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27 posts categorized "Diagnostic Imaging"

February 07, 2014

SGR Fix - Can This Really Be Happening?

MagicianThe Sustainable Growth Rate mechanism creating a zero-sum game for Medicare Part B reimbursement rates (dropping rates as volume picks up) has long been unsustainable, and so Congress has been messing around with short-term SGR fix legislation for years now. Every six to twelve months we've been hearing about the impending 20% or 30% Medicare pay cut about to hit physicians' pocketbooks, and the likely exit of physicians from the rolls of participating providers. However, the stars are now aligned in such a way that real progress seems likely: multiple powerful Congressional committees have signed off on a deal to replace the SGR rule with something more workable: A unified approach to financial incentives to physicians and other medical professionals who are Medicare participating providers intended to promote quality and enrollment in alternative payment arrangements.

The full text of the bill will be available here: It's H.R. 4015. Check out the SGR fix section-by-section-summary and the websites of the House Energy & Commerce Committee and the Senate Finance Committee too. The substance of the proposal is discussed below.

How has this happened?

Continue reading "SGR Fix - Can This Really Be Happening?" »

September 07, 2010

OIG: Imaging pre-authorization may be handled by hospital for referring docs and patients

The OIG released an advisory opinion at the end of last month OK'ing a hospital's proposal to provide insurance pre-authorization srevices free of charge to patients and physiciansThis is an issue that has long vexed folks in the imaging world.  Clearly, this is a free service provided to referral sources (to the extent they are obligated by contract with third party payors to obtain the pre-authorization before referring a patient for an MRI, for example), so why is the OIG OK with it?  In the opinion, the OIG blesses the arrangement for four reasons:

  • The arrangement doesn't target specific referring docs, so the pre-authorization service will be provided for patients of docs who are contractually bound to handle it themselves, as well as for patients of those who aren't, and thus the risk of using the arrangement to reward referrals is low
  • The hospital will not pay the docs under the arrangement and will not guarantee to docs that the pre-authorizations will be forthcoming (the OIG also notes -- not sure why -- that the hospital will collect and pass on only such personal health information as may be necessary to secure a finding of medical necessity for the pre-authorization) 
  • The hospital staff will be transparent with payors and referring docs, and will have little influence on steering volume, because they get involved only after the hospital has been selected (other situations are distinguished, e.g., where referral seekers provide referral sources with staff like discharge planners)
  • The hospital has an interest in being paid for its services, and thus in ensuring that the pre-authorization process is conducted properly, thus "lower[ing] the risk that the ... [a]rrangement is a stalking horse for illicit payments to [the hospital's] referral sources"

Well, the reasoning here doesn't really cut it, as far as I'm concerned.  Referring docs and their staffs hate having to deal with the pre-authorization process, and if a hospital takes on that headache, that's a real benefit (remuneration, in the language of the anti-kickback statute).  If there are two hospitals in town, and -- all other things being equal -- one provides pre-authorization services and the other doesn't, guess where all the docs will refer their patients?  It doesn't really matter that the service is provided to all docs, for all payors.  It is still clearly an inducement.  If, on the other hand, all hospitals take on this added cost of doing business, then nobody gains a competitive advantage.  Finally, to the extent physician networks are more and more tightly tied to particular hospital systems (whether through employment or other relationships, post health reform), the potential for steering volume is negligible at best.

Bottom line: I agree with the outcome, but not the reasoning.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

June 20, 2010

Healthymagination VP Mike Barber speaks with David Harlow about GE's investment in health care and health care improvement

What if you could improve health care across the three intransigent parameters of cost, access and quality by 15%?  That's the challenge GE has set out for itself in the form of its current five-year Healthymagination campaign, and it's investing $6 billion in the effort.  I caught up with GE's VP for Healthymagination, Mike Barber, recently, and I invite you to listen in on our conversation about GE's efforts in the US and globally, within GE's health care business unit and beyond, to roll out this major investment -- which, obviously, GE expects to yield a return in the future.

The audio file of my interview with Mike Barber (about 20 minutes long) is available for listening or download

A full transcript is at the end of this post (and in the linked Mike Barber, VP, Healthymagination, GE, HealthBlawg interview transcript).

One year into this five-year campaign, GE has issued its first Healthymagination annual report.  Check it out; I invite your comments and observations.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HealthBlawg :: David Harlow’s Health Care Law Blog

Interview of Mike Barber, VP, Healthymagination, GE

June 10, 2010

David Harlow:  This is David Harlow on HealthBlawg and I have with me today Mike Barber, who is the VP for Healthymagination at GE.  Hello Mike, and welcome to HealthBlawg.  

Mike Barber:  Hi David.  Thanks for having me.

David Harlow:  Mike, I’ve read the Annual Report that was put out recently for Healthymagination at the end of first full year of the operation.  But let me ask you if you could provide some highlights for our listeners and readers.  First up, what is Healthymagination and what are the accomplishments in the past year that you see as having the greatest promise either on their own account or sort of as first or baby steps towards some greater future promise?

Mike Barber:  Sure.  A year ago, GE launched Healthymagination.  We view it as a strategy and we’re pledging to deliver better health for more people.  We want to do that through lowering cost through technology and innovation, improving access and improving quality.  So, it’s a long-term commitment.  Right now, we’re looking at some goals that we’ve put together between now and 2015, in terms of what we’re going to do.  That includes investing about $3 billion in product development targeted at products which improve cost, quality and access; $2 billion of financing looking at health care technologies, financing solutions in underserved markets; and $1 billion in technology and content which would be related to reaching consumers in new and different ways, whether it be NBC Universal content or through water technologies and other properties that are part of the GE portfolio.  We want to improve each of those by at least 15% and as you said, we’ve just completed our first annual report and we’ve made some key progress. We’re very excited about the progress that we’ve made, that investment -- it’s been about $700 million in R&D towards those health innovations, then we’ve validated 24 products, and when I say validated, we have an outside firm which comes in and takes third-party, peer-reviewed information to see in fact, did this product meet the claims in terms of improving cost, quality or access by at least 15%.

