Centers for Medicare & Medicaid Services

Moderator: Barbara Cebuhar

03-24-11/2:00 p.m. ET

Confirmation # 51513526

Page 1

Centers for Medicare & Medicaid Services

Moderator: Barbara Cebuhar

March 24, 2011

2:00 p.m. ET

Operator: Good afternoon, my 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 any background noise. 

After the speaker’s remarks, there will be comment session. If you like to 

state your comment during this time, simply press star then the number one on 

your telephone keypad. If you’d like to withdraw your comment, please press 

the pound key. 

Thank you. 

I would now like to turn the call over to Barbara Cebuhar. You may begin the 

conference. 

Barbara Cebuhar: Thank you (Christa). Good afternoon. My name is Barbara Cebuhar and I 

work in the office of External Affairs and Beneficiaries Service here at CMS. 

The purpose of this special 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 physician ownership or 

investment interest. 
Centers for Medicare & Medicaid Services

Moderator: Barbara Cebuhar

03-24-11/2:00 p.m. ET

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The center for strategic planning and the center for program integrity 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 payment and 

transfer of value to be considered by CMS. The second issue is accessibility 

to and usability of the reported data by consumers. And the third is 

mechanisms for accurate, efficient and cost effective reporting of data. 

As we have a number of callers on the line, please note that this forum is not 

the only opportunity to provide input to CMS. While we will do our best to 

accommodate the many comments I know you have, we offer you the 

additional opportunity to send us written comments in response to any of the 

questions that we’ll be asking today. 

We have setup an email address and it’s physiciansunshine@cms.hhs.gov. 

Again, that is physiciansunshine@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 the 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 proposed draft rule later 

this year 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 help 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 any background other than the description of the 

legislation that we’ve distributed with the invitation, or answer any questions 
Centers for Medicare & Medicaid Services

Moderator: Barbara Cebuhar

03-24-11/2:00 p.m. ET

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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 implemented based on your experience. As I mentioned earlier, this 

will not be your only opportunity to comment. 

Just a little background, section 6002 of the Affordable Care Act requires the 

public reporting to payments of a – or other value transfers made to physicians 

and teaching hospitals by manufacturers and group purchasing organizations 

of drugs, devices, biologicals and medical supplies that are covered by

Medicare, 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 payment or transfer of value. The 

legislation lists specific forms of payment 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 payment 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 of payment 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 everyone that in order to state your comment, 

please press star then the number one on your telephone keypad. 
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Moderator: Barbara Cebuhar

03-24-11/2:00 p.m. ET

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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 input including 

notice and comment rule making are necessary to fully address the very

complex issues raised by this new law. 

We are pleased that the moderator affirmed that future rule making will occur. 

Question number one requests feedback regarding forms of payment or other 

transfers of value from an applicable manufacturer to a covered recipient. We 

are not aware of any need to expand this category. 

The existing statutory requirement must be clearly addressed in regulations 

before considering any expansion. There are fundamental definitional issues 

that must be addressed first including several relevant to question 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 

responsible 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 emerging 

companies. 

Next definition covered recipient. If the manufacturer makes a payment to 

someone other than a covered recipient and that entity makes a further 

downstream payment to a physician or teaching hospital is that subsequent 

payment reportable? 
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03-24-11/2:00 p.m. ET

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We respectfully request that CMS first consider clarification of these and 

other fundamental terms. 

I appreciate this opportunity 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 (Cypher, 

Inc). 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 already 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 as other speakers have indicated we will be further (winding) our 

recommendations for this. 
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03-24-11/2:00 p.m. ET

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And in the proposed rule making process one area where we do think that 

CMS should consider looking is not only payment from manufacturers and 

MDMA. (Beforehand) MDMA is a national – excuse me – medical device

manufacturers association representing primarily small to big size medical 

technology companies. 

We also believe that any manufacturer payment few group purchasing 

organizations, hospital good purchasing organizations should also be included 

given their level of influence and decision making within 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 happy to go on to the next question but if anybody would like to get in to 

the queue it’s star, one.

(Christa), do we have anybody 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 PhRMA. 

Your line is open. 

Marjorie Powell: Thank you. This is Marjorie Powell from PhRMAarma. 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 of payments to be reported. But we think it’s very important for 

CMS to understand that they're going to be inundated with information 

transaction data from manufacturers for physicians and that their first 
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03-24-11/2:00 p.m. ET

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challenge will be to establish a message for collecting and then reporting to 

patients the vast amount of information. 

