Category Archives: Federal Law
Post-COVID Medicare and Medicaid Provider Audits Are Here!
My esteemed colleagues with curious minds, today we embark on a journey into the complex world of Medicare and Medicaid provider audits, specifically orchestrated by the enigmatic entities known as Recovery Audit Contractors, or RACs. The dates of service (DOS) during COVID are specifically being targeted, and I’ve seen an uptick. With the plethora of exceptions, you need a specialized attorney.
Picture this: You’re a healthcare provider, diligently navigating the seas of Medicare and Medicaid reimbursement. All of a sudden, a tempest approaches – the Recovery Audit Contractors or RACs. These are the bounty hunters of the healthcare world, commissioned to recoup improper payments and ensure the ship of government healthcare funding stays afloat. And paid by contingency creating a financial incentive that some may call bias. The RACs even have the authority to extrapolate, making alleged overpayments to skyrocket, increasing its profit.
Now, you might wonder, “How do these RACs operate, and what laws govern their actions?” Well, let me shed some light on that. The Medicare RAC program was born out of the Tax Relief and Health Care Act of 2006, a legislative “masterpiece” that empowered RACs to review Medicare and Medicaid payments and, when necessary, claw back funds. It’s like having financial watchdogs on the prowl, ensuring taxpayer dollars are spent wisely.
A hospital client of mine provided outpatient services and billed Medicare for reimbursement during COVID. A RAC, armed with their legal authority, started scrutinizing these claims. Suddenly, the RAC believes that the hospital has been billing for services that don’t meet the necessary criteria. I love how RAC auditors without medical licenses purport to determine medical necessity for physicians. I hope you hear the sarcasm. The RAC alleged “upcoding” – alleging services were billed at a higher complexity than they actually were. The RACs, acting within the confines of the law, swoop in to recover those overpayments, ensuring the taxpayer’s purse strings are untangled.
We all know RACs are not infallible. Hopefully, you know this if you are a longtime reader. RACs mistakenly identify an overpayment or misinterpret complex healthcare regulations. That’s where the appeal process becomes crucial. The Medicare appeals process, defined under the Social Security Act, provides a right for providers to challenge RAC decisions. It’s a legal battleground where the provider can present evidence, argue their case, and seek justice against the RAC’s findings.
Now, let’s consider the Medicaid realm. The Medicaid RAC program, established by the Affordable Care Act in 2010, mirrors its Medicare counterpart. These RACs operate at the state level, conducting audits to identify and recover improper Medicaid payments. It’s like a dual-front war on wasteful spending, both federally and within individual states. Again, DOS during COVID are at issue.
For a concrete example, let’s imagine a nursing home submitting claims to Medicaid for resident services. The state-level Medicaid RAC, acting under the Affordable Care Act’s provisions, reviews these claims. If they discover discrepancies – perhaps services billed without proper documentation or purportedly unsupported by medical necessity – the RAC, wielding its legal mandate, initiates the recovery process.
The RACs, armed with the legislative might of the Tax Relief and Health Care Act and the Affordable Care Act, play a crucial role in safeguarding the integrity of Medicare and Medicaid reimbursements. While their actions may feel like storms to providers, it’s essential to recognize the checks and balances in place, including the appeals process, to ensure fairness and accuracy in the audit battlefield. As we navigate the seas of healthcare reimbursement, may our compass be true, our documentation impeccable, and our understanding of the law unwavering.
2024 SNF Audits Are Robust! What You Need to Know:
Skilled Nursing Facilities (“SNF”) have special audits or should I say, more robust audits. The overall gist of these federal audits of SNFs for Medicare compliance, staffing seems to be the most troubling.
We all know that in March of 2020, both The Joint Commission (TJC) and the Centers for Medicare & Medicaid Services (CMS) pressed pause on audits, accreditation surveys, and health inspections due to COVID-19. Shortly thereafter, CMS inspections and rating updates were back in full swing as of January 2021, TJC audits and surveys are proceeding more robustly. COVID funds are especially scrutinized. Passing audits and inspections are crucial to maintaining your nursing home’s accreditation and Medicare-certified status so you can stay in business. Here’s what your HR department should know about SNF audits and ratings, and how you can help prepare for them.
