(July 12, 2018): While no medical specialty has completely avoided the scrutiny of law enforcement and government contractors, for the most part, OB/GYNs and Urogynecologists have managed to stay out of the limelight of auditors and investigators tasked with identifying improper billing practices. Unfortunately, those days appear to be over. Working closely with the staff at the Consolidated Data Analysis Center (CDAC), auditors and investigators at the Department of Health and Human Services (HHS), Office of Inspector General (OIG), have conducted sophisticated data analyses to identify outliers whose billing practices may be an indication of improper billing or fraud. In recent years, CDAC-supported analyses have led to the successful pursuit of several high-profile Medicare fraud cases against urogynecologist providers and practices for the wrongful billing of biofeedback  related claims. Most recently, the OIG confirmed at the March 2018 Health Care Compliance Association Annual Meeting that biofeedback / pelvic floor therapy claims are currently under review and are an agency enforcement initiative. This article examines the cases that have been brought against providers for the improper billing / fraudulent submission of biofeedback claims for payment, along with steps that your practice should take if your claims are subjected to an audit.
I. Overview of Biofeedback Therapy:
At the outset, it is important to recognize that the coverage of biofeedback therapy services varies from payor to payor. Many payors have limited the coverage of biofeedback therapy services to specific conditions and diagnoses. Generally speaking, biofeedback qualifies for coverage and payment by Medicare when it is used to treat stress and urge incontinence in cognitively intact patients, AS LONG AS the medical documentation shows that “pelvic muscle exercise” training has been attempted and has failed.
Two procedural codes (CPT Code 90901 and CPT Code 90911), are primarily used to code for biofeedback therapy. CPT Code 90901 is a non-specific code that can be used for any modality of biofeedback therapy. In contrast, CPT Code 90911 is used to bill for Pelvic Floor Therapy training for the treatment of incontinence.
II. Overview of Pelvic Floor Therapy Training for Urinary Incontinence:
As discussed above, Medicare will only cover biofeedback for the treatment of urinary incontinence when the medical records document that a trial of pelvic muscle exercise training was previously tried and failed.  The Centers for Medicare and Medicaid Services (CMS) has issued National Coverage Determination (NCD) guidance titled “Biofeedback Therapy for the Treatment of Urinary Incontinence (30.1.1). ” As the guidance notes, biofeedback-assisted pelvic muscle exercise training incorporates the use of an electronic or mechanical device to convey feedback (visual and / or auditory) regarding the muscle tone of a patient’s pelvic floor. This feedback assists patients with their performance of muscle tone and pelvic muscle exercises. Notably, CMS has delegated the authority to decide whether or not to cover biofeedback as an initial treatment modality to its contractors.
III. Recent Pelvic Floor Therapy Claims Enforcement Cases:
- On July 2, 2018, a Florida-based network of urogynecology practitioners agreed to pay the government $7 million to resolve allegations that network physicians violated the False Claims Act by knowingly billing the Medicare program for services that were inflated or were not provided. More specifically, the government alleged that network physicians performed and improperly billed for lavage treatments and pelvic floor therapy services that were incorrectly appended with a Modifier -25. A Modifier -25 is intended to reflect the fact that a significant, separately identifiable E/M services was provided by the same physician on the same day as the other procedure at issue (in this case, the lavage and / or pelvic floor therapy services).
- In June 2018, a California urogynecology practice and its Board-Certified physician entered into a $419,578 settlement agreement with the OIG. The settlement resolves allegations that the physician submitted claims to Medicare for items or services that he “knew or should have known were not provided as claimed or were false or fraudulent.”
- In February 2018, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) announced an $877,474 settlement with an Arizona practice accused of submitting false and fraudulent pelvic floor therapy claims to the Medicare program for payment.
- In December 2017, a Virginia-based urogynecology clinic and its Board-Certified physician owner, settled a case with the OIG for $4 million in Civil Monetary Penalties. The OIG also required that the clinic enter into a 3-year Corporate Integrity Agreement which requires that the practice fully comply with a comprehensive set of compliance and regulatory requirements in order to avoid exclusion from the Medicare program.