For example, we’ve heard from one midsize pharmacy that they would expect 

to report up to a million transactions involving approximately 300,000 doctors 

during their first year 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 payments will be very clear and 

simple for manufacturers to use and for CMS to then compile 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 those regulations be completed in time for 

manufacturers to be able implement their systems in 2010 so that they can be 

ready in 2011 to start collecting data. 

We think, therefore, it’s important that you simplify the data collection and 

aggregation process by making a list, a master list of all the teaching hospitals 

and all the physicians for whom payment 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 rather than expanding the universe 

of might be reported. We will be submitting written comments. 

Barbara Cebuhar: Thank you very much (Marjorie).

Do we have anybody 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 Company. 
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03-24-11/2:00 p.m. ET

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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 actually an active admission at Henry Ford Hospital, a 

surgeon and I’m very active in our American Academy of Otolaryngology but 

I’m speaking probably personally. And as a scientist and an (active)

admission and somebody who has several patents in (NIH) funding and the 

process already is quite onerous we're a very large health system and we have 

regulatory places or regulatory systems in place to very carefully report these 

things. 

And I think although onerous, one has to be very careful with what’s the 

intent of this information. I mean, in many ways, already the process stifles

innovation in America 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 myself. 

Barbara Cebuhar: Thank you very much (Michael). 

Do we have other comments? 

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 payment and 

transfers of value that applicable manufacturers are required to report. These 

include consulting fees, compensation for services other than consulting, 
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03-24-11/2:00 p.m. ET

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honoraria, gift, entertainment, food, travel including specified destinations, 

education, research, charitable contribution, royalty or license, current or 

prospective ownership or investment interest, direct compensation for serving 

as faculty 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 I need to have answered. So if you have an 

interest on this, if you could get in to the queue, (Christa) will tell you how 

shortly.

But, should CMS consider additional natures of payment or transfers of value, 

if so, what additional natures of payment or transfer of value should CMS 

consider and what value do they bring? 

Finally, how narrow or broadly should CMS define the nature of payment, 

transfers of value listed in the legislation? For example, what types of 

consulting should CMS specify if any 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 keypad. 

Our first comment comes from the line of Doug Peddicord from ACRO.

Your line is open. 

Doug Peddicord: Hi, it’s Doug Peddicord from ACRO, the Association of Clinical Research

Organizations. I will follow on previous comments by suggesting that in 

regard to questions A and B here should there be additional natures of 

payment or transfer of value, I think our answer would largely be no. 

It’s hard for us to see what additive value 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 broadly should 

CMS define the nature of payments and transfers? 
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03-24-11/2:00 p.m. ET

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Let me explain first that our member-company CROs typically are in – I 

should say in the line of payment between an applicable manufacturer and the 

physician or teaching hospital engaged in – being engaged for research 

services. For us, then, almost all of the payments that we make are passed 

through payments from manufacturers for research purposes. 

And the first thing I’ll point out is that, we would largely believe that all 

payments we make to physicians or teaching hospitals, or for research 

including those payments that might be subdivided then into things like food 

or, travel or education when we convene an investigator meeting for instance 

or a site initiation meeting. 

We may indeed be providing food or travel or education services but we 

believe that all of those payments should in fact be listed under research 

because it is indeed the purpose for making payments to the physician or 

teaching hospital relates to the research project. And so those are not from 

health separately – separate payments 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 should define the payment questions both narrowly 

and quite granularly. The question of whether or not a payment that is made 

to a physician for research services which is then subdivided into payments 

for everything from actual research testing or other services or the payment of 

clinical research coordinators or the like. 

Interesting – we’re interested in how the agency will define payments made to 

somebody with a – with a provider identifier which may ultimately be 

expanded for other services. So we think there’s a need for tremendous 

amount of clarity in regard to the granularity of reporting as well as the 

obligations of physicians and teaching hospitals in terms of their 

understanding the categories of payment ... 

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. 
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03-24-11/2:00 p.m. ET

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

Catalyst. 

Your line is open. 

Marcia Hams: Thank you. I’m Marcia Hams, I’m the Director Prescription Access in

(Quality) at Community Catalyst and we're a national consumer organization 

and we work nationally with advocates in over 40 states and have worked on

the issue in a number of states as well. 

