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New York Health Law

‘Incident To’ Billing: Billing Physician as the Supervising Physician and Ancillary Personnel Requirements

Posted in Audit and Compliance, Medicaid and Medicare, Physicians and Other Licensed Professionals

imagesNG7ROJJTCMS has published a Proposed Rule to clarify how physicians are to bill for services furnished “incident to” the professional services of a physician.

When a medical practice bills Medicare “incident to” for NPP services (i.e. “non-physician practitioners” such as nurses or physician assistants), the bill is rendered by the physician using the physician’s NPI number. Incident to services billed by the physician are paid at 100 percent of the fee schedule amount even though the physician did not perform the services. When the same services are billed by the NPP, the services are paid at 85 percent of the fee schedule amount. Specific requirements must be met for physicians to bill Medicare for incident to services. The services must be:

  • Furnished in a noninstitutional setting to noninstitutional patients.
  • An integral, though incidental, part of the service of a physician in the course of diagnosis or treatment of an injury or illness (understood to mean a physician has seen the patient first and initiated a plan of care being carried out by the NPP).
  • Furnished under direct supervision of a physician or other practitioner eligible to bill and directly receive Medicare payment (meaning the physician is present in the office suite).
  • Furnished by a physician, a practitioner with an incident to benefit, or auxiliary personnel.

NPP services may be billed under the physician’s NPI number when the services are part of the patient’s normal course of treatment, during which a physician performed an initial service and remains actively involved in the treatment.

The current regulations have caused confusion. The regulations state that the “physician supervising the auxiliary personnel need not be the same physician upon whose professional service the incident to service is based.” My interpretation of this is that a physician other than the physician that initiated the plan of care may supervise the NPP in the provision of services and such services will qualify as “incident to” if all other requirements are met. What remains unclear is which physician should bill for the incident to services, the supervising physician or the physician that initiated the plan of care. The proposed rule attempts to clarify that the billing physician must be the physician that supervised the services and not the physician that initially saw the patient and instituted the plan of care.

Care must be taken to ensure the supervising physician’s NPI number is used. This can be a challenge in busy medical offices where the physicians are regularly in the OR or conducting rounds.

EDNY Judge Refuses To Unseal Grand Jury Minutes In Health Care Identity Theft Prosecution

Posted in Fraud and Abuse and Stark, HIPAA and Privacy, Litigation, Medicaid and Medicare

Earlier this month, EDNY Judge Joanna Seybert examined the elements of Aggravated Identify Theft in an interesting context: a motion to unseal grand jury minutes in a health care fraud prosecution, United States v. Cwibeker

Defendants were charged with billing Medicare for fictitious or non-compensable treatments of residents of assisted living facilities.  Defendants would allegedly visit residents at the facilities, not provide Medicare-reimbursable services, and then generate a list of patients they allegedly visited.  Defendants would then use the list to submit fictitious claims to Medicare.  Significantly, defendants legally obtained the personal information from residents in the first instance; the alleged subsequent unlawful use of the information formed the basis of the criminal charges. 

Defendant Cwibeker argued that patients had consented to use of their personal information, and non-consent is an element of the Aggravated Identity Theft charge.  Thus, the grand jury minutes should be unsealed because this element was likely not disclosed.  

The Court first noted the long-established policy of maintaining secrecy of the grand jury.  The Court next looked to the Supreme Court’s three part analysis for allowing disclosure.  A party must show: (1) the material sought is needed to avoid a possible injustice; (2) the need for disclosure is greater than the need for continued secrecy; and (3) the request is structured to cover only the material needed. 

The Court denied the motion, holding that non-consent of the defendant’s purported patients for releasing the information is not an element of the Aggravated Identity Theft offense, which provides that whoever “knowingly transfers, possesses or uses, without lawful authority, a means of identification of another person,” is subject to an additional two years in prison. The Court found that consent of the victim has no bearing on “without lawful authority”  under the statute, as it is the improper use of the information that forms the offense.  The Court distinguished a Seventh Circuit case where the person whose identity was appropriated was a participant in the fraud.  In Cwibeker, the Medicare recipients whose identification was misappropriated were victims, with no knowledge of or participation in the alleged fraud. 

