1. Remove the "all or nothing" approach that requires physicians to meet all 25 objectives and measures contained in the proposed rule, as well as the reporting requirements that involve the use of numerators and denominators particularly when it would involve manual data collection by the provider.  In its place the AMA recommends that physicians should only have to meet 5 of the rule’s 25 objectives and measures.(13)

2. Eliminate objectives and measures that were not germane to EHR adoption (i.e. practice management functions) and others that the AMA feels are not ready for Stage 1 due to the lack of electronic exchange readiness (e.g. reporting immunization data). 

3.  Revise the proposed definition for hospital-based physicians to broaden eligibility; and only require EPs to attest that they have selected three clinically relevant quality measures, if appropriate, and have downloaded and reviewed the Level 1 (human readable) measure specifications for these measures. 

4. Only require EPs to attest that they have selected three clinically relevant quality measures, if appropriate, and have downloaded and reviewed the Level 1 (human readable) measure specifications for these measures.

1. Based on the Act, laboratories are not considered EPs and do not qualify for MU incentives. In defining “hospital-based” EP, CMS should take into consideration whether a pathologist has or will be required to contribute funding towards an EHR. Those EPs who are required to contribute funding should not be considered hospital-based, as they are not provided full access to the “facilities and equipment of the hospital including the hospital’s qualified EHR.” This will reduce the possibility that EPs that do contribute funding will suffer a negative economic impact while complying with the spirit of the EHR regulation.

2. Under the Act, a hospital-based EP is an EP who furnishes ninety-percent or more of his or her covered professional services in the calendar year proceeding the payment year in a hospital setting. A setting is considered a hospital setting if it is identified by the codes used in the HIPAA standard transactions that identifies the site of service as an inpatient hospital, outpatient hospital, or emergency room. Because of the ninety-percent threshold, small changes in a pathologist’s service mix could result in his or her meeting the definition of hospital-based in one year and not the next. The proposed rule is silent as to how such providers should be treated. CAP recommends that in the final rule CMS explicitly address the treatment of providers whose status may change from year to year.

3. Under the proposed rule, pathologists, who performed less than 90 percent of their professional services in any inpatient or outpatient setting in the prior year would be considered an EP pursuant to §495.100 of the Act, and would be subject to the requirements of the regulation. As such, all EPs would be required to report specified Health IT Functionality Measures that include several functions that pathologists do not usually perform, such as transmitting at least 75 percent of all permissible prescriptions electronically using certified EHR technology, or maintaining active medication and medication lists and allergy lists. Further, all EPs have to report on all Core Measures (i.e., preventive care and screening regarding tobacco use, blood pressure measurement, and drugs to be avoided by the elderly) and a subset of clinical measures that are most appropriate to the physician’s specialty. Given the nature of pathology’s scope of practice, none of these Core Measures could be met by pathologists in their day-to-day practice. Additionally, the proposed rule’s specified specialty group measures –cardiology, pulmonology, endocrinology, oncology, proceduralist/surgery, primary care, pediatrics, obstetrics and gynecology, neurology, psychiatry, ophthalmology, podiatry, radiology, gastroenterology, and nephrology -- are also not applicable to pathology.

4. To ensure that pathologists, who are currently defined as EPs, are not penalized for the failure to meet measures they have no way of meeting in their normal scope of practice, the CAP recommends that CMS consider pathologists as “non-qualifying” eligible providers, exempt from future MU penalties. The CAP appreciates CMS’ acknowledgment that certain physicians will not be able to report any specialty MU measures. However, the CAP believes that the exemptions process should be further defined. Specifically, the College recommends clarifying:

1) key terms necessary to support such an exemption process,

2) the exemption process itself, and

3) how and if exempt physicians would be protected from the financial penalties.

