CMS issues final rules on Meaningful Use

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.

At the same time, ONC issued another final rule, finalizing 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."  You can find a copy of this final rule by clicking here.

Stay tuned for much more analysis of the final rules published today, as well as the changes to HIPAA Privacy and Security Rules issued by OCR last week.

Slides from webinar on negotiating "must-have" provisions in HIT contracts

Last Thursday, March 18, 2010, from 1:00PM to 2:00PM (EDT), Post & Schell hosted the second webinar in a series examining the effects of meaningful use and other HITECH Act regulations on the healthcare industry. 

The webinar focused on identifying and negotiating the essential elements of HIT agreements, particularly in light of the HITECH Act and related HHS regulations regarding "meaningful use" of "certified EHR technology." Post & Schell's Steve Fox and Vadim Schick, along with Jim Oakes, Principal at Health Care Information Consultants, discussed:

  • Warranty, limitation of liability and privacy and security provisions in HIT contracts
  • Structuring payments to correspond with certain achievement milestones
  • Acceptance testing procedures
  • Provisions specific to vendor-financing transactions
  • ASP / SaaS models of software licensing

If you missed the presentation, you can listen to the podcast here. You can also view the slides from our presentation here.

This webinar was the second in a series devoted to structuring vendor-provider agreements in the post-HITECH Act world. If you missed our first webinar, A Lawyer's Take on "Meaningful Use," you can still view the slides from that presentation
here.

 

Free Webinar: Negotiating "Must-Have" Provisions in HIT Contracts

On Thursday, March 18, 2010, from 1:00PM to 2:00PM (EDT), Post & Schell will host the next webinar in a series examining the effects of meaningful use and other HITECH Act regulations on the healthcare industry. 

This webinar will focus on identifying and negotiating the essential elements of HIT agreements, particularly in light of the HITECH Act and related HHS regulations regarding "meaningful use" of "certified EHR technology." Post & Schell's Steve Fox and Vadim Schick, along with Jim Oakes, Principal at Health Care Information Consultants, will discuss:

  • Warranty, limitation of liability and privacy and security provisions in HIT contracts
  • Structuring payments to correspond with certain achievement milestones
  • Acceptance testing procedures
  • Provisions specific to vendor-financing transactions
  • ASP / SaaS models of software licensing

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

This webinar is second in a series devoted to structuring vendor-provider agreements in the post-HITECH Act world. If you missed our first webinar, A Lawyer's Take on "Meaningful Use," you can still view the slides from that presentation
here.

 

Breaking: ONC releases NPRM on certification programs

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.
 

 

To this end, an NPRM proposing the establishment of certification programs for purposes of testing and certifying health information technology was issued in March 2010 with a request for comments. The NPRM proposes:

* A temporary certification program to assure the availability of Certified EHR Technology prior to the date on which health care providers seeking the incentive payments would begin to report demonstrable meaningful use of Certified EHR Technology.

* A permanent certification program to replace the temporary certification program.

You can learn more about this new NPRM here.

You can find the full text of the NPRM here.

 

Thursday: Free Webinar on "Meaningful Use"

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.

 

Updated: Meaningful Use Definition Released in the Federal Register

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.*

 

* These are links to PDF versions of the NPRM and IFR published on January 13, 2010 in the Federal Register.

GE and Siemens provide new financing options for Health IT purchases

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.

Back in June of 2009, GE announced its $2 billion commitment as part of its Stimulus Simplicity program. According to the Wall Street Journal, GE, through its GE Capital division, “expects to offer $100 million in interim financing to hospitals and health-care providers for projects that are expected to qualify for funds from the U.S. government's economic-stimulus package. GE said the move offers doctors, community health clinics and hospitals a bridge to qualify for stimulus funds and faster access to electronic medical records.” While the “meaningful use” definition and the EHR certification are not yet finalized, GE guarantees that its EHRs will meet the upcoming requirements, regardless of the details of the final rule. Like IBM’s program, GE’s financing is also restricted specifically for GE Centricity, GE’s EHR product.

On December 24, 2009, GE extended the financing terms available for its Centricity EMR software to other health IT products, including Centricity Enterprise and Centricity Business, a financial and administrative tool for providers.  According to Healthcare IT News:

GE executives say they have seen strong interest in the program, with demand exceeding $140 million in sales opportunities.

In the current economic environment, vendor financing may be the best (if not the only) option for healthcare providers seeking to qualify for incentive payments under ARRA.  However, such  providers should be aware of the many potential pitfalls and related issues inherent in vendor-financed deals, including: (1) additional pressure from vendors to accept standard contractual terms and conditions; (2) failing to obtain necessary warranties 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 vendors’ products fail to achieve certification, or the provider fails to achieve “meaningful use” in a timely manner, as well as a host of other issues. 

