RHC TA Conference Call Transcript

CAPITOL ASSOCIATES

Moderator: Bill Finerfrock
July 8, 2008
1:00 p.m. CT

Operator: Good day everyone. Welcome to the Rural Health Clinic technical assistance national teleconference. Today's conference is being recorded.

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

Bill Finerfrock: Thank you, operator and I'd like to welcome all of our callers and our participants to today's presentation which is going to consist of a review of the CMS recently released proposed changes to the Rural Health Clinic's rules and regulations.

Because we won't be able to cover all of the information in one call, we will be scheduling a second call to cover those topics not covered today. The date and time for the second call will be announced shortly, and that call will likely occur within the next few weeks.

My name is Bill Finerfrock and I am the Executive Director of the National Association of Rural Health Clinics. And I'll be your moderator for today's call.

Our presenter is Captain Corinne Axelrod, who is the Rural Health Clinic's Coordinator at the Centers for Medicare and Medicaid Services. Captain Axelrod will address the background and highlights of the proposed rule, including the Rural Health Clinic location requirements, proposed changes to the location requirements, and the exception criteria, and will answer your questions at the conclusion of her presentation.

In addition, during the presentation Captain Axelrod will open it up for questions if anybody needs clarification during parts of her presentation.

Today's program is scheduled for an hour and a half, which is longer than our normal time allotment. But given the volume of issues and the gravity of the issues involved, we thought it was important to focus more time and attention than we normally do during these sessions.

This call series is sponsored by the Health Resources and Services Administrations, Federal Office of Rural Health Policy, and is done in conjunction with the National Association of Rural Health Clinics. The purpose of the call series is to provide Rural Health Clinic staff with technical assistance and RHC-specific information.

Today's call is the 25th in the series, which began in late 2004. As you all know, there is no charge to participate in the series. We encourage you to refer others who might benefit from this series to sign up to receive announcements regarding call dates, topics, et cetera. You can go to the Web site, which is www.ruralhealth.hrsa.gov/rhc.

During the question period we ask that you please provide your name and the location you're calling from before asking your question. In addition, for future calls if you have questions you'd like to get into the queue, you can e-mail them ahead of time to info@narhc.org and put RHC teleconference question in the subject line.

You should have received the PowerPoint presentation for today's call, and it will also be available online at the Office of Rural Health policy Web site.

I'd like to take this opportunity to thank Captain Axelrod for spending so much time with us today. And we look forward to hearing her comments and answers to your questions.

Captain Axelrod, it's all yours.

Corinne Axelrod: Thanks, Bill. And everybody, you can call me Corinne. So thank you, Bill, and thanks to everybody for taking the time to join on this call today.

I'm going to go through the PowerPoint presentation, so I hope that you all have that with you.

As you can see on the first slide, this is CMS-1910-P2 Medicare Program, Changes in Conditions of Participation Requirements and Payment Provisions for RHCs and FQHCs, and it's a proposed rule.

On the next slide is all of my information.

What we're going to do today is I'm going to go over very briefly a little background of the RHC program and then some highlights of the proposed rule. I'm going to spend then the bulk of our time today talking about the Rural Health Clinic location requirements and the proposed exception criteria.

But before I start, I want to say that we've really tried our best to develop a set of regulations that are clear and reasonable and strike a good balance between the statutory requirements and your needs and preferences. But I'm sure there are things that we've overlooked or didn't say as well as we could have or maybe aren't quite right.

So I just want to remind everybody this is a proposed rule. Nothing in here is final until the rule is published as final. Please let us know what needs to be changed, and what can be improved.

The Rural Health Clinic program is small in comparison to some of the other Medicare programs. But we all recognize how important it is, and we really want to make sure that rural providers get the support they need so that rural beneficiaries can get the care that they need.

So my apologies in advance for any omissions or mistakes or confusion, and I really look forward to working with all of you as we move through the next stages to get the best possible regulations finalized and implemented.

The Rural Health Clinic program was started in 1977 when the Social Security Act was amended to create the Rural Health Clinic program by extending Medicare and Medicaid entitlement and payment for primary and emergency care services furnished at an RHC by physicians, nurse practitioners, and physician assistants, for services and supplies incidental to their services. As you know certified nurse midwives were added later.

The program authorized CMS and states to pay RHCs on a cost-related basis and required that clinics be located in an area that is designated by the Census Bureau as non urbanized and designated or certified by HRSA – HRSA is the Health Resources and Services Administration – as a shortage area. It contained a “grandfather clause” that enabled an RHC to remain in the program even if it no longer met the location requirements.

If we fast forward 20 years to the Balanced Budget Act, BBA of 1997, the BBA amended section 1861(aa)(2) of the Social Security Act to apply the location requirements to new and existing RHCs and permit exceptions to the location requirements for an existing RHC if the RHC can show that it is essential to the delivery of primary care in the service area. Basically it removed the “grandfather clause”, as that was known.

In response to the BBA, in February of 2000 CMS issued a proposed rule, which was known as P1. We got comments on that, and in December of 2003 we issued a final rule. The final rule was suspended in September of 2006 because the Medicare Modernization Act had a requirement in it that no more than three years could elapse between a proposed and a final rule.

So we went back to the drawing board. We looked at the previous final rule, and we have now issued a new proposed rule, which is known as P2. That's where we are now in the process.

The proposed rule would implement the location requirements of the BBA and establish exception criteria for existing RHCs. That's what we're going to be really focusing on today.

Some of the other important provisions included in the proposed rule would allow RHCs to contract with RHC non-physician providers under certain circumstances, create a one-year staffing waiver for existing RHCs, revise the RHC and FQHC payment methodology, clarify commingling policies, and require RHCs to establish a quality assessment and performance improvement program known as QAPI.

The proposal also solicits comments on high cost drugs and includes other changes that would update the regulations to clarify existing requirements, provide the opportunity to make some program improvements, and comply with statutory requirements.

We'll be talking about these other provisions on a subsequent call. But I did want to just mention them because they're also really important.

One of the proposed changes is using RUCAs, which are rural urban commuting areas, instead of urban influence codes. There are several places in the regulation that currently use UICs, as urban influence codes are known. We are proposing that wherever UICs are used- to use RUCAs instead. We believe they provide a more precise measurement of rurality and they're consistent with other CMS programs, such as the hospital and ambulatory payment program.

Here's some information on how to determine the RUCA for the area that your RHC is located in. You can do it by zip code or by census track, and if you don't know your census track, here's a Web site to find out your census track.

So those are just the highlights. What I want to do now is start going into some of the nitty gritty of the RHC location requirements. In each of the sub sections I'm going to stop and then ask people if they have questions so that we don't have to save them all up until the end.

There are two location requirements. The first one is the RHC must be in a non-urbanized area as defined by the Census Bureau, and the second one is that an RHC must be in an area that has been designated or certified by the Secretary within the previous three years as having an insufficient number of needed healthcare practitioners.

The first requirement is the Census Bureau non-urbanized area. The Census Bureau defines urbanized areas (UA) and urbanized clusters (UC). You don't have to know these definitions, but what's really important is that you pay attention to the distinction between the urbanized areas and urbanized clusters because they can be a little bit confusing.

