Bush Directs Federal Agencies to Disclose Health Care Price and Quality Information

On August 22, President Bush signed an executive order directing the four federal agencies that administer or support health care programs to share health care quality and cost information with the general public.

The agencies affected by the order are the Department of Health and Human Services; the Department of Defense, which oversees the military health system; the Department of Veterans Affairs; and the Office of Personnel Management, which administers the Federal Employees Health Benefits Program. They are required to begin working with health care contractors to implement the new information transparency requirements by Jan. 1, 2007.

Under the presidential directive, these agencies are required to provide insurance options that reward cost-conscious consumer decisions and promote quality and efficiency in health care. The executive order also promotes the adoption of standardized and interoperable health information technology to ensure the rapid exchange of clinical data.

Of particular interest to the MTIA membership at large focusing on health information technology. The first set of standards, issued next month, will address the privacy of personal health records, the secure e-mail exchange of information between patients and providers, and the interoperability of this technology and recognized interoperability standards.

Speaking at the August 22 briefing, Daniel A. Green, deputy associate director for the Center for Employee and Family Support Policy at OPM acknowledged that federal agencies already have begun to compile and share health care information. But, he added, the order "codifies" efforts by federal agencies to have "health plans provide more information" for enrollees and to "move promptly" toward the adoption of standardized information technology.

The executive order aims to provide information for beneficiaries about the prices paid to health care providers and the quality of services they receive, Green said.

At the same time, it encourages carriers to adopt interoperable information technology systems. The idea is to use the financial power of the federal government to drive the market, he said. "We want to make sure [carriers] are not buying Beta when VHS has been decided upon," Green explained.

In Aug. 22 comments to the press, HHS Secretary Michael Leavitt said, "Roughly 85 percent of all health care records are still paper. So a part of what we'll be talking about today is the interoperability of systems that manage health records." In describing the goal of an interoperable system, Leavitt compared it to ATMs or credit cards, where "you can use it anywhere in the world and it works, because it's interoperable. Everybody competes but uses the same system, basically, to transact their affairs."

The first set of standards will be issued next month, Green said. The standards will cover personal health records and the secure e-mail exchange of information between patients and providers, he said. Additional initiatives will begin over the next few months, he said.

Federal agencies also will ensure that patient privacy is protected. The "key is privacy and security," Green said, adding that enrollees will have control over their information.

We will continue to keep MTIA updated as the implementation of the President’s Executive Order advances. The text of the executive order is available HERE.

House Passes Health IT Legislation; House-Senate Conference Next Step

By a 270-148 vote, the House July 27 approved legislation (H.R. 4157) that supporters say would spur development of health information technology by health care providers.

The House approved the bill following a floor debate in which Republicans said the bill would help speed implementation of health IT, improving the efficiency and safety of the nation's health care system. Some Democrats said the measure would do little to meet those goals because it does not contain sufficient funding for providers to purchase such equipment, does not contain a deadline for interoperability standards, and would not protect patient privacy. Fifty-six Democrats joined Republicans in voting for the bill. Nine Republicans voted against the measure. The health IT bill now will go to a House-Senate conference. The Senate in November 2005 passed legislation (S. 1418) that differs significantly from the House measure. That bill passed in the Senate on a bipartisan unanimous consent vote. Democrats complained the House Republican leadership did not allow them to offer S. 1418 as a substitute to H.R. 4157.

Key Provisions
The House bill would codify the Bush administration's national coordinator office for health IT, create statutory safe harbors to allow hospitals and other providers to provide physicians with health IT software and hardware, and require the Department of Health and Human Services to develop a health IT strategic plan.

"This is an important bill that sets the foundation for the future," House Ways and Means Health Subcommittee Chairwoman Nancy L. Johnson (R-Conn.) said on the House floor. Health IT "holds vast promise" for improving the nation's health care system, the subcommittee's ranking member, Fortney "Pete" Stark (D-Calif.) said. However, he said that H.R. 4157 "forestalls that promise." He added, "It's a lousy bill and it does nothing."

The bill would provide $40 million over two years in federal grants for health IT. To further spur IT adoption, the House measure would create safe harbors to the federal anti-kickback fraud and abuse law to allow larger providers, such as hospitals, to make health information technology available to smaller ones, such as physician offices. This provision is not included in the Senate bill. The Senate bill contains about $650 million in IT grants. House Republican leaders oppose this level of funding, and have said the safe harbors would help spread IT implementation.