This case highlights again the need for vigilance concerning patients’ personal information.  Courts will hold persons who seek to profit from the improper use of such information accountable.  Providers must take all available steps to safeguard patient information, however, as those who allow such information to fall into the wrong hands will also be held accountable.

Second Circuit Rejects Constitutional Challenge To New York School Vaccination Requirement

Posted in Litigation, Regulatory Issues

The Second Circuit yesterday rejected a Constitutional challenge to New York’s requirement that children be vaccinated to attend public school, and upheld a school’s decision to exclude from class, during a chicken pox outbreak, students with a religious exemption to the vaccination requirement. 

In Phillips v. City of New York, two Catholic parents received a religious exemption from the statutory vaccination requirement for their children. The statute provides an exemption for children of parents who have “genuine and sincere religious beliefs” against vaccination.   A state regulation provides that school officials may exclude children with an exemption from school “in the event of an outbreak … of a vaccine-preventable disease in a school.”  Plaintiffs’ children were excluded from school when a fellow student was diagnosed with chicken pox. 

Plaintiffs first argued that mandatory vaccination violates substantive due process.  The Court upheld New York’s requirement, based on the Supreme Court’s decision in Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905), that school vaccination is a proper exercise of the State’s police powers.  The Second Circuit rejected the argument that an alleged growing body of scientific evidence against vaccinations altered this rule.     

The Court next addressed the exclusion of plaintiffs’ children from school during the chicken pox outbreak, which plaintiffs alleged to be an unconstitutional burden on their free exercise of religion.  The Second Circuit held that the law was neutral and of general applicability, and therefore the State need nor show a compelling government interest, even if there was an incidental burden on religion.  The Court cited the Supreme Court’s statement in Prince v. Massachusetts, 321 U.S. 158 (1944), that “[t]he right to practice religion freely does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death.”  The Court determined that because the State could exclude unvaccinated children from school altogether, the more limited exclusion during a chicken pox outbreak was Constitutional. 

Another plaintiff on the appeal was not granted a religious exemption from vaccination for her children.  The District Court had adopted the Magistrate Judge’s findings that this plaintiff’s objections to vaccination were health-related and not based on genuine and sincere religious beliefs.  The Second Circuit held that this determination had not been appealed and could not therefore be addressed.

5 Lessons for Health Care Providers from Joan Rivers’ Death

Posted in Audit and Compliance, HIPAA and Privacy, Hospitals and Health Care Facilities, Physicians and Other Licensed Professionals

On November 10, 2014, the US Department of Health and Human Services released its investigation report regarding the death of actress and comedian Joan Rivers.  The report, called a “Statement of Deficiencies and Plan of Correction”, highlights numerous mistakes and violations made by Yorkville Endoscopy, the treating facility where Ms. Rivers died (Ms. Rivers was identified as “Patient #1″).  Health care providers, facility owners, and administrators can learn some basic but important lessons from the report’s findings. 

1. Have appropriate policies and procedures (“P&Ps”) in place as required by your licensing agency and accrediting body.  Yorkville Endoscopy is licensed by the State of New York as an ambulatory surgery center (“ASC”) under Article 28 of the Public Health Law, and accredited by the American Association for Accreditation of Ambulatory Surgery Facilities.  The State regulatory requirements for an ASC are much more rigorous than the requirements for non-licensed outpatient surgery centers in New York.  P&Ps cover issues including clinical practices, patient consents, procedures, anesthesia, billing, provider credentialing, employment and more.  An administrator, compliance officer, or other responsible party may review the regulations and accreditation standards, consult with the accrediting body, legal counsel or a consultant, and can purchase policy manuals from numerous sources.  

