Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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**Centers for Medicare & Medicaid Services Moderator**  **: Barbara Cebuhar**  **March 24, 2011 2:00 p.m. E**  **T**

Operator : Good afternoon, m y name is ( Christa) and I’ll be your conference operator

today . This time, I would like to welcome everyone to the Centers for Medicare and Medicaid Services special open door forum, transparency report, and reporting a physician ownership or investment interest. All lines have been placed on mute to prevent an y background noise. After the speaker’s remarks, there will be comment session. I f you like to state your comment during this time, simply press star then the number one on yo ur telephone key

pad. If y ou’d like to withdraw y our comment, please press the pound key

. Thank you. I would now like to turn the c all over to Barbara Cebuhar. You may begin the conference. Barbara Cebuhar: Thank you ( Christa)

. Good afternoon. M y name is Barbara Cebuhar and I

work in the office of External Affairs and Beneficiaries Service here at CMS. The purpose of this speci al open door forum is to gather input from the relevant stakeholders on the implementation of section 6002 of the Affordable Care Act or the transparency reports and reporting a phy sician ownership or investment interest.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 2 The center for strategic plann ing and the center for program integrit y which have joint responsibility

for the development and implementing these regulations, seek your feedback on the following topics. We’re looking at comments on additional forums and natures of pay ment and trans fer of value to be considered b y CMS. The second issue is accessibility to and usability

of the reported data b y consumers. And the third is mechanisms for accurate, efficient and cost effective reporting of data. As we have a number of callers on th e line, please note that this forum is not the only opportunit y to provide input to CMS. While we will do our best to accommodate the man y comments Iknow you have, we offer you the additional opportunity

to send us written comments in response to an y of the questions that we’ll be asking today

. We have setup an email address and it’s ph ys iciansunshine@cms.hhs.gov. Again, that is phy siciansunshine@cms.hhs.gov. It would be very helpful if we could get your comments to us by April the 7th so that we can

– we’ll inform our decision making. The purpose of this open door forum is to gather information from the public that will allow the agency to draft a notice of proposed role making that is more comprehensive and thoughtful than might otherwise be th e case without prior input from the public. It is not intended to supplant the next

– the notice of proposed rulemaking or previewed defended the policy statements or statutory interpretations. In addition, we’re working towards publishing the propose d draft rule later this y ear which time you will have another opportunity to submit written comments to the official rule making process. I just want people to know that I am not an expert on this topic and I want to encourage each of you on the call to h elp us by

providing your insights and experience by responding to the questions that we'll be asking. CMS is in a listening only mode today . We are in the process of rule making so we won’t be able to offer an y background other than the description of the legislation that we’ve dis tributed with the invitation, or answer an y questionsCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 3 today . We will be providing an audio recording and transcript of today ’s call later on in the month on a special open door forum website. We encourage you to use this call as an opportunity to provide brief

– that means about a minute and a half to two minute feedback about how we would be best implement ed based on y our experience. As Imentioned earlier, this will not be your onl y opportunity to comment. Just a l ittle background, section 6002 of the Affordable Care Act requires the public reporting to pay

ments of a

– o r other value transfers made to phy sicians and teaching hospitals b y manufacturers and group purchasing organizations of drugs, devices, b iologicals and medica l supplies that are covered by M edicare, Medicaid, or the Child Health Insurance Program. The Secretary

of the U.S. Department of Health and Human Services is responsible for establishing procedures for the submission of this information as well as its public availability

. Our first question is about other forms of pay ment or transfer of value. The legislation lists specific forms of pay ment or other transfers of value that applicable manufacturers are required to report. That would be cash or cash equivalent, in kind items or services, stock, a stock option, or any other ownership, interest, dividend, profit, or other return on Investment. In addition, the secretary

can define additional forms of pay ment or other transfers of value to require of manufacturers to report. So our first question and then the operator will tell you how to queue up again is should CMS consider additional forms o f pay ment or transfers of value? If so, what additional forms should CMS consider and what additive value do they bring? ( Christa), could you please help people get into the queue please. Operator : At this time, I ’d like to remind every one that in order to state your comment,

please press star then the number one on your telephone key pad.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 4 We’ll pause for a moment to compile the queue . We do have a comment from the line of Sandy Dennis from Biotechnology Industry Corporation. Your line is open. Sandy Dennis : Thank you. This is Sandy Dennis . I’m the Deputy General Counsel for

Health Care at the Biotechnology Industry Organization. We appreciate this forum as a first step but further opportunity to stakeholder inp ut including notice and comment rule making are necessary to fully address the very complex issues raised by

this ne w law. We are pleased that the moderator affirmed that future rule making will occur. Question number one requests feedback regarding forms of pay ment or other transfers of value from an applicable manufacturer to a covered recipient. We are not awar e of an y need to expand this category. The existing statutory

requirement must be clearly addressed in regulations before considering an y expansion. There are fundamental definitional issues that must be addressed first including several relevant to q uestion number one. The definition of applicable manufacturer operating in the U.S, what exactly will this encompass given the global nature of many manufacturers and corporate affiliates that may exist outside of the U.S.? Which entities will be respons ible for reporting where there is co

- development or co

- marketing, or another common joint business practice? Can CMS clarify that the reporting provisions do not apply to pre commercial manufacturers? Those with no approved or marketed products in the U .S. which is a

– which is common among Bio members that are e merging companies. Next d efinition covered recipient. If the manufacturer makes a pay ment to someone other than a covered recipient and that entity makes a further downstream pay

ment to a ph ys ician or teaching hospital is that subsequent pay ment reportable?Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 5 We respectfull y request that CMS first consider clarification of these and other fundamental terms.
I appreciate this o pportunity and we’ll expand on these issues in written comment. Thank you. Barbara Cebuhar: Thank you Sandy . Our next comment please. Operator : Our next comment comes from the line of (Steven Puhusa) from (C ypher,

In c ). Your line is open. Barbara Cebuhar: I think he might be on mute. Operator : I do apologize; that line has now disconnected.

Your next comment comes from the line of Gregory Peterson from AACE. Your line is open. Gregory Peterson : I would just like to further reiterate

– reiterate what the last response was. It

would appear that this is redundant and would just add more regulatory on the side of CMS when there's alread y statutory requirements. Barbara Cebuhar: Thank you Greg.