So, we have 24 of those products that have been reviewed, so we’re well on our way to target of up to 100 innovations by 2015.  And then we have financing, a stimulus simplicity program to help hospitals, doctors who want to start down the IT journey earlier; as you know with the stimulus package, there’s been incentives that have been identified, some of those incentives start in late 2010, 2011 in terms of doing that.  We want people to start taking and getting their value out of IT immediately.  So, we’ve come out with a program to provide them bridge loans until those incentives become available, to be able to start using IT systems right now, we guarantee that we’ll meet any meaningful use criteria that comes through the regulations.  Also, we have a $250 million fund, equity fund that we’ve launched, the Healthymagination Fund, where we’re looking to invest and co-invest in different start-up companies that are in relevant spaces strategically for GE Healthcare, as well as good value for the investment dollars.

David Harlow:  I’ve read about an initial investment through that fund. Could you tell us a little bit about that company?

Mike Barber:  That’s right.  Cardio DX is a company that we’ve invested in and it is one that is in the area that we call high-value diagnostics, areas where there’s in-vivo tests that can help stratify patients in terms of what follow-up diagnostic treatment is most appropriate and so in the area of cardiology is where the Cardio DX team is focused on initially, and they have some unique algorithms and biomarker tests in the area of cardiology that we feel are very exciting and then can marry and provide better overall outcomes and cost, if you look at what again follow-up tests and vivo tests that might be necessary through imaging and then into treatments for patients.  So, combining the strengths of in-vivo and in-vitro diagnostics is something we’re very excited about.

David Harlow:  Now you mentioned earlier that you’re looking for an improvement in cost, quality and access by 15% and you mentioned some third party verification, so you’re looking at improvements on a particular product, on a particular service?  How are you measuring this 15%?  What’s the idea there?

Mike Barber:  The way that we looked at this, really through the eyes, the external eyes.  So, it’s not about just what we do from a product perspective, but how does our product enable the ability to improve the cost of a overall procedure or the continuum of care a patient might have by 15%.  So, if you’re talking about having a better diagnostic or a diagnostic which can lead to a more targeted therapy, where you can differentiate and understand that if a person has cancer, what stage their cancer is at.  Therefore, being more pinpoint, more targeted at what their therapies are, as you know, there’s many cancer treatments that are coming out that are very expensive and they don’t work on everyone in the population.  So, being able to identify those patients or those conditions where this procedure would work versus ones that wouldn’t are ways that you can reduce the overall system cost and that’s what we’re looking at when we talk about cost reduction.  

David Harlow:  You mentioned there a couple dozen innovations that have been certified in this first year.  I wonder if you could give a couple of examples.

Mike Barber:  We have an example of a health care IT product which helps with decision support or looking at the appropriateness of imaging procedures, so a hospital administrator can use it to see based on the issues, the symptoms that a patient has, are the appropriate kinds of tests being run from an imaging perspective?  There’s another one looking at asset management and if you think about a hospital and all the different infusion pumps and other kinds of devices they have that are necessary and we have RFID tracking along with software to help manage and so we’ve had customers’ CFOs show this outside firm their operating statements that show that net of purchasing this software they’re able to save on their operating expenses by 15% in the area of procurement as well as maintenance for really understanding where those assets exist and how they can be best leveraged.  Products like our Discovery CT750 has been launched looking at reducing the dose in a CT scan by over 50%, across body and heart procedures where we’ve had clinical studies done to show that the diagnostic confidence and the speed of diagnosis that the radiologists use, the clinicians use, stays the same the same, but in fact being able to have 50% less dose to the patient; and then for access products like a handheld, portable EKG machine which can travel to the patient, so it’s leveraged in many developing countries where you know if somebody traveling and they need an EKG, they might have to, you know, travel several hundred kilometers to a hospital kind of setting, but being able to have this in a battery-powered, portable, very rugged package, it’s something that can exist in rural villages and a clinician can carry it out with them as they go see the patients.  So, bringing healthcare technology which is important such that somebody in a rural village has the right symptoms, sometimes they get the EKG and then back and should travel for a follow-up care.  They travel 50 or 100 kilometers as necessary but those that don’t need or can be treated locally don’t have to do that.  So, those kinds of products have been shown to increase access to health care technology.  

David Harlow:  Great.  Let’s talk a little bit more, if we could, about the diagnostic imaging innovations, similar to what you just described, that are detailed in the annual report, focused on India and China in particular. Do those in-country efforts hold promise for lower-cost innovations in the US?

Mike Barber:  Potentially, it’s clear at this point we’re focused on what are the needs of those markets like you talked about, India and China, where access to health care professionals might not be the same as it is in a developed market, looking at what is again the essential elements which are needed and it’s focused around that, but clearly, we can see a day where you can leverage some of those technologies and innovations and put it into a package that could be appropriate in the US or other parts of the world, something that might be able to be in a physician’s office versus being in a hospital setting that can provide targeted kind of diagnostics, that could be appropriate.   I talked about that EKG machine, there is a version of that, that is under development, that could be in a physician’s office or be in a rural clinic in the US, where it could be appropriate.  So, even in places in the US and Europe and developed markets you find that urban settings versus rural settings there are different needs that can be there and so these products that are developed primarily for India and China, we do believe could have a place in the US in certain segments of the health care system.

David Harlow:  Could you explore further the degree of coordination or integration across business units in implementing Healthymagination.  It sounds like it’s not simply an effort of GE Healthcare; you mentioned GE Water and other business units as well.

