Category Archives: Patients

Zynx’s Siva Subramanian discusses care transitions and the IMPACT Act of 2014

Siva Subramanian, PhD. SVP, Mobile Products, Zynx Health

Siva Subramanian, PhD. SVP, Mobile Products, Zynx Health

Siva Subramanian, PhD is an expert in mobile health technology and care transitions. He’s the founder of CareInSync, now part of Zynx Health. In this podcast interview we discuss:

  1. Why care transitions are so important
  2. How value based payment approaches are affeting how providers approach care transitions
  3. The Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014
  4. How CareInSync addresses care transitions
  5. How CareInSync fits into Zynx’s broader portfolio
  6. What we can expect in the care transitions world over the next few years

By healthcare business consultant David E. Williams, president of Health Business Group.

 

In praise of FDA collaboration: the cardiac safety example

Making it happen

Making it happen

The Food and Drug Administration gets a lot of grief. Some think the FDA is too restrictive, keeping useful drugs and devices off the market and thus harming patients. Others complain that the agency is too lax, letting dangerous products get through. What many people don’t realize, however, is that FDA has established an excellent track record of collaboration with stakeholders that’s leading to better, faster development pathways.

I’m directly aware of FDA’s longstanding constructive, collaborative efforts in the areas of HIV and HCV through the Forum for Collaborative HIV Research. Those efforts are now expanding into liver fibrosis and beyond.

So I was encouraged to to receive the following correspondence over the weekend from Mikael Totterman, founder of iCardiac Technologies, where I’m a board member.

On Friday, I attended the Cardiac Safety Research Consortium meeting hosted by the Food and Drug Administration announcing the results of a new study that promises significant advances and improvements to the way cardiac safety is assessed for new drugs being developed by pharmaceutical companies.

It was a great opportunity to review  over a decade of work that had gone into enhancing one of the key areas of drug development and to reflect on how industry and government collaboration can lead to dramatic enhancements for all parties, especially patients.

Where It All Started – The FDA’s Critical Path Initiative

Back in March of 2004, the FDA launched the Critical Path Initiative to “drive innovation in the scientific process through which medical products are developed, evaluated and manufactured.” The document identified broad critical bottlenecks in drug development that, if tackled, promised to deliver significant improvements to the process of developing new drugs.

Specific Opportunities – Cardiac Safety – Traditionally Very Costly and Hard to Assess Well

By March of 2006, and as result of broad-based industry support, the FDA continued their collaborative work, and rolled out a highly targeted list of specific opportunities for industry collaboration to improve the overall effectiveness of drug development.

One of the key areas highlighted by the FDA across several specific opportunities was how drugs were assessed for cardiac safety issues, specifically for the potential to cause potentially lethal cardiac safety side effects.

“#18. Predicting Cardiac Toxicity. New tools for early identification of cardiac toxicity would improve product development for a wide array of conditions. Research investments that could produce tangible benefits quickly include creation of an ECG library from clinical trials that could be used for identifying potential early predictors of cardiac risk.

#46. Identification and Qualification of Safety Biomarkers. …For example, a robust database of preclinical and clinical data on cardiac arrhythmic risk could help us understand the clinical significance of QT interval prolongation, reduce the need for clinical studies, and, possibly, help identify individuals who are at risk for this side effect….”

Cardiac Safety – Consortia are Born

The level of interest in these opportunities was intense and so two separate industry/FDA consortia were developed to provide a venue and process for validating tools and methods that could tackle the issues in cardiac safety.

The Cardiac Safety Research Consortium was formed in 2006 through an FDA Critical Path Initiative Memorandum on Understanding and the Telemetric Holter ECG Warehouse was formed in 2008.

Significant Progress Unveiled at Cardiac Safety Research Consortium Meeting at the FDA

The Cardiac Safety Research Consortium meeting this past Friday was particularly exciting as it was the culmination of many years of work on the part of the FDA as well as many industry participants and thought leaders.

