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

ONC announced release of the much-anticipated Notice of Proposed Rulemaking (NPRM) on certification programs.  Via ONC Press Release:

Certification of Health IT will provide assurance to purchasers and other users that an EHR system, or other relevant technology, offers the necessary technological capability, functionality, and security to help them meet the meaningful use criteria established for a given phase. Providers and patients must also be confident that the electronic health IT products and systems they use are secure, can maintain data confidentially, and can work with other systems to share information. Confidence in health IT systems is an important part of advancing health IT system adoption and allowing for the realization of the benefits of improved patient care.

Eligible professionals and eligible hospitals who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology. Once certified, Complete EHRs and EHR Modules would be able to be used by eligible professionals and eligible hospitals, or be combined, to meet the statutory requirement for Certified EHR Technology.
 

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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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On Thursday, February 25, 2010 from 1:00PM to 2:00PM (EST), Steve Fox and yours truly will host a free webinar, the first in a series, which will focus 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.  We will discuss:

• 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

You may view each of these presentations at your desk. There is no charge or limit to the number of people who may listen to each presentation on the same line. Click here to register. After registering, you will receive log-in information by e-mail.

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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HHS Secretary Kathleen Sebelius, appearing with Labor Secretary Hilda Solis, announced the Obama administration will release almost $1 billion set aside in the stimulus bill in order to aid implementation of health information technology.

Secretary Sebelius announced $386 million in grants to advance widespread adoption of EHRs at the state level, including for health information exchanges (HIEs).  HHS also awarded $375 million to 32 nonprofits for Regional Extension Centers which assist providers in updating their medical record systems and train workers on such new technologies.

Secretary Solis announced around $225 million to support 55 job-training programs in 30 states which is expected to train around 15,000 people in the health records technology.

The Obama administration expects to help more than 100,000 health-care providers set up electronic medical records for their patients by 2014.

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Ingenix, the technology unit of United Health Group, and Allscripts-Misys Healthcare Solutions joined Siemens, GE Healthcare and IBM in offering financing for purchasers of electronic medical record technology.   This continues the trend of vendors offering interest-free financing until healthcare providers receive the "meaningful use"  incentive payments or reimbursements under the HITECH Act.

While such offers may provide a solution to some of the credit and financing woes facing the healthcare industry, healthcare providers should be acutely aware of the many potential pitfalls and related issues inherent in vendor-financed deals, including: (1) additional pressure from vendors to accept their standard contractual terms and conditions, rather than engaging in full-blown contract negotiations, because vendors have much more leverage if they are also the creditor in the transaction; (2) failing to obtain necessary warranties and representations from vendors that their systems will comply with all relevant requirements under ARRA and the HITECH Act and will permit the provider to achieve meaningful use; (3) dealing with problems that may arise if either the vendor’s product fails to achieve applicable certification (e.g., CCHIT), is not “accepted” by the provider after completion of acceptance testing or the product does not enable the provider to achieve “meaningful use” in a timely manner, as well as a host of other issues.

Steve Fox and yours truly explore the issues around vendor financing of EHR system purchases in the latest issue of the Journal of Health Information Management, where we suggest recommended courses of action for healthcare providers considering acquiring HIT systems, including EMRs, by using vendor financing options.  A complimentary PDF copy of the article is available here.
 

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CMS released a proposed rule pursuant to the HITECH Act which includes the much-anticipated definition of Meaningful Use of Certified EHR technology.  You can find the full text here.*

HHS has also released an interim final rule with a request for comments to adopt an initial set of standards, implementation specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health Service Act. This interim final rule represents the first step in an incremental approach to adopting standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health information technology and to support its meaningful use. The certification criteria adopted in this initial set establish the capabilities and related standards that certified electronic health record (EHR) technology will need to include in order to, at a minimum, support the achievement of the proposed meaningful use Stage 1 (beginning in 2011) by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR Incentive Programs.  You can find this interim rule here.*

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On the eve of HHS releasing the much-anticipated definition of "meaningful use," health IT divisions of GE and Siemens revealed new financing options for purchases of their EMR and other HIT products.

On December 16, 2009, Siemens followed IBM and GE in offering "a series of flexible financing solutions to help healthcare providers pursue meaningful use objectives and meet [HITECH Act] deadlines <...>  Featuring zero-percent interest terms for qualified customers, the solutions enable organizations to defer up-front payments associated with their technology investment while meeting criteria for future government incentive monies."

