SCGhealth Blog

DOJ to Join Mega-Lawsuit Alleging Opioid Manufacturers Misled Physicians

Monday, March 19, 2018

By Marla Durben Hirsch 

If you prescribe opioids, be forewarned: The Department of Justice (DOJ) has launched a new salvo in its efforts to stem the opioid crisis, announcing February 27 that it planned to file a “statement of interest” in a multi-district class action lawsuit against opioid manufacturers and distributors

The Ohio-based lawsuit, brought by states, municipalities, hospitals and others, claims in large part that the manufacturers misrepresented to physicians the safety of opioids, encouraged off-label use of the drugs and downplayed the risk of addiction, causing overprescribing. As a result, the plaintiffs incurred substantial costs dealing with opioid misuse and addiction. They are seeking reimbursement. 

In addition to joining this large lawsuit, the DOJ will examine the many other similar lawsuits filed around the country against manufacturers to determine what assistance federal law can provide.

The DOJ’s involvement in these lawsuits raises the ante and will give the plaintiffs more clout. The DOJ stated in its press release that it will use “every lawful tool at our disposal to turn the tide. We will seek to hold accountable those whose illegality has cost us billions of taxpayer dollars.” 

The DOJ also announced the creation of a new Prescription Interdiction & Litigation (PIL) task force to coordinate the DOJ’s many efforts and tools to combat the opioid epidemic. 

According to the DOJ, 180 Americans die every day from drug overdoses. It is now the leading cause of death for Americans under the age of 50. 

These are just the latest moves in the DOJ’s stepped-up efforts to deal with opioids in recent months. It has also created a new opioid fraud and abuse detection unit, assembled new enforcement teams dedicated to dealing with opioids, and led crackdowns against both Americans and foreign nationals engaged in unlawful opioid-related activity. 

Prescribers should be wary

While the lawsuits are focused against opioid manufacturers and distributors, prescribers will invariably also face increased scrutiny. The DOJ reiterated in its announcement that it will enforce the law against individuals, including prescribers. 

For instance, Galena Biopharma recently agreed to pay the government more than $7.55 million to resolve allegations under the False Claims Act and other law that it paid physicians kickbacks – such as free meals and payments to attend “advisory boards” – to prescribe Galena’s fentanyl-based drug Abstral. Two physicians involved have been convicted and sentenced to prison; Galena cooperated in those prosecutions. The DOJ has also charged other physicians in its crackdowns. 

As a result, physicians should take steps to protect themselves: 

  • Pay increased attention to what drug representatives are saying about the drugs they’re marketing to ensure that the information is accurate and not misleading. 
  • Be particularly careful about any financial relationship you may have with opioid manufacturers, such as consulting arrangements or free dinners. Make sure that any such relationship is not a payment for referrals and otherwise passes legal muster. 
  • And take a hard look at your opioid prescribing habits. You don’t want to be found prescribing more than your peers, beyond state-imposed limits, or against CDC guidelines.

    Is Your EHR Causing Legal and Financial Headaches? Don’t Expect Your Vendor to Bail You Out

    Wednesday, March 14, 2018

    By Marla Durben Hirsch

    In the market for an electronic medical records (EMR) upgrade or even a new system? Be forewarned: EMR vendor contracts are more onerous than ever, with vendors limiting their liability if their software causes users problems - conveniently just as several problems are coming to light. 

    EMRs have been maligned for their usability and functionality problems for years. But in recent months bigger issues have been surfacing. 

    For instance, it has been discovered that some systems default to particular billing functions when they shouldn’t, causing providers to bill improperly. The bills are now being denied and the providers are being required to return the ensuing overpayments, according to attorney Robert Markette, with Hall, Render, Killian, Heath & Lyman in Indianapolis.

    Other snafus have garnered more media attention. eClinicalWorks paid $155 million several months ago to settle claims that it misrepresented the capabilities of its software and falsely obtained certification in the EMR Meaningful Use incentive program. Allscripts was hit by a ransomware attack in January, causing 1,500 providers to suffer service outages, some lasting a week. 