Skilled Nursing Facility Audits and Quality Rating System
Together, the CMS and The Joint Commission (“TJC”) assess skilled nursing facilities’ patient care, quality of service, and provider qualifications.
The TJC survey and auditing process is designed to evaluate accredited nursing care centers once every 3 years through unannounced visits and documentation reviews that include:
- Assessments of patient safety
- Observations of services and provider or caregiver performance
- On-site or virtual staff interviews
- Physical survey of the facility
- Review of the facility’s ability to maintain updated practitioner documentation
CMS tests nursing home quality levels using a five-star quality rating system, which is updated regularly on its facility comparison site, Nursing Home Compare. The site organizes nursing homes by rating and helps consumers and their families and caregivers choose the right facility. This rating system gives each nursing home a score of between 1 and 5 based on four major factors:
- Health inspections. This portion of the rating is a combination of the results from a facility’s three most recent health inspections and three most recent investigations due to complaints. Trained inspectors pay an on-site visit to test the nursing home’s ability to meet minimum quality requirements through a specific process.
- Staffing. This rating takes into account the average hours of RN care per resident day as well as total staffing hours (RN, LPN, and CNA) based on resident needs.
- Quality measures. This rating is based on 15 different physical and clinical measures to test how well nursing homes are meeting resident needs.
- Retention. This rating measures the amount of turnover at a facility and rewards employers who retain employees for longer periods of time.
Emphasize time and attendance
In 2019, the CMS tightened their quality rating restrictions, reducing the number of days facilities could go without having an on-site nurse. This and other changes resulted in over one-third (37%) of skilled nursing facilities losing one or more stars. It’s impossible to predict what other changes may come in the future, but needless to say, time and attendance will continue to be crucial.
Your facility may not be able to recruit enough new nurses to fill your roster completely, which is why prioritizing timeliness is an important part of maintaining your rating. Make it a point to reward staff who clock in and out on time and stay on top of missed days and late arrivals.
Focus on Retention
In July 2022, CMS announced that staffing and turnover data would be used in assessing star ratings for facilities. As CMS administrator Chiquita Brooks-LaSure stated, “research and experience tell us that staffing levels and staff turnover can substantially affect quality of care and health outcomes for people living in nursing homes.” My BFF DeeDee Murphy is GC for Principal Long-Term Care, which owns hundreds of SNFs. Staff turnover is a huge problem, especially since COVID, according to her.
Retention has long been a practical concern for long-term care facilities, but now the issue is increasingly under the spotlight. Focus on your retention by offering creative and enticing benefits, such as flexible scheduling and flexible benefits. Also, focus on creating career opportunities for your employees, so they stay within the facility instead of seeking career growth elsewhere.
Types of Nursing Home Audits
As an administrator, you’ll likely oversee many different types of audits. Here are some of the most common ones.
- Resident Assessment Instrument (RAI)
The Resident Assessment Instrument is a comprehensive assessment tool used to evaluate the needs of nursing home residents. RAI audits focus on the accuracy and completeness of resident assessments, including the collection and documentation of information related to the resident’s physical, mental, and psychosocial health. These audits aim to ensure that residents’ care plans are individualized and based on accurate and up-to-date assessments.
2. Falls Risk Assessment
Falls are a significant concern in nursing homes, as they can lead to serious injuries and complications. Falls risk assessment audits evaluate the nursing home’s procedures for identifying residents at risk of falling and implementing appropriate interventions to prevent falls. These audits assess whether fall risk assessments are conducted regularly, documented properly, and used to develop personalized care plans to minimize the risk of falls.
3. Medication Management Audit
Medication management audits focus on the safe and effective administration of medications to nursing home residents. These audits assess whether medication orders are properly documented, medications are stored securely, and administration procedures follow established protocols. They also evaluate medication reconciliation processes, medication error reporting, and staff training related to medication management.
4. Infection Control Audit
Infection control audits are conducted to assess the nursing home’s adherence to infection prevention and control practices. These audits evaluate hand hygiene practices, proper use of personal protective equipment (PPE), cleaning and disinfection procedures, and compliance with isolation precautions. The goal is to identify areas where infection control pracctices can be improved to minimize the risk of healthcare-associated infections among residents and staff.