According to Fierce Healthcare:

To provide the greatest possible range of choices for customers, Siemens offers solutions from Siemens Financial Services, Inc. as well as from selected partners, including IBM Global Financing and 3-D Financial Services. These options allow customers to choose a customized financing solution that matches their individual technology acquisition roadmaps, business strategies, financial profiles, and technology needs. <...>

By bridging the gap between the project implementation and the receipt of ARRA incentive, Siemens will be providing its customers an option which allows them to optimize their cash flow while maximizing return on investment.

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The new science of personalized medicine, a new report on the $232 billion personalized medicine industry by PriceWaterhouseCoopers, anticipates an annual 11% growth in this market.  Health IT and telemedicine are among the key drivers for personalized medicine. 

According to Healthcare IT News, the report's findings include:

• The core diagnostic and therapeutic segment of the market – made up primarily of pharmaceutical, medical device and diagnostics companies – is estimated at $24 billion and expected to grow by 10 percent annually, reaching $42 billion by 2015.
• The personalized medical care portion of the market – including telemedicine, health information technology and disease management services offered by traditional health and technology companies – is estimated at $4 billion to $12 billion and could grow to more than $100 billion by 2015 if telemedicine takes off.
• The related nutrition and wellness market – including retail, complementary and alternative medicines offered by consumer products, food and beverage, leisure and retail companies – is estimated at $196 billion and projected to grow 7 percent annually to more than $290 billion by 2015.

You can find the full report here.

"IT helps drive $232B personalized medicine market," Healthcare IT News (December 8, 2009).

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The New York Times reported on a new study led by Dr. Ashish Jha of the Harvard School of Public Health and Catherine M. DesRoches of Massachusetts General Hospital which found only marginal benefits to hospitals using electronic health records in terms of reducing costs and improving the quality of care.

The new study placed hospitals into three groups: those with full-featured electronic health records, those with more basic ones, and those without computerized records. It then looked at their performance on federally approved quality measures in the care of conditions like congestive heart failure and pneumonia, and in surgical infection prevention.

In the heart failure category, for example, the hospitals with advanced electronic records met best-practice standards 87.8 percent of the time; those with basic computer records, 86.7 percent; and those without, 85.9 percent. The differences in other categories were similarly slender.

Reducing the length of hospital stays, according to many experts, should be a big money-saving payoff from electronic health records — as better care aided by technology translates into less time spent in hospitals. For hospitals with full-featured digital records, the average length of stay was 5.5 days; for those with basic computer records, 5.7 days; and those without, 5.7 days.

The upside, if any? Dr. Karen Bell, a former HHS official, was not surprised by the findings and hopes that the real benefits will be achieved after use of EMRs is much more widespread:

'There will be no clear answers on the overall payoff from the wider use of electronic health records until we get further along, five years or more, said Dr. Bell, [now a] senior vice president for health information technology services at Masspro, a nonprofit group. “But that doesn’t mean we shouldn’t go forward.'

"Little Benefit Seen, So Far, in Electronic Patient Records," New York Times (November 16, 2009).

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Our collaborator and friend James Oakes, a Principal at Health Care Information Consultants, LLC in Baltimore, Md., authored a wise and timely call for action for healthcare providers hoping to capitalize on the incentive payments for meaningful use of certified EHR technology included in the HITECH Act. 

The article, appearing in BNA's Health IT Law & Industry Report, argues that even though the HHS has yet to produce final regulations defining such key HITECH Act terms as "meaningful use" and "certified EHR technology," healthcare providers should not wait any longer to begin planning for the transition from paper to digital records, or the likely required updates to existing EHR systems:

Given the uncertainty surrounding these issues, a number of providers have elected to delay any action towards selecting and implementing an electronic health record (EHR) for their institution until answers are made available, reasoning that they want to know as much as possible before committing to a direction. However, providers who take this path may put themselves at risk for forfeiting eligibility for ARRA funds at all, given the time to execute and implement systems.

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By popular demand, here is the video of David Pogue's report on the Obama Administration's efforts to digitize patient records in the U.S. 

Watch CBS News Videos Online

"Charting a New Course," CBS News (September 13, 2009).

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David Pogue, a reporter for the New York Times, posted the transcript of his interview with Dr. David Blumenthal, National Coordinator for Health IT. Mr. Pogue interviewed Dr. Blumenthal for a CBS news report on digitization of healthcare in America (the video is available after the jump).

