TRANSCRIPT

2022-61 HS-STATEWIDE STEMI SYSTEM

August 22, 2023

1:00 p.m. – 4:00 p.m.

EILEEN WORDEN: Good a�ernoon. I am Eileen Worden, Sec�on Manager of the. We’re here

this a�ernoon on the Statewide STEMI rules. I’d like to introduce my colleagues.

RAO: Good a�ernoon. I’m Mary Brennan, Regulatory Aﬀairs Oﬃcer for the Department of

Health, and Human Services. Emily?

EMILY BERQUIST: Emily Berquist, State Division Administrator, Systems of Care - Stroke and

STEMI

AARON BROWN: Good a�ernoon, Aaron Brown, Systems of Care Coordinator.

KATELY SCHLABLE: Good a�ernoon. Katelyn Schlable, Department Manager, Systems of Care -

Stroke and STEMI.

RAO: We are on the record today for MOAHR rule case number 2022-61 HS Statewide STEMI

System. If you haven't signed in for this session, please do so before you leave today.

Some housekeeping maters: the restrooms are out the door, take a le�, go down the ramp and

make another quick le�. If you would like to give tes�mony, please come up and speak at the

podium. I will ask you to spell your name for purposes of the rule package. Your tes�mony will

be recorded for purposes of a transcript. If you do not want to make a public comment, but just

ask ques�ons, you may do so, but the ques�ons and answers will not become part of the record

unless you want them to be.

For your convenience, I have placed two items on the board behind me. The ﬁrst is the email

box to send comments in the event of a 3:00 a.m. epiphany and you forgot to tell us. That is

MDHHS-Adminrules-all one word- at michigan.gov. The second is the rule status website at the

Administra�ve Rules Division LARA website: Htps://ars.apps.lara.state.mi.us. Comments to the

email box closes on Friday.

If there are no ques�ons, let’s begin. If anyone wishes to make a comment, please come

forward.

DR. ABED ASFOUR: Good a�ernoon. My name is Dr. Abed Asfour. I am an interven�onalist

cardiologist for the last 21 years and, just to give you context of why I come here, I’ve been

involved in STEMI programs for the last 21 years. I started two STEMI programs and one

elec�ve PCI without surgical backup. I take between ﬁve to ten days of calls for STEMI. This is

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dear to me, and I work out of many, many hospitals. I am currently represen�ng Corewell

Health East and West and I appreciate the �me of the commitee and everybody here to

address this. I’m going to address two sets of hospitals here: I’m going to address a set of the

rural hospitals in the State of Michigan, as well as I’m going to address, to some degree, but I

will leave it to some of my colleagues, the open-heart surgery hospitals and the limita�ons and

the advantages of looking into this rule in diﬀerent prospect.

Corewell Health has rural hospitals in Big Rapids, Reed City, Ludington, Pennock, and a few

other, and we have mul�ple open heart surgery hospitals between the west and the east of the

State, and I feel like every one of them will be aﬀected. I want to start with the rural hospital

concept because these are safety net and, despite their size, these hospitals are the vital pillars

of communi�es, and there will be, and they o�en stand as the ini�al refuge for the pa�ents as

they’re ﬁrst encounter. These, over �me, have nurtured great rela�onships with the

communi�es around them, and they service the pa�ents 24/7. We are aware of what’s the

status of rural hospitals in America, in general. We are aware of their ﬁnances, we are aware of

what’s, what happens there. Adding more layers of demands and shi�ing resources in those

hospitals to add more administra�ve rules and more compliance staﬀ for those hospitals, and

shi�ing it away from pa�ent care, I think, is a major concern. Although the inten�on of this rule

is amazing, and the centraliza�on is something we all seek, but I feel some�mes that ideals and

reali�es don’t mean, necessarily, pleasantly.

