Thursday, February 3, 2011

It's Showtime for Meaningful Use

By Joseph Goedert
Health Data Management Magazine, 01/01/2011

So it begins. With the new year, provider organizations can register for electronic health records meaningful use incentive payments under the HITECH Act.
Registration requires organizations to provide demographic information and ID numbers that will be entered into a new system designed to administer the meaningful use program.
From there, organizations-anytime they are ready in fiscal year 2011 for hospitals and calendar year 2011 for eligible professionals-can begin a 90-day meaningful use reporting period. Beginning around April 4, organizations that have completed the reporting period and can attest that they are meaningful users can apply for first-year incentive payments.
Hospitals and practices that have been working diligently to hit the deadlines are marking their calendars. But there's a big caveat: meaningful use rule provisions are extremely complex, and many providers that believe they're ready to apply probably aren't.
In addition, even in late 2010, experts say, providers sorely needed clarification on some meaningful use provisions, and those clarifications weren't forthcoming from the federal government. So providers are left to taking their best shots at interpreting the rules and hoping they're right.
To get an idea of how complicated things can get, consider the following scenarios, which are based on meaningful use interpretations made by Pamela McNutt, senior vice president and CIO, and her team at Methodist Health System in Dallas:
The major hospital EHR vendors have certified their core products as "Complete EHRs." The certification number must accompany each declaration of compliance of a meaningful use measure in your attestation. But those Complete EHRs include multiple modules, which a hospital may or may have purchased, to support such functions as emergency department, public health reporting and generation of a continuity of care document.
Hospitals don't have to comply with a meaningful use measure to electronically report public health events if their public health agency can't accept electronic submissions. But, because public health reporting is a meaningful use measure hospitals must have the public health reporting module. Further, generating a Continuity of Care Document (CCD) is an optional measure but even if a hospital doesn't select that measure, it must have the CCD module. A hospital must have all modules that support all measures regardless of whether the measures are optional.
So, what if your hospital doesn't want to use the emergency department module in its core hospital EHR, but will use a third-party application? Once you split from that Complete EHR and select a third-party ED module, or any other module, you have to note on your attestation of meaningful use the certification number of every module-whether or not part of a certified Complete EHR-that is supporting a meaningful use measure.
Now consider this: You accept that your hospital needs all modules that support meaningful use measures. So even if you won't be attesting to the ability to generate a CCD, that means you'll have to buy a certified CCD module. But, the major hospital vendors, as of mid-November 2010, weren't getting their modules certified separately from the Complete EHR. So you may need to pressure your core vendor to get its modules certified, or find a certified third-party module.

Huge issues
"These are huge issues," says McNutt, who also chairs the policy steering committee of the College of Healthcare Information Management Executives. "ED, for one, is a popular substitution, as is quality reporting, and niche quality reporting vendors don't know that they have to be certified."
Here's another issue to chew on for providers that believe they're ready to apply for incentives: Who's entering orders using the computerized physician order entry system-the ordering clinician, a nurse or another staff member?
The meaningful use criteria require the person initiating an order in the CPOE system be the licensed, authorized ordering clinician, such as a physician, physician assistant, nurse practitioner, or resident who has ordering authority through their licensure. "You can't hand a nurse an order and say 'enter this for me,'" McNutt says. So, if the clinicians who are authorized and licensed to initiate orders aren't entering them in your hospital, training and workflow changes need to be made. Immediately.
The more you look at the nitty-gritty of becoming a meaningful user, the tighter the knot in your stomach will become. The meaningful use final rule-along with federal guidance in the form of Frequently Asked Questions at www.cms.gov/EHRIncentivePrograms/ and healthit.hhs.gov/portal/server.pt/community/onc_regulations_faqs/3163-must be heavily scrutinized, because the feds will be conducting audits to ensure organizations proclaiming to be meaningful users truly are. But beware of the FAQs: Some of the answers aren't any easier to figure out than the rule. And, misinterpreting these regulations will not protect you from accusations of fraud, McNutt warns. At least, that's her interpretation.

