Q: Would unpaid Stage 1 payments be in jeopardy if an eligible hospital did not meet the requirements for Stage 2?
A: Once a facility has successfully met the meaningful use requirements for a particular year, the payment for that year is not in jeopardy. However, if an eligible hospital does not continue to be a meaningful user in subsequent years, the Medicare reimbursement reductions will begin. The law stipulates that eligible hospitals must continue to demonstrate meaningful use every year to avoid payment adjustments in subsequent years. Those adjustments may begin as early as 2015 if they successfully attested for Stage 1 in 2011 or 2012. The only way a hospital could lose the previously paid monies would be if it was audited and did not have sufficient documentation to support its attestation.
Q: Table 3 in the Final Rule (44376) breaks down the objectives by whether the denominator must include all patients, just those with an EHR, or only yes/no attestation.
Is there a clear definition for what constitutes "patients whose records are maintained using certified ERH technology?" Specifically, if only labs, triage assessment, and demographics are entered electronically (no H&P or electronic physician/nursing care documentation beyond triage), would these patients count in the denominator? The example I describe is an Emergency Department that only uses electronic registration, triage, and Tracking Board.
Is the intent that the denominator include those patients with a COMPLETE EHR, or also those that only have pieces/parts documented electronically?
A: Table 3 in the Medicare and Medicaid EHR Incentive programs final rule (FR 75 44376-44380) lists measures sorted by the method of measure calculation. Please see the FAQ on the CMS website at www.cms.gov/EHRIncentivePrograms.
Q: If a hospital has satellite clinics, can some of the ARRA monies received by the hospital be used to upgrade the clinics as well? Or must the money for those upgrades come from other sources?
A: It will depend on the ownership structure. If the hospital and clinics are owned by the same entity, then we believe it is a business decision and the hospital can choose how to use the ARRA monies they receive for meeting meaningful use criteria for their EMR. ARRA doesn't specify how the money is spent just that in order to earn it you must meet meaningful use criteria. Are the clinics using an EMR other than the hospitals EMR? If so, they, we’d assume, might be trying to earn their own ARRA incentive moneies.
On the other hand, if the clinics are clients of the hospitals, then the hospital must consider the anti-kickback statutes which have in the past allowed 85% of the cost of the EMR at the clinics to be paid for by the hospital, however, it cannot be predicated on volume or on the expectation that the clinic will then send specimens to the hospital. Bottom line, the hospital should consult with its legal representation on this one.
Q: What are the requirements to qualify for stimulus monies, and is there a deadline to have the EMR completed to qualify, or would there be some stimulus if you were in the middle of an EMR project? How and when do you apply for the stimulus?
A: In order to qualify, the facility must meaningfully use a certified EHR for 90 consecutive days the first year, and the entire 12 months for subsequent years. The EMR project does not need to be complete to register, as long as the EHR is certified on the day of attestation, it does not matter when the actual certification was granted, but incentive payments will not be made without a certified EHR. Registration begins online at the CMS website beginning Jan 1, 2011; the last day for eligible providers to register and attest to meeting meaningful use is Feb 29, 2012 to qualify for CY 2011 incentive payments; for hospitals, the last date to register and attest is Nov 30, 2011 to receive incentive payments for FY 2011. If the hospital has not registered and demonstrated meaningful use by 2015, they will be subject to reduced Medicare and or Medicaid payment.
Q: How will ARRA/HITECH impact organizations that already have an EMR?
A: The impact will depend on the EMR vendor’s plan for certification. If your current EMR becomes certified, your facility will then need to use the EMR functionality to meet the other qualifications for meaningful use (MU). If the EMR vendor has no plans for certification, your facility will then need to decide to forego meaningful use or change EMR vendors. The important task is to have conversations with your current EMR vendor to find out their plans.
Q: I would like to understand the impact that the EMR will have on our current LIS system and a general overview of how things will change for us in the lab, if at all.
A: If the EHR vendor obtains certification, there should be no impact on the current LIS, especially if the LIS is interfaced to the EHR. If the current EHR vendor has no plans for certification, the facility will need to determine whether or not to replace the current EHR in order to qualify for meaningful use. If there is a change in the EHR, the LIS will need to be interfaced to the new EHR system if the facility plans to qualify for future stages of meaningful use. (Receiving structured results is a menu item for stage 1 but is expected to be a core requirement of stage 2.)
Q: If we have 3 providers, does each provider qualify, or is it how we receive payment from CMS? So, if we get paid as a group, then only our group will qualify?
A: Eligible professionals qualify individually, not as a group, and each will receive incentive payments based on 75% of their individual allowable charges up to the maximum amount per participation year. During the registration process, each eligible professional (EP) will be required to provide the TIN to which the 42 CFR Final Rule states: “We believe that, in accordance with 1903(t)(6)(A) of the Act, an EP could reassign payment to a TIN associated with his or her employer or the facility in which she or he works.” See Section 495.10(f) page 44572 of 42 CFR.