Requiring accredita�on may seem reasonable on paper, but it could be like chasing some

(inaudible) in the rural hospitals. The costs, the complexi�es, the diversion of resources are

very import-, very cri�cal to these places. These rural hospitals are like lifelines to the

communi�es. Adding accredita�on or not, pa�ents will s�ll come to the hospital, so, if they

present with a STEMI, and I’m going to give you an example: I have pa�ents, I’m going to use

“John Smith” as a name, I had a pa�ent who literally had symptoms while he was hiking close to

Ludington. Had to be rushed there, had to be ﬂown to a STEMI facility. He wouldn’t care if it

was accredited or not. He cares if there is a doctor who can take care of him there, if that

hospital can provide, and if that hospital couldn’t do it, they took him to the closest facility that

could take care of it. So, adding more layers, I think, is going to be an issue. I see the investment

in rural hospitals instead of inves�ng in the actual accredita�on, the hospital is improving the

transport, from the rural hospitals to the actual facili�es that can, to the receiving facili�es, that

should be taking care of the pa�ents. And my concern when hospitals that have rural status and

they’re now out of the accredita�on, we kind of lost them; they’re nothing (inaudible) part of a

system that should be integra�ng everybody that can support this system.

I can see, and we sat down as a team looking at it, what’s the other side of the story, and we

see what the importance of STEM (inaudible) care, we’re all into STEM resicare. But it shouldn’t

be narrow vision to small accredita�on bodies and restrict what’s been already available, and

our, I’m going to leave it to Eric to explore more about the open-heart surgery hospitals and

other things, but we have matured this process; this has been going on, we have been taking

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care of STEMI for the last 20 some years with high standards. We have clinical trials, both for

urban areas, and we have clinical trials na�onal and interna�onal, when it comes to rural

facili�es. And the standards of care is set and we con�nue to follow them. And we would never

achieve perfec�on in medicine, but we always seek perfec�on.

I see that the resources and the energy should be directed in a diﬀerent direc�on, but I

appreciate your �me and input on this, and also, we appreciate what the commitee is doing

and trying to achieve here. I think it’s very novel, but we also appreciate that you’re listening to

us. Thank you.

RAO: Thank you. Next?

ERIC JAKOVAC: Thank you, Guys, for pu�ng this on. My name is Eric Jakovac. I am the

Director of Heart and Vascular Services at Corewell Health and Beaumont University Hospital,

formerly Beaumont Health-Royal Oak, formerly William Beaumont Hospital. So, you know, I

wanted to say thank you for taking the �me allowing to have a public hearing to allow us to talk

a litle bit more about this and what we feel how this would impact kind of an administra�ve

burden on our health system at our hospitals, speciﬁcally those hospitals that have very mature

programs.

Corewell Health might be a new health organiza�on but the hospitals in our system have been

around for a very long �me. Our Royal Oak campus, our Dearborn campus, our Troy campus,

and our downtown Grand Rapids Buterworth campus have had a very robust, very mature CV

surgery programs, as well as cardiovascular programs as well too, most of which are ranked

within the State very highly and, most recently, our Royal Oak campus was ranked the top 25 in

the na�on with World News Report for Cardiovascular services.

So, I men�on this for open heart surgery programs and our cardiac programs as you know, we

do a lot; we have par�cipated in many, many, many registries, and many pay-for-performance

programs, including the MSTCVS for surgery and CDR Blue Cross & Blue Shield pay-for-

performance programs and the BMC2PCI programs-some of which we do pay out of our pockets

to par�cipate in. We invest a lot of �me in these, we spend a lot of �me looking at our quality,

looking at our metrics, looking at how we stack up against ourselves, how we stack up against

our health system, how we stack up against our peers, regionally and na�onally.

And we do believe that these registries that we do par�cipate in really have set a really great

quality standard and put ourselves up to a level that we are con�nuing to meet the metrics for

STEMI, for cardiac care. You know, I could give many examples of things that we’ve done to

improve what we look at toward balloon, reducing high contrast in cath labs, reducing radia�on

dosing, etc., but these are things that we look at and we know today that these are things we

should be doing for our pa�ents.

You know, we think that adding an addi�onal accredita�on to our cath labs and chest pain

facili�es, especially those that have these very robust programs and CV surgery and open-heart

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surgery back up, it seems a litle redundant. You know, we have been working very hard to

con�nue to improve our pa�ent outcomes, with our quality, we con�nue to do so. And we don’t

necessarily think or see poten�ally the value of accredita�on, on top of what we are already

doing. Not that standardizing care isn’t a good thing, but I think the care is being standardized

within our State right now with the diﬀerent groups we par�cipate in.