- In November 2016, a New Jersey OB/GYN agreed to be excluded from participating in Federal health benefits programs for 20 years as part of his settlement with government. The OB/GYN was also required to pay $25 million to settle False Claims Act allegations. It was alleged that the OB/GYN submitted thousands of claims for pelvic floor therapy training services to the Medicare and Medicaid programs that were either never provided, or were otherwise false or fraudulent.
IV. Steps to Take Before Your Practice is Audited:
When is the last time you conducted an internal audit of the medical necessity of your claims, the completeness of your documentation and / or the accuracy of your coding and billing practices? What did you find?
A well-designed Compliance Program can benefit Urogynecology and OB/GYN practices by speeding up and optimizing the proper payment of claims, minimizing billing mistakes, and reducing the chances that an audit will be conducted by law enforcement or one of the many private contractors now working for CMS. The following seven elements that should be addressed in your Compliance Program include:
- Implementing written policies, procedures and standards of conduct;
- Compliance program administration;
- Screening and evaluation of employees, physicians, etc.;
- Communication, education and training on compliance;
- Monitoring, auditing and internal reporting systems;
- Enforcing standards through well-publicized disciplinary guidelines;
- Responding promptly to detected offenses and undertaking corrective action;
Urogynecology and OB/GYN practices should also conduct an organization-specific review in order to identify and address any regulatory risks that may be present. This baseline audit (also commonly referred to as a “GAP Analysis”) can be utilized to identify problems in need of correction and any potential risk areas that should be incorporated into your Compliance Program. As you review your documentation, try and imagine how it would appear to an outside reviewer. Can a reviewer fully appreciate the patient’s clinical status and the medical necessity of any biofeedback-related therapy services that you have provided? Compare your E/M services to the 1995 or 1997 E/M Guidelines – have you fully and completely documented the services at issue?
To be clear, both law enforcement and CMS contractors recognize that a provider’s care and treatment practices may differ in one aspect or another from those of their peers. Moreover, those differences can result in billing practices which might make a provider appear to be an “outlier.” Just because a provider’s coding and billing practices differ from those of their peers (in the same specialty area), does not necessarily mean that the provider’s practices are improper. Nevertheless, if your utilization or coding / billing practices result in your clinic being identified as outlier, there is higher likelihood that your claims will be audited.
Be sure and engage any outside reviewers through legal counsel. Keep in mind, this is not a paper exercise. If legal counsel is not fully engaged and is not supervising the work, it is doubtful that the result of any review will be privileged. As a final point in this regard, keep in mind that any overpayments identified must be paid back, regardless of whether the results of the internal audit qualify as privileged.
V. What Are the Risks You Face if Your Biofeedback / Pelvic Floor Therapy Claims are Audited?
Despite any assertions that a Medicare auditor may state to the contrary -- there is no such thing as a "Routine Audit." 
You never realize how bad your documentation is until your urogynecology or OB/GYN claims are audited. Unfortunately, a physician’s documentation practices often become more relaxed as time goes on – especially when the physician’s claims have not been audited for an extended period of time. In such situations, both physicians and their staff may fail to fully document the services provided. Specific risk issues identified in recent cases brought by the OIG and, in some cases, the Department of Justice (DOJ) against urogynecology, OB/GYN, and multidisciplinary practices providing biofeedback-related pelvic floor therapy training services include:
- Upcoding involving the inappropriate appending of Modifier -25 to a claim payment for a medically unnecessary E/M services. Urogynecologists, OB/GYNs and multidisciplinary physicians should exercise caution when utilizing Modifier -25. It is important to remember that Modifier -25 has a long and controversial history with respect to Medicare audits and investigations.  In a recent False Claims Act brought by the government, the government alleged that the provider billed the Medicare program for a significant, separately identifiable E/M service, supposedly provided by the same physician on the same day as lavage and / or pelvic floor therapy services. The bottom line is simple, if you are billing Modifier -25 in connection with your claims, you should expect to be audited!
- Failure to provide and document failed pelvic muscle exercise training. Multiple cases brought by the government have denied CPT Code 90911 claims because there was no evidence that prior to trying pelvic floor therapy training, the patient had received a four-week course of failed pelvic muscle exercise training, and the exercise training had failed to remedy the patient’s incontinence issues. CPT Code 90911 audits have regularly found that the required predicate exercise training was not conducted.
