Which Federal & State Exclusion Lists Should Be Screened?

Exclusion Lists

The complex web of regulation encompassing government health care dollars is a lot to take on. With 41 state exclusion lists and several federal lists, it can be difficult to know which exclusion lists to screen, let alone actually screening them all. Each government payor of healthcare dollars has a different set of rules on who is allowed and who isn’t allowed to bill their services. Healthcare providers are not legal experts, nor should they have to be. Rather than taking the risk of non-compliance, we break down exclusion regulations for you and explain which exclusion, sanction, debarment, or termination list you must check  as a healthcare provider.


 



What is an Exclusion?

Exclusions are a final administrative action that is intended to protect the financial integrity of health benefit programs and beneficiaries by removing individuals and entities that pose a risk to them. While a party does have right when noticed that they are about to be excluded, as a final administrative action, once excluded there is no further appeals process.

Impact of Exclusions

An exclusion is the nuclear bomb of administrative actions. As a result of an exclusion, a payment prohibition is enforced. Federal and State programs will not pay or items or services furnished, directly or indirectly, by excluded entities. In essence, the government has decided that they do not want programs to pay for the overhead or salaries of excluded parties. Therefore, to comply with exclusion regulations it is best to screen all employees, contractors, vendors and even volunteers.

Scope of the Payment Prohibition

The payment prohibition extends to anyone who has an effect on patient care. This extends to all services connected to a practice, including but not limited to:

  • Billing, Claim Processing, and Accounting Services
  • Leadership, Management, Administrative, and Strategic Services
  • Human Resource and Information Technology Services
  • Transportation Services – including drivers and dispatchers 
  • Even volunteers if their activities contribute to a bundle of services

Where are exclusions listed? How many exclusion lists are there?

Exclusion Screening recommends for best practice to screen against two Federal Exclusion lists, and 41 state lists. The primary healthcare exclusion list is the OIG/LEIE. Together with the GSA SAM, previously known as the EPLS, the LEIE and the SAM make up the two Federal Exclusion Lists. While the GSA/SAM is not a healthcare-specific list, it is a federal debarment list and any party on it cannot enter into any federal contract.

While screening these lists are best practice, there are many more exclusion lists such as the CMS Preclusion list, OFAC, SDN, among others. Depending on your organization’s payors, contracts, or state requirements you may have to screen more than our recommendation. 

Screening Obligations for Fee for Service Medicare

The Department of Health and Human Services, Office of Inspector General (OIG) maintains the List of Excluded Individuals and Entities (LEIE). This is considered the most comprehensive of all exclusion lists, with over 70,000 names on it. At a minimum, the OIG-LEIE must be checked to participate in Fee for Service Medicare.

However, checking only this list opens an entity up to risk.
This is because although every state is required to send their exclusions-for-cause to the OIG, some states are slow to do so and often miss sending some parties. As a result, the OIG-LEIE is missing several excluded parties. Despite the OIG missing these parties on their list, an entity is still liable if they screen the LEIE and hire the party. For this reason, it is also important to check state-level exclusion lists. 

Screening for Medicare Advantage Providers

Medicare Advantage providers have unique screening requirements. They must screen both the OIG/LEIE and the CMS Preclusion list. Medicare Part C and Part D Plan Sponsors are unique because they are the only group of providers that must screen the Preclusion list and are the only ones to have access to the list (the Preclusion is not public).

The list differs from the OIG/LEIE because, unlike the OIG/LEIE, the Preclusion List does not require a final action for a party to be added to it. If there is a basis for revocation, such as participating in conduct that COULD result in revocation, whether or not the revocation happens, a party may be put on the preclusion list. While Medicaid Advantage Providers are the only ones to have access to the CMS Preclusion list, they may delegate screening of the list to a third-party such as Exclusion Screening. (Read more about the preclusion list here)

Screening Requirements Imposed by State Medicaid Programs

Most states have two different sets of screening requirements. The “Basic” screening requirements flows from letters issued by CMS to each state Medicaid director mandating monthly exclusion screening by Medicaid providers. This requires screening of the OIG/LEIE, the state exclusion list (if there is one), and some state have state-specific lists that must be searched (i.e. sex-offender list, elder abuse list).

