My dear electronic health records
How do I dislike thee?
Let me count the ways
Adaptation of Sonnet 43
By Elizabeth Barrett Browning, 1806–1861
As my tenure as physician editor winds down, it’s worth reviewing some of the more nettlesome issues confronting clinicians that have been previously discussed in these pages and gauge their current impact on our practices. These vexatious items include our dispiriting experience using electronic health records systems (EHRs), our agonizingly futile interactions with pharmacy benefit managers (PBMs) and our interminable challenges reckoning with absurdly priced pharmaceutical products.
This holy trinity of healthcare misery provides the fuel for the raging firestorm of physician burnout. One major study confirmed that doctors suffer from burnout at a statistically higher rate than other occupations. [Compared with high school graduates, individuals with an MD or DO degree were at increased risk for burnout (odds ratio 1.36).1] This finding should come as no surprise considering that primary care physicians devote an estimated six hours, or nearly half of their working day, solely interacting with their EHR.2 Bob Dylan had it exactly right: Twenty years of schooling, and they put you on the day shift.3
Ten years ago, who could have imagined that our newly acquired EHR systems would become the critical driver of physician burnout? In a similar vein, who would have imagined we would waste so much of our precious time contending with the nefarious behaviors of PBMs? Who would have predicted the fallout from rising costs for branded and generic products, a concept predicated on companies being entitled to adjust the cost of their “mispriced assets” to levels they perceived the market could bear?4
Wasn’t technology going to unshackle us from our tedious chores and liberate us from having to deal with the sheaves of paper and faxes strewn across our desks? Wasn’t the 21st century going to be the era when “doctors could be doctors” and could focus solely on their patients’ care? In this brave new world, artificial intelligence would be sufficiently sophisticated so a smart robot could handle our tedious, clerical chores and, when needed, offer us timely clinical advice (see Rheuminations, “Machine Medicine,” February 2017). Instead, we are the robots, mired in the mud, tied and bound by the whims of insurers, PBMs and EHRs.
How Did We Get Here?
Let’s compare the rise of a technology that we love—the smartphone—with the EHR. Ten years ago, Steve Jobs, the late co-founder of Apple had it right: Take a music player, the iPod, add a telephone and a camera, and connect it to the Internet and cellular networks. Create an array of easy-to-use applications that came without detailed instructions yet were simple enough for anyone to use. Smartphones have transformed how we live. Just look around wherever you are and watch all those faces, transfixed on their phones. Nowadays, patients don’t mind if you are running late in clinic—if your Wi-Fi signal is strong, they won’t complain.
Over the past decade, an astounding 34,000 iPhones have been sold on average, every hour of every day.5 Singlehandedly, the iPhone raised the once-moribund stock price of Apple from near bankruptcy levels and transformed the company into the world’s largest company, based on market capitalization.
There is a reason for our deep affinity for this device. It seamlessly connects us with everybody, everywhere. You can check your email, read the papers, deposit your checks, peruse your favorite medical journals, watch a video, snap a photo or text with your pals. The choices are endless. This is a textbook example of technology being optimally designed to maximize the user experience. The user is the center of the developers’ attention.
HITECH
But what happens when developers are agnostic to users’ needs? A couple of years following Steve Jobs’ introduction of the iPhone, Congress passed the Health Information Technology for Economic and Clinical Health (HITECH) Act to jumpstart the adoption of EHRs into clinical practice.6
For decades, many medical practices languished under the burden of paper charts, and the hope was that with sufficient financial incentive, doctors would leap at the opportunity to enter the digital age. Congress authorized spending $36 billion to encourage practices to transform their often illegible, messy collections of papers that masqueraded as medical records into digitized, legible packets that could be easily deciphered and distributed with a simple click to any authorized healthcare provider. These were worthy goals that aimed to radically transform the delivery of healthcare in America.
But there were many potholes along this path to digital nirvana. What doctors anticipated receiving and what was delivered were as different as expecting a smartphone and getting a cable television box delivered instead. Buyer beware!
Cable television systems offer far too many choices to the viewer. Ditto the EHR, with its busy screens packed with excessive data. System portability has never been the cable television standard; your device needs to be tethered by a cable to that hardwired box. Similarly, EHR systems function as closed loops. Unlike your iPhone that connects to your friend’s Samsung device regardless of service provider, EHR systems remain shut, gated communities, with restricted access. Don’t you want your Verizon phone to accept calls and text messages from AT&T customers? Just as it made economic sense for wireless carriers to develop universal standards that allowed their networks to interact with one another, there was a similar, though perverse economic rationale for EHR developers to shut their portals to other systems: They believed that if customers could purchase systems from their less costly competitors, they would be able to gain access at a cheaper price.