But there’s also addi�onal concerns we have when it comes to pay, when it comes to �me,

when it comes to resources to not only get accredita�on, but to maintain that accredita�on

over the course of �me. So, we’ve been all aware that there is a ﬁnancial cost that would, we

would incur choosing a third-party accredita�on. But there’s also the cost of who’s going to

con�nue to manage those data points that we need to, who’s going to con�nue to keep things

rolling if we’re chucking everything, sending everything inappropriately and doing all that, as

well as the �me that it takes to do that. And we do think that some of that �me and some of

those resources does take away from the �me and the care and the resources that we could be

spending taking care of pa�ents at the bedside or delivering care.

Our facili�es with our open-heart surgery programs really possess a high level of readiness to

handle complex cases. I know the facility I work at; we are a high… we take cases from all over

internally within our system and externally without our system. We don’t turn systems down,

we take care of very complex, very ill pa�ents. And I think a lot of that comes down to the

collabora�on that our CV surgeons have with our cardiologists, and visa versa. We do have a lot

of, and this is across our en�re system, a lot of collabora�on. Structured collabora�on within

heart team mee�ngs where we review high risk PCI cases versus open heart surgery, valve

conferences where we look at, should we be doing transcutaneous valve replacements versus

open and what’s going to beneﬁt the pa�ent, and more informal, discussions where I know that

in my cath lab I can call a CV surgeon and talk to them in the middle of a case or have them

come into a lab to evaluate what’s going on.

So, we do think we have this collabora�on that is really able to con�nue to provide great care

for our pa�ents and it meets the standards of what we’re doing for overall STEMI care in guiding

our overall cardiology program.

So, we really think it would be worth reconsidering Corewell Health, as a whole, is asking that,

you know, a reconsidera�on of this rule. We think it might add another layer of cost and

complexity to con�nue doing what we’re already doing within our health ins�tu�on, and I

imagine what other ins�tu�ons are doing around our State as well too. And really in an era that

we are trying to lower costs, deliver high quality care, become eﬃcient, become streamline and

really deliver care to the bedside, you know, we do think that this rule would add to our cost

and complexity with our health system, Importantly, and I think ul�mately, we do think that

there would be a nega�ve impact at the pa�ent care bedside, and that, again, more �me, more

resource, and more money is being spent going a�er accredita�on then what we could be

delivering at, and inves�ng at for our pa�ents. I do appreciate your �me and listening to us, and

we do hope you hear us and consider our message. Thank you.

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RAO: Thank you. Next?

DR. SAMIR DABBOUS: Good a�ernoon, Everyone. My name is Samir Dabbous, interven�onal

cardiologist at Corewell Health East, and I’ve been on staﬀ almost 40 years right now. So, we

run a very good interven�onal program at, what we call right now, Dearborn, and we work

cohesively with the rest of the Corewell hospitals: Royal Oak, Trenton, and other hospitals that

are in the Corewell Health East.

So, I can speak for what we’re doing for quite a while right now. I’m the chair of the Quality

Care Program for Cardiology at the Dearborn, and also chair the (inaudible) commitee. We

review, on a monthly basis, all the pa�ents that come into the emergency room with a Kilo?,

with a heart atack, with a STEMI, and, believe me when I say, we check and review every chart

of every pa�ent and look exactly at what �me did the pa�ent arrived to the ER, what �me did

the pa�ent get the EKG, when was the cardiologist called; no�ﬁed of the STEMI, and what �me

was it when the pa�ent underwent cardio-angioplasty. And we also will take that informa�on

and relay it to the ER physician when the pa�ent comes in with a kilo . And so, there’s always

that dialogue that goes on, on a day-to-day basis, and give that feedback to the ER doctor. And

if there is any missing or delay in the care of the pa�ent, we immediately take care of that, give

the feedback to the physician, or the nurse, or whoever, whether it is posi�ve or nega�ve, and

we make sure that we strive to get (inaudible) room �me within 90 minutes in 100% of the

�me. And we make sure that everybody is taken care of promptly, immediately, and if there is

any delay, we will address it almost within 24 hours.

So, what I want to say is that we really don’t need another body that tells us exactly what we’re

supposed to do, whether how, whether we should be accredited or not because we have been

doing this for quite a while. And instead of spending more money on accredita�on and have

FTEs to look at these metrics and report them to the ACC or whoever. I would rather make,

focus more on staﬃng, pa�ents that we’re having major issues with right now, whether it is the

nursing care or cri�cal care area. Remember, we are just ge�ng over a major health care scare,

ok, because of the pandemic. We lost a lot of staﬃng, and now we are trying to, scrambling to

get that staﬀ back to normal. The last thing we want to do is spend more money on

accredita�on, or whatever we want to call it.

