If The Hunger Games Came to Medicine

““A totalitarian state is in effect a theocracy, and its ruling caste, in order to keep its position, has to be thought of as infallible. But since, in practice, no one is infallible, it is frequently necessary to rearrange past events in order to show that this or that mistake was not made, or that this or that imaginary triumph actually happened.”
                                               - George Orwell

* * *

The brushed, steel belly of the scalpel blade pressed down on the orange antibacterial film and released the subcutaneous yellow fat globules surrounded by small beads of red blood.  The movement of his hand was fluid, purposeful, and without hesitation.  The electrocautery pen carefully seared the points where blood appeared.  A retractor was installed to spread the tissues farther apart as he worked quickly to gain access to the tissue plane just above the muscle.  His movements were deft for he knew they were watching.

The Capitol's campaign to ensure perfect outcomes was well underway. They had installed cameras throughout the hospital just four short years before: in the halls, the changing rooms, at the scrub sinks, and in the operating rooms.  The Capitol had discovered that the operating room was like yesterday's boxing ring, or even farther back in the mists, the Coliseum.  In the New World unpredictable events and venues that stirred primitive passions were few - and yet they were longed for as they were feared.  This context explained the popularity of the annual Hunger Games, created as punishment for the destruction of District 13 by a failed patient uprising after the health care financial apocalypse.  Each year, one male and one female physician "tribute" from each of the surrounding twelve Districts were selected by lottery and performance metrics to fight each other to the death. Providing spectators with a window into the drama, and ensuring that drama by creating just the right conditions, gave spectators a sense of aliveness that they barely remembered, and just enough to stimulate fear.  The Games also served as the perfect venue to deflect blame from the Capitol's expedience in sacrificing people for their own avarice.   

The call had come after a full, exhausting day.  The patient had presented to the Emergency Room only two weeks after open heart surgery for coronary disease and to replace his critically-narrowed aortic valve.  The surgeon-tribute wasn’t sure why his conduction system should fail this late after surgery but it didn’t matter; his heart rate had slowed to a dangerous 19 beats per minute. His blood pressure, while low, remained stable.  A quick review of this medication list disclosed the mandatory heart medications that included an anticoagulant for the heart valve and antiplatelet agents for his coronary disease.  No heart rate slowing medication was being used so the Capitol's appropriateness indication to proceed with the procedure was indisputable.  It was also fortunate that the anticoagulant the patient was taking hadn’t thinned his blood too far.   He decided to take him to the operating room directly.  It was 3 am.

Meanwhile, back at the TV studio:  “I tell you, Frank, every year the footage gets better and better!  How did your team know that these untenable circumstances would result in such great late night viewing?  This is so exciting!” 

The call team had been called, but was short-staffed.  Efficiency meant lower cost, fewer people, and longer work hours.  The designated scrub tech had car trouble and would be delayed.  So the other technician and nurse worked feverishly to ready the room.  The call had already been made to the device representative who brought the new pacemaker hardware, but he was barred from entering the operative suite for he was not part of the medical team.  Rules were rules.   The patient, of course, was agitated, gasping for breath.  The doctor worked as fast as possible to establish pacing – the air was tense.

“Are you kidding?  I love seeing this, don’t you?  The nervousness of his voice!  The anxiety!  The skeleton crew at night!  Beautiful!  I’m not sure it gets much better!”

John had no idea why his car wouldn’t start that night (but the spectators did).  He turned the key again and again, only to hear the engine spit in return.  He slammed his hand against the steering wheel, frustrated that he was unable to keep his car tuned for poor weather.  But such concerns were luxuries now that hospital budgets were tight thanks to the Capitol’s Bundled Payments for Care Improvement campaign.  Finding a ride to work became the imperative.  He raced back into the house to wake his wife in a panic, asking her whom he might call to give him a ride – they each knew the consequences of failure.  They called their neighbor and woke him from a sound sleep.  The pressured nature of their voices convinced him to loan them his car and five precious minutes later, he was off to work calling ahead to notify them of the delay.

