Good day and welcome to this RHC Technical Assistance conference call. As a reminder, this conference is being recorded.

At this time, I would like to turn the conference over to Mr. Bill Finerfrock. Please go ahead, sir.

Thank you, operator. I want to welcome all the callers, participants of today's presentation to Rural Health Clinic rules update.

My name is Bill Finerfrock. I'm the Executive Director of the National Association of Rural Health Clinics. In addition to being your moderator, I'll also be the presenter for today's program.

Today's program is scheduled for one hour. The first 45 minutes will consist of my presentation and we'll do about 15 minutes dedicated to questions and answers you may have with regard to the rules.

This series is sponsored by the Health Resources and Services Administrations, Federal Office of Rural Health Policy in conjunction with the National Association of Rural Health Clinics.

The purpose of this technical assistance series is to provide RHC staff with technical assistance and RHC-specific information. Today's call is the 13th in the series which began in 2004.

A transcript of all of the previous calls is available on the ORHP Web site in addition to the slides for the previous calls. There is, as you know, no charge to participate in this series. Individuals can sign up to receive announcements regarding call dates, topics, and presentations. And that Web site address is www.ruralhealth.hrsa.gov/rhc.

During the question and answer segment of today's call, we ask that you identify yourself by name location, and the state that you're calling from.

I also want to remind callers that there will be a link to today's presentation as well as the transcript of the call.

What we'd like to do today is talk about the RHC rules situation. For those of you who may be new to the program, I'd like to start out with a little bit of history.

In 1997, Congress enacted a number of changes in the Rural Health Clinic's law that required the Department of Health and Human Services to publish new rules for the RHC program. Those rules were published in February of 2000 as proposed rules.

The public had an opportunity to comment on those proposed rules during a 60-day public comment period at which time the public comment period was closed and the agency went back and reviewed all those public comments.

On December 24, 2003, the Centers for Medicare and Medicaid Services published in the Federal Register new final rules adopting, making changes to the RHC program as part of that rulemaking process.

However in publishing those rules on December 24, 2003, the agency violated a change in the federal law that had been enacted in the time period between the publication of the proposed rule and the publication of the final rule which stipulated that Centers for Medicare and Medicaid Services could not publish a final rule three years after the publication of a proposed rule.

Because the proposed rule was issued in February of 2000 that meant that the department had to issue the final rule by February of 2003. By issuing the rule in December of 2003 they violated that statutory requirement.

That necessitated the agencies suspending any enforcement action on those rule changes. And that was done in a letter to state survey and certification agencies and others involved in the RHC program informing them that although those rule changes appeared on the books no enforcement action or any other action was to occur as a result of those changes. They were, in effect, suspended.

That suspension order, however, is not an official removal or withdrawal of those rules. And so they continue to exist on the books. And it was necessary for CMS to formally withdraw those rules.

On September 22nd of this year, just about a month ago, CMS formally issued a notice withdrawing those rules, the December 24th rules changes, that had been published in 2003. It was issued as what is referred to as an interim final rule.

The words - the inclusion of the word interim is, in a lot of ways, irrelevant and sometimes confusing to those of us who simply have to understand what's going on. The reality is it is a final rule which means that those rules are effectively wiped off the books, those rule changes are wiped off the books, and we revert back formally to the rules that existed prior to the publication of new rules in December of 2003.

Now what does that all mean to you? As a practical matter it means nothing because the program continues to exist today as it did in August of this year, as it did in June of this year, as it did last year, the year before, and the year before that.

Essentially nothing has changed in the RHC program from what you have been doing and what your expectations and anticipation has been with regard to any of the program requirements. All the program requirements you've been operating under continue to be in existence.

In publishing that notice, CMS also let the community know that it is their intention to issue new proposed rules at some point in the not-too-distant future at which time the public will have another opportunity to comment on those proposed rules and CMS will once again seek to make rule changes to the RHC program in order to be in compliance with the statutory changes made in 1997.

At this time, we do not know exactly when those new proposed rules will be issued. Our expectation is that it will be some time after the first of the year. We also don't know officially or formally what will be in that proposed rule although we anticipate that a significant part of the new proposed rule will be the language that was in the proposed rule that they have just suspended.

In other words, CMS will now try to adopt those rules in a way that would be in compliance with the statutory requirements for the agency.

So one of the things that we want to do today is go over what some of those anticipated changes are because there are many clinics that are new to the programs since this whole process started. There are new staff. There are a lot of folks who may not even be aware of the potential changes that may be coming down in the not-too-distant future.

Because this is only an hour-long call we're not going to be able to go into great detail on all the provisions, what the implications may be and what clinics may or may not be able to do to prepare themselves.