It’s a great thing, it’s a great eﬀort. I applaud you for doing that but not to centers that have

been doing this for, for decades. Thank you so much.

RAO: Thank you. Next?

COLIN MCDONOUGH: Good a�ernoon. Ms. Brennan, Ms. Worden, and the Michigan

Department of Health and Human Services Bureau of Emergency Preparedness, EMS, and

Systems of Care Sec�on. My name is Colin McDonough and I am the Michigan Government

Rela�ons Director for the American Heart Associa�on. Thank you for allowing me to speak

today on the Statewide STEMI proposed rules.

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The American Heart Associa�on strongly supports eﬀorts to enact a robust STEMI systems of

care framework of care in Michigan that addresses both STEMI registries and facility

designa�on. In this tes�mony I will be providing comments on behalf of the Associa�on and will

provide speciﬁc change recommenda�ons through writen tes�mony.

Ge�ng the right pa�ent to the right facility at the right �me for appropriate care saves lives.

The American Heart Associa�on has iden�ﬁed the criteria for care…, for care facili�es should

meet to provide the most appropriate care possible for heart atack pa�ents. States can use

this criteria to oﬃcially recognize the medical centers for their levels of care and develop a

system of care policy that ensures heart atack pa�ents are transported to these facili�es.

Systems of care must be based on the latest scien�ﬁc guidelines, and an ideal system of care

provides pa�ents with seamless transi�ons for each stage of care to the next. There are gaps in

each… gaps and needs at each stage of the care con�nuum, however, that could be addressed

by more coordinated care. Research has shown that appropriate STEMI framework can lead to

improved pa�ent outcomes and is more cost-eﬀec�ve. We must ensure those experiencing

STEMI receive the right treatment as quickly as possible. To discover and implement future

improvements in systems of care for STEMI treatment, it is important for Michigan to set up a

registry infrastructure and require par�cipa�on by cer�ﬁed centers to track the response and

outcome of each incident.

In R 330.201, the American Heart Associa�on recommends upda�ng the deﬁni�ons of

“accredita�on” and “cer�ﬁca�on” and clarify and avoid confusion. For the deﬁni�on of

“disciplinary ac�on”, we suggest including EMS agencies as they may also fail to comply with the

Code. For R 330.203, it is recommended that the deﬁni�on of “PCI” align with the Michigan

Department of Health and Human Services cer�ﬁcate of need review standards for cardiac

catheteriza�on services. Currently, the term does not include the inter-coronary administra�on

of drugs, FFR, or IVUS where these are the only procedures performed. The regional STEMI

advisory council and the statewide STEMI care advisory subcommitee both pose ambiguity

around their membership. For instance, is the American Heart Associa�on considered a

consumer under the regional STEMI advisory council? For both the council and subcommitee,

we recommend a deﬁni�on inclusive of exper�se in this speciﬁc ﬁeld, such as professional

organiza�on with exper�se in STEMI systems of care.

In sec�on (1)(p), we suggest moving “educa�on”, “risk reduc�on”, and “sub-acute”. These seem

to be beyond the scope of the administra�ve Code and capabili�es of the Bureau. For example,

is the Bureau going to improve sub-acute care like post discharge and rehabilita�on?

Addi�onally, the Associa�on requests the removal of the word “comprehensive” in the

deﬁni�on of “statewide STEMI system of care”.

In totality, the American Heart Associa�on believes STEMI should be replaced with “heart

atack”. The term STEMI is a medical term not o�en used and understood by the public. In that

vein, we believe the deﬁni�on of “STEMI referral facility” should include various other words

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like heart atack, chest pain center, and other relevant terms that hospitals may use to adver�se

themselves as providing STEMI or heart atack care.

R 330.204(1)(a) should remove the term “all-inclusive”. In theory, all-inclusive indicates primary

preven�on through rehabilita�on which may be beyond the scope and capabili�es of the

Bureau. Trauma regula�ons use all inclusive, but does this really include sub-acute and

rehabilita�on? The Associa�on also believes (1)(e) should be modiﬁed because Michigan may

have its own cer�ﬁca�on accredita�on based on the deﬁni�on of veriﬁca�on within the rules.