We want to comment on the categories and specifically and you think that the 

number, the 14 categories under nature of payments are an adequate number 

of payments. I wouldn’t suggest additional categories, however as some other 

speakers have said 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 by consumers and any other researchers, anyone using the data 

as well as for the industry to be able to report accurately. 

And, want to emphasize that each payment to a physician or teaching hospital 

should be reported separately. And that, on the nature of payment category, 

this is – as you look at them they are – a combination of descriptions of 

purpose and types 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 payment should 

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 by – accredited by ACC (Ami) or another comparable 

organization with the same standards for commercial supports and serving on 

the faculty medical education program because of the ACC, I mean standards 

would actually primarily be captured payments for industries speaker's 

bureaus. 
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And, so beyond those categories most of the payment categories reflect – such 

as food or entertainment or consultant reflect types of payment and then that 

would be the next category to look at for each payment. Again, we think 

regulations should really distinguish these so that they're as mutually 

exclusive as possible. 

Just to make one other comment about consulting, I think this consulting 

payment 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 conduct. 

So we’ll be submitting and just one of the things I think – we think is a very

important as in the statute that the drug or device associated with the payment 

be reported 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 may 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 significant amount of 

information. And because there are a number of questions raised by 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 hierarchy that should be 

used for reporting. 
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03-24-11/2:00 p.m. ET

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Because, many of the categories of payments could well overlapped or any 

individual payment might fall into multiple categories. For example, a 

payment to a data safety monitoring board for a – as part of a clinical trial 

which is required by law in connection with conducting the clinical trial could 

be categorized either as a research payment or as a consulting fee. 

The manufacturers will need to have clear information regarding how they are 

to report payments that might fall into multiple categories. So that payments 

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 those 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 Squared. 

Your line is open. 

Michael Bell: Hi, thank you. And thank you CMS 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 majority if 

not the totality of arrangement that would presumably have been sought to be 

recapped by Congress. 
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03-24-11/2:00 p.m. ET

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It’s quite broad as is and does not even any further enhancement. In that 

regard also there is something that, you know, post and vexing questions 

especially when we see things that are unusual as compared to other existing 

state laws such as, including the specified destination for travel. 

In line of the inherent difficulty recapturing this data we would strongly 

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 additional categories of information to 

report. Beyond the categories listed in this statute such as forms and nature of 

payment, the secretary can determine additional categories of information 

regarding the payment 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 in the queue again, please. 

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

on your telephone keypad. 

We’ll pause for a moment to compile the queue. 

First comment comes from the line of Marcia Hams from Community

Catalyst. 
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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 percentage 

where payment is made as a research grant to a teaching institution and not to 

– just one of the case and not to the P.I. directly. That the P.I. and co P.I.s

should be listed as well, not as receiving a payment but for further information 

on that particular payment 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 your comment, please press star then number one. 

Your next comment comes from the line of Marjorie Powell from PhRMA. 

Your line is open. 

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

comment that there should be no double counting of payments and that the 

direction should clearly spell out how payments 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 types of 

payments, 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 comment comes from the line of (Jackie Kim) from Healthcare for 

All. 
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03-24-11/2:00 p.m. ET

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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 

just 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 physicians are covered 

recipients or physicians and teaching hospitals. 

In Massachusetts we did required disclosure not only our physicians but as 

well as nurse practitioners and pharmacists and other prescribers. And in that 

sense, perhaps and we’ve seen a lot of payment actually being made about 

(props). We find it valuable and this information being disclosed. We 

actually recommend that perhaps you may consider including these 

prescribers under 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 physician ownership, or investment interest. 

Should CMS require additional information regarding physician ownership or 

investment interest, and if so, what additional information regarding physician 

ownership or investment interest should CMS consider and what value does 

that bring? 
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If you could dial star, one to get in to the queue that would be very helpful. 

Thank you. 

Operator: Our first 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 you may know, our industry had a 

great transparency early 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 certainly look forward to participating with CMS to 

that process. 

