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What is the CMS Preclusion List? What is the Difference Between an Exclusion and a Preclusion Action? How Can You Appeal a CMS Preclusion Action?

(October 8, 2019):  On April 16th, 2018, the Department of Health & Human Services (HHS), Centers for Medicare and Medicaid Services (CMS), issued a Final Rule entitled, “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program.” [1] This 300+ page issuance revised the Medicare Advantage program (Part C) regulations, along with the Prescription Drug Benefit program (Part D) regulations, in order to implement portions of the Comprehensive Addiction and Recovery Act (CARA).  Among its various provisions, the Final Rule also served to rescind existing regulations that required prescribers of Part D drugs and providers of Medicare Advantage services and items to enroll in Medicare Fee-for-Service in order for the Part D drug or Medicare Advantage service or item to qualify for coverage and payment.[2]  In lieu of the enrollment requirements, CMS now requires that a Part D plan sponsor reject a pharmacy claim for a Part D drug if the provider prescribing the drug is included on a “Preclusion List.” Similarly, if a health care provider or supplier is listed on the preclusion list, no services furnished (or items supplied) by that individual or entity will be covered by Medicare Advantage.  At the time, CMS estimated that these changes would reduce program costs by $34.4 million in 2019.

A year to the day after publishing the Final Rule covering the Preclusion List, CMS published a Final Rule revising the Medicare Advantage (Part C) and Prescription Drug Benefit Program (Part D) regulations[3] on April 16, 2019.  The April 2019 Final Rule made a number of revisions to the Preclusion List provisions set out in the April 2018 Final Rule.  This article examines the CMS Preclusion List in more detail and examines the impact of a provider, supplier and / or prescriber being placed on the list.

I.  What is the CMS Preclusion List?

Simply stated, the CMS preclusion list is a register of all health care providers, suppliers, and prescribers who are precluded from receiving reimbursement for Medicare Advantage items and services or Part D drugs that are provided or prescribed to Medicare beneficiaries. CMS has established the preclusion list in an effort to better ensure patient safety and to protect the integrity of the Medicare Trust Funds from the actions of providers and prescribers that have been identified as bad actors.”

CMS is responsible for maintaining the Preclusion List. The list is made available to Medicare Advantage and Part D payor plans.  If a Medicare Advantage receives a claim for a health care item or service that was furnished by a precluded party, the claim will be denied. Similarly, if a Part D payor plan receives a claim for reimbursement from a pharmacy or Medicare beneficiary that is related to a drug that was prescribed by a precluded individual, the claim will be denied.

II.  What is the Difference Between an “OIG Exclusion” and a “CMS Preclusion” Action?

While based on completely different statutes, both the exclusion and preclusion regulations are intended to protect that safety of Medicare, Medicare and Federal health care beneficiaries AND help safeguard the financial integrity of Federal and State health care programs.  What is the difference between the two programs?

  • Medicare OIG Exclusion. The OIG is responsible for administering the various mandatory and permissive exclusion authorities that have been enacted.  If a health care provider, supplier or other entity is “excluded” from participation in the Medicare or Medicaid programs, the excluded party cannot provide care or services to Medicare and / or Medicaid beneficiaries. Moreover, an excluded party cannot work for a participating provider. Nor can an excluded party serve as an agent, contractor, or vendor for a participating provider or supplier. In my opinion, the definitive analysis of the OIG’s exclusion regulations is covered in Paul Weidenfeld’s article entitled, “Federal Exclusion Regulations and Enforcement Authorities, and How Providers Can Avoid Risk with Proper Exclusion Screening.” [4]

Broadly speaking, an individual or entity is typically excluded from participation in the Medicare or Medicaid programs due to a criminal conviction, the abuse of a patient, and / or an adverse licensure sanction. In contrast with the preclusion regulations set out the updated Final Rule dated April 16, 2019,[5] the exclusion regulations were first mandated by Congress in 1977 as part of the “Medicare-Medicaid Anti-Fraud and Abuse Amendments, Public Law 95-142.”

If an individual or entity (typically a health care provider, supplier) is excluded from Medicare or Medicare, the identity of the excluded party is posted online and is publicly available on the on OIG’s “List of Excluded Individuals/Entities” (LEIE) and / or one the 41 State Medicaid exclusion databases that are currently maintained around the country. Finally, the effect of an exclusion action applies across the board. It applies to services and items covered by traditional Medicare program, Medicare Advantage (Part C), and Part D drug plans.

  • Medicare CMS Preclusion. In contrast to the Medicare exclusion authorities which are administered by the OIG, the Medicare preclusion authorities are managed by CMS.  As described in Section III below, Medicare preclusion actions are typically revocation-based or conduct / behavior-based actions that effectively bar Medicare Part C and Part D plans from making payments to any individuals or entities that have been placed on the CMS preclusion list. Unlike the 43 Federal and State exclusion databases which are publicly accessible, the CMS preclusion database is only available Medicare Advantage (Part C) and Part D payor plans have with a valid Health Plan ID been granted access to the preclusion database by CMS.

III.  How are Individuals and Entities Added to the CMS Preclusion List?

Individuals and entities added to the Preclusion List fall within two broad categories. These categories are examined in more detail below:

Category #1: Preclusion List – Revocation Based Under this category, health care providers, suppliers, and prescribers can be placed on the Preclusion List if:

    • The Medicare billing privileges of an individual or entity are currently revoked under 42 CFR §424.535; and
    • There is an active reenrollment bar in effect under 42 CFR §424.535(c); and
    • CMS has determined that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program. In making this determination, CMS is to consider the following factors:
      • The seriousness of the conduct underlying the individual’s or entity’s revocation.
      • The degree to which the individual’s or entity’s conduct could affect the integrity of the Part D or MA program.
      • Any other evidence that CMS deems relevant to its determination;

If these three revocation-related requirements have been met, CMS may place a health care provider, supplier, or prescriber on the agency’s Preclusion List.

