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What the Supreme Court Decisions Mean For the Future of Employer-Based Insurance

Jul 8, 2014• 6

By PAUL KECKLEY

Monday, in its 5:4 ruling in Burwell v. Hobby Lobby, the Supreme Court affirmed that for-profit employers may opt out of certain methods of contraception it finds objectionable on religious grounds. In effect, the ruling gave standing to a company’s ability to use the 1993 Religious Freedom and Restoration Act, previously applied to individuals. Thursday, the Justices voted 6:3 that Wheaton College, is not required to transfer contraception coverage to a private insurer via submission of ESBA Form 770 deeming it an impermissible burden on its religious exercise. Instead, Wheaton will simply be required to notify HHS of its objection.

Pundits have framed these two decisions as a pivot point for the future of the Affordable Care Act. I think that’s overstated, though it assures the ACA will stay in the news and be prominent in Campaign 2014. I read the rulings and dissenting opinions: the points of view frame complicated questions, like ‘is a company entitled to the same religious freedoms granted individuals’ and ‘what are the limits of a company’s decision-making about matters of health’ and so on.

In practical terms, the immediate implications of the decisions are two:

The White House will have to develop an alternative path to contraceptive coverage.Prominent news organizations have speculated about two possibilities that would secure contraception coverage for women who work for employers who refuse coverage on religious grounds: 1-the federal government could create a new federal program or 2-it could require private insurers provide coverage directly. Each would be challenged by opposition: If the former, the White House would face pushback from critics who would call it “a new entitlement”. If the latter, insurers would need to raise premiums or secure federal funding if expected to add the costs of contraception coverage for this specific circumstance. Either way, it’s a sticky situation.

The rulings mean scores of companies and not-for-profits will file challenges to the ACA invoking religious freedom through the court system: an employer might take the position that vaccinations are a religious objection, or transfusion of non-autologous blood, or others. Already, more than 50 cases are working their way through circuit courts: more are expected.

How Telehealth May Be Promoting Fraud and Abuse

Jul 7, 2014• 15

By TOM LIU

I recently called my primary care physician (PCP) for the first time in years to get my immunization records, and encountered a strange message saying he was not currently seeing patients. My mom had apparently encountered the same message weeks ago. “Maybe he retired,” she suggested.

I did a quick google search of my PCP’s name to find an alternate contact number, and instead found a shocking article from the local newspaper. Apparently my PCP has been indicted for falsifying tax returns and participating in an online pharmacy organization that provided prescription drugs without an in-person physician examination.

Remote Prescribing: Lucrative, Pervasive, and Very Illegal

I did a quick search online and confirmed that the practice of offering prescription drugs through a “cyber doctor” prescription, relying only on a questionnaire is indeed very illegal.

It is also very pervasive. The National Association of Boards of Pharmacy (NABP) reviewed 10,700 websites selling prescription drugs and found that 97% of them were “Not Recommended”. Of these, 88% do not require a valid prescription and 60% issue prescriptions per online consultation or questionnaire only.

What struck me was how this appeared to be a case where the market came together to produce a “triple win” for profit-seeking internet pharmacies, shady physicians (such as my own), and a subset of patients willing to pay a premium to access drugs (most commonly weight loss drugs, erectile dysfunction drugs, and commonly-abused antidepressants and painkillers).

According to one analysis, one such website offering prescriptions from its own doctors listed prices for fluoxetine (brand name Prozac) and alprazolam (brand name Xanax) that were roughly 400% to 1800% higher than prices from a more traditional Internet pharmacy not offering prescriptions. The fact that such “remote prescription” websites remain in business despite the huge price differential suggests that they are attracting patients willing to pay that premium to avoid seeing their regular doctor. And as for where that money is going—well, my doctor was alleged to have received roughly $2.5 million over six years.

Should Medical Ethics Be Modernized?

Jul 7, 2014• 6

By RICHARD GUNDERMAN, MD

Last month the American Medical Association wrapped up its annual meeting in Chicago, where it has reached the final stages of modernizing its 167-year-old Code of Medical Ethics, last updated more than 50 years ago. The central role of ethics in medicine is reflected in the fact that, at the AMA’s first meeting in 1847, it treated the establishment of a code of ethics as one of its two principal orders of business. Much in medicine has changed since 1847, but this founding document, which most physicians and patients have never seen, still offers important insights that deserve to be reaffirmed.