I would encourage you to consider attending one of the Rural Health Clinics meetings that we put on or that others put on. We will be having our annual meeting here in Washington, D.C., in November, November 16th, 17th, and 18th, where we will have a very exhaustive and extensive discussion about these rules.

We will have representatives from the Centers for Medicare and Medicaid Services in attendance who can talk about these rule changes and what it is that they're thinking of doing as this program moves forward.

There are - even though these rules have, however, been suspended and now withdrawn, there are some things that did not change that were adopted as part of either the '97 statute or earlier statutory changes to the RHC program that folks also need to be aware of. And we'll go over those today as well.

But one of the key messages I want you to go away with today is that essentially nothing has changed with regard to how you operate your Rural Health Clinic, the rules under which you operate, et cetera.

You are not in any danger of decertification in the near term. You will not be cited for violations of something that were in those rules that have now been suspended.

As I said, this all started most recently on September 22, 2006 when CMS announced the withdrawal. This was done, as I said, because of the violation of the statute that requires them to issue a final rule within three years of the issuance of a proposed rule. And it simply restores the status quo.

Now there are a couple other provisions that continue to be in effect that I did want to bring to your attention. There is a provision that requires that Rural Health Clinics have to have a certain staffing requirement.

And there's been some confusion on this because of the wording that was in the interim rule. The staffing requirement that you all have operated under with regard to physician assistants and nurse practitioners is a 50 percent requirement.

Fifty percent - you must have a physician assistant, nurse practitioner, certified nurse midwife on-site and available to provide care 50 percent of the time that the clinic is open.

In reading the interim final rule what it says is that they are restoring the old requirement that said 60 percent. And you will see that actually in writing in the rule. Unfortunately although it says that, that is not actually what is happening.

The 50 percent requirement remains in effect. The 60 percent requirement is in the regulation but it is no longer reflective of what the law requires, which is 50 percent. I apologize to you if that's confusing but the status is that you are at a 50 percent requirement. You are not at a 60 percent requirement.

There has also been some confusion with regard to the QAPI requirements, the quality assurance program improvement initiatives. Now, I'm still seeking some clarification on this. QAPI had not been before and is not now a mandatory requirement.

It is a voluntary program. My understanding is that if you wish to participate and undertake a quality assurance program improvement initiative you can and that that would be evaluated by your surveyors as part of your recertification. But we are seeking clarification on that.

One of the other questions that has come up is with regard to commingling and whether or not the commingling requirements are now null and void. Commingling has never been a permissible activity. What was published was an attempt by CMS to clarify what constitutes commingling.

And that remains impermissible as far as the clinics are concerned. You cannot commingle your RHC with a non-RHC services on a simultaneous basis. So I just - I wanted to bring those out as separate issues.

In terms of decertification, under the rules that have now been withdrawn, there was a process by which the secretary could move to decertify clinics that were no longer in a rural area or no longer in an underserved area unless the clinic could demonstrate that they continued to be essential to the availability of care in their community.

And there are a variety of ways in which clinics could demonstrate and apply for a waiver of that decertification process. That decertification process goes away. There is no mechanism under the rules for decertifying a Rural Health Clinic.

That issue will have to be addressed under the new proposed rules along with a process for allowing clinics to demonstrate that they continue to be essential. Same thing with clinics that are no longer in rural areas. There is no process for decertifying clinics that are no longer in rural areas as well.

So until the new rulemaking starts and is completed you are not in jeopardy of losing your RHC certification because you are no longer in a rural area or no longer in an underserved area.

At some point, that may become an issue. But at the current time it is not. Along with that - you are not in jeopardy of losing your RHC designation because your shortage area is out of date.

There is a requirement that your shortage area cannot be more than three years old. They will not be able to decertify you because you have a shortage area that is out of date. Again, at some point they may. But at this time they do not.

That provision, the timeliness of your shortage area is, however, applicable to new Rural Health Clinics. If a facility wants to be designated as an RHC they must be able to demonstrate that the shortage area designation that they're using for that clinic is less than three years old.

So that standard is applied to clinics that want to enter the program but it does not apply to clinics that are already in the program. It may at some point but it does not at this time.

In terms of long-term actions, as I mentioned earlier, what changes can we expect?

I believe that there will be additional issues beyond what was in those final rules that will be incorporated into the new proposed rule as well. So it will not simply be a reiteration or re-publication of what's been drawn. But there will be new issues that are brought forward to the RHC community for comment.

Again, I don't anticipate that occurring until after the first of the year. Once that's published we will make that available to the RHC community. Typically when a rule is published there are 60 days for the public to comment on that at which point the comment period closes, the agency reviews their comments, and then publishes final rules.

So at this point that is the best guess that I can provide you as to when we anticipate or what may happen.

So what was in that rule? What I'd like to do now is go through some of the things that were in the rules that have been suspended and because we do anticipate these issues coming forward again. And I think it's important that you be aware of it and potentially be prepared to deal with these changes if and when they come about.

