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Posts Tagged ‘Fraud and Abuse’

Gainsharing Arrangement Addressed in New Advisory Opinion

Thursday, January 11th, 2018

 OIG Advisory Opinion 17-09

OIG Advisory Opinion Gain SharingThe Office of Inspector General (“OIG”) recently released a new advisory opinion (Advisory Opinion 17-09 – January 5, 2018), addressing a gainsharing arrangement between a group of neurosurgeons and a health center.  Under the proposed arrangement, a neurosurgery group agreed to implement measures to reduce the costs associated with a defined scope of surgical procedures.  As part of its agreement with the health center, the neurosurgeons were to participate in a portion of the cost savings that resulted from the implementation of the measures.

The OIG has historically issued around a dozen Advisory Opinions addressing gainsharing arrangements.  However, the OIG had not issued an advisory opinion in the gainsharing area since the passage of the Medicare Access and CHIP Reauthorization Act (known as MACRA) in 2015.  That law made modifications to Civil Monetary Penalty provisions that are applicable in the gainsharing area by removing some of the impediments to gainsharing arrangements that previously existing in the Civil Monetary Penalty laws.

Gainsharing arrangements have emerged as a way to align the economic interests of hospitals and physicians in efforts to work together to reduce cost and enhance quality of care.  A gainsharing arrangements provides doctors with economic incentives to adhere to practices that reduce the hospital’s costs associated with defined procedures or treatment courses.  Under traditional fee-for-service reimbursement, a financial incentive is created for physicians to provide more service to maximize reimbursement.  A properly structured gainsharing arrangement creates incentives for appropriate levels of service and rewards physicians for efficiencies and quality outcomes.  Interests are aligned because the facility and the physician, who is often the engine driving the level of care, share in the savings.

Prior to the passage of MACRA in 2015, the OIG expressed suspicion about gainsharing through Special Advisory Bulletins as well as advisory opinions.  This has the effect of chilling the proliferation of gainsharing arrangements because providers were cautious about potential regulatory issues. A major impediment prior to 2015 was the CMP law that restricted hospitals from compensating physicians in order to induce a reduction or limitation on services provided to Medicare and Medicaid beneficiaries.  MACRA clarified that the CMP law was only violated if the payment to the physician is for purposes of reducing services that are medically necessary.  This subtle yet significant change opened the door for the proliferation of gainsharing arrangements.

Coming full circle to Advisory Opinion 17-09, the OIG concluded that the specific gainsharing arrangement described in the opinion would not result in sanctions under the Civil Monetary Penalty rules or the Federal Anti-kickback Statute.  The OIG acknowledged that both the CMP laws and the Anti-kickback had potential implication but that the structural issues of the particular arrangement between the neurosurgeons and the health system would not result in the OIG pursuing sanctions.

By their very nature, Advisory Opinions only apply to the requesting party.  However, we can gain useful concepts from the analysis and conclusions of the OIG relating to the specific facts that formed the basis of their opinions.

Fair market value will always remain an issue in gainsharing arrangements.  The Federal Stark Law, Anti-kickback Statutes, and applicable state laws will require adherence to fair market value standards when payment is made between a referring party and the provider of a service. Advisory Opinion 17-09 provides us with some useful guidance regarding some of the consideration that should go into establishing fair market value and structuring a gainsharing arrangements.  Fair market value concepts in these arrangements are often subtle and must be well thought out to avoid regulatory issues. In addition, concepts of commercial reasonableness, which has emerged as a related but distinct issue impacting payments must be considered in addition to fair market value.

Advisory Opinion 17-09 is worth a review to anyone involved in structuring gainsharing arrangements. By no means should 17-09 be the only guidance that you rely upon because the opinion only touches on a few considerations that were relevant to the structure of the specific arrangement.  Some important factors to keep on your radar when structuring a gainsharing arrangement relate to the determination of baselines that are used to measure cost savings through program implementation.  The frequency and method of calculating available gainsharing amounts is subtle but important for regulatory compliance.  Of course the specific protocols or description of the method for reducing costs should be described in detail, together with a method for determining the level of compliance with those protocols.  Another issue that often arises in these arrangements involves the scope of costs that are allocated to the program.  It is important that costs allocated be reasonable to avoid potential disguised kickbacks.

