Monthly Archives: July 2023

Laboratories Are Under Scrutiny by OIG and State Medicaid!

Laboratories are under scrutiny by the OIG and State Medicaid Departments. Labs get urine samples from behavioral health care companies, substance abuse companies, hospitals, and primary care facilities, who don’t have their own labs. Owners of labs entrust their lab executives to follow procedure on a federal and/or state level for Medicare or Medicaid. Well, what if they don’t. For example, one client paid a urine collector/courier by the mile. That courier service collected urine from Medicaid consumers in NC, sometimes in excess of 90 times a year, when Medicaid only allows 24 per year. I have about 10-15 laboratory clients at the present.

Another laboratory’s urine collector collected the urine, but never brought the urine back to get tested. To which I ponder, where did all those urine specimens go?

Another laboratory had a standing order for over 6 years to test presumptive and definitive testing on 100% of urine samples.

OIG has smelled fraud within laboratories and is widening its search for fraudsters. Several laboratories are undergoing the most serious audits in existence. Not RAC, MAC, or UPIC audits, but audits of even more importance. They received CIDs or civil investigative demands from their State Medicaid Divisions. These requests, like RAC, MAC, or UPIC audits, request lots of documents. In fact, CIDs are legally allowed to request documents for a much longer period of time than RACs, which can only request 3 years back. Most CIDs are fishing for false claims under the False Claims Act (FCA). Stark and Anti-Kickback violations are also included in these investigations. While civil penalties can result in high monetary penalties, criminal violations result in jail time.

As everyone knows, labs must follow CLIA or be CLIA certified, which is the federal standard for which labs. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 USC 263a) and the associated regulations (42 CFR 493) provide the authority for certification and oversight of clinical laboratories and laboratory testing.  Under the CLIA program, clinical laboratories are required to have the appropriate certificate before they can accept human samples for testing. There are different types of CLIA certificates, as well as different regulatory requirements, based on the types and complexity of clinical laboratory tests a laboratory conducts. CLIA, like CMS, has its own set of rules. When entities like CLIA or CMS have their own rules, sometimes those rules juxtapose law, which creates a conundrum for providers. If you own a lab, do you follow CLIA rules or CMS rules or the law? Let me give you an example. According to CLIA, you must maintain documentation regarding samples and testing for two years. So, if CLIA audits a laboratory, the audits requests will only go back for two years. Well, that’s all fine and dandy. Except according to the law, you have to maintain medical documents for 5 or 6 years, depending on the service type.

Recently, one of my labs received a CID for records going back to 2017. That is a 6-year lookback. Had the lab followed CLIA’s rules, the lab would only have documentation going back to 2021. Had the lab followed CLIA’s rules, when OIG knocked on its door, it would have NOT had four years of OIG’s request. Now I do not know, because I have never been in the position that my lab client only retained records for two years…thank goodness. If I were in the position, I would argue that the lab was following CLIA’s rules. But that’s the thing, rules are not laws. When in doubt, follow laws, not rules.

However, that takes me to Medicare provider appeals of RAC, MAC, and UPIC audits. Everything under the umbrella of CMS must follow CMS rules. Remember how I said that rules are not laws? CMS rules, sometimes, contradict law. Yet when a Medicare provider appeals an overpayment or termination, the first four levels of appeal are mandated to follow CMS rules. It is not until the 5th level, which is the federal district court that law prevails. In other words, the RAC, MAC, or UPIC, the 2nd level QIC, the 3rd level ALJ, and the 4th level Medicare Appeal Council, all must follow CMS rules. It is not until you appear before the federal district judge that law prevails.

Receiving a CID does not mean that your investigation will remain civil. Most investigations begin civilly. If the evidence uncovered demonstrates any criminal activity, your civil investigation can quickly turn criminal. I co-defend with a federal criminal attorney if the case has a chance to turn criminal. Believe me, there is a huge difference between federal and state criminal lawyers! Even with the best federal criminal lawyers, you want a Medicare and Medicaid expert lawyer on the team to dispute the regulatory accusations that a criminal attorney may not be as well-versed. I am so thankful that I moved my practice to Nelson Mullins, because we have a huge, yet highly-specialized health care practice. While we have a large number of lawyers, each partner specializes in slightly different aspects of health care. So, when I need a federal criminal attorney to partner-up with me, I just walk down the hall.

Laboratories: Beware! Be ready! Be prepared! Be lawyered up!

The No Surprises Act and How It Can Benefit You, Personally! YOU WANT TO READ THIS BLOG!

