A friend forwarded to the FEHBlog this link to an interesting BioCentury report on Senator Orrin Hatch's (R Utah) work to develop a bill that would create a regulatory pathway for "diagnostics" The report explains that
Top FDA officials and lawmakers have concluded that the current oversight system for diagnostics, which imposes premarket review requirements for in vitro diagnostics (IVDs) but not for the vast majority of laboratory-developed tests (LDTs), is not sufficient to protect the public or to support the development of innovative tests that are at the heart of hopes for widespread adoption of personalized medicine. * * *
Under the Hatch bill, IVDs would no longer be regulated as medical devices. Also, FDA would for the first time routinely regulate tests performed in labs, although lab services and operations would continue to be regulated by the Centers for Medicaid and Medicare Services (CMS) under the Clinical Laboratory Amendments (CLIA).
The report discusses other approaches under consideration. These efforts are definitely worth following.Hatch hopes to use a new regulatory system to go even farther, as a platform for launching reform of diagnostics reimbursement policies, and shifting Medicare from a payment system based on the complexity of test procedures to one based on the value of tests, according to diagnostics industry executives and attorneys who are advising his staff.
CMS announced on Friday that Federal Register will include a proposed rule "that would establish a new hospital value-based purchasing program that would reward hospitals for providing high quality, safe care for patients. Under the program, hospitals that perform well on quality measures relating both to clinical process of care and to patient experience of care, or those making improvements in their performance on those measures, would receive higher payments under the program."
Friday's Federal Register included a final Health and Human Services Department rule establishing a permanent certification program for health information technology under the HITECH Act. Information Week explains that
While the new permanent certification program does not impact the criteria and standards used to evaluate and certify e-health record and other health IT products, the new program clarifies the rules for the handful of organizations that provide the testing and certification.
Healthcare providers must meaningfully use "certified" health IT in order to be eligible for Centers of Medicare and Medicaid Services (CMS) financial rewards that are estimated to total more than $20 billion. * * *
Testing and certification under the permanent certification program is expected to begin on Jan. 1, 2012 "or upon a subsequent date when the National Coordinator determines that the permanent certification program is fully constituted,"This rule is relevant to the FEHB Program because FEHB Program carrier contracts include a provision requiring them to use certified health information technology when available and to encourage their network health care providers to do the same. Of course, providers have quite a financial incentive to do so. HHS recently clarified the rules applicable to that incentive program as explained in this iHealthBeat article.