At the hospital, Chloe answered John's call as she sat behind the monitoring console.  She was one of the best young technicians to graduate from her training school.  Still, her hospital’s equipment was not up to date because maintenance contracts were left to expire in these cost-saving times.  Still, although the software it ran was now several versions old, it still reliably fed data to the Capitol's chargemaster.  She looked down at the dust on the keyboard.  Seeing this, it was clear she couldn’t enter the room to assist because the risk of surgical contamination was too great.

The surgeon-tribute was glad he’d placed two venous sheaths to gain vascular access, rather than just one.   He had successfully placed both pacing wires through the sheaths to the patient’s right atrium, ready to be secured to their appropriate chamber.  But he needed a softer shaping wire – the stylette – to insert into the inner lumen of the pacing wire.  Without the stylette, the pacing wire had the consistency of a well-cooked spaghetti noodle.  With it, he could place the pacing wire to its appropriate chamber.    As he turned, his eyes left the surgical field for just a moment.  He scanned the table crammed with scattered instruments and hesitated briefly as he located the proper stylette. 

A hush fell over the audience as they saw the opening.  They leaned forward in anticipation, reveling in their luck to see such a careless mistake.

John leaned his head in the room to notify them he’d finally arrived and would assist as soon as he could change.  The surgeon smiled, acknowledging his dogged efforts to arrive as quickly as humanly possible.  He turned to the field and shaped  the stylette to the perfect curvature that would allow him to affix the pacing wire to the lower, primary pumping chamber of the patient’s heart.  He focused his blurring vision to place the tiny stylette in the endhole of the pacing lead.   Chloe broke the silence of the moment: “Hey guys, did an electrode fall off?”

The doctor looked up briefly to see atrial P waves dancing across the monitor screen without any corresponding ventricular electrical activity. With that, his worst nightmare was realized.  The patient began posturing on the table, his head thrown back beneath the drapes, his arms slowly but powerfully raising.  The surgeon leaned forward to grab the patient while trying to control the leads, stylette, and surgical wound sterility.  The patient began violently thrashing beneath the drapes, his face turning blue and lips crimson as saliva and exhaled gases mixed into a frothy spraying mess.  He was seizing uncontrollably.  His once steady escape rhythm had chosen this unfortunate moment to stop. 

If the surgeon was expecting help from a sponsor it was unlikely to be forthcoming.  Just yesterday, the tribute's most likely supporter/sponsor, Sylvia, a well-to-do matriarch from the Central District, had noticed an incipient sign of aging on her neck – subtle crepe-like thinning of her skin, this despite her  rigorous adherence to all of the Wellness Initiatives the Capitol had advertised.  She had reason to hate, didn't she? She'd  been failed one too many times.   She remembered sitting with her 65 year old mother gasping for air in one of those infernal assembly-line clinics with the young doctor glancing at the red, flashing "Do Not Admit" guideline on the computer screen as he sent them home with morphine with that flat, dead, passive expression on his face!  He didn't care then and so she wouldn't care now!

Seconds felt like hours as the patient's body slowly twisted sideways.  The nurse did all she could to support his weight and keep him from falling.  The surgeon, too, felt helpless as the powerful frame shook uncontrollably beneath the drape.  The restraints tethered his arms but his involuntary leg movement forced him further sideways.  John felt powerless as he watched from the door.  Finally, he could watch no longer and ran into the room just as the patient fell to the floor.

Four cannon blasts were heard in the distance.  The spectators roared.
 

-Wes

A Critical Review of the Insurance Claim Denial Process

"If you can speak what you will never hear, 

if you can write what you will never read, 

you have done rare things."

-Henry David Thoreau

"Doctor, how much longer?"

The case had gone smoothly, but the challenges of mapping the infrequent skipped beats that signified the initiating sequence to the tachycardia was getting more difficult.  "Could it be left sided?" I wondered.  "Anterior or posterior?  I've tried the posterolateral area and that timing was late.  Clearly anteromedial was earlier.  All the darn beats look so similar with pace-mapping."  

I had been working for an hour and a half without effect when I had an idea: "Maybe the 3D mapping system would help."