5. Staffing Audit
Staffing audits focus on evaluating the nursing home’s staffing levels and skill mix to ensure adequate staffing for resident care needs. These audits assess compliance with staffing requirements set by regulatory agencies, review staff qualifications and training, and evaluate the nursing home’s processes for monitoring and maintaining appropriate staffing levels. The goal is to ensure that there are enough qualified staff members available to provide safe and quality care to residents.
As you help prepare your facility for potential audits and inspections, it’s also a good idea to take a closer look at your system for storing and submitting documentation. Your personnel records may be up-to-date, but are they as accessible as they could be?
Many HR departments still handle paperwork manually, with paper folders and filing cabinets rather than a centralized system. And while this may still work for some, it can get tricky if you’re juggling multiple review requests or multiple facilities.
Digitizing files in a central location can help you avoid unnecessary compliance violations and simplify employee management. With access to all files at once, your facility can stay organized, prepare ahead of time, and have all the documentation you need at your fingertips, just in case.
Tips for Audit and Inspection Preparation
You want your facility to look good. My best friend is general counsel you can help your facility prepare for whatever comes their way and increase their rating at the same time.
Here are a few ways your team can improve compliance and maintain your SNF’s quality rating:
- Educate staff about documentation
All nursing home facility staff should be on the same page when it comes to documenting and reporting care. Consider holding a staff meeting to go over the main points of documentation with your attending physician or RN in charge. During this meeting, emphasize the importance of documenting elements like:
- History of reticent care and behavior towards care
- The skilled services provided
- Need for services based on resident’s condition and situation
- Resident’s response to services
- Future care plans
All documentation should be legible (although legibility is NOT a law, just a suggestion or best practices) and report care clearly and accurately. And make sure everyone knows to check state regulations for reporting and documenting COVID-19 procedures and care.
Improve Employee Satisfaction
Satisfied employees mean a better work environment and fewer complaints from residents, which can negatively impact your quality rating. Positive work cultures have been linked to better work attendance and performance, workforce retention, and mental health. It pays to ensure that your RNs, LPNs, CNAs, and other staff members are happy, healthy, and able to attend fully to their work.
Work with your staff to ensure that they’re getting what they need, whether that means flexible scheduling or healthy food on late-night shifts. Check in about their mental health and ask what resources you can provide to help them combat burnout.
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:
- She is an ER Trauma nurse.
- She is good at her job. She was handed a decapitated arm once. I am sure I would have had nightmares, not she.
- 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!
E/M Codes and When You Should NOT Fire Your Attorney!
Lately, I have been inundated with Medicare and Medicaid health care providers getting audited for E/M codes. I know Dr. Hirsh has spoken often about the perils of e/m codes. The thing about e/m codes is that everyone uses them. Hospitals, family physicians, urgent care centers, specialists, like cardiologists. Obviously, for a specialist, like cardiology, the higher level codes will be more common. A 99214 will be common compared to a generalist like a primary care physician, where a 99213 may be more common.
Here’s a little secret: the difference between a 99214 and 99213 is subjective. It’s so subjective that I have seen auditors who are hired by private companies to audit on behalf of CMS and are financially incentivized to find fault find 100% error rates. Who finds a 100% error rate? Not one claim out of 150 was compliant. Then, I come in and hire the best independent auditors or coders. There are generally two companies that I always use. The independent auditors are so good. Most importantly, they come in and find a much more probable error rate of almost zero.
Hiring an independent, expert coder to ensure that the RAC, MAC, UPIC, or TPE audits accurately is always part of my defense.
Recently, I learned what I should have known a long time ago, but is essential for our listeners to know. If your medical malpractice is with The Doctors Company, for free, you get $25k of – what TDC calls – Medi-Guard or regulatory compliance protection. In other words, you get audited by a UPIC and are informed that you owe an alleged $5 million, extrapolated, of course, you get $25k to pay an attorney for defense. Sadly, $25k will not come close to paying your whole defense, but it’s a start. No one scoffs at “free” money.
When accused of an alleged overpayment, placed on prepayment review, or accused of a credible allegation of fraud, your reimbursements could be in imminent danger of being suspended or recouped. It is imperative for the health care provider to stay apprised of what penalties they are facing. You want to know: “best case scenario and worst case scenario.”
