Alzheimer’s Testing Compliance
According to the National Institutes of Health (NIH), it is estimated that more than 5.5 million Americans may suffer from Alzheimer’s disease. Among other things, this means that diagnosing and treating seniors with Alzheimer’s disease presents a significant opportunity for neurologists, psychiatrists, geriatricians, and other healthcare providers to help people in need – and to bill Medicare, Medicaid, and private insurers for their services.
Due to the high volume of aging patients who receive diagnostic and treatment services for Alzheimer’s disease each year, doctors, nursing homes and other providers that bill for Alzheimer’s-related services often face close scrutiny from the insurance companies and the federal and state agencies that oversee Medicare and Medicaid. Recently, private insurers, the Centers for Medicare and Medicaid Services (CMS), the U.S. Department of Justice (DOJ), and the U.S. Department of Health and Human Services’ Office of Inspector General (OIG), among others, have intensified their review of billings related to testing for Alzheimer’s disease.
There are several ways to test for Alzheimer’s, and certain of these tests are eligible for private insurance and benefit program reimbursement. However, excessive testing, billing for ineligible assessment methodologies, and various other issues have made Alzheimer’s testing a hot-button issue in the world of healthcare billing compliance. As with most issues in the realm of healthcare fraud, while most doctors who test patients for Alzheimer’s disease are entirely well-intentioned, a relatively high volume of honest mistakes and a few bad apples have led to intensive oversight and aggressive enforcement.
Testing for Alzheimer’s Disease – Methods, Tools, and Insurance/Benefit Program Coverage
Private insurers, Medicare, and Medicaid all offer varying coverage levels and options for Alzheimer’s testing. While there are various potential compliance issues related to Alzheimer’s testing (which we discuss in detail below), one threshold issue is the simple fact that there are so many diagnostic options available. Furthermore, while these tests allow doctors to diagnose aging patients with dementia with relative certainty, they often come up short in pinpointing the exact cause of a patient’s condition. As summarized by the Alzheimer’s Association:
“There is no single diagnostic test that can determine if a person has Alzheimer’s disease. Physicians (often with the help of specialists such as neurologists, neuropsychologists, geriatricians and geriatric psychiatrists) use a variety of approaches and tools to help make a diagnosis. Although physicians can almost always determine if a person has dementia, it may be difficult to identify the exact cause.”
Generally speaking, testing options for diagnosing patients with dementia caused by Alzheimer’s disease include:
- Assessing the patient’s medical history, including any psychiatric history and any record of cognitive deterioration or behavioral changes;
- Conducting a neurological examination focused on identifying any conditions that are symptomatic of dementia caused by Alzheimer’s disease;
- Performing brain imaging examinations with magnetic resonance imaging (MRI), computed tomography (CT), and positron emission tomography (PET);
- Performing a Mini-Mental State Exam (MMSE) or Mini-Cog Test;
- Utilizing computerized tests, including Cantab Mobile, Cognigram, Cognivue, Cognision and Automated Neuropsychological Assessment Metrics (ANAM); and,
- Genetic testing to determine the existence of genes that increase the patient’s risk of developing Alzheimer’s disease.
There is also ongoing research focused on determining whether and to what extent certain blood tests may able to assist in pinpointing Alzheimer’s disease as the cause of a patient’s dementia.
So, what’s covered, and what isn’t? Medicare covers “cognitive assessments” for Alzheimer’s testing, but the details that are publicly available to doctors and patients are limited. The same is true with regard to Medicaid, and private health insurance coverage for Alzheimer’s testing varies widely from one company to the next. In short, determining when a cognitive assessment or other test for Alzheimer’s disease is eligible for coverage is not an easy task; and, although this is the case, healthcare providers are still expected to maintain strict billing compliance with regard to all patients.
5 Common Compliance Issues with Alzheimer’s Testing
With these considerations in mind, neurologists, psychiatrists, geriatricians, and other healthcare providers must be extremely careful to avoid billing mistakes that could expose them to recoupments, fines, exclusion, and other penalties in the event of an audit or investigation. Some of the most-common compliance issues that create legal exposure for providers include:
1. Lack of Medical Necessity
As a general rule, Medicare, Medicaid, and private insurance companies only provide coverage for services that are deemed “medically necessary.” In this context, the definition of medical necessity is determined by the terms of the particular program or insurance company. While mental health screenings and cognitive assessments are generally covered, conducting a high volume of assessments may suggest that some or all of the assessments are frivolous (regardless of whether this is actually the case), and this can lead to an audit or investigation.
