On February 17, 2016, at a Capitol Hill briefing, leaders in the health industry announced agreement on recommendations in six policy areas to spur high-value, patient-centered health care in the United States. The recommendations involved actions in the following areas: (1) FDA reforms; (2) comprehensive care planning; (3) medication therapy management; (4) health information interoperability; (5) changes to federal anti-kickback and physician self-referral (Stark) laws; and (6) health information flow improvements focused on patient privacy laws and regulations.
The recommendations were presented in a report prepared under the auspices of the Health Leadership Council’s (HLC) National Dialogue for Healthcare Innovation (NDHI) initiative. The initiative convened senior leaders from providers, insurers, drug companies, patient groups, government, and academia to reach a consensus on how to improve U.S. health care, following a summit on innovation and value held last March in Washington, D.C.
In the six areas, it was agreed by the NDHI participants that that the following actions be taken.
FDA reforms. Policy changes that streamline the FDA’s responsibilities, while ensuring that manufacturers remain accountable, are necessary for the FDA to focus on high-priority activities and speed the approval of new medicines and health care products. They include:
- eliminating the prohibition on using a single Institution Review Board of record for medical device trials, reducing the cost and time involved in product approvals;
- allowing companies to make certain changes to devices without a premarket submission, as long as the companies’ quality systems have been certified as capable of evaluating such changes;
- timelier recognition of standards established by international or nationally recognized standards organizations;
- expanding the definition of valid scientific evidence to include evidence described in well-documented case histories, including registry data, studies published in peer-reviewed journals and data collected outside the U.S.;
- providing greater training and improved understanding of the use of “least burdensome provisions” to increase efficiency and consistency for the FDA and manufacturers; and
- increase the flexibility for biopharmaceutical manufacturers, payers and providers to share scientific and health care economic information in order to optimize the clinical benefits of prescribed treatments.
Comprehensive care planning. Comprehensive care plans must address the population’s multiple co-morbidities and complex care needs and be aware of issues related to the individual and community-level context. In addition, chronic disease programs must address these illnesses across the entire continuum of care.
Medication therapy management. CMS’ Part D Enhanced Medication therapy management (MTM) Model, designed to better align prescription drug plan sponsor and government financial interests, should be optimized by: (1) accelerated implementation of the Enhanced MTM Model; (2) expanding it to offer benefits to all Part D members, including those in Medicare Advantage plans; (3) providing participating plans an opportunity to participate in developing quality measures; (4) conducting robust education of providers and pharmacies on the Enhanced MTM model; and (5) allowing collaboration between pharmaceutical manufacturers and health plans.
Health information interoperability. The establishment of a December 31, 2018, deadline for achieving nationwide exchange of health information through interoperable certified electronic health records technologies.
Federal anti-kickback and physician self-referral (Stark) laws. Lawmakers must address the current federal fraud and abuse legal framework to make it more compatible with value-focused, integration-oriented health systems. Several detailed regulatory and legislative options are provided in the report.
Health information flow improvements. A national health privacy standard is needed to mitigate problems deriving from the variation among state laws and regulations. There is also a need for updated and harmonized federal privacy rules to align with new and innovative health care research capabilities.
Members of the HLC have begun meeting with federal legislators regarding the recommendations in the report and plan to continue collaborative discussions in 2016.
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