Patient Safety Bills in Congress: More Surveillance; Less Care?

Comparison of Patient Safety Bills (H 663 and S 720) The Patient Safety and Quality Improvement Act - 2003

Building a National Electronic Health Care System*

Topic H 663 S 720
Titles of the Section in the Bill Promoting the Diffusion and Interoperability of Information Technology Systems Involved with Health Care Delivery

(P. 25)

Promoting the Integration of Health Care Information Technology Systems

(P. 14)

Deadline Not later than 18 months after the date of enactment

(P. 25)

Not later than 36 months after the date of enactment

(P. 14)

Requirements HHS shall:
  1. develop or adopt voluntary national standards that promote the interoperability of information technology systems involved with health care delivery, including but not limited o computerized physician order entry;
  2. in developing or adopting such standards, take into account:
    1. the ability of such systems to capture and aggregate clinically specific data to enable evidence-based medicine and other applications that promote the electronic exchange of patient medical record information; and
    2. the cost that meeting such standards would have on providing health care in the United States and the increased efficiencies in providing such care achieved under the standards.
  3. In developing or adopting such standards, test the efficacy, usability, and scalability of proposed interoperability standards within a variety of clinical settings
  4. submit a report to the Congress

    (pp. 25-26)

HHS shall:
  1. develop or adopt voluntary national standards that promote the integration of health care information technology systems.
  2. Provide for the ongoing review and periodic updating of the standards developed
  3. Provide for the dissemination of the standards developed and updated
Standardization HHS shall consider the recommendations of the National Committee on Vital Health Statistics for the standardization of message formatting, coding, and vocabulary for interoperability of information technology systems involved with health care delivery.

HHS shall consult with representatives of the health information technology industry and the provider community who are involved with the development of interoperability standards

(pp. 26-27)

 
Required Product ID Technology for Drugs and Biologics HHS shall issue and may periodically revise, regulations requiring the manufacturer of any drug or biological product that is subject to regulation by the FDA, or the packager or labeler of a drug or biological product subject of FDA regulation, to include a unique product identifier on the packaging.

It must be readable by a scanner.

HHS may waive the ID requirements, or add additional provisions that are deemed necessary to safeguard the public health

(pp. 27-28)

 
Grants for Electronic Prescription Program E-Prescription programs including hardware and software for the electronic submission and processing of prescriptions to pharmacies, the processing of such prescriptions by pharmacies, and decision-support programs.

Providers receiving grants agree to provide at least 50 percent of the cost, in cash or in kind.

(pp. 29 - 32)

 
Grants to Hospitals and Providers for Information Technologies Grants "to pay the costs of acquiring or implementing information technologies whose purposes are:
  1. to improve quality of care and patient safety;
  2. to reduce adverse events and healthcare complications resulting from medication errors.

    (P. 32)

 
Grants HHS shall give special consideration to applicants who seek to promote:
  1. Interoperability across hospital services or departments using standards developed or adopted by HHS.
  2. Electronic communication of patient data across the spectrum of health care delivery.
  3. Computerized physician order entry or bar coding applications.
  4. Electronic communication of patient data in hospitals that provide services to underserved or low-income populations.
  5. Improved clinical decisionmaking through acquisition and implementation of decision-support technologies.

    (pp. 32-33)

 
Grant Conditions Applicant must:
  1. agree to carry out a program to measure, analyze and report patient safety and medical errors at the hospital or other provider.
  2. have such a program in effect as soon as practicable after the application is approved, whether or not the information technologies under the grant have been implemented.
  3. Arrange for an evaluation of the effectiveness and cost-effectiveness of the information technology for which the grant is provided and its impact on the quality and safety of patient care.
  4. Have or develop a patient safety evaluation system for reporting medical errors to PSOs.
  5. Agree to provide HHS with "such information as the Secretary may require regarding the use of funds under this program or its impact".
  6. Provide assurances that the information technology planned, acquired or implemented with grant funds improves care, improves patient safety and reduces adverse events from medication errors.
  7. Assures HHS that such technology will be part of an information program that "is comprehensive or will be expanded to become comprehensive, regardless of whether Federal Assistance is available for such expansion."

