My first FDA Advisory Committee meeting – refreshing change from CT

I was recently appointed as a consumer representative to the FDA’s Anti-Infective Drug Advisory Committee and yesterday was my first meeting. It was a bit intimidating to open the Wall Street Journal that morning to see an article about our meeting. It was fascinating – I learned more new things yesterday than I did all last year. The committee advises the FDA about new antibiotics with a deep dive into science and clinical trials on effectiveness and safety. Drug resistant bacterial infections affect 2 million Americans each year, killing 23,000, according to the CDC. There are 45 new antibiotics in the pipeline and yesterday we considered two of them. We heard from a small army of very impressive, dedicated, extremely well prepared experts, from both the FDA and the applicant drug companies, who answered every question the committee posed. The room was packed. We heard very moving public comment from families and patients affected by MRSA and from researchers concerned about protecting the public.

But the most striking thing, for a CT advocate, was the FDA’s discipline around ethics. Applicants to FDA committees complete a thick stack of documentation to ensure no conflicts of interest. The only voting members of the committee are independent clinical/academic experts, agency experts and consumer representatives. This may sound strange to anyone in CT policymaking, but they are very strict that drug companies do not vote on or influence the regulations they operate under. Weighing the best interests of consumers was the only priority – for everyone at the meeting. In CT we routinely have industries at the table, and people with financial interests in those industries, usually dominating the membership. In CT, industries are making decisions about what standards they have to reach, what they can charge, and how they will be monitored (if at all). Consumers and advocates have to fight our way into the process -- preferably at the table, but if necessary by other means – and we are punished for it. The entire day I never heard about how our or FDA’s decisions would affect jobs or stock prices. It just never came up – protecting people and saving lives is the only priority.

State Health assessment unveiled

DPH has been working for over a year to develop CT’s State Health Assessment and Health Improvement Plan --  a comprehensive plan to identify health challenges in CT, set priorities and create an action plan to address them. The process has been collaborative, inclusive, transparent and through. The plan focused on promoting health equity, ensuring action steps are feasible, effective and designed to engage and inspire communities. The plan is evidence-based with a focus on systems change. The plan set seven final priority issues with dozens of measurable benchmarks under each. Now comes the hard part – implementing the plan.

Underservice committee starts work

Yesterday’s first meeting of the MAPOC Complex Care Committee underservice workgroup was very productive. (We need a shorter name). The committee is charged with designing a framework for monitoring under service in CT’s plan for health neighborhoods to cover people eligible for both Medicare and Medicaid. Advocates have raised concerns that a shared savings payment model may lead, even unintentionally, to people missing out on necessary care. The workgroup includes over half consumers and advocates, in addition to providers, academics and state agency representatives. The committee reviewed a survey to collect input for the monitoring system. The committee also plans to hear from NCQA accredited Accountable Care Organizations (ACOs), CT ACOs, search the literature, check with other states, and survey national groups.

SIM update

Not much happened at Monday’s SIM steering committee meeting. The lists of recommended workgroup members from both the SIM personnel committee and the Consumer Advisory Board were distributed but not voted on. There was dispute over the number of physicians on workgroups centered on a recommendation from physician groups to add significantly to their numbers. Arguments were made that a wide variety of physician specialties must be represented on each workgroup as they have unique interests. Concerns were raised that this would violate the balance between interested stakeholders. Observers found this an ironic contrast with earlier discussions about types of “real” consumers vs. advocates. There were also objections raised to language in the Equity and Access group charter that they would only monitor for “intentional” underservice. In legal settings “intentional” requires an extremely high standard of proof. Advocates are concerned that requiring proof of intention may make any monitoring system ineffective. The group responded to the independent consumer advocates’ latest letter with concerns about workgroup composition denying that our solicited input was not given consideration, advocates are not excluded from membership, references to expectations that members must agree to support final workgroup recommendations were deleted, and workgroups will not meet during usual business hours but they will circulate meeting times and locations. There was no commitment to post materials for reasonable public review before meetings, to take public comment at workgroup meetings, or to explicitly state that workgroup members are free to follow their best judgment about recommendations.

Check out our new website

We’re very excited to launch the updated CT Health Policy Project’s website. The site has been cleaned up, optimized and reorganized. Links to social media, our blog and listserv sign up are easy to find at the top of the page. It should be easier to find what you are looking for now. If you don’t find it or a link is broken, let us know at information@cthealthpolicy.org.

Medicaid Council update

Today’s Medicaid Council meeting focused on continuing problems with enrollment and recommendations to reduce Medicaid ED use. In response to a letter from Council members, we learned that 63% of calls to the DSS Benefits Center from August through December 2013 were dropped – people waited 17.5 minutes on average before hanging up. Things are getting better however – the backlog of applications is coming down and the average wait time to get a call answered has dropped from 90 to 25 minutes. DSS shared operational improvements they expect will continue to improve customer service and they plan to implement a “call back” option. They also promised to include these measures in the monthly dashboard on program performance starting next month.

The Council also heard from the legislative Program Review & Investigations Committee on their study of ED use by Medicaid consumers and shared their recommendations. ED use consumes only 4% of the entire Medicaid budget, but Medicaid members are twice as likely as other state residents to visit an ED. While Medicaid ED visits dropped between 2008 and 2012, costs per visit rose. There are a small number of Medicaid consumers who are frequent ED visitors, often seeking prescriptions. The researchers made several recommendations and DSS responded that they are implementing some of them. DSS also stated that they will include ED metrics in the monthly dashboard.

Disappointing SIM update

Monday a group of 16 independent consumer advocates delivered a letter to the SIM steering committee voicing deep concerns about the implementation development process. Advocates have voiced concerns about the SIM process from the beginning, offering constructive options that support the goals of improving quality and access to care while controlling costs. Concerns voiced in the latest letter include SIM staff soliciting input from consumers and advocates that was not communicated to or considered by the steering committee, a continuing lack of transparency, and a preference to exclude independent consumer advocates with policy expertise from implementation workgroups. Those workgroups will consider complex questions and develop the critically important details of the plan – effective, independent consumer input is essential to success. Advocates are concerned that conveneing the committees has been delayed, including the critical Equity and Access Committee that is tasked with developing a monitoring system to ensure consumers are not inappropriately denied necessary services under SIM’s new payment model incentives. In yesterday’s Health Care Cabinet meeting we learned that SIM will be going forward with their current plans; the consumer letter was not discussed.

In the Cabinet meeting we also confirmed that critical public health priorities were added to the SIM plan at the last minute to improve CT’s chances of getting a federal grant. Consumer advocates have repeatedly objected to re-making CT health reform priorities for the purpose of securing a grant for hiring state agency staff and consultants. CT priorities should be set here in CT by CT stakeholders in thoughtful consensus processes which are ongoing across our state. We should only pursue funding opportunities that already fit with CT’s priorities, not the other way around. We also learned that they intend to develop a common set of standards across all CT payment sources for medical homes to be eligible for shared savings payments. They are moving ahead with plans to develop a survey of CT providers to inform development of those standards. Mirroring advocates’ questions, concerns were also raised about how traditionally public health functions and consumer choice will be protected in the integration into a medical model of care.