And so, I deployed a highly sophisticated three-dimensional (3D) electroanatomical (EAM) mapping system that sped her successful ablation.  She was relieved.  That is until the bill arrived and the 3D EAM mapping was denied by her insurance carrier.

***

On December 19, 2012, I wrote about the insurance denial for this case.  I  was surprised that a denial for payment was made for a portion of a ventricular tachycardia (VT) ablation procedure that was commonplace in my field: three-dimensional (3D) electroanatomic mapping.   Worse, I was even more surprised that the denial came from an unknown physician who lacked training in my field and appeared to be nothing more than a foot-soldier of a Cigna insurance company medical coverage policy.  Such a denial had never happened to one of my patients before.

Since that blog post was written many months ago, my administrative staff and I have been enduring the appeal.  Here's how it's gone.

Shortly after my piece was published, I was notified that someone at Cigna had called our hospital and inquired if they were aware of my blog post.  They were.  My workplace has graciously permitted me to have this blog since 2005, provided I clearly state the views in that blog are my own, which they are.

Second, I learned that the individual who sent the original coverage denial letter to me was not our local Cigna "regional" medical director.  After my post was published, my local medical director from Cigna wanted to talk and explain the proper way that claim denials should handled.  A telephone conference was arranged between myself and my the medical director (a local pediatrician from a local academic center which will go un-named) along with another non-medical representative of the local regional office of Cigna.  I offered them the opportunity to publish a rebuttal to my post at this site if they desired, but they declined the offer. Instead, I was asked to contact them via e-mail or phone before going public with my concerns about their decision on a blog - "we have a set way of handling disagreements with policy decisions" I was told.  Was this because Cigna's leadership didn't want the bad press or was it a polite way of saying "cease and desist?"  I wasn't sure.

So, in the interest obtaining a reversal of my patient's claim denial as easily as possible, I complied.  I sent them my first rebuttal in writing and communicated with them via email as requested.  My rebuttal went something like this:

Cigna's original denial letter, dated 1 March 2012 stated:

"Use of an intracardiac electrophysiological 3-dimensional mapping system in the diagnosis, treatment, or management of ventricular arrhythmias or any other condition because there is insufficient scientific evidence to support its use does not meet Cigna guidelines for coverage because it is considered experimental, investigational, and/or unproven (E/I/U)."

Cigna's 2012-2013 Medical Coverage Policy regarding 3D electroanatomic mapping systems for VT ablation (which I have copied on my own server, lest it disappear) stated:

The authors state, "although not yet established as requisite or "core" equipment for the EP laboratory, these and other emerging technologies have had, and will continue to have, a major impact on the practice of cardiac arrhythmia management. It is also anticipated that additional new technologies will be developed at ever faster rates in the future" (Tracy, et al., 2006). There has been no update to this statement since 2006.

Baloney.  The EHRA/HRS Expert Consensus statement on VT ablation was subsequently published in in 2009 and that document specifically addresses the use of 3D EAM for VT ablation.  It said:

Technological advances have been critical to the development of the field and will continue to play an important role in improving outcomes. The evaluation of new technologies has generally been based on uncontrolled series. There is limited head-to-head comparison of different technologies. Although new technologies generally increase the cost of a procedure when they are introduced, the costs may be justified if they improve outcomes. 

...

The focal VT origin can be identified from activation and/or pace mapping.^{4,381,385,410} Systematic point-by-point activation mapping is the initial preferred technique.^{233,234,385,409} Some investigators use three-dimensional EAM systems to assist in relating the anatomy to the mapping data.^{4,124,125,233,381,385,428–430} 

Surely they wouldn't deny this claim made before that time given this information, right?

Wrong.

Two MORE submissions for higher-order reviews and over four months later, the verdict was handed down: my patient had exhausted all avenues of appeal for the claim.  The insurance company would not pay this portion of my patient's bill, no matter what.