Our next comment please. Operator : Our next question

– comment comes from the line of (Thomas Nasalis) from

Medical ( Divine )

. Your line is open. ( Thomas Nasalis ): Yes. Thank you very much for the opportunity to provide comment in this forum and a s other speakers have indicated we will be further ( winding ) our recommendations for this.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 6 And in the proposed rule making process one area where we do think that CMS should consider looking is not only pay m ent from manufacturers and MDMA

. ( Beforehand) MDMA i s a national

– excuse me

– m edical device manufacturers association repre senting primari ly small to big size medical technology

companies. We also believe that an y manufacturer pay ment few group purchasing organizations, hospital good purchasing organizations should also be included given their level of influence and decision making withi n the healthcare stream. But again, we will further expand from these comments in the formal rule making process. Thank you. Barbara Cebuhar: Thank you (Thomas).

Our next comment please. Operator : There are no further participants in queue at this time.
Barbara Cebuhar: I’m happ y to go on to the next question but if any body would like to get in to the queue it’s star, one. ( Christa), do we have anybod y else that’s interested? Operator : I think we have a few more participants in queue . Our next one comes from

–

comment comes from the line of Marjorie Powell from Ph RMA

. Your line is open. Marjorie Powell : Thank you. This is Marjorie Powell from Ph RMA arma . We appreciate the

opportunity

to make comments and that CMS is holding this stakeholder open forum. This question and several of the other questions focus on expanding the universe o f pay

ments to be reported. But we think it’s very important for CMS to understand that they 're going to be inundated with information transactio n data from manufacturers for ph ys icians and that their firstCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 7 challenge will be to establish a message for collecting and then reporting to patients the vast amount of information. For example, we’ve h eard from one midsize pharmacy that they would expe ct to report up to a million transactions involving approximately 300,000 doctors during their first y ear alone. And if you think about that number in terms of the total number of prescription drug and medical device companies that will be reporting, you get an idea of the complexity of this. So, we recommend that CMS focus on clear draft and then final regulations so that the

– their requirements for reporting of pay ments will be very

clear and simple for manufacturers to use and for CMS to then compi le in a way that will be clear to people using the website. So, we appreciate hearing that there will be proposed regulations, a chance for comment and then final regulations. We’d like to emphasize that it’s vitally important to manufacturers that th ose regulations be completed in time for manufacturers to be able implement their sy stems in 2010 so that they can be read y in 2011 to start collecting data

. We think, therefore, it’s important that you simplify the data collection and aggregation proc ess b y making a list, a master list of all the teaching hospitals and all the ph ys icians for whom pay ment will be reported. And we’ll expand on this in our written comments but we think that will simplify CMS’s task of aggregating all of the information. Given the complexities of the statute as written we encourage CMS to focus on getting proposed regulations prepared rath er than expanding the universe of might be reported. We will be submitting written comments. Barbara Cebuhar: Thank you very muc h (Marjorie).
Do we have an ybod y else in the queue , ( Christa )? Operator : You have another participant in queue for a comment , comes from the line of

(Michael Whitman) from America and Compan y.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 8 Your line is open. Barbara Cebuhar: (Michael), are you on mute? ( Michael Whitman ): Yes , can you hear me now. Barbara Cebuhar: Yes, we can. Thank you. ( Michael Whitman ): All right. I’m actuall y an active admission at Henry Ford Hospital, a

surgeon and I’m very

active in our American Academy of Oto lary

ngology but I’m speaking probably

personall y. And as a scientist and an ( active ) admission and somebody who has several patents in (N I H) funding and the process alread y i s quite onerous we ' re a very large health sy stem and we have regulatory

places or regulatory

s ys tems in place to very

carefull y report these things. And I think although onerous , one has to be very careful with what’s the intent of this information. Imean, in man y wa ys , alread y the process stifles innovation in Am erica and there are reports recently in the Wall Street Journal about saving a heart and saving a life because of the innovations here in America. So I want to be careful that the process here that CMS is furthering doesn’t further stifle innovation and I’m pleased to see the representation from Pharma and Biolife Resources and Resources as well but I ’m speaking as an academic surgeon m ys elf. Barbara Cebuhar: Thank yo u very much ( Michael )

. Do we have other comment s ? Operator : There are no further participants in queue at this time. Barbara Cebuhar: Great, thank you very much. Our next is question is the legislation lists 14 specific natures of pay ment and transfers of value that applicable manufacturers are required to report. These include consulting f

ees, compensation for services other than consulting,Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 9 honoraria, gift, entertainment, food, travel including specified destinations, education, research, charitable contribution, roy alty or license, current or prospective ownership or investment interest, direct compensation for serving as facult y or speaker for a medical education program, and grants. The secretary

can define additional natures of payment or transfers of value. We have a three

- part question that Ineed to have answered. So if y ou have an interest on this, if you could get in to the queue, (Christa) will tell you how shortly

. But, should CMS consider additional nature s of pay ment or transfers of value, if so, what additional natures of pay ment or transfer of value should CMS consid er and what value do they bring? Finally , how narrow or broadly should CMS define the nature of pay ment, transfers of value listed in the legislation? For example, what t ypes of consulting s hould CMS specify if an y at all? Please provide examples. ( Christa), if you could tell people how to get in the queue again, I’d appreciate it. Operator : Again, if you’d like to state your comment, please press star then number one

on your telephone key

pad. Our first comment comes from the line of Doug Pedd icord from ACRO. Your line is open. Doug Peddicord : Hi, it’s Doug Peddicord from ACRO, the Association of Clinical Research

Organizations. Iwill follow on previous comments by suggesting that in regard to questions A and B here should there be addit ional natures of pay ment or transfer of value, Ithink our answer would largely be no. It’ s hard for us to see what additive va lue would be brought by categories beyond those which Congress specified in legislation. I ’ll focus then mostly on the third question, question C, which is how narrowly or broadl y should CMS define the n ature of pay ments and transfers?Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 10 Let me explain first that our member

- compan y CROs ty picall y are in

– I should say

in the line of pay

ment between an applicable manufacturer and the phy sician or teaching hospital engaged in

– being engaged for research services. For us, then, almost all of the pay ments that we make are passed through pay

ments from manufacturers for research purposes. And the first thing I’ll point out is that, we would largel y believe that all pay ments we make to phy sicians or teaching hospitals, or for research including those pay

ments that might be subdivided then into things like food or, travel or education when we convene an investigator meeting for i nstance or a site initiation meeting. We may indeed be providing food or travel or education services but we believe that all of those pay ments should in fact be listed under research because it is indeed the purpose for making pay ments to the phy sician or teaching hospital relates to the research project. And so those are not from health separatel y
– separate pay ments made for some other purpose. In regard to all of these, I think the question will be that we will obviously think that CMA