And, providers, be cognizant of the gravity of your situation. Infringement of the false claims act can result in high penalties or jail, depending on the circumstances and the provider’s attorney. I had a client, who is an M.D. psychiatrist. She asked me what is the worst penalty possible. I am blunt and honest, apparently to a fault. I didn’t miss a beat. “Jail,” I said. She was horrified, called her insurance company, and requested a new attorney. TDC refused to fire me, so the doctor said that she will draft the self-disclosure herself. She also said that she submitted the falsified documents to the UPIC, so she was confident that the UPIC would not notice, but see below, time stamps are a bitch.
When I told the doctor that we needed to self-disclose to OIG because she had some Medicare claims, she screamed, “No! No! NO!” It was a video call and my sound wasn’t up loud, and I just watch her on the screen with her face all contorted and her mouth getting really big, then contract, then get really big, then contract, then get really big and then even bigger. The expert certified coder was present for the call, and he called me afterward asking me: “What was that?” And his wife, who overheard, said, “OMG. I would have lashed out.” I kept my cool. Honestly, I just felt bad for her because I can see the writing on the wall.
Obviously, a new attorney is not going to change the outcome. She falsified 17 dates of service because she wanted the service notes to be “perfect.” Well, providers, there is no such thing as perfect and changing diagnoses and CPT codes and adding details to the notes that, supposedly, you remember from a month ago is not ok.
I did feel bad for her for leaving me. I could have gotten her off without any penalties.
You see, English is not her first language. She misinterpreted an email from the UPIC and thought it said that you can fix any errors before submitting the documents. She fabricated 17 claims before I was hired instructed her to stop. I had a solid defense prepared. I was going to hire an independent auditor to audit her 147 claims with the 17 falsified claims. I would have hoped for a low error rate. Then, I would have conducted a self-audit and self-disclosed the fabrications to the UPIC with the explanation that it was a nonintentional harmless error that we are admitting. Self-disclosure can, sometimes, save you from penalties! However, if she doesn’t self-disclose, she will be caught. Unbeknownst to her, on page 6 of the service notes, it is time and date stamped. It revealed on what day she changed the data and what data she changed. Those of you who would also terminate your attorney because you think you can get by with the fraud without anyone noticing, think hard about whether you would like to suffer the worst penalty – jail – or have your attorney be honest and upfront and get you off without penalties by following the rules and self-disclosing any problems uncovered.
I have no idea what will happen to the doctor, but had she stayed with me, she would have escaped without penalty. When not to fire your attorney!
Ding Dong! PHE Is Dead!!!
The federal Public Health Emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service (PHS) Act, is expiring at the end of the day on May 11, 2023, today! This is huge. There have been thousands of exceptions and waivers due to COVID throughout the last 2 1/2 years. But on the end of the day on May 11, 2023…POOF….
Most exceptions or waivers will immediately cease.
The Department claims it has been working closely with partners—including Governors; state, local, Tribal, and territorial agencies; industry; and advocates—to ensure an orderly transition out of the COVID PHE.
Yesterday, HHS released a Fact Sheet. It is quite extensive, as it should be considering the amount of regulatory compliance changes that will happen overnight!
Since January 2021, COVID deaths have declined by 95% and hospitalizations are down nearly 91%.
There are some flexibilities and actions that will not be affected on May 11.
Access to COVID vaccinations and certain treatments, such as Paxlovid and Lagevrio, will generally not be affected.
At the end of the PHE on May 11, Americans will continue to be able to access COVID vaccines at no cost, just as they have during the COVID PHE. People will also continue to be able to access COVID treatments just as they have during the COVID PHE.
At some point, the federal government will no longer purchase or distribute COVID vaccines and treatments, payment, coverage, and access may change.
On April 18, 2023, HHS announced the “HHS Bridge Access Program for COVID-19 Vaccines and Treatments.” to maintain broad access to vaccines and treatments for uninsured Americans after the transition to the traditional health care market. For those with most types of private insurance, COVID vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) are a preventive health service and will be fully covered without a co-pay when provided by an in-network provider. Currently, COVID vaccinations are covered under Medicare Part B without cost sharing, and this will continue. Medicare Advantage plans must also cover COVID vaccinations in-network without cost sharing, and this will continue. Medicaid will continue to cover COVID vaccinations without a co-pay or cost sharing through September 30, 2024, and will generally cover ACIP-recommended vaccines for most beneficiaries thereafter.
