The program, funded under the American Recovery and Reinvestment Act, promotes nonproprietary health information exchange based on national standards. In total, 56 states, eligible territories, and qualified state designated entities received awards. 

Awardees are responsible for increasing connectivity and enabling patient-centric information flow to improve the quality and efficiency of care within and across states.

Preceding papers in this series have reviewed the requirements in the notice of proposed rulemaking on meaningful use, published by the Centers for Medicare and Medicaid Services in January 2010. The eighth paper offered an overview of AHIMA’s comments on the proposal. This ninth and final paper highlights AHIMA’s comments on the related interim final rule on standards for certification, including the accounting of disclosure standard.

In order to be eligible for the meaningful use incentive program, healthcare providers must use EHR technology that meets certification standards set by the federal government. On January 13 the Office of the National Coordinator for Health IT (ONC) published an interim final rule for these standards, which became effective February 12. However, the rule is not final, and the comments that ONC receives until March 15 could affect the content of the eventual final rule.

AHIMA’s comments on the IFR were prepared by members and staff. AHIMA has been involved in both the creation of standards through active participation in standards bodies such as Health Level Seven International (HL7) and as a founder of the Certification Commission on Health Information Technology (CCHIT).

[Note: This March 10 overview is based on a draft of AHIMA's comments. On March 15 this post will be updated with a link to the Association's final, submitted comments.]

General Comments on the IFR

AHIMA begins its general comments by asking for clarification of the various bodies that now could be involved with the establishment of health IT standards as well as certification criteria, testing, and other roles that have previously involved groups such as the Healthcare Information Technology Standards Panel, standards bodies, and CCHIT. AHIMA also notes the current involvement of health information management professionals with standards and the need for a national approach and consistent interoperability formats.

The Association stresses the need for ONC and the Department of Health and Human Services to continue to communicate clearly to the industry on the impending HIPAA 5010 and ICD-10-CM/PCS implementation deadlines to ensure that providers do not ignore these requirements while pursuing the meaningful use program.

AHIMA calls for ONC to expand the definition of a qualified EHR to include the ability to produce a health record for legal, business, and disclosure purposes. AHIMA goes on to raise questions on ONC’s definition of disclosure, noting concerns regarding disclosures from the EHR and disclosures that might occur within or between health information exchange organizations. (This is also a concern related to the accounting requirements.)

The Association’s comments also request specific criteria that would ensure a qualified product meets the need for a legal EHR and cites the HL7 Records Management and Evidentiary Support Functional Profile as an established source for those criteria.

AHIMA’s comments also reflect recommendations from the Health IT Policy work groups related to incorporation of clinical lab test results into the EHR as structured data and the need for more detail on how to calculate reporting metrics to substantiate meaningful use functionality reporting.

The Association requests clarification on the “electronic access” described in the IFR. AHIMA suggests that the objective be restated to “Provide patients with secure and timely electronic access.” Further AHIMA requests that ONC address the necessary security and encryption requirements needed to support the objective.

In Support of the CCD and QRDA

There is some debate on whether the rule should adopt the CCR or CCD format. Within its comments AHIMA comes out clearly in favor of the CCD because it has already been approved by the Health Information Technology Standards Panel.

AHIMA likewise comes out in favor of using the HL7 Quality Reporting Document Architecture (QRDA) standard and Implementation Guide, indicating the value of this standard and its relationship to the HL7 Clinical Document Architecture. AHIMA urges ONC to include QRDA as an adopted quality reporting standard during meaningful use stage 1, noting that “adopting QRDA now will prevent switching of standards and rework for vendors in the future.”

Citing the Health Information Exchange work group’s recommendations at a recent Health IT Policy Committee meeting, AHIMA states its support to extend the same certification criteria for hospital lab reports to all lab result reporting and not just to public health as proposed. AHIMA notes that clarifying this expectation will support hospital laboratory results delivery to eligible professionals attempting to comply with the meaningful use requirements.

Gaps in the Certification Standards

AHIMA raises its concern that the proposed standards are targeted to specific functionality and do not address standards for basic EHR functionality. AHIMA notes that CCHIT has already developed consensus-based certification criteria for both inpatient and ambulatory EHRs; however, ONC made a conscious determination to not adopt previously recognized certification criteria in the IFR.

This, AHIMA states, leaves a large gap between the previous standards and the new limited targets that ONC proposes, and the Association makes several recommendations to eliminate this gap. AHIMA comments, “We are concerned that the proposed standards will not adequately support the stated goals of healthcare improvement and adequate privacy and security because of missing foundational requirements for EHR systems and modules. Meaningful use will not be effectively achieved if the underlying data is not accurate, complete, and of unassailable integrity. The government has not identified any standard for underlying EHR systems or modules that support system and data integrity, authentication standards, and non-repudiation.”

AHIMA ends its comments by raising several questions with regard to collection of information regarding the use of the EHR and the required audit logs.

Accounting of Disclosures

The IFR includes a simple standard for the accounting of disclosure provisions called for under ARRA, which extends the HIPAA accounting of disclosure provision to include disclosures from EHRs for uses of treatment, payment, and operations.

AHIMA commented on this standard in a separate letter because the accounting of disclosure issue is of such concern to its members. [Updated March 12 with link to a copy of AHIMA's final, submitted letter.]

In its comments AHIMA notes that although the standard is simple-calling for the capture of just four data elements-it still represents a major challenge for the industry because few EHR products are currently capable of tracking disclosures. Accounting is still a manual process in most provider organizations, and disclosures are typically decentralized across multiple departments and IT systems.