Attestation in action
In late 2010, the Centers for Medicare and Medicaid Services was putting the finishing touches on processes for providers to register for meaningful use incentives and file attestation documents that meaningful use was achieved.
CMS early this month plans to open registration, with instructions posted on a Web site and an operational call center in place, says Elizabeth Holland, HITECH team lead in the Office of eHealth Standards and Services. To register, eligible professionals and hospitals must have a National Provider Identifier and an active user account in the National Plan and Provider Enumerator System, or NPPES.
Hospitals and Medicare-eligible professionals must have an enrollment record in the Provider Enrollment, Chain and Ownership System, or PECOS. Eligible providers participating in the Medicaid incentive program need not enroll in PECOS-CMS will use the system's records to register providers for the meaningful use program and verify enrollment information before making incentive payments. More information is available at CMS

Modern math
The attestation document will be available online in early April. For each Medicare meaningful use measure being attested, a user will enter the numerator (the number of a hospital's or eligible professional's patients compliant with the measure) and the denominator (all patients seen by the hospital or eligible provider during the reporting period). Some measures, such as whether an organization exchanged clinical data with an outside entity, require only a yes/no answer.
Because CMS will not be technically ready, there is no electronic submission of data elements to demonstrate meaningful use in 2011, Holland notes. In 2012, functional measures will be submitted via attestation, but clinical quality measures must be electronically submitted.
Proving meaningful use for Medicaid incentives in 2011 will be much easier. Providers will have to prove, such as show receipts and other supporting documentation, that they have adopted and use, or are adopting and will use, electronic health records software certified as supporting meaningful use requirements.
But there are 56 different Medicaid incentive programs, and they're going live at different times throughout the year. Some will be ready this month, others will have to be added on a monthly basis, Holland says.

Providing proof
Because only surface-level basics were known in late 2010 about the registration and attestation processes, questions that providers have as they prepare for meaningful use have piled up, as did the need for federal clarification.
At first blush, it seems pretty simple to provide yes/no answers on the attestation document for some meaningful use measures. But these quick answers won't be as easy as they seem, McNutt of Methodist Health says. For instance, how do you prove your "yes" answer if later asked to do so? "I'm going to have to create some comprehensive documentation," she says.
McNutt plans to be ready for any questions the feds may ask following Methodist's attestation of meaningful use. "All those metrics we produce in our systems, I'm going to scan them, PDF them and lock them up so I can go back and prove it if I have to." She'll also have the compliance department and maybe an external compliance source review attestation before submitting it.
For now, two-hospital Atlantic Health in Morristown, N.J., is following a "working assumption" of how the attestation process will work, says Judy Wall, director of application support. For instance, one meaningful use measure in the final rule is attesting to a successful test of an exchange of data between disparate systems. But the rule doesn't say how to attest beyond giving a yes/no answer.
Consequently, Atlantic Health is working off the assumption that having screen shots of sending and receiving data, noting the actual version numbers of software in use, the interface code version of HL7, CCD or other formats used, and EHR certification numbers for applicable applications used in the data exchange will suffice.
But whether Atlantic Health will have to transmit that documentation along with the attestation, and how it will be transmitted, isn't yet known. "It's an online application but I'm not sure what documents can be attached to it," Wall says.
Atlantic Health has time to figure everything out-the delivery system intends to apply for its first meaningful use payments in fiscal 2012, which starts Oct. 1, 2011. But there's a lot of preparation work to be done now by Atlantic Health and its software vendors, and more clarification from the feds would be very useful.
"We need to be clear on how to collect the data," Wall explains. "We have a lot of EHRs and have to ensure we're not double-counting patients."
For instance, Atlantic Health has a best-of-breed obstetrics system and believes it will need to extract data from that system and funnel it through the certified core EHR to prevent double-counting.
The OB vendor expects to have the application certified, but Wall's understanding is that data from that system and other ancillary systems-even if not certified-will count if it's run through the EHR, because the reporting application needs to be in a certified system. "That's how we expect to do it, and if not, I don't know how anyone can report from ancillary systems because even if certified, the systems won't support all of the measures-and some of the measures might fall through." For example, emergency department systems don't report on all of the meaningful use quality measures because most of clinical activity being reported doesn't occur in the department.
This is just one of many areas where the industry needs clarification from the federal government, Wall asserts. And clarification is needed now because some ancillary vendors-particularly dental but including others-don't understand the need to be certified.