Here are some highlights from the interview:

On current state of health IT in the US:

We found that about 17 percent of physicians in 2008 had adopted an electronic health record, and about ten percent of hospitals. <...> The rest is paper. It's basically the same system that physicians have used since Hippocrates, which is writing on some piece of paper.

On reimbursement penalties for those failing to achieve meaningful use by 2015:

From 2011 to 2015, there is a bonus. The Congress has put $45 billion on the table to ease physicians and hospitals into this new world of computerized medicine.After 2015, if you have not adopted, and you see Medicare or Medicaid patients, you may experience a penalty. 2015 is six years off. Six years is plenty of time for physicians to get themselves organized to put a record in place and avoid those penalties.

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Dr. David Blumenthal, the National Coordinator for Health IT, gave an update on the Obama Administration's efforts to define "meaningful use" and to further adoption of EHRs nationwide.  Blumenthal did not reveal any new details regarding the upcoming regulations on meaningful use, reminding his audience of the upcoming "notice of proposed rulemaking in late 2009 with a public comment period in early 2010."

Meanwhile, according to Government HealthIT, the next meeting of the HIT Policy Committee, which will meet on October 27 and 28, will focus on how to map meaningful use objectives to medical specialties as well as small practices and hospitals.

Speaking at the 81st annual American Health Information Management Association convention in Grapevine, Texas, Dr. Blumenthal stated that he expects 50,000 health information management (HIM) jobs to be created as the U.S. moves from the paper-based to the digital system of healthcare.  AHIMA's CEO, Linda Kloss, noted that the interest in HIM careers has "exploded" during the last year.

Much more news after the jump.
  

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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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The New York Times reported last week that the North Shore-Long Island Jewish Health System (North Shore) will offer its 7,000 affiliated (though not employed by North Shore) physicians subsidies for implementing electronic health records.  Interestingly, this subsidy does not include or prevent such physicians from qualifying for the approximately $44,000 in Medicare incentive payments under ARRA. 

North Shore plans to subsidize 50% of the total cost of the EMR system (which uses Dell hardware and Allscripts software) for practices "who simply install electronic health records that can communicate between the doctor's office, labs and hospitals."  However, the health system will subsidize 85% of the total cost of the EMR -- a figure driven, no doubt, by the exceptions to the Stark and Anti-Kickback laws -- for physicians willing to share some of their patient data. 

North Shore is counting on the availability of shared data to reduce the cost of care through reduction of unnecessary tests and medical mistakes.  A recent PriceWaterhouseCoopers (PWC) survey may support North Shore's reasoning.  The survey found broad agreement among healthcare executives with respect to secondary uses of EMR patient data.  Among other findings (discussed after the jump), the PWC survey found that 42% of organizations already using some form of secondary data use achieved cost savings, 29% increased their revenue, and 59% saw improvements in quality of care.

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The last few weeks saw a tremendous amount of activity in the health IT market.  Dell and Xerox were among the companies trying to capitalize on opportunities created by the ARRA incentives and certain market trends, including high demand for HIT products due to the ongoing digitization of the industry and, more generally, the expanding healthcare needs of an aging population in the United States.

Dell is quickly establishing itself as a major player in health IT.  In April 2009, Dell aligned itself with Wal-Mart and eClinical Works to supply hardware for Wal-Mart's new EHR system.  Last month, Dell rolled out its own EHR system aimed at physicians affiliated with hospital practices, with Tufts Medical Center and Memorial Hermann Health Care System among the early adopters. 

Even more significantly, on September 21, 2009, Dell announced its plans to acquire the health IT vendor Perot Systems Corp. for $3.9 billion.  Perot is a major player in the healthcare industry:  about half of Perot's $2.8 billion in annual revenue comes from the healthcare market; and as much as half of the hospitals that outsource their IT are Perot clients.   Perot runs over 3,000 healthcare applications for its clients, though the company does not have a preferred provider arrangement with a specific application vendor.

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Via Government Health IT:

The federal Health IT Policy Committee today endorsed recommendations that would leave the Certification Commission for Health IT in the short term as the sole organization authorized to certify health IT systems that qualified for funding under the economic stimulus plan. More certifying organizations would be added later.

Certification of electronic health record systems that met federal criteria for “meaningful use” of health IT could start as early as October, members of the Department of Health and Human Services’ Health IT Policy Committee said at the August 14th meeting.

Under the plan, CCHIT would provide a preliminary stamp of approval that health IT systems were HHS-qualified or certified until a final meaningful use regulation is published at the end of the year, said Marc Probst, chief information office of Intermountain Healthcare and co-chairman of the Committee’s certification work group.