Both UAs and UCs fall under the category of Urban Areas in the Census Bureau. The first one, urbanized areas, is at least 1,000 people per square mile and at least 50,000 people. If you are in an area that's UA, that does not meet the location requirements for Rural Health Clinics.

But if you are in an area that's a UC, an urban cluster, which has at least 2,500 people but fewer than 50,000, you do meet the requirements for Rural Health Clinics. Sometimes it's a little confusing and so I really – I'll probably be a little redundant here but I want to really emphasize that it is important to pay attention to the distinction between the two.

If you're in an area that's neither a UA nor a UC then you do meet this location requirement. The Census Bureau doesn't really have a definition for rural except that it's not urban. So that's why we have all these double negatives.

How to determine if your RHC is in a nonurbanized area - Here are the instructions, step by step. The last item on that slide can be kind of confusing - the Census Bureau Web site may say “urban area” and it may be followed by “urban cluster”. So if you have any questions about that please call your regional office or you can call me. I know that it's confusing and we don't want you to panic.

What should you do if your Rural Health Clinic is located in an urbanized area? If the Rural Health Clinic is in an urbanized area and meets the eligibility criteria for an exception – we're going to talk about the eligibility criteria in a few minutes – submit an application [letter] to be considered an Essential Provider within 90 days from the effective date of the final rule to the appropriate regional office.

There's a lot of stuff in that sentence and we're going to go through all of it.

Let’s go over what an Essential Provider is. An RHC that does not meet one of the location requirements may be considered an Essential Provider if primary care services would otherwise be unavailable in the geographic area served by the clinic. There is some eligibility criteria for the urbanized area location exception.

If your RHC is in a UA (an urbanized area), and you want to apply for an exception, the RHC must be in a level four or higher RUCA and it must demonstrate that at least 51 percent of its patients reside in an adjacent non urbanized area, and it must have a current shortage area designation.

If your RHC is in an urbanized area and meets these three criteria and, you can apply for a location exception.

To recap, there are two location requirements. The first is that the RHC must be in a non urbanized area. We went over how to determine if your RHC is in a non urbanized area, what is an Essential Provider, and what criteria you have to meet in order to apply for the exception based on being an essential provider.

I want to stop and take questions now, but I also have to note that because we're in a comment period, I can only answer clarification questions of things that are in the proposed rules.

So if there's any questions that you have about what we've just covered that's not clear, this would be a good time to ask. But if you have other comments about it, I may not be able to answer that.

Operator, do you want to just tell people how to ask questions?

Operator: Thank you. If you'd like to ask a question, press star one on your touch-tone telephone. Please make sure your mute function is turned off to allow your signal to reach our equipment.

Again, press star one for questions. A voice prompt on your phone line will indicate when your line is open to ask a question. Please state your name and your state before posing your question.

And we will take our first question.

Male: Go ahead, caller.

(Sue Ann): Hi. This is (Sue Ann) from McCloud, California. If you’re neither urban or UA or UC, do you also have to meet an essential provider requirement?

Corinne Axelrod: The question is if your RHC is not in a UA or a UC, do you have to meet the essential provider requirement and the answer is no because you meet this location requirements. If you're not in a UA, your fine, you don't need to do anything else.

Operator: And we will take our next question.

(Cindy Jenkins): Hi. This is (Cindy Jenkins). I'm in (Walden), Colorado. And this is not actually about what you've done, but we would like to know what Web site so that we can find your slides because we weren't sent anything.

Bill Finerfrock: Those will – they're not up there right now. They will be up on the Offices of Rural Health Policy Web site. There wasn't sufficient time to get them up. If you want to send me an e-mail to info – INFO – @narhc.org, I can get them sent to you. They should be up on the RHP Web site within the next 24 to 48 hours.

(Cindy Jenkins): OK. So we're not missing anything that we don't have those.

Bill Finerfrock: I'm sorry?

(Cindy Jenkins): We didn't get those – we didn't get anything so we're not missing anything to follow along on the slides then, correct?

Bill Finerfrock: I guess. I'm not sure if I understand your question. I'm not sure – I don't know how you got the information on the call. We sent out the slides to all the people on the list serve. If you didn't get it then you must have gotten it from somebody who got it from the list serve. I don't know where you got the call-in information.

We can arrange to get you the slides, but we can't do it right now.

(Cindy Jenkins): OK. Thank you.

Bill Finerfrock: I have a question. In the slide regarding the application process, it implies that it is up to the clinic to know that it is in an urbanized area and to take affirmative steps to apply for the exception if they meet the RUCA requirement.

It is up to them to know that? They won't receive notification from CMS indicating that you believe that they are in an urbanized area?

Corinne Axelrod: That's correct.

Bill Finerfrock: OK.

Operator: And we will move to our next question.

Bill Finerfrock: Go ahead, caller.

(Lisa Killely): This is (Lisa Killely) from South Dakota. And I just wanted to ask are all the counties within a metropolitan statistical area considered an urban area?

Bill Finerfrock: Do you want me to answer that?

Corinne Axelrod: Yes. Go ahead, Bill.

Bill Finerfrock: Metropolitan's statistical area is a methodology that is maintained by the Office of Management and Budget and uses different criteria to determine whether or not a community is identified as a metropolitan statistical area. They are countywide so that every entity within a county that is part of the MSA would be considered an MSA.

The urbanized area criteria are maintained by the Census Bureau and are done on a community-by-community basis and are not countywide. So there's nothing in the RHC program that applies to the MSA. You have to specifically look at the Census Bureau's designation of urbanized areas.

(Lisa Killely): OK. Thanks.

Operator: We will take our next question.

(Todd Windher): This is (Todd Windher) with (Vilami) County Hospital in (Milad), Idaho. My question is in regards to the recruitment of providers for your Rural Health Clinic.

Do you stand a risk of recruiting too many docs, and no longer being a medically underserved area?

Corinne Axelrod: If you don't mind, I'll hold that until we get to the next section where we're going to be talking about shortage areas. We can address that then.

(Todd Windher): OK.

Operator: We will move to our next question.

Bill Finerfrock: Operator, this would be the last question for this section and then we'll move on. Any other questions that don't get to we'll have to take later in the presentation.

Operator: Very good. Questioner, please go ahead.

(Chris Sparks): This is (Chris Sparks) in Washington State. When we looked at clinics that are now located in urbanized area, none of them would meet the RUCA four or greater requirement. Are there places in the country that meet that RUCA requirement that are urbanized areas?

Corinne Axelrod: I think this is one of those questions that falls into the category of not really clarifying something that's in the regulation. So I'll have to defer on your question.

Bill Finerfrock: One of the things, though – and this speaks of a comment that Corinne made at the outset which is - these are proposals. And there's nothing that precludes clinics, states, organizations, from proposing alternative methodologies or alternative means of fulfilling this exception.

And so if folks don't feel that what has been put forward is adequate or appropriate or whatever, it is certainly within the context of a proposal to offer up an alternative for consideration. So if Washington State, for example, wanted to put forward an alternative proposal, this would be the appropriate forum, not today's call, but the public comment period, to put that forward for CMS to consider during this process.

Operator: And please continue with your presentation.