If you require additional information regarding this article, gainsharing arrangements, or health care issues in general, please contact us through the contact section of this blog.

DOJ Skilled Nursing Facility Settlement Involving Rehab – Highest Ever

Thursday, December 28th, 2017

Skilled Nursing Facility Single Highest False Claims Act Settlements to Date

Personal Care Agency Fraud2017 saw the largest recovery from a skilled nursing facility under the False Claim Act.  Life Care Centers of America Inc. and its owner agreed to pay $145 million to settle allegations that it caused skilled nursing facilities to submit false claims for rehabilitation therapy services that were not reasonable, necessary, or skilled.  The government’s case alleged that Life Care instituted corporate-wide policies and practices designed to place beneficiaries in the highest level of Medicare reimbursement.  High reimbursement categories were encouraged irrespective of the clinical needs of the patients.  The case alleged that this resulted unreasonable and unnecessary therapy to to be provided to many beneficiaries.

Dermatology Practice Fraud and Abuse Risks Identified in Florida Case

Tuesday, June 27th, 2017

Dermatologist Fraud and Abuse Risks – Identified from Florida Case Targeting Demotologist

Dermatology Risk Areas Fraud and AbuseAn allegation from a competing dermatologist resulted in a Federal government investigation of a Florida dermatologist.  The dermatologist was accused of charging the Medicare program for unnecessary biopsies and radiation treatments that were not rendered, not properly supervised, or given by unqualified physician assistants.  It was alleged the doctor was not even in the country when some of the procedures at issue were performed.  The unnecessary charges were alleged to have totaled around $49 million over a 6-year period.

The dermatologist did not admit wrongdoing in the settlement.  Rather, he alleged the overbilling resulted from his unique practice that relied on radiation, instead of disfiguring surgery, to help patients.  The doctor claimed he had cured “over 45,000 non-melanoma skin cancers with radiation therapy” over a 30-year period.  The problem with that argument appears to be the fact that the dermatologist was not trained or qualified in providing radiation oncology treatments.

There are a number of interesting things about this case.  The case was brought by a competing physician as a whistleblower.  The physician who brought the case expressed concern about having to treat patients that the accused doctor had misdiagnosed with squamous cell carcinoma.

The case also alleged significant billing for services allegedly provided when the doctor was not even in the office.  The accused doctor alleged he was available by phone while the procedures at issue were being performed.  This raises interesting issues under the rules regarding “incident to” billing.  Those rules permit a physician to bill for physician extender services.  In order to qualify to bill a service as “incident to” a physician’s service, the billing physician must meet supervisions requirements.  The physician must be physically present within the office suite during the performance of the procedure in order to qualify to bill a service as “incident to” the physician’s services.

It appears there were a number of things going on in this case.

  • There appears to have been a pattern of diagnosing a higher level of severity than was supported by the patient’s condition.
  • There was a routine use of radiation therapy, even in cases that were not medically appropriate.  This placed patients at potential risk.
  • There appears to have been questions whether the accused doctor was authorized to perform radiation therapy.
  • There were issues regarding improper use of the “incident to” billing rules when the doctor was not present to actively supervise the service.
  • There was also some evidence the doctor had offered incentives for staff to misdiagnose and over utilize the radiation treatment.
  • There was an alleged kickback arrangement with another physician who operated a clinical laboratory.

Personal Care Agency Fraud – Business Structure Can Impact Compliance Risk

Tuesday, June 27th, 2017

Personal Care Agency Structure Can Increase Risk and Government Scrutiny

Personal Care Agency FraudThe OIG recently released a review of Medicaid Fraud Control Unit activities which identified personal care agencies as accounting for nearly one-third of fraud prosecutions.  Previous blogs identified a number of compliance risks that often ensnare agencies.  Risk can also be impacted by the structure and nature of the business that is conducted by the agency.  The business might be perfectly legal, but can still create additional risk.

An good example involves personal care agencies that focus on recruiting patients with extended families who already reside with the patient.  A personal care business plan that focuses on training extended family might be technically legal, but can certainly present risk that a reviewer will more closely scrutinize record-keeping, PCW training, and other requirements.  Closer scrutiny may result in overpayment requests and/or investigation.