Surprisingly, I am talking about the No Surprises Act today. Last year, I had an unwelcome surprise. I was thrown from my horse on February 20, 2022. I’ve been thrown from many horses, and usually, I land on my boots or, at worst, my behind. However, last year, I awoke in the ICU after being thrown from a horse. Surprise! Spoiler alert, I ended up ok, according to most. However, I was helicoptered from the extremely rural area to the closest hospital. And you are probably thinking that I was blessed that someone could contact and obtain a helicopter so quickly for me…it probably saved my life. And you may be right. But there are two things about me that you probably don’t know: 1) my best friend in life is an ER Trauma nurse with over 20 years’ experience; and (2) I don’t like to spend $49,753.00 for a helicopter ride that I don’t even remember.

Let me explain. As I said earlier, I was unconscious when someone contacted a helicopter.  Let me tell you who I was with. Let me set the stage, so to speak. I was with my husband Scott, my bff Tracey – the ER trauma nurse, and her husband Josh. I never asked them, because, quite frankly, I didn’t think to ask who called the helicopter until now. Regardless, I was helicoptered, and received a bill a month or so later for almost $50k. And I freaked.

I am without a doubt even more sympathetic to my provider-clients who get notices of owing tens of thousands or millions of dollars. That $50k stopped my heart for a second. Then, I thought, Dr. Ronald Hirsh and others have spoken about the NSA multiple times on Monitor Monday. Maybe I should re-listen to a couple, really good, detailed podcast episode. I did so.

Last year, in my unconscious-state, I would have entrusted my life with Tracey to drive me about 30 minutes to a hospital because:

  1. She is an ER Trauma nurse.
  2. She is good at her job. She was handed a decapitated arm once. I am sure I would have had nightmares, not she.
  3. She works at the nearest hospital and it was only 30 minutes away. She is/was friends with the ER surgeons. So, yes, had you asked me whether I wanted a $50k helicopter ride or a 30-minute ride with an experienced ER Trauma nurse – I would have chosen the free one. that, from some of her stories, I think may be more experienced than the MDs she performs under.

However, after I presented this story on RACMonitor, Dr. Hirsch, along with several listeners, one of whom is an emergency physician, told me that they would NEVER recommend a private transfer to the hospital, even if Dr. Hirsch were driving, especially for an unconscious, head injury victim. I was told that the helicopter was the way to go in my case, but that I should not be liable for it. I agree, hence the NSA. However, in the same vein, providers need to be paid. Remember, this paragraph was written after RACMonitor and after I was told the helicopter was the way to go.

However, had you asked me then, I would have chosen the free ride to the hospital. Post haste!!! Instead of getting my consent to pay $50k for a helicopter ride or a free ride with an ER Trauma nurse, I was “forced” to the helicopter. And here is where the NSA gets confusing. It was effective January 2022. The political issue arose a stark “T” or perpendicular “behind a rock and a hard place.” A month or so after my accident, I got the bill for almost $50k. Like I said, my heart palpitated. Just like the doctors, hospitals, DME providers, dentists, LTCF, HH, BHP, and anyone who accepts Medicare or Medicaid hearts’ would palpitate when they receive a bill for tens of millions of dollars that they may or may not truly owe.

The DOS happened to be one month after the NSA went into effect. No one wanted to pay for this ride. My health insurance went to bat for me; or, really, for them. My health insurance also didn’t want to pay for my $50k helicopter ride. The letter from my insurance company to the helicopter company said: “Upon review of your request, we have confirmed the claim was processed according to the terms of the No Surprises Act (NSA). Accordingly, your request does not qualify as an appeal under the terms of the member benefit plan.”

While I agree that I should not have been liable for a $50k helicopter ride, I do have empathy for the helicopter company and its nurses. It expended money on my behalf. And I am appreciative. I feel like there should be a less Draconian law than the NSA. Because of my being unconscious during my helicopter admission and my lack of ability to consent, shouldn’t mean the providers shouldn’t be paid for services rendered.

But maybe the letter, which ostensibly shuts down any appeal to additional funds by the provider, means that the provider was paid an amount, maybe a reduced amount, but an amount nonetheless. If anyone knows whether surprised patients’ medical bills get paid at a reduced rate, let me know! Thanks!

Hospitals Hunger for Nurses, Staff, Physicians: ER Wait Times Skyrocket!

Last week, I attended the American Health Lawyers Association (“AHLA”) annual conference in San Franscisco, CA. Attorneys must attend a certain number of continuing legal education (“CLE”) courses each year and this conference helps. The first session was entitled, “Year in Review” and lasted two hours. On a personal note, I had Googled the weather, which claimed to be 60-70 degrees, so, I thought, nice! a bit cooler than NC, but not much difference. I packed for NC’s climate. I pretty much froze the first two days and nights.

Back to the topic of issue. One of the topics at the AHLA conference was the catastrophic consequences of COVID on hospitals. As an attorney specializing in healthcare law, I find myself deeply troubled by the intersecting crises of COVID, nursing shortages, and the resulting closure of hospitals. The recent events in Indiana have left me grappling with the difficult legal and ethical implications of a Court Order that clashed with the reality on the ground.  A northwestern Indiana hospital that was, according to it, days away from closing its emergency room. The Mayor of Hammond, Indiana, was mortified, as this hospital was Hammond’s only hospital. He brought suit demanding a preliminary injunction. Franciscan Health Hammond was Ordered by a Judge to keep those emergency services operational for another nine months, which would be until September 2023.

