the EHR require additional data collection, and measures that require numerator and denominator calculations reduce the efficiency gained from using electronic systems. We urge CMS either to replace the percentages in the proposed measures with a simple attestation that the functionality is in use OR to require a minimum number of uses, similar to the Medicare e-prescribing program.
Enacted by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), the prescribing program provides incentive payments to eligible professionals who adopt
e-prescribing. During the initial year of that program, providers were required to report on 50 percent of the relevant encounters. In the 2009 Medicare Physician Fee Schedule Proposed Rule, CMS noted that once an EP has integrated use of e-prescribing, continued reporting ―represents an administrative burden with little added benefit to the reliability and validity of the data collected.‖ 74 Fed. Reg. 33520, 33598 (July 13, 2009). CMS subsequently changed the requirement from the 50 percent reporting threshold to reporting 25 prescriptions that were transmitted electronically. The AAMC believes the same logic can be applied to the meaningful use functions during the initial years of the incentive program, and encourages CMS to frame measures in terms of minimum number of uses. Also, because the first payment year requires only 90 days of EHR use, CMS should propose different minimum uses for the first payment year.
Second, we believe that the two proposed measures that relate to administrative systems (i.e. ―check insurance eligibility electronically for public and private payers‖ and ―submit claims electronically to public and private payers‖) should be eliminated from the list of meaningful use requirements. These two measures are administrative requirements that are not connected to improving clinical care. Additionally, EPs and hospitals that use clearinghouses and alternative mechanisms for performing these functions would be required to change their claims submission process, as the required information would not have been generated from the EHR.
Third, we request that CMS provide additional details regarding what the attestation process will require. The proposed rule does not clarify what data will need to be reported for a provider to attest to the completion of a given meaningful use measure, in what format, or how it will need to be reported. Additionally, the AAMC is concerned about what might happen in the event that an audit determines that an incentive payment should not have been made. We request that CMS state that as long as all required attestations are done in good faith, the remedy will be the
recoupment of an overpayment, and will not involve referral to the Office of Inspector General for the possible violation of the False Claims Act.
Concern with Lack of Measures for a Group Practice
When implementing the quality reporting and meaningful use measures, CMS should consider measurement across a health system, so that if one EP in a system documents the appropriate information, another EP in the system will not need to repeat the measure. For example, if one doctor has asked a patient about smoking status and has documented the answer (in the
appropriate time period) in a record for a health system, then another doctor in that network should not have to ask the question again. Implementing a system in this fashion encourages EPs to coordinate care and exchange information while minimizing inconvenience to patients and duplication of services.
QUALITY REPORTING (PAGES 1870-1903)
One of the requirements in the ARRA legislation for meeting the definition of ―meaningful use‖ of certified EHR technology is that EPs and eligible hospitals must electronically report on clinical quality measures. The AAMC supports reporting on quality measures from EHRs as a vehicle to improve quality of care. However, utilizing EHRs for quality reporting has not yet matured for either hospitals or EPs. The AAMC believes that any electronic quality reporting program requires an appropriate infrastructure and a reporting process that is well-designed, is well-tested, and avoids duplicate reporting.
CMS proposes the creation of new quality reporting programs to meet the meaningful use requirements. The AAMC appreciates CMS’s desire to encourage submission of quality data, but believes creating a new system without properly aligning it with current quality reporting systems will create additional burden with minimal value. The AAMC strongly opposes the development of new reporting programs. Instead, CMS should look to expand existing programs such as the Reporting for Hospital Quality Data Annual Payment Update (RHQDAPU) and the Physician Quality Reporting Initiative (PQRI) to include electronic data submission once the infrastructure is in place.
The Association urges CMS to remove the interim attestation requirement for hospitals and EPs in FY 2011 and not require electronic submission of quality measures until the following occurs:
CMS has the infrastructure and capacity to accept such measures;
CMS has specified and endorsed measures that have been tested for EHR data collection; and
Vendors, hospitals, and eligible professionals have adequate time to incorporate the measure specifications and to test and validate the data collection and submission.
