WTC Medical Monitoring and Treatment Program
Full Steering Committee Meeting
Mount Sinai
Wednesday, January 5, 2011
Chair: Jim Melius, DrPH, MD, Laborers (JM)
Attendees:
Iris Udasin, MD UMDNJ (IU)
Carol Perret, UMDNJ (CP)
Dave Prezant, MD, FDNY (DP)
Lara Glass, FDNY (LG)
Phil Mouren, FDNY (PM)
Steve Markowitz, MD CBNS (SM)
Lauri Boni, CBNS (LB)
Wajdi Hailoo CBNS (WH)
Phil Landrigan, MD MSSM (PL)
Marie Diven-Stelluti, MSSM (MDS)
Michael Crane, MD MSSM CC (MC)
Vansh Sharma, MD MSSM CC (VS)
Matthew Cassidy, MSSM CC (MCy)
Garry Resnick, MSSM CC (GR)
Julia Nicolaou, MSSM CC (JN)
Lindsay Warren, MSSM CC (LW)
Brian Schroeder, MSSM CC (BS)
Emily Milam, MSSM CC (EM)
Ben Luft, MD LIOEHC (BL)
Henry Sacks, MSSM DCC (HS)
Bill Ruggles, MSSM DCC (BRu)
Laura Crowley, MD MSSM DCC (LCr)
Scottie Hill, MSSM DCC (SC)
Agata Roman, MSSM DCC (AR)
Jean Weiner, MSSM DCC (JW)
Anne Kochman, MSSM DCC (AK)
John Howard, MD NIOSH (JH)
Dori Reissman, MD, MPH NIOSH (DR)
Roy Fleming, NIOSH (RF)
Larry Rhodes, NIOSH (LR)
Lewis Wade, NIOSH (LW)
Melodie Guerrera, LIOEHC (MGue)
Ben Luft, MD LIOEHC (BL)
Denise Harrison, MD Bellevue/NYU (DH)
Micki Siegel de Hernandez, CWA (MSdH)
Chris McGrath, PBA (CMc)
Frank Tramontano, PBA (FT)
Bernadette Royce, UFA (BRo)
Bill Romaka, UFA (BR)
Jim McGowan, UFA (JMc)
Lee Clarke, DC-37 (LC)
Dave N. Tornberg, MD, LHI (DT)
Angie Moen, LHI (AM)
Kelly Anderson, LHI (KA)
Joan Reibman, MD Environmental Health Center (JR)
Terry Miles, Environmental Health Center (TM)
John Feal, FealGood Foundation (JF)
Notetakers: Annie Lok and Dana Schinestuhl
Report on recently deceased WTC Responders
BR: Active Firefighter Fitzroy Haines Jr., Ladder 15, 40 years old, was a 6 year Marine before joining the FDNY in early 2001. He spent much time working at the site. He died of heart complications from his work on the pile. Retired Firefighter John Sullivan, Ladder 34, 52 years old, retired in September of 2010, from cancer that was first found in his intestine and spread throughout his body. He leaves behind a wife and 4 kids. Police Detective Kevin Czartoryski, 46 years old, from a lung ailment (pulmonary fibrosis).
MGue: Theodore Dales, Transportation/Sanitation Department: Driver. (Unknown Cause) – age 53. Chris Saliani – owned company environmental clean up. (Unknown cause) – age: 60.
LB: 2 deaths from the Queens cohort
JR: 1 death
Approval of Minutes
Approved Unanimously
Legislative Update: Jim Melius
JM: The bill was passed! The basic content of the bill was not changed, but cost and administrative issues were. I appreciate everybody's efforts on this- many people's effort over long period of time. It says a lot for how good the program is and how hard everyone has worked. If you haven’t read the bill, I urge you to do so.
LC: Some mention has to go out to congratulate Peg Seminario. Before anyone else, she came to New York and listened to the unions' concerns, and took on the issue.
JM: If you had been down in DC when it passed, you would've seen how happy people were.
DP: I think it was a civics lesson in partnership.
LC: We need to put together some sort of a “cheat sheet” with the basic details of the bill.
JM: Maloney's office is having staff put together two reports. One is a lay summary of the bill. It would be a good background document for legislators and program staff. The other is a more comprehensive legislative explanation. It should be available shortly. The unions have been getting calls from members. A lot of confusion, some shown by lawyers. Our advice to my union is to not rush into anything.
ACTION ITEM: Jim Melius will distribute the two documents from Maloney’s office regarding the bill/statue once they are finalized.