Corinne Axelrod: OK. Thanks, everybody. The second requirement is that an RHC must be in an area that has been designated or certified by the Secretary within the previous three years as having an insufficient number of needed healthcare practitioners.

Designation applications are usually prepared by the state, not the Rural Health Clinic. There's a list of the state primary care offices available at the Web site that's listed here, HRSA's Web site. HRSA has been doing a lot of upgrades to their Web site so things move around a little bit. But hopefully you'll be able to find that easily.

The designation applications are submitted to HRSA, and that is their Web site. This is not something that the Rural Health Clinics normally do. It's usually the state that submits those.

There are four types of designations that satisfy this Rural Health Clinic location requirement; geographic health professional shortage areas – known as HPSAs - geographic HPSAs and population group HPSAs, medically underserved areas, and governor-designated and secretary-certified shortage areas.

The designation types that are not acceptable are medically underserved population designations, automatic HPSA designations, safety net facility designations, dental or mental health HPSA designations, state designations (these are different than the Governor-designated, Secretary-certified ones that are listed above), and basically any others that are not among the four that are listed above. These four are listed in the statute as the only types of designations that are acceptable for RHC certification.

The next slide has instructions on how to determine if your Rural Health Clinic is in a designated HPSA, either a geographic or a population group HPSA. So for the first two types of acceptable designations, this is how you would determine if your RHC is in an area that is designated.

When you go through all these steps, the HPSA screen will come up with the information that’s on this slide that says “HPSA Screen” I’ve underlined the information that is relevant for us.

All of the Rural Health Clinics should know the designation that they are included in. HPSAs can be countywide, they can be a group of townships, they can be one or more census tracks. You want to make sure to know what designation you're part of.

You want to make sure that the area’s status is designated, then type of designation which is the geographic population group, et cetera, and most important is the date of the last update.

The next type of acceptable designation is the MUA, the medically underserved area. Here are the instructions on how to find out if your Rural Health Clinic is in a designated MUA. The next slide is how to determine if your RHC is in any governor-designated, secretary-certified shortage area.

This is not on the HRSA Web site so if you are not in a geographic or population-based HPSA or an MUA then you may want to call HRSA's shortage designation branch – here's the phone number – and ask them if you are in one of these types of designations.

I do want to mention that HRSA has a proposed rule right now that I think many of you are aware of. We’ve gotten a lot of questions about how this proposed rule links up with HRSA's proposed rule.

HRSA's proposed rule proposes changes to the methodology to determine designations. It does not affect the requirement that an RHC be in a designated area. In HRSA's proposed rule, the methodology has tier one and tier two designations. Either one of those would be accepted. Our requirement is that the RHC be in a designated area. It doesn't matter to us if it's a tier one or tier two designation.

We have looked at the data. More RHCs are in areas that retain their designation under the proposed method than under the current method. Also, when that proposal is finalized, many areas will be automatically designated, so that will also help in keeping tabs on what areas are currently designated.

OK. So what to do if your RHC is not in a currently designated area? Well, I'd say the first thing is don't panic. Contact your state primary care office to determine if an application to update the designation of the area that the RHC is located in has been submitted to HRSA.

If HRSA has received a designation application, either for a new designation or an update to an existing designation for the area where the RHC is located, before the end of the three period since the last designation, then no action is needed.

Bill Finerfrock: Corinne, can you amplify on that what that means?

Corinne Axelrod: Yes. RHCs by law are required to be in an area that has been designated or updated within the past three years. So we really encourage the Rural Health Clinics to be proactive in knowing what designation their RHC is part of and keeping track of the date of that designation.

If the area is getting close to the three-year mark since it was last updated then you may want to contact your primary care office to see if they have submitted an application to update the designation. Or if your Rural Health Clinic is not in an area with a current designation, call them because they may well have already submitted an application to designate that area.

That would really be the first step - has the state sent in an application to update the area? Then if they have done that before the end of the three-year period – and I have some examples that we'll go through in just a minute – then you're fine. You are protected from being decertified based on not meeting this location requirement.

Bill Finerfrock: So if it should take them two years to get through to that application, nothing would happen to the RHC during that time period as long as the application was pending?

Corinne Axelrod: That's correct. If your three years is up today – today is July 8 – and the state sent in an application three weeks ago and HRSA received it last week, then even if HRSA took two years to review it, you’re fine. I'm sure that most people would prefer having the peace of mind of knowing that the designation application for their area has been approved. But the fact is that as long as the application has been submitted prior to the end of the three years, no action is needed and you're protected from decertification base don not meeting this requirement..

OK. I'm sure there'll be more questions on that, but why don't we go on right now. The next slide is “When to Apply for an Exception to this Location Requirement”. If the Rural Health Clinic is not in an urbanized area – in other words, the Rural Health Clinic meets the first location requirement – and HRSA has not received an application to designate or update the area before the end of the three-year period, then you should apply for a location requirement exception.

If HRSA has received an application to update the designation but determined that the area no longer qualifies for one of the designation types accepted for RHC certification, then you should apply for location requirement.

Sometimes you may have been in an area that was designated and when it's time to update that designation, the area may no longer qualify for designation. So the state may reconfigure the service area. So you always want to make sure that you are still part of the designation.

And sometimes the type of designation may change. It may change to another type that is still acceptable – for instance from a geographic HPSA to a population-based HPSA, that's not a problem. But there may be some other types of designations that don't qualify.

These are the two conditions under which you would probably want to apply for an exception to the location requirement if you don't meet the requirement of being in a designated area.

OK. “When to Apply for an Exception to this Location Requirement”. Submit an application for an exception to the appropriate regional office within 90 days from the date the designation is no longer current or within 90 days of the effective date of the regulation, whichever is later.

Some people are in areas that have not been designated for years. Generally provisions of a rule go into effect 60 days after the rule is published as final so 90 days after those 60 days would be the deadline for submitting an application for an exception.

If you are in an area that is currently designated but at some date in the future is no longer designated then you would have 90 days from that date. The regional offices will have another 90 days to review the application for an exception to the location requirements. Denial of an exception request can be appealed and there's the regulatory citation for appeals.

Again, RHC is protected from decertification if HRSA has received an application to update the designation before the end of the three-year period. We also really want to emphasize that a clinic that is decertified as a Rural Health Clinic may apply to become another type of Medicare provider who would then bill Medicare using the fee for service system. I do want to say that it is not our goal to decertify clinics. I know there's a lot of concern about that, but that is not our goal - our goal is to comply with the statutory requirements that an RHC be located in a rural area and a shortage area.

The decertification would be effective on the last day of the month in which the 180 day limit was met. The 180 days is the 90 days that the RHC has to submit an application for an exception and then the 90 days that the regional office has to review that.

It would be advantageous for the RHC to submit the request for an exception as soon as possible in the 180 day period just in the event that you are not granted the exception, you'll then have more time to make other arrangements. We would advise people to not wait until the 89th day to submit their application to the regional office.

We are also aware the surveying can take a while in some states. Therefore, a provider-based clinic that does not meet the location requirements and does not qualify for an exception and has submitted to CMS an application for another type of Medicare to be another type of Medicare provider that requires a state survey for certification would have another 120 day extension, and that's on top of the 180 days of their status as an RHC while their application is being processed.