I've already talked about a few of these briefly. The new rules will stipulate that all Rural Health Clinics must be located in an area currently designated as a shortage area. Currently, as I said, means that the shortage area designation cannot be more than three years old.

So for example, we are here in 2006. If the clinic were to contact a state agency and say, "I'm interested in becoming a Rural Health Clinic," and they said what is your date of designation for the health professional shortage area, medically underserved area, or governor's designation that you're looking to use for purposes of RHC.

They would look to see whether or not that was approved or was updated since 2003. So if during 2003 or later, that shortage area designation had been updated and verified as still valid the clinic could use that shortage area designation for becoming an RHC.

If the shortage area designation was done before 2003 then it would not be considered a valid shortage area designation because it didn't meet the current criteria and therefore they could not proceed ahead with the application until such time as that shortage area designation was brought up to date.

The rule that has been withdrawn established a mechanism for RHCs that can no longer meet the location requirements to apply for an exception to this requirement and continue to participate in the RHC program.

This was a mechanism that, as I mentioned earlier, was required by law and stipulates that if you're a Rural Health Clinic that has lost its shortage area designation or its rural designation, the Secretary of HHS has to afford you an opportunity to appeal that determination and demonstrate to the Secretary that you continue to be essential to your community.

The rule laid out some very specific ways in which clinics could demonstrate that they were essential to their community and a timetable under which those considerations for exemption were to unfold.

And those can all be found in those rules. And I would encourage you to take a look at those criteria. If you feel that you are at all in jeopardy of losing your shortage area designation to see what kinds of things you might able to do in order to be able to retain your Rural Health Clinic designation.

The rule also limited the staffing waiver for the PA, nurse practitioner, certified midwife staffing requirement. I mentioned earlier that you must be able to demonstrate that you have a PA, NP, CNM at least 50 percent of the time that the clinic is open.

One of the issues that has come up over the years is what happens when a clinic loses their physician assistant or nurse practitioner, how long do they have to replace that individual? Typically you're given initially 90 days to replace your PA, your nurse practitioner or nurse midwife.

If at the end of 90 days you haven't found a replacement, you would have been subject to citation for a deficiency and potential decertification as an RHC.

However the law was changed several years ago to establish a waiver process by which clinics that were having difficulty finding a replacement could seek a one year waiver of the RHC staffing requirement.

The law was subsequently modified in 1997 to stipulate that that waiver could only be used by clinics that are already in the program. What that means is that when you initially are certified as a Rural Health Clinic you must demonstrate that you can meet the staffing requirement.

You cannot submit a waiver request concurrent with your application to be a Rural Health Clinic. Up until then clinics seeking certification could come in and apply for a waiver at the same time they were applying to be a Rural Health Clinic.

What the law says now is once you're a Rural Health Clinic and you've been certified and you lose your PA, your nurse practitioner, or your nurse midwife, you can then apply for a waiver. But you at least must meet that staffing requirement at the time of initial certification.

That was referenced in the rule. That part of the rule has been withdrawn. But the law remains on the books and so CMS is still bound by the law which means that you still cannot apply for a waiver at the time of initial certification as an RHC.

So even though it has been withdrawn and you see that in the rule it doesn't mean that that requirement goes away.

The rule also codified the definition of a bed for purposes of the RHC cap exception for hospitals with fewer than 50 beds. The key word here is codify. Again, that was done. The underlying change there was done by the statute by the underlying RHC law.

And therefore the change in the regulation was merely a ministerial function to put the language of the regulation to make that consistent with the language of the law. The fact that the regulation now has been withdrawn and that language cannot be found in the regulation does not mean that it goes away because you still have the underlying law.

I like to explain this to people when there's a conflict between the law and the regulation and an interpretation. Many of you may remember the game we played as kids called Scissors, Paper, Rock where whatever you put out something else might trump that.

In that game paper always trumped rock. And in our regulatory/statutory world if you think of the regulation as the rock and the statute as the paper the statute always trumps the regulation.

So it doesn't matter what the regulation says. If the statute is clear, and in this case the statute is clear, just as in the case of the waiver it is clear and the staffing requirement, the 50 percent staffing requirement, the statute is clear. So it does not require regulation in order to make that language effective. The law itself is clear enough. So the law remains in effect.

The rule also clarifies Medicare policy, as I mentioned earlier, as it relates to commingling. And I think the important word here is clarify. It does not - by the withdrawal of the rule and withdrawal of the clarification - it does not mean that commingling is now permissible.

It simply means that the language that was there before saying that commingling is inappropriate remains. However that language is not as clear as it could be.

If you have any questions about whether or not your activities constitute commingling I would encourage you to contact your state survey and certification agency or your fiscal intermediary to get that clarified or to get some assistance.