– CMS sho uld define the pay ment questions both narrowl y and quite granularly . The question of whether or not a pay ment that is made to a phy sician for research services which is then subdivided into pay ments for every thing from actual research testing or other ser vices or the pay

ment of clinical research coordinator s or the like. Interesting

– we’re interested in how the agency will define pay

ments made to somebody

with a

– with a provider identifier which may ultimatel y be expanded for other services. So we think there’s a need for tremendous amount of clarit y in regard to the granularit y of reporting as well as the obligations of ph ys icians and teaching hospitals in terms of their understanding the categories of pay ment ... Barbara Cebuhar: Thank you, Doug

. Doug Peddicord : We’ll of course be providing comments as well. Barbara Cebuhar: I appreciate it. Our next comment please.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 11 Operator : Our next comments comes from the line of Marcia Hams from Community

Cataly st
. Your line is open. Marcia Ham s : Thank you. I’m Marcia Hams , I’m the Director Prescription Access in

(Quality) at Community

Cataly st and we're a national consumer organization and we work nationally with advocates in over 40 states and have work ed on the issue in a number of states as well. We want to comment on the categories and specifically and y ou think that the number, the 14 categories under nature of pay ments are an adequate number of pay ments. I wouldn’t suggest additional categories, however as some other speakers have sa id we think it’s very important that the definition of each of the categories be very

clear. That’s extremely

important both for the interpretation b y consumers and an y other researchers, an yone using the data as well as for the industry to be able to rep ort accuratel y. And, want to emphasize that each pay ment to a phy sician or teaching hospital should be reported separately . And that, on the nature of pay ment category , this is

– as y ou look at them they are

– a combination of descriptions of purpose and t ypes of payment. We would think that top

– we'd identify three top categories as major purposes. One of them is research and another is education, another serving on the fact that we have a medical education program and we think that pay ment shoul d first be categorized there. And by research we would

– we think that the regulation should make it very clear that that is only

bonafide research within the definition, within existing statutes and that education be defined only as activity accredited b y
– accredited b y ACC (Ami) or another comparable organization with the same standards for commercial supports and serving on the facult y medical education program because of the ACC, I mean standards would actuall y primaril y be capture d pay ments for indus tries speaker ' s bureaus

.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 12 And, so bey ond those categories most of the pay ment categories reflect

– such as food or entertainment or consultant reflect t ypes of pay ment and then that would be the next category to look at for each payment. Again, we think regulations should reall y distinguish these so that they 're as mutuall y exclusive as possible. Just to make one other comment about consulting, I think this consulting pay ment should only

be

– should be defined as bonafide services provided at share market value and would recommend agreement and specifies the services to be provided and the compensation and these are actually reflected in current voluntary

industry code of c onduct. So we’ll be submitting and just one of the things I think

– we thi nk is a very important as in the statute that the drug or device associated with the pay ment be r eported for each payment where that is relevant and be listed in a

– in a name that’s recognizable. Include the name that’s recognizable to the consumer who m ay be taking the product. Barbara Cebuhar: I appreciate your comment. Thank you very much. Marcia Hams : Thank you. Barbara Cebuhar: Our next comment please. Operator : Again, if you’d like to state your comment please press star then number one.

Your next comment comes from the line of Marjorie Powell from Pharma. Your line is open. Marjorie Powell : This is Marjorie Powell , I would like to echo a couple of the earlier comments

because CMS is required to collect and aggregate such a signifi cant amount of information. And because there are a number of questions raised b y the terms used in the statute, we think it’s very important that CMS clarify within the regulations the definitions that will be used and the hierarch y that should be used f or reporting.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 13 Because, man y of the categories of payments could well overlapped or an y individual pay

ment might fall into multiple categories. For example, a pay ment to a data safet y monitoring board for a

– as part of a clinical trial which is requir ed b y law in connection with conducting the clinical trial could be categorized either as a research pay ment or as a consulting fee. The manufacturers will need to have clear information regarding how they are to report pay

ments that might fall into mu ltiple categories. So that pay ments are not reported twice, which would provide incorrect information and that the final information when aggregated made available to patients is not misleading. So, we again think that it’s vitally important that thos e are, except 14 regulations, ought for CMS is workload and for manufacturers workloads. Because if there are not clear directions within the regulations companies and CMS will have to go back through this process multiple times as has happened in some of the stake reporting. Thank you. Barbara Cebuhar: Thank you Marjorie

.

Our next comment please. Operator : Your next comment comes from the line Michael Bell from R Square d

.

Your line is open. Michael Bell : Hi, thank y ou. And thank y ou C MS for allowing us to comment at this stage

or process. With respect to the specific values that are articulated in statute, the 14 in our experience and by way of brief background where a consulting and technology

from the list is

– let us work with the number of manufacturers and this is on a very

tactical level would seem to capture the vast majorit y i f not the totality

of arrangement that would presumably have been sought to be recapped b y Congress.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 14 It’s quite broad as is and does not even an y further enhancement. In that regard also there is something that, you know, post and vexing questions especiall y when we see things that are unusual as compared to other existing state laws such as, including the specified destination for travel. In lin e of the inherent difficulty recapturing this data we would strongl y encourage CMS to consider or having that be very broadly

– broad ended so as to perhaps tie in with the nature or purpose of the event rather than seeking a granular specified destination of the travel. Thank you. Barbara Cebuhar: Thank you Mr. Bell . I appreciate it.

I need our next comment, please. Operator : There are no further participants in queue at this time. Barbara Cebuhar: OK. Our next question is regarding addi tional categories of information to

report. Beyond the categories listed in this statute such as forms and nature of pay ment, the secretary

can determine additional categories of information regarding the pay

ment or other transfer of value to require of the manufacturer’s report. Should CMS consider additional categories of information to report and if so, what additional categories should CMS consider requiring and what additive value do they

bring. ( Christa), if you could inform people how to get i n the queue again, please. Operator : Again, if you’d like to state your comment please press star then number one

on your telephone key

pad. We’ll pause for a moment to compile the queue. First comment comes from the line of Marcia Hams from Community Cataly st.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 15 Your line is open. Marcia Hams : Thank you very much. I just

– one issue which has come up and

– in Massachusetts in particular when the (closure) data was

– when the Massachusetts data came out, we would suggest that where a grand p ercentage where pay

ment is made as a research grant to a teaching institution and not to

– just one of the case and not to the P.I . direc tly . That the P.I . and co P.I.s should be listed as well, not as receiving a pay ment but for further information on th at particular pay

ment to the institution. And we would want to have that setup in such a way that there could be no double counting. Thank you very

much. Barbara Cebuhar: Thank you. Our next comment, please, ( Christa). Operator : Again, if you’ d like to state y our comment, please press star then number one.