Q: Will mid-level nurse practitioners (NP) qualify for incentive?
A: Mid-level NPs may be eligible providers for Medicaid. However, to qualify, they must be enrolled in the Medicaid program and have 30% or more Medicaid patients.
Q: Will we qualify for the incentive if we do not see Medicare patients?
A: To qualify for incentive payments, eligible professionals must be enrolled in the Medicare program. Since payments are calculated and paid as 75% of Medicare allowable charges, if the facility does not participate in the Medicare program, there will be no incentive payment.
Q: How is the laboratory paid by Medicare for all the tests being ordered on the patient if the patient is purely medical? Almost all our patients are medical and Medicare, and only a few are with private insurance. Can you address this issue?
A: Meaningful use (MU) will have no impact on how the lab gets paid for lab tests–they will continue to get paid in the same manner that they currently are paid (or not paid, if that is the case). Laboratory testing will still be billed using CPT for outpatient laboratory tests and included in the DRG for inpatient laboratory tests. Incentive payments will go to the hospital, if it meets all meaningful use criteria.
Q: How do we "apply" or obtain an application for reimbursement monies?
A: Beginning in January 2011, you may register at the CMS website: www.cms.gov/EHRIncentivePrograms/50_Registration.asp
Per the CMS website: “All eligible hospitals and Medicare eligible professionals must have a National Provider Identifier (NPI), and be enrolled in the CMS Provider Enrollment, Chain and Ownership System (PECOS) to participate in the EHR incentive program. Most providers also need to have an active user account in the National Plan and Provider Enumeration System (NPPES). CMS will use these systems' records to register for the program and verify Medicare enrollment prior to making Medicare EHR incentive program payments.
“If you are an EP that does not have an NPI and/or an NPPES web user account, you can apply for an NPI and/or create a NPPES user account via the CMS website. The CMS website also has more information about PECOS enrollment.
NOTE: Medicaid eligible professionals who are only participating in the Medicaid EHR incentive program are not required to enroll in PECOS.”
Q: When is the 1st payment from Medicare and Medicaid expected to be issued?
A: Registration will begin on the CMS website beginning in January 2011. Since the first year requirement requires that certified EHR technology be meaningfully used for 90 consecutive days, the first attestation can begin in April 2011. For those early adopters, the first payment is then expected in May 2011.
For detailed information on payments, see Section 495.102 page 44572 of 42 CFR Incentive Program final rule for eligible professionals and Section 495.104 page 44573 for eligible hospitals.
Q: With the increase demand for EMR integration, what is Orchard doing to facilitate this process between labs and EMR vendor?
A: Orchard is doing everything we can to accelerate and deploy our piece of the integration process in a timely manner. Every interface requires the coordination of three different organizations–the LIS vendor, the EMR vendor and the facility–along with the various timelines of each organization. In addition, it is the responsibility of the facility to validate every interface. While it may only take a week or two to actually deploy the interface, the testing and validation process can take much longer.
Q: How do you prove meaningful use of the LIS in a Physician Office Lab?
A: It is not necessary to prove meaningful use of the LIS. Meaningful use is demonstrated by using certified EHR technology in a meaningful manner as described in 42 CFR of the Federal Register.
Q. Primarily, we are a speciality laboratory that deals exclusively with oral head & neck pathology diagnosis and reporting. We are owned and operated under the direction of an MD. Is it possible for the MD to qualify for the reimbursement if the appropriate amount of Medicare or Medicaid is done?
A: The American Recovery and Reinvestment Act (Recovery Act) of 2009 provides for incentive payments for Medicare eligible professionals (EPs) who are meaningful users of certified electronic health record (EHR) technology. Section 1848(o)(5)(C) as added by the Recovery Act section 4101 defines the term eligible professional to mean a physician as defined in section 1861(r), which includes the following five types of professionals: doctor of medicine or osteopathy, a doctor of oral surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor. These professionals are eligible for incentive payments for the “meaningful use” of certified EHR technology, if all program requirements are met.
Since the pathologist is a doctor of medicine, he/she would meet this requirement. The question then becomes - does the doctor see patients? Are those patients seen in a hospital setting? If 90% of the patients are seen in a hospital setting, the doctor is a hospital-based physician and cannot qualify individually.
If the physician qualifies as described above, then the physician must demonstrate meaningful use of a certified EHR. Does the doctor use a certified EHR? If not, there is no incentive.
If the doctor uses a certified EHR, can he/she meet the 15 core criteria and 5 of the 10 menu criteria needed to demonstrate meaningful use? If yes, he/she is eligible for incentive payments. If not, there will be no incentive.