You can also contact us and we can try and provide you with some guidance if you have questions. And my e-mail is, for those of you who may not know it, is info@narhc.org.

I mentioned earlier that it also codified the PA, NP, CNM staffing requirement. And that continues to remain in effect. It restricted the staffing waiver. And the rule mandated the establishment of a quality assessment performance improvement initiative. That QAPI initiative goes away. There is nothing in the rules now with regard to QAPI.

I do believe, and I'm trying to get clarification, that you can voluntarily do a QAPI.

I do want to talk a little bit about some of these points because there is some confusion. On the issue of commingling I think one of the key things there is to understand that commingling refers to the simultaneous operation as an RHC of a traditional fee for service Medicare practice.

And it's important that we understand that this is all in the context of Medicare. This does not speak to what you're doing with commercial, how you're paid by commercial insurers. It doesn't speak to how you are paid by Medicaid.

This only applies to the internal operations of your clinic as it relates to the care of Medicare patients. And what it says is you cannot simultaneously provide "fee for service" services to Medicare patients within the four walls of the RHC at the same time that you are providing RHC services to Medicare patients by the same personnel.

So, for example, we have a rural health clinic whose posted hours are 9am to 6pm Monday through Friday. During RHC hours of operation, a physician goes go into exam room one and see Mrs. Jones, a Medicare patient, and says, "Thanks for coming in and I appreciate it and he does the evaluation, does the diagnosis, does whatever the physician deems appropriate for that patient, and signs the chart. The patient is released and goes out and the physician says, "We're going to bill you for this visit as a Rural Health Clinic visit." Well it has to be billed as an RHC visit because the services provided were RHC services and it occurred within the four walls of the RHC.

Now the physician then immediately enters the second exam room with a different Medicare patient, Mrs. Smith. This is still occurring during RHC Hours. Mrs. Smith is in need of a procedure and the physician says, "I'm going to perform the procedure while you're here today, Mrs. Smith," and then turn around and bill that procedure under Medicare Part B.

Effectively that physician is simultaneously providing Part B services and Rural Health Clinic services, and that is not permissible.

What they're primarily concerned about is really what amounts to double billing. In those instances the practice is effectively double billing Medicare for that second patient during that procedure because they're getting all the physicians costs, overhead, salary as part of their RHC because it's occurring in the four walls during RHC hours but then they're turning around and billing Medicare Part B for services provided by that same physician during RHC hours in RHC space. And that constitutes double billing.

There's some further explanation of commingling that are in the slides that you were sent. And you can read through those and see what some of the additional criteria are.

I do want to point out that there was an exception to the commingling requirement. And that had to do with situations where there was a critical access hospital or a rural hospital where the rule did allow for the sharing of staff in those situations out of recognition that where you have a critical access hospital/Rural Health Clinic there may be a severe shortage of staff and the necessity to share staff. And therefore that was permissible as long as you maintained an effective tracking and cost allocation process in those situations.

Again, this is one of those situations that's not clear what happens to this provision with regard to the withdrawal of the rule and we are seeking clarification on that.

Next I just wanted to touch briefly on the hospital bed definition. This is really going to be very brief. But for those of you who have Rural Health Clinics that are owned and operated by hospitals with fewer than 50 beds I think it's important for you to understand how beds are counted for purposes of the program.

And this provides you with the citation and reference for how you are to count a bed. One of the key components is that it is a bed that is available. So it does not look at what are your licensed beds. You may be a hospital that's licensed for 60 beds but you are effectively only making 45 beds available because of staffing, demand, whatever the reason.

So even though you may be a 60, a licensed 60-bed hospital, if you only make 45 beds available then you can come in under the 50-bed exception and seek and obtain a waiver of the RHC cap.

So it's important for you to understand how beds are counted. It may make a difference for you as to whether or not your hospital qualifies for the exception or it doesn't.

The RHC certification/recertification criteria are also laid out briefly in the slides that you should have received. And it goes through some of the highlights of those which I've already touched on in terms of the shortage area, et cetera.

I do want to highlight some of the criteria. And I encourage you to go back and review these in greater detail and again if you have questions. There are essentially four ways in which a facility would be able to qualify for an exception and that is if you are considered to be the sole community provider, i.e., you're the only primary care provider in your service area; you are the majority community provider, which means that you are providing the lion's share of the care to the Medicare, Medicaid, and uninsured populations in your community, and there are different ways in which those numbers are calculated; you operate a specialty clinic, and there are specific specialty services that if you are providing certain services, mental health, OB-GYN, some others, that you would be considered to be a specialty clinic; and then if you're in an extremely rural community and there are definitions of what it means to be extremely rural that you could apply for.

And again I would encourage you to review some of those criteria to see whether or not you might be able to comply.