    “It’s especially bad when their software screws up,” says Markette.

    Physician practices have filed class action lawsuits against both vendors for their respective transgressions. 

    However, these lawsuits may not do much good, since the vendor contracts the practices signed could leave the practices with little recourse if something goes wrong, according to attorney Elizabeth Litten, with the law firm of Fox Rothschild in Princeton, New Jersey. 

    “You may be on the hook for their failures,” warns Litten.

    Just a quick search on the Internet bears this out. Here is a paragraph from a form contract between Yale New Haven Health Services Corporation and its hospitals with a physician practice that enables the practice to access Yale’s Epic Systems EMR: 

    “Limitation on Liability. Neither YNHHSC nor Hospital shall have any liability for any damages whatsoever (including loss of profits or loss of goodwill) resulting from, arising out of or in connection with the use or inability to use or the performance or non-performance of the EMR System or any items or services provided under or in connection with such EMR System or this Agreement or the Practice Equipment, even if it has been advised of the possibility of such damages or should have known of the possibility of such damages, and whether such liability is based on contract, tort, negligence, strict liability, products liability or otherwise. Practice agrees that YNHHSC’s and Hospital’s aggregate liability for damages arising under this agreement, regardless of the form of action and irrespective of fault or negligence, shall in no event exceed an amount equal to the aggregate Practice Payments made by Practice under this Agreement during the immediately preceding 12-month period. The limitations of liability and disclaimers of warranty stated in this Agreement form an essential basis of the bargain between the parties.”

    In essence, the most the practice can obtain – according to the contract -- is what it paid for the privilege of access in the past year. 

    “This will be a frequently debated issue,” says attorney Michael Kline, also with Fox Rothschild. 

    Know where you stand

    Practices may not have a lot of negotiation leverage regarding their EMRs, but some contracts are more fair than others, so if you’re in the market shop around. If you find a system you like but the contract is onerous, it can’t hurt to try to negotiate better terms. 

    At the very least, read the fine print of any new, existing or renewal contract and know what the vendor is willing to be on the hook for should its software adversely affect you. You probably won’t be made whole but at least you won’t be blindsided.

    The Obesity Epidemic and the Issues that Surround It

    Wednesday, March 07, 2018

    By Makalla Phelps, Intern

    We’ve written briefly about obesity in our blog post about MIPS Measure #128, but the condition is more complex than the simple issue of needing to lose weight. Obesity is at the forefront of diseases plaguing The United States. Over a third of Americans suffer from obesity. Due to this high rate, the life-expectancy of obese individuals has dropped to a short 40 years. Even more concerning is the potential for obesity to become a world-wide epidemic. By 2030, it is estimated that almost half of the world’s population will be considered obese if this trend continues. The need for a change is imminent. 

    An individual with a Body Mass Index (BMI) of 30 or higher is considered obese. This seemingly arbitrary number is wreaking havoc on the individuals who fall into this category. In addition to decreased quality of life, obesity can cause or exacerbate many serious and difficult to treat ailments including:

    • Poor mental health (such as depression)
    • Hypertension
    • Osteoarthritis
    • Diabetes
    • Some cancers

    These ailments are not only costing the individual, but physicians and society as well. Individuals with a body mass index greater than 35 represent only 37% of the obese population but are responsible for 61% of all excess medical costs. This accumulates to approximately $147 billion annually. The Medicare prescription drug cost of this expense is $7 billion dollars alone. Moreover, the cost of the value of lost productivity in the workplace due to obesity comes in at a massive $73.1 billion annually. An individual with a healthy weight and is physically active costs roughly $1,019, annually. The culmination of medical expenses of obese patients amounts to around $1,429 more per individual. Studies suggest that if there were an increase in physical activity among the 88 million inactive adults in America, there would be a $76.6 billion decrease in medical costs. 