I'm going to go through a few examples now. In these examples, the Rural Health Clinic is located in an area that was designated as a geographic primary care HPSA – that's the first type of acceptable designation – on January 1, 2006. That would mean that the deadline for an application to HRSA, which is submitted usually by the state, to update the designation for RHC certification would be January 2, 2009. That's the three-year window.

Under the first scenario, an application to update the designation was received by HRSA before January 2, 2009 and the application was approved. The area's designation is updated so no action is necessary by the Rural Health Clinic for three years from the date of the designation update.

In other words, an application for an exception is not necessary. The designation has been updated so the Rural Health Clinic is fine for three more years.

In the next example, the RHC is in an area that was designated on January 2, 2006 but the application to submit the designation is not submitted to HRSA by January 2, 2009. The Rural Health Clinic would then have until April 2, 2009 – which is 90 days – to submit the request to their regional office for an exception. Again, we would encourage any Rural Health Clinic in that situation to submit their application as soon as possible.

If the RHC doesn’t submit the application [letter] for an exception by April 2, 2009, then it would be decertified July 31st, which is the last day of the month of the 180 days.

I hope this is not too confusing. Again, there's a three-year window and if the application is submitted to HRSA before the end of the three years, you're fine. If it's not submitted before the end of the three years then you would need to apply for an exception to this location requirement. And if you do not apply for the exception then you would be decertified on the last day of the month, 180 days after the three year date.

The next example is that the application to update the designation is not submitted to HRSA by January 2 of 2009. The Rural Health Clinic has until April 2 – 90 days – and the RHC does submit the application by that date, the regional office has up to 90 days to review that application and make a determination. In this scenario, happily, the regional office has approved the exception and so no action is needed for three years from the date of notification.

In the next scenario, the Rural Health Clinic is in an area that has not been updated, an application to update the designation has not been submitted in time, the Rural Health Clinic submits an exception application to the regional office and that exception application has been approved.

The Regional Office will notify the Rural Health Clinic and the date of the notification is when that clock starts for the next three years.

Bill Finerfrock: Corinne?

Corinne Axelrod: Yes?

Bill Finerfrock: You used the word “application” with regard to this process. Is it actually what I would in my mind's eye envision as an application? Or is it better described as a letter requesting consideration of the shortage area designation or a letter to the Regional Office requesting the exception? Or are there actual applications, documents, forms, that folks would need to fill out?

Corinne Axelrod: That's a good question, Bill. There are no forms. At some point perhaps there might be. I don't know. But there are no forms. Your language is probably more accurate that it's a letter requesting consideration as an essential provider.

Bill Finerfrock: OK. Thank you.

Corinne Axelrod: OK. Thanks. In the last example I have here, the application to update the designation is not submitted to HRSA by January 2 of 2009. The Rural Health Clinic has until April 2 – that's the 90 days. They submit the exception application and the Regional Office disapproves the exception request.

The Rural Health Clinic would be decertified 90 days from the date of notification by the Regional Office. Again, it would be effective the last day of the month.

I'm going to stop here again and take your questions. I know this is kind of a confusing area with all these different dates.

So, operator, do you want to open the lines up again for any questions?

Operator: Thank you. As a reminder, press star one on your touch-tone phone if you'd like to ask a question. Please make sure your mute function is turned off to allow your signal to reach our equipment. A voice prompt on your phone line will indicate when your line is open to ask a question. Please state your name and location before posing your question. And we will take our first question.

Questioner, your line's open. Please state your name and location.

(Brian Badchodder): This is (Brian Badchodder). I'm in Morrow County, Ohio. The scenarios you have right now, as I recall just recently it's been actually four years since we have had an update to our designation area. And we're – in fact, I am – going through the process locally trying to get all the information so the state can submit it.

What if the state itself is behind any application process or has not done it when this rule goes into effect? How does the retrospective aspect account for this? Or can you go through that scenario?

Corinne Axelrod: Yes. Thank you. States are all different in the way that they manage their designation process. And so some states are more able to keep track of the designations than other states. There's a lot of variation among states.

That's really not something that we have any control over. So we really encourage people to work with their state primary care office.

I think all of the states are well aware of the requirements for Rural Health Clinics. And one of the problems is that the statutory requirement for Rural Health Clinic is that the designation be no more than three years old. That's a different cycle than the normal cycle for designations.

But again, that's a statutory requirement. That's not something that we have any control over. So all I can say is that we really encourage you all to work with your states. And we will try to keep everybody informed as to the importance of keeping these designations current for Rural Health Clinic purposes.

Bill Finerfrock: Corinne?

Corinne Axelrod: Yes.

Bill Finerfrock: I know this isn't in your area but as with the exception, a request for update can come from anyone, can it not, for the shortage area designation?

Corinne Axelrod: That is correct. They usually come from the state. Anybody can submit an application for a designation. However, the state then will have the opportunity to comment on it. That's really a HRSA issue in terms of what they accept.

I would suggest that anybody who has questions about that contact HRSA's Division of Shortage Designation. Generally it's really best to work with the state and certainly help them in gathering any information that they require. But you're right that anybody can actually submit the designation applications.

Bill Finerfrock: So if a state was being slow – or particularly backlogged – and the application had not been submitted, or the request, if a Rural Health Clinic were to send a certified letter to the Office of Shortage Designation formally requesting an update, would that be satisfactory for meeting your standard that says that the application request has been submitted and is therefore pending and that RHC being proactive would therefore protect itself from adverse action until such time as it was updated?

Corinne Axelrod: The requirement is that a complete designation request be submitted. So it really would depend. And in many cases it would not – it may be easier for some Rural Health Clinics to do this than others, depending on the service area that the Rural Health Clinic is located in.

If the application is complete – meaning that it has all of the required information for the existing designation – then yes, that would be acceptable. But I do have to emphasize that it needs to have all of the information for that service area which would include data not related directly to the Rural Health Clinic.

Male: OK. Thanks.

Operator: And we will move to our next question.

(Sumra): This is Dr. (Sumra) in North Dakota. My question is about the HRSA designation areas. What kind of factors go into the consideration?

Corinne Axelrod: The question is about what factors go into consideration for the designation. It depends on the type of designation. It includes factors such as identifying the service area which could be anything from a group of census tracks, a group of townships, a county; the providers in that area; and other factors.

You may want to look at the HRSA Web site. I think that Web site is included here. The HRSA Web site actually has quite a bit of information on the criteria for each type of designation.

(Sumra): Thank you.

Operator: We will move to our next question.

(Allison Hughes): Hi. This is (Allison Hughes) in Arizona. Corinne, a couple of questions. One, has a similar call like this been held between CMS and all of the states in order that they are on the same page?

Corinne Axelrod: This is the first call of this type. The rule was published last week. so this is the first call. We don't have a formal relationship with the state primary care offices. That comes out of HRSA.

HRSA has a regularly scheduled monthly call with the state offices. I did speak with HRSA’s Division of Shortage Designation Director Andy Jordan the other day. The primary care offices have been told about this over the last several years. She has agreed to include that again on their next call just so they're all aware that the proposed rule has been issued.

