Category Archives: Federal Government

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.

There Is No Law to Be Perfect in Medicare; Just Self-Disclose!

We all know that there is no law, regulation or statute that medical records supporting payment by Medicare or Medicaid must be perfect. There is no mandatory 100% compliant standard. Because humans err. In light of the ongoing financial strain brought about by the pandemic and the constraints imposed by Congress on Medicaid coverage disenrollments, State Medicaid agencies are poised to explore additional audits to manage increasing Medicaid expenditures. Recent developments, such as additional flexibilities granted by CMS, suggest a shifting landscape in how States respond to these challenges.

Anticipating a more assertive approach by States in dealing with service providers, potential measures could include rate cuts and enhanced scrutiny through service audits. This prompts a crucial examination of States’ and providers’ rights under federal Medicaid law to audit service provisions and recover overpayments, a legally intricate and noteworthy domain.

Medicaid RAC Audits are governed by 42 CFR 455 Subpart F—Medicaid Recovery Audit Contractors Program. Other Medicaid alleged overpayments are dictated by 42 CFR Chapter 433.

To establish a foundational understanding, it’s essential to consider the mandate imposed by Congress in section 1902(a)(30)(A) of the Social Security Act. States are required to incorporate provisions in their Medicaid plans to “safeguard against unnecessary utilization of … care and services.” This underscores the federal interest in ensuring responsible use of matching funds, given the federal government’s financial contribution to the program.

A landmark case illustrating the complexities of this mandate is the 1999 decision by the Supreme Judicial Court of Massachusetts in Massachusetts Eye and Ear Infirmary v. Commissioner of Medical Assistance. The court evaluated Massachusetts Medicaid’s retrospective utilization review policy, emphasizing the need for meaningful definitions of terms like “inpatient” and “outpatient” to avoid arbitrary penalties on providers.

Moving to the realm of overpayments, CMS regulations, specifically at 42 C.F.R. § 433.316, provide guidance on how States should proceed when identifying overpayments. The regulations recommend written notification to providers, with states having the discretion to choose whether to notify in cases of suspected fraud. Furthermore, States are required to take “reasonable actions” based on state collections law to recoup overpayments, with a one-year timeframe to return the federal share of identified overpayments to CMS.

Determining when a State “discovers” an overpayment is a critical aspect outlined in the regulations. The discovery is pegged to specific events, such as the state contacting the provider, the provider notifying the state, formal initiation of recoupment, or a federal official identifying the overpayment. Significantly, the regulations focus more on CMS’s relationship with the state than on the state’s relationship with providers.

Recent legal precedents, such as the Wisconsin Supreme Court’s decision in Professional Home Care Providers v. Wisconsin Department of Health Services, underscore the need for states to operate within the bounds of their granted authority. In this case, the court rejected a Medicaid agency’s “perfection” policy, emphasizing that state law must align with CMS regulations in overseeing overpayment recovery.

As States grapple with revenue shortfalls exacerbated by the pandemic, the potential for increased efforts to recoup overpayments from providers looms large. Legal challenges, exemplified by recent decisions in Massachusetts and Wisconsin, underscore the delicate balance States must strike in these endeavors, emphasizing the limits within which they must operate as they navigate the complex terrain of Medicaid law and financial constraints.

Expect audits. Be ready to defend yourself. Self audits are so important. If you self audit and find a problem and self-disclose, you will not receive penalties. Self-disclosures are key. When I told a group of law students this key information, one asked, has you told a client to self-disclose and they refused? To which I said yes. One time. A female doctor informed me that she falsified 7 medical records, I said that she should disclose. She screamed at me in her language, fired me, and hired a new attorney and withheld the information about falsifying records.

She is jail currently.

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:

  1. Assessments of patient safety
  2. Observations of services and provider or caregiver performance
  3. On-site or virtual staff interviews
  4. Physical survey of the facility
  5. 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:

  1. 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.
  2. 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.
  3. Quality measures. This rating is based on 15 different physical and clinical measures to test how well nursing homes are meeting resident needs.
  4. 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.

  1. 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:

  1. 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:

  1. History of reticent care and behavior towards care
  2. The skilled services provided
  3. Need for services based on resident’s condition and situation
  4. Resident’s response to services
  5. 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.

RAC Audits Are BOO-Very Scary, and, Sometimes, Are DEAD wrong!

For Monitor Monday, today, October 30, 2023, I dressed up as a RAC auditor. BOO!!! I get a spooky 13.5% commission for overzealous auditing tactics. RAC auditors come in every shape and size, color or gender.

