With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to “licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.”
While this sounds nice, how, exactly, does one become a “prescribed patient?” Once a doctor “prescribes” such a device, what are his responsibilities? Does this obligate the physician to 24/7/365 availability for EKG interpretations? How are HIPAA-compliant tracings sent between doctor and patient? How are the tracings and medical care documented in the (electronic) medical record? What are the legal risks to the doctor if the patient transmits OTHER patient’s EKG’s to OTHER people, non-securely?
At this point, no one knows. We are entering into new, uncharted medicolegal territory.
But the legal risks for prescribing a device to a patient are, sadly, probably real, especially since the FDA has now officially sanctioned this little iPhone case as a real, “live” medical device. But I must say, I am not a legal expert in this area and would defer to others with more legal expertise to comment on these thorny issues.
This issue came up because a patient saw the device demonstrated in my office and wanted me to prescribe it for them. So I sent AliveCor’s Dr. Dave Alpert a tweet and later received this “how to” e-mail response from their support team:
Continue reading “When Patients Can Obtain Their Own EKG”
Filed Under: THCB
Tagged: AliveCor, Dave Alpert, Dr. Wes, EKG, iPhone, Medical Devices, Workflow
Feb 16, 2013
The new “fiscal cliff” legislation hailed by some as a “one-year doc fix” of the scheduled 26.5% sustainable growth rate (SGR) cut that was scheduled to take effect on 1 January 2013, has passed the Senate and House as part of the American Taxpayer Relief Act ( HR 8 ) goes to President Obama for his likely signature.
But was this “one-year doc fix” really a fix?
Not at all.
In fact, once again Congress has failed to resolve the ever-present sustainable growth rate cuts that repetitively surface year after year by kicking the proverbial can down the road another year.
The cost of the one year patch will be $25.1 billion dollars over 10 years and will be paid for almost entirely by health care cuts in other areas.
- Hospitals (increasingly doctor-employers now, remember?) will see audits of their billings increase as efforts to recoup some $10.5 billion of “overcoding” charges are seen as the largest source of revenue for the one-year “fix.”
- Hospitals will also see an extension of lower Medicaid payments to hospitals that treat a high number of uninsured or low-income beneficiaries, known as “disproportionate share hospitals” to find savings of about $4.2 billion.
- Another $4.9 billion offset will be applied to the lowered bundled payments given for patients with end-stage renal disease – some of the sickest people receiving services from Medicare.
Continue reading “The Fix that Failed”
Filed Under: THCB
Tagged: American Taxpayer Relief Act, Doc Fix, Dr. Wes, fiscal cliff
Jan 3, 2013
Cardiovascular predictions for next year are always fun to contemplate this time of year. So much is happening to the practice of medicine as we’ve known it that it can be helpful to highlight some of those changes, both good and bad, as our medical world continues to evolve. While these predictions contain pure guesses, they also contain one doctor’s observations of our new evolving medical world. Many of these changes will profoundly shape how doctors interact with their patients.
So grab some coffee and strap in. Here are my 2013 predictions of life as a cardiologist in 2013. (Please feel free to add your own predictions in the comments section.)
Valvular Heart Disease
- TAVR for critical aortic stenosis will be applied to progressively younger and healthier patients.
- As smaller delivery systems for percutaneous heart valves gain widespread acceptance, government payers will look for new and inventive techniques to restrict patient access to these devices. No heart valve will remain untouched as creative uses of the approved devices are attempted in non-surgical patients.
- Innovations valve design will improve the safety and effectiveness of this therapy.
Continue reading “My Grand, Sweeping Cardiovascular Predictions for 2013″
Filed Under: Physicians
Tagged: cardiology, Dr. Wes, EHR, the future of medicine
Dec 12, 2012
Diet and exercise: they were supposed to be the answer to all that ails America’s obesity and health care cost problem.
Signs of this Utopian vision are everywhere. From entire government departments encouraging healthy lifestyles through fitness, sports and nutrition, government websites that encourage “healthy lifestyles,” and entire community efforts to partner with health care organizations to fight obesity with the hope of cutting health care costs.
What if, believe it or not, when it comes to people with Type II diabetes, diet and exercise don’t affect the incidence of heart attack, stroke, or hospital admission for angina or even the incidence of death?