Despite Franciscan Health Hammond’s best intentions, the hospital found itself in a seemingly impossible predicament. The confluence of safety concerns and severe staffing shortages forced the hospital’s hand, rendering compliance with the Court Order an insurmountable obstacle.

An Indiana Appellate Court reversed the District Court Decision and lifted the Injunction that the city was granted late December 2022 that had ordered the hospital’s ER to remain open another nine months so the city could find another provider.

The hospital announced its planned closure back in November 2022, saying it was averaging fewer than three inpatients a day. I do not have personal knowledge of whether the only hospital in Hammond has closed its doors. According to a cursory Google search, which we all know wherein always lies the truth, Franciscan Health Hammond, which used to be called St. Margaret’s Hospital, is still open. If anyone knows firsthand, I welcome any information. It may have closed its doors temporarily, according to one source online. Regardless, I am taken aback by the Court’s Order not being able to be followed due to staff shortages. It reminds me of when a federal court Ordered CMS to follow the timeliness rules in the regulations and render decisions for Medicare provider appeals timely. See blog and blog.

The impact of COVID on healthcare systems has been devastating across the country, and Indiana has not been spared. The virus has unleashed unprecedented pressures on hospitals, stretching their resources to the breaking point. Frontline healthcare workers have been tirelessly battling this invisible enemy, putting their lives on the line to save others. But the relentless strain of the pandemic has taken its toll, leaving healthcare professionals physically exhausted and emotionally drained.

Rural hospitals have been disproportionately hit catastrophically. 17 rural hospitals closed last year, according to the AHLA “Year in Review” presentation.

Nursing shortages have only exacerbated the crisis. Even before the pandemic, the shortage of qualified nurses was a pressing issue, but COVID has exacerbated the problem exponentially. The demands placed on nurses have skyrocketed, as they find themselves on the front lines of the battle against the virus. The prolonged stress, burnout, and emotional trauma have led many nurses to reconsider their chosen profession or seek alternative employment options. Consequently, hospitals find themselves in a perpetual cycle of understaffing, perpetuating a domino effect that strains resources and compromises patient care.

You may be asking, how do you, Knicole, an attorney, have firsthand experience about the trauma nurses have endured over COVID?? To which I would respond, “Thank you for that question, reader, however, my best friend is an ER Trauma nurse here in NC. Since COVID, she has become a traveling nurse, her income has, at least, doubled. Not that she doesn’t deserve such an income hike! Oh contraire mon fraire! The stories I have heard…. The emotional distress that she has had to endure… The young people who have died… Being forced to get vaccinated and the emotional toll on her and those similarly situated… Multiple deaths nightly, for over two years… Having to console families… Having to live away from home for weeks… Believe me, she deserved every extra cent she earned during the public health emergency (“PHE”), which was officially declared “over” on May 11, 2023. The problem that hospitals are having now, is basic supply and demand. Nurses are in demand; therefore, it is difficult for hospitals to decrease salaries and hourly wages without losing the nurses it has.”

According to Franciscan Health Hammond, its dire staffing situation made it nearly impossible to maintain safe patient care within the emergency room. The safety and well-being of both patients and employees must always remain paramount, and the hospital administrators were left with an agonizing decision. Ultimately, according to the internet but unconfirmed, it made the difficult choice to close the emergency room temporarily, recognizing the potential risks of operating under severe staff shortages.

As an attorney, it is my duty to uphold the law and advocate for the best interests of my clients. However, in situations like these, I cannot help but empathize with the hospital administrators who faced an impossible dilemma. The judicial system must grapple with the reality on the ground and understand the complex factors that contribute to hospital closures. Simply ordering a hospital to remain open without addressing the underlying challenges, such as nursing shortages and safety concerns, may create an unmanageable burden that compromises patient safety and exacerbates the crisis.

This case in Indiana serves as a sobering reminder of the urgent need for comprehensive solutions. Our healthcare system requires support and resources to address the immediate challenges posed by the pandemic, including expanding nursing education programs, providing incentives for healthcare professionals, and bolstering mental health resources for those on the front lines. Furthermore, long-term planning and systemic reforms are necessary to build a resilient healthcare infrastructure that can withstand future crises.

As I reflect on these current events, I am reminded of the importance of collaboration between the legal, healthcare, and policy-making spheres. Only through a collective effort can we navigate these difficult times and strive for a more robust healthcare system that ensures the safety and well-being of all. It is my hope that this blog entry serves as a testament to the complex issues at hand, spurring further discussions and actions to mitigate the challenges posed by COVID, nursing shortages, and hospital closures.