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HHS Announces Proposed Rules to Reform Stark Law and AKS Regulations

George Indest HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued two proposed rules to reform the federal Stark Law (dealing with prohibited self-referrals) and Anti-Kickback Statute (AKS) (addressing giving or receiving any thing of value in exchange for a patient referral) regulations.

The long-awaited proposed rules aim to “modernize and clarify” federal laws relevant to value-based and patient coordinated care programs. The proposals would ease the compliance burden for healthcare providers across the industry while maintaining strong safeguards to protect patients and programs from fraud and abuse.

The Proposed Stark Rule.

The proposed rule that would further implement and clarify the Stark Law, “Modernizing and Clarifying the Physician Self-Referral” would, if finalized, create new exceptions to the existing Stark Law for value-based arrangements, according to CMS. These exceptions would apply broadly to care provided to all patients, not just Medicare beneficiaries, CMS said. The proposed rule also includes additional clarifications and guidance on key statutory terms and other technical compliance requirements.

For more info, click here to view the Stark proposed rule’s fact sheet issued by CMS.

The Proposed AKS Rule.

The proposed rule to further implement and clarify the AKS, “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” would make several changes to the AKS and beneficiary inducement provisions of the Civil Monetary Penalties Law (CMP). These changes would include the addition of several new AKS safe harbors for certain remuneration exchanged between or among eligible participants.

The new AKS safe harbors include care coordination arrangements aimed at improving quality and outcomes; value-based arrangements with substantial downside financial risk; and value-based arrangements with full financial risk, according to OIG.

Click here to view the fact sheet issued by CMS to learn more about the proposed rule.

To view the press release issued by the HHS in full, click here.

Contact Health Law Attorneys Experienced in Handling Stark Law and Anti-Kickback Statute Compliance.

If you are involved in referring or providing DHS, your arrangements must be reviewed for compliance with Stark and other anti-fraud laws. Violations of these laws can carry severe financial and criminal penalties. One of the best ways to avoid these sanctions is to have your current or potential arrangement reviewed by an attorney who is experienced in these matters.

The Health Law Firm routinely advises healthcare providers on Stark compliance issues for practitioners and providers of all types of DHS. We can advise you on the legality of a particular arrangement and can assist with remedying any perceived compliance issues. Our attorneys also represent providers in cases of medical billing fraud, overbilling, Medicare audits, ZPIC audits and RAC audits, False Claims Act cases, and whistleblower/qui tam cases throughout Florida and across the United States.

They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Kearbey, Amy. “CMS Publishes Proposed Amendments To Stark Law Advisory Opinion Regulations.” The National Law Review. (October 9, 2019). Web.

HHS Press Office. “HHS Proposes Stark Law and Anti-Kickback Statute Reforms to Support Value-Based and Coordinated Care.” HHS.gov, U.S. Department of Health & Human Services. (October 9, 2019). Web.

“CMS, OIG Release Long-Awaited Stark, AKS Proposed Rules.”AHLA. (October 9, 2019). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

By |2019-12-05T20:42:16-05:00December 5th, 2019|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Florida Pharmacist Gets More Than Six Years in Prison For Role in Compounding Fraud Scheme

Attorney George F. Indest IIIBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On November 29, 2018, a Florida pharmacist was sentenced to six and a half years in prison and ordered to pay $3.4 million, for her role in a scheme to defraud the government. Marjorie Robinson pled guilty one count of conspiracy to commit health care fraud for submitting fraudulent claims to Tricare, Medicare and private insurance programs for compounded creams that were not necessary.

The Fraud Scheme.

According to the U.S. Department of Justice (DOJ), Robinson was one of three owners of ASC Pharmacy Inc., a now defunct compounding pharmacy in Miami. Under her direction, the pharmacy made compounded creams that were made to maximize reimbursement from government and private insurance programs, not for patients needs, according to the plea deal. Click here to read the press release from the DOJ.

The other owners were charged separately and have also pled guilty.

This isn’t the first time a Florida pharmacy has defrauded government programs like Tricare, click here to read one of my prior blogs on a similar case.

Health Care Fraud Should Not Be Taken Lightly.

We have been consulted by many individuals, both before and after criminal charges were brought for fraud or related offenses. In many cases, those subject to Medicare and Medicaid fraud audits and investigations refuse to acknowledge the seriousness of the matter. Some may even decide not to spend the money required for a highly experienced health attorney to defend them.

Click here to read one of my previous blog posts regarding Medicare and Medicaid audits.

The government is serious about combating health care fraud. It created a Medicare Fraud Strike Force in March of 2007, in an effort to further prevent and eliminate fraud and abuse of government health care programs. False claims are a growing problem in the program, costing the government billions of dollars each year. Accordingly, punishments for defrauding the system can be quite severe.

If you are accused of Medicare or Medicaid fraud, realize that you are in a fight for your life. Your liberty, property/possessions and profession are all at stake. Often it is possible to settle allegations of fraud by agreeing to pay civil monetary penalties and fines. If given such an opportunity, the provider should consider whether it is worth the risk of facing decades in prison. Be prepared to give up whatever you need to in order to avoid a conviction and preserve your liberty.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now.

The attorneys of The Health Law Firm represent pharmacists and healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also defend pharmacists, physicians, pharmacies and medical groups in actions by Tricare, Medicare, Medicaid and private insurers to recoup overpayments, obtain civil fines and penalties and take other actions against them. They represent pharmacies and pharmacists in DEA actions and administrative (Order to Show Cause ) hearings, Medicare Fraud Control Unit (MFCU) investigations, and administrative and civil litigation, physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Sources:

Bolado, Carolina. “Fla. Pharmacist Gets 6½ Years For Bogus Claims For Creams.” Law360. (November 29, 2018). Web.