NIOSH: John Howard
JH: I want to congratulate everyone on their work. At NIOSH, we followed the bill and provided technical support when asked by Capitol Hill. We hoped something would happen, but didn’t expect it to. The program has run on sentences written in appropriations bills. We've built the program on thin air from a statutory perspective. We didn't know if we were building what we were supposed to. That has come from Congress when they called hearings, or told us we were wasting money. So we've been building the program without guidance. We were always being second-guessed. Now, we have authorization. That's a paradigm change. We used to be able to discuss something and come to a consensus. Now we have words - a law - to adhere to. The words can be interpreted differently, and as long as the executive branch interprets it reasonably, it will stand up in court.
We have nothing to do with the VCF, only the medical programs. We will write regulations, have public hearings, and then implement them. To participate in this process, you have to understand the statute and make it your own. I encourage you all to read it. Between now and July we're going to write the regulations and ask for public comment. One thing we've lacked is a federal advisory committee, which is now required by law, by appointment and charter, which gives the government advice. We've lacked a committee like that to give scientific information to the government. Currently we're having a discussion on carcinogenic effects. Now, we have a statute that tells us how to approach this. Now, by law, the administrator has to present the issue to the committee. And the committee can choose whether or not to take it on. And it will be part of the public record.
Another issue is the flow of funds from the government to the medical providers. We've tortured the CCs about data on individual claims. The vehicle for the Centers of Excellence has been research grants - that's what NIOSH does. That five-year grant is now in its 7th year, as we waited for this bill to become law. You'll see in the statute that none of the centers are named. The names were originally there, but taken out and replaced by criteria. The flow of funds may change, I don't know whether or how yet. Our goal is that five years from now, we have a program that cannot be struck down because of poor implementation, management or fiscal responsibility. As I've testified, this program should be for the lives of the individuals involved, so, beyond 2016. Our job in government is to make sure the program is unimpeachable. Because we don't know what the political climate will be in 2014 or whenever it is we have to talk about reauthorizing the program. At that time, the program will be under scrutiny and there will be people who want to take the program down, for whatever reasons, and they'll find whatever flaws in the program to strike it down.
A formal read(?) will be available after we publish in the federal register. Informally, you can call us to ask questions or provide comments. There are a number of things that has to happen before July 1. Our job in government is making sure the program is unimpeachable. We need this program to extend beyond 2016. I would suggest that any questions anyone may have, please send me (John Howard) an email.
Discussion:
PL: Do we have any sense who will be named the WTC administrator?
JH: The section for that is 3006, item 14 that has A and B sections. A has 2 sections and B just 1. It provides discretion to DHHS secretary to pick person to assume responsibility for some sections of the bill. Some sections would go to director of NIOSH. There's a section that would not go to NIOSH director (about payment for treatment). According to people who worked on the bill, there's a drafting error. Something was left out about the payment for treatment. The actual paying process will not be done by director of NIOSH. And NIOSH has never paid any clinic. The grantees paid themselves. It's not something we want to or are capable of doing. So we, or the Secretary, would select another entity to do it. She can assign all section except 3332 to NIOSH director.
DP: Highlight concerns – 1. Who is the administrator? There is clearly a difference in the way things are interpreted going forward. (JM: Assume the Director of NIOSH will be the administrator.), 2. The bill references 7/1/2011…and that reports need to be filed by this date (consolidation of data centers, national program moving to VA system?, unification of pharmaceutical providers).
JH: GAO’s reports are due on 7/1/2011. What you are talking about is not due for 2 years.
DP: I have several questions. Who is the administrator? Is there a difference whether it's at DHHS, CDC or NIOSH?
JM: I think we should all assume that the director of NIOSH will be the administrator.
DP: Who would be running the claims? There's a reports that needs to be filed on 7/1/11, on whether the data centers can be unified into one, unifying pharmaceutical plans, and melding treatment into VA system. How will that play out in terms of timeline of reports, and also starting the program at 7/1/11.
JH: I think you're incorrect on unification DCCs - timeline is 2 years to file report. The reports you’re talking about are ones the GAO has to do. The report on consolidation of DCCs is secretarial. The report on payment of claims could theoretically have impact on starting the program.
DP: As could the report on pharmaceutical services.
JH: The language is "may" which means it's discretionary, as contrasted with "shall," which means it's mandatory.
DP: There's the issue of how we transition, and what we're transitioning to. There's a sentence that states that it could be a cooperative agreement, and that would be very helpful to my group and our stakeholders.
PL: And we've talked to our financial officers here who say a cooperative agreement would be easiest.
JH: There's discretion in the statute for that.
DP: Another issue is the fee structure. It's not dictated in the bill for monitoring. The original draft of the bill had specific fees for monitoring. The current law doesn’t name them. So there needs to be a discussion for how much that would be, and whether treatment would be fee-for-service, or not. And fee for service would be FICA rates x1.
JH: The payment methodology is discretionary, but the rate isn't.
PL: We interpreted that as administrative structures and activities (such as phone bank, translations)...
DP: I'm not clear whether that would fall under NIOSH administrator or claims administrator.