Parsing Truths

When deciding what therapies are effective for our field, who should set the requirements for the level of evidence required to determine effectiveness of any therapy, EP societies or the insurance industry?  While it is true that prospective randomized trials comparing mapping techniques head-to-head for localizing ventricular arrhythmias have not been done, we should also understand that such a study will never be performed.  Why?  First, who would pay for such a study to be conducted?  The utility of 3D mapping for SVT has been demonstrated and proven effective, in large part because of the greater safety (and greater likelihood of obtaining FDA approval) when supraventricular rhythms are studied compared to ventricular arrhythmias.  Second, because the occurrence of the arrhythmia (in this case RVOT VT) is relatively rare, a compelling reason for industry (or government) to fund such a study doesn't exist.

But like SVT ablation, there are three real advantages to these 3D mapping systems for VT ablation that has been repeatedly demonstrated in the literature: (1) catheters can be returned to prior locations accurately whether the arrhythmia is occurring in a location or not, (2) real reductions in fluoroscopy times can be achieved and (3) certain 3D EAM systems that use mathematical algorithms (non-contact balloon mapping) can localize the origin of an arrhythmia using a single heart beat.  For the rare patient (like mine) that has infrequent arrhythmias, how would a randomized trial be constructed in hopes of proving the utility of such a technology over conventional mapping by point-to-point techniques?  Would such a trial be even ethical to conduct?   So, just because a prospective trial has not been performed to demonstrate the utility of a technology in rare circumstances, does this mean electrophysiologists should never utilize such a technology to achieve a successful ablation outcome when other means fail even though such a technology has been shown to be effective in single-center studies?  According to Cigna's policy statement, the answer to this question is "yes."

Too bad insurers never have to speak with patients when an ablation fails.

One Last Try

Because I did not want to take "no" for an answer, I asked my administrative staff to see if they could obtain the name of the Cigna "external" reviewer.  We had been assured that the case was externally reviewed by an electrophysiologist.  We were given the name of an individual but were surprised to find that the physician was a paid employee of Cigna with credentials as an internist and general cardiologist with a nuclear medicine background.  To me, it seemed Cigna "external" review was actually an "internal" review performed by a paid employee of different regional office of Cigna (hence "external" to our region) who was a general cardiologist, not a cardiac electrophysiologist.

I brought this concern to the attention of my local medical director of Cigna by e-mail.  In that email I also expressed my concerns about the long time each review had taken.  I asked him to examine both issues, since I felt my patient had not received a fair and unbiased claim review.  Also, while my patient had received a final denial letter, I never received a notification of their final determination for coverage. After some delay, the director promised to look into my concerns and contacted me by phone later in the week as promised. 

In our subsequent discussion, it appeared the director felt the timeliness of their reviews was satisfactory, despite a timeline that stretched over fourteen months for this entire process.  In regards to my concerns over who reviewed my patient's claim denial, he claimed there were two "internal" Cigna reviewers and reviewers "external" to Cigna who supported the denial.  Of the external reviewers, the director claimed one was board-certified in internal medicine and interventional cardiology and the other external reviewer was board-certified in internal medicine, cardiology and cardiac electrophysiology.  He refused to disclose either of the external reviewers' names.  When asked, the director stated that the electrophysiologist was in active practice.  I reiterated that I still felt the EHRA/HRS Expert Consensus statement suggested the 3D-mapping falls well within the standard of care.  Surely they should reconsider.  But despite my pleas for reconsideration, no reversal was forthcoming.

I hung up the phone.

Amazingly, there is little else I can do for my patient's insurance payment denial now.  Here I am, a non-anonymous board-certified cardiac electrophysiologist with over twenty years experience who was caught in a challenging case with my patient and am now being told by a pediatrician from an insurance company that there's no merit to my concerns about an unfair denial for coverage of the 3D mapping portion of my patient's claim.  I am dumbfounded, confused, and heartbroken for my patient.

So what have I learned?

1) In Cigna's case, some insurance coverage decisions disregard current standards of care and up-to-date expert consensus statements in lieu of poorly-updated corporate medical coverage policies.

2) Specific challenges I encountered with my patient's RVOT VT ablation case had no bearing on Cigna's  decision.