“South Florida pharmacist sentenced to more than six years in prison for role in $3.4 million compounding pharmacy scheme.” MD Linx. (November 30, 2018). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2018 The Health Law Firm. All rights reserved.

By |2018-12-26T19:49:51-05:00December 26th, 2018|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Two Nursing Home Co-Conspirators Sentenced in $19 Million Fraud Kickback Scheme

Attorney George F. Indest III HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On July 9, 2018, two co-conspirators in a $19.4 million healthcare fraud scheme involving a nursing home chain, American Senior Communities, were sentenced in Indiana federal court. Both pled guilty to various conspiracy and money laundering charges.

The Multi-Million Dollar Scheme.

Prosecutors allege that the men reached side deals with vendors who handled things like nurse call systems, food and medical supplies for the nursing home chain. According to the U.S. Department of Justice (DOJ), the kickback scheme generated nearly $19.4 million that the men spent on vacation homes, private planes, golf trips, Rolex watches, gold bullion and casino chips. Both were charged in 2016, along with two others for their roles in the same scheme. Read more about their involvement here.

The Sentencing.

The DOJ said Steven Ganote received a five-year sentence with two years of supervised release and was ordered to pay $7 million in restitution. Additionally, Joshua Burkhart was handed a four-month sentence with two years of supervised release and ordered to pay $420,000 in restitution. Each of the men is charged with one count of conspiracy to commit mail, wire and health care fraud, money laundering and conspiracy to violate the Anti-Kickback Statute (AKS).

To learn more about these types of illegal kickback schemes, click here to read one of my prior blogs on health care fraud.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues, Fraudulent Billing and Overbilling Now.

The attorneys of The Health Law Firm represent healthcare providers in cases of medical billing fraud, overbilling, Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

 

Sources:

Fowler, Haylay. “Nursing Home Schemer Sentenced In $19M Kickback Scheme.” Law360. (July 9, 2018). Web.

Kass, Dani. “Ex-Nursing Home Execs Indicted In $16M Kickback Scheme.” Law360. (October 12, 2016). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Medical billing fraud, fraudulent billing representation, fraudulent billing attorney, representation for overbilling, representation for submitting false claims, False Claims Act (FCA) violations, representation for submitting false claims, false claims lawyer, FCA defense attorney, Anti-Kickback Statute(AKS) violations, AKS representation, AKS attorney, representation for fraudulent reimbursement, representation for illegal kickback scheme illegal kickback scheme attorney, legal representation for health care professionals, health fraud defense lawyer, health law defense attorney, health law, The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 2018 The Health Law Firm. All rights reserved.

Florida Pharmacy Owner to Serve 15 Years in Prison for $100 Million Billing Fraud Scheme

George F. Indest III HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On April 26, 2018, the owner of several Florida pharmacies was sentenced to 15 years in prison and ordered to give up $54.5 million in restitution. Nicholas A. Borgesano Jr., owner of A to Z Pharmacies, pled guilty to his role in a $100 million scheme involving bogus insurance reimbursements for prescription drugs.

He pled guilty in November to charges of conspiracy to commit health care fraud and conspiracy to engage in monetary transactions in property derived from specified unlawful activity, according to the order. Click here to read more.

Health Care Billing Fraud Schemes. 

According to prosecutors, Borgesano was at the center of an alleged scheme in which the pharmacy owner used his six stores to peddle prescription compound medications. He would then submit fraudulent reimbursement claims to Medicare, Tricare and private insurance companies.

Borgesano and his co-conspirators are accused of manipulating billing codes in the reimbursement claims and submit claims for pharmaceutical ingredients they didn’t even have. Additionally, he used one of his pharmacies in Florida as the hub of operations and paid his co-conspirators through shell companies, checks and the purchase of assets, prosecutors said.

From the pharmacy owner and his group of conspirators, the U.S. Department of Justice (DOJ) has seized $7.6 million worth of property, including several luxury vehicles and a 50-foot racing boat, the DOJ said. To read more about the co-conspirators, click here to read the press release issued by the DOJ.

To read the judgement in full click here.

The expensive prescription medications and creams involved in this case have been targeted by prosecutors in a handful of other Florida suits alleging Medicare and Tricare fraud by pharmacy owners and others. Click here to read one of my prior blogs involving a similar case.


Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEADOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigationadministrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Greene, Kat. “Pharmacy Owner Gets 15 Years For Role In $100M Scheme.” Law360. (April 27, 2018). Web.

Manning, Margie. “New Port Richey pharmacy owner sentenced in $100 million fraud scheme.” Tampa Bay Business Journal. (April 26, 2018). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: False Claims Act defense attorneyFCA legal counselFCA defense lawyer, Anti-Kickback Statute (AKSdefense attorneyFCA representation, legal representation for allegations of violating Anti-Kickback StatuteAKS representation, TRICARE false claims legal defense attorney, TRICARE physician representation, legal representation violating False Claims Act, pharmaceutical fraud lawyer, compounding pharmacy attorney, fraudulent practices of pharmaceutical companies, FCA violations attorneyhealth care fraud representation, TRICARE fraud attorneyhealth law defense attorneyhealth care fraud defense attorney, The Health Law Firm, representation for health care fraud investigations, compounding pharmacy lawyer, prescription reimbursement representation, pharmacy defense attorneypharmacist defense lawter, representation for pharmacies, representation for pharmacistslegal representation for health care facilities, representation for health care professionals, legal defense of TRICARE providers, U.S. Department of Justice (DOJ) investigation representation, DOJ defense attorney, representation for DOJ matters, attorney reviews of The Health Law Firm, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2018 The Health Law Firm. All rights reserved.