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EKRA: Laboratories, Treatment Homes and Clinical Treatment Centers Now Face Increased Enforcement and Penalties for Kickback Tainted Claims that are Reimbursed by Private Payors.

(December 3, 2018): On October 24th, 2018, President Trump signed into law the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.” This bi-partisan legislation is intended to address a number of the fraudulent and abusive business practices currently employed by unscrupulous substance abuse treatment providers in this segment of the market. This legislation effectively amplifies existing anti-kickback measures to better cover schemes involving private insurance. While the aim of widespread expansion of enforcement is to combat opioid and other substance abuse, the implications of many provisions are far reaching.  One particular provision with far reaching consequences is Subtitle J, also known as the “Eliminating Kickbacks in Recovery Act (EKRA).  This article examines SUPPORT and EKRA in more detail and discusses its impact on laboratories, treatment homes and clinical treatment centers.  It also reviews the broader impact of this legislation on providers that were not expressly specified in the Acts.

I. Background of the Problems Leading up to the Passage of the SUPPORT and EKRA Acts:

Despite the fact that progress has been made in recent years, our country is still grappling with an Opioid Epidemic. In 2017, 11.4 million Americans misused opioids.  It is estimated that 2.1 million of these individuals are addicted to opioids.[1] Approximately 42,249 Americans died of an opioid overdose with over a third of opioid overdoses being from commonly prescribed opioids. Understandably, both federal and state legislatures have repeatedly enacted measures aimed at curbing the illegal diversion of prescription opioids and the misuse of these drugs.  Adding insult to injury, the government has found that highly vulnerable, opioid addicted individuals are being taken advantage by unscrupulous health care providers and suppliers. Addiction and substance abuse treatment is big business. It has been estimated that addiction treatment industry alone is estimated to be worth $35 Billion.[2]  When you consider the fact that a 30-day substance abuse treatment regimen typically costs between $15,000 – $26,000, it is easy to see why the industry has attracted individuals that are willing to employ improper marketing and business schemes in order to maximize profits.  A number of these improper practices have resulted in health care fraud, waste, abuse and even the death of the patients under the care of these treatment centers.[3]  The passage of the SUPPORT and EKRA Acts are merely the latest steps taken by the government to prevent abusive business practices by laboratories, treatment homes and clinical treatment centers.

II. EKRA is Intended, in Part, to Curb Improper and Abusive Patient Brokering Practices by Opioid and Substance Abuse Treatment Providers:

Simply put, “Patient Brokering” occurs when an addiction or substance abuse treatment center or provider pays (or provides some other type of remuneration) to a third-party for referring, directing or otherwise channeling a patient to their treatment facility, center or clinic.  It is one of the primary improper business practices that has resulted in the abuse of patents suffering from opioid and substance abuse addiction. This type of scheme not only wastes money by rewarding the broker, but it also drives up costs and can result in underfunded, substandard care.  Notably, patient brokering does not just occur in connection with provider-patient residential treatment care.

A. Patient Brokering Involving Individuals Covered by Medicare or Medicaid.

Regardless of the provider type or treatment setting, when associated with care reimbursed by Medicare or Medicaid, improper patient brokering may constitute a violation under the Federal Anti-Kickback Statute.  As the Federal Anti-Kickback Statute provides under 42 U.S.C. § 1320a-7b(b):

“(1) Whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind— 

(A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program,[4] or

(B) in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program, shall be guilty of a felony and upon conviction thereof, shall be fined not more than $100,000 or imprisoned for not more than ten years, or both.  

(2) Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person

(A) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or

(B) to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program, shall be guilty of a felony and upon conviction thereof, shall be fined not more than $100,000 or imprisoned for not more than ten years, or both.”  Emphasis Added.

As 42 U.S.C. § 1320a-7b(b) reflects, violations of the Anti-Kickback Statute involving Medicare, Medicaid and other Federal health care programs can result in a maximum penalty $100,000 and 10 years imprisonment.[5]  As discussed below, the potential penalties and period of imprisonment for kickback violations in connection with recovery home, clinical treatment facilities and laboratories claims submitted to private payors are considerably higher.

B. Patient Brokering Involving Individuals Covered by Private Payor Insurance.

Under the SUPPORT Act, kickback violations committed in connection with private payor claims are a criminal violation under EKRA. As the title suggests, this legislation addresses patient brokering and other kickback schemes by expanding liability and raising the maximum penalties for kickbacks. An offense under this provision is described as;

“(a) Offense — Except as provided in subsection (b), whoever, with respect to services covered by a health care benefit program, in or affecting interstate or foreign commerce, knowingly and willfully—

(1) solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind, in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory; or

(2) pays or offers any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind—

(A) to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory; or

(B) in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory…” Emphasis Added.

Under EKRA, the maximum penalties for illegal remunerations paid by recovery homes, clinical treatment facilities, or laboratories in an effort to induce referrals can result in penalties of $200,000 and 20 years of imprisonment per occurrence.[6] In enacting EKRA, the government’s clear intention is to take more aggressive action against patient brokering in the context of the opioid crisis and will likely have far reaching and possibly unintended implications.

V. Laboratory-Related Violations of EKRA:

EKRA specifically targets recovery homes, clinical treatment facilities, and laboratories that participate in illegal remuneration schemes. The definition of each is significant to the applicability of this provision:

Recovery Home: “A shared living environment that is, or purports to be, free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders.”

Clinical Treatment Facility: “A medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

Both of these definitions make sense in the context of this bill’s intentions. However, the definition of laboratory is not included, but rather cites the definition of a laboratory laid out in 42 U.S.C. § 263a(a):

Laboratory: “As used in this section, the term “laboratory” or “clinical laboratory” means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.”           

Unlike the definitions of the terms “recovery home” and “clinical treatment facility,” the definition of “laboratory” is not confined to the provision to opioid or substance-use related matters. As a result, all health care providers, not merely recovery homes and clinical treatment facilities, who utilization or laboratory services need to ensure that their business relationships with laboratories do not violate EKRA.  As one study found, 29% of outpatient encounters typically result in the performance or ordering of laboratory tests.[7]  Several outpatient specialty areas that are likely to receive considerable scrutiny include:

Pain Management Physicians and Clinics: Pain management physicians, nurse practitioners (NPs) and physician assistants (PAs) heavily rely on laboratory testing in their management of pain patients.  Notably, a number of professional organizations, including the Centers for Disease Control and Prevention (CDC) have issued written recommendations on the use of urine drug tests and other laboratory tests that should be used to monitor a patient’s compliance.  Such tests also serve to identify potential instances of pain medications.

Endocrinology Physicians and Clinics:  Endocrinologists are often involved in determining the diagnosis and treatment of a patient’s endocrinological problem.  This may involve the measurement of various hormones in a patient’s body, a determination of whether a patient’s endocrine glands are properly working, or an assessment of other of hormonal-related conditions.  Understandably, in the course of their work, endocrinologists rely heavily on diagnostic laboratory tests.  Some examples of these tests include: (1) ACTH Stimulation Tests, (2) 24-Hour Urine Collection Tests, (3) CRH Stimulation Tests, (4) Oral Glucose Tolerance Tests, and (5) TSH Blood Tests.

Allergists / Immunologists and Associated Clinics:  Allergists / Immunologists manage both pediatric and adult patients with a variety of medical problems.  These include, but are limited to diseases of the respiratory tract, allergic diseases of the eye and skin, adverse reactions to foods and other agents, and diseases of the immune system.  There are often extensive laboratory tests ordered in connection with these medical conditions.

VI. Non-Laboratory Related Violations of EKRA:

ALL health care providers (not merely recovery homes and clinical treatment facilities) must exercise great care before entering into a business relationship, regardless of whether the care provided is covered by Medicare, Medicaid or a private payor.  It is important to keep in mind that improper business relationships (in this case, kickbacks), can take many forms. The following business relationships may be a violation of the Federal Anti-Kickback Statute (when dealing Federal health care programs) or EKRA (when dealing with private payors):

  • Entering into a business relationship with a marketing company whose job it is to steer or direct patients to a recovery home or clinical treatment center. In recent years, a number of improper relationships have been identified in connection with online marketing companies. Does the business relationship you are contemplating qualify for coverage under a Safe Harbor?
  • A continuing concern of the government involves lease arrangements with actual or potential referral sources.
  • Serving as a medical director to a laboratory to whom a provider makes patient referrals.
  • Serving as a consultant to a recovery home or clinical treatment center to whom the health care provider refers patients.
  • While old school dine and dash approaches may be gone, bringing lunch and other goodies to a practice or office is still both commonplace and potentially problematic.
  • Participating in a sham arrangement where the provider receives a loan, research grant, speaking fees, etc. from a recovery home or clinical treatment center to whom the provider makes referrals.
  • Acquiring or having a financial interest in a recovery home or clinical treatment center (or a related entity) to whom a health care provider sends referrals.
  • Accepting or soliciting any type of remuneration (something of value), such as a gift card, sporting event tickets or liquor, from representatives of a recovery home or clinical treatment center to whom the health care provider sends business.

Robert W. Liles serves as Managing Partner at the health law firm, Liles Parker, Attorneys and Counselors at Law.  Liles Parker attorneys represent health care providers and suppliers around the country in connection with UPIC audits, ZPIC audits, OIG audits and DOJ investigations.  He also advises health care providers in connection with the Federal Anti-Kickback Statute and EKRA.  Are you currently being audited or under investigation?  We can help.  For a free initial consultation regarding your situation, call Robert at: 1 (800) 475-1906.

[1] https://www.hhs.gov/opioids/sites/default/files/2018-09/opioids-infographic.pdf

[2] https://www.forbes.com/sites/danmunro/2015/04/27/inside-the-35-billion-addiction-treatment-industry/#3d256aaf17dc

[3] https://www.nbcnews.com/feature/megyn-kelly/florida-s-billion-dollar-drug-treatment-industry-plagued-overdoses-fraud-n773376

[4] Under 42 USC § 1320a-7b(f), the term “Federal health care program” is defined as:

(1) any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under Chapter 89 of Title 5); or

(2) any State health care program, as defined in section 1320a-7(h) of this title.

[5] This penalty is not even a year old, as it was updated from a maximum penalty of $25,000 and 5 years of imprisonment via Section 50412 of the Bipartisan Budget Act of 2018.

[6] https://www.congress.gov/bill/115th-congress/house-bill/6/text#toc-HB10AD8D0FD9C456F81EE0083634020CB

[7] http://jalm.aaccjnls.org/content/jalm/1/4/410.full.pdf

Home Health Providers Under the Microscope — The Review Choice Demonstration Project is Here

(October 4, 2018):  Last week, the Centers for Medicare & Medicaid Services (CMS), confirmed that it intends to initiate the Review Choice Demonstration for Home Health Services project on December 10, 2018.  The Review Choice Demonstration project is slated to initially begin in Illinois. This initiative is the renamed, repackaged version of the prior Pre-Claim Review Demonstration project that was initiated, then placed on hold (due in large part to provider protests), in April 2017.  This article provides an overview of the long and sorted history leading up to the Review Choice Demonstration project.

I. Although Dropping, the Improper Payment Rates for Home Health Services Remain Excessive:

The last few years have been rough on home health providers.  As the government has been quick to note, one of the primary components of the Medicare Fee-for-Service (FFS) improper payment rate has consistently been the excessive level of improper payments made for home health services.  Broken down by fiscal year, the improper payment rates for home health services have included:

Fiscal Year

Report Period

Home Health Improper Payment Rate

FY 2014

July 1, 2012 – June 30, 2013


FY 2015

July 1, 2013 – June 30, 2014


FY 2016

July 1, 2014 – June 30, 2015


FY 2017

July 1, 2015 – June 30, 2016


Although the improper payment rate for home health services has dropped considerably from FY 2015 to FY 2017, it still constitutes a major portion of the overall Medicare FFS improper payment rate.  During the FY 2017 report period, it is estimated that more than $6.1 billion in improper payments was made by Medicare for home health services.  When reviewing the improperly paid claim lines associated with FY 2017, the Comprehensive Error Rate Testing (CERT) contractor tasked with this project found that more than 89% of the errors were due to documentation deficiencies. 

II. Overview of Corrective Actions and Initiatives Taken by CMS to Address Home Health Documentation Deficiencies:

The FY 2017 CERT contractor findings with respect to documentation have merely further strengthened the government’s long-standing belief that home health providers (and referring physicians), need ongoing education and guidance with respect to the medical necessity, documentation, coverage and payment requirements that must be met.  Over the last few years, CMS and its contractors have implemented a variety of corrective actions intended to address documentation and medical necessity deficiencies that have been identified in connection with Medicare home health claims. Examples of these actions have included Probe and Educate Reviews[1], the initiation of the Pre-Claim Review Project[2], the development of Home Health Plan of Care / Certification and Progress Note Clinical Templates[3], and the establishment of a Home Health Recovery Audit Contractor[4].  CMS also revised the Physician Face-to-Face Narrative Requirement[5] for home health services. Several of these corrective initiatives are discussed in more detail below:

A. Probe and Educate Reviews.

In late 2015, home health Medicare Administrative Contractors (MACs) began pulling five claims sample from each home health agency in their jurisdiction for prepayment review purposes.  The claims subject to review covered episodes of service beginning on or after August 1, 2015.  The purpose of the Probe and Educate Review initiative was to better ensure that home health agencies were fully complying with applicable medical necessity, documentation, certification, coverage and payment requirements.[6] Systemic problems identified by home health MACs through the Probe and Education Review process has included:

  1. Failure to comply with face-to-face requirements. For example, in some cases, the certifying physician signature was missing. In other cases, the encounter notes did not document the elements required to show that the patient was eligible for home health services.
  2. Failure to identify an estimate of time for continued need when recertifying the medical necessity of services.
  3. Failure to fully complete and / or properly complete the initial certification documentation required.
  4. Bailure to timely respond to an Additional Documentation Request (ADR) request from a Medicare contractor in a timely fashion.

B. Pre-Claim Review Demonstration Project.

Section 402(a)(1)(J) of the Social Security Amendments of 1967 authorizes the Secretary, HHS, to:

‘‘develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by the Social Security Act (the Act).’’