We’ll submit 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 physician 

owned company reporting under Section A-2 of the legislation that CMS 

should very carefully review and consider the legislative history that rise to 

these provisions. And also, review the LRG correspondents that would 

exchanged with AdvaMed a few years back relative to this class of – of 

arrangements with physicians 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 distribution model of physician 

owned companies. Because to do so, would be in consistent certainly 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 which 
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present identical policy risks and nearly 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 

implementation 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 types of information to CMS consider reporting to the public 

beyond forms and natures of payment or transfers of value and physician 

ownership and applicable manufacturers, and group purchasing organizations? 

So, what types of background information on industry physician 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 your telephone keypad and let us know if you 

have a comment on this, these series of questions. That would be very

helpful. Thank 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. 
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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 clearly 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, physician 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 comes from the line of Christopher White from 

AdvaMed. 

Your line is open. 

Julie Cohen: Thank you. Actually, this is Julie Cohen from AdvaMed. I’m sitting here 

with Chris. I appreciate the opportunity to comment on this. 

As Chris mentioned, AdvaMed does supports disclosure of relationship 

between medical technology companies and physicians. However, in order to 
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ensure that patients receive useful information and do not mistakenly form 

impression that all payments to physicians are sub-taxed. 

We 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 physician play in medical technology innovation. For example, 

physicians are often themselves the inventors of new technologies. Other 

physicians provide valuable feedback, research, and technical expertise to 

improve existing technologies. 

It’s also important to emphasize that physicians receive critical training, both 

from companies and other skilled physicians so that they can use and operate 

medical technologies safely and effectively. 

AdvaMed believe that the background information provided in the public 

database 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 the payments 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

Catalyst. 

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 extensive 

research that has done by CMS and done by the – being done by 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 really does what 
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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, I think that would be an important – that should be the basic information 

available. I guess I would also want to reiterate to that, for the reason that 

many speakers have said that the categories and understanding of each of this, 

categories should be very clearly placed because we think there’s no – we 

don’t want to see payments misinterpreted as problematic when they’re not 

problematic. 

We want patients be able to understand when there might be payments that 

they might think were problematic and it doesn’t serve anyone’s interest to 

have those confused. 

So, thank you very much. 

Barbara Cebuhar: Thank you Marcia. 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 consumers, 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 

physicians and hospitals. ACRO has already seen some – some negative 

impact on the issue of physicians being willing to engage in research 

activities. To be principal investigators based on – based on the notion of 
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information in a publicly available database around which those physicians 

have some concerns. 

So, I think the issue of again building in potentially mechanisms for feedback 

from consumers as well as from the effective physicians 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) from 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 really strongly

felt was that the information available really needs to be consumer friendly 

and this (inaudible) be a term that people throw out. That is being consumer 

friendly. 

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 you 

know, but to explain how people should be using those data especially 

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 really, honestly, is 

conflict of interest but that possible are – are made possibly exist and – and 

under the current environments. So, that information should be clearly 

outlined to the consumers and you know, once the information is out there and 

it’s clearly explained it’s really up to the consumers and the providers to talk 

about the issues and (statistical) forward with the healthcare decisions. 
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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 

Academy. Your line is open. 

(Sharon MacNeil): Yes, hello. This is (Sharon MacNeil). I’m with the American Academy 

of 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 physicians or other providers 

to be able to correct errors that might be in this information also. You know, 

if somehow, a physician’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 

Academy. 

Your line is open. 

Michael Seidman: Hi, I’m Michael Seidman again from Henry Ford Hospital, your nose and 

throat surgeon and the – you 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. Nielson who is our executive director of the American 

Otolaryngology, 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 

your 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 – it 
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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 by our legal advisers that you can have conflicts of interest. It’s what 

you choose to do with them and clearly we have several examples. 

We have 300 different prosthesis 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 types of rules do not this type of the innovation that we need to 

see. And – and I think that most people are morally correct and appropriate 

but clearly 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 best way to 

structure a covered entity 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 keypad. 

We do have a comment from the line of Luanna Saulino from Bayer

Healthcare. Your line is open. 

Luanna Saulino: Hi, I guess 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 

certainly not a tacky here but to a secured website whereby it is not live in 

production and perhaps manufacturers having a secured code or log in to 

check their payments before it’s released to the public perhaps is a way to go 

about doing this. 

Barbara Cebuhar: Thank you Luanna. Any other comments? 
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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 Coalition which is a broad based organization of providers, 

payers, and consumers. Looking at the integrity of prescribing so the 

information I think engaged in this, it’s important that the data provider be 

accurate. 