Release of Measure Specifications
In the proposed rule CMS states that the Agency is ―targeting finalization and publication of the detailed specifications documents for all 2011 payment year Medicare EHR incentive program quality measures for eligible hospitals on the CMS Web site on or before April 1, 2010.‖ As this date is only two weeks after the close of the comment period, the AAMC is concerned that CMS intends to finalize the specifications without giving adequate consideration to the comments that will be submitted in response to the proposed measures. Similarly, for the measures where no specifications are available, the AAMC has no opportunity to comment on the accuracy and feasibility of the measures. It is critical that all measures implemented in the HIT incentive program be subject to the same review process laid out for the already-specified Stroke, VTE and ED throughput measures.
In the future, the AAMC believes measures specifications should be released at least 9 to 12 months prior to their required implementation. This would provide vendors, hospitals and eligible professionals the necessary time to program, test, and validate the measures.
Electronic Submission
ARRA requires EPs and eligible hospitals to report on clinical quality measures through EHRs to earn incentives. The statute also states that ―[t]he Secretary may not require the electronic reporting of information on clinical quality measures…unless the Secretary has the capacity to accept the information electronically.‖ In its proposed rule, CMS acknowledges that the Agency does not expect to have the capacity to receive quality data through EHRs by the 2011 reporting period and proposes to require EPs and eligible hospitals to calculate their clinical measures and submit that data to CMS by attestation.
The AAMC believes this proposal creates a barrier to achieving meaningful use and adds an unnecessary burden. The requirement forces EPs and hospitals to set up temporary data collection and reporting processes that will need to be updated or replaced once CMS has the appropriate infrastructure in place.
The AAMC urges CMS to remove the attestation requirement for FY 2011 and only require electronic submission once the Secretary has the capacity to accept the data and selected measures have been fully specified, tested and validated.
Aligning Quality Reporting Programs
In implementing the EHR requirement, the AAMC encourages CMS to leverage the knowledge gained from implementing current hospital and physician quality reporting programs. It would be beneficial to all hospitals and EPs for CMS to align all quality programs to minimize
confusion and reduce the reporting burden.
When the RHQDAPU program was established, hospitals, vendors, and CMS experienced operational challenges and technical complexities, even though the program was based on an existing reporting structure. Both CMS and hospital associations invested significant time and
resources in ensuring RHQDAPU was administered appropriately. It is now a well-functioning quality reporting program.
When the Tax Relief and Health Care Act of 2006 (TRHCA) required hospitals to report outpatient quality measures, CMS created a new reporting program rather than expand the inpatient program. Significant differences between the two programs in administration and processes caused confusion among hospitals. If finalized without significant revisions, the proposed rule would create a third hospital reporting program. Experience suggests that this will cause confusion, require additional resources, and continue to move away from aligning
reporting programs, with no evidence that a third program will contribute to the overall improvement of care delivery.
The AAMC strongly encourages CMS to expand the current RHQDAPU program to incorporate electronic reporting for hospital quality measures, as soon as CMS is able to accept such reporting. The RHQDAPU program has standardized processes and policies for measure selection, data submission, validation, and appeals. Utilizing this framework with the option of electronically submitting performance data to satisfy the requirements for meaningful use would give hospitals the predictability of knowing how the program would operate,
minimize CMS resources for the creation of a new reporting program, and ultimately achieve alignment between reporting programs.
For eligible professionals, CMS has encouraged participation in the voluntary Physician Quality Reporting Initiative (PQRI). Now in its fourth year, PQRI has seen an increase in the number of EPs reporting and the number of measures being reported. CMS also spent the past few years pilot testing data submission through EHRs. Starting in 2010, EHR data submission will be permitted for a limited number of measures and EHR vendors.
The AAMC applauds CMS’s work on EHR quality measures; however, at this time, only nine measures of the 176 individual PQRI measures can be reported through this mechanism. Many EPs who have invested in reporting quality information cannot yet transfer their measures to EHR reporting. This drastic change in measures available for reporting could discourage EPs from submitting quality information and/or from obtaining an EHR. Until such measures are available for PQRI EHR submission, CMS should allow PQRI participation through any reporting mechanism to meet the ARRA quality reporting criteria.
Technical Assistance
In addition to having the technical capacity to receive electronic submissions from EPs and hospitals, no new reporting requirement should be implemented until CMS has in place sufficient resources for customer support and technical assistance. Technical assistance has been regularly under-resourced, yet such assistance is critical in the expansion to electronic data submission.