2. Billing for Ineligible Tests
As we alluded to above, not all types of Alzheimer’s testing are eligible for reimbursement. For example, PET scans (which typically cost upwards of $3,000) are not eligible for Medicare reimbursement when used for Alzheimer’s testing. Even if it is determined that a particular type of test is necessary in order to accurately diagnose the cause of a patient’s dementia, if the test isn’t covered then billing for it constitutes a form of healthcare fraud.
3. Billing for Novel (and Non-FDA-Approved) Tests
Billing for new Alzheimer’s tests that have not yet been proven and that have not yet received approval from the U.S. Food and Drug Administration (FDA) can be charged as healthcare fraud as well. This includes the new blood testing methodologies that are currently undergoing trials.
4. Unlawful “Kickbacks” and Referral Fees
Doctors who accept payments (and other forms of compensation) from nursing homes, home health agencies, and other providers that serve aging patients with Alzheimer’s are at risk for being prosecuted under the federal Anti-Kickback Statute. Similarly, the federal Stark Law prohibits doctors from engaging in unlawful transactions with entities with which they have qualifying financial relationships. Both of these statutes are extremely broad, and many doctors commit violations unknowingly.
5. Other Billing and Coding Errors
Both intentional and unintentional billing and coding errors can trigger healthcare fraud audits and investigations. This includes submitting the wrong billing code, transposing numbers, and billing at a higher reimbursement rate than the one allowed. Although evidence of intent is required in order to establish criminal culpability, even providers whose billing administrators inadvertently make mistakes can face substantial civil penalties.
Ensuring Billing Compliance with Regard to Alzheimer’s Testing
When it comes to Alzheimer’s testing, what can doctors do to avoid compliance mistakes that can potentially expose them to civil or criminal healthcare fraud charges? Regardless of the size or scope of a doctor’s practice, the key is to develop and implement a comprehensive compliance program. Although each practice’s compliance program should be custom-tailored to its individual needs, at a high level, a few of the basic elements of an effective Alzheimer’s testing compliance program include:
- Staying Up-to-Date on Eligible Assessment Tools and Methodologies – As researchers continue to develop new and more-effective tools for diagnosing Alzheimer’s disease, more assessment options will become eligible for reimbursement. However, doctors must be careful to only bill for new assessments once they become eligible. Billing for tests that are still undergoing trials and that only have anecdotal support for their reliability is highly likely to trigger an audit or investigation, and this inquiry could go well beyond the specific testing protocol at issue.
- Documenting Medical Necessity for Alzheimer’s Testing – When auditors or investigators question the medical necessity of cognitive assessments and other Alzheimer’s testing methodologies, the key to avoiding recoupments and other penalties is being able to supply thorough documentation. Even if you have consistently made appropriate determinations regarding medical necessity, if you do not have the documentation to prove it, you are going to face challenges when it comes to substantiating your practice’s billings.
- Anti-Kickback Statute and Stark Law Compliance – Even if you do not have written agreements with home health agencies, nursing homes, or any other third-parties that provide treatment and care for Alzheimer’s patients, you could still be at risk under the Anti-Kickback Statute. This statute does not require the existence of a formal written agreement, nor is it limited to direct monetary payments for beneficiary referrals. Likewise, if you or a family member owns or has any other financial relationship with a third-party provider that serves Alzheimer’s patients, you must be certain that the terms of the relationship meet the requirements for Stark Law compliance.
These are just a few examples of the numerous compliance issues facing physicians that bill Medicare, Medicaid, and private insurers for Alzheimer’s testing. Learn more about the core elements of an effective healthcare fraud compliance program.
Speak with a Healthcare Compliance Attorney at Oberheiden, P.C.
If you are concerned that your practice’s compliance efforts may be inadequate, if you are thinking about expanding your practice to include Alzheimer’s testing, or if you have any other questions or concerns about federal healthcare compliance, we encourage you to contact us for a confidential consultation. To speak with a healthcare compliance attorney at Oberheiden, P.C., call 888-680-1745 or inquire online now.
Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.