Using this authority, and inn consideration of the excessively high home improper payment rate for home health services, in June 2016, CMS announced[7] the initiation of a new Pre-claim Review Demonstration project. Theoretically, the demonstration project was not intended to create any new clinical home health documentation requirements. Home health agencies covered by the demonstration project would be required to submit supportive medical documentation to the CMS contractor for review prior to being paid. This approach was intended to help educate providers and better ensure that home health claims qualified for coverage and payment. The demonstration project was also intended to test whether the use of a pre-claim review process would improve the government’s ability to identify, investigate, and prosecute home health fraud. Originally, the demonstration project was scheduled to be put into place in five states. CMS and its contractors planned on rolling out the project over a six-month period: 

  • Illinois: August 1, 2016
  • Florida: October 1, 2016
  • Texas: December 1, 2016
  • Michigan and Massachusetts: January 1, 2017

Two months later, CMS took its first steps towards putting the planned three-year project into place by implementing it in Illinois.  To characterize the implementation as “problematic” would be generous.  From its very start, Illinois home health providers, both large and small, experienced significant problems meeting the reviewer’s documentation requirements, thereby resulting in significant provider payment delays. Bending under political pressure, the planned roll-out in Florida was placed on hold. This effectively delayed implementation in the remaining three states as well.  After several false starts, the initiative was ultimately placed on hold in March 2017.  For a more detailed discussion of the Pre-Claim Demonstration project, please see the following article.  Additional information may also be found here.

C. Home Health Plan of Care / Certification and Progress Note Clinical Templates:

As required under 42 CFR 484.60, Condition of participation: Care planning, coordination of services, and quality of care, Medicare patients are accepted for treatment on the reasonable expectation that a home health agency can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. In order to accomplish this:

“Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice.”

Similarly, 42 CFR 424.22, Requirements for home health services, mandates that a physician certify and recertify a patient’s eligibility for home health services in order to qualify for coverage and payment by Medicare.  Additional certification and recertification requirements are set out under the regulations.

Finally, CMS develop a template Progress Note that could be used by a physician and, when permitted under state law, by a physician assistant, a nurse practitioner, a clinical nurse specialist  and / or a certified nurse midwife to document that home health services are medically necessary and appropriate and to confirm that a Medicare patient is, in fact, homebound.

III. Rise of the Review Choice Demonstration Project:

In consideration of the various challenges encountered when trying to roll-out the Pre-Claim Review Demonstration project, CMS ultimately placed the initiative on hold in April 2017.  It is important to keep in mind that the underlying problem that gave rise to the Pre-Claim Review Demonstration project – an excessively high improper payment rate associated with home health services – was still (and continues to be) a serious program integrity concern. Additionally, it was abundantly apparent that wholesale changes would need to be made if the initiative were to be reintroduced. 

Over the next year, CMS completely reworked its prior initiative in an effort to provide additional flexibility for home health agencies that may be covered by an updated version of the project.   As reflected in the Federal Register, the “new and improved” initiative was named the Review Choice Demonstration project. As with its earlier iteration, the revised version of the demonstration project is intended to:

“help assist in developing improved procedures for the identification, investigation, and prosecution of potential Medicare fraud. The demonstration would help make sure that payments for home health services are appropriate through either pre-claim or postpayment review, thereby working towards the prevention and identification of potential fraud, waste, and abuse; the protection of Medicare Trust Funds from improper payments; and the reduction of Medicare appeals.”

CMS has again proposed that the demonstration project will be implemented in five states. Much to the dismay of Illinois, Florida and Texas home health providers, they are STILL on the list of targeted states.  Michigan and Massachusetts are no longer slated to be part of the demonstration.  In their place, CMS has substituted Ohio and North Carolina.  CMS has stated that the new list of five states are:

“known areas of fraudulent behavior and had either a high home health improper payment rate or a high denial rate during the home health Probe and Educate reviews.”

Notably, CMS has indicated that there is the possibility that the Review Choice Demonstration project may later be expanded to other states in the Palmetto / JM jurisdiction.

As set out in the September 28th Federal Register notice, CMS intended to implement the Review Choice Demonstration project in Illinois on December 10, 2018. 

A. The Review Choice Demonstration Project is Intended to Offer Flexibility to Home Health Providers.

CMS has designed the Review Choice Demonstration project so that home health agencies in affected states have several ways that they may show their “compliance with CMS’ home health policies.”  Options available to home health providers include[8]:


Robert W. Liles defends health care providers in Medicare auditsRobert W. Liles serves as Managing Partner at the health law firm, Liles Parker, Attorneys and Counselors at Law.  Liles Parker attorneys represent health care providers and suppliers around the country in connection with UPIC audits, ZPIC audits, OIG audits and DOJ investigations.  Are your transcranial magnetic stimulation claims being audited?  We can help.  For a free initial consultation regarding your situation, call Robert at:  1 (800) 475-1906.


[1] https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/Home_Health_Medical_Review_Update.html

[2] https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Pre-Claim-Review-Initiatives/Overview.html

[3] https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/Electronic-Clinical-Templates/Downloads/Home-Health-Services-Plan-of-Care-Certification-Template-Draft-20180709-R20.pdf

[4] https://www.cms.gov/research-statistics-data-and-systems/monitoring-programs/medicare-ffs-compliance-programs/recovery-audit-program/

[5] https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/Electronic-Clinical-Templates/Downloads/Home-Health-Services-F2F-Encounter-Template-Draft-20180709-R20.pdf


[6] Additional information regarding the Probe and Educate process is outlined in MLN Matters, MLN Matters ® Number:SE1524.

[7] 81 Fed. Reg. 37598.  June 8, 2016.

[8] 83 Fed. Reg. 48818September 27, 2018.

Transcranial Magnetic Stimulation Claims Audits by Medicare MACs and UPICs are Underway. Are Your CPT 90868 Claims Compliant?

(July 16, 2018):  Do you provide Transcranial Magnetic Stimulation care and treatment services?  If so, you need to ensure that your medical necessity, documentation, coding and billing practices fully comply with applicable statutory, regulatory and administrative guidelines. In recent weeks, a flurry of prepayment review letters from Medicare Administrative Contractors (MACs) have been sent to physicians and health care entities seeking copies of the medical records and related documentation associated with transcranial magnetic stimulation services (also commonly referred to as TMS services).  Billed as CPT 90868, transcranial magnetic stimulation services are merely the latest risk area being examined by MACs and the associated Uniform Program Integrity Contractor (UPIC) assigned to a specific jurisdiction of the country.


I.  Why Are My Transcranial Stimulation Services Being Audited?

If you received notice of a prepayment or audit of your claims from a MAC or UPIC contractor working for the Centers for Medicare and Medicaid Services, you may have contacted the contractor to find out why your claims were selected for audit.  Although the CMS contractor may have advised you that your claims were “randomly” chosen for audit, nothing could be further from the truth.  At this time, CMS has not authorized its contractors to conduct random audits of provider claims.  As set out in the Federal Register:

“Although section 934 of the MMA sets forth requirements for random prepayment review, our contractors currently do not perform random prepayment review. However, our contractors do perform non-random prepayment complex medical review. We are cognizant of the need for additional rulemaking should we wish our contractors to perform random review.”[1]

If your claims were not audited as a result of a random review, then why were your claims selected for prepayment or postpayment review?  As set out in the Medicare Program Integrity Manual, Chapter 2, Section 2.4, Subsections A-C,  CMS processing and program integrity contractors have been directed to utilize data analyses as their primary tool to identify outliers and other providers that may be engaging in improper, fraudulent, wasteful and / or abusive coding and billing practices.  UPICs and other program integrity contractors have more than a dozen various utilization, coding and billing databases at their disposal in this regard.  Simply put, your claims were likely chosen for prepayment review because of a specific concern with respect to a type of service or because your utilization of one or more claims differed from that of your peers.

II. Overview of Transcranial Magnetic Stimulation Services:

Transcranial magnetic stimulation involves the noninvasive use of magnetic pulses to stimulate the brain. This treatment protocol involves the positioning of an electromagnetic coil on a patient’s scalp.  Once properly placed, an electric current is intermittently run through the electromagnetic coil, thereby producing brief magnetic pulses that painlessly pass through a patient’s brain. Transcranial magnetic stimulation services are normally conducted in an outpatient setting and do not require anesthesia or analgesia.  Although a number of proponents have consistently pressured Medicare to expand its current scope of coverage, at this time, only adults who have a confirmed diagnosis of Major Depressive Disorder, and meet a number of other requirements, qualify for transcranial magnetic stimulation under Medicare’s strict medical necessity requirements.

III.  Transcranial Magnetic Stimulation Claims Audits:

  • MAC prepayment targeting of transcranial magnetic stimulation claims.

Among its many functions, National Government Services (NGS) and other MACs around the country are required to conduct medical reviews of provider claims on a prepayment basis, to better ensure compliance with Medicare’s coverage and payment rules.[2]  The fact that NGS and other MACs are currently auditing transcranial magnetic stimulation (CPT Code 90868) claims, is significant because MACs are only required to initiate targeted provider-specific prepayment reviews “when there is the likelihood of a sustained or high level of improper payments.”[3]  It is also worth noting that providers are being directed to submit their supporting documentation directly to the Uniform Program Integrity Contractor (UPIC) assigned to their jurisdiction.

  •  UPIC reviews of transcranial magnetic stimulation claims.

UPICs are private, for-profit companies that awarded contracts to provide program integrity services for the Centers for Medicare and Medicaid Services (CMS).  UPICs are tasked with investigating instances of suspected fraud, waste, and abuse in the Medicare and Medicaid programs. Should the UPIC identify possible overpayments, the results of their audits will be sent back to the MAC for recoupment action. However, if evidence of possible fraud is identified, a UPIC may forward their findings to law enforcement for review, investigation and possible prosecution.[4]

IV.  Transcranial Magnetic Stimulation Audit Risk Issues (Partial Listing):

If you are providing transcranial stimulation services and billing them to Medicare, you need to keep in mind that the failure to meet the following requirements can quickly lead to an audit of your CPT Code 90868 claims:

  • Is the transcranial magnetic stimulation device approved by the Food and Drug Administration (FDA)?  In most instances, if a treatment device has not been approved by the FDA, CMS and its contractors will consider the device to be “experimental.”  As such, any transcranial magnetic stimulation treatment services performed will not be covered by Medicare.
  • Does the patient have a “confirmed” diagnosis of major depressive disorder?   For Medicare, this is a deal-breaker. Although a number of studies have been conducted examining the use of this treatment modality in connection with other diagnoses, none of these additional diagnoses are currently covered and will be considered “experimental” by CMS and its contractors.  A few examples of diagnoses that will be denied include schizophrenia, schizoaffective disorder epilepsy, cerebrovascular disease, and dementia.  Finally, it is important to keep in mind that UPIC auditors will be examining each case carefully to ensure that the diagnosis of major depressive disorder has been fully documented and validated (or otherwise confirmed).  UPIC auditors will be looking for assessments of the patient’s condition using standardized rating scales (such as the Beck Depression Scale or the Montgomery-Asberg Depression Rating Scale) that have been found to reliably measure the intensity of a patient’s depressive symptoms.  Merely concluding that a patient suffers from major depressive disorder without the test results to support your diagnosis is insufficient to support medical necessity.  Finally, under the LCD guidance issued by NGA, once transcranial magnetic stimulation treatment has been initiated, the provider is required to monitor the patient’s treatment response using the standardized rating scales discussed above (or a similar, widely accepted rating scale).
  • Transcranial magnetic stimulation treatment sessions must be ordered and supervised by a qualified individual. As LCD L33398 reflects, in order for transcranial magnetic stimulation therapy to be ordered (or reordered), the ordering physician must issue the order in writing.  Moreover, the ordering physician must have examined the patient, reviewed the record AND must have experience in administering transcranial magnetic stimulation therapy services.  As a final point, the treatment must be given under the direct supervision of the ordering physician.  In other words, the physician must be in the area and be immediately available.
  • Does your practice also bill for CPT Code 90836 claims? We have seen a higher likelihood of audit if you are also billing CPT Code 90836[4] claims along with your billing of transcranial magnetic stimulation services (CPT Code 90868). It is important to keep in mind that the billing of this “add-on” code may trigger an audit even in the absence of CPT Code 908686 billings. For example, in a September 2016 Medicaid case brought under Connecticut’s False Claims Act, it was alleged that the defendant was billing this “add-on” code for psychotherapy sessions when in fact, she instead provided medication management services, or a brief meeting with the patient for drug change/dosage adjustment.
  • Does your practice also bill for CPT Code 99214 claims? Audits of transcranial magnetic stimulation claims have also sometimes included a concurrent review of the provider’s CPT Code 99214[6] claims.  Since at least 2012 the Department of Health and Human Services (HHS), Office of Inspector General (OIG) has expressed its concerns with respect to the unsupported, improper billing of this Evaluation and Management (E/M) code.

V.  When Are Transcranial Magnetic Stimulation Services Covered by Medicare?

  • “Indications” — a confirmed diagnosis of Major Depressive Disorder is required for coverage.

Medicare has adopted strict requirements on the coverage and payment of transcranial magnetic services.  As set out in the Local Coverage Determination[7] (LCD) guidance published by NGS (LCD L33398)[8], transcranial magnetic stimulation services are only considered medically necessary “in adults who have a confirmed diagnosis of major depressive disorder (MDD), single or recurrent episode.”  Additionally, in order for the care to qualify for coverage and payment, the record must show:

In addition to having a diagnosis of "Major Depressive Disorder," one of these four conditions must be fully documented in the patient's medical records.

In addition to having a diagnosis of “Major Depressive Disorder,” one of the above four conditions must be fully documented in the patient’s medical records.

These requirements must be met in order to qualify for coverage under the “Limitations” section of LCD L33398.

  • Limitations to be considered.

As discussed in LCD L33398, providers must carefully assess the benefits to be derived from the use of transcranial magnetic stimulation. The benefits of TMS use must be carefully considered against the risk of potential side effect in patients with any of the following:

  • Transcranial magnetic stimulation is NOT considered reasonable and necessary in any of the following situations.