Your next comment comes from the line of Marjorie Powell from Ph RMA

. Your line is open. Marjorie Powell : Thank you. This is Marjorie Powell . I would like to echo on Marcia Ham’s

c omment that there should be no double counting of pay ments and that the direction should clearl y s pell out how pay ments are to be defined such that they are reported in one category . Recognizing that CMS may decide in the interest of

– of informing patients about the purposes of the various t ypes of pay ments, that CMS may decide to aggregate some of these categories into larger, more meaningful categories to patients. Thank you. Barbara Cebuhar: Thank you. Our next comment? Operator : Your next co mment comes from the line of (Jackie Kim) from Healthcare for

All.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 16 Your line is open. ( Jackie Kim ): Hello, my name is (Jackie Kim) representing Healthcare for All, consumer advocates organization in Massachusetts. Thank you for the opportunity. I j ust want to make a short comment on our short experience in Massachusetts regarding disclosure. This really

wasn’t on the list of questions but I think it falls under the third question of categories that we’re looking into. We understand that under the law, the definition of the reportable individuals or phy sicians are covered recipients or ph ys icians and teaching hospitals. In Massachusetts we did required disclosure not only our ph ys icians but as well as nurse practitioners and pharmacists and o ther prescribers. And in that sense, perhaps and we’ve seen a lot of pay ment actually

being made about (props). We find it valuable and this information being disclosed. We actuall y recommend that perhaps you may consider including these prescribers und er the definition of teaching hospitals for covered recipients. Thank you. Barbara Cebuhar: Thank you (Jackie).

Do we have other comments? Operator : There are no further participants in queue at this time. Barbara Cebuhar: Great. We’ll go on to our next question.

The secretary

can determine whether to require additional information regarding ph ys ician ownership, or investment interest. Should CMS require additional information regarding ph ys ician ownership or investment interest, and if so, what additional information regarding ph ys ician ownership or investment interest should CMS consider and what value does that bring?Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 17 If you could dial star, one to get in to the queue that would be very helpful. Thank you. Operator : Our f

irst comment comes from the line of Christopher White from AdvaMed, Your line is open. Christopher White : Hi, good afternoon. This is Christopher White AdvaMed, the Advanced

Medical Technology

Association. And as y ou may know, our industry

had a gr eat transparency

earl y on in the legislator process than we

– supported the draft they call it legislation that ultimately was incorporated into the health care reform legislation. For that reason, we look forward to working with CMS to ensure that the implementation meets the legislative objectives. We’re very pleased with the

– with your statement, the outset, that CMS would proceed to endorse and comment process and we certainl y look forward to participating with CMS to that process. We’ll submi t some more comprehensive comments following this call as well. However, I would like to preview our thinking on an issue within the scope of questions forum. However, if our view that in connection with the phy sician owned compan y reporting under Sectio n A

- 2 of the legislation that CMS should very

carefull y review and consider the legislative history that rise to these provisions. And also, review the LRG correspondents that would exchanged with AdvaMed a few ye ars back relative to this class of

– of ar rangements with phy sicians owned companies. It’s our view that although Section A

- 2 includes express reporting obligations for applicable manufacturers and applicable GPOs that CMS could and should clarify to guidance that these terms include the distr ibution model of phy sician owned companies. Because to do so, would be in consistent certainl y with the legislative history

and is also consistent with the authority that is granted to CMS within the defined term of applicable GPOs that are in the legislation. We think that this would ensure that these three business models positioned on GPOs, positioned on manufacturers, and positioned on distributors whichCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 18 present identical policy

risks and nearl y identical legal risks. This should be treated the same under the statute notwithstanding different business levels or business structures. Again, we appreciate the opportunity to participate in this forum. We’ll submit more detailed comments on our thinking on this question as well as the implementatio n overall. Thank you. Barbara Cebuhar: Thank you Chris. I appreciate it.

The next comment, please. Operator : Again, if you’d like to state your comment, please press star then number one.

There are no participants in queue at this time. Barbara Cebuhar: Thank you all. Our next question is about average consumer information.

What additional ty

pes of information to CMS consider reporting to the public beyond forms and natures of pay ment or transfers of value and phy sician ownership and applicable manufacturers, and group purchasing organizations? So, what ty

pes of background information on industry phy sician relationships should CMS consider including and what are best practice approaches for presenting the data in a way that is most understandable by consumers? How can CMS maximize the use data reported on the website? If you could do star, one on yo ur telephone key pad and let us know if you have a comment on this, these series of questions. That would be very helpful. Th ank you. Operator : Again, if you’d like to state your comment, please press star then number one.

Our first comment comes from the line of Sandy Dennis from Biotechnology. Your line is open.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 19 Sandy Dennis : Thank you again for this opportunity

. Regarding question five, the reporting

provisions directs the secretary to consult the stakeholders as part of the process of establishing procedures to submit information and propel a (saleability) to ensure that the information that’s made available to the public is presented in the appropriate overall context. This is a very

important provision and highlights the need to assure that the information that will be provided publicly is preceded by

and accompanied by objective background is directed at the target audiences and that the information presented is clearl y defined and explained. By which stated in other comments to other agencies within the department on similar issues and where information is to be provided to patients and consumers. We ’ve advised that the agency conduct focus group research and consult with experts to assure that the information presented is useful and not misleading to consumers and patients. We also recommend here that CMS conduct such research to help determine the appropriate website information for the public. And we’d like CMS to also consider establishing a task force that would consist of representatives from industry , the provider community , and public advocacy groups to help advice on the development of this required background information on industry , phy sician relationships to be posted on the website. Thank you, and again, we will expand in written comment. Barbara Cebuhar: Thank you Sandy . Our next comment please. Operator : Your next comment com es from the line of Christopher White from

