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Thursday, May 10, 2018

The Danger of The Regulatory State



The regulatory organs of clinical medicine not only hand down and enforce trivial, silly and costly diktats, as a recent blog on this site related, but also impose dangerous constraints on the practice of medicine.  Case in point is the College of American Pathologists (CAP) which acts as the surrogate laboratory inspector for the government.   CAP’s inspection of our academic training program’s “lab,” which consisted of two microscopes, shut down an entire clinic building’s laboratories in a major academic medical center because, as an untrained and uncertified physician, I was performing gram stains.  

I have been doing gram stains since I was taught to perform them 50 years ago in my 7th grade science class; preparing slides is trivial enough that it can be mastered by a 13 year old.  Performing gram stains was a requisite competency in my medical school as it has been for virtually all medical students in the 134 years since Christian Gram published his technique in 1884.   And I have been interpreting them for over thirty years of medical practice.  As an intern thirty years ago when seeing a febrile patient with purulent sputum I would have been severely reprimanded for not having personally done a gram stain and had it available for the attending physician to review.  Now it is a cause for action on the order of the breaching of a Level 4 biohazard unit with commensurately severe disciplinary proceedings to follow for the responsible “untrained” and “uncertified” practitioner.  
Gram stains offers important, often essential and not infrequently time critical information that may not be obtained from culture or at least not obtained in a timely manner. 

1. Gram staining gives immediate results: infectious vs. non-infectious; gram positive vs. gram negative organisms; mycotic vs. bacterial, and does so days before culture results are available.

2. Culture requires viable organisms; gram stain does not.  Gram stain works on bacteria that are alive or dead so where an infectious etiology is suspected but only purulent material with non-viable organisms is available a gram stain can still direct treatment.

3. Gram stains can identify the presence of fastidious infectious organisms, especially fungi, that will not culture out on conventional media such as Sabouraud’s dextrose.  Mycotic infections can be missed or inappropriately ruled out if the results of cultures are accepted as definitive.

4. It is inexpensive: pan-culture for multiple organisms including fungi will run $500-$1000.  Culture may be completely avoided by the gram stain if there is a clear cut clinical correlation; or it can restrict culturing to the class of organisms seen under the scope to determine sensitivity.  

Multiple cases from my inpatient service underwrite these attributes.  In just the six weeks before the CAP inspection threatened disciplinary action against me the cases below relied heavily on my performance and readings:

1.   A 7 day old premature infant in the NICU with KID syndrome, possible sepsis and a localized pustular rash was evaluated; beginning empirical antibiotic treatment would further complicate management of this ventilator dependent baby.  The gram stain showed numerous budding yeast as the sole finding and with the clinicopathologic correlation of the rapid appearance of pustules this indicated candida.  The contemplated systemic antibiotic therapy was avoided and the parents reassured.  Candida was subsequently confirmed by culture but only several days later.

2.   A 44 year old man with HIV, toxoplasmosis, mental status changes and cerebral infiltrates on CT scan presented with multiple fungating nodules thought by infectious disease to be either Kaposi’s sarcoma or T-cell lymphoma.  A gram stain of scant exudate from these lesions showed dense gram positive cocci making the clinical lesions consistent with the rare staph infection botyromycosis.  ID challenged this diagnosis and instructed the primary service to discontinue vancomycin but photos of the gram stain taken with an iPhone convinced them to continue vancomycin before culture subsequently confirmed staph infection as the sole cause of these tumor like nodules.   

3. A 65 year old man post-op for glioblastoma on high dose prednisone with mental status changes presented with a rapidly evolving, acneiform facial rash raising the concern for crytptococcal infection.  A gram stain from pustules showed a dense infiltrate of gram positive cocci (characteristic of Staph epi), gram positive rods (diphteroids characteristic of P. acnes) and round to oval non-budding yeast (characteristic of Pityrosporum), the classic findings of steroid induced acne avoiding both a biopsy and empirical antibiotic therapy for crypto and permitted his discharge from the hospital the next day.

Again, these were just in the previous 6 weeks of one attending encompassing only 6-9 days of actual inpatient service.

A more critical example from our institution was the early diagnosis of a 50 year old man with a high C-spine fracture from an MVA, in the ICU, septic and rapidly deteriorating. A generalized pustular eruption that I gram stained disclosed candidiasis days before blood culture demonstrated candidemia allowing earlier intervention.  And going back in time to when I was expected to perform a gram stain, as a third year resident 30 years ago I evaluated a septic patient transferred in in the middle of the night with multi-organ failure.  Blastomycosis was suspected but empirically giving him amphotericin, the only antimycotic available at that time, risked destroying what was left of his kidneys.  I called blastomycosis on a gram stain from one of the rare pustules on his leg underwriting the necessity of using amphotericin despite the risk.  That diagnosis was subsequently confirmed—but only weeks later by culture.

