Health Care Fraud Anti Kickback Statute & False Claims Act Defense

Mr. Feldman has defended health care providers, doctors, pharmacies, including compounding pharmacies, and sales and marketing representatives under investigation for or charged with health care fraud, violations of the Anti-Kickback Statute, or pharmaceutical diversion, and has defended individuals in False Claims Act litigation and in connection with False Claims Act investigations. The Firm has also conducted internal investigations on behalf of health care providers in response to government actions and in response to internal audits or whistleblower complaints.

Mr. Feldman is a published author on the Anti-Kickback Statute and the False Claims Act and has been an honored speaker on health care fraud and abuse topics at the ABA White Collar Crime Institute, the ABA National Health Care Fraud Institute, and at medical societies and CPA conferences in Florida.

As an adjunct to the Firm’s health care fraud and abuse defense practice, the Firm also strives to provide guidance to health care providers on the pitfalls of fraud and abuse laws including the potential application of the Anti-Kickback statute and/or state anti-kickback laws and will educate individuals and organizations about the potential benefits of voluntary disclosure through the Office of Inspector General Department of Health and Human Services Voluntary Self Disclosure Protocol.

The Firm also has experience defending health care providers in audits by program integrity contractors (ZPICs), including SafeGuard, in administrative proceedings before professional boards of medicine and pharmacy, and has assisted providers facing exclusion from federal health care programs.

Some of Mr. Feldman’s representative health care matters include:

Representing former employee in conspiracy alleging fraudulent conduct in connection with the performance of a clinical trial monitored by FDA. Case No. 21-cr-20301-DPG (S.D. Fla.)

Representing a veterinarian in the largest thoroughbred horse doping prosecution in the U.S. involving allegations that client engaged in misbranding with the intent to defraud and mislead the FDA in violation of the Food Drug and Cosmetic Act. Case No. 20-cr-00160-MKV (S.D.N.Y.)

Representing health care marketer in multi-defendant kickback conspiracy. Case No. 19-cr-00025-RWS(E.D. Tex.)

Representing former owner of pharmacy in connection with health care fraud and drug diversion investigation.

Representing health care organization in connection with multi-district durable medical equipment and telemedicine investigation.

Represented principals of behavioral and mental health facility in Medicaid fraud investigation. Attorney Generals Office declined prosecution of company and its principals.

Represented billing company in connection with nationwide rural hospitals and laboratory billing investigation. The Government declined prosecution of client.

Represented board of directors in multi-state internal investigation of compounding pharmacies in New Jersey and Alabama and Georgia related to potential violations of the Anti-Kickback Statute in response to execution of search warrant by 4 different federal agencies including Department of Defense (DCIS). After a thorough investigation and after the Firm recommended corrective measures, the investigation resulted in no charges against any board members or any of the principals of the corporate entities.

Represented sales and marketing professional in OIG-HHS and DCIS (OIG-DOD) grand jury investigation related to compounding pharmacy fraud and violations of the Anti-Kickback Statute, involving the TRICARE program. The Government had initially designated the client as a “target.” After retaining the firm and meeting with the Government for several proffer sessions, the Government declined prosecution against the client.

Represent compounding pharmacy for more than 5 years. The Firm has represented pharmacy in response to FDA audits and inspections, DOH inspections, DEA matters, and Board of Pharmacy actions. Representation includes obtaining numerous “no probable cause” determinations by the Board, and dismissal of an administrative action alleging violation of Florida’s sterile compounding laws. In that action, after extensive discovery and pre-hearing investigation the Department of Health agreed to reconsider and recommend that the initial finding of probable cause be denied and that the case be closed administratively.

Obtained declination of prosecution for marketer in investigation targeting violations of the Anti-Kickback statute in connection with compounding pharmacies and speaker fee arrangements.

Represented owner of sales and marketing organization in connection with IRS investigation into compounding pharmacy practices and violations of the Anti-Kickback Statute; investigation resulted in no charges.

Represented marketer in multi-defendant Tricare compounding pharmacy fraud conspiracy prosecution involving telemedicine and violations of the Anti-Kickback Statute. Client received second lowest sentence of 6 defendants after the district court granted a variance from the high-end of the Guidelines to a below Guidelines sentence. Case No. 18-cr-20710-CMA (S.D. Fla.)