    There are many different factors that contribute to an individual becoming obese. The most common cause of obesity is an individual’s behavior. These behaviors include dietary patterns, physical activity (or more likely lack thereof), social aspects, and medication use. A very common excuse that obese patients use is that their ailments are caused by genetics. However it is usually a learned behavior from an individual’s parents. In most cases, an individual may have a genetic predisposition to a certain weight range or an increased risk for diabetes, but it is the individual’s lifestyle habits that will truly determine their fate. Interestingly, the popular personal genomics and biotechnology company, 23andMe, has launched a massive study into the genetic basis of weight loss and obesity. The company hopes to provide their clients with information on how to maintain and/or lose weight based on their genome sequence in the future. Another common social factor contributing to the continuation of obesity can be found in the various body positivity movements that have gained popularity. These social movements began with the message to improve an individual’s self-image. However, what was once something positive turned dangerous when individuals began interpreting the movement as a means of condoning unhealthy behaviors and weights.

    Obesity is extremely difficult to treat. Even if social and emotional factors were to be removed, the availability of cheap high-calorie foods and an absence of any obligatory need for exercise has resulted in obesity being very difficult to reverse. Thus, it is important that physicians stress the importance of prevention to their patients when possible. Because obesity is such a complex issue, even the most receptive patients may be easily discouraged when trying to change their lifestyle. Most physicians will find they have to try multiple approaches before something clicks with each individual patient.

    6 Ways One Employer Cut Their Medical Assistant Turnover Rate In Half

    Monday, March 05, 2018

    By Clay Dubberly, Intern

    The Northwestern Memorial Physicians Group (NMPG) may have solved the problem of low medical assistant (MA) retention. 

    After experiencing an MA turnover rate which reached a high of 38%, they realized something had to change. In a detailed study, they described how frustration and dissatisfaction led them to implement a variety of practices which decreased their MA turnover rate from 32-38% in 2007/2008 to 16-17% in 2009/2010. 

    Many MAs were unsatisfied with a low salary and lack of opportunity for advancement. These were some of the main reasons that NMPG reported a high MA turnover rate. Other physicians say that bureaucracy, heavy government regulations, and a negative work environment contributed as well. 

    What did NMPG do to boost MA retention?

    Cindy Davis, Director of Human Resources for NMPG stated, “We are recognizing that the MA is in a critical role (i.e., a vital piece of the puzzle to delivering collaborated, organized, and efficient patient care); it only makes sense that we nurture and develop them and make sure that they are and remain engaged; to help them grow within the organization as much as they can within the role.”

    Here’s how NMPG managed to cut their turnover rate in half in only three years:

    1. They gave MAs a pay increase
    NMPG raised MA pay by 2%, which saved money in the long term. According to HR consultants, the cost to recruit, train and a hire a new MA averages $9,000, which is less than the 2% increase.

    2. MAs received customer service training
    Customer service can make or break any organization. In response to comments from patients like, “Why do you hire people that never smile?” they instituted a customer service training program which produced immediate results.

    3. Cross-training was given to MAs
    MAs were taught to fulfill other roles, like working the front desk, laboratory, or medical records. This enabled them to cover for other employees and to better understand the relation of other roles to their role, making them more valuable.

    4. They were given incentives
    Based on an annual performance review, MAs were given the opportunity for a raise.

    5. Staff recognition was promoted
    Public praise is perhaps one of the most important aspects of promoting a healthy work environment and pushing your employees to excel. In a survey, Psychology Today discovered that 83% of respondents believe that “recognition for contributions was more fulfilling than rewards or gifts.” NMPG capitalized on this when they launched a program which allowed patients and employees to nominate an exceptional employee each quarter. 

    6. MAs were granted a chance to participate in the clinical career ladder
    NMPG created a clinical career ladder that offers three levels: MA, MA I and MA II. Each level can be attained by completing requirements for clinical ladder projects. Because of this, some MAs reported greater satisfaction and searched for additional education to increase their value to NMPG. According to NMPG, the clinical career ladder program “allows MAs to participate in career exploration and make positive contributions to their divisions.” 

    While NMPG hasn’t advertised their system to any other organizations, they say that it can be easily replicated elsewhere.