As the recommendations from the meeting are rolled out, the expectation is that cardiac safety testing in clinical trials will become ever more thorough and at the same time accomplished at a lower cost.

This is something that everyone should celebrate; patients, drug developers and regulators are all better off as a result of this long-term collaborative approach.

photo credit: ePublicist via photopin cc

By healthcare business consultant David E. Williams, president of Health Business Group.

 

Do you understand your medical bills? I don’t

Piling up the bills

Piling up the bills

The Consumer Financial Protection Bureau has issued a report that indicates that at least 43 million people in the US have unpaid medical bills. That has consequences since unpaid medical bills hurt credit scores, often substantially. Tellingly, many of these ‘debtors’ don’t have issues with any other creditor.

The report concludes that many non-payers simply don’t understand their medical bills.

I have a confession to make: Even though I’ve been working as a healthcare business consultant for more than 20 years, I don’t understand my bills either. Here are a few of the problems I face –and I know I’m not unique:

  • Providers send bills while insurance claims are still pending, so I don’t understand whether I’m being asked to pay the right amounts
  • Explanations of benefits from my health plan aren’t timely and aren’t informative. The services described sound completely generic and are hard to trace back to the provider bill
  • We now have a high-deductible plan and are being asked to pay more by our providers, but I’m not confident that providers are correctly taking into account our out-of-pocket maximums on an individual and family basis
  • Providers aren’t coding claims in line with the Affordable Care Act or insurance company rules, resulting in incorrect out-of-pocket amounts. (See my recent piece on the on again, off again co-pay for a routine physical)
  • Few providers (at least around here) allow online payments. I have to either call the office during work hours or mail in a check –both a hassle

I’ve said before that unpaid medical bills shouldn’t be counted for credit scoring purposes. And it appears that FICO has also come around to that way of thinking. Still the big problem is that the whole payment system is way too complex, expensive and confusing.

I understand that providers need to get paid, and increasingly that means collecting from patients. There are companies out there, like PatientPay and Simplee, that try to make this process easier. But we’ve got a long way to go.

photo credit: urbanbohemian via photopin cc

By healthcare business consultant David E. Williams, president of Health Business Group.

An expensive $25

One of the most visible benefits of the Affordable Care Act is that preventive services are covered with no out-of-pocket cost. So I was happy not to be charged a co-pay when I visited my doctor’s office for my routine physical in April. Not that $25 is a lot of money in comparison with my premium, but hey I’ll take it.

So I was unhappy when I started getting bills for a $25 co-pay from the doctor. I used the patient portal to send an administrative note in May, which was ignored. After a lot of back and forth with the office and my health plan the charge was finally dropped yesterday. But it makes me wonder just how much money the physician’s office and health plan spent to push this $25 around.

This is just one small example of the administrative costs imposed by the US’s convoluted healthcare financing system. Here’s the play by play from my case:

August 29, 2014

Dear [Physician Practice]:

I keep receiving bills for a $25 co-pay for 4/4/14 date of service. This was a routine physical. Under the ACA I am not supposed to be charged a co-pay for this preventive service, which I confirmed with BCBS MA. I sent a message about this months ago on the provider portal but have never received a reply, just more bills.

Please reverse the charge.

Thank you,

David

——

September 2, 2014

Good Morning Mr. Williams,

Thank you for your email inquiry regarding the balance of $25, for service date 4.4.14.  Upon review of the account, I confirmed Dr. X billed a medical office visit in conjunction with the annual physical.  Per the Affordable Care Act, you may still be required by your insurance company to pay a copayment if the physician treats you for any new medical issues discussed during the physical, or if she needs to change medication, order tests, or refer you to a specialist to deal with a pre-existing issue.  I have attached the ACA for your review.

 I have taken the liberty of asking our Medical Coder to review Dr. X’s medical notes for your visit on 4.4.14.  She will determine if the documentation supports the charge of the office visit.  If it does not, then and only then, will we reverse the charge.  This may take up to 7 business days.  I will email you as soon as I receive this back.  Please let me know if I can be of further assistance at this time.