Democrats said the safe harbor provision would increase Medicare fraud and abuse and will not achieve its intended goal. In a July 27 analysis of H.R. 4157, the Congressional Budget Office said the bill "would not significantly affect either the rate at which the use of health technology will grow or how well that technology will be designated and implemented." "If we can't get this technology into the hands of providers, what are we doing here," Rep. Patrick J. Kennedy (D-R.I.) said on the House floor.

The bill also mandates a transition from the current ninth version of the International Classification of Diseases (ICD) to the tenth version, for purposes of Medicare billing and transactions, by October 2010. The Senate bill does not contain the provision. Health insurers oppose the deadline, saying it is unrealistic and costly. In a July 26 letter to lawmakers, America's Health Insurance Plans said it could not support the bill as currently written. The bill "falls short of its stated goals and will lead to serious unintended consequences for consumers," the letter said.

Patient Privacy Debated
Republicans and Democrats also debated patient privacy protections. Johnson said H.R. 4157 "sets the groundwork" for improving patient privacy laws by mandating a study of state and federal laws on the issue.

"It's absolutely irresponsible" to move ahead with privacy provisions until more is known about current laws, she said. Patient privacy also is protected under the Health Insurance Portability and Accountability Act, Johnson said. Democrats complained they were not allowed to offer amendments strengthening patient privacy protections in the bill. In a July 26 letter to House members, a coalition of 13 consumer, union, and patient organizations, including Consumers Union, the National Partnership for Women & Families, and Service Employees International Union, expressed their opposition to the bill for several reasons, including its lack of patient privacy protections. "Some provisions of H.R. 4157 could eventually take us backward, jeopardizing privacy protections that states have already put in place," Janlori Goldman, Director of the Health Privacy Project, another group that signed the letter, said in a statement.

Six Amendments
The House approved six amendments to the bill. Four were sponsored by Democrats, one by a Republican, and one was a bipartisan measure.

The amendments would improve the availability of information and resources for low-literacy individuals, create a study that provides benchmarks for best practices of health IT in medically underserved areas, ensure next-of-kin information is included in electronic medical records, focus integrated health system grants in the bill for those in geographically isolated or underserved urban areas, require the Department of Health and Human Services to evaluate several aspects of the ICD-10 system, and requires HHS to establish a two-year demonstration project to demonstrate the impact of IT on disease management for Medicaid beneficiaries with chronic diseases. In a Statement of Administration Policy issued July 27, the Bush administration threw its support behind H.R. 4157, but addied it "is still assessing the cost of the bill and looks forward to working with Congress to ensure that it does not cause a net increase in spending." Earlier in the week, a provision requiring hospitals to report the prices they charge patients was stripped from H.R. 4157. Johnson told BNA July 26 the provision was removed because "there wasn't time to educate people about that" and lawmakers "needed to work with hospitals" on the provision. Johnson said hospitals had expressed concern about the item.

The CBO analysis is available at http://www.cbo.gov/ftpdocs/74xx/doc7438/hres952.pd

From BNA.com

Final Health IT Rules Ease Restrictions on Aiding Doctors to Adopt New Technology

Final rules lifting restrictions on providing physicians financial help in purchasing health information technology products were released Aug. 1 by the Centers for Medicare & Medicaid Services and the Department of Health and Human Services Office of Inspector General.

The CMS rule, scheduled to appear in the Aug. 8 Federal Register, creates Stark rule exceptions to allow physicians to accept donations from hospitals and certain other health care groups for establishing electronic prescribing and electronic health records (EHR) capabilities.

The OIG rule, also to appear in the Aug. 8 Federal Register, creates anti-kickback safe harbors for financial arrangements between doctors and other health care providers. Among changes made from the proposed rules, issued in October 2005, are interoperability requirements for donated EHR technologies, provisions HHS Secretary Michael O. Leavitt said were omitted from a health IT bill, Health Information Technology Promotion Act of 2006 (H.R. 4157), which the House passed July 27.

Other rule changes include allowing for a broader scope of donors and recipients that can engage in financial arrangements, HHS IG Daniel R. Levinson said. Furthermore, the agencies placed no cap on the amount donors could give to recipients for either e-prescribing or EHR technology. Instead, the rules create a cost-sharing provision that requires physicians contribute at least 15 percent toward the cost of EHR.

The rules also allow for a broader scope of technologies that can be donated. E-prescribing technology allows physicians to transmit electronically prescriptions to patients' pharmacies or other health care providers, while EHR technology allows doctors and other providers to share patient information across a variety of settings. Until now, Stark (self-referral) and anti-kickback rules prevented physicians from accepting donations of software and equipment to implement the costly technologies, meaning many doctors could not afford to implement health information technologies, Leavitt said. "Electronic health records help doctors provide higher quality patient care, improved efficiency and with less hassle," Leavitt said. "By removing barriers, these regulations changes will help physicians get these systems in place and working for patients faster."