So, I’m actually concurring with the comment 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 types of gifts that the lock are 

being able to get the opportunity to have corrections done is important. 

But this issue really relies to embank on the manufacturers and payers of these 

issues to properly 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 types of approaches or mechanisms should CMS consider to ensure 

accurate, efficient, and cons effective of reporting the data?

What electronic form should submissions take? What types of electronic 

forms are currently available that CMS can leverage or use as a model for the 

purpose of satisfying this requirement, i.e. electronic form views by states 

with sunshine laws or other ideas. 
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We would appreciate some additional feedback about procedures CMS should 

establish for the correction of mistakes in the reported data provided by 

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 comment, please press star and then number 

one on your telephone keypad. 

Our first comment comes from the line of (Norman Collin) from Council of 

Medical Specialties Society. 

Your line is open. 

(Norman Collin): This is (Norman Collin). Thank you for calling on me, I was actually in the

queue for a previous comment. I apologize, 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 from the line of Michael Bell from R Squared. 

Your line is open. 

Michael Bell: Hi, thank you. 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 industry 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 physician’s specialty and national provider identification or 

NPI. And I light of the public availability of the NPI database 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 then current NPI database for purposes of 
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the reporting, which I note does not always includes the physician’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 issues but thank you. 

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 PhRMA 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 the 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 point 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 systems to support collection and reporting of substantial 

amount of data 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

Catalyst. 
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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 probably is the 

corrected technology that would be searchable or downloadable and that be 

available both to patients and maybe 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 access to their web can also access the information about a 

particular provider that they maybe 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 publicly. 

Barbara Cebuhar: Thank you again, Marcia. Our next comment please. 

Operator: The next comment comes from the line of (Garcia Tacko) from the Deloitte. 

Your line is open. 

(Garcia Tacko): Thank you. Hi, this is (Garcia). I was actually wanting 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 there should be some shared accountability with those entities as well that 

should be a part of your law in terms them reporting accurately to the former 

companies, this burden so the whole burden is not just on Pharma. 

Barbara Cebuhar: Thank you very much. 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 

information on physician ownership to and I quote, “applicable group 

purchasing organizations”. The secretary is given the discretion to define 

what is an applicable group purchasing organization. 
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What types of group purchasing organizations should CMS consider in this 

definition and if you could give example of group purchasing organizations 

that this requirement may apply to? 

If you could do put star, one on your keypad if you have a comment, we 

would appreciate it. Thank you. 

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 

Academy of Otolaryngology. 

Your line is open. 

Michael Seidman: You know, we are (inaudible) in Otolaryngology’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 by 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, I mean, to me, that business as usual, am I supposed, you know, one 

can argue if you’re making more money because you’re saving more money. 

Is that a bad thing or a good thing? I mean, I suppose that’s capitalism on 

something just lost your passing on some other savings to the patient, to the 

purchaser. With that, caveat in mind, I think 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 PhRMA. 

Your line is open. 

Marjorie Powell: This is Marjorie Powell I’m actually taking this opportunity to go back and 

comment on the question, five because I do somehow couldn’t get in the 
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queue. We – on question five, the – how to present information seem as this 

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 information does not chill the relationship between 

physicians and their patients which would have a public health impact if 

patient felt uncomfortable with particular physicians 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 physicians 

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 physicians 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 

Physician.

Your line is open. 
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(Jane Suveyor): Hi, thanks. This is a comment, question relate to most recent questions and 

also I think to number five too which is – would be useful I think to know in 

terms of the data you collect on a physician 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 Physicians Alliances strongly 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 Cebuhar: Thank you (Jane). Our next comment please. 

Operator: Our next comment comes from the line of Michael Seidman from American 

Academy. 

Your line is open. 

Michael Seidman: Hi, Michael Seidman again from Henry Ford Hospital speaking as an 

academic surgeon. You know, I had the opportunity to review drugs coming 

in specifically odor topical drops and anytime, any of us were on the 

Formulary Committee, we were not actually even allowed to comment which 

is sometimes or obviously conflicts of interest, reasons, you could think but 

when somebody has the most information of all about that particular product, 

then you’re not using that particular expertise. 