Promises kept?
November's elections resulted in a shift in power in the House of Representatives, and plenty of newly elected Republicans ran as deficit hawks committed to reexamining all federal spending, especially the Obama administration's massive health care and economic stimulus packages.
The deficit hawks promise investigations in the House and lots of questions about the president's budget priorities. And the stimulus law in which the HITECH Act was embedded is in the crosshairs of congressional freshmen.
So, is $19 billion-plus in funding for the EHR incentive program in jeopardy?
Probably not, without the stimulus law or parts of it being repealed. To do so would requires Republicans to get significant Democratic support in the Senate to override a guaranteed presidential veto of any legislation that would kill the incentive program.
Still, there's cause for concern, says Mike Sauk, vice president and CIO at University of Wisconsin Hospitals & Clinics in Madison. He recalls the bi-partisan support during the Bush administration's push to increase use of health information technology, but notes that few Republicans voted for the American Reinvestment and Recovery Act.

GOP support in doubt
Sauk's not sure if the new GOP House members sworn in this month believe the government should be paying subsidies to buy EHRs. "Whether the federal government will fund meaningful use in April 2011, I have no idea," he says. "That's something we'll find out hopefully sooner rather than later."
Doug Arnold, executive director of Medical Professional Services Inc., a Middletown, Conn.-based independent practice association serving about 400 physicians, goes a little further, saying the GOP could de-fund meaningful use. "I think there's a definite risk the deficit hawks will look at that and say 'That's money we can't spend.'"
As long as the law stands, meaningful use incentive payments will be made as promised, says McNutt of Methodist. Asked if she trusts Medicare and Medicaid, her response is emphatic. "Yes, implicitly, and I'll tell you why: because it's written in law."
Throughout out the negotiating that went on during the writing of meaningful use rules, the Centers for Medicare and Medicaid Services said it understood the concerns behind certain requests to make changes, but could not change certain measures or other provisions because they were specifically mentioned in the HITECH Act, McNutt notes. Absent repeal, she sees the payments coming as laid out in the final rules.

Deep pockets
McNutt also does not worry that cash-strapped state Medicaid plans will find ways not to pay their meaningful use incentives. States have to pay only about 10 percent of the costs to implement incentive programs, and the feds are funding everything else, including the actual payments. "What's not set in stone is the exact method of payment," she cautions. "So, some states may pay a lump sum and others spread out payments."
Wall of Atlantic Health trusts Medicare and Medicaid, but the newly empowered GOP is "definitely a concern. The money is just sitting there."
On the flip side, Atlantic Health has been talking up meaningful use and emphasizing to employees and others that it's something that the delivery system should be doing anyway, she adds.
So incentive payments or not, it's game on. "We have invested far more money in I.T. than we will get back in incentives."
Among independent physicians, there is deep concern that the GOP will yank the meaningful use rug out from under them, says Doug Horner, co-founder and chief technology officer of ambulatory EHR vendor Medical Informatics Engineering, Fort Wayne, Ind.
Even if meaningful use survives, Horner fears that problems that have reared up with Medicare's Physician Quality Reporting Initiative and electronic prescribing incentive programs will be repeated in meaningful use payments. "There were mistakes during the PQRI and e-prescribing programs where some doctors were getting bonuses and others who qualify didn't, and there's been no redress from CMS," he contends. "If that happens with meaningful use, it's going to turn people off and make meaningful use seem risky going forward."
The basis for physician skepticism is that in 2010, when the feds were trumpeting the new meaningful use incentive program, the government also was fixing to cut Medicare physician payments by 25 percent this month, says Arnold of Medical Professional Services. So, a lot of doctors believe Medicare is robbing Peter (Medicare payments) to pay Paul (meaningful use incentives).
The hope is that Congress will put another fix on the Medicaid funding problem and the 25 percent payment cut would go away. If they don't fix it, "that will substantially increase the skepticism of doctors," Arnold says, some of which would then stop treating Medicare patients or stop accepting new ones. "This is definitely counterproductive and will slow growth of meaningful use."

