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June 27, 2005

Capitol Hill News

Appearing before the House Committee on Energy and Commerce, Carolyn M. Clancy, M.D. Director, AHRQ, summed up information on the patient safety initiatives that have been undertaken by HHS and other Federal agencies. These initiatives include:

  • FDA’s Safety Information and Adverse Event Reporting Program called MedWatch, provides timely clinical information about safety issues involving medical products, information on prescription and over-the-counter drugs, biologics, devices, and dietary supplements. FDA has issued a final rule requiring the bar coding of most drugs to promote electronic prescribing
  • FDA’s program called MedSun provides two way communications between FDA and healthcare facilities to improve the identification, understanding, and sharing of information on medical device problems. The program is currently being used to pilot data on tissue surveillance
  • FDA is working on an integrated reporting system that will enable an adverse event report to be submitted on any FDA regulated product through a single gateway and website.
  • FDA is working on human factors engineering to make medical devices more user friendly and to eliminate device errors that cause harm
  • CMS in collaboration with CDC, AHRQ, plus other private sector partners has launched a patient safety initiative called the Surgical Care Improvement Project to eliminate surgical complications.
  • The Department of Veterans Affairs has the National Surgical Improvement Project that is being tested in civilian hospitals with support from AHRQ, and is now being implemented nationwide through Medicare’s Quality Improvement Organizations (QIO)
  • CDC maintains a sentinel network of hospitals through the National Nosocomial Infection Surveillance System
  • CDC funds Prevention EpiCenters to conduct research to prevent healthcare associated infections and improve patient safety.
  • AHRQ has created a Patient Safety Improvement Corps, which is a training program to bring together teams of state officials and private sector providers to learn and work together
  • DOD and AHRQ have developed a public domain curriculum for training healthcare professionals on how to improve teamwork. The curriculum has been field tested and will be made available to all healthcare institutions in 2005.
  • AHRQ has set up Morbidity and Mortality conferences to assess what went wrong in problem cases and have developed a website http://www/webmm.ahrq.gov where cases are shared
  • AHRQ has developed a set of indicators that any hospital can run against its hospital discharge data to evaluate how it is doing in terms of safety and quality
  • AHRQ has developed and released in collaboration with DOD and Premier, another tool known as the Hospital Survey on Patient Safety Culture

Dr. Clancy mentioned the $8 million in grant funding called Partnerships in Implementing Patient Safety that includes 15 projects to help clinicians, facilities, and patients implement evidence-based patient safety practices. These projects will develop implementation toolkits to share lessons learned on how best to implement patient safety practices, and help to identify barriers.


Legislation Recently Introduced

Senate Majority Leader Bill Frist, M.D, (R-TN) and Senator Hillary Rodham Clinton (D-NY) have introduced the “Health Technology to Enhance Quality Act of 2005” or referred to as the “Health TEQ Act”. Senators Frist and Clinton are cosponsoring this legislation along with Senator Mel Martinez (R-FL) Barbara Mikulski (D-MD), Senator Jim Talent (R-MO)

This bipartisan legislation would implement health information technology standards to guide the design and operation of interoperable health information systems, would direct relevant federal agencies to adopt uniform health care quality measures, codifies the Office of National Coordinator for Information Technology, and identifies laws that may be barriers to electronic exchange of health information.

The legislation would also encourage the use of interoperable health information systems by authorizing $125 million annually for five years in grants that would go to local or regional collaborations of hospitals, health plans, doctors, consumers, employers, and others to develop health information using national standards. Local and regional collaboratives would contribute matching funds.

There would be exemptions from the Stark and Antikickback laws to allow hospitals, health plans, and others to offer health information technology equipment to physicians as long as the purpose is to reduce medical errors, improve quality, reduce costs, improve care coordination, and streamline administration.

The bill would establish two budget-neutral value-based purchasing pilot programs under Medicare, and Medicaid. The Medicare pilot program would include provisions to encourage the adoption of health information technology standards, and the reporting of quality information by physicians treating Medicare beneficiaries. The program may be expanded after two years, and a similar purchasing pilot program could be established under Medicaid.

Senator Christopher Dodd (D-CT) introduced similar legislation called “Information Technology for Healthcare Quality Act” that would help to develop and adopt standards to improve the quality and interoperability for information technology. The legislation would also establish an Office of Health Information Technology within the Executive Office of the President.

Another piece of legislation recently introduced includes the “Health Information Technology Act” introduced by Senators Debbie Stabenow (D-MI) and Olympia Snowe (R-ME) to improve patient care and save as much as $300 billion in the U.S. annually.

The legislation would authorize funding for grants totally over one billion that would help health providers and hospitals to implement HIT. The grants would include expenditures to buy or lease computer software and hardware, including handheld computer technologies, and funding would be available to make improvements to present technologies. Hospitals, critical access hospitals, skilled nursing facilities, health centers, physicians, physician group practices, and community mental health centers would be eligible.