In my experience, RACs are garishly incorrect in their assessments. I will reveal three, real life examples where these audit contractors accused healthcare providers of owing money but were found to be dead wrong:

Example 1 – Medical Necessity quibbles:

In a haunting case involving a hospital, the RAC alleged that certain cardiac procedures were billed inappropriately, citing concerns about the medical necessity of these services. They claimed the hospital should refund a repugnant amount for these procedures. However, upon closer examination and an appeal process, it was revealed that the services were indeed medically necessary and aligned with the standard protocols. The ghastly RAC’s accusation was disproven, and the hospital was not required to return any funds. Spine-tingling!

Example 2 – Improper Coding of Diagnosis:

A healthcare provider, particularly a large physician group, was accused by the RAC of using suspicious, improper diagnostic codes, leading to overbilling for certain services provided to Medicare and Medicaid beneficiaries. After a thorough internal audit, it was determined that the codes used were accurate and supported by the patient’s medical records. The RAC’s allegations were unfounded, and no repayment was required. Suspicious. A haunting reminder to spook audits.

Example 3 – Alleged Duplicate Billing:

In a murderous case involving a nursing facility, the RAC identified what they believed were instances of duplicate billing for certain procedures and services. Upon further review, it was revealed that the billing discrepancies were due to the RAC’s misunderstanding of the facility’s billing processes. Mysterious. The facility provided evidence showcasing that the billed services were distinct and not duplicates. Consequently, the RAC’s claim was refuted, and no repayment was deemed necessary. Suspicious.

These examples underscore the critical need for providers to have robust internal compliance measures in place. While RACs serve a vital purpose in identifying billing errors, they are not infallible. Providers need to be equipped to challenge these audit findings, ensuring they are based on accurate and comprehensive information.

It’s crucial for healthcare providers to engage in a proactive approach by conducting their internal audits, maintaining accurate documentation, and being prepared to challenge RAC determinations when necessary. These efforts not only protect providers from unwarranted financial obligations but also ensure that Medicare and Medicaid funds are appropriately allocated.

In conclusion, the relationship between RACs, healthcare providers, and government healthcare programs is complex. The examples provided demonstrate that while RACs play a critical role in safeguarding the integrity of Medicare and Medicaid, their findings are not always accurate. Providers must be diligent in ensuring their billing practices align with regulations and be prepared to contest any erroneous audit findings to maintain fiscal stability and fair reimbursement for services rendered.

Happy Halloween!!!!

Amidst Medicaid Expansion, Provider Shortages Skyrocket!

From February 2020 through March 2023, enrollment in Medicaid increased by 35.3 percent, or over 22 million individuals. Enrollment in Medicaid increased in every State during COVID. Concurrently, many States report a shortage of providers willing to accept Medicaid. Today NC will be announcing its Medicaid expansion, so the nationwide numbers will rise in the near future. However, as we are introducing over 22 million Americans to Medicaid, the number of physicians, oral surgeons, BH providers, or any health care provider type who accept Medicaid is not increasing. In many places, providers who accept Medicaid is shrinking. See blog.

For example, Arkansas expanded Medicaid in 2014, leading to a surge in Medicaid enrollees. While the expansion successfully reduced the state’s uninsured rate, it also highlighted the shortage of healthcare providers, especially in rural areas. Many residents in these underserved regions face long wait times to see a doctor, limiting their access to timely care.

Nationwide, access to mental health services has been a concern. Medicaid expansion aimed to provide mental health coverage to more people, but there has been a shortage of mental health professionals to meet the growing demand. In many states, there are waitlists regardless the crisis.

Providers continue to face insurmountable challenges. Such challenge is the burden of audits conducted by Recovery Audit Contractors (RACs), Medicare Administrative Contractors (MACs), and Targeted Probe and Educate (TPE) programs. These audits are designed to ensure that healthcare providers comply with the complex web of regulations governing reimbursement and patient care. However, the reality is that these audits often impose an overwhelming burden on providers and their attorneys, making compliance a Herculean task.

The healthcare industry in the United States is governed by a myriad of rules, regulations, and guidelines. From Medicare and Medicaid requirements to state-specific laws, providers must navigate a complex regulatory maze to ensure compliance. RACs, MACs, and TPE programs scrutinize providers’ billing practices, medical necessity of services, and documentation to identify overpayments and potential fraud or abuse.

