Health IT Law Blog : Health IT Law Blog : Post & Schell: Law Firm : HIT & Electronic Health Records

On July 13, 2010, CMS issued the final rule defining "meaningful use" and establishing the parameters and requirements for eligible professionals, hospitals and other providers to receive incentive payments provided under the HITECH Act for widespread adoption of electronic health records.  According to CMS, the key changes included in the final rule (from the meaningful use NPRM published in the Federal Register on January 13, 2010) include:

• Greater flexibility with respect to eligible professionals and hospitals in meeting and reporting certain objectives for demonstrating meaningful use. The final rule divides the objectives into a “core” group of required objectives and a “menu set” of procedures from which providers may choose any five to defer in 2011-2012. This gives providers latitude to pick their own path toward full EHR implementation and meaningful use.
• An objective of providing condition-specific patient education resources for both EPs and eligible hospitals and the objective of recording advance directives for eligible hospitals, in line with recommendations from the Health Information Technology Policy Committee.
• A definition of a hospital-based EP as one who performs substantially all of his or her services in an inpatient hospital setting or emergency room only, which conforms to the Continuing Extension Act of 2010
• CAHs within the definition of acute care hospital for the purpose of incentive program eligibility under Medicaid.

You can view the PDF of the final rule on Meaningful Use by clicking here.

You can learn more about it from the HHS press release by clicking here.  Also, the New England Journal of Medicine published an excellent summary by Dr. Blumenthal of the changes included in the final rule; you can find this article by clicking here.

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Courtesy of the American Health Lawyers Association:

On April 15, 2010, President Barack Obama signed into law the "Continuing Extension Act of 2010" (Public Law 111-157). Section 5 of the Act contains "EHR Clarification" provisions which amend the definition of "hospital based eligible professional" that was created under the American Recovery and Reinvestment Act of 2009 (ARRA). As background, ARRA created incentives for the adoption and meaningful use of certified electronic health record (EHR) technology. However, the ARRA additions to the Social Security Act (42 U.S.C. 1395w-4) contained a limitation providing, in part, that no incentive payments would be made for these hospital-based eligible professionals.

This term was originally defined to include any professional who furnishes substantially all of the relevant services in a hospital "setting (whether inpatient or outpatient)."1 The new EHR Clarification provisions amend the ARRA definition/exclusion to only apply to a professional who furnishes substantially all of the relevant services in a hospital "in-patient or emergency room setting."2 The effect of this amended definition is that physicians practicing in an outpatient hospital setting are not excluded from and are now eligible to participate in the ARRA Medicare/Medicaid incentive programs.

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On April 13, 2010, the Wall Street Journal published two fascinating articles on health information technology issues.  In "Can Technology Cure Health Health Care?" author Jacob Goldstein examined the complexities and major risks of adopting electronic medical records.  Goldstein also suggested a few high-level policies necessary to combat such risks, including designing the software with patient care in mind (rather than focusing on billing and other administrative tasks); customizing the software to fit the unique needs of one's organization; and taking the time to implement the EMR in a carefully crafted, staged manner. 

The last recommendation seems to be indeed crucial to a successful EMR implementation, but it will likely put many healthcare providers trying to capitalize on HITECH incentive payments in a peculiar situation.  Such providers must carefully balance their need to achieve "meaningful use" in a short time frame, while preventing as many disruptions to patient care as possible.

In "Breaking Down the Barriers," Laura Landro examined the state of regional health organizations (RHIOs) and health information exchanges (HIEs). While RHIO/HIE's are still rare, the number of such electronic patient data exchanges grows every day.  In fact, according to the Journal, the number of RHIO/HIE's increased by 57% since last year.  Such exchanges are also likely to benefit from HITECH Act funding distributed by HHS. 

There is an interesting nexus between these two articles:  interoperability and exchange.  A successful widespread adoption of EMR technology seems to depend upon different EMRs talking to each other, and different - including competing - healthcare providers exchanging patient information.  While EMRs may only marginally improve patient care in each individual hospital, they are likely to have a far greater impact as part of a nationwide health information exchange.

"Can Technology Cure Health Care?" Wall Street Journal (April 13, 2010).

"Breaking Down the Barriers," Wall Street Journal (April 13, 2010).