Preliminary certification is meant to give providers and vendors enough certainty to proceed with planning, designing and purchasing systems in 2010. The HHS certification-qualification would mean that a provider purchasing the systems would be eligible for Medicare and Medicaid incentive payments under the stimulus law beginning in 2011.

"CCHIT will be sole health IT certifier, for now," Government Health IT (August 14, 2009).

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The New York Times reported on Americans' growing concern regarding commercial use of their personal health information, especially the use of re-identified prescription drugs information for marketing purposes.  

The article points out correctly that the Recovery Act of 2009 (ARRA) included a few key changes to the present privacy regime, which would make it more difficult for pharmacies and data mining companies to use patient information for marketing or fundraising purposes.  While the new law (and the upcoming applicable HHS regulations sanctioned by ARRA) will close a few loopholes in the current medical privacy regime, data mining companies like IMS Health and Verispan do not seem to be overly worried about these new developments:

The law won’t shut down the medical data mining industry, but there will be more restrictions on using private information without patients’ consent and penalties for civil violations will be increased. Government agencies are still writing new regulations called for in the law.  <...>

IMS Health reported operating revenue of $1.05 billion in the first half of 2009, down 10.6 percent from the period a year earlier. [An IMS representative] said he did not expect growing awareness of privacy issues to affect the business.

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While we anxiously await ONC's preliminary definition of "meaningful use" (due to be published on Thursday of this week), let us consider the future of American healthcare through the prism of recent industry analysis and new developments in Texas.

The New York Times Bits blog had a posting today about "an ambitious experiment" at the Cook Children's Health Care System in Ft. Worth, Texas.  Cook Children's is implementing a new EHR technology system (see details after the jump) which the administration hopes "will help the clinic improve care management and curb costs."  This outcome-oriented approach is also consistent with the payment and reimbursement structure at the clinic: "a capitated payment -- a set annual payment for each patient, instead of the standard fee-for-service system of American health care."

This development reminded me of Atul Gawande's fascinating article in The New Yorker last month about the bottom line-driven culture of hospitals and medical practices in McAllen, TX, which, according to his analysis, may lead to significantly higher cost of health care, while showing no real improvement in the quality of care.  The article contrasts the McAllen model with an outcome-oriented, collaborative model of practice of medicine in such healthcare enterprises as the Mayo Clinic in Minnesota and Grand Junction in Colorado, which produce better quality of care while significantly lowering costs.

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The Washington Post provides an interesting behind-the-scenes account of how the funds for electronic health records adoption were included into the American Recovery and Reinvestment Act of 2009, commonly known as the stimulus bill.  Health Information and Management System Society (HIMSS) played a crucial role in this lobbying effort.  According to the Post:

[HIMSS] had worked closely with technology vendors, researchers and other allies in a sophisticated, decade-long campaign to shape public opinion and win over Washington's political machinery.

You can read the whole article here.

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Steve Fox was interviewed in this month's Cover Story "The Big Push", in For the Record, a biweekly  magazine for health information management professionals, regarding the incentives and challenges of EHR adoption.  On incentives included in the HITECH Act, Steve argued that:

“it’s almost crazy not to adopt EHRs because we’re talking about a significant amount of money ... From my discussions with hospitals and other physicians, the consensus seems to be that leaving that large sum on the table would just be foolish. Some hospitals I’ve spoken with are anticipating this will bring in millions.”

Steve also identified interoperability as a crucial goal for EHR systems:

“Trying to encourage not just adoption of EHRs but having them all interconnected is definitely the next step and perhaps even the definition of success in the end ... Hospitals need to be connected with one another or the EHRs are not being used to their full potential. Take Philadelphia, for instance. There are a lot of hospitals there but almost no connectivity among them. If a patient has his records at one hospital but gets taken to a different hospital, there’s no way to access his records, even if they do have an EHR in place.”

You can read the full article here.

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Healthcare Informatics Editor-in-Chief Anthony Guerra recently talked with our own Steve Fox and fellow Post & Schell partner Edward Shay about the substance of the HITECH Act and what this new legislation means for healthcare providers. The interview appears under the "Online Exclusives" section of the Healthcare Informatics Web site.

Healthcare Informatics recently published Part III and Part IV of the interview on its Web site.