 OR

Category #2: Preclusion List – Conduct / Behavior Based:  Under this category, health care providers, suppliers, and prescribers can be placed on the Preclusion List if:

    • The individual or entity has engaged in behavior for which CMS could have revoked the individual or entity to the extent applicable, if they had been enrolled in Medicare; and
    • CMS determines that the underlying conduct that would have led to the revocation is detrimental to the best interests of the Medicare program. In making this determination under this paragraph, CMS considers the following factors:
      • The seriousness of the conduct underlying the individual’s or entity’s revocation.
      • The degree to which the individual’s or entity’s conduct could affect the integrity of the Part D or MA program.
      • Any other evidence that CMS deems relevant to its determination.

It is also important to keep in mind that CMS significantly expanded the bases for revoking a provider’s, supplier’s. or prescriber’s Medicare billing privileges under 42 CFR § 424.535(a)   As discussed in a recent article examining the Final Rule entitled, “Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process,” the revised reasons for revocation that may be asserted by the government will be effective November 4, 2019.[6]

As a final point in this regard, please note that OIG Exclusions and felony convictions will also result in an individual or entity being placed on the CMS Preclusion List.

IV.  How Will an Individual or Entity Learn of Their Inclusion on the CMS Preclusion List?

When placing an individual or entity on the Preclusion List, CMS (through one of its Medicare Administrative Contractors (MAC)) is supposed to send written notice to the party.  The MAC will send the letter to the address listed in the Provider Enrollment Chain and Ownership System (PECOS) system.  The effective date of the preclusion action, along with reason(s) an individual or entity has been added to the list is required to be included in the letter. Additionally, the notice letter is supposed to provide information advising the individual or entity of their right to appeal their inclusion on the list.[7]

CMS Preclusion List

V.  How Long Can a Provider, Supplier, or Prescriber Stay on the CMS Preclusion List?

If a provider, supplier, or prescriber exhausts their first level of administrative appeal (either due to the fact that no appeal was filed in a timely fashion[8] OR CMS denied the appellant’s request for reconsideration), CMS will add the individual or entity’s name to the Preclusion List.  Please note, if the preclusion action has been taken due to the fact that the provider, supplier, or prescriber has been excluded from participation in Federal and State programs, the individual or entity will be placed on the CMS Preclusion List effective the date of the party’s exclusion. The length of time that an individual or entity will remain actively precluded will depend on the following:

  • Length of Preclusion if Based on an Exclusion Action. If a provider, supplier, or prescriber is placed on the CMS Preclusion List due to the fact the individual or entity has been excluded from participation in Federal and State health care programs, the party will remain actively precluded for at least until the excluded party has been reinstated by the OIG.
  • Length of Preclusion if Based on a Revocation Action. If a provider, supplier, or prescriber is placed on the CMS preclusion list due to the fact that the individual or entity is currently revoked (or would have been revoked had they enrolled in the Medicare program), the individual or entity will remain actively precluded for the length of their re-enrollment bar. The length of a re-enrollment bar ranges from 1 to 3 years, depending the seriousness of the reason for revocation.
  • Length of Preclusion if Based on a Felony Conviction. If a provider, supplier, or prescriber is placed in the CMS preclusion list due to a felony conviction, the length of the preclusion will remain in effect for a 10-year period, beginning on the date of the felony conviction, unless CMS determines that a shorter time period is warranted (effective January 1, 2020).

Importantly, at the expiration of a preclusion action, a precluded party’s name is NOT totally removed from the CMS Preclusion List.  As set out in April 2019 Final Rule, once a precluded party is reinstated, the party’s name will remain on the preclusion database list, but will be annotated to reflect the fact that the provider, supplier or prescriber has been reinstated.  Once reinstated, the individual or entity may again submit claims for services and items to Medicare Advantage (Part C)) plans, and / or issue prescriptions for Part D drugs.

VI.  Can an Individual or Entity Participating in the Medicare Program “Screen” to Ensure that Precluded Parties Aren’t Hired?

Unfortunately, Medicare providers and suppliers do not have access to the CMS Preclusion List.  Only CMS approved Medicare Advantage (Part C) and Part D payor plans have with a valid Health Plan ID been granted access to the preclusion database.  As CMS notes:

“CMS makes the Preclusion List available to the Medicare Advantage (MA) plans and Part D plans. MA [Medicare Advantage] plans will deny payment for a health care item or service furnished by an individual or entity on the Preclusion List. Part D plans will reject a pharmacy claim (or deny a beneficiary request for reimbursement) for a Part D drug that is prescribed by an individual on the Preclusion List.”[9]

Under 42 CFR § 422.204(b),  a Medicare Advantage organization is required to establish and comply with a comprehensive set of written credentialing and recredentialing requirements.  The credentialing process is intended to serve as the initial set of program integrity safeguards used by Part C and Part D payor plans to prevent bad actors from enrolling in the programs.  Unfortunately, this system is imperfect at best.  More often than not, the credentialing of a newly-hired provider, supplier or prescriber is not requested by a participating health care organization prior to the organization’s employment of the newly-hired party.  Notably, it is entirely possible that an individual may have been placed on the CMS Preclusion List due to his or her improper conduct or behavior (as described in Category #2 above), yet may not have been excluded from participation in Federal health care programs by the OIG.  Therefore, even assuming that your organization properly screens its applicants against all available Federal and State exclusion lists prior to extending an offer of employment, it is still possible that you may unknowingly employ or enter a contract with a precluded individual or entity.  We strongly recommend that your organization conduct proper due diligence before employing or contracting with a provider, supplier or prescriber.  Should you inadvertently hire, or continue to employ, an individual who is precluded from providing services or items that will be billed to Medicare Advantage (Part C) plans, or issue prescriptions that will be billed to a Medicare Part D plan, those claims will be denied.

VII.  How Do You Appeal a CMS Preclusion Action?

To establish the administrative framework to appeal a CMS preclusion action, CMS revised 42 CFR § 498.3(b), adding a new provision, Section (20), which made the decision to place an individual or entity on the Preclusion List an “Initial Determination” for appeal purposes.  CMS further modified 42 CFR § 498.5, adding paragraph (n)(1).  Under 42 CFR § 498.5(n)(1):

“Any individual or entity that is dissatisfied with an initial determination or revised initial determination that they are to be included on the preclusion list (as defined in § 422.2 or § 423.100 of this chapter) may request a reconsideration in accordance with § 498.22(a).  (emphasis added).