  • Documentation requirements.

UPIC Audits of Transcranial Magnetic Stimulation claims (also referred to as TMS claims) are ongoing.

UPIC audits are focusing on your compliance with the LCD’s documentation requirements. Are your Transcranial Magnetic Stimulation services fully documented?

  • Utilization guidelines.

VI.  How Can You Reduce Your Level of Regulatory Risk?

As discussed above, if your transcranial magnetic stimulation claims are targeted by a UPIC, the OIG or DOJ, the types of enforcement actions that can be pursued vary widely, depending the facts in your particular case. Unfortunately, since data mining is one of the primary ways that a potential target is identified for review, the first time that you know find out that your claims utilization practices are being assessed could be when you receive notice that your practice has been placed on prepayment review.  In more serious cases, you may receive a OIG subpoena for records or a Civil Investigative Demand for records from the DOJ.

As a first step, if you have not already done so, you need to develop and implement an effective Compliance Program.  Assuming that you already have such a program in place, take the time now, before you have a problem, to assess your care and treatment practices.  Does your documentation meet applicable requirements?  Have you documented that the care and treatment decisions made were medically necessary and appropriate?  Were the services properly coded and billed?

VII.  Responding to an Audit of Your Transcranial Magnetic Stimulation Claims:

  • Learning of a prepayment or postpayment audit.

If your practice is placed on prepayment review, you will likely learn of the action through the electronic claims status system maintained by your MAC.  Providers are normally given 45 days to submit the requested supporting documentation to their UPIC.  Should you fail to submit the requested documentation to the UPIC in a timely fashion, the very least that will happen is that your claims will be denied.  As set out under the Section 1815(a) of the Social Security Act:

“…no such payments shall be made to any provider unless it has furnished such information as the Secretary may request in order to determine the amounts due such provider under this part for the period with respect to which the amounts are being paid or any prior period.”

  • Don’t turn an administrative audit into a civil or criminal case.

In cases where a provider repeatedly ignores a request for records (or fails to submit the supporting documentation within the allotted time period), a UPIC will likely make a referral to the OIG for investigation and review.  Unfortunately, such a referral significantly raises the level of risk that a provider may face.  Depending on the OIG’s findings, a provider may be assessed Civil Monetary Penalties or even be excluded[9] from participation in Federal and State health benefits programs.  Additionally, if evidence of fraud or other improper conduct is identified, the case may be referred to the DOJ for civil action and / or criminal prosecution.

Moreover, once a problem has been discovered, a physician can significantly complicate matters by concealing the problem, destroying evidence or falsifying records.  Under various Federal obstruction statutes, a physician may be charged with obstruction of justice for willfully engaging in activities that obstruct, mislead, deceive, or impede a health care fraud investigation.

  • Engage qualified, experienced health law counsel.

Unfortunately, the days when a practice could feel comfortable directly handling a medium to large-sized audit, without assistance from legal counsel are becoming fewer and fewer each year.  There are a number of strategies that legal counsel may employ in an effort to minimize a physician’s possible exposure and liability.  Call an experienced health lawyer and ask him or her to walk you through the process. If the attorney hasn’t handled these cases on a regular and repeated basis, talk to another firm.

Robert W. Liles defends health care providers in Medicare audits

Robert W. Liles serves as Managing Partner at the health law firm, Liles Parker, Attorneys and Counselors at Law.  Liles Parker attorneys represent health care providers and suppliers around the country in connection with UPIC audits, ZPIC audits, OIG audits and DOJ investigations.  Are your transcranial magnetic stimulation claims being audited?  We can help.  For a free initial consultation regarding your situation, call Robert at:  1 (800) 475-1906.




[1] For additional information on how your claims may have been targeted for audit, please see the following related article, please see Physicians Being Placed on Non-Random Prepayment Review in Unprecedented Numbers. Are You Ready for an Audit?

[2] Medicare Program Integrity Manual, Chapter 3 – Verifying Potential Errors and Taking Corrective Actions. Section 3.4 Prepayment Review of Claims.

[3] See MPIM Section 3.4.A.

[4] Referrals to law enforcement are typically made to the Department of Health and Human Services, Office of Inspector General (OIG) and / or the U.S. Department of Justice (DOJ).

[5] CPT Code 90836 is an add-on code for individual psychotherapy, insight oriented, behavior modifying and/or supportive, 45 minutes with the patient and/or family member (time range 38-52 minutes) when performed with an evaluation and management service.

[6] This Evaluation and Management (E/M) code is used when billing for an “office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: a detailed history, a detailed examination and medical decision making of moderate complexity.”

[7] As set out in Medicare’s program integrity guidance, “An LCD is a decision by a Medicare administrative contractor (MAC) whether to cover a particular item or service on a MAC-wide basis in accordance with Section 1862(a)(1)(A) of the Social Security Act (i.e., a determination as to whether the item or service is reasonable and necessary).”  See MPIM 13.1.3. an issuance published by a MAC setting out coverage parameters for a particular service.  The LCD only applies to providers in states included in the MAC’s jurisdiction.  Having said that, if a particular jurisdiction does not have an LCD addressing a certain service, LCD guidance published by other MACs is often cited as persuasive (but not binding) authority.  The requirements set out in an LCD must be consistent with all applicable laws, regulations, and national policies for coverage, payment, and coding.  LCDs may address a specific clinical topic using procedure codes to define one or more treatments and using diagnostic codes to describe the clinical indications that would make the treatment(s) reasonable and Social Security Act § 1862(a)(1)(A), 42 U.S.C. § 1395y(a)(1)(A). necessary. For example, an LCD may limit coverage of an item or service to specific diagnoses, or it may prohibit coverage of an item or service completely. The coverage policy created by an LCD is applicable only in States within a contractor’s jurisdiction.

[8] NGS’s LCD guidance for Transcranial Magnetic Stimulation services is covered in LCD L33398.  This guidance applies to all services performed on or after June 15, 2018.

[9] For instance, under 42 USC §1320a-7(b)(6), an individual or entity can be excluded for a minimum of a year if found have submitted claims for excessive charges, unnecessary services or services which fail to meet professionally recognized standards of care.

Is Your Urogynecology, OB/GYN or Multidisciplinary Practice Prepared for a Medicare Biofeedback Claims Audit or a Pelvic Floor Therapy Claims Audit?

Medicare Audits of CPT Code 90911, Pelvic Floor Therapy Claims are Increasing!(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[1] 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.[2]  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.[3]  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).[4]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:

  1. Implementing written policies, procedures and standards of conduct;

  2. Compliance program administration;

  3. Screening and evaluation of employees, physicians, etc.;

  4. Communication, education and training on compliance;

  5. Monitoring, auditing and internal reporting systems;

  6. Enforcing standards through well-publicized disciplinary guidelines;

  7. 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.”[5]   

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. [6].  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.”[7]  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[8] 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:

          An assessment of Civil Monetary Penalties by the OIG;

          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.

VII.  Conclusion:

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.

Robert W. Liles defends health care providers in Medicare pelvic floor therapy claims auditsRobert W. Liles serves as Managing Partner at the health law firm, Liles Parker, Attorneys and Counselors at Law.  Liles Parker attorneys represent health care providers and suppliers around the country in connection with ZPIC audits, UPIC audits, OIG audits and DOJ investigations.  For a free initial consultation regarding your situation, call Robert at:  1 (800) 475-1906.

[1] 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.

[2] 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.”  

[3] 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.”

[4] National Coverage Determination (NCD) for Biofeedback Therapy for the Treatment of Urinary Incontinence (30.1.1),”  (effective July 1, 2001).

[5] 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.

[6] Use of Modifier 25;

[7] 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.

[8] 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.

CMS has Confirmed the Coverage of Personal Care Services by Medicare Advantage Plans Starting 2019.

Personal Care / Home Care Services will be Covered by Medicare Advantage in 2019.(June 26, 2018):  The coverage of personal care services by Medicare has been advocated by advocacy groups for many years.  As we reported last April, the Centers for Medicare and Medicaid Services (CMS) announced in its Final Call Letter for bids from plans that participate in the Medicare Advantage program (MA) for 2019.  In that Bid Letter, CMS announced that MA plans would be permitted to cover as supplemental benefits, certain types of health-related services even if the primary purpose of those services is daily maintenance.  Previously, CMS had considered an item or service to be primarily health related “…if the primary purpose of the service is to prevent, cure or diminish an illness or injury,” but not if the primary purpose is simply daily maintenance. As I noted in that article, that will change beginning in 2019.


I.  CMS Has Confirmed the Coverage of Personal Care Services by Medicare Advantage Plans in 2019:

At the time that I wrote that article, we posited that it was likely, but not made clear, that plans would be able to cover personal care services under the revised standards for supplemental benefits.  However, that appears to have now been confirmed that the new definition covers these services. In a speech that she made in May of this year at a conference presented at CMS Headquarters, Seema Verma, the Administrator of CMS stated:

For the first time ever, Medicare Advantage beneficiaries can access significant new flexibility for additional benefits that can help them live healthier, more independent lives. [MA] plans can offer benefits [beginning in 2019] that compensate for physical impairments, diminish the impact of injuries or health conditions, or reduced avoidable emergency room utilization.  This means Medicare Advantage beneficiaries will be provided adult day care services, respite care for caregivers, and in-home assistance with activities like bathing and managing medications.  Additionally, Medicare Advantage beneficiaries will have access to safety devices to better prevent injury in the home ….”[1]

Also at the conference, two CMS employees made a presentation the slide deck for which listed as examples of supplemental benefits that plans will now be able to cover in 2019, “Adult Day Care Services, Home-Based Palliative Care, In-Home Support Services, Transportation for Non-Emergent Medical Services, and Home & Bathroom Safety Devices and Modifications.”  That same slide deck describes the type of In-Home Support Services that MA plans will be able to cover as:

In-home support services performed by a personal care attendant or by another individual that is providing these services consistent with state requirements in order to assist individuals with disabilities and/or medical conditions with performing ADLs and IADLs as necessary to compensate for physical impairments, ameliorate the functional/psychological impact of or health conditions, or reduce avoidable emergency and healthcare utilization.  Services must be performed by individuals licensed by the state to provide personal care services, or in a manner that is otherwise consistent with state requirements.[2]

Thus, it is clear that MA plans will now be authorized to cover personal care services in the home beginning in January 2019, if they so choose.  The slide show presentation also specifies as requirements that the services: (a) must be medically appropriate; (b) must focus directly on an enrollee’s health care needs; (c) must be recommended by a physician or licensed medical professional as part of a care plan if not directly provided by one; must not be used primarily for comfort, general use, or other non-medical reasons; and (d) must not include items or services used to induce enrollment.[3]


Agencies and other providers that wish to provide these services to plan beneficiaries in 2019 should already have been speaking with the appropriate people at the MA plans that provide coverage in their service areas about covering these services in 2019, and should be speaking with the plans regarding their interest and requirements for becoming participating providers of these services.  If the plans are not covering these services in 2019, these agencies should be developing and presenting data that demonstrate cost-effectiveness of these programs, e.g.in preventing or reducing ER and hospital utilization, in order to convince the plans to cover these services in 2020 and thereafter.

Additionally, as I pointed out in our April article on the topic, the Bipartisan Budget Act of 2018 expands even further the supplemental benefits that MA plans may provide in 2020 and thereafter, to cover services that address certain social determinants that we now are discovering to be related to health.  Agencies should be tracking the progress of implementation of this provision as CMS begins to provide additional guidance on implementation, and also should begin speaking with their MA plans and developing data that support coverage of certain of these services that they wish to provide.

Finally, MA plans will expect providers of home and personal care that wish to be participating providers to have developed and implemented an effective compliance plan.  This will be especially critical given some of the compliance issues that have arisen in the past, of which they almost certainly will be aware.  In this regard, MA plans will almost certainly require that providers have a system for tracking their aides, which will also be required under state Medicaid programs in the future.


This article should be read in conjunction with the April article which goes into a bit more depth on the issues in the prior section.  CMS has now confirmed that MA plans will be afforded the opportunity to cover home and personal care services beginning in 2019.  Michael Cook and other Liles Parker attorneys have extensive experience in assisting clients throughout the health care industry, including home and personal care and home health agencies, in responding to new government and payor initiatives, and in establishing and maintaining an effective compliance program.  Anyone seeking a copy of either the speech by Seema Verma or the slide deck should contact Michael at the contact information provided, below.

MIchael Cook Represents Personal Care / Home Care Providers Around the Country.Michael Cook is a Partner and Co-chair of the Health Care Group at Liles Parker PLLC.  Mr. Cook has extensive experience in representing providers and suppliers of all types, including home and personal, and home health, agencies in regulatory, compliance, policy, and business matters throughout the country.  Mr. Cook also serves on the Board of the agency that advises Virginia’s Medicaid program. Anyone interested in discussing the material presented in this article should contact Michael Cook at 202-298-8750 or mcook@lilesparker.com.  

[1] Speech: Remarks by Administrator Seema Verma at the Medicare Advantage and Prescription Drug Plan Spring Conference (As prepared for delivery – May 9, 2018).

[2] Slide deck, Medicare Advantage Benefit Flexibility (Supplemental Benefits and Uniformity) presented by Heather Kilbourne, Division of Policy, Analysis, and Planning, Medicare Drug and Health Plan Contract Administration Group, Center for Medicare, CMS and Brandy Alston, Division of Policy, Analysis, and Planning, Medicare Drug and Health Plan Contract Administration Group, Center for Medicare, CMS.

[3] Id.  These requirements should not present a burden to home care agencies that participate in Medicaid given that many, if not all, states place similar requirements on personal or home care providers under that program.

An Overview of Administrative Rheumatology Audits / Adverse Actions AND Civil / Criminal Enforcement Actions

Rheumatology Audits are Increasing Around the Country.(May 20, 2018):  It’s been a rough week for at least one Texas rheumatologist.  Last Monday, the U.S. Attorney’s Office for the Southern District of Texas announced the indictment of a South Texas rheumatologist for multiple counts of health care fraud and one count of conspiracy to commit money laundering.  The magnitude of the alleged fraud is daunting — the government has estimated the size of the fraud at approximately $240 million Commenting on the case, John P. Cronan, Acting Assistant Attorney General for the Justice Department’s Criminal Division stated that the physician:

“. . . violated his oath to do no harm by administering unnecessary chemotherapy and other toxic medications to patients with serious diseases — including some of the most vulnerable victims imaginable — are almost beyond comprehension.”