5. Several necessary definitions appear to be omitted from the regulation text. CAP is concerned with the omission of the term “specialist.”  This definition is not only necessary to identify what and who a specialist is, but who would qualify for the exemption.  In addition, while referenced on several occasions in the preamble of the regulation, the key term “qualified EP” was not clearly defined; nor did CMS formally provide a definition for a “Non-Qualifying EP.”(14) Taken as a whole, the preamble and regulation text seem to define any EP who cannot report any specialty group and core measures as essentially a “Non-Qualifying Eligible Provider.” For example, pathologists cannot report any measures, specialty or core. CMS should more clearly define or adopt the above-suggested language for “Non-Qualifying EPs” thereby exempting the non-qualifying physicians from potential financial penalties, starting in 2015, for non-compliance with the MU regulation.

Further, based on the suggested definition, the CAP recommends that CMS create a structured regulatory-defined process for the “Non-Qualifying Eligible Provider,” to “attest” as to the “inapplicability of selecting and/or reporting any specialty group or core measures,” and that pathologists be presumed to be “Non-Qualifying EPs.” Lastly, as long as a specialist’s specialty could be identified as pathology (through an analysis of the preponderance of their submitted billing codes), they would not need to attest on an individual basis, but could be presumed to be exempt by virtue of being a pathologist.

CAP supports the MU objectives and measures for EPs, eligible hospitals and critical access hospitals contained in §495.6 of the Act, and the incorporation of clinical lab-test results in EHRs. However, CAP observes that this is a rigorous goal that may be difficult for many EPs to meet. As such, the measure may require modification. Therefore, the CAP recommends that the MU requirement that “at least 50 percent of all clinical lab tests results ordered by the EP ….. are incorporated in certified EHR technology as structured data,” be modified to clarify its specifications and that CMS consider the effects of the requirement on laboratory competition, particularly given the importance of small laboratories to many rural and underserved communities.

6. CAP recognizes that the proposed MU rule is focused on ordering physicians, particularly primary care doctors and the specialties listed in the rule. However, laboratory data is essential to the achievement of MU by EPs since many measures rely on laboratory data. Specifically, as noted above, labs will need to harmonize their HIT systems (i.e. LIS) with qualified EP EHR systems. Such support and data exchange is supported by the CAP and advances the goal of care coordination, achievable through the bidirectional EHR communication between the “Qualifying” and “Non-Qualifying Eligible Provider.” However, as the Exchange Subcommittee of the ONC HIT Policy Committee recognized in a December 15, 2009, presentation, these interfaces often cost from $5,000 to $25,000 each (these numbers are for results systems only; the cost would be considerably higher for Computerized Physician Order Entry interfaces where they are even possible in the ambulatory environment) and the cost (except for low-volume customers) is usually borne by the lab. Therefore, the CAP suggests that CMS, in concert with ONC, identify a funding stream to help underwrite the cost of these interfaces. If no such funding stream is available under the Department’s current legal authority, we recommend that HHS request such authority given the centrality of lab data to the achievement of MU. While the refinement of standards will bring the cost of these interfaces down over time, the market for laboratory services may experience heightened concentration before this cost reduction can occur.

7. The CAP looks forward to working with CMS as it implements the additional stages provided for in this proposed rule. In Stage 2, CMS anticipates requiring that pathology reports be reported as structured data. Pathologists will be essential to the achievement of this MU goal. Pathologists can play an important role in coordinating care with primary care and other clinicians, both inside and outside the hospital setting. However, to do so they need access to complete EHRs that includes the necessary software integration with electronic LIS infrastructures. Pathologists, regardless of practice setting, utilize LIS and anatomic pathology information systems (APIS) that enable them to order and track tests as well as monitor a patient’s disease state. However, by itself the LIS/APIS does not provide enough information for a pathologist to track a patient’s disease state. This information is stored and managed in the EHR. LIS/APIS systems only have the ability to work with a limited subset of patient data. Pathologists need to have direct access to the patient’s electronic health record, not indirectly through their LIS/APIS system. Without access to robust EHRs, pathologists cannot access the clinical information necessary to determine appropriate testing, test interpretation and follow-up care.