If an individual or entity files a Request for Reconsideration and is dissatisfied with the decision, the individual or entity can seek a hearing before an Administration Law Judge (ALJ).[10]  After an ALJ renders a hearing decision, either party (CMS or the individual / entity on the Preclusion List) may request Departmental Appeals Board review.  Additionally, the individual or entity may also seek judicial review of the Department Appeals Board’s decision.[11]  For additional background information on the preclusion list, you may wish to review a recorded webinar presentation we made for the Texas Association for Home Care and Hospice.

Robert W. Liles Healthcare LawyerHave you been placed on the CMS Preclusion List? Although the CMS Preclusion List has only been in place a short time, a number of Liles Parker attorneys have already handled (or, are in the process of handling) preclusion appeal cases. Our experienced health law attorneys can advise you on how to best respond to this challenge and represent you throughout the complex appeal process that has been established. For a free initial consultation regarding your situation, call us at: 1 (800) 475-1906.

 

 

[1] 83 FR 16440 (April 16, 2018).

[2] Institutional providers and suppliers must still be enrolled in Medicare Fee-for-Services.  Additionally, as part of their credentialing requirements, some Medicare Advantage plans may require that a provider or supplier be enrolled in the Medicare Fee-for-Service program.

[3] “Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021.”  84 FR 15680.  (April 16, 2019).

[4] Part I of the article “Federal Exclusion Regulations and Enforcement Authorities, and How Provider’s Can Avoid Risk with Proper Exclusion Screening,” is in the process of being published in a series part series by the folks at Exclusion Screening.

[5] 84 FR 15680.

[6] See article entitled “Medicare, Medicaid and CHIP Enrollment Revocation and Denial Authorities Have Expanded.  What Steps are You Taking to Reduce Your Level of Risk? (September 18, 2019).

[7] An example of the letter sent to a revocation-based precluded party can be found at:

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/Downloads/Preclusion_List_Model_Letter-Revoked_With_Active_Enrollment_Bar.pdf

An example of the letter sent to a conduct / behavior-based precluded party can be found at:

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/Downloads/Preclusion_List_Model_Letter-Could_Have_Been_Revoked.pdf

[8] This would occur upon the expiration of the 60-day period in which a provider, supplier or prescriber has to file a reconsideration appeal to the proposed preclusion action. See 84 FR 15680, 15781.

[9] See CMS “Preclusion List Frequently Asked Questions.”  Updated 08/07/2019.

[10] 42 CFR § 498.5(n)(2).   Notably, CMS may also seek a hearing before an ALJ if it is dissatisfied with the reconsideration decision.

[11] 42 CFR § 498.5(n)(3).

Exclusion Screening-OIG Screening: The New “Seventh Element” of Compliance.

 Exclusion Screening-OIG Screening(May 17, 2017): Exclusion screening-OIG screening duties are now more important than ever before!  The recently issued Resource Guide for Measuring Compliance Program Effectiveness,” a product of Office of Inspector General staff and compliance professionals roundtable discussions, reconfigures the traditional “Seven Elements of an Effective Compliance Program” by making the “Screening and Evaluation of Employees, Physicians, Vendors and other Agents” an element unto itself – or the new Seventh Element of Compliance! The Resource Guide, prepared under the auspices of the Health Care Compliance Association (HCCA), serves to once again underscore the critical role of exclusion screening-OIG screening, and background checks in compliance.

Paul Weidenfeld, Counsel at Liles Parker, has recently assessed this important change and provided an overview of the impact this change for the folks at Exclusion Screening.  For a detailed discussion of the statutory requirements of screening, the potential damages that may be assessed in the event of a violation AND your obligations as a provider participating in Medicare or Medicaid, we recommend you see the article on Exclusion Screening’s website.  This article may be accessed by clicking here.

Paul Weidenfeld is a Partner at Liles Parker, Attorneys & Counselors at Law.  Our attorneys are experienced and knowledgeable of your obligations under the law to conduct periodic “Exclusion Screening-OIG Screening” duties.  For a free consultation, please call: 1 (800) 475-1906.-

Exclusion Screening / OIG Screening and Background Checks in Dental Practices

Dental practice must conduct exclusion screening.(March 31, 2016):  Many of the dental practices around the country do not participate in the Medicaid program and only a small number of dental practices provide services that might qualify for coverage under Medicare.  Notably, the fact that most dental practices only accept cash or a handful of private payor plans significantly reduces their overall level of regulatory risk.  Unfortunately, restricting a dental practice’s payor mix isn’t enough to ensure legal and statutory compliance.  As one recent case reflects, dental practices must remain diligent in their efforts to conduct exclusion screening on applicants prior to employment.  In the case discussed below, the failure to conduct screening ultimately led to the falsification of a number of prescriptions by a practice employee for painkillers.

I.  Basic Case Facts:

In a recent Washington State case, a suspended dental hygienist working as a dental office manager took advantage of her position and to gain access to the practice’s prescription software.  After receiving an anonymous tip, a local police detective contacted the dentist in charge of the office and conducted an audit of the prescriptions ordered using the practice’s software. At that time, it was found that the office manager furtively used the prescription software to print out at least 15 orders for patients who were not patients of the practice.  Upon reviewing the list of individuals who were not patients of the practice, the dentist noted that a number of the individuals were family members of the office manager. The detective subsequently obtained video recordings showing that the dental practice’s office manager had in filled a number of the unauthorized prescriptions.

II.  Background — Exclusion Screening / OIG Screening:

The Department of Health and Human Services, Office of Inspector General (HHS-OIG) has been delegated the authority to “exclude” individuals and entities from participating in federal health benefits programs. Exclusion actions taken by HHS-OIG can be either mandatory or permissive.  Regardless of which type of exclusion is pursued by the agency, the action has the impact of barring the participation of an individual or entity in federal health benefit programs, until such time as the agency affirmatively agrees to reinstate the individual or entity back into the program. Similarly, states also have the authority to exclude individuals and entities from participating in state health care benefit programs, such as Medicaid.  As of today, 38 states maintain their own exclusion lists that are separate from those maintained by HHS-OIG. Adding in the System for Award Management (SAMs) database maintained by the General Services Administration, there are currently a total of 40 exclusion databases that must be checked every 30 days. Importantly, neither Medicare nor Medicaid will pay for the claim if an excluded individual or entity contributed in any way to the basket of services provided to the patient — either directly or indirectly.