Again, that would be something out of HRSA's Division of Shortage Designation.

(Allison Hughes): Right. My next question is we had heard that for applications for new Rural Health Clinic designation, CMS had told the state licensure offices to put this at the bottom of the barrel in terms of the site reviews, that it was not a high priority. Is that true? And how are you handling requests for new Rural Health Clinic designations?

Corinne Axelrod: YTis is not part of this proposed rule but I do want to answer it because it's an important question and sitting here with me is Shonte Carter from our Survey and Certification Division and she's going to answer your question for you.

(Shonte Carter): Hello, everyone. A few months back we did issue a letter – I believe it was regarding (our) budget in the tier placement of all surveys. And initially we did have those surveys placed in tier three [correction – tier four].

But after reconsideration of some of the information that was submitted to Central Office, I do believe another letter was issued to the Regional Offices and also forwarded to the state agencies which actually increased the tier level, I believe moving it up to tier two [correction – tier three]. I'm not exactly sure. But it did increase the level.

But it depends on each individual state and the state's budget. And the state does have the final decision on when they'll be able to survey new provider type covenant, not just RHC's but across the board.

So it is state specific, but the tier level has been increased. But again, it is state specific. And it really just depends on where that RHC is located and the need.

Operator: We will take our next question.

Bill Finerfrock: This will be the last one and then we'll have to move on for this section.

Operator: Very good. Questioner, please go ahead.

(Tom): This is (Tom) from Missouri. And my question is if in scenario four the request for an exception is denied then there's an appeal process. Is the clinic decertified and then has to appeal? Or is the decertification put on hold during the appeal?

Corinne Axelrod: That's a good question and I'm not sure of the answer to that so I'll have to check that out. I'm not familiar with the appeal process. That may be something that you want to send a comment in on and that way we can clarify that in the next round.

(Tom): Thank you.

Corinne Axelrod: Thank you. OK, let's move on to the next section, the proposed Rural Health Clinic location exception criteria. There are four different categories: Sole Community Provider, Major Community Provider, Specialty Clinic, and Extremely Rural Community Provider.

Some of you that are familiar with the 2003 final rule will recognize these.

The term “Participating Primary Care Provider” means another RHC, FQHC (a federally qualified health center), or a primary care provider that is actively accepting and treating Medicare beneficiaries, Medicaid recipients, low-income patients, and the uninsured regardless of their ability to pay. It's a phrase that is used here so I just wanted to clarify that right up front.

Bill Finerfrock: So I'm just going to – if we can just pause a second on that, Corinne, because I do think this is an area where there has been some – I know we've heard questions.

If you're a physician who's in private practice and you know you're seeing Medicare or Medicaid patients but a physician does not see low income or uninsured patients – in other words, doesn't have a sliding scale or anything of that nature – for purposes of the exception process, that privately practicing physician would not be considered a participating primary care provider. Correct?

Corinne Axelrod: The primary care provider you said is not seeing Medicare or Medicaid or low income or the uninsured?

Bill Finerfrock: Is seeing Medicare or Medicaid but not seeing low income or uninsured.

Corinne Axelrod: That provider would be considered a participating primary care provider. I think that when we go through these in terms and when we get to the major community provider, for instance, there's a distinction between some of these.

So let me go through these and we can come back and talk about that some more.

Bill Finerfrock: All right.

Corinne Axelrod: The first one is the Sole Community Provider. This one is probably the easiest one. The RHC is at least 25 miles from the nearest participating primary care provider or at least 15 miles but less than 25 miles from the nearest participating primary care provider and can demonstrate it's more than 30 minutes from the nearest primary care provider based on local topography, predictable weather conditions, or posted speed limits.

For some clinics this would be easy because there's nobody else within 25 miles. Other clinics, there may be nobody else within 15 miles, but based on the local conditions it would be more than 30 minutes to that other primary care provider. So that would be the first category for eligibility.

The second one is the Major Community Provider. For this one the Rural Health Clinic has to meet both of the following requirements; has a Medicare, Medicaid, low-income and uninsured patient utilization rate greater than or equal to 51 percent or a low-income patient utilization rate greater than or equal to 31 percent.

Low income can include Medicaid and the uninsured. The first one includes Medicare. The second one includes any combination except for Medicare that meets that requirement and is actively accepting and treating a major share of Medicare/Medicaid low-income uninsured patients compared to other participating primary care providers that are within 25 miles of the RHC.

I want to comment on the term “major share”. It's not quantified and that's intentional because we know that there is considerable variation within a community. Factors such as the size of the community, the number of Medicare beneficiaries, the number of Medicaid recipients, the availability of other providers, all of those things could be considered. We want to provide as much flexibility as possible to show that the Rural Health Clinic is actively accepting and treating a major share of these populations.

The next one is the Specialty Clinic, and that could be either obstetrics/gynecology, or pediatrics. In this one, the RHC would have to meet all of the following requirements; that it exclusively provides OB/GYN or exclusively provides pediatric services; it's actively accepting and treating Medicare/Medicaid low-income uninsured patients – and obviously that's as applicable because if it's a pediatric clinic it may well not have any Medicare patients – it has a Medicare/Medicaid low-in patient and uninsured utilization rate greater than or equal to 31 percent; and it provides these services on site to the clinic patients; and it's a sole or major source. I won't read all this to you because it's right here but it's similar to the other one.

On the obstetrics/gynecology as well as the pediatric, being a specialty clinic does not mean that the clinic has to provide every type of OB/GYN service or every type of pediatric service.

For instance there may be types of conditions that the pediatric clinic may not treat , or the ob/gyn clinioc may not do deliveries – but in any case, if a clinic, for instance, is exclusively providing prenatal care, that would fall under the category of OB/GYN clinic. If the clinic is providing prenatal care and other OB/GYN services, that's fine.

I just want to make the point that it doesn't mean that everything possible under those categories has to be provided. I hope I didn't make that more confusing!

The next category is the Extremely Rural Community Provider. In this category, the Rural Health Clinic needs to meet both of these following requirements: It's located in a frontier county which is six or less persons per square mile as determined by the Census Bureau or is in a RUCA code 10, and is actively accepting and treating Medicare/Medicaid low-inc and uninsured patients.

Just a note here - the previous regulation used UICs, urban influence codes, eight through nine. Those urban influence codes have been revised, so what used to be UICs eight through nine is now UICs nine through 12. About 25 percent of the Rural Health Clinics are in UICs nine through 12, and about 36 percent of the Rural Health Clinics are in RUCA 10s, just to give you a little context on that.

In the 2003 final rule, there was another category which was mental health specialty clinics. That was included as one of the types of specialty clinics that was acceptable for the location requirement exceptions.

However, the statue prohibits a Rural Health Clinic from being a facility which is primarily for the care and treatment of mental diseases. Because the statue imposes a ceiling on mental health services, we really questioned whether it's still appropriate to include Rural Health Clinics that provide mental health services for the purposes of an exception to the location requirement.

Let me clarify that a Rural Health Clinic can still be a mental health specialty clinic as long as it meets both the location requirements and not more than 50 percent of its services are mental health. But in terms of using this category for the purposes of an exception to the location requirements, we really want to solicit comments from the community of whether that is still an appropriate category, and if so, should there be a minimum level of mental health services in order to qualify for an exception?

