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A report released April 16 by a group of Senate Republicans raises serious concerns about interoperability of health information systems in the United States and suggests federal regulators consider a “pause” for the “meaningful use” program.
The report, titled REBOOT: Re-examining the Strategies Needed to Successfully Adopt Health IT, outlines what its authors characterize as deficiencies in implementing the Health Information Technology for Economic and Clinical Health (HITECH) Act, including too-little attention to ensuring interoperability of disparate electronic health record systems used by the nation's hospitals and physicians and poor oversight of the Medicare and Medicaid Electronic Health Record Incentive programs.
The report also says the federal EHR incentive program is unsustainable because it is not certain whether providers can afford to maintain their EHR systems after meaningful use incentives expire and because small providers may not be able to afford the health IT systems or the penalties (in the form of Medicare reimbursement cuts) that begin in 2015 if they have not yet meaningfully adopted EHRs as set out by federal standards.
The report was released simultaneously with two letters:
• one asking Health and Human Services Secretary Kathleen Sebelius to report on various aspects of the meaningful use and related programs; and
• one asking health IT vendors, health care providers, patients, and others to provide feedback to the senators on the report.
The letters were sent by Sens. John Thune (R-S.D.), Lamar Alexander (R-Tenn.), Pat Roberts (R-Kan.), Richard Burr (R-N.C.), Tom Coburn (R-Okla.), and Mike Enzi (R-Wyo.).
“[W]e have significant concerns with the implementation of the HITECH Act to date, including the lack of data to support the Administration's assertions that this taxpayer investment is being appropriately spent and actually achieving the goal of interoperable health IT,” the senators wrote in the letter to Sebelius.
The tone of the letter to Sebelius echoes the concerns raised in the report.
The report cites interoperability as the key to achieving the efficiencies in health care delivery that have been promised by the meaningful use program and federal grants for health IT projects.
But the report questions whether the meaningful use program is focused enough on interoperability rather than one-size-fits-all technology adoption among hospitals and providers.
“Unfortunately, the program as laid out by [the Centers for Medicare & Medicaid Services] and the Office of the National Coordinator for Health IT continues to focus less on the ability of disparate software systems to talk to one another and more on providing payments to facilities to purchase new technologies,” according to the report.
Specifically, the report criticizes the meaningful use program for an unrealistic time frame in which to adopt EHR systems and for failing to address interoperability at the outset of the program, instead leaving the issue to later phases of the program.
“To date, the lack of unified, well-specified standards is a chief impediment to achieving interoperability,” the report states.
In particular, the report suggests unified interoperability standards should be part of the EHR certification process, put in place by ONC to certify EHRs used by meaningful use program participants, and casts doubt on the ability of disparate EHR systems to share data by Stage 3 of the incentive program.
The report also criticizes the “aggressive, one-size-fits-all implementation schedule” of the meaningful use program that the authors say does not account for different types of providers and their abilities to comply with the program requirements.
“For example, some technologically integrated suburban hospitals are being held back from using more advanced capabilities, while small, rural physicians' offices are being overwhelmed by one-size-fits-all requirements,” the report states.
While the report recognizes that CMS has delayed meaningful use Stage 3 rulemaking, it also solicits comments on the possibility of delaying the program altogether, starting at Stage 2, to assess its progress to-date and make changes.
“We seek comments on whether it would be in the best interest of CMS, [ONC], vendors, providers, taxpayers, and other stakeholders to hit 'pause' while reexamining the current procedures put in place to safeguard and ensure meaningful use of EHRs prior to forging ahead with Stages 2 and 3,” according to the report.
The open letter to stakeholders released alongside the report similarly asks for comments on how well the program is working and about concerns raised in the report.
Among other concerns raised in the report are those about federal oversight of the meaningful use program, including the design of the program that allows participants to self-attest that they meet program requirements for earning incentives.
“This is a startling lack of program integrity,” the report states. “In few other government programs can an applicant simply claim eligibility without offering some documentation.”
The report cites a November 2012 report from the HHS Office of Inspector General that raises similar program vulnerability concerns (see previous article).
Of particular concern, the report states, is CMS's lack of prepayment review in the incentive program and its response to the OIG report that it does not believe such reviews are necessary because they would delay payments to program participants.
In fact, the reports states, CMS appears to be “overly focused on getting payments out the door,” and is measuring the success of the program by how much has been paid to participants.
In the letter to Sebelius, the senators posed a laundry list of questions about CMS and ONC implementation of various aspects of the HITECH Act and asked for a response by June 16.
Among questions were two asking about contracts to the National Opinion Research Center at the University of Chicago and the American Institute for Research to assess various HIT programs and activities.
The letter also asked about ONC Beacon Communities, which received a total of $250 million in HITECH grants for EHR and health information exchange work, and the results of ONC studies on HITECH implementation and the impact of health IT in communities associated with health disparities.
The report is at http://www.thune.senate.gov/public/index.cfm/files/serve?File_id=0cf0490e-76af-4934-b534-83f5613c7370. The letter to Sebelius is at http://www.thune.senate.gov/public/index.cfm/files/serve?File_id=04df81b9-3080-4c78-9bc9-9e896cf54df0. The open letter to stakeholders is at http://www.thune.senate.gov/public/index.cfm/files/serve?File_id=92d23a53-4de8-42e1-8cfd-ff861779cf44.
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