III. Lessons Learned When Conducting Exclusion Screening / OIG Screening of Your Staff:

If your dental practice does not participate in Medicare or Medicaid, why should you care whether your employees, agents, vendors and contractors have been subjected to exclusion screening / OIG screening of all federal and state exclusion databases?  Ultimately, it comes down to “risk.”  Regardless of whether your practice takes Medicaid, would you want to employ someone who has been barred from working for a Medicaid provider because he or she has been convicted of fraud?  Similarly, would you want to employ an individual who has been barred from employment by a Medicaid provider because their professional license has been suspended or revoked?  To effectively reduce your level of risk, we recommend that you screen your employees, agents and contractors on a monthly basis.  Exclusion screening / OIG screening is a fundamental component of an effective Compliance Plan.  There are a number of companies that can provide these screening services for a low monthly cost. Two of our attorneys established a company, Exclusion Screening, LLC to conduct these screening services. For information on their services, you can call:  1 (800) 294-0952.

robert_w_lilesRobert W. Liles, M.B.A., M.S., J.D., serves as Managing Partner at Liles Parker, Attorneys & Counselors at Law. Liles Parker is a boutique health law firm, with offices in Washington DC, Houston TX, San Antonio TX, McAllen TX and Baton Rouge LA. Robert represents dental practices and other health care providers around the country in connection with claims audits by federal and state-engaged specialty contractors. Our firm also represents health care providers in connection with federal and state regulatory reviews and investigations. For a free consultation, call Robert at: 1 (800) 475-1906.

Exclusion Screening Enforcement Actions by OIG are Increasing.

Exclusion screening enforcement by OIG and state officials is increasing.

(December 8, 2015): Since the passage of the Patient Protection and Affordable Care Act of March 2010[1] (ACA) and progeny such as the HITECH Act [2], enforcement efforts have been better funded and consequently, better staffed. The enactment of HIPAA in 1996 [3] and the Balanced Budget Act (BBA) of 1997 [4], further expanded the OIG’s sanction authorities and scope of current CMP and exclusion authorities beyond programs funded by the Department to all “Federal health care programs.” Further, on May 31, 2011, CMS published guidance to providers regarding the enforcement of ACA Section 6501.

 

As the ACA requires:

Termination of Provider Participation Under Medicaid and CHIP

Section 6501 of the Affordable Care Act, Termination of Provider Participation Under Medicaid if Terminated Under Medicare or Other State Plan amends section 1902(a)(39) of the Social Security Act and requires States to terminate the participation of any individual or entity if such individual or entity is terminated under Medicare or any other Medicaid State plan. (emphasis added) [5] On February 2, 2011, the Centers for Medicare & Medicaid Services (CMS) published the final rule implementing this provision, applicable to terminations occurring on or after the statutory effective date of January 1, 2011 [6]

Subsequently, the U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) is now engaging a specialized task force to check for excluded individuals. 2015 Enforcement Actions demonstrate a much higher focus on, among other areas, reviewing providers against employing excluded individuals than in previous years. While this was a relatively easy compliance area to meet, since the OIG issued its Special Advisory Bulletin and amended its Self-Disclosure Protocol in May and June of 2013, it has since become a hotbed of government reviews, tighter restrictions, shorter compliance deadlines and higher civil monetary penalties. As a result, checking exclusion lists has moved from being one of the easiest compliance steps for a provider to undertake, to being an essential compliance step for every provider.

I. So many exclusion screening databases to check, so little time…

A health care provider, biller, or supplier must check both federal exclusion screening databases including, the List of Excluded Individuals/Entities (LEIE), and the System for Award Management (SAM), formerly maintained by the General Services Administration (GSA), and the currently 38 existing State OIG Medicaid exclusion databases on a regular basis. In New York and Texas, this means monthly (every 30 days), and the list of states adding the monthly requirement continues to grow. Some providers find it difficult to devote the staff and man-hours required to perform this task. Exclusion database review services, such as Exclusion Screening, LLC, allow these providers to perform the voluminous task of searching and documenting the employee searches on multiple state databases.

II.  Formerly excluded employees or applicants must take affirmative steps to be taken off of the list of excluded individuals.

Employers should also be wary of employees who state they were previously excluded, but the exclusion period has run and they are no longer on the list. Simply stated, exclusions do not expire because there is no automatic reinstatement provision. A health care provider must apply to HHS OIG to be reinstated and to any State where they were previously excluded to be allowed to again participate. The individual must be approved and a written letter received before they can again work for a participating provider without breaking the law and risking penalty. As OIG’s website states:

Reinstatement of excluded entities and individuals is not automatic once the specified period of exclusion ends. Those wishing to again participate in the Medicare, Medicaid and all Federal health care programs must apply for reinstatement and receive authorized notice from OIG that reinstatement has been granted [7].

OIG has the authority to exclude individuals and entities from Federally funded health care programs pursuant to sections     1128 External link and 1156 External link of the Social Security Act External link and maintains a list of all currently excluded individuals and entities called the List of Excluded Individuals and Entities (LEIE). Anyone who hires an individual or entity on the LEIE may be subject to civil monetary penalties (CMP).[8] If an individual is excluded, and the employer participates in federal programs, the employee must be terminated. If an employee was excluded and states the period has run and they are no longer excluded, they must apply for reinstatement to OIG. Reinstatement is not automatic. OIG will send written notice if the application is accepted. The employee must wait until their name is removed from the exclusions list. Then the employee may again work for a provider who participates in a federally funded healthcare program. Finally, employers should remember that where an excluded individual provided services or items, directly or indirectly (as in administrative support) to Medicare, Medicaid or another federally funded health care program, such claims are tainted under the False Claims Act and may be subject to fines and penalties as previously stated.