- Failure to properly supervise anorectal manometry diagnostic services. It was alleged that the physician failed to personally supervise the performance of anorectal manometry procedures performed by his medical assistants. Anorectal manometry (CPT Code 91122) testing procedures are used as a diagnostic tool to measure a patient’s anal sphincter pressures. The testing is also used to provide an assessment of a patient’s rectal sensation, rectoanal reflexes, and rectal compliance. When supervising the provision of these services, all of the supervision requirements set forth in 42 C.F.R. § 410.32 regarding diagnostic tests apply. When billing for services covered by CPT Code 91122, the required Supervision Level is “2.” In other words, direct supervision requirements apply to services billed under this code. Moreover, under 42 C.F.R. § 410.32, “these diagnostic testing services must be ordered by the physician / nonphysician practitioner who is treating the patient, that is, the physician / nonphysician practitioner who furnishes a consultation or treats a patient for a specific medical problem and who uses the results in the management of the patient’s specific medical problem. Tests not ordered by the physician / nonphysician practitioner who is treating the patient are not reasonable and necessary.” As a final point, providers should take care to ensure that CPT Code 91122 is not confused with CPT Code 90911. As LCD 33263 further reflects, “diagnostic testing is not a medically necessary part of physical therapy, rehabilitation, biofeedback, or [an] exercise program.”
- Billing for services not rendered. There have been multiple instances where law enforcement has alleged that biofeedback / pelvic floor therapy claims were billed to Medicare, when in fact the services were not provided.
- Billing for therapy services provided by unlicensed and unqualified individuals. The basis for denial is increasingly being cited in audits around the country. It is essential that practices review the applicable LCD requirements to ensure that individuals providing the therapy services meet the qualifications set out in the guidance. For example, several cases brought by law enforcement have alleged that urogynecology, OB/GYN, and multidisciplinary practices improperly billed for pelvic floor physical therapy services that were provided by an unqualified individual.
- Failure to properly supervise pelvic floor therapy training services. In one recent case, it was alleged that the physician failed to personally perform or directly supervise pelvic floor therapy services during time periods when he was out of the state or out of the country. Although now superseded, LCD 33631  sets out:
“Medicare billable therapy services may be provided by any of the following within their scope of practice and consistent with state and local law: Physician; Non-physician practitioner (NPP) (physician assistants, nurse practitioners, clinical nurse specialists); Qualified physical and occupational therapists, speech language pathologists (for CPT codes G0515 and 97533), and assistants working under the supervision of a qualified therapist; Qualified personnel, with or without a license to practice therapy, who have been educated and trained as therapists and qualify to furnish therapy services only under direct supervision incident to a physician or NPP.” (Emphasis added).
- Failure to properly document the services provided. Although this reason for denial is among the most frequent we have seen cited in administrative audits, it has also been a component of both Civil Monetary Penalty assessments and False Claims Act cases against urogynecology, OB/GYN, and multidisciplinary practices. Government contractors, the OIG and DOJ often use this deficiency to support their claims that the services billed were not medically necessary.
- Billing for medically unnecessary services. In multiple instances, defendants were alleged to have provided and billed for diagnostic services that were not reasonable and necessary.
- Submitted claims for diagnostic services when therapeutic services were provided. For example, in at least one case, the defendants were alleged to have improperly submitted claims for diagnostic electromyography (CPT Code 51784) and diagnostic anorectal manometry (CPT Code 91122) when therapeutic, not diagnostic, services had been provided.
- Billing for Evaluation & Management services that were never provided.
It is important to keep in mind that if your clinic is audited, the results of the government’s review can lead to:
Allegations of violations of the False Claims Act by either DOJ or by a whistleblower; and
Allegations of violations of criminal law.
If your claims are audited, it is essential that you assess your documentation before turning it over to the government. We typically assess the date of service / claim at issue and submit a comprehensive analysis of the documentation to ascertain whether the claim qualifies for coverage and payment.