Mike Barber:  That’s correct.  It’s really looking at the health sector as a mega market and how can we leverage the various assets of the General Electric Company in that market, for instance.  So, one of the biggest that we’ve looked at it is, how do we reach consumers in new and different ways and clearly the NBC Universal team has a lot of expertise and ability to do that.  So, we’ve leveraged that platform and we’ll continue to leverage that platform to understand that.  They’re launching a campaign on nutritional literacy, something that’s important for all of us to understand and so will be leveraging them in that area.  As you mentioned GE Water, you think about the foundation of health – it’s clean water and so wastewater reuse technology, as well as, you know water filtration are things that we’re looking at with that business.  Our research labs are looking at new and innovative ways to, again, in the diagnostics space and life sciences space, as to what’s possible how do, you know, leverage our various technologies which can be in a developing market to provide better access to care again to people that are in those markets.  And then, GE Capital.  GE Capital, we financed MR and CT machines for many years but can we leverage the capital business to look at, you know, financing of IT systems, something that we’ve started to do, as well as look at new markets like community health clinics and other places which have a different profile than some of our standard customers, but again, could be a way to leverage the capital infrastructure to provide better access to care for technologies and products that can serve patients and consumers.

David Harlow:  Right.  And you mentioned earlier that there is a $2 billion commitment to serve as bridge financing for HIT systems.

Mike Barber:  That 2 billion is not all for HIT.

David Harlow:  Oh okay.  What other sorts of technology would be financed through that fund and do you see that as a revolving fund or sort of short term bridge loan as you mentioned ?

Mike Barber:  No, there are various aspects. The $2 billion commitment is in total from what we call our GE Capital portfolio.  Of that, there is a $250 million fund which was started and that fund will look at technologies which are in the life sciences space, health care IT space or the diagnostic imaging space.  So, the bulk, the rest of that, other things that we’re looking at is the bridge loans that we talked about is something that we launched last year and again, it will have a limited life because the incentives will then be available directly from the government, but we looked at that and then we’re looking at expanding the portfolio of financing that we do to community health centers, we’re looking at more financing on the international side of the business, potentially looking, you know, at markets which are growing and doing local currency financing as appropriate in some of those markets.  So, given this is a long term commitment and journey between now and 2015, everything is not defined today, but as we learn, as we really get into these markets and understand what’s the need, what the needs are and what are the key issues we have to solve, we’ll adopt and adapt but the commitment at the top levels is one that we’re going to reach.  

David Harlow:  So, you’ve set yourself quite an ambitious goal for a 5 year, 6 year time horizon.  Particularly, I’m just thinking about the commitment to improve along the parameters of cost, quality and access which is something that payers, providers and governments have been struggling with for decades and I’m wondering what, I guess to put it bluntly, what gives you the confidence that you can be successful in this arena where success has eluded so many people for so long.

Mike Barber:  Well, there’s confidence and this isn’t GE standing alone doing all this, we’re working in partnerships with many of the stakeholder groups which you’ve talked about, but it is going to take people coming together and fundamentally we have a strong belief and confidence that investments in the right technologies and the right solutions can provide that kind of improvement and so it’s really leveraging and focusing our own investments in areas that are well focused around cost, quality and access.  We’re working with those stakeholders groups which you talked about to understand what are the real needs and issues, how can we leverage, there’s been you know, lots of discussion around Health Care IT and how IT can help us solve this problem, putting in decision support, making sure through e-health collaboration can happen between clinicians to make things more efficient so you hear about duplicate tests being run on patients that potentially aren’t necessary.  You think about looking at payers and governments and we’ve worked with them in many parts of our market, we’re a global company, so we sell products today and to marketplaces which are, you know fully public, some fully private, mixture of both and some of it’s, we feel it’s our ability to interact with those stakeholders, leverage our deep understanding of the technology and of the innovations that are necessary and work with those stakeholders, use the complete power of the General Electric Company to get those stakeholders together that gives us the confidence that we can do this and we’ve proven that in the area of Ecomagination in environment, we’ve been able to do this in another mega market in a large societal issue and so, health is the next one that’s key for our businesses, we want to be in the health, we plan to be in health business for many decades in the future and so we want to be a key part of making it better.

David Harlow:  Great.  I was about to ask about Ecomagination and just sort of wondering whether this effort is modeled on the Ecomagination effort, are there similarities beyond the name and if you could speak to that a little bit more.

Mike Barber:  Well clearly, Ecomagination was a similar commitment from, that was in 2004, 2005 time frame, where GE as a large industrial company, but in many businesses, which touches the environment and looking at, you know, renewable energies and power generation and carbon emissions and again wanting to be in those marketplaces for decades into the future just like we’ve been for decades into our past, we know that there’s needs, determined there were needs that were needed to be viewed and looked at in new and different ways and commitments that we could make.  So, commitments were made to increase our funding for products which improve the environment, green products, looked at increasing our revenues and growing our business in those products with our customers, looked at our own greenhouse gas emissions and commitments in reducing those and then being open and transparent in working with partners on that, so if you, if that at top level, the same kind of words, yes can be applied to Healthymagination in terms of partnership, in terms of commitment for investment in R&D in particular area and for commitments for ourselves, we have a program with our employees that we call Health Ahead and to look at from our own employee health, how we get the maximum, maximize the value that our employees get, as well as reduce the cost that we have as a company, as a self-insured company, so there’s been several parallels between Ecomagination and Healthymagination.

David Harlow:  Very good.  Well, I thank you very much for your time today.  I’ve been speaking with Mike Barber, VP for Healthymagination at GE.  Thanks again, Mike.

Mike Barber:  Thanks David.  Have a great day.

April 20, 2010

FDA takes it up a notch: A fresh look at radiation emitting equipment regulation, and what about EHRs?

Earlier this month, the FDA released a letter announcing a new focus on radiation-emitting products.  Here's the core of the letter:

In order to reduce the number of under-doses, over-doses, and misaligned exposures from therapeutic radiation the FDA is taking several steps to improve the safety and safe use of certain radiation therapy devices. Analyses of Medical Device Reports (MDRs) revealed device problems that appear to be the result of faulty design or use error that could be mitigated by the incorporation of additional safeguards. Between December 31, 1999, and February 18, 2010, FDA received 1,182 MDRs associated with the use of radiation therapy devices. Of these MDRs, linear accelerators accounted for 74%, radiation therapy treatment planning systems (RTP) accounted for 19%, and ancillary devices (e.g., radiation therapy simulators) accounted for 7%. The most frequently reported device problems were computer software issues, use of device, and incorrect display. In some reports, the manufacturer was unable to determine or identify the problem and reported the problem as “unknown.”