3) Physician reviewers often do not hold expertise in the specialty areas they are asked to review.  Because they are first and foremost paid employees of the insurer, they turn to corporate medical coverage directives for guidance, even though they are woefully lag current medical practice.  As health care dollars get tighter and medicine becomes increasingly codified, significant conflicts of interest will continue to rise for a fair and impartial review of payment denials.

4) If the insurance company claims to have an individual of the same specialty externally review a case, physician providers are not notified of the basis for the denial nor given the names of the reviewers, limiting one's ability to verify the reviewer's credentials or to understand the rationale for the denial.  As a result, there is no transparency to the process, nor opportunity for learning or system improvement.  To me, this practice should not be condoned.  Health care requires continuous quality improvement.  More importantly, health care requires trust of all those who touch the field, especially when the care provided, no matter how seemingly far removed, impacts a patient's physical or socioeconomic well-being.

5) Cardiac electrophysiologists should be aware that both Cigna (here) and Aetna insurance companies (here) in Illinois now have coverage policies that may opt to deny payment for three-dimensional electroanatomic mapping for VT ablation because they claim they are experimental procedures for this indication based on their outdated internal review of the literature.

6)  When confronted about the obsolete nature of their medical coverage policy,  Cigna refused to take this into consideration and still refused to overturn by patient's payment denial.  Instead, the medical director only promised to include the EHRA/HRS document I sent them in their next annual review of their corporate medical coverage policy for 3D mapping scheduled for 2013-2014.

7) There are technologies that have certain niche benefits for patients, but because they are not "proven" beneficial by randomized trials, in some cases they are no longer be paid for by insurers.

8) My patient will now has four months from the date of her final denial letter to ask for an state-directed independent external review of the Cigna's coverage decision via the Illinois Insurance Fairness Act as her only remaining avenue for recourse.

So now what?

As I reflect on this case, I used this sophisticated mapping technology because I felt I needed it to improve my patient's outcome and safety.  I wonder what this denial of coverage does to the relationship with my patient.  Has trust been eroded?  As I look forward, how I will perform my next RVOT VT ablation?  What do I say to the next patient with a similar arrhythmia?  Should I warn all my future patients requiring VT ablation that some of the technology we routinely use to expedite their procedure might not be paid for by their insurer because of a paucity of prospective randomized trials exist (and never will)?  Will I have to avoid the use of this technology knowing my patient may have to pay for it because a pediatrician or a general cardiologist who knows nothing about my field might not approve its use?   Can I afford to devote this amount of time for wrestling future insurance payment denials that surface?

These are not minor concerns.

So there's the current status of this long, arduous months-long insurance denial review process for just one patient, critically reviewed.  It would be easy to make this post a screed against one insurer, and while I have to say that the way this claim denial process was handled was poor at best, we should recall that other insurers have similar policies.  It is in the interest of insurers to make the payment denial/review process as difficult as possible for patients and providers.  It is also in insurers' best interest to keep out-of-date medical coverage policies in place that consider new technologies "experimental."   Better yet, it is even better for insurers to claim niche technologies are "unproven" despite evidence to the contrary and should therefore never be paid.  Finally, it is in insurers' best interest to perform internal reviews by uninformed physician reviewers of another subspecialty rather than peer-to-peer independent reviews.

What will it take to change this system?

Maybe we should start with the truth.

-Wes

When the Government Puts Prices on Patients' Heads

Recently, another predictable Trojan-horse provision of the Patient Protection and Affordable Care Act appeared that promises to pit doctor versus patient by literally placing a price on patients' heads:

Twenty-thousand physicians in four Midwest states received a glimpse into their financial future last month. Landing in their e-mail inboxes were links to reports from Medicare showing the amount their patients cost on average as well as the quality of the care they provided. The reports also showed how Medicare spending on each doctor’s patients compared with their peers in Kansas, Iowa, Missouri and Nebraska.

The “resource use” reports, which Medicare plans to eventually provide to doctors nationwide, are one of the most visible phases of the government’s effort to figure out how to enact a complex, delicate and little-noticed provision of the 2010 health-care law: paying more to doctors who provide quality care at lower cost to Medicare, and reducing payments to physicians who run up Medicare’s costs without better results.