JH: I would guess the former.
DP: How can we process a new contract or agreement for institutional review...
JH: I'm not even sure we can get things processed on our end in six months. So we will need some kind of transition plan in place.
JM: I would warn everyone not to plan on that. There's pressure to get it done sooner rather than later.
DP: In the past, when we talked about changing to fee for service. There was a thought that the first year of FFS, would have some failsafe mechanisms based on previous year's budget, because when you have many people on salary, it would be great if for six months or a year there is guaranteed money for the number of FTEs.
JH: And that's an infrastructure issue. It would be great if CCs could provide us what they think would be the best and most appropriate payment method. It's been very difficult to get data on individual treatment. In my mind now, it's conceivable there will be a capitated fee.
PL: I think we're with you on capitated fee for monitoring. For treatment, here at the Sinai DCC we are prepared to change to claims system.
JH: That's good to know as there will be time pressure.
DP: The scientific advisory committee, who would appoint them?
JH: In 3614a, the administrator will select the committee.
SM: When you write the regulations, can you make sure there's room in the process for input by various constituents?
JH: In the advisory committee meetings, there can be time for people to come and provide their input.
BL: Can you give us your vision of the scientific agenda?
JH: From my perspective, as an administrator, it'll be wonderful to have a committee of experts to discuss the science. They will provide advice to the administrator.
BL: Who will appoint them?
JH: In the appointment process, I would like to hear from all of you, after reading the statute about it, whether we need to change it. You can tell me what you think needs to be changed.
MC: Can you talk about the fraud provisions?
JH: The inspector general of DHHS is responsible for them. The CCs are responsible for quality assurance. The IG has now expressed responsibility to treat this program like all federal health program, and they can audit it. In a way, this program has become like all other health programs. In Medicare, it is written that it is the secondary payor. In this program, we have to try to recoup money from Workers' Compensation.
MC: Who would recoup the money?
JH: There is a provision under the health insurance section for the Bellevue program that they don’t have responsibility for claiming from health insurance companies. But that's down in the weeds kind of stuff.
JM: Things you should really think about in next six months - treatment must be medical necessary. Treatment and diagnostic protocols need to be tightened up and expanded – think about them sooner rather than later.
JH: For doctors providing care in the program - the issue of protocol, medically associated with WTC - just focus on those provisions.
PL: We've talked about convening working groups to update protocols.
JM: After enactment of law, every time someone is added to the program, or to treatment, the NIOSH administrator has to approve them.
JH: The administrator is supposed to select provider. Not sure how that will work yet.
IU: Are we still the Steering Committee, PIs?
JH: The SC is as it is on the day of enactment, which is when the President signed it.
JM: The SC, list of conditions, are all frozen in place for now. The SC will most likely be frozen, and there are provisions for adding people. As for naming the Centers directly, Congress doesn't like earmarks any more, and naming them would be considered earmarking.
IU: Can anyone write a proposal to compete with us?
JH: The law has a series of criteria for who can compete for contract/agreement. There is a provision about experience. And there's nothing to stop the administrator from choosing two centers in NJ.
JM: Nor to choose a center in Salt Lake City or wherever people need care.
BL: In the Medicare fraud cases, it seemed to be Medicare and not the doctors decided how much care was needed. Will there be some kind of review here of the criteria for care?
JH: So you're worried about protocol here that would be at variance with Medicare protocol?
BL: Yes.
JH: I think that would be unlikely since these conditions are common.
PL: But if there's deep and long-lasting asthma here, that might require more steroids than usual.
JH: There's some discretion.
FT: This isn't really an entitlement program because there are limits on things?
JM: This has gone from program that entitled the centers to provide care; to law that entitles the patients to receive care.
FT: But there's a limit to the money. What happens when it runs out?
JM: I think CBO were generous in overestimating certain costs. There is a limit on how many people can be in the program, but we can possibly make a case to change that. At the end of the six years there may well be money left, and new legislation will be required.
FT: In your opinion, the provisions would cover new emergent sicknesses?
JM: Yes.
JH: The legislation took money from the discretionary side of the ledger to the mandatory side at DHHS.
MGue: We've been existing on extensions. Are multi-year agreements being considered?
JH: LHI has a multiyear agreement now. So it's possible.
CC/DCC Updates: not reported
MGue: We have not yet received our data that we requested from the DCC for presentation on the proposed Brooklyn satellite.
JW: It was sent to you today.