Spanning 15 pages, the 1847 Code of Ethics addressed just three fundamental concerns: the duties physicians and patients owe each other, physicians’ duties to each other and the profession at large, and the reciprocal duties of the profession and the public. This structure, focused on moral duties, evinces an important feature of the authors’ view of medicine. Namely, medicine is essentially a moral enterprise, grounded in mutual responsibilities, in which patients, physicians, and the public unite to serve the interests of the suffering.

In fact, the preamble to the 1847 Code of Ethics states explicitly that medical ethics “must rest on the basis of religion and morality.” Ethics is not merely a matter of consensus, and the boundaries of professional ethics are not outlined by what a particular patient or physician might happen to agree to. The fact that an employment contract or informed consent form has been signed is insufficient. Professional ethics requires loyalty to ideals that transcend any particular person or group of people. Like taking an oath, it rests on the presumption that professionals serve something higher than themselves.

The preamble to the 1847 Code also acknowledges that, in framing their code of ethics, the authors have “the inestimable advantage of deducing its rules from the conduct of many eminent physicians who have adorned the profession by their learning and piety.” It explicitly holds up the example of the “Father of Medicine,” Hippocrates, by whose conduct and writing the duties of a physician “have never been more beautifully exemplified.” The Code’s authors emphasize that these ideals are not only aspirational but achievable, having been exemplified by “many.”

The first chapter stresses the physician’s duty to answer the call of the sick, which is all the more deep and enduring “because there is no tribunal other than the physician’s own conscience to adjudge penalties for neglect.” In other words, the Code entrusts the ethics of medical practice not to lawmakers, the courts, or hospital executives, but to the conscience of each physician. We can detect and punish violators, the Code’s authors are saying, but it is impossible to legislate goodness, whose flame must ultimately burn nowhere else but in the hearts of professionals themselves.

The first chapter also states explicitly that physicians should never abandon a patient because a case is deemed incurable. In an era obsessed with improving measurable outcomes such as length of stay and cost of care, many of today’s healthcare leaders need a reminder that a physician’s contribution cannot be fully assayed in terms of cures. Incurable does not mean hopeless, and it is always possible to care well even for those who are dying. The authors state that physicians should strive to be “ministers of hope and comfort to the sick.”

Maslow’s Hierarchy of Health IT

Jul 3, 2014• 4

By David Do, MD

EMR adoption is skyrocketing, in no small part due to government incentives. The office of the national coordinator lauds this hockey-stick curve as a success. Advocates promise electronic records will improve patient care, reduce mistakes, and save healthcare costs. At the same time, doctors love to complain about implementation cost and poor usability. How can we reconcile these differing opinions? The truth is they are describing very different technologies. EMRs, the way they are implemented now, will not accomplish these goals. In fact, early adopters can become stuck at a rudimentary level of functionality, and the extensive feature lists described by meaningful use criteria fail to address the most basic needs for patient care.

I have been at medical institutions at different levels of technological development. Each has a different attitude toward the EMR; for some its loathing, others longing. Some devote resources to try to improve it, but others give up. I realized the parallels with Maslow’s Hierarchy of Needs, people are motivated to attain something only after their very basic needs have been fulfilled. So are EMRs good or bad? Well, it depends on where you are on the hierarchy.

The figure above describes the steps to building a technology infrastructure that will lead to improved patient care. Yes, incentives help us achieve some very basic needs, but the problem is that decisions and investments we make now will determine the ceiling as well.

The Cost Curve Probably Won’t Bend Downwards. But That’s Ok.

Jul 3, 2014• 9

By SARAUBH JHA, MD

To control the nation’s overarching fecundity the government of India raised mass awareness of condoms; the chief effect of which were a load of giggling school boys and a load of giggling school girls. Further, in an initiative by Sanjay Gandhi, vasectomies were performed, nearly en masse, through a mixture of cajolement, economic incentives and coercion.

The fertility curve remained unbent.

Then along came color TV. Paul Ehrlich’s doomsday prophecies were forestalled. I know correlation is not causation, let alone abstinence. I’m just saying.

Policy is a strange and lucky beast. It can survive its futility. It is not so much occasionally inept as often incidental. And it has the epistemological luxury of not being easily falsifiable: i.e. it’s hard to prove that it was not responsible for the effect for which it was instituted.

Can you prove that it was not condoms but color TV that derailed India’s logarithmic fecundity? Good luck randomizing to the television arm.