An excluded party is in violation of its exclusion if it furnishes to Federal program beneficiaries items or services for which Federal health care program payment is sought. An excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a CMP of $10,000 for each item or service furnished during the period that the person or entity was excluded (section 1128A(a)(1)(D) of the Act). The individual or entity may also be subject to treble damages for the amount claimed for each item or service. In addition, since reinstatement into the programs is not automatic, the excluded individual may jeopardize future reinstatement into Federal health care programs (42 CFR 1001.3002).

III. A partial list of OIG’s 2015 exclusion screening enforcement actions.  Are you ready if audited in 2016?

In August 2015, HHS published a study which exposed a loophole in exclusion enforcement in Medicaid managed care programs. [9] It found that 25 States did not require providers who participated via managed care to be directly enrolled with the State. Texas requires every provider who treats Medicaid patients to enroll in the program.

Federal enforcement actions in 2015 increasingly assessed Civil Monetary Penalties against health care providers who employ excluded individuals. The number of enforcement actions and the amounts of penalties continue to trend upward. Note that enforcement is ongoing all over the country and for all types of provider entities.

This is particularly noteworthy for Texas providers, because in the HHSC Inspector General’s Quarterly Report to the Governor, September 21, 2015, new Texas Inspector General Stuart W. Bowen emphasized to Governor Greg W. Abbott that HHSC OIG is “clearing the decks” of old business and settling outstanding cases in anticipation of a concentrated effort beginning January, 2016 in increased effort in all areas, with a particular emphasis on the area of managed care fraud enforcement. This does not mean other providers will be neglected. Indeed, Mr. Bowen’s reputation as an overachiever at the national level means that exclusion screening will receive additional attention at the state level, whether in the managed care setting, or in the provider setting.

Providers should remember that claims tainted by utilization of services by an excluded individual date back to the date of hire and continue through the date of termination. The False Claims Act imposes a potential liability of $5,500-$11,000 and treble damages along with CMPs of up to $10,000 per violation. In § 3729(b)(1) of the False Claims Act, knowledge of false information is defined as being (1) actual knowledge, (2) deliberate ignorance of the truth or falsity of the information, or (3) reckless disregard of the truth or falsity of the information. That means a negligent failure to check the databases for excluded individuals will be regarded by the government as “knowledge” in the filing of false claims. The more immediate threat to providers comes in the form of Civil Monetary Penalties and return of overpayments, which must be made within 60 days from the time they are discovered and verified.

The following examples of enforcement actions taken by the federal government in 2015 illustrates that all providers and all areas of health care are subject to these increasing Civil Monetary Penalties. Avoiding this potential liability is relatively simply, though labor intensive. However, the cost of failing to do so has risen to the point where the survival of your practice or business may be jeopardized by your failure to do so.

02/04/15 – A California hospital agreed to pay $121,316.55 in CMPs to settle OIG allegations it employed someone it knew or should have known was excluded from California Medicaid.

02/25/15 – A Denver, CO skilled nursing facility agreed to pay $242,434.92 in CMPs because it had employed an excluded nurse. No payment may be made by any Federal health care program for any items or services furnished by an excluded individual.

03/17/15 – A Wilkes-Barre, PA healthcare staffing agency agreed to pay $24,775.56 to settle allegations it employed an LPN who was excluded from any Federal health care program.

03/19/15 – A Skokie, IL home health agency employed an excluded nurse. As a result the HHA was excluded for three (3) years from participation in all Federal health care programs.

03/13/15 – A northeast IN / northwest OH community-based health system entered into a $129,216.80 settlement agreement with OIG for employing an excluded lab tech.

03/31/15 – A Farmville VA mission and rehabilitation facility paid $399,573.85 in CMPs for employing an individual it knew or should have known was excluded from Federal programs.

04/16/15 – A Drexel, PA personal in-home care provider paid $69,130 in CMPs for employing an excluded individual for 18 months between July 2010 and December, 2011.

04/10/15 – a Winter Park, FL mental health counselor agreed to pay $120,000 in CMPs and was excluded for twelve (12) years from participation all federal health care programs for allegedly using an Orlando physician to submit claims for services not rendered or not supervised by a licensed physician.

04/27/15 – An Arlington, TX skilled nursing facility agreed to pay $70,000 in CMPs to OIG for allegedly employing an excluded licensed vocational nurse.

04/27/15 – An Beaumont, TX skilled nursing facility agreed to pay $163,740.54 in CMPs to OIG for allegedly employing an excluded individual.

05/13/15 – A Maryland cardiology practice paid $134,506.47 in CMPs for allegedly employing an individual it knew or should have known was excluded from participation in Federal programs.

05/14/15 – A Houston, TX respiratory and sleep disorder specialist agreed to pay $152,821.07 in CMPs to OIG for fraudulent claims provided at a non-participating facility using its NPI number.

06/01/15 – A Waco, TX managed care provider agreed to pay $100,000 in CMPs to OIG to settle allegations they employed 3 excluded individuals who provided items and services to Federal health care programs beneficiaries.

06/08/15 – A Dallas, TX area skilled nursing facility agreed to pay $77,772.08 to settle allegations it employed a certified nurse’s aide who was excluded from Federal programs.

IV.  Final Remarks:

As a final item, one should remember that both the ACA and Texas Medicaid require that all providers have a compliance plan in place. Exclusion screening, while very important, is just one part of a comprehensive, effective compliance program that every provider is required to have. Staying in compliance is the single best and necessary means to minimize your risk of liability.

For additional reading and guidance regarding exclusions, reinstatement, and the potential penalties for employing an excluded individual, please reference HHS OIG’s Special Advisory Bulletins from September 1999 and May 8, 2013 [10].   For questions regarding creating a compliance for your health care practice or business, please contact Richard B. Pecore at Liles Parker, PLLC at (202) 298-8750 or rpecore@lilesparker.com .

Pecore, RichardRichard Pecore, Esq. is a health law attorney with the firm, Liles Parker, Attorneys & Counselors at Law.  Liles Parker has offices in Washington DC, Houston TX, McAllen TX and Baton Rouge LA.  Our attorneys represent dentists, orthodontists and other health care professionals around the country in connection with government audits of Medicaid and Medicare claims, licensure matters and transactional projects.  Need assistance?  For a free consultation, please call: 1 (800) 475-1906.