Additional requirements are associated with Provider Agreement and Reenrollment forms. These contain significant disclosure and verification requirements. However, there is no consistent standard between the states. For example, as part of the Texas Medicaid participation agreement, a provider must check ALL states and federal databases and certify, under penalty of perjury, that none of their employees, contractors, and vendors are on them. While in Louisiana a provider must certify that no employee, vendor or contractor has EVER been excluded from ANY program. Although many state requirements do not explicitly say what must be screened, how could a provider give an honest answer and protect themselves from perjury without screening all exclusion lists.

A map of states with their own exclusion list (in red) can be found below.

Exclusion Lists

Medicaid Advantage Care Screening Requirements

Medicaid Managed Care Plans may not work with any of the following to provide, directly or indirectly, “the administration, management, or medical services or establishment of policies or provision of operational support for such services.”

  • Any individual or entity that is (or affiliated with a person or entity that is) debarred, suspended, or excluded from participating in procurement activities under the Federal Acquisition Requirement (FAR) or,
  • Any individual or entity that is excluded from participation in any Federal healthcare program…
To ensure that your organization is complying with the FAR regulation, it is important to screen against the GSA/SAM, as well as the OIG/LEIE and the 41 state exclusion lists. 

Enforcement Mechanisms

OIG’s Civil Money Penalties Authority for Exclusion Related Violations:

Exclusion Lists

It is important to remember that each of these Civil Money Penalties is for each offense. A provider who has worked with an excluded party can quickly rack up several offenses with each claim submitted to a health benefits program.

Failure to screen can also result in False Claims Act liability. While a provider must “knowingly” hire an excluded party to be open to False Claims Act liability, “knowingly” by statute includes reckless disregard or deliberate ignorance, such as not doing exclusion screening. 

Additional Consideration #1: Almost Every Risk Area is Directly Related to Employees or Contractors

Human capital is the heart of your practice, but also is the biggest risk in your organization. Any plan to lessen risk needs to start with ensuring that all employees and contractors are screened.

Additional Consideration #2: Screening is part of an effective compliance plan

As of 2017, the OIG has included “screening and evaluation of employees, physicians, vendors, etc.” as part of the seven elements of an effective compliance plan. The OIG views screening as an important step to mitigate risk.

Additional Consideration #3: Exclusions show up on different lists at different times. And sometimes not on lists you expect.

When states take an exclusion action they are supposed to report it to other states and the OIG so they can be added to other lists. However, it doesn’t always happen. Even the OIG/LEIE, the biggest list of them all, doesn’t have all exclusion records. It is important to remember that as public knowledge, a provider is presumed to know if any employees or contractors are on ANY of the exclusion lists. Screening only the OIG/LEIE is not enough and will not shield a practice from liability. 

Additional Consideration #4: Can Failure to Screen be Excused?

Imagine this, an accident or incident resulting in patient harm or financial loss to the practice occurs and the harm was caused by or related to an employee on one of the exclusion list. A judge or jury would have no sympathy for the practice that failed to screen. There is no excuse not to screen all State and Federal exclusion lists. 

Final Thoughts

Screening the OIG-LEIE, GSA-SAM, and the 41 State exclusion lists is not only good business practice, it is essential to protecting your organization from legal implications. At Exclusion Screening, LLC. we provide a simple, automated, and cost-effective solution to the complexity of monthly screening of over 40 exclusion lists. We use the sophisticated algorithms in our SAFER system to screen all lists, including variations of individual names, to ensure your organization complies with exclusion screening obligations.

Call 1-800-294-0952 or fill out the form below to discuss your exclusion screening needs and a free assessment.