Yes I can hear you muttering “ahem seatbelts.” This is not to say policy never achieves its desired aims. It’s to say that it’s not easy to distinguish policy’s true successes from pseudo successes.

The Coming Debate Over Specialty Drugs

Jul 2, 2014• 17

By Ceci Connolly

The debate over the price of specialty drugs is intensifying and could well be the next major healthcare issue to dominate the national, even international, agenda. In a nutshell, how will society pay for breakthrough scientific innovation?

Specialty drugs, complex therapies used to treat severe illnesses such as cancer, multiple sclerosis and Hepatitis C, are coming in with price tags that have purchasers sounding alarm bells. At $1,000 per pill, the newest Hep C medication runs about $86,000 for a course of treatment. Two major insurers have publicly cited the price of this single new drug as contributing to next year’s rise in premiums.

In fact, analysis by our team at PwC’s Health Research Institute shows that this one new therapy will impact overall U.S. health costs by .5% this year and .2% next year. Considering the nation’s total healthcare budget is $2.8 trillion, that is a remarkable budgetary impact for one product.

But the story doesn’t end there. Drug costs represent just 15% of total health spending, compared to nearly one-third spent on inpatient care. Short-term budget spikes could become long-term savers from both a cost and health standpoint. For the most severe patients, the price of Hep C medication – that is nearly 90% effective – is three to six times less than treating a lifetime of cirrhosis ($270,000) or providing a liver transplant ($580,000.) Patients essentially “cured” of Hepatitis C can go on to have productive, long lives.

Physician Burnout: It’s Time to Take Care of Our Own

Jul 2, 2014• 22

By SAMANTHA MELTZER-BRODY, MD

Despite highly skilled physicians and advanced technology, the U.S. has not yet figured out how to provide effective affordable health care to everyone. Meanwhile, the health care system is increasingly fractured and stressed—and so are our doctors. Physician burnout impacts nearly half of all seasoned physicians in practice and up to 75% of resident physicians in training1. Over water cooler conversations, as well as in my work as a psychiatrist at the University of North Carolina at Chapel Hill (UNC), I hear more and more physicians report anxiety, stress and emotional exhaustion. Many feel as if they are perpetually swimming upstream; others feel there is no joy or meaning in their work; some want to quit medicine altogether. These good doctors are in crisis in increasingly high numbers — an epidemic that requires immediate attention.

Last year, the UNC School of Medicine launched the Taking Care of Our Own program to address the problem of physician burnout and we have been met with a deluge of physicians asking for help. Burnout, however, is not a diagnosis. It is a constellation of symptoms that include emotional exhaustion, depersonalization and loss of perspective that work is meaningful2. Untreated, burnout syndrome can erode professional behavior at work and healthy relationships at home. This leads to decreased empathy and compassion, poor communication and potentially worse patient outcomes. The personal consequences include disrupted relationships with family and friends, self-medicating with alcohol or other substances, depression and an increased risk of suicide, which is higher among physicians than the general population, in part due to the stigma associated with seeking mental health treatment.

Not a day goes by without my hearing from a physician in distress who has learned about the Taking Care of Our Own program. These conversations have a striking degree of similarity. They typically begin with an apology—a statement about how embarrassing it is to ask for help in dealing with anxiety or depression; or a recent loss; or other emotional stressor that makes it too difficult for the doctor to remain professional and compassionate while managing a demanding workload.

Big Data in Healthcare: Good or Evil? Depends on the Dollars

Jul 1, 2014• 25

By JOE FLOWER

An organization’s “business model” means: How does it make a living? What revenue streams sustain it? How it does that makes all the difference in the world.

Saturday, Natasha Singer wrote in the New York Times about health plans and healthcare providers using “big data,” including your shopping patterns, car ownership and Internet usage, to segment their markets.

The beginning of the article featured the University of Pittsburgh Medical Center (UPMC) using “predictive health analytics” to target people who would benefit the most from intervention so that they would not need expensive emergency services and surgery. The later part of the article mentioned organizations that used big data to find their best customers among the worried well and get them in for more tests and procedures. The article quoted experts fretting that this would just lead to more unnecessary and unhelpful care just to fatten the providers’ bottom lines.

The article missed the real news here: Why is one organization (UPMC) using big data so that people end up using fewer expensive healthcare resources, while others use it to get people to use more healthcare, even if they don’t really need it?

Because they are paid differently. They have different business models.