The vendor view
If you listen to Horner of Medical Informatics Engineering, achieving meaningful use is very doable-as long as you use electronic health records software that's up to the task.
Of course, vendors speak through the prism of racing to get their EHRs federally certified as having the functionality to support the collection, organizing and reporting of meaningful use measures. "We will make sure the software gives them everything they need to get their bonus," Horner says. His company was in the early batch of vendors that got their EHRs certified in late 2010.
Nothing in the meaningful use requirements "requires physicians with their own fingertips to do much at all," Horner contends. Physicians must enter orders via CPOE and they must review a security risk analysis and update protection as necessary-even though someone else may actually do the analysis and updating.
But assuming a physician already is an EHR veteran, meaningful use won't change much, Horner says. "For the most part, you can keep your workflows or keep pretty close to them, and just make sure things are getting in the computer," he adds.
But that's the rub-making sure information that needs to be in the EHR to meet a meaningful use measure actually gets put in. For instance, one of the measures requires more than 80 percent of all unique patients seen by an eligible provider or hospital have at least one entry in an active medication list (or an indication that the patient is not currently prescribed any medications) as structured data.

Physician registry
To attest to meeting a meaningful use measure, a physician or staff member will enter the physician registry in the EHR, click the physician's name, and enter a date to start the 90-day reporting period. Then the user will chose a measure, such as the active medication list.
A computer program will search the EHR and give a numerator (the number of the physician's patients compliant with the measure) and the denominator (all patients seen by the physician during the reporting period). But hitting the 80 percent threshold will be virtually impossible unless patients who are not taking any medications are noted as such in the EHR.
A "details" button can bring up a list of a physician's patients who are not compliant with the measure. A user can scroll down the list of non-compliant patients and click on a "not on meds" button to change patients without medications from noncompliant with the measure to compliant.
To avoid this added work, clinicians and staffers in a practice should make sure that all pertinent meaningful use data is being entered during encounters, Horner advises.
Some of the measures are almost ridiculously easy to meet, such as running reports to identify patients with specific medical conditions, such as diabetes, Horner says. But he has a theory on why federal officials made sure that such measures were part of meaningful use. "I think the reason the measure is so low is that they want physicians to learn that this feature is in the EHR. The point of the measure is to expose the physician to the ease of doing that."
Medica Informatics Engineering, like many EHR vendors, is holding frequent meetings with customers either in person or via Web seminars to show which reports support which measures-and which optional measures are so easy they should definitely be chosen. The measure to conduct drug formulary checks, for instance, is a function already automatically done in many EHRs, Horner says.
Medical Informatics Engineering's EHR better be up to the task of supporting meaningful use, because client Steve Smith wants to apply for incentive payments as early as possible and is counting heavily on his vendor to help him make it.
Then again, Smith has high standards as well for two-site Fort Wayne (Ind.) Neurological Center, where he serves as CEO and administrator. The center has 37 eligible professionals, and the percentage compliance rates in many of the meaningful use measures are meaningless to him, because if the doctors are using the EHR they may as well fully use it. "We are structuring the practice to comply with the criteria 100 percent of the time. I can't run my practice three different ways."
The practice's I.T. Director, Kate Barton, believes the EHR has all the reporting tools it needs to demonstrate meaningful use. She and Smith do not anticipate having to manually collect or enter data into the EHR.
"We've had the EHR since 2003 so our staff is used to feeding everything into the system," Smith says.

A dry run
The practice planned a dry run in December to enroll eligible professionals in the reporting applications and see where they stood in relation to the criteria. But there are a few areas where Smith would like to have a better understanding of how the registration and application processes will work.
Here's what he knows: "The application for payment will rely on the practice officer to give a statement that we're in compliance and probably give some evidence in the statement of where we stand."