Of course, no real assessment of physician "quality" is taking place with this scheme nor any outcome assessment.  "Quality" as it is defined in this scheme consists of only an electronic review of patient costs, doctor billing codes, and the patient characteristics of  age, gender, Medicaid eligibility, and medical conditions.   No government entity will actually observe and assess any physician in practice to determine their "value" to the system.  Instead, patients electronically determined to be "low-cost" will be heralded as favored electronic "value" benchmarks.   Even the health care law's original physician cheerleader, former Administrator of the Center for Medicare and Medicaid Services Donald Berwick, MD, was taken back:

“We do have to be cautious in this case. It could lead to levels of gaming and misunderstanding and incorrect signals to physicians that might not be best for everyone.”

Ya think?

-Wes

DOJ Takes Aim at Doctors

... as conspirators:

This case is a watershed for two reasons:

First, until now the Federal Trade Commission, not the Justice Department, has taken the lead in prosecuting physicians. Since 2000, the FTC has brought about three dozen cases against physicians (all but one of which settled without any trial). But the FTC only has civil and administrative jurisdiction; the Antitrust Division has civil and criminal jurisdiction. The Sherman Act makes no distinction between civil and criminal “price fixing,” so in a case like this, it’s entirely a matter of prosecutorial discretion whether to charge the doctors with a civil or criminal offense.

Based on the descriptions in the Antitrust Division’s press release, there’s certainly no reason they couldn’t have prosecuted the doctors criminally and insisted upon prison sentences — and there’s little doubt such threats were made or implied to obtain the physicians’ agreement to the proposed “settlement.”

The second reason this is a landmark case is that the Justice Department has unambiguously stated that refusal to accept government price controls is a form of illegal “price fixing.” (Emphasis mine)

The FTC has hinted at this when it’s said physicians must accept Medicare-based reimbursement schedules from insurance companies. But the DOJ has gone the final step and said, “Government prices are market prices,” in the form of the Idaho Industrial Commission’s fee schedule. The IIC administers the state’s worker compensation system and is composed of three commissioners appointed by the governor. This isn’t a quasi-private or semi-private entity. It’s a purely government operation.

What’s more, the Antitrust Division has linked a refusal to accept government price controls with a refusal to accept a “private” insurance company’s contract offer. This lives little doubt that antitrust regulators consider insurance party contracts the equivalent of government price controls — and physicians and patients have no choice but to accept them.

Read the whole thing to understand the implications of this settlement. Given the 21% cut to Medicare payments that occurred today (but CMS is 'holding claims' for ten days to allow for another stop-gap measure to be implemented), ask yourself two questions: (1) "Where was the AMA?" and (2) Are you ready to be a government employee?"

-Wes

Might Medicare "Bundled Payment" Incentives Influence Patient Care Decisions?

One wonders, might this be construed as a bribe?

Under the pilot project, Medicare is saving 4.4% on the base rates for heart and joint surgeries at Hillcrest because the hospital is offering a discount. For Morrow's knee replacement, for example, the government is paying $13,211, about $450 less than it normally would.

Meanwhile, Morrow, who is eager to get back to playing basketball, gets a portion of the savings from Medicare — $271 as an incentive for going to a hospital that participates in the program.

The three-year experiment, which began in May, is taking place at five hospitals identified by Medicare for high-quality, cost-efficient care. All competed to get into the program by offering discounts to Medicare.

Besides Hillcrest, Baptist Health System in San Antonio is taking part, while hospitals in Denver, Albuquerque and Oklahoma City are expected to begin participating this year.

Patients who use the hospitals for most heart and orthopedic procedures are paid up to $1,157 for participating, with the bigger amounts pegged to more complicated cardiac surgeries, such as heart-valve replacements.

The incentive payment is supposed to help drive higher admissions to the hospitals in the program, and the pilot is designed to test whether paying Medicare beneficiaries from $250 to $1,157 sways their choice of facilities.

I can see it now: having a hard time paying your phone bill? Why, get your knee replaced!

I thought we supposed to be keeping patients out of the hospital?

-Wes