UPMC is an integrated system with its own insurance arm covering 2.4 million people. As a system it has largely found a way out of the fee-for-service model. It has a healthier bottom line if its customers are healthier and so need fewer acute and emergency services. The other organizations are fee-for-service. Getting people in for more tests and biopsies is a revenue stream. For UPMC it would just be a cost.

The evil here is not using predictive modeling to segment the market. The evil here is the fee-for-service system that rewards waste and profiteering in medicine.

Electronic Cigarettes: What’s in the Vapors?

Jun 30, 2014• 5

By Maciej Goniewicz

Users and non-users of electronic cigarettes (e-cigarettes) have many legitimate questions about these nicotine-delivery devices. E-cigarettes represent a nearly $2-billion-a-year industry, and one that’s growing exponentially. The number of young people trying e-cigarettes doubled from 2011 to 2012, according to the Centers for Disease Control. So it is natural that so many people are interested in the health consequences of using e-cigarettes.

Research from the Department of Health Behavior at Roswell Park Cancer Institute has documented the impact of first-, second- and third-hand exposure to e-cigarette vapors. Our most recent research, done in collaboration with scientists from the Medical University of Silesia in Poland, offers insight into the user’s exposure to carcinogenic carbonyls.

The e-liquids used in e-cigarettes are primarily composed of glycerin and propylene glycol. We set out to find out what chemicals are generated during use of e-cigarettes, particularly at variable voltages. Some devices allow the user to adjust the voltage to increase vapor production and nicotine delivery.

We found that when e-cigarettes were operated at lower voltages, the vapors that were generated contained only traces of some toxic chemicals. These chemicals included the carbonyls formaldehyde, acetaldehyde, and acetone. However, when the voltage was increased, the levels of these toxicants also significantly increased.

The novel finding of our study is that the higher the voltage, the higher the levels of carbonyls. Increasing battery output voltage leads to higher temperature of the heating element inside the e-cigarette. Increasing the voltage from 3.2 to 4.8 volts resulted in increases of anywhere from 4 times to more than 200 times the exposure to formaldehyde, acetaldehyde and acetone. The levels of formaldehyde in vapors from high-voltage devices were similar to those found in tobacco smoke.

Is the Electronic Health Record Defunct?

Jun 30, 2014• 28

By JEROME CARTER , MD

When building software, requirements are everything.

And although good requirements do not necessarily lead to good software, poor requirements never do. So how does this apply to electronic health records? Electronic health records are defined primarily as repositories or archives of patient data. However, in the era of meaningful use, patient-centered medical homes, and accountable care organizations, patient data repositories are not sufficient to meet the complex care support needs of clinical professionals. The requirements that gave birth to modern EHR systems are for building electronic patient data stores, not complex clinical care support systems–we are using the wrong requirements.

Two years ago, as I was progressing in my exploration of workflow management, it became clear that current EHR system designs are data-centric and not care or process-centric. I bemoaned this fact in the post From Data to Data + Processes: A Different Way of Thinking about EHR Software Design. Here is an excerpt.

Do perceptions of what constitutes an electronic health record affect software design? Until recently, I hadn’t given much thought to this question. However, as I have spent more time considering implementation issues and their relationship to software architecture and design, I have come to see this as an important, even fundamental, question.

The Computer-based Patient Record: An Essential Technology for Health Care, the landmark report published in 1991 (revised 1998) by the Institute of Medicine, offers this definition of the patient record:

A patient record is the repository of information about a single patient. This information is generated by health care professionals as a direct result of interaction with the patient or with individuals who have personal knowledge of the patient (or with both).

Note specifically that the record is defined as a repository (i.e., a collection of data). There is no mention of the medium of storage (paper or otherwise), only what is stored. The definition of patient health record taken from the ASTM E1384-99 document, Standard Guide for Content and Structure of the Electronic Health Record, offers a similar view—affirming the patient record as a collection of data. Finally, let’s look at the definition of EHR as it appears in the 2009 ARRA bill that contains the HITECH Act:

ELECTRONIC HEALTH RECORD —The term ‘‘electronic health record’’ means an electronic record of health-related information on an individual that is created, gathered, managed, and consulted by authorized health care clinicians and staff. (123 STAT. 259)

Even here, 10 years later, the record/archive/repository idea persists. Now, back to the issue at hand: How has the conceptualization of the electronic health record as primarily a collection of data affected the design of software systems that are intended to access, manage, and otherwise manipulate said data?