HHS is spending big to promote adoption of health information technology at the same time it's holding providers to legal standards that discourage IT adoption among hospitals and physicians, the Government Accountability Office has concluded.
The conflict within HHS between forces of health IT policy and the office of inspector general might be something only Secretary Tommy Thompson can resolve. "It's up to the HHS secretary to strike the balance," said Bruce Fried, a healthcare policy lawyer and general counsel to the eHealth Initiative, a coalition for health IT adoption.
The GAO reported that HHS has 19 major health IT initiatives and provided $228 million for them in fiscal 2004. A majority of the initiatives and most of the funding went to activities and grant programs administered by operating divisions such as the CMS and the Agency for Healthcare Research and Quality. HHS also set up an office of health IT coordination to push the government and private sector toward greater investment in, and adoption of, clinical information networks.
But legal issues of permissible cooperation among hospitals and also with their referring physicians-arising from laws enforced by the inspector general's office-present barriers to promoting IT adoption, the GAO said in its report to a Senate committee.
Those laws, which cover healthcare fraud and abuse and illegal kickbacks to referring providers, do not specifically address health IT arrangements and thus are silent on what would be judged illegal, Janet Heinrich, director of healthcare and public health issues for the GAO, said in a letter to the Senate Health, Education, Labor and Pensions Committee.
The report also cited problems with laws enforced by other federal departments in areas of antitrust, federal income tax, intellectual property and malpractice, as well as state licensing barriers.
"To the extent there are uncertainties and ambiguity in predicting legal consequences, healthcare providers are reluctant to take action and make significant investments in health IT," Heinrich said.
The GAO analysis was a response to the Senate committee's call for an accounting of HHS' IT initiatives, as well as legal barriers to IT adoption and what the agency is doing to surmount them. A spokeswoman for committee Chairman Judd Gregg (R-N.H.) said the senator had been working on a bill establishing the government's leadership role in health technology that he introduced July 21.
Much of the HHS promotional activity catalogued in the GAO report already had been laid out by Thompson and his national IT coordinator, David Brailer, during a secretarial summit on the issue, also on July 21.
"We could potentially modify our bill based on this report as well as based on on-going negotiations with colleagues," the spokeswoman said.
A quiet conflict
The impact of legal barriers, however, has been a quiet conflict until now, mentioned in passing. The legal issue was among those discussed by Tom Scully, then the CMS administrator, at the first industry summit on health IT in April 2003, said Fried, a lawyer in the Washington office of Sonnenschein, Nath & Rosenthal.
"Healthcare information technology strategies are being stymied all across the country by fraud and abuse laws," Fried said. Agreements by hospitals to provide computer hardware, software, broadband network connections or training have often foundered on stern warnings from legal counsel not to proceed.
HHS' inspector general's office countered in a written response that the GAO report "fails to address the risk of fraud or abuse that might arise when hospitals or other entities give valuable items or services to potential referral sources." For example, there was "legitimate concern" that providers may provide free or deeply discounted computer technology "in an effort to influence referral decisions, which may result in fraud or abuse," the office said.
Any exceptions to the physician self-referral law, often called the Stark law, or safe harbors in Medicare's antikickback statute "would need to be crafted carefully to exclude abusive arrangements," according to the statement. A spokeswoman for the inspector general said the office would have no further comment.
In March, the CMS issued for comment a revision to the self-referral law creating a new exception for "communitywide health information systems." But experts told GAO investigators that the exception doesn't cover many health IT arrangements and that the definition of communitywide is unclear. In addition, there is no parallel exception under the antikickback law.
HHS' office emphasized that providers can request an advisory opinion to determine whether a particular arrangement would violate the antikickback law or the self-referral law. "However, the process is time-consuming," the GAO concluded, "and such case-by-case guidance is not an appropriate mechanism for addressing broader industry concerns."
"If we hold the healthcare community to these very high fraud-and-abuse standards, it inevitably creates a barrier to the dissemination of IT," said Fried, one of the experts consulted by the GAO.
Compared with the potential of abusive arrangements, the urgency of disseminating IT to help reduce healthcare costs and prevent medical errors "is so significant that on balance you've got to tilt toward (choosing) the dissemination," he said.