VI. Responding to an Audit:
Should you receive notice of an audit or investigation from a CMS contractor, the OIG or the Department of Justice (DOJ), we strongly recommend that you contact a qualified health care regulatory lawyer before responding to the request. To be clear, not every CMS contractor audit requires the services of an attorney. Nevertheless, it is in your best interests to first consult with your attorney. Every case is different. The approach you take when responding to an audit will depend, in part, on the claims at issue, the entity conducting the audit and the scope of review. When we are engaged to handle these audits, several of the steps we take include:
Legal counsel should contact the CMS contractor, the OIG or DOJ and attempt to obtain any additional information regarding the nature and scope of the audit. All requests for medical records and other information must be taken seriously. You can't take the position that a request from a CMS contractor (such as Zone Program Integrity Contractor (ZPIC) or a Uniform Program Integrity Contractor (UPIC)) can be taken less seriously. Both ZPICs and UPICs are program integrity contractors and will not hesitate to make a referral to OIG or DOJ if evidence of improper billing or fraud is identified.
We strongly recommend that you limit any direct communications between you and the auditors. Remember, everything you say is evidence. A quick review of high-profile cases now in the news will confirm that the government won’t hesitate to pursue prosecutions based on obstruction, false statements and similar legal violations other than those based on the substantive claims under review.
Qualified legal counsel should immediately conduct its own assessment of the claims at issue. For instance, in our firm, the attorneys working on your case are also likely to be “Certified Medical Reimbursement Specialist” and / or a “Certified Medical Compliance Officer.” Make sure that your legal counsel is experienced in assessing the medical necessity, documentation, coding and billing issues in your case.
Work through your counsel to properly and fully respond to a request for documentation. Always keep a copy of any information shared with the government or its contractors. Most of the time, you will submit a copy of the medical records requested when responding to the request. However, in limited instances, a subpoena may require that you turn over the original documents (or send over a mirror image of the electronic records). If that is the case, be sure and keep a copy!
Legal counsel will try to “get in front of the case.” You need to know about, and prepare to respond to potential problems that the government may raise after reviewing your claims.
Don’t wait until you are being audited to review your medical necessity, documentation, coding and billing practices! Urogynecology, OB/GYN, and multidisciplinary practices should take steps now to ensure that an effective Compliance Program is in place and that you and your staff are fully complying with applicable statutory and regulatory requirements.
-  Biofeedback is a mind–body technique that can be used to train individuals how to modify their physiology for the purpose of improving physical, mental, emotional health. Clinical biofeedback can be assist in managing a patient’s symptoms through stress management training and can assist in the re-education of muscles to help address urinary incontinence. For additional information, see Ment Health Fam Med. 2010 Jun; 7(2): 85–91.
-  In order to qualify for coverage, biofeedback must be rendered by a qualified practitioner in an office or other facility setting. The Centers for Medicare and Medicaid Services (CMS) has reaffirmed its existing national noncoverage policy for home biofeedback devices in the treatment of urinary incontinence. For additional information in this regard, please see CMS’s guidance dated March 1, 2002, titled “Coverage Decision Memorandum for Home Biofeedback for Urinary Incontinence.”
-  A failed trial of pelvic muscle exercise training is defined as “no clinically significant improvement in urinary incontinence after completing 4 weeks of an ordered plan of pelvic muscle exercises to increase periurethral muscle strength.”
-  National Coverage Determination (NCD) for “Biofeedback Therapy for the Treatment of Urinary Incontinence (30.1.1),” (effective July 1, 2001).
-  Comprehensive Error Rate Testing (CERT) audits are a limited exception to this general rule. Pursuant to the Improper Payments Information Act of 2002, CMS is required to estimate the improper Medicare fee-for-service payments made to health care providers each year by Medicare Administrative Contractors (MACs). Consistent with this mandate, CMS utilizes the CERT program to estimate the error rate. Essentially, the purpose of a CERT audit is to verify whether a Medicare Administrative Contractor is properly paying Medicare claims and has effective edits in place to deny (or place in suspense) claims that for one reason or another may not qualify for coverage and payment.
-  Use of Modifier 25;
-  This example of the supervision requirements governing CPT Code 91122 services is set out the Local Coverage Determination guidance issued by First Coast Service Options sets out the supervision requirements See “Anorectoral Manometry and EMG of the Urinary and Anal Sphincters” (L33263). Applies to services performed on or after October 1, 2016.
-  For example, the supervision requirements governing these services is set out the Local Coverage Determination guidance issued by National Government Services, Inc. See “Outpatient Physical and Occupational Therapy Services,” (L33631). Applies to services performed on or after January 1, 2018.