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• Javelin Strategy & Research survey found over 275,000 cases of medical identity theft in 2009, with an average price tag greater than $12,000 per incident.  This is twice as many cases as in 2008.  Keeping health information safe is going to be of paramount importance in the next decade, especially considering the steep rise in use of electronic health records. According to Computerworld.com (citing a study by IDC, a research firm), "about a quarter of all Americans -- 77 million people -- already have an EHR, up from 14% from in 2009." By 2015, experts believe the number will reach up to 60%, partially due to the transformation of the health IT industry by the HITECH Act.

• In its comments to CMS regarding the meaningful use NPRM, College of Healthcare Information Management Executives (CHIME) insisted that the present "all or nothing" approach to achieving meaningful use is going to prevent significant numbers of eligible providers from receiving any incentive payments under the HITECH Act.  According to American Medical News:

Among CHIME's suggestions: a gradual implementation process that would allow physicians to qualify for incentives by achieving 25% of meaningful use objectives by 2011, 50% by 2013, 75% by 2015, and 100% by 2017.

'Without an approach that rewards progress or provides sufficient time, organizations with limited resources will likely have little chance of qualifying for payments, thus widening the 'digital divide' in the country,' CHIME wrote.

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Here are the slides from  our February 25, 2010 Webinar on Meaningful Use.  This webinar was first in a series, and focused on the critical definition of "meaningful use" of "certified EHR technology," as described in proposed regulations released and published by CMS pursuant to the HITECH Act on January 13, 2009.  Steve and I discussed:

• Key policy goals and objectives behind meaningful use

• Measures required to achieve meaningful use

• Structure of incentive payments under Medicare and Medicaid

• Eligibility requirements for professionals and hospitals

Our next webinar, to be held on Thursday March 18, 2010, from 1:00 to 2:00 PM, will focus on how to negotiate software and EHR licensing agreements and other transactional issues with respect to dealing with health IT vendors.

For more information, please contact me at vschick@postschell.com or 202-661-6945.

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Via Healthcare IT News:

The Certification Commission for Health Information Technology has certified 14 electronic health record products that pass muster for provider use under the American Recovery and Reinvestment Act of 2009 (ARRA).

"We believe it will be a challenge for providers who have not yet begun to evaluate products to purchase and implement EHR technology and achieve meaningful use in time for the 2011-2012 incentives," said Alisa Ray, the CCHIT's executive director. "We have received more than 30 applications for our 2011 certification programs – more than half of which are for the comprehensive program – and are announcing new certifications regularly so providers can begin to consider EHR technology that demonstrates compliance with the proposed federal standards."

According to Ray, the Preliminary ARRA 2011 program is a modular, limited certification and inspects technology only against the federal standards. It offers flexibility for health IT companies, developers and providers in meeting ARRA 2011-2012 certification requirements.

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According to Modern Healthcare, several HIT vendors, including GE Healthcare, NextGen Healthcare Information Systems, and Athenahealth, will guarantee that their EHR products will meet or "evolve to meet" the federal requirements for "meaningful use," even though such requirements have not been promulgated yet by CMS.  In fact,

Athenahealth recently upped the ante by guaranteeing that, not only will the company's AthenaClinicals Internet-based electronic health-record service meet federal standards, but the doctors who use it will receive a bonus payment for the 2011 program year under the terms of the [HITECH Act].

The HITECH Act provides for a first-year incentive payment of $18,000 for those eligible professionals who achieve meaningful use of certified EHR technology in 2011 or 2012, instead of a first-year payment of $15,000 thereafter.

Some vendors hope that such guarantees will spur activity in the market, persuading some reluctant healthcare providers not to wait until CMS issues its final "meaningful use" regulations next year.  There is also some doubt whether such guarantees apply to each vendor's existing customers or solely to new customers.

However, whenever a healthcare organization enters into an EMR purchase or license agreement, it must obtain strong warranties from the vendor that its product(s) and system will meet the applicable federal requirement standards at time of issuance of such standards, as well as for duration of the applicable license.  "Meaningful use" requirements will likely change over the life of a license, and a vendor's obligation to meet such evolving standards is absolutely essential.  Healthcare providers must also include proper remedies and appropriate carve-outs from vendor's limitation of liability for a vendor's breach of such warranties.

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