Experts: US electronic health records still a way off

By: Grant Gross 7/06/2007 www.intergovworld.com

U.S. President George Bush’s administration gets high marks for its vision in pushing electronic health records, but the U.S. is far from implementing a national health IT system, according to an author of a government report released Thursday.

Although the U.S. could see significant benefits from more use of IT in the health-care industry, including fewer deaths from medical errors, more work needs to be done to create standards for electronic health records and other health IT initiatives, said David Powner, director of IT management issues for the U.S. Government Accountability Office (GAO).

The U.S. government still faces an “enormous challenge” in getting electronic health records to patients, Powner told the U.S. House Committee on Government Reform.

Asked to grade the Bush-created office of the National Coordinator for Health Information Technology, Powner gave the office an “A” for leadership and vision but an incomplete grade for implementation. In January 2004, Bush called for the U.S. health-care industry to embrace electronic health records, with the records available to all U.S. residents by 2014.

Powner’s report to the committee called for the Bush administration and the U.S. Department of Health and Human Services to push for health IT standards that don’t yet exist. “Otherwise, the health care industry will continue to be plagued with incompatible systems that are incapable of exchanging key data that is critical to delivering care and responding to public health emergencies,” Powner wrote.

The Bush administration is working toward setting standards, said Dr. David Brailer, the national coordinator for health IT in the U.S. Department of Health and Human Services. Next week, Brailer’s office will announce a federal government partner to harmonize health IT standards, he said.

In addition to standards, the cost of implementing electronic health records, and a lack of technical expertise, is holding up adoption at many small health-care facilities, Brailer told the committee. While existing research has sent “mixed signals” on the ability of electronic health records to cut costs, health IT can “save lives, improve care and improve efficiency in our health system,” he said.

Part of his office’s job is to convince health-care providers and patients of health IT’s benefits, Brailer added. Some health-care providers have been slow to adopt electronic health records because they’re paid per patient visit, and they aren’t paying the bills, he said. “It is against the financial interest of many providers to improve quality or to improve efficiency, because we pay by volume, and greater efficiency and quality, by definition, reduce volume,” he said.

Committee member Jon Porter, a Nevada Republican, said he plans to introduce legislation in the next couple of weeks that will require electronic health records for people using U.S. government health insurance coverage. With about 9.5 million members on the federal health plan, the requirement would push adoption to the private sector as well, Porter said.

Porter repeated concerns that the lack of electronic health records is adding to medical errors. “We are so far behind in our technology, we are costing lives of many Americans,” he said.

In 1999, the Institute of Medicine, a nonprofit health analysis organization, issued a study saying between 44,000 and 98,000 U.S. residents die each year due to medical errors.

Continue article here: http://www.intergovworld.com/

Some cautious of additions to IRS health IT ruling

By: Joseph Conn / HITS staff writer

Story posted: May 17, 2007 - 9:54 am EDT

Initial reactions to the long-awaited decision last week by the Internal Revenue Service to join HHS and the CMS in clearing a path for hospitals to subsidize healthcare information technology systems to affiliated physicians were overwhelmingly positive.

But in the passing of a few days and with sober reflection, not everyone sees the new IRS policy as an unalloyed good thing.

Healthcare lawyer Andrew Blustein, a partner with Garfunkel, Wild & Travis, Great Neck, N.Y., while joining the early voices saying the IRS ruling is “wonderful news,” also urged caution. “It’s a major step forward, but people need to realize there are some additions (in the ruling) that may not fit their particular program.”

HHS and the CMS last summer issued safe harbors to the federal anti-kickback law and exceptions to Stark laws prohibiting inducements for referrals in separate documents totaling more than 70 pages. Hospitals can qualify for the HHS and CMS dispensations by providing under specific conditions subsidized electronic medical-records systems and support to physician practices.

After the HHS and CMS rulings, attention turned almost immediately to the IRS. Not-for-profit hospitals were cautioned by their lawyers that IT contributions to for-profit organizations such as physician practices, though legal under the new Stark and anti-kickback modifications, could still jeopardize hospitals’ tax-exempt status.

By November 2006, the American Hospital Association sent a letter to Lois Lerner, director of the exempt organizations division at the IRS, asking for a broad ruling favoring the IT subsidies. Lerner’s response came last Friday in a two-page “field directive” memo she sent to two department directors under her division.

It said: “We will not treat the benefits a hospital provides to its medical staff physicians as impermissible private benefit or inurement in violation of section 501(c)(3) of the code if the benefits fall within the range of health IT items and services that are permissible under the HHS EHR regulations and the hospital operates in the manner described below.”

The IRS conditions were:

• Hospitals must enter into health IT subsidy agreements with physicians receiving IT items and services.
• Hospitals and physicians must comply with HHS rules.
• “The health IT subsidy arrangements provide that, to the extent permitted by law, the hospital may access all of the electronic medical records created by a physician using the health IT items and services subsidized by the hospital.”
• “The hospital ensures that the health IT items and services are available to all of its medical staff physicians.”
• “The hospital provides the same level of subsidy to all of its medical staff physicians or varies the level of subsidy by applying criteria related to meeting the healthcare needs of the community.”

The key provisions of the HHS and CMS policies dovetailed, but the IRS memo outlines some unique features, according to Blustein.