I want to jump ahead to the application of the Part B co-pay and deductible, the revised - the regulations sought to clarify how a Rural Health Clinic must apply the deductible in coinsurance rules for a Medicare beneficiary. It pointed out that the deductible is the same.

The RHC will pay - or the patient pays RHC charges up to the unmet annual deductible. And then it clarifies that Medicare pays 80 percent of the RHC all inclusive rate. The patient is responsible for coinsurance equal to 20 percent of the charges for the encounter.

Now again even though this is a provision that is in the rules this is what is considered a clarification of the RHC rules. Therefore the withdrawal of the rule does not negate any of these. And I don't think that should come as a surprise.

One of the things that's in the rules was a reflection of the fact that there is now the imposition, it has been since 1997, a cap on all Rural Health Clinics payments, the per-visit payment, except for those RHCs that are owned and operated by a hospital with fewer than 50 beds.

Again, this is laid out in the rules. Even though the rules are withdrawn the exception still exists for hospitals with fewer than 50 beds. And the cap continues to apply to all other RHCs and again because the statute is clear on this particular point the withdrawal of the rule does not overturn the underlying law. And the underlying law continues to be operational.

Again, in your slides there are definitions of beds and also there is a special exception definition for hospitals that can have an alternative definition of 50 beds if you are sole community hospital, you are located in a level eight or level nine non-metropolitan area, and you have an average daily census that does not exceed 40.

It's a fairly narrowly construed alternative definition that was put into the rules.

The QAPI program is something that I would encourage all of you to take a look at the slides and try to become more familiar, attend some programs. We will be doing programs and initiatives on how to establish a QAPI.

If you go to the ORHP Web site that was referenced earlier in the presentation you will see some presentations that were done, how clinics had set up a quality assurance program improvement initiative, and information that you can download that might give you some ideas on how to do a QAPI initiative.

As I mentioned this is not a mandatory program. However, we do anticipate that at some point this will become a mandatory program and would encourage you to give some thought to look at this particular initiative and see whether or not there are some things you might already be able to start to do to allow you to be in compliance with the QAPI program once it does go into effect.

Those are really the highlights of what is in the rule and what is - or the rule that has been suspended. I don't think I can say strongly enough that folks should not be getting upset. They shouldn't be concerned. Essentially nothing has changed in the way that you operate your RHC today compared to where you were a year ago, six months ago, three years, et cetera.

The action was taken on the 22nd of September was a ministerial action. It was necessary in order to allow the program to move forward. To get the rules clarified they had to go through this process.

But despite the fact that the language may look like there have been significant changes and in particular things like I said, the staffing requirement, the amount of staffing, the waivers, some of the other provisions, essentially the rules are unchanged from what you have been complying with since you got into this program.

I'm ending a little bit early in terms of my formal presentation. But at this point I'd like to open it up to any questions that you may have for clarification on the rule or anything else that I might be able to assist you with.

Operator, if we can start to open the lines up for questions. I'd just like to remind the callers that when your line is opened up if you would please identify yourself by name and your location, not necessarily the city but the state that you're calling from, it would be helpful. Operator?

Thank you. The question and answer session will be conducted electronically. To ask your question, please press star one on your telephone keypad at this time. A voice prompt on your phone line will indicate when your line is open. And once again, please state your name and city and state when you pose your question. Once again, star one at this time.

And we'll take our first question now.

Hi. (Mary Peterson, Miles Bluff Clinic in Wisconsin.

Hey, Mary.

The - what we are wondering about is the, you know, within 30 miles, Rural Health - another facility within 30 miles.

Right.

Let's say there are other facilities, you know, multiple Rural Health Clinics within whatever radius, 30 or more miles, 30 or less miles. Who is the decider of which of those would survive that scrutiny if that's in the final rule?

Right. I think that's a good question. I think that probably what you would look at is that are there other criteria that you could demonstrate. I think each of these criteria exists as a standalone. In other words, you don't have to meet all of them. You could just meet one.

So it may be that in that situation the sole community provider is not an appropriate exception for you. But you could demonstrate that you are the majority provider for your community which means that over 50 percent of your volume is Medicare, Medicaid, or uninsured for the patient volume that you're handling.

And if each clinic can demonstrate that they are meeting that majority criteria then the sole community criteria becomes irrelevant.

But does the 30 miles then kick in? The 30 miles - even though there is - say there's four within 30 miles and they each can demonstrate one of the exceptions they would each be able to have, maintain that Rural Health Clinic?

Correct.

OK. So the 30 miles gets kind of thrown out the window.

In that particular - I mean, I think that the - we are talking about the sole community provider exception, correct?

Or majority. Is it the majority of the community you're in or is it the majority of the people within the 30 mile - I'm just going by any exception that you may qualify for, whether I - we're in Town A, I qualify for the sole community, in Town B I qualify for the majority. Does the 30 mile criteria kick in?