2. Follow your own policies and procedures.  The report cites numerous examples of Yorkville Endoscopy failing to follow its own P&Ps.  For example, the staff failed to follow the “Time Out” policy which helps ensure that the correct procedure is being performed; also, one of the physicians performing the procedures was not credentialed by the facility, in violation of the Physician Credentialing P&P. A facility’s P&P manual should not be gathering dust on a shelf in a back office (same goes for the Compliance Manual).  If a particular policy or procedure is not effective, the facility should develop a new policy or procedure that works better.  A facility that consistently follows its own P&Ps exhibits traits of a compliant and quality oriented organization; while this will not prevent accidents or unexpected occurrences, many issues may be avoided.  All staff, including physicians, should be regularly educated on the facility’s P&Ps.

3. Credentialing protects you.  The federal report stated that one of the physicians performing a procedure on Ms. Rivers was not credentialed by the facility.  Credentialing is a fairly simple process that allows a facility to review a provider’s licensure, education and work history, insurance, and past lawsuits or disciplinary actions before allowing them to treat patients.  This enables a facility to determine whether a provider meets facility requirements in general, and often whether they are qualified for specific procedures.  This helps weed out bad providers up front, limits certain procedures to physicians with an appropriate level of training and experience, and allows the facility to have a record of who is providing services under its roof.

4. Keep the cameras away from the patients.  The report notes that one of the physicians took a photograph of Ms. Rivers with his cell phone while she was under sedation during a procedure.  There is no evidence she consented to this photo.  This is a violation of Ms. Rivers’ right to privacy (under HIPAA and State laws), and violated the facility’s own “Cell Phone Policy.”  Taking photos of patients without their consent exposes the individuals and their facilities to liability, and often results in loss of employment for the offending staff.  Facilities should review their photo and video policies, with an eye toward protection of the privacy of patients, staff and guests.

5. Beware of “VIP Medicine”. Accommodating a VIP in certain ways is reasonable and acceptable, but it is not occasion to ignore important policies and procedures.  The investigation states that Ms. Rivers’ medical record did not contain an informed consent for the nasolaryngoscopy, and contained no documentation of her body weight (needed to calculate anesthesia dosages).  Allowing a VIP to enter though a separate door to increase their privacy, keeping their visit private, or using a private room are certainly appropriate.  However, clinical guidelines should be followed regardless of the star power of the patient.  This means they must be subject to the same clinical oversight, undergo the same process for obtaining informed consent for any procedure, and receive the same pre-procedure screening and testing in accordance with good medical practices.

It is unknown whether compliance with any of the above-noted issues would have resulted in a better outcome for Ms. Rivers – sometimes the negative risks discussed during the informed consent process do occur, and sometimes this results in the death of a patient.  What is clear is that inattention to regulations, failing to follow basic policies and procedures, and violating a patient’s rights suggest a facility and providers that fail to place a high value on quality of care and the safety of their patients.

Visiting Nurse Service Settles Some SDNY False Claims Act Allegations, Leaves Others Open As Part Of A “Remaining Investigation”

Posted in Audit and Compliance, Fraud and Abuse and Stark, Insurance and Managed Care, Litigation, Long Term Care, Home Health and DME, Medicaid and Medicare, Physicians and Other Licensed Professionals

An interesting SDNY settlement agreement resolves some False Claims Act allegations, but leaves others for another day.  Visiting Nurse Service of New York (VNS) paid just under $35 million to the United States and New York State to settle allegations that VNS improperly billed Medicaid for 1,740 members whose needs did not qualify for a managed care plan.  The government alleged that these members were improperly referred by social adult day care centers (SADCC), or received services primarily from SADCCs, many of which provided substandard and minimal care.   

In the settlement agreement, VNS admitted that 1,740 Medicaid long term care  program members were referred by SADCCs or used SADCC services, and were not eligible to be members of the plan; and that various SADCCs in the provider network did not provide services that qualified as “personal care services” under the long term care program contract with New York’s Department of Health. 