And I have a degree in Nutrition of Studied Herbs in the University of 

Michigan and I direct wellness 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 actually 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, yes, top patients, the best medicines cause 

no medicines are best surgeries, no surgeries that being said we used lots of 

medicines and lots of survey but my point is – is that you sometimes need 
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those people that are there but clearly that has to be disclosed and maybe that 

person has to be excused from that particular discussion. That they are 

actually 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. Seidman. Do we have another comment? 

Operator: There are no further participants in queue at this time. 

Barbara Cebuhar: OK. I am very grateful for everybody’s feedback and insights. We are 

interested in other thoughts that you might have about implementing this 

legislation. 

Any additional comments or insights are very helpful. 

(Christa), if you could tell people how to queue up, I would be grateful, thank 

you. 

Operator: Again, if you’d like to state your comment, please press star then the number 

one on your telephone keypad. 

I think you have a comment from (Norman Collin), Council of Medical 

Specialty Society. 

Your line is open. 

(Norman Collin): Thank you. Well, this is a comment I was hoping to make earlier so thank 

you for giving me the opportunity. We’re going to be communicating with 

you 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 physician 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. 
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The second is, in the area of clarity and that is to be clear that we are 

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. 

Thirdly, is simply the issue of consistency. This is going to be a potentially

burdensome for physicians in collecting the information that would be proper 

both – for both physician and consumers alike if the information that was 

collected by 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 

actually on record is being supported by the Physician Payment Sunshine Act 

and disclosure 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 press star then number one 

on your telephone keypad. 

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 you are 

looking at the rule making process to at least consider developing not only 

mechanisms for reporting but a reporting template. 

There are tremendous number of applicable parties here. Regulated parties 

and the extent of which the regulatory process can encourage of consistency in 
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reporting such likely to reduce the level of burden that all of that – that all of 

this reporting 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. I know that we have been moving pretty quickly through the questions. 

And, we just want to make sure that folks know that you can dial star, one and 

offer any additional comments. 

This will be very helpful to our decision making process. 

(Christa), are there others that have queued up? 

Operator: Yes, we do have a few comments. Participants 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 your start things so good luck for 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, you 

know, a cookie or a coffee of an exhibit booth. 

In addition, I think if you got a premium vicious list of items that you already

have to collect information on, I don’t see and the physicians that we were 

quite – we don’t see any real reason to expand that list beyond a crams stoop 
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of what you have. So – and then the other piece was it's just that there’d be a 

mechanism for physicians to verifying without that question about that before 

but somehow a physician can look at that information before it goes public. 

Maybe 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 Squared. 

Your line is open. 

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

in our early 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, you know, the direct graduate medical 

education and indirect medical education rules that I could be – something 

that could be supplied with little effort. Also, another technical issued that 

perhaps could be clarified easy to help those who are in front of this is – is a 

clarification on which NPI to use frequently 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 physician would be 

that anyone of those applicable valid NPIs could be used. I know these are 

highly technical but we’re on the width on this so like I said follow up some 

additional information. 

Thank you. 

Barbara Cebuhar: Thank you very much Mr. Bell. Our next comment please. 

Operator: Our next comment comes from the line of Christopher White from AdvaMed. 

Your line is open. 
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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 

physician owned entity 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 I stated earlier in connection 

with question four although it probably 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 other 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 physician 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 

process in order to better define or educate folks who are going to be looking 

at the information, understand what that means. 

And yet, we have avoided in health letter C and just translating to patient that 

we see on a daily basis that need that seem education. Now, aside from all 

that, the cost concern the question of expanding reporting process. Questions 
Centers for Medicare & Medicaid Services

Moderator: Barbara Cebuhar

03-24-11/2:00 p.m. ET

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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 questions or other comments

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 everybody’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 

physiciansunshine@cms.hhhs.gov. And if we could get them by April the 

7th, that would be very helpful to inform our decision making. 

Also, I just 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 any other people 

queuing up for a call, (Christa)? 

Operator: We do have one participant that has queued 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 some 
Centers for Medicare & Medicaid Services

Moderator: Barbara Cebuhar

03-24-11/2:00 p.m. ET

Confirmation # 51513526

Page 38

guidance. I understand, obviously, there are categories already 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 its regulation, specifically 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 Ms. (Rava). Do we have any other comments that have

come in? 

Operator: No further participants are in queue at this time. 

Barbara Cebuhar: Once again, we are very grateful for everybody’s insights and ideas. We look 

forward to getting your comments and I do hope that people will make use of 

physiciansunshine@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. 

END