The defendant is alleged to have “misdiagnosed” numerous patients, some of which were vulnerable individuals who were young, elderly or disabled.  Four of the five counts of health care fraud in the indictment are alleged to arise out of the defendant’s “False Diagnosis of Rheumatoid Arthritis.”  You may wonder, how does something like a false diagnosis happen?  Unfortunately, diagnosing a patient with rheumatoid arthritis isn’t as straight-forward as it may seem from reading the government’s indictment.  There isn’t a single test that can be run to determine whether a patient has this diagnosis.  Instead, a physician has to take into consideration a patient’s symptoms, blood and diagnostic test results (none of which are definitive on their own), and a patient’s family and prior medical history.  Taken collectively, a physician will typically use this information and apply industry-accepted diagnostic criteria.  Regardless of how this case ends up being resolved, rheumatologists around the country should take note of the concerns that the government has raised. While this case currently dominates the headlines, it is important to keep in mind that this isn’t the first time that law enforcement has focused its attention on rheumatologists.  Far from it.  This article provides an overview of cases that have been brought against these specialty practices and will cover a number of steps that a rheumatologist can take to reduce his / her level of risk.

I.  Overview of Administrative Adverse Actions and Rheumatology Audits Against Physicians and Rheumatology Practices:

Administrative adverse actions against rheumatologists can take a number of forms, including, but not limited to: licensure actions, exclusion actions, and administrative claims audits.

A.  Texas Medical Board Disciplinary Actions.

As illustrated in this first case, it is imperative that rheumatologists fully document their mental impressions and the reasoning behind diagnostic conclusions reached.    

  • Texas Physician Failed to Properly Document Objective Medical Evidence to Support a Rheumatology Diagnosis.

In this case, the Texas Medical Board (Board) entered into an Agreed Order[1] with a physician alleged to have violated the standard of care in a number of cases.  More specifically, the Board alleged that the physician provided treatment that was inappropriate and nontherapeutic. Additionally, the physician was alleged to have failed to perform adequate testing and document objective medical evidence to support his diagnosis for several patients.  Under the Agreed Order, the Board required that the physician submit the medical records of all of his rheumatology patients to a Board-approved rheumatologist for monitoring purposes for a set period of time.  The physician was also required to complete 24 hours of CME (four hours in medical record-keeping and 20 hours in rheumatology). How can you avoid committing these types of licensure violations? When documenting your medical decision-making process, Texas rheumatologists need to ensure that their medical records comply with both the applicable standard of care[2] AND fully meet the documentation mandates outlined in the Texas Administrative Code, Title 22, Part 9, Chapter 165. Medical Records §§165.1-165.6.[3]

B.  OIG Exclusion Actions.

As early as 1977, the Department of Health and Human Services (HHS) has been “excluding” individuals and entities from participation in Federal health benefits programs.  The HHS, Office of Inspector General (OIG) assumed responsibility for taking these administrative actions in 1981.[4]  What is an exclusion?  Simply put, if an individual is subjected to an adverse licensure action[5], is convicted of certain crimes, or has engaged in other specific enumerated conduct[6], he / she may be excluded from participation in Federal health benefits programs. It is important to keep in mind that an excluded party is not merely barred from participating in Medicare, Medicaid and other Federal health benefit programs.  Excluded parties may not even work for an organization that participates in these government health benefit programs.  There are two types of exclusion actions that are taken by the OIG.  “Mandatory” exclusion actions must be imposed by the OIG if an individual or entity is convicted of certain crimes.  In contrast, the OIG exercises the authority to impose or to waive certain exclusion actions that may be triggered by one or more other violations.  These types of exclusion actions are “Permissive” in nature.

As of April 2018, there are a total of 69,875 individuals and entities named in the List of Excluded Individuals and Entities (LEIE) maintained by the OIG.  The LEIE is one of 40 various databases that are supposed to be checked every 30 days[7] by providers in order to better ensure that no excluded parties have been hired. Of the 69,875 excluded individuals and entities currently on the LEIE, only five are specifically identified as physicians specializing in rheumatology.  Nevertheless, it is difficult to fully assess the number of physicians on the list that provide rheumatology services because of the limitations in the specificity of OIG’s database.  As we will see below, a number of the cases brought against rheumatologists for criminal conduct would undoubtedly require mandatory exclusion, in addition to any civil and criminal sanctions that may have been imposed.

C.  Administrative Rheumatology Audits by ZPICs and UPICs.

As a participating provider in Medicare’s Part B program, rheumatologists and their practices are subject to prepayment audit by a number of federal, state and private payor audit entities.  If your practice is placed on prepayment audit by a Medicare contractor, you may want to know how you ended up on the auditor’s radar.  We have repeatedly heard of instances where a Medicare contractor has told the practice that their placement on prepayment review was the result of a “random audit.”  Despite their assurances to the contrary, physicians should keep in mind that virtually NONE[8] of the Medicare audits we have seen are truly random.  The following Federal Register issuance included agency comments that confirm what we have all thought, CMS and its contractors do not conduct random prepayment audits of health care providers.  As CMS expressly set out in the Federal Register:

“Although section 934 of the MMA sets forth requirements for random prepayment review, our contractors currently do not perform random prepayment review. However, our contractors do perform non-random prepayment complex medical review. We are cognizant of the need for additional rulemaking should we wish our contractors to perform random review.”

How is a rheumatology practice targeted for an audit?  As the Centers for Medicare and Medicaid Services (CMS) has expressly noted in Chapter 2, Section 2.3 of the Medicare Program Integrity Manual (MPIM):

“Claims data is the primary source of information to target abuse activities.”

Utilizing this data, Medicare program integrity contractors employ predictive modeling and data mining to identify rheumatology care, treatment, coding and billing practices that would be considered “outliers” when compared to the utilization, coding and billing practices of their peers.  In the first quarter of 2018, we have already seen evidence that law enforcement, government agencies and their contractors are continuing to rely on data mining for targeting purposes.  How do your utilization, coding and billing practices compare to those of your peers?  No idea?  Now is the time to find out! Rheumatology audits are actively being conducted by Zone Program Integrity Contractors (ZPICs) and Uniform Program Integrity Contractors (UPICs) around the country.

Other sources of an audit include complaints by beneficiaries, overpayment data, referrals from other Medicare program integrity contractors, and reports published by OIG and Government Accounting Office (GAO) of specific improper coding and billing practices that they identified. Several of the specific issues identified in ZPIC and UPIC audits of rheumatology-related claims that we have defended have included:

  1. Failure to Document a Diagnosis of Arthritis. The alleged failure to document a diagnosis of arthritis has been cited as a basis for taking action in ZPIC and UPIC administrative audits, Texas Medical Board disciplinary actions, civil False Claims Act cases and criminal prosecutions of rheumatologists.  As discussed in more detail in our discussion of rheumatology audits, this denial reason is subject to considerable dispute.  Unfortunately, there isn’t a single “test” or “symptom” that can be relied on by a physician when diagnosing a patient with rheumatoid arthritis, ankylosing spondalytis or a host of other rheumatic diseases.  Instead, a physician often relies on his / her professional experience and knowledge when diagnosing a patient with one of the conditions.  This problem is further exacerbated by the fact that CMS and its contractors have not issued specific guidelines (in the form of National Coverage Determination (NCD) or Local Coverage Determination (LCD) guidance) that outlines precisely what the government expects to see in order for a diagnosis to be properly documented.  Ultimately, a physician will need to show that the diagnosis has been based on accepted criteria such as 2010 American College of Rheumatology / European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis.”[9]

  2. Failure to Properly Document the Evaluation and Management (E/M) Level of the Visit. Despite the fact that specific guidance (1995 and 1997 E/M Guidance) on how Medicare E/M claims are supposed to be documented, coded and billed, many physicians still apply the less-specific, incorrect guidance set out in the AMA’s CPT Codebook.  When audited, Medicare program integrity contractors have often downcoded (or in some case, denied in their entirety) E/M claims.  (Although the AMA CPT Codebook is applicable when billing E/M services to private payors, the 1995 and 1997 E/M Guidance first issued by HCFA should be used as the proper measuring tool for Medicare claims).

  3. Failure to Fully Document a Patient’s Condition. ZPICs and UPICs are regularly denying claims on the basis that a physician’s physical examination of the patient does not document the specific joints where swelling has been identified, the extent a patient’s range of motion has been impacted, the level of pain cited by a patient, and the duration of the patient’s painful condition.

  4. Failure to Document the Medical Necessity of Biologics Used in Infusions. Not surprisingly, in large part due to its high cost, the medical necessity of infusions has been a favorite target of Medicare program integrity contractors and federal / state prosecutors.  Auditors often point out the fact that a physician has failed to document less invasive (and less expensive) treatment options that had been tried and failed to provide relief.

If a rheumatology practice is placed on prepayment review, it can be financially devastating for the organization.  Once put in place, it can take months to satisfy the Medicare contractor that it should be lifted.  Adding insult to injury, after a practice is placed on prepayment review, it is fairly common for a ZPIC or UPIC to then initiate a postpayment audit of the practice’s rheumatology claims.  While postpayment audits are not new, the number of these audits appears to be increasing.  Moreover, ZPICs and UPICs are frequently pulling a relatively small sample of 30 – 60 claims and then are extrapolating the alleged damaged based on the error rate that has been identified in the sample. In such case, we almost always work our own statistical experts to challenge the validity of the statistical sampling process and the resulting extrapolation of damages. Due to the high costs of biologics, it is fairly common for ZPICs and UPICs to seek alleged overpayments of millions of dollars.

II.  Overview of Civil and Criminal Fraud Cases Brought Against Physicians for Rheumatology-Related Care and Treatment Services: 

  • Rhode Island Remicade® Infusion Fraud Case.

In this Rhode Island case, a physician was indicted by a Federal Grand Jury for health care fraud, illegal distribution of controlled substances, and money laundering.  The 152-count indictment also sought the forfeiture of about $5.9 million, alleged to be the proceeds of the physician’s criminal activity.  Over a four-year period, the physician was alleged to have personally treated more than 4,800 patients. A significant portion of the physician’s practice was the administration of infusion therapy to treat the symptoms of such diseases as rheumatoid arthritis, various blood disorders, and certain cancers.  Among the many counts set out in the indictment, the physician is alleged to have administered Remicade® without substantiating that a number of patients had been properly diagnosed as having rheumatoid arthritis.  Notably, he also reportedly failed to treat patients with necessary ancillary drugs and failed to test patients for certain risks associated with Remicade®, such as tuberculosis.  Finally, the physician is also alleged to have recorded dosages of Remicade® that greatly exceeded the recommended maximum dosages.  Before he could be arrested, the physician fled the country and is a fugitive on the OIG’s “Most Wanted List” today.  He is thought to have fled to Lebanon.

  • Virginia Remicade® Infusion Fraud Case.

In this case, the Federal Bureau of Investigation (FBI) first began investigating a Virginia-based physician after receiving a report from a former patient that the physician had been overprescribing controlled substances.  Essentially, the former patient claimed that the physician prescribed the patient “whatever drugs she wanted” without performing a physical exam or medical tests.  As a result of the FBI’s investigation, the physician was indicted for the illegal distribution and for conspiring to distribute controlled substances. In the course of the investigation, the FBI interviewed two of the physician’s former employees.  In doing so, the FBI learned that the physician was also allegedly engaged in fraudulent conduct involving Remicade®.  After analyzing the physician’s billing practices, purchasing records and bank records, the government concluded that the physician had engaged in a number of fraudulent practices involving the billing of Remicade®.  The government’s concerns in this regard were later confirmed when the physician’s former assistant pleaded guilty to conspiring to distribute controlled substances.  The physician’s former assistant later testified at trial that the following four main fraudulent schemes were employed by the physician.  First, the physician was alleged to have billed for more Remicade® than the patients actually received.  Second, the physician billed for Remicade® infusions when the patients received a less expensive steroid medication.  Third, the physician supposedly billed for Remicade® infusions when the patients did not receive any infusions.  And, finally, the physician is alleged to have billed for Remicade paid for by other patients’ health care benefit programs.  Before the physician could be arrested, he fled the jurisdiction and is thought to have gone to Turkey.

  • Kentucky Remicade® Infusion Fraud Case. 

In a case out of the Western District of Kentucky, a Louisville physician and his practice were alleged to have falsely billed the Medicare program for infusions of infliximab, a drug used in the treatment of patients with rheumatoid arthritis.  The specific allegations were that the physician and practice were “splitting” vials of infliximab across the infusions of multiple patients but billed the Medicare program as if a whole vial were used for each Medicare beneficiary.  It was further alleged that this improper conduct took place over a period of three years. A former employee of the practice filed a whistleblower case against the physician and his practice under the civil False Claims Act. The case was later settled for $349,860.00.  The defendants also had to pay for the whistleblower’s attorney’s fees.

  • Oklahoma Remicade® Infusion Fraud Case.

In a case that was initially filed by a whistleblower under the civil False Claims Act, an Oklahoma physician in the Western District of Oklahoma was also later criminally charged with Medicare fraud. Through its investigation, the government claims that over a period of approximately 28 months, the practice billed Medicare for the infusion of 112,110 milligrams of Remicade.®  However, it was alleged that during this period the practice had only ordered approximately 49,600 milligrams from its suppliers. The government further alleged that the physician had falsified patient records and caused his staff to submit false claims to Medicare for payment.  The physician was sentenced to 33 months in prison and surrendered his state medical license.  A $1.5 million civil consent judgement was entered in the case.  The defendant was also ordered to pay $473,881.55 in restitution to Medicare and $69,685.26 in restitution to BlueCross BlueShield of Oklahoma. 

  • Texas Allergy / Arthritis / Pain Management Clinic Alleged to be a Pill Mill.