Represented career medical device sales representative in one of the first trials relating to payment and receipt of kickbacks in connection with the marketing of Terocin and Lidopro creams which were reimbursed by the Office of Workers Compensation Program via the Federal Employees Compensation Act (FECA). After a two-week trial, the jury returned a split verdict (guilty and not guilty) acquitting the client of all charges related to receiving kickbacks.  Case No. 19-cr-60157-RAR (S.D. Fla.)

Obtained sentence of probation for podiatrist in indicted health care fraud prosecution resulting in $1.5 Million loss to Medicare. At sentencing, the court granted a downward variance of 12 levels, without the application of a 5K for substantial assistance, and even though, at sentencing, our client was facing a 46-month sentence at the low-end of the Guidelines.  Case No. 17-cr-0012-BJD (M.D. Fla.)

Represented former owner of assisted living facilities in federal Medicaid prosecution based, in part, on worthless services fraud; after a two day sentencing hearing which focused heavily on the loss calculation and during which the Government and Probation had recommended a 9 year sentence the district court reduced the “loss” in this case significantly from more than $1M to $120,000 and the client received a sentence of less than 3 years. Case No. 15-cr-00462-MSS (M.D. Fla.)

Obtained a declination of prosecution for a sober-home owner in connection with state investigation into patient brokering.

Obtained a sentence of probation for individual charged with defrauding various insurance companies and obtained a declination of prosecution on criminal charge carrying a mandatory minimum three-year jail sentence. As part of representation, negotiated terms in the plea agreement which permitted client to avoid deportation and removal consequences as non-U.S. citizen.

Obtained declination of civil and criminal prosecution focusing on violations of False Claims Act and Anti-Kickback Statute on behalf of sales representative of diagnostics laboratory in connection with national investigation into laboratories conducting certain blood tests.

Obtained termination of pre-payment suspension for home health care company subject to ZPIC audit and inspection after CMS and MAC terminated client’s suspension.

Represented interventional pain specialist in response to grand jury subpoena; investigation resulted in no charges.

Represented owner of retail pharmacy in indicted Anti-Kickback prosecution involving $1.5 Million loss and obtained reduction in sentence.

Represented individual in indicted Prescription Drug Marketing Act prosecution with multiple search warrants and mitigated sentence at lengthy sentencing hearing addressing application of the food and drug guidelines (FDA) to the charged offense.

Served as part of a team representing owner of home healthcare agency in multiple federal sentencing proceedings, including a separate proceeding concerning restitution, and multiple appeals to the Eleventh Circuit Court of Appeals in a healthcare fraud case.

Advise individuals, medical professionals, and organizations on the pitfalls of fraud and abuse laws including the potential application of the Anti-Kickback statute and/or state anti-kickback laws

Signs That You Might Consider Contacting a Health Care Fraud and Abuse Attorney:

If federal agents have interviewed you or attempted to interview you at your home or at your office

If federal agents have executed a search of your office or business

If you have received a grand jury subpoena to produce documents or appear for testimony

If a network provider has notified you that they are terminating your coverage because of substantial billing discrepancies or improper billing

If you have been accused of a health care fraud offense or if you have reason to believe that you may be the subject of a health care fraud investigation

If an internal audit has unearthed a potential violation of health care fraud and abuse laws

If an employee or former employee has unearthed a potential violation of health care fraud and abuse laws

If you have received a Civil Investigative Demand from the Department of Justice

If a CMS contractor has placed your Medicare payments on suspension or pre-payment review

If a ZPIC has notified you that they will be conducting an onsite inspection

If DEA Diversion agents have conducted or have indicated they will conduct an inspection of your pharmacy based on an internal complaint about dispensing of controlled substances

HEALTH CARE FRAUD

FEDERAL ANTI KICKBACK STATUTE

COMPOUNDING PHARMACY FRAUD

TELEMEDICINE FRAUD AND KICKBACKS

RURAL HOSPITALS AND REFERENCE LAB FRAUD

SOBER HOME FRAUD

FALSE CLAIMS ACT DEFENSE

PATIENT BROKERING

MISBRANDING OF DRUGS OR MEDICAL DEVICES

PHARMACEUTICAL DIVERSION

PRESCRIPTION DRUG DIVERSION

DEA INSPECTION AND ADMINISTRATIVE SEARCH

OIG VOLUNTARY DISCLOSURE

ZONE PROGRAM INTEGRITY CONTRACTOR (ZPIC) INSPECTION