Interoperability Requirements
Levinson said interoperability was crucial to making EHR work. For that reason, the rules require that donated technologies demonstrate interoperability with other e-health systems. EHR software can be deemed interoperable in certain cases, the rules stated.

Leavitt said interoperability was vital to the success of health information technology, and that requiring interoperability now was more cost-effective and efficient than creating interoperability later among incompatible systems. To that end, Leavitt said he was concerned that H.R. 4157 did not contain language that would require interoperability, calling the omission a "serious flaw." As such, the bill would allow for closed network and encourage anti-competitive behavior, he said.

The bill has been sent to a House/Senate conference to work out differences between it and an IT measure (S. 1418) the Senate passed in November 2005. Leavitt said he is urging conferees to make interoperability a requirement in the final language, adding that whatever is in the law would trump regulatory language, meaning HHS interoperability requirements would carry little relevance.

He said he would be "comfortable" with lawmakers adopting the language in the rules. "We think what we've put forward is a good template for the House and Senate," he said, noting that the agencies spent a year drafting the rules using industry research and input. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 mandated the e-prescribing exception, and the law required prescription drug plans and Medicare Advantage plans to support e-prescribing.

The rules become effective Oct. 10. The e-prescribing regulations do not expire, but the Stark exceptions sunset on Dec. 31, 2013. Levinson said the sunset provision was included to align the rule with the president's goal of instituting health IT by 2014.

More information is available at http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1920.

From BNA.com

HHS Recognizes Criteria for Deeming Some Electronic Health Technologies Interoperable

The Department of Health and Human Services has recognized criteria developed by an advisory commission for deeming health information technologies interoperable and therefore eligible as acceptable donations under new Stark rule exceptions and anti-kickback safe harbors.

According to an HHS notice published in the Aug. 4 Federal Register (71 Fed. Reg. 44295), the department has recognized certain Certification Commission for Healthcare Information Technology (CCHIT) criteria for ambulatory electronic health records functionality, interoperability, security, and reliability standards.

The criteria are intended to be used by recognized certifying bodies to deem software donated to physicians by hospitals and other health care entities as interoperable, a requirement for the donations to qualify as acceptable items of value under the Stark exceptions and anti-kickback safe harbors, the notice stated.

Two rules scheduled to appear in the Aug. 8 Federal Register create the physician self-referral rule (Stark) exceptions and anti-kickback safe harbors for certain donations of health information technology to physicians to spur implementation of electronic prescribing and electronic health records (EHR) capabilities. The rules require that donated technologies be compatible with other e-health systems, and the CCHIT criteria can be used by certifying bodies to deem technologies interoperable, the notice stated. Interoperability refers to how technology products interact with each other, such as how an electronic health record at a doctor's office would receive test results from a laboratory.

"The CCHIT criteria that the Secretary has recognized serve to establish the initial EHR certification criteria that are referenced in the final physician self-referral law and anti-kickback statue rules," according to the notice.

HHS also chose to recognize the CCHIT criteria in hopes that certification will alleviate fears among physicians who are wary of investing in expensive technology that might not meet their expectations and federal requirements.

"Stories abound about providers making large investments in EHRs only to discover that they do not meet their functionality, interoperability, security, and/or other reliability needs," the notice stated. "Certification could respond to investment fears generated by stories about failed investments. A reduction of such fears could further the Department's goals of higher rates of sustained health IT adoption and interoperability."

Certifying Body Guidance
In a second notice published in the Aug. 4 Federal Register (71 Fed. Reg. 44296), HHS announced the availability of interim guidance to entities wanting to become recognized certification bodies for the purpose of deeming EHRs interoperable for the purposes of the Stark rule exceptions and anti-kickback safe harbors.

The guidance explains factors that the Office of the National Coordinator for Health Information Technology (ONC)--an agency within HHS--will use to recommend an entity to the HHS secretary for Recognized Certification Body (RCB) status, the notice stated. The notice also explained that HHS will engage in rulemaking procedures to formalize and finalize the policies and procedures that will govern whether ONC will recommend a body for RCB status. The ambulatory EHR criteria are available on the Web at http://www.hhs.gov/healthit/documents/AEHRRecognizedCertCriteria.pdf.

The RCB guidance is available at http://www.hhs.gov/healthit/documents/RCBGuidance.pdf.