The normal business plan for a personal care agency involves the hiring and training of personal care worker who are assigned to clients who retain the agency’s services.  Normally, a PCW and a client do not know each other and certainly are not sharing a residence with the client.  Some agencies might focus their business on recruitment of patients who live with extended family.  Simply by providing training to the existing family member, the agency is able to generate reimbursement.  The extended family member is able to earn a wage for the service that it performed.

Immediate family will normally not qualify to generate reimbursement as a personal care work.  More distant family might be able to generate reimbursement.  There may be nothing specific in the laws of the applicable state that prohibits this type of arrangement.  At the same time, there is nothing prohibiting a regulator from more closely scrutinizing regulatory requirements when presented with agencies that may be technically legal but could be viewed as being abusive at their core.

The main point here is that business structure and other factors might present additional levels of risk to an agency.  Business structure should be considered as a factor when conducting risk analysis.  Businesses that are operated in technical compliance could present higher degrees of risk than more traditional business structures.

Criminal Exposure for Failing to Repay Known Overpayment

Monday, April 3rd, 2017

Known Overpayments can Implicate Criminal Statutes

failing to repay overpaymentWe hear a lot about potential liability under the False Claims Act for the failure to repay overpayments within 60 days after discovery. Focus on the 60 day rule has taken some of the focus away from the potential for criminal charges for retaining known overpayments. Section 1128B(a)(3) of the Social Security Act (42 U.S.C. § 1320a-7b(a)(3)) makes it a crime to conceal or fail to disclose any occurrence that affects the initial or conued right to any benefit payment. A violations of the statutes requires a showing that the charged individual have knowledge of the event affecting the right to the applicable benefit. A violation of the statute is a felony and is punishable by a maximum of five years in prison and a fine of $250,000 for individuals or $500,000 for corporations.

The Office of Inspector General has applied this statute, even in cases where the overpayment occurs innocently but a party fails to repayment an overpayment after receiving knowledge. This type of situation is clearly subject to the False Claims Act where repayment is not made within 60 days. Criminal responsibility is also a potential; particularly when a decision is made not to repay after learning about the existence of an overpayment. Criminal exposure is present for the entity as well as the individuals who are responsible for failing to make repayment of a known overpayment. There is an element of ambiguity regarding application of the criminal component, but this has not stopped prosecutors from asserting the statute in the past.

The Federal Criminal False Claims Statute (18 U.S.C. § 287) can also apply to impose potential criminal liability.  That statute applies potential criminal liability on any person who “makes or presents” any claim to an agency of the U.S. Government “knowing such claim to be false, fictitious, or fraudulent.”   This statute can lead to potential 5 years imprisonment plus potential criminal penalties.   Conspiracies to violate the Federal Criminal Claims Statute impose double penealties on participants.  Failing to disclose and repay known overpayments could form the basis of a violation of this statutes as well.

Other criminal statutes could potentially apply to the failure to repay known overpayments.  Mention of these above statutes is not intended to be an exhaustive list of potential exposure.

What Is The Different Between Fraud, Abuse, and Criminal Conduct

Thursday, September 1st, 2016

Fraud, Abuse, Over-payment – When Does a Mistake Become Fraud?

Fraud Abuse OverpaymentIf you are involved in any way in the health care system, it should be obvious by now that the government has committed ever increasing resources to the prosecution of fraud and abuse cases. Simply put, from a governmental standpoint, prosecuting fraud and abuse is good business. Every dollar that the government puts into pursuing health care fraud and abuse brings a return of around 7 or 8 dollars. If you are in business what do you do if you know that you can invest $1 and obtain a consistent $7 return on that investment; you spend the $1 as many times as you can. That is exactly what the government is doing when it comes to health care fraud and abuse. It is worthy of note that we are not just talking about pursuing criminals when we talk about health care fraud and abuse.