The exclusion of physicians from performing gram stains has left the microbiology lab techs as the sole authorities on their interpretation. There are many capable lab techs performing and reading gram stains; as noted above preparation and interpretation is typically straightforward as I demonstrated as a 13 year old. But reliance on lab techs should not be taken at face value.  My personal observations from the concurrent processing and interpretation of slides with them discloses significant variations in their capabilities particularly in difficult cases.  Techs follow the guidelines for performance of the procedure which were developed by bacteriologists for uniformly dense specimens skimmed from culture media. This does not account for variations in specimen thickness or content when obtained from necrotic, infected, inflammed or hemorrhagic tissue where variations in the preparation of slides is necessary.

A case that illustrates this occured following the CAP injunction when I was ordered to discontinue gram stains. I saw an 18 year old boy hospitalized for multiple large ulcers on his leg that began several months previously after he cut himself at the farm where he lived.  HIs parents consulted infectious disease and multiple cultures including fungal cultures were obtained, all negative for microorganisms.  I performed a touch prep from a biopsy and submitted it to the micro lab for evaluation.  At this point I was prohibited from performing gram stains myself and the prep was read by the lab tech as negative.  I asked to take a look and pointed out multiple large aggregates of yeast that were missed by the otherwise conscientious technician.  Culture was again negative but initiation of itraconazole resolved the ulcers in several weeks confirming the mycotic nature of an otherwise undeterminable fungal species. 

If physicians are not performing, interpreting, teaching and supervising those doing gram stains the results will often result in the above scenario.  For example, virtually every technician I’ve observed places the stained slide on the stage, immediately applies immersion oil, goes straight to 1000x and evaluates several fields, likely what they were taught.   However in a 2 x 1 cm smear of a specimen the evaluation of ten 1000 sq micron fields surveys less than 1% of the sample.  As the case above illustrates low and medium power surveys of a specimen that are not performed by the technician can miss infectious infiltrates.  I have pointed this to our micro lab techs on a number of occasions when concurrently reading slides.  I do not relate this in disciplinary terms but as a teaching opportunity and the techs are universally grateful for such oversight.  But I am one physician—and one who is been told to physically stay out of the main lab.

Regulatory diktats have subcontracted these tests to technicians and physicians have lost this skill and have no incentive to push back and take on such regulatory entities as CAP.  Those are not good reasons for abdicating responsibility and subordinating what should be a physician performed microscopic exam if the clinician desires or where a practitioner is in the best position to make a clinicopathologic correlation from the results. This is especially true in an academic medical center which should be setting the standard.
  
CAP’s injunctions resulting in our suspending performance of gram stains and other advanced physician performed microscopy need to be forcefully challenged.  Moreover, we need to reinstitute training in these techniques.  Gram stain is simpler, more definitive, easier to learn and often critical to the undertaking of acute therapeutic interventions in seriously ill patients—or avoiding undertaking them at all.  If CAP or anyone else doesn't think that’s important—just ask the mother of that premie in the NICU.  






Sunday, April 29, 2018

Adding cost without adding value- baked into how we practice and the process measures we use

We recently went through a Joint Commission visit in one health system and mock visits in two other systems. The preparations leading up to these visits are remarkably resource intensive and without question divert resources from other activities which may be more valuable for patient care. We had one particular demand which was both silly and crazy at the same time. For reasons of privacy, we were instructed by our internal reviewer to turn all of our exam chairs such that a patient sitting in the chair could not be identified from the door. No matter that we have installed curtains which are pulled and block the view from an open door. No matter that the rooms were configured where the desk where the provider sits and documents when they are interviewing the patient will now afford the MD/PA a view of the back of the chair. No matter, our work and our opinions are beside the point.

If it were only that the Joint Commission were a bad actor but alas that is not the case. The practice of medicine is riddled with expensive and arbitrary practices which someone thinks might be a good idea and are implemented with limited if any evidence that they actually add value to patients lives. The value that might be added may be dwarfed by the actual cost of delivery.  However, it appears that no additional cost is ever viewed as excessive if it is borne by some other party and/or if the cost can be made sufficiently opaque. I spend my time taking training courses to maintain credentials, courses which impart questionable knowledge and assessed via tests which measure nothing of value pertaining to trivia which is quickly forgotten. On a regular basis, we participate in credentialing processes which remind me of the movie Men in Black. It appears that those involved have had their memories wiped on a regular basis forcing us to repeat steps which have been done over and over again over the course of literally decades.