Healthcare providers, from hospitals to individual practitioners, must allocate significant resources to respond to audits and maintain compliance. The burden starts with the anticipation of an audit, as providers are often left in the dark about when and how they will be audited. This uncertainty can be paralyzing, as it requires providers to divert time, personnel, and financial resources away from patient care to prepare for an audit that may or may not occur.

Once an audit is initiated, providers are faced with a deluge of demands. They must gather and submit an extensive amount of documentation, which can include patient records, billing records, and other relevant materials. The process is not only time-consuming but also disruptive to day-to-day operations. Smaller practices, in particular, may struggle to allocate the necessary personnel and resources to meet these demands, potentially affecting patient care quality.

One of the most significant challenges faced by healthcare providers and their attorneys is the ever-changing nature of healthcare regulations. Keeping up with the latest rules and guidelines is a daunting task, and providers must constantly adapt their practices to remain compliant. The complex interplay between federal and state regulations further complicates matters, as what is compliant at one level may not be at another.

Healthcare attorneys play a critical role in assisting providers through the audit process. However, we too are challenged by the intricate nature of healthcare regulations and the constant need to stay abreast of updates and changes. David would concur, I believe, in my statement that, being a health care regulatory attorney is not a laid-back, calm career choice. We have to continue to educate ourselves at quite a fast pace. Think about how often laws and rules change federally and in 50 States. Tomorrow I am going to Baltimore Maryland for the Fraud and Abuse Conference by the American Health Law Association. I will let you know if I learn anything mind-blowing.

The burden of RAC, MAC, and TPE audits in healthcare is undeniable. While these audits are essential to protect the integrity of the healthcare system, the complex regulatory landscape, coupled with the uncertainty and resource-intensive nature of the audit process, places an overwhelming burden on providers and their attorneys. Healthcare providers are in a constant struggle to balance compliance with the delivery of quality patient care, and their legal representatives are similarly tasked with navigating an ever-changing regulatory maze.

Addressing this burden requires a collaborative effort among stakeholders, including government agencies, healthcare providers, and legal experts. Streamlining audit processes, providing clearer guidance, and ensuring that audits are conducted fairly and transparently can go a long way in alleviating the burden on providers. In the end, the goal should be to strike a balance between safeguarding taxpayer dollars and allowing healthcare providers to focus on what they do best – caring for patients. Or maybe we just need a computer program for audits that is NOT Excel.

RAC Audits: If It Walks Like a Duck and Quacks Like a Duck, It Is a Duck!

Today, I am going to talk about RAC audits. I know what you are thinking…don’t you always talk about RACs? Of course, you are going to talk about RAC audits. No. Today, I’m taking this blog in a different direction.

I want to talk about secret, hidden RAC audits. As you are aware, the federal regulations limit RACs from going back more than 3 years to audit claims. Juxtapose the UPICs, TPEs, SMRCs, MACs, OIG, and even State Medicaid agencies. Everyone, but the RACs are allowed more than a 3-year lookback period. Some, like OIG, have long lookback periods. Coincidentally, when a company responds to an RFP or a request for proposal from CMS to act as CMS’ vendor to conduct Medicare audits on America’s Medicare providers, a clause in the proposed contract between CMS and the vendor is highly argued or negotiated. Which clause in the vendor’s contract is most negotiated? I will tell you. The clause that states that the vendor is a RAC is most negotiated. Because if the vendor is called a UPIC instead of a RAC, the vendor has a longer lookback period. Being called a UPIC, suddenly, becomes a commodity. There are no laws mandating UPICs to a 3-year lookback period. All of a sudden, it is not hip to be a RAC.

Look into it. Do your research. The contracts are public record. Ask for Cotiviti’s contracts with CMS. Notice I said contracts, not contract. What I have realized over time is that a vendor may be hired by CMS to be a RAC auditor, but, once the vendor realizes the limit of 3 years, it goes back to CMS and asks if it can be considered an UPIC. Why? A UPIC can do everything that a RAC does; however, it gets an additional 3 years to lookback at claims and that means money. Cha-ching!  Even Dr. Ron Hirsh commented today on RACMonitor about this story, which I presented this morning at 10:00am, as I present every Monday morning, live, on the national podcast RACMonitor , hosted by Chuck Buck and produced by MedLearn. If you want to listen to the podcast, click the following link: Nelson Mullins – Monitor Mondays Podcast Featuring Knicole Emanuel; Defeating Statistical Extrapolations, Expansion of Medicaid RACs, IPPS Final Rule, Smart Hospitals, and Physician Advisors Episodes

The podcast is also on video, but I don’t know how to view that. If you do, you would see my baby duck Biscuit on the screen. He joined me this morning to talk about, “What Walks Like a Duck and Quacks Like a Duck, Must be a Duck.” Dr. Hirsh commented that companies like Cotiviti have many, many contracts deeming Cotiviti many different acronyms. If you get a letter from Cotiviti, do not assume it is acting as a RAC. Instead, ask for the contract which allows Cotiviti to do what it purports to want to do.