Law enforcement investigators have found that a significant number of rheumatology patients are being treated multidisciplinary practices.  In this case, a husband and wife (both physicians) ran a number of Texas clinics that provided care allergy, arthritis and pain management patients.  Government investigators carefully tracked the number of patients being seen by the physicians, noting that they went from seeing 50-60 patients per day to 279 patients per day over a seven-year period. Additionally, through data-mining and the intra-agency sharing of information, law enforcement also noted that one of the physicians allegedly prescribed 615,671 tablets of hydrocodone (Vicodan®), 66,000 tablets of alprazolam (Xanax®), and 26,000 tablets of diazepam (Valium®) over a nine-month period. In fact, one patient received 92 hydrocodone prescriptions, totaling 8,040 tablets over an eight-month period. After conducting search warrants of the couple’s two clinics, residence and safe deposit boxes, investigators found $700,000 at the residence and $816,000 in the safe deposit boxes (allegedly only accessible by one of the physicians).[10]  In addition to the improper prescription of controlled substances outside the scope of professional practice and not for a legitimate medical purpose, the couple was also alleged to have billed Medicare and Medicaid for a number of fraudulent interventional procedures.  Investigators alleged that the physicians would inject patients with a lidocaine / steroid combination that would provide patients with a temporary relief of various joint and muscle pain.  Despite the fact that these injections were superficial, the procedures were falsely billed to insurance companies as facet joint injections, paravertebral injections, sacroiliac nerve injections, sciatic nerve injections and various nerve block injections.[11] Nearly every patient was prescribed one or more controlled substances and put on a regimen of shots every two weeks. Initially, patients were required to sign the medical progress and procedure notes in their patient chart to prove they were at the clinic and received the shots. This subsequently changed and the physician had certain patients sign blank procedure/progress notes and then used those forms to generate a superbill in order to bill the insurance companies for injection procedures on days when the patient was not in the clinic.

  • New Jersey Rheumatologist Convicted of Investigational Research Fraud.

A New Jersey rheumatologist was sentenced to four years in prison after pleading guilty[12] to the falsification of clinical data.  The physician had been paid $1.86 million by drug companies to provide investigational new drug research nonsteroidal anti-inflammatory drugs (NSAIDS).  The physician failed to conduct the research as agreed. Instead, he fabricated lists of patients supposedly participating in the study.  He then is alleged to have falsified urine, stool and blood studies and forged the signatures of other clinicians.  The rheumatologist also failed to report the deaths of two patients supposedly included in the “study.”  Notably, the deaths were not related to the drugs being studied because they were never really in the study.

  • Ohio Rheumatologist Convicted of “Misbranding.”

In this case, an Ohio rheumatologist pleaded guilty to importing medications that had not been approved by the Federal Drug Administration (FDA). The physician admitted causing the shipment of misbranded[13] drugs, which is a misdemeanor violation of the Food, Drug and Cosmetic Act.  As a misdemeanor violation, the physician faces a statutory maximum of up to one year in prison and fines up to $100,000.

  • Kentucky Rheumatologist Convicted of “Misbranding.”

In this case, a Kentucky physician pleaded guilty to a misdemeanor criminal charge of treating patients with misbranded medications.  He was later sentenced to a term of one-year probation and was ordered to pay $176,915.55 in restitution.  The physician admitted to purchasing Rituxan®, Actemra®, Remicaid®, Aclasta®, Prolia®, and Synvisc® from foreign drug distributors based in the United Kingdom.  The drugs originated outside the United States and were never approved by the FDA for introduction into the United States. These misbranded medications were then administered to patients under the physician’s supervision.  Additionally, under a separate civil agreement, the physician agreed to pay $338,493.30 to settle certain claims brought against him by the OIG.

III.  Steps You Can Take to Reduce Your Level of Risk:

  • Fully Document Your Basis for Concluding that a Patient has a Specific Diagnosis.

As the administrative, civil and criminal cases above reflect, it is imperative that physicians providing rheumatology care and treatment services take a critical look at their documentation practices.  More than likely, there are a number of additional steps you can take to fully document the process you went through when diagnosing a patient with rheumatoid arthritis, ankylosing spondalytis or another rheumatic disease.  Moreover, you need to tie your evaluation to the applicable standard of care and industry recognized protocols for diagnosing the patient’s condition.   Have you fully documented a patient’s medical, family and present history?  Have you noted the results of your hands-on evaluation of the patient’s joints, range of motion, etc.?  Have you documented all of the prior treatment approaches that were tried and failed to address the patient’s painful condition? Have you ordered and documented the results of specific blood tests that should be considered in the course of reaching a diagnosis?  Have radiology test results been included your decision-making process?

Just to be clear, despite the fact that the government often heavily relies on “Industry Standards of Care” when assessing a provider’s case, it is important to keep in mind that diagnostic algorithms (such as those published by the American College of Rheumatology) are only part of the answer. As Jeffrey A. M.D., a Visiting Fellow at the Goldwater Institute and a Senior Fellow at the Cato Institute has noted:

“[P]racticing under the yoke of the algorithm discourages critical thinking. There is a tendency to surrender to the algorithm. This jeopardizes good patient care and can impact outcomes. There are times when a patient’s presentation and response to treatment do not follow the algorithm—their DNA did not get the memo about the guidelines. A physician must think “outside the box” to help that patient—an attribute that is discouraged and becomes a lost skill under the algorithmic regime.”

  • Your Infusion of Costly Biologics Will Undoubtedly be Audited at Some Point.

Is a rheumatology audit in your future? If your practice or clinic administers infusions, your claims will be audited by one or more Medicare program integrity contractors.  With this in mind, you need to carefully document the medical necessity of this treatment option.  Moreover, keep in mind that CMS and its MACs have issued NCDs, LCDs and other specific guidance governing the utilization of Remicade, Enbrel, and a number of other costly drugs.  When is the last time you have reviewed this guidance?

  • Develop, Implement and Comply with the Provisions Set Out in an Effective Compliance Program.

The government doesn’t expect you to be perfect.  Nevertheless, you do expect you to try your best to follow applicable rules and regulations governing the billing of claims to the Medicare program.  If you implement an effective Compliance Program and diligently work to comply with its requirements, you will significantly reduce your level of claims risks.  Remember, self-audits aren’t just encouraged, they are required by law under the Affordable Care Act and are especially important if your practice wants to be viewed as a good corporate citizen.  Through periodic auditing and monitoring your practice’s activities you can better avoid:

  1. The submission of false and fraudulent claims;

  2. Engaging in overbilling;

  3. Improperly using a provider’s number to bill for claims that were provided by a different individual;

  4. The improper solicitation of referrals;

  5. Engaging in medical identity theft;

  6. The improper billing for services by unlicensed individuals;

  7. The improper administration of infusion by unsupervised staff; and

  8. The employment of excluded individuals.

  • Avoid Engaging in Business Practices that Could Constitute (or be Misinterpreted to be) Kickbacks / Disguised Kickbacks and / or Bribes.

It isn’t sufficient to only focus on your documentation, medical necessity, coverage, coding and billing practices.  If you or your practice is ever investigated, federal and state prosecutors will systematically evaluate each and every one of your business arrangements.  Simply put, where do your referrals come from and where do you send referrals.  These business relationships will be exhaustively examined by the government.  Some of the risk areas identified have included:

  1. Be especially careful before your practice or clinic enters into any business arrangement with a compounding pharmacy.

  2. A continuing concern of the government involves lease arrangements with actual and / or potential referral sources.

  3. Situations where a physician serves as a medical director to a hospice, home health agency, or nursing home to whom you make patient referrals.

  4. Serving as a consultant or speaker to a pharmaceutical manufacturer, compounding pharmacy or durable medical equipment supplier whose products you prescribe.

  5. Participating in a sham loan arrangement with an entity to whom you make referrals or whose products you prescribe, order or recommend.

  6. Acquiring or having a financial interest in an entity to whom you send referrals (especially if the referral is for Designated Health Services which could implicate Stark).

  7. Accepting cash, gifts or other Items of value from a patient or other individual in exchange for a prescription for opioids or other controlled substances.

  8. Accepting or soliciting any type of remuneration (something of value), such as a gift card, sporting event tickets or liquor, from a pharmaceutical representative, compounding pharmacy or DME supplier whose products you order or prescribe (or could order or prescribe).

Prior to entering into a business arrangement, we strongly recommend that you contact an experienced health lawyer so that an assessment of the risks can be conducted and an evaluation of whether the arrangement may violate the False Claims Act, the Anti-Kickback Statute or Stark.

  • Keep in Mind that the Government is Actively Pursing Individuals for Their Role in the Commission of White Collar Fraud.

While culpable individual defendants have regularly been prosecuted, over the past decade, most DOJ prosecutors have focused on seeking large financial fines and penalties from corporations.  For example, how many individuals can you think of that went to jail when the banking sector almost collapsed?  On September 9, 2015, Deputy Attorney General Sally Quillian Yates issued a Memorandum entitled “Individual Accountability for Corporate Wrongdoing” (Yates Memo).  This historic document instructs DOJ prosecutors to stop resolving corporate cases that release individuals from personal liability, absent extraordinary circumstances. Throughout the rest of 2018, we expect to see an increase in parallel proceedings and prosecutions of physicians, managers, coders, billers and other non-clinical staff who are alleged to have violated the law. Your personal conduct, and your efforts to comply with applicable rules and regulations will be assessed by DOJ if there is ever a problem.

Robert W. Liles defends health care providers in Medicare audits

Robert W. Liles, J.D., M.B.A., M.S., serves as Managing Partner at Liles Parker, Attorneys & Counselors at Law.  Robert and other Liles Parker attorneys represent rheumatologists and rheumatology practices in connection with Medicare ZPIC and UPIC prepayment and postpayment audits, Medicaid investigations and audits, and private payor payment holds.  Is your practice being audited or under investigation?  Call Robert for a free initial consultation.  1 (800) 475-1906. 



[2] The American College of Rheumatology has prepared decision trees that can be used to diagnose (or rule out) certain type of rheumatic disease.  For example, the algorithm used to determine if a patient is suffering from rheumatoid arthritis is set out at the following link: https://www.rheumatology.org/Portals/0/Files/2010%20RA%20Classification%20Tree_Tree%20Format%202010.pdf

[3] http://www.tmb.state.tx.us/idl/3E399486-3B51-843A-AAD2-E67B31810FB0

[4] https://oig.hhs.gov/faqs/exclusions-faq.asp

[5] Such as a licensure suspension or revocation.

[6] For instance, under Section of the Medicare Program Integrity Manual, if a provider is placed on prepayment review for an extended period of time and has not corrected their pattern or practice after receiving educational/warning letters, Zone Program Integrity Contractors (ZPICs) and Uniform Program Integrity Contractors (UPICs) are directed by the Centers for Medicare and Medicaid Services (CMS) to refer the provider to the OIG for possible “exclusion” action.

[7] For additional information on exclusions, and your obligation to check Federal and State databases every 30 days, see the articles published on the Exclusion Screening website.  www.exclusionscreening.com

[8] Please note, there is one narrow exception to this basic rule that I am aware of.  When a Comprehensive Error Rate Testing (CERT) audit is conducted, the CERT auditor is essentially auditing a specific previously-paid type of claim to determine whether a Medicare Administrative Contractor (MAC) was correct in allowing the claim to be paid.  To accomplish this, the CERT auditor pulls a sample of specific paid services submitted for payment in a MAC region.  Providers with claims in the sample universe are then randomly pulled by the CERT auditor.

[9] https://www.aafp.org/afp/2011/1201/p1245.html#afp20111201p1245-t1

[10] FBI Press Release, SDTX, June 24, 2009, “Husband and Wife Charged with Operating a Pill Mill,” https://archives.fbi.gov/archives/houston/press-releases/2009/ho062409.htm

[11]U.S. Attorney’s Office, Southern District of Texas, Press Release. June 3, 2013.


[12] https://pink.pharmaintelligence.informa.com/PS015210/NSAID-INVESTIGATOR-ORDERED-TO-REPAY-DRUG-FIRMS–186-MIL

[13] Section 502 of the Federal Food, Drug and Cosmetic Act (FFDCA) contains provisions on misbranding including some that relate to false or misleading labeling.  A device’s labeling misbrands the product if:

  • Its labeling is false or misleading in any particular;
  • It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
  • Any required wording is not prominently displayed as compared with other wording on the device, or is not clearly stated;
  • Its label does not bear adequate directions for use including warnings against use in certain pathological conditions or by children where its use may be dangerous in health or against unsafe dosage, or methods, or duration of administration or application;
  • It is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labeling; or
  • It does not comply with the color additives provisions listed under Section 706 of the FFDCA;
  • The device’s established name (if it has one), its name in an official compendium, or any common or usual name is not prominently printed in type at least half as large as that used for any proprietary name;
  • The establishment is not registered with FDA as required by Section 510 of the FFDCA and has not listed the device as required by Section 510(j) of the FFDCA or obtained applicable premarket notification clearance as required by Section 510(k) of the FFDCA;
  • The device is subject to a performance standard and it does not bear the labeling prescribed in that standard;
  • There is a failure or refusal to comply with any requirement related to notification and other remedies prescribed under Section 518 of the FFDCA, if there is a failure to furnish any materials or information required by, or requested by the Secretary pursuant to, Section 519 of the FFDCA, or if there is a failure to furnish materials or information relating to reports and records required by Section 522 of the FFDCA; or
  • There is any representation that creates an impression of official approval because of the possession by the firm of an FDA registration number.


Expect an Increase in Audits of Chiropractic Services!

Chiropractic Services(April 16, 2018): Chiropractors around the country are again finding their services and claims under intensive scrutiny from Medicare contractors and investigators, despite the fact that only three services even qualify for coverage and payment.  Several weeks ago, the Department of Health and Human Services (HHS), Office of the Inspector General (OIG) released its latest critical assessment of chiropractic services currently being billed to the Medicare program. The agency’s report, entitled “Medicare Needs Better Controls To Prevent Fraud, Waste, And Abuse Related To Chiropractic Services,”[i] reemphasizes the OIG’s prior findings that the Centers for Medicare and Medicaid Services (CMS) still lacks appropriate safeguards to prevent the submission and payment of improper, sometimes fraudulent claims for chiropractic services to the Medicare program.  This article is intended to highlight the government’s concerns and outline the steps that a provider should take to better ensure that any chiropractic services billed to Medicare qualify for coverage and payment.