Within the actual practice, we seem to be blind to the concept of diminishing returns. Any anecdote, no matter how rare or exceptional, can serve as a justification for some intervention which is pushed to be universally applied. The authority to hold people and systems to comply with such mandates tends to be delegated to regulatory entities which become interested primarily in perpetuation of their own existence and use their ability to publicly shame and operationally cripple health care delivery systems to force people and systems to kowtow to their demands, no matter how little value they add to patient care and how much cost is layered on.

There is little incentive to take on such regulatory entities. When you are under scrutiny, you would be crazy to challenge their authority. They hold all of the cards and while they may use such words as "partnership", don't be fooled. When you have finished the review process and met all of the demands, no matter how obscure, irrelevant, or trivial, the incentives drive you and your organization to get back to the work or your core missions. There is no clear pathway to hold the regulatory entities accountable and any effort to shine a light on the absurdity and arbitrariness of their work and rules will almost certainly come back to haunt your organization at the next review cycle.

This again brings to mind the quote from the movie "Bananas" -
Esposito: From this day on, the official language of San Marcos will be Swedish. Silence! In addition to that, all citizens will be required to change their underwear every half-hour. Underwear will be worn on the outside so we can check.

Who should drive cost control efforts in health care?

Ever since I was in medical school almost 40 years ago, we have been talking about the growth of health care expenditures and how the growth rate is unsustainable. Like the proverbial frog in the heated pot, we have adjusted to increasing costs as we approach the boiling point. I believe we are approaching the boiling imminently and payers at all levels are trying to figure out how they can remain solvent while at the same time finance needed health care spending. 

The WSJ published a piece in late March of 2018 highlighting that two major issues are creating financial challenges for state budget, pensions and health care, particularly Medicaid. (WSJ). The result is crowding out of expenditures on virtually all other state functions. The effects of growth in spending diffuse across all levels of payer, public and private. Private insurers are engaged in pitched battles with large and increasingly consolidated health systems over rates while at the same time trying to move costs back to consumers, increasing deductibles and co-pays. It is getting very ugly. We recently experienced a showdown between Piedmont Healthcare and Blue Cross within the Atlanta market which required the Governor to weigh in to get the parties back to the negotiating table.  

At the same time, CMMS is searching for innovative approaches to effectively deliver health care to its covered populations at lower costs (or at least at slower growth rates). They announced a requests for comments and information on 4/23/18 (CMMS RFI). The RFI throws out a host of ideas, driven by the theme of market based approaches. It is not especially cohesive or cogent. That is not surprising since no one knows the magic formula by which were can consistently do a good job at substantially lower costs. The request is just that: for input from interested parties who can assist them in their goals. 

The responses from the physician community are fairly predictable.  We do not want to act like insurers. We never have and it places us in a very conflicted position. It is essentially impossible to act as advocates for our patients while at the same time function as stewards of system resources. That job is unpalatable and is extremely difficult (perhaps impossible) to do. The AMA has weighed in on this (AMA cost control) and from what I can tell, they take the same tack as politicians who say they will balance budgets by eliminating fraud and abuse without recognizing the underlying structural faults. The amounts saved via the former interventions are rounding errors. The real work requires very fundamental changes in how programs are structured. To take that on means taking on vested interests directly. Professional organizations like the AMA are ill equipped to take these types on jobs on. They function as guilds and are driven by member concerns. 

The Physician community does not want to do the difficult and unpalatable work of driving cost control, acting like insurers, limiting care, and explicitly pushing costs on to patients.  However, we do not want to delegate that job to any other party. We want to be in control. It boils down to whether we as physicians want to lead and exert some degree of control over whatever processes are put in place to try to control costs or whether we present the face of resistance. It is clear to me that CMMS has no real clue as to drive cost savings but I do not think we are particularly constructive in our criticism. We are basically washing our hands of the problem for the simple reason that any solutions we can come up with will either result in transfer of costs to patients (which we believe will result in them balking at payment), decrease in the amount of care activity we are engaged with (with decreased revenue), or decrease the payment per unit of work.  We don't like any of these for obvious reasons but in my opinion, we still should come to terms with whether bending the cost curve is something which is desirable or really essential. If it is, then if not us to deal with it, who then should be empowered to address it? 