Cancer Update: Dave Prezant
DP: The WTC analytic group which was tasked to come up with common exposure and cancer definitions - we're not asking new questions, only using collected data. Each cohort can do analysis on all of their own data. We want to do common analysis on arrival time, duration, work tasks, location. We want to use those in all cancer papers. Other data, such as respirator use, is not common among us. Cancer definitions (rules for analysis) have been “finalized”. But we have put in a caveat that these are changeable. The FDNY timeline for getting report out—the last time we were waiting for latest NYS cancer registry data for part of 2006 and 2007. We're processing it now - we got a data dump from the NYS Cancer Registry at the end of December 2010. A preliminary report first goes to our own unions, then to SC, sometime in March - April 2011. This report would be about all confirmed cancers up to end of 2007. Would be able to analyze them by anatomic site and compare them to NYS Registry, public data, and our pre-9/11 data.
ACTION ITEM: FDNY will send two brief abstracts to SC members.
Consortium Cancer Update: Phil Landrigan
Anne Kochman – new addition to the DCC…now the cancer coordinator. She has a lot of experience in occupational medicine, worked previously at the COEM as nurse practitioner. When a responder reports cancer, it will be Anne’s job to reach out to that person to get as much data as possible. We need to get the medical records for these responders.
Announcement: Dr. Laura Crowley published paper on sarcoid on our responder population in American Journal of Industrial Medicine.
10th Anniversary Publications: Phil Landrigan
The Lancet, medical journal in England, sent out a call for papers a few months ago with deadline of 3/31/11, for special issue on 9/11. At the DCC, we've been working hard, and plan to bring work to Consortium as soon as we have something to share on a paper to look at all major diseases and conditions. For each disease, prevalence and trends in these diseases since 9/11, and where possible, pre-9/11. It’s an extension of 2006 paper we published in EHP.
Discussion:
DP: A month ago, we submitted a paper on mental health conditions that was an extension of prior data. They rejected it. They were looking for something groundbreaking. They also were not interested in PTSD data without diagnostic certainty.
PL: The Lancet turns rejections around quickly. So if we get shot down, we should get together and submit to EHP.
BL: Can you share those Lancet reviews with us?
DP: They were pretty brief and said what I shared.
JM: We have two new research protocols to review at the PPC.
Patient Advisory Committee: Scottie Hill
In the interest of time, I am going to just speak briefly today about the idea of a patient advisory committee for the program, where the idea came from, and the purpose of such a group. I will also put some questions on the table for initial consideration, but realize that a more robust discussion may be necessary at a subsequent meeting given today’s time constraints.
Soon after I assumed the role of the Director of the Member Services Core within the DCC, I told my staff that I hoped the Member Services Core could become the entity within the DCC in which patients felt free and comfortable to express good things and bad things about their experience as program participants and offer feedback and input into the program’s operations and services. In order to facilitate such communication between the DCC and program participants, the Member Services Core has opened up lines of communication with patients via an e-newsletter, an email listserv of program participants, the responder conference survey, and meetings with concerned patient groups.
In the course of these conversations with patients, several patients have come forward and asked if the program might consider a more formalized structure for receiving and considering patient input into the program. Several have asked about the creation and development of a patient advisory committee, a group that could take on program-wide issues that are important to patients and consider possible solutions to be recommended to the program at large.
This idea is not a new one; it has been used by multiple medical research and clinical programs as a way to not only generate helpful and valuable feedback and input, but also as a way to increase participation and retention in such programs as participants help program leaders to better understand the concerns and issues of participants.
In addition, the Zadroga Act mandates the “establishment of a formal mechanism for consulting with and receiving input from representatives of eligible populations receiving monitoring and treatment” from Centers of Excellence. We currently have such a mechanism through the Steering Committee and some CC-specific advisory groups via the active participation and input of representatives from labor and other groups. I think this perspective could be further enhanced by providing a venue for actual program participants to participate in the life of the program and offer related feedback.
Via the DCC, I would like to create a patient advisory committee comprised of representatives from each of the clinical centers within the NY/NJ consortium of centers. The purpose of the committee would be to consider program-wide, not CC-specific, issues that affect the satisfaction and participation of responders participating in our program.
Examples of such issues that have come my way recently include:
With a clear purpose and strong facilitation, I think such a group could be valuable in helping the program think through how to address issues such as these and others in a way that patients feel is fair and equitable.
Clearly, though, questions arise when thinking about how to implement such a group in a responsible, fair, and equitable way. I throw some questions out today for initial consideration, but perhaps further discussion could take place at a subsequent meeting if necessary.
ACTION ITEM: Scottie Hill will email the questions mentioned regarding this patient advisory committee to the SC members for further consideration.
Discussion:
JM: we will discuss this at greater length at later meeting. And appeals process is in the legislation.
LC: You make an assumption that people on advisory committees are not patients, and that's not a good assumption to make.
Announcement:
SM: Scientific Update presentations are this afternoon, beginning at 1pm in the Goldwurm Auditorium. All are invited.
DP: Our sixth anniversary book will be updated and sent out to members October or November this year.
Adjourn.
Next meeting: February 2, 2011 at FDNY.