The settlement agreement has a unique “Remaining Investigation” provision.  Most FCA settlement agreements are designed to settle all claims against the defendants.  The VNS settlement agreement, however, provides that it resolves only part of the United States investigation. Examples of allegations that are part of the “Remaining Investigation” are redacted in the publicly-filed document.  In a provision that could lead to interesting questions of interpretation, VNS agrees  “to cooperate with the Remaining Investigation,” but without waiving attorney-client or joint defense privileges, work product protections, or factual or legal defenses covering claims the government may bring against VNS.  The issue of whether VNS is satisfying its duty of cooperation under the agreement while maintaining assertions of privilege and factual and legal defenses will be difficult to sort out if it is ever litigated.  The settlement agreement carves out any potential claims against the president of the corporation that administered the managed health care plan, so that individual could be the focus of the “Remaining Investigation.”  In addition, the Court approved keeping the relator’s complaint and the government’s complaint-in-intervention under seal.

During the pendency of the “Remaining Investigation,” VNS agrees to monitor and further revise standards for credentialing SADCCs; only credential SADCCs that have necessary certificates; monitor SADCCs to ensure compliance with credentialing; ensure that SADCCs provide proper personal care services; and prohibit marketing practices directed at enrolling members through SADCCs.

Columbia Pays $9 Million In False Claims Act Case For Mischarging Federal Grant Money

Posted in Audit and Compliance, Fraud and Abuse and Stark, Litigation

Columbia University agreed to pay $9 million this week in settlement of a SDNY False Claims Act case alleging that it had submitted false claims in connection with federal grants funding AIDS and HIV related work.  Columbia was the grant administrator on behalf of ICAP, an entity that received millions of dollars in federal grants for support and services for HIV prevention and treatment.  The government’s complaint alleged that the federal grants at issue required that recipients charge grants only for work actually performed as part of that grant.  It further alleged that Columbia charged for work that was not devoted to the programs that grants funded, and did not have a suitable means of verifying that the employees actually performed the work charged to a particular grant. 

A settlement was approved by the Court earlier this week.  In keeping with the SDNY practice of requiring defendants to stipulate to an agreed statement of facts, Columbia admitted that ICAP allocated salaries and wages of employees among various grants without using a suitable means of verifying whether the charges were based on an employee’s actual effort for that grant. Columbia admitted that certain reports were inaccurate and for a number of years, ICAP mischarged grant agreements for work that was not allocable to them. 

SDNY U.S. Attorney Preet Bharara made clear that the government will target not-for-profits, and a charitable intent will not allow potential defendants to avoid False Claims Act damages.  After praising Columbia for its work combatting AIDS and HIV, Bharara said that “Grantees are required to use federal money for the purpose for which the grant was given and nothing else. … Educational institutions, like everyone else, should be held accountable.”  Federal grant recipients must take care to ensure compliance with all the requirements of their grant agreements, or they could face treble damages and penalties under the False Claims Act. 


DOJ Criminal Chief Caldwell Outlines New Joint Criminal-Civil Qui Tam Process

Posted in Fraud and Abuse and Stark, Litigation, Medicaid and Medicare, OMIG and OIG

Leslie Caldwell, DOJ Assistant Attorney General for the Criminal Division, spoke to the qui tam relators’ bar at a Taxpayers Against Fraud conference last month, stating a new DOJ policy for criminal and civil division coordination of qui tam cases, starting with intake. 

Taxpayers Against Fraud is an organization of whistleblowers and their counsel, which seeks to combat fraud against the government.  Caldwell encouraged TAF members to reach out to the criminal division, and its 40 attorney Health Care Fraud unit, in qui tam cases that could potentially involve criminal conduct.  Stating that “qui tam cases are a vital part of the Criminal Division’s future efforts,” she outlined a newly implemented procedure so that all new qui tam cases will be shared by the Civil Division with the Criminal Division as soon as they are filed.  “Those prosecutors then coordinate swiftly with the Civil Division and U.S. Attorney’s Offices about the best ways to proceed in the parallel investigations.”   

