Medical Device Daily Washington Editor
The Office of the National Coordinator for Healthcare Information Technology (ONCHIT) has published a plan for making use of the funds provided in the American Recovery and Reinvestment Act of 2009 (ARRA), detailing both funding sums and timelines for specific objectives. However, one of the key questions for doctors and hospitals, that of the definition of "meaningful user," does not come with a deadline in the document.
The meaningful user question has surfaced frequently over the past few weeks as physicians and hospital administrators attempt to plan their HIT purchases. During a session at this year's edition of the World Health Care Congress in Washington (Medical Device Daily, April 20, 2009), Kelly Cronin, the director of the office for programs and coordination at ONCHIT, said that the definition of meaningful user is not likely to be static, but made no mention of when ONCHIT might provide a definition. According to the ONCHIT document, the definition "will be determined through a process that will include broad stakeholder input and discussion.
Of the $2 billion allocated to ONCHIT's efforts, $300 million will go toward bolstering the operations of regional HIT exchanges, also known as regional health information organizations (RHIOs). The National Institute of Standards and Technology will use another $20 million to help the Department of Health and Human Services craft rules that guide standards for electronic health records (EHRs), with a deadline of Dec. 31 to publish a proposed final standard in the Federal Register.
Roughly $1.6 billion of the total amount is allocated to "unspecified" uses, no doubt some of which will go toward bolstering IT infrastructure in hospitals and doctors' offices. One of the measures ONCHIT is employing to gauge its success is to get one of every four physician offices to have adopted EHRs by February 2010. The document states that 21% of physician practices have EHRs in 2008. For small physician practices, a term that is not defined, the objective is to have 12% working with EHRs, a substantial percentage increase from the current 8%, although the document does not indicate the sheer numbers involved.
FDA inks guidance for risk information
FDA has published a guidance dealing with how risk information is presented in promotions for drugs and devices. This is far from the first guidance the agency has posted on the issue, but many elements of the current guidance echo earlier efforts, including a series of steps taken by FDA at the beginning of the decade to rein in some advertising practices by drug and device makers.
The relative positioning and size of information regarding the benefits and risks are both still issues. FDA notes in the guidance that an ad makes use of large, bold-face fonts to describe the benefits but which also leaves risk information in a small, plain font at the bottom of the ad gives rise to a disproportionate emphasis, which can in turn "cause readers to receive an erroneous impression that the drug is safer than it has proven to be, even though the statements themselves may be factually accurate."
Among the semantic considerations detailed in the guidance is the use of the word "syncope" rather than its plain-English synonym "fainting."
The guidance also mentions the concept of "signaling," described as the use of "writing devices designed to emphasize aspects of a text's structure or content without altering the information in the text." FDA states that because readers may put more effort into reading headlines than body text, "accurate information in the text may not remedy a false headline." As for signaling in audio or audiovisual media, the guidance states that "when a word on the screen identifies a new topic, or when headlines emphasize some messages but not others," a form of signaling can take place that is distortive of the overall message.
Other issues enumerated in the guidance include the hierarchy of risk information and the tendency of the human mind to recall material at the beginning and the end of a broadcast ad much more readily than the content in the middle, an effect known in communication studies as "primacy and recency." Stakeholders have 90 days to comment on the guidance.
GAO says dialysis costs uneven
The Government Accountability Office (GAO) recently examined the reimbursement rubric for dialysis at the Centers for Medicare & Medicaid Services and determined that the outcome of an effort on the part of CMS to encourage dialysis in the home may have mixed results.
The May 22 GAO report notes that CMS plans to go to a bundled payment for dialysis by 2011, but cost data obtained by GAO from providers of all sizes "indicated variation in the costs to provide home dialysis when compared with costs to provide dialysis in their facility." Each of the six entities polled by GAO indicated that home treatment costs less in general, but the difference varied. Furthermore, the cost of a home dialysis treatment along with training often exceeded the cost of facility treatment. GAO indicated that CMS is still "considering factoring the costs of home dialysis treatments and training into the expanded bundled payment, but the details for the expanded bundled payment are still under development and subject to change."
GAO recommended that CMS put in place a cost-monitoring system to establish the cost differential and possibly tweak the payment to encourage the lower-cost situation.