Trauma regula�ons speciﬁcally reference the American College of Surgeons, and the American

Heart Associa�on strongly recommends adop�on of the joint commission American Heart

Associa�on. At minimum, we suggest lis�ng both the joint commission and the American

College of Cardiology.

AHA believes the verbiage surrounding (1)(f) could lead to confusion and should be revisited.

Further, when developing a statewide STEMI data collec�on system, we believe MDHHS should

follow the trauma regula�ons which read, quote: The Department shall do all of the following:

a. Adopt the na�onal trauma data standard elements in deﬁni�ons as a minimum set of

elements for data collec�on, with the addi�on of elements as recommended by the STAC,

unquote.

The state work to develop a process of submi�ng data to the Na�onal Trauma Data Bank. In

these rules, the Associa�on would like to see an exporta�on to get with the guidelines coronary

artery disease. In disciplinary situa�ons, the Department should include EMS, as well as the

STEMI center or facility.

Through the development of a statewide STEMI system of care listed in sec�on (4), we suggest

the addi�on of addi�onal criteria that would incorporate na�onal standards, like developing

another registry and adop�ng na�onal cer�ﬁca�on standards to make the program more

eﬃcient and cost-eﬀec�ve. R 330.205 seems to conﬂict with the State’s cer�ﬁcate of need for

PCI. Can the State designate, verify, cer�fy, or accredit STEMI receiving center Level 1 or 2 if the

hospital hasn’t met CON? Addi�onally, we suggest removing CON to ensure it aligns with

cer�ﬁca�on criteria. There are some CON requirements, including protocols, data collec�on and

measures that may need to be addressed. CON for PCI without SOS requires accredita�on for

cardiovascular excellence, accredita�on, or an equivalent body to perform an onsite review. Is

the Bureau considered an equivalent body?

In R 330.206, the language should read “Level 1, TG…TJCHA comprehensive STEMI center or

Level 2, TJCHA primary heart atack center or ACC pain center” because it will align with stroke

and trauma levels. This will allow for future development of the system of care, especially for

pa�ents STEMI that involved cardiac arrest and/or cardiogenic shock. In subsec�on (i), STEMI

receiving centers will need to comply with CON regula�ons. Those are not men�oned here.

Sec�on (b) should read “Level 3 TJCHA acute heart atack ready center, or ACC non-PCI chest

pain center” because it will align with the stroke and trauma levels. This will allow for future

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developments in the system of care, especially for pa�ents with STEMI that involved cardiac

arrest and/or cardiogenic shock. In sec�on (8) we believe there is a mismatch between the rules

in CON, which limits the number of facili�es that can do PPCI STEMI receiving centers.

Addi�onally, the use of the word “level” should align with our Level 1, 2, and 3 in administra�ve

language to demonstrate they exist.

To eﬀec�vely eﬀectuate a STEMI system of care in Michigan, it is necessary to interface with Get

with the Guidelines. We strongly support the changes men�oned to ensure we can beter serve

Michigan STEMI pa�ents and serve lives, save lives. Thank you for your �me today and I will

provide contact informa�on for any ques�ons you might have.

RAO: Thank you. Next?

DAVID FULLER: Hi, Everyone. My name is David Fuller, and I’m from Corazon, I’m joined by a

couple of my colleagues here today. Thank you for le�ng us present our, our opinions on this

important mater. So, Corazon has long been an expert in the ﬁeld of cardiovascular program

development and management, and its in its 10^thyear as an accredi�ng body for interven�onal

cardiology services, as well as other cardiovascular programing including chest pain centers. Our

accredita�on services are endorsed by the Society for Coronary and Angiography Interven�ons,

which is the leading nonproﬁt medical society for invasive and interven�onal cardiology.

Furthermore, Corazon has been recognized by the Department of Health and Human Services as

an accredi�ng body under the exis�ng CON review standards for cardiac catheteriza�ons

services since 2015, demonstra�ng an ongoing commitment to the health and safety of pa�ents

in community, communi�es across the State.

Corazon supports the goal of standardizing STEMI care across the State of Michigan to improve

cardiovascular pa�ent outcomes. In fact, Corazon has long recognized the importance of

standardizing STEMI care by incorpora�ng STEMI procedures and protocols into our current PCI

and chest pain center accredita�on standards. This includes the ability of hospitals to

appropriately manage STEMI and suspected STEMI pa�ents, with an emphasis on �mely

iden�ﬁca�on, treatment, and evidence-based medical decisions. In addi�on to reviewing

providers’ standards of protocols, Corazon’s PCI and chest pain accredita�ons require quarterly

submissions of key clinical outcomes data, including indices related to the �mely treatment or

transfer of STEMI pa�ents.