Early civil-criminal coordination of qui tam cases has been standard practice for some time in several U.S. Attorney’s Offices, including locally in the Eastern District of New York.  As early as 1997, Attorney General Janet Reno issued a Memorandum on Coordination of Parallel Criminal, Civil and Administrative Proceedings.  In the 1997 Memo, Attorney General Reno recognized the necessity of coordinating criminal, civil and administrative investigative and litigative resources,  stating that “every United States Attorney’s office and each Department Litigating Division should have a system for coordinating the criminal, civil and administrative aspects of all white-collar crime matters within the office.”  In 2012, Attorney General Eric Holder updated this policy in a Memorandum on Coordination of Parallel Criminal, Civil, Regulatory and Administrative Proceedings.   Attorney General Holder stressed that this coordination should operate at all stages of fraud investigations, including intake, investigation and resolution. 

Healthcare providers can expect DOJ to continue to expand its aggressive efforts in combatting healthcare fraud.  DOJ has signaled that it intends to increase its coordination of civil and criminal investigations and remedies for maximum deterrence and collection of healthcare dollars.  Providers facing scrutiny from the government will need to be aware that, behind the scenes, there is likely an organized and coordinated effort that includes civil, criminal, regulatory, and administrative resources.

Dismissal Motions Filed In SDNY Computer Glitch Reverse False Claim Act Case

Posted in Audit and Compliance, Fraud and Abuse and Stark, Hospitals and Health Care Facilities, Litigation, Medicaid and Medicare, OMIG and OIG

When does the 60-day clock start for an identified overpayment of federal funds to become a reverse false claim under amendments to the False Claims Act?  A closely watched SDNY qui tam  case may provide an answer. 

In June, the United States and New York intervened in United States v. Continuum Health Partners, Inc., alleging that defendants had knowingly failed to return overpayments owed to Medicaid arising out of a computer glitch.  Defendants have now filed motions to dismiss the Federal and New York State FCA claims. 

In 2009, the Fraud Enforcement and Recovery Act defined “obligation” in the FCA to include “the retention of an overpayment.”  The following year, in 2010, the Affordable Care Act provided that an overpayment of federal funds must be reported and returned within “60 days after the date on which the overpayment was identified.”  In addition, the ACA amendments provided that the failure to return an overpayment in 60 days constitutes a reverse false claim, subjecting the provider to treble damages and civil penalties under the FCA. 

In their motion to dismiss, Beth Israel Medical Center, St. Luke’s-Roosevelt Hospital Center, and Continuum Health Partners argued that there was never an “obligation” to the Federal government, because there must be a present, existing duty to repay.  Defendants asserted that an overpayment is not “identified” unless it has been confirmed and quantified, and the 60 day period does not start until that occurs.  Defendants referenced the process most providers undertake when they become aware of a potential overpayment, including an internal audit, sampling of claims, consultations with physicians and staff, and factual and legal analysis.  This process ordinarily cannot occur within 60 days of initially becoming aware of a potential overpayment. 

The complaint attached an internal summary, by one of Continuum’s employees, of approximately 900 Medicaid claims, totaling over $1 million, that were potential overpayments.  Defendants stressed that this was not a list of actual overpayments, and in fact only 465 of the claims were paid.  As further analysis was required to determine if the claims did result in overpayments, defendants argued that the summary did not “identify” overpayments, and the complaint therefore did not allege any obligation owed the government under the FCA. 

Defendants also argued that the complaint failed to allege any affirmative act of concealment to prevent an overpayment from being disclosed, and that an overpayment from Medicaid is not an obligation owed to the Federal government under the reverse false claim section of the FCA.  In a separate memorandum seeking to dismiss the state FCA claims, defendants incorporated their Federal FCA arguments and also argued that the state reverse false claim provision was enacted after the alleged conduct, and therefore could not be applied retroactively. 