Kind regards,

[Practice Administrator]

—–

December 1, 2014

Good Morning Mr. Williams.

This email is in follow up to my email sent on 9/2/14, regarding the balance of $25, for the service date 4/4/14.  Our medical coder determined Dr. X’s notes do not support the office visit.  Therefore, we are refunding your insurance company and reversing the charge.  You may disregard the statement.  Please let me know if you have any further questions.

Kind regards,

[Practice Administrator}

By healthcare business consultant David E. Williams, president of Health Business Group.

Ebola and the bigger patient safety issue

Did somebody say #Ebola?

Did somebody say #Ebola?

A Texas hospital blames its electronic medical record for the release of an Ebola patient who was sent home from the ER with an antibiotic (useless for a viral infection) and later came back to the hospital and died. In Spain, the government is blaming a nurse for catching Ebola from a patient and defending how it handled the disinfection of the ambulance an Ebola patient rode in.

Fact is, these sorts of screwups happen in hospitals every day. Individual cases are being reported now because they’re Ebola-related and therefore newsworthy. I’m hopeful that a positive byproduct of the Ebola scrutiny will be a renewed awareness of patient safety and quality of care issues by hospitals and patients.

It’s worth revisiting a post I wrote back in 2006 (Going to the hospital? BYMOD). I’ve reposted it below:

By now, most people know that hospitals are dangerous places, filled with medication errors, infections, poor communications and generally bad service. In case anyone needs to be convinced, the Institute of Medicine has just released a report on medication errors, indicating –among other things– that the rate of medication error is about 1 per patient per day!

In the A Piece of Mind column in the July 12 JAMA, Dr. Frederick Hecht of San Francisco recounts the story about his daughter’s bout with leukemia four years ago and subsequent recovery. The story is about the extra burden of being a physician when a family member is ill –no blissful ignorance and wishful thinking for him.

But as with any true story about illness and hospitalization, there is a subtext of error and danger:

Several days into my daughter’s treatment, I observed that one of the pills she was getting had changed, and it didn’t match anything she was supposed to be getting in the Physicians’ Desk Reference, which I already had at her bedside. It turned out that she was getting cis retinoic acid (Accutane) rather than all trans retinoic acid (ATRA) due to a pharmacy error. An acne medicine had been substituted for a critical chemotherapy treatment.

Maybe this was the hospital’s rendition of “live fast, die young, and leave a good looking corpse.” Anyway, he continues:

At another point, I noted a potentially life-threatening drug-induced hepatitis, which had been missed on her maintenance chemotherapy laboratory tests.

In other words, his daughter could well have died if she hadn’t had her father, the doctor, looking after her.

Don’t be lulled into trusting the hospital to take care of you. If you go to the hospital, try your best to take someone who knows what they are doing and isn’t afraid to speak up for you. If possible, BYOMD.

photo credit: cheerfulmonk via photopin cc

By healthcare business consultant David E. Williams of the Health Business Group

Watch your back! Surprise medical bills may await

Show me where it hurts

Show me where it hurts

 

Dr. Richard Amerling, president of the Association of American Physicians and Surgeons, writing from New York, had this to say in yesterday’s Wall Street Journal:

A patient recently asked, “What would happen if there was no health insurance?” I responded, “The prices for all medical goods and services would immediately plummet.”

I would direct his attention to Sunday’s New York Times (After Surgery, Surprise $117,000 Medical Bill From Doctor He Didn’t Know), which presents a much more realistic view of what goes on in New York City and around the country. To wit:

  • A patient had a neck surgery he may or may not have needed. (There are 2x-5x as many spine surgeries in the US as elsewhere in the rich world. The multiples are particularly high in places where surgeons like to live)
  • The orthopedist charged $133,000 but was reimbursed (and willingly accepted) $6,200. That’s on top of $60,000 or so in other charges from the hospital and anesthesiologist
  • An out-of-network “assistant surgeon,” probably not needed, billed an additional $117,000, which the insurance company ended up paying in full. The orthopedist says he didn’t take a cut of the assistant’s fee. Whether it’s true in this case or not, it happens

So what does this tell us?