These issues are subject of an upcoming article by yours truly, in the Journal of Health Information Management.  We will link to the article when it becomes available online.

"Siemens Unveils Flexible Financing Solutions to Help Providers Achieve Meaningful Use," Fierce Healthcare (December 16, 2009).

"GE expands healthcare IT loan program," Healthcare IT News (December 24, 2009).

"GE Unit Offers Interim Loans to Hospitals, Health-Care Providers" The Wall Street Journal (June 16, 2009), B3.

"G.E. Offers Loans for E-Health Record Purchases," New York Times Bits Blog (June 15, 2009).
 

ONC names 17 members of the privacy and security workgroup

The Office of National Coordinator for Health IT named 17 members of the newly formed privacy and security workgroup of the HIT Policy Committee.  According to Government Health IT:

The work group will be co-chaired by Deven McGraw, director of the Health Privacy Project at the Center for Democracy and Technology, and Rachel Block, executive director of the New York eHealth Collaborative and deputy commissioner for health IT transformation at the New York State Department of Health.

Their team will advise the Policy Committee on such matters as how safeguards for the exchange of health information should fit into the “meaningful use” test for health IT incentives that ONC has been working on.

The ONC has previously announced the establishment of a separate workgroup devoted to creation of a national health information network, which, of course, will have to deal with its own set of privacy and security concerns.  There is also a privacy and security workgroup under the HIT Standards Committee.

Government Health IT provides a list of the other members of the workgroup:

Some of the privacy and security work group members named today already sit on its parent Policy Committee. They are: are Dixie Baker, SAIC; Paul Egerman, consultant; Judy Faulkner, Epic Inc.; Gayle Harrell, a consumer representative with the state of Florida; Dr. Mike Klag, Johns Hopkins University School of Public Health; Latanya Sweeney, Carnegie Mellon University; and Paul Tang, Palo Alto Medical Foundation and Policy Committee vice chairman.

New members who are not current members of the Policy Committee are: Dr. Peter Basch; a healthcare practitioner, Dr. A. John Blair, a practitioner; Marianna Bledsoe, the National Institutes for Health; Joyce DuBow, AARP; Justine Handelman, Blue Cross Blue Shield; John Houston, University of Pittsburgh Medical Center; Terri Shaw, Children’s Partnership; and Paul Uhrig, SureScripts. Jodi Daniel and Sarah Wattenberg will represent the Office of the National Coordinator for Health IT on the workgroup.

"ONC names privacy, security workgroup members," Government Health IT (December 8, 2009).

In the news: EHR incentives; the rising threat of medical identity theft

  • In a letter to Dr. Blumenthal, the Medical Group Management Association (MGMA) urged the ONC to define "meaningful use" in a practical and achievable way.  Otherwise, many providers could fail to qualify for the HITECH Act's incentives.  The MGMA is recommending, inter alia, instituting a pilot test prior to the start of the program and before each new phase of the program; including only criteria for meaningful use that have widespread industry use or have been tested; permitting physicians to test their reporting systems prior to their “go-live” date; permitting flexibility in achieving meaningful use and avoiding a “pass/fail” approach; developing a simple process for physicians to attest that they have achieved meaningful use; simplifying the data-reporting process and ensuring that the government is ready to accept the data; closely monitoring the industry to ensure that the program logistics operate appropriately; and ensuring government oversight of the vendor community for its ability to produce high-quality and reasonably priced software.

  • A former Johns Hopkins hospital employee, Michelle Johnson, was sentenced to 18 months in prison and ordered to pay $200,000 in restitution for stealing patient information.  According to the Associated Press, Ms. Johnson, formerly a patient services coordinator, "provided a conspirator with names, Social Security numbers and other identifying information of more than 100 current and former patients of Johns Hopkins. That information was used to apply for credit. Johnson kept some of the fraudulently ordered merchandise for herself, including a computer monitor, a cordless phone, and clothes for herself and her children."

 

  • The Wall Street Journal reported on the rise in medical identity theft and that the situation is "expected to worsen."   Most of medical identity theft cases are committed by those who pay medical workers for patient data, exactly what Michelle Johnson was caught doing at Johns Hopkins.  According to the Journal and the World Privacy Forum report it cited, the adoption of electronic medical records may contribute to the problem by making such information more easily available. Data indicates that states with a high population of retirees experienced the most significant increases in medical identity theft, including California, Texas, New York, Arizona, and Florida.

"Patient ID Theft Rises," Wall Street Journal (November 30, 2009).

"MGMA concerned about success of EHR incentive program," Healthcare IT News (November 23, 2009).

"Woman Sentenced for Stealing Patients' Info," Associated Press (November 20, 2009).

 

 

Timely advice: Begin preparations for "meaningful use" now

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.