AdvaMed. Your line is open. Julie Cohen : Thank you. Actuall y, this is Julie Cohen from AdvaMed. I’m sitting here

with Chris. Iappreciate the opportunity to comment on this. As Chris mentioned, AdvaMe d does supports disclosure of relationship between medical technology companies and phy sicians. However, in order toCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 20 ensure that patients receive useful information and do not mistakenly form impression that all pay

ments to phy sicians are sub

- taxed. W e think it’s essential that the background information provided by CMS includes clear information about why these relationships exist and how they benefit patients. We would suggest that CMS include information about the vital role of ph ys ician play in me dical technology

innovation. For example, phy sicians are often themselves the inventors of new technologies. Other phy sicians provide valuable feedback, research, and technical expertise to improve existing technologies. It’s also important to emphas ize that phy sicians receive critical training, both from companies and other skilled phy sicians so that they can use and operate medical technologies safely and effectivel y. AdvaMed believe that the background information provided in the public databas e should emphasize how these interactions contribute to continued advances in medical technology and to providing safe and effective medical care. In addition, CMS should allow companies at their discretion to provide additional contacts surrounding th e pay ments listed in the database so that patients can better understand the relationships that exists. Thank you, and again, we’ll provide more details in our written comment. Barbara Cebuhar: Thank you Julie. Our next comment please. Operator : Our next comment comes from the line of Marcia Hams from Community

Cataly st. Your line is open. Marcia Hams : Thank you very much again for having opportunity to comment. I think in terms of background information that we would suggest that the extens ive research that has done b y CMS and done by the

– being done b y the end to the management, would be the best starting. A place for information that’s provided in the context of this and that there is more I think it reall y does whatCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 21 are the purpose of the law and the relationships and does put the main context and include multiple stakeholders in the development of that research. So, Ithink that would be an important

– that should be the basic information available. I guess I would also want to rei terate to that, for the reason that many speakers have said that the categories and understanding of each of this, categories should be very clearl y placed because we think there’s no

– we don’t want to see pay

ments misinterpreted as problematic when they ’ re not problematic. We want patients be able to understand when there might be pay ments that they might think were problematic and it doesn’t serve anyone’s interest to have those confused. So, thank y ou very

much. Barbara Cebuhar : Thank you Marc ia . Our next comment please. Operator : Our next comment comes from the line of Doug Peddicord from ACRO.

Your line is open. Doug Peddicord : Again, thanks for the opportunity to comment. In regard to

– to the availability

of this information to cons umers, we very much appreciate the previous comments about the importance of background information and about the issue of understandability for consumers. We might well want to suggest in addition that CMS consider mechanisms for feedback in relation to this publicly available database. Two kinds of feedback would seem to be important. One, in fact from consumers to

– for the agency

to assess in some way

to evaluate the usefulness of this information for consumers and how it impacts their decision making in regard to healthcare participation and research and the like. The other feedback that I think would be important would be from effective phy sicians and hospitals. ACRO has alread y s een some

– some negative impact on the issue of phy sicians bei ng willing to engage in research activities. To be principal investigators based on

– based on the notion ofCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 22 information in a publicly

available database around which those phy sicians have some concerns. So, Ithink the issue of again building in pote ntially mechanisms for feedback from consumers as well as from the effective ph ys icians and hospitals would be useful feature. Barbara Cebuhar: Thank you Doug. Our next comment please. Operator : Our next comment comes from the line of (Jackie Kim) f rom Healthcare for All. Your line is open. ( Jackie Kim ): Hello, thank you again for the opportunity . I again want to share our

experience in Massachusetts. The first

– so we had our first disclosure information out couple of months ago. And the things that we reall y strongly felt was that the information available really needs to be consumer friendl y and this (inaudible) be a term that people throw out. That is being consumer friendl y. You know, if people are at the disclosure data should not just be a dumping of information for consumers to use and understand by themselves. We do agree that there should be a very strong explanation as to what the data is and yo u know, but to explain how people should be using those data especiall y consumers who are not healthcare experts. And we feel that there needs to be a clear explanation of the policy reasons of why this disclosure

– new disclosure is being made and why this information is being made public. And the most important reason reall y, hones tly , is conflict of interest but that possible are

– are made possibly exist and

– and under the current environments. So, that information should be clearl y outlined to the consumers and y ou know, once the information is out there and it’s clearl y explai ned it’s reall y up to the consumers and the providers to talk about the issues and (statistical) forward with the healthcare decisions.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 23 And we’ve really

feel that transparency

is extremely

important issue based on our experience. Thank you. Barbara Cebuhar: Thank you (Jackie). Our next comment? Operator : Our next comment comes from the line of ( Sharon MacNeil) from American

Academ y. Your line is open. ( Sharon MacNeil ): Yes, hello. This is ( Sharon MacNeil). I’m with the American Academ y

o f Ophthalmology . I’m not sure if this is the exact right place to put this comment. Very

effecting with what some of the other were saying. I think there also needs to be a clear pathway for phy sicians or other providers to be able to correct errors that might be in this information also. You know, if somehow, a ph ys ician’s name was inappropriately provided and it turned out that they

hadn’t actually

received what had been indicated and there needs to be a way

to correct

– correct information and we just want to make sure that CMS outlines the pathway for that. Barbara Cebuhar: Thanks ( Sharon ). Our next comment please. Operator : Our next comment comes from the line of Michael Seidman from American

Academ y. Your line is open. Michael Seidman : Hi, I’m Michael Seidman again from Henry Ford Hospital, y our nose and throat surgeon and the

– yo u know, I think it’s a

– and I heard it mentioned to some degree, you know, not all conflicts of interest make a person scoundrel on

– I conclude Dr. Niel son who is our executive director of the American Otolary ngology , he pinpoints others, it’s merely pointing out that you have an important area of your life that competes for your attention, your time, and yo ur resources and that might reward you or pull you in a different direction, It’s whether or not how we choose to disclose them or how we manage these things. The truth speaks about our character and our morals. And, I

– itCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 24 resonates clear to me because in my institution, most others I’m aware of, we have to disclose reasons. There’s nothing wrong with disclosing and I’m taught b y our legal advisers that you can have conflicts of interest. It’s what yo u choose to do with them and clearl y we have several examples. We have 300 different prosthe sis that people uses in their ear. Everyone has a different persons name on them. None of them worked, no offense to people who made them, terribly

well. Yes, that’s the best we have. So we want to be sure that these t ypes of rules do not this ty pe of the innovatio n that we need to see. And

– and I think that most people are morally correct and appropriate but clearl y there are a greatest examples out there and again, I think we need to be careful about more regulation and more strengths and more ties and to recall that they

are not all bad, derogatory or negative. Barbara Cebuhar: Thank you Dr. Seidman.