I. Improper Chiropractic Claims Remain a Problem:

At the outset, it is important to recognize that in recent years, CMS and its program integrity contractors have taken a number of steps to elevate the level of scrutiny placed on questionable chiropractic claims billed to Medicare. Nevertheless, the OIG has taken the position that considerable work still needs to be done in order to better protect the Medicare program from fraudulent, wasteful and abusive chiropractic billings. For example, the average improper payment rate for Medicare Part B services has been estimated at between 9.9%-12.9%. For chiropractic services, the improper payment rate has been estimated to be between 43.9%-54.1%. About half of all chiropractic services covered by Medicare were not supposed to be covered.  The OIG has estimated that of the nearly $450 million spent by Medicare on chiropractic services every year, between $257 million and $304 million in improper payments are being made every year for chiropractic services.[ii] Over a six-year period, $2.9 billion was spent by Medicare on chiropractic services. Theoretically, this means that at least $1.27 billion was wasted over those six years.

  • Submit claims for services that never occurred.

  • Submit claims for services that were medically unnecessary.

  • Bill for services covered by Medicare but provided other services such as a massage or acupuncture.

  • Falsified patient medical records.

  • Provided services to beneficiaries without a valid license.

  • Offered incentives to patients to receive unnecessary services.

During this six-year period, 11[iii] of the chiropractors were incarcerated and over 500 chiropractors were excluded from participation in the Medicare and Medicaid programs by the OIG for various reasons. The OIG remains concerned that inadequate oversight is continuing to allow fraudulent chiropractors to hide their improper billings from regulators

II. What Solutions Has CMS Tried?

In an effort to spur more detailed documentation, CMS implemented the initial treatment date requirement for claims. This requirement has been more effective than the AT modifier requirement, as 7 out of 8 contractors do check to ensure this requirement is met. In that respect, this is a successfully implemented requirement. However, when audited, this requirement has largely failed due to inadequate documentation. Approximately 86% of all claims that included an initial treatment date did not adequately document the medical necessity of the services provided. Once again, it appears that chiropractors are aware that the initial date is necessary for payment and will include the date regardless of the quality of their documentation.

At the urging of the OIG, CMS has made significant efforts to better educate chiropractors on the importance of proper documentation and which chiropractic services are actually covered by Medicare Part B. CMS has create publications, seminars, and an educational video for chiropractors to learn about services that are covered under Medicare Part B and how to meet documentation standards. Unfortunately, either through lack of provider participation or because of difficulties in accessing the information, this initiative has largely failed.  Many chiropractors and beneficiaries remain ignorant with respect to the  medical necessity, documentation and coverage requirements of chiropractic services under Medicare Part B. For example, one of the educational videos created by CMS is supposed to educate chiropractors on how to meet documentation requirements. This video only received 8,898 views between December 2015 and January 2017. Even if we were to assume that every view was by a licensed chiropractor (which is highly unlikely), it only reached a fraction of the chiropractors participating in the Medicare program. CMS will likely need to implement more changes that may lead chiropractors to utilize educational resources and improve documentation.

III. Would A Medical Review Threshold or Service Limit Work?

Approximately 61% of private insurance plans that participate in the federal employee health benefits program (FEHBP) cover chiropractic services. Of the FEHBP private insurance plans that cover chiropractic services, there are limits between 10 and 60 services per year, with the average plan limiting patients to 21 chiropractic services per year. The concept of limiting the number of services a beneficiary has been proposed by the OIG in the past, but CMS did not agree with this solution.

A medical review threshold is a limit on the number or cost of services before a review of medical necessity must be completed to continue coverage of future services. CMS states that contractors may set thresholds for the number of services allowed before medical review, but may not limit the number of services provided. There is no CMS-level medical review threshold, but as mentioned earlier 2 of the 8 contractors have already set medical review thresholds. CMS-level medical review thresholds are already in place for out-patient therapy specialties such as physical therapy and speech-language pathology. The threshold for these two specialties is monetary, at $1,920. After a beneficiary reaches $3,700 in physical therapy or speech -language pathology services, a medical review s needed for the beneficiary to continue treatment.

The OIG conducted a nationwide review of the percentage of “unallowable payments” made for three groups of beneficiaries, divided by the number of services received in a calendar year. The first group received 1-12 chiropractic services in a year, 76% of which were unallowable payments. The second group received between 12-30 chiropractic services in a year, of which 95% were unallowable payments. The final group received more than 30 chiropractic services in a year, of which every single payment was unallowable. It is worth noting that the two contractors that had set a medical review threshold had no beneficiaries in the last category. Based on this assessment, HHS-OIG estimates that a threshold for medical review between 12-30 services would have saved Medicare between $95 million and $447 million between 2013-2015. Additionally, that same threshold would have saved beneficiaries between $24 million and $114 million in out-of-pocket expenses over the same period. 

IV. HHS-OIG Recommendations:

In addition to highlighting issue with the current system, OIG’s report provided a few recommendations for CMS to consider implementing:

  • Work with contractors to educate chiropractors on the training resources that CMS has already made available to them
  • Educate beneficiaries on which chiropractic services are and are not covered by Medicare Part B, and encourage beneficiaries to report chiropractors that are providing services that should not be covered by Medicare.
  • Identify chiropractors with high-service denial rates or aberrant billing practices, estimate the amount of overpayments made through a statistically significant sample, and recover the overpayments
  • Establish a threshold for the number of services that may be provide before a medical review is needed

V. Chiropractic Basics – Medicare Coverage Limitations: 

Chiropractors diagnose and treat subluxation disorders primarily through manual adjustment and manual manipulation of the spine.  CMS defines subluxation as “a motion segment, in which alignment, movement integrity, and/or physiological function of the spine are altered although contact between joint surfaces remains intact”[iv] More simply put, a spinal subluxation is a purported misalignment of the spinal column that can cause pain and other symptoms in patients suffering from this misalignment.  One question that regularly arises when documenting chiropractic services is:

“How does Medicare expect me to show that evidence of subluxation if present?”

In most instances, a Medicare contractor will review a provider’s documentation to determine if an x-ray has been used, or a physical examination was conducted to document subluxation. Each of these diagnostic methods are discussed below:

• Subluxation determination based on an x-ray. If a provider has determined that a subluxation is present based on an x-ray,[v] a Medicare contractor will likely take into consideration when the x-ray was taken and how much time has elapsed before a course of treatment was initiated. As discussed in Local Coverage Determination (LCD) L34009 published by Noridian Healthcare Solutions, LLC (Noridian), the contractor requires that an x-ray must have been taken at a time “reasonably proximate” to the start of care. Noridian considers an x-ray to be reasonably proximate to the initiation of care if it was taken no more than 12 months prior to or 3 months following the initiation of a course of chiropractic treatment. Understandably, Noridian will typically allow a chiropractor to base his / her subluxation determination on an older x-ray if a beneficiary’s medical records show that the patient has suffered from a chronic subluxation condition (such as scoliosis) for longer than 12 months AND there is a reasonable basis to believe that the chronic condition is permanent.

• Subluxation determination based on an a physical examination. If a provider has determined that a subluxation is present based on a physical examination that has been conducted, a CMS contractor is going to review the medical documentation to determine if two of the following four criteria have been identified during the examination of the patient’s musculoskeletal / nervous system, one of which must be either asymmetry / misalignment or range of motion abnormality. The four criteria examined include:

• Pain/tenderness evaluated in terms of location, quality, and intensity;
• Asymmetry/misalignment identified on a sectional or segmental level;
• Range of motion abnormality (changes in active, passive, and accessory joint movements resulting in an increase or a decrease of sectional or segmental mobility); and
• Tissue, tone changes in the characteristics of contiguous, or associated soft tissues, including skin, fascia, muscle, and ligament.

A limited scope of chiropractic services qualify for coverage under Medicare Part B if they are performed by a licensed, qualified chiropractor. Regrettably, CMS still takes the position that most of the various services offered by a chiropractor are “supportive” in nature rather than “corrective.”  In other words, CMS considers most chiropractic services to be “maintenance therapy,” which is not covered under Medicare Part B. As maintenance therapy, CMS does not consider most chiropractic services to be medically necessary.

So what chiropractic services ARE covered under Medicare Part B?  Frankly, not many. CMS specifically limits Medicare Part B coverage to hands-on manual manipulation of the spine for symptomatology associated with spinal subluxation. Additionally, qualifying hand-held manual devices (where the thrust of the force of the device is manually controlled) may also be used by chiropractors in performing manual manipulation of the spine. Notably, Medicare does not recognize any additional charges associated the use of such a hand-held device.

When documenting a covered service, a chiropractor must note the precise level of the subluxation. Depending on the number of spinal regions involved, one of three Current Procedural Terminology (CPT) codes can be billed:

• CPT Code 98940 (for treatment of one or two spinal regions);
• CPT Code 98941 (for treatment of three or four spinal regions); and
• CPT Code 98942 (for treatment of all five spinal regions).

The five regions of the, from the cervical area (neck) to the coccyx (tailbone) are illustrated below:

Chiropractic Services

When providing chiropractic services that are intended to provide active / corrective treatment, Medicare requires chiropractors to append the claim with an AT modifier.  The AT modifier is intended to denote the fact that “Acute Treatment” for subluxation was provided to the beneficiary.  If a chiropractor bills one of the three covered codes without an AT modifier, the service will be automatically denied as not medically necessary when the claim is processed by your Medicare Administrative Contractor (MAC).

In most instances, properly coded chiropractic services (limited to 98940, 98941 and 98942) will qualify for payment.  Having said that, both CMS contractors and OIG have repeatedly found that just because a claim has been appended with the AT modifier does not mean that the chiropractic services billed were in fact, medically necessary. In multiple audits conducted over the last decade, government reviewers have found that chiropractors have failed to properly document the medical need for services billed to Medicare.

Although Medicare has not placed a limit on the number of chiropractic services that a beneficiary can receive, providers who appear to be billing an excessive number of services will quickly be flagged for medical review by a MAC, a Zone Program Integrity Contractor (ZPIC) or a Uniform Program Integrity Contractor (UPIC). It is essential that you carefully document the medical necessity of any services billed. At present, pre-authorization to confirm the medical necessity of a treatment is only required by two MACs. One contractor sets its threshold for medical review as 12 services per month but no more than 30 services per year. The other sets a threshold of 25 chiropractic services per year.

VI. Documenting Chiropractic Services:

It is important to keep in mind that under Title XVIII of the Social Security Act, §1862(a)(1)(A), services must be medically reasonable and necessary in order to qualify for coverage and payment.  Similarly, Title XVIII of the Social Security Act, §1833(e) prohibits Medicare from paying for any claims that lacks the necessary information to process the claim.  Therefore, regardless of whether the determination of a subluxation has been based on an x-ray or a physical examination, a chiropractor must ensure that complete and accurate records of the encounter are taken.

Experience has shown that in the event of an audit by a CMS contractor, the MAC, ZPIC or UPIC auditing chiropractic services will primarily base claims on a provider’s failure to properly document the medical necessity of the services billed. It is therefore essential that you review and understand your documentation obligations when billing for chiropractic claims. As a first step, you need to review:

CMS Medicare Benefit Policy Manual, Pub. 100-2, Chapter 15, Sections 30.5 and 240.
• CMS Medicare Claims Processing Manual, Pub. 100-4 Chapter 12, Section 220.

Moreover, you should continue to periodically review any LCD guidance on chiropractic services that has been issued by your MAC.  Again using Noridian’s LCD guidance as an example, during an initial visit, the MAC expects a provider to document the following six categories of information when providing chiropractic services:

A. Documentation Requirements – Initial Visit. The following documentation requirements apply whether the subluxation is demonstrated by x-ray or by physical examination:

#1. Family History / Past Medical History.
• Symptoms causing patient to seek treatment;
• Family history if relevant;
• Past health history (general health, prior illness, injuries, or hospitalizations; medications; surgical history);
• Mechanism of trauma;
• Quality and character of symptoms/problem;
• Onset, duration, intensity, frequency, location and radiation of symptoms;
• Aggravating or relieving factors; and
• Prior interventions, treatments, medications, secondary complaints.

#2. Description of the Present Illness.
• Mechanism of trauma;
• Quality and character of symptoms/problem;
• Onset, duration, intensity, frequency, location, and radiation of symptoms;
• Aggravating or relieving factors;
• Prior interventions, treatments, medications, secondary complaints; and
• Symptoms causing patient to seek treatment.

Importantly, the “symptoms” covered in your description of the patient’s present illness are required to be directly related to the level of subluxation. When describing a patient’s symptoms:

• The symptoms should refer to the spine, muscle, bone, rib and / or joint and be reported as pain, inflammation, or as signs such as swelling, spasticity, etc.
• The symptoms documented must be related to the level of the subluxation that has been cited. A statement on a claim that there is “pain” is insufficient.

Finally, the location of a patient’s pain must be described and the symptoms documented must be related to the level of the subluxation that has been cited.  Noridian further requires that the location of pain must be described and whether the particular vertebra listed is capable of producing pain in the area determined.

#3. Evaluation of musculoskeletal/nervous system through physical examination.

#4. Diagnosis. The primary diagnosis must be subluxation, including the level of subluxation, either so stated or identified by a term descriptive of subluxation. Such terms may refer either to the condition of the spinal joint involved or to the direction of position assumed by the particular bone named.

#5. Treatment Plan. The treatment plan should include the following:
• Recommended level of care (duration and frequency of visits);
• Specific treatment goals; and
• Objective measures to evaluate treatment effectiveness.

#6. Date of the initial treatment.

B. Documentation Requirements: Subsequent Visits.  The following documentation requirements apply whether the subluxation is demonstrated by x-ray or by physical examination:

#1. History.
• Review of chief complaint;
• Changes since last visit;
• System review if relevant.

#2. Physical exam.
• Exam of area of spine involved in diagnosis;
• Assessment of change in patient condition since last visit;
• Evaluation of treatment effectiveness.