Confusion rules
But less than two months from going for meaningful use, Smith didn't know the exact method of attestation-electronically via a Web site or paper-based-or the procedural rules. He's also not yet clear on how to track use of decision support software. "We feel internally that we're ready to go, but we don't know how to go yet." Asked if he expected to know more from the feds by late 2010, he responds, "I'm used to being disappointed by the government."
Smith is very confident of meeting meaningful use, but cautions that the confidence rests on having seven years experience with EHRs. "I'd shudder at the thought of being someone who hasn't picked a system yet."
But asked if he's confident Congress will continue to support meaningful use, Smith becomes less optimistic, thanks to the tense and polarized political environment. "I have no idea. I've never witnessed a political situation where everything is so up in the air and subject to change. There's no constant anymore."
Looking forward, Smith doesn't see any changes in his practice's burden to demonstrate meaningful use in 2012, but his EHR vendor needs by then to be able to electronically submit compliance measures to the government.
And he fully expects to be audited to examine the veracity of his 2011 attestation. Medicare contractors on a regular basis already return sets of five submitted claims to the practice and ask for additional documentation, he notes. "To sleep at night, I have to have the practice in position that if we're audited we can produce the data rather easily."

Where's the Beef?
Between July 2010 when the final meaningful use rules came out and January 2011 when providers can first register for incentive payments, there's been a dearth of information from the federal government even as it implores providers to jump on the bandwagon.The hundreds of pages of federal rules are difficult for even the most experienced attorneys and consultants to understand. And there are "Frequently Asked Questions" pages on federal Web sites that more often than not leave the reader as confused after reading as before.
So, during the final stretch for Stage 1 meaningful use, there were a lot of physicians who didn't know much about the program and its processes. "Until the information comes, we don't know what we don't know," says Doug Arnold, executive director of Medical Professional Services Inc., a Middletown, Conn.-based independent practice association serving about 400 physicians.
Even physicians who want to be early adopters of the program and be first in line for incentive payments are in a "hurry up and wait" period, Arnold contends. Docs go to federal Web sites to see what they need to do to get ready and how they will report measures, and the information isn't there.
Some of the IPA's smaller practices have been using a physician services network called DocSite, which Detroit-based Covisint recently purchased, to manage chronic patients, electronically prescribe and participate in Medicare's Physician Quality Reporting Initiative, among other initiatives. Using DocSite has helped dispel the fears of electronic records and shown how the technology can help physicians, Arnold believes.

Lessons From a Test Run
University of Wisconsin Hospitals & Clinics in Madison expects to be among the first provider organizations to register and apply for electronic health records meaningful use payments. The two-hospital academic medical center during October 2010 started running meaningful use reports and had its "first month of qualified results," says Mike Sauk, vice president and CIO. That means they came this close to 100 percent compliance.
The organization was seeking to have October through December be its 90-day reporting period. If that didn't work, they had until April, when organizations can first apply for incentive payments, to get it right.
But October looked good, with verification of meeting five menu and 13 of 14 core measures. The 14th, a series of quality measures, came up just short. But here's the lessons learned before and during the October test that Sauk wants other providers to know about:
Lesson 1: U-Wisconsin uses electronic records software and related applications from Epic Systems Corp., Verona, Wis.
Sauk thought he could use analytics and reporting tools in the vendor's Clarity data warehouse and report off the data in the warehouse.
But Epic learned while getting its EHR certified that reports have to come off the reporting module in the certified EHR. "Had we known, we wouldn't have expended all our labor to write our own reports if we knew we had to use Epic's EHR," Sauk muses. So, the university became a beta site for Epic's effort finishing off its meaningful use reporting programs in the EHR.
Lesson 2: The core measure to have 80 percent of patients with at least one listed problem on their problem list was problematic because the hospitals couldn't reach the threshold. The Centers for Medicare and Medicaid Services had said that the measure had to cover patients from the emergency department and inpatient units.
But ED patients not admitted to observation or inpatient don't have problem lists-they are treated and sent home.
So the university devised workflow changes to add a problem list to the records of these patients, then CMS clarified that the measure covered only patients admitted to observation or inpatient units. "So that's more work we didn't need to do," Sauk says. But he chalks up the first two lessons to the hazards of being an early adopter.
Lesson 3: A requirement in the patient demographics measure is to document the cause of death, but an official determination often isn't known until after an autopsy.
So software and workflow had to be tweaked to have coders enter the preliminary cause of death. Another lesson learned: Making sure the field for the patient's primary language isn't left blank. If it is, the university's Epic system now defaults the language to English since that's the primary language for about 90 percent of the service population.

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