Just a note to others, in response to the comments on feedback and corrections from covered entities; we would appreciate suggestions on the bes t way to structure a covered entit y review and correction process. Any comments on that, please. Operator : Again, if you’d like to state your comments, please press star then number one

on your telephone key

pad. We do have a comment from the lin e of Luanna Saulino from Ba ye r Healthcare. Your line is open. Luanna Saulino : Hi, Iguess in regard to manufacturers having the opportunity to look at the data before complied. It’s an opportunity to have disclosed to add in and I’m certainl y not a ta cky here but to a secured website whereb y it is not live in production and perhaps manufacturers having a secured code or log in to check their pay

ments before it’s released to the public perhaps is a way to go about doing this. Barbara Cebuhar: Th ank yo u Luanna . Any other comments?Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 25 Operator : We do have another comment from the line of (Peter Vicoff) from Minnesota.

Your line is open. ( Peter Vicoff

): Thank you for the opportunity to make this comment and with the benefit of Prescription Coali tion which is a broad based organization of providers, pay ers, and consumers. Looking at the integrity of prescribing so the information Ithink engaged in this, it’s important that the data provider be accurate. So, I ’m actuall y concurring with the c omment of the earlier speakers. So that when it

– once is made available the public can rely on the data being accurate. We have seen and in Minnesota where we have a getting legislation in place, it allows where transparency of certain t ypes of gifts th at the lock are being able to get the opportunity to have corrections done is important. But this issue reall y relies to embank on the manufacturers and pay ers of these issues to properl y report and they need to make sure that the data information is there and accurate before that information goes public. Thank you. Barbara Cebuhar: Thank you ( Peter ) . Do we have other comments? Operator : There are no further participants in queue at this time. Barbara Cebuhar: Thank you very much, ( Christa)

. We are looking at our next question which is on reporting of data. What ty pes of approaches or mechanisms should CMS consider to ensure accurate, efficient, and cons e ffective of reporting the data? What electronic form should submissions take? Wh at ty pes of electronic forms are currently

available that CMS can leverage or use as a model for the purpose o f satisfying this requirement, i.e. electronic form views b y states with sunshine laws or other ideas.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 26 We would appreciate some additional fee dback about procedures CMS should establish for the correction of mistakes in the reported data provided b y manufacturers. ( Christa), if you could tell people to

– how to queue up, I’d appreciate it. Operator : Again, if you’d like to state your comm ent, please press star and then number

one on y our telephone key pad. Our first comment comes from the line of (Norman Collin ) from C ouncil of Medical Specialties Society

. Your line is open. (Norman Collin) : This is (Norman Collin ) . Thank you fo r calling on me , I was actuall y in the

queue for a previous comment. Iapologize, I’ll pass on this one and come back later. Barbara Cebuhar: Sorry , (Norman )

. Barbara Cebuhar: ( Christa), our next comment please. Operator : Our next comment comes f rom the line of Michael Bell from R Square d

. Your line is open. Michael Bell : Hi, thank y ou. With respect to the electronic form, we would recommend that

CMS strongly

consider the use of the spreadsheet as this is ubiquitous technology

in the indus try

and is the common form of accepted reporting in those states that currently require reporting. Also, with respect to the electronic forms, the law expressly requires the submission of the phy sician’s specialt y and national provider identification o r NPI . And I light of the public availability of the NPIdatabase and HHS is substantial investment and same. We would our (semantics) consider beaming compliant and satisfactory those manufacturers that relied on the information and contained them of th en current NPIdatabase for purposes ofCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 27 the reporting, which I note does not alway s includes the phy sician’s specialties, something that is called for in the statute. So, we’ll follow up in writing to provide more specific details of these and other is sues but thank y ou. Barbara Cebuhar: Thank you Michael. Our next comment please. Operator : Our next comment comes from the line of Sandy Dennis from Biotechnology Industry

. Your line is open. Sandy Dennis : Thank you. These are very complicated issues and we at Bio are also not techies and as mentioned by a Ph RMA representative earlier, there will be enormous amount of data to be organized and collected. So this is a big challenge for both the agency and the manufacturers. As an initial comment here, we recommend that the standardized template be provided for manufacturers to use in providing and formatting data so there will be consistency

and uniformity . It would also be useful to have a confirmation mechanism to acknowledge receipt of th e data and CMS should provide a reasonable amount of time for manufacturers to correct data that has been reported as well as an opportunity to seek correction of data or information after it’s posted by CMS in the event there are questions at that later p oint regarding accuracy

. Given the brief amount of time that we had to prepare for this open door forum and the challenges that are inherent in developing the internal manufacturers s ys tems to support collection and reporting of substantial amount of d ata to CMS, we request that agency provide additional opportunity to discuss these technical issues as well as other issues. Thank you. Barbara Cebuhar: Thank you Sandy . Our next comment please. Operator : Our next comment comes from the line of Marcia Hams from the Community

Cataly st.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 28 Your line is open. Marcia Hams : Thank you again. I just want to add. I think that the data needs as a

requirement of the statute be submitted in a spreadsheet probabl y is the corrected technology

that would be se archable or downloadable and that be available both to patients and may be to other users, and to researchers, and others that are looking at the data. But I think there also need to be translation of that to

– in such a way that any consumer that has a ccess to their web can also access the information about a particular provider that they may be interested in looking at. And so that would not be sufficient because the, you would not have the broad data to be examined so both need to be available publicl y . Barbara Cebuhar: Thank you again, Marcia . Our next comment please. Operator : The next comment comes from the line of (Ga rcia Tacko) from the Deloitte

. Your line is open. ( Garcia Tacko ): Thank you. Hi, this is (Garcia). I was actuall y wantin g to address your

previous questions regarding the data and accountability or the former manufacturers. I think in terms of what is being reported, understand that it is related to the recipient which in this case are ATPs and ECOs and I believe that ther e should be some shared accountabilit y with those entities as well that should be a part of your law in terms them reporting accuratel y to the former companies, this burden so the whole burden is not just on Pharma. Barbara Cebuhar: Thank you very muc h. Do we have another comment? Operator : There are no further participants in queue at this time. Barbara Cebuhar: OK, great. We will move on to our next question.