You still have a - they're still going to look at that criteria as far as who else is providing care. But it's not - as I understand it - now some of this is obviously going to be interpretation. And this may be something during the new proposed rule that we will have to comment on because in many ways we're getting a second bite at the apple.

What was in the proposed rule, some of the things that ended being in the proposed rule were changed to the final rule. So I can't answer your questions officially because I'm not the one who's going to do the interpretation.

But based on our discussions it was felt that clinics could demonstrate different criteria. And so this one might be a specialty clinic, this one might be a majority clinic, et cetera.

I think the other thing is that how they calculate your 30 minute is going to be a reflection of the kinds of roads. So this may be a clinic that is 20 miles away, 15 miles away, and would not be considered within your 30 minute window.

So I think the other thing is where are those clinics located relative to you.

OK. Thanks.

And moving on to our next question.

OK.

Caller, go ahead. Your line is open. No response. We'll move on to the next question.

Who's next? Hello?

Please go ahead, caller.

William Hare, Maurice Community Clinic in Louisiana.

OK.

I'm just trying to get a little further clarification on the commingling. We're new into the RHC program and we are a rural hospital under 50 beds.

OK.

And so this will be a hospital based Rural Health Clinic.

Will be or is?

It will be. It's - we're opening in February.

OK.

And we've already got the designation, the rural designation and the non-urban certification.

OK.

This intends to be an outreach program from our hospital in that we will establish the Rural Health Clinic services as well as expand our radiology department and our lab department to provide those services.

OK.

So what considerations do I have for commingling with that scenario?

Where will the lab and x-ray be located?

They will be located in their own square footage.

So you don't have a (clinical issue).

(In their own clinic).

If they're not located within the RHC then you don't have a commingling issue. It's what's occurring within the four walls of the RHC. And if the radiology and the lab are clearly occurring outside you don't have an issue.

Well, and then the other point is that radiology and lab are not considered RHC services. So even with that you wouldn't have a commingling issue because the technical component of both lab and x-ray are not considered RHC services.

OK. Thank you.

And moving on to the next question.

Yes. This is (Kathy Davis) from Wellington, Kansas.

Hi, Kathy.

A couple questions. My first one is in regards to the decertification part. If you know that you're already not in a shortage area or the rural health but you're under the governor's designation, we are still subject for decertification if you do not meet the four types of essential providers. Is that correct?

No. No, no. Let me understand - if I understand your question. You are not a health professional shortage area and medically underserved area but you are designated by your governor…

Correct.

…as a shortage area.

Correct.

As long as that shortage area designation is current you have - there would be no process for decertification.

OK.

You are in a current shortage area. The decertification only would come into play if your clinic is in an area that it is no longer considered a shortage area, which is health professional shortage area, medically underserved area, governor's designated shortage area…

OK.

…or your shortage area designation is out of date and cannot be brought into compliance.

I got you.

If you have a valid shortage area designation you don't have anything to worry about.

OK. And the governor's exception or the governor is considered a valid shortage. I mean that's just part of that whole definition of…

It's part of the underlying definition…

OK.

…of eligibility for an RHC, health professional shortage area, medically underserved area, governor's designated.

OK.

It has to be current.

Right.

You're not exempt from the current requirement but it is a valid designation for purposes of RHC.

OK. Right and one other question. Just on the - like on the essential provider piece when you're talking about specialty clinic - and I'm asking in particular to the mental health services. Do you have to be specifically a mental health clinic or an RHC that also provides mental health services?

No, an RHC that provides mental health.

OK. So not necessarily a mental - just a…

Right.

…nothing but a - OK. All right. Very good. Thank you.

A Medicare Rural Health Clinic that you are the only one in your area who's providing mental health services.

So if you're - if you've got a mental health service already in your community it wouldn't be beneficial to be an RHC that provides…

Not for purposes if you wanted to use that for the exception because you are not the sole source.

Got you. OK. Very good. Thank you.

OK?

And as a reminder that is star one to ask your question today. And we'll move on to the next question.

Next one?

Hello. Hi. This is Sue (Morrison) from Sparta Community Hospital in Illinois. We're provider based. And I have a question back on when you lose a midlevel. Is it that you have 90 days and if you don't replace then you go and apply for the waiver for the year or do you apply for the waiver right away?

No, I would - I mean, it's your call. I would generally do your due diligence, you know, 30, 60 days. If you're getting up on your 60 days and you really are not having much in the way of response and you're concerned that you're not going to be able to meet the 90, have someone on board by 90 days I would initiate the communication with the state survey and certification office at that point.

Say you are concerned that we're not going to be able to meet the 90 day requirement. And we will probably need a waiver. And go ahead and start it and get the waiver.