Suddenly, all health care cost savings bets are off. Suddenly, we have to re-tool, re-think our approach, understand and appreciate the limitation of lifestyle interventions to alter peoples’ medical destiny. Suddenly we have to come to grips with a the reality that weight loss and exercise won’t affect outcomes in certain patients. Suddenly, there is a sad reality that patients might note be able to affect their insurance premiums by enrolling in diet and exercise classes after all.
These thoughts are so disruptive to our most basic “healthy lifestyle” mantra that few can fathom such a situation. Nor would any members of the ever-beauty-and-weight-conscious main stream media be likely to report such a finding if it came to pass.
And yet, that is exactly what has happened.
Continue reading “The Return of Counter-Conventional Wisdom”
Filed Under: OP-ED, THCB
Tagged: Diet and exercise, Dr. Wes, fitness, Health Care Costs, Lifestyle, Look AHEAD trial, Obesity, type 2 diabetes, Wellness
Oct 25, 2012
Oh, that clever Center for Public Integrity. Look what they’ve gone and done now! My, oh my. According to the article, doctors are much of the the problem, billing “billions” of Medicare upcharges according to the center.
But what if the medical coding game itself is flawed? Stop for a moment and imagine what it would look like if lawyers billed like doctors. Suddenly, we see how bizarre the world of government billing codes and chart-completion mandates has become.
Not long ago I asked readers what my time is worth on a per-hour basis. Collectively and independently, they settled on a number of about $500/hr (see the comments). Now look for a moment at what Medicare pays, even at its highest level of billing for a physician’s time for evlauation and management of a medical problem: for 40 minutes of a physician’s time, it’s $140 (or $210/hr) before taxes. Again, we see another disconnect as to how doctors are valued in our current system.
Doctors are working long hours to collect these fairly low fees from Medicare while jumping more hoops than ever to do so. They have become pseudo-experts at the coding game, trying to get as much money for their extra efforts as legally possible. But these fees paid by Medicare do not cover payments for time spent on phone calls, e-mails, and working insurance denials. These services are still considered by our system as gratis. To partially counteract this coding problem, doctors realized (and the government insisted) that doctors use electronic medical records.
But when independent doctors set out to implement these records they quickly discovered that the expense and long-term maintenance costs of local office-based EMRs could not compete with more sophisticated systems already in use by their neighboring large health care systems. Because of ever-increasing cost-of-living and overhead costs, not to mention the threats of large fee cuts, doctors have migrated to large health systems faster than ever. With the fancier electronic record at those systems (streamlined for billing, collections, and marketing) fields required for higher billing codes (but not always material to the problem at hand) are completed in less time. So are doctors really the problem?
Continue reading “Kill the Codes”
Filed Under: Physicians, THCB
Tagged: Billing Codes, Center for Public Integrity, Dr. Wes, ICD-10, Medicare, Medicare, Reimbursement
Sep 23, 2012
As a cardiac electrophysiologist, I’m pretty far removed from public policy. But I have to admit that I was interested in the latest move by CMS to cut their Medicare payment rates to hospitals by invoking pay cuts for hospital readmissions. The Chicago Tribune‘s article is enlightening and filled with some interesting anecdotes after the first round of pay cuts were implemented:
(1) The vast majority of Illinois hospitals were penalized (112 of 128)
(2) Heart failure, heart attack, and pneumonia patients were targeted first because they are viewed as “obvious.”
(3) “A lot of places have put a lot of work and not seen improvement,” said Dr. Kenneth Sands, senior vice president for quality at Beth Israel.
(4) Even the nation’s #1 Best Hospital (according to US News and World Report) lost out.
So what’s a hospital to do?
Continue reading “Out of the Box Thinking on Avoiding Hospital Readmissions. Stop Trying”
Filed Under: Hospitals, THCB
Tagged: CMS, Dr. Wes, hospital readmissions, Medicare, Pay for Performance, Penalties
Sep 17, 2012
Recently I was asked to serve as a consultant on a medical matter. Interestingly, they requested my hourly price for my services. I thought about this and wondered, “What am I worth in per hour in the open market?”