Sunday, April 1, 2018

Price fixing is not OK when you want to do it but is OK when I want to do it.

The NYT reports a story this morning on attempts of the state of Massachusetts to rein in the growth of spending on prescription drugs. Nothing new or surprising here. Medicaid costs are growing and projections across the board for all states are that if nothing different is done , Medicaid costs will crowd out all other state spending over the next 10-20 years.

The Massachusetts experiment is contingent upon getting a Medicaid waiver from the Feds. Seems reasonable given the basic premise of the waiver concept. Try things in a limited space and if they work, they can be adopted elsewhere. What is difficult to understand is the push back and particularly where the push back is coming from. The AMA, ACP, and the ACS, as well as a number of big pharmaceutical firms (J&J, Merck, Lilly, Teva, and Pfizer)  are pushing back against this proposal.

I get the drug companies resistance. They desire the largest degrees of freedom to push their pricing power. They may say they are motivated by getting the best drugs to patients and that may be true to some extent. We should not be so naive to believe that is their primary motivation. However, the MD professional societies are another matter, especially the AMA. Here you have an organization that is behind the largest price fixing apparatus in a segment of the economy that constitutes nearly 20% of GDP.

The mantra is that such efforts will limit patient access to life saving therapies. However, the ongoing price fixing actions of the AMA have limited patient access to life saving expertise for more than 25 years. We still allow for pharmaceuticals to be priced at various tiers based upon a host of factors but according to the AMA, all expertise is generic and linked to common billing codes which do not account for quality or unique expertise. That is entirely acceptable even though it has devastating effects on access to expertise, especially diagnostic expertise or chronic care management.

In digging deeper into the AMA position, I found this news story from Axios last October. It almost defies comprehension. (Axios Link)
Context: McAneny, an oncologist, made her comments in Chicago at a meeting of the AMA's Relative Value Scale Update Committee, an influential panel known as the RUC. A crowd member asked her if the AMA was "missing an opportunity to throw the weight of our collective influence" behind asking the federal government to negotiate drug prices, which Medicare cannot do by law.  The AMA has been outspoken about rising drug prices and the factors behind them. "There's a lot of places where we can look at significant amounts of waste," McAneny said after calling out pharmacy benefit managers, insurance companies and specialty pharmacies.
However, official AMA policy currently "opposes the use of price controls in any segment of the health care industry, and continues to promote market-based strategies to achieve access to and affordability of health care goods and services." Instead, it backs transparency measures like requiring drug companies to post prices in ads.
Looking ahead: The RUC's main business of examining new payment rates for physician services starts Thursday. Medicare has said it would adopt nearly all of the RUC's recommendations for the upcoming year.
Here we had the AMA President railing against price fixing at the meeting of the AMA RUC, their own price fixing entity.

Sunday, February 11, 2018

Private equity in health care



Money chases returns. It is a fact of life. As opportunities for returns get squeezed in industries which have been the hunting grounds for private equity, opportunities within health care start to look more attractive. The latest waves have identified physician practices where value can be unlocked by using PE magic. The targets for PE are multiple including anesthesia, ophthalmology, orthopedics, dermatology, dentistry, radiology, pain medicine, behavioral medicine, urology, and even primary care.
Those pushing PE hold it out as a potential savior for physicians, with acquisition meaning they get a pot of money and relief from tasks other than caring for patients. It sounds too good to be true. However, I can't really say for sure how the proponents of PE investment are wrong. I have some hunches. There are apparently certain advantages that PE firms have over other health care entities such as hospitals or health systems. Unlike hospitals and health systems, whose acquisition prices are subject to fair market value (FMV) in order to comply with Stark and Anti-Kickback statutes, private equity firms have no such restrictions. They can form partnerships based on the strategic value of the practice as opposed to FMV. The strategic value may calculated by applying a multiple to a practice’s EBITDA (earnings before interest, taxes, depreciation and amortization). In addition, PE generally has equity and generally much more equity available than health systems or other suitors already involved directly in health care delivery.