    OIG to CMS: We’re Worried About How You Review Extrapolation

    Monday, February 26, 2018

    By Marla Durben Hirsch

    Physicians may soon see some welcome relief when it comes to dealing with denied Medicare claims and overpayment demands involving statistical sampling, also known as extrapolation. The Office of the Inspector General (OIG) announced this month that is has added to its work plan a review of how the government is applying “statistical methods” during the Medicare fee-for-service administrative appeal process. 

    Medicare program integrity contractors are authorized to use statistical sampling to determine how much a provider had been overpaid. 

    Statistical sampling applies the rate of billing errors found in a sample of claims to a similar total group of claims. Medicare auditors use this methodology regularly.

    However, providers often disagree with the calculated result and challenge these statistical estimates by using Medicare’s five step administrative appeals process. According to the OIG’s announcement, if an extrapolation estimate is overturned during this process, the provider is liable for any overpayment upheld in the sample, but not the full extrapolated total. The OIG acknowledges that the difference is “often substantial.” 

    The first two levels of appeal, conducted by Medicare Administrative Contractors (MACs) and Qualified Independent Contractors (QICs) “play a critical role in deciding which extrapolations will be upheld.” Evidently the OIG has determined that these contractors may be dropping the ball and has decided to review whether they are “reviewing statistical estimates in an appropriate and consistent manner.” 

    In other words, the OIG knows that mistakes can be made when applying extrapolation and wants to make sure that they’re being caught. The errors include:

    • The underlying audit that the sampling is based on is wrong. For instance, the audit used the wrong codes or wrong error rate in determining whether there was any overpayment.
    • The rules of extrapolation weren’t followed. For example, it’s only supposed to be used in certain situations, such as when there is a sustained or high level of payment errors.
    • The sample wasn’t valid. For instance, the sample may have been too small.
    • The government made a math error.

    In addition, the government is supposed to give the provider a report of the extrapolation so that the provider can review it but that doesn’t always occur or is provided late, so that the provider must file an appeal before having had a chance to see if the calculations are correct. 

    The OIG probably has two objectives here. It not only wants to ensure that the appeals process is working correctly, but also to reduce the logjam of appeals currently choking the appeals process

    The OIG has previously reported that providers are more likely to have an adverse determination overturned only after getting to the third level of appeal, the administrative law judge (ALJ) level, which is the first stage independent of the Centers for Medicare and Medicaid Services and the first stage which allows hearings. The OIG found fully favorable results in just 20 percent of cases decided at the QIC level of appeal, compared to a fully favorable result 56 percent of the time at the ALJ level. 

    Why this review is important to physicians
    This new review is good news for physicians and other providers, and could have a major impact. It may uncover inconsistencies and other issues with the way that MACs and QICs currently handle extrapolation appeals and could ultimately lead to improvements in not only the use of extrapolation but also the appeals process itself. 

    It may mean that fewer sampling mistakes will be made so fewer appeals will need to be filed, and if an appeal is filed, a mistake may be caught sooner on appeal.

    It may also raise awareness among physicians that they should not take extrapolation calculations at face value but review them carefully and challenge them if necessary.

    Gimme 15 Minutes-How are New Medical Codes Made?

    Friday, February 23, 2018

    Join us on Monday, March 12, 2018 at 12:00 PM for a free webinar event covering how medical codes are made.

    Have you ever wondered about the process that goes into making a new CPT code? What about the decision making behind ICD-10 (and soon ICD-11) codes? In this webinar Jen will tell you everything you want to know about the when, what, who and why behind the creation of medical codes.

    If you are interested in this free event, you can register here. After registering, you will receive an email about how to access the webinar.

    Won’t be available for the event? No worries! All our past webinars are posted to our YouTube channel. Keep an eye on our events schedule so you can keep your calendar free for the next one.

    We Fired Amazon's Alexa

    Wednesday, February 21, 2018

    By Clay Dubberly, Intern 

    Amazon’s Alexa is being criticized by the healthcare industry, not because of a design error, but because of its passive listening ability. This function led Jennifer Searfoss, CEO of SCG Health to ban Alexa from its premises.