A separate analysis of these MDRs for software problems identified 362 MDRs. Of these MDRs, linear accelerators accounted for 66%, RTP accounted for 29%, and ancillary devices accounted for 5%.

It is important for manufacturers to investigate the cause of nonconforming product and analyze factors in addition to use error as part of Corrective and Preventive Actions (CAPA). Such analysis may include an assessment of the correlation between product user interface, controls, or user information and use error.

FDA plans to hold a public workshop on radiation therapy treatment planning, medical linear accelerators, and ancillary devices. Additional information will be published in a Federal Register notice. Topics will include:
  • New safeguards and other special controls to improve safety;
  • Possible changes in premarket device testing to provide appropriate assurances of safety and effectiveness, particularly for software; and
  • Premarket review of all modifications to software.

FDA encourages manufacturers to attend the public workshop to discuss these issues.

The top issue identified by the FDA in this letter is software, and the proposed solution includes possible premarket testing of software (which FDA asserts comes within the definition of "device.")  Issues concerning inappropriate radiation doses raised a couple of months ago extend to the use of diagnostic radiology as well, and have led to the proposal for the establishment of a central radiation dose registry.  (Testimony at the FDA hearings on diagnostic radiology included a presentation from MITA's Executive Director, Dave Fischer, who was interviewed here at HealthBlawg the week before the hearing, in early March.  A second public meeting was held March 30-31.)

The NY Times reported upon the issuance of the FDA letter:

Dr. Howard I. Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York, said the F.D.A.’s action did not address what he believed were more serious problems stemming from shortcomings in staffing, personnel competency and hospital quality assurance programs.

“I’d also caution that however commendable tougher standards for premarket approval of software may be, its not clear that F.D.A. has the expertise to police this,” Dr. Amols said. “In fact, I’m not sure anybody does. That’s one of the big problems with software. It comes down to a qualified user recognizing that something is amiss.”

Questions about the FDA's ability to regulate software are of great concern since it has asserted the right to regulate software as a device, not only in the context of radiology, but also in the context of electronic health records. 

In the EHR context, Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, has signaled the agency's willingness to step back from asserting the right to require premarket approval of all EHR software -- good news for the market, though maybe not so good for some of the big players in that market, since a PMA requirement could debilitate the market, and limit entrants to large organizations able to bankroll the PMA process and longer time-to-market.  See Shuren's testimony at the February 25 HIT Policy adoption/certifciation workgroup meeting, and the transcript, too, for starters. 

The idea that the FDA would exercise regulatory restraint and coordinate with the ONC, so that ONC could incorporate FDA requirements as part of the definition of Stage 2 Meaningful Use is very encouraging (two agencies within HHS coordinating their efforts ... wipeout concept, man).  I am encouraged that there can be use made of existing systems within government to capture and process incident reports -- though, of course, Shuren makes the point that reporting is only the tip of the iceberg. There needs to be a commitment to addressing issues, and increased transparency. The point was made at the workgroup meeting that EHR license agreements constrain communications among providers about problems and potential improvements. It seems to me that the industry should be encouraging, not restricting, that sort of communication and opportunity for continuous improvement, rather than face more draconian governmental controls.

Bottom line: Both with respect to the software controlling radiation-emitting diagnostic and therapeutic technologies, and EHRs, there are alternatives to FDA full-bore PMA regulation of the software as devices -- alternatives that can encourage a quality improvement mindset even in an arena where we need to have zero tolerance for errors.  The challenge is to bring the quality home at a price point we can live with.  The PMA approach (like the Pentagon's former build-it-from-scratch model vs. current buy it off-the-shelf model when it comes to computer hardware and software acquisitions) guarantees higher process costs without guaranteeing better outcomes.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 28, 2010

Diagnostic Radiology Controls: David Harlow Interviews MITA Executive Director Dave Fischer

MITA Executive Director Dave Fischer spoke with HealthBlawg last week about industry efforts to control radiation dose in diagnostic radiology modalities such as CT. 

A congressional hearing on radiation dose control took place the day after we spoke, and the FDA will be holding a hearing on diagnostic radiology issues in late March.  Earlier last week, timed in part perhaps because of the upcomng congressional committee hearing, MITA kicked off the dose check initiative, a tool for manufacturers and providers to use in better regulating diagnostic imaging radiation dose, which Dave Fischer describes in our interview.  He also referred to the CMS demonstration project on appropriateness of imaging services now underway, authorized by MIPPA.  

It now seems surprising that there has been no demand by clinicians, technologists, medical physicists, regulators, accreditation entities, consumer groups or others for this sort of rudimentary standard-setting and introduction of failsafe mechanisms to avoid dangerous levels of medical radiation, and a more rigorous approach to a cost-benefit analysis for CT scan ordering (though the CMS demo is perhaps a good first step).  However, media reports about unreasonably high radiation doses in the CT setting at Cedars-Sinai and elsewhere around the country have galvanized our attention so that we have focused on this issue. 

Here's hoping that in the future, areas of concern may be identified empirically and safeguards put in place before patients are harmed. 

The audio file of my interview with Dave Fischer (about 20 minutes long) is available for download/podcast.  A full transcript is at the end of this post (and in the linked Dave Fischer - MITA - HealthBlawg interview transcript).

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HealthBlawg :: David Harlow’s Health Care Law Blog
Interview of Dave Fischer, Executive Director of MITA
(Medical Imaging and Radiation Therapy Manufacturers Alliance)

February 25, 2010

David Harlow:  This is David Harlow at HealthBlawg, and I have with me today Dave Fischer who is the Executive Director of the Medical Imaging and Radiation Therapy Manufacturers Alliance, or MITA.  It’s an organization that represents most of the manufacturers of equipment in this area and works to establish some common principles and protocols for this industry.  Dave, I appreciate you taking the time to speak with HealthBlawg.