I’ve noticed this trend in real life, but only for 10-20 individual cases, maybe 30. I have not had the time to draft a FOYIA request, and, quite frankly, my name on a FOYIA request nowadays result in a response that says, something to the effect of, use discovery instead. Even though my personal experiences should not be extrapolated across the country because that would be inappropriate and judgmental, I will give an example and you may extrapolate or not. There is a company that has been doing RAC audits in NC for the last 5-8 years. It is called Public Consulting Group (“PCG”). PCG and I go way back. If you are a longtime listener of RACMonitor, you will recall that Ed Roche and I presented numerous podcasts about the debacle in NM in 2013. The State of NM put 15 Medicaid providers who constituted 87.6% of the BH providers in NM at the time. The consequences were catastrophic; thousands were out of BH services overnight. There is even a documentary about the unraveling of BH in NM in 2013. The reason that these 15 BH providers were put out of business overnight was because of a NM vendor called PCG. PCG issued a report to NM after conducting Medicaid audits on these 15 BH facilities, which accused the 15 facilities of fraud. In 2013, PCG was considered a RAC per contract. Today, when I have a case against PCG and make the 3-year lookback period argument, I get a retort that it’s not a RAC. Instead it’s a UPIC.

To which I say, if it walks like a duck and talks like a duck, it is a duck.

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!

SNFs Are on the Medicare Chopping Block! Caveat!

Every skilled nursing facility in the US will be subject to a five-claim audit starting THIS WEEK as regulators try to better assess and root out improper payments. Blah. Blah. Blah. The former is the first sentence in an article that is giving warning to skilled nursing facilities (“SNF”). But, we all know that PROPER PAYMENTS get caught in the wide net cast for improper payments. Innocent people get accused of crimes. Health care providers get accused of Medicare and Medicaid fraud or, at least, abhorrent billing.

The Centers for Medicare & Medicaid Services (“CMS”) announced the nationwide audits, which will be conducted by Medicare Administrative Contractors (“MACs”) on a rolling basis, with the MAC in every region required to pull five Medicare Part A claims from every facility they cover and review them for potential errors.

The results will lead to alleged overpayments, credible allegations of fraud, submittals to the OIG, and False Claims Act (“FCA”) penalties. The effort follows an HHS report that found skilled nursing facilities had the highest rate of improper payments, with nearly a quarter of those tied to insufficient documentation.

Most of the rest of my blog (except for what is important) is cut and pasted from the article (since I am not a journalist and cannot procure quotes):

“We haven’t seen anything like this in the recent past, at least not in the last 10 years,” said Stacy Baker, OTR/L, RAC-CT, director of audit services for Proactive LTC Consulting. “But it’s no surprise to see this sector-wide probe and educate. Looking back on Medicare FFS improper payment data, we’ve never seen SNF improper payment rates this high, and nearly doubling since the 2021 report.”

Improper payments have jumped nearly 10% since 2020, according to data in the Comprehensive Error Rate Testing (“CERT”) reports.

That rate stood at 15.1% in 2022, almost double the 7.79% rate in 2021. A CMS report blamed missing case-mix group component documentation. Baker billed the new initiative as an attempt to improve poor billing practices that emerged with the implementation of the Patient Driven Payment Model.

But the improper payments can’t be attributed to PDPM alone, said Alicia Cantinieri BSN, vice president of MDS policy and education for Zimmet Healthcare Services. 

“That’s probably not the whole reason,” she said on a webinar earlier this month.

She noted that risk areas that could move providers to the front of the audit process include past performance, such as a history of additional documentation requests (“ADR”); frequent errors in Section GG, which sets payment rates for physical therapy, occupational and nursing groups; diagnoses without medical record to support MDS inclusion; and even illegible RN signatures. I bolded “even illegible RN signatures” because I cannot tell you how many times I have seen denials by auditors because they couldn’t read someone’s signature, and, therefore, could not verify their license. Have auditors heard of a phone?