If you find someone in 30 days and they come on board you can just give back the waiver. But if you need it it's there and you can just continue operations. So I wouldn't wait until the very end but I wouldn't go in immediately either and seek it.

For your purposes, I mean essentially what you would be doing is losing several months of the waiver. The waivers are routinely approved. There's really not a process for denying a waiver request once it's been submitted.

So you effectively could go 15 months-your 90 days plus 12 months, while you are continuing to look.

Now I do want to point out to folks who may be thinking that they do need a waiver. During the waiver period you must be able to demonstrate that you are actively seeking to recruit an employee, a PA, a nurse practitioner, and a nurse midwife during the time of the waiver.

If at the end of the waiver you still have not found a PA, nurse practitioner or nurse midwife the state will come back and ask you for documentation to show what you did to actively recruit to fill that position.

If you cannot demonstrate to the state that you actively recruited for that position during the waiver period they can make you - they can decertify you back to the end of your initial 90-day period.

So getting the waiver is important. It's easy to do. But there are certain things you need to do during the waiver in order to continue its validity.

OK? Next question?

We have no further questions in the queue.

No. If we don't have any questions or if anybody still wants to buzz in, we can take a few more. We have a few more minutes on the call.

I do want to announce that there will be a transcript of today's presentation available on the RHP Web site. Generally we try and get it a week to 10 days but sometimes depending on how quickly the transcript gets reviewed it slips a little bit.

I do want to encourage you to reach out to others. If you think that there are other individuals who would find value in participating in this conference call series please reach out to them and encourage them to sign up.

The next call will be in mid-November and we will be getting information out about that. As I mentioned I think on the last call we're pleased to announce that this series has been continued by the Office of Rural Health Policy. And we have a - we've been approved for a five-year continuation. We'll be doing six calls a year.

I also want to encourage folks to consider signing up for the Rural Health Clinic list serve which is essentially an e-mail or a list serve chat room, if you will, where you can post questions, responses to questions, and create a network with clinics from other parts of the country. And we get a very - we have a very lively group of participants there. And we get some good discussions going on a range of topics.

Are there any other questions at this point, operator?

Yes. We do have questions in the queue.

OK. Go ahead.

Yes. My name is (Amber) from Kansas. And we're in the process of looking at setting up some provider-based Rural Health Clinics.

OK.

And in regard to the QAPI program, what is your suggestion on that going into this process? Should we - would that be something we look at setting up and establishing as we set forth? Or would you say we should go with the program evaluation at this time?

Well, I would look at the examples and the kinds of things that QAPI is going to be requesting you to do and see whether or not there's some things that would be relatively easy to do as you are setting up your clinic because I do think it's easier to do some things if you incorporate it into the operation at the outset rather than perhaps trying to change your operation a year or so down the road.

But having said that, I would not do anything that requires you to make a significant financial investment or a change in your operations as an RHC because this is going to have to go back through a rule making process.

I think the things that QAPI outlined are good things to do, the things that you might want to consider doing even if you weren't required to do them. But if you were - if you're looking to do it as part of the setup I would look to do something that's relatively simple to incorporate into your overall operations.

OK. Great.

And moving on to our next question.

Hello?

Yes?

Bill, this is a little off the subject but we were wondering if you will be doing another teleconference on Rural Healthcare billing.

I suspect that we will be. We get a lot of requests for that. We had our advisory committee call yesterday or the other day. And there were a couple of the folks said we need to repeat topics because there's ongoing interest in particularly billing and reimbursement kinds of things. So yes, I can tell you that in all likelihood we will do that.

Where are you from? I'm sorry. I didn't hear who it was.

We're from Sparta, Illinois.

OK. Great.

Thank you.

Yes.

And moving on to the next question.

Hi, Bill. This is (Beth Ann) from Michigan. And I just wanted you to go back over the midlevel practitioner waiver because it's in my experience that you cannot apply for that, you know, unless you have 90 days worth of documented, documentation that says you've been recruiting.

So the state really won't even take a look at that and process it to the regional office without a previous 90 days showing that you've actively been recruiting.

Well, I appreciate that. I had not experienced that nor had that communicated to me from other states. But does that not create a time lag? I mean, is it - what has been your experience in terms of how quickly they are turning those requests around?

Well, they scrutinize the data on the documentation, you know, they really scrutinize that. So they look to see when the practitioner left and at what point then you started actively recruiting. They look at all of the recruitment activity that you, you know, that you've done then for the 90 days following the termination of that midlevel.

And then at that point it really takes them probably another 60 days for it to go to the state, go to the regional office and then for them to act on the request.

Have you ever had a situation where a request has been denied?

I have had one denied but that dealt with a CHOW which became a separate issue. I have not had any besides that denied. But I have had them ask for additional information. I've asked for them to have signed affidavits. They wanted signed affidavits from the medical director or from the owner of the clinic.