  • That the information Dr. Amerling provided to his patient is naive at best
  • That insurance companies need to find better ways to contain costs or that regulators need to change the rules to allow them to do so
  • That patients need to be more skeptical of recommendations for surgery (especially spinal surgery)
  • That a single payer system, for all its faults, looks superior to the current state of affairs

There are benefits managers like MedSolutions that help insurance companies and employers deal with this sort of nonsense. At the very least this news should be good for their business.

photo credit: Darcie via photopin cc

By healthcare business consultant David E. Williams of the Health Business Group

Apple Health App: A first taste

Blood alcohol might be of interest to hackers

Blood alcohol might be of interest to hackers

Nothing for now, but it's coming

Nothing for now, but it’s coming

I was brave (or stupid enough) to download iOS8 on my iPhone 5 early yesterday morning at Boston’s Logan Airport. Luckily the update completed before I had to get on the plane. It was neat to see a Health icon pop up on the home screen, and I had a chance to give it a quick look. There wasn’t all that much I could do with it for now, beyond entering some basic data like height and weight, but it’s an intuitive app that fits in with the rest of Apple’s iOS offerings. We’ll have to wait for 3rd party apps to hook into Health through HealthKit, which will take awhile. And the Apple Watch isn’t out yet either.

I think Health is going to lead the market, but not dominate. Here’s my logic:

  • Like other Apple innovations –think iPod and iPad– decent products already existed in those categories and were starting to get some traction. I had mp3 players and a tablet computer years before, but Apple did a better job of packaging everything up and taking usability to the next level. For me, the iTunes store differentiated the iPod and the long battery life made iPad worth ponying up for. In this case Apple is entering a market that others have already been prospecting in. Some of those others –like Fitbit– have taken a lesson from Apple and tried to make elegant products that won’t be so easily pushed out of the way by Apple mania
  • The soon-to-be-introduced Apple Watch should work very smoothly with the iPhone or iPad. I’m planning to get one when it arrives, and I’m holding out hope for a high quality heart rate monitor as part of the package. This is the type of product that should evolve quickly, with new sensors and improved performance, but it will take some getting used to before I start trading in my watch every year or two and charging it up every night
  • Despite the recent dustup over iCloud accounts being hacked, I do trust Apple with my personal data more than I trust competitors like Google.  Apple’s business model allows it to make money by selling products and services to consumers without resorting to data mining. Apple seems to be going out of its way on the Health side to emphasize its trustworthiness. That’s a selling point competitors will have trouble matching –because data mining is the business model. More consumers are going to care about this as things move along
  • One reason use of personal health data technology has been so low is that while younger people are open to it they are generally healthy and don’t need to deal with their records nearly as much. But it’s been seven years since Microsoft’s HealthVault was introduced –and those same tech-embracing folks are getting older. Also, there’s been a remarkable change in the level of use of smartphones in the past few years. They’ve gone from non-existent to ubiquitous, so Apple doesn’t need to convince people to bring another device along. The passive collection of data through sensors also makes a huge difference in ease of use and accuracy of the information. (See Health tracking apps: Not yet ready to make a big impact)
  • Apple’s move is going to bring a lot of app developers into the market and we’ll see some pretty clever uses for Health before long. That will include general purpose apps and those for folks with specialized needs, like those who need to track specific parameters for a chronic illness

Makers of health apps and tools will all need to look to Apple Health to figure out how they fit in. The opportunities for data suppliers and vendors serving doctors and hospitals are there, too, but it will take at least a couple years to sort out the most promising approaches.

I look forward to going along for the ride.

By healthcare business consultant David E. Williams of the Health Business Group