The reviews will be conducted on a prepayment basis unless the provider requests post-payment review due to a financial burden. Holy cow! See blog, blog, and blog.

“Keep in mind, there’s lots of low-hanging fruit for payment error aside from PDPM accuracy, such as but not limited to, compliant SNF Certs and Recerts and physician oversight regs,” Baker added. “These components should be included in the Triple Check process as well.”

The CMG for each HIPPS code also must be clearly supported to validate the claim.

The MACs will complete one round of probe and educate for every provider, instead of that usual potential three rounds, as per their traditional TPE program.

It is a good idea for providers to start analyzing data and conducting internal self-audits.

TIPS for an effective ADR response:

  • SECURE AN ATTORNEY WHO SPECIALIZES IN THIS TYPE OF LEGAL WORK.
  • Develop a process and team now. Assign responsibilities for tasks such as, but not limited to: identifying ADR requests, ensuring timely response to deadlines are met, pulling together medical records and documents required to support the HIPPS code, and reviewing the packet for completeness.
  • Make copies. Never ever, ever, ever send originals.
  • Organize documentation to make the contractor’s review easy, labeling critical sections such as physician orders, MDS assessments, Section GG documentation and more.
  • Allow sufficient time for your lawyers and hired experts, both with clinical and MDS coding expertise, to review the claims and documentation for accuracy. If your attorney believes that your documentation has concerning issues, it is best to SELF-DISCLOSE. Self-disclosure can prevent penalties; whereas if you are caught, penalties will ensue.

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.

Texas Judge Poo Poos the ACA Preventable Services Mandate!

In March, the U.S District Court in the Northern District of Texas vacated the requirement that ACA-compliant health plans cover certain U.S. Preventive Services Task Force (USPSTF) recommended preventive services without cost sharing.

The DOJ argued the lower-court ruling from a federal judge in Texas “has no legal justification and threatens the public health.” The Health and Human Services Department estimates the ACA covered preventive services for more than 150 million people in 2020.

I am not taking a stance on the ACA. As a lawyer, I can tell you that to obtain an injunction, you have to prove:

  1. Likelihood of success on the merits;
  2. Irreprepable harm;
  3. Balancing the equities;
  4. Public interest.

Those standards come from a Supreme Court case called Winter v. Natural Resources Defense Council, 555 U.S. 7 (2008).

I understand that the Texas case vacating that the ACA-compliant health plans cover preventive services has become highly polarizing in politics. Obviously, the Republicans are Plaintiffs in this case and fighting against Obamacare. But I do not care about the politics. My contention with this case is if the government is mandating (well, was mandating before this TX judge’s decision) preventive care to be free, how is that not forcing doctor’s to work for whatever the government deems to be fair. Will they get paid Medicare or Medicaid prices? They should be so lucky. I don’t want to go out on a limb and compare mandating doctors to provide services for Medicare and Medicaid prices, regardless whether that physician is even enrolled in Medicare or Medicaid to slavery, but if the shoe fits…

On another note, the Recovery Audit Contractors (RACs) added  hospice to the list of CMS approved audit targets. The review will determine if Hospice General Inpatient Care (GIP) was reasonable and necessary to achieve pain control or acute or chronic symptom management which could not be managed in any other setting. Claims that do not meet the indications of coverage and/or medical necessity will be recoded to Routine Hospice Care 0651 and result in an overpayment.” The affected code will be REV code 0656.

On March 31, CMS issued the FY 2024 proposed rule which includes a 2.8% rate increase and the FY 2024 cap of $33,396.55. The proposed rule also includes updates on the Hospice Outcomes & Patient Evaluation (HOPE) tool, CAHPS® tool, the Hospice Special Focus Program, and a proposed addition of hospice physicians to the Medicare enrollment process. For a full analysis of the proposed rule, view NHPCO’s regulatory alert from April 4. Comments are due by May 30, 2023.

Other CMS approved audit targets for 2023 and 2024 are : Ambulance Providers, Ambulatory Surgery Center (ASC), Outpatient Hospital, Inpatient Hospital, Inpatient Hospital, Inpatient Psychiatric Facility, Inpatient, Outpatient, ASC, Physician, IP, OP, SNF, OP Clinics, ORF, CORF, OPH, OP Non-Hospital, SNF, ORF, CORF, Physician, Physician/Non-physician Practitioner (NPP), Physician/NPP, Professional Services (Physician/Non-Physician), and Radiologists/Part B providers.

To name a few.