 

Oakes suggests several initial steps to EHR implementation:

  1. Gain a high-level understanding of the basic provisions of ARRA and the HITECH Act.
  2. Develop a realistic plan for your institution based on your assessment of the level of automation that is right for your circumstances, environment, and budget.
  3. Discuss the implementation, transition and any relevant software changes with your current health IT vendor.  Considering the huge increase in demand in HIT services, it is important to secure your vendor's support and involvement early on, so that your organization does not end up at the end of the line.
  4. Know the health IT market because your organization will benefit from having the most customized solution (as opposed to, e.g.,  the most expensive or feature-rich), at the right price.

"Get started!" urges Oakes:

Going through all of these steps will not be accomplished overnight. Indeed, past experience suggests that if a hospital has not started these steps already, it will take from 24 months to 48 months for a mid-sized hospital to transition from planning to live operation, including full use of clinical capabilities. Given that ARRA incentives start phasing down in FY 2013 for physicians (2014 for hospitals), it is not beyond the realm of possibility that an institution that waits too long to start could find itself shut out of maximum incentive payments.

You can find the full article, courtesy of BNA's Health IT Law and Industry Report, here.

In the news: Blumenthal on "meaningful use," new health information management jobs, etc.

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.
  

 

  • American Medical News reported on the staffing changes for healthcare organizations necessitated by the nationwide switch to electronic health records. According to the article:

There are some assumptions about staff changes that are easy to make, experts say. Any job that was strictly paper-based prior to implementation, for example, will need to be overhauled or eliminated.

Other changes are not so easy to predict, and could depend on how willing your employees are to adapt and learn new skills.

  • According to Crain's Detroit Business, urban hospitals lag behind rural hospitals and physicians' practices in joining health information exchanges (HIE's) because such HIE's pose a combination of monetary, strategic, and technological challenges.
     
  • Washington Post reported on a pilot project in Ohio aimed at streamlining the cost of healthcare administration.  The state's eight major health insurers - representing 91% of the patients - have signed on to participate in this initiative.  The Post described the program as:

a single Web portal [that the participants] believe will reduce duplication, miscommunication, and confusion between doctors and insurance companies. That will mean quicker office and hospital service, more time for patient care, and, ultimately, cost savings, participants said.

  • Healthcare IT News reported that -- according to e-prescribing company Surescripts -- "the number of physicians using electronic prescribing will have more than doubled in 2009 and that "more than 140,000 – 23 percent of all office-based physicians, nurse practitioners and physician assistants in the United States – are e-prescribing today."
     
  • USA Today reported on the various hardships and setbacks to widespread implementation of EHRs.  The article ended on a somewhat hopeful note, with a great quote by Stephanie Reel, the CIO of Johns Hopkins University:

We've been saying that we're five years away from electronic medical records for the past 40 years ... Now maybe we really are only five years away.

"Meaningful" Progress Toward Electronic Health Information Exchange, David Blumenthal, MD (October 1, 2009).

"Specialists, primary care providers differ in meaningful use," Government HealthIT (October 6, 2009).

"Health IT effort to create thousands of new jobs, says Blumenthal," Healthcare IT News (October 6, 2009).

"How electronic medical records affect staffing," Amednews.com (October 5, 2009).

"Slow with the flow: Hospitals lag in joining health info exchanges," Crain's Detroit Business (October 4, 2009).

"Paperwork angst drives Ohio doctor, insurer effort," The Washington Post (October 5, 2009).

"More than 140,000 physicians on growing list of e-prescribers," Healthcare IT News (October 5, 2009).

"High-tech 'scribes' help transfer medical records into electronic form, " USA Today (October 7, 2009).
 


 

 

HIT Policy Committee Reveals "Meaningful Use" Proposal

Via Healthcare-Informatics:

By 2011, at least 10 percent of all orders processed in a hospital must be entered through CPOE to qualify that institution for CMS incentives under the HITECH Act, according to a proposed matrix of meaningful use released today by ONC’s HIT Policy Committee.

Other 2011 hospital requirement are:

  • implementation of drug-drug, drug-allergy, and drug-formulary checks
  • maintenance of up-to-date problem lists of current and active diagnoses based on ICD-9 or SNOMED
  • incorporation of lab-test results into EHR as structured data
  • reporting of hospital quality measures to CMS
  • implementation of one clinical decision rule related to a high-priority hospital condition
  • providing of patients with an e-copy of their health information
  • capability to exchange key clinical information (eg. discharge summary, procedures, problem lists, medication lists, allergies, test results) among providers of care

In another major development, the committee recommended that incentives be paid according to an ‘adoption year’ timeframe rather than a calendar year timeframe. “Under this scenario, qualifying for the first-year incentive payment would be assessed using the 2011 Measures. The payment rate and phaseout of payments would follow the calendar dates in the statute, but qualifying for incentives would use the ‘adoption-year’ approach,” the committee stated.

Here is the link to the matrix.

Stay tuned for more on meaningful use definition.