What makes specific specialties attractive are common elements. These include currently fragmented delivery systems, favorable payment environments with strong procedural focus, inclusion of Texas IG)(DDS the menace).
pathology specimen generation, and at least some portion of the business being cash.  Leading this movement was dentistry with a history of corporate dentistry going back more than a decade. There have been what appear to be financial successes but there have also been some spectacular failures including abusive Medicaid clinics investigated by Congress and state authorities(

Of all of the acquisition activities, the one that has captured the most news recently is in the dermatology realm. A recent highlighted article in the NYT (Link) peeled back some of the sausage making involved in making PE investment work, at least in this specialty.
 It has raised a firestorm within the field (Resneck) with the current Chair Elect of the AMA Board of Trustees, Dr. Jack Resneck weighing in. PE firms tend to leverage non-physician clinicians, who are less expensive than physicians, to deliver care, often under limited supervision. This is an especially attractive specialty for PE since there are fewer regulatory burdens involved. Clinics are generally free standing and not burdened with hospital or health system credentialing requirements. A number of dermatologists are cashing out. A number are also raising dire warnings regarding the immediate effects on patient care and the long term effects on the specialty.

This appears to be the start of the wave of consolidation. There are still mountains of cash looking for returns and interest rates are still at historic lows. In the cross hairs are specialties that have bucked the trend toward acquisition by health systems. PE is likely to compete successfully for practices because of the inherent advantages noted above. There are inherent issues which will need to be grappled with, primarily focusing on where capturing efficiencies driven by financial concerns and non-clinicians begins to drive care decisions. In addition, expanded use of non-MD clinicians practicing at "the top of their licenses" will create additional tensions, especially if these changes are deployed in environments where few if any relevant clinical outcomes are measured.

One additional factor which may loom large is how PE influences will play out in an industry where the prices are fixed by administrative mechanisms. The niches within healthcare targeted by PE are specifically the services with the largest profit margins, likely so because they have been mis-priced. In other industries, PE driven expansion in supply will generally drive down prices, creating a feed back loop to discourage additional entry into the field. However, in healthcare, increased supply often drives increased demand, with the pricing controlled by the RUC and Medicare, and private payers simply following their lead.

For those who think that PE entry driving inefficiencies out of the industry will drive down health care costs, guess again. Heavily utilized services which deliver high margins develop interest groups which maintain mispricing by political means. Prices are not set by any sort of market. They are set by the RUC. Be prepared for an explosion of costs as PE driven expansion drives more and more utilization. PE may be good for extracting value from industries but there is reason for skepticism that they will add value to consumers. I believe this pathway may be good for investors in the short term but bad for everyone else.



















Thursday, February 1, 2018

Informed consents, documentation of encounters, and Larry Nasser

I hate to perseverate about this particular scandal, but the more I think about this situation, the stranger it appears. Dr. Nassar is a doctor and by any standard, his interactions with the gymnasts represent patient encounters. Furthermore, many of these patient encounters were with under aged minors.

I see patients in this age group as well. My encounters happen almost invariably in the presence of some adult guardian. If I do anything to these patients, it is done after informed consent is done. Not always written consent but with explicit permission granted after explaining what I am planning to do and what specifically I hope to accomplish. This is followed by a note in the medical record which documents the events that transpired.

There is a large void in the news reports when it comes down to descriptions of of specific contexts of the assaults perpetrated by Dr. Nassar. The implication is that he touched young girls inappropriately under the guise of treatment.  I don;t work in the sport medicine field and I don't know what their standard workflows and processes are. Do practitioners routinely ask for consent prior to doing manipulations? How do they handle this for minors, especially when the interventions may happen repeatedly and during times when parents are not around? What sort of documentation do they do? Does the documentation acknowledge consent was granted and for what?

I don't know for certain but I suspect that Dr. Nassar and much of the sports medicine world operates in a way which is very different from from the rest of medicine. The rest of medicine is adherent to protocols put in place to protect both practitioners and patients, which also allows for what otherwise represents violation of personal spaces. Are these protocols applied in the realm of sports medicine? It does not appear to be the case. Are there notes written by Dr. Nassar describing each therapeutic intervention, the justification for the intervention, the outcome desired, and subsequent measurement of whether the specific outcome was attained? I do not think so.

Is there evidence that either the gymnast or an adult guardian was fully informed regarding the specifics of the intervention proposed (I am going to do this manipulation requiring me to touch this part of your body), the purpose of the intervention, and the outcome desired. I do not think so.

In my opinion, there are minimum standards which should be required for all doctor (or non-MD clinician) - patient relationships and interventions. These include explicit recognition of patient autonomy, informed consent (not all of which is written informed consent), rigorous protocols for dealing with vulnerable populations (including minor children), and at least a minimum of documentation of intervention deployed which captures the above elements. Furthermore, patients and their adult guardian should have access to all of the medical documentation.  If Dr. Nassar had been required to adhere to these minimum standards, I doubt the events would have transpired.