AHIMA agrees that consumers have a right to know to whom their record was disclosed. However, given the number of legacy systems to be adapted and the cost of adopting new systems, the Association believes the industry cannot meet the timetable set by the statute, and not without significant cost. It recommends that ONC modify the compliance deadlines to better reflect the work and cost involved.

Further, AHIMA suggests that it would be helpful to the healthcare industry and consumers to understand the issues and costs associated with the accounting of disclosure requirement. Because disclosures occur through systems beyond the EHR, this estimate should include all systems in an entity that must track disclosure, not just the EHR system.

Extending the original HIPAA accounting provisions to include treatment, payment, and operations raises questions and concerns about how the IFR intends to define an entity (e.g., a specific provider or an entire enterprise) and exactly what transfers are covered (e.g., disclosures to physicians in a hospital EHR network who are not hospital employees).

AHIMA also notes that while the certification standards apply to the EHR, many of the disclosures possible under its interpretation of the rule come from systems outside the EHR. The Association asks for clarification on whether ONC intends to suggest that an EHR is all records within the medical enterprise, or at a minimum any system that contains protected health information.

Although the standard identifies the data elements to be captured, AHIMA’s notes in its comments that the industry will require standards for how those data are to be represented (e.g., the formats for date, time, and patient name). The Association also comments that the description of the disclosure will of necessity be a coded process, and it asks who will designate a code set for this use.

Given the volume of disclosures that even a small physician practice will log, even abbreviated descriptions will come to require considerable server space. AHIMA notes that striving for simplicity and uniformity in the rule will help minimize administrative costs.

Download a PDF version of this paper. For more ARRA resources and ongoing analysis of future regulation, visit www.ahima.org/ARRA.

Preceding papers in this series have reviewed the requirements in the notice of proposed rulemaking on meaningful use, published by the Centers for Medicare and Medicaid Services in January 2010. This paper highlights AHIMA’s comments on the NPRM and links to the full document.

[Updated March 12 with link to a copy of AHIMA's final, submitted comments]

The Centers for Medicare and Medicaid Services (CMS) released its proposal for the meaningful use program as a notice of proposed rulemaking (NPRM) in part to solicit comment on the details of this complex initiative prior to proceeding with the rulemaking process. Comments are due March 15.

CMS intends to post the final rule in late spring or early summer. The number and variety of comments it receives will affect the final rule’s timeliness as well as its content.

AHIMA’s comments on the NPRM were prepared by its members and staff, who reviewed and analyzed not only the NPRM itself, but all related activity beginning with initial testimony taken at the National Committee on Vital and Health Statistics hearings in April 2009 through the recommendations of the Health IT Policy and Standards Committees and CMS’s own comments within the NPRM.

AHIMA has focused its comments on subjects that affect the health information management profession directly and on which it has direct expertise.

The Association’s intention in posting a draft preview of its comments is to offer perspectives that individual members or state associations might want to consider as they write their own comments. It is not AHIMA’s intention that members or state association resubmit this same set of comments under their own names.

Meaningful Use

[Note: Page numbers refer to AHIMA’s draft comments.]

AHIMA supports the payment year concept proposed by CMS. AHIMA also supports the concept of beginning year 1 with a 90-day eligibility period and using the fiscal or calendar year of eligible hospitals (EHs) or eligible providers (EPs) (p. 2).

AHIMA also indicates its support for the proposal that Medicare and Medicaid programs employ the same definitions and objectives in the interest of making the incentive programs as uniform and simple as possible.

While the Association also agrees with the three-stage concept proposed by CMS, it raises its concern about the time available for vendors and providers to gear up for the program. AHIMA also underscores its concern that there must be significant integration of clinical workflow, data quality processes, and technology (pp. 2–3).

AHIMA points out that the NPRM uses the term “evidence-based order set” but does not define it. The Association therefore proposes the following definition:

“Evidence-based orders sets are sets of orders for services and/or medications that are considered the most effective for a given condition and are listed in the sequence that provides the most efficacies for treating the findings and/or obtaining the best results. They are based on best practices that have been published and often are more efficient and cost-effective than less structured traditional approaches. These sets are incorporated into EHR’s CPOE and will prompt the physician when an order is entered to consider other tests and/or medications in addition to or in lieu of the original order entered.”

Criteria and Functionality Measures

AHIMA turns considerable attention to the criteria for meaningful use and the health IT functionality measures, discussing the level of requirements and reporting flexibility (p. 3). It further comments on the need for feedback in the reporting process, parallel reporting requirements from other CMS programs, and the attestation program that CMS has proposed (pp. 3–4).

The Association raises concern with the testing of the measurements or metrics used in the measurement process as well as the manual data collection that will be required. Throughout its comments AHIMA expresses concern that the manual requirements caused by the current lack of integrated systems could deter providers from electing to participate in the program (p. 5).

AHIMA also raises concerns on the testing required of providers to demonstrate meaningful use. Most of the NPRM requirements call for one test to demonstrate the abilities of the EHR system. AHIMA suggests that attempting such a test might require considerable effort from providers given the lack of infrastructure and networking at this time and in the near future (pp. 5–6). This difficulty also could deter providers from taking part in the program.

Within its comments the Association offers feedback on the functionality measures for eligible professionals (pp. 6–14) and eligible hospitals (pp. 14–21). These comments are presented with their measures in a table to aid readability.

Among the comments related to EPs, the Association recommends that:

• CPOE requirement be held until stage 2
• The drug check requirements be merged with those of e-prescribing
• The problem list not be generated from coded data and that eventually SNOMED-CT be used
• CMS clarify the rules on medications lists
• Laboratories be required to use standards-based reporting
• Eligibility and claims requirements should not be required because they are not available in many EHRs that EPs use
• CMS clarify requirements for consumer access to electronic information
• Progress notes be required in stage 1

Many of AHIMA’s comments with regard to EHs mirror those made regarding EPs, but the Association also comments on:

• The need to clarify the use of SNOMED-CT and ICD classifications (noting that AHIMA has long advocated that the US should adopt SNOMED-CT) 
• The collection of race and ethnicity data (which AHIMA supports) and body mass index in age groups 2–20 (which AHIMA does not support for EHs at this time)

Quality Measures

Given its extensive work on quality measures, AHIMA comments in depth on the proposed submission of clinical quality measures (pp. 23–26).

The Association calls for consideration of the measures themselves as they apply to different provider groups and different methods of submission. AHIMA’s comments are consistent with its previous calls for uniform reporting of clinical quality measure across all health plans and providers and its advocacy for an agreed-upon set of data to be captured in EHRs that will enable quality reports to be generated uniformly and allow providers to collect data once and report them for many subsequent uses.

Finally, AHIMA notes its understanding of CMS’s proposal to recognize only hospital inpatient services initially; however, the Association states its concern for the impact this could have on hospital-based outpatient clinics.

AHIMA also comments that if EHRs are meant to support patient-centered healthcare, then the meaningful use programs should include outpatient clinics and long-term care facilities. Doing so enables the continuity of a person’s care through the use of EHRs across the care continuum and health information exchange (p. 27.)

This is the last paper in the series to address the meaningful use NPRM. The next and final paper will offer an overview of AHIMA’s comments on the certification standard interim final rule from the Office of the National Coordinator for Health IT, which is closely related to the meaningful use NPRM.

Download a PDF version of this paper. For more ARRA resources, visit www.ahima.org/ARRA.

Professionals and hospitals seeking to receive payments under the program must use EHR products that meet federal criteria. The meaningful use program was created under the HITECH Act, part of the American Recovery and Reinvestment Act signed in February 2009.

The meaningful use program is scheduled to begin October 1 for hospitals and January 1, 2011, for professionals. In order to get the certification program running as quickly as possible, ONC is proposing a temporary certification process that will serve until a permanent program makes its way through the rulemaking process. The temporary program is expected to run through 2011.

The phased approach “provides a bridge to detailed guidelines to support an ongoing program of testing and certification of health IT,” wrote David Blumenthal in a March 2 e-mail announcing the rule.

Under the temporary program, ONC would authorize organizations to assume many of the responsibilities that will eventually be fulfilled under the permanent certification program. The proposed permanent program would transition much of the responsibility for testing and certification to organizations in the private sector, according to the announcement.

ONC anticipates issuing separate final rules for each of the proposed certification programs, according to an online FAQ. It plans to issue a final rule for the temporary program around the same time that the final rules for meaningful use stage 1 and standards and certification criteria appear. It expects to issue a final rule for the permanent certification program by early fall of this year.

Any organization or consortium of organizations that can “successfully demonstrate competency with internationally recognized standardized certification and testing standards and methods” may apply for the program, according to the FAQ. ONC will begin accepting applications when the final rule for the temporary program is published.

The meaningful use certification program is independent of any other certification initiatives, such as that of the Certification Commission for Healthcare Information Technology.

ONC’s NPRM on the certification program follows two closely related rules published at the start of the year. In January the Centers for Medicare and Medicaid Services published an NPRM describing the qualification requirements, objectives, and measures of the meaningful use program itself. At the same time, ONC published an interim final rule defining the technical standards and certification criteria for EHR products.

HHS will accept comments on the temporary program for 30 days following publication in the Federal Register. It will accept comments on the permanent program for 60 days.

Preceding papers in this series have reviewed the requirements in the notice of proposed rulemaking on meaningful use, published by the Centers for Medicare and Medicaid Services in January 2010. This paper summarizes the proposed process for qualifying for the program and also offers a look at the program’s next steps.

CMS published its program requirements as a notice of proposed rulemaking (NPRM) in order to solicit public comment. That comment period closes March 15. CMS will then proceed to write a final rule with the assistance of the Office of the National Coordinator for Health Information Technology (ONC). The rule will then be reviewed by the Office of Management and Budget before its official publication in the Federal Register.

CMS is targeting late spring or early summer for publication. The number and variety of comments will affect the timeliness as well as the content. For the most part, it should be presumed that the proposed requirements will not be significantly increased in a final rule. The debate over the NPRM has been whether there are too many reporting requirements, and indeed CMS has requested comment to this effect, and the best that can be predicted is that some requirements will be eliminated in the final rule.

For eligible hospitals, the meaningful use program is scheduled to begin FY 2011, which for the government starts October 1, 2010. The program begins January 1, 2011, for eligible professionals (EPs). Thus the sooner CMS can produce a final rule, the more time providers will have to assess their readiness and begin preparing to qualify. Final definitions also will allow the regional extension centers, IT vendors, and the Medicaid and Medicare programs to prepare.

Each of these parties is currently trying to determine which provisions of the NPRM will become requirements under the final rule. They face similar uncertainty in considering the ONC’s related rule on IT certification standards. The requirements outlined within ONC’s interim final rule identify the standards and criteria that will enable the meaningful use reporting through an electronic health record (EHR).

In the coming weeks and months, eligible professionals and hospitals will continue to learn and assess the proposed requirements; prepare comments on their value and feasibility; determine how the proposed rule would affect their own practice, process, and systems; and identify what changes they would need to make to receive incentive payments. The starting point for each eligible provider will be different, dependent upon its current use of IT.

It should be noted that in the first year of the program, eligible participants may qualify by meeting the requirements during any 90-day period.

Qualifications for Participation

To be eligible for the meaningful use program, a professional or hospital must participate in one or more Medicare or Medicaid programs: Medicare Fee-for Service, Medicare Advantage, or Medicaid. The provider’s patient mix and volume will to some extent dictate which program will yield the best incentive.

Eligible hospitals can qualify for both Medicare and Medicaid incentives; however, EPs must choose between the programs, and they have only one opportunity to switch their choice before 2015 (p. 1904).

EPs that see Medicaid patients from more than one state may receive incentive payments from only one state, but they can change states each year. The incentive payment should be the same no matter which state the provider chooses, but states have the option of adding requirements in addition to those specified by CMS.

EPs participate in the incentive program as individuals, and it will be up to the individual and the practice how the individual might reimburse the organization. For purposes of the program, CMS defines a physician as a doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor. The volume and mix will be determined by the EP, not the practice.

Only short-term, acute hospitals are eligible under the Medicare proposal. Critical access hospitals will be paid under a different reimbursement rules than the Fee-for-Service program. Requirements and payments also vary for EPs and hospitals when services are rendered in a federally qualified health center or a rural health clinic.

Hospital-based physicians are not eligible for the program as proposed in the NPRM. CMS’s definition of hospital-based in this instance extends beyond the typical groups such as anesthesiologists and emergency physicians to include EPs performing more than 90 percent of their services in a hospital setting, including hospital outpatient departments on or off the campus.

The exclusion is intended to prevent duplicate payments, since CMS assumes that all of these providers are using the hospital’s EHR system. Of note is the fact that hospital outpatient services are not part of the calculation for hospital incentive payments.

The qualifications are even more specific with regard to Medicaid, which sets patient volume thresholds for EPs. Five types of professionals are eligible: physicians, dentists, certified nurse-midwives, nurse practitioners, and physician assistants practicing in a federally qualified health center or rural health clinic led by a physician assistant (p. 1930).

To qualify for Medicaid incentives, these professionals cannot be hospital-based, with the exception of EPs practicing predominantly in a federally qualified health center or rural health clinic.

The Medicaid incentive program also includes additional qualifications for acute hospitals (an average patient stay of 25 days or fewer) and children’s hospitals (separately accredited).

The incentive program related to Medicare Advantage contains its own set of additional requirements, since some entities may qualify for multiple Advantage programs (pp. 1920–28).

To avoid duplicate payments among the states and Medicare, CMS proposes a single repository that would uniquely identify each participating provider and indicate which incentive program the provider has selected.

Technology Requirements

To qualify as meaningful users, EPs and hospitals must use certified electronic health record technology as defined in the NPRM and ONC’s certification and standards IFR. ONC specifies that the standard it describes will be the sole standard to determine meaningful use eligibility.

There is some exception to the certification requirement in the Medicaid program, which allows payment to “certain Medicaid providers to adopt, implement, upgrade, and meaningfully use certified EHR technology.” Participants will have to attest that the technology—which can be either a single EHR system or a collection of EHR modules—is certified. Providers will have to work with their vendors to determine their systems meet the requirements.

The reporting methods vary over the initial two years of the program, given the capabilities of CMS and the states to receive electronic reporting (see papers 5a and 6a for providers and papers 5b and 6b for hospitals.) Initially participants will demonstrate that they meet the functional and clinical quality measures requirements through attestation. Specific reporting requirements are detailed on pages 1901–3.

As technology advances, the requirements for meaningful use and clinical quality reporting will increase in stages 2 and 3 of the incentive program. EHR systems thus must be capable of adapting to future changes, which is one requirement for certification.

Payment

State Medicaid programs have the option of starting payments in 2010; however, with a short period of time between the final rule and the end of 2010, and with a number or administrative processes to be established and tested, very few states will likely take advantage of this early payment option.

Payments will vary across each of the programs, but CMS proposes they be the same across state Medicaid programs. Payments will vary by the type of provider and when the provider enters the program. It should be noted that for the most part payments are made after the provider has invested in an EHR and its implementation.

The following table locates the detailed description of eligibility and payment processes by program and type of provider.

ARRA provides additional state grant and loan payments for EHR adoption, and the Department of Health and Human Services and ONC have already provided some funding to the states and Indian tribes for this purpose. Providers can follow up with their states to determine what additional funding might be available. The Medicare program also has an option for payment through “Entities Promoting the Adoption of Certified EHR Technology,” described on pages 1932–33, and as noted above, limited potential for payment in 2010.

CMS suggests that some of the current reporting required under Medicare and Medicaid, such as the cost report, be used in determining payment amounts. However, a number of the volume reports required for eligibility and for describing meaningful use are new, and they will require changes to internal processes.

In determining payments CMS also notes that its calculations include the cost of hardware, software, and workforce training associated with system implementations. This is described throughout the document and especially in section V, “Regulatory Impact Analysis.” However, as CMS notes, it is difficult to estimate the cost, because participation in the incentive program is voluntary and those who do participate will begin from varying starting points.

In February ONC announced funding for additional programs designed to assist providers in their EHR implementation, including the first contract awards to regional extension centers. It is too early to identify how these resources will be made available to providers, but their availability should be monitored.

This is the last paper in this series to review the NPRM. The next paper will describe AHIMA’s comments to CMS.

Download a PDF version of this paper. For more ARRA resources, visit ahima.org/arra.

Under the ARRA breach notification provisions, HIPAA covered entities and their business associates must notify HHS of any breaches affecting the unsecured protected health information of 500 or more people. The notification must be made without unreasonable delay and no later than 60 days from the discovery of the breach.

The rule went into effect September 22, 2009. Enforcement began this past Monday, February 22.

The majority of breaches resulted from lost or stolen hardware. The number of individuals affected ranged from a low of 501 (Alaska Department of Health and Social Services) to a high of 500,000 (Blue Cross Blue Shield of Tennessee). Providers, payers, and business associates appear on the list.

Covered entities and business associates must also report smaller breaches to HHS, but they may do so in a single report filed at the end of the year. Reports for 2009 are due by March 1, 2010. Organizations must notify breach victims directly for breaches of any size that they judge could result in harm.

Do three dozen large-scale breaches represent a lot or a little? Collectively they involved more than 1 million individuals in the first months of the reporting program. As HHS continues to compile and report incidents, a clearer picture of the prevalence of privacy breaches will emerge. Already the reports make clear that breaches are occurring across the industry, in both private and public entities, large and small.

Papers 5a and 5b in this series reviewed the functionality measures for providers and hospitals described in the notice of proposed rulemaking on meaningful use, published by the Centers for Medicare and Medicaid Services on January 13, 2010. This paper offers an overview of the requirements for reporting clinical quality measures for eligible hospitals. A companion paper (6a) provides an overview of the requirements for providers.

When Congress developed the meaningful use EHR incentive program, one of its goals was to improve the quality and efficiency of care for the Medicare and Medicaid populations. Accordingly, hospitals and providers that participate in the program will be required to capture and report clinical quality measures using certified EHR technology, in addition to the functionality measures they must report to prove they are using EHR technology in a meaningful way.

For purposes of the incentive program, CMS defines clinical quality measures as the “processes, experience, and/or outcomes of patient care, observations or treatment that relate to one or more quality aims for health care such as effective, safe, efficient, patient-centered, equitable, and timely care” (p. 1871).

Electronic Reporting to Begin in 2012

CMS acknowledges that it cannot require program participants to submit measures electronically until it has the capacity to receive them. CMS does not anticipate it will have that capacity for the 2011 payment year (FY2011). There will be a pilot test of electronic reporting, but it is unlikely that by 2011 there will be adequate testing and demonstration on a widespread basis.

In addition, electronic reporting requires that the Department of Health and Human Services promulgate technical specifications for the transmission of measurement data from hospitals to CMS. Once EHR vendors have these specifications, they will need time to develop and adapt software.
 
CMS anticipates that electronic reporting will begin in FY2012. Any eligible hospital reporting in that year will be required to report accordingly, whether or not the hospital is in its first or second year of participation in the program.

If CMS is not ready to receive electronic reports in 2012, the attestation program it is proposing for 2011, described below, will continue. CMS will post notifications of its status and the required method for reporting in the Federal Register.

Proof through Attestation in 2011

In 2011 eligible hospitals will meet the reporting requirements through attestation. As described in the NPRM, the process utilizes the same system as that it used for meaningful use attestation (p. 1871 and 1901).

CMS proposes that in 2011 eligible hospitals attest to the following (p. 1901):

• The information submitted was generated as output from an identified certified EHR.
• The information is accurate and complete to the knowledge and belief of the official submitting on behalf of the eligible hospital.
• The information submitted includes information on all patients to whom the measure applies.
• The identifying information for the eligible hospital.
• For eligible hospitals that do not report one or more measures an attestation that the clinical quality measures not reported do not apply to any patients treated by the eligible hospital during the reporting period.
• The numerators, denominators, and exclusions for each clinical quality measure result reported, providing separate information for each clinical quality measure including the numerators, denominators, and exclusions for all patients irrespective third party payer or lack thereof; for Medicare FFS patients; for Medicare Advantage patients; and for Medicaid patients.
• The beginning and end dates for which the numerators, denominators, and exclusions apply.

CMS notes that it believes it has the authority to require clinical quality measures reporting on all patients regardless of payer type.

Duplication of Reporting Requirements

Within the NPRM CMS acknowledges concern that hospitals could be required to submit a different set of clinical quality measures to states for the Medicaid program. It recommends that the measures adopted for the Medicare incentive program also apply to hospitals in the Medicaid programs (p. 1871).

Alternative Medicaid-specific measures have been developed for eligible hospitals whose population might warrant their use.

Proposed Clinical Quality Measures

CMS recognizes that “considerable work needs to be done by measure owners and developers” on the clinical quality measures it has proposed. Such work includes completing electronic specifications for measures, implementing those specifications into EHR technology to capture and calculate the results, and implementing the systems.

CMS believes there is sufficient time to complete all of these tasks. However, it writes that it will delay finalizing any measures where this work has not been completed.

The proposed measures for hospitals appear on table 20; the alternative Medicaid measures appear in table 21 (linked here in a single file—table 21 begins on page 1899).

The tables identify the measure title, number, owner or developer, and contact information as well as a link to existing electronic specifications where applicable. As noted, these measures are to apply to all patients, not just those covered in the Medicaid or Medicare programs.

HITECH requires that the Health and Human Services secretary provide preference to those measures that have been endorsed by an entity contracted with the secretary as provided under the Medicare Improvements for Patients and Providers Act of 2008 or measures that have been selected for the Reporting Hospital Quality Data for Annual Payment Update program under Medicare.

CMS notes that not all of the measures it proposes are from these programs and that it has the authority to add additional measures that need only its own approval or that of “professional societies or other stakeholders” to be included in the incentive program.

The proposed list of measures will likely undergo revision before a final rule is issued. CMS requests comments on the proposed measures, and it has stated publically that it expects to retract some measures as a result of the comment process.

The requirements will take effect 60 days after the final rule is published, and no changes will be made except through further rulemaking (p. 1872). However, CMS “may make administrative and/or technical modification or refinements such as revisions to the clinical quality measures titles and code additions, corrections, or revisions to the detailed specifications for the 2011 and 2012 payment year measures.”

CMS will post the final measures in a group on its Web site, even if the measures are already used in another Medicare incentive program. On or before April 1, 2010, CMS intends to finalize and publish the detailed eligible hospital specification documents for all 2011 payment year Medicare EHR incentive program clinical quality measures.

It should be noted that CMS solicits comment on whether it is appropriate to defer some or all clinical quality reporting until 2012, and it asks for rationale on what measures should or should not be deferred (p. 1895).

CMS writes that the measures it selected (pp. 1872–73):

• Facilitate alignment with, or allow determination of satisfactory reporting in other Medicare programs, including RHQDAPU, Medicaid, and Children’s Health Insurance Program (CHIP) program priorities
• Are widely applicable to eligible hospitals based on the services provided for the population of patients seen
• Promote CMS and [Health and Human Services] policy priorities related to improved quality and efficiency of care for the Medicare and Medicaid populations that will allow the tracking of improvement in care over time
• Have been recommended to CMS for inclusion in the EHR incentive by federal advisory committees including the Health IT Policy Committee

Eligible hospitals will be required to report summary data to CMS in FY2011 and electronically in FY2012 (p.1895). It is unclear if this summary report will be in addition to the attestation previously described.

2013 Payment Year

CMS expects the number of clinical quality measures that can be reported will grow rapidly in 2013 and beyond (p. 1900).  It notes the source of such growth and requests comments. CMS lists some of the new clinical areas for reporting as well.

Alternatives to Electronic Reporting

Finally, CMS discusses alternatives for electronic reporting using certified EHR technology, including the use of portals and structures such as the Clinical  Document Architecture (p.1902). An alternative to portals might be the use of health information exchange though health information organizations. Again, CMS seeks comments on these alternatives.

Download a PDF version of this paper. For more ARRA resources, visit www.ahima.org/ARRA.

The next paper in this series will finalize coverage of the NPRM and will discuss the processes for demonstrating meaningful use.

Papers 5a and 5b in this series reviewed the functionality measures for providers and hospitals described in the notice of proposed rulemaking on meaningful use, published by the Centers for Medicare and Medicaid Services on January 13, 2010. This paper offers an overview of the requirements for reporting clinical quality measures for eligible providers. A companion paper (6b) provides an overview of the requirements for hospitals.

When Congress developed the meaningful use EHR incentive program, one of its goals was to improve the quality and efficiency of care for the Medicare and Medicaid populations. Accordingly, hospitals and providers that participate in the program will be required to capture and report clinical quality measures using certified EHR technology, in addition to the functionality measures they must report to prove they are using EHR technology in a meaningful way.

For purposes of the incentive program, CMS defines clinical quality measures as the “processes, experience, and/or outcomes of patient care, observations or treatment that relate to one or more quality aims for health care such as effective, safe, efficient, patient-centered, equitable, and timely care” (p. 1871).

Many of the clinical quality measures identified for eligible providers (EPs) have been pulled from CMS’s Physician Quality Reporting Initiative (PQRI), a quality reporting initiative currently in use. CMS intends to create an added incentive for EPs to adopt EHRs by leveraging the PQRI measures.

Proposed Clinical Quality Measures

The NPRM is not intended to be used a means to update or modify clinical quality measure specifications. This is accomplished through a consensuses-based process guided by the National Quality Forum (NQF), an organization that ensures clinical quality measures are developed and maintained through a consistent and collaborative process.

However, CMS will supplement the clinical quality measures proposed for 2011 and 2012 payment years with technical specification for EHR submission. It will post the measures on its Web site to solicit comments (p. 1873).

The measures appear in table 3, including title, description, developer, links to existing electronic specification where applicable, and whether the measure belongs in the core or specialty group (pp. 1874–89).

As part of the public comment process, CMS is requesting input on each measure’s readiness for use in the incentive programs.

Clinical Quality Measure Priorities

The top clinical quality measure priorities are PQRI measure numbers 1, 2, 3, 5, and 7. These address the high priority chronic conditions of diabetes, coronary artery disease, and heart disease.

The next area of importance include the preventive care measures: PQRI numbers 110–15 and 128.

In addition, CMS also proposes clinical quality measures that were not included in recommendations from the Health IT Standards Committee but which it believes are of high importance to the overall population, including (p. 1890):

• IVD: Use of Aspirin or Another Antithrombotic (PQRI 204)
• IVD: Complete Lipid Profile (PQRI 202)
• IVD: Low Density Lipoprotein (LDL–C) Control (PQRI 203)
• IVD: Blood Pressure Management Control (PQRI 201)

Finally, CMS included a variety of other measures which it believes address important aspects of clinical quality. CMS concludes that the set of clinical quality measures is expansive enough to allow for reporting for all EPs and addresses high priority conditions.

CMS recognizes the work required to integrate the measures into certified EHR products and that not all measures may be ready in time for the 2011 payment year. It is requesting comment on the advisability of deferring some or all clinical quality reporting until the 2012 payment year (p. 1895).

CMS expects to expand the set of clinical quality measures in future years. Clinical quality measure considerations and potential topics for 2013 and beyond are addressed on pp. 1900–1. CMS welcomes comment on the potential topics as well as specific clinical quality measures.

Measures to Report for 2011 and 2012 Reporting Years

For the 2011 and 2012 reporting periods, CMS proposes that each EP submit information on two measures groups—core measures and specialty measures. CMS believes the core measures are sufficiently general and of such importance to population health that all EPs treating Medicare and Medicaid patients in the ambulatory setting should report on them, as applicable for their patients.

The core measures are listed in table 4 (p. 1890), summarized below:

• PQRI 114 and NQF 0028: Preventive Care and Screening: Inquiry Regarding Tobacco Use
• NQF 0013: Blood pressure measurement
• NQF 0022: Drugs to be avoided in the elderly: (a) Patients who receive at least one drug to be avoided; (b) Patients who receive at least two different drugs to be avoided

CMS proposes the following specialty groups:

• Cardiology
• Pulmonology
• Endocrinology
• Oncology
• Proceduralist/Surgery
• Primary Care 
• Pediatrics
• Obstetrics and gynecology
• Neurology
• Psychiatry
• Ophthalmology
• Podiatry
• Radiology
• Gastroenterology
• Nephrology

The clinical quality measures for each specialty group are listed in tables 5–19 (pp. 1891–95).

Each EP will select for itself the specialty group it will report, and it must submit all measures within that group. EPs must report on the same specialty group of measures for the first two payment years of the program.

CMS recognizes that the second set of quality measures are not necessarily specialty specific. The denominator of the measure is determined by the patient population to whom the measure applies and the services rendered by the particular EP. However, CMS has grouped the measures according to the type of patients commonly treated and services rendered by EPs of various specialties.

This is the way measure groups are used in PQRI—they are based on conditions rather than specialty types. Grouping measures by condition provides EPs with a standard set of measures. CMS anticipates reducing the number of proposed measures per group down to 3 to 5 measures based on the availability of electronic measure specification and comments received.

Exempt EPs

In the final rule, CMS will specify which EP specialties will be exempt from reporting on a specialty measure group. EPs seeking exemption will be required to attest to the inapplicability of any of the specialty groups. They will not be required to report on measures from a specialty group, but they will still be required to report information on all of the core measures (p.1891).

No Electronic Reporting until 2012

CMS proposes that electronic reporting of clinical quality measure begin in 2012. It acknowledges that it is not prepared to receive electronic reports in 2011 and, further, that HHS must first provide EHR vendors with technical specifications for the transmission of measurement data.

If these pieces are in place for 2012, CMS will require EPs to electronically submit quality measure information directly to CMS and the states using certified EHR technology. If electronic reporting is not viable for 2012, CMS will extend the attestation process it proposes for 2011 (see below).

Within the NPRM CMS requests comments on its proposed  reporting criteria—particularly on the requirement that all EPs would report all core measures. CMS is also interested in reasons why an EP would be unable to meet a proposed reporting requirement and if there are other alternatives.

Reporting via Attestations for 2011

CMS proposes that for 2011 Medicare EPs attest to their use of a certified EHR system to capture the data elements and calculate the results for the clinical quality measures. EPs must also attest to the accuracy and completeness of the measures submitted. The attestation for clinical quality measures will utilize the same system as attestation for meaningful use.

The NPRM lists the following elements for attestation in 2011 (p.1901):

Elements for EPs submitting measures:

• The information submitted with respect to clinical quality measures was generated as output of an identified certified electronic health record.
• The information submitted is accurate to the best of the knowledge and belief of the EP.
• The information submitted includes information on all patients to whom the clinical quality measure applies.
• The national provider identifier (NPI) and tax identification number (TIN) of the EP submitting the information, and the specialty group of clinical quality measures that are being submitted.
• The numerators, denominators, and exclusions for each clinical quality measure result reported, providing separate information for each clinical quality measure including the numerators, denominators, and exclusions for all patients.
• The beginning and end dates for which the numerators, denominators, and exclusions apply.

Elements for EPs submitting their exclusionary status:

• For an EP who is exempt from reporting each of the core measures, an attestation that one or more of the core measures do not apply to the scope of practice of the EP.
• For an EP who is exempt from reporting on a specialty group, an attestation that none of the specialty groups applies to the scope of practice of the EP.
• For an EP who does report on a specialty group, but is exempt from reporting on each of the clinical quality measures in the group, an attestation that the clinical quality measures not reported do not apply to any patients treated by the EP.

Duplicate Reporting

CMS recognizes the possibility that some EPs could be required to report the same measures to multiple Medicare initiatives.

In instances in which a particular clinical quality measure is included in the Medicare EHR incentive program and another Medicare quality reporting incentive program, CMS proposes that an EP would only report under the Medicare EHR incentive program. A single reporting would satisfy parallel reporting requirements under all other applicable Medicare programs.

Other Reporting Methods

EPs participating in the Medicaid incentive program will report their clinical quality measures data to the states. The states will propose to CMS how they plan to accept and validate the measures in their state Medicaid health IT plans, which are subject to CMS review and approval (p.1902).

CMS proposes allowing EPs several alternatives to submitting data from EHRs. The primary method would enable EPs to log on to a CMS-designated portal and upload data based on specified structures, such as Clinical Document Architecture and accompanying templates produced as output from the certified EHR.

Alternately, an EP could submit the required measures using certified EHR technology through a health information exchange or health information organization. CMS acknowledges that this option would be dependent on the ability to collect information through such networks.

The third option proposed is to submit data through registries using certified EHR technology.

Reporting Period

The reporting year period for clinical quality measures is aligned with the period for the functionality measures—any continuous 90-day period within the first payment year. Subsequent years, however, would require reporting for the entire year.

CMS encourages comment on the option of fixed reporting periods: either four quarterly periods or two six-month periods.

Download a PDF version of this paper. For more ARRA resources, visit www.ahima.org/ARRA.

The next paper in this series will finalize coverage of the NPRM and discuss the processes for demonstrating meaningful use.

More than $375 million was awarded to 32 nonprofit organizations to support primary care providers in selecting, implementing, and using health IT. The centers will provide education, outreach, and technical assistance.

HHS will award a second round of contracts in the coming months. In total, it expects to establish 70 centers that support 100,000 providers through the Health Information Technology Extension Program.

Also announced today were grants for state HIE initiatives and healthcare job training programs.