This is something that we're specifically asking for comments on. We recognize the importance of mental health, especially in rural communities. But the statute does limit the amount of mental health services that a Rural Health Clinic can provide, so we are soliciting comments on that.

Let me stop here and take any questions that you may have on these categories for exceptions.

Operator: And as a reminder, press star one if you'd like to ask a question. A voice prompt on your phone line will indicate when your line is open to ask a question. Please state your name and location before posing your question.

We will take our first question.

(Derek Gruen): Good afternoon, Corinne. This is (Derek Gruen) from (Hanford), California. How are you?

Corinne Axelrod: I'm good, thanks.

(Derek Gruen): Good. I have two questions for you. In your example, if I could take you back to the location requirements, in your PowerPoint presentation you used the word "and" after the Census Bureau definition. In the rule, it appears to say "or".

Can I understand clearly if our situation is we've just crossed over the Census Bureau definition for urban that essentially trumps any exceptions that we may be able to apply for?

Corinne Axelrod: Tell me the title of which slide you're looking at.

(Derek Gruen): It is Rural Health Location Requirements. It's about six or seven slides into your presentation.

Corinne Axelrod: It's the one that has the Roman numeral three and says, “Rural Health Clinic Location Requirements”, two location requirements, and one and two? Is that the one?

(Derek Gruen): Correct.

Corinne Axelrod: OK. There are two location requirements. The Rural Health Clinic must be in a non-urbanized area as defined by the Census Bureau and it must be in an area that has been designated or certified within the previous three years.

"And" is correct. That comes directly out of the statute. That has been in there since 1977 in terms of the requirements for RHCs. The RHC does need to meet both of those requirements.
Is that – am I answering your question?

(Derek Gruen): It is. I guess just in quick summary, we are not able to apply for the essential provider or the major community provider exception if we are designated as an urban community per the Census Bureau. Is that accurate?

Corinne Axelrod: If the Census Bureau has listed the area that you're in as an urbanized area then you can apply for an exception as long as you are in an area that's currently designated.

(Derek Gruen): OK. Very good. Thank you very much.

Corinne Axelrod: If you are in an area that is an urbanized area and you do not have a current designation, that's when you cannot apply. But if you meet one of the two requirements, you can apply. If you don't meet either of them, you cannot.

Operator: And our next questioner, please go ahead with your question.

(Carol Fronk): My name is (Carol Fronk). I'm from the (Miles Love) Clinic in (Mosco), Wisconsin. I have a two-part question. The first part is for governor-designation areas of a state, do you know are they still doing that or is that a state-by-state determination?

Corinne Axelrod: The designation is the Governor-Designated, Secretary-Certified designation. Yes, those are still being done.

(Carol Fronk): OK. And then my second question I have is, within a certain area, within like a 30-mile radius, you have several, three or four Rural Health Clinics, smaller Rural Health Clinics but individual towns and if you're not in a designated area, then we would have to make a determination of either sole community provider or an exception thing? Or will it go strictly by the mileage?

The additional question is what if there are no non-Rural Health Clinics within a fairly broad geographic area like an entire county? There are multiple Rural Health Clinics and typically they are 15 to 20 miles from each other and they are each serving the majority of the Medicare/Medicaid, low income and uninsured populations in the local communities.

But unfortunately by including other Rural Health Clinics in your rule as far as how it was a distance rule, it makes almost the Rural Health Clinics fight against each other since none of them could claim being the sole or essential community provider even though they are located in actually multiple different small communities.

Corinne Axelrod: The first category, the Sole Community Provider, would be the one to start out with. It sounds like in your situation the Rural Health Clinic is less than 25 miles from another participating provider and also not more than 30 minutes. If that's the case then you would want to look at the second category, which is Major Community Provider, to see if you would qualify under that one.

(Carol Fronk): But the issue is you made reference to other participating providers if, in this case, the only other participating providers are also Rural Health Clinics. Now you've created a situation in which let's say there are three Rural Health Clinics equidistance from each other, how is anyone to determine which one of them – or none of them – would meet the exception. They're each in different communities and there are no other participating providers.

Corinne Axelrod: If there are,, for instance, three Rural Health Clinic in an area that is not an urbanized area but does not have a current designation then all three of those Rural Health Clinics could apply for an exception, and all three of them – if they meet any of the qualifications – could get an exception.

(Carol Fronk): OK. So you wouldn't be limited, say, of the three, Clinic A got it so the other two are just exempt because of the 25, the 30 mile rule?

Corinne Axelrod: That's correct.

(Carol Fronk): OK. So all three could still get it?

Bill Finerfrock: Yes. You would, as Corinne was suggesting, look at the major community provider. And as she indicated, the first criteria is percentage of patients, Medicare/Medicaid, uninsured over 51 percent, or uninsured Medicaid over 31 percent.

So we're going to assume that each of the three clinics meets that threshold.

Female: That's correct.

Female: Yes.

Bill Finerfrock: The next test is you're actively accepting and treating a major share of Medicare/Medicaid compared to other providers within the 25 miles. And this is where she indicated that there's flexibility that the term major share is going to be very flexible in how they were going to interpret it.

So each clinic would then be able to demonstrate that they were providing a major share of care within their service area within that 25 mile radius. So as she indicated, it is possible for each of them to get an exception based on their ability to demonstrate the percentage of care provided and that within their community they're doing a major share of that care.

(Carol Fronk): Thank you. That answers the question.

Operator: And we will move to our next question.

(Tim Frye): This is (Tim Frye) with the National Rural Health Association in Washington, D.C. Corinne, thank you so much for doing this for the Rural Health Clinic community. I know this is important and I know the community appreciates your help and leadership on this.

I have a question hopefully you can help me clarify in my own mind and some of the questions I've gotten and even on this call, I think. There's the two location requirements. And on the first location requirement that they're located in the non urbanized area, there's an exception there if they meet certain criteria.

And then there's the second location requirement that has been an underserved area. And you refer a lot in that part to exception.

Is the exceptions you're referring to simply these what we're now talking about in this third section with questions? Or is that exceptions apply to both one and two? Does that question make sense?

Corinne Axelrod: Yes, it does. Thanks, Tim. As Tim said, there are two location requirements. If the RHC doesn't meet one of those then the RHC can apply for an exception.

The exceptions are the Sole Community Provider, Major Community Provider, Specialty Clinic, and the Extremely Rural Community Provider.

If the reason that the clinic is applying for an exception is because it's in an urbanized area then it has to meet a few other requirements in order to apply for this. That's where the RUCA level four comes in and the 51 percent comes in.

I know, this is another area of some confusion. If you're in an urbanized area and your area is designated, you have to be in a RUCA four or higher and 51 percent of your patients have to be in an adjacent non-urbanized area for you to apply for an exception. You still have to meet either the Sole Community Provider, Major Community Provider, Specialty Clinic, or Extremely Rural Community Provider criteria.

(Tim Frye): OK. So to even get to the exception process, you have to meet those – that extra criteria?

Corinne Axelrod: If you are not in a non-urbanized area, yes.