Q: How do nursing homes fit in this incentive plan? Are they considered a provider?
A: Skilled Nursing Facilities are not eligible for incentive payments. However, the MDs and NPs (Medicaid only) practicing at the facility may qualify for eligible professional (EP) incentives if they meet the requirements listed in the final rule. Refer to Section 495.304(d) page 44578 of 42 CFR for Medicaid eligibility and Section 495.100 page 44572 for Medicare qualification.
Q: Do specialty hospitals and Long Term Acute Care Hospitals (LTAC) qualify for the ARRA/HITECH stimulus? How are non-acute care hospitals (i.e. psychiatric) are impacted?
A: Page 44484 of 42 CFR defines acute care hospitals. Acute care hospitals qualify if they are subsection (d) hospitals with CCN numbers ending in 0001 – 0879 or 1300 – 1399 for Critical Access Hospitals and have an average length of stay <25 days. Acute care and children’s hospitals are the only facilities that can qualify for Medicaid as well. Long term facilities (those with average length of stay greater than 25 days) and Skilled Nursing Facilities do not qualify. Specialty hospitals will qualify if their CCN ends in the ranges listed above. Eligible Professionals at these facilities may qualify for Medicare or Medicaid payments if they meet the criteria. See Table 15 on page 44487, Section 495.304 page 44578, and Section 495.100 page 44572 for additional information on qualification criteria.
Q: Is a publicly traded for-profit long term acute care facility eligible for federal stimulus money to help interface the LIS to a hospital EMR system?
A: Refer to the previous answer for long term acute care qualification. As the rule stands today, there is no money specified for interfaces. ARRA/HITECH provides incentive payments to eligible providers (professionals or hospitals) to encourage the adoption and meaningful use of certified health care technology. The regulations describe what must be done to receive the incentive payments. What each facility does to get there is up to the facility. Incorporating structured lab results in the EHR is one way to assist in meeting meaningful use.
Q: Is there any stimulus money available for independent reference labs? Are there funds available (and how do we apply) for independent labs to help in meeting the needs of interfacing with the physician/client offices?
A: Incentive monies are not available to independent reference labs. The incentive payments are made to users, either professionals or hospitals, of EMR/EHR, not laboratories. However, you may want to consider the following:
- EMR will eventually need results sent electronically to meet stage 2 or 3, so the clients may be willing to partner.
- Interoperability – the next rulemaking process may address funding for interoperability, but no one knows at this point. States also have grant money available to establish HIE (Health Information Exchanges).
- Federally designated healthcare shortage areas may have other mechanisms for funding.
- Opportunities for leadership in your community.
- Provide accurate and timely information on meaningful use.
- Your clients will be asking for interfaces to their EMR systems. Meeting their needs will enhance your customer satisfaction. Each independent lab will need to determine the appropriate resource allocation and cost/benefit of this strategy.
Q: We are a gastroenterology group with a separate pathology division. The lab is in need of an upgraded LIS due to growth. I am specifically interested in finding out what Federal assistance is available to our facility regarding this matter.
A: Unfortunately, there are no incentive payments specific to upgrading the LIS under meaningful use. If the pathologists are hospital-based (employed by or contractual relationship with the hospital and more than 90% of their patient volume is identified by place of service 21 inpatient, 22 outpatient, 23 emergency room) they are not eligible for incentive payments (Section 495.4 page 44566 of 42 CFR); the hospital receives the incentive payment. If the pathologists are not hospital-based, and the pathologists plan to qualify for MU, can the existing LIS send results to the EMR as structured data as required for MU? If not, you have a good case with your administration, since the money comes from demonstrating MU and part of MU is receiving laboratory results as structured data. Although structured lab results are currently a menu item for stage 1, it is expected to be a core requirement in stage 2.
Q: What impact, if any, does the ARRA/HITECH stimulus have on specialty laboratories, such as a treatment center laboratory in a penitentiary setting or small independent drug screening labs for non-profit organizations?
A: ARRA/HITECH has no direct impact on the laboratory. Labs themselves cannot qualify for MU, but they can certainly assist their providers and facilities in meeting meaningful use by receiving CPOE (stage 2) and sending structured results back to the EHR (currently a menu item in stage 1 and expected to be a requirement in stage 2).
If the facility meets the requirements for meaningful use, the facility will receive incentive payments. If the facility is not eligible for meaningful use, the eligible professionals may qualify, and the incentive then goes to the professional.
Q: Do you anticipate any changes in the way reference labs deliver results? For example, we receive a lot of reports as HL7 "comments," and we are wondering if there are criteria to determine how structured "structured data" really is?