Quality Measure Requirements
The AAMC strongly believes that before being included in the HIT incentive program, any quality measure must be supported by clinical evidence and be fully specified and tested for EHR data collection. All measures must be endorsed by the National Quality Forum (NQF). In addition, hospital measures should be approved by the Hospital Quality Alliance, a multi-stakeholder organization that evaluates and approves measures based on their readiness for national implementation. EP measures should go through an extensive testing process, such as the PQRI EHR testing protocol.
Quality Reporting for Eligible Professionals: Measure Selection
Of the ninety proposed quality measures for EPs, only nine have been specified and tested for EHR data submission. These are the nine measures that CMS is allowing for the 2010 PQRI EHR reporting. The AAMC strongly believes these are the only measures that should be included in the meaningful use requirements at this time.
At the same time, however, these nine measures are not relevant to all EP practices. CMS should establish an exemption process so that EPs who are not able to report, due to the lack of available measures, are not unduly penalized for not reporting. The AAMC anticipates that specialty societies will provide suggestions to CMS about which specialties and subspecialties should be exempt.
Similar to the proposed measures for hospitals, CMS has proposed reporting on readmission rates for EPs. EPs do not have access to the data needed to accurately calculate a risk-adjusted rate. This measure has not yet been specified nor endorsed and should not be included in such a program.
Quality Reporting for Eligible Professionals: Framework
There is wide variation in physician practices—including size of the practice, setting, and types of services provided. In the four years since the Physician Quality Reporting Initiative (PQRI) began, CMS has recognized this diversity by increasing the measures that can be reported as well as by offering different mechanisms for reporting data. CMS should use a similar approach for the quality reporting requirement.
CMS is proposing that EPs report on a core set of measures and, in addition, report on a set of specialty-specific measures. The proposed core measures are intended to apply to a broad range of patients, while the specialty measure groups (cardiology, pulmonology, endocrinology, oncology, proceduralist/surgery, primary care, pediatrics, obstetrics/gynecology, neurology, psychiatry, ophthalmology, podiatry, radiology, gastroenterology, and nephrology) are grouped ―according to the types of patients commonly treated and services rendered by EPs of various specialties.‖ 75 Fed. Reg. at 1891. CMS proposed between 3 and 29 measures per group, but
indicated it would narrow the options down to 3 to 5 measures per group. The AAMC strongly opposes requiring EPs to report the core and specialty measures for the reasons discussed below.
Not all practices within a specialty are similar. Among the services that academic medical centers provide to the community is specialty care that has limited availability. Many academic medical centers have subspecialists with niche practices that are not comparable to the practices of other physicians within their broad specialty. Subspecialists in dermatology, infectious disease, pathology, oral surgery and allergy currently struggle to find appropriate measures in PQRI to report, which has wider variety of measures than the current proposed measures. Requiring these EPs to report on measures that are not relevant to the patients they treat would be counterproductive and would not improve patient care. It also may mean that these
subspecialists will not be able to achieve meaningful use and may face penalties in future years due to circumstances beyond their control.
The relevance and importance of the “core” measures vary across all practices. CMS proposes that EPs report on the three ―core‖ measures (smoking status, blood pressure
measurement, and drugs to be avoided in the elderly), because they are ―sufficiently general in application and of such importance to population health.‖ The AAMC believes that EPs should report on measures that are relevant to their patient population and not report if it does not improve the physician quality of practice. For example, patient smoking status and blood pressure may not be the most relevant measures if an EP is a consulting physician and not the primary care provider. Requiring all EPs to report core measures would add to the regulatory burden rather than improve care.