After the transition to the traditional health care market, out-of-pocket expenses for certain treatments, such as Paxlovid and Lagevrio, may change, depending on an individual’s health care coverage, similar to costs that one may experience for other covered drugs. Medicaid programs will continue to cover COVID treatments without cost sharing through September 30, 2024. After that, coverage and cost sharing may vary by state.
Major telehealth flexibilities will not be affected. The vast majority of current Medicare telehealth flexibilities that people with Medicare—particularly those in rural areas and others who struggle to find access to care—have come to rely upon throughout the PHE, will remain in place through December 2024. Plus, States already have significant flexibility with respect to covering and paying for Medicaid services delivered via telehealth. This flexibility was available prior to the COVID PHE and will continue to be available after the COVID PHE ends.
What will be affected by the end of the COVID-19 PHE:
Many COVID PHE flexibilities and policies have already been made permanent or otherwise extended for some time, with others expiring after May 11.
Certain Medicare and Medicaid waivers and broad flexibilities for health care providers are no longer necessary and will end. During the COVID PHE, CMS used a combination of emergency authority waivers, regulations, and sub-regulatory guidance to ensure and expand access to care and to give health care providers the flexibilities needed to help keep people safe. States, hospitals, nursing homes, and others are currently operating under hundreds of these waivers that affect care delivery and payment and that are integrated into patient care and provider systems. Many of these waivers and flexibilities were necessary to expand facility capacity for the health care system and to allow the health care system to weather the heightened strain created by COVID-19; given the current state of COVID-19, this excess capacity is no longer necessary.
For Medicaid, some additional COVID PHE waivers and flexibilities will end on May 11, while others will remain in place for six months following the end of the COVID PHE. But many of the Medicaid waivers and flexibilities, including those that support home and community-based services, are available for states to continue beyond the COVID PHE, if they choose to do so. For example, States have used COVID PHE-related flexibilities to increase the number of individuals served under a waiver, expand provider qualifications, and other flexibilities. Many of these options may be extended beyond the PHE.
Coverage for COVID-19 testing will change.
State Medicaid programs must provide coverage without cost sharing for COVID testing until the last day of the first calendar quarter that begins one year after the last day of the PHE. That means with the PHE ending on May 11, 2023, this mandatory coverage will end on September 30, 2024, after which coverage may vary by state.
The requirement for private insurance companies to cover COVID tests without cost sharing, both for OTC and laboratory tests, will end at the expiration of the PHE.
Certain COVID data reporting and surveillance will change. CDC COVID data surveillance has been a cornerstone of our response, and during the PHE, HHS had the authority to require lab test reporting for COVID. At the end of the COVID-19 PHE, HHS will no longer have this express authority to require this data from labs, which will affect the reporting of negative test results and impact the ability to calculate percent positivity for COVID tests in some jurisdictions. Hospital data reporting will continue as required by the CMS conditions of participation through April 30, 2024, but reporting will be reduced from the current daily reporting to weekly.
FDA’s ability to detect shortages of critical devices related to COVID-19 will be more limited. While FDA will still maintain its authority to detect and address other potential medical product shortages, it is seeking congressional authorization to extend the requirement for device manufacturers to notify FDA of interruptions and discontinuances of critical devices outside of a PHE which will strengthen the ability of FDA to help prevent or mitigate device shortages.
Public Readiness and Emergency Preparedness (PREP) Act liability protections will be amended. On April 14, 2023, HHS Secretary Becerra mailed all the governors announcing his intention to amend the PREP Act declaration to extend certain important protections that will continue to facilitate access to convenient and timely COVID vaccines, treatments, and tests for individuals.
More changes are occurring than what I can write in one, little blogpost. Know that auditors will be knocking on your doors, asking for dates of service during the PHE. Be sure to research the policies and exceptions that were pertinent during those DOS. This is imperative for defending yourself against auditors knocking on your doors.
And, as always, lawyer-up fast!