A: Incorporating laboratory results as structured data is not required to meet the requirements for Stage 1 Meaningful Use. Incorporating laboratory results, as you indicated, is one of the 10 optional menu objectives. A provider must meet all 15 core objectives plus any 5 of the 10 menu objectives to satisfy the requirements. The only stipulation for menu items is that one of the 5 menu items selected must be a public health menu item (immunization data or surveillance data).
Please note that the proposed rule for Stage 2 suggests moving all menu items to core items. The final rule for Stage 2 is expected to be published next summer, so I would begin planning as if incorporating lab results will become a required item for Stage 2.
Q: Do you anticipate any changes in the way reference labs deliver results? For example we receive a lot of reports as HL7 "comments" and wondering if there are criteria to determine how structured "structured data" really is?
Q: Can you define "test results as structured data"? Is the only way through interfaces or could this also be accomplished through EMR/EHR's ability to receive a paperless fax report that is then attached to the patient account by the provider?
Q: Can lab results be scanned into the EMR and be acceptable for structured data?
A: As currently used, the term “structured data” is somewhat ambiguous and not defined in the regulation. We have reached out to ONC to define “structured data.” When we receive a reply, we will post it on our website. What we know thus far:
If the comments are received as structured data in the EMR, there is no need for changes to the reference lab result delivery. If the comments are not received as structured data, the reference lab result format will impede their client’s efforts to achieve meaningful use. Clients may change to another lab that does send structured results, and this business decision may encourage reference labs to change.
It is beyond the scope of the rule to describe how lab results must be sent. (Section 170 page 44607 of 45 CFR) Per ONC guidance, the requirement for displaying structured data and vocabulary coded values in human-readable form requires that the received structured data be rendered in some way that does not display the message in raw delimited or XML format to the user.
From Section 170 page 44602 of 45 CFR, the ONC final rule page:
“We recognize that Certified EHR Technology may also store health information in scanned documents, images, and other non-interoperable non-computable formats and, consequently, do not expect Certified EHR Technology to be capable of reading or accessing the information in these other formats.”
Based on this statement, it can be inferred that a paper report that is scanned and attached will not be considered structured data.
Q: Would the structured pathology report, i.e. the CAP standards, be what is coming in later stages?
A: Stage 2 goals will expand on Stage 1 criteria to encourage electronic transmission of data, including laboratory results. Since pathology reports are specifically mentioned (page 44321 42 CFR) it is likely that structured pathology reports will be proposed in stage 2. However, whether they use CAP standards as the standard is not yet defined.
See also page 44609 of 45 CFR Certification Standards final rule.
Q: What is the mandate regarding LOINC codes? Are LOINC in HL7 messages? How are the LOINC codes going to work with Orchard Harvest LIS? Can we link them to our current order choices?
A: LOINC (Logical Observation Identifiers Names and Codes) is the standard approved for receiving laboratory results. If structured lab results are received using LOINC, certification criteria requires that they are displayed in human-readable format. There is no specific requirement identified for the type of structured format to be used.
Certified testing bodies (ATCB) will test messages in HL7v2, HL7 CCD, and ASTM CCR formats. If the vendor chooses to use a structured format other than those listed above, the ATCB conducting the test will determine whether the vendor’s structured format meets the criteria.
For additional information, please refer to the following pages in 45 CFR, the ONC Final Rule:
- Discussion of LOINC codes on page 44608
- Section 170.207(c) on page 44650
- Page 44500
Orchard Harvest LIS is ready for LOINC. The Lab Tests table in Harvest LIS contains a field to enter the appropriate LOINC codes for each lab test.
Q: If our EMR doesn’t have an order import interface capability and the lab receives a “plan item/request” and then manually enters the order, does this affect meaningful use?
A: Based on how this question is worded, we assume the EMR does not have the capability for a CPOE interface. Stage 1 meaningful use does not require CPOE of lab orders. However, page 44321 42 CFR Incentive Program final rule suggests that Stage 2 will propose CPOE as a requirement. We, therefore, highly recommend working with your current EMR vendor to determine their plans for certification, including CPOE and the expected requirements for exchanging information.
Q: Is the HIE (Health Information Exchange) part of one of these stages? Has Orchard started to look into this?
A: HIE is the sharing and exchange of data among EHR systems, and may occur simultaneously at the local, regional, and state levels, with the ultimate goal of exchange at the national level. Many regional organizations are already putting together the infrastructure to position themselves to share information as will be required in future stages for MU.
Per page 44321 42 CFR Incentive Program final rule, we expect HIE to be included in stage 2.
Although laboratory results comprise the majority of information in the patient record, the LIS itself will not play a major role in HIE. The information to be exchanged includes much more than laboratory results in the patient record. The LIS will continue to send structured results to the EHR and lab results will be a large component of the exchanged information, but the exchange will be between EHR systems.
For more information on national exchange and NHIN: