Building a Better PACS: Part 7 -- Radiology and meaningful use

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The $27 billion U.S. healthcare IT stimulus plan has generated significant buzz in radiology over the past year, as the specialty eyes its share of funds for meaningful use of IT. For the vast majority of radiology practices, however, this goal may prove elusive or yield a negative return on investment.

Let's get the basics out of the way. Most radiologists now qualify to participate in the program, whether or not they are hospital employees or exclusively affiliated with a private practice or teleradiology service.

Michael J. Cannavo
Michael J. Cannavo
Any healthcare professional who provides more than 10% of professional services outside inpatient and/or emergency room settings can be eligible. But there's more required to capture the revenue than just being in the game.

Two regulations have been released: One defines the meaningful use objectives that providers must meet to qualify for the bonus payments, and the other identifies the technical capabilities required for certified electronic health record (EHR) technology.

The first regulation is the Incentive Program for Electronic Health Records. Issued by the U.S. Centers for Medicare and Medicaid Services (CMS), this defines the minimum requirements that providers must meet through their use of certified EHR technology to qualify for the payments.

The second regulation is the Standards and Certification Criteria for Electronic Health Records. This rule, issued by the Office of the National Coordinator for Health Information Technology (ONC), identifies the standards and certification criteria for the certification of EHR technology, so eligible professionals and hospitals may be assured that the systems they adopt are capable of performing the required functions.

The EHR

Understanding the premise behind an EHR is crucial to understanding the impact that meaningful use has on patient care. EHRs can make a patient's health information available when and where it is needed. Too often patient care has to wait because the chart is in one place and needed in another. EHRs also give clinicians secure access to information needed to support high-quality and efficient care.

They can also bring a patient's total health information together to support better healthcare decisions and more coordinated care. And EHRs can support better follow-up information for patients. For example, after a clinical visit or hospital stay, instructions and information for the patient can be effortlessly provided, and reminders for other follow-up care can be sent easily or even automatically to the patient.

Lastly, EHRs can improve patient and provider convenience. Patients can have their prescriptions ordered and ready even before they leave the provider's office, and insurance claims can be filed immediately from the provider's office.

EHRs also provide three key benefits to providers and patients:

  1. Complete and accurate information: This allows providers to know more about their patients and their health history before they walk into the examination room.
  2. Better access to information: This allows greater access to the information providers need to diagnose health problems earlier and improve the health outcomes of their patients. It also allows information to be shared more easily among doctors' offices, hospitals, and health systems, leading to better coordination of care.
  3. Patient empowerment: This allows patients to take a more active role in their health and in the health of their families. Patients can receive electronic copies of their medical records and share their health information securely over the Internet with their families.

The American Recovery and Reinvestment Act (ARRA) of 2009 indicates that meaningful use must entail the use of e-prescribing as determined to be appropriate by the secretary of the U.S. Department of Health and Human Services (HHS); the connection of the certified EHR technology in a manner that provides for the lawful electronic exchange of health information to improve the quality of healthcare; and the submission of information, in a form and manner specified by the secretary of HHS, on clinical quality measures and other measures elected by the secretary of HHS.

One also cannot talk about meaningful use without discussing the Health Information Technology for Economic and Clinical Health (HITECH) Act, which provides HHS with the authority to establish programs to improve healthcare quality, safety, and efficiency through the promotion of healthcare IT, including electronic health records and private and secure electronic health information exchange.

Under HITECH, eligible healthcare professionals and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt certified EHR technology and use it to achieve specified objectives.

Is PACS left out?

So is PACS part of HITECH? Because PACS is not directly included in the generally agreed upon definitions of meaningful use presented to date, except by inference (and even that is stretching it a bit), it is not affected by HITECH or its requirements.

In fact, no PACS or RIS vendor can meet the HITECH requirements, even those that promote themselves as meeting them. It simply can't be done.

So even though this may be a future for radiology, what is the payoff? Between $9.7 billion to $27 billion is available for disbursement, with CMS payments beginning in May 2011.

Timing is everything with meaningful use, which is why it's broken into three stages:

  1. Stage 1 (2011-2012) emphasizes "electronically capturing health information in a coded format; using that information to track key clinical conditions and communicating that information for care coordination purposes."
  2. Stage 2 (tentatively slated for 2013-2014) encourages "the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible." This is the stage where RIS and PACS were supposed to take effect, but this has since been delayed.
  3. Stage 3 (tentatively slated for 2015) promotes "improvements in quality, safety, and efficiency, focusing on decision support for national high-priority conditions, patient access to self-management tools, access to comprehensive patient data, and improving population health."

There are two years of payments per stage, and the sooner you begin, the more money you stand to make. Eligible individual physicians can make up to $44,000 under Medicare if begun before 2013. The total amount cannot exceed 75% of the Medicare total fee schedule.

Payments will be made in a lump sum each year, as soon as physicians prove they are meeting the meaningful use requirements. CMS payments will begin in May 2011 and physicians need only report 90 days of data in their first year of participation to receive payment. Hospitals have the potential to receive millions of dollars in payments.

Where the requirements for participation were previously inflexible -- all 25 measures had to be met without exception -- CMS has since reduced the requirements from 25 to 20 for eligible medical practices and from 23 to 19 for hospitals. In addition, requirements have been divided into a group of 15 core requirements and 10 discretionary requirements, of which five must be met.

Of the core requirements, six require clinical quality measures for professionals and 15 for hospitals. For professionals, there are three core measures required (or three alternative core measures, where applicable), and a choice of three others from a pool of 38 discretionary measures. Reporting by attestation is required in 2011, while electronic reporting is required in 2012. Clinical quality measurements for specialists have been eliminated for stage 1.

Meaningful use dollars for radiology

Now how do radiologists qualify for meaningful use dollars? It's not very easy or cheap -- in fact, the cost might actually outweigh the return on investment -- but it can be done. Radiologists have the choice of installing individual certified EHR modules which, in combination, can meet all of ONC's certification criteria, or of utilizing a comprehensive certified EHR system, which by itself meets all of ONC's certification criteria.

If the EHR module approach is selected, a certified radiology healthcare IT product could potentially include a list of all the medications being taken by a patient, confirmation that drug-drug and drug-allergy interactions have been checked, and a field for known medication allergies of a patient (three core requirements).

Patient demographic information including gender, race, ethnicity, date of birth, and preferred language also needs to be recorded in a structured data format for at least 50% of a physician's patients. Diagnoses or an indication that no clinical problems have been identified for the patient also needs to be captured for 80% of the patients (two core requirements).

In addition, medical records for at least half of the patients must include other patient information, including height, weight, blood pressure, body mass index, and -- for children ages 2 to 20 years -- growth charts. However, if this information has no relevance to a scope of practice, an exclusion may be claimed. This exclusion option is specifically applicable to teleradiology service providers.

Patient's smoking status (if older than 13) may be provided by the referring physician if not collected by radiology department or imaging center support staff. At least one clinical decision-support rule of the radiologist's choice needs to be implemented and tracked as well.

The exchange of "key clinical information," defined by the physician, with other healthcare providers needs to be tested. Proof of maintaining secure data by conducting security risk analyses and implementing security updates is required.

Additional requirements include:

  • Sending reminders to patients who need follow-up examinations, such as mammograms
  • Providing at least 10% of patients with timely electronic access to their health information, such as radiology reports
  • Providing patient-specific educational resources to at least 10% of the patients, as determined by the radiologist
  • Providing summary-of-care records, which could be paper-based, by DICOM CD/DVD, or by direct electronic transfer, to patients seeing another physician

Keep in mind some -- and many might say most -- of the requirements are really not applicable to the practice of radiology. That's where the exclusions step in. Exclusions are also counted as satisfying the requirements of a measure, which will benefit radiologists.

Requirements for computerized physician order entry (CPOE) of prescriptions, submitting electronic data to immunization registries, and ordering clinical laboratory tests and diagnostic imaging exams are not applicable to radiology. As long as radiologists write fewer than 100 prescriptions during the reporting period, they can be exempt from satisfying two of the core electronic prescription requirements. Contrast media is also exempt, and is considered a "supply" rather than a prescription.

Disenfranchised?

So let's cut to the chase. Is radiology included in meaningful use? In theory, yes; in real-world practice for the vast majority of radiologists, no. In a question and answer page put up by the American College of Radiology (ACR), the organization said the following:

It is unlikely that most existing RIS and/or PACS products would meet the necessary requirements, although the legislative language gives a certain degree of flexibility to regulators as to what constitutes EHR technology. It is important to note that ONC is exploring developing one or more modular/component HHS certification pathways for noncomprehensive EHR technologies. Some type of modular/component certification could prove to be important to a specialty like radiology which may not utilize all the functionalities and options of comprehensive EHR products.

Since this was published, the ACR has slightly softened its posture to include the possibility of RIS and PACS being included as a part of an EHR, but it has given no clear direction as to how this may occur, other having RIS and PACS being "combined with additional EHR modules that cover any missing certification criteria." The ACR also indicates you should check with vendors to "fully understand if they have any certification plans in place."

In a March 12, 2010, letter to CMS jointly sent by the ACR, the American Board of Radiology (ABR), RSNA, and the Society for Imaging Informatics in Medicine (SIIM), the groups stated the following:

CMS' proposed implementation of the "meaningful use of certified EHR technology" incentives program ... does not appreciate the leadership of radiology in HIT/HIE, nor the unique role radiologists and other specialists play in patient care. In fact, contrary to congressional intent, most radiologists in ambulatory settings would be disenfranchised by the proposed incentives program unless it is modified in CMS' Final Rule to be cognizant of the various scopes of practice and HIT functionality needs of radiology specialists.

Disenfranchised? How about just saying that radiology is being cut out? The letter goes on, but it basically just reiterates that radiology wasn't considered in the development of meaningful use, and while other physicians may be set up to get the gold mine, radiology is destined to get the shaft unless things change.

There was the hope that stage 2 would directly address RIS and PACS, yet in early February 2011, radiology once again missed out.

The ACR has participated extensively with the U.S. government and private sector on the "meaningful use of certified EHR technology" issue over the past year, and it continues to do so. But the society has little to show for it, despite taking actions that include working within a coalition on a meaningful use matrix for radiologists; submitting written testimony to the ONC and HIT policy committee; monitoring relevant public meetings (including the monthly meetings of the ONC's advisory committees); communicating with CMS, ONC advisors, and HIT policy committee members regarding radiology's issues and concerns; and submitting letters to ONC and CMS together with other medical specialties.

Even the medical imaging division of the Medical Imaging and Technology Alliance (MITA) has gotten involved in the lobbying effort, issuing a white paper to policymakers suggesting that the integration of medical images into medical records should be considered for inclusion in the meaningful use criteria in 2013. That's still a few years out before even being considered, let alone acted on. But has it helped? No.

What's next?

So should radiologists start preparing now to collect their share of the pie? Even that is an unknown. The same ACR question and answer page referenced above had the following information:

Q: If I currently own a [Certification Commission for Health Information Technology (CCHIT)]-certified EHR product, will I be able to participate in the program beginning in 2011?

A: This is currently unknown. CCHIT created a new certification paradigm called Preliminary ARRA 2011 for EHR products that fit the initial 2011 meaningful use recommendations of the ONC advisory committees; however, this is based on recommendations and not regulations, so consumers of these products are taking a risk. The ONC's advisory committees are exploring various ways to avoid penalizing pre-ARRA implementers of EHRs.

As with the prior statement, the ACR has also softened its stance on this somewhat, allowing for a wider interpretation of the rules and putting it back on the vendors to meet the ONC's requirements.

"Certified EHR technology" means those qualified electronic health records certified as meeting the associated HHS standards. To be qualified, the product must include patient demographic and clinical health information (such as medical history and problem lists) and have the capacity to do the following:

  • Provide clinical decision support
  • Support physician order entry
  • Capture and query information relevant to healthcare quality
  • Exchange electronic health information with and integrate such information from other sources

No RIS, no PACS, and very few other clinical systems can provide everything needed to achieve meaningful use now. That is why a mere 1% of all 5,000+ hospitals in the U.S. have achieved stage 7 in the Healthcare Information and Management Systems Society (HIMSS) U.S. EMR Adoption Model, and less than 10% are above stage 4.

A losing proposition

Unless you belong to a large radiology group, hospital, or academic facility, or plan on implementing an electronic medical or health record that could ultimately cost you more than you will ever get back in meaningful use dollars (again, unless you are part of a large group, hospital, or academic facility), then you are basically out of luck, despite all the hoopla to the contrary about getting your own piece of the pie -- at least for now.

You also need to factor in additional costs such as interfaces to other clinical systems, ongoing maintenance and support (including hardware and software upgrades), full-time equivalent costs associated with the required meaningful use data entry points, required documentation by ONC, and other tasks. These can easily exceed one-third to one-half of the initial system purchase price annually or triple the initial system costs over a five-year return-on-investment period. The requirements for radiology to get its piece of the pie could change in 2013, but more realistically it probably won't happen until the 2014-2015 time frame, if then.

So do we hope for the best while planning for the worst? The joint letter from the ACR, ABR, RSNA, and SIIM to ONC summed it up best after taking nine pages to outline exceptions for radiology to meaningful use in the hope that someone from ONC will listen:

In summary, the meaningful use measure must align with, and support, radiology's scope of practice to the extent possible. Many of the proposed HIT functionality measures, as well as the core ambulatory/clinical quality measures, do not make clinical sense for radiology medical record keeping. It is imperative that a solution be implemented in the Final Rule whereby all eligible professionals (EPs) can participate in the program in a meaningful way. This is particularly important for radiology as most radiologists are not hospital-based and almost all radiologists participate extensively in the Medicare program due to the general age demographic of patients in need of diagnostic imaging and radiation therapy procedures. We propose that EPs should choose from the HIT functionality measures, rather than requiring all 25 measures of all EPs.

It's up to the ONC to eventually include radiology as part of meaningful use, but until that happens, the best you can do is plan for the future and not count your chickens before they're hatched. PACS and RIS will continue to play a crucial part in the EHR and fully digital hospital of the future. We just need to get others to see that, so that we, too, can share in the meaningful use wealth.

Michael J. Cannavo, aka the PACSman, is a leading PACS consultant who has authored more than 350 articles on PACS technology in the past 25 years. He can be reached via e-mail at [email protected]. More information about the author can also be found on his website at www.pacsman.com.

The comments and observations expressed herein do not necessarily reflect the opinions of AuntMinnie.com, nor should they be construed as an endorsement or admonishment of any particular vendor, analyst, industry consultant, or consulting group. Rather, they should be taken as the personal observations of a guy who has, by his own account, been in this industry way too long.

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