EHR system users, doctors and other healthcare providers were blindsided by this records lockdown and its subsequent burdens. Nowadays, patients expect the seamless integration of their records and are miffed when told that their electronic charts first need to be printed out, faxed and then scanned into your system’s record. This cumbersome procedure is repeated in reverse when they return to their primary care doctor.
Interoperability is at the core of a functioning system. Yet according to one government report, in 2015, a mere 56% of hospitals had received electronic records from other practices—and just 40% of those had successfully merged the information into their own databases.6 Instead, EHR companies consider interoperability a threat to their business models and have delayed the full integration of medical records until the next decade. The founder of the largest EHR company has been quoted as saying: “Do good. Have fun. Make money.”6 EHR executives sure have; she, along with an executive from a rival company, made the Forbes magazine billionaires list.7
Although EHR executives may rejoice, some experts in health information technology have been forthright about the troubles with their products. A recent mea culpa penned by two of them summarized the fallout from the disastrous rollout of the EHR:8
“Along the way, however, we lost the hearts and minds of clinicians. We overwhelmed them with confusing layers of regulations. We tried to drive cultural change with legislation. We expected interoperability without first building the enabling tools. In a sense, we gave clinicians suboptimal cars, didn’t build roads, and then blamed them for not driving.” Touché!
Some readers may look back at paper records with a sense of nostalgia. They contained personal observations of the patient visit, scribbled free of the modern template dribble. Office notes were short, succinct and usually to the point. No need to meet the yet-to-be created Meaningful Use parameters.
There may have been an additional benefit to using paper charts—they were not likely to be hacked and held for ransom. A recent spate of EHR hacks has demonstrated how vulnerable some of these systems may be to thieves. This past May, the aptly named WannaCry virus attacked the venerable British National Health Service, shutting down more than 40 of its districts and hospitals. Other hacks have attacked the Presbyterian Medical Center in Hollywood, Calif., and the MedStar Health system that operates in Maryland and the District of Columbia.9 Long live pen and paper!
EHR companies consider interoperability a threat to their business models & have delayed the full integration of medical records until the next decade.
PBM Chicanery
One day soon, the inner workings of PBMs, the dominant gatekeepers to prescription drug access in America, may be revealed. Working under cover of darkness, they have antagonized many of their stakeholders, including the biopharmaceutical companies, health insurers, pharmacies and patients. Myriad complaints leveled against their business practices have caught the attention of Congress. That is never a good thing.
PBMs negotiate rebates from drug manufacturers on behalf of the insurance companies they have contracted with. It is the newest form of pay to play, in which manufacturers who pay these rebates get their drugs favorably placed on the PBM formulary while their nonplaying competitors’ drugs languish in the lower tiers of preference. The rebates’ importance in helping companies gain market share has recently led to lawsuits filed between drug manufacturers competing in a therapeutic space familiar to rheumatologists—infliximab.10
The rebate model has created a brisk business for PBMs, which have pocketed $130 billion annually.11 The PBM drug formulary promotes products with the highest rebates and discourages patients from taking drugs that produce less profit for them. They can wield a big stick: 1) by charging higher co-payments for these drugs, and 2) by establishing barriers, such as prior authorizations, that create onerous paperwork for physicians who may choose to reconsider their prescription choice.
The PBMs are under attack in the courts, where several lawsuits have been filed alleging that they often force patients to pay higher costs for certain generic products when using their drug coverage plans rather than simply paying for the drug out of pocket.12 Court proceedings may help strip away their opaque veneer and expose their obfuscatory workings.
Although one can rationalize the need for having a checkpoint, such as the prior authorization, to carefully review a prescriber’s choices, especially when these products are costly, how does one justify the prior authorization when it is applied to cheap generics, such as methotrexate, hydroxychloroquine, proton pump inhibitor drugs and prednisone, to name a few?
Finally, the pernicious nature of prior authorizations may be a critical—though a neglected—factor driving the opioid abuse crisis that has engulfed our nation. The investigative reporting group, ProPublica, and The New York Times analyzed Medicare prescription drug plans covering 35.7 million people in the second quarter of this year. They found that only one-third of the individuals covered had access to buprenorphine skin patches, considered a less risky opioid option for managing chronic pain than oxycodone or hydrocodone. And every drug plan that covered lidocaine patches, which happen to cost more than other generic pain drugs, required prior authorization approval.13
The Steep Ascent of Drug Prices
But let’s not focus our ire about drug costs solely on the PBM. Clearly, drug manufacturers shoulder much of the blame. Their pricing models are not sustainable. The annual cost of most biological therapies has risen well into five digits, and some have broken the six-digit barrier. This should not be surprising, given the reality that the FDA and Medicare are prohibited from determining whether a drug is cost effective. Medicare is forbidden from using its massive buying power when negotiating the purchase of drugs for covered patients. Congress believed this would provide Medicare with an unfair advantage over drug companies. I’m confused: Wouldn’t that be leveling the playing field for our patients?