This case is being closely watched, as it raises significant issues on when the government can assert reverse false claim liability for overpayments.  Significantly, in this case, there is no dispute that the overpayments resulted from a computer glitch and not fraud, and that defendants repaid the overpayment to the government.  The complaint alleges that defendants did not make that payment soon enough.  The government intervened to seek treble damages and civil penalties, signaling that it will be aggressively pursuing cases where providers become aware of overpayments and fail — in the government’s view — to promptly reimburse the government. 

The case is pending before SDNY District Judge Edgardo Ramos, and the government opposition papers are due on October 22.

Shareholder Liability for the Misconduct of Others: What is “Direct Supervision and Control?”

Posted in Audit and Compliance, Corporate and Business, Hospitals and Health Care Facilities, Physicians and Other Licensed Professionals

Physicians often practice through a limited liability entity to shield the physician from practice liabilities. In New York, such entities may take the form of a professional service corporation, professional limited liability company, or professional limited liability partnership. Regardless of the type of entity selected, professionals in New York remain “personally and fully liable and accountable for any negligent or wrongful act or misconduct committed by him or her or by any person under his or her direct supervision and control while rendering professional services on behalf of [the entity],” See NY BCL§1505(a); NY LLCL §1205; N.Y. PTR. LAW § 26(c).

The issue of whether certain alleged tortfeasers were under a physician-shareholder’s “direct supervision and control” was recently presented in Schaefer v. Mackinnon, 117235/09, NYLJ 1202669507383, at *1 (Sup., NY, Decided August 27, 2014). In Schaefer, Plaintiffs Frank Schaefer and his wife, Maria Schaefer, brought a medical malpractice suit against Broadway Cardiopulmonary, P.C. and its four shareholders for injuries Mr. Schaefer sustained during a cardiac stress test. Additional defendants include the alleged tortfeasers, David Mackinnon, M.D., a non-shareholder physician, a medical assistant and a medical technologist, all employees of Broadway Cardiopulmonary, P.C.  According to the record, the test was ordered by Dr. Mackinnon, but Dr. Mackinnon did not interview or examine Mr. Schaefer prior to or during the course of testing. The test was administered by the medical technologist who apparently left the room during testing. Mr. Schaefer passed out and fell resulting in injuries.

The defendant shareholders moved for summary judgment arguing they did not directly supervise or control the alleged tortfeasers during the rendering of professional services as the test was performed by the other named defendants and not the shareholders. Plaintiffs opposed the motion stating the shareholders failed to implement guidelines, controls and procedures for proper and safe testing.

In analyzing the issue, Justice Joan B. Lobis looked to the Appellate Divisions ruling in Wise v. Greenwald, 208 A.D.2d 1141 (3rd Dep’t 1994).

“In Wise, the appellate court considered the liability under Section 1505(a) of the Business Corporation Law of a shareholder of a dental practice, whose employee dentist allegedly negligently extracted Wise’s tooth. Indicia of liability included the shareholder’s hiring responsibilities, setting hours of operation, evaluation of employees, and whether any intermediary supervisor lay between the shareholder and employee whose actions were at issue. Id. at 1142. Applying these factors, the Wise Court affirmed the denial of the shareholder’s motion for summary judgment. Id. at 1143.”

Turning to the case at hand, Justice Lobis looked to the testimony of the defendants finding that

• the four shareholders met at least every two months to discuss practice operations;

• all four shareholders signed the office lease, approved of the imaging machine at issue, and ordered medical and office supplies;

• all four shareholders hired and/or evaluated Dr. Mackinnon and the defendant medical technologist;

• one of the shareholders regularly discussed operational issues and staff scheduling with Dr. Mackinnon;

• the shareholders had the power to terminate employees;

• the medical technologist testified he reported directly to one of the shareholders yet he had not been trained or given procedures to follow in operating the imaging machine, he failed to monitor blood pressure, respiration or pulse before the resting portion of the stress test and he was not instructed to remain in the room with the patient during the equipment’s operation.