 

Pennsylvania Doctor Excluded in Connection with Quality of Care


(September 26, 2019): 
Over the past year, both State and Federal law enforcement investigators and prosecutors have gone to considerable lengths to publicize the government’s fight against opioid abuse.  While much of this fight has focused on the manufacturers of prescription opioid products, the improper prescribing practices of physicians and other medical professionals found to be prescribing these drugs “without any legitimate purpose and outside the usual course of professional practice” have been repeatedly highlighted in criminal prosecutions by U.S. Attorney’s Offices around the country.  A recent case against a Philadelphia-area cardiologist provides a classic example of how improper opioid prescribing practices can lead to criminal prosecution, civil penalties AND severe administrative sanctions (in this case, exclusion from participation in Federal health care programs).  The article examines how the cardiologists was identified and steps you should take to reduce your level of risk in this regard.

 I. Background of the Case:

Like many big cities, Philadelphia has a problem with illegal drugs.  Despite the city’s efforts to curb illicit drug use, unintentional drug overdoses have steadily grown since 2010 and have only slightly tapered-off from their all-time high since 2017.[1]


What is NPDB?

Are you unsure your screening requirements depending on your business and location?  Our FREE Consultation has you covered. It includes: An overview of exclusions in addition to an overview of your specific requirements and obligations. Furthermore a demonstration of our product and service (SAFER) will be performed prior to a presentation of your personalized solutions. This consultation is a free of charge consultation for your benefit only!





Social Security Act 1128(b)(6)
While the percentage of opioid-related deaths changes from quarter to quarter, it is estimated that approximately 80% of all unintentional drug deaths in Philadelphia are due to opioid misuse and overdose.  In response to the opioid abuse crisis in Philadelphia and other areas of the country, a multi-agency team of Federal and State investigators and prosecutors, known as the Medicare Fraud Strike Force[2] (Philadelphia Strike Force) has been targeting physicians, nurse practitioners and other medical professionals who have been improperly prescribing and / or distributing opioids.  In this particular case, the prescribing practices of this Philadelphia cardiologist (defendant) were identified by the Philadelphia Strike Force as warranting further review.  Upon investigation, the government alleged that from 2016 to 2018, the defendant wrote a number of prescriptions for oxycodone and / or benzodiazepine to patients without a legitimate medical purpose.  

In light of the allegations presented, the U.S. Attorney’s Office pursued both civil and criminal claims against the cardiologist.  It is important to keep in mind that the Department of Justice has long instructed its prosecutors to pursue parallel criminal and civil actions against a defendant, when appropriate.  As Title 9, Section 27 of the Justice Manual[3] provides:

Department policy is that criminal prosecutors and civil trial counsel should timely communicate, coordinate, and cooperate with one another and agency attorneys to the fullest extent appropriate to the case and permissible by law, whenever an alleged offense or violation of federal law gives rise to the potential for criminal, civil, regulatory, and/or agency administrative parallel (simultaneous or successive) proceedings. By working together in this way, the Department can better protect the government’s interests (including deterrence of future misconduct and restoration of program integrity) and secure the full range of the government’s remedies (including incarceration, fines, penalties, damages, restitution to victims, asset seizure, civil and criminal forfeiture, and exclusion and debarment).”  (emphasis added). 

The Justice Manual guidance further notes that:
“Courts have recognized that “[t]here is nothing improper about the government undertaking simultaneous criminal and civil investigations provided that we use those proceedings and associated investigative tools for their proper purposes and in appropriate ways.”  (emphasis added).

II. Criminal Prosecution for Violations of 21 USC §841(a)(1) and (b)(1)(C):

In March 2019, the defendant pleaded guilty to eight felony counts of the unlawful distribution and dispensing of a controlled substance, in violation of 21 USC §841(a)(1) and (b)(1)(C).   The defendant’s sentencing is scheduled to take place later this year.  As a result of the criminal conviction, the defendant may be sentenced to prison for a significant period of time AND assessed criminal fines for his unlawful conduct.

III.  Civil Liability under the False Claims Act, 31 USC §3729:

Notably, it does not appear that the defendant entered into a “global” settlement at the time he decided to plead guilty to the criminal charges discussed above.  As a result, any civil and / or administrative actions that the government might choose to pursue remained active.  On July 1, 2019, the defendant agreed to enter into a False Claims Act settlement with the government and pay $107,584 in penalties and damages to the government.   