Join me on Thursday, December 10th for our free monthly webinar presentation where we will discuss what areas of government enforcement providers can expect HHS-OIG and Texas HHSC-OIG to focus on in 2016.

[1] The Patient Protection and Affordable Care Act, Pub. L. 111-148, as amended by the Health Care and Education Reconciliation Act of 2010, Pub. L. 111-152, together called the “Affordable Care Act.” 42 U.S.C. § 18001 (2010).

[2] The American Recovery and Reinvestment Act of 2009 (ARRA) Public Law No. 111-5, 123 Stat. 115, included the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), 42 U.S.C. §17935.

[3] Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104–191.

[4] Public Law 105-33.

[5] Although Section 6501 of the Affordable Care Act does not specifically include terminations from CHIP, CMS has required CHIP, through Federal regulations, to take similar action regarding termination of a provider that is also terminated or had its billing privileges terminated under Medicare or any Medicaid State plan.

[6] CMS Bulletin dated 05/31/11, CPI-B 11-05, 6501-Term.pdf https://downloads.cms.gov/cmsgov/archived-downloads/CMCSBulletins/downloads/6501-Term.pdf , last accessed 12/03/15.

[7] http://oig.hhs.gov/exclusions/reinstatement.asp

[8] See HHS-OIG website, Exclusions http://oig.hhs.gov/exclusions/background.asp, last accessed 12/08/15.

[9] Supra at Footnote 7.

[10] http://oig.hhs.gov/exclusions/effects_of_exclusion.asp (1999) and http://oig.hhs.gov/exclusions/files/sab-05092013.pdf (2013), last accessed 12/03/15.

Medicaid Dental Audits: Exclusion Screening Issues

January 22, 2015 by  
Filed under Dental Audits & Compliance

Audit(January 22, 2015): Medicaid dental audits have greatly expanded over the past few years. As many (if not all) dentists and orthodontists are painfully aware, the both federal and state law enforcement agencies have doggedly pursued Medicaid dental providers in their efforts to recoup funds paid to dentists and orthodontists for the provision of medically unnecessary services and other allegedly improper services. One of the least understood mandatory obligations applicable to ALL dentists and orthodontists who accept Medicaid is the requirement that all participating providers MUST screen their employees, contractors, vendors and agents through literally dozens of federal and state exclusion databases. While there a number of important exclusion screening concerns to consider, today we will be focusing on two risk areas:

I.     Medicaid Dental Audits.  Have You Complied with Your Exclusion Screening Obligations?

Prior to the significant changes enacted under the Affordable Care Act (ACA), there were are already both mandatory and permissive bases for exclusion from participation in the Medicare and Medicaid programs. Importantly, there are bases for mandatory or permission exclusion from federal health care programs that may be pursued by the government. Moreover, each state has established its own list of infractions and/or other instances of improper conduct that can result in exclusion from Medicaid.

What is the scope of an exclusion action? Importantly, HHS-OIG has taken the position that if a dentist, orthodontist or other party is excluded from participating in the Medicare or Medicaid programs, they are effectively barred from working with most health care provider and supplier entities. As HHS-OIG writes:

“Excluded persons are prohibited from furnishing administrative and management services that are payable by the Federal health care programs. This prohibition applies even if the administrative and management services are not separately billable. For example, an excluded individual may not serve in an executive or leadership role (e.g., chief executive officer, chief financial officer, general counsel, director of health information management, director of human resources, physician practice office manager, etc.) at a provider that furnishes items or services payable by Federal health care programs. Also, an excluded individual may not provide other types of administrative and management services, such as health information technology services and support, strategic planning, billing and accounting, staff training, and human resources, unless wholly unrelated to Federal health care programs.”

Importantly, a dental practice cannot limit its screening activities to only “new employees.” The Compliance Officer in a dental or orthodontist office should be routinely (at least every 30 days) checking both federal exclusion databases to ensure “that the HHS–OIG’s List of Excluded Individuals and Entities, and the General Services Administration’s (GSA’s) List of Parties Debarred from Federal Programs have been checked with respect to all employees, medical staff and independent contractors.” Dental and orthodontist practices are also responses for checking all state exclusion databases (at the time of this article, 36 states maintained their own databases. However, this number is constantly growing. You should therefore keep up with the status of all 50 states.

Using Texas as an example, HHSC-OIG is very aggressive in its approach towards compliance. It expects “[a]ll [Medicaid] service providers [to] check OIG’s exclusion list monthly.” First pioneered by New York State, this trend (of requiring monthly screening checks) is steadily being adopted by states around the country.  As Medicaid dental audits expand, it is essential that all dental providers take steps to comply with their mandatory obligation to perform comprehensive exclusion screening of procedures of their staff, contractors, vendors and agents.

What the penalty for improperly hiring an excluded party or for contracting with a vendor, contractor or other third party? Essentially, any Medicaid dental claims submitted for coverage and payment after an excluded party enters on board your practice would be tainted, thereby exposing the practice to potential Civil Monetary Penalties (CMPs), along with other administrative, civil and / or potentially criminal sanctions.

II.     Don’t Play Games! Sham Ownership Schemes:

As an example, in a federal criminal case out of Massachusetts, a registered dentist was convicted of fraud for submitting false claims to the government for payment. As a result, the Department of Health and Human Services, Office of Inspector General (HHS-OIG) notified the dentist that he was being excluded from participation in federal and state health care programs, including Medicare and Medicaid. As part of that notice, the convicted dentist was notified that he may not “submit claims or cause claims to be submitted” for payment from the federal and state health care programs (in this case, specifically Medicaid). Additionally, the convicted dentist was advised that Medicaid reimbursement payments could not be made to any organization in which the convicted dentist served as an “employee, administrator, operator, or in any other capacity…” After his conviction, the dentist surrendered his right to practice dentistry in states where he was licensed.

Despite the fact that this individual was no longer licensed as a dentist and was expressly excluded from participating federal and state health benefit programs, he went out and established several dental practices, which were operated by both other dentists and the excluded individual. These dental practices treated Medicaid patients and received millions of dollars in Medicaid payments from the state Medicaid program, despite the fact that the practices were effectively run by an excluded individual. The excluded dentist was found to have been involved in “reviewing patient charts, suggesting dental procedures to be performed, reviewing billing records, reviewing income reports, interviewing and hiring dentists, and providing overall management direction to the offices.”