So I mean, they have come back and asked for additional information to further document your efforts.

Well, I think probably the best thing to do for folks is when you lose your PA, your nurse practitioners, nurse midwife, is contact your state survey and certification office, let them know immediately that that has occurred and ask them what their expectation is as far as actively recruiting during the initial 90 days when they - if you are coming up and you are unsuccessful what it is that they would expect you to do and when they would be willing to accept a waiver application and just work with your state to deal with that issue on a state-by-state basis.

Is that fair?

Absolutely. Absolutely.

Next question?

Moving on.

Hi. This is (Dicey) in California. And we applied at the state level for a change of ownership. And that has gone through but we have not heard from our regional office. Is there a timeline that they have to get back to us by or?

I'm not aware of any timeline requirements for a change of ownership application or form as far as how quickly. There are some things that they have a timeline that they have to approve within and if they fail to do that it's automatically approved.

But I don't - I'm not aware of the application of any of those deadlines to the CHOW. But you said the state has approved it or?

Yes. The state approved it and sent it to the regional office. And I can't even get the regional office to return my calls.

I'm not sure - what type of a change of ownership are you doing?

We went from private RHC ownership to a hospital.

Provider based?

Yes.

Did you - did you fill out all of the requisite criteria form for the provider based designation?

Yes. We sent the whole package to the state and the state did, you know, they kept it for 180 days and then sent it mid-September to the regional office. And they won't even - I can't even get them to return my call to say if I need to do anything or not.

I'm proceeding as normal. I haven't changed anything. But I can't change - apply for a new rate or do anything until I hear from them.

You've got - you've got two issues. One is change of ownership is typically just a notification to the fiscal intermediary that there is a change in ownership. In your case, however, going from an independent to a provider base there are additional criteria that have to be verified and reviewed.

So I suspect that it's the fact - it's not the change of ownership per se but the fact that you're going from independent to provider base and the need to verify that you comply with all the criteria to be provider-based.

And so I would just stay on the regional office. If you want to send me an e-mail separately we may be able to do some checking into it. Just send me an e-mail at info@narhc.org and I'll see if there's anything we can do to try and figure out what's going on.

OK. Thank you.

Yes.

And moving on.

This is (Sherry) from Nebraska. And my question is about the PA having to be in the clinic 50 percent of the time.

Yes.

Was that like an initial rule that was set from the beginning of Rural Healthcare or - because sometimes it just seems like, you know, maybe a doctor could be in there, you know, 60 percent of the time or 70 percent of the time. And so why is that important that the PA be there 50 percent of the time because sometimes I'll find that I have to have two, you know, providers in there just so I can get that PA in there 50 percent of the time.

Sure. It really goes back to the inception of the program, the initial law that was adopted back in 1977. It mandated the utilization of PAs, nurse practitioners, and nurse midwives, actually PAs and NPs initially and subsequently nurse midwives,.

So that is something when it was created by law that the law has required and has always required in the nearly 30 years of operation. So, I mean, it's - you'd have to change the law in order to change that. But that's the way the program was designed.

Do you ever get any complaints about that, that maybe that isn't a good, you know, a good law to have?

We certainly have over the years had some individuals question that. It's not something that anyone has actively sought to change other than to reduce the amount of time. The original was 60 percent as we discussed earlier and then the law was changed to reduce that to 50 percent to allow for some more flexible staffing.

That's the only change that I'm aware of that ever looked at that staffing requirement. So it's certainly something that people are free to raise. I can tell you that there are people who feel very strongly that that requirement should be there.

It is the only federal program that mandates utilization of physician assistants, nurse practitioners, or nurse midwives unlike many programs that mandate utilization of physicians and, you know - so it's a political decision.

OK. Thank you.

Yes.

And there are no further questions in the queue at this time.

And I think that's about the end of our time here, operator. So I want to thank everyone for your participation today. We will have the transcript up on the Web site, and that will be available for you to go back and review.

If you do have questions in the future send them to info, info@narhc.org. I want to thank the Office of Rural Health Policy for their support for this Rural Health Clinic technical assistance series.

And I want to remind everyone to encourage others who may be interested to register for this program. The next call, as I mentioned, will be in mid-November, and we will be putting information out about that.

I do want to say that we will be looking to - in the past we've been holding the calls at three o'clock. We will be looking to conduct the calls at two o'clock Eastern time to try and get it closer to the middle of the day that more people might be able to do this over their lunch hour.

In the future I encourage you to try and call in just a little bit early. It takes some time to sometimes get through so that we try and get started right at the staring time and don't take too much of people's times.

Again, thank you. I appreciate your participation. Look forward to talking to you next month. Thank you.

This does conclude today's conference. We want to thank you for your participation.

END