In May, Representative Patrick Kennedy (D-RI) and Representative Tim Murphy (R-PA) introduced the 21st Century Health Information Act to support the development of RHIOs and establish uniform interoperability standards between regional networks.

Recently, Missouri Congressman Kenny Hulshof and Congressman Mike Thompson of California introduced the “Medicare Telehealth Enhancement Act of 2005”. The legislation would provide an additional $10 million in telehealth grants to develop telehealth networks through HRSA’s Office for the Advancement of Telehealth (OAT). The legislation reauthorizes the Telehealth Network grant program at $10 million and the Telehealth Resource Centers grant program at $10 million.

The legislation provides for additional originating sites to include skilled nursing, dialysis, county or publicly funded mental health facilities, encourages HHS to work on interstate licensure issues, eliminates reimbursement restrictions based on geography, allows telehealth providers to be reimbursed for seeing patients including sites that are not designated as originating sites. Lastly, the legislation requires OAT to study store and forward technologies for telehealth and the feasibility and advisability of costs for expanding the use of technology in the future.

Senator Joe Lieberman (D-CT) has introduced legislation S 1274 to help first responders communicate during emergencies. Other recent legislation introduced that relates to health IT, telehealth, and telemedicine includes:

  • S 16 the Affordable Health Care Act to reduce the cost of healthcare coverage
  • S 544 the Patient Safety and Quality Improvement Act
  • HR 1132 the National All Schedules Prescription Electronic Reporting Act to establish controlled monitoring programs in states
  • HR 747 the National Health Information Incentive Act to establish refundable credit for expenditures for healthcare when implementing high tech infrastructure
  • S 1064 and HR 898 to provide telemedicine grants to patients who have had strokes.


Update on the Washington University Medicare Coordinated Care Demonstration Program

“Quality Matters” a Commonwealth Fund newsletter has published a case study on the Medicare Coordinated Care Demonstration Program (MCCD) at Washington University in St. Louis Missouri. CMS has launched several demonstration programs to look at Medicare recipients in terms of helping with chronic conditions and whether chronic care management programs developed in the private sector will also help the Medicare population.

The Washington School of Medicine hosts the MCCD program in partnership with the Washington University Physicians Network (WUPN), an independent physician association that includes more than 900 full time faculty physicians at the School of Medicine and approximately 500 community-based physicians. StatusOne located in Nashville Tennessee, an American Healthways company, is also part of the partnership. The company provides disease management and care enhancement services.

According to the paper, about 90 percent of care management in the program is done through telephone calls. Patients with less complex cases are assigned to care managers at StatusOne’s remote telecenter. More complicated cases are handled locally by care managers at Washington University through a combination of telephone and face-to-face contacts. Care managers contact physicians and office staff on a daily basis to discuss matters of care coordination and obtain their input for the care plan.

The MCCD targets non-institutionalized fee-for-service Medicare beneficiaries living in the St. Louis metropolitan area who have at least one chronic medical condition and who are at high risk of incurring substantial medical costs within the next year. The program has a current case load of 2.100 patients divided between the treatment and control groups. About 20 to 25% of high risk patients invited to participate ultimately enroll in the program.

It was found that patient recruitment using the “opt-in” approach required by the MCCD program was time-consuming compared with the “opt-out” approach typically used in commercial disease management programs, in which patients are automatically enrolled unless they specifically ask not to be included. Creative approaches were needed to locate patients with incomplete contact information.

The program’s positive track record and preexisting established relationships with physicians paved the way for a positive reception among providers, who saw the benefits of care management and the value of referring patients to the program. Outreach to community organizations helped to broaden the program’s reach. In the future, it would be helpful if MCCD programs could have access to Medicare claims data on the target population which would enable more accurate identification of high risk patients.

For further information and a copy of the report “Coordinating Care for Medicare Beneficiaries: Early Experiences of 15 Demonstration Programs, Their patients and Providers” prepared for Congress by Mathematica Policy Research, contact Sandy Graff R.N. at the Washington University School of Medicine at graffs@msnotes.wustl.edu.


Sandia Labs Develops Portable Device to Instantly Detect Heart and Gum Disease

Researchers at Sandia National Laboratories with funding by NIH are developing technology to enable patients while in the doctors office, to provide a sample of saliva or blood, and the doctor will let them know in minutes if they are prone to heart disease,

gum disease, or cancer. The patient will not have to wait days to obtain the information.

Sandia is taking technology that researchers have been working on for several years called “Lab-on-a-chip devices”, and have adapted these devices to develop a five pound hand-held medical device for doctors to use in making medical diagnoses. So far, researchers have tested saliva samples from healthy patients for gum disease and now are using the diagnostic tool to test diseased samples.

For more information, contact Anup Singh aksingh@sandia.gov or Mike Janes mejanes@sandia.gov.