At one point, the excluded dentist hired another licensed dentist to run one of the dental practices he had opened. The newly hired dentist later learned of the legal and regulatory sanctions (included exclusion) that had been taken against the convicted dentist. The hired dentist subsequently submitted an application with the state Medicaid agency to become a Medicaid program provider. During the Medicaid application process, the hired dentist failed to disclose that a convicted, excluded, unlicensed dentist had an ownership or control interest in the dental practice. Notably, the convicted dentist repeatedly engaged in this sham ownership / control interest scheme.

Ultimately, the government learned of the sham ownership / control interest schemes perpetrated by the convicted dentist. Both the convicted dentist and at least one of the licensed dentist he had roped into the scheme were subsequently arrested and charged with conspiring to commit health care fraud, committing health care fraud, and making false statements involving federal health care programs health care fraud.

III.     Final Conclusion.

Dentists and orthodontists around the country are under the regulatory microscope.  While most of the audits and investigations currently underway involve Medicaid claims, we have worked on several cases involving Medicare claims as well.  Most recently, we have seen a number of dental audits being undertaken by private payors.  In years past, regulatory and enforcement actions have focused almost exclusively on non-dental related health care providers and suppliers.  Those days are over.  It is imperative that you review your current medical necessity, coding, billing and documentation practices to help ensure that your practice will be prepared for an audit.  Effective exclusion screening  practices are merely a step in the right direction.  Dentists and orthodontists should develop, implement and follow an effective Compliance Program — one that has been tailored to address the specific risks they face.   Have questions?  Give us a call if we can be of assistance.  We can be reached at: 1 (800) 475-1906.

Liles Parker attorneys represent health care suppliers and providers around the country in connection with regulatory compliance reviews, Medicare prepayment reviews and postpayment audits, HIPAA Omnibus Rule risk assessments, privacy breach matters, and State Medical Board inquiries. Robert W. Liles, Esq., is a Managing Partner at Liles Parker, Attorneys & Counselors at Law.  Call Robert for a free consultation at: 1 (800) 475-1906.

Proposed Rule Seeks the Expansion of OIG’s Exclusion Authority

OIG’s Exclusionary Authority

(July 15, 2014): On May 9, 2014, the Department of Health and Human Services, Office of Inspector General (OIG) published a Proposed Rule in the Federal Register (79 Fed. Reg. 26810) that seeks the expansion of OIG’s exclusionary authority. The new rule is consistent with previous statutory changes passed as part of the Affordable Care Act (ACA).  The expansion of OIG’s exclusionary authority is significant.  Providers and suppliers participating in Medicare, Medicaid and other federal / state health benefits programs need to fully understand the new reasons that may be relied upon by OIG when excluding an individual or entity.  Additionally, providers, suppliers and their affiliated contractors must know how to conduct a thorough screening to ensure that they are not employing an excluded party.  An overview of the primary purpose of the expansion of OIG’s exclusionary authority is discussed below.

I. Primary Purpose of this Proposed Expansion of OIG’s Exclusionary Authority:

Passage of the ACA has resulted in the expansion of OIG’s exclusionary authority.  Simply put, OIG’s authority to exclude individuals and entities involved in misconduct from federal health care programs has significantly broadened.  The purpose behind exclusion is to protect beneficiaries from untrustworthy health care providers suspected or implicated in Medicare fraud.

OIG has authority to impose mandatory and permissive exclusion. Mandatory exclusions are for a period of at least 5 years. The OIG is required to exclude those who commit more serious or repeated offenses. Permissive exclusions apply to specified categories of misconduct, and can have minimum benchmarks and timelines, depending on the basis for exclusion. OIG generally has discretion to determine whether to impose an exclusion and what the appropriate duration of an exclusion should be.

To decide how long a proposed exclusion period will last, HHS-OIG will use a set of factors. The same factors will also be used to determine recommended penalties and assessments, which generally accompany exclusion.

II.  Codifying ACA Provisions Pertaining to Exclusion:

The Proposed Rule implements several provisions of the ACA that authorize OIG to exercise permissive exclusionary authority over individuals and organizations that obstruct audits, fail to supply payment information, or make false statements.

  • Obstruct Audits.  The ACA extended the OIG’s existing discretion to exclude an individual or entity who was convicted of an offense in connection with obstruction or interference with an audit. A conviction regarding an audit obstruction is usually part of a plea bargains or settlement concerning a Federal health care investigation, such as direct or indirect misuse of funds.
  • False Statements.  The OIG has proposed a provision incorporating the ACA’s grant of authority to exclude any individual or entity that makes false statements, omissions, or misrepresentations of material facts in applications to participate as a provider or supplier under a Federal health care program.
  • Failure to Supply Payment Information.  The OIG proposes to impose exclusions for failure to supply payment information for items or services for which payment may be made under Medicare or any State health care program. Originally this provision applied to those individuals who furnish items or services for payment. The ACA expanded it to also apply to individuals who “order, refer for furnishing, or certify the need for,” items or services for payment.
  • Issuance of Testimonial Subpoenas. Another proposed change would allow OIG to issue testimonial subpoenas in investigations for exclusions, which the OIG already had the right to do under its Civil Monetary Penalty (CMP) authority.

III.  Other Propositions to Consider:

In addition to the changes under the ACA, OIG proposed a modification to the waiver authority and reinstatement rules for individuals excluded as a result of losing their licenses. This is to allow them to rejoin Federal healthcare programs earlier, when appropriate.  The OIG has also recommended removing the statute of limitations on exclusion actions based on the false or improper claims provision of the Social Security Act. Finally, the OIG’s proposes modified procedures for exclusionary proceedings, including updates and clarifications to certain aggravating and mitigating factors.