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• After what has become a rather typical breach of patient privacy for Southern California, Kaiser Permanente fired fifteen employees (and disciplined eight additional employees) for looking at the medical records of Nadya Suleman, the mother of octuplets commonly referred to as "Octomom".  Previously, similar breaches occurred at UCLA when that medical center's staff leaked celebrities' medical records to the tabloids.  (MercuryNews.com, via AP, March 30, 2009.)
• Wall Street Journal reported last week that HIT stocks, especially smaller companies, like eClinicalWorks (which provide the software component of Wal-Mart's new EHR package) will benefit greatly from the billions of dollars in HIT funding included in the stimulus bill.  Also, in another sure sign of a growing industry, Quality Systems, the maker of the NextGen EHR software, is "beefing up its sales force." ("Stimulus Funds for E-Records Augur Big Windfall for Small Health Firms", Wall Street Journal, March 24, 2009.)

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The New England Journal of Medicine published a study describing dismal rates of adoption and use of EHR technology in the United States.  The authors of the study found that

less than 2% of acute care hospitals have a comprehensive electronic-records system, and that, depending on the definition used, between 8 and 12% of hospitals have a basic electronic-records system.  With the use of the definition that requires the presence of functionalities for physicians' notes and nursing assessments, information systems in more than 90% of U.S. hospitals do not even meet the requirement for a basic electronic-records system.

Financial restraints is the most commonly cited reason for lack of electronic health records.  The authors found higher adoption rates among larger, urban, teaching hospitals (which the authors partially attributed to such institutions' financial resources available for EHR technology).  Interoperability and low levels of health information exchange also have a negative effect on EHR adoption levels.

However, the authors did provide a glimmer of hope, if not good news:

From a policy perspective, our data suggest that rewarding hospitals — especially financially vulnerable ones — for using health information technology may play a central role in a comprehensive approach to stimulating the spread of hospital electronic-records systems. Creating incentives for increasing information-technology staff and harmonizing information-technology standards and creating disincentives for not using such technology may also be helpful approaches.

Thus, hopefully the incentive payment provisions in the HITECH Act will have a positive effect on adoption rates in the foreseeable future.

It is worth pointing out that Dr. Blumenthal, the new head of ONCHIT, is one of the study's authors.  This study was covered by major national news outlets, including the Wall Street Journal and the New York Times.

"Use of Electronic Health Records in U.S. Hospitals" (New England Journal of Medicine, March 25, 2009).

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A battle royal rages on among various Harvard physicians about the effects of a widespread adoption of EHR technology.  In a Wall Street Journal op-ed, two Harvard doctors questioned President Obama's claim that nationwide adoption of EHR technology will save the taxpayers as much as $80 billion annually.   Drs. Groopman and Hartzband call on Mr. Obama to "apply real scientific rigor to fix our health-care system rather than rely on elegant exercises in wishful thinking."  

However, three other Harvard physicians, including Geek Doctor John Halamka, published a Letter to the Editor in response to the Groopman/Hartzband Op-Ed, claiming that the latter did not present a full or accurate picture of the positive effects of widespread adoption of EHR technology.  In part, Drs. Halamka, Bates and Middleton claim that:

The electronic health record represents a transformational change in healthcare, and will enable an array of improvements—although it will not necessarily result if implemented badly. The electronic record is to the paper record as the automobile was to the horse and buggy. No one will want to go back.

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• Kaiser Permanente and IBM inked a $500 million, seven-year IT services deal.  IBM will manage Kaiser's data center operations, storage and software, but IBM will not have access to patients' medical records.  AP, San Francisco Chronicle (March 17, 2009).
• A new study expects that as much as three-quarters of prescribers will use e-prescribing by 2014 because of the incentives for adoption of e-prescribing technology included in the HITECH Act (though only about 15% of current prescribers use e-prescribing).  This could result in a massive $22 billion reduction in drug and medical costs.  Government Health IT (March 17, 2009).
• Wal-Mart is bringing its "high-volume, low-cost" approach to the medical records industry.  Wal-Mart's Sam's Club division will produce a package that will include hardware from Dell, software from eClinicalWorks, as well as installation, maintenance and training services.  According to the New York Times (March 11, 2009), the "Sam’s Club offering, to be made available this spring, will be under $25,000 for the first physician in a practice, and about $10,000 for each additional doctor. After the installation and training, continuing annual costs for maintenance and support will be $4,000 to $6,500 a year, the company estimates." This development has huge implications for the EHR market, and may actually aid the widespread adoption of EHR technology.   Healthcare IT News (March 11, 2009) also covered this story.

More news after the jump.

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