Dave Fischer:  Of course.

David Harlow:  Dave, I am interested - as we all are - in exploring questions about patient safety in dealing with imaging technologies, particularly in light of the news about CT scanner dose issues, initially at Cedars-Sinai last fall and then, as came out, elsewhere in the country.  And now we’re looking at an information gathering process and probably a regulation development process with FDA as a result of the public hearing that’s being held next month.  And I’m interested in hearing from you about where you see the industry right now, how you see the industry as a whole responding to this issue and how you see the interplay between the equipment-related issues and the professional practice related issues whether it’s physician issues or technologist issues.

Dave Fischer:  Sure, I think might be instructive to start with describing just for a minute  the distinct difference between imaging manufacturers and imaging technologies and radiation therapy technologies.  The diagnostic technologies, for example CT, on the ionizing radiation side of the equation are specifically designed for detecting abnormalities in a patient.  And over the course of nearly a decade MITA and its member companies have been working to reduce dose for the use of those technologies.  And the thing I think whether it’s through new innovative technologies or new practices, new information provided to operators, we’ve been working diligently to reduce dose and to provide the same quality of image for the patients and their providers.  On the radiation therapy side of the equation, actually the intent of the therapy is to use radiation to kill cancer cells.  And so the focus there is to focus the radiation to a specific spot without damaging surrounding tissues.  And so when folks talk about or people talk about dose reduction, they are generally talking about the diagnostic side of the equation.  Now, with regard how we have been responding to radiation dose issues and you’ve mentioned a number of things that have been in the press recently, like I said a moment ago, on the diagnostic imaging side our companies have spent years developing technologies to reduce the amount of radiation that a quality scan requires as well as providing operators with additional information about the amount of radiation a particular scan will utilize to make that image.  And many of these features are designed specifically to reduce radiation and to make the operator aware of the amount of radiation so that changes can be made prior to the scan to reduce the amount of radiation a patient will actually receive.  Now, how do manufacturers interact or what’s the partnership between all of the different folks who work on this?  Now, I think like I just mentioned, it clearly is a partnership.  The equipment that we manufacture is a tool that physicians, medical physicists, technologists all use to screen patients or treat patients or determine if they have disease.  And in all of these cases, we have to work in partnership with all of these providers to ensure the safe and effective use of our equipment.

David Harlow:  Now, one of the issues raised in anticipation of the FDA hearings is a question about establishing radiation dose reference levels, which relates to one of the things you were just saying.  And I’m wondering what you see as the way forward for incorporating this information and failsafe controls into the everyday workflow of the professionals using this requirement.

Dave Fischer:  I’m glad you asked about that.  One of the things that we’ve announced this week with regard to reducing radiation dose and making operators more aware of dose is the CT manufacturers have all agreed to three things.  One, to what we call a dose check or the MITA dose check initiative.  Those items are first, a dose alert - already the equipment provides the operator with a dose level for a particular scan.  However, we believe it’s important to put that level into context, and so we’re creating a tool that will allow providers or hospital imaging centers to enter in reference levels just as you mentioned just a moment ago to provide the operator with a data point to help them understand where the dose in the scan they are about to do - the dose level for that scan ranks in the overall distribution of dose for that particular type of scan.  And so it’s like a yellow light.  It’s an alert to allow that make sure the operators know this is above our reference level, we need to have a very good reason for that.  Second thing, --

David Harlow:  So if I can interrupt you just to make sure we understand that.  What you’re saying is that you’re going to create the technology to establish a set of guardrails if you will and each institution would calibrate those guardrails.

Dave Fischer:  I think it is a decent analogy.  I mean, we’re creating the tool to inform the operator but it will require the imaging facility or the hospital to provide the data, the information, the value that would cause that pop up screen to come up.  In addition, I’ve mentioned the yellow light, we’ve also created a red light, which is a dose warning if a particular scan has the potential to be dangerous to a patient.  A perfect example of this is a scan that has enough radiation to cause deterministic effects, like hair loss or burns.  Now, there is almost no reason why a CT machine would ever cause that unless it had been set inappropriately.  And so we want to make sure that if that is set that way that we have a red light that pops up - a warning - to the operator to let them know there is something wrong here that you need to check out.  The last thing, and this is something I think that will fit very nicely into the President’s recent proposal for a national dose registry.  We believe that this dose information needs to be recorded in a standard manner.  It currently is recorded in the DICOM system, which is the language of interchange, the exchange language that allows imaging products to all communicate with each other.  But recording this dose image in a standard manner will also facilitate the use of a national dose registry as well as facilitate the analysis of dose to make sure to better understand how it use, how it changes, how it varies.

David Harlow:  And what do you see as the likely timeline for implementation of this system?  You say that CT manufacturers have agreed to move forward with this; will this involves significant retrofitting of existing systems?

Dave Fischer:  CT manufacturers will begin to apply this technology to their new releases beginning this year.

David Harlow:  So new releases meaning software upgrades to machines that are –

Dave Fischer:  That are being sold, correct.  And then additionally we will also begin pushing out this technology to the installed base as well.

David Harlow:  You mentioned earlier the notion that doses on average per study have been reduced overtime.  And my question there is - another analogy if you will, the introduction of the catalytic converter reduced automobile emissions tremendously but then again the volume of vehicle miles has increased tremendously since that time.  So what are we looking at in terms of controls on the uses of the technology, the numbers of scans per thousand population, is that on your radar screen as well?

Dave Fischer:  Absolutely. One of the things that we’re strong supporters of is something called appropriateness criteria, there was actually legislative language with that theme that was included in a physician payment update bill about a year and a half ago.  What the appropriateness criteria means is we want to make sure that the patients gets the right scan at the right time.  What that means is we want to incorporate into the physicians’ thinking that CT or other diagnostic imaging is appropriate for certain conditions in certain periods and it should be used in those times in those periods.  We do not support the idea of the principle of maximizing CT scans or any diagnostic tool. We believe we should be using the right scan at the right time.