In a more ominous twist of what may become a standard practice, consider the recent legal maneuver made by one company that is trying to extend its patent protection for its cyclosporine eye drops. They sold the drug’s patents to the St. Regis Mohawk tribe in upstate New York. Their aim is to block rivals from challenging the patents for the dry-eye drug at the U.S. Patent and Trademark Office based on the tribe’s special legal status as a sovereign government, which the tribe says provides it immunity from patent-office review.14 Should this strategy succeed, the company will avoid a pending hearing before a patent-office panel, and it would continue to reap the bulk of the profits from the sale of the drug, since the proposal would have the tribe receive a paltry $15 million annually in royalties as the drug continues to rake in $1.4 billion annually.
Simple Simon’s Solutions
Healthcare is a complicated subject. And our system has a proclivity for sometimes making things far more complicated than they ought to be. Drug reimbursement costs, physician fees, rules regarding access to specific drug coverage all seem to require a deep understanding of linear algebra coupled with a doctor of laws degree. It may be worthwhile trying a far simpler approach. Here are a few unsolicited suggestions:
To EHR developers, take a lesson from Steve Jobs: Style, form and function matter! He was obsessed with font style; people laughed then, but not now. You should know who uses your systems and listen carefully to their opinions. Don’t just rely on information technology experts for advice. When have they used your systems to order prescriptions or look up lab results?
To PBMs, employ some common sense: Stop treating prescribers as fools. Acknowledge that your working model does not always serve patients fairly. Understand that the uncommon diseases that constitute much of rheumatology often require innovative therapeutic approaches. So adopt a more rational approach to drug coverage. Be nice to us—you’ll need all the friends you can get when you testify before Congress.
To the biopharmaceutical industry, it’s time to get real! Your astronomical drug pricing models will eventually buckle under their own weight, and when they collapse there will be considerable collateral damage. American biotechnology is a cutting-edge industry, but this prominence should not allow it to price your products with impunity. How about dropping one digit when calculating the annual cost of new products? It’s not such a crazy idea given that the average annual retail cost of specialty drugs used to treat cancer, rheumatoid arthritis and multiple sclerosis now exceeds the median U.S. household income.15
Sound simple enough?
Simon M. Helfgott, MD, is associate professor of medicine in the Division of Rheumatology, Immunology and Allergy at Harvard Medical School in Boston.
References
- Shanafelt TD, Boone S, Tan L, et al. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377–1385.
- Arndt BG, Beasley JW, Watkinson MD, et al. Tethered to the EHR: Primary care physician workload assessment using EHR event log data and time-motion observations. Ann Fam Med. 2017 Sep;15(5):419–426.
- Bob Dylan—Subterranean Homesick Blues. YouTube.
- Hunter C. Valeant CEO sees new drug pricing environment ahead. Reuters. 2015 Oct 19.
- Apple sold 34,000 iPhones per hour, 24 hours a day, every day of the holiday quarter. Mac Daily News. 2015 Jan 28.
- Caldwell P. We’ve spent billions to fix our medical records, and they’re still a mess. Here’s why. Mother Jones. 2015 Oct 21.
- Monegain B. EHR vendors among Forbes’ richest. 2012 Sep 21.
- Halamka JD, Tripathi M. The HITECH era in retrospect. N Engl J Med. 2017 Sep 7;377(10):907–909.
- Gordon WJ, Fairhall A, Landman A. Threats to information security—public health implications. N Engl J Med. 2017 Aug 24;377(8):707–709.
- Grant C. The murky world of drug rebates gets airing in lawsuit. The Wall Street Journal. 2017 Sep 20.
- Goldberg R. Reduce drug prices by eliminating PBM rebates. The Hill. 2017 Feb 14.
- Chuck E. CVS charges more for generic drugs paid for with insurance, lawsuit claims. NBC News. 2017 Aug 9.
- Thomas K, Ornstein C. Amid opioid crisis, insurers restrict pricey, less addictive painkillers. The New York Times. 2017 Sep 17.
- Rockoff JD. Allergan partners with Indian tribe to protect drug patents. The Wall Street Journal. 2017 Sep 8.
- Johnson CY. Specialty drugs now cost more than the median household income. The Washington Post. 2015 Nov 20.