And just like the Wicked With of the West, DING DONG! The PHE is dead.
Medicare Extrapolation Under 50% Error Rate? No Extrapolation ALLOWED!
Earlier this year, I reported on the new extrapolation rules for all audits, including RAC, UPIC, TPE, CERT, etc. You know, that alphabet soup. The biggest change was that no extrapolation may be run if the error rate is under 50%. This was an exciting and unexpected new protection for health care providers. Now I have seen it in action and want to tell you about it.
A client of mine, an internal medicine facility in Alabama, received a notice of overpayment for over $3 million. This is the first case in which I saw the 50% error rate rule in action. Normally, I always tell clients that the first two levels of appeals are rubber-stamps. In other words, don’t expect to win. The QIC and the entity that conducted the audit saying you owe money are not going to overturn themselves. However, in this case, we were “partially favorable” at the QIC level. “Partially favorable” normally means mostly unfavorable. However, the partially favorable decision took the error rate from over 50% to under 50%. We re-grouped. Obviously, we were going to appeal because the new extrapolation was still over $1 million. However, before our ALJ hearing, we received correspondence from Palmetto that said our overpayment was $0. Confused, we wrote to the ALJ pointing out that Palmetto said our balance was zero. The Judge wrote back saying that, certainly, the money has already been recouped and the practice would get a refund if he reversed the denials.” “Ok,” we said and attended a telephonic hearing. We were unsuccessful at the hearing, and the ALJ upheld an alleged overpayment of over $1 million. We argued that the extrapolation should be thrown out due to the error rate being under 50%. The Judge still ruled against us, saying that CMS has the right to extrapolate, and the courts have upheld CMS’ ability to extrapolate. Ok, but what about the NEW RULE?
Later, we contacted Palmetto to confirm what the zero-balance meant. The letter read as if we did not owe anything, yet we had an ALJ decision mandating us to pay over a $1million. There was serious juxtaposition. After many hours of chasing answers on hold with multiple telephone answerers of Palmetto, we learned that, apparently, because the error rate dropped below 50% after the QIC level, Palmetto “wrote off” the nominal balance. Since an extrapolation was no longer allowed, the miniscule amount that Palmetto thought we owed wasn’t enough to pursue. However, the letter sent to us from Palmetto did not explain, “hey, we are writing off your overpayment because the error rate fell below 50%.” No, it was vague. We didn’t even know if it were true.
It took us reaching out to Palmetto and getting an email confirmation that Palmetto had written off the alleged overpayment due to the error rate dropping. Even the ALJ misinterpreted the letter, which tells me that Palmetto should revise its notices of write offs.
If Palmetto unilaterally dismisses or writes off any balance that is allegedly owed, the letter should explicitly explain this. Because providers and attorneys are not accustomed to receiving correspondence from a MAC, CMS, Palmetto, or any other auditing entity with GOOD NEWS. If we get GOOD NEWS from an auditing entity, that correspondence should be explicit.
Regardless, this was a huge win for me and my client, who was positively ecstatic with the outcome. Tune in next week, during which I will tell a story of how we battled successfully a qui tam action against a facility of 9 specialists due to a disgruntled employee who tried to blow the whistle on my specialists and their facility…falsely!
Supreme Court to Decide Mens Rea in FCA Claims!
First, I would like to give a quick shout out to my husband Scott. It’s his birthday today. Speaking of important days, another important day is imminent. Back in mid-January 2023, the United States Supreme Court granted certiorari in two consolidated cases from the 7th U.S. Circuit Court of Appeals — U.S. ex rel. Schutte v. SuperValu Inc., No. 21-1326, and U.S. ex rel. Proctor v. Safeway, Inc., No. 22-111 — which has teed up a case that could undermine one of the government’s most powerful tools for fighting fraud in government contracts and programs and, dare I say, overreaching tool. The False Claims Act (“FCA”). A jackhammer where a scalpel would suffice.
At issue is whether hundreds of major retail pharmacies across the country knowingly overcharged Medicaid and Medicare by overstating what their usual and customary prices were. In other words, the question presented is: Whether and when a defendant’s contemporaneous subjective understanding or beliefs about the lawfulness of its conduct are relevant to whether it “knowingly” violated the False Claims Act. Unlike most civil fraud actions, the FCA allows treble damages, which in “non-lawyer-ese” equals triple damages.