David Harlow:  And so are you working through that initiative with clinical groups, professional organizations to develop the evidence based guidelines that may affect utilization?

Dave Fischer:  Manufacturers can’t practice medicine and so we really have to leave it to the professionals in that area.  But I can tell you that the Center for Medicare and Medicaid Services is beginning to implement the demonstration program that was included in the MIPPA bill.

David Harlow:  Do you participate with the professional associations, societies in terms of education programs in order to get the word out about issues like this?

Dave Fischer:  Oh, absolutely.  Another example is the Image Gently Campaign, which is run by the American College of Radiology.  We’re a participant in the Image Gently Campaign which is specifically designed to reduce radiation in pediatric medicine so that is one example of our efforts to work closely with the radiologists, the physicians, medical physicists in that effort.  We will be cosponsoring both a CT dose summit and a radiation therapy dose summit in the coming month.  We believe very strongly in the partnership that I mentioned earlier between all the providers and the manufacturers.

David Harlow:  Is it too early to see a result from that partnership, from those educational efforts?  I ask because in recent weeks there has been news about evidence based medicine studies that show relative benefits of different approaches to managing care – I’m thinking specifically of stents versus medications in the cardiac arena - and despite the evidence, clinical practice does not seem to be shifting.

Dave Fischer:  There is a larger issue within our healthcare system about variations in care across the country.  What we feel like as manufacturers what we feel we can do is do our best to make sure we’re educating our customers as well as the national societies and also in our local level to try to make sure they understand our views on the applicable reasons for these tests.

David Harlow:  What else can you tell us about communications with either the FDA or with other regulators at the federal and state level, or professional associations at the federal and state level, dialog around this issue and where you see this going in the context of the upcoming of public hearing at the end of March?

Dave Fischer:  Last fall, MITA convened a stakeholders meeting with radiologists, physicists, technologists as well as the FDA, to discuss the issues of radiation dose and we have been working since then on this topic with them and communicating with them.  Those meetings were the beginning of our own efforts to create the MITA dose check initiative.  And we welcomed the FDA’s announcement a couple of weeks ago.  Much of what they have proposed are things that we agree with and we intend to work closely with the FDA and participate fully in the FDA’s process moving forward.

David Harlow:  One of the other points that you’ve endorsed is the expansion of mandatory accreditation for advanced imaging facilities and my sense is that many if not most payers already require some sort of accreditation in order to bring facilities into their networks.  Do you see an additional significant opportunity for further accreditation?

Dave Fischer:  I believe the accreditation program that was included in the MIPPA bill that that I mentioned earlier is for the non-hospital setting.  We support examination of whether or not that policy needs to be expanded to include hospitals.  Generally speaking, I think there is a lot of value to accreditation in the sense that it ensures that an imaging facility is up to speed on all of the different techniques, that their machines work appropriately.  And I think its also important to remember this is a new program that has just gotten of the ground.  And so I believe there is a lot of room for moving providers into that category.

David Harlow:  Another issue raised in these endorsements is the notion of some standards for personnel involved in the imaging exams and radiation therapy treatments.  And I’m wondering whether you see our 50-state system as an impediment to achieving this sort of standardization?

Dave Fischer:  Our organization hasn’t taken a position on whether or not the minimum standards that we support should be a national-based system or a state-based system.  I think the key is that we establish the standards for training and education for the personnel performing medical imaging exams in the radiation therapy arena, I’m sorry in the radiation arena.

David Harlow:  We spoke a little bit about a national dosage registry and I’m wondering whether there is any comparable registry in place today where the infrastructure could be built on that is in current use among the professionals who’d be called upon to using this registry?

Dave Fischer:  I do not know the answer to that question.

David Harlow:  Is that something that you have been involved in looking at talking about what the infrastructure would be for that registry?

Dave Fischer:  The challenge with a registry system like this is that we have, as everyone knows, a fragmented healthcare system, that is the nature of our system.  And as we add health information technology we gain additional ability to gather this information and to understand it.  While it’s true that the imaging sector is fairly advanced in regard to exchanging information - like I mentioned the DICOM standard earlier - and in recording dose information, having that information at a single hospital doesn’t provide you the same robust information that it would if it’s captured by a city or a state or a hospital system or a national version of that.  And so what I think is critical first about our dose check initiative is (1) standardizing the recording of that information so it’s more easily accessible and then (2) just the ongoing development and advancement of health information technology which will facilitate the sharing of that information over time.

David Harlow:  So you’re saying that just as an example, the DICOM standard could be used in order to support a registry that would be interoperable or could receive information and share information with existing provider systems in place?

Dave Fischer:  Absolutely, it’s already functioning, it includes radiation dose information and in fact the FDA mentions the DICOM standard in their white paper. 

David Harlow:  What would you expect that future to bring this says public hearing is called for the end of next month, what do you as happening over the next 6 to 18 months as a result of that hearing?

Dave Fischer:  I expect we’re going to see additional efforts.  I could speak from my own organization’s perspective.  I mentioned today our dose check initiative for CT: we’re already exploring ways to expand that effort to include radiation therapy, nuclear medicine as well as x-ray.  So we believe that including additional information for the providers and the operators of this equipment is essential to reducing medical errors and we will continue that effort.  I expect that FDA will continue to examine this.  I do not know whether or not they will issue regulations or how will impact the clearance process.  But we intend to work with FDA closely to ensure that the newest innovations are able to get to market and to make sure that medical radiation is reduced and medical errors as well.

David Harlow:  Well, thank you very much.  I’ve been speaking with Dave Fischer, Executive Director of the Medical Imaging and Radiation Therapy Manufacturers Alliance.  Thanks again, Dave.

Dave Fischer:  Thank you.

December 28, 2009

Health Reform: What's a Provider to Do?

What should health care providers be doing in anticipation of the likely passage of an historic health reform bill?  There are at least three possibilities: (1) Lament the passing of the good old days and oppose it; (2) Insist that it isn't good enough because it is lacking some key provision (tort reform; SGR replacement; robust public option); or (3) Embrace it, because incrementalism works, and prepare for what's coming down the pike.