It is not feasible to implement the proposed number of measures by 2011. The PQRI program is a good guide for estimating the number of measures that can be implemented in one year. Under PQRI, EPs only need to report on three individual measures or a single measures group. While PQRI measures group reporting has at least four individual measures, all measures apply to the same patient population, thus simplifying data collection. In contrast, CMS
proposes that to achieve meaningful use, EPs would have to report on a minimum of six measures starting in calendar year 2011. Additionally, the proposed meaningful use measures apply to a variety of patient populations – which means EPs need to implement logic to identify several denominator populations. Because the EHR measure specifications and systems are not currently in place, many EPs may find that the only way to meet this requirement by 2011 is to pay for extensive customization of their EHRs, and even this may not be possible by then. Based on an analysis of 2007 PQRI participation by academic physicians, we know that
professionals on average initially reported on fewer than three measures. This data suggests that most professionals begin reporting in a limited fashion to understand the issues related to
reporting, and make the necessary adjustments to their practice workflow before taking on reporting on additional measures. Given this information, it is unreasonable to establish a requirement that will force EPs who wish to achieve meaningful use to report immediately on such a large number of measures.
Alternative to the CMS Quality Proposal
Rather than reporting on the core measure group and a specialty-specific measure group, the AAMC suggests that EP participation in the PQRI program should suffice for the quality reporting requirement until appropriate measures are available for EHR reporting. This option will require EPs to incorporate quality reporting into their EHR adoption, while allowing them the flexibility to determine the measures appropriate for their practice and avoiding penalties if their appropriate measures are not ready for EHR reporting. This option also encourages EPs that have invested in reporting systems to continue reporting on quality measures and provides them the time to make a smooth transition to EHR reporting. In this option, CMS may choose to implement a minimum reporting threshold (for example, an EP must report at least 25 quality data codes) to ensure that EPs are actively participating in PQRI. Under this option CMS should implement a system that will exempt specialties and subspecialties from quality reporting until such time as they have measures that are tested, validated, and ready for use.
Quality Reporting for Hospitals: Measure Selection
Currently, none of the proposed quality measures for eligible hospitals have been fully specified and tested for national implementation. CMS has developed e-specifications for the Stroke, Emergency Department, and Venous Thromboembolism (VTE) measures; however, testing of these measures has not yet occurred and is not scheduled to be completed until later this year. The AAMC supports the planned testing of these measures. The PQRI EHR pilot indicates that testing measures for hospital use will yield important information which can be used to modify measure specifications or measure implementation. The AAMC believes that no measure should be implemented prior to successful completion of pilot testing.
The AAMC has specific concerns with several measures included in the proposed list. The Association believes the readmission measures should be rescinded. The 30-day readmission measures are already being calculated based on Medicare claims and are being publicly reported by CMS. Moreover, while hospitals could calculate readmissions to their own hospital, they would not be able to identify those patients who were discharged from their hospital and then readmitted to another facility. In addition, hospitals would not be able to apply the risk adjustment methodology, as it requires access to physician claims that is not available to
hospitals. Since CMS is already calculating these measures, it is unclear why hospitals should be required to duplicate this effort.
The AAMC also believes that the Ventilator Associated Pneumonia (VAP) and Urinary Tract Infection (UTI) measures should be removed. The HQA conditionally endorsed both the VAP and UTI measures; however, that endorsement was contingent upon the measure definitions being updated. There is no agreed-upon definition in the provider community for VAP. While an updated definition was in process for the UTI measure, it is unclear if this process has been completed. Neither of these measures should be implemented until updated standardized definitions have been developed.
Quality Reporting for Hospitals: Reporting Period
The proposed rule suggests the reporting period for submission of quality data should be the same as the reporting period for the meaningful use measures. The AAMC strongly suggests that CMS utilize quarterly reporting periods to align with current quality reporting programs and support ongoing quality improvement efforts. Utilizing a single, annual reporting period could be problematic, as it gives hospitals only one opportunity per year to submit their data, thus creating a greater risk of not being able to report successfully.
DEFINITION OF EHR REPORTING PERIOD (PAGES 1848-1849)
For any provider’s first payment year, CMS proposes to define the term ―EHR reporting period‖ to mean any continuous 90-day period within a payment year in which an eligible professional (EP) or eligible hospital successfully demonstrates meaningful use of certified EHR technology. The AAMC strongly supports the proposal to define the EHR reporting period for a provider’s first payment year as a 90-day period. We believe this time period is reasonable and encourages participation in the incentive program. We request clarification, regarding whether, for eligible hospitals, the 90-day period may be a different period for Medicare than it is for Medicaid. Please refer to the Quality Reporting for Hospitals section of this letter for recommendations specific to reporting periods for the quality reporting requirements.