It is an interesting question to ponder.
I have decided to ask the blog-o-sphere. Call it a bit of “free market economics.” For the record, 100% of my hourly wage for my services will be sent to our cardiovascular research fund at our hospital to avoid any conflict of interest. I will not see ANY of the money the blog-o-sphere decides personally, but I really want to know what people think.
So where to begin?
Should I compare my hourly wage to MGMA standards for the annual physician salary of a physician of my subspecialty? If so, do I pick the 50% percentile, 25th percentile, 75th percentile, or 95th percentile? On what basis do I have to assure this is a fair price? Who sets this price? Are these data accurate or based on earlier years’ hospital data and physician surveys? Can I verify that their hourly price is justified? If so, how? Or are their data proprietary?
Continue reading “What Am I Worth?”
Filed Under: Physicians, THCB
Tagged: cardiology, Dr. Wes, Hourly Wage, MGMA standards, Physician Fee Schedule Proposed Rule, Price for Service
Aug 24, 2012
In our rush to establish a national electronic medical record (EMR) system as part of the American Recovery and Reinvestment Act of 2009, powerful silos of independent EMR systems have sprung up nationwide.
While most systems are being developed responsibly, like the Wild, Wild West, many have been developed without an objective eye toward quality and the potential harm they may be causing our patients.
As most readers of this blog are aware, since 2005 the medical device industry in which I work has had widely publicized instances of patient deaths splashed all over the New York Times and other mainstream media outlets from defibrillator malfunctions that resulted in a just a few patient deaths.
The backlash in response to these deaths was significant: device registries were developed, software improvements to devices created, and billions of dollars in legal fees and damages paid to patients and their families on the path to improvement. In addition, we also learned about the limits of corporate responsibility for these deaths thanks to legal precedent established by the Reigel vs. Medtronic case.
Continue reading “Why the Electronic Medical Record Needs to be Viewed as a Medical Device”
Filed Under: Uncategorized
Tagged: American Recovery and Reinvestment Act, Cerner, Data, Dr. Wes, EHR, FDA, Medical Devices, Medical errors, medications, Patient Safety, Reigel vs. Medtronic
Aug 20, 2012
It was a chance encounter.
After all it’s not every day you see an internist who still frequents a hospital. We’ve known each other for years and he’s been watching the changes in health care, too.
“Boy, they’re really not happy Over There. Seems they’ve contracted with Big Boy insurance as part of their new ACO model. Everyone’s going to get their piece before the doctors: Over There hospital, their four million administrators, lawyers, grounds crews, parking staff…. Then, after everyone else is paid, the doctors might get a few scraps if there’s some left over. No guarantees. All risk, no certainty of reward. There was no way I could still go there. I joined them, but had to leave when I saw how unworkable that was.”
“Isn’t this our new way forward?” I asked.
“I guess so. Scary. But I’ve got just a few more years. Just have to get the kids through college.”
Continue reading “Things Are About to Get Interesting”
Filed Under: Uncategorized
Tagged: Dr. Wes, Physician Shortage
Jul 31, 2012
Doctors wanting to determine a patient’s atrial fibrillation burden have a myriad of technologies at their disposal: 24-hour Holter monitors, 30-day event monitors that are triggered by an abnormal heart rhythm or by the patient themselves, a 7-14 day patch monitor that records every heart beat and is later processed offlineto quanitate the arrhythmia, or perhaps an surgically-implanted event recorder that automatically stores extremes of heart rate or the surface ECG when symptoms are felt by the patient. The cost of these devices ranges from the hundreds to thousands of dollars to use.
Today in my clinic, a patient brought me her atrial fibrillation burden history on her iPhone and it cost her less than a $10 co-pay. For $1.99 US, she downloaded the iPhone app Cardiograph to her iPhone.
Every time she feels a symptom, she places her index finder over the camera on the phone, waits a bit, and records a make-believe rhythm strip representing each heart rhythm. With it, comes the date and time.
Continue reading “How the iPhone Might Disrupt The Medical Device Industry”
Filed Under: Uncategorized
Tagged: Apps, atrial fibrillation, Dr. Wes, ECG, FDA, Health 2.0, iPhone
Jul 27, 2012