As you may guess, I would recommend taking the third approach, which requires focused preparation for the road that lies ahead.  So, what is a provider to do?

In the future, there will be pilots, demonstrations and mainstream programs trying to do more with less: providing health insurance and health care services to more people, with effectively fewer dollars per capita.  Payors -- be they public sector or private sector -- will therefore be squeezing providers.  The House and Senate versions of the health reform bill are equally clear on this point.  Providers therefore need to be proactive in preparing themselves to provide high-quality health care services at competitive rates.Instead of simply resigning themselves to negotiating percentage discounts off of current rates of payment, all providers need to be prepared to negotiate global payments, pay for performance deals, quality incentives and more -- as some forward-thinking provider organizations have been doing for some years now.

In order to be able to negotiate these terms effectively, providers must have a good handle on their own cost structure, and must begin to work at developing broader alliances of providers so as to be better positioned for negotiations with public and private payors.

In my years of experience in working with health care providers at that moment -- the point in time when folks with otherwise disparate interests realize the tremendous value of working together effectively in order to simultaneously promote better clinical outcomes for patients and better financial outcomes for providers -- I am always heartened by the epiphanies of the providers who realize that a new approach, or a new structure, can take them beyond their historical, positional, sometimes defensive attitudes, and into a future that they are able to shape and help define.

I look forward to working with more providers and provider organizations at this critical juncture so that they can be prepared for the future that will soon be upon us, and so that they can have a hand in crafting that future.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

July 15, 2009

Red Flags Rule: The FTC piles on, because HIPAA, ARRA and overlapping state laws just weren't enough

Update 5/28/10:  Red Flags? Nah ... nothin' but blue skies.  The FTC delays implementation of the Red Flags Rule yet again, to December 31.

Update 11/3/09:  The FTC announced that implementation of the Red Flags Rule will be delayed once more, this time until June 1, 2010.  The announcement came on the heels of losing a court case to the American Bar Association -- the court ruled that the rule does not apply to lawyers -- and on the heels of a legislative attempt to bar its applicability to small health care, accounting and legal practices.  Stay tuned.  

Update 7/29/09:  The FTC announced today that implementation of the Red Flags Rule will be delayed once again, this time til November 1, 2009.  The agency promises to roll out additional information targeted at low-risk entities covered under the rule.  Thus far, nothing has changed with respect to the rule and its ultimate effect, so organizations subject to the rule should take the extra time to assess their compliance needs and implement their plans in advance of November 1.

After a couple of delays, the FTC Red Flags Rule will be effective August 1, 2009.  This rule requires "creditors" under certain "covered accounts" to maintain a heightened alertness to numerous categories of "red flags" that may indicate that the consumer who is the rightful account holder is the victim of identity theft.  If a red flag is triggered, the creditor must take steps to notify the consumer and correct any inappropriate information included the creditor's records.

As you probably already know, the FTC is extending its reach with this rule (among others) into the health care sector.  (Cf. the FTC's role in enforcing certain Son of HIPAA provisions.)  The AMA has all but dropped a draft complaint on the FTC's desk, citing assorted legal precedents in its correspondence with the FTC arguing that the Red Flags Rule should not apply to physician practices.  The FTC is unmoved -- except to the extent that it has been willing to delay the effective date twice (from November 2008 to May 2009 to August 2009).

At any rate, the August 1 effective date is around the corner, and affected health care entities need to develop and implement compliance plans now, if they haven't already.  (Even the AMA says so, and has published guidance and a sample policy for members.)

A few more general comments before stepping back and examining the language of the rule and its applicability to health care providers.

The federales are taking something of a common-sense approach here, recognizing that a compliance plan needs to be tailored to the specific entity, the nature of its "covered accounts" and its operations.  Bank of America, N.A. and Springfield Medical Associates, P.C. will have very different compliance plans, because their potential red flags and the potential risks are vastly different.

Affected health care providers need to understand that the Red Flag Rule requirements overlap with HIPAA and state privacy law requirements (and looming Son of HIPAA requirements in ARRA), but will not be satisfied by implementation of existing privacy policies and compliance plans.  Review of the intersection of existing policies and procedures with the new rule's requirements is the first order of business.

As with any other new regulatory scheme, preparing a compliance plan and putting it on the shelf won't cut it.  The rule calls for regular monitoring of the plan and issues that arise by a senior manager.  Furthermore, best practices would dictate the training of staff to deal with individual issues and, most importantly, with the affected consumers.

Even if not clearly subject to the Red Flags Rule, providers should undertake to comply, for a couple of interrelated reasons:

  • Good patient PR.  Data security is top of mind these days.  Much of the effort required under the rule should be expended anyway simply to respond to market pressures calling for improved data security.
  • Potential liability.  The creative trial attorney will seek to use the Red Flags Rule as establishing a standard of care for the stewardship of personal information.  The incensed jury will go along.  The health care provider caught in the middle between thieves and victims may be the only perceived deep pocket available.

OK, so what is a "creditor" and what is a "covered account?"

Any entity that accepts payment other than payment in full at the time of service is a creditor.  Health care providers that go the cash-on-the-barrelhead route aren't creditors; all others are creditors.

The FTC Guide defines covered accounts as follows: either

  • a consumer account you offer your customers that’s primarily for personal, family, or household purposes that involves or is designed to permit multiple payments or transactions; or
  • any other account that a financial institution or creditor offers or maintains for which there is a reasonably foreseeable risk to customers or to the safety and soundness of the financial institution or creditor from identity theft, including financial, operational, compliance, reputation, or litigation risks.” Examples include small business accounts, sole proprietorship accounts, or single transaction consumer accounts that may be vulnerable to identity theft. Unlike consumer accounts designed to permit multiple payments or transactions – they always are “covered accounts” under the Rule – other types of accounts are “covered accounts” only if the risk of identity theft is reasonably foreseeable.