Bill Finerfrock: There are basically two location requirements to be a Rural Health Clinic. One has to do with the rurality of the community you're in, it has to do with the fact that you're in an underserved area.

If you're a clinic that is no longer in a non-urbanized area but you're still a shortage area, you then can apply for an exception to the requirement that you be in a non-urbanized area, and that's the RUCA standard and the 51 percent from outside the urbanized area.

The other type of clinic that you have is the clinic that is in a non-urbanized area that has lost its shortage area designation. Those clinics would apply for an exception under the four types of standards – for one of the standards that Corinne has just gone through.

If the clinic is no longer in a non-urbanized area and it's no longer in an shortage area then it can no longer be a Rural Health Clinic. It's going to – it will be decertified. But as long as you retain one of the core criteria but have lost the other, there's an exception process for clinics in either situation.

Does that make sense?

Operator: We will move to our next question.

(Tom): This is (Tom) from Missouri again. I have a question on what constitutes low income. Can you give me a good definition?

Corinne Axelrod: Well, that's another good question that I don't have an answer to. So we'll have to – we'll have to look at that.

(Tom): Thank you.

Corinne Axelrod: Yes. Thank you.

Operator: We'll take – I'm sorry.

Bill Finerfrock: Corinne, could I ask for some clarification on the OB/GYN pediatrics and also then the mental health?

Corinne Axelrod: Yes, please.

Bill Finerfrock: The criteria would be that for a clinic that only provides OB/GYN or only provides pediatrics. So if you were a Rural Health Clinic that is a family practice situation and you are – because of that you also happen to be the only provider of pediatric and the only provider of OB/GYN, that would not meet that criteria. You would have to only provide OB/GYN or only provide pediatrics. Is that what you're saying?

Corinne Axelrod: That's correct.

Bill Finerfrock: And then with regard to the mental provision, the distinction from there would be that – and what you're asking for is what the threshold would be – is that you can be providing primary care services and mental health services. You wouldn't be providing exclusively mental health. But what would be the threshold criteria that 30 percent of your patients are mental health or 30 percent of the services or something along those lines?

Corinne Axelrod: That's correct. Because the statute imposes a “ceiling”, it cannot be more than 50 percent mental health services. So what we're looking for is the “floor”.

Bill Finerfrock: Right. OK.

Operator: And our next questioner, your line is open.

(Roslyn Schulman): Hi. This is (Roslyn Schulman). I'm with the American Hospital Association. I have – well, now I have two questions. I had one to start but something that was just said sparked it and that is, if you are a clinic that is in an urbanized area but you do have a current designation as a shortage area, in order to get an exception, what I had understood – and actually from speaking to you, Corinne – was that first of all you would have to meet the location exception related to the – in a level four and above RUCA and the majority of your patients would have to come from a non-urbanized area (for) those requirements.

But I had understood you to say on the phone with me that you would also have to choose one of these essential provider categories and apply under one of those categories. Is that correct?

Corinne Axelrod: Yes. That's correct, if you are in an urbanized area and you have a designation, you have to be in a RUCA four or higher area and meet the 51 percent in order to apply to be an essential provider. The Essential Provider criteria are these four catgories: the Sole Community Provider, Major Community Provider, Specialty Clinics, and Extremely Rural Community Provider.

(Roslyn Schulman): OK. Great. That's consistent with what I had understood.

Bill Finerfrock: That's not what I had understood so you confused me now.

Corinne Axelrod: Uh oh.

Bill Finerfrock: Why would a clinic that has a current health professional shortage area but happens to now be in a community that is 50,000 have to apply for one of the majority or sole community exceptions? It doesn't have a problem with regard to its shortage area. It only has a problem with regard to its geographic location.

Corinne Axelrod: The reason for that is exceptions can only be granted to clinics that demonstrate that they are an Essential Provider. ..

Bill Finerfrock: You're already a health professional shortage area. That, by definition, means you're an essential provider. Why would you have to meet an additional criteria that says you're a sole community provider? I mean, they're already a health professional shortage area. That by definition means you're essential.

Corinne Axelrod: Well, that's certainly something that you may want to send in a comment on.

Bill Finerfrock: OK.

(Roslyn Schulman): My other question just is a more general one. Does CMS or HRSA have a list of current RHCs that somebody could purchase or download that would include their geographic area, whether they're an urbanized or non urbanized area? And also what type of designation they currently have?

Is there like a file somewhere that has that information that we can get?

Corinne Axelrod: We have on our Web site a listing of all of the Rural Health Clinics that we are updating now on a quarterly basis. We're due for an update - I think that file that's on there is from February.

It does not list whether a clinic is in a UA or a UC or neither of those or have any information on their designation. I'm not sure what HRSA has on their Web site at this point. But I think if you have the address of a clinic, the information in here will tell you how you can determine whether they're in a UA or not and what their designation status is.

It would be great if we had that. And maybe some day we will. But right now it's a multi-step process.

Bill Finerfrock: We do have a list. A few years ago the University of Southern Maine Rural Research Office did a zip code match between Rural Health Clinic zip codes and zip codes that fell within urbanized areas. And we do have a list of clinics that fell out when we did that zip code match. There are about 110 Rural Health Clinics that based on a zip code match fell out.

Now that list is old. We'd be happy to share that with anyone who wants it. But I think we may want to talk to University of Southern Maine about updating that match. But it was a relatively easy computerized process to go through by doing a zip code match through that mechanism.

(Roslyn Shulmet): Does that data indicate whether they are provider-based Rural Health Clinics or not?

Corinne Axelrod: No. It does not. The urbanized area status is a little bit easier because that only changes every 10 years but the designation status may change more frequently. But since the urbanized area is determined by the Census Bureau, that's an every 10 year determination.

Bill Finerfrock: You did mention I think earlier in your presentation that you had information indicating that more Rural Health Clinics would qualify under the revised HRSA methodology than would qualify under the current methodology which implies you have some ability to know whether or not Rural Health Clinics, where they might fall out. Is...

Corinne Axelrod: Actually, that data is from HRSA. So that's based on HRSA's data.

Bill Finerfrock: OK. All right.

Corinne Axelrod: Well, we only have I think about seven minutes left. I do just want to mention a couple things and I know, Bill, you want to say a few things and then we can certainly take more questions if there's time.

As Bill mentioned earlier, there will be another technical assistance call, and on that one we're going to cover staffing, payment requirements and health, safety, and quality issues.

There is also going to be a CMS rural open door forum on July 29. On that one we'll just do a summary of the provisions. But a week later we have scheduled a special Rural Health Clinic open door forum that's going to be exclusively on this proposed rule. That's August 5th from two to four.

The CMS Regional Rural Health Coordinators are really your first source for information. Hopefully you all know who your rural health coordinator is.

In terms of the final rule, the comment period closes at five o'clock on August 26th. All comments will be addressed and considered for the final rule, and the provisions of the final rule will be effective 60 days after publication of the final rule.

I do want to encourage you to send us your comments. As I said at the outset, our goal is to have a final rule that may not be everything that you want but strikes a balance between the requirements of the statute and what works for you all in the community.