#3. Documentation of treatment given on day of visit.  The patient must have a significant health problem in the form of a neuromusculoskeletal condition necessitating treatment, and the manipulative services rendered must have a direct therapeutic relationship to the patient’s condition and provide reasonable expectation of recovery or improvement of function. The patient must have a subluxation of the spine demonstrated by x-ray or physical exam as described above.

VII.  Conclusion

It has been more than 20 years since the OIG first identified chiropractic billings as a potential fraud and abuse problem.  To their dismay, the AT modifier requirement, initial treatment date documentation requirement, and educational resources have failed to significantly remedy the level of improper claims for chiropractic services being billed to the Medicare program. In light of the OIG’s latest report, chiropractors should expect CMS and its MAC, ZPIC and UPIC contractors to increase their audits of chiropractic claims.  Providers should also expect to see oversight through education, medical review, limits to the number of services, and documentation requirements.

What should you do?  Get back to basicsWhen is the last time you compared your medical necessity, documentation, coding and billing practices to those outlined in your respective LCD and the Medicare Benefit Policy Manual.

Need help?  Give us a call.  Our attorneys are experienced in representing chiropractors in audits and investigations of their Medicaid and private payor claims.

Chiropractic ServicesRobert W. Liles, J.D., M.B.A., M.S., serves as Managing Partner at Liles Parker, Attorneys & Counselors at Law.  Liles Parker attorneys represent chiropractors and chiropractic practices around the country in connection with Medicare, Medicaid and private payors claims audits.  We also represent chiropractors in connection with complaints filed against our clients with the State Chiropractic Board.  For a complimentary review and discussion of your issues, you can call Robert at: (202) 298-8750.  


[i] Department of Health and Human Services, Office of Inspector General. Medicare Needs Better Controls To Prevent Fraud, Waste, And Abuse Related To Chiropractic. A-09-16-02042. February 2018.
[ii] CMS’s Supplementary Appendices for the Medicare Fee-for-Service Improper Payment Reports for 2010–2015.
[iii] In one case, when an audit was initiated against a chiropractic practice, the chiropractor supposedly falsely reported a robbery had taken place and that medical records were stolen from his car. This triggered a fraud investigation that led to a 63-month fraud conviction, over $1 million in restitution, and a 23-year exclusion for the chiropractor.
[iv] Medicare Benefit Policy Manual, Chapter 15, §240.1.2.
[v] Noridian will usually permit a previous CT scan MRI to be used as evidence if a subluxation of the spine is demonstrated.

CBRs for Spinal Orthoses (CBR201803): What Do You Need to Know?

CBR201803(April 12, 2018): The Centers for Medicare & Medicaid Services (CMS) utilizes a variety of private contractors to process Medicare claims and conduct both administrative and program integrity audits of claims submitted by healthcare providers and suppliers.  At the present time, CMS has contracted with eGlobalTech (eGT) to analyze data and prepare “Comparative Billing Reports (CBRs) of various services and claims billed to the Medicare program. eGT works directly with another CMS contractor, Palmetto GBA (Palmetto), to conduct the statistical work that is necessary to complete the CBR process. The latest report to be issued by eGT is CBR201803.

I.  eGT is Currently Distributing CBRs to Spinal Orthoses Suppliers:

The most recent CBR review initiated by eGT has been focused on Spinal Orthoses Suppliers. On April 2, 2018, eGlobalTech sent out letters to affected suppliers around the country advising them of the initiation of CBR201803: Spinal Orthoses Suppliers. This CBR is focused on orthotic suppliers that have billed the Medicare Part B program for both off-the-shelf and custom-fitted prefabricated spinal orthoses (commonly referred to as “braces”[1]) in claims with dates of service from October 1, 2016 to September 30, 2017.[2]  CBR201803 focuses on the following Healthcare Common Procedure Coding System (HCPCS) codes:

Prefabricated Custom-Fitted Spinal Orthoses.[3]

L0627: Lumbar orthosis, sagittal control, with rigid anterior and posterior panels

L0631: Lumbar-sacral orthosis, sagittal control, with rigid anterior and posterior panels

L0637: Lumbar-sacral orthosis, sagittal-coronal, with rigid anterior and posterior panels

Prefabricated Off-the-Shelf-Fitted Spinal Orthoses.[4]

L0642: Lumbar orthosis, sagittal control, with rigid anterior and posterior panels

L0648: Lumbar-sacral orthosis, sagittal control, with rigid anterior and posterior panels

L0650: Lumbar-sacral orthosis, sagittal-coronal, with rigid anterior and posterior panels

 II.  The Improper Billing of Medicare Claims for Spinal Orthoses Has Been a Long-Standing Problem for CMS:

The initiation of CBR201803 is merely the government’s most recent attempt to address long-standing problems that have repeatedly been identified in connection with the coverage, coding and billing of spinal orthoses by authorized Medicare suppliers.  As eGT has noted on its website (and in correspondence with affected suppliers), Lumbar-Sacral Orthoses have been on the government’s Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMSPOS) list of “Top 20 Service Types with Highest Improper Payments” as far back as 2013. In fact, as set out in the most recent assessment of improper billing data by the Department of Health and Human Services (HHS), entitled “2017 Medicare Fee-for-Service Supplemental Improper Payment Data,” the estimated improper error rate for Lumbar-Sacral Orthoses was 52.5%. The magnitude of this problem is easily seen when compared with the overall improper payment rate for ALL Medicare claims which has been estimated at 9.5%.  Finally, it is worth noting that the HHS Office of Inspector General (OIG) identified concerns with the billing of orthotic braces in both its 2016 and 2017 Work Plans.[5]

III.  How Were Spinal Orthoses Suppliers Categorized this Review?

At last count, more than 6,000 qualified DME suppliers billed Medicare Part B for spinal orthoses under one of the six HCPCS codes outlined above.  In an effort to define peer groups for general comparison purposes, DMEPOS suppliers and physicians / non-physicians were assigned to a specialty peer group, based on their assigned Medicare Specialty Code and whether or not the provider / supplier was likely to have orthotist training The following categories were used by eGT:

 Peer Group#1:  DMEPOS Supplier Not Likely to Have Orthotist Training 
Medicare Specialty CodeMedicare Provider / Supplier Type Description
A6Medical Supply Co. with Respiratory Therapist
B1Oxygen Supplier
54Medical Supply Co. — Other
58Medical Supply Co. with Registered Pharmacist
63Portable X-Ray Supplier
87All Other Suppliers
 Peer Group#2:  DMEPOS Supplier Likely to Have Orthotist Training 
Medicare Specialty CodeMedicare Provider / Supplier Type Description
B3Medical Supply Co. with Pedorthic Personnel
51Medical Supply Co. with Certified[6] Orthotic Personnel
52Medical Supply Co. with Certified Prosthetic Personnel
53Medical Supply Co. with Prosthetic / Orthotic Personnel
 Peer Group#3:  Physician / Non-Physician Not Likely to Have Orthotist Training 
Medicare Specialty CodeMedicare Provider / Supplier Type Description
01General Practice
02General Surgery
08Family Practice
11Internal Medicine
16Obstetrics / Gynecology
19Oral Surgery (Dentists Only) (LLP)
30Diagnostic Radiology Head
40Hand Surgery
41Optometry (LLP)
48Podiatry (LLP)
84Preventative Medicine
93Emergency Medicine
94Interventional Radiology
99Unknown Physician Specialty
 Peer Group#4:  Physician / Non-Physician Likely to Have Orthotist Training 
Medicare Specialty CodeMedicare Provider / Supplier Type Description
B2Pedorthic Personnel
12Osteopathic Manipulative
20Orthopedic Surgery
23Sports Medicine
25Physical Medicine and Rehabilitation
35Chiropractic (LLP)
55Individual Orthotic Personnel
56Individual Prosthetic Personnel
57Individual Prosthetic / Orthotic Personnel
65Physical Therapist in Private Practice
67Occupational Therapist in Private Practice
70Single or Multispecialty Clinic or Group Practice
72Pain Management

CBR contractors (eGT and Palmetto) then calculated statistics for each of the separate peer groups.  As the categories reflect, the CBR contractors separated suppliers from providers and then further stratified the two primary groups by whether or not they were “likely” to have orthotist training.  While the CBR contractors expressly recognized that an individual may be specially trained to custom fit beneficiaries with a medically necessary orthosis, for the purposes of this review, they still ultimately categorized both suppliers and providers by Medicare specialty code based on the contractors’ assessment of whether a specific specialty was likely to have specialized orthotist training.[7] Unfortunately, there are likely a number of instances where eGT’s presumption of whether a supplier has orthotist training may be just plain wrong.

IV.  Why Was My DME Company Included in this Review?

A Comparison of Your Billing Percentages for Each of the Six HCPCS Categories of Spinal Orthoses.  As a first step, the CBR contractors compared each supplier’s billing patterns, by HCPCS code, with those of other suppliers in their peer specialty group.  To the extent that a supplier’s utilization ratios were aberrant when compared to the ratios of their peers, the supplier was more likely to be sent a CBR.

The Percentage of Allowed Services Defined as Custom-Fitted.  Another primary assessment conducted by the CBR contractors is whether the percentage of spinal orthoses submitted for payment by a supplier was billed as a “custom fitted” brace.  The percentage of custom-fitted braces billed by a specific supplier was compared to the percentage billed to their DME MAC contractor by other suppliers in their respective peer specialty group.  Each supplier’s percentage of custom-fitted brace billings were also compared to the national average.  If a specific supplier’s percentage was deemed to be “significantly higher” than one of these peer groups, it was one step closer to being sent a CBR.

The Percentage of Allowed Services Submitted without a Visit to the Referring Provider within 90 Days of the DMEPOS Service Date.  Another factor analyzed by the CBR contractors is whether a significant percentage of beneficiaries fitted (either custom-fitted or off-the-shelf) for a brace by a specific supplier had not been seen by their referring provider within 90 days of the DMEPOS service date (the date that the spinal orthosis order was filled by the DMEPOS supplier).  Simply stated, red flags are going to be raised if you fill a prescription / order for a brace and the patient hasn’t seen his / her referring provider within the previous 90 days.[8]  Once again, the CBR contractor compared each specific supplier’s percentage to the percentage billed to their DME MAC contractor by other suppliers in their respective peer specialty group.  Each supplier’s percentage of custom-fitted brace billings were also compared to the national average.

The Average Allowed Charges per Beneficiary for the One-Year Period.  The CBR contractors also examined the average allowed charges of each supplier billed to Medicare per beneficiary and compared this number to average allowed charges of other suppliers in their peer specialty group.  If a supplier’s average allowed charged were significantly higher than that of their peers, it was more likely to be issued a CBR.

V.  The Results of an Assessment by eGT:

After reviewing the utilization and billing practices of each spinal orthoses supplier, if a specific supplier’s measures were considered to be Significantly Higher than their peers in at least one of the three factors discussed above, the supplier was issued a CBR.

  1. Supplier is significantly higher than at least one of its peer groups on at least one of the measurements studied;

  2. Supplier is near or above the 45th percentile in allowed charges ($5,000); and

  3. Supplier had at least ten beneficiaries.

VI. Responding to a CBR:

If your company received a CBR, you likely noted the fact that eGT may expressly state in its reports that “no reply is necessary.”   While that may technically be the case, after handling CBRs for many years, our experience (and the collective experience of our associates) has been that your organization is much more likely to be audited if you do not respond and address any misconceptions or incorrect positions about your billing pattern stated by the contractor in its report.

To be clear, if you receive a CBR, you need to immediately take steps to validate or invalidate eGT’s findings.  If, in fact, your billing practices have been improper, you have an affirmative obligation to take steps to remedy any deficiencies. Additionally, the risk issues identified by eGT should be incorporated into your existing Compliance Program and should be taken into account when you perform periodic internal claim audits and monitoring functions.

VII.  Get Ready for Follow-Up Audits by ZPICs / UPICs!

Although your claims haven’t yet been audited, if you received one of these reports an audit of your claims may be right around the corner.  While it has been our experience that responding to a CBR is helpful, (and may reduce your chances of having a prepayment or postpayment Zone Program Integrity Contractor (ZPIC) or Uniform Program Integrity Contractor (UPIC) audit) if eGT has based its assessment on incorrect assumptions, there are no guarantees that a CMS program integrity contractor won’t still choose to initiate an audit of your claims for one or more braces billed to Medicare.

As a CBR recipient, you need to recognize that your organization has been identified as an outlier and there is significant likelihood that your spinal orthoses claims will be audited in the near future by a ZPIC or a UPIC, especially if you have not taken steps to identify and correct any misconceptions about your billing practices that the CBR contractor has made.

Now, more than ever, it is essential that suppliers review their documentation and ensure that they are fulling complying with all applicable requirements to show that each brace was medically necessary, fully documented, properly coded and billed.  For instance, as set forth under the Medicare Program Integrity Manual:

“All DMEPOS items…require detailed written orders prior to billing. Detailed written orders may take the form of a photocopy, facsimile image, electronically maintained, or original ‘pen-and-ink’ document. The written order must be sufficiently detailed, including all options or additional features that will be separately billed or that will require an upgraded code. The description can be either a narrative description (e.g., lightweight wheelchair base), or a brand name/model number. All orders must clearly specify the start date of the order.”

The failure to fully document the delivery of a brace is another significant risk faced by spinal orthoses suppliers.  ZPICs and UPICs routinely refuse payment citing this reason for denial.  As discussed in the Medicare Program Integrity Manual:

“Suppliers are required to maintain proof of delivery documentation in their files. Proof of delivery documentation must be maintained in the supplier’s files for 7 years (starting from the date of service).” 

Pursuant to 42 C.F.R. Sec. 424.57(c)(12), proof of delivery:

Must be responsible for the delivery of Medicare covered items to beneficiaries and maintain proof of delivery. (The supplier must document that it or another qualified party has at an appropriate time, provided beneficiaries with necessary information and instructions on how to use Medicare-covered items safely and effectively).”[9]

VIII.  Potential Liability for Non-Compliance:

After receiving a CBR, you may soon find that your supplier claims will be subject to  prepayment or postpayment audit by a ZPIC or UPIC. Alternatively, you may merely receive an “Additional Document Request” (ADR) from a CMS contractor.  ADRs aren’t uncommon and most suppliers have received multiple such requests since becoming a participating supplier in the Medicare program.  Nevertheless, in recent years, ADRs have taken on a new level of importance. ZPICs and UPICs aren’t hesitating to place a supplier on 100% prepayment review if the documentation submitted in response to an ADR results in the denial of one or more claims.