Certainly there are a lot of criminals out there who are intentionally trying to steal from the system through fraudulent schemes. Fraud and abuse encompasses a much broader type of activity. There are numerous situations where unintentional activity (i.e. a billing or coding error) can result in being overpaid by the federal government under a governmental health care program. I don’t want to say that this happens to everyone in the health care system; but it certainly happens to a lot of people, usually as a result of some sort of neglect or misinterpretation of some very complex regulations. Take for example the supervision rules that are discussed in another article in this newsletter. They are extremely convoluted and it is hard to imagine who every doctor could have it clear in his or her mind which rules apply and exactly what is required in each specific instance. Nevertheless, a billing occurs and if the proper supervision is later found to not be present, an over-payment results. This is an example of what the government considers to be “abuse.” No criminals are involved here, but an over-payment and technical abuse of the system has occurred.

The manner in which this situation is dealt with becomes critically important in determining whether there is a simple correction of the situation or whether it is escalated to higher levels of culpability; whether the simple inadvertent abuse becomes fraud. Let’s skip forward to a time when the doctor discovers that a mistake has been made in the level of supervision that was provided in the past. What happens now it very important. First, lets imagine that the doctor comes forward and admits the error. There is some money owed back to the governmental health program. This part of it will never go away. But lets say that the doctor lets it slide for half of a year and does nothing. Under current law, the doctor’s potential exposure has just escalated into a completely different zone of risk and potential culpability. Federal law says that the Federal False Claims Act applies if an over-payment is not corrected within 60 days after discovery. There are a lot to technical rules about when an over-payment is deemed to have been discovered. I am not going to get into that right now.  the doctor is potentially exposed to three times the original over-payment. But that is not the extent of it. The doctor is also exposed to additional damages in the amount of $11,000 per claim; for every individual service claim that resulted from the initial mistake in complying with the supervision regulations. This case has now escalated from abuse into fraud. From here it is just a matter of establishing intent to make this a criminal case.

Medigap PHO Discount Program Receives OIG Approval

Tuesday, June 23rd, 2015

OIG Releases Yet Another Advisory Opinion 15-08

Medigap Arrangment Involving PHO Discounts

Medigap PHO Discount ProgramSomeone must be busy at the Office of Inspector General’s Office. Last week they released two new advisory opinions and a Special Fraud Alert. This week they released another Advisory Opinion, this time addressing sharing savings from a preferred hospital network between a Medigap insurer and its policy beneficiaries. The program at issue provided a premium credit of $100 toward the policyholder’s next renewal premium for participating in a discount program involving price reductions from a physician-hospital organization.

The second part of the program involved negotiated service rates with a physician-hospital organization (PHO). The PHO agreed to discounts of up to 100% of the Medicare Part A inpatient deductibles which would normally be paid by the Medigap plan. The PHO received an administrative fee from the Medigap plan for each discount that was provided by the PHO.

The OIG analysed the program under the civil monetary penalty (CMP) provisions and the Anti-Kickback Statute (AKS) and concluded that the arrangement would not constitute grounds for civil monetary penalties or administrative sanctions.

The OIG found that discounting of the inpatient deductible created a low risk of fraud or abuse because the Medicare Part A payments are fixed and the discount would not impact reimbursement amounts. Additionally, the OIG observed that patients would not generally haveknowledge of the discount and would not be encouraged to seek additional care. The program did not offerfinancial rewards to the physicians involved in the patient’s care and the program was open to all providers who agreed to the discount program through participation in the PHO.
The OIG also found that the premium credits that were provided to beneficiaries created minimal risk of program abuse.

The OIG also noted that the proposed arrangement has the potential of lowering costs for policyholder under the Medigap plan and that the savings would be reported to the state regulatory agency.

Wednesday, April 2nd, 2014

From HCCA Compliance Institute – False Claims Act Developments

I am in the morning session of HCCA Compliance Institute covering False Claims Act issues.  Some interesting items being covered.  I will summarize a few of the major points being made and will provide some additional analysis and observations on some of these points.  Forgive my typos or poor writing.  I am blogging live from within the session on my handheld device.