    Alexa is an “intelligent personal assistant” capable of voice interaction, music playback, making to-do lists, setting alarms, streaming podcasts, playing audiobooks, and offering other real-time information.

    The way Alexa works is by listening for its wake word (its name) which prepares it to analyze a command. It then listens and responds to everything that it hears afterward. You can ask it questions about the weather, converting measurements, or even for help shopping. It can even be used as an intercom.

    In a medical environment, it can be used to help physicians take notes, remotely monitor patients, or allow them to ask health-related questions.

    Passive listening and hacking: The Downsides to Alexa

    The problem is that Alexa is listening to its surroundings at all times. This means that 24/7, she can be picking up personal information, which is sent back to Amazon or a potential hacker.

    “There’s too much risk to be hacked,” Jen Searfoss says. “SCG Health used to have the device in its building,” but “We kicked Alexa out of our office after considering the vulnerabilities of the passive listening technology.”

    There isn’t just a “possibility” of being hacked; it’s a reality. There are already several documented instances of Alexa being compromised. One way is through a “Dolphin Attack,” which is when it picks up frequencies which humans are unable to hear.

    In this type of attack, hackers increase the frequency of a voice command to over 20,000hz and can play it through another phone’s speaker. While humans can’t hear this, smartphones will pick it up. Another concern for users is that a device that’s been compromised looks no different from one that hasn’t been compromised.

    After picking up the frequencies, Alexa can carry out the command without the user’s permission. All that’s needed to do this is a battery, a smartphone, an ultrasonic transducer and an amplifier. All of this is readily sold online for a low price.

    After a successful attempt, invaders can open your garage door (granted the right technology is installed) or make calls.

    Another way Alexa can be hacked involves pre-installing software onto the device which transforms it into a wiretap that records any sound picked up onto a computer at another location.

    Forbes successfully tested this out. One of the disadvantages (to the hacker) is that it takes several hours of installation on the hacker’s part, but this still poses a threat to anyone that buys Alexa from a secondhand source.

    In one of those less-concerning instances when hacking is used for something good (or at least something funny), Alexa was hacked into a Big Mouth Billy Bass -- one of those wall-mounted fish that sings songs like “Don’t Worry Be Happy” or “Take Me To The River.”

    Alexa isn’t HIPAA compliant. Here is how Amazon plans to fix it.

    Another big concern for Amazon’s Alexa (as if being hacked wasn’t big enough) is that it’s not HIPAA compliant. As such, its use in healthcare is extremely limited.

    The idea of having a device which could be recording patient data presents a clear threat: “It’s collecting info that has PII,” Ms. Searfoss says.

    To help Alexa reach HIPAA compliance guidelines, Amazon recently hired a HIPAA Compliance Agent to help them reach legal requirements, including Business Associate Agreements (BAA), federal and state laws, and standards and regulations. The Compliance Agent is expected to help ensure that “technology and business processes meet [Amazon’s] HIPAA BAA requirements, as well as all applicable federal and state laws, regulations and standards.”

    Some healthcare organizations have begun testing the device’s capabilities despite the risk. WebMD allowed Alexa to deliver its web content to users at their own homes for example. The Beth Israel Deaconness Medical Center (BIDMC) ran a successful pilot study in an inpatient setting (without actual patient data). It eventually plans to use it in a clinical setting, but not until Amazon signs a BAA.

    The Boston’s Children’s Hospital (BCH) also experimented with using Alexa to give info to its clinical staff, but because it didn’t have a BAA only non-identifiable health information was used. The BCH also created an Alexa skill called KidsMD, which allows users to ask advice for when their kids have a fever.

    SCG Health will continue to stand strong and enforce its ban on Alexa -- at least until Amazon approves a business associate agreement.

    Winter Liabilities- It’s Not Too Late to Keep Yourselves and Your Customers Safe

    Monday, February 19, 2018

    By Audrey Landers

    On February 2nd, the famed meteorologist Punxsutawney Phil declared that we would be having a long winter. After seeing the snow and freezing rain that has struck our office since then, we certainly believe him. 