Similarly, if a supplier is placed on prepayment review and a significant percentage of your claims are denied when the associated supporting documentation is submitted, there is much higher risk that your claims will be subjected to a postpayment audit.  In some cases, a high error rate identified in a prepayment or postpayment audit has led to the suspension of Medicare supplier’s billing privileges. Unfortunately, this “snowball effect” of cumulative adverse administrative actions may not be over. In accordance with 42 C.F.R. Sec. 424.57(e), a CMS contractor may recommend to the agency that your billing privileges are “revoked” if a supplier is found not meet applicable conditions of payment:

“Failure to meet standards. CMS will revoke a supplier’s billing privileges if it is found not to meet the standards in paragraphs (b) and (c) of this section. (The revocation is effective 15 days after the entity is sent notice of the revocation, as specified in §405.874 of this subchapter.)” 

IX. Conclusion:

Despite what you may have been told, CBRs are far from benign.  If a provider or supplier has received a CBR (such as, but not limited to CBR201803), it may be a harbinger of future administrative audits or in more serious cases, a possible civil and / or criminal investigation of your billing practices.  While every case is different, if the CBR contractor’s CBR findings (as outlined in their letter to your organization) are incorrect, it is typically in your best interests to correct the record.  Our attorneys are experienced in assessing these matters and can assist your organization is putting its best foot forward when responding to a CBR, the receipt of an ADR, prepayment review or postpayment audit.  Give us a call for a free consultation.  1 (800) 475-1906.

CBR201803Robert W. Liles, J.D., M.B.A., M.S., serves as Managing Partner at the law firm of Liles Parker, Attorneys & Clients at Law.  Robert represents providers and suppliers around the country in ZPIC / UPIC audits, Medicare suspension actions and revocation cases.  For a complimentary consultation, please call: 1 (800) 475-1906.

[1] As set out in the Chapter 15, Section 130 of the Medicare Benefit Policy Manual, braces are “rigid and semi-rigid devices which are used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body.”

[2] eGT’s analysis is based on a snapshot of claims in the Integrated Data Repository as of January 24, 2018.

[3] As set out in the Joint DME MAC Publication, a “Custom-Fitted Orthosis,” is defined as:

  • Devices that are prefabricated.
  • They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
  • Classification as custom fitted requires substantial modificationfor fitting at the time of delivery in order to provide an individualized fit, i.e., the item must be trimmed, bent, molded (with or without heat), or otherwise modified resulting in alterations beyond minimal self-adjustment.
  • This fitting at delivery does require expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthosis to fit the item to the individual beneficiary.

[4] Off-the-shelf (OTS) orthotics are defined as:

  • Items that are prefabricated.
  • They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
  • OTS items require minimal self-adjustmentfor fitting at the time of delivery for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit an individual.
  • This fitting does not require expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthoses to fit the item to the individual beneficiary.

[5] In both its 2016 and 2017 Work Plans, OIG noted that it would be reviewing the reasonableness of Medicare payments for orthotic braces when compared to the amounts paid by other non-Medicare payers..

[6]A “certified” individual is someone who is certified by either the American Board for Certification in Orthotics and Prosthetics, Inc., or the Board for Orthotist/Prosthetist Certification.

[7] As set out in Appendix C of the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Quality Standards, “Individuals supplying the item(s) set out in this appendix must possess specialized education, training, and experience in fitting, and certification and/or licensing.”  While the CBR contractors expressly recognized that an individual specially trained to custom fit beneficiaries that have a medical need for an orthosis.

[8] To determine this, the CBR contractor checks to see if the referring provider billed for a Part B visit within 90 days of the service date of the DMEPOS claim.

[9] https://www.gpo.gov/fdsys/pkg/CFR-2005-title42-vol2/pdf/CFR-2005-title42-vol2-sec424-57.pdf


ZPIC Audits / UPIC Audits: The Impact of Transmittal 768 on the Medicare Appeals Process Timeline.

Transmittal 768(April 12, 2018): A big concern with the Medicare appeals process is the ghastly backlog at the Office of Medicare Hearings and Appeals (OMHA) for an Administrative Law Judge (ALJ) hearing coupled with the government’s authority to recoup alleged overpayments after the second level of appeal (reconsideration). There is renewed buzz regarding the backlog and potential recourse given the Fifth Circuit’s decision on March 27, 2018 in Family Rehabilitation, Inc. v. Azar, No. 17-11337, which affirmed the possibility for providers to sue for an injunction to prevent Medicare Administrative Contractors (MACs) from recouping overpayments until administrative appeals are concluded under the collateral-claim exception. But what about the snail-like pace of postpayment reviews at the very beginning of this process?  As discussed below, Medicare’s Transmittal 768 may alleviate this continuing problem to some extent.

I.  Continuing Delays by ZPICs / UPICs in Completing an Initial Review – Overview of the Problem:

Before claims are appealable, they have to be denied on review. A major source of massive extrapolated alleged overpayments are postpayment reviews by Zone Program Integrity Contractors (ZPICs) and their successor Unified Program Integrity Contractors (UPICs). Our experience has been that these reviews usually take many months, even years. This is in spite of the fact that providers are required to turn over the requested records in somewhere between 15 and 30 days, maybe even 45 days if the provider requests an extension. The investigators typically remain tight-lipped throughout the review and investigation process. Inquiries about the status of a review are usually met with no response or cryptic feedback like “The review findings will be provided at the conclusion of the review.” In the meantime, providers are expected to sit on their hands. Then one day, a letter arrives which often reflects an unmanageable alleged overpayment figure for the provider and the provider is left to dispute the alleged overpayment through “Medicare’s Byzantine four-stage administrative appeals process” – in the words of Circuit Judge Jerry E. Smith in Family Rehabilitation, Inc. v. Azar.

II.  New Timelines Under Transmittal 768 for ZPICs / UPICs to Complete a Postpayment Review:

There has been a development that may effectuate speedier postpayment reviews by ZPICs and UPICs. The Centers for Medicare and Medicaid Services (CMS) issued guidance, which imposes a new timeline and requirements on these contractors effective March 1, 2018. Specifically, the transmittal adds the following requirements to Chapter 3 of the Medicare Program Integrity Manual:

the UPICs / ZPICs shall complete postpayment medical review and provide the lead investigator with a final summary of the medical review findings that includes reference to the allegations being substantiated/not substantiated by medical review, reasons for denials, and any observations or trends noted within 60 calendar days” and “[t]he counting for the 60-day time period begins when all of the documentation is received by the UPIC / ZPIC contractor.”

Please note, however, that this is an internal timeline for the contractors (as between the medical reviewer(s) and lead investigator), meaning that providers should not expect to receive the postpayment audit results within 60 days of having submitted the records to the UPIC / ZPIC. However, Transmittal 768 may be useful to put pressure on the contractors when reviews are pending for months or years on end.

For a detailed discussion of the ZPIC program and process, please see: ZPIC Audits.

Lorraine Rosado is Experienced Applying Transmittal 768 When Handling ZPIC Audits and UPIC Audits.Lorraine A. Rosado, J.D., is a Senior Associate at Liles Parker and has extensive experience representing Medicare providers and suppliers around the country in administrative claims audits, suspension and revocation cases.  She is also performed a number of IRO reviews in connection with annual CIA reviews by HHS-OIG.  Should you have any questions regarding an administrative enforcement action, please feel free to call Lorraine for a free consultation.  She can be reached at: (202) 298-8750.

Medicare Advantage Plans May Soon Offer Personal Care Services

Personal Care

(April 10, 2018):  On April 2, the Centers for Medicare and Medicaid Services (CMS) announced an expansion of the benefits that private health plans may offer Medicare beneficiaries under the Medicare Advantage (MA) program in 2019.  In its Final Call Letter for bids from plans that participate in the MA program (“MA plans”) for 2019, CMS expanded the services that plans would be permitted to offer in 2019 as supplemental health related benefits, even if the primary purpose of those benefits includes daily maintenance.  While these benefits are not required to be included in MA plans, plans are provided the latitude to include them if they choose and may very well change the reimbursement landscape for personal care agencies around the country.

I.  Background:

As background, MA Plans are permitted to offer certain benefits that are not included as part of the Medicare fee for service, or Original Medicare, benefits, if those benefits are, among other things, primarily health related.  As discussed in the Final Call Letter, CMS considers an item or service to be primarily health related “…if the primary purpose of the item or service is to prevent, cure, or diminish an illness or injury.”  However, CMS previously has not considered a service to fit within this category if the primary purpose is daily maintenance.

II.  Expansion of Coverage for Personal Care Services:

In the Final Call Letter, CMS recognizes that there is value in certain services that “diminish the impact of injuries or health related conditions and reduce avoidable emergency and health care utilization.”  The Letter does not specify the benefits that would fall under this rubric, but includes as an example, fall prevention devices for individuals at risk high risk for falling and similar products that protect against injury resulting from falls.  The Letter further states that services that diminish the impact of injuries and health conditions and reduce avoidable utilization can be included as supplemental benefits under certain circumstances, even if a significant purpose of the item is daily maintenance.”

As further described in the Letter, “[u]nder the new interpretation, in order … to be ‘primarily health related’ … [an item] must diagnose, prevent, or treat an illness or injury, compensate for physical impairments, act to ameliorate the functional/psychosocial impact of injuries or health conditions, or reduce avoidable emergency and healthcare utilization.”  The intent is to provide plans with the flexibility to offer supplemental benefits that can enhance quality of life and improve health outcomes.

The service must, however, be medically appropriate, recommended by a licensed provider as part of a plan of care, and cannot include items or services that are solely to induce enrollment.  The Letter also indicates that CMS will be issuing more detailed guidance in the future.

As noted, above, while not entirely clear, it is quite possible that MA plans will be permitted to cover personal care services under the revised standards for supplemental benefits.  Indeed, in a press release issued by CMS announcing a draft of the Bid Letter for comment in early February, CMS described the proposal as allowing supplemental benefits to “include services that increase health and improve quality of life, including coverage of non-skilled in-home supports, portable wheel chair ramps and other assistive devices and modifications when patients need them.” (Emphasis supplied.)  While neither the press release accompanying the Final Bid Letter nor the Letter, itself, includes any language specifically referencing these items, the broader language of the Final Letter can certainly be read to permit plans to offer personal care services under certain circumstances.

III.  What Steps Should Your Personal Care Agency Take?

So what can a provider that wishes to offer these services, including personal care services, as part of an MA plan for 2019, do at this point?  First, providers can be watchful for additional guidance from CMS that should be forthcoming.  Second, they can begin to approach the MA plans that cover a significant number of MA subscribers in their service area to discuss both including these items or services as supplemental benefits in the plans’ upcoming bids to CMS for the 2019 year, and to discuss pricing.   In doing so, providers should be prepared with data or other information demonstrating that offering the service will reduce costs without harming patients.  For example, a provider that wished to offer personal home care services would attempt to prepare a cost benefit analysis showing that home visits reduce the incidence for hospital admissions or admissions to skilled nursing facilities. Additionally, if the MA plan is also a provider of Medicaid managed care services, the provider may also include in the analysis the cost/benefit of lowering admissions to the nursing facility long stay side of the equation.  There are other permutations to the analysis, but the key is to begin discussions with the various plans, and to accumulate data that demonstrate both the short term and long-term cost and health benefits of the particular service.

Providers that wish to take advantage of this opportunity should also note that the Bipartisan Budget Act of 2018 expands supplemental benefits for chronically ill enrollees to also encompass benefits that are not primarily health related in certain circumstances beginning in 2020.  This change recognizes the importance of certain social determinants to health status – something that some state Medicaid programs are beginning to recognize as well.  However, this change only affects “chronically ill” beneficiaries and does not begin until 2020, whereas the expanded definition of supplemental benefits in the Bid Letter affects services provided to all MA beneficiaries and begins in 2019.  Additionally, the Final Bid Letter notes that the expanded definition of supplemental benefits in that Letter requires that the benefit address specific illnesses and/or injuries, and reiterates that it will be issuing further guidance on both expansion options in the future.

We would also note that all MA plans are required to have compliance programs in place that meet the seven elements of an effective program.  Under this program, they are also responsible for providing certain training for providers under their programs, as well as for the compliance of those providers.  While Liles Parker attorneys, and in fact, virtually all knowledgeable health care attorneys, have long counseled their clients on the importance of establishing and maintaining effective compliance programs, and while some segments of the industry are required to maintain such programs by law, any entity that wishes to contract with MA plans to provide health care related services almost certainly will be required by the plan to maintain a compliance program.  Thus, any entity that wishes to take advantage of the expanded coverage of services under the Final Bid Letter should be prepared to demonstrate that it has an effective compliance program.

With respect to providers of personal care services, there are a number of areas of vulnerability.  One major such area is ensuring that aides actually perform the services for which a program is billed.  Several years ago, there were a number of investigations and prosecutions where aides were alleged to have colluded with clients to defraud the Medicaid program by failing to provide the service for which the aides were paid, and paying the client a portion of the payments.  There are mechanisms to monitor this type of activity; however, it is a major risk area for home care agencies and should be addressed in any compliance program.

IV.  Conclusion:

In short, the Final Bid Letter for 2019 presents the possibility of expanding the services that certain MA plans will cover, including the possibility of covering personal care services.  However, providers that wish to contract with MA plans for these services should be taking the actions described, above. Liles Parker attorneys have extensive experience in assisting clients throughout the health care industry, including home care and home health, in responding to new government and payor initiatives, including establishing and maintaining an effective compliance program.

Personal CareMichael Cook, J.D., is a Partner at the firm Liles Parker, Attorneys & Counselors at Law.  Mr. Cook represents nursing home, assisted living, home health and personal care clients in regulatory matters.  Anyone interested in discussing the material discussed in this article should feel free to contact Michael Cook at 202-298-8750 or mcook@lilesparker.com.       







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