Based on the record, Justice Lobis found that genuine issues of material fact remain for a jury to determine whether the shareholders are liable for the actions of other persons at the practice.

Direct supervision and control by a shareholder-physician goes beyond supervision of the professional care provided. Shareholder-physicians who take on administrative oversight  responsibilities can be liable if they fail to properly train and control persons rendering professional services for the practice.

October Jury Trial in EDNY False Claims Act Case

Posted in Fraud and Abuse and Stark, Hospitals and Health Care Facilities, Litigation, Medicaid and Medicare, Physicians and Other Licensed Professionals

False Claims Act cases do not often go to trial, so they are noteworthy when they do.  EDNY Judge John Gleeson has scheduled an FCA jury trial in October, United States ex rel. Ryan v. Lederman.  Earlier this year, the Court granted summary judgment to the government in part and scheduled the remaining issues for trial. 

Dr. Gilbert Lederman was Director of Radiation Oncology at Staten Island University Hospital (“SIUH”), where he performed various radiological procedures, usually for cancer treatment.  One such treatment was stereotactic radiosurgery, a form of radiation therapy that focuses high-power energy on a small area of the body.  Elizabeth Ryan filed a qui tam action in 2004, alleging that Lederman and SIUH had improperly billed the federal government for health services under Medicare, because stereotactic radiosurgery was not “reasonable and necessary.”  The government intervened in 2008.  SIUH had also been a defendant in the case, but settled all claims against it later that year for $25 million. 

Under local medical review policies (“LMRP”), now called “local coverage determinations,” treatment of below the neck diseases such as lung carcinoma with stereotactic radiosurgery was considered “investigational.”  The government alleged, and Lederman did not dispute, that he had submitted claims for at least 300 below-the-neck stereotactic radiosurgeries.   

Summary Judgment Establishes Claims Were False; Knowledge Issue Set For Trial

In its summary judgment decision, the Court first determined that the claims were “false” on two grounds.  Lederman had submitted false claims because the LMRPs excluded coverage for stereotactic surgery performed below the neck.  Lederman argued that the LMPRs provided only guidance, but the Court held that local coverage determinations are mandatory for the areas they cover.  In addition, the Court held that Lederman had misrepresented the procedures performed, because they were not coded as below-the-neck procedures. 

The False Claims Act requires a knowing submission of a false claim, however, so the Court next looked to whether Lederman had acted “knowingly.”   The Court found the government’s case persuasive, but not sufficient for summary judgment, necessitating a trial on that issue. 

With respect to common law claims of payment based on mistake of fact and unjust enrichment, however, there is no knowledge element, so the Court granted summary judgment to the government on those claims. 

The Court scheduled a trial on the issues of: (1) whether Lederman acted with a culpable mental state for FCA liability, and (2) the amount of damages on the government’s common law claims, and possibly also the FCA claims. 

Court Finds Jury Trial Appropriate, Bifurcates Liability and Damages

Recently, Judge Gleeson addressed two procedural issues in advance of trial, Lederman’s request for a jury trial and the bifurcation of liability and damages. 

The relator’s complaint contained a jury demand, but the government’s complaint-in-intervention did not.  Lederman did not demand a jury in answering the government’s complaint.  The Court held that he could rely on the relator’s jury demand, rejecting the government’s argument that, once it intervened, the original complaint ceased to operate and it could not be bound by the relator’s jury demand. 

Earlier this month, the Court decided that it would bifurcate the trial, trying first the issue of Ledermen’s mental state for FCA liability, and then the issue of damages on the common law claims and, if necessary, on the FCA claims.  The jury trial is scheduled for October 20.