Corazon STEMI requirements are based on the same clinical guidelines and best prac�ces as the

other accredi�ng organiza�ons that are named in the proposed rule. This includes the same

requirements related to program readiness, 24 hours a day, seven days a week, access to

emergency services, and the ability of cardiology exper�se as appropriate to the designated

level of care.

As part of its accredita�on process, Corazon ensures medical providers maintain good standing

and experience in line with current prac�ce recommenda�ons from medical socie�es. Corazon

ac�vely par�cipates in ongoing quality improvement eﬀorts, including par�cipa�on in quality

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mee�ngs while on site, valida�on of quality infrastructure, and a quarterly review of program

outcomes. However, it is important to note that Corazon’s accredita�on does not require a

speciﬁc registry to par�cipate. Therefore, not only is Corazon accredita�on poised to beter

comply with the proposed rule, as a registry aspect has not yet been deﬁned, but it also

prevents addi�onal cost burdens for program, programs that may not otherwise need to

par�cipate in addi�onal registries. For example, some providers may manage chest pain

outcomes through an internal dashboard, par�cularly for a STEMI referral center, while others

may already have the required informa�on available through the Michigan BMC 2 Registry.

From our understanding, the BMC 2 Registry is not currently recognized by the other named

accredi�ng bodies, but it would be recognized by Corazon.

Corazon currently accredits 23 hospitals in Michigan for PCI or chest pain services. 10 of these

hospitals have PCI programs that are required to achieve and maintain accredita�on by the

State of Michigan’s CON review standards. Corazon already maintains a na�onal accredita�on

data-, client-base, and has the capacity to accredit the Michigan providers aﬀected by the

proposed rule. Historically, Corazon’s wait �me for an onsite survey averages just two to four

weeks.

Currently, the proposed rule includes language that a provider would need to gain accredita�on

by a Department-approved, na�onally recognized professional cer�fying and accredita�on,

accredi�ng organiza�on. But it includes no informa�on as to how such organiza�ons are

approved. However, the proposed rule then lists two organiza�ons for this accredita�on, yet

amidst Corazon is a named provider despite our approved standing as an approved

cardiovascular accredi�ng body by the Michigan Department of Health and Human Services,

and our ability to meet or exceed the equivalent criteria maintained by the other named

organiza�ons. This omission is already created confusion among Corazon’s Michigan accredited

programs in terms of what the diﬀerences will be between the proposed STEMI accredita�on

and the current PCI accredita�on requirements that already include the necessary quality and

safety monitoring for the STEMI pa�ent popula�on.

There are also concerns related to the confusion this may cause within the community served

by our clients with EMS providers in the State, and possibly even within the Department, as to

the good standing of these programs. In speaking with our clients, we want to be sure that

there will be no addi�onal ﬁnancial or procedural burden placed on them by requiring an

addi�onal accredita�on.

We request, request that paragraph (6)(4)(a) and (b) be amended to include Corazon PCI and

chest pain center accredita�on as recognized STEMI and receiving, and referral center

accredita�on because our experience and current accredita�on process and requirements are

already used by many Michigan hospitals.

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We look forward to con�nuing to work with the Department and the State of Michigan to

ensure Michigan pa�ents receive the best care in the country. Thank you for your considera�on

in this mater.

RAO: Thank you. Next?

DR. ABED ASFOUR: Ah, yes, Abed Asfour. I just want to follow up on the previous comment

that was made regarding the, I don’t think STEMI and stroke and trauma are the same when it

comes to chest painers, because trauma, you can iden�fy it; stroke, 90% or more, it’s iden�ﬁed

that it’s a stroke. STEMI or chest pain for every, chest for every probably thousand chest painers,

there less than one STEMI. So, if we’re going to shi� ambulances and move them away from

local hospitals to just creden�al places, we are shi�ing the whole business. We are dooming

some hospitals for failure; ﬁnancially, and we’re conges�ng hospitals that deliver STEMI

programs, we’re botlenecking them dras�cally. So, I really don’t think they’re all in the same

category, although, I agree with you on every point where we want to improve the care for

pa�ents, but it falls into a diﬀerent umbrella of condi�ons. And I really would want it consider,

you to consider this point because it will be very, in fact, unintended consequences at this point

could be dras�c to the livelihood to a lot of hospitals in the areas. Between rural or even urban

areas, because you’re, we are going to be, if, if any hospital loses accredita�on for it, they, for

any reason, they’ll lose massive business that could doom them to failure. So, I want to just,

consider this point, and thank you for very much for allowing me to (unintelligible).