The legislation expands reporting requirements related to the collection of infor mation on phy sician ownership to and I quote, “applicable group purchasing organizations”. The secretary is given the discretion to define what is an applicable group purchasing organization.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 29 What ty pes of group purchasing organizations should CMS con sider in this definition and if you could give example of group purchasing organizations that this requirement may appl y to? If you could do put star, one on your keypad if yo u have a comment, we would appreciate it. Thank y ou. Operator : Again, if you’d like to state your comment, please press star and then number

one. We do have a comment from the line of Michael Seidman from American Academ y of Otolary

ngology

. Your line is open. Michael Seidman : You know, we are (inaudible) in Otolary ngol ogy ’s side formed the group purchasing. I was not part of it in order to reduce the price of hearing aid which can range from a thousand to $3,000 for single hearing aid. And b y so doing, you know, we of course passed on these benefits to patients to buy in bulk and I heard a comment earlier as we begin that, you know, many hospitals obviously

get purchasing breaks. And so, Imean, to me, that business as usual, am I suppose d , you know, one can argue if you’re making more money because you’re saving m ore money . Is that a bad thing or a good thing? Imean, I suppose that’s capitalism on something just lost your passing on some other savings to the patient, to the purchaser. With that, caveat i n mind, Ithink that any purchasing organization theories me then should have an obligation to report the arrangement if for looking forward for disclosure. Barbara Cebuhar: Thank you Dr. Seidman. Do we have other comment? Operator : You have other comment from the line of Marjorie Powell from Ph RMA

.

Your line is open. Marjorie Powell : This is Marjorie Powell I’m actuall y taking this opportunity to go back and

comment on the question, five because I do somehow couldn’t get in theCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 30 queue. We

– on question five, the

– how to present information seem as th is going to need to aggregate, organize and then report a vast amount of information but we think it’s vitally important that they

think very

hard about how to make the information available to the public useful and understandable. First, so that the inf

ormation does not chill the relationship between phy sicians and their patients which would have a public health impact if patient felt uncomfortable with particular ph ys icians for any risk for

– because they misunderstood the information presented on this

– in the website. And that it not chill the relationships between manufacturers and ph ys icians because those relationships are essential both to innovation and to improve patient medical care. To this end, we think one of the essentials paths that CMS will have to do is to provide lay

person definitions of the relevant statutory terms and also educational information about the benefits of the important relationships between healthcare providers and the developers, and manufacturers of medical products. We think it’s important that CMS reach out to both phy sicians and particularly to teaching hospitals to get suggestions for and perhaps assistance in figuring out how this information can be presented to patients and what kind descriptive information should a company , the categories on the website and we’d be pleased to work with CMS on both figuring how to present information and what kinds of descriptors to have around it. Thank you. Barbara Cebuhar: Thank you Marjorie. Our next comment please

. Operator : Our next comment comes from the line of (Jane Suveyor) from National

Phy sician. Your line is open.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 31 ( Jane Suvey or ): Hi, thanks. This is a comment, question relate to most recent questions and

also Ithink to number five too which is

– wo uld be useful I think to know in terms of the data you collect on a ph ys ician whether that person sits on a hospital Pharmacy

and Therapeutics Committee and therefore has influence over pharmacy

purchasing preferences and (formularies). If, yes, our the National Phy sicians Alliances strongl y supported this transparent public database and we need to be able to see patterns and see whether there are problems of undoing influence. That’s one area that would be useful to be able to track. Barbara Cebuh ar: Thank you ( Jane ) . Our next comment please. Operator : Our next comment comes from the line of Michael Seidman from American

Academ y. Your line is open. Michael Seidman : Hi, Michael Seidman again from Henry Ford Hospital speaking as an academi c surgeon. You know, I had the opportunity to review drugs coming in specificall y odor topical drops and an yt ime, any of us were on the Formulary

Committee, we were not actuall y even allowed to comment which is sometimes or obviously conflicts of interest , reasons, y ou could think but when somebod y has the most information of all about that particular product, then y ou’re not using that particular expertise. And I have a degree in Nutrition of Studied Herbs in the University of Michigan and I direct wel lness at our hospital and there’s a line of (nutriceuticals) that we brought in and

– and you know I have several patterns from these things. I was actuall y taken off the least for those exact reasons that were just brought up because I could not probably a certain bias behind their state what might be best because we

– most of us have some form of bias in our life. As a surgeon I tend to recommend, y es, top patients, the best medicines cause no medicines are best surgeries, no surgeries that being sai d we used lots of medicines and lots of survey but m y point is

– is that you sometimes needCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 32 those people that are there but clearl y that has to be disclosed and maybe that person has to be excused from that particular discussion. That they are actuall y an a formulary

perhaps their comments can at least be heard and weighed and as long as the disclosure made with someone we know and then we have decide how strong that conflict is. Barbara Cebuhar: Thank you Dr. Seidm an. Do we have another comment ? Op erator : There are no further participants in queue at this time. Barbara Cebuhar: OK. I am very grateful for every

body ’s feedback and insights. We are interested in other thoughts that you might have about implementing this legislation. Any additi onal comments or insights are very helpful. ( Christa), if you could tell people how to queue up, Iwould be grateful, thank yo u. Operator : Again, if you’d like to state your comment, please press star then the number

one on y our telephone key pad. I think you have a comment from (Norman Collin ) , Council of Medical Specialty Societ y. Your line is open. (Norman Collin ) : Thank you. Well, this is a comment I was hoping to make earlier so thank

yo u for giving me the opportunity . We’re going to be communicating with yo u in writing but we may have three suggestions for you. The first is to be sure that when relationships of physicians are disclosed that there is a context that is communicated. In other words, one relationship that a phy sician has versus another one may not be obvious to the public, to the consumers who are seeking the information and they may need to understand the context of this relationship means.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 33 The second is, in the area of clarit y and that is to be clear that we ar e disclosing direct financial relationship and not fall into the trap of disclosing indirect relationships such as serving as a faculty member. A meeting which is supported by

industry when the faculty

member has no relationship with the industry

. Thi rdly , is simply

the issue of consistency . This is going to be a potentially burdensome for ph ys icians in collecting the information that would be proper both

– for both phy sician and consumers alike if the information that was collected b y various groups was consistent. And finally , the context that we’re communicating and our organization which represents the 37 major medical specialties aside in the United States is actuall y on record is being supported b y the Phy sician Pay ment Sunshine Act and discl osure transparency . The council has its own code to guide specialties aside isn’t a relationship industry

. Thank you. Barbara Cebuhar: Thank you Dr. ( Collin ) . Our next comment please. Operator : Again, if you’d like to state your comment please p ress star then number one

on your telephone key

pad. Your next comment comes from the line of Doug Peddicord from ACRO. Your line is open. Doug Peddicord : Thank you again, I just and thanks to CMS for holding this open door forum.

Just a comment, I’d like to support the earlier comment about the notion of a reporting template. It would be very much advantageous for CMS as y ou are looking at the rule making process to at least consider developing not onl y mechanisms for reporting but a reporting te mplate. There are tremendous number of applicable parties here. Regulated parties and the extent of which the regulatory process can encourage of consistency inCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 34 reporting such likel y to reduce the level of burden that all of that

– that all of this re porting will require. Thank you. Barbara Cebuhar: Thank you Doug. Our next comment please. Operator : Again, to state your comment, please press star then number one.