To the extent that you can make your comments specific and constructive, that makes it easier for us to incorporate them wherever we can. So please continue to ask us questions and we look forward to getting any comments and other feedback.

So Bill, did you have some other things that you wanted to say?

Bill Finerfrock: No. I mean, we have closing remarks I can make when we're all done. But why don't we see if we can get a few more questions in here.

Corinne Axelrod: OK. Great.

Operator: We will move to our next question.

Bill Finerfrock: Go ahead, caller.

(Glenn Bisakiture): Hi. This is (Glenn Bisakiture) in Missouri. One of my comments is on slide, I believe it's 42, whenever you discussed the issue of 51 percent. Is that patients or is that actually the visits that the patients use?

For instance, in primary care clinics that are pediatric, you might have 40 percent of your patients using 55 percent or 60 percent of your utilization. That was number one question.

And number two question has to do with new clinics – but I don't know if this is appropriate – but currently CMS is looking at three years plus the current year and they will go ahead and do a clinic survey. Will that continue or will we be dealing with this whole three-year, date-to-date cycle?

Thank you.

Corinne Axelrod: Your first question is about the 51 percent. It says that at least 51 percent of the patients must reside in an adjacent non-urbanized area. So that is patients, not visits.

Your second question is about new clinics. And I'm sorry, would you mind repeating your second question for me?

(Glenn Bisakiture): Well, on the new clinic – and I want to refer back to that. I'm looking at slide 50 – 42, I'm sorry. And my – I just wanted to clarify utilization was on slide 42. So I keep going back to this. Patients are utilization of services offered.

The second question was currently for a new clinic, CMS will survey a clinic if they're within three-years plus the current year, which actually can give you almost four years to get a new clinic surveyed.

Corinne Axelrod: Shonte Carter, from our survey and certification division, do you want to answer that?

(Shante Carter): Yes. I'm not sure this is going to be a good answer because I really don't have an answer as to whether or not that's going to change. I don't want to put something out without being absolutely for sure about it.

Corinne Axelrod: OK. Let me get back to your first question. I apologize, I misunderstood you because you were referring to a different 51 percent. You're referring to the utilization rate.

And your question was whether that was patients or visits. Is that right?

(Glenn Bisakiture): Correct. Slide 42.

Corinne Axelrod: Right.

Bill Finerfrock: Majority community provider criteria.

Corinne Axelrod: Right. It is not specified.

(Glenn Bisakiture): Thank you.

Operator: And we will move to our next question.

(Mark Jordan): Hi, Corinne. This is (Mark Jordan) with the primary care office in South Carolina.

Corinne Axelrod: Hi, Mark.

(Mark Jordan): I have a question again about the Major Community Provider. I realize that you all left that somewhat ambiguous, but that's going to be very important for us.

We've got – out of 100 RHCs, we have around 30 that are no longer in HPSAs and are not designatable. So they need to meet one of the exception criteria, hopefully, and that's the only one they can – we may have a couple of pediatric clinics that could meet the specialty clinic, but a lot of them are going to be maybe applying for this major community provider.

All of them probably see in excess of 50 percent low income patients. But several of them are in the same community. Now, I'm not understanding – especially since there's not an application process – what they would submit to CMS to try to gain that exception.

Would they just send in their own information about the numbers of patients that they see? Or would they need to make some argument that they're seeing more than anybody else in the community?

I mean, they could be literally be within a block of each other. We had that situation where you may have four or five within two or three city blocks.

Corinne Axelrod: Utilization has to be greater than or equal to 51 percent, either patients or visits. “Major share” has been left open. It's not saying that they have to see more than any other clinic, it's not 51 percent of the community.

(Mark Jordan): OK. So if they – if they – let's say they all see over 51 percent low income.

Corinne Axelrod: Yes.

(Mark Jordan): Is that all they need to submit? I thought there was an "and" to that exception that had something to do with other providers within – related to how many you see versus other providers in the community.

Corinne Axelrod: That's correct. There is an "and" there. It's "and” is actively accepting and treating a major share of these patients compared to other participating providers. ..

(Mark Jordan): That's the piece I don't understand how they tell CMS they're doing it.

Corinne Axelrod: We have not defined major share. We didn't want to give a percentage number to that. That would be looked at on a case-by-case basis. That may also be something that people want to submit comments on if you have recommendations or suggestions.

(Mark Jordan): Would they need to say what their neighbors are seeing? I mean, in order for you all to be able to make a determination? I mean, are they going to have to know that? I don't know how you can compare to them other providers in the community if they don't submit that information.

Corinne Axelrod: Yes. I think you're making a good point. That may be, again, something that you want to submit some comments on.

(Mark Jordan): OK.

Operator: And we will move to our next question.

(Tommy Barnhart): This is (Tommy Barnhart) in North Carolina. I have a question about your – on the exception criteria for – the location exception criteria (and various of them), how you would anticipate the individual Rural Health Clinics gaining the information about how the other operators you know the providers are operating and to whether they are seeing low income patients – however that ends up being defined – and (its) uninsured and how, if there's any publicly available data out there if the other providers choose not to participate in this kind of a survey.

Corinne Axelrod: That's a good question and that's going to vary a lot from community to community. In some places I would imagine that you could pick up the phone and ask the person at the other clinic and you would get the information. And other places, that's not going to be so easy.

That's another reason why we really want to look at these on a case-by-case basis. If you have comments about any other aspects of this that you think should be included then we'd be really interested to hear that.

Also this is a regulation. There are certain things that we want in a regulation and other things that would be more appropriate to be put in our manuals, our guidances, things like that.

That may be something that would be more appropriate to put in later on in instructions and further guidance on this. But again, these are – these are good questions. And I appreciate your asking them.

But all I can do right now is just clarify what's in here to the extent possible.

(Tommy Barnhart): OK. Thank you.

Corinne Axelrod: Thank you.

Bill Finerfrock: This is going to have to be our last question, operator, the next one.

Operator: All right. We will take our final question.

Bill Finerfrock: Go ahead, caller.

(Sue Ann): Hello. This is (Sue Ann) from McCloud, California. We're in a HPSA – we're in a non-urban area. We've had a HPSA designation, an MUA designation, and also meet the other location exceptions.

But our HPSA designation was last updated in 2005. Is that something that the state should be moving forward on? Is there something that we need to do?

Corinne Axelrod: That is something that hopefully the state is aware of. Your first course of action is to contact your state primary care office and ask them if they have submitted an application to update that designation.

(Sue Ann): Good. Thank you.

Corinne Axelrod: Yes.

Bill Finerfrock: I want to thank all of our participants and our questioners and, in particular, Corinne Axelrod and then also (Shonte Carter) from CMS, for spending so much time with us today.

We will be having a second call, as has been mentioned several times, and we will be announcing the date and time of that very shortly.

A transcript and a recording of today's presentation will be available on the Office of Rural Health Policy Web site – I gave you the address earlier – in approximately one week.

I want to remind you again that we will be doing a second call on the topics that Corinne mentioned that were not covered in today's call and that you will receive that information through the Rural Health Clinics list serve that we maintain and distribute all of our information on.

Again, thank you all for participating today. And we look forward to your participation in a couple weeks when we do part two of this important series.

Thank you.

END

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