DEFINITION OF PAYMENT YEARS (PAGE 1848)
CMS proposes to define the term ―payment year‖ as a calendar year, for EPs, and as a federal fiscal year, for eligible hospitals. The AAMC supports this approach, because it is consistent with the Agency’s other payment programs.
CMS proposes to define the ―second, third, fourth, fifth, and sixth payment year[s]‖ to mean the ―second, third, fourth, fifth, and sixth calendar or Federal fiscal year, for which an EP or eligible hospital receives an incentive payment.‖ Under CMS’s proposal, the determination of the payment year affects which stage of the meaningful use requirements the provider is required to meet.
The proposal does not, however, address the situation of a provider that qualifies one year but fails to qualify in a subsequent year. Take, for example, a situation where a provider first receives an incentive payment in 2012, fails to meet the requirements in 2013, but then meets them again in 2014. In this example, is 2014 the provider’s ―second payment year,‖ even though it is the third year, chronologically, from the time of the first payment? If so, it is then not clear which stage of the meaningful use requirements the provider would be required to meet in 2014. AAMC requests clarification from CMS on the definition of subsequent payment years, given that providers may not qualify in each consecutive year.
INCENTIVE PAYMENTS FOR ELIGIBLE PROFESSIONALS (pages 1907-1911) General Comments and Concerns:
The AAMC supports requiring the carrier/MAC to disburse the incentive payment ―once a qualifying EP’s allowed charges reach the minimum threshold of allowed charges for the payment year.‖ The AAMC asks that CMS provide additional information on how this will occur, what happens if there is a disagreement between the EP and the carrier/MAC about whether meaningful use has been achieved, and how long the carrier/MAC will have to make the payment.
The AAMC also would like further information about whether the carrier/MAC scopes of work will be revised to reflect the additional work that this will entail.
The AAMC agrees with the CMS proposal that EPs who work in multiple group practices must select one practice to receive the incentive.
The AAMC also supports the CMS proposal to allow EPs to make a one-time switch between the Medicare and Medicaid programs. We request that CMS provide more information about how this will occur, including whether notifications must be given to the carrier/MAC (and when).
Concerns Regarding the Lack of a Group Practice Option
The AAMC is disappointed that CMS has chosen not to exercise the authority granted by Congress to propose meaningful use criteria and incentives for group practices. Many of the most advanced EHR users provide services through faculty practice plans or other large physician group practices. A physician group can implement and optimize EHR use across physicians and clinics thereby encouraging the coordination and sharing of data, such as test results, images and notes. In addition, logistics for a thoughtful group roll-out differ
significantly from those at a small physician office.
Respondents to a 2009 AAMC survey of faculty practices indicated that on average, faculty practices have 49 clinics. It is not unusual for a faculty practice to begin using EHRs in a limited roll-out that implements certain functions for a few specialties at a few clinic sites. As
physicians become comfortable with the EHR—and as lessons learned during the initial implementation are used to guide future implementation—its use is then expanded to other specialties and locations, so that over a period of time the majority of physicians are using the EHR in the ambulatory setting. Because no group option is available, a practice that uses an integrated approach to care for patients cannot be evaluated as a system. CMS has already considered the issue of individual versus group reporting in PQRI. Starting in 2010, CMS implemented an optional PQRI group reporting mechanism that evaluates quality metrics at the group level. The AAMC urges CMS to consider adding a group reporting option for meaningful use as soon as possible.
INCENTIVE PAYMENTS FOR HOSPITALS (PAGES 1911-1916) Incentive Payment Calculation for Eligible Hospitals (pages 1911 – 1912)
Both the Medicare and Medicaid incentive payment formulas provide for a ―discharge related amount‖ of $200 for each hospital discharge within a payment year from the 1,150th discharge through the 23,0000th discharge. Neither the statute nor CMS’s regulations specifies whether nursery bed discharges are included in the total number of discharges. The AAMC requests clarification on this point.