HHS award $386 million to 40 states and qualified state-designated entities to facilitate health information exchange at the state level.

The job training funds came through the Department of Labor, which awarded more than $225 million to fund 55 training programs in 30 states. The programs, based in community colleges and other local education providers, will train individuals to work in healthcare.

All three programs were established within the American Recovery and Reinvestment Act, signed in February 2009.

The fourth paper in this series reviewed the EHR certification requirements related to the notice of proposed rulemaking on meaningful use, published by the Centers for Medicare and Medicaid Services on January 13, 2010. This paper offers an overview of the health IT functionality measures for eligible hospitals. A companion paper (5a) provides an overview of the requirements for providers.

Hospitals that intend to qualify early for the meaningful use EHR incentive program can first apply in the federal fiscal year 2011, which begins October 1, 2010, less than a year after the rules were first published. The qualification period in the first year is only 90 days.

While this is a short period, hospitals seeking to qualify should be determining their current capabilities to qualify and what related functionalities will be available from existing vendors in products to be offered or upgraded in the next year.

Criteria and Objectives

To qualify as a meaningful user an eligible hospital must demonstrate that it meets all of the objectives and their associated measures (p. 1854). Except as otherwise indicated, each objective must be satisfied by an individual hospital as determined by unique CMS certification numbers. Within the NPRM CMS asks for public comment on whether hospitals might have difficulty meeting the proposed objectives.

The objectives proposed were guided by the recommendations presented by the Health IT Policy Committee, the advisory body also established under HITECH. The objectives are grouped under care goals, which are in turn grouped under health outcomes policy priorities.

The criteria for meaningful use are based on these objectives and their associated measures. Pages 1854–58 cover the five objectives and CMS’s rationale for choosing each, including those instances where they differ from the recommendations of the Health IT Policy Committee.

Health IT Functionality Measures

CMS next discusses the functionality measures, stating: “In order for an…eligible hospital to demonstrate that it meets these proposed objectives, we believe a measure is necessary for each objective” (p. 1858). CMS then breaks the measures down into functionality and clinical quality measures (which will be the subject or the next paper).

CMS notes: “without a measure for each objective we believe that the definition of meaningful use becomes too ambiguous to fulfill its purpose. The use of measures also creates the flexibility to account for realities of current HIT products and infrastructure and the ability to account for future advances.”

The functionality measures describe either the eligible provider or eligible hospital requirement for each objective and the target compliance in order to meet the eligibility criteria. Many of these targets are percentages for which CMS provides a numerator, denominator, and the required percentage. In most instances the numerator is the number of activities or functions performed using an EHR, and the denominator being the full population.

It is this concept that is receiving considerable discussion, particularly a hospital’s ability to record these numbers, especially the denominator, during a specified period (i.e., the EHR reporting period). Hospitals will have to take a careful look at how such numbers might be captured in order to meet the recording requirements and possible audit of such numbers.

This review should serve to both suggest comments hospitals might wish to make on the NPRM as well as specify requirements for hospital staff and vendors to discuss so that hospitals can take advantage of the program.

The list of functionality measures provides further rationale and detail on exactly what needs to be recorded and reported (pp. 1858–67). Not all of the measures require a reporting of a percentage. For instance, the requirement for implementation of drug-drug, drug-allergy, and drug-formulary checks merely requires affirmation that the eligible hospital has enabled the functionality.

The reason is partly due to the inability of CMS and some states to receive electronic reports of hospital quality as early as 2011. This requirement could change in 2012, when CMS expects to have the electronic capability.

Clinical decision support rules are another example of a measure that will require attestation, while certain capabilities such as exchange of electronic information requires attestation that the systems has been tested and not necessarily that an ongoing exchange is under way. As hospitals look to qualify as eligible facilities, they will have to develop audit trails of these attestations, as it is expected that audits will occur.

Privacy and Security Requirements

The final requirement is to “protect electronic health information maintained using certified EHR technology through the implementation of appropriate technical capabilities.” The measure requires that the hospital complete a security risk analysis as prescribed under the HIPAA security rules. HIPAA requires that such risk assessments be made periodically.

In this case, such an assessment would not only include security as it relates to the EHR, EHR modules, and other technology, but also the full hospital system that is affected by the increase or introduction of EHR technology as required for meaningful use.

Hospitals should also be aware that there will be additional HIPAA requirements added or modified by HITECH. The proposal for these requirements should be published before February 18, 2010, and most of these requirements will likely be in effect before October 1, 2010.

The attached table is developed from table 2 in the NPRM (pp. 1867–70). It collects the eligible hospital objectives, Stage 1 measures, numerators and denominators, as well as the related technology requirements for the EHR technology required (the table appears in the full PDF version of this paper).

While the technology requirements are not part of the measures, and are described in a separate rule from the Office of the National Coordinator,  this table provides a look at what certification and standards are  necessary to meet a requirement.

Finally, under the functionality measurement section, CMS highlights its needs for public comment both on the measures presented for Stage 1 and future stages (p. 1870). CMS notes that it intends to build up health IT functionality measures, including:

• CPOE use to include not only the percentage or orders entered directly by provides but also the electronic transmission of those orders
• Extend incorporated clinical lab test results into EHR structured data to include “the full array of diagnostic test data used for the treatment and diagnosis of disease, where feasible”
• Capture measures in situations that currently allow provision and exchange of unstructured data where now there will be the requirement for the provision and exchange of electronic and structured data that currently require the performance of a capability tests and will require the actual submission of data.

Download a PDF version of this paper. For more ARRA resources, visit www.ahima.org/ARRA.

The next papers in this series will cover the reporting of clinical quality measures using EHRs.