    (pp. 33-34)

 
Studies and Reports   HHS shall enter into a contract with an appropriate research organization for the conduct of a study to assess the impact of medical technologies and therapies on patient safety, patient benefit, health care quality, and the costs of care as well as productivity growth.

Not later than 18 months after enactment, HHS shall provide Congress a report containing the results of the studies.

Each study shall determine:

  1. the extent to which the current health care system's use of labor versus the use of technology has contributed to increases in the share of the gross domestic product that is devoted to health care and the impact of medical technologies and therapies on such increases.
  2. The extent to which early and appropriate introduction and integration of innovative medical technologies and therapies may affect the overall productivity and quality of the health care delivery systems of the United States; and
  3. The relationship of such medical technologies and therapies to patient safety, patient benefit, health care quality and cost of care

    (pp. 14-15)

Taxpayer Dollars Appropriated for Information Technology Grants "…there are authorized to be appropriated $25,000,000 for each of fiscal years 2004 and 2005"

(P. 39)

"There is authorized to be appropriated such sums as may be necessary to carry out this part."

(P. 14)

Creation of Medical Information Technology Advisory Board (MITAB) Not later than 3 months after enactment, HHS shall appoint a 17-member advisory board:MITAB

(P. 39)

 
MITAB duties On an ongoing basis, MITAB shall advise and make recommendations regarding medical information technology

(P. 42)

 
Recommendations by MITAB
  1. best current practices in medical information technology,
  2. methods to adopt a uniform health care information system interface between and among old and new computer systems,
  3. health care vocabulary, messaging, and other technology standards necessary to achieve the interoperability of health care information systems.
  4. Methods of implementing interoperability standardization and records security.
  5. Methods to promote information exchange among health care providers so that long-term compatibility among information systems is maximized, in order to do one or more of the following:
    1. maximize positive outcomes in clinical care by providing decision support for diagnosis and care, and by assisting in the emergency treatment of a patient presenting at a facility where there is no medical record of the patient.
    2. contribute to the development of the patient assessment instrument provided in Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000.
    3. assist in minimizing the need for new and different records as patients move from provider to provider.
    4. reduce or eliminate the need for redundant records, paperwork and the repetitive taking of patient histories and administering of tests.
    5. minimize medical errors, such as administration of contraindicated drugs.
    6. provide a compatible information technology architecture that facilitates future quality and cost-saving needs and that avoids the financing and development of information technology systems that are not readily compatible.

      (pp. 42-44)

 
Initial MITAB Report No later than 18 months after enactment, MITAB report shall include:
  1. status of healthcare information technology standards being developed by private sector and public-private groups,
  2. recommendations for accelerating the development of common health care terminology standards,
  3. recommendations for completing development of health care information system messaging standards, and
  4. progress toward meeting the 2-year deadline for adopting a uniform health care information system interface between and among old and new computer systems

    (pp. 44-45)

 
State Laws Relating to Patient Safety Peer Review Systems   The Attorney General shall conduct a survey of State laws that relate to peer review systems, including laws that establish an evidentiary privilege applicable to data developed by such systems, and shall review the manner in which such laws have been interpreted by the courts.

Not later than 9 months after enactment, the A.G. must submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(P. 16)

* "HHS Secretary Tommy G. Thompson today announced two new steps in building a national electronic health care system that will allow patients and their doctors to access their complete medical records anytime and anywhere they are needed, leading to reduced medical errors, improved patient care, and reduced health care costs." (HHS Press Release, July 1, 2003)

Note: This Act is not listed in the HHS press release. Instead, HHS announced it is purchasing a standardized medical volubulary system for $32.4 million, and commissioning the Institute of Medicine to develop a standardized model of an electronic medical record.

Note Also: References to decision-support programs are highlighted due to the potential for such systems to influence and monitor medical decision-making.

Copyright © Citizens' Council on Health Care 2003
July 23, 2003

Media Contact:

Twila Brase, President
Phone: 651-646-8935 (office)
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