    With winter weather comes ice and with ice come falls, slips and all kinds of accidents. Our clients tell us stories all the time! Several years ago a delivery man slipped on the ice in front of a two-story medical center and slid under his truck! The poor guy was stuck on the freezing ground for nearly an hour before someone on the second story saw his arm waving from underneath the vehicle. This same story played out again this year, when our own CEO Jen Searfoss heard a woman crying for help as she was walking into a store. The woman had fallen on the icy parking lot and, just like the delivery man, slid under her car.

    The idea that a patient could hurt themselves on your property may seem like bad luck. But beyond their injury, there is another issue: liability. 

    It is all too common for businesses to focus only on employee liability, completely ignoring the risks seen by customers and delivery people. While many businesses do well with day-to-day liability prevention, for some reason that all tends to go out the window when winter hits. This is even more true for lesser-prepared businesses located in the south. 

    You can help decrease your liability in these dangerous conditions by making sure you keep your property safe, and by clearly marking anything that may be a danger. As the winter season continues and snow continues to melt and refreeze, here are a few things you can do to make sure you have done your due diligence in maintaining the safety of your property:

    • Spread salt in the parking lot
    • Keep walkways shoveled and clear of snow
    • Place cones around the most dangerous areas of icy parking lots to redirect traffic
    • Place “drive slow” and “slippery” signs outside
    • Place “wet floor” signs inside
    • Place mats or carpet tiles at the entrance to allow patients, customers and employees to dry their shoes
    • Remain aware of the conditions so you can take additional action as necessary

    While some of these may seem like a lot of work, it’s less work than fighting a lawsuit from a patient, third party or staff. It is better to overprepare than to be caught unprepared.

    Gimme 15 Minutes- February Events

    Friday, February 16, 2018

    We are wrapping up the month with three great events.

    On Monday, February 19 we are pulling double duty once again to bring you two webcasts in one day!

    From 12:00 PM to 12:15 PM Jen will be going over highlights from the massive Bipartisan Budget Act. 

    From 12:30 PM to 12:45 PM Jen will be explaining the new process allowing those participating in MIPS as individuals to view their 2017 quality performance scores.

    Our final Event for February will be held on Monday February 26.

    Tune in from 12:00 PM to 12:15 PM to learn more about business associates and why they matter.

    Not interested in any of these events? We would love to hear what questions you want answered.

    Won’t be available for the event? No worries! All our past webinars are posted to our YouTube channel. Keep an eye on our events schedule so you can keep your calendar free for the next one.

    Maryland Healthcare Providers: Prescription Drug Monitoring Program required for those who prescribe and dispense controlled substances

    Thursday, February 15, 2018

    By Audrey Landers

    Effective today, Thursday, February 15, 2018 all Maryland healthcare providers that prescribe or dispense controlled dangerous substances (CDS) will be required to register as part of the Prescription Drug Monitoring Program (PDMP) in order to obtain or renew their CDS registration.

    If you have already registered with the PDMP then you will have no issues with obtaining or renewing your CDS as PDMP registration never expires, even if you don’t use it.

    If you are not registered with the PDMP and try to obtain or renew your CDS license then your application and payment will be returned to you with a notification that PDMP registration is required.

    If you are not registered with the PDMP, you can register for free on their homepage.

    If you aren’t sure whether you are registered with the PDMP or not, you can check by attempting to register. If you fill out the form and you have already registered then the system will state that you have been registered and send you a confirmation code to enter.

    About the Prescription Drug Monitoring Program
    A PDMP is a state-run electronic database that is used to track controlled substances. Maryland’s PDMP monitors Schedule II-V drugs. Healthcare practitioners can use the database to electronically report the prescription and distribution of controlled substances. This information can then be accessed by physicians, nurse practitioners, and others in order to care for their patients. Healthcare professionals may only access information regarding their own patients. The PDMP also supports research and education related to prescription drug abuse and the opioid epidemic.

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