Charity Care (pages 1913 – 1914)
CMS proposes to use the charity care charges hospitals report on Line 19 of the revised Worksheet S-10 of the hospital cost report to calculate charity care for the Medicare share of hospital incentive payments. The AAMC expressed concerns with the instructions for Line 19 in a comment letter to CMS dated August 31, 2009, and remains concerned about how this line will be calculated. Specifically, the Association noted in its comment letter that CMS’s proposed instructions for Line 19 were ambiguous, in that it was difficult to determine whether CMS intended to collect data regarding the hospital’s full charges or the patient’s discounted
obligation. The AAMC also expressed concerns that the instructions were conflicting regarding insured patients versus uninsured patients. Given this confusion, we recommended that CMS revise the instructions for Line 19 to clarify exactly what data should be entered in this line. The data a hospital enters in Line 19 will have a clear and significant effect on the determination of a hospital’s HIT incentive payment, yet it is not possible to offer constructive and meaningful comments regarding CMS’s proposal for determining hospital charity care, as the final version of the cost report and instructions has not yet been released. Given that CMS’s final version of the cost report and its accompanying instructions were not released prior to the close of the comment period for this proposed rule, the AAMC is concerned that the public did not have a comment period to assess the implications of the final Line 19 instruction language on this HIT proposed regulation. The AAMC requests that CMS provide the public with the opportunity to comment on the use of Line 19 for charity care data after the final version of the cost report has been released and requests a sufficient period of time to provide such comments.
Regardless of the date of publication of the final version of the new cost report and its
instructions, the AAMC requests clarification regarding what charity care data CMS will use for the period of time in 2010 that occurs prior to the release of the new cost report. Hospitals whose cost reporting period follows a calendar year and who wish to become meaningful users in FY 2011 will not be able to report Worksheet S-10 data for their first EHR incentive reporting year. The AAMC encourages CMS to establish an alternative method of calculating charity care charges for these hospitals.
APPEALS PROCESS FOR MEDICARE PAYMENTS
In the proposed rule, CMS sets forth an appeals process that the Agency plans to require of state Medicaid programs (see proposed 42 C.F.R. § 495.370). CMS does not, however, propose such an appeals process for the Medicare incentive program. Having recourse to an appeals process is vital to ensuring fair implementation of the program; thus, the AAMC urges CMS to incorporate an appeals process into the Medicare HIT incentive payment program. This process should mirror that which CMS proposed for the Medicaid program by permitting providers to appeal (1) the denial of incentive payments; (2) incentive payment amounts; (3) provider eligibility determinations; and (4) demonstration of meaningful use. While ARRA precludes judicial review of the methodology and standards for determining payment amounts, meaningful EHR users, hospital-based eligible professionals, and reporting periods for the Medicare HIT incentive payment program, nothing in the statute precludes appeals of individual provider determinations. ATTESTATIONS AND THE FALSE CLAIMS ACT
For the first year, CMS will require attestation for meaningful use and the submission of clinical quality results. Medicare EPs and eligible hospitals will attest to the accuracy and completeness of the numerators, denominators, and exclusions submitted for each of the applicable measures and to all other information that must be reported. The AAMC requests that all attestations include language stating that the attestation is ―provided in good faith‖ and ―to the best of my knowledge and belief.‖
Should an audit reveal that the Medicare EP or hospital should not have qualified for the incentive, the AAMC requests that, absent a showing of fraud, the remedy will be limited to the recoupment of an overpayment, and will not involve referral to the Office of Inspector General for the possible violation of the False Claims Act.
MEDICAID
Common Definition of Meaningful Use Under Medicare and Medicaid (pages 1851-1852)
Although CMS emphasizes the importance of aligning the Medicare and Medicaid definitions of meaningful use and states that it is creating a ―common definition‖ between the two programs, the Agency then ―clarifies‖ that the common definition would simply be a minimum standard for state Medicaid programs. The AAMC is extremely concerned with CMS’s proposal to permit states to add additional objectives to the definition of meaningful use and to modify how the existing objectives are measured. A consistent, national approach is imperative, given the HIT incentive program’s ultimate goal of achieving nationwide interoperability of EHRs. The AAMC recommends that CMS not permit states to add additional requirements to the definition of meaningful use.
CMS also proposes to ―deem‖ hospitals that are found to be meaningful users under the Medicare incentive program to be classified as meaningful users under the Medicaid incentive program. The AAMC supports this proposal and believes it is reasonable to not require hospitals that are meaningful users under the Medicare program to meet additional, state-specific