IV.  A Simple Solution to Protect Your Healthcare Organization:

Even though most of the Proposed OIG’s exclusionary authority Rule simply codifies changes from the ACA, the new regulation will still expand OIG’s ability to effectively utilize its exclusion authority to combat alleged healthcare fraud and abuse.  How can you best avoid potential penalties for the wrongful employment or engagement of an excluded individual of entity?  If you participate in Medicare, Medicaid or other federal / state health benefits programs, you need conduct regular, periodic screening of all available exclusion databases.  At last count, there are 40 different federal and state databases that list individuals and entities that have been excluded from Medicare, excluded from Medicaid or debarred from doing business with the government.  An excellent low-cost option to perform these OIG screening / exclusion screening functions is Exclusion Screening.  Their website is located at: www.exclusionscreening.com

Health care AttorneyRobert W. Liles, Esq., serves as Managing Partner at Liles Parker, Attorneys & Counselors at Law.  Liles Parker attorneys represent health care providers around the country in connection with both regulatory and transnational legal projects. For a free consultation, call Robert at: 1 (800) 475-1906.

There are Seven Compliance Plan Elements – Is Your Healthcare Company Compliant?

Seven Compliance Plan Elements(August 2, 2012): Under the Affordable Care Act (ACA), which was recently upheld by the Supreme Court, the Secretary of the Department of Health and Human Services (currently Kathleen Sebelius) may require that all providers participating in federal health care programs implement an effective compliance plan. While regulations covering this issue have not yet been released, compliance will more than likely be mandatory in the near future. As a result, it is important that your organization begin to implement a compliance plan that will protect your business and comply with the requirements of the law. What, then, are the elements of a compliance plan?

 

I.  Seven Compliance Plan Elements — A Refresher:

The elements of a compliance plan include:

  1. Conducting internal monitoring and auditing;
  2. Implementing compliance and organizational standards;
  3. Designating a Compliance Officer or contact;
  4. Conducting appropriate training and education;
  5. Responding appropriately to detected offenses and developing corrective action;
  6. Developing open lines of communication; and
  7. Enforcing disciplinary standards through well-publicized guidelines.

II.  Internal Monitoring and Auditing:

Before engaging in any of the other steps, except perhaps designating an officer to do all of this work, it is important to conduct a baseline audit of your practice’s current operations so that you can ascertain areas that need improvement, or “risk areas.” The first element of a compliance plan – at least, this initial audit – is known as a “gap analysis” and should be conducted by a qualified individual (either an attorney, experienced compliance professional, or a Certified Medical Compliance Officer). Nevertheless, a single initial audit should not be all you do. Instead, audits should be conducted on an ongoing basis, either at a set date (i.e. annually, bi-annually) or in the event of an identified problem, and preferably both.

III. Implementing Standards:

The second element of a compliance plan is to implement standards that effectively convey to your staff and third-parties your goals and expectations with regard to the business. More specifically, you should have written policies and procedures which inform your staff on their own duties and responsibilities, and how your office will conduct its business operations, and coding and billing functions. Standards may vary from practice to practice, but they should all include a code of conduct, mission statement, and policies that demonstrate your effort and commitment to following the law.

IV.  Designated a Compliance Officer:

As discussed above, one of the first things to do is designate an appropriately-qualified individual to be your compliance officer. While smaller organizations may require the compliance officer to wear multiple hats (such as also being the office manager), larger organizations should dedicate an individual, or even multiple individuals, solely to compliance-related tasks. We recommend the use of either a Certified Medical Compliance Officer or even an outside Compliance Officer (for example, friend of the firm D.K. Everett).

V.  Training your Staff:

You can be as thorough as possible in attempting to remain compliant with applicable laws and rules, but if you staff doesn’t have that same vision and makes a mistake, the entire organization will still likely be held liable. That is why it is so important to provide ongoing, comprehensive training and education to your staff – the third element of a compliance plan. They, ultimately, are the eyes, ears, and hands of your organization, and they need to know their responsibilities not only to your practice, but to the requirements of laws like HIPAA, OSHA, and Stark, and other billing requirements. The method of training may vary, but all training sessions should be documented and signed off on by your employees.

VI. Responding to Detected Offenses:

When something occurs at an office, a natural response may be to cover it up or “fix it and forget it.” The healthcare industry is different. In most cases, covering up a detected problem can lead to severe penalties, up to and including criminal prosecution (i.e. jail time). As a result, the fifth element of a compliance plan – responding to detected offenses – is in many ways what the compliance program is all about. The other elements are there to make sure nothing happens, but if it does, this element guides you in making it right, so that you and/or your practice can limit the future liability of such acts.

VII: Developing Open Lines of Communication:

This element of a compliance plan is all about making sure everyone not only knows the rules, but can report any problems to you so that they can be properly addressed (either by management or corporate counsel). You need to establish effective lines of communication, such as anonymous reporting mechanisms, exit interviews, and an open-door policy, so that you actually find out about any problems and attempt to resolve them. While there are a number of ways to implement these mechanisms, be sure that they will reasonably allow an employee, patient, or family member of a patient to make a complaint or report without the consequences of retribution.

VIII.  Enforcing Disciplinary Standards:

No one likes this, but the final element of a compliance plan is enforcing discipline in your office. Correcting the actions of your staff and colleagues can be difficult and uncomfortable, but it has the potential to save your practice. You need to have written guidelines which set out both prohibited conduct and the penalties for engaging in such conduct. Moreover, you should use a sliding scale of discipline – start with a verbal warning, but become progressively more strict as the number or severity of incidents goes up. This needs to include termination of employment.

IX. Conclusion:

The seven compliance plan elements serve as a framework and a model. They themselves will not form a complete and effective compliance plan, but they will give you sufficient guidance to being working on a plan yourself. In addition, consider using qualified health law attorneys to conduct a gap analysis, implement an effective compliance plan, and/or provide compliance training to your staff. While a compliance plan, and compliance in general, can seem like a burdensome exercise, it is the ultimate insurance policy considering the myriad statutory and regulatory problems a healthcare provider can run into. As the government and private enforcers increase their funding, skills, and sophistication, you need to keep pace to ensure your business will continue to thrive.

Robert LilesHealthcare Lawyer represents providers in Medicare post-payment audits and appeals, and similar appeals under Medicaid. In addition, Robert counsels clients on regulatory compliance issues, performs gap analyses and internal reviews, and trains healthcare professionals on various legal issues. For a free consultation, call Robert today at 1 (800) 475-1906.