RAO: Thank you. Next?

RAO: Oﬀ the record.

DR. IVAN HANSEN: Thank you. And thank you to the panel for allowing me to comment today. I

just had a, my name is Ivan Hansen, the Medical Director of Cardiac Catheteriza�on Laboratory

at William Beaumont University Hospital, Corewell East, that’s a mouthful, formerly Beaumont

Royal Oak, and I just had a few ques�ons, actually, about the proposal.

The way I understand it is that there are eight STEMI systems that are being proposed, and it

seems that they parallel the accredited chest pain centers, is that correct? In terms of the chest

pain centers that are accredited and the zones in Michigan…

EMILY BERQUEST: Oh, regions. Yes, there are eight regions.

EILEEN WORDEN: They mirror the emergency preparedness regions and the trauma regions,

and then we use that same piece of geography because that is already organized to add those

other two service centers for Stroke and STEMI, so they’ll be integrated into that exis�ng

organiza�onal structure.

DR. HANSEN: Ok, thank you. And are there any concerns about using that dis�nc�on for STEMI

speciﬁcally since STEMI care involves considerably diﬀerent resources than some of those other

systems of care?

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EILEEN WORDEN: The other thing that we are very clear about saying is we understand the

geography is porous, and that pa�ents ﬂow is, can be conscribed by that piece of geography.

However, we needed a structure so that the groups can sit in some sort of an arranged fashion.

So, that’s why we added the layers to the preparedness region. So, the systems discuss care in

their geography with a loose aﬃlia�on understanding pa�ents can ebb and ﬂow. And they can

also talk amongst each other, the eight regions can talk to each other. They have an

organiza�onal structure like that.

DR. HANSEN: Ok, understood. Thank you. And another ques�on I had was how are the, how is

the advisory commitee chosen?

EILEEN WORDEN: An applica�on. There are some �tles that we’d like to see represented on

those advisory commitees and, once there are submited applica�ons, we will look at them all

we’ll appoint them by then. Are you asking about the regional advisory commitees or the state

advisory commitee?

DR. HANSEN: Sorry, maybe the choice of wording was poor. The advisory commitee on the

crea�on of this proposal, because it was an advisory commitee names listed in the back of

the…

EILEEN WORDEN: Oh, so that evolved from the conversa�ons started in ’06, then we invited a

group of panel of (inaudible) of (inaudible) groups. They met for two years on, Aaron chaired

those workgroups, represen�ng all of the health care systems and the content exper�se they’re

in, and they advised the Department. And that was the result of that paper we had printed, the

white paper.

DR. HANSEN: Ok, right. And so, what you’re saying is that in terms of going forward should this

pass, then they’ll be an applica�on process for an advisory commitee.

EILEEN WORDEN: That’s correct.

DR. HANSEN: Ok.

EILEEN WORDEN: There’ll be an advisory commitee to advise the system as a whole. There is

also each region, each piece of geography that I already described, will have its organiza�onal

board, a regional network council, and we’re using the terms (inaudible) and integra�onal works

the same. A regional professional standards review organiza�on which already exists, and they

are responsible for the care and delivery for stroke and STEMI In that piece of geography, so

that’s their work.

DR. HANSEN: Ok, thank you. And what is the es�mated overall cost of this proposal should it be

implemented overall.

EILEEN WORDEN: The budget is $3 million.

DR. HANSEN: Ok. And the cost of each par�cipa�ng center or…

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EILEEN WORDEN: That I can’t speak to.

EMILY BERQUIST: We don’t charge a fee.

EILEEN WORDEN: We don’t, we don’t charge anything, and we are hoping to, our plan is in the

RFP for the data, the IT project is that data entry would be free for them.

EMILY BERQUIST: It would allow them access to our system for no charge. No charge to them, it

will cost us money, not them.