To Calculate Base Damages, you look at the injury. Determine what damages to the government resulted “because of” the defendant’s acts. The burden is on the government or the relator to prove that the damages sought were caused by the fraud. The defendant will want to be able to distance the alleged damages from the fraudulent acts to the extent possible (such that the damages cannot be said to have been caused by the defendant’s acts) in order to minimize its potential financial liability.
This case essentially began in 2006, when Walmart upended the retail pharmacy world by offering large numbers of frequently used drugs at very cheap prices — $4 for a 30-day supply — with automatic refills. That left the rest of the retail pharmacy industry desperately trying to figure out how to compete.
The pharmacies came up with various offers that matched Walmart’s prices for cash customers, but they billed Medicaid and Medicare using far higher prices, not what are alleged to be their usual and customary prices.
Walmart did report its discounted cash prices as usual and customary, but other chains did not, like Safeway and Supervalu. Even as the discounted prices became the majority of their cash sales, other retail pharmacies continued to bill the government at the previous and far higher prices.
For example, between 2008 and 2012, Safeway charged just $10 for almost all of its cash sales for a 90-day supply of a top-selling drug to reduce cholesterol. But it did not report $10 as its usual and customary price. Instead, Safeway told Medicare and Medicaid that its usual and customary price ranged from $81 to $109. In the Petition, Petitioner’s “expert estimated that Safeway received $127 million more in reimbursements from government health programs than it would have if it reported its price-match and discount club prices as its usual and customary prices.
A decision is expected this summer. Quote from the Petitioner about Safeway trying to hide their price matching policy from media or investigtors:
“With respect to price-matching, Safeway adopted an “official company policy” of denying that it would match Walmart prices “if an unidentified customer calls in. This is to avoid trouble with the media or competitors.” But “[i]f a regular customer known to you asks if we will match . . . the answer is YES.””
I foresee the pharmacies facing a looming overpayment. The Petition explains that, for example, after a pharmacy manager informed executives that Nebraska’s Medicaid program was requiring price-matched discount prices to be reported as U&C prices, an executive asked: “Does anyone think we have an issue here? My question is how the state of Nebraska will know that we offered to match any price out there.” In a follow-up communication, other executives pointed out that advertising their price-matching program would “Alert the Medicaid programs to start looking” into what Safeway was doing, and therefore stressed the “need to keep a low profile.” We shall see in June or July.
Dueling Ophthalmologists: Accusations of Violations of the False Claims Act for Refusal to Hire?
Today I have a story about dueling ophthalmologists. And, yes, I wrote “dueling,” as in fighting. This is a true story that the 6th Circuit heard about the False Claims Act (“FCA”). With the Appellate Circuit Courts split regarding the issue I will be discussing in this blog, I foresee the U.S. Supreme Court taking an appeal of this case for a final review if the losing ophthalmologist appeals. So, be on the watch. Because this case is defining what the FCA statute does not….remuneration.
Issue: Does renumeration cover (1) just payments and transfers of value; or (2) any act that may be valuable to another?
The case was published March 28, 2023, from the 6th Circuit. United States ex rel. Martin v. Hathaway, No. 22-1463, 2023 WL 2661358 (6th Cir. Mar. 28, 2023). In a rural part of Michigan, there was an ophthalmology group consisting of two physicians, the owner of the practice, Dr. Hathaway, and one employee physician, Dr. Martin. Dr. Martin overheard Dr. Hathaway negotiating a sale to a larger practice, and began to question her employment path. The sale fell through, but she had begun negotiations with the local hospital to become the hospital’s sole ophthalmologist. Well, Drs. Hathaway and Martin were the only ophthalmologists in this area, and Dr. Hathaway knew that if Dr. Martin went in-house to the local hospital Oaklawn that his business would suffer because his now-employee would become a competitor.
The hospital gave her a pending offer. Dr. Hathaway was infuriated. He told the hospital that if it hired Dr. Martin that he would move all his surgeries to another hospital. He even told the local hospital’s CEO that if the Board approved the hiring of Dr. Martin, it would be the “death knell” of his practice because the hospital’s future patients referrals would go to Dr. Martin and not him.