Any creditor with covered accounts must have a red flags rule compliance plan in place with policies and procedures for dealing with "red flags" -- i.e., signs that personal information may have been compromised.  The World Privacy Forum suggests that the following red flags are the ones most applicable in the health care context:

• A complaint or question from a patient based on the patient’s receipt of:
   o a bill for another individual
   o a bill for a product or service that the patient denies receiving
   o a bill from a health care provider that the patient never patronized or
   o a notice of insurance benefits (or Explanation of Benefits) for health services never received.
• Records showing medical treatment that is inconsistent with a physical examination or with a medical history as reported by the patient.
• A complaint or question from a patient about the receipt of a collection notice from a bill collector.
• A patient or insurance company report that coverage for legitimate hospital stays is denied because insurance benefits have been depleted or a lifetime cap has been reached.
• A complaint or question from a patient about information added to a credit report by a health care provider or insurer.
• A dispute of a bill by a patient who claims to be the victim of any type of identity theft.
• A patient who has an insurance number but never produces an insurance card or other physical documentation of insurance.
• A notice or inquiry from an insurance fraud investigator for a private insurance company or a law enforcement agency.

If a situation is flagged, a creditor must take steps to mitigate the risk of identity theft or continued identity theft.  Again, the World Privacy Forum notes:

There need to be uniform but appropriately flexible answers to these questions:

  • What do we do when a patient claims fraud is in their files?
  • What do we do when a patient says the bills are for services she did not receive?
  • What do we do for patients and other impacted victims when we uncover a fraudulent operation?
  • When we have a real case of medical identity theft, how can we work with patients to fix the records and limit future damages?
  • What do we do when a provider has altered the patient records?
  • How do we handle police reports and requests for investigation from victims?

The answers to these questions need to viewed not just from the provider’s perspective, but also from the victim’s perspective, which can differ substantially.

There are a number of useful resources available for health care providers seeking to take stock of their situation, establish Red Flags Rule compliance policies and procedures, and undertake staff training on the subject.  For example, the FTC, the AMA and the World Privacy Forum have all released valuable guidance documents (all linked to above) that would assist any organization with coming into compliance. 

As with any effort of this sort, it is often valuable to have someone outside the organization come in to review existing policies, procedures and workflow in order to highlight potential risks and opportunities for improvement.  The HealthBlawger and members of the HealthBlawger's virtual consulting network are available to come in and assess, plan and help implement compliance strategies for organizations large and small touched by the Red Flags Rule.

Whatever the size or nature of your business, please take a moment to consider how the Red Flags Rule may apply to its operations, and how it may relate to other regulatory schemes such as HIPAA and state laws.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

July 02, 2009

2010 MPFS: CMS proposes 21.5% physician pay cut (yes, really)

Let's go down the rabbit hole with the federales. 

Remember the Sustainable Growth Rate, that congressional hedge against inflation of health care costs, specifically payments under the Medicare Physician Fee Schedule?  Well, the CY 2010 MPFS went on display yesterday, and is due to be published in a couple weeks.  As written, the rule would (among other things) fully implement the SGR by cutting physician payments 21.5% (see the press release).  That's because Congress has overridden every other cut mandated by the law since 2002, yet has not taken the time to rethink it -- even though it called for a review in 2005's DRA, and MedPAC obliged in 2007.  To cut to the chase, MedPAC recommended that Congress either (a) come up with another cockamamie formula or (b) repeal the SGR and develop incentives for providers to provide higher quality care at lower cost.  Yes, they've done a fine job so far . . . .

So, we all know that Congress will step in before the rule takes effect January 1, 2010; perhaps it will be in a systematic way this time, however, with a real replacement for the SGR wrapped into a broader health care reform bill.  The Tri-Committee bill in the House (see sec. 1121, p. 181) is the only leading bill that addresses this issue head-on, as far as I know (please let me know if I'm missing something), though it does not include a radical enough reformation and seems to fall in line with MedPAC recommendation (a).

As the WSJ Health Blog notes, another part of the crazy logic at work in the draft rule is a CMS proposal to carve out reimbursement for physician-administered drugs ($87.5B over ten years, per the CBO) from that which is subject to the SGR.  That would help with the narrow issue of how-many-percentage-points-of-the-SGR-can pass through the eye of a needle, but obviously doesn't address the fundamental systems issue.  (I'll take (b) for $2.4 trillion, Alex.)

There's plenty of other goodies in this draft rule -- especially around imaging -- but the big across-the-board cuts certainly deserve the headline.  For example:

  • Capital reimbursement for physician-office diagnostic equipment was originally calculated by CMS based on the assumption of a 50% utilization rate.  Since the actual utilization rates are much higher, that assumption is now being formally thrown out the window.
  • Under MIPPA, imaging providers will be subject to new accreditation requirements as of January 2012; accreditation organizations are identified in the rule, and additional controls will be forthcoming in separate rulemaking.
  • Finally, more measures are being added to the PQRI set, and automatic EHR-to-CMS reporting is being explored (as is the case with hospital RHQDAPU reporting), as pay-for-reporting (in lieu of meaningful pay-for-performance) continues at the Federal level.

Bottom line: This is a complicated set of issues, but it is only one of many that Congress and the President hope to have all wrapped up neatly by November.  Perhaps a post-SGR approach to physician payment will help build the coalition necessary for meaningful systemic reform.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

March 06, 2009

David Harlow quoted in Medicare Compliance Alert on pre-employment background checks

Take some advice from the HealthBlawger in screening new employees.  Check out some specifics in the current edition of DecisionHealth's Medicare Compliance Alert, offered in point-counterpoint format with tips from my friend Bill Mandell.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

December 05, 2008

Constabulary notes from all over

The ever-vigilant law enforcement community meets the health care system:

Item: Massachusetts state trooper pulls over woman in labor; asks "what's under your jacket?" while writing ticket for driving in breakdown lane en route to hospital.

Item: New Hampshire state trooper pulls over man after PET scan; asks for proof of medical procedure after radioactive isotope detected by anti-terrorist hardware.

Can't be too careful, eh?

David Harlow
The Harlow Group LLC
Health Care Law and Consulting