Complete article here: http://www.modernhealthcare.com/

HHS Promulgates New Regulations to Facilitate Adoption of Health Information Technology

On August 1, 2006, the U.S. Department of Health & Human Services (”HHS”) promulgated final rules (”Final Rules”) that will permit hospitals, physician practices and certain other organizations to donate electronic prescribing (”e-prescribing”) and electronic health records (”EHR”) technology and supporting services to physicians without violating either the federal physician self-referral (”Stark”) law or the federal health care program anti-kickback law (”AKL”). Both Final Rules are a result of the Congressional mandate in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (”MMA”) for the creation of a Stark law exception and an AKL safe harbor that would enable entities (such as hospitals) to encourage and assist physicians to embrace the use of e-prescribing technology. In promulgating the Final Rules,

HHS elected to go beyond e-prescribing, providing immunity for the donation of EHR technology and services under certain circumstances, as well.

I. The Final Rules

The Stark law exceptions and AKL safe harbors established by the Final Rules

are considerably more protective than was originally contemplated in the

October 11, 2005 proposed rules (the “Proposed Rules”). Among other things, the Final Rules allow for a broader range of qualifying donors and recipients; cover a more extensive range of technology; and replace a possible cap on the value of the donated e-prescribing or EHR technology with a recipient cost sharing provision for EHR.

A. E-prescribing

The e-prescribing exception and safe harbor are nearly identical, protecting donations by a hospital, physician group practice, Medicare Part D Prescription Drug Plan (”PDP”) sponsor, or Medicare Advantage (”MA”) organization of hardware, software, information technology (including internet connectivity), and training and support services that are necessary and used solely to receive and transmit electronic prescription information, provided that several conditions are met. For example: (1) the donor may not limit or restrict the use or compatibility of the donated technology or services with other e-prescribing or electronic health information systems; (2) the technology and services must be capable of being used for any patient regardless of payor status; (3) the donation of the items and services cannot be conditioned on an agreement by the recipient to do business with the donor; and (4) the decision to make the donation - including the amount and nature of the items and services - must not be determined in a manner that takes into account the volume or value of referrals or other business generated between the parties. Significantly, HHS did not impose a limit on the value of e-prescribing technology that may be donated to an eligible recipient.

 

B. EHR

The Final Rules also establish a new regulatory Stark law exception and AKL safe harbor for the donation of EHR technology and services. The most significant aspects of this exception and safe harbor are discussed below.

1. Donors

In comparison to the Proposed Rules, the Final Rules expand the types of entities that may donate EHR items and services. Under the Stark law exception, donations may be made by any entity that furnishes “designated health services.” Under the AKL safe harbor, the donor may be (1) any individual or entity that provides covered items and services and seeks reimbursement, either directly or through reassignment, from any federal health care program, or (2) any health plan. This generous definition encompasses hospitals, group practices, physicians, nursing and other facilities, pharmacies, laboratories, oncology centers, community health centers, and dialysis facilities, among others.

2. Recipients

The Stark law exception protects items and services donated to any physician. The AKL safe harbor protects donations to any individual or entity engaged in the delivery of health care, such as physicians, group practices, physician assistants, nurse practitioners, nurses, therapists, audiologists, pharmacists, nursing and other facilities, community health centers, and laboratories.

3. Protected Items and Services

The Final Rules protect “information technology” (e.g., internet connectivity and maintenance) in addition to the software and training services (e.g., help desk) covered under the Proposed Rules. Software must contain, or link to, an e-prescribing component. (Protection is not afforded to the donation of hardware, however.) Unlike the e-prescribing Final Rule, EHR items and services must be necessary and used predominantly (rather than solely) to create, maintain, transmit or receive the EHR of the donor’s or physician’s patients in order to be protected. Although it is not clear what regulators will consider to be “necessary and predominant,” Preamble commentary indicates that software packages may include, depending on the circumstances, functions related to the care and treatment of individual patients, such as patient administration, scheduling functions, billing, and clinical support. Expressly excluded, however, is any technology used primarily for personal business or business unrelated to the recipient’s clinical practice or operations.

 

4. Interoperability

Under the Final Rules, which abandon the pre- and post-interoperability distinction

contained in the Proposed Rules, donated EHR technology must be interoperable with other e-health systems at the time of its donation in order to be protected.

“Interoperable” is defined as software able to (1) communicate and exchange data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks, in various settings, and (2) exchange

data such that the clinical or operational purpose and meaning of the data are preserved without alteration. Software is “deemed” interoperable if a certifying body recognized by HHS has certified the software no more than 12 months prior to the date

of donation. In notices published in the August 4, 2006 edition of the Federal Register,

HHS (1) recognized certain ambulatory EHR criteria developed by the Certification

Commission for Healthcare Information Technology that may be used by certifying

bodies to deem technologies interoperable and (2) promulgated interim guidance for entities that want to become recognized EHR certifying bodies.

5. Cost Sharing

The Final Rules require the recipient physician to pre-pay a minimum of 15 percent of the donor’s costs. Neither the donor nor a related party may finance the physician’s payment.

6. Selection of Recipients

EHR donors may not directly take into account the volume or value of referrals or other business generated between the parties when determining whether, and the extent to which, a particular recipient is provided EHR. The Final Rules, however, list various selection criteria that donors may use without triggering the volume or value or other business generated standards. For example, donors may consider such practice specific criteria as the total number of prescriptions written, practice size, number of hours worked by the physician, and the physician’s overall use of automated technology.

II. Conclusion

The Final Rules reflect an unprecedented degree of coordination between CMS and OIG, resulting in consistent treatment of health information technology donations under the Stark law and AKL. This coordination reflects the government’s desire to remove impediments to the adoption of important, but expensive, software and related information technology that will enhance patient care and safety and reduce medical errors while simultaneously protecting federal health care programs from fraud, waste and abuse.

The Final Rules are scheduled to be published in the Federal Register on August 8, 2006, and will become effective 60 days thereafter. Although the exception and safe harbor for EHR donations will sunset on December 31, 2013, the e-prescribing provisions are indefinite.