AHRQ Issuing Pre Solicitation Notice for a Project called ACTION

AHRQ within HHS has issued a pre solicitation notice (AHRQ-06-00001) for nine to twelve contracts to provide services for a project called “Accelerating Change and Transforming Organizations and Networks (ACTION).

The purpose of the ACTION program is to accelerate the development, implementation, dissemination, for demand-driven and evidence based products, tools, and strategies to improve healthcare delivery systems. The tasks include assessing needs, disseminating information, conducting research in key areas, and evaluating interventions and strategies to demonstrate improvement in quality, safety, efficiency, and effectiveness.

AHRQ is looking for proposals from partnerships that include one of more organizations that will be able to turn research into practice for proven interventions. Partnerships may be with healthcare organizations with a proven track record for promoting healthcare improvement, but may also include Quality Improvement Organizations, VA sites, governmental organizations, health plans, universities, academic health centers, and research consulting firms.

The 9-12 task order contracts will be awarded for a period of three years with one two year option and awards are expected by December 30, 2005. It is anticipated that the solicitation will be issued on or about July 6, 2005 and proposals will be due within 75 days.

The point of contact is Mary Haines, Contracting Officer at (301) 427-1786 or email mhaines@ahrq.gov or contact Sharon Williams, Contracting Officer (301) 427-1781 or email swilliam@ahrq.gov. For a copy of the pre solicitation notice go to http://www.fedbizopps.gov or when the solicitation is issued go to http://www.ahrq.gov.


New Global Partnership Will Focus on Strengthening Health Information Systems

The World Health Assembly has launched a new global partnership called the Health Metrics Network (HMN) that will work to improve public health decision-making by having better health information systems available. HMN, a partnership comprised of countries, multilateral and bilateral development agencies, foundations, global health initiatives and technical experts will increase the use of timely, reliable health information by catalyzing the funding and development of core health information systems in developing countries. HMN will help countries gather vital health information and bring together health and statistical constituencies.

Other global initiatives including the Millennium Development Goals, the Global Fund to Fight AIDS, Tuberculosis and Malaria, Global Alliance for Vaccines & Immunization, and the president’s Emergency Plan for AIDS Relief have also increased the demand for health information.

HMN will enable low and middle income countries to be eligible to apply for grant funding up to $500,000 to use to strengthen health information systems and countries will be able to call upon HMN and HMN partners for technical assistance. By 2011, HMN expects that at least 80 countries will be able to agree on standardized global health goals and indicators.

HMN has received an initial grant of $50 million over seven years from the Bill & Melinda Gates Foundation along with additional contributions from other donors, including the Department for International Development (U.K), U.S. Agency for International Development, and the Danish International Development Agency.

For more information contact Christine McNab at +41 22 791 4688 or email mcnabc@who.int.


Department of Commerce Releases Paper on Radio Frequency Identification

According to the paper, the large-scale adoption of RFID in commerce and security applications is going to have important implications for businesses, government, and consumers in the U.S. As new applications develop, the technology will continue to evolve. Growth beyond today’s user-specific systems will occur as RFID is deployed across the marketplace and the related hardware and software achieves a high degree of harmonization.

However, challenges include:

  • Developing standards for hardware/software and wireless spectrum operations, privacy and security concerns, and implementation cost barriers
  • Developing technical standards for tags, readers, and interface systems, and the ability to allocate operational limits for frequency and transmission power will determine global interoperability
  • Small and medium sized enterprises will have more new opportunities to compete in the global market, but limited budgets, lack of in-house expertise, and a lack of access to new technologies could be an impediment for adoption
  • Dealing with the collection, use, and storage of data rather than the technology itself can be a concern. Industry driven solutions are beginning to include a combination of operational guidelines, technical solutions, and educational campaigns

For a copy of the paper go to http://www.technology.gov/reports.


President’s Information Technology Advisory Committee Expired June 1, 2005

The President’s Information Technology Advisory Committee (PITAC) was chartered by Congress under the High Performance Computing Act of 1991, and the Next Generation Internet Act of 1998 as a Federal Advisory Committee. PITAC is formally renewed through Presidential Executive Orders, but the latest Executive order expired on June 1, 2005, and hasn’t been renewed. The Committee provided the President, Congress, and the Federal agencies with information on IT research and development.

In June 2005, PITAC released a new report “Computational Science: Ensuring America’s Competitiveness” that found that computational science is one of the most important technological fields of the 21st century because it enables investigation of extremely complicated phenomena and processes such as the folding of proteins, the atomic organization of nanoscale materials, and the global spread of disease. PITAC published a report last year on Health IT.

For more information, go to http://www.nitrd.gov/pitac.



The editor of this newsletter is Carolyn Bloch. Bloch Consulting Group is not responsible for the information provided on other Web sites. If you have any comments or additions, please contact cb@cbloch.com