There are no further participants in queue at this time. Barbara Cebuhar: If people have additional thoughts, I just want to make sure that there’s ample

opportunity

to share your insights on this or any other question that may

come up. Iknow that we have been moving prett y quickly through the questions. And, we just want to make sure that folks know that y ou can dial star, one and offer an y additional comments. This will be very

helpful to our decision making process. ( Christa) , are there others that have queue d up? Operator : Yes, we do have a few comments. Partic ipants in queue are

– next participant

comes from the line of ( Thomas Soliven ) from ( Rocklin )

. Your line is open. ( Thomas Soliven ) : Hi, this is ( Tom ) . Thank you very much for taking comments. I’ve had trouble with y our start things so good luck fo r some other folks. (Inaudible) it’s important as far as you’re the minimum is in your listing of things. The things like a non sequential items such as coffee at booth at

– at an exhibit booth and where there’s

– where they ’ve given out all participants that they off to truck the

– the information for every person that make the, y ou know, a cookie or a coffee of an exhibit booth. In addition, Ithink if you got a premium vicious list of items that you already have to collect information on, Idon’ t see and the phy sicians that we were quite

– we don’t see an y real reason to expand that list beyond a crams stoopCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 35 of what you have. So

– and then the other piece was it ' s just that there’d be a mechanism for ph ys icians to verifying without that question about that before but somehow a ph ys ician can look at that information before it goes public. May be during his unique identifier to him and some kind of additional codes so he can look out and check this information before it goes out. Barbara Cebuhar: Thank you Mr. ( Soliven ) . Our next comment please. Operator : Our next comment comes from the line of Michael Bell from R Square d

.

Your line is open. Michael Bell : Hi, Barbara. Since you’re asking, if what would be wonderful is that CMS as

i n our earl y on in the process could provide publicly a list of those entities which it deems to be a teaching institution and as a terms as set forth in the statute. I would assume presumably based on, y ou know, the direct graduate medical education an d indirect medical education rules that Icould be

– something that could be supplied with little effort. Also, another technical issued that perhaps could be clarified eas y to help those who are in front of this is

– is a clarification on which NPIto us e frequentl y at a healthcare organization and including academic medical standards and teaching hospitals. There may

be a multitude of NPI designed to that entity up to 14th and 16th or some cases they

associated with facility

and ideally

that phy sician would be that anyone of those applicable valid NPIs could be used. I know these are highl y technical but we’re on the width on this so like Isaid follow up some additional information. Thank you. Barbara Cebuhar: Thank you very much Mr. Bell. O ur next comment please. Operator : Our next comment comes from the line of Christopher White from AdvaMed.

Your line is open.Centers for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 36 Christopher White : Good afternoon. This is Christopher White at AdvaMed again. And in

the spirit of full transparency , I just wanted to amend my earlier comments. I think in the

– the open door noticed that was posted on the CMS website does not include the seventh question that you read earlier concerning the definition of applicable GPOs input where manufacturers for purposes of the phy sician owned entit y provision. And so, when I offered my comment on that topic I offered them in connection in response to question four. And I just wanted to make clear for CMS that our substantive position remains as Istated earl ier in connection with question four although it probabl y for no taking purposes is more responsive to the seventh question that you read that we did not see on the website. Thank you. Barbara Cebuhar: Thank you very much Mr. White. Do we have othe r comment? Operator : I think you have another comment from the line of Gregory Peterson from AACE. Your line is open. Greg Peterson : Hi, this is Dr. Greg Peterson and I’m really speaking as a phy sician in practice. You know the cost of the program are going to be

– are yet to be defined. And so when we start talking about discussing, reporting of information and how that information has relevancy

– relevancy to the public and of course the question of how much public education has been volatile pr ocess in order to better define or educate folks who are going to be looking at the information, understand what that means. And y et, we have avoided in health letter C and just translating to patient that we see on a dail y basis that need that seem ed ucation. Now, aside from all that, the cost concern the question of expanding reporting process. QuestionsCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 37 that could be raised about other government agencies or department should be as well doing the same. Another question that arises in my mind is this one in which what would be the consequences that both reporting of information. Another is if information is reported at factual what would be the consequences and how would those

– that those depth source statements could be rectified later. Thank you. Barbara Cebuhar: Thank you Dr. Peterson. Do we have other ques tions or other comment s

please? Operator : There are no further participants in queue at this time. Barbara Cebuhar: We want to make sure that you know that we appreciate every bod y’s insights and interest today . I don’t know if we have other people that want to offer their comments. Don’t forget to get your comments and insights to us at phy siciansunshine@cms.hhhs.gov. And if we could get them by April the 7th , that would be very helpful to inform our decision making. Also, Ijust want to make sure folks know that there will be an encore recording of this call in case people weren’t able to join us. All you need to do is dial 180

- 642

- 1687 and you’ll be asked for the meeting number and that’s 51513536. This encore call will be available four hours after the close of this call and will be available until the 28th at midnight. Have we had an y other people queuing up for a call, ( Christa)? Operator : We do have one partici pant that has queue d up. It comes from the line of

(Sabina Hassan Rava) from Saint Barbara Healthcare. Your line is open. ( Sabina Hassan Rava): All right. Thank you very much for this opportunity . With respect

to the definition of transfer of value, if CMS would consider giving someCenters for Medicare & Medicaid Services Moderator: Barbara Cebuhar 03

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Page 38 guidance. I understand, obviously , there are categories alread y listed but there are also if a

– you know, catchall of the (inaudible). With respect to the group purchasing organization then, they mentioned about the Pharmaceutical and Therapeutic Committee. I’d like, if CMS would consider defining or clarifying a little bit further the definition of transfer of value. A part of it s regulation , specificall y letting us know with respect to discounts obviously

as a group purchasing organization. That

– you know when you’re purchasing and there are discount specifically those items would be considered a transfer of value. Barbara Cebuhar: Thank you very much M s . (Rava). Do we have any other comment s that have come in? Operator : No further participants are in queue at this time. Barbara Cebuhar: Once again, we are very grateful for every

body ’s insights and ideas. We look forward to getting your comments and Ido hope that people will make use of phy siciansunshine@cms.hhs.gov. We appreciate your time today and look forward to getting the benefit of your experience. Operator, we can disconnect from the call now. Operator : That concludes today ’s conference call. You may now disconnect.

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