  • This discussion is in the context of the False Claims Act and determining whether there is an obligation to self disclose or take other remedial action.  The following points are made:
  • Ambiguities in the law will be identified that cast doubt on whether or not a violation exists.  A provider cannot bury its head in the sand.  If relying on a legal interpretation on whether and overpayment or self disclosure should take place, make certain to document the process you took to make a reasonable determination on how a law applies.  Reasonable efforts should be documented to indicate that a reasonable assessment was made and a reasonable determination was made concerning interpretation.
  • I always advise providers to completely document their investigation of issues regarding application of specific laws.  The process taken should be documented to memorialize that a reasonable decision was made concerning potential legal application.
  • Reasonable steps should be taken to reach an answer.  If guidance is sought from an FI or state agency, the contact and results should be documented in the investigation process.  Many ambiguous cases of legal interpretation come through my office.  I tend not to see the easy cases.  I get the cases where the answer is not entirely clear or well defined under legal authorities.  Response from legal review should be provided to you in writing as privileged communication.  If there are any false assumptions made in the legal analysis, make certain they are properly addressed and that the opinion is properly modified to be based on the correct assumptions.
  • You should never chose to simply ignore legal advice and opinion on interpretation of a legal issue.  Failing to follow a legal opinion or analysis can create very bad evidence in your files.  If there is disagreement or a false assumption in the legal opinion, it is fair to address the issue and ask for a correction.  But you should never put yourself in a position of putting your head in the sand when you have a legal opinion or analysis that you simply do not like.

More on false claims act coming.

Annual Health Care Fraud and Abuse Control Program Report

Tuesday, March 11th, 2014

Record Recovery for Health Care Fraud and Abuse

The U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) recently released its annual Health Care Fraud and Abuse Control Program (HCFAC) report. This report indicates that in the last three years for every dollar spent on health care related fraud and abuse investigations through HCFAC and other government programs, the government recovered $8.10. This is a record high for the 17-year old program.  HCFAC focuses on eliminating fraud, waste, and abuse in the health care industry.

A few notes on the report’s numbers:shutterstock_1766714

•      The federal government recovered a record-breaking $4.3 billion in fiscal year 2013 alone.
•      Over the last five years, the federal government recovered $19.2 billion—this is more than double the previous five-year period.
•      In fiscal year 2013, the DOJ and HHS strike force team filed 137 cases, charged 345 individuals with crimes, secured 234 guilty pleas, and achieved 46 convictions.
•      Defendants sentenced in fiscal year 2013 served an average of 52 months in prison.
•      Centers for Medicare and Medicaid Services (CMS) have banned 225,000 individuals and entities from billing Medicare between March 2011 and September 2013.

Attorney General Eric Holder states that, “With these extraordinary recoveries, and the record-high rate of return on investment we’ve achieved on our comprehensive health care fraud enforcement efforts, we’re sending a strong message to those who would take advantage of their fellow citizens, target vulnerable populations, and commit fraud on federal health care programs,” said Attorney General Eric Holder.

The return on investigation investment suggests that the federal government’s interest in investigating and prosecuting health care fraud and abuse is substantial. In short, health care compliance is more important than ever.

Annual Health Care Fraud and Abuse Control Program Report

Monday, March 10th, 2014

The U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) recently released its annual Health Care Fraud and Abuse Control Program (HCFAC) report.  This report indicates that in the last three years for every dollar spent on health care related fraud and abuse investigations through HCFAC and other government programs, the government recovered $8.10. This ishutterstock_1766714s a record high for the 17-year old HFAC program. The HFAC program focuses on eliminating fraud, waste, and abuse in the health care industry.

A few notes on the report’s numbers:

• The federal government recovered a record-breaking $4.3 billion in fiscal year 2013 alone.
• Over the last five years, the federal government recovered $19.2 billion—this is more than double the previous five-year period.
• In fiscal year 2013, the DOJ and HHS strike force team filed 137 cases, charged 345 individuals with crimes, secured 234 guilty pleas, and achieved 46 convictions.
• Defendants sentenced in fiscal year 2013 served an average of 52 months in prison.
• Centers for Medicare and Medicaid Services (CMS) have banned 225,000 individuals and entities from billing Medicare between March 2011 and September 2013.

Attorney General Eric Holder states that, “With these extraordinary recoveries, and the record-high rate of return on investment we’ve achieved on our comprehensive health care fraud enforcement efforts, we’re sending a strong message to those who would take advantage of their fellow citizens, target vulnerable populations, and commit fraud on federal health care programs,” said Attorney General Eric Holder.

The return on investigation investment suggests that the federal government’s interest in investigating and prosecuting health care fraud and abuse is substantial. In short, health care compliance is more important than ever.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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