IV. Administrative Actions Taken Against the Defendant:

As part of his civil settlement reached with the government, the defendant cardiologist agreed to:
  • Surrender his medical license and Drug Enforcement Administration Certificate of Registration and further agreed not to seek to renew or reinstate either one in the future.
  • Be excluded from participation in Federal Health programs.
As HHS-OIG’s records reflects, the defendant was excluded from participation in Federal health care programs on July 18, 2019.  The basis for exclusion cited by the government is Section 1128(b)(6) of the Social Security Act – Quality of Care.

As you will recall, under Section 1128 of the Social Security Act, if an individual or entity is convicted of certain crimes, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) is required by law to exclude the individual or entity from participation in Federal health care programs.  These types of actions are referred to as “Mandatory Exclusions.”  The bases for imposing a mandatory exclusion are set out in Section 1128(a)(1) through Section 1128(c)(3)(G)(ii).  In contrast to mandatory exclusion actions, there are also a number of “Permissive Exclusion” authorities that may be used (at the agency’s discretion) by HHS-OIG to bar an individual or entity from participating in Federal health benefit programs.  The permissive exclusion authorities that may be exercised by HHS-OIG are covered in the Social Security Act from Section 1128(b)(1)(A) through 1128(b)(16).  HSS-OIG may also exercise its permissive exclusion authority under Social Security Section 1156, if a provider fails to meet its obligations to provide medically necessary services that meet the professional recognized standards of care.
In this particular case, HHS-OIG chose to exercise its permissive exclusion authority under Section 1128(b)(6) of the Social Security Act – Quality of CareThis particular basis for excluding an individual or entity can be assessed if a defendant or target is alleged to have submitted:
“Claims for excessive charges, unnecessary services or services which fail to meet professionally recognized standards of health care, or failure of an HMO to furnish medically necessary services.”
Under this statutory provision, an individual or entity can be excluded for a minimum period of one year.  In light of the allegations presented, the defendant cardiologist was excluded from participation by HHS-OIG for a total of seven years.[4]

V. Impact of Medicare Exclusion on the Defendant’s Career:

As the case synopsis above reflects, Federal law enforcement prosecuted the defendant in this case to the full extent of their abilities.  In addition to facing incarceration, the defendant was also assessed penalties and damages of more than $107,000 under the False Claims Act.  While the criminal and civil actions taken against the defendant are quite serious, the cardiologist’s problems are further magnified by the fact that he has also been excluded from participation in Federal health care programs.  At the end of the day, it is quite conceivable that the U.S. Sentencing Guidelines, the defendant’s criminal sentence will be relatively brief.  Depending upon the terms of his civil / administrative settlement, he may be free to seek licensure in another state upon his release from jail. 

VI. Final Thoughts:

Even assuming that the defendant regains licensure in another state, the administrative exclusion action taken against him will effectively bar him from enrolling in Federal health care benefit programs for the entire period that he remains excluded.  While excluded, he will not be eligible to work for any provider or supplier who participates in one or more Federal health care plans.  Should a health care provider or supplier choose to employ the defendant (an excluded party), each of the claims submitted to Medicare, Medicaid and other government plans may be subject to significant civil monetary penalties. 

How can you protect your practice?  Consistent with your obligations under the law, it is imperative that you screen your employees, agents, contractors and vendors against all of the 43 exclusion databases currently in operation.  Unfortunately, it is practically impossible for a medical practice or other entity to screen one or more of its employees against all 43 databases.  Luckily, the folks at Exclusion Screening can take this time-consuming (and often frustrating) task off of your shoulders. 

Give us a call at 1 (800) 294-0952 for a complimentary discussion of your screening needs and a quote or fill out the form below!




[2] The government’s Medicare Fraud Strike Force is primarily composed of Federal agents and investigators of the Department of Health and Human Services, Office of Inspector General (HHS-OIG) and the Federal Bureau of Investigation (FBI), along with Federal prosecutors working for U.S. Attorneys Offices around the country.  First established in March 2007, the Strike Force has been instrumental in investigating and prosecuting cases of health care fraud, waste and abuse. 
[4] “Pennsylvania physician Agrees to Voluntary Exclusion” https://oig.hhs.gov/fraud/enforcement/cmp/cmp-ae.asp