Dr. Hathaway pled with the CEO. It would be a lose-lose if you hire Dr. Martin, he said. It will cost hundreds of thousands of dollars to set up an internal ophthalmology line, while it would force Dr. Hathaway to pull his cases and go elsewhere.
Perhaps due to Dr. Hathaway’s threats, the Board elected to not hire Dr. Martin.
Dr. Martin did not take the rejection well.
She sued Dr. Hathaway, South Michigan, and Oaklawn in a qui tam action under the False Claims Act and Michigan’s False Claims Act. She accused Dr. Hathaway and Oaklawn Hospital of engaging in an illegal fraudulent scheme under the Anti-kickback Statute (“AKS”) and that claims for Medicare and Medicaid reimbursement resulting from the kickbacks violated the False Claims Act.
The definition of remuneration was at stake. The statute does not define renumeration. Does renumeration cover just payments and transfers of value or any act that may be valuable to another. The 6th Circuit held that renumeration only cover payments and other transfers of value.
The Complaint’s main theory of remuneration turns on the Oaklawn Board’s refusal to hire Dr. Martin in return for Dr. Hathaways general commitment to continue sending surgery referrals for his patients to Oaklawn.
You may recall that the FCA uses the word “payment,” whereas the AKS uses the word “remuneration,” which prompts the question whether remuneration means something broader.
The Court held, “no” – money and value needs to be defined as just that…money and value.
Dr. Hathaway gave Oaklawn no payment, no value. Dr. Martin lost in this case, but if she appeals, like I said, I foresee the US Supreme Court to weigh in.
Defending Medicare Providers Against FCA or Qui Tam Lawsuits
As a health care partner at Nelson Mullins, I’ve seen my fair share of False Claims Act (FCA) and Qui Tam actions against health care providers. It’s not uncommon for practices to receive unwarranted accusations of false claims, especially when it comes to billing Medicare. But fear not, my friends, for I’m here to provide some guidance on how to defend yourself. These cases are long and tedious, so it is important to maintain a bit of humor throughout the process – that and hire a really good attorney.
First things first, let’s talk about the False Claims Act. This federal law imposes liability on individuals and companies that defraud the government by submitting false claims for payment. Essentially, if you submit a claim for reimbursement from Medicare that you know is false, you could be on the hook for some serious penalties. However, the government has to prove that you had actual knowledge that the claim was false, which can be a tough burden to meet.
Now, let’s talk about Qui Tam actions. These are lawsuits brought by private individuals, also known as “whistleblowers,” on behalf of the government. The whistleblower stands to receive a percentage of any damages recovered by the government, so there’s a financial incentive for them to pursue these cases. Qui Tam actions can be especially tricky because the whistleblower doesn’t have to prove that you had actual knowledge that the claim was false – they just have to show that you submitted a false claim.
So, what can you do to defend yourself against these accusations? Well, for starters, make sure that you’re submitting accurate claims to Medicare. Seems obvious, right? But you’d be surprised at how many practices make mistakes when it comes to billing. Double-check your codes, make sure you’re only billing for services that were actually provided, and make sure your documentation supports the services you’re billing for.
If you do find yourself facing an FCA or Qui Tam action, don’t panic. You have the right to defend yourself, and there are plenty of strategies that can be employed to fight back. For example, you could argue that the government hasn’t met its burden of proof, or that the whistleblower doesn’t have enough evidence to support their claim. And don’t forget about the power of humor – a well-timed joke can go a long way in disarming your accusers. Obviously, I am kidding. The investigators have no humor.
In all seriousness, though, these cases can be incredibly complex and time-consuming, so it’s important to have experienced legal counsel on your side. At Nelson Mullins, we’ve represented numerous health care providers in FCA and Qui Tam actions, and we have the knowledge and expertise to help you navigate these challenges.
So, to sum it up: be accurate in your billing, be prepared to defend yourself, and don’t be afraid to use a little humor to lighten the mood. And if all else fails, just remember the wise words of Mark Twain: “Humor is the great thing, the saving thing after all. The minute it crops up, all our hardnesses yield, all our irritations and resentments flit away, and a sunny spirit takes their place.”
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