EILEEN WORDEN: The analysis is that everything else we can feed reports back to them, we can

do inventories, we can do (inaudible), that they will get back from us.

DR. HANSEN: Ok. So, the program will be funded by taxpayer dollars, grant…

EILEEN WORDEN: General fund.

DR. HANSEN: Ok. In the white paper, there was some verbiage to the eﬀect that its

recommended that par�cipa�ng hospitals or centers be accredited by both joint

commission/AHA and ACC, did I understand that correctly?

EILEEN WORDEN: No, it’s either/or.

DR. HANSEN: Either/or, ok.

EILEEN WORDEN: Or an equivalent. But we wrote that, we hope, to establish a baseline for

standards because without them, we have anything (inaudible) in terms of what somebody

would say, this is a STEMI facility. So that was the design is to create a na�onally recognized

standards set, however, any en�ty that can provide that, or an equivalent, or the advisory body

tells us this is equivalent, that will be something we would accept.

DR. HANSEN: Ok. My last ques�on is, my overall sense from this eﬀort is that, if the goal is to

improve access to STEMI care for people who live in Michigan, a lot of eﬀort is being directed

toward geographical areas where there would be no, there would be no access to PCI within 90

minutes of their presenta�on and even access to ﬁbrinoly�c therapy, maybe, not ideal. So that

certainly of, you know, of an area of concern. Now what about centers in my region of

Southeast Michigan where we have mul�ple STEMI centers. How would this regula�on impact

us?

EILEEN WORDEN: Not much, in terms of delivery, once the resources are categorized, the pre-

hospital world understands who has what resources, that is, a provider in the ﬁeld at the minute

decision about whether or not they get an airway, whether or not the closest appropriate is-,

you know, and I know the resources are at this par�cular building. That is something that

protocol and the pre-hospital provider will have that informa�on, that very important

informa�on, to deliver those services. And that’s the fundamental reason to do this.

Categorizing resources so the pre-hospital provider and the sending facility understands where

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to go down the road next. That’s o�en a problem. Who has got the cath lab that’s 24/7 that

doesn’t have an interven�onalist that I need to send them to, especially in the far-ﬂung areas

where they don’t necessarily know? It’s built on rela�onships, not exactly understanding

resources. So, categorizing those really makes it much simpler to make those decisions. And if

things didn’t go well, why not? Let’s have a conversa�on in a RPSRO environment where we can

have a good “why didn’t it work and what can we do beter”?

DR. HANSEN: Thank you. And, I lied, I had one more ques�on. Piggybacking oﬀ…

EILEEN WORDEN: We have un�l 4.

DR. HANSEN: So, for well-established centers that have been providing STEMI care for a long

�me, that choose not to par�cipate in accredita�on bodies, if this proposal passes, what, would

there be some type of puni�ve ac�on against those centers or how would that aﬀect them?

EILEEN WORDEN: Well, if we don’t understand your resources, if you haven’t told us they’ve

been categorized by any en�ty, then, then it’s a challenge for us, right? We don’t understand

what area you deliver, like, you could be the cath lab that is only has, doing diagnos�cs and

would we want to stay there or stop there? Not necessarily ideal for the pa�ent. So, so that is a

considera�on. We are also very clear this is voluntary and inclusive. Those systems are highly

func�oning 100% of the �me when everybody par�cipates. However, it is every facility’s

decision whether or not they choose to par�cipate. We cannot designate you, which is only

something a state can do, so not only are you accredited but are designated by the State of

Michigan as a par�cular level of facility. We can’t do that unless we’ve had some sort of process

that veriﬁes you do have the resources that you say you do. So, this is an eﬀort to codify what

we already know what the trauma surgeons are very conﬁdent about; that they have to deliver

those services. The other thing we want to do is to talk about it from a system perspec�ve. The

EMS provider already knows that appropriately. Did they get to right place, do they have the

right resources, was the care delivery the way you hoped it would be? If not, why not? Talk to

your group, talk to your mentors, talk to your other building surgeons, how can we do this

beter? And I say this with such passion because I know Trauma did it extraordinarily well and

con�nues to do it well. And we would really like to move out that same process to other service

lines.

DR. HANSEN: Thank you. I have no further ques�ons. Thank you.

RAO: Any other comments? Oﬀ the record.

RAO: Back on the record. It is now 4:00 p.m. The public hearing has ended.

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